EXHIBIT 10.81


[* * *] REDACTED CONFIDENTIAL TREATMENT REQUESTED


PENTOSTATIN SUPPLY AGREEMENT


THIS PENTOSTATIN SUPPLY
AGREEMENT (the “Agreement”) is effective as of the 13th day of
December, 2002 (“Effective Date”) by and between Hauser Technical Services, Inc.,
a Delaware corporation with principal offices at 6880 N. Broadway, Ste. H,
Denver, Colorado 80221 (“Hauser”) and SuperGen, Inc., a Delaware corporation
with principal offices located at 4140 Dublin Blvd, Suite 200, Dublin,
California 94568 (“SuperGen”).


WHEREAS,
SuperGen desires Hauser to batch process Pentostatin Crude Concentrate in
accordance with the Master Production Record (as defined herein) as allowed by
cGMP to yield pentostatin API (as used herein, pentostatin API is referred to
as “Active Pharmaceutical Ingredient” and “API”);


WHEREAS,
Hauser has the necessary facilities, personnel and professional experience to
batch process [***] of Pentostatin Crude Concentrate per Batch (as defined
herein) and perform Stability Studies (as defined herein); and


WHEREAS,
SuperGen and Hauser desire to incorporate the terms and conditions of the
Quality Systems Agreement for Production of Pentostatin, executed by the
parties on August 30, 2002 (the “Quality Agreement”), as Exhibit A to this
Agreement.


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


1.             DEFINITIONS


1.1       “Affiliate”
of a party shall mean any corporation or other business entity controlled by,
controlling or under common control with, such party.  For this purpose “control” shall mean direct or indirect
beneficial ownership of more than fifty percent (50%) of the voting or income
interest in such corporation or other business entity or the ability to direct
policy or management of such corporation or other business entity.


1.2       “Active
Pharmaceutical Ingredient” or “API” is defined in the Quality Agreement.


1.3       “Batch”
is defined in the Quality Agreement.


1.4       “Batch
Record” shall mean the document(s) created pursuant to 21 CFR § 211.188 et.
seq., as the same may be amended, relating to each Batch that is Processed
that, if complete and accurate, reflects and incorporates aspects of the Master
Production Record specific to the Batch, and shall include, if applicable,
production support documents (line clearances and charts), TCA’s, MRB’s, copies
of raw analytical data, a Certificate of Analysis, and any Exception Reports
issued with respect to such Batch.


 

















 


1.5       “Contract
Year” shall mean the 12-month period commencing on the Effective Date of this
Agreement, and each subsequent 12-month period thereafter.


1.6       “Campaign”
shall mean a minimum of three (3) Batches, but no more than five (5) Batches.


1.7       “Certificates
of Analysis” shall mean the document(s) associated with each of the Raw
Materials and Containers used when each Batch is Processed, specifying the
results of analytical testing (if applicable) on such Raw Materials and
Containers to assure such Raw Materials and Containers meet appropriate Raw
Materials and Containers Specifications.


1.8       “cGMPs”
shall mean the then current Good Manufacturing Practices, as specified in
regulations at 21 CFR §§ 210-211 et seq., and by International Conference on
Harmonisation (“ICH-Q7A”) guidelines applicable to the manufacture of Active
Pharmaceutical Ingredients for human use in the United States including current
FDA policies and guidance documents and industry practices applicable to the
manufacture of API, which may be modified or amended throughout the Term of
this Agreement.


1.9       “Containers”
is defined in the Quality Agreement.


1.10     “Deliverables”
shall mean, with respect to each Batch, the Hauser Release Certificate (if
applicable), a copy of the completed and approved manufacturing Batch Record, a
copy of any deviation or investigational reports, the Certificates of Analysis
for all Raw Materials and Containers used, the Hauser Certificate of Analysis
for the API and the packaged API.


1.11     “Facility”
and “Facilities” shall mean Hauser’s Gunbarrel facility at 4750 Nautilus Court
S., Boulder, Colorado 80301 and Hauser’s Clear Creek facility located at 6880
N. Broadway Suite H, Denver, Colorado 80221.


1.12     “Failed
Batch” shall mean any Batch (a) which does not conform to the requirements of
the Specifications, or (b) fails to meet a cGMP requirement, or (c) was not
Processed in accordance with the Master Production Record as allowed by cGMP,
such that identity, purity, strength or potency is compromised.


1.13     “FDA”
is defined in the Quality Agreement.


1.14     “Gunbarrel
Facility” shall mean Hauser’s Gunbarrel facility at 4750 Nautilus Court S.
Boulder, Colorado 80301.


1.15     “Hauser’s
Approval Date” is defined in the Quality Agreement


1.16     “Hauser
Certificate of Analysis” shall mean a certificate issued by Hauser documenting
the final API analytical test results and indicating whether or not API
Specifications are met.


1.17     “Hauser
Release Certificate” shall mean a letter or other document issued by Hauser for
a Batch, certifying that the API Specifications have been met, and that per
Hauser’s review the Batch complies with cGMPs and the Batch Record is complete
and accurate.


1.18     “Hazardous
Waste” is defined in the Quality Agreement.


1.19     “Exception
Report” shall mean a report indicating any deviation from the Processing
procedures or Specifications set forth in the Master Production Record.


 


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1.20     “Master
Production Record” is defined in the Quality Agreement.


1.21     “Material
Review Board” shall mean a committee that reviews deviations and out of
specification results for Raw Materials, in-process materials and API, and
determines the actions needed to investigate the deviation, the
corrective/preventive action, and disposition of the product. The MRB is
composed of management representatives from Quality Assurance, Quality Control,
and Manufacturing.


1.22     “MSDS”
is defined in the Quality Agreement.


1.23     “NDA”
shall mean new drug application.


1.24     “NDA
Supplement” shall mean a supplemental filing to a NDA.


1.25     “Non-hazardous
Waste” is defined in the Quality Agreement.


1.26     “Pentostatin
Crude Concentrate” shall mean pentostatin crude concentrate as supplied to
Hauser by SuperGen or parties authorized by SuperGen.


1.27     “Pentostatin
NDA Submissions” shall mean documents, records and data submitted as part of
the pentostatin NDA.


1.28     “Process”,
“Processed” or “Processing” shall mean the pharmaceutical processing procedures
for the Deliverables as described in the Master Production Record as allowed by
cGMP.  Processing will be performed in
Suite Number One at the Gunbarrel Facility.


1.29     “Processing
Fees” shall mean the processing fees set forth in Schedule A of this Agreement.


1.30     “Raw
Materials” and “Components” shall have the meaning set forth in the attached
Quality Agreement.


1.31     “Regulatory
Authority” is defined in the Quality Agreement.


1.32     “Schedules”
shall mean the schedules and exhibits attached hereto and incorporated herein
by this reference.


1.33     “Sponsor
Release Letter” is shown, as an example, in Schedule E.


1.34     “Specification”
shall generally mean those specifications for Raw Materials, Containers and
API.  When determining the
Specifications for Raw Materials and Containers,  reference shall be made to the Pentostatin NDA Submissions and
supplement(s) thereto or current Master Production Record and the applicable
vendor Certificates of Analysis.  When
determining the Specifications for API, reference shall be made to  P/N 4424 and Schedule B.


1.35     “Stability
Studies” is defined in the Quality Agreement.


1.36     “Stability
Study Fees” shall mean the stability study fees set forth in Schedule A of this
Agreement.


1.37     “SuperGen
Equipment” has the meaning set forth in Section 13.


1.38     “USP”
shall mean the United States Pharmacopeia.


 


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1.39     “Validation
Agreement” shall have the meaning set forth in Section 19.3.


1.40     “Waste
Contractor” shall mean a company responsible by contract with Hauser for removing
hazardous and non-hazardous wastes from Hauser facilities and disposing of
wastes according to state and federal regulations.


1.41     “Work
-in -Process” shall mean all labor, the Pentostatin Crude Concentrate and Raw
Materials expended or included in processing the API, beginning on the date
set-up for manufacturing is initiated, and ending on the date Processing is
ceased.


2.             PROCESSING ARRANGEMENT


2.1       Processing
Responsibility.  During the Term (as
defined herein), Hauser shall Process the Pentostatin Crude Concentrate with
approved and released Raw Materials into API and produce the Deliverables in
accordance with the directions contained in the Master Production Record as
allowed by cGMP.  Hauser shall Process
the Batch with the skills reasonably required of a contract research
organization that tests and manufactures drug substances and is regulated by
the FDA.  Hauser shall also provide
SuperGen the Batch Records, copies of raw data, all calculated data, Exception
Reports and other documents approved by Hauser’s QA Department for review prior
to shipping the Deliverables.  Hauser
shall ship all Deliverables with SuperGen’s instructions.


2.2       Sub-Contracting.  Hauser shall not, without prior notification
to SuperGen, sub-contract any part of its responsibilities under this Agreement
to another party.


3.             RAW MATERIALS, COMPONENTS,
CONTAINERS, AND LABELING


3.1       Supply.  Upon the receipt by Hauser of (i) SuperGen’s
forecast pursuant to Section 5.1, (ii) a valid purchase order from SuperGen,
and (iii) advance payment from SuperGen pursuant to Section 6.5, Hauser shall
acquire the Raw Materials and Containers in sufficient quantity to meet the
requirements in the purchase order.  If
Hauser determines that the continued supply of any of the Raw Materials (except
Pentostatin Crude Concentrate) and Containers might be interrupted or not
available in a timely fashion or in accordance with quality standards, then
Hauser shall promptly inform SuperGen so that the parties may seek alternate
suppliers.  The cost of the Raw
Materials (except Pentostatin Crude Concentrate) and Containers shall be borne
by Hauser.  If the parties mutually
determine that it makes business sense for SuperGen to supply any Raw Materials
or Containers from the approved vendors listed in Hauser’s specification
documents, then the cost of required quantities of Raw Materials or Containers
purchased by SuperGen and supplied to Hauser shall be deducted from the price
of the Batches involved, which price is determined under Section 6.4.


