Exhibit 99.3
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.
WORLDWIDE SALES, DISTRIBUTION, AND DEVELOPMENT AGREEMENT
This Sales, Distribution, and Development Agreement (the "Agreement") is made as
of December 21, 1999 by and between SuperGen, Inc., ("SuperGen"), a California
corporation with its principal offices at Xxx Xxxxxxx Xxxx, Xxxxx 000, Xxx
Xxxxx, Xxxxxxxxxx 00000, and Xxxxxx Laboratories, an Illinois corporation
("Abbott"), with its principal offices at 000 Xxxxxx Xxxx Xxxx, Xxxxxx Xxxx,
Xxxxxxxx 00000.
RECITALS:
WHEREAS, SuperGen is developing a pharmaceutical compound known as Rubitecan (as
defined below) for the treatment of pancreatic cancer and other indications;
WHEREAS, SuperGen desires to collaborate with Abbott with respect to the
clinical development, obtaining of regulatory approvals, distribution and
marketing of Rubitecan product(s) throughout the world;
WHEREAS, Abbott desires to collaborate with SuperGen with respect to such
product(s); and
WHEREAS, Abbott and SuperGen shall enter into three other agreements in support
of their collaboration: (i) a U.S. Distribution Agreement pursuant to which
SuperGen will grant to Abbott the right to distribute SuperGen's product Nipent
in the United States (the "U.S. Distribution 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")
(both of which other agreements, along with this Agreement, collectively
referred to as the "SuperGen-Abbott Agreements");
NOW, THEREFORE, in consideration of the foregoing and the mutual covenant
undertakings contained herein, the parties hereto hereby agree as follows:
ARTICLE I: 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):
1.1 "Abbott Cost of Goods" means (i) with respect to the Net Units of Product
Sold in the U.S. Territory, the aggregate U.S. Transfer Price paid by Abbott to
SuperGen for the Net Units of Product Sold in the U.S. Territory during the
given calendar quarter or year; (ii) with respect to the Net Units of Product
Sold in the International Territory, the aggregate International Transfer Price
paid by Abbott to SuperGen for the Net Units of Product Sold in the
International Territory during the given calendar quarter or year, and
in the event that Sections 8.5(b) or (c) apply, (A) to the extent that the
Compound or Product for the International Territory is sourced from the same
Abbott-owned manufacturing facilities as the facilities used for the Product for
the U.S. Territory, the purchase price for the sale of such goods to SuperGen in
the U.S. Territory during the given calendar quarter or year, (B) to the extent
that the Compound or Product is sourced from a different Abbott-owned
manufacturing facility, the direct costs and expenses of manufacturing and
packaging such goods during the given calendar quarter or year and (C) to the
extent that the Compound or Product is sourced from a Third Party manufacturer,
the actual price paid by Abbott for the manufacture, supply and packaging of
such goods during the given calendar quarter or year; and (iii) with respect to
the Territories, Xxxxxx'x direct costs and expenses of (A) damaged and/ or
returned inventory during the given calendar quarter or year, (B) any
governmentally imposed duties, sales, excise, turnover, inventory. value-added
and similar taxes assessed on the Compound and Product during the given calendar
quarter or year, and (C) in-bound freight and brokerage fees if not included in
the finished cost of the Product during the given calendar quarter or year,
provided that in no event shall Abbott Cost of Goods include any overhead or
indirect costs or expenses (including but not limited to such overhead or
indirect costs or expenses attributable to medical, regulatory, or marketing
activities of Abbott), and further provided that in no event shall Abbott Cost
of Goods include any item which is not an actual cost or expense calculated in
good faith, nor shall Abbott Cost of Goods include any item in any way contrived
so as to inflate the calculation of Abbott Cost of Goods. Xxxxxx'x Cost of Goods
shall be calculated separately for the U.S. Territory and the International
Territory.
1.2 "Abbott Distribution Expenses" means, for the U.S. Territory only, a
percentage of Abbott Net Sales in the U.S. Territory during the given calendar
quarter or year, which percentage shall be agreed by the parties no later than
sixty (60) days prior to Launch in the U.S. Territory.
1.3 "Abbott Distribution Margin" means the Abbott Net Sales minus (i) the Abbott
Cost of Goods and (ii) the Abbott Distribution Expenses for the given calendar
quarter or year.
1.4 "Abbott Net Sales" means the total gross sales of the Product (as set forth
on the invoice for such Product) by Abbott and permitted Sublicensees (as
defined in Section 2.5(d) below) to Third Parties in the given calendar quarter
or year, plus, if applicable, the fair market value of all properties and
services received in consideration of a sale of Product by Abbott and permitted
Sublicensees to Third Parties during such calendar quarter or year, less the
following deductions directly paid or incurred by Abbott or its permitted
Sublicensees with respect to the sale of the Product in such calendar quarter or
year:
(i) with respect to the U.S. Territory, standard, percentage-based
discounts, credits. rebates, including Xxxxxx'x standard cash terms and
returned goods, as well as rejections, recalls, bad debt write-offs,
returns and retroactive price reductions in lieu of returns, and other
discounts, credits, rebates (including but
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not limited to Medicare/Medicaid Rebates), adjustments, allowances and
management fees to group purchasing organizations and wholesaler fees;
(ii) with respect to the International Territory, rejections, recalls,
returns and retroactive price reductions in lieu of returns, and to the
extent offered or allowed in a manner consistent with those offered or
allowed with respect to Xxxxxx'x other products in the same oncology
category (to the extent applicable), discounts, credits, rebates,
adjustments, allowances and management fees to group purchasing
organizations; and
(iii) with respect to the Territories (A) chargebacks granted to drug
wholesalers and (B) to the extent imposed by government authorities,
retroactive rebates or other rebates.
Xxxxxx'x Net Sales shall be calculated separately for the U.S. Territory and the
International Territory.
1.5 "Abbott Operating Margin" means the Abbott Distribution Margin minus the
Abbott SG&A for the given calendar quarter or year. The Abbott Operating Margin
shall be calculated separately for the U.S. Territory and the International
Territory.
1.6 "Abbott SG&A" means the verified costs and expenses permitted under Section
4.2 which are incurred by Abbott and/or its permitted Sublicensees in the
advertising, Detailing, sales, marketing and promotion of the Product and, to
the extent permitted under Section 4.4, the Marketing Studies for the Product
during any given calendar quarter or year, in the categories set forth in
Exhibit 1.8. provided that in no event shall Abbott SG&A include any overhead or
indirect costs or expenses (including but not limited to such overhead or
indirect costs or expenses attributable to medical, regulatory, or marketing
activities of Abbott), and further provided that in no event shall Abbott SG&A
include any costs or expenses actually incurred by Abbott in connection with the
Co-Promotion of the Product in the U.S. Territory but not approved in advance by
the U.S. Marketing Board.
1.7 "Abbott Trademark" means the trademark(s) to be selected and registered by
Abbott for the Product in the International Territory.
1.8 "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.
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1.9 "Co-Promote" or "Co-Promotion" means the joint activities of the Parties to
Promote the Product under the SuperGen Trademark in the U.S. Territory.
1.10 "Competing Product" means any pharmaceutical product containing
nitro-camptothecin or a derivative thereof as an active ingredient.
1.11 "Compound" means rubetican, known as 9-nitro-20 (S)-camptothecin, also
known as 4-ethyl-4-hydroxy-9-nitro-1H-pyrano-[3',4':6,7] indolizino [1,2-b]
quinolone-3, 14(4H, 12H)-dione; CAS. Reg. No. 7689-03-4.
1.12 "* Plan" shall mean the formal action plan which shall be jointly agreed
upon by the Parties in response to the findings of, and recommendations
resulting from, the audit of SuperGen's clinical development activities
conducted by * in November 1999.
1.13 "Current Good Clinical Practice" means clinical practice as set out in: (i)
current Guidelines for Good Clinical Practice for Trials on Medicinal Products
in the European Union; (ii) US Code of Federal Regulations Title 21, Chapter 50
(Protection of Human Subjects), Chapter 56 (Institutional Review Boards), and
relevant final FDA Guidance and Points to Consider for drugs and/or
biotechnology-derived products, as may be amended from time to time; or (iii)
the equivalent current law or regulation in any market.
1.14 "Current Good Laboratory Practice" means laboratory practice as set out in:
(i) Rules Governing Medicinal Products in the European Union Vol. III, ISBN
92.825 9619-2 (ex. OECD principles of GLP), as may be amended from time to time;
(ii) US Code of Federal Regulations, Title 21, Chapter 58 (Good Laboratory
Practice for Nonclinical Laboratory Studies), and relevant final FDA Guidance
and Points to Consider for drugs and/or biotechnology-derived products, as may
be amended from time to time; or (iii) the equivalent current law or regulation
in any market.
1.15 "Current Good Manufacturing Practice" means manufacture in accordance with:
(i) EC Directive 91/456/EEC, as may be amended from time to time; (ii) the
current principles and guidelines of Good Manufacturing Practice for medicinal
products for human use as required by, but not limited to, the applicable
sections of the US Federal Food, Drug and Cosmetic Act, the US Public Health
Service Act, the US Code of Federal Regulations, Title 21, Parts 210 (CURRENT
GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF
DRUGS; GENERAL) and 211 (CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED
PHARMACEUTICALS), and relevant final FDA Guidance and Points to Consider for
drugs and/or biotechnology-derived products, as amended from time to time; or
(iii) the equivalent current law or regulation in any market.
1.16 "Detail" means a face-to-face sales presentation by a Sales Representative
during which the Product is marketed and promoted to an appropriate health care
professional. This shall include, but not be limited to, discussions with health
care professionals, meetings with or presentations to managed care entities,
purchasing decision-makers or
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formulary committees of health care providers, and participation in conventions
and continuing education programs.
1.17 "Detailing" means the act of marketing and promoting the Product through
Details.
1.18 "Discretionary Funds" means the miscellaneous costs and expenses which
represent that portion of the U.S. Co-Promotion Budget that are used by the
Sales Representatives in support of their Detailing and marketing activity for
the Product.
1.19 "EMEA" means the European Medicines Evaluation Agency or any successor
entity thereto in the European Union, provided that if submission for regulatory
approval for the Product is made in the EU via the decentralized procedure, then
reference to the "EMEA" in this Agreement shall be deemed a reference to the
appropriate reference member state in the EU.
1.20 "FDA" means the U.S. Food and Drug Administration or any successor entity
thereto.
1.21 "Finished Product" means the Product packaged and labeled for sale in
accordance with applicable laws and regulations in the Territories.
1.22 "International Promotional Materials" means all electronic and computer
managed information (including the Internet), all written, printed or graphic
materials, brochures, sales aids and other promotional items relating to a
Product approved for use in the International Territory, including but not
limited to advertising, Continuing Medical Education programs, seminar
presentations, symposia and speaker programs.
1.23 "International Territory" means all areas of the world outside the U.S.
Territory.
1.24 "International Transfer Price" means the price for the sale of Product by
SuperGen to Abbott in the International Territory as determined pursuant to
Section 8.2(c).
1.25 "Know-How" means any proprietary technology (other than the Licensed
Patents) owned by or licensed (with a right of sublicense) to SuperGen during
the term of this Agreement relating to the Compound or the Product; including
but not limited to, all pharmacological and toxicological data, including animal
test results and human clinical data and evaluation reports, and all performance
specifications.
1.26 "Launch" means the date upon which the first commercial sale of a Product
by Abbott or its Affiliates to Third Parties (as evidenced by the invoice date
for such sale) occurs in the Territories.
1.27 "Licensed Patents" means all patents and patent applications set forth in
Exhibit 1.23 throughout the Territory, including without limitation
substitutions,
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CONFIDENTIAL TREATMENT REQUESTED
extensions, additions, reissues, reexaminations, renewals, divisions,
continuations, continuations-in-part or supplementary patent certificates
thereof or therefor, owned by or licensed (with the right to sublicense) to
SuperGen during the term of this Agreement relating to the Compound and/ or
the Product.
1.28 "Losses" means any liabilities, costs, damages, judgments, settlements and
other reasonable out-of-pocket expenses (including legal and other professional
fees and expenses).
1.29 "Major European Countries" means France, Italy, Germany, Spain and the
United Kingdom.
1.30 "Marketing Studies" means those clinical trials and studies (including, for
the purposes of this Agreement, physician-held IND studies) which are performed
essentially for marketing purposes and expressly excludes all clinical studies
and trials which are required to pursue, obtain, and maintain Regulatory
Approval in the Territories.
1.31 "Medicare/ Medicaid Rebates" means those rebates that are due to either
U.S. federal or state administered programs on purchases of the Product by such
programs as established by applicable U.S. federal or state law or regulation.
1.32 "NDA" means, with respect to each commercially launched Product, an
approvable New Drug Application filed by SuperGen with the FDA for the U.S.
Territory, and the equivalent regulatory submission with the applicable
governmental authorities in the European Union and/ or in a given country in the
International Territory, and all subsequent submissions to that NDA.
1.33 "Net Units of Product Sold" means the total number of units of Product
which are sold by Abbott or its Affiliates to Third Parties during the given
calendar quarter or year less any returned, recalled, damaged or any other such
units of Product for which the customer has been credited the original sales
price. For any given period, the Net Units of Product Sold shall equal that
number of units of Product included in the calculation of Abbott Net Sales for
the same period. The Net Units of Product Sold shall be calculated separately
for the U.S. Territory and the International Territory.
1.34 "Party" means Abbott or SuperGen, and "Parties" means Abbott and SuperGen,
except as provided in Section 20.2.
1.35 "Patent Protected" means, with respect to the Product in a specific country
of the Territories, that the manufacture, use or sale of such Product in such
country infringes a Valid Claim in such country.
1.36 "Person" means a natural person, a corporation, a partnership, a trust
venture, any governmental authority, and any other entity or organization.
1.37 "Product" means any pharmaceutical product containing the Compound or a
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CONFIDENTIAL TREATMENT REQUESTED
derivative thereof as an active ingredient.
1.38 "Product Sales" means the total gross sales of the Product.
1.39 "Promote" or "Promotion" means the act of Detailing or otherwise
advertising, marketing and promoting sales of the Product and conducting as
necessary Marketing Studies.
1.40 "Regulatory Approval" means (i) with respect to the U.S. Territory,
approval from the FDA to market a Product in the United States and (ii) with
respect to the International Territory, all governmental approvals and
authorizations necessary for the commercial sale of the Product in a country in
the Territory, including but not limited to marketing authorization, pricing
approval and pricing reimbursement, as applicable.
1.41 "Sales Representative" means, with respect to each Party, an individual:
(i) who is regularly employed by such Party on a full-time or part-time basis as
a member of one of its sales forces or as a field-based medical liaison
representative or, with the written consent of the other Party, is retained on a
contractual basis to act as a part of its sales force; and (ii) who is
appropriately qualified and experienced in pharmaceutical product promotion to
make effective sales presentations for the Product.
1.42 "Sales Year" means, for both the U.S. Territory and the International
Territory, for the first Sales Year, a twelve (12) month period commencing on
the date of Xxxxxx'x Launch of the Product in such Territory, or any succeeding
twelve (12) month period.
1.43 "Sample Pack" means Product for distribution to Third Parties as
professional samples not to be sold.
1.44 "Specifications" means written manufacturing release specifications, which
shall be agreed between the Parties for, respectively, the Compound, the Product
and the Finished Product, and attached to this Agreement as Exhibit 1.44.
1.45 "SuperGen Cost of Goods" means the direct costs and expenses of
manufacturing and packaging the Net Units of Product Sold during the given
calendar quarter or year, including the actual costs and expenses, if any,
incurred by SuperGen during the given calendar quarter or year for (i) the
warehousing, handling and shipping of the Compound and Product; (ii) any
governmentally imposed duties, sales, excise, turnover, inventory, value-added
and similar taxes assessed on the Compound and Product, and (iii) in-bound
freight and brokerage fees if not included in the finished cost of the Product;
and (iv) any reimbursement to Abbott pursuant to Section 8.5(d), provided that
in no event shall SuperGen Cost of Goods include any overhead or indirect costs
or expenses (including but not limited to such overhead or indirect costs or
expenses attributable to medical, regulatory, or marketing activities of
SuperGen), and further provided that in no event shall SuperGen Cost of Goods
include any item which is not an actual cost or expense calculated in good
faith, nor shall SuperGen Cost of Goods include any item in any way contrived so
as to inflate the calculation of SuperGen Cost of Goods. The SuperGen
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CONFIDENTIAL TREATMENT REQUESTED
Cost of Goods shall be calculated separately for the U.S. Territory and the
International Territory.
1.46 "SuperGen Distribution Margin" means the SuperGen Product Sales in the U.S.
Territory minus the SuperGen Cost of Goods with respect to the U.S. Territory
for a given calendar quarter or year. The SuperGen Distribution Margin shall be
calculated only for the U.S. Territory.
1.47 "SuperGen Operating Margin" means the SuperGen Distribution Margin in the
U.S. Territory minus the SuperGen SG&A for a given calendar quarter or year. The
SuperGen Operating Margin shall be calculated only for the U.S.
Territory.
1.48 "SuperGen Product Sales" means the total aggregate U.S. Transfer Price
received by SuperGen from Abbott for the Net Units of Product Sold by Abbott to
Third Parties in the U.S. Territory during a given calendar quarter or year. The
SuperGen Product Sales shall be calculated only for the U.S. Territory.
1.49 "SuperGen SG&A" means, with respect to the U.S. Territory during the given
calendar quarter or year, the verified costs and expenses permitted under
Section 4.2 which are incurred by SuperGen in the advertising, Detailing, sales,
marketing and promotion of the Product in the U.S. Territory and, to the extent
permitted under Section 4.4, the Marketing Studies for the U.S. Territory for
the Product during the given calendar quarter or year, in the categories set
forth in Exhibit 1.8, provided that in no event shall SuperGen SG&A include any
overhead or indirect costs or expenses (including but not limited to such
overhead or indirect costs or expenses attributable to medical, regulatory, or
marketing activities of SuperGen), and further provided that in no event shall
SuperGen SG&A include any costs or expenses actually incurred by SuperGen in
connection with the Co-Promotion of the Product in the U.S. Territory but not
approved in advance by the U.S. Marketing Board. The SuperGen SG&A shall be
calculated only for the U.S. Territory.
1.50 "SuperGen Technology" means the Licensed Patents and the Know-How.
1.51 "SuperGen Third Party Royalties" means the royalty payments made, for a
given period during the term of this Agreement, by SuperGen to The Xxxxxxx
Foundation for Cancer Research ("Xxxxxxx") pursuant to the license agreement
dated September 3, 1997 between SuperGen and Xxxxxxx relating to the Compound
(the "Xxxxxxx License Agreement").
1.52 "SuperGen Trademark" means the trademark to be selected by the U.S.
Marketing Board and registered by SuperGen for the Product in the U.S.
Territory.
1.53 "Territories" means the U.S. Territory and the International Territory.
1.54 "Third Party" means any Person that is not a Party or an Affiliate of a
Party.
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CONFIDENTIAL TREATMENT REQUESTED
1.55 "U.S. Product Profit" means the following: (i) with respect to the first
calendar quarter of each year, the total of the Abbott Operating Margin and the
SuperGen Operating Margin for such calendar quarter and (ii) for the second,
third and fourth calendar quarters of each year, the total, for the subject
calendar quarter and each previous calendar quarter during such calendar year,
of the Abbott Operating Margin and the SuperGen Operating Margin.
1.56 "U.S. Promotional Materials" means all electronic and computer managed
information (including the Internet), all written, printed or graphic materials,
brochures, sales aids and other promotional items relating to a Product approved
by the U.S. Marketing Board for use in the U.S. Territory, including but not
limited to advertising, Continuing Medical Education programs, audio programs,
seminar presentations, symposia and speaker programs.
1.57 "U.S. Territory" means the continental United States of America, Hawaii and
Alaska.
1.58 "U.S. Transfer Price" means the price for the sale of the Product by
SuperGen to Abbott in the U.S. Territory pursuant to Section 8.2(b) below.
1.59 "Valid Claim" means (a) an issued claim of any unexpired patent included
among the Licensed Patents, or (b) a pending claim of any pending patent
application included among the Licensed Patents, which has not been held
unenforceable, unpatentable or invalid by a decision of a court or governmental
body of competent jurisdiction, unappealable or unappealed within the time
allowed for appeal, which has not been rendered unenforceable through disclaimer
or otherwise or which has not been lost through an interference proceeding.
ARTICLE 2: DISTRIBUTION AND PROMOTION
2.1 EXCLUSIVE DISTRIBUTOR. SuperGen hereby appoints Abbott, and Abbott hereby
accepts appointment, as the exclusive distributor of the Product in the U.S.
Territory and the International Territory, with the sole and exclusive right,
exclusive even as to SuperGen, to sell commercially and to distribute the
Product to Third Parties in the Territories, with the right to appoint Affiliate
sub-distributors, and with the right to appoint Third Party sub-distributors
with SuperGen's prior written consent, which consent shall not be unreasonably
withheld or delayed.
2.2 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 relating to other SuperGen products.
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 other SuperGen products.
2.3 PROMOTION.
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CONFIDENTIAL TREATMENT REQUESTED
(a) SuperGen hereby grants to Abbott, and Abbott hereby accepts, the
exclusive right to Co-Promote the Product in the U.S. Territory jointly
with SuperGen. Neither Abbott nor SuperGen shall appoint any Third
Party to act on its behalf with respect to the Detailing of the Product
in the U.S. Territory. At any time during the term of this Agreement,
if SuperGen (or its successors or permitted assigns), at its sole
discretion, decides not to Co-Promote or to cease Co-Promoting the
Product in the U.S. Territory, SuperGen shall provide Abbott with at
least one hundred eighty (180) days prior written notice of such
decision. In such event, Xxxxxx'x right to Co-Promote the Product in
the U.S. Territory pursuant to this Article 2.3 shall automatically
become an exclusive right to Promote the Product in the U.S. Territory,
exclusive even as to SuperGen, without requiring any amendment of this
Agreement, effective one hundred eighty (180) days after receipt of
such notice from SuperGen.
