Exhibit 99.4
CONFIDENTIAL TREATMENT REQUESTED
* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.
U.S. DISTRIBUTION AGREEMENT
This U.S. Distribution Agreement (the "Agreement") is made as of December 21,
1999 by and between SuperGen, Inc., a Delaware corporation ("SuperGen"), with
its principal offices at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇, and ▇▇▇▇▇▇ Laboratories, an Illinois corporation ("Abbott"), with its
principal offices at ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇.
RECITALS:
WHEREAS, SuperGen has received regulatory approval for its proprietary drug
Nipent -Registered Trademark- (Pentostatin);
WHEREAS, SuperGen desires to collaborate with Abbott with respect to the
distribution of such product in the continental United States, Hawaii and
Alaska;
WHEREAS, Abbott desires to collaborate with SuperGen with respect to such
product;
WHEREAS, the parties desire to enter into this Agreement for an interim period
of time and expect to negotiate thereafter in good faith a longer term agreement
expanding ▇▇▇▇▇▇'▇ role; and
WHEREAS, Abbott and SuperGen shall enter into two other agreements in support of
their collaboration: (i) a Worldwide Sales, Distribution and Development
Agreement pursuant to which SuperGen and Abbott will collaborate with respect to
the clinical development, obtaining of regulatory approvals, distribution and
marketing of Rubitecan products throughout the world (the "Worldwide
Agreement"); and (ii) a Common Stock and Option Purchase Agreement pursuant to
which Abbott shall purchase an equity interest in SuperGen's common stock (the
"Stock Purchase Agreement"and together with the Worldwide Agreement, the
"SuperGen-Abbott Agreements").
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants and
undertakings contained herein, the parties hereto agree as follows:
ARTICLE 1: DEFINITIONS
In addition to the other terms defined elsewhere herein, the following terms
shall have the following meanings when used in this Agreement (and any term
defined in the singular shall have the same meaning when used in the plural, and
vice versa, unless stated otherwise):
CONFIDENTIAL TREATMENT REQUESTED
1.1 "Affiliate" means any corporation or non-corporate business entity
which controls, is controlled by, or is under common control with a Party. A
corporation or non-corporate business entity shall be regarded as in control
of another corporation or non-corporate business entity if it owns, or
directly or indirectly controls, in excess of fifty percent (50%) of the
voting stock of the other corporation, or (a) in the absence of the ownership
of in excess of fifty percent (50%) of the voting stock of a corporation or
(b) in the case of a non-corporate business entity, if it possesses, directly
or indirectly, the power to direct or cause the direction of the management
and policies of such corporation or non-corporate business entity, as
applicable.
1.2 "Confidential Information" shall mean any and all technical data,
information, materials and other know-how including trade secrets presently
owned by or developed by, or on behalf of either Party and/or its Affiliates
during the term of this Agreement, which relate to the Product, its
development, manufacture, regulatory filings, promotion, marketing,
distribution, sale or use and any and all financial data and information
relating to the business of either of the Parties and/or of their Affiliates,
which a Party and/or its Affiliates discloses to the other Party and/or its
Affiliates in writing and identifies as being confidential, or if disclosed
orally, visually or through some other media, is identified as confidential
at the time of disclosure and is summarized in writing within thirty (30)
days of such disclosure and identified as confidential, except any portion
thereof which:
(a) is known to the receiving Party and/or its Affiliates at
the time of the disclosure, as evidenced by its written
records;
(b) is disclosed to the receiving Party and/or its Affiliates
by a Third Party having a right to make such disclosure;
(c) becomes patented, published or otherwise part of the
public domain through no fault of the receiving Party and/or
its Affiliates;
(d) is independently developed by or for the receiving Party
and/or its Affiliates without use of Confidential Information
disclosed hereunder as evidenced by its written records; or
(e) is required by law to be disclosed.
The obligations of the Parties relating to Confidential Information shall expire
ten (10) years after the termination of this Agreement.
1.3 "Current Good Manufacturing Practices" or "CGMPs" shall mean all
applicable standards relating to manufacturing practices for intermediates,
bulk products or finished pharmaceutical products (i) promulgated by FDA in
the form of laws or regulations or (ii) promulgated by FDA in the form of
guidance documents (including but not limited to advisory opinions,
compliance policy
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CONFIDENTIAL TREATMENT REQUESTED
guides and guidelines) which guidance documents are being implemented within
the pharmaceutical manufacturing industry for such products.
1.4 "FDA" shall mean the U.S. Food and Drug Administration or any
successor entity thereto.
1.5 "Net Sales" shall mean the total of the gross amount billed or
invoiced to Third Parties for the sale of Product, less amounts actually
repaid and/or credited to a Third Party by reason of rejection or return of
defective and/or damaged Product or returned goods in the ordinary course of
business and any Wholesaler Reversals.
1.6 "Party" shall mean ▇▇▇▇▇▇ Laboratories or SuperGen, Inc., and
"Parties" shall mean ▇▇▇▇▇▇ Laboratories and SuperGen, Inc.
1.7 "Person" shall mean a natural person, a corporation, a partnership,
a trust, a joint venture, any governmental authority, and any other entity or
organization.
1.8 "Product" shall mean Nipent -Registered Trademark- (Pentostatin),
known as 2'-deoxycoformycin, 2'DCF, co-vidarabine, DEOCF, NSC-218321.
1.9 "Territory" shall mean the continental United States of America,
Hawaii and Alaska.
1.10 "Third Party" shall mean any Person that is not a
Party or an Affiliate of a Party.