3.2       Verification.  Pursuant to 21 CFR § 211.84, during the Term
Hauser is responsible for inspection and testing Components and Containers
according to the mutually agreed-upon quality methods.  Hauser shall certify that the Components and
Containers received meet the specifications documented in the NDA and most
current submission.


3.3       Availability.  The parties acknowledge that performance by
Hauser under this Agreement is conditioned upon SuperGen’s performance in
providing Pentostatin Crude Concentrate and the SuperGen Equipment, and that
such performance also may be affected by the satisfactory availability of
qualifiable Raw Materials and Containers. 
To the extent that Hauser becomes aware of problems with respect to the
availability of qualifiable Raw Materials and Containers, Hauser will promptly
notify SuperGen. Hauser shall inform SuperGen reasonably in advance of making
major changes in Suite Number One that would affect its performance under this
Agreement.


 


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4.             CRUDE CONCENTRATE


4.1       Delivery
of Pentostatin Crude Concentrate. 
At least ten (10) calendar days, but not more than thirty (30) calendar
days, prior to the start date for Processing each Batch, SuperGen shall furnish
to Hauser, at no cost to Hauser, a sufficient amount of Pentostatin Crude
Concentrate to Process at least one (1) Batch, but no more than number of
Batches in one Campaign.  Hauser will
not be required to store Pentostatin Crude Concentrate for more than one
Campaign.


4.2       Production
Standards.  Hauser shall use all
reasonable efforts to Process each Batch (i) to meet the yield set forth in the
Master Production Record; (ii) in accordance with instructions and production
requirements in the Master Production Record as allowed by cGMP; and (iii) to
meet the Specification and cGMP requirement of such Batch.  It is understood by the parties that
Hauser’s responsibility is to Process according to the Master Production Record
as allowed by cGMP.


4.3       Storage.  Other than while Processing a Batch, Hauser
shall store Pentostatin Crude Concentrate at a temperature of  -10 to -30 degrees centigrade at all times.


4.4       Damage.  If any damage or loss of Pentostatin Crude
Concentrate occurs prior to completing Processing of the API and such damage or
loss is the result of Hauser’s mishandling of the Pentostatin Crude Concentrate
(whether by negligence or breach of its obligations under this Agreement
(including the Quality Agreement as incorporated)), then to remedy such loss or
damage, Hauser shall credit SuperGen on the next invoice (or if it is the last
Batch of Campaign, reimburse SuperGen within 30 days) for:


(a)               the
cost of labor and Raw Materials (if any) that were used, damaged or lost in
conjunction with the lost or damaged Pentostatin Crude Concentrate, provided
SuperGen paid for such labor and Raw Materials, and


(b)               $[***]
to mitigate the loss of the Pentostatin Crude Concentrate.


Hauser
shall provide SuperGen with written notification of loss or damage promptly
after it occurs.


The parties acknowledge that the above
credits (or reimbursement) of the labor and Raw Materials used, damaged or lost
and the $[***] payment [(including interest on credits or reimbursement not
timely made, which shall be calculated in the same manner as interest is
calculated in Section 6.5 herein)] shall be the sole and exclusive remedy of
SuperGen pursuant to this Section 4.4. 
The parties further acknowledge that to the extent Hauser is obligated
to credit SuperGen pursuant to this Section 4.4, Hauser shall not have an additional
obligation to credit SuperGen pursuant to this Agreement, including, without
limitation, Section 8.2 of this Agreement.


5.             ORDERS AND TIMING


5.1       Forecast.  During the Term, SuperGen shall provide to
Hauser written forecasts on January 15th and June 15th of each Contract
Year.  The forecast shall set forth the
number of Batches SuperGen will require Hauser to Process over the subsequent
12-month period.


5.2       Non-use
of Facility.  SuperGen acknowledges
that (i) in order to satisfy Hauser’s obligations pursuant to this Agreement,
Hauser will reserve Suite Number One within the Gunbarrel Facility for
Processing; (ii) Hauser’s reservation of such cGMP suite for use pursuant to
this Agreement significantly limits the ability of Hauser to use such suite to
provide services to its other clients; and (iii) Hauser has 


 


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reserved such cGMP suite with the expectation
that SuperGen will require Hauser to Process at least three  (3) Batches in
each Contract Year.  SuperGen agrees
that in the event that it does not order Processing and delivery of at least
three (3) Batches in each Contract Year, SuperGen shall pay to Hauser an amount
equal to the product obtained by multiplying (A) [***] dollars times (B) the
difference obtained by subtracting (a) the number of Batches purchased by
SuperGen during the applicable Contract Year from (b) [***] (such product being
the “Shortfall Payment”).  SuperGen
shall pay the Shortfall Payment within thirty (30)  calendar days  following
the end of the Contract Year.  To the
extent SuperGen fails to pay Hauser the Shortfall Payment within such period,
Hauser shall be entitled to interest on the Shortfall Payment calculated in the
manner set forth in Section 6.5 herein.  SuperGen shall be entitled to
offset any amounts owed pursuant to this Section 5.2 by advance payments paid
by SuperGen to Hauser towards the Batches that are not Processed by Hauser
during the applicable Contract Year, excluding
those amounts paid by SuperGen for authorized acquisition and qualification of
Raw Materials.  The parties acknowledge
that the amount of actual loss to Hauser stemming from SuperGen’s failure to
require Hauser to Process at least three (3) Batches in each Contract Year is
impossible or difficult to ascertain, and the amount called for in this Section
5.2 is reasonably proportionate to the probable loss, and is Hauser’s sole and
exclusive remedy for SuperGen’s failure to require Hauser to Process and
deliver the minimum amount of API. 
Shortfall Payment does not apply in the event SuperGen terminates this
Agreement under Section 18, provided, however, the facilities are
in continuous use up to the point of termination.


5.3       Processing.  Upon receipt of a valid purchase order from
SuperGen and the amount of advance payment required under Section 6.5,  Hauser will conduct Processing of Batches in
the quantities set forth on such purchase order and pursuant to this
Agreement.  During each Contract Year,
SuperGen agrees to submit at least one purchase order for a Campaign.  Hauser will make reasonable efforts to
initiate Processing upon receipt of an approved purchase order and advance
payment from SuperGen, and to obtain and qualify Components and Containers
within three (3) months thereafter.  The
parties acknowledge that Processing will take approximately nine (9) weeks per
Batch after Raw Materials are released.


6.             DELIVERY AND PAYMENT TERMS


6.1       Acceptance.  For each Batch, Hauser will provide SuperGen
with the Batch Record, Certificate(s) of Analysis, the Hauser Release
Certificate, and sample of API, if requested, pursuant to Section 8.1.  SuperGen shall have thirty (30) calendar
days from the date of receipt of all such documentation to review that
documentation and test samples, and notify Hauser if SuperGen determines that
the API is a Failed Batch, or if there are discrepancies in the Batch Record,
Certificate(s) of Analysis and the Hauser Release Certificate, such that the
Batch is not in compliance with cGMP. 
If SuperGen determines that the Batch is a Failed Batch or there are
discrepancies in the Batch Record, Certificate(s) of Analysis and the Hauser
Release Certificate, such that the Batch is not in compliance with cGMP (as
discussed in the preceding sentence), SuperGen shall provide Hauser written
notification specifically setting forth the basis of SuperGen’s determination
that the API was a Failed Batch and/or its determination that there are
discrepancies in the Batch Record, Certificate(s) of Analysis and the Hauser
Release Certificate, such that the Batch is not in compliance with cGMP.  Failure to notify Hauser within the thirty
(30) day period shall constitute acceptance of the Batch by SuperGen.


6.2       Shipping.  Upon SuperGen’s acceptance of the Batch,
either by Hauser’s receipt of a Sponsor Release Letter from SuperGen, or
SuperGen’s failure to timely notify Hauser pursuant to Section 6.1, Hauser will
ship the packaged API, Hauser Release Certificate and Hauser Certificate of
Analysis to the destination as specified by SuperGen.  Delivery of the Deliverables shall be deemed to have taken place
upon delivery to a common carrier at a Facility with appropriate instructions
and forwarding documents.  Thereafter,
the handling, possession, use or sale of the Deliverables shall be the sole
responsibility of SuperGen.


 


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6.3       Storage.  At no cost to SuperGen, Hauser shall store
the Processed API according to the Master Production Record and the Quality
Agreement, in a controlled temperature room which is currently defined by USP
25 as being between fifteen and thirty degrees centigrade (15o to 30oC).


6.4       Fees.  Processing Fees and Stability Study Fees for
the first Contract Year are set forth in Schedule  A to this Agreement.  The
Stability Study Fees are not applicable until the FDA qualifies Hauser as a
stability testing site.  Upon completion
of the first Contract Year, Hauser may adjust the Processing Fees and the
Stability Study Fees each subsequent Contract Year thereafter.  In adjusting the Processing Fees and the
Stability Study Fees pursuant to this Section 6.4, Hauser shall be entitled to
adjust such fees to include increases in costs and expenses incurred by Hauser
in connection with its businesses, including, without limitation,
increased costs of labor, storage and overhead incurred by Hauser; provided,
however, in adjusting such Processing Fees and Stability Study Fees,
Hauser shall take into account changes in the cost of materials; provided
further, however, such increases in the Processing Fees and the
Stability Study Fees shall not exceed the then-current consumer price index
(urban west) plus three percent (3%). 
The parties acknowledge that the foregoing shall not limit Hauser’s
ability to increase the fees pursuant to Section 6.8 and 10 herein.  Notwithstanding the above, Hauser agrees to
provide SuperGen with two (2) copies of any changed documents and supporting
documentation for the change at no cost to SuperGen.