(b) SuperGen hereby grants to Abbott, and Abbott hereby accepts, the
exclusive right, exclusive even as to SuperGen, to Promote the Product
in the International Territory, with the right to appoint Third Parties
to Co-Promote the Product in the International Territory.
2.4 NON-COMPETE. During the term of this Agreement, the Parties shall not
market, offer for sale or sell a Competing Product within the Territories.
2.5 LICENSE.
(a) SuperGen hereby grants Abbott an exclusive license under the
SuperGen Technology to offer to sell and sell the Product in the U.S.
Territory, with the right to sub-license to Affiliates, and with the
right to sub-license to Third Parties with SuperGen's prior written
consent, such consent not to be unreasonably withheld or delayed. Such
license shall be exclusive even as to SuperGen, except to the extent
necessary to enable SuperGen to perform any obligations or activities
that SuperGen is required or permitted to perform under this Agreement.
(b) SuperGen hereby grants Abbott an exclusive license under the
SuperGen Technology to import, use, offer to sell and sell the Product
in the International Territory, with the right to sublicense. Such
license shall be exclusive even as to SuperGen, except to the extent
necessary to enable SuperGen to perform any obligations or activities
that SuperGen is required or permitted to perform under this Agreement.
(c) Solely for the purpose of enabling Abbott to exercise its rights
pursuant to Article 8.5 of this Agreement, SuperGen hereby grants
Abbott a non-exclusive license to make and have made the Product in the
Territories.
(d) If at any time during the term of this Agreement, the financial
resources of SuperGen are not reasonably sufficient to enable it to
continue to meet its obligations hereunder for at least the next six
months, SuperGen will so notify
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CONFIDENTIAL TREATMENT REQUESTED
Abbott and the parties will meet to review and consider steps that
might be taken to preserve Xxxxxx'x rights to the SuperGen Technology
under the terms of the Agreement.
2.6 RIGHTS TO ADDITIONAL PRODUCTS.
(a) SuperGen hereby grants to Abbott, and Abbott hereby accepts, a
right of first discussion with respect to all pharmaceutical compounds,
other than the Compound, which are licensed to, owned by and/ or
developed by SuperGen (regardless of their stage of development) as
provided herein. If SuperGen desires to sell, or grant any rights
relating to, any such compound, SuperGen shall first notify Abbott in
writing, and shall provide to Abbott a data package which shall consist
of all material information relating to such compound in the possession
or control of SuperGen at such time, and shall also provide any other
information in its possession or control reasonably requested by Abbott
for the evaluation of the compound and the business opportunity. Within
ninety (90) days after the receipt of the data package and such other
information, Abbott shall notify SuperGen whether it is interested in
such compound.
(b) If Abbott notifies SuperGen that it is not interested in such
compound, SuperGen shall be free to grant the rights declined by Abbott
to any Third Party without restriction, or may commercialize directly.
(c) If Abbott notifies SuperGen of Xxxxxx'x interest, the Parties
shall, in good faith, negotiate the terms of an agreement under which
SuperGen shall grant such rights to Abbott. If the Parties are unable
to agree to the terms of such an agreement, after good faith
negotiations, within ninety (90) days from SuperGen's receipt of such
notice pursuant to this Article 2.6(c), then SuperGen shall be free to
grant such rights to any Third Party, provided that SuperGen shall not
enter into an agreement which grants any rights to such compound to any
Third Party on terms which, taken as a whole, are more favorable to
such Third Party than those offered to Abbott, without first offering
such terms to Abbott. If SuperGen offers such terms to Abbott, then
Xxxxxx shall have thirty (30) days in which to notify SuperGen as to
whether Xxxxxx accepts such terms. If Xxxxxx accepts such terms, then
the Parties shall promptly enter into such agreement, granting such
rights to Xxxxxx.
(d) In licensing any compounds from Third Parties, SuperGen shall use
its reasonable efforts to ensure that such compound can be offered to
Xxxxxx in accordance with the provisions of this Section 2.6.
2.7 RIGHT OF FIRST REFUSAL FOR SUPERGEN ACQUISITION.
(a) In the event that SuperGen wishes to initiate an inquiry or solicit
an offer, or receives an offer or inquiry, from any Third Party
relating to the potential merger with or acquisition of SuperGen or of
a controlling portion of the voting
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CONFIDENTIAL TREATMENT REQUESTED
securities or substantially all of assets of SuperGen, SuperGen shall
first so notify Xxxxxx ("Acquisition Offer Notice") and Xxxxxx shall have
the right of first refusal to merge with or acquire SuperGen or a
controlling portion of the voting securities or substantially all of
assets of SuperGen.
(b) The Acquisition Offer Notice shall set forth the principal
financial and other terms under consideration by SuperGen. Xxxxxx shall
have ninety (90) days from receipt of the Acquisition Offer Notice to
respond with either an offer to merger with or acquire SuperGen, or a
notice that Xxxxxx is not interested in making any offer to merge with
or acquire SuperGen. If Xxxxxx makes an offer to merge with or acquire
SuperGen, the Parties shall enter into good faith negotiations for such
merger or acquisition, and shall enter into a definitive agreement or
agreements in order to effect such merger or acquisition subject to the
terms and conditions of such definitive agreement or agreements. If the
Parties are unable to reach agreement and to enter into such definitive
agreement or agreements within ninety (90) days of the start of
negotiations, then SuperGen shall be free to initiate an inquiry or
solicit an offer, or to entertain an offer or inquiry, from any Third
Party relating to the potential merger with or acquisition of SuperGen
or of a controlling portion of the voting securities or substantially
all of assets of SuperGen; provided that SuperGen shall not enter into
any definitive agreement or agreements with any such Third Party, on
terms and conditions equivalent to or more favorable to such Third
Party than the terms and conditions last offered to Xxxxxx by SuperGen,
without first offering to enter into the definitive agreement or
agreements with Xxxxxx.
(c) Notwithstanding any other provision of this Section 2.7, if the
SuperGen Board of Directors determines in good faith that accepting an
offer from Xxxxxx to acquire SuperGen pursuant to this Section 2.7(a)
or (b) would not meet the Board's fiduciary duties under applicable
laws and regulations, then SuperGen's non-compliance with this Section
2.7(a) or (b) shall not constitute a breach of this Agreement.
ARTICLE 3: CLINICAL DEVELOPMENT, PRODUCT APPROVAL AND LAUNCH
3.1 CLINICAL DEVELOPMENT
(a) SuperGen shall exercise its reasonable efforts to pursue, and shall
bear the full cost and expense of, the Clinical Development of the
Product to support Regulatory Approval for the treatment of pancreatic
cancer for the U.S. Territory, Canada, and those countries in the
International Territory which are, as of the Effective Date, member
states of the European Union ("EU"). For purposes of this Agreement,
"Clinical Development" includes but is not limited to all clinical
studies and trials, and all safety, toxicology, efficacy, and other
data required to pursue, obtain and maintain Regulatory Approval in the
U.S. Territory, in Canada, and in the EU, as well as the clinical
studies set forth in Exhibit 3.1 attached to this Agreement. In
performing its obligations under this Article 3.1(a), SuperGen
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CONFIDENTIAL TREATMENT REQUESTED
shall act in accordance with Article 4.4 below, and in so doing SuperGen
shall keep Xxxxxx fully apprised with respect to its clinical development
activities and shall provide Xxxxxx with reasonable advance opportunity
for input regarding these activities, including the right to review and
approve the protocols and SuperGen's audit reports relating to all
clinical studies.
(b) Xxxxxx shall exercise its reasonable efforts to pursue, and shall
bear the full cost and expense of the clinical development of the
Product for the countries of the International Territory other than
Canada and the EU. Xxxxxx shall keep SuperGen fully apprised with
respect to its clinical development activities and shall provide
SuperGen with reasonable advance opportunity for input regarding these
activities, including the right to review the protocols and Xxxxxx
audit reports relating to all clinical studies.
3.2 U.S. REGULATORY APPROVAL. SuperGen shall exercise its reasonable efforts to
file, obtain and maintain Regulatory Approval for the Product in the United
States, and to obtain reimbursement approval for the Product in the United
States (including but not limited to any and all applicable programs
administered by government and private third-Party payors), and shall bear the
full cost and expense thereof. SuperGen shall keep Xxxxxx fully apprised with
respect to its regulatory and reimbursement activity in the United States.
Specifically, SuperGen shall (i) promptly provide Xxxxxx with a copy of all
filings, documents, and material correspondence with the FDA and other
applicable regulatory or governmental authorities and any inspection reports
relating to Third Party manufacturers, (ii) provide Xxxxxx with advance notice
of meetings with the FDA and allow Xxxxxx to attend or participate in any such
meeting, (iii) allow Xxxxxx representatives opportunity to audit any and all
manufacturing facilities, processes, clinical sites, and documentation for the
Product; and (iv) provide Xxxxxx with a written right of reference to all U.S.
regulatory filings.
3.3 INTERNATIONAL REGULATORY APPROVAL.
(a) SuperGen shall provide Xxxxxx, at SuperGen's expense, with the
dossier SuperGen uses for obtaining U.S. Regulatory Approval, along
with any and all other data, information and materials reasonably
requested by Xxxxxx for obtaining Regulatory Approval from the EMEA for
the Product. Xxxxxx shall exercise its reasonable efforts to file,
obtain and maintain Regulatory Approval for the Products in the
International Territory, and shall bear the full cost and expense
thereof, provided that if the EMEA requests or requires additional
clinical data beyond that provided to Xxxxxx by SuperGen, or Xxxxxx in
its reasonable commercial judgement deems such additional clinical data
to be necessary for such Regulatory Approval, then SuperGen shall
reimburse Xxxxxx for Xxxxxx'x costs and expenses for such additional
clinical studies. Xxxxxx shall keep SuperGen fully apprised with
respect to its regulatory activity in the International Territory.
Specifically, Xxxxxx shall (i) promptly provide SuperGen with a copy of
all filings, documents, and material correspondence with the relevant
governmental authorities (without an obligation to translate into
English,
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CONFIDENTIAL TREATMENT REQUESTED
unless otherwise available), and (ii) provide SuperGen with advance notice
of meetings with such authorities and consider, at Xxxxxx'x sole
discretion, SuperGen's request to attend or participate in any such
meeting or to obtain a written right of reference to Xxxxxx'x regulatory
filings for the Product in the International Territory.
(b) Xxxxxx shall use its reasonable efforts to obtain Regulatory
Approval in at least three (3) of the following countries within five
(5) years of SuperGen's receipt of U.S. Regulatory Approval: Mexico,
Canada, Japan, the United Kingdom, France, Italy, Germany, and Spain.
If Xxxxxx fails to obtain Regulatory Approval pursuant to this Section
3.3(b) within such time frame, SuperGen shall have the right to take
over Xxxxxx'x Regulatory Approval efforts in these countries. In such
event, Xxxxxx shall transfer to SuperGen all of the filing materials or
information then in Xxxxxx'x possession or control necessary for
SuperGen to file for the Regulatory Approval, or to continue the filing
if Xxxxxx has commenced the filing process, in these countries.
3.4 REASONABLE COOPERATION.
(a) Each Party shall provide the other Party with all reasonable
assistance requested by the other Party with respect to the foregoing
clinical development and regulatory activities, including, but not
limited to, promptly providing the other Party with any and all
authorizations, approvals, certificates of free sale, and other
information, documents, materials and assistance reasonably required by
the other Party to file, obtain, and maintain Regulatory Approval for
the Product. The Party providing such assistance shall be reimbursed by
the other Party for its reasonable out-of-pocket costs and expenses.
(b) If SuperGen so requests and Xxxxxx so agrees, Xxxxxx shall perform
certain clinical research services for particular clinical studies to
be conducted by SuperGen, subject to the terms and conditions of a
separate agreement between the Parties including, but not limited to,
the provision for an appropriate fee to be paid Xxxxxx for its services
thereunder.
(c) SuperGen shall provide to Xxxxxx, at SuperGen's expense, the
dossier SuperGen uses for obtaining U.S. Regulatory Approval, along
with any and all other data, information and materials reasonably
requested by Xxxxxx for obtaining Regulatory Approval from the EMEA for
the Product.
(d) In connection with its NDA for the Product in the U.S. Territory,
and with Xxxxxx'x NDAs for the Product in the International Territory,
SuperGen shall take any and all actions necessary or reasonably
requested by Xxxxxx in order to qualify Xxxxxx as a secondary
manufacturing source for the Product in the Territories, solely for the
purpose of enabling Xxxxxx to exercise its rights pursuant to Article
8.5 below without delay or impediment in the supply of Product to
Xxxxxx for Sale in the Territories.
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CONFIDENTIAL TREATMENT REQUESTED
(e) Within four (4) months of the Effective Date, the respective
pharmacovigilance groups of each Party shall prepare and enter into a
separate agreement relating to the exchange of adverse event
information.
3.5 EXCUSED PERFORMANCE. The Parties acknowledge and understand that the
development, obtaining of Regulatory Approval, and marketing of the Product, as
with any pharmaceutical product, is subject to certain inherent risks including
that (a) the Product will be ineffective, toxic, or will not receive Regulatory
Approval, or will receive Regulatory Approval but with labeling which the
Parties agree is insufficient to render the Product commercially viable; (b) the
Product will be too expensive to manufacture or market or 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 (i) will be successfully developed; (ii) will receive
all necessary and/ or commercially viable Regulatory Approvals, (iii) will be
Launched; or (iv) will be commercially successful. The respective obligations of
the Parties under this Article 3, and Articles 4 and 5 below, are expressly
conditioned upon the safety, efficacy and commercial feasibility of the Product,
and, except as expressly provided herein, 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. Furthermore, Xxxxxx'x obligation to market and
Promote the Product in a given country in the International Territory shall not
apply if Xxxxxx has not commenced or has ceased marketing the Product in such
country substantially due to adverse business or financial conditions, including
those caused by the regulatory authorities or other governmental authorities of
such country, which would cause the marketing of such Product in such country to
be contrary to the financial best interest of the Parties. Each Party shall
promptly notify the other Party in the event any material issue arises as to the
safety, efficacy, commercial feasibility, or adverse business or financial
conditions with respect to any Product.
3.6 XXXXXX SUPPORT OF DEVELOPMENT EFFORTS. Xxxxxx shall staff incremental
headcount in support of the clinical, regulatory and CMC obligations set forth
in this Agreement. SuperGen shall make the following payments to Xxxxxx in cash
to cover Xxxxxx'x expenses for such support: a total of three million dollars
($3,000,000), with a first installment of seven hundred fifty thousand dollars
($750,000) payable on April 1, 2000, followed by seven (7) equal installments of
three hundred seventy-five thousand dollars ($375,000) per installment payable
within five (5) days of the beginning of each calendar quarter thereafter,
through calendar year 2001.
3.7 SUPERGEN DEVELOPMENT EFFORTS. SuperGen shall ensure that the development
activities it undertakes pursuant to Article 3 and Article 4 hereof shall be
carried out in accordance with Current Good Clinical Practice, Current Good
Laboratory Practice and Current Good Manufacturing Practice.
3.8 GOOD CLINICAL PRACTICE AUDITS. The parties shall appoint a mutually
acceptable
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CONFIDENTIAL TREATMENT REQUESTED
third party independent clinical research organization to conduct a Current
Good Clinical Practice audit of the clinical development activities set forth
herein in each of June 2000 and December 2000 (each, a "GCP Audit"). The
costs of both GCP Audits shall be borne by SuperGen. If either GCP Audit
reveals a material deficiency which Xxxxxx concludes, in its sole discretion,
may jeopardize the success of the U.S. NDA filing for the Product, and if
SuperGen does not rectify such deficiency to Xxxxxx'x reasonable satisfaction
within sixty (60) days of Xxxxxx'x notice of such deficiency, then Xxxxxx
shall thereafter assume all development and registration activities for the
Product in the Territories, including but not limited to conducting or having
conducted, and completing or having completed, all clinical studies and other
activities required for Regulatory Approvals under the Development Plan.
Xxxxxx shall use reasonable efforts to pursue such development and
registration activities under the Development Plan with the objective of
filing applications for Regulatory Approval throughout the Territories. In
the event that Xxxxxx assumes SuperGen's development and registration
responsibilities pursuant to this Section 3.8, (i) SuperGen shall remain
responsible for all costs and expenses otherwise payable by SuperGen under
Article 3 and Article 4 hereof; and (ii) SuperGen shall transfer to Xxxxxx
all of the filing materials and information in SuperGen's possession or
control necessary for Xxxxxx to develop the Product and file for Regulatory
Approvals.
3.9 XXXXXX OPTION. SuperGen shall have ninety (90) days from completion of the
Phase III pancreatic cancer clinical studies with the Product to determine
whether the results of such study are sufficient to support an NDA filing for
the Product in the United States. In the event that SuperGen determines that
such results are insufficient to support such a filing and SuperGen elects not
to continue any further development of the Product, Xxxxxx shall have the option
to thereafter assume all development and registration activities for the Product
in the Territories, including but not limited to conducting or having conducted,
and completing or having completed, all clinical studies and other activities
required for Regulatory Approvals under the Development Plan. Xxxxxx shall use
reasonable efforts to pursue such development and registration activities under
the Development Plan with the objective of filing applications for Regulatory
Approval throughout the Territories. In the event that Xxxxxx exercises its
option under this Section 3.9, (i) Xxxxxx shall further develop the Product at
Xxxxxx'x sole cost and expense and in Xxxxxx'x sole discretion as to the
development strategy and plan, and (ii) SuperGen shall transfer to Xxxxxx all of
the filing materials and information in SuperGen's possession or control
necessary for Xxxxxx to develop the Product and file for Regulatory Approvals.
In such event (i) for the U.S. Territory, the provisions for profit sharing
under Article 6 below shall not apply and instead the Parties shall negotiate in
good faith a royalty based on Xxxxxx'x Net Sales in the U.S. Territory; and (ii)
the provisions of Article 7 below shall apply for the International Territory.
3.10 XXXXXX ACCESS TO DATA. Promptly after the Effective Date and throughout the
term of this Agreement, SuperGen shall provide to Xxxxxx, within a reasonable
time, a shared database so that Xxxxxx shall have ready access to all
preclinical and clinical and manufacturing documentation, information and data
resulting from SuperGen's Product research and development activities in the
Territories which Xxxxxx requires for regulatory filings in the Territories or
which Xxxxxx may reasonably request, including
16
CONFIDENTIAL TREATMENT REQUESTED
but not limited to the studies set forth in Exhibit 3.1, case report forms,
monitoring documents, patient informed consents, institutional review board
approvals, medical and statistical programming and study reports for
individual studies, clinical data summaries, and expert reports. Upon
Xxxxxx'x request, SuperGen shall provide Xxxxxx with copies of such
documentation and data. If at any time during this Agreement SuperGen fails
to provide Xxxxxx with such database (including but not limited to any
updates thereof) or any such access in a reasonable timely fashion, and if
SuperGen does not provide such database and/ or access to Xxxxxx within sixty
(60) days of Xxxxxx'x notice to SuperGen of such failure, then Xxxxxx shall
have the option to thereafter assume all development and registration
activities for the Product in the Territories, including but not limited to
conducting or having conducted, and completing or having completed, all
clinical studies and other activities required for Regulatory Approvals under
the Development Plan. Xxxxxx shall use reasonable efforts to pursue such
development and registration activities under the Development Plan with the
objective of filing applications for Regulatory Approval throughout the
Territories. In the event that Xxxxxx exercises its option under this Section
3.10, (i) Xxxxxx shall develop the Product at SuperGen's sole cost and
expense and SuperGen shall transfer to Xxxxxx all of the filing materials and
information in SuperGen's possession or control necessary for Xxxxxx to
develop the Product and file for Regulatory Approvals.
ARTICLE 4: CO-PROMOTION AND PROMOTION
4.1 MARKETING EFFORT. Xxxxxx and SuperGen shall use their reasonable efforts to
Co-Promote the Product in the U.S. Territory, and Xxxxxx shall use its
reasonable efforts to Promote the Product in the International Territory, to
maximize Product Sales in the Territories. Xxxxxx shall use its reasonable
efforts to implement, and shall make tactical decisions with regard to,
Promotion in the International Territory, consistent with the terms of this
Agreement.
4.2 U.S. MARKETING BOARD.
(a) Xxxxxx and SuperGen shall work together to Co-Promote the Product
in the U.S. Territory and shall present their views on the Co-Promotion
of the Product through a committee (the "U.S. Marketing Board") which
shall oversee and direct the Co-Promotion of the Product in the U.S.
Territory. The U.S. Marketing Board shall review and approve strategies
for the Co-Promotion of the Product, develop and approve the annual
Co-Promotion budget, and undertake the activities necessary to
implement those strategies in accordance with a U.S. Co-Promotion Plan
and U.S. Promotional Materials (including by coordinating the Parties'
Detailing messages and methodologies, physician, trade, managed care
and formulary committee targeting, and call programs and efforts).
(i) The U.S. Marketing Board shall consist of no more than
four (4) individuals, two (2) of which shall be
representatives, respectively, from Xxxxxx and SuperGen, and
shall be chaired alternatively on an annual
17
CONFIDENTIAL TREATMENT REQUESTED
basis by one (1) of the SuperGen representatives and by one
(1) of the Xxxxxx representatives. Each Party's representatives
on the U.S. Marketing Board shall be full-time employees of such
Party and each shall have one (1) vote on any matter arising for
decision by the Board. The U.S. Marketing Board may invite,
from time to time, one or more additional employees of the
Parties who offer specialized assistance to the Board (e.g.,
legal, finance or regulatory personnel) to participate in any
meeting in a non-voting, advisory capacity, provided that,
when one or more specialists from one Party is invited, the
same number of similar specialists from the other Party shall
also be invited to the same meeting. Each Party shall have the
right, at any time, to designate by written notice to the
other Party, a replacement, on a permanent or temporary basis,
for any of such Party's members on the U.S. Marketing Board.
