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LICENSE AGREEMENT
This LICENSE AGREEMENT (the "Agreement"), effective as of September 3,
1997 (the "Effective Date"), is made by and between SuperGen, Inc., a
California corporation, with a principal place of business at Xxx Xxxxxxx
Xxxx, Xxxxx 000, Xxx Xxxxx, Xxxxxxxxxx 00000 ("SuperGen," as further defined
below), and The Xxxxxxx Foundation for Cancer Research, a not-for-profit
foundation, with a principal place of business at St. Xxxxxx Medical Place,
0000 Xxxxxxx, Xxxxx 0000, Xxxxxxx, Xxxxx 00000 ("Xxxxxxx," as further defined
below), and its affiliate, SuperCampto Corporation, a Texas corporation, with
a principal place of business at St. Xxxxxx Medical Place, 0000 Xxxxxxx,
Xxxxx 0000, Xxxxxxx, Xxxxx 00000.
RECITALS
X. Xxxxxxx is the owner of certain intellectual property rights
relating to ** (the "Compound," as further defined below).
B. SuperGen desires to obtain, and Xxxxxxx desires to grant SuperGen
certain rights under such intelligent property to develop and commercialize
products on the terms and conditions herein.
NOW, THEREFORE, Xxxxxxx and SuperGen agree as follows:
1. DEFINITIONS
1.1 "AFFILIATE" means any corporation or other entity which is directly
or indirectly controlling, controlled by or under the common control with
SuperGen. For the purpose of this Agreement, "control" shall mean the direct
or indirect ownership of at least fifty percent (50%) of the outstanding
shares or other voting rights of the subject entity to elect directors, or if
not meeting the preceding, any entity owned or controlled by or owning or
controlling at the maximum control or ownership right permitted in the
country where such entity exists.
1.2 "AVERAGE PRICE" shall mean the average of the closing prices of
SuperGen's registered Common Stock at the close of business for the thirty
(30) trading days preceding the applicable date of issuance as quoted on the
Nasdaq National Market, adjusted for any splits, conversions, or
distributions of shares.
1.3 "COMMON STOCK" shall mean common stock, par value $.001, of
SuperGen.
1.4 "COMPOUND" shall mean, **, including pharmacologically acceptable
salts thereof and in any pharmaceutically acceptable dosage form.
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1.5 "CONFIDENTIAL INFORMATION" shall mean (i) any proprietary or
confidential information or material in tangible form disclosed hereunder
that is indicated as "Confidential" at the time or promptly after the time it
is delivered to the receiving party, or (ii) proprietary or confidential
information disclosed orally hereunder which is identified as confidential or
proprietary when disclosed and such disclosure of confidential information is
confirmed in writing within thirty (30) days by the disclosing party.
1.6 "DOMINATING PATENT" shall mean a patent that is owned by an
unaffiliated third party covering Licensed Products made or sold by SuperGen
or its Sublicensees under circumstances such that SuperGen or the Sublicensee
has no commercially reasonable alternative to obtaining a royalty-bearing
license under such patent in order to commercialize Licensed Products under
this Agreement.
1.7 "FIELD" shall mean all human medicinal uses.
1.8 "JOINTLY OWNED PATENTS" shall mean any patent (including, without
limitation, any inventor's certificate) and patent application in any country
that claims a Joint Invention (as defined in Section 2.4), any substitution,
division, continuation, continuation-in-part application thereof, and any
reissue, reexamination, or extension or confirmation, registration,
revalidation, or addition thereof.
1.9 "KNOW-HOW" shall mean all Confidential Information and materials,
including without limitation, instructions, processes, formulas, biological,
chemical, pharmacological, toxicological, pharmaceutical, physical and
analytical, clinical, safety, manufacturing and quality control data and
information owned in whole or in part, or controlled by license, assignment,
or otherwise by Xxxxxxx as of the Effective Date or thereafter, useful for
the development, manufacture, use, or sale of the Compound in the Field.
1.10 "LICENSED PRODUCT" will mean any product containing the Compound
whose manufacture, use, formulation or sale, including the regulatory
approval to market thereof, which, but for an ownership interest in a
Jointly Owned Patent and/or the rights granted herein, would constitute the
misappropriation of a material part of the Know-How or infringe a Valid Claim
in the country such product is made or sold. A material part of the Know-How
in any country shall include any of the Know-How whose use could accelerate
the regulatory approval in such country.
1.11 "LICENSED TECHNOLOGY" shall mean the Know-How and Patent Rights.
1.12 "NDA" means a New Drug Application, as defined in the U.S. Food,
Drug and Cosmetic Act and the regulations promulgated thereunder.
1.13 "NET SALES" means the gross revenues received from sales of
Licensed Products to unaffiliated parties, made by SuperGen or its Affiliates
and Sublicensees, less (i) normal and customary rebates, and cash and trade
discounts, actually taken, (ii) sales, use and/or other excise taxes or
duties actually paid, (iii) the cost of any packages and packing; (iv)
shipping insurance costs and outbound transportation charges prepaid or
allowed, (v) import and/or export duties actually paid, and (vi) amounts
allowed or credited due to returns. **
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**
1.14 "PATENT RIGHTS" shall mean (i) those U.S. patent applications and
patents listed in attached Exhibit A, and all foreign counterparts thereof;
(ii) any patent (including, without limitation, any inventor's certificate)
and patent application in any country that is at any time owned, in whole or
in part, or controlled by license, assignment, or otherwise by Xxxxxxx,
including the Jointly Owned Patents, which claim one or more inventions that
are useful for the development, manufacture, use, or sale of the Compound,
including, without limitation, any patent or patent application claiming a
composition of matter containing the Compound; a process for making the
Compound; or a method of using the Compound; (iii) any substitution,
division, continuation, continuation-in-part application of (i) or (ii)
above; and (iv) any patent (including, without limitation, any inventor's
certificate) issuing in any country on any of the preceding, including,
without limitation, any reissue, reexamination, or extension or confirmation,
registration, revalidation, or addition.
1.15 "XXXXXXX" means The Xxxxxxx Foundation for Cancer Research and
SuperCampto Corporation.
1.16 "SUPERGEN" means SuperGen, Inc. and its Affiliates.
1.17 "SUBLICENSEE" means a third party to whom SuperGen has granted a
license or sublicense under the Licensed Technology to make, have made,
import, use, sell, offer for sale, or otherwise exploit a Licensed Product.
As used in this Agreement, "Sublicensee" shall also include a third party to
whom SuperGen has granted the right to distribute a Licensed Product,
provided that such third party has the responsibility in whole or in part for
marketing and/or promotion of the Licensed Product within the territory for
which such distribution rights are granted.
1.18 "TERRITORY" means worldwide, except that seven (7) years after
the date of regulatory approval to market a licensed product in the United
States, Territory shall exclude any country within the Excluded Countries (as
defined below), in which SuperGen has not commenced efforts to seek
regulatory approval in market in such country and Xxxxxxx has appointed a
Successor Licensee as provided under Section 4.10. The "Excluded Countries"
are: Mexico, Canada, Spain, Japan, the United Kingdom, France, Italy and
Germany.