6.5       Payment
Terms.  With each purchase order,
SuperGen shall provide an advance payment equal to one-third (1/3) of the total
cost of the Campaign being ordered, which amount will be used to purchase and
test Raw Materials and Containers.  If
Raw Materials or Containers are obtained through a separate agreement for use
in the performance of this Agreement, or if those items are provided by
SuperGen, then the costs will be deducted from that advance payment for
equivalent Batches. The remainder of the cost of the Campaign will be invoiced
by Hauser in equal installments, by Batch, in the following manner:  the first invoice for each Batch shall be
issued at the time Processing on that Batch commences; and the second invoice
shall be issued upon acceptance of that Batch by SuperGen pursuant to Section
6.1 of this Agreement.  The payment term
is thirty (30) calendar days from SuperGen’s receipt of the invoice, after
which time interest shall be due and payable on all undisputed, unpaid balances
at the lower of 1.5% per month or the highest lawful contract rate.  SuperGen shall make checks payable to
“Hauser Technical Services, Inc.” and send payment to Hauser Technical
Services, Inc., Attn: Accts Receivables, P.O. Box 211414, Denver, CO 80221.


6.6       Sales
and Use Taxes.  SuperGen shall be
responsible for the payment of any sales, use, value-added and other taxes
assessed on the API and associated services provided by Hauser to SuperGen, but
specifically excluding any taxes on Hauser’s net income.


6.7       Consultant
and Legal Fees.  The costs
associated with obtaining legal and consulting services in support of meeting
foreign regulatory requirements for manufacture of the API shall be negotiated
by the parties in a separate agreement.


6.8       Other.  If cGMPs are amended, Hauser shall have
thirty (30) calendar days from the date of receiving the amendment to submit
supporting documentation to SuperGen for approval if Hauser’s costs increase
due to such amendments. The parties acknowledge that cost increases resulting
from changes in the requirements for the Facility not directly related to the
Processing of Pentostatin Crude Concentrate are Hauser’s responsibility, and
cost increases due to changes in manufacture or handling of the API are
SuperGen’s responsibility.


 


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7.             INSPECTION AND AUDITING RIGHTS


7.1       Processing
and Packaging.  Hauser shall permit
SuperGen or its representatives, at no additional cost to SuperGen, to observe
and consult with Hauser during the Processing, including the quality control
testing and analysis of the API; provided, however, such
observation and consulting rights are conditioned upon SuperGen and its
representatives receiving appropriate training and meeting all safety
requirements.  Neither SuperGen nor its
representatives will physically participate in Processing. SuperGen’s
observation and audit rights shall be limited to five (5) working days per
Batch.  If SuperGen requires additional
time per Batch (other than for following up on observed problems), SuperGen
shall reimburse Hauser at full billable rates. 
In either case, SuperGen shall bear the costs of its own travel and
lodging. Observation and consulting time by SuperGen may cause delays in the
processing schedule, but Hauser shall notify SuperGen of those delays promptly.


7.2       Inspections
and Audits.  Annually, SuperGen
shall have the right during normal business hours, and at no additional cost to
SuperGen, to (i) inspect Hauser’s Facilities and documentation relating
directly to the API, the Processing or to the system support used to Process
the API; (ii) inspect and  audit all
equipment facilities, operations, procedures and records relating directly to
the API, the Processing or to the system support used to Process the API; and
(iii) audit and certify Hauser’s laboratory where quality control testing of
the API is conducted pursuant to this Agreement.  SuperGen shall provide Hauser at least two (2) weeks advance
notice of its intent to inspect or audit. Audit dates will be mutually agreed
upon by the parties.  The inspection or
audit shall be limited to four (4) working days per year.  SGI’s right to inspect and audit also
includes follow-up audits, if needed to verify corrective actions directly
related to Pentostatin or to the system support used to process Pentostatin. In
either instance, SuperGen shall bear the costs of its own travel and lodging.
Inspections of a Facility and documentation by SuperGen may cause delays in the
processing schedule, but Hauser shall notify SuperGen of those delays promptly.


8.             TESTING AND INSPECTION OF API


8.1       Batch
Records.  Hauser shall use
reasonable efforts to have Hauser’s Approval Date for a Batch occur within
fifteen (15) business days following Processing of such Batch. Within five (5)
business days after each Hauser Approval Date, Hauser shall send a complete and
accurate copy of the Batch Record and Hauser Certificate of Analysis applicable
to such Batch to SuperGen.


8.2       Independent
Testing.  Within the timeframe
specified for inspection pursuant to Section 6.1 of this Agreement, SuperGen
may inspect the submitted documentation and test API samples to determine if
the API is a Failed Batch.  If the
parties disagree with the results of such inspection or testing, either party
may request, in writing at any time, that an independent consultant or
laboratory be used to make the determination. 
Thereafter, the parties shall promptly agree to and name a reputable
independent consultant or laboratory (the “Consultant”) to review and test the
API samples and/or submitted documentation. 
The selected Consultant must be appropriately qualified in order to make
such determination. Pending a decision by the Consultant, Hauser shall store
the API in accordance with Section 6.3.


            (a)        If the Consultant
determines that the submitted documentation indicates that the API was
Processed in accordance with the Master Production Record as allowed by cGMP,
SuperGen shall pay to:


(1)   Hauser the Processing Fees for that Batch due
pursuant to Section 6, and


 


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(2)   the Consultant the amount of fees charged by
the Consultant for such review and testing.


            (b)        If the Consultant
determines that the submitted documentation indicates that the API was not
Processed in accordance with the Master Production Record as allowed by cGMP,
Hauser shall:


(1)   pay to the Consultant the amount of fees
charged by the Consultant for such review and testing; and


(2)   credit SuperGen on the next invoice (or if it
is the last Batch of Campaign, reimburse) for amounts calculated in the manner
provided pursuant to Section 4.4 of this Agreement.


The parties acknowledge that the above
credits or reimbursement are SuperGen’s sole and exclusive remedy pursuant to
Section 8.2.  The parties further
acknowledge that to the extent Hauser is obligated to credit (or reimburse)
SuperGen pursuant to this Section 8.2, Hauser shall not have an additional
obligation to credit (or reimburse) SuperGen pursuant to this Agreement, including,
without limitation, Section 4.4 of this Agreement.


8.3       Failure
by Hauser to Process In Accordance With the Master Production Record.  If without resorting to the Consultant
described in Section 8.2, the parties mutually agree that any of the
Deliverables were not Processed in accordance with the Master Production Record
as allowed by cGMP due to Hauser’s breach of its obligations pursuant to this
Agreement, the parties shall investigate the noncompliance and Hauser shall use
reasonable efforts to remedy all such noncompliance prior to its Processing of
the next Batch in accordance with Section 8.2(b)(2).


8.4       Failure
To Meet Specifications.  If without
resorting to retaining a Consultant as described in Section 8.2, the parties
agree that the Batch is a Failed Batch due to no fault of Hauser, Hauser shall
be paid the Processing Fees in full. 
SuperGen, at SuperGen’s sole option and cost, shall (i) request that
Hauser reprocess the API as mutually agreed upon, if allowed by the Master
Production Record prior to Hauser Processing the next Batch, or (ii) request
disposal or return of the non-conforming API in accordance with the terms of
this Agreement.  SuperGen acknowledges
Hauser will have met its obligation under this Agreement for Processing a Batch
when it complies with this provision.


8.5       Samples.  Within five (5) business days following
SuperGen’s request for samples pursuant to Section 6.1, Hauser shall ship
routine samples taken as directed in the Master Production Record, or such
additional samples as reasonably requested by SuperGen, at SuperGen’s expense
(release of additional samples is subject to decision of the Material Review
Board) to such destinations as instructed by SuperGen, F.O.B. the Facility, for
purposes of quality control. SuperGen will notify Hauser at least one (1) week
prior to the point in Processing at which SuperGen desires Hauser to pull the
additional samples. The costs associated with any additional samples not
included in the Master Production Record are not included in the Processing Fee
for such Batch and will be invoiced by Hauser accordingly.  SuperGen has the option to periodically monitor
the accuracy and reliability of the analytical tests performed by Hauser on the
API.


9.             REGULATORY COMPLIANCE AND RELATED
MATTERS


9.1       NDA
Supplement.  SuperGen shall (i) be
solely responsible for applying for and obtaining all approvals from Regulatory
Authorities relating to registration of the API; (ii) pay any applicable user
fee for such registration of the API; and (iii) own the NDA Supplement.  Upon the request of SuperGen, Hauser shall
cooperate as reasonably necessary to assist SuperGen in obtaining such
approvals.