1.11 "Wholesaler Reversal" shall mean the positive difference between the
amount invoiced by Abbott to a wholesaler for Product and the price
stipulated in a contract between SuperGen and the ultimate end-user of
Product at which the wholesaler resells such Product to such end-user.
ARTICLE 2: DISTRIBUTION
2.1 EXCLUSIVE DISTRIBUTOR.
(a) As of March 1, 2000 (the "Effective Date"), SuperGen appoints
▇▇▇▇▇▇, and ▇▇▇▇▇▇ accepts appointment, as the exclusive
distributor of the Product currently approved for hairy cell
leukemia in the Territory, with the sole and exclusive right
to commercially distribute the Product to Third Parties within
the Territory, including all activities ancillary thereto
(including, without limitation, warehousing, order entry,
shipping, billing and collection, but excluding any
promotional, advertising, marketing and sales activities).
Abbott may appoint sub-distributors in the Territory. ▇▇▇▇▇▇'▇
efforts to distribute the Product in the Territory shall be at
least commensurate with those used to distribute its own
pharmaceutical products of similar nature and comparable
market potential.
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CONFIDENTIAL TREATMENT REQUESTED
(b) Abbott shall keep SuperGen fully apprised with respect to its
distribution activities hereunder and shall allow SuperGen to
offer input regarding these activities. Subject to the terms
of this Agreement, Abbott shall control all final decisions
regarding such distribution activities.
2.2 DISTRIBUTION ACCESS FEE. In consideration for the grant by SuperGen
of exclusive distribution rights with respect to Product in the Territory and
SuperGen's past research and development efforts with respect to Product,
Abbott shall pay SuperGen by wire transfer five million dollars ($5,000,000)
within thirty (30) days of the execution date of this Agreement.
2.3 FUTURE NEGOTIATIONS. Within six (6) months of the Effective Date,
the Parties hereto shall enter into good faith negotiations regarding
expansion of ▇▇▇▇▇▇'▇ role as exclusive distributor of the Product in the
Territory to include co-promotion of Product in the Territory.
2.4 RESERVATION OF RIGHTS. Except as expressly provided in this Article
2 and elsewhere in this Agreement, no right, title, or interest is granted,
whether express or implied, by SuperGen to Abbott, and nothing in this
Agreement shall be deemed to restrict SuperGen's right to exploit technology,
know-how, patents, or any other intellectual property rights relating to
products other than the Product. SuperGen reserves the right to appoint other
authorized distributors or resellers outside the Territory without
restriction. Abbott shall have no right to directly solicit sales, promote,
advertise, market or sell Product inside or outside the Territory.
ARTICLE 3: MANUFACTURE, SUPPLY AND DEVELOPMENT
3.1 MANUFACTURE AND SUPPLY. Subject to the terms of this Agreement, in
the Territory Abbott shall accept delivery exclusively from SuperGen or from
its designated Third Party manufacturers, and SuperGen or its designated
Third Party manufacturers shall supply exclusively to Abbott, Product for
distribution in the Territory. SuperGen shall be responsible for the
manufacture, packaging, sterilization, labeling and pricing of Product as
well as marketing activities. Any Third Parties performing manufacturing
activities on behalf of SuperGen shall be subject to reasonable compliance
and quality assurance provisions of this Agreement.
3.2 PRODUCT REGISTRATION. SuperGen shall obtain and maintain regulatory
approval of Product required by government regulatory agencies in the
Territory to market and sell the Product. Upon reasonable request, SuperGen
shall provide Abbott with access to its regulatory filings.
3.3 QUALITY ASSURANCE. SuperGen shall be responsible for all quality
control and quality assurance matters related to the manufacture of Product.
3.4 PRODUCT DEVELOPMENT. SuperGen shall be responsible for research and
development required for improvements in the Product, provided, however,
SuperGen shall have no obligation to research and develop improvements in the
Product.
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CONFIDENTIAL TREATMENT REQUESTED
3.5 EXCUSED PERFORMANCE. The Parties acknowledge and understand that the
marketing of the Product, as with any pharmaceutical product, is subject to
certain inherent risks including that (a) the Product will be ineffective or
toxic; (b) the Product will not achieve broad market acceptance; (c) Third
Parties will hold proprietary rights that will preclude the marketing and
sale of the Product; or (d) Third Parties will market equivalent or superior
products. Neither Party makes any representation or warranty that the Product
will be commercially successful. The respective obligations of the Parties
under this Agreement are expressly conditioned upon the safety, efficacy and
commercial feasibility of the Product, and a Party's obligation hereunder
shall be delayed or suspended for so long as any condition or event exists
which reasonably causes a Party to question the safety, efficacy or
commercial feasibility of the Product.
ARTICLE 4: COMPLIANCE
4. COMPLIANCE MATTERS
4.1 The Parties acknowledge that SuperGen shall be solely responsible
for complying with FDA requirements with respect to the manufacture,
marketing, promotion, advertising and sale of Product, and Abbott shall be
solely responsible for complying with FDA requirements with respect to the
distribution, storage, warehousing and delivery of Product.
4.2 SuperGen warrants and represents to Abbott that it has all required
FDA approvals for the Product for hairy cell Leukemia indication, and shall
maintain, or have its supplier maintain, at all times during the term of this
Agreement an FDA registered manufacturing plant in which it will manufacture
Product for Abbott in compliance with CGMPs and all applicable regulations of
the FDA.