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1.19 "VALID CLAIM" means a claim of an issued and unexpired patent
included within the Patent Rights except for a claim that has been held
unenforceable or invalid by a court or other governmental agency of competent
jurisdiction, or a claim which has not been disclaimed or admitted to be
invalid or unenforceable through reissue or otherwise.
1.20 "YEAR" means a twelve-month period beginning on either the first
day of the calendar quarter in which SuperGen first sells a Licensed Product
to the public or any yearly anniversary of such first day.
2. JOINT DEVELOPMENT
2.1 DEVELOPMENT PROGRAM.
(a) GENERALLY. SuperGen will use commercially reasonable efforts
to develop the Licensed Products and obtain regulatory approval for the
Licensed Products ("Sponsored Research") in the Territory. Xxxxxxx
acknowledges and agrees that SuperGen may, at its sole discretion, enter into
agreements with third parties with respect to the development of the Licensed
Products.
(b) COSTS. SuperGen shall bear its own costs incurred in
connection with the performance of the Sponsored Research. SuperGen shall
pay Xxxxxxx the amounts set forth in Section 4.2 but otherwise Xxxxxxx shall
bear its own costs incurred in connection with the performance of the
research activities that SuperGen requests and Xxxxxxx agrees to undertake in
connection with efforts to develop the Licensed Products.
(c) ACKNOWLEDGMENT. The parties acknowledge that SuperGen's
efforts may not result in the regulatory approval of Compound and hereby
specifically disclaim any warranty that such regulatory approval will be
achieved.
(d) TERM. The Sponsored Research shall commence on the Effective
Date and have a term established by the Committee (as defined in Section 2.2).
2.2 DEVELOPMENT COMMITTEE.
(a) COMPOSITION AND RESPONSIBILITY. The parties' performance of
the development responsibilities hereunder shall be coordinated by a
committee ("Committee") consisting of an equal number of employees of each of
SuperGen and Xxxxxxx; provided that SuperGen shall have the deciding vote in
the event of any disagreement. Each party may replace its Committee
representatives at any time, with written notice to the other party. Each
representative of Xxxxxxx and SuperGen, acting in good faith so as to advance
the best interests of both parties, shall have one vote on the Committee,
which vote may be cast by proxy. The responsibilities of the Committee shall
include monitoring and overseeing development efforts and ensuring open and
frequent exchange between the parties.
(b) MEETINGS. During the term of this Agreement, the Committee
shall meet on a periodic basis at such locations as each party shall select
on an alternating basis with the other. With
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the consent of the parties, representatives of third parties may attend
Committee meetings as non-voting observers. Each party will be responsible
for paying its own expenses in connection with the meetings of the Committee.
2.3 RECORDS; EXCHANGE OF INFORMATION.
(a) RECORDS. Xxxxxxx shall maintain scientific records as will
properly reflect all work done and results achieved in the performance of any
development activities (including all data in the form required under any
applicable governmental regulations.) During the term of this Agreement, and
for three (3) years thereafter, Xxxxxxx shall provide SuperGen with access
to such records, upon request, during ordinary business hours, and the right
to make copies thereof at no expense to Xxxxxxx.
(b) REPORTS. The Committee shall periodically while development
activities are ongoing, request and the parties shall have the obligation to
prepare and provide to the Committee written reports summarizing the progress
of the work performed. Each party shall provide a final written report
summarizing its development activities hereunder and the results thereof
within sixty (60) days after the conclusion of all development efforts.
2.4 INTELLECTUAL PROPERTY OWNERSHIP; LICENSE. Title to all Inventions
(as defined below) and other intellectual property made solely by employees
or consultants of Xxxxxxx in connection with such activities shall be owned
by Xxxxxxx ("Xxxxxxx IP"). Title to all Inventions and other intellectual
property made solely by employees or consultants of SuperGen in connection
with such activities shall be owned by SuperGen. Title to all Inventions and
other intellectual property made jointly by employees or consultants of
Xxxxxxx and SuperGen in connection with such activities shall be jointly
owned by Xxxxxxx and SuperGen (each a "Joint Invention"). As used above,
"Invention" means an invention or discovery relating to the Compound first
conceived or reduced to practice pursuant to the parties' performance of the
activities undertaken pursuant to this Agreement. Inventorship of Inventions
shall be determined in accordance with the patent and other intellectual
property laws of the United States. Ownership of inventions shall be
determined in accordance with the ownership that would pertain in the United
States based on inventorship of the patent as determined in accordance with
U.S. patent laws.
3. GRANT
3.1 GRANT. Xxxxxxx hereby grants to SuperGen an exclusive,
royalty-bearing license under the Licensed Technology, with the right to
grant and authorize sublicenses, to make, have made, import, have imported,
use, sell, offer for sale and otherwise distribute and exploit the Licensed
Products in the Field in the Territory.
3.2 RETAINED RIGHTS. Xxxxxxx shall retain the non-transferable right to
practice the Licensed Technology solely for its non-commercial research
purposes. Xxxxxxx may not disclose the Know How to any third party, except
to third parties that Xxxxxxx has granted a license to distribute Licensed
Products outside of the Territory and only if such third parties agree in
writing in advance to maintain the confidentiality of such Know How.
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3.3 DELIVERY OF KNOW-HOW. At SuperGen's request at any time during the
term of this Agreement, Xxxxxxx shall promptly disclose and deliver to
SuperGen the Know-How.
3.4 JOINTLY OWNED PATENTS. Pursuant to Section 3.1, Xxxxxxx may not
grant any third party a license under a Jointly Owned Patent to make, have
made, import, use, sell or otherwise distribute any product containing the
Compound in the Field in the Territory. Subject to the remaining provisions
of this Agreement, each party may license and otherwise exploit Jointly Owned
Patents without accounting to the other party.
3.5 RIGHT OF FIRST REFUSAL. In the event Xxxxxxx elects to license any
product (other than Licensed Products) in the Field for any uses that include
pancreatic cancer or antineoplastic use, SuperGen shall have the right of
first refusal with respect to obtaining from Xxxxxxx a license under patents
owned or controlled by Xxxxxxx to market such product in the Field for such
use or uses, to the extent provided in this paragraph. In particular,
Xxxxxxx shall notify SuperGen with respect to each such offer, shall provide
SuperGen with a description of any such offer, and shall present SuperGen
with a proposal for a license from Xxxxxxx to SuperGen with respect to each
such offer. If SuperGen exercises rights under this paragraph within thirty
(30) days of notification, both parties shall negotiate in good faith with
respect to the offer for not more than thirty (30) days. If the parties have
not come to a definitive agreement during such time or if SuperGen does not
exercise its rights within thirty (30) days of notification. Xxxxxxx may
thereafter accept other offers on terms the same as or not materially
different from the offer presented to SuperGen. **
4. CONSIDERATION
4.1 STOCK PAYMENT. In partial consideration for the license granted
herein, on the date hereof, SuperGen shall pay two million and five hundred
thousand dollars ($2,500,000) in shares of unregistered restricted Common
Stock, valued at a per share purchase price equal to the Average Price (the
"License Shares").
