PURCHASE AND SALE AGREEMENT
PURCHASE AND SALE AGREEMENT, dated September 30, 1996, between Xxxxxx-
Xxxxxxx Company, a Delaware corporation having its principal place of business
at 000 Xxxxx Xxxx, Xxxxxx Xxxxxx, Xxx Xxxxxx 00000 ("X-X"), and SuperGen, Inc.,
a California corporation having its principal place of business at 0000 Xxxxxx
Xx., Xxxxxxxxxx, Xxxxxxxxxx 00000 ("SuperGen") (the "Agreement").
WITNESSETH:
WHEREAS, X-X desires to sell to SuperGen and SuperGen desires to purchase
from X-X the Assets (hereinafter defined) upon the terms and conditions and for
the Purchase Price (hereinafter defined) as set forth in this Agreement;
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, SuperGen and X-X hereby agree as follows:
ARTICLE I
DEFINITIONS
1.01 DEFINITIONS. As used in this Agreement, the following defined terms
shall have the meanings set forth below:
"ACQUIRED KNOW-HOW" means all data, information, know-how (including,
without limitation, processes and methods) relating exclusively to the
manufacture of the Product.
"AFFILIATE" means any Person that directly, or indirectly through one or
more intermediaries, controls, is controlled by, or is under common control with
the Person specified. As used herein the term "control" means possession of the
power to direct, or cause the direction of, the management and policies of a
corporation or other entity whether through the ownership of voting securities,
by contract or otherwise.
"ASSETS" means all of the Bulk Active Ingredient, Inventory, the NDA
(including the Orphan Drug Designation), the NDS, Intellectual Property and
Customer List.
"BULK ACTIVE INGREDIENT" means all of X-X's unpurified crude concentrate
form of Pentostatin set forth in Exhibit A.
"BULK SALES LAWS" means any statutes, rules or regulations of any
Governmental or Regulatory Authority relating to or affecting bulk sales or
transfers.
"CLINICAL STUDY AGREEMENTS" means the contracts set forth in Exhibit B.
"CLOSING DATE" means September 30, 1996 or such other date as is determined
in accordance with Article II.
"CONSENT DECREE" means the Consent Decree for Permanent Injunction filed in
the United States District Court, District of New Jersey on August 16, 1993 in
UNITED STATES OF AMERICA X. XXXXXX-XXXXXXX COMPANY.
"CUSTOMER LIST" means the list of contract customers set forth in Exhibit
C.
"DISTRIBUTION AGREEMENT" means the agreement, made as of June 1992 and as
amended twice as of March 1, 1993 and February 6, 1996, between American
Cyanamid Company, a wholly owned subsidiary of American Home Products Corp.
("AHP") and X-X covering the distribution of the Product by AHP in all countries
of the world except the United States, Canada, Japan and Mexico.
"DRUG MASTER FILES" means all drug master files referred to or referenced
in the NDA owned or controlled by or in the possession of X-X.
"EXHIBITS" means the Exhibits annexed to this Agreement, each of which is
hereby incorporated as a part of this Agreement.
"FDA" means the United States Food and Drug Administration.
"FDA APPROVAL" means approval by the FDA permitting SuperGen to purify the
Pentostatin from the Bulk Active Ingredient at one or more manufacturing
facilities designated by SuperGen.
"GOVERNMENTAL OR REGULATORY AUTHORITY" means any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of any country
in the Territory or state, province, county, city or other political subdivision
thereof.
"INTELLECTUAL PROPERTY" means the Trademarks, Acquired Know-How and
Patents.
"INVENTORY" means X-X's Pentostatin inventory set forth on Exhibit D.
"LICENSED KNOW-HOW" means all technical know-how reasonably required or
useful for the manufacture of the Product, excluding the Acquired Know-How.
"LOSSES" means any and all damages, fines, liabilities, fees, penalties,
deficiencies, losses and expenses (including, without limitation interest, court
costs, fees of attorneys, accountants and other experts and other expenses of
litigation or other proceedings or of any claim, default or assessment).
"NDA" means the New Drug Application No. 20122-001.
"NDS" means the Canadian New Drug Submission (Control #6HN914496, File #
9427-P0002-189).
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"PATENTS" means Xxxxxx Xxxxxx Xxxxxx Xx. 0000000; Xxxxxx Xxxxxx Patent
No. 5366960 and Mexican Patent No.80565, including any and all divisions,
continuations, continuations in part, extensions, substitutions, renewals,
confirmations, registrations, revalidations, reissues or additions, including
supplementary certificates of protection of or to any of the aforesaid Patents.
"PENTOSTATIN" means the pharmaceutical compound (R) -3 - (2
deoxy-B-D-erythro-pento- furanosy1) - 3, 6, 7, 8-tetrahydroimidaze [4, 5-d] [1,
3] diazepin-8-01.
"PERSON" means any natural person, corporation, general partnership,
limited partnership, proprietorship, other business organization, trust, union,
association or Governmental or Regulatory Authority.
"PRODUCT" means any pharmaceutical preparation for human use containing
Pentostatin as the active ingredient.
"SECOND CASH PAYMENT DATE" means the earlier of (i) the date of the FDA
Approval, or (ii) 15 months from the Closing Date.
"TERRITORY" means the United States, Canada and Mexico.
"TEST DRUM" shall have the meaning set forth in Section 6.05
"TRADEMARKS" means the trademarks listed on Exhibit E.
"UNITED STATES" means the United States of America, its territories and
possessions, the Commonwealth of Puerto Rico and the District of Columbia.
ARTICLE II
CLOSING
2.01 CONVEYANCE. On the Closing Date, subject to the terms and conditions
set forth in this Agreement, X-X shall sell, transfer, assign, convey and
deliver to SuperGen good and marketable title to the Assets free and clear of
liens or encumbrances of any kind and SuperGen shall purchase good and
marketable title to the Assets from X-X free and clear of any liens or
encumbrances of any kind. X-X shall execute and deliver such documents of
conveyance and take any other action as may be necessary to transfer the Assets
to SuperGen as set forth in the preceding sentence. Notwithstanding the
foregoing or any other provisions in this Agreement, except as set forth in
Section 6.02 with respect to the Clinical Study Agreements, X-X shall not on the
Closing Date sell, transfer, assign, convey or deliver to SuperGen any assets of
X-X other than the Assets and SuperGen shall not assume, and X-X shall retain
and be responsible for, any and all liabilities or obligations of X-X of any
kind, including but not limited to any liability relating to the Assets as of
the Closing Date ("Non-Assumed Liabilities").