(ii) The U.S. Marketing Board shall be responsible for making
all final decisions related to the Co-Promotion of the Product
in the U.S. Territory, pursuant to the terms and conditions of
this Agreement. Each Party shall use its reasonable efforts to
implement the final decisions of the U.S. Marketing Board.
(iii) The U.S. Marketing Board shall endeavor to work by
consensus. In the event of a deadlock in any vote or on any
issue relating to this Section 4.2, the Parties shall refer
the deadlocked issue to SuperGen's Executive Vice President of
Commercial Operations and Xxxxxx'x Hospital Products Division
Vice President of Commercial Operations. These individuals
shall attempt, promptly and in good faith, to resolve such
issue amicably. If such issue remains deadlocked, the Parties
shall refer such issue to, respectively, the President of
SuperGen, and the President of Xxxxxx'x Hospital Products
Division. Any issue remaining deadlocked after this last step
shall be resolved through an Alternative Dispute Resolution
("ADR") procedure pursuant to Section 20.3 below.
(iv) During the first three (3) Sales Years in the U.S.
Territory, the U.S. Marketing Board shall meet as necessary,
in person or otherwise as the Parties shall agree, but no less
than once per calendar quarter. Thereafter, for the remaining
term of this Agreement, the Board shall meet as necessary, in
person or otherwise as the Parties shall agree. The
chairperson shall be responsible for scheduling and arranging
such meetings and ensuring that all four (4) members or their
designated replacements are able to attend
(v) Each Party shall bear its own costs, including travel
costs, for its representatives on the U.S. Marketing Board or
its specialists attending any meeting of the U.S. Marketing
Board.
(b) No later than November 15th of each year during the term of this
Agreement, the
18
CONFIDENTIAL TREATMENT REQUESTED
Parties shall reach written agreement, through the U.S. Marketing Board,
on an annual budget for the Co-Promotion of the Product in the U.S.
Territory (the "U.S. Co-Promotion Budget"), which shall set forth in
appropriate detail, the costs and expenses to be incurred pursuant to
Section 1.8(i) (Xxxxxx SG&A) and Section 1.55(i) (SuperGen SG&A) and as
further described in Exhibit 1.8; provided that if, in the proposed budget
for a given year exceeds twenty million dollars ($20,000,000), then that
budget must be approved by both the U.S. Marketing Board and SuperGen's
Executive Vice President of Commercial Operations and Xxxxxx'x Hospital
Products Division Vice President of Commercial Operations. The initial
U.S. Co-Promotion Budget shall be approved within sixty (60) days of the
Effective Date and such initial U.S. Co-Promotion Budget shall provide for
SuperGen to spend a minimum of four million dollars ($4,000,000) on
pre-marketing and marketing activities for the Product (and SuperGen hereby
agrees to comply with such minimum requirement), which four million dollars
($4,000,000) shall not be included in any SuperGen SG&A or otherwise
accounted for in any calculation of SuperGen U.S. Profit Amount (as
defined in Article 6 below). The U.S. Co-Promotion Budget shall be
expended consistent with the strategies outlined in the U.S.
Co-Promotion Plan, allowing for management discretion of the respective
Parties in the implementation of specific tactical components, provided
that Xxxxxx'x obligation to make any expenditure for U.S. Co-Promotion
until the date of the acceptance by the FDA of the U.S. NDA for the
Product. The U.S. Marketing Board may recommend adjustments to an
approved U.S. Co-Promotion Budget up to two (2) times per calendar
year, for review and approval by SuperGen's Executive Vice President of
Commercial Operations and Xxxxxx'x Hospital Products Division Vice
President of Commercial Operations, according to the following
time-table:
U.S. Marketing Board Recommends Parties Approve in Writing
------------------------------- --------------------------
No later than February 1 No later than May 1
No later than June 1 No later than September 15.
(c) No later than November 15th of each year during the term of this
Agreement, the Parties shall reach written agreement, through the U.S.
Marketing Board, on an annual plan for the Co-Promotion of the Product
in the U.S. Territory (the "U.S. Co-Promotion Plan"). The U.S.
Marketing Board shall oversee the implementation of the U.S.
Co-Promotion Plan. The U.S. Co-Promotion Plan shall specify the number
of the total Sales Representatives required (measured on a full time
equivalent basis) and define the activities of such Sales
Representatives which are included in such Party's SG&A account
hereunder (the "Detailing Commitment"), the sampling program for the
Product (including a maximum number of Sample Packs), the Discretionary
Funds available to the Sales Representatives, any Marketing Studies for
the Product, medical education programs and special marketing incentive
programs; provided, however, that, unless expressly agreed otherwise by
the Parties, the Xxxxxx Sales Representatives and the SuperGen Sales
Representatives shall be treated in a like and equal manner such that:
(i) the sampling program (as well as the number of samples) per Sales
Representative shall be substantially the same for both sales forces;
(ii) the level of Discretionary Funds per Sales Representative shall be
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CONFIDENTIAL TREATMENT REQUESTED
substantially the same for both Parties; and (iii) the amount and type
of U.S. Promotional Materials per Sales Representative shall be
substantially the same for both sales forces.
(d) Under the U.S. Co-Promotion Budget and the U.S. Co-Promotion Plan,
Xxxxxx shall maintain no less than sixty percent (60%) of the total
number of Sales Representatives required to Co-Promote the Product, and
SuperGen shall be permitted to maintain up to forty percent (40%) of
such total number of Sales Representatives.
(e) Xxxxxx and SuperGen shall be authorized to account for such Sales
Representatives, on a fully allocated cost of one hundred seventy-five
thousand dollars ($175,000) per full-time equivalent basis, as part of
the Xxxxxx SG&A and SuperGen SG&A, respectively (for example, two Sales
Representatives who are full-time employees and are assigned to
dedicate 50% of their time to the Product shall be counted as one
full-time equivalent at a cost of $175,000). The cost of one hundred
seventy-five thousand dollars ($175,000) per full-time equivalent shall
be increased no more than once per calendar year based upon the U.S.
Consumer Price Index.
(f) Each Party shall be responsible for staffing, selling skills
training, supervising, and compensating (including incentives) its own
Sales Representatives. The Parties shall jointly develop, review and
agree upon Product-specific training materials, and shall use the same
such training materials, for their respective Sales Representatives.
The Parties shall conduct Product training for their respective Sales
Representatives jointly, at such times and in such manner as set forth
in the U.S. Co-Promotion Plan. Each Party shall have full control over
and be responsible for the salary, incentives, benefits and other
employment matters related to its Sales Representatives.
(g) Each Party shall use its reasonable efforts to perform those tasks
and responsibilities assigned to such Party in the U.S. Co-Promotion
Plan. The Detailing of a Product shall commence upon the Launch of such
Product. Each Party may perform Details throughout the U.S. Territory.
The U.S. Marketing Board shall coordinate the Parties' Detailing
activities so as to maximize Product sales by, for example, maximizing
geographic coverage, eliminating unnecessary duplication, identifying
promising managed care targets, enhancing managed care penetration, and
optimizing participation in conventions continuing educational programs
for health care professionals.
(h) As part of the Co-Promotion of the Product in the U.S. Territory,
each Party may distribute a reasonable number of Sample Packs free of
charge to health care professionals on an ongoing basis in accordance
with the sampling program as outlined in the U.S. Co-Promotion Plan and
approved by the U.S. Marketing Board. Each Party shall comply with all
applicable laws and regulations with respect to the distribution of
Sample Packs in the U.S. Territory,
20
CONFIDENTIAL TREATMENT REQUESTED
including but not limited to maintaining all records required pursuant
to the Prescription Drug Marketing Act of 1987. Xxxxxx shall promptly
report to SuperGen any thefts of Sample Packs or any losses of Sample
Packs. SuperGen shall be responsible for providing to both Parties'
sales forces the quantities of Sample Packs set forth in the U.S. Co-
Promotion Plan.
(i) SuperGen and Xxxxxx shall jointly develop, review and agree upon
the U.S. Promotional Materials from a regulatory and medical
perspective. To the extent that any U.S. Promotional Materials are
required by law or regulation to be submitted to the FDA, SuperGen
shall make such submissions; and SuperGen shall be the FDA liaison for
both Parties on all marketing issues. The Parties shall disseminate in
the U.S. Territory only those promotional and advertising materials
which have been approved for use by the U.S. Marketing Board. Neither
Party shall be required to use U.S. Promotional Materials which are
prohibited under applicable FDA regulations or other applicable laws
and regulations, or which have not been approved in writing by that
Party's responsible regulatory and medical departments. Xxxxxx and
SuperGen shall use the same U.S. Promotional Materials in connection
with the Co-Promotion of the Product.
(j) Each Party shall cause its sales force, and all other employees and
approved agents and representatives, to comply with all applicable laws
and regulations in connection with the Co-Promotion of the Product in
the U.S. Territory, including but not limited to applicable FDA
regulations, the Prescription Drug Marketing Act and the Federal
Anti-Kickback Statutes. Each Party shall cause its sales force (A) to
Co-Promote the Product consistently with the U.S. Marketing Board's
then approved U.S. Promotional Materials and U.S. Co-Promotion Plan,
and (B) not to do anything knowingly or recklessly which will
jeopardize the goodwill or reputation of the Product or the other
Party. In addition, each Party shall exercise its reasonable efforts to
conduct the Co-Promotion of the Product in adherence to the American
Medical Association Gifts to Physicians From Industry Guidelines.
(k) In addition to the Co-Promotion activities covered under this
Agreement, the U.S. Marketing Board may establish and operate an
indigent program for distribution of the Product and/or Sample Packs to
needy individuals and/or the physicians and other providers serving
such needy individuals, and an expanded access program. The costs and
expenses of both the indigent program and the expanded access program
shall be included as part of SuperGen SG&A and Xxxxxx SG&A, as the case
may be. SuperGen shall provide for reasonable telephone support
services for reimbursement under this program during normal business
hours.
(l) Notwithstanding anything in this Agreement to the contrary, if at
any time during the term of this Agreement SuperGen notifies Xxxxxx of
its decision not to Promote or to cease to Promote the Product in the
U.S. Territory, then the U.S. Marketing Board shall cease to exist as
of the date of such notice and Xxxxxx shall
21
CONFIDENTAIL TREATMENT REQUESTED
determine, in its sole discretion, the strategy, tactics, materials and
budget for the Promotion of the Product in the U.S. Territory. In such
event, however, SuperGen shall remain obligated to make the minimum
four million dollar ($4,000,000) pre-marketing and marketing
expenditure as provided in Article 4.2(b) above, to comply with the
provisions of Article 4.2(j) above, and to provide telephone support
services in connection with reimbursement under any indigent program
and/ or expanded access program for the Product in accordance with
Article 4.2(k) above.
4.3 INTERNATIONAL TERRITORY. Xxxxxx shall use its reasonable efforts, to the
extent possible, to coordinate its promotional activities and methods in the
International Territory with those used by the Parties in the U.S. Territory.
Xxxxxx shall cause its sales force, and all other employees and approved agents
and representatives, to comply with all applicable laws and regulations in
connection with the Promotion of the Product in the International Territory.
4.4 CLINICAL DEVELOPMENT COMMITTEE.
(a) The Parties shall form a Clinical Development Committee which
shall:
(i) oversee the implementation of (1) the clinical studies
as set forth in Exhibit 3.1 and (2) the pursuit of
Regulatory Approval in the U.S. Territory including but
not limited to the preparation and filing of the U.S.
NDA;
(ii) be responsible for developing further clinical
strategies for the Product in the U.S. Territory and in
the EU; and
(iii) shall act in an advisory capacity to the Parties with
respect to (1) potential combination therapies using the
Product and one or more other pharmaceutical products;
and (2) studies to obtain additional approved
indications for the Product.
(b) The Clinical Development Committee shall consist of no more than
eight (8) total members, four (4) representatives each from Xxxxxx and
SuperGen, and shall be chaired alternatively on an annual basis by one
(1) of the SuperGen representatives and by one (1) of the Xxxxxx
representatives. It shall follow the rules established by Section
4.2(a)(i) through (v) for the U.S. Marketing Board, except that:
(i) final decisions with respect to clinical development and
regulatory strategy for the Product in the U.S.
Territory (including but not limited to, for example,
when and how to close the data base, when and how to
file for Regulatory Approval, when and how to conduct
interim analyses, and all protocols for clinical
studies) and for clinical development in the EU shall
be made by the Clinical Development
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CONFIDENTAIL TREATMENT REQUESTED
Committee;
(ii) final decisions with respect to Marketing Studies
intended for use solely within the U.S. Territory shall
be made by the U.S. Marketing Board, and by Xxxxxx with
respect to Marketing Studies intended for use solely
within the International Territory, irrespective of the
country or countries in which such Marketing Studies are
conducted;
(iii) final decisions with respect to clinical development for
the Product in the International Territory outside the
EU, and for clinical development and regulatory strategy
for the Product in the International Territory, shall be
made by Xxxxxx; and
(iv) The Clinical Development Committee shall endeavor to
work by consensus. In the event of a deadlock in any
vote or on any issue relating to this Section 4.4 on
which the Clinical Development Committee is to make a
final decision, the Parties shall refer the deadlocked
issue to SuperGen's Executive Vice President of Medical
Affairs and Xxxxxx'x Hospital Products Division Vice
President of Medical Affairs. These individuals shall
attempt, promptly and in good faith, to resolve such
issue amicably. If such issue remains deadlocked, the
Parties shall refer such issue to, respectively, the
President of SuperGen, and the President of Xxxxxx'x
Hospital Products Division. Any issue remaining
deadlocked after this last step shall be resolved
through an Alternative Dispute Resolution ("ADR")
procedure pursuant to Section 20.3 below.
(c) The cost of any clinical study for the Product in the U.S., the EU
and Canada beyond those which are SuperGen's responsibility pursuant
to Section 3.1 above undertaken by a Party or by the Parties shall be
approved in advance by the Clinical Development Committee and shall
be borne in equal shares by the Parties. The Parties shall use their
reasonable efforts, working through the Clinical Development
Committee, to coordinate Marketing Study strategies and the
implementation of such strategies so as to maximize the benefit of
Marketing Studies to the Product worldwide and to avoid duplication
or conflict in such Marketing Studies.
(d) At any time during the term of this Agreement, whether through the
Clinical Development Committee or otherwise, if SuperGen develops or
SuperGen and Xxxxxx jointly develop any improvements, modifications,
enhancements, additions to or extensions of the Product (an
"Improvement"), such Improvement shall be deemed to be a Product
under this Agreement. The Parties shall bear in equal shares the cost
of developing such Improvement for Co-Promotion by SuperGen and
Xxxxxx in the U.S. Territory and for
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CONFIDENTAIL TREATMENT REQUESTED
Promotion by Xxxxxx in the International Territory pursuant to a
development plan and budget to be agreed between the Parties. For
purposes of clarification, the Parties agree that no milestones shall
be payable by Xxxxxx to SuperGen with respect to any such
Improvement, but that the provisions for profit sharing under Article
6 below and for royalties under Article 7 below shall apply to such
Improvement(s). Notwithstanding anything to the contrary in this
Agreement, if both Parties agree in writing to do so, then Xxxxxx may
take over the development of any one or more Improvements, at
Xxxxxx'x sole cost and expense and at Xxxxxx'x sole discretion as to
the development strategy and plan. In such an event: (i) for the U.S.
Territory, the provisions for profit sharing under Article 6 below
shall not apply to such Improvement(s) and instead, the Parties shall
negotiate in good faith a royalty based on Xxxxxx'x Net Sales in the
U.S. Territory; and (ii) the provisions of Article 7 below shall
apply to any such Improvement(s) for the International Territory.
(e) The Clinical Development Committee shall in good faith agree upon
and complete a development plan for the activities required to
achieve Regulatory Approvals of the Product in the U.S., the EU and
Canada (the "Development Plan") within ninety (90) days after the
Effective Date. The Development Plan shall include, but not be
limited to, the activities set forth on Exhibit 4.4(e). It is the
intent of the Parties that U.S. Phase III clinical data may be used
together with European data, if needed, for the European regulatory
filings and thus will be done to EMEA and U.S. standards and with
EMEA and U.S. FDA acceptable endpoints.
4.5 NAMES. While the configuration and placement of the Xxxxxx name and the
SuperGen name shall be decided by the U.S. Marketing Board in the U.S. Territory
and by Xxxxxx for the International Territory, the Parties agree that Xxxxxx'x
name and SuperGen's name shall appear and be equally prominent on all Product,
Sample Packs and U.S. Promotional Materials in the U.S. Territory, to the extent
allowed by applicable laws and regulations. The Product's N.D.C. number shall be
in SuperGen's name. The Product will utilize an Xxxxxx list number in the U.S.
Territory.
4.6 RESEARCH AND DEVELOPMENT BUDGET.
(a) The Clinical Development Committee shall be responsible for
reviewing and proposing timelines for research and development
activities as well as an annual research and development budget
("Annual R&D Budget"). The Parties shall prepare general timelines
and detailed budget estimates for all research and development
activities as part of the Development Plan. In addition, the
Development Plan shall also contain the agreed upon Annual R&D Budget
for 2000.
(b) For 2001 and every year of the Development Plan thereafter, the
Clinical Development Committee shall prepare an Annual R&D Budget by
June 1 of
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CONFIDENTAIL TREATMENT REQUESTED
the preceding year, which it shall submit to each Party for its final
review and approval.
(c) The Clinical Development Committee may propose adjustments to the
Annual R&D Budget up to two (2) times per calendar year, for review
and approval by SuperGen's Executive Vice President of Commercial
Operations and Xxxxxx'x Hospital Products Division Vice President of
Commercial Operations, according to the following time-table:
CDC Recommends Parties Approve in Writing
-------------- --------------------------
No later than February 1 No later than May 1
No later than June 1 No later than September 15
ARTICLE 5: MILESTONE PAYMENTS
5.1 R & D PAYMENTS. In consideration of past research and development
performed by SuperGen, Xxxxxx shall make the following milestone payments to
SuperGen, which payments shall be due and payable as set forth below and within
thirty (30) days after the date or event specified. For the purposes of
clarification, the Parties agree that the "first occasion" on which total annual
Product Sales by Xxxxxx in the Territories reaches a specified amount, as
referred to in Articles 5.1(g) through (p) below, shall be deemed to occur on
the last date of the calendar month in which each such amount is reached.
(a) Twenty-six million five hundred thousand dollars ($26,500,000)
worth of equity investment in SuperGen, subject to the terms and
conditions of the Stock Purchase Agreement, upon the Effective Date.
(b) seven million, five hundred thousand dollars ($7,500,000) worth of
equity investment in SuperGen, subject to the terms and conditions of
the Stock Purchase Agreement, upon the completion (as defined below)
of each Phase II study with the Product which is conducted in patients
with * with a U.S. Territory patient annual incidence of greater than
* (up to a maximum of two (2) studies, so that payment of this
milestone shall not exceed fifteen million dollars ($15,000,000)),
provided that, in each case: (i) the study is completed and the final
report on such study is delivered to Xxxxxx; (ii) an independent
outside expert board, consisting of no less than three (3) and no more
than five (5) members, and acceptable to both Parties, confirms that
the findings of each such study demonstrate an equivalent or improved
clinical response with improved quality of life measurements as
compared to the applicable standard of care; (iii) *; (iv) the study
includes at least * patients; and (v) the study has been approved by
the Clinical Development Committee. All five (5) of the provisos set
forth above are deemed to be "completion" of such studies;
(c)
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CONFIDENTIAL TREATMENT REQUESTED
(i) five million dollars ($5,000,000) worth of equity
investment in SuperGen, subject to the terms and conditions of the
Stock Purchase Agreement, upon SuperGen's implementation, to Xxxxxx'x
reasonable satisfaction, of the * Plan and completion and delivery to
Xxxxxx of analysis of all patients in the Phase II SuperGen pancreatic
cancer clinical study with the Product (study RFS 2000-01), provided
that the findings of such analysis demonstrate, with equal clinical
efficacy, an adverse event profile for the Product which is equal or
better to that of *, as judged by an independent outside expert board,
consisting of no less than three (3) and no more than five (5) members,
and acceptable to both Parties hereto. Key measurements shall include,
but not be limited to:
(1) *
(2) *
(3) *; and
(4) *;
(ii) five million dollars ($5,000,000) worth of equity
investment in SuperGen, subject to the terms and conditions of the
Stock Purchase Agreement, upon SuperGen's completion, to Xxxxxx'x
reasonable satisfaction, of the * Plan and completion and delivery to
Xxxxxx or to an independent safety board of the * case reports on
patients in the *;
(d) two million dollars ($2,000,000) in cash, upon acceptance by
the FDA of the NDA submitted by SuperGen for the Product;
(e) two million dollars ($2,000,000) in cash, upon acceptance by
the EMEA of the NDA submitted by Xxxxxx for the Product for
the EU;
(f) two million dollars ($2,000,000) in cash, upon acceptance by
the competent governmental authority in Japan of the NDA
submitted by Xxxxxx for the Product for Japan;
(g) seven million dollars ($7,000,000) in cash, upon Launch of the
Product in the U.S. Territory, provided that, if at the time of such
Launch the Product does not have an approved indication for
treatment of a specific cancer patient population with an annual
incidence of at least * patients in the United States, then this
milestone shall be modified such that Xxxxxx shall pay to SuperGen
three million five hundred thousand dollars ($3,500,000) in cash
upon Launch of the Product in the U.S. Territory, and an additional
three million five hundred thousand dollars ($3,500,000) in cash
upon the earlier to occur of (i) the first occasion on which total
annual Product Sales by Xxxxxx in the Territories reaches one
hundred million dollars ($100,000,000) or (ii) U.S. Regulatory
Approval for any one or more additional indications for the Product
where the aggregate annual incidence of patients in the United
States for all approved indications for the Product is at least *;
(h) five million dollars ($5,000,000) worth of equity investment in
SuperGen,
26
CONFIDENTIAL TREATMENT REQUESTED
subject to the terms and conditions of the Stock Purchase Agreement,
upon Launch of the Product in the U.S. Territory, provided that, if
at the time of such Launch the Product does not have an approved
indication for treatment of a specific cancer patient population
with an annual incidence of at * patients in the United States, then
this milestone shall be modified such that Xxxxxx shall pay to
SuperGen two million five hundred thousand dollars ($2,500,000)
worth of equity investment in SuperGen, subject to the terms and
conditions of the Stock Purchase Agreement, upon Launch of the
Product in the U.S. Territory, and an additional two million five
hundred thousand dollars ($2,500,000) worth of equity investment in
SuperGen, subject to the terms and conditions of the Stock Purchase
Agreement, upon the earlier to occur of (i) the first occasion on
which total annual Product Sales by Xxxxxx in the Territories
reaches one hundred million dollars ($100,000,000) or (ii) U.S.
