Document:

EXHIBIT 10.1

THE
SECURITIES EVIDENCED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933 AND HAVE BEEN TAKEN FOR INVESTMENT PURPOSES ONLY AND NOT
WITH A VIEW TO THE DISTRIBUTION THEREOF, AND SUCH SECURITIES MAY NOT BE SOLD OR
TRANSFERRED UNLESS THERE IS AN EFFECTIVE REGISTRATION STATEMENT UNDER SUCH ACT
COVERING SUCH SECURITIES, OR SUPERGEN, INC. (THE “COMPANY”) RECEIVES AN OPINION
OF COUNSEL (WHICH MAY BE COUNSEL FOR THE COMPANY) STATING THAT SUCH SALE OR
TRANSFER IS EXEMPT FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS
OF SUCH ACT.

 

	
  June 24, 2003

  	
   

  	
  Right to Purchase 188,294

  
	
  Void After June 23,
  2007

  	
   

  	
  Shares of Common Stock

  

 

 

SUPERGEN,
INC.

WARRANT

THIS CERTIFIES THAT, subject to the terms of this agreement, PAUL REVERE,
LLC, (the “Holder”) is entitled to subscribe for and purchase from
SuperGen, Inc, a Delaware corporation (the “Company”), at the Warrant
Price defined in Section 2 herein, 188,294 fully paid and non-assessable
shares of the Company’s Common Stock (the “Common Stock”), such price and such number
of shares being subject to adjustment upon occurrence of the contingencies set
forth in this Warrant.

This Warrant is issued in connection with the issuance of certain
Senior Convertible Notes by the Company pursuant to a Securities Purchase
Agreement dated June 24, 2003 between the Company and the purchaser(s) named
therein (the “Purchase Agreement”).

Upon delivery of this Warrant (with the Notice of Exercise in the form
attached hereto as Exhibit A), together with payment of
the Warrant Price of the shares of Common Stock thereby purchased, at the
principal office of the Company or at such other office or agency as the
Company may designate by notice in writing to the holder hereof, the holder of
this Warrant shall be entitled to receive a certificate or certificates for the
shares of Common Stock so purchased. 
All shares of Common Stock which may be issued upon the exercise of this
Warrant will, upon issuance, be fully paid and non-assessable and free from all
taxes, liens and charges with respect thereto.

This Warrant is
subject to the following terms and conditions:

1.             Term of Warrant.

This Warrant may be
exercised in whole or in part, at any time, and from time to time, after
issuance and prior to the first to occur of the following:

 

(a)           5:00
p.m., Pacific Standard Time, June 23, 2007; or

(b)           The
consummation of any transaction or series of transactions (collectively, the “Transaction”),
including without limitation, the sale, transfer or disposition of all or
substantially all of the Company’s assets or the merger of the Company with or
into, or consolidation with, any other corporation, whereby the holders of the
Company’s voting securities prior to the Transaction do not hold more than 50%
of the voting securities of the surviving entity following consummation of the
Transaction (a “Change of Control”).

2.             Warrant
Price.  The exercise price of this
Warrant (the “Warrant Price”) shall equal $6.00 per share.

3.             Adjustment
of Purchase Price and Number of Shares; Limitation on Exercise.

The number and kind of
securities purchasable upon the exercise of this Warrant and the Warrant Price
shall be subject to adjustment from time to time in accordance with the
following provisions:

(a)           Reclassification,
Consolidation or Merger.  In case of
any reclassification or change of outstanding securities of the class issuable
upon exercise of this Warrant (other than as a result of a subdivision or
combination), or in case of any consolidation or merger of the Company with or
into another corporation (other than a Change of Control as provided in
Section 1(b) hereof), the Company, or such successor corporation, as the
case may be, shall execute a new Warrant, providing that the holder of this
Warrant shall have the right to exercise such new Warrant and procure upon such
exercise in lieu of each share of Common Stock theretofore issuable upon
exercise of this Warrant the kind and amount of shares of stock, other
securities, money and property receivable upon such reclassification, change,
consolidation or merger by a holder of one share of Common Stock.  Such new Warrant shall provide for
adjustments which shall be as nearly equivalent as may be practicable to the
adjustments provided for in this Section 3.  The provisions of this subsection (a) shall similarly apply
to successive reclassifications, changes, consolidations and mergers.

(b)           Subdivision
or Combination of Shares.  If at any
time on or after the date of this Warrant the Company shall subdivide its
outstanding shares of Common Stock into a greater number of shares, or shall
pay a dividend with respect to its outstanding shares of Common Stock in shares
of Common Stock, the Warrant Price in effect immediately prior to such
subdivision shall be proportionately reduced and the number of shares
receivable upon exercise of the Warrant shall be proportionately increased;
and, conversely, if at any time on or after the date of this Warrant the
outstanding number of shares of Common Stock shall be combined into a smaller
number of shares, the Warrant Price in effect immediately prior to such
combination shall be proportionately increased and the number of shares
receivable upon exercise of the Warrant shall be proportionately decreased.

(c)           Adjustment
of Number of Shares.  Upon each
adjustment in the Warrant Price, the number of Shares of Common Stock
purchasable hereunder shall be adjusted, to the nearest whole share, to the
product obtained by multiplying the number of Shares purchasable immediately
prior to such adjustment in the Warrant Price by a fraction, the numerator of
which 

 

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shall be
the Warrant Price immediately prior to such adjustment and the denominator of
which shall be the Warrant Price immediately thereafter.

4.             Notices.

(a)           Upon
any adjustment of the Warrant Price and increase or decrease in the number of
shares of Common Stock purchasable upon the exercise of this Warrant, then, and
in each such case, the Company, within thirty (30) days thereafter, shall give
written notice thereof to the registered Holder of this Warrant (the “Notice”).  The Notice shall be mailed to the address of
such holder as shown on the books of the Company, and shall state the Warrant
Price as adjusted and the increased or decreased number of shares purchasable
upon the exercise of this Warrant, setting forth in reasonable detail the
method of calculation of each.

(b)           The
Company shall send to the Holder at least twenty (20) days’ prior written
notice of the date when any change of control of which the Company has
knowledge shall take place.

(c)           Each
such written notice shall be given by first class mail, postage prepaid,
addressed to the Holder at the address as shown on the books of the Company for
the Holder.

5.             Investment
Letter.  Upon exercise or conversion
of this Warrant in accordance with the provisions hereof, if the Common Stock
issuable upon exercise of this Warrant is not registered as contemplated by
Section 6 below, the Holder shall either (i) execute and deliver to the Company
an investment letter in the form attached to the Notice of Exercise on Exhibit
A, or (ii) deliver to the Company an opinion of counsel for the Holder
reasonably satisfactory to the Company, stating that such exercise or
conversion is exempt from the registration and prospectus delivery requirements
of the Securities Act of 1933, as amended (the “Securities Act”).

6.             Registration
Rights.  The Company shall include
the shares of Common Stock issued or issuable upon the exercise of this Warrant
in the S-3 Registration Statement that the Company shall file pursuant to that
certain Registration Rights Agreement dated June 24, 2003.

7.             Restrictions
on Transfer.  Certificates
representing any of the Common Stock acquired pursuant to the provisions of
this Warrant shall have endorsed thereon legends substantially in the following
form, as appropriate.

Unless such shares of Common Stock are registered under the Securities
Act and qualified (if necessary) under applicable state securities laws:

(a)           “THE SHARES REPRESENTED BY THIS
CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND HAVE NOT BEEN REGISTERED
UNDER THE SECURITIES ACT OF 1933.  SUCH
SHARES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION
UNLESS THE COMPANY RECEIVES AN OPINION OF COUNSEL REASONABLY ACCEPTABLE TO IT
STATING THAT SUCH SALE OR TRANSFER IS EXEMPT FROM THE REGISTRATION AND
PROSPECTUS DELIVERY REQUIREMENTS OF SAID ACT.”

 

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(b)           Any
legend required to be placed thereon by any applicable state securities laws.

8.             Compliance
with Act.  The Holder, by acceptance
hereof, agrees that this Warrant and the Common Stock to be issued upon the
exercise or conversion hereof are being acquired solely for its own account and
not as a nominee for any other party and not with a view toward the resale or
distribution thereof and that it will not offer, sell or otherwise dispose of
this War­rant or any of the Common Stock to be issued upon the exercise or
conversion hereof except in accordance herewith and under circumstances which
will not result in a violation of the Securi­ties Act or of applicable state
securities laws.

9.             Miscellaneous.

(a)           The
terms of this Warrant shall be binding upon and shall inure to the benefit of
any successors or assigns of the Company and of the holder or holders hereof
and of the Common Stock issued or issuable upon the exercise hereof.

(b)           No
holder of this Warrant, as such, shall be entitled to vote or receive dividends
or be deemed to be a stockholder of the Company for any purpose, nor shall
anything contained in this Warrant be construed to confer upon the holder of
this Warrant, as such, any rights of a stockholder of the Company or any right
to vote, give or withhold consent to any corporate action, receive notice of
meetings, receive dividends or subscription rights, or otherwise.

(c)           Receipt
of this Warrant by the holder hereof shall constitute acceptance of and
agreement to the foregoing terms and conditions.

(d)           The
Company will not, by amendment of its Restated Certificate of Incorporation or
through any other means, avoid or seek to avoid the observance or performance
of any of the terms of this Warrant, but will at all times in good faith assist
in the carrying out of all such terms and in the taking of all such action as
may be necessary or appropriate in order to protect the rights of the holder of
this Warrant against impairment.

(e)           Upon
receipt of evidence reasonably satisfactory to the Company of the loss, theft,
destruction or mutilation of this Warrant and, in the case of any such loss,
theft or distribution, upon delivery of an indemnity agreement reasonably
satisfactory in form and amount to the Company or, in the case of any such
mutilation, upon surrender and cancellation of such Warrant, the Company at its
expense will execute and deliver, in lieu thereof, a new Warrant of like date
and tenor.

(f)            This
Warrant shall be nontransferable, other than pursuant to (i) a transfer not
involving a change in beneficial ownership, (ii) a distribution without
consideration of the Warrant by the Holder to any of its partners, or retired
partners, or to the estate of any of its partners or retired partners, or if
the Holder is a limited liability company, to any of its members, former
members, or to the estate of any of its members or former members, (iii) any
transfer by any Holder to (A) any individual or entity controlled by,
controlling, or under common control with, such Holder or (B) any individual or
entity with respect to which such Holder (or any 

 

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person
controlled by, controlling, or under common control with, such Holder) has the
power to direct investment decisions, and (iv) a transfer exempt from
registration under the Securities Act, upon the Company’s receipt of an opinion
of counsel (which may be counsel for the Company) satisfactory to the Company
stating that such transfer is exempt from the registration and prospectus
delivery requirements of the federal securities laws.

(g)           This
Warrant or any provision of this Warrant may be amended, waived, discharged or
terminated by a statement in writing signed by the Company and the Holder, and
in the event of any permitted transfer(s) of this Warrant, by the Company and
the Holder and transferee(s) representing at least fifty percent (50%) of the
Common Stock issuable upon exercise of the Warrant.

(h)           This
Warrant shall be governed by the laws of the State of Delaware.

[Signature
Page Follows]

 

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IN WITNESS WHEREOF, the Company has caused this Warrant to be signed by
its duly authorized officer.

Dated: June 24, 2003

 

	
   

  	
  SUPERGEN,
  INC.