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2.02 PURCHASE PRICE. (a) SuperGen will pay to X-X in consideration of the
Assets, (i) $2,073,000 in cash and $1,000,000 in unregistered restricted common
stock, par value $.001, of SuperGen (the "Shares") on the Closing Date, at a per
share purchase price calculated based on the average closing price of SuperGen's
registered common stock at the close of business for the 10 business days
preceding the Closing Date as quoted on the Nasdaq National Market, and
(ii) $500,000 in cash on the Second Cash Payment Date (collectively, the
"Purchase Price").
(b) The cash payments of the Purchase Price shall be made in United
States dollars by bank wire transfer in immediately available funds to the
account designated in writing by X-X.
(c) The amount of the cash payment of the Purchase Price to be made
on the Closing Date is based in part upon the Inventory including no less than
1,960 vials of Product as shown on Exhibit D. Should the Inventory as actually
delivered include less than 1,960 vials, then X-X shall promptly upon written
notice from SuperGen, refund to SuperGen in cash the amount of $50 multiplied by
the difference between 1,960 and the actual number of vials delivered. It is
understood and agreed that X-X shall not deliver at the Closing to SuperGen
those vials shown on Exhibit D as "unlabeled" although title to all such vials
shown on Exhibit D shall pass to SuperGen at the Closing. X-X agrees that it
shall label and package all unlabelled vials at X-X's cost, including but not
limited to labor costs, within 6 weeks after SuperGen provides written notice to
X-X; provided, however, SuperGen shall provide X-X with the necessary packaging
materials at its cost.
2.03 TIME AND PLACE OF CLOSING. The Closing shall take place at the
offices of Xxxxxx-Xxxxxxx Company located at 000 Xxxxx Xxxx, Xxxxxx Xxxxxx, Xxx
Xxxxxx at 9:00 a.m., local time, on September 30, 1996, or at such other place
or at such other time as X-X and SuperGen may mutually agree.
2.04 CLOSING TRANSACTIONS. At the Closing:
(a) SuperGen will deliver to X-X a certificate or certificates
representing the Shares duly registered in the name of X-X.
(b) X-X shall prepare, execute and deliver to SuperGen all necessary
and applicable notifications of change to the relevant Governmental or
Regulatory Authorities respecting the change in the ownership of the Assets to
SuperGen.
(c) X-X shall prepare, execute and deliver to SuperGen assignment
documents for each country in the Territory where it owns Patents and Trademarks
assigning its rights thereunder to SuperGen.
(d) X-X shall deliver to SuperGen all other documents necessary to
transfer, assign, convey and deliver good and marketable title to the Assets.
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ARTICLE III
REPRESENTATIONS AND WARRANTIES
3.01 REPRESENTATIONS AND WARRANTIES OF X-X. X-X hereby represents and
warrants to SuperGen as follows:
(a) DUE ORGANIZATION. X-X is a corporation duly organized, validly
existing and in good standing under the laws of the State of Delaware and has
all requisite power and authority to own, operate and lease its properties and
to carry on its business as now being conducted.
(b) POWER AND AUTHORITY. X-X has full corporate power and authority
to enter into this Agreement and to consummate the transactions contemplated
hereunder, and the execution, delivery and performance of this Agreement and the
transactions contemplated hereby by X-X have been duly and validly authorized by
proper corporate action, and no other proceedings on the part of X-X are
necessary to authorize this Agreement and the transactions contemplated hereby.
(c) LEGALITY AND VALIDITY. This Agreement has been duly executed and
delivered by X-X and constitutes a legal, valid and binding obligation of X-X,
enforceable against X-X in accordance with its terms, subject to the general
principles of equity and except as the enforceability hereof may be limited by
applicable bankruptcy, insolvency, reorganization or other similar laws of
general application relating to creditors' rights.
(d) NO VIOLATION. The execution, delivery and performance of this
Agreement and the consummation of the transactions contemplated hereby by X-X
shall not (i) conflict with or result in any breach of any provision of the
Restated Certificate of Incorporation, as amended, or By-laws of X-X; (ii)
conflict with, or result in any breach or default (or would constitute a default
but for any requirement of notice or lapse of time or both) under, or give rise
to a right of termination, cancellation or acceleration of any obligation or to
a loss of a benefit under, or result in the creation or imposition of any lien,
charge or encumbrance on any of the Assets pursuant to any agreement, contract,
note, mortgage, indenture, lease, sublease, instrument, permit, concession,
franchise or license to which X-X is a party or by which X-X or the Assets may
be bound or affected; or (iii) violate any order, writ, injunction, decree
(including the Consent Decree), or any statute, rule or regulation, applicable
to X-X.
(e) CONSENTS AND APPROVALS. X-X has obtained all necessary consents,
approvals, orders or authorizations of, and has performed all necessary
registrations, declarations or filings with any Governmental or Regulatory
Authority required by or with respect to X-X in connection with the execution
and delivery of this Agreement by X-X or the consummation by X-X of the
transactions contemplated hereby. X-X is conducting, and has conducted, its
business and operations as it relates directly or indirectly to the Assets and
Clinical Study Agreements in compliance in all material respects with all
governmental laws, rules and regulations applicable thereto and is not in
violation or default in any material respect under any statute, regulation,
order, decree (including the Consent Decree) or governmental authorization
applicable to it or any of its properties or business as presently
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conducted or proposed to be conducted as it relates directly or indirectly to
the Assets and Clinical Study Agreements, including without limitation laws,
rules and regulations administered or issued by the FDA and any environmental
laws, rules and regulations. Except for the Consent Decree, X-X is not subject
to any order or consent decree of any court or administrative body that relates
in any way to the Assets.
(f) TITLE/DEFECTS. X-X has full right, title and interest to, and at
the Closing will sell, convey, assign, transfer and deliver to SuperGen good
title to all Assets. The Assets and the Clinical Study Agreements are free and
clear of any claim, liability, security interest or encumbrance of any party.