 


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9.2       Inspections.  Hauser shall allow representatives of
Regulatory Authorities to inspect and audit its Facilities.  To the extent that representatives of a
Regulatory Authority request an inspection and audit of the Facilities for the
purpose of inspecting and auditing the Deliverables or any components thereof,
Hauser shall notify SuperGen promptly, and, in any event, not later than one
(1) business day following the request of such a Regulatory Authority.  Unless otherwise prohibited by the
Regulatory Authority, SuperGen shall have the option of having a reasonable
number of its representatives onsite at (i) any such inspection or audit or
(ii) any meeting with such Regulatory Authorities to discuss the results of
such inspection or audit.  Unless
otherwise prohibited by the Regulatory Authority, after the inspection and
audit has been completed, Hauser shall notify SuperGen in writing of the
results of such inspection or audit.  Within
five (5) business days of the receipt by Hauser of documentation from the
Regulatory Authority performing such inspection and audit Hauser will provide
SuperGen copies of any resulting document of action (including FDA Form 483
inspection observation report and regulatory letters, etc.) resulting
therefrom; provided, however, Hauser shall have no obligation to
provide such documentation to SuperGen to the extent such documentation is not
related to API or to the suites of the Facility reserved for Processing the
API.  Unless the Regulatory Authority
prohibits disclosure of the results of such inspection or audit by Hauser to a
third party, including, without limitation, SuperGen, Hauser
shall inform SuperGen of such results and Hauser shall work together in
preparing responses to such inspection and audit; provided, however,
SuperGen shall have the responsibility for submitting responses on filing
issues related to the process provided by SuperGen to Hauser, related to
Pentostatin Crude Concentrate and related to the API, while Hauser shall have
the responsibility for submitting responses on issues related to the Facility; provided
further, however, to the extent SuperGen does not provide the
foregoing responses within the deadline set by the Regulatory Authority, Hauser
shall have the right to respond on such matters.  If any Regulatory Authority determines that Hauser is not in
compliance with any applicable laws, rules, regulations, or requirements, to
the extent the API or Deliverables are or could reasonably be expected to be
affected by such non-compliance, Hauser shall promptly inform SuperGen.  In addition, if Hauser agrees with such
determination, Hauser shall inform SuperGen of its plans to come into compliance
with such laws, rules, regulations and requirements and shall continue to keep
SuperGen informed of its progress until compliance has been attained.  SuperGen shall reimburse Hauser at full
billable rates for pentostatin-specific inspections.  Hauser shall bear the cost of general cGMP inspections or a
general cGMP audit, even if such general inspection or audit focuses on
pentostatin processes.


9.3       Communications.  If Hauser intends to submit documentation to
the Regulatory Authorities or otherwise communicates with Regulatory
Authorities (including, without limitation, one or more responses
to the FDA under Section 9.2), then to the extent such communications relate
directly to the API or could reasonably be expected to affect the API, Hauser
shall submit all such regulatory filings and other communications jointly with
SuperGen or shall obtain SuperGen’s advance notice, consent and reasonable
approval with respect to those items related to the API.  Hauser shall advise SuperGen in advance of
any material changes Hauser intends to make to any documents to the extent
those changes relate directly to the API, and shall request that SuperGen
submit such changes to the FDA.  Hauser
shall notify SuperGen promptly of any adverse finding by any Regulatory Authority
that relates directly to the API or that could reasonably be expected to affect
the API.


9.4       Modifications
to Equipment and Facility.  Hauser
shall notify SuperGen of any modifications to parts of the Facility used for
Processing or storage if such modifications impact or otherwise could reasonably
be expected to affect the API or the Master Production Record.  Hauser shall not implement any Material
Changes (as defined below) relating to the API without obtaining prior written
approval from SuperGen, which approval shall not be unreasonably withheld.  As used in this Section 9.4, a “Material
Change” shall mean any change that  (a)
impacts the regulatory commitments made to Regulatory Authorities for the API;
or (b) will require revalidation; or (c) could reasonably be expected to affect
the quality, purity, identity, strength or yield of the in process or finished
API; or (d) would necessarily result in changing or modifying the
Specifications; or (e) constitutes a significant change to 


 


10

















 


test methods, sampling procedures, Hauser’s
standard operating procedures or the Master Production Record; or (f) would
require material modifications to the equipment used in the Facility. Hauser
shall pay for any expenses to the extent they are for any modifications and
Material Changes made to the Facility initiated by Hauser; such changes may not
be the basis of any increase in the Processing Fee.  SuperGen shall pay for any expenses to the extent they are for any
modifications and material changes made to Processing the Deliverables, or if
the changes are in excess of cGMP requirements initiated by SuperGen.


9.5       Responsibility
for Compliance.  SuperGen shall be
responsible for and ensure the compliance of the API and the Master Production
Record, including Specifications, with the requirements of applicable
Regulatory Authorities; provided, however, that the foregoing
shall not limit Hauser’s obligations hereunder.  Hauser shall comply in all material respects with all applicable
laws and regulations, rules, ordinances, injunctions, orders and decrees, and
shall maintain in effect all required governmental permits, licenses, orders,
applications and approvals regarding the API and the use of its Facilities to
Process and store the API, and Hauser shall Process and store the API in
accordance with all such permits, licenses, orders, applications and approvals.


10.          MSDS


Hauser
shall comply with the procedure set forth in the MSDS associated with the
Pentostatin Crude Concentrate, API and Raw Materials.  If MSDS’s for the API or Pentostatin Crude Concentrate are
amended, SuperGen shall promptly provide Hauser with all such amendments.  Hauser shall, within thirty (30) days of
receipt of such amendment, notify SuperGen in writing whether and the extent to
which its production costs for the API will increase, or decrease, as the case
may be, as a result of such amendment. 
Any increase in Hauser’s production costs and the Processing Fee must be
directly related to changes required with respect to the API, Pentostatin Crude
Concentrate, or Raw Materials, and shall be supported by documentation and
submitted to SuperGen for approval, which approval shall not be unreasonably
withheld.  The Processing Fee will be
increased by the agreed amount as of the date such amendment impacted or
impacts production costs, but no earlier than thirty (30) calendar days after
such amendment, by the amount of such additional or reduced production costs,
and the related schedules will be amended accordingly. Fee increases under this
Section are not subject to Section 6.4.


11.          MAINTENANCE OF RECORDS AND REPORTS


11.1     By
Hauser.  Hauser shall maintain
Records (as defined below) as specified in Hauser’s P/N 4674, Document
Retention Procedures and cGMPs.  During
the Term, Hauser will consult with SuperGen prior to destroying any Records
related to Processing pentostatin API. 
If SuperGen wishes to retain Records beyond the standard Hauser
retention periods, SuperGen may request that (i) the Records be sent to
SuperGen or (ii) the Records be stored by Hauser, the cost of which will be
borne by SuperGen.  As used in this
Section 11.1, “Records” shall mean Batch Records, records of purchase orders,
Hauser invoices and payments received from SuperGen, Certificates of Analysis
from vendors for Raw Materials received, records of Pentostatin Crude
Concentrate furnished, API and Deliverables Processed, Works-in-Process,
Pentostatin Crude Concentrate and API analyses, and file samples kept in the
ordinary course, in each case “Records” shall only mean those “Records required
by cGMP” directly related to Processing the API. To the extent required by law,
Hauser shall also keep and maintain Records relating to regulatory compliance,
environmental, health or safety and quality assurance and quality control of
the API.  Hauser shall make all such
Records available for inspection by SuperGen or its representatives and shall
allow SuperGen to copy such Records as SuperGen may designate.  The cost of additional copies for SuperGen
shall be borne solely by SuperGen.  Each
party acknowledges that it has legal obligations regarding record-keeping, and
will use its best efforts to comply with those obligations.


 


11

















 


11.2     By
SuperGen.  With the exception of the
documentation required to be made or kept by Hauser pursuant to Section 11.1,
SuperGen shall maintain such documentation relating to the manufacture, sale
and distribution of any final drug or pharmaceutical incorporating the
Deliverables as is required by all applicable rules, laws and regulations.


12.          REVISIONS TO MASTER PRODUCTION RECORD
OR SPECIFICATIONS


12.1     Master
Production Record.  Any proposed
change to the Master Production Record must be approved by both parties.  No revisions to the Master Production Record
that would affect the Processing of the API or Deliverables shall be submitted
to the FDA unless approved by both parties in writing.  Both parties acknowledge that implementation
due to changes may delay Processing.


12.2     Difference
in Cost.  SuperGen shall notify
Hauser in writing of any proposed revisions to the Master Production Record,
test methods or the Specifications (the “Proposed Revisions”).  To the extent the Proposed Revisions are
greater than required under cGMP, SuperGen shall be responsible for costs
incurred in implementing the Proposed Revisions.  Hauser shall, within thirty (30) calendar days of receipt of such
notice, notify SuperGen in writing whether and the extent to which the
foregoing Processing costs for the API will increase or decrease as a result of
such Proposed Revisions (i.e., costs not related to the Facility or its
maintenance as required by cGMP).  Any
proposed increase in Hauser’s costs shall be supported by documentation and submitted
to SuperGen for approval.  If SuperGen
elects to adopt the Proposed Revision, the then current Processing Fees and/or
Stability Study Fee (as set forth in Schedule A) will be adjusted and the
related schedules will be amended accordingly. 
Hauser shall not implement a Proposed Revision until SuperGen elects to
adopt the Proposed Revision.


12.3     Hauser
Unable to Comply.  If Hauser
determines it is technically unable to comply with a Proposed Revision it shall
so inform SuperGen.  To the extent a
Proposed Revision is required by cGMP or a Regulatory Authority, SuperGen may
terminate pursuant to Section 18.2(h).


12.4     Hauser
Initiated Changes.  Hauser shall
bear the cost of all changes that Hauser initiates to the Master Production
Record, test methods or Specifications to correct grammar or format, or to
clarify instructions (“Hauser Initiated Changes”).  Any revision resulting from process changes will not be regarded
as Hauser Initiated Changes.