4.3 SuperGen shall comply with all applicable state and federal laws and
regulations regarding the manufacture and delivery of Product for use in the
Territory, including but not limited to the Federal Food, Drug, and Cosmetic
Act.
4.4 SuperGen shall promptly advise Abbott of the findings of FDA
inspections and shall take all reasonable steps necessary to correct
deficiencies, if any, found by the FDA relating to production of the Product.
SuperGen shall advise Abbott of any FDA compliance issues, including but not
limited to the receipt of FDA form 483, or any quality assurance problems
with SuperGen's production facilities used in the manufacture of Product.
SuperGen shall have sole authority to interact with FDA.
ARTICLE 5: FORECASTS, DELIVERIES AND ACCEPTANCE
5.1 FORECASTS. At least thirty (30) days prior to the end of each
calendar quarter during the term of this Agreement, SuperGen shall provide to
Abbott SuperGen's estimate of the timing and quantity
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CONFIDENTIAL TREATMENT REQUESTED
of shipments of Product to be made to Abbott during the next calendar
quarter. Abbott acknowledges that forecasted shipment dates and quantities
are estimates only and not binding on SuperGen.
5.2 ACCEPTANCE. SuperGen shall have Product tested before delivery to Abbott and
shall provide Abbott with certificates of analysis for each shipment setting
forth the items tested and the test results. SuperGen shall send such
certificates to Abbott with each shipment of Product.
5.3 RETURN OF DEFECTIVE PRODUCT. Abbott shall notify SuperGen in writing of
any defect or shortage in the quantity of any shipment of Product no later
than ten (10) business days following receipt of the Product. In the event of
any such defect or shortage, SuperGen shall, at SuperGen's choice, replace
the defective Product or make up the shortage if replacement stock is
available in the next shipment of Product, but in any case no later than
twenty (20) days or, if no such replacement stock is available, as soon as
reasonably practical after receiving such notice, at no additional cost to
Abbott. The remedy provided herein shall be deemed to be the exclusive remedy
for any defect or shortage in shipment.
ARTICLE 6: INVENTORY AND DISTRIBUTION PAYMENTS
6.1 INVENTORY. SuperGen shall supply Product inventory to Abbott on a
consignment basis. At no time during the performance of the activities
contemplated by this Agreement shall title to Product pass from SuperGen to
Abbott. Upon the receipt by Abbott of orders for Product, Abbott shall ship
and invoice Product at the wholesale acquisition cost for Product established
by SuperGen and reported to Abbott. SuperGen shall provide written notice to
Abbott of changes to the wholesale acquisition cost for Product at least
sixty (60) days prior to any such changes going into effect. In addition,
SuperGen shall provide written notice to Abbott of any agreement it may have
with a Third Party pursuant to which Product is to be sold to such Third
Party at a price other than the wholesale acquisition price at least
forty-five (45) days prior to such agreement going into effect. Any such
notice shall include pricing and special payment terms, term of pricing and a
list of facilities entitled to such pricing. In the event SuperGen does not
notify Abbott as set forth above of any such applicable price, Abbott shall
invoice Product in accordance with the wholesale acquisition cost in effect
and SuperGen shall be responsible for payment of any refund due, or
collection of any additional amount from, the Third Party purchaser.
SuperGen shall provide written notice to Abbott of any agreement it has
entered into with a Third Party that provides for a discount in excess of one
percent (1%) for payments made within fifteen (15) days of invoice for
end-user customers and/or two percent (2%) for payments made within thirty
(30) days of invoice for drug wholesalers. SuperGen shall reimburse Abbott
for any discounts set forth in such notice.
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CONFIDENTIAL TREATMENT REQUESTED
6.2 PAYMENT TO SUPERGEN. Except as provided below, Abbott shall pay to
SuperGen * for Product distributed in accordance with this Agreement (the
"SuperGen Percentage"). In the event that the Parties do not enter into an
agreement as contemplated by Section 2.3, the SuperGen Percentage shall be
calculated as set forth above for *. Within forty-five (45) days of the end
of each calendar quarter during the term of this Agreement, Abbott shall pay
SuperGen by wire transfer the SuperGen Percentage for Product distributed by
Abbott in such quarter. Abbott shall deliver sales reports to SuperGen within
thirty (30) days of the end of each month during the term of this Agreement.
SuperGen shall approve in advance the sales and collections reporting forms
to be used by Abbott.
6.3 AUDIT OF ▇▇▇▇▇▇. ▇▇▇▇▇▇ shall keep and maintain books and records
reasonably required to determine accurately Net Sales and amounts payable to
SuperGen hereunder. Such books and records shall be open to inspection and
audit by SuperGen once per calendar year during normal business hours and
upon at least two (2) weeks prior notice. SuperGen shall have the right to
audit the books and records kept pursuant to this Agreement to determine
whether there was any mistake or impropriety in determining amounts payable
to SuperGen by Abbott. A copy of any audit report developed hereunder shall
be given to ▇▇▇▇▇▇. ▇▇▇▇▇▇'▇ books and records and any audit report shall be
considered Abbott Confidential Information by SuperGen.
ARTICLE 7: MARKETING AND DISTRIBUTION
7.1 PROMOTION, MARKETING AND SALES. All Product promotion, advertising,
marketing and sales shall be the sole responsibility of SuperGen.