There are no material problems or defects in any of the Assets which would
directly or indirectly adversely affect such Assets or SuperGen's ability to
manufacture and sell Products after the Closing or, as a direct or indirect
result of such defects, would render the Products unmarketable for the purposes
for which they were intended. To the best of X-X's knowledge, there is no
infringement by any third party of its title to the Assets.
(g) LEGAL PROCEEDINGS, ETC. There are no adverse third party actions
or claims pending against X-X in any court or by or before any Governmental or
Regulatory Authority with respect to the Assets or the Clinical Study
Agreements. There are no other actions, suits, proceedings, claims or
investigations pending against X-X, nor has X-X received notice of any of the
foregoing, with respect to the transactions contemplated hereby or materially
affecting the value of the Assets or which, if adversely determined, would
prevent X-X from consummating the transactions contemplated hereby. To the best
of X-X's knowledge, there is no reason that could preclude SuperGen from
marketing and selling Products incorporating the Assets in the Territory after
the Closing (excluding as a result of any action or inaction by SuperGen after
the Closing).
(h) ORPHAN DRUG DESIGNATION. Pentostatin has valid and effective
Orphan Drug Designation under the applicable FDA statutes, rules or regulations,
effective October 11, 1991, which X-X has no reason to believe such Orphan Drug
Designation shall be terminated prior to October 11, 1998.
(i) INVENTORY. As of the Closing Date (i) all the Inventory is in
good and merchantable condition; (ii) all of the Inventory was prepared in
compliance with current good manufacturing practice regulations for
pharmaceuticals and certified in compliance with the Consent Decree, and
(iii) all finished Product which has been released meets all applicable
specifications and legal requirements and may be lawfully sold in the United
States.
(j) BULK ACTIVE PRODUCT. As of the Closing Date, (i) all drums of
bulk active ingredient purified prior to the date hereof in accordance with the
Acquired Know-How and the Licensed Know-How have yielded between 250 and 500
grams of purified Pentostatin and X-X has no reason to believe that SuperGen or
its designee should not obtain similar yields and (ii) all Bulk Active
Ingredient is, and will be at the time of delivery to SuperGen, in good
condition and is usable for production of good and marketable Products.
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(k) VIALS LABELED AND PACKAGED AFTER THE CLOSING DATE. At the time
of delivery to SuperGen, all vials of the Product which X-X shall label and
package after the Closing Date in accordance with Section 2.02(c) shall meet all
applicable specifications, rules and regulations, have been prepared in
compliance with the Consent Decree and may be lawfully sold in the United
States.
(l) TAXES. X-X has duly paid all taxes and other governmental
charges, if any, due and payable upon the Assets and any income or sales tax, if
any, relating to the Assets on or prior to the Closing Date. Neither the
Internal Revenue Service nor any other taxing authority has in the past asserted
or is now asserting or, to the best knowledge of X-X, is threatening to assert
against X-X, any deficiency or claim for additional taxes or interest thereon or
penalties in connection therewith with respect to the Assets.
(m) RECORDS. X-X has delivered to SuperGen true and complete copies
of all material documents and correspondence with any Governmental or Regulatory
Authority relating to the Assets.
(n) AGREEMENTS. There are no outstanding contracts, leases,
instrument, obligations, commitments, understandings and agreements, whether
written or oral, to which X-X is a party and to which the Assets will be subject
subsequent to the Closing. Except with respect to the obligations set forth in
the Clinical Study Agreements, and subject to the valid assignment thereof, X-X
has no material agreement with any third party which will obligate SuperGen to
make any payments to such third parties with respect to any of the Assets.
(o) SALES DATA. All historical sales, marketing and product expense
data provided to SuperGen by X-X concerning the Product is accurate in all
material respects as of the dates set forth therein.
(p) INVESTMENT EXPERIENCE. X-X is aware of SuperGen's business
affairs and financial condition and has acquired sufficient information about
SuperGen to reach an informed and knowledgeable decision to acquire the Shares.
(q) INVESTMENT INTENT. X-X 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. X-X
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 X-X
investment intent as expressed herein.
(r) REGISTRATION OR EXEMPTION REQUIREMENTS. X-X 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. X-X 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.
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(s) RULE 144. X-X 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 two years 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 maker," and the number
of shares being sold during any three-month period not exceeding specified
limitations. X-X 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 three
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.
(t) FURTHER LIMITATIONS ON DISPOSITION. Without in any way limiting
the representations set forth above or the limitations set forth in
Section 6.18, X-X further agrees that X-X 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) X-X 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) X-X
shall have furnished SuperGen with an opinion of X-X's counsel to the effect
that such disposition will not require registration of such stock under the
Securities Act and (C) such opinion of X-X's counsel shall have been concurred
with by counsel for SuperGen, which concurrence shall not be unreasonably
withheld, and SuperGen shall have advised X-X of such concurrence.
(u) FULL DISCLOSURE. No representation, warranty or statement of X-X
in this Agreement contains or will contain at the Closing Date any untrue
statement of a material fact or omits or will omit to state a material fact
necessary in order to make the statements contained herein, in light of the
circumstances under which made, not misleading.
3.02 REPRESENTATIONS AND WARRANTIES OF SUPERGEN. SuperGen hereby
represents and warrants to X-X as follows:
(a) DUE ORGANIZATION. SuperGen is a corporation duly organized,
validly existing and in good standing under the laws of the State of California
and has all requisite power and authority to own, operate and lease its
properties and to carry on its business as now being conducted.
(b) POWER AND AUTHORITY. SuperGen has full corporate power and
authority to enter into this Agreement and to consummate the transactions
contemplated hereunder, and the execution, delivery and performance of this
Agreement and the transactions contemplated hereby by SuperGen have been duly
and validly authorized by proper corporate action, and no other
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proceedings on the part of SuperGen are necessary to authorize this Agreement
and the transactions contemplated hereby.
(c) LEGALITY AND VALIDITY. This Agreement has been duly executed and
delivered by SuperGen and constitutes a legal, valid and binding obligation of
SuperGen, enforceable against SuperGen in accordance with its terms, subject to
the general principles of equity and except as the enforceability hereof may be
limited by applicable bankruptcy, insolvency, reorganization or other similar
laws of general application relating to creditors' rights.
