CONFIDENTIAL TREATMENT REQUESTED
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 [________________________] 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 [________________________] 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
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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 [________________________] 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
[________________________] 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 [________________________] during the given calendar
quarter or year; and (iii) with respect to the Territories,
[________________________] 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 [________________________] 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, [________________________]
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[__________________________] ;
(ii) with respect to the International Territory,[_____________________];
and
(iii) with respect to the Territories (A) [________________________]
and (B) [________________________].
Xxxxxx'x Net Sales shall be calculated separately for the U.S. Territory and
the International Territory.
1.5 "Abbott Operating Margin" means the [________________________] 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 [________________________] 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 [________________________] 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
[________________________].
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.
1.9 "Co-Promote" or "Co-Promotion" means the joint activities of the Parties
to
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Promote the Product under the SuperGen Trademark in the U.S. Territory.
1.10 "Competing Product" means any pharmaceutical product
[________________________].
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 [________________________]
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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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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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 [________________________] during the
given calendar quarter or year, [________________________] during the given
calendar quarter or year for (i) the [________________________]; (ii) any
[________________________]; and (iii) [________________________]; and (iv) any
[________________________]. The SuperGen
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Cost of Goods shall be calculated separately for the U.S. Territory and the
International Territory.
1.46 "SuperGen Distribution Margin" means the [________________________] 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 [________________________] 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
[________________________] 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 [________________________] 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
[________________________] 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
[________________________]. 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
[________________________].
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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1.55 "U.S. Product Profit" means the following: (i) with respect to the first
calendar quarter of each year, the total of the [________________________]
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
[________________________].
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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(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
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obligations hereunder for at least the next six months, SuperGen will so
notify 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
[________________________].
(b) [________________________].
(c) [________________________].
(d) [________________________].
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
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merger with or acquisition of SuperGen or of a controlling portion of
the voting securities or substantially all of assets of SuperGen,
SuperGen shall first so notify Abbott ("Acquisition Offer Notice") and
Abbott 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. Abbott 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 Abbott is not interested in making any offer to merge with
or acquire SuperGen. If Abbott 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 Abbott by SuperGen,
without first offering to enter into the definitive agreement or
agreements with Abbott.
(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 Abbott 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
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this Agreement. In performing its obligations under this Article 3.1(a),
SuperGen shall act in accordance with Article 4.4 below, and in so doing
SuperGen shall keep Abbott fully apprised with respect to its clinical
development activities and shall provide Abbott 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) Abbott 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. Abbott 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 Abbott 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 Abbott fully apprised
with respect to its regulatory and reimbursement activity in the United
States. Specifically, SuperGen shall (i) promptly provide Abbott 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 Abbott with advance
notice of meetings with the FDA and allow Abbott to attend or participate in
any such meeting, (iii) allow Abbott representatives opportunity to audit any
and all manufacturing facilities, processes, clinical sites, and
documentation for the Product; and (iv) provide Abbott with a written right
of reference to all U.S. regulatory filings.
3.3 INTERNATIONAL REGULATORY APPROVAL.
(a) SuperGen shall provide Abbott, 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 Abbott for obtaining Regulatory Approval from the EMEA for the
Product. Abbott 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 Abbott by SuperGen, or Abbott 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
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relevant governmental authorities (without an obligation to translate
into English, 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 [________________________]. 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
14
Product to Xxxxxx for Sale in the Territories.
(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. [________________________]
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.
15
3.8 GOOD CLINICAL PRACTICE AUDITS. The parties shall appoint a mutually
acceptable 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 [________________________] and
[________________________] (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
[________________________].
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 studies 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
[________________________].
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
16
regulatory filings in the Territories or which Xxxxxx may reasonably request,
including 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 [________________________].
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
-------------------------------------------------------------
[_____] individuals, [____] of which shall be representatives,
respectively, from
17
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. 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
[________________________].
(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 [____] 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.
18
(b) No later than [________________________] of each year during the
term of this Agreement, the 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 [________________________], 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 [________________________]. 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
[____] 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
[________________________] [________________________]
[________________________] [________________________]
(c) No later than [_______________] 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
19
forces; (ii) the level of Discretionary Funds per Sales Representative
shall be 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 [_____________] of the total
number of Sales Representatives required to Co-Promote the Product, and
SuperGen shall be permitted to maintain up to [_________________] 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 [________________________]
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
[_________________]). The cost of [________________________] 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
20
regulations with respect to the distribution of Sample Packs in the U.S.
Territory, 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.
[__________________________], 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 [___]
21
[__________________________].
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) [__________________________].
(b) The Clinical Development Committee shall consist of no more than
[_______] total members, [________] 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,
[__________________________]) and for clinical
22
development in the EU shall be made by the Clinical
Development 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 [__________________________].