7.2 DISTRIBUTION. Products shall be delivered to Abbott designated
distribution centers for subsequent delivery to SuperGen customers for
Product. Abbott shall designate carriers to be used. SuperGen shall give
Abbott at least thirty (30) days prior notice of any shipment of Product to
be made to Abbott for distribution under the terms of this Agreement. Upon
the receipt by Abbott of orders for Product, Abbott shall ship and invoice
Product at the wholesale acquisition cost for Product established by SuperGen
and reported to Abbott. In addition, Abbott agrees to send SuperGen monthly
sales reports within thirty (30) days of the end of each month, showing at a
minimum: units and dollar value of Product sold, by customer name and city /
state. The report formats will be mutually agreed upon by the Parties prior
to March 1, 2000.
7.3 COMPLAINT HANDLING AND CUSTOMER SERVICE. Any and all product complaints
of which Abbott becomes aware relating to the Product during the terms of the
Agreement shall promptly be forwarded to SuperGen. Notification shall be
given by telephone, with a facsimile confirmation immediately following.
7.4 ADVERSE EVENTS. For purposes of this Agreement, "Adverse Event" shall
mean any adverse event associated with the use of the Product in humans,
whether or not considered drug-related. The
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CONFIDENTIAL TREATMENT REQUESTED
definition includes an Adverse Event occurring in the course of the use of
the Product in professional practice, studies, investigations or tests. The
definition also includes an adverse event occurring from Product overdose
(whether accidental or intentional), from Product abuse or from Product
withdrawal, as well as any toxicity, sensitivity, failure of pharmacological
action or laboratory abnormality, which is or is thought by the reporter to
be serious or associated with relevant clinical signs or symptoms. Abbott
shall notify SuperGen as soon as possible following its receipt of
information of a possible Adverse Event. Notification shall be given by
telephone, with a facsimile confirmation immediately following. Abbott shall
provide SuperGen all the information Abbott has available concerning the
Adverse Event and shall co-operate fully in any investigation conducted or
directed by SuperGen.
7.5 RECALLS. In the event SuperGen shall be required (or shall voluntarily
decide) to initiate a recall, withdrawal or field correction of, or field
alert report with respect to, Product manufactured by SuperGen and
distributed by Abbott pursuant to this Agreement, whether or not such recall,
withdrawal, field correction or field report has been requested or ordered by
FDA, SuperGen shall notify ▇▇▇▇▇▇, and ▇▇▇▇▇▇ shall fully co-operate with
SuperGen to implement the same. SuperGen shall make all contacts with the FDA
and shall be responsible for coordinating all of the necessary activities in
connection with any such recall, withdrawal, field correction or field alert
report, and SuperGen shall make all statements to the media, including press
releases and interviews for publication or broadcast. Abbott agrees to make
no statement to the media, unless otherwise required by law, and in any such
event, Abbott shall cooperate with SuperGen on the content of any such
statement. SuperGen shall indemnify Abbott against all reasonable and
necessary costs and expenses which Abbott may incur as a result of any recall
for which SuperGen is responsible. Abbott shall indemnify SuperGen against
all reasonable and necessary costs and expenses which SuperGen may incur as a
result of any recall for which Abbott is responsible.
ARTICLE 8: TERM AND TERMINATION
8.1 TERM AND TERMINATION. ▇▇▇▇▇▇'▇ distribution obligations under this
Agreement shall commence on the Effective Date and the initial term shall
expire on February 28, 2005, unless this Agreement is terminated earlier
pursuant to this Article 8. Upon expiration of the initial term, the
Agreement shall continue automatically until February 28, 2010 (the "Second
Term"), unless terminated by Abbott by giving written notice to SuperGen six
(6) months prior to expiration of the initial term or any succeeding one year
period. Upon expiration of the Second Term, the Agreement shall continue
automatically from year to year unless terminated by either Party by giving
written notice to the other Party six (6) months prior to expiration of the
Second Term or any succeeding one year extension.
8.2 TERMINATION FOR BREACH. Either Party may terminate this Agreement upon
sixty (60) days written notice of the other Party's breach of a material term
or condition of this Agreement, provided
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CONFIDENTIAL TREATMENT REQUESTED
that such termination shall not take effect if the other Party remedies such
breach, to the terminating Party's reasonable satisfaction, within such sixty
(60) day notice period.
8.3 TERMINATION FOR INSOLVENCY. Either Party may terminate this Agreement by
giving the other at least sixty (60) days prior written notice upon the
bankruptcy or insolvency of the other Party or upon the breach of any
material provision of this Agreement by the other Party, if the breach is not
cured within sixty (60) days after written notice thereof to the Party in
default.
8.4 EFFECT OF TERMINATION
(a) Accrued Obligations. Except as otherwise provided,
expiration or termination of this Agreement for any reason shall not release
any party hereto from liability accrued under this Agreement prior to such
expiration or termination, nor preclude either party hereto from pursuing any
rights or remedies accrued prior to such expiration or termination or accrued
at law or in equity with respect to any breach of this Agreement.
(b) Inventory. Within thirty (30) days after the expiration
or termination of this Agreement, Abbott shall use its reasonable efforts to
provide SuperGen with a complete inventory of Product in ▇▇▇▇▇▇'▇ possession
or control. Within thirty (30) days after the expiration or termination of
this Agreement, SuperGen may inspect ▇▇▇▇▇▇'▇ Product inventory and audit
▇▇▇▇▇▇'▇ records with respect to Product inventory during normal business
hours and upon at least two (2) weeks prior notice. ▇▇▇▇▇▇'▇ records with
respect to Product inventory shall be considered Abbott Confidential
Information by SuperGen.