(d) NO VIOLATION. The execution, delivery and performance of this
Agreement by SuperGen shall not (i) conflict with or result in any breach of any
provision of the Certificate of Incorporation or Bylaws of SuperGen; or
(ii) violate any order, writ, injunction, decree, or any statute, rule or
regulation applicable to SuperGen or its Affiliates or any of its properties or
assets.
(e) LITIGATION. There are no actions, suits, proceedings, claims or
investigations pending, nor has SuperGen received written notice of any threats
of any of the foregoing, against SuperGen with respect to the transactions
contemplated hereby or which, if adversely determined would prevent SuperGen
from consummating the transactions contemplated hereby.
(f) TITLE TO SHARES. The Shares are duly authorized, validly issued,
fully paid and nonassessable. The delivery of a certificate or certificates at
the Closing representing the Shares in the manner provided in Section 2.04(a)
will transfer to X-X good and valid title to the Shares, free and clear of all
liens.
(g) REPORTS. As of their respective dates, SuperGen's material
reports filed with the Securities and Exchange Commission (the "SuperGen SEC
Reports") and provided to X-X complied in all material respects with the
requirements of the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended, as the case may be, and the rules and
regulations of the Securities and Exchange Commission thereunder applicable to
such SuperGen SEC Reports. As of their respective dates, the SuperGen SEC
Reports did not contain any untrue statement of a material fact or omit to state
a material fact required to be stated therein or necessary to make the
statements therein, in the light of the circumstances under which they were
made, not misleading.
(h) FULL DISCLOSURE. No representation, warranty or statement of
SuperGen in this Agreement contains or will contain at the Closing Date any
untrue statement of a material fact or omits or will omit to state a material
fact necessary in order to make the statements contained herein, in light of the
circumstances under which made, not misleading.
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ARTICLE IV
LICENSE TO X-X
4.01 LICENSE TO X-X. Subject to Section 6.16, SuperGen hereby grants to
X-X, effective as of the Closing Date, an irrevocable, non-exclusive, worldwide,
perpetual and royalty-free license to use the Acquired Know-How in or outside of
the Territory to the extent necessary to manufacture Product to be sold
exclusively outside of the Territory (provided, however, that Product shall not
be deemed to be sold within the Territory if ownership title passes within the
Territory for resale and use exclusively outside the Territory). X-X may,
without restriction, sublicense or assign its rights granted in the foregoing
license to any third party, provided, however, that such party agrees to be
bound by Section 6.16 of this Agreement to the same extent as X-X.
ARTICLE V
LICENSE TO SUPERGEN
5.01 LICENSE TO SUPERGEN. X-X hereby grants to SuperGen, effective as of
the Closing Date, an irrevocable, non-exclusive, worldwide, perpetual and
royalty-free license to use the Licensed Know-How and any other intellectual
property owned or licensed by X-X at the Closing Date necessary or helpful in
the manufacture of Pentostatin or Product. SuperGen may, without restriction,
sublicense or assign its rights granted in the foregoing license to any third
party, provided, however, that such party agrees to be bound by Section 6.17 of
this Agreement to the same extent as SuperGen.
ARTICLE VI
COVENANTS
X-X covenants and agrees with SuperGen and SuperGen covenants and agrees
with X-X as follows:
6.01 SUPPORT AND SERVICES. From and after the Closing Date X-X shall
actively cooperate with and assist SuperGen in its efforts to obtain FDA
Approval. Without limiting the foregoing, X-X shall provide SuperGen with such
technical assistance and personnel as may be reasonably required or helpful to
SuperGen, including, but not limited to, making available at such sites as
designated by SuperGen, employees of X-X ("Support Employees") to assist
SuperGen in establishing manufacturing capacity for the Product and all other
matters relating to the manufacture of the Product, provided, however, that in
the event Support Employees are required to travel, SuperGen shall pay the
reasonable travel and out-of-pocket expenses of such Support Employees.
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6.02 ASSIGNMENT OF CERTAIN RIGHTS AND OBLIGATIONS UNDER AGREEMENTS. X-X
shall assign to SuperGen and SuperGen shall assume the rights and obligations to
the Clinical Study Agreements, subject to the receipt of the required consent of
any party to the assignment of such Clinical Study Agreements. X-X shall use
its reasonable commercial efforts to obtain all consents required for such
assignments of the Clinical Study Agreements and shall furnish copies of each
such consent to SuperGen. To the extent an agreement cannot be assigned by X-X
to SuperGen, SuperGen shall not be responsible (and X-X shall remain liable for)
any liabilities and obligations relating to such Clinical Study Agreement.
6.03 POST-CLOSING ORDERS. After the Closing Date, X-X agrees to forward to
SuperGen all unfilled orders for Product received after the Closing Date.
6.04 SALE OF THE PRODUCT. (a) X-X hereby agrees that SuperGen shall have
the right to sell in the Territory any Inventory bearing the "Xxxxx-Xxxxx" or
"Xxxxxx-Xxxxxxx Company" name which may be included in the Assets. SuperGen
agrees to maintain any such Inventory under conditions required by the NDA and
any other applicable laws and regulations in order to assure that the Product
meets all approved specifications at the time of distribution.
(b) SuperGen agrees to use its commercially reasonable efforts to
change the labeling of Product packaged after the Closing Date so as to not
include any reference to "Xxxxx-Xxxxx" or "Xxxxxx-Xxxxxxx Company", at
SuperGen's sole cost and expense. Such change shall take place as soon as
reasonably practicable but in no event later than 9 months from the Closing
Date.
6.05 TEST DRUM AND TESTING. X-X agrees to use its commercially reasonable
efforts to assist SuperGen in determining the best manner of transporting,
handling and storing the Bulk Active Ingredient. In this respect, X-X agrees
to, at SuperGen's expense, provide such assistance as may be required or
helpful, as reasonably determined by SuperGen, including, but not limited to,
undertaking reasonable instructions from SuperGen with respect to the breaking-
up of one drum of Bulk Active Ingredient (the "Test Drum") into several
containers, assisting SuperGen in testing and gathering data and information
regarding the stability of the Bulk Active Ingredient under various conditions
and making employees of X-X available to assist SuperGen with respect to the
foregoing. Until such time as SuperGen has determined that it has sufficient
information, data and knowledge with respect to the transportation, handling and
storage of the Bulk Active Ingredient, X-X agrees to store the Bulk Active
Ingredient, other than the Test Drum, with the same care and in compliance with
the same procedures it has stored such Bulk Active Ingredient prior to the
Closing; provided, however, that X-X shall not be required to store the Bulk
Active Ingredient for longer than 30 days following the completion of the
testing on the Test Drum.