  
	
   

  	
   

  
	
   

  	
  /s/ DR. JOSEPH RUBINFELD

  
	
   

  	
  Dr.
  Joseph Rubinfeld

  
	
   

  	
  President
  and Chief Executive Officer

  
	
   

  	
   

  

 

 

6

 

EXHIBIT A

NOTICE OF EXERCISE

TO:         SuperGen, Inc.

1.             The undersigned
hereby elects to purchase ___________ shares of the Common Stock of SUPERGEN,
INC. pursuant to the terms of the attached Warrant, and tenders herewith
payment of the purchase price of such shares in full, together with all
applicable transfer taxes, if any.

2.             Please issue a
certificate or certificates representing said shares of Common Stock in the
name of the undersigned or in such other name as is specified below:

 

 

	
   

  	
   

  	
   

  
	
   

  	
  (Name)

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  (Address)

  	
   

  

 

3.             The undersigned
represents that the aforesaid shares of Common Stock are being acquired for the
account of the undersigned for investment and not with a view to, or for resale
in connection with, the distribution thereof and that the undersigned has no
present intention of distributing or reselling such shares.  In support thereof, the undersigned has
executed the Invest­ment Representation Statement attached hereto as
Exhibit A.

 

	
   

  	
  Signature
  of Holder

  
	
   

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:

  	
   

  

 

 

EXHIBIT A TO NOTICE OF EXERCISE

SUPERGEN, INC.

WARRANT EXERCISE

INVESTMENT REPRESENTATION STATEMENT

 

	
  PURCHASER

  	
  :

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  COMPANY

  	
  :

  	
  SuperGen, Inc.

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SECURITY

  	
  :

  	
  Common Stock

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NUMBER OF SHARES

  	
  :

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  DATE

  	
  :

  	
   

  	
  ,

  	
   

  	
   

  

In connection with the
purchase of the above-listed Securities, I, the Purchaser, represent to the
Company the following:

(a)           I am an accredited
investor within the meaning of Rule 501 under the Securities Act of 1933,
as amended (the “Securities Act”) and have such knowledge and experience in
financial and business matters that I am capable of evaluating the merits and
risks of the purchase of the Securities.

(b)           I am aware of the
Company’s business affairs and financial condition, and have acquired
sufficient information about the Company to reach an informed and knowledgeable
decision to acquire the Securities.  In
making my decision to acquire the Securities, I am not relying on representations
of any officer, director, stockholder or agent of the Company.  I am purchasing these Securities for my own
account for investment purposes only and not with a view to, or for the resale
in connection with, any “distribution” thereof for purposes of the Securities
Act.

(c)           I understand that
the Securities have not been registered under the Securities Act in reliance
upon a specific exemption therefrom, and that reliance by the Company on such
an exemption is predicated in part on the representations set forth in this
letter.

(d)           I further understand
that the Securities must be held indefinitely unless subse­quently registered
under the Securities Act or unless an exemption from registration is otherwise
available.  In addition, I understand
that the certificate evidencing the Securities will be imprinted with a legend
which prohibits the transfer of the Securities unless they are registered or
such registration is not required in the opinion of counsel for the Purchaser
satisfactory to the Company or unless the Company receives a no-action letter
from the Securities and Exchange Commission.

(e)           I am familiar with
the provisions of Rule 144, promulgated under the Securities Act, which,
in substance, permits limited public resale of “restricted securities”
acquired, directly or indirectly, from the issuer thereof (or from an affiliate
of such issuer), in a non-public offering subject to the satisfaction of
certain conditions, including, among other things:  (1) the resale 

 

 

occurring not less than one year after the later of
the date the securities were sold by the Company or the date they were sold by
an affiliate of the Company, within the meaning of Rule 144; and, in the
case of an affiliate, or of a non-affiliate who has held the securities less
than two years, (2) the availability of certain public information about
the Company, (3) the sale being made through a broker in an unsolicited
“broker’s transaction” or in transactions directly with a market maker (as said
term is defined under the Securities Exchange Act of 1934), and (4) the amount
of securities being sold during any three month period not exceeding the
specified limitations stated therein, if applicable.

(f)            I further
understand that at the time I wish to sell the Securities there may be no
public market upon which to make such a sale, and that, even if such a public
market exists, the Company may not be satisfying the current public information
requirements of Rule 144, and that, in such event, I would be precluded
from selling the Securities under Rule 144 even if the one-year minimum
holding period had been satisfied.

(g)           I further understand
that in the event all of the applicable requirements of Rule 144 are not
satisfied, registration under the Securities Act, compliance with
Regulation A, or some other registration exemption will be required; and
that, notwithstanding the fact that Rule 144 is not exclusive, the Staff
of the SEC has expressed its opinion that persons proposing to sell private
placement securities other than in a registered offering and otherwise than
pursuant to Rule 144 will have a substantial burden of proof in
establishing that an exemption from regis­tration is available for such offers
or sales, and that such persons and their respective brokers who participate in
such transactions do so at their own risk.

 

	
   

  	
  Signature
  of Purchaser

  
	
   

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:EXHIBIT
10.2

[* * *] REDACTED
CONFIDENTIAL TREATMENT REQUESTED

 

DRUG
SUBSTANCE VALIDATION

AND
SUPPLY AGREEMENT

This DRUG SUBSTANCE
VALIDATION AND SUPPLY AGREEMENT (this “Agreement”) is
effective as of July 2, 2003 (the “Effective Date”) by and between *** (“***”),
a Delaware corporation located at ***, and SUPERGEN, INC. (“SuperGen”),
a Delaware corporation located at 4140 Dublin Road, Suite 200,
Dublin, CA 94568 (each of *** and SuperGen, is referred to below as a “Party”
and together as the “Parties”).

WHEREAS, *** has
expertise and experience in conducting development related to the synthesis of
active pharmaceutical ingredients and has a research development laboratory,
pilot plant and commercial scale facilities to manufacture such products, and
*** is interested in providing such research, development and manufacturing services
to SuperGen;

WHEREAS, SuperGen has a
commercial interest in the manufacture of the drug substance Decitabine
(hereinafter the “Product” as defined in more detail in Exhibit A
hereto) and wishes to use the services of *** in a phased development program
whereby *** will confirm, adapt and validate certain technology to enable the
commercial manufacture of the Product; and

WHEREAS, *** and SuperGen
desire to enter into a relationship for such development, manufacture, and
supply of the Product according to the terms and conditions of this Agreement.

NOW, THEREFORE, in
consideration of the above and of the mutual covenants contained herein and for
other good and valuable consideration, receipt of which are hereby
acknowledged, the Parties agree as follows:

Article 1 - Definitions

1.1                               Definitions.  Exhibit A
sets forth the definitions of certain terms used in this Agreement.  Those terms shall have the meanings set
forth on Exhibit A where used in this Agreement and identified with
initial capital letters.

1.2                               Construction.  For purposes
of this Agreement, except where the context otherwise requires:

(A)                              All currency amounts stated in this
Agreement are in United States Dollars.

(B)                                References to “days” mean calendar
days.  (If, however, an action or obligation
is due to be undertaken by or on a day other than a business day, i.e., a
Saturday, Sunday, or public holiday, in the United States, then that action or
obligation will be deemed to be due on the next following business day.)

 

(C)                                When introducing a series of items, the
term “including” is not intended to limit the more general description that
precedes the items listed.

Article 2 - Development Program

2.1                               Program Scope.  *** will use
commercially reasonable efforts to carry out the Development Program attached
hereto as Exhibit B on the terms and conditions set forth therein
and in this Agreement.  The Development
Program includes the terms and conditions by which *** shall:

2.1.1                     Develop and confirm the existing
Manufacturing Process, including equipment and cleaning verification, stability
testing, process validation, and material and package testing;

2.1.2                     Establish the Specifications and
Validated Analytical Test Procedures for Materials, manufacturing, packaging
and release of the Product;

2.1.3                     Manufacture *** engineering demonstration
run and *** stability/validation batches of Product at an appropriate
regulatory scale;

2.1.4                     Prepare Documentation for use in support
of SuperGen’s Regulatory Filings; and

2.1.5                     Provide SuperGen with Deliverables as
further described in the Development Program.

In addition, *** will
provide SuperGen with all Documentation (including regulatory documentation)
and Deliverables as further described in the Development Program.  *** will use reasonable commercial efforts
to complete the Development Program, including each Development Phase and the
delivery of all Deliverables to SuperGen, in accordance with the program
schedule set forth in the Development Program.

2.2                               Development Program Costs and Payments. 
*** will use commercially reasonable efforts to conduct all activities
under the Development Program on a phase-by-phase basis, and perform each
Milestone, Deliverable, and Development Phase in accordance with the terms and
conditions herein and the Development Program. 
SuperGen will pay *** an aggregate fee for performance of the
Development Program equal to:

2.2.1                     A non-refundable, fully creditable “Project
Initiation Fee” of $*** plus

2.2.2                     Milestone Payments as outlined in Exhibit B
(the “Estimated Cost”) (subject to prior approval and adjustment as
provided in Section 6.2 and this Section 2.2 below).

SuperGen will pay *** the
Project Initiation Fee within thirty (30) days of the Effective Date.  The Project Initiation Fee will be applied
to the initial Development Phases approved by SuperGen in the form of a
Purchase Order.  Before starting work on
each Development Phase of the Development Program, *** will request SuperGen’s
prior written authorization of such work in the form of a Purchase Order and
will not begin, or be required to begin, such Development Phase until it has
received such written authorization from SuperGen.  SuperGen will have the right, in its discretion, to modify,
postpone or cancel any Development Phase, or part thereof, without charge or
penalty 

 

2

 

upon written notice to
***; provided that if, after work on a particular Development Phase has begun,
SuperGen: (i) cancels such Development Phase, SuperGen will reimburse ***
for actual, reasonable out-of-pocket expenses incurred by *** that are directly
allocated to that Development Phase to the extent such obligations cannot
reasonably be mitigated; or (ii) desires modifications to such Development
Phase which results in significant increases in the costs therefor, in which
case the payments for such Development Phase hereunder shall be equitably
adjusted to account for such modifications in the Development Phase.

Article 3 - Manufacturing and Processing
Activities

3.1                               Quality Systems Agreement.  Promptly
after the Effective Date, the Parties will negotiate and execute a “Quality
Systems Agreement” specifying the testing, storage, release, cGMP,
regulatory and other quality assurance requirements relating to manufacture and
shipment of Product by *** under this Agreement.  Upon execution, the Quality Systems Agreement shall be deemed
incorporated into this Agreement by this reference.  In the event that any term or condition set forth in this
Agreement conflicts with any term or condition set forth in the Quality Systems
Agreement, the terms and conditions of this Agreement shall govern.

3.2                               Manufacturing Site.  *** will
manufacture all Product to be supplied to SuperGen under this Agreement solely
at ***’s manufacturing facility in *** (the “Manufacturing Facility”).  *** will not commence any manufacture of
Product for commercial distribution until successful process validation is
completed pursuant to terms of this Agreement. 
*** may change the Manufacturing Facility, upon prior written notice and
approval by SuperGen, if Product can be manufactured at the new site in
accordance with all pertinent Regulatory Requirements, cGMPs, the
Specifications and the Quality Systems Agreement, and delivered in accordance
with ***’s delivery obligations under this Agreement.  *** will be responsible for all scheduling related to the
Manufacturing Facility and for the operation of such facility.