13.          TITLE; EQUIPMENT


13.1     Ownership.  Title to all Pentostatin Crude Concentrate,
all Work -in -Process, all API and/or Deliverables Processed for SuperGen
(including stability samples), standards for pentostation, and the s-isomer
standards shall at all times remain in SuperGen (collectively, the “SuperGen
Property”).  Provided SuperGen is
current in all payments owed to Hauser, SuperGen may at its sole discretion for
any reason notify Hauser that it wishes to take possession of the SuperGen
Property and Hauser shall permit SuperGen or its representatives to do so
during regular business hours and upon reasonable advance notice.  Notwithstanding any provision in this
Agreement to the contrary, if SuperGen takes possession of such SuperGen
Property as set forth herein, SuperGen accepts such SuperGen Property in “AS
IS” condition, and Hauser shall (i) not be responsible or liable for the
condition of such SuperGen Property or the compliance or failure of any
Work-in-Process to meet the Specifications; or (ii) have any further
obligations with respect to such SuperGen Property, except to the extent that
SuperGen Property represents SuperGen’s Confidential Information or
intellectual property rights, in which case it is further subject to applicable
law and the other provisions of this Agreement.  Hauser shall acquire no right, title or interest in the SuperGen
Property.  Except with SuperGen’s prior
written consent, the SuperGen Property may be used by Hauser only to satisfy
its obligations under the Agreement. 
Hauser shall not take or permit any action inconsistent with SuperGen’s
ownership interest in the SuperGen Property, 


 


12

















 


including,
but not limited to, the imposition
of any lien or other encumbrance thereon, the conveyance of any interest
therein, or any use thereof, except as authorized by the terms of this
Agreement.  Hauser  shall not encumber or grant a security
interest in or to the SuperGen Equipment. 
Hauser shall pay all costs associated with securing the release of any
such liens, encumbrances and interests on the SuperGen Property.


13.2     SuperGen
Equipment.  The parties each
acknowledge that SuperGen has paid for and has provided certain equipment and
materials to Hauser, which equipment and materials are identified in Exhibit D
(the “SuperGen Equipment”). SuperGen shall own all right, title and interest in
and to the SuperGen Equipment.  These
provisions shall apply to equipment purchased and provided by SuperGen to
Hauser in the future for Processing under this Agreement.


            (a)        Hauser may use the
SuperGen Equipment for the sole purpose of performing its obligations under
this Agreement.  Hauser shall use the
SuperGen Equipment only in accordance with instructions prescribed by SuperGen
or the manufacturer of the SuperGen Equipment. 
Hauser shall only provide routine maintenance to the SuperGen Equipment
in accordance with Hauser standard operating procedures, the manufacturer’s and
SuperGen’s instructions, at no additional charge to SuperGen, during the
Term.  Except in connection with routine
maintenance, Hauser shall not, without SuperGen’s written consent, make any
alterations, additions or improvements to the SuperGen Equipment.  All alterations, additions or improvements
so approved shall become the property of SuperGen.


            (b)        SuperGen retains title
to the SuperGen Equipment. Hauser assumes any risk of loss, damages, theft or
destruction while the SuperGen Equipment is in Hauser’s possession or on
Hauser’s premises, except to the extent such risk of loss, damage, theft or
destruction could not have been prevented by Hauser exercising reasonable care.


            (c)        THE SUPERGEN EQUIPMENT
IS PROVIDED AS IS. SUPERGEN MAKES NO WARRANTIES, EXPRESS, IMPLIED OR STATUTORY,
WITHOUT RESPECT TO THE SUPERGEN EQUIPMENT LOANED HEREUNDER, INCLUDING BUT NOT
LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.


13.3     SuperGen
Equipment Option. Upon termination or expiration of this Agreement,
SuperGen may offer to Hauser the option to purchase any or all of the SuperGen
Equipment, or SuperGen may request Hauser promptly to return any and all of the
SuperGen Equipment and materials to SuperGen. 
If SuperGen offers Hauser the option to purchase the SuperGen Equipment,
then Hauser may at its option, purchase any or all of the SuperGen Equipment
and/or materials from SuperGen at a price equal to the then current fair market
value of the SuperGen Equipment.  For
the SuperGen Equipment that SuperGen does not offer Hauser the option to
purchase or for which Hauser declines to do so, Hauser promptly shall return
the SuperGen Equipment to SuperGen.  SuperGen
Equipment returned to SuperGen must be returned freight prepaid by SuperGen and
properly insured, in its original condition, reasonable wear and tear
excepted.  Repairs to damaged SuperGen
Equipment caused by Hauser’s neglect, that is not of reasonable wear and tear,
will be paid by Hauser.  Disassembly,
removal, shipping and insurance shall be at SuperGen’s expense.


14.          WARRANTIES AND REPRESENTATIONS


14.1     Hauser’s
Warranties.  The services performed
while Processing the API and preparing the Deliverables shall be executed in a
professional manner.


 


13

















 


            (a)        Hauser further warrants
that the API and Deliverables shall be Processed or otherwise prepared in
accordance with the Master Production Record as allowed by cGMP and as
specified by SuperGen and accepted by Hauser, and Processed and handled as
required under this Agreement in all material respects.


            (b)        Hauser agrees that it
will comply in all material respects with appropriate federal, state, and local
laws, regulations, guidelines and industry standards that may be applicable to
Processing, including the handling of the Hazardous Waste prior to pick up by
the Waste Contractor, and the handling and disposal of the Non-Hazardous Waste.


            (c)        Hauser states that to
its knowledge there are no pending or threatened governmental actions it is
aware of at the time of execution of this Agreement that could result in an
injunction or affect Hauser’s ability to provide the Processing hereunder.


            (d)        Hauser agrees that
during the Term, it will not assert any of its intellectual property rights
against SuperGen with respect to the processes or procedures used to
manufacture pentostatin API performed by or on behalf of SuperGen.


            (e)        Hauser warrants that,
to its actual knowledge, its processes and procedures for Processing the API do
not infringe the intellectual property rights of any third party.


14.2     SuperGen’s
Warranties.  SuperGen hereby
represents and warrants that the Pentostatin Crude Concentrate shall, at the
time it is shipped to Hauser.


            (a)        not be adulterated or
misbranded within the meaning of the Federal Food Drug and Cosmetic Act
(“FFDCA”) or within the meaning of any applicable state or municipal law in
which the definitions of adulteration and misbranding are substantially the
same as those contained in the FFDCA;


            (b)        not be articles that
may not, under Section 505 of the FFDCA or any other provision of the FFDCA or
any other applicable law, statute or regulation, be introduced into interstate
commerce;


            (c)        have been manufactured,
Processed, and packed in compliance with all requirements under the FFDCA
(including drug establishment registration and applicable good manufacturing
practice) or under any other applicable laws, rules, or regulations of the
United States or any other country in which the Pentostatin Crude Concentrate
is manufactured; and


            (d)        conform to the
identifications for the Pentostatin Crude Concentrate set forth in the Master
Production Record and conform to the release specifications documented in the
Certificate of Analysis included with each delivery of Pentostatin Crude
Concentrate, confirming the identity and purity of such Pentostatin Crude
Concentrate.


            (e)        To the actual knowledge
of SuperGen, the handling, use, packaging, sale or distribution by SuperGen or
its Affiliates of the Pentostatin Crude Concentrate or API does not infringe
the intellectual property rights of any third parties.


14.3     Disclaimer.  NEITHER PARTY MAKES ANY WARRANTIES, EITHER
EXPRESS, IMPLIED OR OTHERWISE, EXCEPT THOSE HEREIN EXPRESSLY PROVIDED.  HAUSER SPECIFICALLY DISCLAIMS THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE OF ANY
FINISHED PRODUCT WHICH INCORPORATES OR UTILIZES THE WORK PRODUCT
HEREUNDER.  SUPERGEN SPECIFICALLY
DISCLAIMS THE IMPLIED WARRANTIES OF MERCHANTABILITY AND OF 


 


14

















 


FITNESS FOR A PARTICULAR PURPOSE OF THE
PENTOSTATIN CRUDE CONCENTRATE SUPPLIED TO HAUSER FOR WORK PERFORMED HEREUNDER.


15.          RECALLS AND PRODUCT LIABILITY ISSUES


If any Regulatory Authority or law shall
request or require the recall of all or some of the API (including, without
limitation, the finished formulated product incorporating the API) or require
the dissemination of information regarding the API, SuperGen shall promptly
notify Hauser in writing pursuant to Section 22 of such recall or required
dissemination and SuperGen shall consult with Hauser regarding the timely
compliance with all applicable laws and regulations. If there is an inquiry by
another public agency having jurisdiction or by a private party with legal
standing, then the party with knowledge of such inquiry shall inform the other
party promptly after it becomes aware of such inquiry.  In any of the foregoing circumstances,
Hauser shall cooperate as reasonably required and at the request of SuperGen,
assist SuperGen in effecting a recall, or providing or disseminating
information, all on a time and materials basis.  SuperGen is responsible for compliance with the requirements of
the Regulatory Authorities concerning the reporting of adverse effects which
may occur as the result of the use of the API.


16.          FORCE MAJEURE


16.1     Excusing
Performance.  Either party shall be
excused from performing its obligations under this Agreement to the extent that
its performance is delayed or prevented by an event beyond such party’s
reasonable control, including, but not limited to, acts of God,
fire, flood, earthquake, explosion, weather, disease, war, insurrection, civil
strife, riots, government action, or power failure (such event, a “Force
Majeure Event”).  Upon the occurrence of
a Force Majeure Event, the party whose performance is so affected shall
promptly give written notice to the other party of the occurrence or
circumstances upon which it intends to rely to excuse its performance.  Duties and obligations of both parties shall
be suspended for the duration of the Force Majeure Event; provided, however,
a party shall not be relieved of its obligation to make payments already due
and payable for services performed prior to the Force Majeure Event.


16.2     Resumption.  Each party shall employ reasonable efforts,
at its cost, toward resumption of its performance hereunder if such performance
is delayed or interrupted by reason of a Force Majeure Event.