(c) Return of Materials. All trademarks, trade names,
patents, formulas or other data, photographs, samples, literature, and sales
and promotional aids of every kind related to the Product or provided by
SuperGen shall remain the property of SuperGen. Within thirty (30) days after
the effective date of termination of this Agreement, Abbott shall destroy all
tangible items bearing, containing, or contained in, any of the foregoing, in
its possession or control and provide written certification of such
destruction, or prepare such tangible items for shipment to SuperGen, as
SuperGen may direct, at SuperGen's expense. Abbott shall not make or retain
any copies of any confidential items or information which may have been
entrusted to it; however, Abbott may retain one copy of each such item or
information received by it hereunder and notes regarding the same, provided
that said copy shall be retained and used solely for compliance purposes and
shall be held in ▇▇▇▇▇▇'▇ confidential file. Effective upon the termination
of this Agreement, Abbott shall cease to use all trademarks and trade names
of SuperGen related to Product in the Territory. During the term of this
Agreement and after any termination or expiration of this Agreement, SuperGen
shall have the right to continue to use and disclose for any purpose customer
lists, customer data and other customer information and any and all clinical
trial results and other data relating to the Product and provided by Abbott
to SuperGen during the term of this Agreement.
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CONFIDENTIAL TREATMENT REQUESTED
(d) Products. Upon termination of this Agreement, all of
▇▇▇▇▇▇'▇ inventory of Product on the effective date of such termination shall
be shipped to SuperGen at SuperGen's sole cost and expense.
(e) Limitation on Liability. Except as otherwise provided,
neither party shall be liable for any special, incidental, indirect or
consequential damages arising out of or relating to this Agreement; provided
however, this limitation shall not apply to losses arising from Third Party
claims for which a party is indemnified under the terms of this agreement.
(f) Transition. Upon termination of this Agreement, Abbott
and SuperGen shall diligently cooperate to effect a smooth and orderly
transition in the distribution of the Product in the Territory. From the time
that a notice of termination is received by either party until the effective
termination date, Abbott shall refer all Product inquiries to SuperGen and
shall cooperate fully with any newly-appointed distributors.
(h) No Renewal, Extension or Waiver. Acceptance of any
order from, or sale of, any Product to Abbott after the date of termination
of this Agreement shall not be construed as a renewal or extension hereof, or
as a waiver of termination by SuperGen.
8.5 SURVIVAL. The provisions of Sections 6.2, 7.3, 7.4, 7.5 and 8.4, and
Articles 9, 10, and 11 shall survive the expiration or termination of this
Agreement for any reason. All other rights and obligations of the parties
shall cease upon termination of this Agreement.
ARTICLE 9: GUARANTEES, WARRANTIES AND INDEMNIFICATION
9.1 SUPERGEN GUARANTEES. SuperGen guarantees to Abbott that Product delivered
to Abbott pursuant to this Agreement shall at the time of delivery not be
adulterated or misbranded within the meaning of the Federal Food, Drug, and
Cosmetic Act, as amended, or within the meaning of any applicable state law
in which the definitions of adulteration and misbranding are substantially
the same as those contained in the Federal Food, Drug, and Cosmetic Act, as
such act and such laws are constituted and effective at the time of delivery
and will not be an article which may not under the provisions of Section 505
of such Act be introduced into interstate commerce.
9.2 SUPERGEN WARRANTIES.
(a) SuperGen warrants that it has full power and authority
to enter into this Agreement and grant to Abbott the exclusive
distributorship granted hereunder. SuperGen further warrants that it has made
no commitments inconsistent with this Agreement.
(b) Any warranty for the Product shall run directly from
SuperGen to customers, notwithstanding the fact that customers may return
Product to Abbott and not to SuperGen. Abbott shall not make any warranty or
representation to any customer which is more protective of such
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customer than the warranties and/or representations provided by SuperGen.
For purposes of clarification, the sole remedy of customers in the case of
defective Product shall be that SuperGen shall replace such returned
defective Product.
(c) End User Warranty and Representations. Abbott shall pass
on to customers SuperGen's standard limited warranties and disclaimers. Abbott
further agrees not to represent the Product in a manner that is inconsistent
with the Product label claims or Product literature or to otherwise misrepresent
the Product.
9.3 ABBOTT INDEMNIFICATION. Abbott shall indemnify, defend and hold SuperGen and
its Affiliates and their officers, directors, employees, and representatives
harmless from and against any and all third party claims, causes of action,
suits, proceedings, losses, damages, demands, fees, expenses, fines, penalties
and costs (including reasonable attorney's fees) arising out of, related to or
in connection with: (a) the breach of ▇▇▇▇▇▇'▇ warranties, representations or
covenants set forth in this Agreement; (b) any acts or omissions of Abbott or
its employees and agents in the distribution of Product or otherwise relating to
the performance of this Agreement, (c) any claim alleging noncompliance by
Abbott with the Food, Drug and Cosmetic Act and the regulations promulgated
thereunder; and/or (d) any wrongful or negligent acts or omissions on the part
of ▇▇▇▇▇▇'▇ employees, agents or representatives, except to the extent caused by
any wrongful or negligent acts or omissions on the part of SuperGen's employees,
agents or representatives.