4.2 MONTHLY PAYMENTS. During the term of this Agreement until the
Final Month (as defined below) subject to the provisions of Section 14.4,
SuperGen shall pay Xxxxxxx ** per calendar month, according to the following
schedule: (i) **, corresponding to the first consecutive six calendar months
starting with the month of September ("Initial Month"), within seven (7) days
after the Effective Date; and (ii) ** on or before the beginning of each
calendar month following the initial six calendar months but preceding the
calendar month ("Final Month") immediately following the earlier of the
calendar month in which the FDA provides SuperGen with notice ("FDA Notice")
that it has first
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approved the Compound for marketing or the forty eighth (48th) consecutive
calendar month following the Initial Month.
4.3 MILESTONE PAYMENTS. Within sixty (60) days after the achievement
of the following milestones, SuperGen shall pay Xxxxxxx as follows: (i) **
upon notification by the FDA of the acceptance of the first NDA filed for the
Compound, and (ii) ** upon SuperGen's receipt of the FDA Notice (as defined
in Section 4.2). Each of such payments shall be made in shares of
unregistered restricted Common Stock at a per share purchase price equal to
the Average Price (collectively, the "Milestone Shares" and together with the
Licenses Shares, the "Shares").
4.4 ROYALTIES. In consideration of the license granted herein, SuperGen
shall pay to Xxxxxxx or Xxxxxxx'x designee royalties on Net Sales as set
forth below:
**
4.5 ** OF MARKETING RIGHTS PAYMENTS. In addition to the royalties
subject to Section 4.4 above, SuperGen shall pay to Xxxxxxx ** of
consideration received by SuperGen from sublicensees, joint venture partners,
other marketing partners or like affiliated persons, in consideration for
making marketing rights to Licensed Products available, whether by license or
otherwise; provided, however, if SuperGen provides to any such person
consideration in addition to such
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marketing rights as a part of an overall transaction in which such marketing
rights are made available, then SuperGen shall determine the consideration
for making such marketing rights available by deducting, from the total value
of the consideration that it receives under the overall transaction, the fair
market value attributable to any additional consideration provided by
SuperGen, including but not limited to: (1) services to be performed by
SuperGen (including research and development), (2) notes in exchange for debt
financing, (3) the license of any technology or product other than a Licensed
Product, (4) reimbursement for patent or other expenses, and (5) any equity
interest in SuperGen. Consideration received by SuperGen in granting
marketing rights as set forth under this Section 4.5 shall not be treated as
"Net Sales" and shall not be subject to payment of royalties as provided in
Section 4.4. Consideration that is attributable to Net Sales on which
royalties are paid under Section 4.4 shall not be included in the
determination of consideration received by SuperGen in granting marketing
rights under this Section 4.5. Payments made to Xxxxxxx under this Section
4.5 shall be accompanied by a description of the basis on which the payment
was calculated, including the basis on which any allocation was made as
between Net Sales subject to royalty and consideration received by SuperGen
in granting marketing rights. Except as otherwise provided in this Section
4.5, the provisions of Article VI relating to the payment of royalties shall
apply MUTATIS MUTANDIS to the payments made under this Section 4.5. Any
request for an audit with respect to a payment made by SuperGen based on
marketing rights that it has granted must be made within one year from the
date on which the payment for which the audit is requested was received by
Xxxxxxx. If the audit indicates an underpayment has been made and SuperGen
disputes the correctness of the audit, the parties shall attempt an amicable
resolution of the dispute. If none is reached, either party may request
"baseball" arbitration under Article XII to select from between the last
offer made to resolve the dispute by each of the parties.
4.6 MINIMUM ROYALTY. In the event that the sum of the payments due
under Sections 4.4 and 4.5 ("Actual Yearly Royalty") for any Year fails to
exceed ** ("Minimum Royalty"), SuperGen shall pay to Xxxxxxx the excess of
the Minimum Royalty over the Actual Yearly Royalty. Such payment shall be
made along with the payment due for the last calendar quarter of any such
Year. In the event of any termination of this Agreement by SuperGen pursuant
to Section 14.4, the Minimum Royalty due for the Year in which such
termination occurs shall be equal to ** multiplied by a fraction, the
numerator of which is the number of days that have elapsed between the first
day of such Year and the effective date of termination, the denominator of
which is the total number of days in such Year.
4.7 COMBINATION PRODUCTS. In the event that a Licensed Product is sold
in combination as a single product with an active ingredient other than the
Compound, Net Sales from such sales for purposes of calculating the amounts
due under Sections 4.4 and 4.5 above shall be as allocated between such
Compound and such other active ingredient, based upon relative costs of
active ingredients therein.
4.8 ONE ROYALTY. No more than one royalty payment shall be due with
respect to a sale of a particular Licensed Product. No multiple royalties
shall be payable because any Licensed Product, or its manufacture, sale or
use is covered by more than one Valid Claim. No royalty shall be payable
under Section 4.4 above with respect to sales of Licensed Products among
SuperGen and its Sublicensees or Affiliates, nor shall a royalty be payable
under this Article 4 with respect to Licensed Products
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distributed free of charge for use in research and/or development, in
clinical trials or as promotional samples.
4.9 ROYALTY TERM. Royalties due under Article 4 shall be payable on a
country-by-country and Licensed Product-by-Licensed Product basis until the
expiration of the last-to-expire issued Valid Claim covering such Licensed
Product in such country or **, whichever is later.
4.10 COMMERCIAL IMPRACTICABILITY; SUCCESSOR LICENSEE. In the event
that SuperGen has not commenced efforts to seek regulatory approval in an
Excluded Country within seven (7) years after the date of regulatory approval
to market a Licensed Product in the United States, Xxxxxxx shall have the
right, subject to the provisions of this Section 4.10, to appoint itself or a
third party as a licensee ("Successor Licensee") and grant licenses in such
Excluded Country under the Licensed Technology. No such license may be
granted, except following receipt of written notice to SuperGen of the
appointment of a Successor Licensee. Notwithstanding Section 4.4, in the
event that SuperGen reasonably believes that the royalty payments set forth
in Section 4.4 above would make the sale of Licensed Products commercially
impracticable in any country, it may notify Xxxxxxx in writing, and in such
event the parties shall negotiate in good faith a reduction in such payments.
If such written notice states that the sale of Licensed Products is
commercially impracticable in one of the Excluded Countries (as defined in
Section 1.18), after 60 days from the date SuperGen sends Xxxxxxx such
written notice, Xxxxxxx shall have the right to identify a Successor Licensee
willing to pay royalties as set forth in Section 4.4, if SuperGen is unable
or unwilling to market under royalties as negotiated herein. With respect to
any Successor Licensee, any license granted by Xxxxxxx to such Successor
Licensee shall be subject to the provisions of Section 3.4 and,
notwithstanding Article 8 or anything to the contrary herein, in no event may
Xxxxxxx disclose any of SuperGen's Confidential Information (as defined in
Article 8) to such Successor Licensee. No license under any of SuperGen's
intellectual property is granted by SuperGen to such Successor Licensee by
implication, estoppel or otherwise.
4.11 THIRD PARTY ROYALTY OFFSET. In the event that SuperGen enters
into a license agreement with any third party with respect to a Dominating
Patent or to avoid or settle a claim of infringement or misappropriation by a
third party of any intellectual property right relating to SuperGen's
practice of the Patent Rights, SuperGen may offset any payments made in
accordance with such license agreements against any royalties owed Xxxxxxx
pursuant to Section 4.4 herein, up to a ** of the amounts due under such
license agreement, but in no event may the reduction taken with respect to
sales of Licensed Product in any country exceed more than ** of the royalties
due Xxxxxxx or its designee on annual Net Sales in such country, as
calculated on the basis of the average royalty rate applicable to aggregate
Net Sales less any reduction taken as described in Section 4.4.