17.          INDEMNIFICATION AND LIMIT OF LIABILITY


17.1     SuperGen’s
Indemnification.  SuperGen shall
defend, indemnify, and hold harmless Hauser, its officers, agents, employees
and Affiliates from any loss, claim, action, damage, expense or liability
(including reasonable defense costs and reasonable attorneys’ fees) (a “Hauser
Loss”) arising out of or relating to:


            (a)        The breach of any
representation, warranty or obligation made by SuperGen herein; or


            (b)        The handling,
possession, use, sale or distribution by SuperGen or its Affiliates of
Pentostatin Crude Concentrate or API, including packaged API, including,
but not limited to, any claims arising out of or in connection with the
design, development, manufacture, assembly, packaging or labeling of API or
packaged API; or


            (c)        Infringement of a
trademark owned by a third party relating to the Processing; or


 


15

















 


            (d)        Negligence or willful
misconduct of SuperGen or its officers, agents or employees.


SuperGen’s indemnification obligation
pursuant to this Section 17.1 shall be limited proportionately (but not
extinguished) to the extent any such Hauser Loss is due to the negligence or
willful misconduct of Hauser or its Affiliates, officers, agents, or employees,
due to a breach by Hauser of any of its representations, warranties or
obligations in this Agreement, or to the extent Hauser is required to indemnify
SuperGen with respect to the same circumstance. SuperGen shall not be liable
for any civil or regulatory liabilities relating to the disposal by Hauser of
any Hazardous or Non-hazardous Waste generated by Hauser.


17.2     Hauser’s
Indemnification.  Hauser shall
defend, indemnify, and hold harmless SuperGen, its officers, agents, employees
and Affiliates from any loss, claim, action, damage, expense or liability
(including reasonable defense costs and reasonable attorneys’ fees) (“SuperGen
Loss”) arising out of or relating to:


            (a)        The breach of any
representation, warranty or obligation of Hauser herein; or


            (b)        Infringement of Hauser
patents; or


            (c)        Negligence or willful
misconduct of Hauser or its officers, agents or employees.  This indemnification is limited to any
injury directly caused by Hauser employees due to their failure to follow the
procedures set forth in the cGMP, MSDS, or Hauser’s standard operating
procedures.


Hauser’s indemnification obligation pursuant
to this Section 17.2 shall be limited proportionately (but not extinguished) to
the extent such SuperGen Loss is due to the negligence or willful misconduct of
SuperGen, its Affiliates, officers, agents, or employees, due to a breach by
SuperGen of any of its representations, warranties or obligations in this
Agreement, or to the extent SuperGen is required to indemnify Hauser with
respect to the same circumstance. 
Hauser shall not be liable for any civil regulatory liabilities relating
to the disposal of any Hazardous or Non-Hazardous Waste from the API generated
by SuperGen after SuperGen takes delivery of the API.


17.3     Procedures
and Limits. Provided that prompt notice is given of any potential or
claimed Hauser Loss or SuperGen Loss, the indemnifying party promptly will
defend, contest, or otherwise protect against any such potential or claimed
Hauser Loss or SuperGen Loss, as applicable, at its own cost and expense; provided,
however, the failure so to notify the indemnifying party will not
relieve its indemnification obligation pursuant to this Section 17 unless and
to the extent the indemnifying party did not otherwise learn of such action and
such failure results in the forfeiture by the indemnifying party of substantial
rights and defenses. The indemnified party may, but will not be obligated to,
participate at its own expense in a defense thereof by counsel of its own
choosing, but the indemnifying party shall be entitled to control the defense
unless the indemnified party has relieved the indemnifying party from liability
with respect to the particular matter. 
The indemnifying party has no obligation with respect to costs or
attorney’s fees that are incurred prior to the indemnified party’s having
informed the indemnifying party of the potential or claimed Hauser Loss or
SuperGen loss or that are a result of a compromise or settlement entered into
without the indemnifying party’s consent; and the indemnified party shall not,
except at its own cost and expense and with the prior written approval of the
indemnifying party which shall not be unreasonably withheld, compromise or
settle, or seek to compromise or settle, any claim resulting from a Hauser Loss
or SuperGen Loss, as applicable. 
Subject to Section 17.5, if the indemnifying party fails to timely
defend, contest, or otherwise protect against any such Hauser Loss or SuperGen
Loss after written notice by the indemnified party, which notice includes a
deadline to initiate or continue the defense, then the indemnified party may,
but will not be obligated to, defend, contest, or otherwise protect against the
same, and make any compromise or settlement thereof, and recover the 


 


16

















 


entire costs thereof from the indemnifying
party, including reasonable attorneys’ fees, disbursements, and all amounts
paid as a result of such Hauser Loss or SuperGen Loss, if applicable or the
compromise or settlement thereof.  The
indemnified party shall cooperate and provide such assistance as the
indemnifying party may reasonably request in connection with the defense of the
matter subject to indemnification.


17.4     Insurance.


            (a)        Hauser shall maintain
Property of Others insurance in the amount of $[***] for processing Pentostatin
Crude Concentrate.  Hauser shall
maintain General Liability Insurance coverage including coverage for products
and completed operations that is consistent with what is reasonable and
customary in the industry.  Hauser shall
provide SuperGen a certificate Liability Insurance coverage upon request.  SuperGen will be notified at least thirty
(30) days prior to cancellation except ten (10) days for non-payment of premium
per Colorado law.


            (b)        SuperGen shall maintain
commercial general liability insurance coverage including coverage for products
and completed operations that is consistent with what is reasonable and
customary in the industry.


17.5     Limitation
of Liability.  Excluding a breach of
the provisions of Section 19, in no event shall either party be liable or
responsible for any direct, indirect, incidental or consequential loss or
damage of any nature whatsoever, including, without limitation,
any lost profits, loss of use, business interruption, loss of data or cost of
cover, arising out of this Agreement, even if such party has been advised of
the possibility of such damages. 
Excluding a breach of the confidentiality provisions set forth in
Section 19.1 and/or the non-compete provisions in Section 19.3, in no event
shall Hauser’s aggregate liability (i) pursuant to Sections 17.2 and 17.3 or
(ii) for breach of this Agreement or related to the services provided pursuant
to this Agreement, exceed the fees actually paid to Hauser by SuperGen
hereunder for the services directly resulting in the loss.  Excluding a breach of the confidentiality
provision set forth in Section 19.1, in no event shall SuperGen’s aggregate
liability (y) pursuant to Sections 17.1 or 17.3 or (z) for breach of this
Agreement or related to the services provided pursuant to this Agreement,
exceed the fees actually paid to Hauser by SuperGen hereunder, for the
applicable Campaign.


17.6     Employees.  As between the parties, SuperGen is
responsible for its own employees, including during the time those employees
are at a Facility.  As between the
parties, an employer is responsible for any injury to its employees (regardless
of their location) provided that such injuries are not caused by the gross
negligence or willful misconduct of the other party.


18.          TERM AND TERMINATION


18.1     Term.  Unless otherwise terminated pursuant to
Section 18.2, this Agreement shall commence as of the Effective Date and shall
continue for a period of two (2) years, thereafter (the “Initial Term”).  The Initial Term may be renewed for
additional one-year periods upon the mutual written agreement of SuperGen and
Hauser.  The Initial Term and any
renewal term are referred to collectively as the “Term”.  Notwithstanding the foregoing, any Stability
Studies under this Agreement (subject to Section 18.2) continue until the
Stability Study itself is completed.


18.2     Termination:  This Agreement may be terminated upon any of
the following:


            (a)        This Agreement may be
terminated upon the mutual written consent of Hauser and SuperGen.


 


17

















 


            (b)        SuperGen may elect to
terminate an ongoing Stability Study, provided SuperGen pays to Hauser such
reasonable costs for Work-in-Progress and a termination fee of $1,000 per
Stability Study.  If a Stability Study
is terminated because the associated API is a Failed Batch, or because the FDA
rejects Hauser as a testing site, then the $1,000 termination fee shall be
waived.  If the Batch is a Failed Batch
due to Hauser’s breach of its obligations under this Agreement (including the
Quality Agreement as incorporated herein) or the submitted documentation is not
in accordance with the Master Production Record as allowed by cGMP, then
SuperGen also is not required to pay for Work-in-Progress.


            (c)        Hauser may terminate
this Agreement if Hauser or its successors choose to move to a location other
than the Facilities, provided Hauser renders SuperGen twelve (12) months prior
written notice of termination.  In that
case, Hauser and SuperGen each shall cooperate to enter into an agreement to
cease production.


            (d)        Either party shall have
the right to terminate this Agreement effective upon written notice to the
other party in the event: (a) the non-notifying party becomes insolvent or makes
an assignment for the benefit of creditors; (b) a receiver is assigned to the
non-notifying party; or (c) bankruptcy proceedings are instituted against the
non-notifying party or on the non-notifying party’s behalf.


            (e)        Either party may
terminate this Agreement if the other party (i) materially breaches any of its
obligations under this Agreement, and fails to cure such material breach within
thirty (30) days following receipt of written notice from the non-breaching
party, or (ii) repeatedly breaches any of its obligations under this Agreement,
the cumulative effect of which constitutes a material breach of this Agreement,
and fails to cure and cease committing repeated breaches within thirty (30)
days following written notice from the non-breaching party.


            (f)         Either party may
terminate this Agreement if there is a Force Majeure Event which continues for
a period of sixty (60) days from the date written notice is given by the party
claiming a Force Majeure Event.  The party
terminating the Agreement due to a Force Majeure Event shall give notice that
it intends to terminate because of such Force Majeure Event.


            (g)        Hauser may terminate
this Agreement if SuperGen:


(1)   does not approve increases to the Processing
Fees, to the extent the increase is due to cost increases for MSDS pursuant to
Section 10  herein; or


(2)   removes SuperGen Property pursuant to Section
13.1 herein, and such removal prevents Hauser from fulfilling its obligations
hereunder, which shall be determined by Hauser in its sole discretion.