3.3                               Supply of Materials.  *** will be
solely responsible for procuring and supplying all Materials required under the
Development Program and as necessary to meet its Product supply obligations
pursuant to Article 4, at its expense. 
*** warrants that all such Materials meet all applicable Specifications.

3.4                               Process Data and Information.  For purposes
of this Agreement, any information, documentation and data relating to product
safety, stability, all analytical support methods, manufacturing processes and
methods, drug substance stability data, impurity profiles, reference standards
and the like associated with the Product or its manufacture that SuperGen
provides or has previously provided to ***, or which was received from
Pharmachemie B.V., is called the “Product Information” and shall be
deemed the Confidential Information (as defined below) of SuperGen.  If *** requests additional Product Information
that SuperGen owns or controls reasonably necessary for *** to complete its
obligations under this Agreement, SuperGen will provide *** with such information
in a timely fashion.  For the avoidance
of doubt, all of the Product Information, whether provided to *** before or
during the Term, is and shall remain SuperGen’s property, and SuperGen retains
all right and title to such Product Information.

 

3

 

3.5                               SuperGen’s Assistance.  To assist
*** in its performance of this Agreement, SuperGen will:

3.5.1                     Provide *** in a timely manner upon
request with all reasonably relevant information, documentation and data
necessary or appropriate for ***’s performance of its obligations under this
Agreement, including Product Information, documentation and data relating to
product safety, stability, analytical support methods, drug substance stability
data, impurity profiles, reference standards and the like for the Product, to
the extent such items are in SuperGen’s possession or control;

3.5.2                     Ensure that all materials supplied to ***
by or on behalf of SuperGen pursuant to the Development Program (as may be set
forth in Exhibit B) are suitable for use as contemplated under this
Agreement, comply with all applicable laws and regulations (including those
relating to the import of such materials) and have received all required
governmental and regulatory approvals for use hereunder, including customs and
FDA approvals; and

3.5.3                     Provide *** with all information in
SuperGen’s possession or control concerning any health hazards or potential
health hazards associated with exposure to or the handling, storage, use or
disposal of Product, including a Material Safety Data Sheet for Product.  (If any such information is updated or
corrected, SuperGen will promptly notify *** of that fact and provide *** with
the updated or corrected information.)

3.6                               Subcontractors.  *** may, subject
to SuperGen’s prior written approval, use subcontractors to perform any part of
this Agreement, provided that such subcontractors are bound by a
confidentiality agreement with *** that protects the Confidential Information
of SuperGen on terms and conditions at least as protective as those set forth
in Sections 11.3 – 11.6 and meet such other quality standards as may be
imposed on *** under this Agreement.

3.7                               Hazards.  *** will inform its
employees, contractors and other personnel of any known or reasonably
ascertainable chemical hazards associated with the Materials, Product, or any
Wastes generated through performance of the manufacturing and processing activities
hereunder, and provide such persons with required training in the proper
methods of handling and disposing of such items.

3.8                               Handling of Materials; Notification. 
*** will handle, accumulate, label, package, store, transport and
dispose of all Wastes generated through performance of the manufacturing and
processing activities hereunder in accordance with all Regulatory Requirements.  *** will promptly notify SuperGen in writing
of any unauthorized reportable release or emission of any Wastes generated
through performance of the manufacturing and processing activities hereunder
and any potential environmental violation or litigation related thereto.  To the extent required by Law, each Party
will promptly notify the other of any health hazards or potential health
hazards of which it or they are or become aware of concerning exposure to or handling
of the Materials or Wastes.  In any of
the foregoing instances, *** will promptly inform SuperGen of any remedial
actions required by Law and will promptly undertake such actions.

 

4

 

3.9                               Changes.  *** will not make any changes
to Materials (or suppliers thereof), formulations, processes, equipment,
facilities, Specifications, tests or any other item in any manner that would
affect the manufacturing or processing activities to be performed by *** under
this Agreement, or affects any Regulatory Filing, without SuperGen’s prior
written approval.  SuperGen shall have
the right to modify the Specifications from time to time upon reasonable
advance written notice to *** if such modifications are required or recommended
by a Regulatory Authority or necessary to comply with Regulatory Requirements
or otherwise, by mutual agreement of the Parties.  All such modifications shall be in writing and shall be signed by
an authorized representative of SuperGen and ***, and shall be effective for
all orders placed after such notice.  If
such modifications result in a change in ***’s manufacturing costs, the Parties
shall agree upon an appropriate adjustment to the price of the Product
hereunder; and if such modifications result in a delay in delivery, the Parties
shall negotiate a reasonable extension of the affected lead times.

Article 4 - Supply of Product

4.1                               Exclusivity During Clinical Trials. 
During the course of clinical trials covering the Product conducted
prior to SuperGen’s first filing of a NDA for the Product, SuperGen will
purchase from *** *** (***%) of its Product requirements necessary to support
such clinical development on the terms and conditions described in Exhibit C.

4.2                               Commercialization.  If, after
the filing of a NDA for the Product, SuperGen elects to proceed with commercial
marketing of the Product, either alone or through an Affiliate, agent, licensee
or commercial partner (each a “Designee”), then SuperGen and/or its
Designee will purchase at least *** (***%) of SuperGen’s and its Designee’s
requirements for Products from *** for suchcommercial marketing.

4.3                               Supply Obligation.  *** will
supply to SuperGen quantities of Product ordered by SuperGen or its Designee in
accordance with the terms and conditions of this Agreement and Exhibit C.

4.4                               Terms of Sale.  All purchases
and sales of Product pursuant to Sections 4.1 and 4.2 above will be made
on the terms and conditions set forth herein and on Exhibit C, as
applicable.

4.5                               Exclusivity.  If SuperGen
and its Designees purchase from *** the quantities of Product specified in
Sections 4.1 and 4.2, then for the Term and for a period of *** (***)
years thereafter (the “Exclusivity Period”), neither *** nor any Affiliate,
will engage in any activity directed at the development, manufacture, supply,
or commercialization of the Product, or use any information, know-how,
technology, equipment or other materials received from SuperGen hereunder, for
itself or any Third Party.  Without
limiting the foregoing, during the Exclusivity Period, *** and its Affiliates
shall not:  (i) manufacture, sell
or otherwise distribute Product, (ii) assist any Third Party to
manufacture, sell or otherwise distribute Product, or (iii) otherwise
perform any research activities with respect to the Product, in each case
except at the direction of SuperGen.

4.6                               No Additional Restrictions.  Nothing in
this Agreement will restrict either Party in any way with respect to any
product other than the Product except as expressly stated in this
Article 4.

 

5

 

Article 5 - Intellectual Property

5.1                               SuperGen Materials.  Subject to
Sections 5.3 and 5.4 below, SuperGen will own all Deliverables, as well as
all information, data, documents, processes, protocols, methods, assays,
techniques, operating procedures and materials created or compiled by *** in
the course of performing its obligations under this Agreement, including all
Product, Documentation, records, reports, documents, data and other tangible
materials that *** provides to SuperGen under the Development Program, any and
all modifications, additions or improvements to the Product Information created
or compiled by *** in the course of performing its obligations under this
Agreement, and all intellectual property rights embodied therein (collectively,
the “SuperGen Materials”).  ***
will assign (or cause to be assigned) and does hereby assign fully to SuperGen
all right, title and interest in and to the SuperGen Materials and all
intellectual property rights therein. 
*** will assist SuperGen, or its designee, at SuperGen’s expense, in
every proper way to secure SuperGen’s rights in the SuperGen Materials and any
patent rights relating thereto in any and all countries, including the
disclosure to SuperGen of all pertinent information and data with respect
thereto, the execution of all applications, specifications, oaths, assignments
and all other instruments that SuperGen deems necessary in order to apply for
and obtain such rights and in order to assign and convey to SuperGen, its
successors, assigns and nominees the sole and exclusive right, title and
interest in and to such SuperGen Materials, and any intellectual property
rights therein.  *** will execute or
cause to be executed, when it is in ***’s power to do so, any such instrument
or papers necessary to carry out the provisions of this Section 5.1.  The provisions of this Section 5.1 will
continue after the termination of this Agreement.

5.2                               Reporting/Transfer of Results.  During the
Development Program, *** will regularly provide SuperGen, at ***’s expense,
with written reports of development results, which have been developed,
compiled or learned during the course of the Development Program as outlined in
Exhibit B.  Further, as
provided in Exhibit B, *** will also respond to SuperGen’s
reasonable inquiries, at ***’s expense, regarding the status of the Development
Program on an ongoing basis, and *** will endeavor to keep SuperGen reasonably
informed of interim results on an informal basis, including, if requested,
periodic meetings at ***’s facility to discuss Development Program results and
progress.  In addition at SuperGen’s
option and request, *** will package and ship to SuperGen, pursuant to SuperGen’s
instructions and at SuperGen’s expense with SuperGen bearing all packaging,
shipping and insurance charges (title and risk of loss passing to SuperGen upon
delivery to the common carrier) batches of Product prepared during the Development
Program as outlined in the Exhibit B and in Section 2.1
above.  Such deliveries will be made FOB
***’s facility in ***.  *** will retain
representative samples from each batch of Product for record keeping, stability
testing and other regulatory purposes in accordance with the Specifications and
Regulatory Requirements.

5.3                               *** Background Property.  SuperGen
acknowledges that *** possesses certain inventions, processes, know-how, trade
secrets, improvements, other intellectual properties and other assets,
including procedures and techniques, computer technical expertise, software,
and certain technical expertise and conceptual expertise in the area of drug
substance processing and manufacturing, as well as improvements to the
foregoing, that have been independently developed by *** prior to the Effective
Date without the benefit of any Product Information, SuperGen Materials or
other information provided by SuperGen (collectively, the “*** Background
Property”).  All *** Background
Property (and improvements to such *** Background Property) that is used,
improved, 

 

6

 

modified, or developed by *** under or during the Term will be and remain the
sole and exclusive property of ***.  ***
hereby grants SuperGen a non-exclusive, perpetual, ***, worldwide license, with
the right to grant and authorize sublicenses, under the *** Background
Property, solely as necessary or useful to develop, make, have made, use, sell,
have sold, import and export the Product.

5.4                               Ownership and Rights to Inventions and
Technology.  All inventions, technology and
information (other than those described in Sections 5.1 and 5.3 above),
whether or not patentable, that are conceived, reduced to practice or created
solely by *** and/or its agents during the performance of ***’s obligations under
this Agreement:

(A)                              will be and remain the exclusive property
of SuperGen, as and to the extent exclusively related to the Product,
Deliverables, Documentation, Product Information, or SuperGen Materials (the “SuperGen
Inventions”); and

(B)                                will be and remain the exclusive property
by ***, if the same are not included in clause (A) above (the “*** Inventions”).

All inventions, technology
and information (other than those described in Sections 5.1 and 5.3
above), whether or not patentable, that are conceived, reduced to practice or
created jointly by *** and SuperGen (“Joint Inventions”) will, subject
to the provisions of this Section 5.4 below, be jointly owned by *** and
SuperGen and each Party will have the full right to exploit such Joint Inventions
for any and all purposes without any obligation to the other Party.