5. PAYMENTS
5.1 PAYMENTS. SuperGen agrees to pay all royalties due to Xxxxxxx
within sixty (60) days after the last day of the calendar quarter in which
they accrue.
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5.2 CURRENCY; FOREIGN PAYMENTS. All payments due hereunder shall be
paid in United States dollars. If any currency conversion shall be required
in connection with the payment of any royalties hereunder, such conversion
shall be made by using the exchange rate for the purchase of U.S. dollars
reported by the Bank of America on the last business day of the calendar
quarter to which such royalty payments relate.
5.3 TAXES. Any income or other tax that must be withheld on behalf of
Xxxxxxx with respect to the royalties owed pursuant to this Agreement shall
be deducted by SuperGen from the royalties prior to remittance. SuperGen
shall on a country-by-country basis use diligent efforts to reduce the amount
of tax withheld and SuperGen shall furnish to Xxxxxxx evidence of any such
taxes withheld.
6. REPORTS AND RECORDS
6.1 ROYALTY REPORTS. SuperGen shall deliver to Xxxxxxx within thirty
(30) days after the end of each calendar quarter in which Licensed Products
are sold a report setting forth in reasonable detail the calculation of the
royalties payable to Xxxxxxx for such calendar quarter, including the
Licensed Products sold in each country, the Net Sales thereof. Such reports
shall be Confidential Information of SuperGen subject to Article 8 herein,
except to the extent of the amounts due Xxxxxxx as reported therein.
6.2 INSPECTION OF BOOKS AND RECORDS. SuperGen shall maintain accurate
books and records which enable the calculation of royalties payable hereunder
to be verified. SuperGen shall retain the books and records for each
quarterly period for seven (7) years after the submission of the
corresponding report under Section 6.1 hereof. Upon thirty (30) days prior
notice to SuperGen, independent accountants selected by Xxxxxxx, reasonably
acceptable to SuperGen, after entering into a confidentiality agreement with
SuperGen, may have access to SuperGen's books and records to conduct a review
or audit once per calendar year, for the sole purpose of verifying the
accuracy of SuperGen's payments and compliance with this Agreement. The
accounting firm shall report to Xxxxxxx only whether there has been a royalty
underpayment and, if so, the amount thereof. Such access shall be permitted
during SuperGen's normal business hours during the term of this Agreement and
for three (3) years after the expiration or termination of this Agreement.
Any such inspection or audit shall be at Xxxxxxx'x expense, however, in the
event an inspection reveals underpayment of ten percent (10%) or more in any
audit period, SuperGen shall pay the costs of the inspection. In any event
SuperGen shall promptly pay to Xxxxxxx any underpayment with interest from
the date such amount(s) were due, at the prime rate reported by the Chase
Manhattan Bank, New York, New York.
7. DILIGENCE
SuperGen agrees to use commercially reasonable efforts to develop and
commercialize the Licensed Products at such times and in those countries in
the Territory in which SuperGen determines, in its sole discretion but acting
in good faith, such activities to be commercially practicable. SuperGen (or
its designees), shall be responsible for and control the development of
Licensed Products, including, without limitation, toxicology, preclinical
development, conduct of regulatory affairs and preparation
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and submission of regulatory filings, manufacturing and supply for
preclinical, clinical, and commercial purposes, and all other activities
relating to the clinical development and commercialization of each Licensed
Product. For purposes of this Agreement, "commercially reasonable efforts"
shall mean efforts at least equal to those exerted in connection with an
internally developed SuperGen product at a like stage of development, with an
advantage over its potential competitors that is similar to the advantage
afforded by the Licensed Technology, and with similar potential commercial
value. Prior to the time of NDA approval by the FDA of a Licensed Product,
SuperGen shall provide to Xxxxxxx a detailed summary of its market plans for
such Licensed Product and the parties shall, at Xxxxxxx'x option, meet and
review such plans. Such plans shall be updated and reviewed annually.
8. CONFIDENTIALITY
8.1 CONFIDENTIAL INFORMATION. Except as expressly provided herein, the
parties agree that, for the term of this Agreement and for five (5) years
thereafter, the receiving party shall keep completely confidential and shall
not publish or otherwise disclose and shall not use for any purpose except
for the purposes contemplated by this Agreement any Confidential Information
furnished to it by the disclosing party hereto pursuant to this Agreement,
except that to the extent that it can be established by the receiving party
by competent proof that such Confidential Information:
(i) was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure;
(ii) was generally available to the public or otherwise part of
the public domain at the time of its disclosure to the receiving party;
(iii) became generally available to the public or otherwise part of
the public domain after its disclosure and other than through any act or
omission of the receiving party in breach of this Agreement;
(iv) was independently developed by the receiving party as
demonstrated by documented evidence prepared contemporaneously with such
independent development; or
(v) was subsequently lawfully disclosed to the receiving party by
a person other than a party hereto.
8.2 PERMITTED USE AND DISCLOSURES. SuperGen may disclose Xxxxxxx'x
Confidential Information to third parties that assist SuperGen with respect
to the development of Licensed Products provided that such third parties
agree in writing to provisions no less protective of Xxxxxxx than the
provisions of this Article 8. Further, each party hereto may use or disclose
information disclosed to it by the other party to the extent such use or
disclosure is reasonably necessary in filing or prosecuting patent
applications, prosecuting or defending litigation, complying with applicable
governmental regulations or otherwise submitting information to tax or other
governmental authorities, conducting clinical trials, or making a permitted
sublicense or otherwise exercising its rights hereunder (except as
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provided by Section 4.10), provided that if a party is required to make any
such disclosure of another party's confidential information, other than
pursuant to a confidentiality agreement, it will give reasonable advance
notice to the latter party of such disclosure and, save to the extent
inappropriate in the case of patent applications, will use its best efforts
to secure confidential treatment of such information prior to its disclosure
(whether through protective orders or otherwise).
8.3 PUBLIC DISCLOSURES. Xxxxxxx shall provide to SuperGen copies of
any proposed publication or abstract relating to the Patent Rights or Jointly
Owned Patents prior to submission of such documents. Proposed publications
shall be supplied at least sixty (60) days in advance of submission to a
journal, editor or other third party, and proposed abstract at least thirty
(30) days prior to such submission. In addition, the topic and contents of
any proposed oral disclosures regarding the Patent Rights or Jointly Owned
Patents which will be made to third persons by Xxxxxxx shall be disclosed in
writing to SuperGen at least thirty (30) days prior to any proposed oral
presentation. SuperGen shall have thirty (30) days after receipt of such
proposed publications and disclosures to review them. At SuperGen's request,
Xxxxxxx will delay submitting abstracts or manuscripts or making public
presentations for up to ninety (90) days to allow for the filing of patent
applications. Xxxxxxx agrees that it will honor SuperGen's reasonable
requests to remove the Confidential Information of SuperGen included in any
such proposed public disclosure. Notwithstanding the above, in the event
that Xxxxxxx submits any manuscript subject to this Section 8.3
electronically or via an on-line filing, then each of the thirty (30) day
periods set forth above shall be extended to sixty (60) days.