In the event Hauser terminates this Agreement
pursuant to this Section 18.2(g), SuperGen shall immediately pay to Hauser
Hauser’s reasonable costs due to such termination, including the cost of Raw
Materials unique to the performance of the tasks under this Agreement (but only
to the extent the Raw Materials were procured as required under this Agreement
and cannot be used by Hauser in the ordinary course of business). In addition
to the costs of termination, within thirty (30) calendar days from the date
Hauser terminates pursuant to this Section 18.2(g), SuperGen shall pay Hauser a
termination fee of [***] dollars.  To
the extent SuperGen fails to pay Hauser the amounts owed to it within such
thirty (30) day period, Hauser shall be entitled to interest on such payment
calculated in the manner set forth in Section 6.5 herein.


 


18

















 


            (h)        If Hauser determines
that it is technically unable to comply with a Proposed Revision pursuant to
Section 12.2 and/or SuperGen is unwilling to accept any increase in the
Processing Fee arising therefrom, SuperGen may choose to exercise one of the
following options:


(1)   If the Proposed Revision is not necessary in
order to ensure Processing is in compliance with cGMP, SuperGen may  either:


(i)     withdraw the Proposed Revision and continue
Processing according to then-existing methodology; or


(ii)   terminate the Agreement pursuant to Section
18.2(i) (for SuperGen’s convenience).


(2)   If the Proposed Revision is necessary in
order to ensure Processing is in compliance with  cGMP, SuperGen may terminate the Agreement; in which case
Hauser will reimburse SuperGen any amounts paid in advance, whether for Raw
Materials or for Processing.


            (i)         For SuperGen’s
Convenience.  SuperGen may terminate
this Agreement upon thirty (30) days written notice to Hauser for any reason or
no reason.  In the event SuperGen elects
to terminate this Agreement pursuant to this Section 18.2(i), SuperGen shall
immediately pay to Hauser Hauser’s reasonable costs due to such termination,
including the cost of Raw Materials unique to the performance of the tasks
under this Agreement (but only to the extent the Raw Materials were procured as
required under this Agreement and cannot be used by Hauser in the ordinary course
of business).  In addition to the costs
of termination, within thirty (30) calendar days from the date SuperGen
terminates pursuant to this Section 18.2(i), SuperGen shall pay Hauser a
termination fee of [***] dollars.  To
the extent SuperGen fails to pay Hauser the amounts owed to it within such
thirty (30) day period, Hauser shall be entitled to interest on such payment
calculated in the manner set forth in Section 6.5 herein.


18.3     Upon
termination of this Agreement, regardless of the reasons or the party
initiating termination, Hauser shall:


            (a)        furnish to SuperGen a
complete inventory of the following in its possession:


(1)   the Pentostatin Crude Concentrate,


(2)   Work-in-Process,


(3)   finished API,


(4)   stability samples,


(5)   all SuperGen Equipment,


(6)   Raw Materials, and


(7)   One (1) copy of all current versions of
SuperGen-specific documents.


            (b)        at SuperGen’s option,
either dispose of Pentostatin Crude Concentrate according to the waste handling
procedures documented in the Quality Agreement, or return the Pentostatin Crude
Concentrate to SuperGen, at SuperGen’s expense, in accordance with SuperGen’s
instruction,


            (c)        deliver to SuperGen API
Processed pursuant to and commenced by Hauser against purchase orders from
SuperGen and paid for in accordance with this Agreement,


            (d)        deliver to SuperGen all
unused Raw Materials and Containers paid for in advance by SuperGen, and


 


19

















 


            (e)        deliver to SuperGen, at
SuperGen’s expense, the SuperGen Equipment, SuperGen Property, and any other
equipment and materials provided by SuperGen to Hauser pursuant to this
Agreement.


18.4     The
expiration or termination of this Agreement shall not operate to release any
party from any liability incurred prior to or upon termination hereof.


19.          CONFIDENTIALITY AND NON-COMPETITION


19.1     Confidential
Information.


            (a)        The term “Confidential
Information” shall mean any information disclosed by one party to the other
party in connection with this Agreement and in connection with preparing the
Hauser Facility and Processing the API. 
Confidential Information disclosed by the parties in writing shall be
marked as “CONFIDENTIAL”, “SECRET”, or the like.  Likewise, Confidential Information disclosed orally, shall be
incorporated in a written document within thirty (30) calendar days of
disclosure, shall also be marked “CONFIDENTIAL”, “SECRET”, or the like.


            (b)        Each party shall, and
shall use reasonable efforts to cause its officers, agents and employees who
receive Confidential Information to, treat as confidential all Confidential
Information received from the other party, shall not use such Confidential
Information except as expressly permitted under this Agreement, and shall not
disclose such Confidential Information to any third party without the other
party’s prior written consent.  Each
party shall take reasonable measures to prevent the disclosure and unauthorized
use of Confidential Information of the other party; those measures including,
without limitation, providing access only to those employees who are
subject to Hauser’s standard confidentiality agreements, which includes
provisions regarding non-use and non-disclosure of third party confidential
information. Neither party shall disclose the other party’s Confidential
Information to any third parties unless the non-disclosing party gives advance
approval, and those third parties have executed an agreement protecting the
non-disclosing party’s Confidential Information to the same extent as protected
under this Agreement.  The obligations
in this Section continue for the shorter of ten (10) years after termination or
expiration of this Agreement or until the Confidential Information is in the
public domain.


            (c)        After termination or
expiration of this Agreement and upon request by the disclosing party, the
recipient of Confidential Information shall at the disclosing party’s option
either return the disclosing party’s Confidential Information or destroy such
Confidential Information and certify such destruction in writing, provided retention
of such Confidential Information by Hauser or SuperGen is not mandated by any
Regulatory Authority.


19.2     Exceptions.  Notwithstanding the above, the restrictions
of Section 19.1 shall not apply to Confidential Information that:


            (a)        Was independently
developed by the receiving party without any use of the Confidential
Information of the other party and by employees or other agents of (or
independent contractors hired by) the receiving party who have not been exposed
to the Confidential Information;


            (b)        Becomes known to the
receiving party, without restriction, from a third party without breach of this
Agreement and who had a right to disclose it;


            (c)        Was in the public
domain at the time it was disclosed or becomes in the public domain through no
act or omission of the receiving party;


 


20

















 


            (d)        Was rightfully known to
the receiving party, without restriction, at the time of disclosure (provided
that this exclusion shall not apply to the Confidential Information); or


            (e)        is disclosed pursuant
to the order or requirement of a court, administrative agency, or other
governmental body; provided, however, that the receiving party
shall provide prompt notice thereof to the other party and shall use reasonable
efforts to cooperate with the disclosing party if it elects to obtain a
protective order or otherwise prevent public disclosure of such information all
at the disclosing party’s expense.


19.3     Exclusivity
Period.  In order to preserve the
confidentiality of SuperGen’s Confidential Information and to protect
SuperGen’s substantial investment of money, time and regulatory advice, Hauser
agrees that for a period beginning on the Effective Date and ending [***] years
after the last Batch is Processed (“Exclusivity Period”) under this Agreement,
neither Hauser nor any Related Entity (as defined below) will: (i) manufacture,
sell or otherwise distribute the Pentostatin Crude Concentrate or API, except
at the direction of SuperGen; or (ii) assist any third parties to manufacture,
sell or otherwise distribute the Pentostatin Crude Concentrate or the API; or
(iii) perform any research or other services 
with respect to the Pentostatin Crude Concentrate or the API.  A “Related Entity” is any entity: (i)
controlled by Hauser; or (ii) in which Hauser has a substantial equity
interest; or (iii) that has the ability to control or direct what is done at
the Facility and has an indirect or direct corporate relationship with
Hauser.  Upon the expiration of the
Exclusivity Period, SuperGen shall provide prompt notice to Hauser that
indicates the Exclusivity Period has expired. 
The Exclusivity Period supersedes all previous agreements between the
parties regarding exclusivity, including, without limitation, the
Pentostatin Processing Services Agreement, dated as of May 4, 2001, by and
between Hauser and SuperGen (the “Validation Agreement”).  The parties acknowledge that Hauser’s
obligations with respect to this Section 19.3 shall apply solely with respect
to Suite Number One at the Gunbarrel Facility (the suite at which Processing of
the Pentostatin Crude Concentrate pursuant to this Agreement is completed) and
shall not limit Hauser’s or a Related Party’s ability to provide the services
set forth in subsections (i), (ii) and (iii) above at locations other than
Suite Number One of the Gunbarrel Facility. 
Failure of SuperGen to provide notice of the expiration of the
Exclusivity Period, shall not be deemed to extend the Exclusivity Period.


20.          INDEPENDENT CONTRACTOR


The
parties are independent contractors. 
Neither party shall be deemed to be an employee, agent, partner or legal
representative of the other for any purpose and neither shall have any right,
power or authority to create any obligation or responsibility on behalf of the
other.


21.          PUBLIC STATEMENTS


Neither
party shall use or refer to the name of such other party in any public
statements, whether oral or written, including, but not limited to,
shareholder reports, communications with stock market analysts, press release or
other communications with the media, or prospectuses, advertising or sales
promotional material or in any other way, without the other party’s prior
written consent, except for factual references to the existence of this
Agreement.  Notwithstanding the foregoing,
nothing in this Section 21 will preclude any party from making any disclosures
required by law or regulation or necessary and proper in conjunction with the
filing of any tax return or other document required to be filed with any
federal, state or local governmental body, authority or agency, including to
comply with the accounting and the Securities and Exchange Commission
disclosure obligations. If a party does find it necessary to make such
disclosures or file such documents, then, to the extent reasonably practicable,
it shall consult with the other party at least three calendar  days in advance of such disclosure or
filing, and 


21

















 


the
parties will determine which portions to redact, or which other methods to use
to keep that information confidential.