9.4 SUPERGEN INDEMNIFICATION. SuperGen shall indemnify, defend and hold Abbott
and its Affiliates and their officers, directors, employees, and representatives
harmless from and against any and all third party claims, causes of action,
suits, proceedings, losses, damages, demands, fees, expenses, fines, penalties
and costs (including reasonable attorney's fees) arising out of, related to or
in connection with: (a) the manufacture and shipment of Product to Abbott or the
use of Product including product liability claims, product recalls and
government regulatory actions; (b) the breach of SuperGen's warranties,
representations or covenants set forth in this Agreement; (c) the termination by
SuperGen of any distributor of Product in the Territory (other than Abbott and
any sub-distributor appointed by Abbott hereunder); and/or (d) the wrongful or
negligent acts or omissions on the part of SuperGen's employees, agents or
representatives except to the extent caused by wrongful or negligent acts or
omissions on the part of ▇▇▇▇▇▇'▇ employees, agents or representatives.
9.5 CONDITIONS OF INDEMNIFICATION. If either Party seeks indemnification from
the other hereunder, it shall promptly give notice to the other Party of any
such claim or suit threatened, made or filed against it which forms the basis
for such claim of indemnification and shall cooperate fully with the other Party
in the investigation and defense of all such claims or suits. The indemnifying
Party shall have the option to assume the other Party's defense in any such
claim or suit with counsel reasonably satisfactory to the other Party. No
settlement or compromise shall be binding on a Party hereto without its prior
written consent.
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ARTICLE 10: CONFIDENTIALITY AND PUBLIC ANNOUNCEMENTS
10.1 CONFIDENTIALITY. The Parties acknowledge and agree that during the term of
this Agreement, each of them and their Affiliates may exchange Confidential
Information, and the disclosure and use of any such Confidential Information
shall be governed by the provisions of this Article 10. Each Party shall use the
Confidential Information of the other Party only for the purpose of the
activities contemplated by this Agreement and shall not disclose such
Confidential Information to a Third Party except in accordance with the
provisions of this Agreement. The Parties shall ensure that their Affiliates
keep all Confidential Information exchanged hereunder confidential in accordance
with the provisions hereof as though the Affiliates were parties hereto. This
provision shall remain in effect for a period of ten (10) years after
termination or expiration of this Agreement for all Confidential Information
excluding trade secrets. Trade secrets shall be kept confidential by the
Receiving Party (as defined in Section 10.2 hereof) according to the terms set
forth in Section 10.2.
10.2 HANDLING OF TRADE SECRETS. During the course of its performance hereunder,
a Party (the "Disclosing Party") may desire or be requested to disclose
Confidential Information to the other Party (the "Receiving Party"), which the
Disclosing Party considers a trade secret. In such event, the Disclosing Party
first shall inform the Receiving Party, on a non-confidential basis, the general
nature of the trade secret information. The Receiving Party shall have ten (10)
days to decide whether it wishes to have such trade secrets disclosed to it and
to inform the Disclosing Party in writing that it wishes to receive such a
disclosure. Any trade secrets so disclosed between the Parties shall be marked
"Trade Secret," and the Receiving Party shall not disclose or use such trade
secret for the Term and thereafter except as expressly permitted under this
Agreement. In the event the Disclosing Party discloses the trade secrets to the
Receiving Party without written approval of the Receiving Party and/or without
appropriately marking such information as "Trade Secret" that trade secret shall
be handled as Confidential Information under Section 10.1.
10.3 PUBLIC ANNOUNCEMENTS. Neither Party shall make any public announcement
concerning this Agreement, nor make any public statement which includes the name
of the other Party or any of its Affiliates, or otherwise use the name of the
other Party or any of its Affiliates in any public statement or document without
the written consent of the other Party, which consent shall not be withheld
unreasonably except: (i) as may be required by law or judicial order, without
the consent of the other Party; or (ii) either Party may include in a subsequent
public statement or document, information regarding the SuperGen-Abbott
Agreements which has already been approved by the other Party.
ARTICLE 11: MISCELLANEOUS
11.1 INSURANCE. Beginning on the Effective Date and until the date which is one
day prior to the date of initial Launch (as defined in the Worldwide Agreement),
SuperGen shall maintain product liability insurance with an A.M. Best Company
rating of at least A+ with a minimum annual amount
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CONFIDENTIAL TREATMENT REQUESTED
of: (a) Five Million Dollars ($5,000,000) per occurrence; and (b) Ten Million
Dollars ($10,000,000) in the aggregate. Beginning on the date of initial
Launch and for a period of five (5) years after termination of this
Agreement, SuperGen shall maintain product liability insurance with an A.M.
Best Company rating of at least A+, with minimum annual amounts per
occurrence and in the aggregate which are adequate to ▇▇▇▇▇▇'▇ reasonable
satisfaction. Upon ▇▇▇▇▇▇'▇ request, SuperGen shall deliver to Abbott a
certificate of insurance evidencing such insurance and stating that the
policy will not be canceled or modified without at least thirty (30) days
prior written notice to ▇▇▇▇▇▇. ▇▇▇▇▇▇ shall be named as an additional
insured party under any such insurance policies.
11.2 APPLICABLE LAW. This Agreement shall be construed, interpreted and governed
by the laws of the State of Illinois, except for choice of law rules.
11.3 ALTERNATIVE DISPUTE RESOLUTION. The Parties agree that any dispute that
arises in connection with this Agreement shall first be presented to the
respective presidents of SuperGen and the ▇▇▇▇▇▇ Laboratories Hospital Products
Division, or their designees, for resolution. If no resolution is reached, then
such dispute shall be resolved by binding Alternative Dispute Resolution ("ADR")
in the manner described in Exhibit 11.3.
11.4 INDEPENDENT CONTRACTORS. The relationship of SuperGen to Abbott established
by this Agreement is that of an independent contractor. Nothing contained in
this Agreement shall be construed to constitute SuperGen as a partner, agent or
joint venturer with Abbott or as a participant in a joint or common undertaking
with Abbott.