6.06 PRODUCT TESTING. Except as set forth in Section 6.05 above or
otherwise agreed by the parties, SuperGen shall be responsible for conducting
all applicable stability and release testing and any other actions required by
the NDA or other applicable laws and regulations in the Territory in respect of
Product sold after the Closing Date.
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6.07 THE DRUG MASTER FILES. X-X shall provide SuperGen with reasonable
access to and the right to use without further charge by X-X the Drug Master
Files upon the prior written request of SuperGen.
6.08 EXPENSES. Whether or not the transactions contemplated hereunder are
consummated, all costs, expenses and disbursements incurred in connection with
this Agreement and the transactions contemplated hereunder, except as otherwise
provided herein, shall be paid by the party incurring such costs and expenses.
6.09 DRUM BUY-BACK. To the extent available at the time, SuperGen agrees
to sell X-X one drum of Bulk Active Ingredient at a cash purchase price of
$125,000, plus 10% interest per annum, which obligation will terminate six years
from the Closing.
6.10 REGISTRATION RIGHTS. The parties shall enter into a registration
rights agreement within 30 days after the Closing Date, pursuant to which
SuperGen shall provide X-X beginning two years after the Closing Date one demand
registration and piggyback registration rights (subject to standard underwriter
cutbacks).
6.11 ACTION. The parties shall take, or cause to be taken, all action, and
do, or cause to be done, all things necessary, proper or advisable under
applicable laws and regulations to consummate and make effective the
transactions contemplated by this Agreement.
6.12 CONSENTS. Each of the parties hereto shall cooperate with the other
party and shall use reasonable commercial efforts to obtain all material
consents of all Persons necessary to effect the transactions contemplated by
this Agreement.
6.13 PUBLIC ANNOUNCEMENTS. Except as required by law, X-X and SuperGen
shall obtain the other party's prior written approval of any press release to be
issued announcing the consummation of the transactions contemplated by this
Agreement.
6.14 FURTHER ASSURANCES. From time to time, without further consideration,
each party, at its own expense, shall execute and deliver such documents to the
other party as such other party may reasonably request in order more effectively
to consummate the transactions contemplated hereby. In addition, without
limiting and subject to the indemnification set forth in Section 8.04, X-X
agrees that it will reasonably cooperate, at SuperGen's request, in the event of
any litigation regarding the Assets, provided that SuperGen agrees to pay X-X's
out-of-pocket expenses relating thereto.
6.15 SALES AND TRANSFER TAXES. All sales and transfer taxes, if any,
incurred in connection with this Agreement and the transactions contemplated
hereby shall be borne by X-X. X-X shall further file all necessary tax returns
and all other documentation with respect to such sales and transfer taxes.
SuperGen shall, at its sole expense, provide all relevant sales tax exemption
certificates and, if required by applicable law, SuperGen shall join in the
execution of any such certificates, tax returns or other documentation, as may
be reasonably required.
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6.16 X-X'S COVENANT NOT TO COMPETE.
(a) In furtherance of the transactions contemplated by this Agreement
and in order to secure the interests of the parties hereto, X-X agrees that it
will not, for a period of 10 years from the Closing Date, for any reason
whatsoever, directly or indirectly, for itself or on behalf of or in conjunction
with any other Person:
(i) sell Product anywhere in the Territory or have any ownership
interest in, or participate in the financing, operation, management or control
of any Person selling Product in the Territory or enter into any partnership,
joint venture or similar collaborative arrangement with any Person to sell
Product in the Territory, or knowingly transfer Product to a third person with
the intent to sell Product in the Territory; provided, however, that Product
shall not be deemed to be sold within the Territory if ownership title passes
within the Territory for resale and use exclusively outside the Territory.
(ii) call upon any person who is at that time an employee of
SuperGen who is engaged in any aspect of SuperGen's Product related business for
the purpose or with the intent of enticing such employee away from or out of the
employ of SuperGen.
(b) It is expressly understood and agreed that, if any of the
agreements contained in this Section 6.16 are for any reason found to be
unreasonably broad, oppressive or unenforceable in an action, suit or proceeding
before any federal or state court, such court (i) shall narrow the covenant not
to compete or shall otherwise endeavor to reform the scope of such agreements in
order to ensure that the application thereof is not unreasonably broad,
oppressive or unenforceable and (ii) to the fullest extent permitted by law,
shall enforce such agreements as so reformed.
(c) All of the covenants in this Section 6.16 shall be construed as
an agreement independent of any other provision in this Agreement, and the
existence of any claim or cause of action of X-X against SuperGen, whether
predicated on this Agreement or otherwise, shall not constitute a defense to the
enforcement by SuperGen of such covenants. It is specifically agreed that the
period of ten years stated at the beginning of this Section 6.16, during which
the agreements and covenants of X-X made in this Section 6.16 shall be
effective, shall be computed by excluding from such computation any time during
which X-X is found by a court of competent jurisdiction to have been in
violation of any provision of this Section 6.16. The covenants contained in
Section 6.16 shall not be affected by any breach of any other provision hereof
by an party hereto and shall have no effect if the transactions contemplated by
this Agreement are not consummated.
(d) X-X and SuperGen hereby agree that the covenants set forth in
this Section 6.16 are a material and substantial part of the transactions
contemplated by this Agreement.
(e) Because of the difficulty of measuring economic losses to
SuperGen as a result of a breach of the restrictive covenants set forth in this
Section 6.16, and because of the immediate and irreparable damage that would be
caused to SuperGen for which monetary damages would not be a sufficient remedy,
it is hereby agreed that in addition to all other remedies that may be available
to
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SuperGen at law or in equity, SuperGen shall be entitled to specific performance
and any injunctive or other equitable relief as a remedy for any breach or
threatened breach of the aforementioned restrictive covenants.