22.          NOTICES


Any
notice required or permitted to be given hereunder shall be deemed sufficient
if sent by facsimile letter or overnight courier, (e.g. DHL, Federal Express,
etc.), certified United States mail, or delivered by hand to Hauser or SuperGen
at the respective addresses and facsimile numbers set forth below or at such
other address and facsimile number as either party hereto may designate if sent
by Certified United States Mail, notice shall be deemed given five (5) days
after posting.  If sent by facsimile
letter, notice shall be deemed given when the transmission is completed if the
sender has a confirmed transmission report. 
If a confirmed transmission report does not exist, then the notice will
be deemed given when the notice is actually received by the person to whom it
is sent.  If delivered by overnight
courier, notice shall be deemed given when it has been signed for.  If delivered by hand, notice shall be deemed
given when received.  All correspondence
to Hauser shall be addressed as follows:


Hauser
Technical Services, Inc.


6880 N. Broadway Ste H


Denver CO 80221


Attention: Contract
Administrator


Fax: 720-406-4614


cc:           Hauser Technical Services, Inc.


                4750 Nautilus Court South


                Boulder, CO 80301


                Attention: Peggi Thompson


                Fax: 303-530-7083


Correspondence
to SuperGen regarding technical matters shall be sent to:


SuperGen,
Inc.


4140
Dublin Blvd, Suite 200


Dublin, California 94568


Attention: QA Department at
fax: 925-551-6479


cc: PharmOps Department at
fax:  925-461-1734


All
other correspondence to SuperGen shall be sent to:


SuperGen,
Inc.


4140 Dublin Blvd, Suite 200


Dublin, California 94568


Attention: Lucy Chang


Fax: 925-551-6483


23.          ASSIGNMENT


This
Agreement may not be assigned by either party, whether by operation of law or
otherwise, without prior written consent of the other party, which shall not be
unreasonably withheld. Notwithstanding the foregoing, either party may assign
this Agreement in connection with a merger, asset 


22

















 


sale,
spin off, change of control or similar transaction.  Subject to the foregoing, this Agreement will bind and inure to
the benefit of the parties, their respective successors and permitted assigns.


24.          GOVERNING LAW; ARBITRATION


24.1     Except
as provided below, any and all disputes arising under or related to this
Agreement which cannot be resolved through negotiations between the parties
shall be submitted to binding arbitration. 
If the parties fail to reach a settlement of their dispute within
fifteen (15) days after the earliest date upon which one of the parties
notified the other(s) of its desire to attempt to resolve the dispute, then the
dispute shall be promptly submitted to arbitration by a single arbitrator
through JAMS Endispute (“JAMS”).  The
arbiter shall be selected by JAMS on the basis, if possible, of his or her
expertise in the subject matter(s) of the dispute.  The decision of the arbitrator shall be final, nonappealable and
binding upon the parties, and it may be entered in any court of competent
jurisdiction.


24.2     In
the event SuperGen initiates arbitration, arbitration shall take place in
Colorado.  The arbitrator shall be bound
by the laws of the State of Colorado applicable to the issues involved in the
arbitration and all Colorado rules relating to the admissibility of evidence, including,
without limitation, all relevant privileges and the attorney work
product doctrine.  All discovery shall
be completed in accordance with the time limitations prescribed in the Colorado
rules of civil procedure, unless otherwise agreed by the parties or ordered by
the arbitrator on the basis of strict necessity adequately demonstrated by the
party requesting an extension of time.


24.3     If
arbitration is initiated by Hauser, arbitration shall take place in
California.  The arbitrator shall be
bound by the laws of the State of California applicable to the issues involved
in the arbitration and all California rules relating to the admissibility of
evidence, including, without limitation, all relevant privileges
and the attorney work product doctrine. 
All discovery shall be completed in accordance with the time limitations
prescribed in the California rules of civil procedure, unless otherwise agreed
by the parties or ordered by the arbitrator on the basis of strict necessity
adequately demonstrated by the party requesting an extension of time.


24.4     In
either case, the arbitrator shall issue a written opinion setting forth his or
her decision and the reasons therefor within thirty (30) days after the
arbitration proceeding is concluded. 
The obligation of the parties to submit any dispute arising under or
related to this Agreement to arbitration as provided in this Section shall
survive the expiration or earlier termination of this Agreement.  Notwithstanding the foregoing, either party
may seek and obtain an injunction or other appropriate relief from a court to
preserve or protect trademarks, tradenames, copyrights, patents, trade secrets
or other intellectual property or proprietary information or to preserve the
status quo with respect to any matter pending conclusion of the arbitration
proceeding, but no such application to a court shall in any way be permitted to
stay or otherwise impede the progress of the arbitration proceeding.


24.5     In
the event of any arbitration or litigation being filed or instituted between
the parties concerning this Agreement, the prevailing party will be entitled to
receive from the other party or parties its reasonable attorneys’ fees, witness
fees, costs and expenses, court costs and other reasonable expenses, whether or
not such controversy, claim or action is prosecuted to judgment or other form
of relief.


24.6     Notwithstanding
anything to the contrary in this Section 24, either party may apply to a court
having jurisdiction for injunctive or other equitable relief.


 


23

















 


25.          SEVERABILITY


If
any provision of this Agreement is held by a court of competent jurisdiction to
be contrary to law, such provision shall be changed and interpreted so as to
best accomplish the objectives of the original provision to the fullest extent
allowed by law and the remaining provisions of this Agreement shall remain in
full force and effect.


26.          SURVIVAL OF TERMS


In
the event of an expiration or termination of this Agreement pursuant to Section
18, this Agreement shall forthwith become void and there shall be no further
liability on the part of any party hereto (i) except Sections 1, 17.1, 17.2,
17.3, 17.5, 19, 22, 24, 25 and 26 hereof shall survive the expiration or
termination of this Agreement pursuant to their terms and the parties hereto
shall be entitled to enforce such provisions pursuant to their respective terms
notwithstanding any such expiration or termination; and (ii) nothing herein
shall relieve either party from liability for any breach hereof occurring on or
prior to the date of such expiration or termination, including, without
limitation, obligations of the parties to make payments hereunder.


27.          ADDITIONAL TERMS


27.1     Entire
Agreement.  This Agreement,
including the Quality Agreement incorporated herein and all schedules attached
hereto, constitutes the final and complete agreement between the parties with
respect to Processing Batches of Pentostatin Crude Concentrate and API, but
only for activities covered under this Agreement and undertaken after the
Effective Date.  Except as provided in
Section 19.3 herein, earlier agreements remain in effect for the items covered
therein; provided, however, in the event of any conflict or other
difference between this Agreement and earlier agreements (including the
Validation Agreement), the provisions of this Agreement shall control.


27.2     Amendments:
No Waiver.  No modification,
amendment or waiver of any provision this Agreement shall be effective unless
in writing and signed by both parties. 
No failure or delay by either party in exercising any right, power, or
remedy under this Agreement, except as specifically provided herein, shall
operate as a waiver of any such right, power or remedy.  Purchase orders, releases, purchase
acknowledgements, bills of lading and other routine documents which may be used
by the parties in the course of transactions hereunder shall be used for
convenience only and to the extent inconsistent herewith the terms and
provisions of this Agreement shall control and not be amended or otherwise
modified by such documents.


27.3     Interest.  In the event either Hauser or SuperGen is
required to make a payment to the other party pursuant to the terms of the
Agreement and such payment expressly provides for interest to accrue thereon
pursuant to or in accordance with Section 6.5 hereof, the parties acknowledge
that interest shall not accrue on such payment if the party obligated to make such
payment is delayed due to an investigation, analysis, review and/or inspection
by an insurer providing coverage for such payment; provided, however,
in the event the insurer’s investigation, analysis, review and/or inspection
results in such insurer declining coverage for such payment, interest shall
accrue on the payment pursuant to the express terms of this Agreement.


27.4     Headings.  The descriptive headings are inserted for
convenience of reference only and are not intended to be part of or to affect
the meaning of or interpretation of this Agreement.


27.5     Signatures.  Faxed signatures on written amendments are
deemed acceptable provided the signatures are rendered by duly authorized
personnel.


 


24

















 


IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
as of the day and year written below to be effective as of the Effective Date.


 


	
  Hauser
  Technical Services, Inc.

  	
   

  	
  SuperG  en, Inc.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ RODNEY B. MCKEEVER

  	
   

  	
  By:

  	
  /s/ DR. JOSEPH RUBINFELD

  
	
   

  	
  Rodney B. McKeever, P.E.

  	
   

  	
   

  	
  Joseph Rubinfeld, Ph.D.

  
	
   

  	
  VP & Managing
  Director, Hauser CRO

  	
   

  	
   

  	
  President and CEO

  
	
  Date: December 17, 2002

  	
   

  	
  Date: December 13, 2002

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ DAN W. CHILDERS

  	
   

  	
   

  	
   

  
	
   

  	
  Dan W. Childers, R.A.C

  	
   

  	
   

  	
   

  
	
   

  	
  Director, Pharm Quality
  Unit

  	
   

  	
   

  	
   

  
						



 


Date:  December 18, 2002


 


25

















 


Exhibit A


Quality
Agreement


[***]


 


 

















 


Schedule A


Processing Fees for API


Stability Study Fees


[***]


 


 


 

















 


Schedule B


API Specifications


[***]


 


 


 

















 


Schedule C


Stability Protocol


[***]


 


 


 

















 


Schedule D


SuperGen Equipment


[***]


 


 


 

















Schedule E


Sponsor Release Letter


[***]