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CONFIDENTIAL TREATMENT REQUESTED
11.5 NOTICES. All notices hereunder shall be delivered personally, or by
registered or certified mail (postage prepaid), or by facsimile with a
confirmation copy sent by registered or certified mail (postage prepaid), to the
following addresses of the respective Parties:
▇▇▇▇▇▇ Laboratories
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: General Counsel
With copy to: Senior Vice President, Hospital Products
Division
SuperGen, Inc.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇. ▇▇▇ ▇▇▇▇▇▇▇▇▇
Chief Executive Officer and President
With copy to: Wilson, Sonsini, ▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: ▇▇▇▇ ▇▇▇▇, Esq.
Notices shall be effective upon receipt if personally delivered or delivered by
facsimile, or on the third business day following the date of mailing. A Party
may change its address listed above by notice to the other Party.
11.6 ASSIGNMENT. The Parties shall not assign this Agreement or any part thereof
without the prior written consent of the other Party; provided, however, a Party
may assign this Agreement without consent of the other in connection with the
transfer or sale of its entire business to which this Agreement pertains or in
the event of its merger or consolidation with another company. Any permitted
assignee shall assume all obligations of its assignor under this Agreement. No
assignment shall relieve any Party of responsibility for the performance of any
accrued obligation which such Party then has hereunder.
11.7 ENTIRE AGREEMENT. This terms and conditions contained herein and in the
other SuperGen-Abbott Agreements constitute the entire agreement between the
Parties relating to the subject matter hereof and thereof and shall supersede
all previous communications and/or agreements between the Parties with respect
to the subject matter hereof and thereof, respectively. No course of dealing or
usage of trade shall be used to modify the terms and conditions hereof.
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CONFIDENTIAL TREATMENT REQUESTED
11.8 SEVERABILITY. This Agreement is subject to the restrictions, limitations,
terms and conditions of all applicable laws, governmental regulations, approvals
and clearances. If any term or provision of this Agreement shall for any reason
be held invalid, illegal or unenforceable in any respect, such invalidity,
illegality or unenforceability shall not affect any other term or provision
hereof, and this Agreement shall be interpreted and construed as if such term or
provision, to the extent the same shall have been held to be invalid, illegal or
unenforceable, had never been contained herein.
11.9 WAIVER - MODIFICATION OF AGREEMENT. No waiver or modification of any of the
terms of this Agreement shall be valid unless in writing and signed by
authorized representatives of both Parties. Failure by either Party to enforce
any rights under this Agreement shall not be construed as a waiver of such
rights nor shall a waiver by a Party in one or more instances be construed as
constituting a continuing waiver or as a waiver in other instances.
[SIGNATURE PAGE FOLLOWS]
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CONFIDENTIAL TREATMENT REQUESTED
The Parties intending to be bound by the terms and conditions hereof
have caused this Agreement to be signed by their duly authorized representatives
on the date first above written.
▇▇▇▇▇▇ LABORATORIES SUPERGEN, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Title: President, HPD Title: President &
Chief Executive Officer
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CONFIDENTIAL TREATMENT REQUESTED
* Portions denoted with an asterisk have been omitted and filed separately
with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
SUPERGEN, INC.
AND
▇▇▇▇▇▇ LABORATORIES
U.S. Distribution Agreement
EXHIBIT 11.3
ALTERNATIVE DISPUTE RESOLUTION
The parties recognize that bona fide disputes as to certain matters may
arise from time to time during the term of this Agreement which relate to either
party's rights and/or obligations. To have such a dispute resolved by this
Alternative Dispute Resolution ("ADR") provision, a party first must send
written notice of the dispute to the other party for attempted resolution by
good faith negotiations between their respective presidents (or their designees)
of the affected subsidiaries, divisions, or business units within twenty-eight
(28) days after such notice is received (all references to "days" in this ADR
provision are to calendar days).
If the matter has not been resolved within twenty-eight (28) days of
the notice of dispute, or if the parties fail to meet within such twenty-eight
(28) days, either party may initiate an ADR proceeding as provided herein. The
parties shall have the right to be represented by counsel in such a proceeding.
1. To begin an ADR proceeding, a party shall provide written notice to
the other party of the issues to be resolved by ADR. Within fourteen (14) days
after its receipt of such notice, the other party may, by written notice to the
party initiating the ADR, add additional issues to be resolved within the same
ADR.
2. Within twenty-one (21) days following receipt of the original ADR
notice, the parties shall select a mutually acceptable neutral to preside in the
resolution of any disputes in this ADR proceeding. If the parties are unable to
agree on a mutually acceptable neutral within such period, either party may
request the President of the CPR Institute for Dispute Resolution ("CPR"), ▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇, to select a neutral
pursuant to the following procedures:
(a) The CPR shall submit to the parties a list of not less
than five (5) candidates within fourteen (14) days after receipt of the request,
along with a CURRICULUM VITAE for each
CONFIDENTIAL TREATMENT REQUESTED
candidate. No candidate shall be an employee, director, or shareholder of either
party or any of their subsidiaries or affiliates.
(b) Such list shall include a statement of disclosure by each
candidate of any circumstances likely to affect his or her impartiality.
(c) Each party shall number the candidates in order of
preference (with the number one (1) signifying the greatest preference) and
shall deliver the list to the CPR within seven (7) days following receipt of the
list of candidates. If a party believes a conflict of interest exists regarding
any of the candidates, that party shall provide a written explanation of the
conflict to the CPR along with its list showing its order of preference for the
candidates. Any party failing to return a list of preferences on time shall be
deemed to have no order of preference.
