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 Two Annabel Lane, Suite
220, San Ramon, California 94583, and Abbott Laboratories, an Illinois
corporation ("Abbott"), with its principal offices at 100 Abbott Park Road,
Abbott Park, Illinois 60064. RECITALS:
WHEREAS, SuperGen is developing a pharmaceutical compound known as Rubitecan
(as defined below) for the treatment of pancreatic cancer and otherindications;
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 1
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,
[________________________] Abbott's 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, [________________________] 2
[__________________________] ;
(ii) with respect to the International Territory,[_____________________]; and
(iii) with respect to the Territories (A) [________________________]
and (B) [________________________].
Abbott's 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, asapplicable.
1.9 "Co-Promote" or "Co-Promotion" means the joint activities of the Parties to 3
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 4
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 limitationsubstitutions, 5
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 orregulation.
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 6
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 Abbott's 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 7
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. 8
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 speakerprograms.
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. 9
(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, Abbott's 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 10
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 Abbott's 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 11
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 12
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 Abbott for
Abbott's costs and expenses for such additional clinical studies. Abbott
shall keep SuperGen fully apprised with respect to its regulatory
activity in the International Territory. Specifically, Abbott shall (i)
promptly provide SuperGen with a copy of all filings, documents, and
material correspondence with the 13
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
Abbott's sole discretion, SuperGen's request to attend or participate in
any such meeting or to obtain a written right of reference to Abbott's
regulatory filings for the Product in the International Territory.
(b) Abbott shall use its reasonable efforts to obtain Regulatory
Approval in [________________________]. If Abbott fails to obtain
Regulatory Approval pursuant to this Section 3.3(b) within such time
frame, SuperGen shall have the right to take over Abbott's Regulatory
Approval efforts in these countries. In such event, Abbott shall
transfer to SuperGen all of the filing materials or information then in
Abbott's possession or control necessary for SuperGen to file for the
Regulatory Approval, or to continue the filing if Abbott 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 Abbott so agrees, Abbott 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 Abbott for its services thereunder.
(c) SuperGen shall provide to Abbott, 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 Abbott 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 Abbott's NDAs for the Product in the International Territory,
SuperGen shall take any and all actions necessary or reasonably
requested by Abbott in order to qualify Abbott as a secondary
manufacturing source for the Product in the Territories, solely for the
purpose of enabling Abbott to exercise its rights pursuant to Article
8.5 below without delay or impediment in the supply of 14
Product to Abbott 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, Abbott's obligation to market and
Promote the Product in a given country in the International Territory shall
not apply if Abbott 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 ABBOTT SUPPORT OF DEVELOPMENT EFFORTS. Abbott 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 Abbott 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 Abbott's reasonable satisfaction within sixty (60)
days of Abbott's notice of such deficiency, then Abbott shall thereafter[________________________].
3.9 ABBOTT 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 ABBOTT ACCESS TO DATA. Promptly after the Effective Date and throughout
the term of this Agreement, SuperGen shall provide to Abbott, within a
reasonable time, a shared database so that Abbott 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 Abbott requires for 16
regulatory filings in the Territories or which Abbott 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
Abbott's request, SuperGen shall provide Abbott with copies of such
documentation and data. If at any time during this Agreement SuperGen fails
to provide Abbott 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 Abbott within sixty
(60) days of Abbott's notice to SuperGen of such failure, then Abbott shall
have the option to thereafter [________________________].
ARTICLE 4: CO-PROMOTION AND PROMOTION
4.1 MARKETING EFFORT. Abbott and SuperGen shall use their reasonable efforts
to Co-Promote the Product in the U.S. Territory, and Abbott shall use its
reasonable efforts to Promote the Product in the International Territory, to
maximize Product Sales in the Territories. Abbott 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 thisAgreement.
4.2 U.S. MARKETING BOARD.
(a) Abbott 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
Abbott and SuperGen, and shall be chaired alternatively on an
annual basis by one (1) of the SuperGen representatives and by one
(1) of the Abbott 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) (Abbott
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 Abbott's 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 Abbott's 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 Abbott's 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 Abbott 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,
Abbott 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) Abbott 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 Abbott 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. Abbott 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 Abbott 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. Abbott 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 Abbott 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. Abbott 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.
Abbott 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
Abbott and SuperGen, and shall be chaired alternatively on an
annual basis by one (1) of the SuperGen representatives and by one
(1) of the Abbott 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 Abbott 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
Abbott; 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 Abbott 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 Abbott in the U.S. Territory and for
Promotion by Abbott 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 Abbott name and the
SuperGen name shall be decided by the U.S. Marketing Board in the U.S.
Territory and by Abbott for the International Territory, the Parties agree
that Abbott's 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 Abbott 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 Abbott's 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, Abbott 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 Abbott 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 implementati