8.4 CONFIDENTIAL TERMS. Except as expressly provided herein, each
party agrees not to disclose any terms of this Agreement to any third party
without the consent of the other party; provided, disclosures may be made as
required by securities or other applicable laws, or to actual or prospective
investors or corporate partners, or to a party's accountants, attorneys and
other professional advisors. Notwithstanding the foregoing, promptly after
the Effective Date, each party may issue a press release, describing the
general nature of this Agreement, that is reasonably acceptable to the other
party.
8.5 KNOW-HOW. In no event may Xxxxxxx disclose the Know-How to any
third party except to a Successor Licensee (as defined in Section 4.10) who
agrees in writing to terms and conditions no less protective of SuperGen than
those set forth in this Article 8 as if such Know-How was SuperGen's
Confidential Information.
9. REPRESENTATIONS AND WARRANTIES
9.1 XXXXXXX. Xxxxxxx represents and warrants that: (i) it is a
not-for-profit foundation duly organized and validly existing and in good
standing under the laws of the State of Texas, (ii) the execution, delivery
and performance of this Agreement have been duly authorized by all necessary
action on the part of Xxxxxxx; (iii) it is the sole and exclusive owner of
all right, title and interest in the Patent Rights in existence as of the
Effective Date and has the right to grant the rights and licenses granted
herein; (iv) the Patent Rights are free and clear of any lien, encumbrance,
security interest, or restriction of license, provided that the foregoing
shall not be construed to be a representation or warranty that the
manufacture, use or sale of Licensed Products will not infringe any third
party patent; (v) to the best of
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Xxxxxxx'x knowledge and belief, there are no threatened or pending actions,
suits, investigations, claims or proceeding in any way relating the Licensed
Technology; (vi) it has not previously, and will not at any time while
SuperGen has exclusive rights in any country within the Territory according
to the terms and conditions of this Agreement, grant any third party a
license under the Licensed Technology to make, use or sell Licensed Products
in the Field in such country; and (vii) to the best of Xxxxxxx'x knowledge
and belief as of the Effective Date, the manufacture, use or sale of Licensed
Products will not infringe any third party patent.
9.2 ADDITIONAL XXXXXXX REPRESENTATIONS AND WARRANTIES. In addition to
the representations and warranties set forth in Section 9.1, Xxxxxxx
represents and warrants that:
(a) EXPERIENCE. Xxxxxxx is capable of evaluating the merits and
risks of its investment in SuperGen and has the capacity to protect Xxxxxxx'x
own interests.
(b) ACCESS TO INFORMATION. Xxxxxxx has received and had an
opportunity to review SuperGen's Report on Form 10-K for the fiscal year
ended December 31, 1996, Proxy Statement for the 1997 Annual Meeting of
Shareholders, Report on Form 10-Q for the quarters ended March 31, 1997 and
June 30, 1997 and Report on Form 8-K filed with the Securities and Exchange
Commission on July 2, 1997 (collectively, the "Public Reports") and discuss
SuperGen's business, management and financial affairs with SuperGen's
management. Xxxxxxx has also had an opportunity to ask questions of officers
of SuperGen, which questions were answered to Xxxxxxx'x satisfaction.
Xxxxxxx understands that such discussions, as well as any written information
issued by SuperGen, including the Public Information, were intended to
describe certain aspects of SuperGen's business and prospects but were not a
thorough or exhaustive description.
(c) INVESTMENT INTENT. Xxxxxxx is purchasing the Shares for
investment for its own account only and not with a view to, or for resale in
connection with, any "distribution" thereof within the meaning of the
Securities Act. Xxxxxxx understands that the Shares have not been
registered under the Securities Act or other securities laws in reliance on
specific exemptions therefrom, which exemptions depend upon, among other
things, the bona fide nature of Xxxxxxx investment intent as expressed herein.
(d) REGISTRATION OR EXEMPTION REQUIREMENTS. Xxxxxxx further
acknowledges and understands that the Shares must be held indefinitely unless
they are subsequently registered under the Securities Act or an exemption
from such registration is available. Xxxxxxx understands that the
certificate(s) evidencing the Shares will be imprinted with a legend that
prohibits the transfer of the Shares unless they are registered or such
registration is not required.
(e) RULE 144. Xxxxxxx understands Rule 144 promulgated under the
Securities Act permits limited resale of shares purchased in a private
placement subject to the satisfaction of certain conditions, including, among
other things, the existence of a public market for the Shares, the
availability of certain current public information about SuperGen, more than
one year having elapsed between the resale and the date the security to be
sold was last held by SuperGen or an affiliate of SuperGen, the sale being
made through a "broker's transaction" or in transactions directly with a
"market
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maker," and the number of shares being sold during any three-month period not
exceeding specified limitations. Xxxxxxx is further aware that Rule 144(k)
permits persons who have not been affiliates of SuperGen for at least three
months and whose shares have been beneficially owned by other than SuperGen
or its affiliates for at least two years after full payment for such shares
to sell such shares without regard to the current public information, manner
of sale and volume limitations described above.
(f) FURTHER LIMITATIONS ON DISPOSITION. Without in any way
limiting the representations set forth above or the limitations set forth in
Section 10.1, Xxxxxxx further agrees that Xxxxxxx shall in no event make any
disposition of all or any portion of the Shares, unless and until (i) there
is then in effect a Registration Statement under the Securities Act covering
such proposed disposition and such disposition is made in accordance with
said Registration Statement, (ii) the resale provisions of Rule 144(k) are
available in the opinion of counsel to SuperGen or (iii) (A) Xxxxxxx shall
have notified SuperGen of the proposed disposition and shall have furnished
SuperGen with a detailed statement of the circumstances surrounding the
proposed disposition, (B) Xxxxxxx shall have furnished SuperGen with an
opinion of Xxxxxxx'x counsel to the effect that such disposition will not
require registration of such stock under the Securities Act and (C) such
opinion of Xxxxxxx'x counsel shall have been concurred with by counsel for
SuperGen, which concurrence shall not be unreasonably withheld, and SuperGen
shall have advised Xxxxxxx of such concurrence.
(g) BROKERS OR FINDERS. Xxxxxxx has not engaged any brokers,
finders, or agents, and SuperGen has not incurred, and will not incur,
directly or indirectly, as a result of any action taken by Xxxxxxx, any
liability for brokerage or finders' fees or agents' commissions or any
similar charges in connection with this Agreement and the transactions
contemplated hereby. In the event that the preceding sentence is in any way
inaccurate, Xxxxxxx agrees to indemnify and hold harmless SuperGen from any
liability for any commission or compensation in the nature of a finder's fee
(and the costs and expenses of defending against such liability or asserted
liability) for which SuperGen, or any of Xxxxxxx'x officers, directors,
employees or representatives, is responsible.
9.3 SUPERGEN. SuperGen represents and warrants that: (i) it is a
corporation duly organized validly existing and in good standing under the
laws of the State of Delaware; (ii) the execution, delivery and performance
of this Agreement have been duly authorized by all necessary corporate action
on the part of SuperGen; and (iii) the License Shares are and the Milestone
Shares will be duly authorized, validly issued, fully paid and nonassessable.