(c) The cost of any clinical study to support Regulatory Approval 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
[__________________________]. 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
[__________________________] such Improvement for
23
Co-Promotion by SuperGen and Xxxxxx in the U.S. Territory and for
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
[__________________________] with respect to any such Improvement,
but that the [__________________________] to such Improvement(s).
Notwithstanding anything to the contrary in this Agreement, if
both Parties agree in writing to do so, then
[__________________________].
(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 [__________________________] 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
24
Development Committee shall prepare an Annual R&D Budget by
[__________] of 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 [_____________] 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
-------------- --------------------------
[_________________] [_______________]
[_________________] [_______________]
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)
[_________________]
25
[__________________________];
(c)
(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 [__________________________]:
(1) [__________________________] [__________________________];
(2) [__________________________] [__________________________];
(3) [__________________________] [__________________________];
(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 [____________________];
(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,
[__________________________]
26
[________________];
(h) 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 the U.S. Territory, provided
that, [__________________________];
(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, [__________________________];
27
(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, [__________________________];
(k) five million dollars ($5,000,000) in cash, upon Launch of the
Product in Japan, provided that, [__________________________];
(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
[__________________________];
(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
[__________________________];
(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
28
reaches [__________________________];
(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
[__________________________]; 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 [__________________________].
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
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 [__________]. If SuperGen
increases its share capital (other than by purchase of any equity in SuperGen
by Xxxxxx) during such [________] 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 [________] period SuperGen has not increased its share capital (other
than by purchase of any equity in SuperGen by Xxxxxx) during such [______]
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
29
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
[__________________________]) for the U.S. Territory; and
(c) the Xxxxxx Operating Margin (including the
[__________________________]) for the U.S. Territory.
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 3 for the U.S. Territory (including
the [__________________________]);
(c) the SuperGen Operating Margin for the U.S. Territory (including
the [__________________________]); 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
30
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 [__________________________] in the
U.S. Territory and shall be determined for SuperGen by subtracting the
[__________________________] 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.
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, [__________________________].
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
31
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 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 [______] years from
the First Commercial Sale or so long as the Product remains Patent Protected
in any country in the International Territory, [___________________],
("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
32
Parties shall [__________________________].
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 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
33
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.
(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. [__________________________] 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 [__________________________]
fiscal quarter in which Xxxxxx is purchasing such
34
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 [__________________________] 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 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 [______] months prior to the agreed projected Launch of
the 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 [_____________] commencing approximately [_________] 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) 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 [_____________] commencing approximately [________________]
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
35
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 [__________________________], 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 [__________________] 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, delivery
locations and delivery schedule and invoice information;
(b) All purchase orders for delivery during a calendar month that do
not exceed [_________________________] 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 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 [__] to Xxxxxx'x
designated destination. Title and risk of loss shall pass from SuperGen
to Xxxxxx [_____________________].
(d) SuperGen shall invoice Xxxxxx at the applicable U.S. or
International
36
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 [_______________] 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
[__________________________], Xxxxxx may at its sole option:
[__________________________].
(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 [__________________________].
(d) [__________________________].
37
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
[__________________________].
(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 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
38
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 [__________________________].
(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 quantity of any shipment of Finished Product no later than
[_______________] 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 [__________________________] 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. [__________________________]
39
[__________________________]. 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.
[__________________________], 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 and shall co-own any such Xxxxxx
filed patents. 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 [_____________________]
or other 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 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
[__________________________] 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 [__________________________]
40
[__________________________];
(d) provide Xxxxxx with a copy of any reports, correspondence or
notice within three (3) business days from the submission to or receipt
from [________________________] under any SuperGen License Agreement.
(e) notify Xxxxxx no later than [________] 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
[__________________________]; 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 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 [__________________________], 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 [__________________________].
9.5 ALLOCATION OF DAMAGE OR SETTLEMENT AMOUNTS. Any damage award or
settlement
41
obtained by a Party enforcing a Licensed Patent pursuant to Article 9.3 or
9.4 above shall [__________________________].
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.
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.
42
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 [__________________________].
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:
43
(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
(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
44
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;
(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
45
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;
(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
46
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 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:
47
(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
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.
48
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 [_________] 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 [__________________________].
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, 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 [_____________] 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
49
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 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
50
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:
[__________________________].
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 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.
51
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: [__________________________].
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 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 [__________________________].
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.
52
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 [__________________________] 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 [__________________________].
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.
[__________________________] .
16.4 TERMINATION FOR NON-APPROVAL OR LACK OF COMMERCIAL VIABILITY.
53
(a) Commencing [_______________________], 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
[__________________________].
(b) Commencing [__________________________], 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
[__________________________].