(d) If the parties collectively have identified fewer than
three (3) candidates deemed to have conflicts, the CPR immediately shall
designate as the neutral the candidate for whom the parties collectively have
indicated the greatest preference. If a tie should result between two
candidates, the CPR may designate either candidate. If the parties collectively
have identified three (3) or more candidates deemed to have conflicts, the CPR
shall review the explanations regarding conflicts and, in its sole discretion,
may either (i) immediately designate as the neutral the candidate for whom the
parties collectively have indicated the greatest preference, or (ii) issue a new
list of not less than five (5) candidates, in which case the procedures set
forth in subparagraphs 2(a) - 2(d) shall be repeated.
3. No earlier than twenty-eight (28) days or later than fifty-six (56)
days after selection, the neutral shall hold a hearing to resolve each of the
issues identified by the parties. The ADR proceeding shall take place at a
location agreed upon by the parties. If the parties cannot agree, the neutral
shall designate a location other than the principal place of business of either
party or any of their subsidiaries or affiliates.
4. At least seven (7) days prior to the hearing, each party shall
submit the following to the other party and the neutral:
(a) a copy of all exhibits on which such party intends to rely
in any oral or written presentation to the neutral;
(b) a list of any witnesses such party intends to call at the
hearing, and a short summary of the anticipated testimony of each witness;
(c) a proposed ruling on each issue to be resolved, together
with a request for a specific damage award or other remedy for each issue. The
proposed rulings and remedies shall not contain any recitation of the facts or
any legal arguments and shall not exceed one (1) page per issue.
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CONFIDENTIAL TREATMENT REQUESTED
(d) a brief in support of such party's proposed rulings and
remedies, provided that the brief shall not exceed twenty (20) pages. This page
limitation shall apply regardless of the number of issues raised in the ADR
proceeding.
Except as expressly set forth in subparagraphs 4(a) -
4(d), no discovery shall be required or permitted by any means, including
depositions, interrogatories, requests for admissions, or production of
documents.
5. The hearing shall be conducted on two (2) consecutive days and
shall be governed by the following rules:
(a) Each party shall be entitled to five (5) hours of hearing
time to present its case. The neutral shall determine whether each party has had
the five (5) hours to which it is entitled.
(b) Each party shall be entitled, but not required, to make an
opening statement, to present regular and rebuttal testimony, documents or other
evidence, to cross-examine witnesses, and to make a closing argument.
Cross-examination of witnesses shall occur immediately after their direct
testimony, and cross-examination time shall be charged against the party
conducting the cross-examination.
(c) The party initiating the ADR shall begin the hearing and,
if it chooses to make an opening statement, shall address not only issues it
raised but also any issues raised by the responding party. The responding party,
if it chooses to make an opening statement, also shall address all issues raised
in the ADR. Thereafter, the presentation of regular and rebuttal testimony and
documents, other evidence, and closing arguments shall proceed in the same
sequence.
(d) Except when testifying, witnesses shall be excluded from
the hearing until closing arguments.
(e) Settlement negotiations, including any statements made
therein, shall not be admissible under any circumstances. Affidavits prepared
for purposes of the ADR hearing also shall not be admissible. As to all other
matters, the neutral shall have sole discretion regarding the admissibility of
any evidence.
6. Within seven (7) days following completion of the hearing, each
party may submit to the other party and the neutral a post-hearing brief in
support of its proposed rulings and remedies, provided that such brief shall not
contain or discuss any new evidence and shall not exceed ten (10) pages. This
page limitation shall apply regardless of the number of issues raised in the ADR
proceeding.
7. The neutral shall rule on each disputed issue within fourteen (14)
days following completion of the hearing. Such ruling shall adopt in its
entirety the proposed ruling and remedy of one of the parties on each disputed
issue but may adopt one party's proposed rulings and remedies
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CONFIDENTIAL TREATMENT REQUESTED
on some issues and the other party's proposed rulings and remedies on other
issues. The neutral shall not issue any written opinion or otherwise explain
the basis of the ruling.
8. The neutral shall be paid a reasonable fee plus expenses. These fees
and expenses, along with the reasonable legal fees and expenses of the
prevailing party (including all expert witness fees and expenses), the fees and
expenses of a court reporter, and any expenses for a hearing room, shall be paid
as follows:
(a) If the neutral rules in favor of one party on all disputed
issues in the ADR, the losing party shall pay 100% of such fees and expenses.
(b) If the neutral rules in favor of one party on some issues
and the other party on other issues, the neutral shall issue with the rulings a
written determination as to how such fees and expenses shall be allocated
between the parties. The neutral shall allocate fees and expenses in a way that
bears a reasonable relationship to the outcome of the ADR, with the party
prevailing on more issues, or on issues of greater value or gravity, recovering
a relatively larger share of its legal fees and expenses.
9. The rulings of the neutral and the allocation of fees and expenses
shall be binding, non-reviewable, and non-appealable, and may be entered as a
final judgment in any court having jurisdiction.
10. Except as provided in paragraph 9 or as required by law, the
existence of the dispute, any settlement negotiations, the ADR hearing, any
submissions (including exhibits, testimony, proposed rulings, and briefs), and
the rulings shall be deemed Confidential Information. The neutral shall have the
authority to impose sanctions for unauthorized disclosure of Confidential
Information.
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