Regulatory Approval for any one or more additional indications for
the Product where the aggregate annual incidence of patients in the
United States for all approved indications for the Product is at
least * patients;
(i) nine million dollars ($9,000,000) in cash, upon Launch of the
Product in at least three (3) of the Major European Countries,
provided that, if at the time of such Launch the Product does not
have an approved indication for treatment of a specific cancer
patient population with an annual incidence of at least * patients
in Europe, then this milestone shall be modified such that Xxxxxx
shall pay to SuperGen four million five hundred thousand dollars
($4,500,000) in cash upon Launch of the Product in at least three
(3) of the Major European Countries, and an additional four million
five hundred thousand dollars ($4,500,000) in cash upon the earlier
to occur of (i) the first occasion on which total annual Product
Sales by Xxxxxx in the Territories reaches one hundred million
dollars ($100,000,000) or (ii) Regulatory Approval in at least three
(3) Major European Countries for any one or more additional
indications for the Product where the aggregate annual incidence of
patients in Europe for all approved indications for the Product is
at least * patients;
(j) five million dollars ($5,000,000) worth of equity investment in
SuperGen, subject to the terms and conditions of the Stock Purchase
Agreement, upon Launch of the Product in at least three (3) of the
Major European Countries, provided that, if at the time of such
Launch the Product does not have an approved indication for
treatment of a specific cancer patient population with an annual
incidence of at least * patients in Europe, then this milestone
shall be modified such that Xxxxxx shall pay to SuperGen two million
five hundred thousand dollars ($2,500,000) worth of equity
investment in SuperGen, subject to the terms and conditions of the
Stock Purchase Agreement, upon Launch of the Product in at least
three (3) of the Major European Countries, and an additional two
million five hundred thousand dollars ($2,500,000) worth of equity
investment in SuperGen, subject to the terms and conditions of the
Stock Purchase Agreement, upon the earlier to occur of (i) the first
occasion on which total annual Product Sales by Xxxxxx in the
Territories reaches one hundred million dollars ($100,000,000) or
(ii) Regulatory Approval in at least three (3) Major European
Countries for any one or more additional indications for the Product
where the aggregate annual incidence of
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CONFIDENTIAL TREATMENT REQUESTED
patients in Europe for all approved indications for the Product is at
least * patients;
(k) five million dollars ($5,000,000) in cash, upon Launch of the
Product in Japan, provided that, if at the time of such Launch the
Product does not have an approved indication for treatment of a
specific cancer patient population with an annual incidence of at
least * patients in Japan, then this milestone shall be modified
such that Xxxxxx shall pay to SuperGen two million five hundred
thousand dollars ($2,500,000) in cash upon Launch of the Product in
Japan, and an additional two million five hundred thousand dollars
($2,500,000) in cash upon the earlier to occur of (i) the first
occasion on which total annual Product Sales by Xxxxxx in the
Territories reaches one hundred million dollars ($100,000,000) or
(ii) Regulatory Approval in Japan for any one or more additional
indications for the Product where the aggregate annual incidence of
patients in Japan for all approved indications for the Product is at
least * patients;
(l) ten million dollars ($10,000,000) in cash, upon the first occasion
on which total annual Product Sales by Xxxxxx in the Territories
reaches one hundred fifty million dollars ($150,000,000);
(m) ten million dollars ($10,000,000) in cash, upon the first occasion
on which total annual Product Sales by Xxxxxx in the Territories
reaches four hundred million dollars ($400,000,000);
(n) ten million dollars ($10,000,000) worth of equity investment in
SuperGen, subject to the terms and conditions of the Stock Purchase
Agreement, upon the first occasion on which total annual Product Sales
by Xxxxxx in the Territories reaches four hundred million dollars
($400,000,000);
(o) ten million dollars ($10,000,000) in cash, upon the first occasion
on which total annual Product Sales by Xxxxxx in the Territories
reaches five hundred million dollars ($500,000,000); and
(p) ten million dollars ($10,000,000) worth of equity investment in
SuperGen, subject to the terms and conditions of the Stock Purchase
Agreement, upon the first occasion on which total annual Product Sales
by Xxxxxx in the Territories reaches five hundred million dollars
($500,000,000).
5.2 EQUITY PAYMENTS LIMITATION. The Parties acknowledge and agree that any and
all milestone payments to be made by Xxxxxx pursuant to this Agreement as
equity investments in SuperGen shall be subject to the terms and conditions
of the Stock Purchase Agreement, which terms and conditions shall govern in
the event of any inconsistency or conflict between this Agreement and the
Stock Purchase Agreement with respect to any equity investment in SuperGen
by Xxxxxx. In particular, the Parties acknowledge and agree that in no
event shall Xxxxxx be required to make any equity investment in SuperGen,
through the payment of the equity milestones as set forth above or in any
other manner, which would cause Xxxxxx to own in excess of nineteen percent
(19%) of the voting securities of SuperGen at any time; provided, however,
that in the event that any equity investment to be made by Xxxxxx under
this
28
CONFIDENTIAL TREATMENT REQUESTED
Agreement would cause Xxxxxx to own in excess of nineteen percent (19%)
of the voting securities of SuperGen, then Xxxxxx'x obligation to make
such equity investment shall be tolled for a period of one (1) year. If
SuperGen increases its share capital (other than by purchase of any
equity in SuperGen by Xxxxxx) during such one-year period, such that
Xxxxxx would then be able to make such equity investment and would not
thereby own in excess of nineteen percent (19%) of the voting securities
of SuperGen, SuperGen may so notify Xxxxxx and Xxxxxx shall make such
equity investment, provided that SuperGen may make only one such
notification, with respect to the entire amount of such equity
investment, during such one-year period. If by the end of such one-year
period SuperGen has not increased its share capital (other than by
purchase of any equity in SuperGen by Xxxxxx) during such one-year
period, such that Xxxxxx would then be able to make such equity
investment and would not thereby own in excess of nineteen percent (19%)
of the voting securities of SuperGen, then Xxxxxx shall have no further
obligation to make such equity investment.
5.2 SINGLE PAYMENT OBLIGATION. Each of the foregoing milestones shall only
be paid once regardless of the number of acceptances or Launches with respect to
such Product, including multiple product forms of the same Compound, additional
active or inactive ingredients, indications, modalities and/or dosage strengths.
5.4 METHOD OF PAYMENT. All cash payments due under this Article 5 shall
be paid by wire transfer or by such other means agreed upon by the Parties,
in each case at the expense of Xxxxxx, with twenty-four (24) hours advance
notice of each wire transfer, to the bank account(s) as SuperGen shall
designate in writing following the occurrence of each cash milestone event.
ARTICLE 6: U.S. PROFIT SHARING
6.1 REPORTS BY XXXXXX. Within forty-five (45) days from the end of each
calendar quarter starting with the first calendar quarter for which the
Parties have budgeted expenditures under Article 4, Xxxxxx shall deliver to
SuperGen a true and accurate written report showing whichever of the
following are applicable for such calendar quarter:
(a) the Xxxxxx Net Sales and Net Units of Product Sold in: (i) the U.S.
Territory and (ii) the International Territory (each in the aggregate
and on a country-by-country basis;
(b) the Xxxxxx Distribution Margin (including the Xxxxxx Cost of Goods
and the Xxxxxx Distribution Expenses used to arrive at the Xxxxxx
Distribution Margin from the Xxxxxx Net Sales) for the U.S. Territory;
and
(c) the Xxxxxx Operating Margin (including the Xxxxxx SG&A used to
arrive at the Xxxxxx Operating Margin from the Xxxxxx Distribution
Margin) for the U.S. Territory.
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CONFIDENTIAL TREATMENT REQUESTED
6.2 REPORTS BY SUPERGEN. Within ten (10) days from the date of SuperGen's
receipt of Xxxxxx'x report pursuant to Article 6.1 above, SuperGen shall deliver
to Xxxxxx a true and accurate written report showing whichever of the following
are applicable for such calendar quarter:
(a) the SuperGen Product Sales in the U.S. Territory;
(b) the SuperGen Distribution Margin for the U.S. Territory (including
the SuperGen Cost of Goods used to arrive at the SuperGen Distribution
Margin from the SuperGen Product Sales);
(c) the SuperGen Operating Margin for the U.S. Territory (including the
SuperGen SG&A used to arrive at the SuperGen Operating Margin from the
SuperGen Distribution Margin in the U.S. Territory); and
(d) the Xxxxxx U.S. Profit Amount, the SuperGen U.S. Profit Amount, the
U.S. Adjustment Amounts for each Party, and the Final Payment (as
defined in Section 6.5 below) due to either Xxxxxx or SuperGen.
6.3 U.S. PROFIT SPLIT. Commencing on the date of acceptance by the FDA
of the U.S. NDA for the Product, the U.S. Product Profit for each calendar
year (or portion thereof less than a full calendar year) shall be shared
equally between the Parties, fifty percent (50%) for SuperGen and fifty
percent (50%) for Xxxxxx. The allocation of U.S. Product Profit (whether a
positive (profit) amount or a negative (loss) amount) between Xxxxxx and
SuperGen pursuant to this Article 6.3 as of the end of the applicable
calendar quarter or year shall be called the "Xxxxxx U.S. Profit Amount" and
the "SuperGen U.S. Profit Amount," respectively, which together shall equal
the U.S. Product Profit as of the end of such period. The Parties understand
that the U.S. Product Profit, the Xxxxxx U.S. Profit Amount, and the SuperGen
U.S. Profit Amount can each be a negative number and represent a net loss.
6.4 U.S. ADJUSTMENT AMOUNT. With respect to the U.S. Territory, for each
calendar quarter of each calendar year, the "U.S. Adjustment Amount" shall be
determined for Xxxxxx by subtracting the Xxxxxx U.S. Profit Amount from the
Xxxxxx Operating Margin in the U.S. Territory and shall be determined for
SuperGen by subtracting the SuperGen U.S. Profit Amount from the SuperGen
Operating Margin in the U.S. Territory. If the U.S. Adjustment Amount is
positive for one Party and negative for the other Party, then the Party with
the positive U.S. Adjustment Amount shall pay such amount to the other Party,
so that each Party receives or bears fifty percent (50%) of the U.S. Product
Profit for such calendar quarter.
6.5 FINAL PAYMENT. After each calendar quarter, any amount payable by
one Party to the other Party pursuant to Article 6.4. above ("Final Payment")
shall be paid by the owing Party within ten (10) business days of Xxxxxx'x
receipt of SuperGen's report under Section 6.2.
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CONFIDENTIAL TREATMENT REQUESTED
6.6 YEAR-END RECONCILIATION. Within forty-five (45) days after the end
of each calendar year starting with the first calendar year for which the
Parties have budgeted expenditures under Article 4, the U.S. Product Profit
split between the Parties pursuant to Article 6.3 above for such calendar
year shall be recalculated (the "Reconciliation Amount") to reflect any
amended information (including, but not limited to, amended sales data,
product returns or chargebacks) relevant to the calculation of the
Reconciliation Amount for such calendar year. Within ten (10) business days
after any such recalculation, Xxxxxx shall pay to SuperGen, or SuperGen shall
pay to Xxxxxx, as the case may be, an amount equal to the difference between
the most recent prior calculation of the Final Payment or the Reconciliation
Amount and the latest Reconciliation Amount.
6.7 EXAMPLE OF U.S. PRODUCT PROFIT SHARING. Exhibit 6.7 attached hereto
shall illustrate, by way of example only and not as a limitation of any kind,
the method agreed by the Parties under this Article 6 for calculating and
splitting the U.S. Product Profit.
6.8 PAYMENT PROCEDURE. All payments due under this Article 6 shall be
paid in United States Dollars by wire transfer or by such other means agreed
upon by the Parties, in each case at the expense of the payor, for value no
later than the due date thereof (with twenty four (24) hours advance notice
of each wire transfer) to the bank accounts as the payee shall designate in
writing within a reasonable period of time prior to such due date.
6.9 RECORDS. Each Party shall keep and maintain records relating to the
subject matter of all reports and payments to be made pursuant to this
Article 6 for the U.S. Territory, so that the reports and payments may be
verified. Such records shall be open to inspection at any reasonable time
within two (2) years after the period to which such records relate, but in
any event not more than once per Sales Year, by a nationally recognized
independent certified public accountant selected by the inspecting Party,
approved by other Party, which approval shall not be unreasonably withheld,
and retained at inspecting Party's expense. Said accountant shall sign a
confidentiality agreement prepared by the other Party and shall then have the
right to examine the records kept pursuant to this Agreement and report to
the inspecting Party the findings (but not the underlying data) of said
examination of records as are necessary to evidence that the records were or
were not maintained and used in accordance with this Agreement. A copy of any
report provided to the inspecting Party by the accountant shall be given
concurrently to the other Party. If said examination of records reveals more
than five percent (5%) underpayment of the royalty payable, expenses for said
accountant shall be borne by other Party and the other Party shall promptly
pay to the inspecting Party the balance due plus interest calculated at the
prime rate of interest as reported in the WALL STREET JOURNAL for the date of
the accountant's report which reveals such underpayment.
6.10 TAXES. Where any sum due to be paid to a Party under this Article 6
is subject to any withholding or similar tax, the Parties shall use their
reasonable efforts to do all such acts and things and to sign all such
documents as will enable them to take advantage of any applicable double
taxation agreement or treaty. In the event there is no applicable double
taxation agreement or treaty, or if an applicable double taxation agreement
or
31
CONFIDENTIAL TREATMENT REQUESTED
treaty reduces but does not eliminate such withholding or similar tax, the
Party making a payment shall pay such withholding or similar tax to the
appropriate government authority, deduct the amount paid from the amount due
to the other Party, and secure and send to the other Party the best available
evidence of such payment.
6.11 NO DOUBLE COUNTING OF COSTS. For the purpose of determining any cost
or expense which is shared by the Parties under this Agreement or otherwise
invoiced by one Party to another under this Agreement, any cost or expense
allocated by either Party to a particular cost category shall be consistent
with the terms of this Agreement and shall not also be allocated to another
category. In the event a cost or expense might arguably fall into more than
one category, the Parties shall mutually determine which category such cost
or expense most appropriately falls into.
ARTICLE 7: INTERNATIONAL ROYALTY
7.1 ROYALTY PERIOD AND ROYALTY RATE. For a period of ten (10) years from
the First Commercial Sale or so long as the Product remains Patent Protected
in any country in the International Territory, whichever is longer, ("Royalty
Period"), Xxxxxx shall pay to SuperGen a royalty of * of the Xxxxxx Net Sales
of the Product in the International Territory.
7.2 ROYALTY RATE REDUCTION If during the Royalty Period, a generic
version of the Product is marketed by a Third Party in a country in the
International Territory, the Parties shall promptly and in good faith
negotiate a reduction in the royalty rate for that country. If SuperGen and
Xxxxxx do not agree on a reduction in the royalty rate under this
circumstance, then the appropriate reduction shall be determined in an ADR
pursuant to Article 20.3 herein. Once the appropriate royalty rate reduction
has been determined, the difference between the royalty amount paid by Xxxxxx
from the date of initiation of ADR through the date of the ADR decision, and
the royalty amount due for such period under the reduced calculation shall be
credited against any future payments owed by Xxxxxx to SuperGen.
7.3 ROYALTY STATEMENTS. Each royalty payment shall be accompanied by a
statement from Xxxxxx showing Xxxxxx Net Sales for the Product in the
International Territory, by country. The royalty shall be computed in United
States Dollars pursuant to Xxxxxx'x standard internal accounting practices
and policies.
7.4 ROYALTY PAYMENT. Royalty payments shall be made by Xxxxxx to SuperGen
in United States Dollars within sixty (60) days after the last day of
February, May, August, and November for royalties accruing on Net Sales
during the three (3) preceding Months.
7.5 PAYMENT PROCEDURE. All payments due under this Article 7 shall be paid
by wire transfer or by such other means agreed upon by the Parties, in each
case at the expense of the payor, for value no later than the due date
thereof (with twenty four (24) hours
32
CONFIDENTIAL TREATMENT REQUESTED
advance notice of each wire transfer) to the bank accounts as the payee shall
designate in writing within a reasonable period of time prior to such due
date.
7.6 NO MULTIPLE ROYALTIES. No multiple royalties shall be payable because a
Product, its manufacture, use or sale is or shall be covered by more than one
Valid Claim of a patent included in the Licensed Patents or more than one patent
under the Licensed Patents.
7.7 SALES TO AFFILIATES. No royalties shall be payable on sales between and
among Xxxxxx and/or its Affiliates, but shall be payable on the first sale by
Xxxxxx and/or its Affiliates to a Third Party in the International Territory.
7.8 RECORDS. Xxxxxx and/or its Affiliates shall keep and maintain records
of sales made pursuant to the license granted by SuperGen to Xxxxxx for the
Product in the International Territory under this Agreement, so that the
royalty payable and the royalty statement may be verified. Such records shall
be open to inspection at any reasonable time within two (2) years after the
royalty period to which such records relate, but in any event not more than
once per Sales Year, by a nationally recognized independent certified public
accountant selected by SuperGen, approved by Xxxxxx, which approval shall not
be unreasonably withheld, and retained at SuperGen's expense. Said accountant
shall sign a confidentiality agreement prepared by Xxxxxx and shall then have
the right to examine the records kept pursuant to this Agreement and report
to SuperGen the findings (but not the underlying data) of said examination of
records as are necessary to evidence that the records were or were not
maintained and used in accordance with this Agreement. A copy of any report
provided to SuperGen by the accountant shall be given concurrently to Xxxxxx.
If said examination of records reveals more than five percent (5%)
underpayment of the royalty payable, expenses for said accountant shall be
borne by Xxxxxx and Xxxxxx shall promptly pay to SuperGen the balance due
plus interest calculated at the prime rate of interest as reported in the
WALL STREET JOURNAL for the date of the accountant's report which reveals
such underpayment.
7.9 TAXES. Where any sum due to be paid to SuperGen under this Article 7 is
subject to any withholding or similar tax, the Parties shall use their
reasonable efforts to do all such acts and things and to sign all such documents
as will enable them to take advantage of any applicable double taxation
agreement or treaty. In the event there is no applicable double taxation
agreement or treaty, or if an applicable double taxation agreement or treaty
reduces but does not eliminate such withholding or similar tax, Xxxxxx shall pay
such withholding or similar tax to the appropriate government authority, deduct
the amount paid from the amount due SuperGen and secure and send to SuperGen the
best available evidence of such payment.
ARTICLE 8: PRODUCT SUPPLY AND DISTRIBUTION
8.1 PRODUCT DISTRIBUTION.
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CONFIDENTIAL TREATMENT REQUESTED
(a) SuperGen shall be responsible for the manufacture, packaging,
sterilization and labeling of the Product. Xxxxxx shall exclusively
distribute the Product in the Territories to Third Party customers,
including all activities ancillary thereto (including, without
limitation, warehousing and shipping).
(b) Xxxxxx shall use its reasonable efforts to distribute the Product
in the Territories to maximize the sales of the Product in the
Territory. Such efforts shall be at least commensurate with those
efforts made by Xxxxxx to maximize the sales of Xxxxxx'x own
pharmaceutical products of a similar nature and comparable market
potential. Xxxxxx shall keep SuperGen fully apprised with respect to
its distribution. Xxxxxx shall control all final decisions regarding
such distribution activities.
8.2 PRODUCT SUPPLY.
(a) Xxxxxx shall exclusively purchase from SuperGen or from its
designated Third Party manufacturer(s), and SuperGen shall exclusively
supply to Xxxxxx (or shall cause or its designated Third Party
manufacturer(s) to supply exclusively to Xxxxxx), Xxxxxx'x requirements
for the Product in the Territories.
(b) Xxxxxx shall purchase Finished Product for the U.S. Territory from
SuperGen or from its designated Third Party manufacturer(s) at the U.S.
Transfer Price, which shall be equal to * for the Finished Product in
the U.S. Territory for the Xxxxxx Hospital Products Division fiscal
quarter in which Xxxxxx is purchasing such Product from SuperGen or
from its designated Third Party manufacturer(s). Xxxxxx shall calculate
its average net selling price for this purpose in accordance with
Xxxxxx internal accounting policies and practices.
(c) Xxxxxx shall purchase Finished Product for the International
Territory from SuperGen or from its designated Third Party
manufacturer(s) at the International Transfer Price, which shall be
equal to * for the Finished Product in the International Territory for
the Xxxxxx International Division fiscal quarter in which Xxxxxx is
purchasing such Product from SuperGen or from its designated Third
Party manufacturer(s). Xxxxxx shall calculate its average net selling
price for this purpose in accordance with Xxxxxx internal accounting
policies and practices.