9.4 EFFECT OF REPRESENTATIONS AND WARRANTIES. It is understood that if
the representations and warranties made by a party under this Article 9 are
not true and accurate, and the other party incurs damages, liabilities, costs
or other expenses as a result, the party making such representations and
warranties shall indemnify and hold the other party harmless from and against
any such damages, liabilities, costs or other expenses incurred as a result.
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10. COVENANTS
Xxxxxxx covenants and agrees that, notwithstanding anything in Article 9
to the contrary, it will not sell, transfer or otherwise dispose of its title
to or interest in the Shares acquired pursuant to Article 4 for a period of
eighteen (18) months from the applicable date of issuance of such Shares.
11. PROSECUTION AND ENFORCEMENT
11.1 SUPERGEN'S RESPONSIBILITIES. Xxxxxxx shall be responsible, using
patent counsel acceptable to SuperGen, for the preparation, filing,
prosecution, and maintenance of the patent applications and patents within
Licensed Technology to the extent such patents have issued before the
Effective Date or such patent applications with an effective filing date in
whole or in part before the Effective Date ("Initial Patents"). Except as
set forth above and in subsection (a) below, SuperGen shall have the sole
right (but not the obligation) to control the preparation, filing,
prosecution and maintenance of the Patent Rights and all Jointly Owned
Patents using patent counsel of its choice. Each party shall consult with
the other party regarding the prosecution of any patent applications, by
providing the other party a reasonable opportunity to review and comment on
all proposed submissions to any patent office before submittal, and provided
further that the prosecuting party shall keep the other party reasonably
informed as to the status of such patent applications by promptly providing
the other party with copies of all communications relating to such patent
applications that are received from any patent office, including but not
limited to notices of any interference, reissue, reexamination, opposition,
or request for patent term extension. Each party shall cooperate with
respect to the filing, prosecution and maintenance of patents performed by
the other party.
(a) FAILURE TO PROSECUTE. In the event that Xxxxxxx declines to
further prosecute and/or maintain any patent applications or patents that are
Initial Patents, Xxxxxxx shall provide SuperGen notice thereof at least
thirty (30) days prior to the expiration of any non-extendable deadline
relating to such activities, and SuperGen shall thereafter have the right to
file, prosecute, and maintain such patent applications or patents, at its
expense, using counsel of its choice. SuperGen shall have the right to
offset such expenses against any amounts owed pursuant to Sections 4.4 or
4.5. Xxxxxxx will cooperate with respect to such filing, prosecution and
maintenance under this paragraph. In the event that SuperGen declines to
further prosecute and/or maintain any patent applications or patents that
SuperGen has the right to prosecute and maintain according to this Section
11.1, SuperGen shall provide Xxxxxxx notice thereof at least thirty (30) days
prior to the expiration of any non-extendable deadline relating to such
activities, and Xxxxxxx shall thereafter have the right to file, prosecute,
and maintain such patent applications or patents, at its expense, using
counsel of its choice.
11.2 ENFORCEMENT. If either party hereto becomes aware that any Patent
Rights or Jointly Owned Patents are being or have been infringed by any third
party, such party shall promptly notify the other party hereto in writing
describing the facts relating thereto in reasonable detail. SuperGen shall
have the initial right, but not the obligation, to institute, prosecute and
control any action, suit or proceeding (an "Action") with respect to such
infringement, including any declaratory judgment action,
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REDACTED
CONFIDENTIAL TREATMENT REQUESTED
at its expense, using counsel of its choice; provided, however, SuperGen
shall be entitled to offset any amount expended in connection with such
Action against up to ** of royalties due under Article 4 with respect to Net
Sales in the country in which such infringement has taken place. Xxxxxxx
shall cooperate reasonably with SuperGen and/or join as a party plaintiff, at
SuperGen's request, in connection with any such Action. Any amounts
recovered from third parties in any such Action with respect to infringement
of the Patent Rights shall be used first to reimburse Xxxxxxx and SuperGen
for their costs and expenses associated with such Action (including
attorneys' and expert fees) and any remainder treated as Net Sales of
Licensed Products pursuant to Section 4.4, such that Xxxxxxx shall receive
the applicable percentage set forth in Section 4.4. In the event SuperGen
fails to initiate or defend any Action involving the Patent Rights within one
hundred eighty (180) days of receiving notice of any commercially significant
infringement, Xxxxxxx shall have the right, but not the obligation, to
initiate and control such an Action, and SuperGen shall cooperate reasonably
with Xxxxxxx, at Xxxxxxx'x request, in connection with any such Action. Any
amounts recovered in such Action filed by Xxxxxxx shall be used first to
reimburse SuperGen and Xxxxxxx for the expenses incurred in connection with
such Action, and any remainder shall be split between SuperGen and Xxxxxxx,
with Xxxxxxx receiving ** of such remainder and SuperGen shall receive ** of
such remainder.
11.3 INFRINGEMENT CLAIMS. If the practice by SuperGen of the license
granted herein results in any allegation or claim of infringement of an
intellectual property right of third party against SuperGen, SuperGen shall
have the exclusive right to defend any such claim, suit or proceeding, at its
own expense, by counsel of its own choice and shall have the sole right and
authority to settle any such suit; provided, however, Xxxxxxx shall cooperate
with SuperGen, at SuperGen's reasonable request, in connection with the
defense of such claim. SuperGen shall be entitled to offset any costs and
expenses (including attorneys' and professional fees) incurred in connection
with any such proceeding against any amounts it would otherwise owe Xxxxxxx
under Article 4, with respect to Net Sales in the country in which such
infringement is alleged to have occurred, up to a maximum of ** of such
amounts.
12. ARBITRATION
Xxxxxxx and SuperGen agree that any dispute or controversy arising out
of, in relation to, or in connection with this Agreement, or the validity,
enforceability, construction, performance or breach thereof, shall be settled
by binding arbitration in Chicago, Illinois, United States of America, under
the then-current Commercial Arbitration Agreement Rules of the American
Arbitration Association by one (1) arbitrator appointed in accordance with
such Rules. The arbitrators shall determine what discovery will be
permitted, based on the principle of limiting the cost and time which the
parties must expend on discovery; provided, the arbitrators shall permit such
discovery as they deem necessary to achieve an equitable resolution of the
dispute. The decision and/or award rendered by the arbitrator shall be
written, final and non-appealable and may be entered in any court of
competent jurisdiction. The parties agree that, any provision of applicable
law notwithstanding, they will not request, and the arbitrator shall have no
authority to award, punitive or exemplary damages against any party. The
costs
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of any arbitration, including administrative fees and fees of the arbitrator,
shall be shared equally by the parties. Each party shall bear the cost of
its own attorneys' fees and expert fees.