6.17 SUPERGEN'S COVENANT NOT TO COMPETE.
(a) In furtherance of the transactions contemplated by this Agreement
and in order to secure the interests of the parties hereto, SuperGen agrees that
it will not, for a period of 10 years from the Closing Date, for any reason
whatsoever, directly or indirectly, for itself or on behalf of or in conjunction
with any other Person sell Product for anti-cancer indications anywhere outside
the Territory or have any ownership interest in, or participate in the
financing, operation, management or control of any Person selling Product for
anti-cancer indications outside the Territory or enter into any partnership,
joint venture or similar collaborative arrangement with any Person to sell
Product for anti-cancer indications outside the Territory, or knowingly
transfer Product to a third person with the intent to sell Product with anti-
cancer indications outside the Territory; provided, however, that Product for
anti-cancer indications shall not be deemed to be sold outside the Territory if
ownership title passes outside the Territory for resale and use exclusively
within the Territory.
Notwithstanding the above, the foregoing covenant shall not be deemed
to prohibit SuperGen (i) from acquiring as an investment not more than five
percent (5%) of the capital stock of a business engaged in the activities
described in the paragraph above whose stock is traded on a national securities
exchange or over-the-counter, (ii) from being acquired by a business which is
engaged in the activities described above (in which event this Section 6.17
shall have no effect and shall not be binding upon the acquiror), or (iii) from
selling Product outside the Territory anywhere in the world so long as it
complies with the noncompetition provisions relating to Product for anti-cancer
indications set forth above. In addition, it shall not be deemed to be a
violation of this covenant in the event any governmental or regulatory requires
that a Product include a labeling for an anti-cancer indication where SuperGen
is seeking regulatory approval for a different indication.
(b) It is expressly understood and agreed that, if any of the
agreements contained in this Section 6.17 are for any reason found to be
unreasonably broad, oppressive or unenforceable in an action, suit or proceeding
before any federal or state court, such court (i) shall narrow the covenant not
to compete or shall otherwise endeavor to reform the scope of such agreements in
order to ensure that the application thereof is not unreasonably broad,
oppressive or unenforceable and (ii) to the fullest extent permitted by law,
shall enforce such agreements as so reformed.
(c) All of the covenants in this Section 6.17 shall be construed as
an agreement independent of any other provision in this Agreement, and the
existence of any claim or cause of action of SuperGen against X-X, whether
predicated on this Agreement or otherwise, shall not constitute a defense to the
enforcement by X-X of such covenants. It is specifically agreed that the period
of ten years stated at the beginning of this Section 6.17, during which the
agreements and covenants of SuperGen made in this Section 6.17 shall be
effective, shall be computed by excluding from such computation any time during
which SuperGen is found by a court of competent jurisdiction to have been in
violation of any provision of this Section 6.17. The covenants contained in
Section
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6.17 shall not be affected by any breach of any other provision hereof by an
party hereto and shall have no effect if the transactions contemplated by this
Agreement are not consummated.
(d) SuperGen and X-X hereby agree that the covenants set forth in
this Section 6.17 are a material and substantial part of the transactions
contemplated by this Agreement.
(e) Because of the difficulty of measuring economic losses to X-X as
a result of a breach of the restrictive covenants set forth in this Section
6.17, and because of the immediate and irreparable damage that would be caused
to X-X for which monetary damages would not be a sufficient remedy, it is hereby
agreed that in addition to all other remedies that may be available to X-X at
law or in equity, X-X shall be entitled to specific performance and any
injunctive or other equitable relief as a remedy for any breach or threatened
breach of the aforementioned restrictive covenants.
6.18 RESTRICTION ON SHARES. X-X covenants and agrees that it will not
sell, transfer or otherwise dispose of its title to or interest in the Shares
acquired pursuant to Section 2.02(a) for a period of 2 years from the Closing
Date, provided, that, such restriction shall not apply in the event of a change
in control of SuperGen. As used herein, "change in control" means that, after
the Closing Date, a third party acquires more than 50% of the outstanding voting
securities of SuperGen (through a reverse triangular merger or otherwise).
6.19 AHP SUPPLY AGREEMENT. SuperGen covenants, that should it be requested
by X-X, it will negotiate in good faith with AHP the terms of an agreement under
which SuperGen shall supply Product or arrange for the supply of Product to AHP
outside of the Territory, provided, that, SuperGen shall not be obligated to
enter into such an agreement if the parties cannot mutually agree on the terms
of such agreement after good faith negotiations. In the event SuperGen does not
enter into a supply agreement with AHP, SuperGen covenants it will negotiate in
good faith with X-X the terms of an agreement under which SuperGen shall supply
Product or arrange for the supply of Product to X-X, in order for X-X to meet
its obligations under the Distribution Agreement to supply AHP; provided that
SuperGen shall not be obligated to enter into such an agreement if the parties
cannot mutually agree on the terms of such agreement after good faith
negotiations.
6.20 CONTRACT CUSTOMERS. SuperGen covenants that, to the extent Product is
available and subject to SuperGen's standard terms and conditions, it will sell
Product to each of the customers appearing on Exhibit C at the corresponding
contract prices (subject to the price expiration dates set forth on Exhibit C).
-15-
ARTICLE VII
CONDITIONS TO CLOSING
7.01 CONDITIONS TO OBLIGATIONS OF SUPERGEN. The obligations of SuperGen
under Section 2.02 of this Agreement are subject to the satisfaction at or prior
to the Closing Date of the following conditions, provided that compliance with
any such conditions or parts thereof may be waived by SuperGen:
(a) X-X shall have delivered to SuperGen all documents reasonably
necessary in order to complete any and all transfers and assignments provided
for in this Agreement.
(b) X-X shall have obtained all material orders, permits,
authorizations, consents and approvals and shall have made all material filings
and declarations required for the consummation of the transactions contemplated
hereby.
7.02 CONDITIONS TO OBLIGATIONS OF X-X. The obligations of X-X under
Section 2.01 of this Agreement are subject to the satisfaction at or prior to
the Closing Date of the condition that SuperGen shall have obtained all material
orders, permits, authorizations, consents and approvals and shall have made all
material filings and declarations required for the consummation of the
transactions contemplated hereby; provided that compliance with any such
conditions or parts thereof may be waived by X-X.