Each Party will be
responsible, at its expense, for the filing, prosecution and maintenance for
patents and patent applications claiming its respective solely-owned Inventions
(i.e., SuperGen for the SuperGen Inventions and *** for the ***
Inventions).  SuperGen shall have the
first right to pursue patent protection for Joint Inventions and *** agrees to
take reasonable actions to cooperate with SuperGen in this regard.  SuperGen will notify *** before pursuing any
such patent application and *** will have a reasonable period, not greater than
thirty (30) days to advise SuperGen in writing whether *** intends to
participate in the prosecution of such patent application.  If *** so elects to participate in such
prosecution, then *** will reimburse SuperGen for one-half (1⁄2) of
SuperGen’s out-of-pocket expenses in connection with such activities as they
are incurred.  If *** so elects not to
participate in such prosecution, then *** will not be responsible for any costs
under this Section 5.4 related to such prosecution, in which case all
right, title and interest thereto shall be owned by SuperGen (subject to the
rights granted to *** under this Agreement, if applicable) and the same shall thereafter
not be a Joint Invention for purposes of this Agreement.  If SuperGen fails or declines to take such
actions with respect to any Joint Inventions in accordance with this
Section 5.4, then *** shall have the right to file, prosecute and maintain
such Patents at its sole expense, in which case all right, title and interest
in and to such Patents shall be owned by *** (subject to the rights granted to
SuperGen under this Agreement, if applicable) and the same shall thereafter not
be a Joint Invention for purposes of this Agreement.  If SuperGen notifies *** that it will bear all of the costs and
expenses associated with the filing, prosecution and maintenance of a Patent
claiming a Joint Invention, then, *** will grant to SuperGen an exclusive, perpetual, ***, worldwide
license, with the right to grant and authorize sublicenses, under such Patent,
solely as necessary or useful to develop, make, have made, use, sell, have
sold, import and export the Product.

 

7

 

SuperGen hereby grants to
*** a non-exclusive, ***, worldwide right and license under the SuperGen
Inventions to manufacture and sell the Product to SuperGen. 
Likewise, *** hereby grants to SuperGen a non-exclusive, perpetual,
***, worldwide license, with the right to grant and authorize sublicenses,
under the *** Inventions, solely as necessary or useful to develop, make, have
made, use, sell, have sold, import and export the Product.

Article 6 - Payments

6.1                               Development Program Payments.  SuperGen will
pay *** the Project Initiation Fee and the Milestone payments as provided in
Section 2.2.

6.2                               Adjustments.  If during
the course of performing a given Development Phase, *** determines that either
the actual manpower and other costs for the tasks set forth on Exhibit B
will be greater than the amount authorized in the Purchase Order issued by
SuperGen with respect to that Development Phase, or that additional tasks not
contemplated on Exhibit B will be required in order to complete the
Development Program, then *** will notify SuperGen of that fact.  The Parties will then negotiate in good
faith an appropriate adjustment to the Estimated Costs or, if they cannot
agree, will escalate the dispute to the dispute resolution process set forth in
Article 16.

6.3                               Invoices.  Upon the
completion of all work and the delivery and acceptance of all Deliverables and
Documentation for a given Development Phase in accordance with Exhibit B,
*** will invoice SuperGen for the pre-approved fees for such Development Phase.  *** may invoice SuperGen for Product upon
shipment of Product or, if earlier, SuperGen’s release of such Product ordered
by SuperGen pursuant to Article 4. 
SuperGen will pay such invoices within thirty (30) days of receipt
thereof.  Payment of all amounts shall
be in U.S. dollars, by wire transfer of immediately available funds to the
financial institution, account number and account name designated in writing by
*** as the place of payment.  All
invoices for Product shall be sent to the address specified in the Product
Purchase Order (as defined in Exhibit C) therefor, and each such
invoice shall state the aggregate and unit price for all Product in a given
shipment, plus any taxes or other costs incident to the purchase or shipment
initially paid by *** but to be borne by SuperGen hereunder.

Article 7 - Delivery and Documentation

7.1                               Delivery.  *** will
arrange for the delivery of Product and/or Deliverable to the location as
stated on the Product Purchase Order or Purchase Order, as the case may be (including
any Third Party location) and in a manner consistent with good commercial
practices, validated shipping procedures (including in approved containers),
the shipping documentation required by Section 7.5, and any agreed-upon
shipping specifications and the Quality Systems Agreement.  All Product and Deliverables shall be
delivered FOB (Incoterms 2000) Manufacturing Facility to the designated
delivery location specified in the Product Purchase Order or Purchase Order.

7.2                               Acceptance.  Acceptance
by SuperGen of any Product or Deliverable delivered hereunder shall be subject
to inspection and applicable testing by SuperGen or its designee.  If on such inspection SuperGen or its
designee discovers that the Product or Deliverable fails to conform with the
Specifications or other applicable regulatory requirements, the warranties set
forth in Section 12.4 below, or Exhibit B, as the case may be,
SuperGen or such designee may not accept such Product or Deliverable, which 

 

8

 

nonacceptance shall be accomplished by giving written notice to *** specifying
the manner in which such Product or Deliverable fails to meet the foregoing
requirements and returning the nonconforming Product or Deliverable in
accordance with ***’s reasonable instructions at ***’s expense.  If the Parties disagree as to whether any
Product or Deliverable conforms to the applicable Specification, then the
Parties will refer the question of whether the Product or Deliverable does or
does not conform to a mutually agreeable independent testing laboratory for a
final determination.  The determination
of such independent testing laboratory will be binding on both Parties for
purposes of payment under this Agreement and the Party against which the
determination is made will bear all out-of-pocket costs and expenses incurred
to obtain such determination. 
Notwithstanding such determination, *** shall use its best efforts to
replace any Product or Deliverable returned by SuperGen within the shortest possible
time.

7.3                               Batch.  Each Batch of Product
manufactured by *** shall meet the applicable Specifications.  If a deviation from such Product
Specifications occurs, then *** will prepare and deliver to SuperGen a
deviation report and the Parties will resolve such situation in accordance with
applicable cGMP and Regulatory Requirements.

7.4                               Certificates.  With respect
to each delivery of Product hereunder, *** will provide SuperGen with a Certificate
of Analysis certifying that the Product being delivered was manufactured in
compliance with cGMP and conforms to the Specifications.

7.5                               Shipping Documentation.  *** will
assure that each Product delivery includes commercially appropriate shipping
documentation (including bills of lading), which will, at a minimum:

7.5.1                     Describe the shipment and state the Batch
identification numbers for the shipment,

7.5.2                     State any order number for the shipment
that has been provided by SuperGen, and

7.5.3                     Show the destination to which such
shipment is being sent.

In addition, *** will assure that each shipment is accompanied by a
Material Safety Data Sheet and samples (for identification testing) and such
additional documentation as SuperGen may reasonably require from time to time.

7.6                               Supporting Data.  At
SuperGen’s request, *** will provide SuperGen with reasonable access to any
applicable supporting data relating to the Product Information, Documentation,
and work performed under the Development Program (including Batch records and
laboratory notebooks).

7.7                               Sample Retention.  *** will
properly store and retain representative samples (identified by Batch number)
(collectively, the “Retained Samples”) of all Product and all Materials
(except water and compressed gases) used to manufacture Product, in each case
in conditions and for times consistent with all applicable Regulatory
Requirements, the Quality Systems Agreement and to permit appropriate or
required internal and regulatory checks and references.  *** will provide SuperGen with reasonable
access to and 

 

9

 

portions of the Retained Samples for testing, trouble-shooting and other
purposes as SuperGen may reasonably require from time to time.

7.8                               No Other Disposition.  Except as
expressly permitted under this Agreement, *** will not dispose of any Product
without the advance written approval of SuperGen.  If SuperGen approves any such disposition of Product, then ***
will carry out such disposition in accordance with applicable Regulatory
Requirements.

Article 8 - Inspections and Audits

8.1                               Inspection by Quality Assurance. 
SuperGen’s quality assurance personnel or its agents will have the
right, upon reasonable advance notice and during regular business hours, to
inspect, observe and audit:

8.1.1                     The Manufacturing Facility and

8.1.2                     Any of ***’s manufacturing and quality
control records and other documentation relating to the manufacturing and
processing activities (including any internal quality control audits or reviews
conducted by ***) for the Product.

Such inspections, observations and audits shall be for the purpose of
ascertaining compliance with Regulatory Requirements, cGMPs, the Quality
Systems Agreement and this Agreement, reviewing correspondence, reports,
filings and other documents from or to Regulatory Authorities to the extent
related to the manufacturing and processing activities, approving all variances
from applicable requirements hereunder or under the Quality Systems Agreement,
and evaluating the implementation of all manufacturing and process changes pursuant
to this Agreement.  Any information
obtained by SuperGen through such inspections and audits shall be treated as
Confidential Information of ***, provided that SuperGen shall be permitted to
disclose such information to Third Parties under an obligation of
confidentiality.  SuperGen will conduct
such inspections and audits in a manner designed to minimize disruption of
***’s business operations.

8.2                               Notice of Non-Compliance.  If SuperGen
reasonably determines during any inspection or audit of a Manufacturing
Facility or other facility at which any of the manufacturing or processing
activities are performed, or the records being maintained by *** in connection
with such manufacture (including Batch records), that *** is not in compliance
with Regulatory Requirements, cGMPs, the Quality Systems Agreement or this
Agreement, then SuperGen will give *** a written notice detailing the suspected
non-compliance.  When *** receives any
such notice from SuperGen, *** will provide SuperGen with a corrective action
plan within thirty (30) days and then, as soon as reasonably practicable, remedy
or cause to be remedied any actual non-compliance, at ***’s expense, in
accordance with a mutually agreed schedule. 
*** will provide SuperGen with reasonable documentary and other evidence
of such correction.  SuperGen will then
have the right to re-inspect and re-audit such Manufacturing Facility or other
facility, or the records being maintained by *** in connection with such manufacture,
upon reasonable notice and during regular business hours to determine whether
*** has remedied or caused to be remedied such non-compliance.

8.3                               Records.  *** will maintain complete
and accurate records (including files, certificates and authorizations)
necessary to evidence compliance with all applicable Laws and other
requirements of applicable Governmental Authorities relating to the Development

 

10

 

Program or manufacture of Product, including all validation data, stability
testing data, development reports, Batch records, quality control and
laboratory testing, and any other data required under cGMPs and other
Regulatory Requirements.  *** will
provide SuperGen with such records promptly upon SuperGen’s request.  *** will also maintain records with respect
to its obligations and performance under this Agreement.  All such records, and all samples required
to be maintained under this Agreement, shall be maintained for a period of not
less than five (5) years from the date of expiration of Product produced from
each Batch of Product to which those records and samples pertain (or, if
longer, for a period of one (1) year after the final resolution of any dispute
to which such records or samples are relevant), or such longer period as may be
required by Regulatory Requirements.  If
and when *** opts to dispose of records or samples generated in conjunction
with this Agreement, it will first offer to transfer such records to SuperGen
or its designee at SuperGen’s expense.

Article 9 - Regulatory Matters

9.1                               Permits.  *** will maintain in good
order, at its sole cost and expense, such current governmental registrations,
permits and licenses as are required by Governmental Authorities and all
applicable Laws in order for *** to perform all of its obligations under this
Agreement.  *** will make copies of
registrations and all related documents available to SuperGen and its designees
for inspection, upon reasonable request from SuperGen.