(d) The Parties shall cooperate to determine manufacturing strategy and
objectives for the supply of Compound, Product, and Finished Product
consistent with the terms of this Agreement, including but not limited
to agreeing in writing on the Specifications and attaching such
Specifications to this Agreement as Exhibit 1.39 within ninety (90)
days of the Effective Date, and to qualifying a second manufacturer for
the Compound, acceptable to both Parties, as soon as possible after the
Effective Date.
(e) Within twelve (12) months prior to the agreed projected Launch of
the
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CONFIDENTIAL TREATMENT REQUESTED
Product in the U.S. Territory, the U.S. Marketing Board shall establish
a sales forecast for such Product specifying the Parties' anticipated
requirements of the Finished Product in the U.S. Territory for the
twelve (12) month period commencing approximately ninety (90) days
prior to the anticipated date of Launch (the "U.S. Sales Forecast").
The U.S. Marketing Board shall be responsible for establishing,
preparing and updating the U.S. Sales Forecast.
(f) Within twelve (12) months prior to the agreed projected Launch of
the Product in the International Territory, Xxxxxx shall establish a
sales forecast for such Product specifying Xxxxxx'x anticipated
requirements of the Finished Product in the International Territory for
the twelve (12) month period commencing approximately ninety (90) days
prior to the anticipated date of Launch (the "International Sales
Forecast"). Xxxxxx shall be responsible for establishing, preparing and
updating the International Sales Forecast.
(g) Such Sales Forecasts for the U.S. Territory and the International
Territory, respectively, shall be updated on a quarterly basis so that
at the beginning of each calendar quarter, SuperGen shall have been
provided with rolling Sales Forecasts for the twelve (12) month period
commencing with the third (3rd) calendar quarter after the date on
which such Sales Forecasts are submitted (i.e. approximately 270 days).
By way of example only, at the end of the first quarter of a calendar
year (assuming the Product has been Launched), the U.S. Marketing Board
shall provide SuperGen with a Sales Forecast of the anticipated
requirements of Finished Product for the U.S. Territory for the twelve
(12) months consisting of the four quarters of the next calendar year.
8.3 COMMERCIAL SCALE-UP AND DEVELOPMENT. SuperGen shall exercise its
reasonable efforts to pursue the process development of the Product. The
Parties shall cooperate to determine the Specifications, process development
strategy and objectives for the production of the Compound, the Product, and
the Finished Product, consistent with the terms of this Agreement; provided
that SuperGen shall have control of all final decisions regarding process
development. SuperGen shall bear the full costs and expenses of such process
development, provided that the costs and expenses of producing validation
batches of the Product shall be included in Xxxxxx Cost of Goods and/or
SuperGen Cost of Goods, as applicable, to the extent that the Product from
such validation batches are ultimately sold.
8.4 PRODUCT ORDERING AND DELIVERY.
(a) Xxxxxx shall purchase Finished Product at the applicable U.S. or
International Transfer Price by means of purchase orders submitted to
SuperGen at least ninety (90) days in advance of the requested delivery
date. Each purchase order shall be governed by the terms of this
Agreement and none of the terms or conditions of Xxxxxx'x purchase
orders, SuperGen's acknowledgment forms or any other forms exchanged by
the parties shall be applicable, except those, to the extent consistent
with the terms set forth herein, specifying quantity ordered,
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CONFIDENTIAL TREATMENT REQUESTED
delivery locations and delivery schedule and invoice information;
(b) All purchase orders for delivery during a calendar month that do
not exceed one hundred twenty five percent (125%) of the latest Sales
Forecast covering such month (excluding any amendments subsequent to
the original date of such Sales Forecast) shall be deemed accepted by
SuperGen. SuperGen shall use its reasonable efforts to supply Xxxxxx
with any Finished Product in excess of one hundred twenty five percent
(125%) of such Sales Forecast. All other purchase orders must be
accepted or rejected by SuperGen, in writing, by facsimile or air
courier, within fifteen (15) business days after receipt from Xxxxxx.
If SuperGen does not provide such notice of acceptance or rejection
within fifteen (15) business days, it shall be deemed to have accepted
such purchase orders in full. SuperGen shall deliver all accepted
orders to Xxxxxx promptly and shall deliver Xxxxxx'x first order for
Finished Product to be sold in the U.S. Territory and the International
Territory, respectively, within thirty (30) days of Regulatory Approval
in those respective territories.
(c) All Finished Products shall be delivered C.I.P. to Xxxxxx'x
designated destination. Title and risk of loss shall pass from SuperGen
to Xxxxxx when the Finished Products are delivered to the carrier for
transport to the designated destination.
(d) SuperGen shall invoice Xxxxxx at the applicable U.S. or
International Transfer Prices for all Finished Product delivered, and
Xxxxxx shall pay to SuperGen the amount invoiced within thirty (30)
days of the invoice date.
8.5 INVENTORIES AND ALLOCATION.
(a) Subject to the receipt of Finished Product from SuperGen in
accordance with this Article 8, Xxxxxx shall use its reasonable efforts
to maintain adequate inventories of the Finished Product in the
Territories to meet the needs of its customers on a timely basis based
upon, among other factors, the Sales Forecast, previous demand
histories and seasonal trends, and any customers' contractual
commitments. SuperGen shall use its reasonable efforts to maintain
adequate inventories of Finished Product to meet the needs of Xxxxxx on
a timely basis, including but not limited to ensuring that any Third
Party manufacturer shall maintain at least thirty (30) days' worth of
Finished Product in inventory.
(b) In the event that SuperGen (or its designated Third Party
manufacturer(s)) are unable to fill accepted orders for the Finished
Product placed by Xxxxxx pursuant to this Agreement for a total of four
(4) months, whether or not consecutive, in any twelve (12) month
period, Xxxxxx may at its sole option: (i) forgo the quantities ordered
which SuperGen is unable to supply; (ii) take delivery within a
reasonable period of time after SuperGen becomes able to supply the
quantities ordered; or (iii) make or have a Third Party make, or permit
SuperGen to have a Third Party (approved by Xxxxxx) make, the Finished
Product.
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CONFIDENTIAL TREATMENT REQUESTED
(c) In the event that a visit or report by an authorized agent of a
governmental agency in the Territories, or a visit by an outside
independent quality assurance auditor acceptable to both Parties,
reveals that SuperGen's (or SuperGen's Third-Party manufacturer's)
facilities and processes for manufacturing the Compound, the Product or
the Finished Product do not comply with applicable laws and
regulations, including without limitation Current Good Manufacturing
Practices, and if SuperGen does not rectify the situation to Xxxxxx'x
reasonable satisfaction within sixty (60) days of Xxxxxx'x notice to
SuperGen of such situation, then Xxxxxx may make or have a Third Party
make, or permit SuperGen to have a Third Party (approved by Xxxxxx)
make the Compound, the Product and/ or the Finished Product.
(d) In the event Xxxxxx elects to make or have made the Compound, the
Product and/ or the Finished Product pursuant to Article 8.5(b) or (c)
above, SuperGen shall (i) transfer to Xxxxxx or Xxxxxx'x or SuperGen's
designated Third Party all information and authorizations useful and
necessary with respect to the manufacture, storage and shipment of the
Compound, the Product and/ or the Finished Product, in a timely manner
so as to avoid any delay or interruption in supply of Finished Product
to Xxxxxx, and (ii) reimburse Xxxxxx for that portion of the cost of
manufacturing or having such Third Party manufacture and supply the
Compound, the Product, and/ or the Finished Product which is in excess
of the applicable Transfer Price.
8.6 CUSTOMER RELATIONS.
(a) With respect to customer complaints relating to the Promotion or
distribution of the Product, each Party shall act promptly to remedy
such complaints. All Product-related inquiries and Product complaints
in the U.S. Territory shall be addressed by SuperGen, and all
Product-related inquiries and Product complaints in the International
Territory shall be addressed by Xxxxxx. Each Party shall keep the other
Party fully and promptly apprised of its receipt of any such
significant complaints in the Territories, and provide reasonable
cooperation and assistance in dealing with customer complaints in the
Territories, the verifiable out-of-pocket cost of such cooperation and
assistance being borne by SuperGen in the U.S. Territory and by Xxxxxx
in the International Territory.
(b) Any Product warranty to the customers of Xxxxxx and SuperGen shall
run directly from SuperGen to such customers, notwithstanding the fact
that Xxxxxx'x customers may return Product to Xxxxxx and not to
SuperGen. Xxxxxx shall not make any warranty or representation to any
customers which is more protective of such customers than the
warranties and/ or representations provided by SuperGen. For purposes
of clarification, the sole remedy of Xxxxxx and/ or SuperGen customers
in the case of defective Product shall be that the Party which sold the
defective Product to the customer shall replace such returned defective
Product. SuperGen's Product warranties shall not apply to Product that
has been modified
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CONFIDENTIAL TREATMENT REQUESTED
or altered in any manner by anyone other than SuperGen or Xxxxxx (or
their respective Affiliates or subdistributors or sublicensees), or to
defects caused (i) through no fault of SuperGen SuperGen or Xxxxxx (or
their respective Affiliates or subdistributors or sublicensees), during
shipment, (ii) by negligence or misuse on the part of anyone other than
SuperGen or Xxxxxx (or their respective Affiliates or subdistributors
or sublicensees) or (iii) by storage, handling, or usage in any manner
inconsistent with the approved Product labeling.
(c) Neither Party shall represent the Product in any manner which is
inconsistent with the approved Product labeling or with applicable laws
and regulations, or otherwise misrepresent the Product.
8.7 QUALITY CONTROLS. Both Parties shall institute quality controls in
accordance with, and shall comply with, applicable laws and regulations and
generally accepted industry standards (including cGMPs as defined below) for
the manufacture, storage, shipment, handling and distribution of the
Compound, the Product and the Finished Product (as the case may be) and shall
define responsibilities for key quality systems and a quality manual agreed
to by both Parties (including without limitation, Sample Packs) and shall
comply with all applicable laws and regulations relating to the storage,
shipment, handling and distribution of the Compound, the Product and the
Finished Product. Each Party shall have the right to audit all facilities
used by the other Party to fulfill their obligations under this Agreement
(including any Third Party manufacturing facilities). For the purposes of
this Agreement, "cGMPs" means all applicable standards relating to
manufacturing practices for intermediates, bulk products, or finished
pharmaceutical products (i) promulgated in the form of laws or regulations by
the FDA or its counterpart governmental agencies or entities in the EU and/
or a country in the International Territory or (ii) promulgated by the FDA or
its counterpart governmental agencies or entities in the EU and/ or a country
in the International Territory in the form of guidance documents (including
but not limited to advisory opinions, compliance policy guides and
guidelines) which guidance documents are being implemented within the
pharmaceutical manufacturing industry for such products.
8.8 PRODUCT CHARACTERISTICS.
(a) Xxxxxx shall not be obligated to accept from SuperGen any Finished
Product with less than the greater of (i) seventy-five percent (75%) of
approved shelf life for such Finished Product or (ii) thirteen (13)
months of remaining shelf life.
(b) SuperGen shall provide Xxxxxx with a certificate of analysis with
respect to the shipment of the Finished Product to Xxxxxx. Full batch
documentation, including batch production records, and manufacturing
and analytical records shall be available for review by Xxxxxx on site
at the manufacturing facility used by SuperGen (or by SuperGen's Third
Party manufacturer(s)), during regular business hours and upon
reasonable advance written notice from Xxxxxx.
(c) Xxxxxx shall notify SuperGen in writing of any defect or shortage
in the
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CONFIDENTIAL TREATMENT REQUESTED
quantity of any shipment of Finished Product no later than ten (10)
business days following receipt of the Finished Product. In the event
of any such defect or shortage, SuperGen shall, at SuperGen's choice,
replace the defective Finished Product or make up the shortage if
replacement stock is available in the next shipment of Finished
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 Xxxxxx.
(d) With respect to all SuperGen Third Party manufacturers of the
Compound, the Product, and the Finished Product, SuperGen shall provide
Xxxxxx with a continuing FDA guarantee in the format as set forth in 21
C.F.R. Section.7.13(A)(j).
ARTICLE 9: LICENSE AND PATENT MATTERS
9.1 PATENT PROSECUTION AND MAINTENANCE. SuperGen at its sole cost and
expense shall maintain the Licensed Patents listed in Exhibit 1.23, and shall
use its reasonable commercial efforts to prosecute any such patent
applications included therein, in at least the countries listed on Exhibit
1.23, and obtain all available patent term extensions. The Parties shall
consult together and shall jointly determine patent issues, including but not
limited to patenting strategy, prosecution, and response to patent office
actions, and Xxxxxx shall provide such assistance as SuperGen may reasonably
request with respect to such matters. SuperGen shall reimburse Xxxxxx for its
verifiable out-of-pocket expenses in providing such consultation and
assistance. SuperGen shall inform Xxxxxx, on an annual basis and also on
Xxxxxx'x written request, about the status of such patent applications and/or
patents.
Prior to March 31, 2000, SuperGen shall commit to file additional patent
applications claiming the indications listed in Exhibit 3.1 and as determined to
be appropriate in consultation with Xxxxxx. In the event SuperGen fails to
submit such patent applications, Xxxxxx shall be entitled to prepare and file
such applications on behalf of SuperGen. SuperGen shall bear the cost of such
patent applications. In addition, SuperGen shall have the obligation to file
patent applications as deemed appropriate by the Clinical Development Committee
on a on-going basis throughout the term of this agreement.
9.2 SUPERGEN COVENANTS. SuperGen covenants that during the term of this
Agreement, it will:
(a) fulfill all of its obligations under the Xxxxxxx License Agreement
and any other Third Party license agreements or other agreements
relating to the Product to which SuperGen is a Party or becomes a Party
during the term of this Agreement (collectively, the "SuperGen License
Agreements"), including, but not limited to, any royalty, milestone or
other monetary obligations set forth therein;
(b) take no action nor will it omit to take any action which would
cause it to be in breach of any provision of any of the SuperGen
License Agreements relating to the
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CONFIDENTIAL TREATMENT REQUESTED
Product which would or could otherwise trigger termination of any such
Agreements (e.g., bankruptcy, change of control in whole or with
respect to any part of the Territories) or which would or could cause
the conversion of any SuperGen License Agreement from an exclusive to
nonexclusive agreement, in whole or with respect to any part of the
Territories;
(c) notify Xxxxxx in the event that, and within three (3) business days
after, SuperGen receives notice from any of SuperGen's licensors that
SuperGen is in default under any SuperGen License Agreement relating to
the Product or that any such SuperGen licensor has terminated or
intends to terminate any SuperGen License Agreement in whole or with
respect to any part of the Territories or convert any SuperGen License
Agreement from an exclusive to non-exclusive agreement in whole or with
respect to any part of the Territories, or otherwise take any action in
connection with a SuperGen License Agreement which would adversely
affect Xxxxxx'x rights under this Agreement. In the event of any
default of the type described in this Section 9.2(c), SuperGen agrees
that if it fails or does not intend to cure such default, Xxxxxx may,
at Xxxxxx'x option and to the extent permitted under the applicable
license agreement, do so and may offset against SuperGen's share of the
U.S. Product Profit and the royalty payable to SuperGen by Xxxxxx
pursuant to Article 7 above, as applicable, any reasonable expenses
Xxxxxx incurs in curing such default, except for any portion of such
expenses that would have otherwise been included as part of Third Party
Royalties. Xxxxxx and SuperGen shall account for such portion of
expense as a SuperGen Third Party Royalty;
(d) provide Xxxxxx with a copy of any reports, correspondence or notice
within three (3) business days from the submission to or receipt from
Xxxxxxx or any other Third Party licensor under any SuperGen License
Agreement.
(e) notify Xxxxxx no later than thirty (30) days prior to implementing
any decision to abandon or allow to lapse any patent application or
patent or not to initiate or take any other patent prosecution activity
with respect to any Product Patent. In such event, SuperGen agrees that
Xxxxxx may assume any such patent prosecution activity in connection
therewith, and SuperGen shall reasonably cooperate with Xxxxxx in
connection with any such patent prosecution activity and, if requested
by Xxxxxx, shall use its reasonable efforts to seek the cooperation of
Xxxxxxx or any other Third Party licensor; and
(f) take no action nor will it omit to take any action which would
result in derogation of the Licensed Patents in any existing or future
litigation or interference with any Third Parties or future oppositions
to foreign patents of any Third Parties.
9.3 THIRD PARTY INFRINGEMENT. If Xxxxxx or SuperGen become aware of any
activity on the part of any Third Party that such Party believes
infringes a Valid Claim of a Licensed Patent, such Party shall promptly
notify the other Party of all relevant
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CONFIDENTIAL TREATMENT REQUESTED
facts and circumstances pertaining to the potential infringement.
SuperGen shall have the right to enforce any rights within the Licensed
Patents against such infringement, at its own cost and expense. Xxxxxx,
at its own expense, shall cooperate with SuperGen in such effort,
including but not limited to being joined as a Party to such action,
and SuperGen shall use its reasonable efforts to obtain the cooperation
of Xxxxxxx and any other Third Party licensor in connection with such
enforcement.
9.4 XXXXXX'X RIGHT TO PURSUE THIRD PARTY INFRINGERS. If SuperGen shall fail,
within the lesser of (i) ninety (90) days of the notice of infringement
required by Section 9.3 or (ii) one-half the period of time allowed
therefor under the applicable SuperGen License Agreement, to either (A)
terminate such infringement or (B) institute an action seeking to
prevent continuation thereof, and thereafter to diligently prosecute
such action, or if SuperGen sooner notifies Xxxxxx that it does not plan
to terminate the infringement or institute such action, then Xxxxxx
shall have the right to do so at its own expense. SuperGen, at its own
expense, shall cooperate in such effort, including being joined as a
Party to such action, and SuperGen shall use its reasonable efforts to
obtain the cooperation of Xxxxxxx and any other Third Party licensor.
9.5 ALLOCATION OF DAMAGE OR SETTLEMENT AMOUNTS. Any damage award or
settlement obtained by a Party enforcing a Licensed Patent pursuant to
Article 9.3 or 9.4 above shall first be used to reimburse the enforcing
Party and then shall shared equally between the Parties.
ARTICLE 10: ADVERSE EVENTS, RECALLS AND OTHER REGULATORY MATTERS
10.1 ADVERSE REACTION REPORTING. Each Party shall keep the other Party informed
of information in or coming into its possession or control concerning side
effects, injury, toxicity or sensitivity reaction and incidents of severity
thereof associated with commercial and clinical uses, studies, investigations or
tests of each Product in the Territories, whether or not determined to be
attributable to the Product. SuperGen shall be responsible for filing with the
FDA, as required pursuant to 21 C.F.R. Sec. 314.80, any adverse reaction reports
that it receives. Xxxxxx shall be responsible for filing with the appropriate
regulatory authorities in the International Territory, as required, adverse
reaction reports that it receives. Within four (4) months of the Effective Date,
the respective pharmacovigilance groups of SuperGen and Xxxxxx shall enter into
a separate agreement covering adverse event information exchange relating to the
Product.
10.2 SAFETY ISSUES. In order to ensure that both Parties are provided with an
adequate opportunity to review safety matters, the Parties shall mutually agree
after the Effective Date on procedures with respect to (i) regulatory reporting
requirements, (ii) the review of Product labeling, (iii) maintenance of a safety
database and (iv) other safety issues.
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CONFIDENTIAL TREATMENT REQUESTED
10.3 PRODUCT COMPLAINTS AND INQUIRIES.
(a) Any medical or technical Product-related inquiries from consumers,
physicians or other Third Party customers who reside in the (i) U.S.
Territory shall be handled by SuperGen and (ii) International Territory
shall be handled by Xxxxxx. SuperGen shall supply Xxxxxx with copies of
its standard response information for the Product as well as any
updates thereto. Xxxxxx shall use such information to respond to any
such inquiries from the International Territory. Each Party shall
prepare and maintain a database containing responses to such inquiries
from consumers, physicians or other Third Party customers who reside in
the territory for which it is responsible, and shall make the contents
available to the other Party promptly from time to time upon request.
(b) Each Party shall maintain a record of all complaints or reports of
an actual or potential failure of any Product to meet the
specifications set forth in regulatory filings or in agreements among
the Parties. Such failure may involve the finished Product or one of
its intermediate stages. The responsibilities of the Parties with
respect to (a) notification of the product complaint from the receiving
Party to the other Party and (b) the handling of product complaints
shall all be performed in accordance with a procedure to be mutually
agreed by the Parties after the Effective Date.
10.4 PRODUCT RECALL. In the event that either Party determines that an event,
incident or circumstance has occurred which may result in the need for a recall
or other removal of any Product, or any lot or lots thereof, from the market in
any part or all of the Territories, such Party shall advise the other Party and
the Parties shall consult with respect thereto. SuperGen shall have the sole
authority to decide whether to commence, and the sole responsibility for the
handling and disposition of, a recall or other removal of such Product in the
U.S. Territory, and Xxxxxx shall have the sole authority to decide whether to
commence, and the sole responsibility for the handling and disposition of, a
recall or other removal of such Product in the International Territory. Any such
recall or other removal, by either Party, shall occur pursuant to a procedure to
be mutually agreed by the Parties after the Effective Date. Except as provided
below, if a Product (or any lot or lots thereof) is recalled or otherwise
removed from the market, the costs and expenses of such recall or removal,
including, without limitation, expenses and other costs or obligations to Third
Parties, the cost and expense of notifying customers and the costs and expenses
associated with shipment of the recalled Product and the cost and expense of
destroying the Product removed from the market, if necessary, except as provided
below shall be borne by SuperGen to the extent such expenses relate to the U.S.