13. INDEMNIFICATION
13.1 XXXXXXX INDEMNITY. SuperGen shall indemnify, defend and hold
harmless Xxxxxxx and its directors, officers and employees (each a "Xxxxxxx
Indemnitee") from and against any and all liabilities, damages, losses, costs
or expenses (including reasonable attorneys' and professional fees and other
expenses of litigation and/or arbitration) (a "Liability") resulting from a
claim, suit or proceeding brought by a third party against a Xxxxxxx
Indemnitee, arising from or occurring as a result of activities performed by
SuperGen or its Affiliates, licensees, partners, joint venturers or
distributors in connection with the development, manufacture or sale of any
Licensed Product, except to the extent caused by the willful misconduct of a
Xxxxxxx Indemnitee or as otherwise provided by Section 9.4.
13.2 SUPERGEN INDEMNITY. In the event that and to the extent that
Xxxxxxx appoints a Successor Licensee as provided under Section 4.10 and
excluding claims for which SuperGen is required to indemnify Xxxxxxx pursuant
to Section 13.1, Xxxxxxx shall indemnify, defend and hold harmless SuperGen
and its directors, officers and employees (each a "SuperGen Indemnitee") from
and against any and all Liabilities resulting from a claim, suit or
proceeding brought by a third party against a SuperGen Indemnitee, arising
from or occurring as a result of activities performed by Xxxxxxx or its
Affiliates, licensees, partners, joint venturers or distributors in
connection with the development, manufacture or sale of any Licensed Product,
except to the extent caused by the willful misconduct of a SuperGen
Indemnitee or as otherwise provided by Section 9.4.
14. TERM AND TERMINATION
14.1 TERM. The term of this Agreement shall commence on the Effective
Date, and unless earlier terminated as provided in Article 14, shall continue
in full force and effect on a country-by-country and Licensed
Product-by-Licensed Product basis until there are no remaining royalty
payment obligations in a country, at which time the Agreement shall terminate
in its entirety in such country provided that SuperGen shall have a
perpetual, non-exclusive, royalty-free license under the Know-How, with the
right to grant and authorize sublicenses, to make, have made, import, have
imported, use, sell, offer for sale and otherwise distribute and exploit the
Licensed Products in the Field in such country. As used in this Article 14,
"termination" and all conjugates thereof means any termination or expiration
of this Agreement.
14.2 TERMINATION FOR CAUSE. If either party materially breaches this
Agreement, the other party may elect to give the breaching party written
notice describing the alleged breach. If the breaching party has not cured
such breach within sixty (60) days after receipt of such notice, the
notifying party will be entitled, in addition to any other rights it may have
under this Agreement, to terminate this Agreement effective immediately;
provided, however, if either party receives notification from the other of a
material breach and if the party alleged to be in default notifies the other
party in writing within thirty
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(30) days of receipt of such default notice that it disputes the asserted
default, the matter will be submitted to arbitration as provided in Article
12 of this Agreement. In such event, the nonbreaching party shall not have
the right to terminate this Agreement until it has been determined in such
arbitration proceeding that the other party materially breached this
Agreement, and the breaching party fails to cure such breach within ninety
(90) days after the conclusion of such arbitration proceeding.
14.3 TERMINATION FOR INSOLVENCY. Either party may terminate this
Agreement if the other becomes the subject of a voluntary or involuntary
petition in bankruptcy or any proceeding relating to insolvency,
receivership, liquidation, or composition or the benefit of creditors, if
that petition or proceeding is not dismissed with prejudice within sixty (60)
days after filing.
14.4 PERMISSIVE TERMINATION. SuperGen may terminate this Agreement
with respect to any country with sixty (60) days written notice to Xxxxxxx,
and agrees that upon such date of termination that it shall then and
thereafter cease all manufacture, use, sale or development of Licensed
Products in the Field in such country.
14.5 EFFECT OF TERMINATION.
(a) ACCRUED RIGHTS AND OBLIGATIONS. Termination of this Agreement
for any reason shall not release any party hereto from any liability which,
at the time of such termination, has already accrued to the other party or
which is attributable to a period prior to such termination, nor preclude
either party from pursuing any rights and remedies it may have hereunder or
at law or in equity which accrued or are based upon any event occurring prior
to such termination.
(b) RETURN OF MATERIALS. Upon any termination of this Agreement,
each party shall promptly return to the other party all Confidential
Information received from the other party (except one copy of which may be
retained for archival purposes).
(c) STOCK ON HAND. In the event this Agreement is terminated for
any reason, SuperGen and its Affiliates and sublicensees shall have the right
to sell or otherwise dispose of the stock of any Licensed Product subject to
this Agreement then on hand, subject to Articles 4 and 5, except to the
extent of materials stockbilled in contemplation of termination.
(d) SUBLICENSEES. In the event of any termination of this
Agreement any sublicensees granted by SuperGen shall remain in full force and
effect and shall be assigned by SuperGen to Xxxxxxx provided that such
sublicenses were entered into in good faith by SuperGen provided that such
sublicenses contain terms and conditions no less protective of Xxxxxxx than
the terms and conditions set forth in Sections 13.1 (subject to Section
13.3), 14.2, 14.3, 14.5(a), 14.5(b), 14.5(c) and Articles 5 (with respect to
royalties due under the sublicense), 6 (with respect to royalties due under
the sublicense), 7, 8 and 15 and further provided that any per unit royalties
set forth in such sublicenses were negotiated in good faith by SuperGen based
upon SuperGen's expectation that it would be receiving such royalties.
(e) USE OF DATA. In the event of any termination of this
Agreement, SuperGen will negotiate in good faith to reach an agreement that
allows Xxxxxxx to use, for commercial purposes, data
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or other information related to the Licensed Products and generated pursuant
to this Agreement. However, absent reaching such an agreement, Xxxxxxx
request "baseball" arbitration under Article XII to select from between
proposed terms of Xxxxxxx and proposed terms of SuperGen.
14.6 SURVIVAL. Articles 8, 9, 10, 12, 13, 14 and 15 and Sections
2.3(a) and 3.4 of this Agreement shall survive termination of this Agreement
for any reason. For purposes of clarification, SuperGen's unaccrued
obligations under Sections 4.1, 4.2 and 4.3 shall terminate immediately upon
termination of this Agreement for any reason except to the extent that
Xxxxxxx'x rights to certain stock have accrued prior to such termination.
For purposes of clarification, all provisions of Section 4.6 shall terminate
immediately upon any termination of this Agreement except to the extent that
SuperGen is required to pay a portion of the Minimum Royalty (as defined in
Section 4.6) according to the terms and conditions of the last sentence in
Section 4.6.
15. MISCELLANEOUS
15.1 GOVERNING LAW. This Agreement shall be governed by and construed
in accordance with the laws of the State of New York, without reference to
principles of conflicts of laws.
15.2 INDEPENDENT CONTRACTORS. The relationship of the parties hereto
is that of independent contractors. The parties hereto are not deemed to be
agents, partners or joint venturers of the others for any purpose as a result
of this Agreement or the transactions contemplated thereby.
15.3 ASSIGNMENT. The parties agree that their rights and obligations
under this Agreement may not be delegated, transferred or assigned to a third
party without prior written consent of the other party hereto except that
SuperGen may assign this Agreement, without such consent, to an entity that
acquires all or substantially all of the business or assets of SuperGen
whether by merger, reorganization, acquisition, sale, or otherwise and
Xxxxxxx may assign this Agreement to a wholly-owned Affiliate. This
Agreement shall be binding upon and inure to the benefit of the parties and
their successors and assigns.