9.2                               Regulatory Communications and Correspondence. 
*** will promptly notify SuperGen of all communications from and to the
FDA or other Regulatory Authorities that may impact or change the manufacturing
or processing activities performed by ***, or affect the ability of *** to
comply with its obligations under this Agreement.  Without limiting the foregoing, *** will notify SuperGen of any
written or oral inquiries, notifications or inspection activities by any
Regulatory Authority in regard to the Product or the Manufacturing Facility
within five (5) days of *** obtaining knowledge of such inquiries, notifications
or inspection activities.  Moreover, ***
will furnish to SuperGen copies of all inspection reports and related
correspondence of such Regulatory Authority related to or which might
reasonably affect the Product or the performance of any manufacturing or
processing activities hereunder (including any FDA Form 483 or other inspection
reports, warning letters, citations, indictments, claims, lawsuits or
proceedings issued or instituted against ***, or of any revocation of any
license or permit issued to ***) and when such reports and correspondence
become available to ***, but in any event within five (5) days after obtaining
knowledge of such inquiries, notifications or inspection activities.  *** will discuss with SuperGen any
Regulatory Authority comments directly related to and affecting the Product or
***’s performance of any manufacturing or processing activities hereunder, and
before *** submits a final response to such comments, *** will give SuperGen no
fewer than five (5) days to comment on its proposed response to such comments,
and any resultant SuperGen comments will be incorporated to the response, if
reasonably possible.  *** will promptly
rectify or resolve any deficiencies noted by a Regulatory Authority in a report
or correspondence issued to *** that relate to performance of any of the manufacturing
or processing activities under this Agreement.

9.3                               Pre-Approval Inspections.  *** will
prepare for and be responsible for Product pre-approval inspections as required
by Regulatory Requirements.  *** will be
responsible for ensuring that ***’s Manufacturing Facility and Product-related
equipment, processes, test methods and reports are prepared and/or qualified
for such pre-approval inspections, as 

 

11

 

determined in good faith by SuperGen’s quality assurance audit team (“PAI
Ready”) in a time frame consistent with SuperGen’s Product-related
regulatory strategy and consistent with reasonable timelines agreed by the Parties.  SuperGen will cooperate with *** to
achieve PAI Readiness by such date. 
Until *** is PAI Ready, process validation will not commence.  This cooperation will include the
performance of periodic inspections to evaluate progress towards PAI Readiness
and the reporting to *** of all deficiencies identified during such
inspections.  In turn, *** will remedy
all deficiencies, whether or not such deficiencies are identified by a SuperGen
inspection, and will comply with all necessary Regulatory Requirements.  Notwithstanding anything to the contrary in
this Agreement, if *** fails any pre-approval inspection by any Regulatory
Authority with respect to Product, then *** will stop all manufacturing and
processing activities hereunder (to the extent under such Regulatory
Authority’s jurisdiction) unless and until all problems and issues identified
by such Regulatory Authority have been corrected to the satisfaction of such
Regulatory Authority.

9.4                               Process Validation.  After
SuperGen and *** determine in collaboration that *** is PAI Ready in accordance
with Section 9.3, *** will complete protocols for validation of the
Product manufacturing processes, cleaning processes, and other processes and
activities as required by cGMPs and any other applicable Regulatory
Requirements.  SuperGen will review and
approve such protocols in a timely manner. 
*** will complete such process validation within a timeframe consistent
with SuperGen’s Product-related regulatory strategy and consistent with
reasonable development timelines mutually agreed by the Parties and upon
completion, shall provide a validation report to SuperGen for approval.  *** will routinely assemble and retain any
required validation/qualification documents and validation summary reports
pertaining to the manufacturing and processing activities hereunder in
accordance with Section 8.3.  ***
will submit copies of such documents and reports to SuperGen for approval.

9.5                               Notification of Changes to the Manufacturing Process. 
*** will notify SuperGen in writing and provide SuperGen the right to
review and reasonably approve before submitting any documentation to any
Regulatory Authority regarding any manufacturing process changes approved by
SuperGen pursuant to Section 3.9 above. 
Upon reasonable notice, SuperGen will be permitted to review all
documentation proposed to be filed with any Regulatory Authority regarding such
changes.  Within fifteen (15) days after
receiving such documentation, SuperGen will provide *** with comments, which
comments will be fully considered in good faith by *** for incorporation into
the documentation prior to filing it with any Regulatory Authority.  *** will obtain SuperGen’s written approval
prior to submitting any such documentation.

9.6                               Cooperation in Obtaining Government Approvals. 
*** will reasonably assist SuperGen, at SuperGen’s request, to secure
and maintain governmental approvals for the Product and will participate as is
reasonably necessary and as may be requested in resolving the concerns of any
Regulatory Authority arising with respect to the manufacture of Product for
SuperGen.  Without limiting the
foregoing, *** will produce stability batches and validation batches and
perform testing as is necessary for SuperGen to receive approvals for Product
from Regulatory Authorities.

9.7                               Accident Reports.  Each Party
will report to the other as soon as possible all material accidents related to
the manufacture, handling, use or storage of any Materials or Product,
including:

 

12

 

9.7.1                     Accidents resulting in significant
personal injury requiring more than first aid treatment,

9.7.2                     Accidents resulting in chronic illness or
loss of consciousness,

9.7.3                     Accidents resulting in material property
damage,

9.7.4                     Accidents resulting in material
environmental release, and

9.7.5                     Accidents that result in regulatory,
safety, health or environmental audits.

9.8                               SuperGen Access to Manufacturing Data and Documentation. 
SuperGen shall have full access to and the right to use and reference
any regulatory filings, correspondence, validation documentation, batch
records, reports, analyses, and any other information and documentation in
***’s possession or control related to the manufacturing activities conducted
by *** hereunder, or that are necessary or useful for SuperGen to apply for,
obtain and thereafter maintain Regulatory Filings for the Product, including
information relating to the Manufacturing Facility, process, methodology or
components used in the manufacture of the Product or other such information
required to be submitted to the FDA (or its foreign equivalent) in the form of
a marketing application.  Without
limiting the foregoing, *** agrees to immediately inform SuperGen when any such
information is no longer current and reflective of current manufacturing
practices, procedures or the Specifications and to promptly provide updated
information to SuperGen.

Article 10 - Recalls

10.1                        Notification.  Each Party
will keep the other Party fully informed of any notification, or other
information of which it has actual knowledge, which might result in the Recall
(as defined below) or Seizure of the Product.

10.2                        ***’s Recall or Withdrawal Suggestion. 
If *** independently believes that a Product Recall or Product
withdrawal may be necessary or appropriate, *** will so notify SuperGen of
***’s conclusion within twenty-four (24) hours and the Parties will cooperate
with each other to ascertain the necessity and nature of such action.

10.3                        Recall Determination by SuperGen. 
Promptly after SuperGen determines that a Recall or Product withdrawal
is necessary, and before SuperGen notifies a Regulatory Authority of a Product
withdrawal or Product Recall, SuperGen will notify *** of SuperGen’s determination
and the basis therefor.  *** will assist
SuperGen, at SuperGen’s reasonable request, in its investigation to determine
the cause and extent of the problem.

10.4                        SuperGen Discretion.  SuperGen will
be solely responsible for making the final decision whether Product is
withdrawn or Recalled.  SuperGen will be
solely responsible for any resulting product liability claims, except to the
extent such product liability claims are attributable to ***’s or any of its
subcontractors’ negligence, recklessness or intentional wrongdoing, in which
case *** will be responsible for such product liability claims.

10.5                        Responsibility for Expenses of Recall. 
If any Governmental Authority withdraws its approval to sell the Product
or issues a directive or request that all or specified quantities 

 

13

 

of the Product be Recalled for product safety reasons or SuperGen reasonably
determines that all or specified quantities of the Product should be Recalled,
then SuperGen will pay all costs, including ***’s reasonable out-of-pocket
expenses, associated with the Recall, except to the extent such Recall is
attributable solely to ***’s or any of its subcontractors’ negligence, recklessness
or intentional wrongdoing, in which case:

10.5.1              *** will be responsible for all such
costs,

10.5.2              SuperGen will have the right to cancel
any Product Purchase Orders already submitted, and

10.5.3              SuperGen will have no obligations or liabilities
with respect to any Product not yet shipped to SuperGen or for any Materials
used or ordered in anticipation of fulfilling any such Product Purchase Orders.

10.6                        Definition of Recall.  For purposes
of this Article 10, the term “Recall”  means any action by
SuperGen, or any Affiliate or subsidiary of SuperGen, to recover title to or
possession of Product sold or shipped to Third Parties.

Article 11 - Publicity and Confidentiality

11.1                        Publicity.  Except as
required by Law or the standards of any securities regulatory authority,
including, without limitation, the United States Securities and Exchange
Commission, NYSE and NASDAQ, neither *** nor SuperGen will make any official
press release, announcement or other formal publicity relating to the terms of
this Agreement or transactions that are the subject of this Agreement without
first obtaining in each case the prior written consent of SuperGen or ***,
respectively (which consent may not be unreasonably withheld).  If either Party is required to file this
Agreement with the United States Securities and Exchange Commission or another
applicable securities regulatory authority, then that Party will seek
confidential treatment for any provisions of this Agreement that either Party
believes would disclose trade secrets, confidential commercial or financial
information and thereby impair the value of the contractual rights represented
by this Agreement or provide detailed commercial and financial information to
competitors or other Persons.  Except as
required by Law or the standards of any securities regulatory authority, ***
and SuperGen may not use the name or trademarks of SuperGen or ***,
respectively, or any director, officer or employee thereof or any adaptation
thereof without the prior written approval of SuperGen or ***, respectively.

11.2                        Publications.  *** will
send to SuperGen for its approval, at least sixty (60) days before it is filed
or submitted, any publication or abstract resulting from this Agreement.  The authorship on any publication or
abstract shall be determined by agreement of the Parties or as deemed
scientifically appropriate.  Any
publication resulting from this Agreement will be delayed or prohibited if, in
either Party’s reasonable opinion, delay or prohibition is required in order to
file or procure patent application or rights protection in respect of any
invention or discovery arising from this Agreement.

11.3                        Confidential Information.  In carrying
out the Development Program both Parties are likely to need to disclose to the
other information of a business or technical nature, which is proprietary and
confidential to the Party disclosing it (“Confidential Information”).  For purposes of this Agreement, Confidential
Information shall include any proprietary 

 

14

 

information, technical data, trade secrets or know-how, including, but not
limited to, research, product plans, products, services, customers, customer
lists, markets, software, developments, inventions, processes, formulas,
technology, designs, drawings, engineering, hardware configuration information,
marketing, finances or other business information disclosed by a Party to the
other Party either directly or indirectly in writing, orally or by drawings or
inspection of parts or equipment.

11.4                        Form of Disclosure.  A Party (a “Disclosing
Party”) may disclose Confidential Information to the other Party (the “Receiving
Party”) in written or tangible form, orally, or by other media.  The method by which the Disclosing Party
chooses to disclose information to the Receiving Party will not, however,
affect whether such information is or is not Confidential Information.  A Disclosing Party will use
reasonable efforts to notify the Receiving Party which of the information the
Disclosing Party discloses under this Agreement constitutes Confidential
Information.  Such efforts will include
placing confidentiality legends and other written notices on the Confidential
Information and such other means of notification as will provide the Receiving
Party with fair and seasonable notice of the confidential nature of such
Confidential Information.

11.5                        Obligations.  Each Party
as a Receiving Party acknowledges that the other Party’s Confidential
Information is the property of the Disclosing Party and is treated by the
Disclosing Party as confidential business information.  A Receiving Party shall:

11.5.1              Use such Confidential Information only
for the purposes contemplated by this Agreement,

11.5.2              Treat such Confidential Information as
confidential and protect the same in the same manner and with the same degree
of care the Receiving Party protects its own trade secrets and other
confidential business information, and

11.5.3              Not disclose any of the Confidential
Information to any other person or entity without the Disclosing Party’s
written permission, except only to those of its employees who need access to
the Confidential Information in order for the Receiving Party to accomplish the
purpose of this Agreement.