Territory and shall be shared equally by SuperGen to the extent such expenses
relate to the International Territory. In the event that such recall or removal
costs, expenses or obligations result from one Party's: (i) improper or
negligent manufacturing, distribution, storage or shipment of the Product; .(ii)
improper sampling practices or mishandling of Sample Packs; (iii) Co-Promotion
or Promotion of the Product in a manner inconsistent with the Product's
labeling; or (iv) violation of this Agreement, such costs, expenses and
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CONFIDENTIAL TREATMENT REQUESTED
obligations shall be borne solely by such Party.
10.5 GOVERNMENTAL CONTACT REPORTING . Each Party shall promptly notify the other
Party upon being contacted by the FDA or any other competent governmental
authority or agency in the Territories for any material regulatory purpose
pertaining to this Agreement or to the Product. Neither Party shall respond to
the FDA or such other authority or agency before consulting with the other
Party, unless under the circumstances pursuant to which FDA or such other
authority or agency contacts such Party, it is not practical or lawful for the
contacted Party to give the other Party advance notice, in which event the
contacted Party shall inform the other Party of such contact as soon as
practical and lawful. In addition, each Party shall keep the other Party advised
with respect to information concerning the safety or efficacy of the Product,
including but not limited to providing, within three (3) business days of the
creation or receipt thereof, all information regarding such safety, efficacy and
medical information issues and copies of safety reports filed with the FDA or
any other authority or agency.
ARTICLE 11: REPRESENTATIONS AND WARRANTIES
11.1 XXXXXX REPRESENTATIONS AND WARRANTIES. Xxxxxx hereby represents to SuperGen
as follows:
(a) Xxxxxx is a corporation duly organized and validly existing in good
standing under the laws of its state of incorporation, with all
requisite corporate power and authority to own, lease and operate its
properties and assets and to carry on its business as presently
conducted and as proposed to be conducted;
(b) Xxxxxx has all requisite corporate right, power and authority to
enter into this Agreement and the other SuperGen-Xxxxxx Agreements and
to consummate the transactions contemplated hereby and thereby. The
execution and delivery of this Agreement and the other SuperGen-Xxxxxx
Agreements by Xxxxxx and the consummation by Xxxxxx of the transactions
contemplated hereby and thereby have been duly authorized by all
necessary corporate action on Xxxxxx'x behalf. This Agreement and the
other SuperGen-Xxxxxx Agreements constitute legal, valid and binding
obligations of Xxxxxx, enforceable against Xxxxxx in accordance with
the terms hereof and thereof;
(c) the execution, delivery and performance by Xxxxxx of this Agreement
and each of the other SuperGen-Xxxxxx Alliance Agreements and Xxxxxx'x
compliance with the terms and provisions hereof and thereof will not,
result in any violation of, or default under (with or without notice or
lapse of time, or both), or give rise to a right of termination,
cancellation or acceleration of any obligation pursuant to, or a loss
of benefits under, any provision of Xxxxxx'x Articles of Incorporation
or By-laws, or any mortgage, indenture, lease or other agreement or
instrument, license, judgment, order, decree, statute, law, ordinance,
rule or regulation applicable to Xxxxxx, its properties or assets; and
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CONFIDENTIAL TREATMENT REQUESTED
(d) no consent, approval or authorization of, or designation,
declaration or filing with any governmental authority is required in
connection with the valid execution, delivery or performance of this
Agreement and the other SuperGen-Xxxxxx Agreements by Xxxxxx or the
consummation by Xxxxxx of the transactions contemplated hereby or
thereby. Upon their execution and delivery, and assuming the valid
execution thereof by SuperGen, this Agreement and the other
SuperGen-Xxxxxx Agreements will constitute valid and binding
obligations of Xxxxxx, enforceable against Xxxxxx in accordance with
their respective terms, except as enforceability may be limited by
applicable bankruptcy, insolvency, reorganization, moratorium or
similar laws affecting creditors' and contracting parties' rights
generally and except as enforceability may be subject to general
principles of equity (regardless of whether such enforceability is
considered in a proceeding in equity or at law) and except to the
extent that the indemnification agreements of in Section 15 hereof may
be legally unenforceable.
11.2 SUPERGEN REPRESENTATIONS AND WARRANTIES. SuperGen hereby represents and
warranties to Xxxxxx as follows:
(a) SuperGen is a corporation duly organized and validly existing in
good standing under the laws of its state of incorporation, with all
requisite corporate power and authority to own, lease and operate its
properties and assets and to carry on its business as presently
conducted and as proposed to be conducted;
(b) SuperGen has all requisite corporate right, power and authority to
enter into this Agreement and the other SuperGen-Xxxxxx Agreements and
to consummate the transactions contemplated hereby and thereby. The
execution and delivery of this Agreement and the other SuperGen-Xxxxxx
Agreements by SuperGen and the consummation by SuperGen of the
transactions contemplated hereby and thereby have been duly authorized
by all necessary corporate action on SuperGen's behalf, including but
not limited to approval by the stockholders of SuperGen with respect to
the SuperGen-Xxxxxx Agreements. This Agreement and the other
SuperGen-Xxxxxx Agreements constitute legal, valid and binding
obligations of SuperGen, enforceable against SuperGen in accordance
with the terms hereof and thereof,
(c) the execution, delivery and performance by SuperGen of this
Agreement and each of the other SuperGen-Xxxxxx Agreements and
SuperGen's compliance with the terms and provisions hereof and thereof
will not result in any violation of or default under (with or without
notice or lapse of time, or both), or give rise to a right of
termination, cancellation or acceleration of any obligation pursuant
to, or a loss of benefits under, any provision of its Certificate of
Incorporation or By-laws, or any mortgage, indenture, lease or other
agreement or instrument, license, judgment, order, decree, statute,
law, ordinance, rule or regulation applicable to SuperGen or SuperGen's
properties or assets;
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CONFIDENTIAL TREATMENT REQUESTED
(d) no consent, approval or authorization of, or designation,
declaration or filing with any governmental authority is required in
connection with the valid execution, delivery or performance of this
Agreement and the other SuperGen-Xxxxxx Agreements by SuperGen or the
consummation by SuperGen of the transactions contemplated hereby or
thereby. Upon their execution and delivery, and assuming the valid
execution thereof by Xxxxxx, this Agreement and the other
SuperGen-Xxxxxx Agreements will constitute valid and binding
obligations of SuperGen, enforceable against SuperGen in accordance
with their respective terms, except as enforceability may be limited by
applicable bankruptcy, insolvency, reorganization, moratorium or
similar laws affecting creditors' and contracting parties' rights
generally and except as enforceability may be subject to general
principles of equity (regardless of whether such enforceability is
considered in a proceeding in equity or at law) and except to the
extent that the indemnification agreements of in Section 15 hereof may
be legally unenforceable;
(e) to its knowledge and information, as of the Effective Date, there
are no patents, trademarks or other proprietary rights which are valid
and which would be infringed by making, having made, using, selling,
offering for sale or importing the Product in the Territories in
accordance with the terms of this Agreement;
(f) as of the Effective Date, SuperGen is not aware of any compounds or
products, the manufacture, use, importation, selling or offering for
sale of which would constitute an infringement by a Third Party of the
Product Patents;
(g) as of the Effective Date, SuperGen is aware of no pending
interference, opposition proceeding, litigation or any communication
which threatens an interference or opposition proceeding or litigation
before any patent and trademark office, court, or any other competent
entity in any jurisdiction in regard to the Product Patents;
(h) as of the Effective Date, SuperGen has disclosed to Xxxxxx all
protocols, data (including but not limited to preclinical and clinical
data), reports, and other information and materials regarding the
Compound and the Product;
(i) as of the Effective Date, SuperGen has provided to Xxxxxx a
complete and accurate copy of each of the SuperGen license agreements
with respect to the Product;
(j) as of the Effective Date, there are no material facts which
SuperGen has not disclosed to Xxxxxx regarding the manufacture, use or
sale of any Product or the practice of any inventions included in the
Product Patents or the use of the Product Technology by Xxxxxx,
including without limitation any material facts regarding the
possibility that such manufacture, use, sale or practice might infringe
any Third Party's know-how, patent rights or other intellectual
property in the Territories;
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CONFIDENTIAL TREATMENT REQUESTED
(k) at no time during the term of this Agreement shall SuperGen enter
into any transaction providing for debt financing which by its terms
(A) imposes a lien, license, security interest or other encumbrance
upon or (B) transfers any of the SuperGen Technology relating to the
Compound or the Product;
(l) with respect to the Compound, (A) SuperGen has obtained and is in
substantial compliance with all applicable regulatory approvals,
applications, licenses, requests for exemption, permits or other
regulatory authorizations with the FDA, or any state or local
regulatory body necessary to conduct its business activities to date;
and (B) to the extent the Compound is intended for export from the
United States, and to the extent applicable, SuperGen is in compliance
in all material respects with either all FDA requirements for marketing
or as set forth in 21 U.S.C. Section 38l(e) or 382;
(m) to the knowledge and information of SuperGen, all manufacturing
operations performed by or on behalf of SuperGen for the Compound and/
or the Product have been and are being conducted in substantial
compliance with the current good manufacturing practices issued by the
FDA and all other relevant governmental authorities or agencies, to the
extent applicable;
(n) to the knowledge and information of SuperGen, all nonclinical
laboratory studies, as described in 21 C.F.R. Section 58.3(d),
sponsored by SuperGen for the Compound and/ or the Product have been
and are being conducted in substantial compliance with the good
laboratory practice regulations set forth in C.F.R. Part 58 and similar
regulations of all other relevant governmental authorities or agencies,
to the extent applicable; and
(o) Finished Product supplied to Xxxxxx by SuperGen under this
Agreement shall conform to the Specifications applicable thereto and
shall be manufactured in compliance with applicable cGMPs and other
applicable laws and regulations in the Territories, and Compound and
Product used in Finished Product supplied to Xxxxxx by SuperGen under
this Agreement shall conform to the Specifications applicable thereto
and shall be manufactured in compliance with applicable cGMPs and other
applicable laws and regulations in the Territories.
11.3 LIMITATION ON WARRANTIES. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN
THIS AGREEMENT, EACH PARTY MAKES NO OTHER WARRANTIES OR REPRESENTATIONS,
INCLUDING FITNESS FOR PURPOSE INTENDED OR MERCHANTABILITY, WHETHER EXPRESS OR
IMPLIED.
ARTICLE 12: LIMITATION ON LIABILITY
EXCEPT AS OTHERWISE PROVIDED, NEITHER PARTY SHALL BE LIABLE FOR ANY SPECIAL,
INCIDENTAL, INDIRECT OR CONSEQUENTIAL ARISING OUT OF OR RELATING TO THIS
AGREEMENT; PROVIDED HOWEVER, THIS
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CONFIDENTIAL TREATMENT REQUESTED
LIMITATION SHALL NOT APPLY TO LOSSES ARISING FROM THIRD PARTY CLAIMS FOR
WHICH A PARTY IS INDEMNIFIED UNDER THE TERMS OF THIS AGREEMENT.
ARTICLE 13: CONFIDENTIALITY AND NONDISCLOSURE
13.1 CONFIDENTIALITY OBLIGATION. Each of Xxxxxx and SuperGen (the "Receiving
Party") shall keep strictly confidential any information disclosed in writing,
orally, visually or in any other manner by the other Party (the "Disclosing
Party") or otherwise made available to the Receiving Party which the Disclosing
Party considers to be and treats as proprietary or confidential ("Confidential
Information"). Without limiting the generality of the foregoing, all proprietary
information concerning the Disclosing Party's business, operations, suppliers,
products, product manufacture, sale, marketing or distribution, trade secrets
and intellectual property shall be considered Confidential Information by the
Receiving Party. Any data or other information relating to or resulting from the
clinical trials of the Product shall be deemed to be Confidential Information of
SuperGen. The Disclosing Party shall use commercially reasonable efforts to
designate any written Confidential Information disclosed to the other Party as
Confidential Information by prominently marking it "confidential," provided that
the failure to so xxxx shall not exclude such written information from the
provisions of this Section 13. "Confidential Information" shall not include
information:
(a) which is or becomes generally available to the public other than as
a result of unauthorized disclosure thereof by the Receiving Party;
(b) which is lawfully received by the Receiving Party on a
nonconfidential basis from a Third Party that is not itself under any
obligation of confidentiality or nondisclosure to the Disclosing Party
or any other Person with respect to such information;
(c) which by written evidence can be shown by the Receiving Party to
have been independently developed by or for the Receiving Party; or
(d) which the Receiving Party establishes by competent proof was in its
possession at the time of disclosure by the other Party and was not
acquired, directly or indirectly from the other Party under any
obligation of confidentiality.
All information, data and other materials disclosed by one Party to the other
pursuant to the Confidentiality Agreement, dated May 2, 1999, shall be deemed to
have been disclosed by the disclosing Party under this Agreement.
13.2 NONDISCLOSURE OF CONFIDENTIAL INFORMATION. The Receiving Party shall
use Confidential Information solely for the purposes of this Agreement and
shall not disclose or disseminate any Confidential Information to any Third
Party at any time without the Disclosing Party's prior written consent,
except for disclosure to those of its directors, officers, employees,
accountants, attorneys, advisers, permitted sublicensees, agents and
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CONFIDENTIAL TREATMENT REQUESTED
representatives whose duties reasonably require them to have access to such
Confidential Information, provided that such directors, officers, employees,
accountants, attorneys, advisers, agents and representatives are required to
use the Confidential Information solely for purposes of this Agreement and
maintain the confidentiality of such Confidential Information to the same
extent as if they were Parties hereto.
13.3 EXCEPTION. The foregoing confidentiality and nondisclosure
obligations shall not apply to information which is required to be disclosed
by law or by regulation; provided, that (i) the Receiving Party gives the
Disclosing Party reasonable advance notice of the disclosure, to the extent
reasonably practicable and legally permissible; (ii) the Receiving Party uses
reasonable efforts to resist disclosing the Confidential Information; (iii)
the Receiving Party reasonably cooperates with the Disclosing Party on
request to obtain a protective order or otherwise limit the disclosure; and
(iv) upon the reasonable request of the Disclosing Party, the Receiving Party
shall provide a letter from its counsel confirming that the Confidential
Information is, in fact, required to be disclosed.
13.4 INJUNCTIVE RELIEF. The Parties acknowledge that either Party's
breach of this Article 13 may cause the other Party irreparable injury for
which it would not have an adequate remedy at law. In the event of a breach,
the non-breaching Party shall be entitled to injunctive relief in addition to
any other remedies it may have at law or in equity.
13.5 SURVIVAL. The confidentiality and nondisclosure obligations of this
Article 13 shall survive the expiration or termination of this Agreement and
remain in effect for a period of ten (10) years following the expiration or
termination of this Agreement.
ARTICLE 14: TRADEMARKS
14.1 SUPERGEN TRADEMARKS. Subject to approval by the U.S. Marketing
Board, SuperGen shall be solely responsible for the selection, filing,
registration and maintenance of the SuperGen Trademark(s) in the U.S.
Territory. SuperGen shall keep Xxxxxx fully apprised with respect to its
trademark activities and shall consult with Xxxxxx regarding the selection of
the SuperGen Trademark(s) for the U.S. Territory. All reasonable
out-of-pocket costs and expenses associated with the selection, filing,
registration and maintenance of the trademarks for the Product in the U.S.
Territory shall be included in SuperGen SG&A.
14.2 LIMITED TRADEMARK LICENSE. Subject to the terms of this Agreement,
SuperGen hereby grants to Xxxxxx (i) a nonexclusive limited license in the
Territories to use SuperGen's name and logo, and (ii) a coexclusive limited
license in the U.S. Territory to use the SuperGen Trademark(s), in each
instance solely for the purpose of promoting distributing and selling the
Product in the Territories in accordance with the terms and conditions of
this Agreement. Xxxxxx shall promote the Product in the U.S. Territory only
under the SuperGen Trademark(s).
14.3 XXXXXX TRADEMARK(S). Xxxxxx shall be solely responsible for the
selection, filing,
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CONFIDENTIAL TREATMENT REQUESTED
registration and maintenance of the Xxxxxx Trademark(s) in the International
Territory. Xxxxxx shall keep SuperGen fully apprised with respect to the its
trademark activities and shall consult with SuperGen regarding the selection
of the Xxxxxx Trademark(s) for the International Territory. Xxxxxx shall
control all final decisions regarding the Xxxxxx Trademarks.
14.4 LIMITED TRADEMARK LICENSE. In the event that Xxxxxx'x rights under
this Agreement shall cease, and upon request by SuperGen, Xxxxxx shall xxxxx
to SuperGen an exclusive limited license in the International Territory to
use the Xxxxxx Trademark(s), solely for the purpose of promoting distributing
and selling the Product in the International Territory. SuperGen shall pay
Xxxxxx a trademark royalty of two percent (2%) of SuperGen's Net Sales of the
Product in the International Territory, subject to the terms of a separate
trademark license to be entered into by the Parties.
14.5 USE OF TRADE NAMES AND LOGOS. Each Party recognizes that the name
and logo of each of the Parties represents a valuable asset of such entity
and that substantial recognition and goodwill are associated with each
Party's name, and logo. Each Party hereby agrees that, without prior written
authorization of the other Party, it shall not use the name or logo of the
other Party for any purpose other than the promotion, distribution and sale
of the Product solely to the extent required to fulfill its obligations under
this Agreement. In addition, SuperGen shall only use the Xxxxxx name and logo
in the form, manner and logotype approved in writing by Xxxxxx, and Xxxxxx
shall only use the SuperGen name and logo and the SuperGen Trademarks in the
form, manner and logotype approved in writing by SuperGen. Except for the
limited license granted in Section 14.2 above, nothing in this Agreement
shall be construed as an assignment by SuperGen to Xxxxxx of any right, title
or interest in or to the SuperGen name or logo or the SuperGen Trademarks, or
an assignment by Xxxxxx to SuperGen of any right, title or interest in or to
the Xxxxxx name or logo or the Xxxxxx Trademarks; it being understood that
all right, title and interest (including the goodwill associated therewith)
in and to the SuperGen name and logo and the SuperGen Trademark(s) is
expressly reserved by SuperGen, and all right, title and interest (including
the goodwill associated therewith) in and to the Xxxxxx name and logo and the
Xxxxxx Trademarks is expressly reserved by Xxxxxx.
14.6 INJUNCTIVE RELIEF. Each Party acknowledges that a violation of this
Article 14 would cause irreparable harm to the other Party for which no
adequate remedy at law exists, and each Party therefore agrees that, in
addition to any other remedies available, and notwithstanding any other
provision in this Agreement, the aggrieved Party shall be entitled to
injunctive relief to enforce the terms of this Article 14. If either Party
prevails in any such action, it shall be entitled to recover all costs and
expenses, including reasonable attorney's and other professional fees and
expenses incurred because of any legal action arising in relation to this
Article 14.
14.7 NOTIFICATION OF INFRINGEMENT AND ENFORCEMENT. Each Party shall
notify the other Party of any infringement or misuse of SuperGen's
Trademark(s) of which such Party becomes aware. SuperGen shall be solely
responsible to prosecute any infringement of
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CONFIDENTIAL TREATMENT REQUESTED
the SuperGen Trademark(s). Any damage award or settlement, in excess of
SuperGen's cost and expenses of enforcement, shall be shared equally between
the Parties.
ARTICLE 15: INDEMNIFICATION
15.1 INDEMNIFICATION BY SUPERGEN. Except as may be otherwise provided
herein, SuperGen shall defend, indemnify and hold Xxxxxx, all of its
directors, officers and employees, and Xxxxxx Sales Representatives
(collectively the "Xxxxxx Indemnitees") harmless from and against all Losses
incurred in connection with any Third Party suits, claims or causes of action
arising out of or resulting from:
(a) SuperGen's breach of any representation, warranty, covenant, or
obligation provided for in this Agreement;
(b) an infringement claim arising from Xxxxxx'x use of the SuperGen
name or logo or a SuperGen Trademark in connection with the promotion
or sale of the Products, provided Xxxxxx'x use is in compliance with
the terms of this Agreement;
(c) the negligence, recklessness or willful misconduct of SuperGen and
its directors, officers or employees or SuperGen Sales Representatives,
including, but not limited to, product liability claims arising out of
off-label promotions by SuperGen, its directors, officers, employees or
SuperGen Sales Representatives; or
(d) any patent infringement claim arising from the manufacture,
importation, use or sale of the Product.
Provided, however, that SuperGen shall not be required to indemnify the Xxxxxx
Indemnitees to the extent that any Losses arise out of or result from: (A) the
negligence, recklessness or willful misconduct of any of the Xxxxxx Indemnitees,
including, but not limited to, off-label promotion of the Product, (B)
utilization of process technology for the manufacture of Product which has not
been approved by SuperGen, (C) continued Promotion in a country after receipt of
notice from SuperGen indicating that the sale or Promotion of such Product in
such country should be terminated because such further sale or Promotion would
constitute willful infringement of a valid and issued patent in such country
and/or (D) any breach by Xxxxxx of this Agreement. Xxxxxx shall not be
considered negligent for purposes of this Section 15.1 if such claim arises
solely with respect to the content of the Promotional Materials, Product
labeling or other materials provided to Xxxxxx by SuperGen as long as Xxxxxx has
distributed or employed such Promotional Materials or other such materials as
directed herein.
15.2 INDEMNIFICATION BY XXXXXX . Except as may be otherwise provided herein,
Xxxxxx shall defend, indemnify and hold SuperGen, its directors, officers and
employees, and SuperGen Sales Representatives (collectively the "SuperGen
Indemnitees") harmless from and against all Losses incurred in connection with
any Third Party suits, claims or
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CONFIDENTIAL TREATMENT REQUESTED
causes of action arising out of or resulting from:
(a) Xxxxxx'x breach of any representation, warranty, covenant, or
obligation provided for in this Agreement;
(b) an infringement claim arising from SuperGen's use of the Xxxxxx
name or logo in connection with the promotion or sale of the Product,
provided SuperGen's use is in compliance with the terms of this
Agreement;
(c) the negligence, recklessness or willful misconduct of Xxxxxx, its
directors, officers or employees or Xxxxxx Sales Representatives,
including, but not limited to, product liability claims arising out of
off-label promotions by Xxxxxx, its Affiliates, their directors,
officers or employees, or Xxxxxx Sales Representatives; or
(d) any patent infringement claim arising from Xxxxxx'x or its
Affiliates' or permitted sublicensee's (A) utilization of process
technology for the manufacture of the Product which has not been
approved by SuperGen or (B) continued Promotion in a country after
receipt of notice from SuperGen indicating that the sale or Promotion
of such Product in such country should be terminated because such
further sale or Promotion would constitute willful infringement of a
valid and issued patent in such country.