15.4 RIGHT TO DEVELOP INDEPENDENTLY. Nothing in this Agreement will
impair SuperGen's right to independently acquire, license, develop for
itself, or have others develop for it, intellectual property and technology
performing similar functions as the Licensed Technology or to market and
distribute Licensed Products or other products based on such other
intellectual property and technology, except as otherwise explicitly provided
in this Agreement.
15.5 NOTICES. Any required notices hereunder shall be given in writing
by certified mail or overnight express delivery service (e.g., D.H.L.) at the
address of each party below, or to such other address as either party may
substitute by written notice. Notice shall be deemed served when delivered
or, if delivery is not accomplished by reason or some fault of the addressee,
when tendered.
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If to Xxxxxxx:
The Xxxxxxx Foundation for Cancer Research
St. Xxxxxx Medical Place
0000 Xxxxxxx, Xxxxx 0000
Xxxxxxx, Xxxxx 00000
Attn: Xxxxxx X. Xxxxxxxx, Executive Director
with a copy to:
Xxxxxx & Xxxxxx
Suite 800, The Xxxxxxx Office Building
0000 Xxxxxxxxxxxx Xxxxxx, X.X.
Xxxxxxxxxx X.X. 00000-0000
Attn: Xxxxxx X. Xxxxxxxx
If to SuperGen:
SuperGen, Inc.
Xxx Xxxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: Chief Financial Officer
with a copy to:
Wilson, Sonsini, Xxxxxxxx & Xxxxxx
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000-0000
Attn: Xxxx Xxxx
15.6 FORCE MAJEURE. Neither party shall lose any rights hereunder or
be liable to the other party for damages or losses (except for payment
obligations) on account of failure of performance by the defaulting party if
the failure is occasioned by war, strike, fire, Act of God, earthquake,
flood, lockout, embargo, governmental acts or orders or restrictions, failure
of suppliers, or any other reason where failure to perform is beyond the
reasonable control and not caused by the negligence, intentional conduct or
misconduct of the nonperforming party has exerted all reasonable efforts to
avoid or remedy such force majeure; provided, however, that in no event shall
a party be required to settle any labor dispute or disturbance.
15.7 COMPLIANCE WITH LAWS. Each party shall furnish to the other party
any information requested or required by that party during the term of this
Agreement or any extensions hereof to enable that party to comply with the
requirements of any U.S. or foreign federal, state and/or government agency.
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15.8 PATENT MARKING. SuperGen agrees to xxxx and have its Affiliates
and sublicensees xxxx all Licensed Products they sell or distribute pursuant
to this Agreement in accordance with the applicable statute or regulations in
the country or countries of manufacture and sale thereof.
15.9 LIMITATION OF LIABILITY. EXCEPT AS OTHERWISE PROVIDED BY ARTICLE
13 OR SECTION 9.4, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY
SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES ARISING OUT OF THIS
AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY.
15.10 FURTHER ASSURANCES. At any time or from time to time on and
after the date of this Agreement, each party shall at the request of the
other (i) deliver to the other party such records, data or other documents
consistent with the provisions of this Agreement, (ii) execute, and deliver
or cause to be delivered, all such consents, documents or further instruments
of transfer or license, and (iii) take or cause to be taken all such actions,
as the other party may reasonably deem necessary or desirable in order for
the other party to obtain the full benefits of this Agreement and the
transactions contemplated hereby.
15.11 SEVERABILITY. In the event that any provisions of this Agreement
are determined to be invalid or unenforceable by a court of competent
jurisdiction, the remainder of the Agreement shall remain in full force and
effect without said provision. The parties shall in good faith negotiate a
substitute clause for any provision declared invalid or unenforceable, which
shall most nearly approximate the intent of the parties in entering this
Agreement.
15.12 MODIFICATION; WAIVER. This Agreement may not be altered, amended
or modified in any way except by a writing signed by both parties. The
failure of a party to enforce any provision of the Agreement shall not be
construed to be a waiver of the right of such party to thereafter enforce
that provision or any other provision or right.
15.13 ENTIRE AGREEMENT. This Agreement including, its Exhibit, sets
forth the entire agreement and understanding of the parties with respect to
the subject matter hereof, and supersedes all prior discussions, agreements
and writings in relating thereto.
15.14 COUNTERPARTS. This Agreement may be executed in two
counterparts, each of which shall be deemed an original and which together
shall constitute one instrument.
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IN WITNESS WHEREOF, Xxxxxxx and SuperGen have executed this Agreement by
their respective duly authorized representatives.
SUPERGEN, INC. XXXXXXX FOUNDATION
FOR CANCER RESEARCH
By: /s/ Xxxxxx Xxxxxxxxx By: /s/ Xxxx X. Xxxxxxx
------------------------------------ ------------------------------
Xxxxxx Xxxxxxxxx, Ph.D. Xxxx X. Xxxxxxx
President and Chief Executive Officer Scientific Director
By: /s/ Xxxxxx X. Xxxxxxxx
------------------------------
Xxxxxx X. Xxxxxxxx
Executive Director
By: /s/ Xxx X. Xxxxxxx
------------------------------
Xxx X. Xxxxxxx
Chairman of the Board
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APPENDIX A: PATENTS
U.S. Patent No. 5,352,789, issued OCTOBER 4, 1994, and entitled: METHODS OF
PURIFYING CAMPTOTHECIN COMPOUNDS
U.S. Patent No. 5,527,913, issued JUNE 18, 1996, and entitled: METHOD FOR
PURIFYING CAMPTOTHECIN COMPOUNDS
U.S. Patent No. 5,552,154, issued SEPTEMBER 3, 1996, and entitled: METHOD
FOR TREATING CANCER WITH WATER-INSOLUBLE S-CAMPTOTHECIN OF THE CLOSED LACTONE
RING FORM AND DERIVATIVES THEREOF.
U.S. Patent No. 5,608,066, issued MARCH 4, 1997, and entitled: METHODS FOR
PURIFYING CAMPTOTHECIN COMPOUNDS.
Allowed U.S. Patent Appln. Serial No. 08/474 764, filed JUNE 7, 1995, and
entitled: METHOD FOR TREATING CANCER WITH WATER-INSOLUBLE S-CAMPTOTHECIN OF
THE CLOSED LACTONE RING FORM AND DERIVATIVES THEREOF.
Pending U.S. Patent Appln. Serial No. (UNASSIGNED), filed AUGUST 8, 1997,
(Rule 62 Cont. Appln. of USSN 08/470 427) entitled: METHODS FOR PURIFYING
20(S)-CAMPTOTHECIN
Pending U.S. Patent Appln. Serial No. 08/767,861, filed DECEMBER 17, 1996,
entitled: A METHOD FOR TREATING CANCER WITH WATER-INSOLUBLE S-CAMPTOTHECIN
OF THE CLOSED LACTINE RING FORM AND DERIVATIVES THEREOF.
Pending U.S. Patent Appln. Serial No. 08/713,392, filed SEPTEMBER 13, 1996,
entitled: A METHOD FOR TREATING PANCREATIC CANCER IN HUMANS WITH
WATER-INSOLUBLE S-CAMPTOTHECIN OF THE CLOSED LACTONE RING FORM AND
DERIVATIVES THEREOF.