11.5.4              Except with respect to any Confidential
Information to which a Party has ongoing rights, at the end of the Term,
immediately stop using Confidential Information and, if the Disclosing Party so
requests in writing, promptly return to the Disclosing Party or destroy all
records (whether in written form or other media) containing Confidential
Information.  (A Receiving Party may, however,
retain records that demonstrate the Receiving Party’s full compliance with this
Agreement if such retained records are used only for that purpose.)

11.6                        Exceptions. 
Notwithstanding the foregoing, Confidential Information will not include
any information that:

11.6.1              Was already known by the Receiving Party
when the Disclosing Party disclosed it to the Receiving Party,

11.6.2              Is publicly known or comes into the
public domain without a breach by the Receiving Party of the Receiving Party’s
duties under this Agreement,

 

15

 

11.6.3              Is subsequently independently conceived
or discovered by the Receiving Party or its employees without access to or use
of the Confidential Information of the Disclosing Party,

11.6.4              Is subsequently disclosed to the
Receiving Party by another person who is not under an obligation of confidence
to the Disclosing Party, or

11.6.5              A Receiving Party must disclose under a
non-appealable decree or other order of a court or other governmental
authority.

A Receiving Party will promptly notify the Disclosing Party if and when
a Receiving Party becomes aware of any fact or circumstance that might
reasonably be expected to cause any information that a Disclosing Party has
identified as Confidential Information to fall within the scope of categories
of Sections 11.6.1 through 11.6.5 above.

Article 12 - ***’s Representations, Warranties
and Covenants

12.1                        Commercially Reasonable Efforts. 
*** represents and warrants to SuperGen that *** will use its
commercially reasonable efforts to successfully complete the Development
Program according to the Development Program schedule.  SuperGen acknowledges, however, that since
the services are of a developmental or research nature, there can be no guarantee,
and *** has given no guarantee, that the Development Program will be
successfully completed, or successfully completed within the contemplated time
frame, despite ***’s commercially reasonable efforts to do so.

12.2                        Performance Standards.  *** represents
and warrants to SuperGen that *** will perform all manufacturing and processing
activities hereunder and maintain the Manufacturing Facility in accordance with
cGMPs, the Specifications, the Quality Systems Agreement, all applicable
Regulatory Requirements and other requirements of any Governmental Authority,
and such quality assurance and quality control practices as are standard in the
pharmaceutical manufacturing industry.

12.3                        Qualified Personnel.  ***
represents and warrants to SuperGen that *** will engage and employ
professionally qualified personnel to perform the services contemplated under
this Agreement.

12.4                        Product Warranty.  ***
represents and warrants to SuperGen that at the time of delivery, the Product:

12.4.1              Will conform to the Specifications;

12.4.2              Will have been manufactured in compliance
with the requirements of cGMP, including both 21 CFR Parts 210 and
211, and ICH Q7A;

12.4.3              Will have been manufactured in compliance
with all Regulatory Requirements;

12.4.4              Will have been packaged in accordance
with SuperGen’s shipping guidelines; and

 

16

 

12.4.5              Will have been transferred free and clear
of any liens or encumbrances of any kind to the extent arising through or as a
result of the acts or omissions of ***, its Affiliates or their respective
agents.

12.5                        Disclaimer.  THE
WARRANTIES PROVIDED IN THIS ARTICLE 12 ARE THE ONLY WARRANTIES *** HAS
GIVEN SUPERGEN CONCERNING THE PRODUCT. 
SUCH WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS, GUARANTEES, OR
OTHER WARRANTIES INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR INTENDED USE AND/OR INFRINGEMENT, THAT *** MIGHT HAVE GIVEN OR WHICH MIGHT
BE PROVIDED OR IMPLIED BY LAW OR COMMERCIAL PRACTICE, WHICH OTHER WARRANTIES
ARE HEREBY EXCLUDED.

Article 13 - Mutual Representations, Warranties
and Covenants

Each Party represents, warrants and covenants to the other as follows:

13.1                        Good Standing.  The Party is
a corporation validly existing and in good standing with the power to own all
of its properties and assets and to carry on its business as it is currently
being conducted.

13.2                        Power and Authorization.  The Party
has all requisite power and authority (corporate and otherwise) to enter into
this Agreement and to perform its obligations under this Agreement.  The Party is not required to obtain the
consent of any Person, including, without limitation, the consent of any party
to any contract to which it is a party, in connection with execution and
delivery of this Agreement and performance of its obligations under this
Agreement.

13.3                        No Conflict.  The Party’s
execution and delivery of this Agreement and the performance of its obligations
hereunder do not and will not conflict with or result in a breach of or a default
under its organizational instruments or any other agreement, instrument, order,
law or regulation applicable to it or by which it may be bound.

13.4                        Enforceability.  The Party’s
execution and delivery of this Agreement and performance of its obligations
under this Agreement do not and shall not (A) conflict with, result in a
breach of, constitute a default under (or an event which, with notice or lapse
of time or both, would constitute a default under), accelerate the performance
required by, result in the creation of any Lien upon any of its properties or
assets under, or create in any party the right to accelerate, terminate, modify
or cancel, or require any notice under, any contract to which it is a party or
by which any of its properties or assets are bound, or (B) to the best of
its knowledge, violate any applicable Law or Judgment currently in effect to
which it is subject.

13.5                        Compliance with Applicable Laws. 
The Party will comply with applicable federal, state and local laws in
connection with the performance of this Agreement.

13.6                        No Violations.  Neither it
nor any of its agents, subcontractors or other representatives, nor any of
their respective Affiliates, nor any members of their respective staffs, are,
nor will they be, at the time of performance of any material obligation under
this Agreement,

 

17

 

(A)                              Disqualified or debarred by the FDA or
any other Regulatory Authority for any purpose pursuant to 21 U.S.C.
§ 355a or any foreign counterparts thereof; or

(B)                                Charged with or convicted under United
States federal law, or foreign counterparts thereof, for conduct relating to
the development or approval of, or otherwise relating to the regulation of, any
drug product under the Generic Drug Enforcement Act of 1992 or any other
relevant statute, law or regulation.

13.7                        Full Rights.  It owns or
possesses adequate licenses or other rights necessary to enter into this
Agreement, and its fulfillment of its obligations hereunder will not  violate
the rights of any Third Party.

13.8                        Safety Claims.  Each Party
will promptly notify the other of any information or notice it or they are or
become aware of concerning the safety claims of any Product, including any
threatened or pending action by any Regulatory Authority.  (SuperGen will be solely responsible for
handling all complaints and communications from Regulatory Authorities with
respect to the Product and *** will cooperate in resolving such complaints and
responding to such communications to the extent they pertain to Product and are
reasonably requested by SuperGen in connection therewith.)

Article 14 - Indemnification.

14.1                        Indemnification by ***.  ***
will indemnify SuperGen, all SuperGen service providers and subcontractors,
each Affiliate of the foregoing, and the heirs, executors, successors and
assigns of any of the foregoing, against the following:

14.1.1              Indemnifiable Losses arising out of a
material breach by *** of any of its obligations under this Agreement
(including any Exhibits hereto);

14.1.2              Indemnifiable Losses arising out of a
breach of any representation or warranty of *** contained in Article 12 or
Article 13 of this Agreement;

14.1.3              Indemnifiable Losses arising from ***’s
manufacturing and processing activities; and

14.1.4              Indemnifiable Losses arising from ***’s
handling, accumulation, labeling, packaging, storing, transport or disposal of
Wastes;

but only if and to the
extent any such Indemnifiable Losses were proximately caused by ***’s gross
negligence, recklessness or intentional wrongdoing provided, however, that ***
shall have no liability to SuperGen for any such Indemnifiable Losses to the
extent that such Indemnifiable Losses were caused by: (x) the gross
negligence, recklessness or willful misconduct of SuperGen or any Person for
whose actions or omissions SuperGen is legally liable; or (y) a breach by
SuperGen of its representations and/or warranties contained in Article 13
of this Agreement or a material breach by SuperGen of its obligations under
this Agreement.

14.2                        Indemnification by SuperGen.  SuperGen
will indemnify ***, all *** service providers and subcontractors, each
Affiliate of the foregoing, and the heirs, executors, successors and assigns of
any of the foregoing, against the following:

 

18

 

14.2.1              Indemnifiable Losses arising out of a
material breach by SuperGen of any of its obligations under this Agreement
(including any Exhibits hereto);

14.2.2              Indemnifiable Losses arising out of a
breach of any representation or warranty of SuperGen contained in
Article 13 of this Agreement; and

14.2.3              Indemnifiable Losses arising out of the
sale, promotion, distribution, or use of the SuperGen Product;

but only if and to the
extent any such Indemnifiable Losses were proximately caused by SuperGen’s
gross negligence, recklessness or intentional wrongdoing provided, however,
that SuperGen shall have no liability to *** for any such Indemnifiable Losses
to the extent that such Indemnifiable Losses were caused by: (x) the gross
negligence, recklessness or willful misconduct of *** or any Person for whose
actions or omissions *** is legally liable, or (y) a breach by *** of its
representations and/or warranties contained in Article 12 or
Article 13 of this Agreement or a material breach by *** of its obligations
under this Agreement.

14.3                        Procedures Relating to Indemnification. 
In order to be entitled to indemnification under this Article 14 in
connection with a claim made or litigation initiated by any Third Party against
any other Person with respect to which that other Person (a “Claimant”)
is entitled to indemnification pursuant to this Article 14 (any such
claim, a “Third Party Claim”), that Claimant must do the following:

14.3.1              Notify the Person or Persons obligated to
indemnify it (the “Indemnitor”) in writing, and in reasonable detail, of
that Third Party Claim as soon as possible but in any event within thirty (30)
days after receipt of notice of that Third Party Claim, except that any failure
to give any such notification will only affect the Indemnitor’s obligation to
indemnify the Claimant if the Indemnitor has been prejudiced as a result of
that failure; and

14.3.2              Deliver to the Indemnitor as soon as
possible but in any event within thirty (30) days after the Claimant receives
them a copy of all material notices and documents (including court papers)
delivered to that Claimant relating to that Third Party Claim.

14.4                        Defense of Claims.  If Third
Party Claim is made against one or more Claimants, the Indemnitor will have the
right to participate in the defense of that Third Party Claim and, if it so
chooses, assume at its expense the defense of that Third Party Claim with
counsel selected by the Indemnitor and reasonably satisfactory to the
Claimant.  If the Indemnitor assumes
defense of any Third Party Claim, the Claimant will be entitled to participate
in the defense of that Third Party Claim and to employ counsel, at its own
expense (subject to the foregoing sentence), separate from counsel employed by
the Indemnitor, but the Indemnitor will be remain authorized to control that
defense except as stated above.  The Indemnitor
will be liable for the fees and expenses of counsel employed by the Claimant
for any period during which the Indemnitor did not assume the defense of any
Third Party Claim (other than during any period in which the Claimant failed to
give notice of the Third Party Claim as provided above and a reasonable period
after such notice) or as stated above. 
If the Indemnitor chooses to defend or prosecute a Third Party Claim,
the Parties will cooperate in the defense or prosecution of that Third Party
Claim, including by retaining and providing to the Indemnitor records and 

 

19

 

information reasonably relevant to that Third Party Claim, and making employees
available on a reasonably convenient basis. 
If the Indemnitor chooses to defend or prosecute any Third Party Claim,
the Claimant will agree to any settlement, compromise or discharge of that
Third Party Claim that the Indemnitor recommends, except that the Indemnitor
may not without the Claimant’s prior written consent agree to entry of any
judgment or enter into any settlement that provides for injunctive or other
nonmonetary relief affecting the Claimant or that does not include as an unconditional
term that each claimant or plaintiff give to the Claimant a release from all
liability with respect to that Third Party Claim.  Whether or not the Indemnitor has assumed the defense of a Third
Party Claim, the Claimant will not admit any liability with respect to, or
settle, compromise or discharge, that Third Party Claim for which
indemnification is sought hereunder without the Indemnitor’s prior written
consent.