Provided, however, that Xxxxxx shall not be required to indemnify the SuperGen
Indemnitees to the extent that any Losses arise out of or result from: (A) the
negligence, recklessness or willful misconduct of any SuperGen Indemnitee
including, but not limited to, off-label promotion of the Product; and/or (B)
any breach by SuperGen of this Agreement.
15.3 INDEMNIFICATION PROCEDURE. Any Xxxxxx Indemnitee or SuperGen Indemnitee, as
the case may be, shall notify SuperGen or Xxxxxx (the "Indemnifying Party")
promptly in writing of an indemnifiable claim or cause of action under Article
15.1 or 15.2 upon receiving notice or being informed of the existence thereof.
The Indemnifying Party shall assume, at its cost and expense, the sole defense
of such claim or cause of action through counsel selected by the Indemnifying
Party and reasonably acceptable to the other Party. The Indemnifying Party shall
maintain control of such defense, including any decision as to settlement;
provided that:
(a) the Indemnifying Party shall not enter into any binding settlement,
consent to any judgment, or otherwise resolve any such claim or action
pursuant to which the other Party would be obligated to take or refrain
from taking any action (including but not limited to being enjoined
from making, using, importing, selling or offering to sell the Product)
or to make any payments or admissions, without the other Party's prior
written consent; and
(b) in the event that the Indemnifying Party does not diligently defend
such
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CONFIDENTIAL TREATMENT REQUESTED
claim or cause of action on a timely basis, then, without prejudice to
any other rights and remedies available to the other Party under this
Agreement, the other Party may take over such defense with counsel of
its choosing at the Indemnifying Party's cost and expense. The other
Party may, at its option and expense, participate in the Indemnifying
Party's defense, and if the other Party so participates, the Parties
shall cooperate with one another in such defense. The Indemnifying
Party shall bear the total costs of any court award or settlement of
such claim or cause of action and all other costs, fees and expenses
related to the resolution thereof (including reasonable attorney's and
other professional fees and expenses except for attorneys' fees for
which the other Party is responsible in the event that the other Party
participates in the Indemnifying Party's defense of such claim or cause
of action). The indemnification obligations herein shall apply on a
first dollar basis without limitation or reduction due to any
deductible or self-insured retention which SuperGen or Xxxxxx
respectively may have under their respective insurance coverage.
15.4 PRODUCT LIABILITY. In the event of a product liability claim with respect
to the Product which is not covered by the foregoing indemnity provisions in
this Article 15, the Parties shall bear equally the amount of any awards or
other losses and costs attributable directly thereto. Xxxxxx shall maintain
control of the defense of any such product liability claim with respect to the
International Territory and SuperGen shall maintain control of the defense of
any such product liability claim with respect to the U.S. Territory.
ARTICLE 16: TERM AND TERMINATION
16.1 TERM. The term of this Agreement shall commence on the Effective Date and,
unless terminated sooner in accordance with this Article 16:
(a) for the U.S. Territory, the term of this Agreement shall expire
upon the earlier of (i) the date upon which a generic version of the
Product is first sold in the U.S. Territory, or (ii) the date which is
fifteen (15) years after the date of Regulatory Approval of the Product
in the U.S. Territory, provided that the Parties may renew this
Agreement for the U.S. Territory for (i) further successive one (1)
year periods, or (ii) further successive periods of time during which
any applicable marketing exclusivity precludes the effective approval
by the FDA of any product containing the Compound, upon written
agreement made no later than thirty (30) days prior to the end of the
original term and any succeeding extensions thereof; and
(b) for the International Territory, the term of this Agreement shall
expire upon the later of (i) the date which is fifteen (15) years after
the date of Regulatory Approval of the Product in the first country
within the International Territory, and (ii) the date upon which the
last Valid Claim expires or is found invalid or unenforceable by the
final, unappealable or unappealed decision of a court or other entity
of competent jurisdiction.
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CONFIDENTIAL TREATMENT REQUESTED
16.2 Upon expiration of this Agreement in the International Territory,
Xxxxxx shall have a fully-paid up, irrevocable license to use and sell
the Product in the International Territory under the SuperGen
Technology.
16.3 TERMINATION FOR MATERIAL BREACH. Either party may, in addition to any
other remedies available to it by law or in equity, terminate this
Agreement, upon sixty (60) days' written notice in the event that the
other party breaches a material provision of this Agreement and fails
to cure such breach within sixty (60) days of notice of the breach. The
party giving notice of breach may withhold any payments otherwise due
and owing to the breaching party, to be used as a setoff against any
loss or damage arising from the breach, and such withholding shall not
constitute breach of this Agreement. If the breaching party cures the
breach within the sixty (60) day cure period and this Agreement is not
terminated, then the withholding party shall promptly pay to the other
party the withheld amount, less that portion of such amount which was
applied as a setoff. Notwithstanding the foregoing provision, if Xxxxxx
gives notice of breach to SuperGen, Xxxxxx may withhold other payments
pursuant to this Article 16.3 but shall not be entitled to withhold
payment for Finished Product actually ordered from and delivered and
invoiced by SuperGen pursuant to Article 8 of this Agreement.
16.4 TERMINATION FOR NON-APPROVAL OR LACK OF COMMERCIAL VIABILITY.
(a) Commencing one (1) year after the Effective Date, Xxxxxx may
terminate this Agreement at any time, on a Territory-by-Territory basis
or in whole, upon thirty (30) days written notice to SuperGen that (i)
the Product has not obtained Regulatory Approval in the U.S. Territory
and/ or in one or more of the Major European Countries (as the case may
be), or (ii) Xxxxxx, in the exercise of its reasonable commercial
judgment, has determined that the Product and/ or the material terms
and conditions of this Agreement are not commercially viable.
(b) Commencing on the Effective Date, Xxxxxx may terminate this
Agreement at any time, on a Territory-by-Territory basis or in whole,
upon thirty (30) days written notice to SuperGen in the event that the
milestones defined in Article 5.1(c)(i) above are not met by June 30,
2000.
16.5 BANKRUPTCY OR INSOLVENCY. Either Party may, in addition to any other
remedies available to it by law or in equity, terminate this Agreement,
upon thirty (30) days' written notice to the other Party in the event
the other Party shall have become insolvent or bankrupt, or shall have
made an assignment for the benefit of its creditors, or there shall
have been appointed a trustee or receiver of the other Party or for all
or a substantial Party of its property, or any case or proceeding shall
have been commenced or other action taken by or against the other Party
in bankruptcy or seeking reorganization, liquidation, dissolution,
winding-up, arrangement, composition or readjustment of its debts or
any relief under any bankruptcy, insolvency, reorganization or other
similar act or law of any
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CONFIDENTIAL TREATMENT REQUESTED
jurisdiction now or hereinafter in effect (an "Insolvency Event").
However, in the event that SuperGen experiences an Insolvency Event and
any trustee acting on behalf of SuperGen or its debtors rejects this
Agreement, Xxxxxx shall have the right to elect to retain its rights
under this Agreement upon written notification to said trustee of its
intentions to do so. All rights and licenses granted hereunder are for
all purposes of this Agreement licenses of rights to intellectual
property and may not be terminated upon an Insolvency Event without the
express agreement of the Party that is not insolvent. Notwithstanding
anything to the contrary in this Agreement, in the event that SuperGen
experiences an Insolvency Event and Xxxxxx does not elect to terminate
this Agreement, then Xxxxxx shall automatically have the right to make,
in its sole discretion, any decisions relating to the clinical
development of the Product, regulatory strategies and tactics for the
Product, and the marketing, promotion and sale of the Product which
decisions were heretofore to be made either jointly by the Parties or
solely by SuperGen under this Agreement.
16.6 SERIOUS EVENTS. Should there occur serious and unexpected events which,
from a reasonable pharmaceutical company's point of view, would make it
impossible or impracticable to pursue the commercialization of the Product,
including but not limited to (i) a serious adverse event associated with the
Compound and/ or the Product or (ii) infringement of any Third Party
intellectual property rights by the manufacture, importation, use or sale of the
Product, either Party may terminate this Agreement upon thirty (30) days'
written notice.
16.7 CHANGE OF CONTROL OR OWNERSHIP. Either Party may terminate this Agreement
upon thirty (30) days' written notice if the ownership or control of at least
fifty percent (50%) of the assets or voting securities of the other Party are
transferred and, in the non-changing Party's reasonable judgement, the other
Party's new owner or controlling entity is a competitor of the non-changing
Party in the field of oncology. In addition to this right, if fifty per cent
(50%) or more of SuperGen's assets or if the ownership of the controlling
interest in SuperGen becomes subject to the control of persons not presently
owners of SuperGen, then within thirty (30) days of receipt of notice to Xxxxxx
from SuperGen of such a change in control, Xxxxxx may request from such
controlling persons a written affirmation that the same level of time, money,
personnel and other resources devoted by SuperGen to meet its obligations under
the terms and conditions of this Agreement prior to the change of control will
be available to SuperGen to meet its obligations under the terms and conditions
of this Agreement after the change of control. If the controlling persons do not
provide such written affirmation to Xxxxxx within thirty (30) days after the
date of Xxxxxx'x request, then Clause 20.3 of this Agreement shall automatically
be amended to provide that a dispute between the Parties that cannot be resolved
by reference to the appropriate Divisional Presidents of Xxxxxx and the
President of SuperGen, will be resolved in Xxxxxx'x favor.
16.8 EFFECT OF TERMINATION.
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CONFIDENTIAL TREATMENT REQUESTED
(a) Any termination with respect to a particular Territory shall only
result in the termination of rights and obligations hereunder as they
relate to that Territory.
(b) Expiration or termination of this Agreement (on a
Territory-by-Territory basis or as a whole) shall not release any Party
from liability accrued under this Agreement prior to such expiration or
termination, nor preclude either Party 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.
(c) Termination of this Agreement (on a Territory-by-Territory basis or
as a whole) in good faith by any Party shall not in itself constitute
any basis for claims for compensation, damages (direct, indirect or
consequential) or any other remedy in law or at equity by the other
Party, including but not limited to any claim for lost sales, profits,
goodwill or business opportunity or any claim on account of
expenditures, investments or commitments made in connection with the
Product or the Agreement.
(d) If this Agreement is terminated under this Article 16, the
terminating Party shall have the right to terminate each or any of (i)
the U.S. Distribution Agreement; (ii) the Stock Purchase Agreement, to
the extent that there are any continuing obligations thereunder; and
(iii) the Stockholder Rights Agreement (provided that the provisions
contained in sections 3 and 5 thereof shall survive such termination)
upon thirty (30) days written notice, in its sole discretion and in
addition to any other rights and remedies which may be available at law
or in equity or under the terms of the SuperGen-Abbott Agreements set
forth above.
16.9 PHASE-OUT PERIOD. Within thirty (30) days of the expiration or termination
of this Agreement under this Article 16 (on a Territory-by-Territory basis or as
a whole), Xxxxxx shall use its reasonable efforts to provide SuperGen with a
complete inventory of the Product in Xxxxxx'x possession or control. Upon
expiration or termination of this Agreement under this Article 16 (on a
Territory-by-Territory basis or as a whole), Xxxxxx may continue to distribute
the Product for a period of nine (9) months (the "Phase Out Period"), unless
such period is terminated earlier in writing by SuperGen, provided that this
Article 16.9 shall not lessen or restrict in any way the rights of Xxxxxx in the
International Territory pursuant to Article 16.2. During such Phase-Out Period,
Xxxxxx may continue to fill all outstanding orders for the Product and Xxxxxx
shall refer any new orders for the Product to SuperGen. During the Phase-Out
Period, Xxxxxx shall not be required to perform any Details for the Product and
Xxxxxx shall receive its share of the U.S. Product Profits, unless Xxxxxx was
terminated hereunder for its material breach of this Agreement. Xxxxxx shall
promptly return all Promotional Materials and Sample Packs for the terminated
Product to SuperGen and shall delete the Product from its catalogues and price
lists as soon as reasonably practical. In the event of any problems relating to
the Product or customer relations issue during the Phase-Out Period, Xxxxxx
shall cooperate fully with SuperGen to ensure customer satisfaction and
compliance with all applicable laws and regulations.
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CONFIDENTIAL TREATMENT REQUESTED
16.10 POST-TERMINATION ORDERS. After expiration or termination of this
Agreement (on a Territory-by-Territory basis or as a whole) the placement of
any order for Product by Xxxxxx to SuperGen, and the acceptance of any order
from, or sale of any Product to Xxxxxx by SuperGen, shall not be construed as
a renewal or extension of this Agreement nor as a waiver or reversal of
termination of this Agreement.
16.11 SURVIVAL. Other than obligations which have accrued and are outstanding
as of the date of any expiration or termination of this Agreement (on a
Territory-by-Territory basis or as a whole), all rights granted and
obligations undertaken by the Parties hereunder shall terminate immediately
upon the termination or expiration of this Agreement, subject to Article 16.2
above and except for the following which shall survive according to their
terms:
(a) The limitations on liability of Article 12;
(b) The confidentiality and nondisclosure obligations of Article 13;
(c) The indemnification obligations of Article 15 with respect to
events occurring prior to termination or expiration of the Agreement;
(d) The insurance obligations of Article 18; and
(e) The provisions of Sections 4.2(f) (as well as Section 4.3 as its
relates to Section 4.2(f) with respect to the International Territory),
7.5, 7.8, 16.4 through 16.8, 20.12, 20.3 and Section 20.11.
16.12 NONEXCLUSIVE RIGHTS AND REMEDIES. Except as otherwise set forth in
this Agreement, all rights and remedies of the Parties provided under this
Agreement are not exclusive and are in addition to any other rights and
remedies provided by law or under this Agreement.
16.13 CONDITIONS TO EFFECTIVENESS. The Effective Date shall be the date on
which the following conditions have been satisfied, as confirmed by both
Parties in writing:
(a) No order, statute, rule, regulation, executive order, injunction,
stay, decree or restraining order shall have been enacted, entered,
promulgated or enforced by any court of competent jurisdiction or
governmental or regulatory authority that prohibits the execution,
delivery or performance of any of the SuperGen-Xxxxxx Agreements, and
no proceeding by any governmental or regulatory authority or
instrumentality shall be pending or threatened, which seeks to prohibit
or declare illegal the execution, delivery or performance of any of the
SuperGen-Xxxxxx Agreements;
(b) The "First Tranche Closing" as such term is defined in the Stock
Purchase Agreement shall have occurred or shall be occurring
simultaneously;
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CONFIDENTIAL TREATMENT REQUESTED
(c) All corporate and other proceedings taken or to be taken in
conjunction with the transactions contemplated in the SuperGen-Xxxxxx
Agreements, and all documents incident thereto, shall be reasonably
satisfactory in form and substance to Xxxxxx and to SuperGen,
respectively;
(d) SuperGen shall have obtained the consents and/ or approvals
identified in Article 11.2 and Xxxxxx shall have received from SuperGen
a copy of the executed consents and/ or approvals identified in Article
11.2 and a certificate signed by an appropriate officer of SuperGen as
to SuperGen's compliance with the conditions set forth in this Section
16.9.
(e) The representations and warranties of SuperGen contained herein and
in the other SuperGen-Xxxxxx Agreements shall be true and correct at
and as of the Effective Date as though restated on and as of the
Effective Date;
(f) SuperGen shall have received from Xxxxxx a certificate signed by an
appropriate officer as to Xxxxxx'x compliance with this Section 16.13;
and
(g) Each of the Parties shall have approved the * Plan in writing.
16.14 NON-FULFILLMENT OF CONDITIONS. The non-fulfillment of any of the
conditions described in Article16.14 above (whether or not the Effective Date
occurs) shall not result in any liability to any Party unless such
non-fulfillment is a result of a breach of this Agreement or any of the other
SuperGen-Xxxxxx Agreements by such Party.
ARTICLE 17: TRANSFER OF TECHNOLOGY
17.1 TRANSFER BY SUPERGEN. Within thirty (30) days following the
Effective Date and as far as it has not previously done so, SuperGen shall
supply Xxxxxx with all SuperGen Technology necessary for the manufacture, use
and sale of the Product in SuperGen's possession or control (including but
not limited to technical information reasonably required by Xxxxxx for
regulatory, marketing and sales purposes under this Agreement). With respect
to any SuperGen Technology subsequently developed or obtained by SuperGen
during the term of this Agreement, such disclosure will be made to Xxxxxx at
least on a monthly basis or sooner, if practicable.
17.2 TECHNICAL ASSISTANCE. Solely for the purpose of enabling Xxxxxx to
exercise its rights pursuant to Article 8.5 above, SuperGen shall, upon
request by Xxxxxx, provide Xxxxxx with reasonable cooperation and assistance,
consistent with the other provisions hereof, in connection with the transfer
of SuperGen Technology. Such assistance may include, but is not limited to,
development of the formulations of the Product; procurement of supplies and
raw materials; initial development and production batch manufacturing runs;
process, specification and analytical methodology design and improvement;
and, in general, such other reasonable assistance as may contribute to the
efficient application by Xxxxxx of the Product Technology. In this regard,
SuperGen agrees to make appropriate employees of SuperGen reasonably
available to assist Abbott,
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CONFIDENTIAL TREATMENT REQUESTED
and SuperGen agrees to provide reasonable numbers of appropriate Xxxxxx
personnel with access during normal business hours to the appropriate
personnel and operations of SuperGen for such periods of time as may be
reasonable in order to familiarize Xxxxxx personnel with the SuperGen
Technology as applied by SuperGen. At Xxxxxx'x reasonable request, such
assistance shall be furnished at Xxxxxx'x or its subcontractors' or permitted
sublicensees' facilities in the Territories, subject to a mutually agreed
upon schedule. Such technical assistance shall include but not be limited to
the following:
(a) SuperGen shall: (A) provide Xxxxxx with a written right of
reference to any and all Drug Master File(s) or counterparts thereof in
any countries of the Territories ("DMF") relating to the manufacture of
the Compounds existing during the term of this Agreement; and (B)
reasonably cooperate with Abbott in obtaining access to and letters of
authorization to refer to the DMF's of SuperGen's subcontractors or
Third Party manufacturer(s) which are, or will be, supplying any
Compound or Product; and
(b) Within forty five (45) days after the Effective Date, SuperGen
shall provide Abbott with copies of all documentation in SuperGen's
possession or control, including all correspondence between SuperGen
and its subcontractors and/ or Third Party manufacturer(s), regarding
the manufacture of the Compound and the Product which would be
necessary or useful to assist Abbott in the commercial production of
the Compound or Product.
(c) During the period prior to the fifth anniversary of the Effective
Date; (i) SuperGen shall provide up to twenty (20) man-days of such
technical assistance during each year of such period at SuperGen's sole
expense and (ii) subsequent to such twenty (20) man-days of technical
assistance, SuperGen shall provide such additional technical assistance
as may be reasonably requested by Abbott; provided, that all reasonable
out-of-pocket travel costs and expenses incurred by SuperGen in
rendering technical assistance pursuant to this Article 17.2(b) in
excess of such twenty (20) man-days per year shall be reimbursed to
SuperGen by Abbott. Technical assistance furnished pursuant to this
Article 17.2(b) shall continue only until the fifth anniversary of the
Effective Date of this Agreement.
17.3 LANGUAGE OF DISCLOSURES. All disclosure pursuant to this Agreement
will be in English.
ARTICLE 18: INSURANCE
Beginning on the Effective Date and until the date which is one day prior to the
date of initial Launch, SuperGen shall maintain product liability insurance with
an A.M. Best Company rating of at least A+ with a minimum annual amount 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
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CONFIDENTIAL TREATMENT REQUESTED
occurrence and in the aggregate which are adequate to Xxxxxx'x reasonable
satisfaction. Upon Xxxxxx'x 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 Abbott. Abbott shall be named as an additional
insured party under any such insurance policies.
ARTICLE 19: FORCE MAJEURE
If any circumstance beyond the reasonable control of either Party occurs which
delays or renders impossible the performance of certain of that Party's
obligations under this Agreement on the dates herein provided ("Force Majeure"),
such obligations shall be postponed for such time as such performance
necessarily has had to be suspended or delayed on account thereof, provided such
Party shall notify the other Party in writing as soon as practicable, but in no
event more than ten (10) business days after the occurrence of such event of
Force Majeure, which notice shall reasonably attempt to identify such
obligations under this Agreement and the extent to which performance thereof
will be affected. In such event, the Parties shall meet promptly to determine an
equitable solution to the effects of any such event, provided that such Party
who fails because of an event of Force Majeure to perform its obligations
hereunder shall upon the cessation of the Force Majeure event take all
reasonable steps within its power to resume with the least possible delay
compliance with its obligations. Events of Force Majeure shall include, without
limitation, war, revolution, invasion. insurrection, riots, mob violence.
sabotage or other civil disorders, acts of God, limitations imposed by exchange
control regulations or foreign investment regulations or similar regulations,
laws, regulations or rules of any government or governmental agency, any
inordinate and unanticipated delays in the regulatory review or governmental
approval process that are within the sole control of such government or
governmental agency, any delay or failure in manufacture, production or supply
by Third Parties of any goods or services, any withdrawal or recall of a Product
at the direction of any governmental authority and any failure of a computer
system.