7.03 CONDITIONS TO OBLIGATIONS OF EACH PARTY. The respective obligations
of each party under this Agreement are subject to the satisfaction on the
Closing Date of the following conditions, provided that compliance with any
such conditions or parts thereof may be waived by the applicable party:
(a) The representations and warranties of each party made in
Article III shall be true and each party shall have performed all obligations
and conditions herein required to be performed or observed by it on or prior to
the Closing Date.
(b) No temporary restraining order, preliminary or permanent
injunction or other order issued by any court of competent jurisdiction or other
legal or regulatory restraint or provision challenging the consummation of the
transactions contemplated by the Agreement shall be in effect, nor shall any
proceeding brought by a Governmental or Regulatory Authority, seeking the
foregoing be pending. There shall be no action, suit, claim or proceeding of
any nature pending or threatened, against SuperGen or X-X that could materially
and adversely affect the ability of SuperGen to manufacture and sell the
Product.
-16-
ARTICLE VIII
GENERAL PROVISIONS
8.01 ADDITIONAL INDICATION. In the event that SuperGen receives FDA or a
counterpart agency outside of the United States approval for use of the Product
in the treatment of rheumatoid arthritis (the "Additional Indication"), X-X
shall be entitled to an annual royalty in an amount equal to 9% of Net Sales (as
defined below) of Products labeled for such Additional Indication in the
particular country (in or outside of the Territory) when there is Marketing
Exclusivity (as defined below) in that country for the Additional Indication and
3% on Net Sales of Products labeled for such Additional Indication when there is
no Marketing Exclusivity in that country. As used herein, the term "Net Sales"
means the actual gross sales proceeds received by SuperGen and its Affiliates
from unrelated third parties for the Additional Indication, calculated as gross
invoice amounts less each and all of the following: rebates, trade, quantity
and cash discounts, if any, actually allowed or paid; allowances and adjustments
actually granted to customers; returns; sales taxes, duties or other
governmental charges levied on, absorbed or otherwise imposed on sales of the
Additional Indication; and transportation costs and insurance if separately
stated on the invoice. As used herein, the term "Royalty Period" shall mean the
10 year period that begins on the day Net Sales are first achieved; PROVIDED,
HOWEVER, that the Royalty Period cannot begin after the 10th anniversary of this
Agreement. As used herein, the term "Marketing Exclusivity" means that the FDA
or a counterpart agency in another country has agreed that it will not permit a
third party to market a product containing Pentostatin indicated for rheumatoid
arthritis. SuperGen shall notify X-X as soon as SuperGen reasonably believes
that a Royalty Period shall begin and the parties shall enter into a royalty
agreement to confirm the obligation of SuperGen to make royalty payments in
accordance with this Section 8.01, said royalty agreement to contain terms and
conditions which are customary for similar agreements. It is understood and
agreed however that the obligation on the part of SuperGen to remit royalties in
accordance with this Section 8.01 is not contingent upon the parties having
entered into a royalty agreement.
8.02 RETURNS. Any returns of the Product sold before or after the Closing
Date in the Territory, whether returned to SuperGen or X-X, shall be for the
account of SuperGen; provided, however, that any returns which are outdated as
of the Closing Date shall be for X-X's account. X-X shall notify SuperGen in
writing within 30 days of its receipt of any returns of the Product received by
X-X in accordance with this Section 8.02 and SuperGen shall promptly at is own
cost arrange for collection of such returns. SuperGen shall handle and value
all such returns in accordance with the applicable Return Goods Policy of X-X (a
copy of which has been provided by X-X to SuperGen).
8.03 REPRESENTATIONS AND WARRANTIES. SuperGen acknowledges that X-X has
not made any representations or warranties of any kind, either express or
implied, except as expressly set forth in this Agreement. SUPERGEN AGREES THAT
THE REPRESENTATIONS AND WARRANTIES GIVEN HEREIN BY X-X ARE IN LIEU OF, AND
SUPERGEN HEREBY EXPRESSLY WAIVES ALL RIGHTS TO, ANY IMPLIED WARRANTIES WHICH MAY
OTHERWISE BE APPLICABLE BECAUSE OF THE PROVISIONS OF ANY STATUTE, INCLUDING,
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WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
8.04 INDEMNIFICATION.
(a) INDEMNIFICATION BY X-X. X-X covenants and agrees to indemnify,
defend, protect and hold harmless SuperGen and its officers, directors,
employees, stockholders, assigns, successors and Affiliates (individually, a
"SuperGen Indemnified Party" and collectively, "SuperGen Indemnified Parties")
from, against and in respect of:
(i) all Losses suffered, sustained, incurred or paid by any
SuperGen Indemnified Party in connection with, resulting from or arising out of
or relating to, directly or indirectly:
(A) any breach of any representation or warranty of X-X set
forth in this Agreement or any certificate, document or instrument delivered by
or on behalf of X-X in connection herewith;
(B) any nonfulfillment of any covenant or agreement on the
part of X-X in this Agreement;
(C) claims or causes of actions relating in any way to the
Assets arising prior to the Closing, including but not limited claims or causes
of action relating to X-X's manufacture, promotion, use, sale or distribution of
Product;
(D) claims or causes of actions arising subsequent to the
Closing relating to X-X's manufacture of Product prior to the Closing;
(E) any breach in the terms of the license set forth in
Article V hereof;
(F) any negligent or reckless actions by X-X or its
employees in connection with the fulfillment of its obligations set forth in
this Agreement, including but not limited to the services provided by employees
of X-X pursuant to Section 6.01 and 6.05 above;
(G) the Non-Assumed Liabilities; and
(H) non-compliance with the terms and conditions of any
Bulk Sales Laws with respect to the transactions contemplated by this Agreement.
(ii) any and all Losses arising from the foregoing or to the
enforcement of this Section 8.04(a).
-18-
(b) INDEMNIFICATION BY SUPERGEN. SuperGen covenants and agrees to
indemnify, defend, protect and hold harmless X-X and its officers, directors,
employees, stockholders, assigns, successors and Affiliates (individually, a
"X-X Indemnified Party" and collectively, the "X-X Indemnified Parties") from,
against and in respect of:
(i) all Losses suffered, sustained, incurred or paid by any X-X
Indemnified Party in connection with, resulting from or arising out of or
relating to, directly or indirectly:
(A) any breach of any representation or warranty of
SuperGen set forth in this Agreement or any certificate or other writing
delivered by SuperGen in connection herewith;
(B) any nonfulfillment of any covenant or agreement on the
part of SuperGen set forth in this Agreement; and
(C) Subject to Sections 8.04(a)(i)(D) and (F), SuperGen's
promotion, use, sale or distribution of Product after the Closing Date.