14.5                        Limitation of Liability.  EXCEPT FOR
ANY BREACH OF THE OBLIGATIONS OF CONFIDENTIALITY SET FORTH IN
SECTION 11.5, UNDER NO CIRCUMSTANCES WILL EITHER PARTY HAVE ANY LIABILITY
TO THE OTHER PARTY OR ANY PERSON OR ENTITY CLAIMING THROUGH SUCH PARTY FOR ANY
LOSS OF PROFITS, SPECIAL, INDIRECT, CONSEQUENTIAL, EXEMPLARY, PUNITIVE OR
INCIDENTAL DAMAGES ARISING OUT OF OR RELATED TO THIS AGREEMENT HOWEVER CAUSED
AND ON ANY THEORY OF LIABILITY (INCLUDING NEGLIGENCE), WHETHER OR NOT A PARTY
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

14.6                        Meaning of Indemnifiable Loss.  For purposes
of this Article 14, the term “Indemnifiable Loss” means all losses,
liabilities, taxes, damages, deficiencies, obligations, fines, expenses,
penalties, costs, fees, settlement amounts and expenses (including without
limitation court costs, interest and reasonable fees for attorneys, accountants
and other experts) awarded or otherwise required to be paid to Third Parties
with respect to any Third Party Claim by reason of any Judgment, order, decree,
stipulation or injunction, or any settlement entered into in accordance with
the provisions of this Agreement, together with all documented out-of-pocket
costs and expenses paid to Third Parties and incurred in connection with
defending against or settling such Third Party Claim (including without
limitation reasonable fees of attorneys, accountants and other experts and
expenses incurred in asserting, preserving or enforcing any of the Indemnified
Party’s rights to indemnification hereunder). 
For purposes of determining the amount of any Indemnifiable Loss the
following will apply:

(A)                              The amount will be reduced to give full
effect to any indemnity, contractual, or noncontractual recoveries the
indemnified party actually received in connection therewith;

(B)                                The amount will be reduced to give full
effect to any net reduction in tax liability or other tax benefit the
indemnified party actually received in connection therewith; and

(C)                                The amount will be reduced to give full
effect to any unreasonable failure by the indemnified party to mitigate any
liability, damage, claim, loss, cost, or expense incurred by such indemnified
party.

 

20

 

Article 15 - Term and Termination

15.1                        Term.  The term of this Agreement
will commence on the Effective Date and continue for a period of *** years
unless this Agreement is previously terminated in accordance with the
provisions of this Article 15 (the “Term”).

15.2                        Termination by SuperGen.  SuperGen may
terminate this Agreement or any Development Phase for any or no reason upon sixty
(60) days’ notice thereof to ***.

15.3                        Termination by Mutual Agreement. 
This Agreement may be terminated at any time upon mutual written
agreement between the Parties.

15.4                        Termination for Default.  This
Agreement may be terminated by either Party in the event of a Default by the
other Party.  A “Default” shall
be deemed to have occurred when:

15.4.1              A Party breaches its material obligations
under this Agreement,

15.4.2              The other Party gives the breaching Party
written notice of breach in sufficient detail to apprise the breaching Party of
the scope and extent of the alleged breach, and

15.4.3              After having received such written breach
notice, the breaching Party fails to cure such default within ten (10) days (in
the case of a failure by SuperGen to pay any amounts hereunder when due) or
ninety (90) days (in the case of any other breach), provided, however, if a
breach is incapable of cure within ninety (90) days and the breaching Party
certifies to the other Party in writing that it is working diligently to cure
such breach, such ninety (90) day period will be extended to one hundred fifty
(150) days.

In such case, this
Agreement will be deemed terminated effective upon the expiration of the
applicable cure period described in Section 15.4.3 above.  Termination of this Agreement pursuant to
this Article 15 shall not affect any other rights or remedies, which may
be available to either Party.

15.5                        Bankruptcy; Insolvency.  Either Party
may terminate this Agreement upon the occurrence of either of the following:
(i) the entry of a decree or order for relief by a court having
jurisdiction in the premises in respect of such Party in an involuntary case
under the federal bankruptcy code, as now constituted or hereafter amended, or
any other applicable federal or state insolvency or other similar law and the
continuance of any such decree or order un-stayed and in effect for a period of
sixty (60) consecutive days; or (ii) the filing by such Party of a
petition for relief under the Federal Bankruptcy Code, as now constituted or
hereafter amended, or any other applicable federal or state insolvency or other
similar law.

15.6                        Rights and Duties on Termination or Cancellation. 
Upon expiration or termination of this Agreement: *** will, as promptly
as practicable (i) cease all work on the Development Program, and
(ii) turn over to SuperGen all Deliverables, Documentation and SuperGen
Materials (whether in written or electronic form, including any work in
progress) which are then in ***’s possession and which are the property of
SuperGen in accordance with Section 5.1 of this Agreement.  Except for termination by SuperGen

 

21

 

pursuant to Section 15.4, SuperGen will promptly pay or reimburse *** for
all undisputed fees, expenses and uncancellable obligations incurred hereunder
through the date of such termination or expiration.  At SuperGen’s option: (i) the Parties will promptly agree on
a procedure by which possession of any equipment located at *** facility that
is owned by SuperGen is delivered to SuperGen (with SuperGen paying all
reasonable out-of-pocket costs associated with the removal of such equipment,
including ***’s facility restoration costs), or (ii) *** may purchase all
or any portion of such equipment from SuperGen by paying SuperGen the
depreciated (calculated on a straight-line basis) book value thereof.

15.7                        Survival.  The
following Articles and Sections shall survive any termination or expiration of
this Agreement: Sections 3.4, 4.5, 5.1, 5.3, 5.4, 7.7 7.8, 8.3, 11.3,
11.5, 11.6 and Articles 10, 14, 16 and 17.

Article 16 - Dispute Resolution

If the Parties ever have
a dispute involving their respective rights and obligations under this
Agreement, then the Parties will attempt to resolve such dispute as follows:

16.1                        Dispute Notice.  Either ***
or SuperGen may at any time deliver to the other a written dispute notice
setting forth a brief description of the issues for which such notice initiates
the dispute resolution mechanism set forth in this Article 16.  Such dispute notice shall also specify the
provision or provisions of this Agreement and the facts or circumstances that
are the subject matter of the dispute.

16.2                        Informal Negotiations; Escalation. 
During the thirty (30) day period following delivery of a dispute notice
described in Section 16.1, the Parties will cause their representatives to
meet and seek to resolve the disputed items cordially through informal negotiations.  Any disputes relating to the relationship
between the Parties that are not resolved by informal negotiations shall be
first referred to senior officers of each Party.  The senior officers shall in good faith attempt to resolve the
dispute presented to them.  If, however,
the senior officers are unable to resolve such a dispute within thirty (30)
days of being requested by a Party to resolve the dispute, either Party may, by
written notice to the other, invoke the provisions of Section 16.3.  Any statute of limitations or similar time
periods shall be tolled during such period.

16.3                        Dispute Resolution Proceedings.  If
representatives of the parties are unable to resolve disputed items through the
informal negotiations described in Section 16.2, then within 30 days after the
informal negotiation period the parties will refer the disputed issues to a
dispute resolution panel for final resolution as follows:

16.3.1              Designation of Representatives. 
Within seven days after such informal negotiation period, *** and
SuperGen will each designate one representative to serve on the dispute resolution
panel.  (If either party fails or
refuses to designate a representative, then the other party will be entitled to
have a representative appointed for such party by the CPR Institute.)

16.3.2              Selection of Neutral.  Promptly
after they have been designated, the designated representatives will meet and
select a neutral person (the “Neutral”) to serve as the third member of the
dispute resolution panel.  If the
designated 

 

22

 

representatives of parties cannot agree on a Neutral, then either
representative may request the CPR Institute to select the Neutral.

16.3.3              Procedures and Process.  At the time
the matter is referred to the dispute resolution panel, *** and SuperGen will
jointly establish the procedures to be followed with respect to the
presentation of the parties’ respective positions and the process by which the
dispute resolution panel will reach and render its decision on the disputed
issues.  If *** and SuperGen cannot
agree on such procedures and processes, then the Neutral will establish such
procedures and process, which will, in all events, be consistent with the
foregoing.

16.3.4              Decision.  The dispute
resolution panel will act by majority vote. 
The dispute resolution panel will base its decision on applicable
provisions of this Agreement or, if the provisions of this Agreement do not
resolve the matter, on general principles of substantive Delaware law.  (The dispute resolution panel may, if it so
desires, seek the opinion of an attorney licensed to practice law in the State
of Delaware on any matter of substantive Delaware law on which the panel
desires clarification.)  The decision of
the dispute resolution panel will be final and binding on both Parties and not
subject to appeal or collateral challenge, except in the case of disputes
concerning the Parties’ respective rights with respect to intellectual
property.

16.4                        Injunctive Relief.  Each Party
acknowledges and agrees that nothing in this Article 16 shall prevent a
Party from seeking injunctive relief in a court of law if such Party reasonably
believes that complying with the dispute resolution procedures set forth herein
would cause it irreparable harm.

Article 17 - Miscellaneous

17.1                        Independent Contractor.  SuperGen
will not have the right to direct or control the activities of *** performing
the service provided herein, and *** will perform services hereunder only as an
independent contractor, and nothing herein shall be construed to be
inconsistent with relationship or status. 
Under no circumstances shall *** be considered to be an employee or
agent of SuperGen.

17.2                        Use of Other Party’s Name.  Except as
expressly provided or contemplated under this Agreement or as otherwise
required by applicable law, neither Party has granted or intends to grant any
right to the other Party to use in any manner its trademarks or name, or any
other trade name, service mark, or trademark owned by or licensed to it, in
connection with the performance of the Agreement.

17.3                        Severability.  If any
provision of this Agreement shall finally be determined to be unlawful, then
such provision will be deemed to be severed from this Agreement and replaced by
a lawful provision which carries out, as closely as possible, the intention of
the Parties and preserves the economic bargain contemplated by this Agreement
and, in such case, each and every other provision of this Agreement will remain
in full force and effect.

17.4                        Assignment.  Neither
Party may assign any right or delegate any duty under this Agreement without
the written approval of the other Party; provided, however, that either Party may,
without such consent, assign this Agreement in connection with the transfer 

 

23

 

or sale of all or substantially all of the business or assets of such Party to
a Third Party, whether by merger or otherwise or in connection with the merger
or consolidation of such Party with an Affiliate, in either case the applicable
assignee shall agree in writing to be bound by the terms and conditions of this
Agreement.  Any purported assignment in
violation of the preceding sentence will be void.  Any permitted assignee will assume all obligations of its assignor
under this Agreement.  No assignment
will relieve either Party of responsibility for the performance of any
obligation, which accrued prior to the effective date of such assignment.