ARTICLE 20: MISCELLANEOUS
20.1 RELATIONSHIP OF THE PARTIES. Each of the Parties shall be furnishing
its services hereunder as an independent contractor, and nothing herein shall
create any association, partnership or joint venture between the Parties or
any employer-employee or agency relationship. No agent, employee or servant
of either Party shall be or shall be deemed to be the employee, agent or
servant of the other Party, and each Party shall be solely and entirely
responsible for its acts and the acts of its employees.
20.2 RELATIONSHIP WITH AFFILIATES. Unless the context otherwise indicates
or as set forth in this Article 20.2, (i) any reference to a Party herein
shall include the Affiliates of such Party , with the following exceptions:
(A) the appointment of exclusive distributorship pursuant to Article 2.1; (B)
the grant of right to co-promote the Product pursuant to Article 2.2; (C) the
grant of license to sell the Product pursuant to Article 2.5; (D) the grant
of right with respect to additional products pursuant to Article 2.6; (E) the
right of
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CONFIDENTIAL TREATMENT REQUESTED
first refusal to acquire SuperGen pursuant to Article 2.7; and (F) the right
with respect to patent prosecution and infringement pursuant to Article 9;
and (ii) each Party may utilize the services of its Affiliates to perform
services, activities and/or obligations permitted or required under this
Agreement to the same extent as if such Affiliate were a Party to this
Agreement; provided that any such services, activities or obligations under
this Agreement permitted or required to be performed by such Party relating
to the U.S. Territory will be performed only by such Party or a wholly-owned
U.S. subsidiary of such Party. Any Affiliates so utilized shall be subject to
all the terms and conditions applicable to such Party under this Agreement,
including but not limited to provisions establishing standards for
performance. With respect to the International Territory, Abbott may use its
Affiliates as set forth in this Section 20.2; provided that Abbott shall make
all payments required and provide all reports required under this Agreement.
The use of any Affiliates as set forth in this Section 20.2 shall in no way
relieve the applicable Party of any of its obligations or liabilities
hereunder and each Party shall be liable for the actions of its Affiliates
under this Agreement and the indemnification provisions of Article 15 shall
apply with respect to all actions of a Party's Affiliates under this
Agreement.
20.3 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 Xxxxxx Laboratories Hospital Products Division and
Xxxxxx Laboratories International 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 20.3.
20.4 COUNTERPARTS. The Agreement may be executed simultaneously in any
number of counterparts and may be executed by facsimile. All counterparts
shall collectively constitute one and the same Agreement.
20.5 NOTICES. In any case where any notice or other communication is
required or permitted to be given hereunder, such notice or communication
shall be in writing, and sent by overnight express, facsimile or registered
or certified mail (with return receipt requested) and shall be sent to the
following address (or such other address as either Party may designate from
time to time in writing):
If to SuperGen: SuperGen, Inc.
Xxx Xxxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Telefax: (000) 000-0000
Attention: Xx. Xxx Xxxxxxxxx
Chief Executive Officer and President
Copy to: Xxxxxx Xxxxxxx Xxxxxxxx & Xxxxxx
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, XX 00000-0000
60
If to Abbott: Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, XX 00000
Telefax: (000) 000-0000 / (000) 000-0000
Attention: Senior Vice President, Hospital Products
Division, and Senior Vice President,
International Operations
Copy to: General Counsel
Xxxxxx Laboratories
Dept. 364; Bldg. AP6D
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, XX 00000
Telefax:(000) 000-0000
20.6 BINDING EFFECT; ASSIGNMENT. This Agreement may not be assigned, in whole or
in part, by either Party without the prior written consent of the other Party,
and any attempted assignment without such consent shall be null and void;
provided that no prior written consent shall be required in the event that a
Third Party acquires substantially all of the assets or outstanding shares of,
or merges with, the assigning Party, but only so long as (i) such Third Party
agrees to be bound by all of the assigning Party's responsibilities and
obligations hereunder and (ii) the other Party has determined, in the exercise
of its reasonable commercial judgment, that the interests of such Third Party
are not in conflict with the interests of such other Party with respect to the
Product. No assignment of this Agreement or of any rights hereunder shall
relieve the assigning Party of any of its obligations or liability hereunder.
This Agreement shall inure to the benefit of and be binding upon each of the
Parties hereto and their respective successors and permitted assigns.
20.7 ENTIRE AGREEMENT. The terms and conditions contained herein and in the
other SuperGen-Abbott Agreements constitute the entire agreement between the
Parties relating to the subject matter of 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. Neither Party has
entered into this Agreement in reliance upon any representation, warranty,
covenant or undertaking of the other Party that is not set out or referred to in
this Agreement.
20.8 AMENDMENT. The Agreement may be varied, amended or extended only by the
written agreement of the Parties through their duly authorized officers or
representatives, specifically referring to this Agreement.
20.9 SEVERABILITY. In case any one or more of the provisions contained herein
shall, for any reason be held to be invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall not affect any
other provision of this Agreement, but this Agreement shall be construed as if
such invalid, illegal or unenforceable provision or provisions had never been
contained herein unless the deletion of such provision or provisions would
result in such a material change as to cause completion of the transactions
contemplated herein to
61
be impossible and provided that the performance required by this Agreement
with such clause deleted remains substantially consistent with the intent of
the Parties.
20.10 COMPANY EMPLOYEES. Each Party shall not directly or indirectly solicit for
employment, any employee of the other Party who has been directly involved in
the performance of this Agreement during the term of this Agreement and for one
year after the earlier of the termination or expiration of this Agreement or the
termination of such individual's employment with the other Party. It shall not
be a violation of this provision if any employee responds to a Party's general
advertisement of an open position.
20.11 PUBLICITY. Except as otherwise provided herein, each Party shall maintain
the confidentiality of all provisions of this Agreement and this Agreement
itself and, without the prior written consent of both Parties, neither Party
shall make any press release or other public announcement of or otherwise
disclose to any Third Party this Agreement or any of its provisions or anything
relating to the Compound, the Product or the Finished Product, except for: (i)
for disclosure to those of its directors, officers, employees, accountants,
attorneys, advisers and agents whose duties reasonably require them to have
access to the Agreement, provided that such directors, officers, employees,
accountants, attorneys, advisers, and agents are required to maintain the
confidentiality of the Agreement to the same extent as if they were Parties
hereto, (ii) such disclosures as may be required by applicable laws and
regulations, in which case the disclosing Party shall provide the nondisclosing
Party with at least five (5) business days prior written notice of such
disclosure so that the nondisclosing Party shall have the opportunity if it so
desires to seek a protective order or other appropriate remedy and, in
connection with any such required disclosure, the disclosing Party shall use
reasonable efforts to obtain confidential treatment for such disclosure and/ or
to prevent or modify such disclosure as may be requested by the nondisclosing
Party (to the extent permitted by applicable law and regulation); and (iii) such
disclosure as contained in the joint press release which is attached to this
Agreement as Exhibit 20.11.
20.12 APPLICABLE LAW. The Agreement shall be governed by the laws of the State
of Illinois applicable to contracts made and to be performed entirely within
such jurisdiction and without giving effect to its choice or conflict of laws
rules or principles. If any action at law or in equity is necessary to enforce
or interpret the terms of this Agreement, the prevailing Party shall be entitled
to reasonable attorneys' fees, costs and necessary disbursements, in addition to
any other relief to which the Party may be entitled.
20.13 MILLENNIAL COMPLIANCE. Each Party hereby covenants and agrees that it will
use its reasonable efforts to ensure that there will be no failure or erroneous
receipt, storage, processing or production of data as a consequence of the
inability to receive, store, process or output date information regardless of
the date(s) utilized (including, without limitation, relating to the change of
century) in any and all computer software, computer hardware, automation systems
or other devices owned, licensed or otherwise used by such Party, its permitted
sublicensees or suppliers that would result in the inability of such Party to
either (i) comply with its obligations hereunder with respect to any
Confidential Information or any other data or information of other Party, or
(ii) successfully perform its obligations
62
hereunder. At either Party's request, the other Party agrees to disclose in
reasonable detail its millennial compliance plan and procedures, including
but not limited to the applicable testing results concerning its hardware and
software systems.
20.14 HEADINGS. The descriptive headings contained in this Agreement are
included for convenience of reference only and shall not affect the meaning or
interpretation of this Agreement.
20.15 INTERPRETATION.
(a) Wherever any provision of this Agreement uses the term "including"
(or "includes"), such term shall be deemed to mean "including without
limitation" and "including but not limited to" (or "includes without
limitation" and "includes but is not limited to") regardless of whether
the words "without limitation" or "but not limited to" actually follow
the term "including" (or "includes").
(b) Wherever any provision of this Agreement provides that a Party's
consent shall not be unreasonably withheld, such provision shall be
deemed to provide that such consent shall in addition not be
unreasonably delayed.
(c) The recitals set forth at the start of this Agreement, along with
the Exhibits to this Agreement, and the terms and conditions
incorporated in such recitals and Exhibits shall be deemed integral
parts of this Agreement and all references in this Agreement to this
Agreement shall encompass such recitals and Exhibits and the terms and
conditions incorporated in such recitals and Exhibits.
(d) In the event of any conflict between the terms and conditions of
this Agreement and any terms and conditions that may be set forth on
any order, invoice, verbal agreement or otherwise, the terms and
conditions of this Agreement shall govern.
(e) Unless otherwise explicitly stated, in the event of any conflict
between the terms of this Agreement and the terms and conditions of any
of the Exhibits hereto, the terms of this Agreement shall prevail.
(f) The Agreement shall be construed as if both Parties drafted it
jointly, and shall not be construed against either Party as principal
drafter.
(g) Unless otherwise provided, all references to Sections, Articles and
Exhibits this Agreement are to Sections, Articles and Exhibits of and
to this Agreement.
20.16 NO WAIVER OF RIGHTS. No failure or delay on the part of either Party in
the exercise of any power or right hereunder shall operate as a waiver thereof.
No single or partial exercise of any right or power hereunder shall operate as a
waiver of such right or of any other right or power. The waiver by either Party
of a breach of any provision of this Agreement shall not operate or be construed
as a waiver of any other or subsequent
63
breach hereunder.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their duly authorized officers as of the date first written above.
SUPERGEN, INC. XXXXXX LABORATORIES
By: /s/ Xx. Xxxxxx Xxxxxxxxx By: /s/ Xxxxxxx X. Xxxxxxxx
Name: Xx. Xxxxxx Xxxxxxxxx Name: Xxxxxxx X. Xxxxxxxx
Title: Pres.--CEO Title: President, HPD
By: /s/ Xxxxxxx X. Xxxxxxx
Name: Xxxxxxx X. Xxxxxxx
Title: President, Abbott International
64
EXHIBIT 1.8
EXPENSE DEFINITIONS
ITEMS TO BE SUBTRACTED FROM GROSS SALES - BASED ON ACTUAL COSTS
Bad Debt Expense Cost of write offs for bad debt
Management Fees GPO management fees and performance rebates
Cash Discounts Cash discounts taken for early payment
Medicare / Medicaid Rebates
=================================================
ABBOTT COST OF GOODS Transfer Price from SuperGen
Fixed Annual & Reconciled at Year-End
ABBOTT DISTRIBUTION COST Costs associated with warehousing, shipping,
billing, collections, etc.
Fixed % of Net Sales
SUPERGEN COST OF GOODS Actual Per Unit Standard Cost
Established annually
SUPERGEN THIRD PARTY ROYALTIES Royalties owed to Xxxxxxx based
upon contractual obligations
Fixed %
U.S. - SG&A
VARIABLE SALES FORCE EXPENSE: Base expense shall be set at $175,000 /
representative adjusted annually with an annual cost of living index using
the Consumer Price Index (CPI). Such expense may be reviewed and adjusted as
necessary by the U.S. Marketing Board. This expense includes the following
items:
- payroll
- fringe benefits, including FICA, FUI, SUI, Medical, Dental, Life,
ADD, EDP, Workers Compensation, OPEB (Healthcare for Retirees), Stock
Retirement/ 401(k), Annuity Retirement/ Investment Fees (Pension),
and Profit Sharing
- travel and entertainment expenses
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CONFIDENTIAL TREATMENT REQUESTED
- office supplies, car phone, postage and printing
- fleet car expense
- incentives
- all-star recognition awards and trips
- PC lease/ depreciation
ITEMS ESTABLISHED BY MARKETING BOARD. BUDGETED ANNUALLY AND RECONCILED QUARTERLY.
Product Samples Production and shipping cost of samples
Discretionary Funds Funds allocated to sales reps to use to promote products
Continuing Education Cost to provide development programs for representatives
Grants / Contributions Funds given to institutions or third parties to support product
research and xxxxxx general company goodwill, including
scientific/ marketing studies (other than any clinical studies
provided for in Articles 3 and 4 of this Agreement)
Reminder Items / Giveaways Tangible goods to be distributed by reps to customers, excludes
literature and reprints
Sales Aids Printed reference materials for reps. Usually a multi-page booklet
highlighting a product's key attributes
MD/Pharmacist Kits Brochures, pamphlets, and other information distributed to clinicians,
excluding reprints
Product Training Sales rep training cost including: materials and the meeting itself
Speaker Program Cost of staging speaker programs including: speaker cost, attendee
travel / meal costs
Convention - Exhibiting Cost of exhibiting at major conventions, including booth displays
Convention - Symposia Costs of satellite symposia / meetings conducted at a major convention
Faculty / Advisory Board Costs of meetings to cultivate / influence opinion leaders
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CONFIDENTIAL TREATMENT REQUESTED
Fellowships - Tutorials All costs to support doctors/third Party participation in fellowships,
tutorials, and preceptorships
Journal Ads Cost to run journal ads
Ad Agency Fees Services provided by an ad agency
Market Research/Statistics Costs of primary market research
Indigent Care Program Operations costs, mgmt and drug to support uninsured and low income for a
limited duration
Direct Mail Mailings (including postage, and database expenses) to clinicians
Reprints/Publication Planning Costs of reprinting journal articles and cost of planning / preparing
journal articles & abstracts
Direct to Consumer Advertising Costs to run electronic print, television or radio advertising intended
to reach the public
Web Site Costs to establish and maintain a web site with the appropriate
information regarding the product(s)
Telepoint Program Costs to associated with making clinical presentations via telepoint
Community Advocacy Cost of programs to establish and maintain relationships with relevant
community groups
Patient Education Cost of materials to educate patients on disease and treatment
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CONFIDENTIAL TREATMENT REQUESTED
Exhibit 1.23
Rubitecan (RFS-2000) Patent Portfolio
To the best of SuperGen's knowledge the patents and patent applications listed
below relate to Rubitecan as of November 4, 1999
*
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CONFIDENTIAL TREATMENT REQUESTED
Exhibit 1.39
Specifications
*
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CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT 3.1
Clinical Development
PANCREATIC CANCER: Three (3) randomized Phase III clinical trials:
X Study RFS2000-02: Rubitecan versus Gemcitabine as first line
therapy in chemonaive patients. Primary efficacy endpoint is survival
time; * (n = 964).
X Study RFS2000-06: Rubitecan as second line therapy versus 5FU following
unsuccessful treatment with Gemcitabine. Primary efficacy endpoint is
survival time; * (n = 400).
X Study RFS2000-09: Rubitecan as second line therapy versus most
appropriate chemotherapy in refractory patients. Primary efficacy
endpoint is survival time; * (n = 400).
MYELODYSPLASTIC SYNDROME - Phase II clinical trial (n = 125)
PILOT / ADDITIONAL PHASE II STUDIES:
1) Which will be agreed upon by the Clinical Development Committee.
2) *
3) The studies may include, but no be limited to:
*
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CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT 4.4 (e)
Development Plan
The development plan may include, but not be limited to, the detailed plans for
completion of the following:
- Strategy and plan for U.S. and EMEA Regulatory Approval for the Product
- 2000 R&D Budget
- *
- *
- *
- *
- CMC work to complete an acceptable file for the regulatory authorities.
- Finalize commercial manufacturer.
- Approved production and validation of qualification batches
representative of commercial manufacture of Rubitecan.
- Safety testing and stability studies generated from the qualification
batches representative of commercial manufacture.
- Final Product Specifications.
- Process validation.
- Rubitecan trial analysis and reporting, trial references *.
- Validation of all test methods for bulk and final product.
EXHIBIT 5.1
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CONFIDENTIAL TREATMENT REQUESTED
Sales Milestone Payments Example
For illustration purposes, one time sales milestone payments shall be paid
for the calendar year in which the worldwide aggregate annual Product Sales
achieve the designated milestone levels as shown within Section 5.1 (l - p) as
below:
*
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CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT 6.7
U.S. PROFIT SHARING EXAMPLE
*
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CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT 20.3
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"), 000 Xxxxxxx Xxxxxx, 00xx
Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, 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
candidate. No candidate shall be an employee, director, or
shareholder of either Party or any of their subsidiaries or
affiliates.
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CONFIDENTIAL TREATMENT REQUESTED
(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;
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CONFIDENTIAL TREATMENT REQUESTED
(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.
(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.
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CONFIDENTIAL TREATMENT REQUESTED
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 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.
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CONFIDENTIAL TREATMENT REQUESTED
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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CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT 20.11
JOINT PRESS RELEASE
ABBOTT AND SUPERGEN SIGN WORLDWIDE SALES AND DISTRIBUTION AGREEMENT FOR
CHEMOTHERAPY COMPOUND RUBITECAN
Abbott Park, Ill. And San Ramon, Calif., December xx, 1999 - Xxxxxx Laboratories
(NYSE: ABT) and SuperGen, Inc. (NASDAQ: SUPG & SUPGW & SUPGZ) today announced
the signing of a worldwide sales and marketing agreement for rubitecan.
Rubitecan is an oral chemotherapy compound in the camptothecin class and is
currently in Phase III studies for the treatment of pancreatic cancer.
Pancreatic cancer is associated with high patient mortality with over 75,000
deaths annually in the United States and Europe. It is the fourth leading cause
of death by cancer in the U.S. with an average survival rate of four to five
months following diagnosis at an advanced stage.
"Clinical data suggest that rubitecan has the potential to become a safe and
effective therapy for the treatment of pancreatic cancer, a disease for which
there are limited treatment options available," said Xxxxxx X. Xxxxxxxxx,
president and chief operating officer, Xxxxxx Laboratories. "Furthermore,
feedback from patients and clinicians worldwide has indicated a great interest
and need for an oral chemotherapy alternative."
"Completing this agreement with Abbott is certainly an historic milestone in our
continuing mission to build an independent pre-eminent cancer-fighting company,"
said Xxxxxx Xxxxxxxxx, Ph.D., chairman and chief executive officer of SuperGen.
"As one of the world's largest health care companies, Abbott possesses the
resources to ensure significant global market penetration of rubitecan upon
regulatory approval. This agreement allows SuperGen to maintain its considerable
U.S. presence and oncology franchise."
Under terms of the agreement, Abbott will make an initial equity investment in
SuperGen. Additional equity investments, cash milestones and option exercises
are contemplated over the life of the agreement. Abbott will have exclusive
distribution and promotion rights for rubitecan outside the U.S., and
co-promotion rights with SuperGen for rubitecan within the U.S. In addition,
Abbott will become the exclusive U.S. distributor for Nipent-Registered
Trademark-, SuperGen's currently marketed product for the treatment of hairy
cell leukemia. SuperGen retains U.S. marketing rights for Nipent-Registered
Trademark-.
Rubitecan is currently being studied at over 200 clinical sites for the
treatment of pancreatic cancer. SuperGen has previously reported that it expects
to initiate clinical trials of rubitecan for additional tumor types. Under the
agreement announced today, SuperGen will be responsible for funding clinical
development of a pancreatic claim.
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CONFIDENTIAL TREATMENT REQUESTED
Xxxxxx Laboratories is a global, diversified health care company devoted to the
discovery, development, manufacture and marketing of pharmaceutical, diagnostic,
nutritional and hospital products. The company employs 56,000 people and markets
its products in more than 130 countries. In 1998, the company's sales and net
earnings were $12.5 billion and $2.3 billion, respectively, with diluted
earnings per share of $1.51.
Xxxxxx'x news releases and other information are available on the company's Web
site at xxxx://xxx.xxxxxx.xxx.
Based in San Ramon, California, SuperGen is a pharmaceutical company dedicated
to the development and commercialization of products to treat life-threatening
diseases, particularly cancer.
THIS PRESS RELEASE CONTAINS "FORWARD-LOOKING" STATEMENTS WITHIN THE MEANING OF
SECTION 27A OF THE SECURITIES ACT OF 1933, AS AMENDED, AND SECTION 21E OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND ARE SUBJECT TO THE SAFE HARBORS
CREATED THEREBY. SUCH STATEMENTS, INCLUDING THOSE REGARDING THE "EXPECTED"
SAFETY PROFILE OF CAMPTOTHECIN COMPOUNDS, THE "PROMISING" NATURE AND "POTENTIAL"
OF CAMPTOTHECIN COMPOUNDS AND THE "SUGGESTION" OF REDUCED SIDE EFFECTS OF
CAMPTOTHECIN COMPOUNDS, INVOLVE CERTAIN RISKS AND UNCERTAINTIES INHERENT WITH
RESEARCH IN THE BIOTECHNOLOGY/PHARMACEUTICAL FIELD. ACTUAL RESULTS COULD DIFFER
MATERIALLY FROM THOSE PROJECTED IN THE "FORWARD-LOOKING" STATEMENTS AS A RESULT
OF FURTHER STUDY AND CLINICAL TRIALS. FURTHER INFORMATION ON POTENTIAL FACTORS
THAT COULD AFFECT SUPERGEN'S FINANCIAL RESULTS IS DISCUSSED IN SUPERGEN'S
REPORTS IN FILE WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (INCLUDING BUT
NOT LIMITED TO THE REPORT ON FORM 10K FOR THE FISCAL YEAR ENDED DECEMBER 31,
1998 AND ON FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 1999)
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