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 jurisdiction now or hereinafter in effect (an
"Insolvency Event"). However, in the event that SuperGen
experiences an Insolvency Event and [__________________________].
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
[__________________________].
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
[__________________________], either Party may terminate this
Agreement upon thirty (30) days' written notice.
54
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 [________] 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
[___________].
16.8 EFFECT OF TERMINATION.
(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
55
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), [_________________________].
Upon expiration or termination of this Agreement under this Article 16 (on a
Territory-by-Territory basis or as a whole), [_______________________].
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.
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
56
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;
(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 [_____________] in
writing.
16.14 NON-FULFILLMENT OF CONDITIONS. The non-fulfillment of any of the
conditions described in Article 16.14 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
57
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, 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 Xxxxxx 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 Xxxxxx 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 Xxxxxx in the commercial production of
the Compound or Product.
58
(c) During the period prior to the [__________________________], (i)
SuperGen shall provide up to [__________________________] and (ii)
subsequent to such [__________________________]. Technical
assistance furnished pursuant to this Article 17.2(b) shall
continue only until [__________________________].
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:
[__________________________]. Beginning on the date of initial Launch and for
a period of five (5) years after termination of this Agreement, SuperGen shall
maintain product liability insurance with an A.M. Best Company rating of at
least A+, with minimum annual amounts per occurrence and in the aggregate which
are adequate to Xxxxxx'x reasonable satisfaction. Upon Xxxxxx'x request,
SuperGen shall deliver to Xxxxxx 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 Xxxxxx. Xxxxxx 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
59
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 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
60
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
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 [__________________________]. No
61
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 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 [__________________________]. 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
62
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
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
63
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 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
[__________________________]
65
[__________________________]
66
[__________________________]
67
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
[__________________________]
68
[__________________________]
69
[__________________________]
70
[__________________________]
71
EXHIBIT 1.44
SPECIFICATIONS
[__________________________]
-----------------------------------------------------------------------------
[__________________]
-----------------------------------------------------------------------------
[__________________]
-----------------------------------------------------------------------------
-----------------------------------------------------------------------------
[__________________]
-----------------------------------------------------------------------------
[__________________]
-----------------------------------------------------------------------------
[__________________]
-----------------------------------------------------------------------------
[__________________]
-----------------------------------------------------------------------------
[__________________]
-----------------------------------------------------------------------------
[__________________]
72
EXHIBIT 3.1
Clinical Development
[_________________]
73
EXHIBIT 4.4 (e)
Development Plan
[___________________]
74
EXHIBIT 5.1
Sales Milestone Payments Example
[__________________]
--------------------------- --------- ---------- --------- --------- ---------- --------- ---------
[__________________]
--------------------------- --------- ---------- --------- --------- ---------- --------- ---------
[__________________]
--------------------------- --------- ---------- --------- --------- ---------- --------- ---------
75
EXHIBIT 6.7
U.S. PROFIT SHARING EXAMPLE
[__________________]
[__________________________]
76
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.
77
(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;
78
(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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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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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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EXHIBIT 20.11
JOINT PRESS RELEASE
FOR IMMEDIATE RELEASE
XXXXXX LABORATORIES
MEDIA:
Xxxx Xxxx (000) 000-0000
FINANCIAL COMMUNITY:
Xxxx Xxxxxx (000) 000-0000
ABBOTT AND SUPERGEN SIGN WORLDWIDE SALES AND DISTRIBUTION AGREEMENT FOR
CHEMOTHERAPY COMPOUND RUBITECAN ABBOTT PARK, Ill., and SAN RAMON, Calif.,
December 22, 1999 -- Xxxxxx Laboratories (NYSE:ABT) and SuperGen, Inc. (NASDAQ:
SUPG & SUPGW & SUPGZ) today announced the signing of a worldwide sales and
marketing agreement for the cancer drug 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 causing more than
75,000 deaths annually in the United States and Europe. It is the fourth leading
cause of death by cancer in the United States, with an average survival rate of
four to five months following diagnosis at an advanced stage. "Rubitecan is a
potentially valuable addition to our Oncology franchise. 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 Xxxxxxx X. Xxxxxxxx, senior vice president, hospital
products at Xxxxxx Laboratories. "Furthermore, feedback from patients and
clinicians worldwide has indicated a great need for an oral chemotherapy
alternative."
"Completing this agreement with Abbott is certainly a historic milestone in
our continuing mission to build an independent, preeminent 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
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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 United States and co-promotion rights with SuperGen for
rubitecan within the United States. In addition, Abbott will become the
exclusive U.S. distributor for Nipent-R-, SuperGen's currently marketed
product for the treatment of hairy cell leukemia. SuperGen retains U.S.
marketing rights for Nipent. Rubitecan is currently being studied at more
than 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 cancer
claim for the drug.
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 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.
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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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