17.5                        Effect of an Event of Force Majeure. 
Neither Party will be held liable or responsible for any loss or damages
resulting from any failure or delay in its performance due hereunder (other
than the payment of money) caused by an Event of Force Majeure.  If either Party is delayed or rendered
unable to perform due to an Event of Force Majeure, the affected Party will
give notice of the same and its expected duration to the other Party promptly
after the occurrence of the cause relied upon, and upon the giving of such
notice the obligations of the Party giving the notice will be suspended during
the continuance of the Force Majeure; provided, however, such Party will take
commercially reasonable steps to remedy the Force Majeure with all reasonable
dispatch.  The requirement that Force
Majeure be remedied with all reasonable dispatch will not require the
settlement of strikes or labor controversies by acceding to the demands of the
opposing Party.

17.6                        Governing Law.  This
Agreement will be governed by and construed in accordance with the internal
substantive laws of State of Delaware, without reference to conflicts of laws
principles.

17.7                        Notices.  All notices, requests and
other communications under this Agreement will be in writing and will be deemed
to have been duly given at the time of receipt if delivered by hand or communicated
by electronic transmission (receipt confirmed), or, if mailed, three (3) days
after mailing by registered or certified mail, return receipt requested, with
postage prepaid:

 

	
   

  	
  If to SuperGen, to:

  	
   

  	
  SuperGen, Inc.

  4140 Dublin Road

  Suite 200

  Dublin, California 94568

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Attention:  Lucy Chang

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Phone:1.925.560.0100

  
	
   

  	
   

  	
   

  	
  Telefax:1.925.551.6483

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  If to ***, to:

  	
   

  	
  ***

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Attention:  General
  Manager

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Phone:  ***

  
	
   

  	
   

  	
   

  	
  Telefax:  ***

  
	
   

  	
   

  	
   

  	
   

  

 

 

24

 

 

	
   

  	
  With a copy to:

  	
   

  	
  ***

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Attention:  General
  Counsel

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Telefax:  ***

  

Either Party may change its notice address above to a different address
by giving the other Party written notice of such change.

17.8                        Headings.  Paragraph
headings and captions used herein are for convenience of reference only and will
not be used in the construction or interpretation of this agreement.

17.9                        Continuing Obligations.  Termination,
assignment or expiration of this Agreement will not relieve either Party from
full performance of any obligations incurred prior thereto.

17.10                 Waiver.  Neither Party’s waiver of any
breach or failure to enforce any of the terms and conditions of this Agreement,
at any time, will in any way affect, limit or waive such Party’s right
thereafter to enforce and compel strict compliance with every term and
condition of this Agreement.

17.11                 Construction.  This
Agreement has been jointly prepared on the basis of the mutual understanding of
the Parties and will not be construed against either Party by reason of such
Party’s being the drafter hereof or thereof. 
When introducing a series of items, the term “including” is not intended
to limit the more general description that precedes the items listed.  References to “days” mean calendar
days.  (If, however, an action or
obligation is due to be undertaken by or on a day other than a business day,
i.e., a Saturday, Sunday or a public holiday in the United States, then that
action or obligation will be deemed to be due on the next following business
day.)

17.12                 Counterparts.  More than
one counterpart of this Agreement may be executed by the Parties hereto, and
each fully executed counterpart will be deemed an original without production
of the others.

 

25

 

17.13                 Complete Agreement.  This
Agreement together with the Exhibits sets forth the entire understanding of the
Parties hereto with respect to the subject matter of this Agreement and
supersedes all prior letters of intent, agreements, undertakes, arrange­ments,
communica­tions, representations, or warranties, whether oral or written, by
any officer, employee, or representative of either Party relating thereto.  All Exhibits hereto are hereby incorporated
into this Agreement by this reference.

To evidence their
agreement as stated above, SUPERGEN, INC. and
***, have each caused their respective duly authorized directors, officers, or
attorneys to execute this DRUG SUBSTANCE VALIDATION AND
SUPPLY AGREEMENT as of the Effective Date.

 

	
   

  	
  SUPERGEN, INC.

  	
   

  	
   

  	
  ***

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Joseph Rubinfeld

  	
   

  	
  By:

  	
   

  
	
   

  	
  Dr. Joseph Rubinfeld

  	
   

  	
   

  	
  ***

  
	
   

  	
  President and CEO

  	
   

  	
   

  	
   

  

 

 

 

Exhibit A

Definitions

 

 “Affiliate” means any
corporation, partnership or other entity that is controlled by, controls, or is
under common control with a Party; and “control” means the direct, indirect or
beneficial ownership of fifty percent (50%) or more of the voting stock or
other ownership interest of such corporation, partnership or other entity, or
the possession, directly or indirectly, of the power to direct or cause
direction of the management of such corporation, partnership, or other entity.

“Batch” means that quantity of Product that is manufactured by
*** from a single production cycle or run as further set forth in the
validation reports.

“cGMP” means the current good manufacturing practice and standards
as provided for (and as amended from time to time) in European Community
Directive 91/356/EEC (Principles and guidelines of good manufacturing practice
for medicinal products) and in the Current Good Manufacturing Practice
Regulations of the U.S. Code of Federal Regulations Title 21
(21 C.F.R. §§ 210 and 211) in relation to the production of
pharmaceutical intermediates and active pharmaceutical ingredients, as
interpreted by ICH Harmonised Tripartite Guideline, Good Manufacturing Practice
Guide for Active Pharmaceutical Ingredients, Q7a and subject to any
arrangements, additions or clarifications, and respective roles and
responsibilities, agreed from time to time between the Parties in the Quality
Systems Agreement.

“Deliverables” means the information, material, reports,
Documentation and other items that *** is obligated to provide under the terms
of the Development Program, including such deliverables as specification
sheets, progress reports, master production records, certificates of analysis
and certificates of quality.

“Development Phase” means each separate phase of work identified
and outlined in the Development Program.

“Development Program” means the development program outlined in
the detailed proposal attached to this Agreement as Exhibit B,
together with any modifications and additions thereto agreed upon by the
Parties.

“Documentation” means all written materials describing the
conduct and results of the Development Program, including the Master Production
Record, all Batch records and any other documents related to the Manufacturing
Process, the Manufacturing Facility, as well as such other documents reasonably
necessary for SuperGen to complete its Regulatory Filings.

“Event of Force Majeure” means a war, strike, fire, Act of God,
acts of terrorism, earthquake, flood, lockout, embargo, governmental acts or
orders or restrictions, failure of suppliers, or any other reason where failure
to perform is beyond the reasonable control and not caused by the negligence,
intentional conduct or misconduct of the non-performing Party.

 

A-1

 

“FDA” means the U.S. Food and Drug Administration, or any
successor entity thereto or foreign counterpart thereof.

“Governmental Authority” means any (1) nation, state,
county, city, town, village, district or other jurisdiction of any nature,
(2) federal, state, local, municipal, foreign or other government,
(3) governmental or quasi-governmental authority of any nature (including
any governmental agency, branch, department, official or entity and any court
or other tribunal, including an arbitral tribunal), (4) multi-national
organization or body, or (5) body exercising, or entitled to exercise, any
administrative, executive, judicial, legislative, police, regulatory or taxing
power of any nature.

“Judgment” means any award, decision, injunction, judgment,
order, ruling, subpoena, or verdict of any court, arbitral tribunal,
administrative agency or other Governmental Authority having jurisdiction of a
Party.

“Law” means any applicable federal, state, local, municipal,
foreign, international, multinational or other administrative order,
constitution, law, ordinance, principle of common law, regulation, statute or
treaty.

“Lien” means any charge, claim, community property interest,
condition, equitable interest, lien, option, pledge, security interest, right
of first refusal or restriction of any kind, including any restriction on use,
voting, transfer, receipt of income or exercise of any other attribute of
ownership.

“Manufacturing Process” means that certain process for
synthesizing and manufacturing the Product that was developed or acquired by
SuperGen prior to the Effective Date, as the same may be amended and revised
during the Term.

“Master Production Record” means the document, proposed by ***
and approved by SuperGen, that defines the manufacturing methods, test methods,
specifications, materials, and other procedures, directions and controls
associated with the manufacture and testing of Product.  No changes may be made to the Master
Production Record without review and approval by both Parties, including
quality assurance and regulatory review, as described in the Quality Systems
Agreement.

“Materials” means all chemicals, ingredients, solvents and other
components required to perform the manufacturing and processing activities
hereunder in accordance with the Specifications.

“Milestone” means completion of a specifically identified
Deliverable per Exhibit B.

“NDA” shall mean a New Drug Application (as described in
21 C.F.R. § 314.50 et. seq.) filed with the FDA for marketing
approval for a drug pursuant to the Act and the regulations promulgated
thereunder, including any amendments or supplements thereto.

“Product” means Decitabine and its associated CAS [2353-33-5]
assigned chemical names or trademarked name(s).

“Purchase Order” means a written purchase order from SuperGen
that authorizes the completion of certain work under the Development Program.

 

A-2

 

“Regulatory Authority”  means the FDA or any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of any
federal, state, county, city or other political subdivision, domestic or
foreign, that performs a function for such political subdivision similar to the
function performed by the FDA for the United States with regard to the
approval, licensing, registration or authorization to test, manufacture,
promote, market, distribute, use, store, import, transport or sell a product in
the defined territory or political subdivisions.

“Regulatory Filing”  means a new drug application (“NDA”)
or biologic license application (“BLA”) or any foreign counterparts
thereof and any other filings required by Regulatory Authorities relating to
the manufacture of Product under this Agreement.

“Regulatory Requirements” means (i) obtaining and
maintaining any and all permits, licenses, filings and certifications required
by the FDA or other Regulatory Authorities, and compliance with the cGMPs of
the FDA or other Regulatory Authorities, applicable to any manufacturing or
processing activities hereunder or the Manufacturing Facility or other
facilities at which any of the manufacturing or processing activities hereunder
are performed, and (ii) any Laws, rules, guidelines, regulations, and
standards of any Governmental Authority, whether within or outside the United
States (including, without limitation, the Environmental Protection Agency
(EPA), the Occupational Safety and Health Administration (OSHA), the Drug Enforcement
Administration (DEA) and state and local authorities), that apply to any
manufacturing or processing activities hereunder or the Manufacturing Facility
or other facilities at which any of the manufacturing or processing activities
hereunder are performed.

“Specifications” means those Specifications as set forth in the
applicable Regulatory Filings for the Product or such other specifications as
the FDA will approve, as such specifications may be amended from time to time
by SuperGen in accordance with the terms and conditions of this Agreement or as
may be required to obtain approval from the FDA and other applicable regulatory
authorities and which may include release specifications for raw materials,
released intermediates, and other components.

“Third Party”  means any person other than the Parties
and their respective Affiliates.

“Validated Analytical Test Procedures” means the testing and
qualification procedures mutually agreed between *** and SuperGen for the
Materials or Product.

“Waste” will mean any “hazardous substance” and/or “hazardous
material” as provided under the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA), any “hazardous waste” as provided
under the Resource Conservation and Recovery Act (RCRA), and/or any other waste
material, pollutant and/or contaminant of any kind including, without
limitation, any routine process waste or any by-product arising from any
activities conducted pursuant to this Agreement.

 

A-3

 

EXHIBIT B

Development
Program

***

 

 

B-1

 

Exhibit C

 

Minimum Terms and
Conditions of Commercial Supply of Decitabine

 

***

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