(ii) any and all Losses arising from the foregoing or to the
enforcement of this Section 8.04(b).
(c) All Claims for indemnification under this Section 8.04 shall be
asserted and resolved as follows:
(i) Any party that may be entitled to indemnification under this
Agreement, (an "Indemnified Party") shall send a Claim Notice (as defined below)
to the party obligated to indemnify it (an "Indemnifying Party") with reasonable
promptness upon becoming aware of any claim or other facts upon which a claim
for indemnification might be based. If the Indemnifying Party does not notify
the Indemnified Party within 30 days from the date of receipt of such Claim
Notice that the Indemnifying Party disputes such claim, the amount of such claim
shall be conclusively deemed a liability of the Indemnifying Party hereunder.
In case the Indemnifying Party shall object in writing to any claim made in
accordance with this Section 8.04(e), the Indemnified Party shall have fifteen
(15) days to respond in a written statement to the objection of the Indemnifying
Party. If after such fifteen (15) day period there remains a dispute as to any
claims, the parties shall attempt in good faith for sixty (60) days to agree
upon the rights of the respective parties with respect to each of such claims.
If the parties should so agree, a memorandum setting forth such agreement shall
be prepared and signed by both parties.
(ii) In the event that any claim for which an Indemnifying Party
would be liable to an Indemnified Party hereunder is asserted against an
Indemnified Party by a third party, the Indemnified Party shall with reasonable
promptness notify the Indemnifying Party of such claim, including a copy of the
claim made if the claim was made in writing, specifying the nature of such claim
and the amount or the estimated amount thereof to the extent then feasible
(which estimate shall not be conclusive of the final amount of such claim) (the
"Claim Notice"). The Indemnifying Party
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shall have 30 days from the receipt of the Claim Notice (the "Notice Period") to
notify the Indemnified Party (i) whether or not the Indemnifying Party disputes
the Indemnifying Party's liability to the Indemnified Party hereunder with
respect to such claim and (ii) if the Indemnifying Party does not dispute such
liability, whether or not the Indemnifying Party desires, at the sole cost and
expense of the Indemnifying Party, to defend against such claim, provided that
the Indemnifying Party is hereby authorized (but not obligated) prior to and
during the Notice Period to file any motion, answer or other pleading and to
take any other action which the Indemnifying Party shall deem necessary or
appropriate to protect the Indemnifying Party's interests. In the event that
the Indemnifying Party notifies the Indemnified Party within the Notice Period
that the Indemnifying Party does not dispute the Indemnifying Party's obligation
to indemnify hereunder and desires to defend the Indemnified Party against such
claim and except as hereinafter provided, the Indemnifying Party shall have the
right to defend by appropriate proceedings, which proceedings shall be
diligently settled or prosecuted by the Indemnifying Party to a final
conclusion; PROVIDED that, unless the Indemnified Party otherwise agrees in
writing, the Indemnifying Party may not settle any matter (in whole or in part)
unless such settlement includes a complete and unconditional release of the
Indemnified Party. If the Indemnified Party desires to participate in, but not
control, any such defense or settlement the Indemnified Party may do so at the
Indemnified Party's sole cost and expense. If the Indemnifying Party elects not
to defend the Indemnified Party against such claim, whether by failure of the
Indemnifying Party to give the Indemnified Party timely notice as provided above
or otherwise, then the Indemnified Party, without waiving any rights against the
Indemnifying Party, may settle or defend against any such claim in the
Indemnified Party's sole discretion and the Indemnified Party shall be entitled
to recover from the Indemnifying Party the amount of any settlement or judgment
and, on an ongoing basis, all indemnifiable costs and expenses of the
Indemnified Party with respect thereto, including interest from the date such
costs and expenses were incurred.
(iii) Nothing herein shall be deemed to prevent an
Indemnified Party from making a claim, and an Indemnified Party may make a claim
hereunder, for potential or contingent claims or demands provided the Claim
Notice sets forth the specific basis for any such potential or contingent claim
or demand to the extent then feasible and an Indemnified Party has reasonable
grounds to believe that such a claim or demand may be made.
(iv) The Indemnified Party's failure to give reasonably prompt
notice to the Indemnifying Party of any actual, threatened or possible claim or
demand which may give rise to a right of indemnification hereunder shall not
relieve the Indemnifying Party of any liability which the Indemnifying Party may
have to the Indemnified Party unless the failure to give such notice materially
and adversely prejudiced the Indemnifying Party.
8.05 INDEMNIFICATION FOR BROKERAGE CLAIMS. X-X and SuperGen each
represents that no broker or finder has been used in connection with the
transactions contemplated by this Agreement and X-X and SuperGen shall mutually
indemnify the other against any claim for brokerage or like commission arising
from each other's conduct or alleged conduct.
8.06 SURVIVAL OF REPRESENTATIONS, WARRANTIES AND COVENANTS. All
representations, warranties and covenants contained in this Agreement shall
survive for a period of four years from the
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date hereof and thereafter shall be of no force or effect. Any claim for
indemnification with respect thereto must be asserted by written notice to the
Indemnifying Party prior to such date.
8.07 ASSIGNABILITY AND AMENDMENTS. This Agreement may not be assigned by
either party without the prior written consent of the other party, which consent
shall not be unreasonably withheld, except that, subsequent to the Closing Date,
either party may assign this Agreement to any of its Affiliates, provided, that
such Affiliates agree to be bound by the provisions of this Agreement. No such
assignment will relieve the assigning party of any of its liabilities hereunder.
This Agreement cannot be altered or otherwise amended except pursuant to an
instrument in writing signed by each of the parties.
8.08 NOTICES. All notices or communications to be given hereunder will be
deemed to have been duly given only if delivered personally or by facsimile
transmission or by registered or certified mail (first class or air mail in the
case of international correspondence, postage prepaid) or by an internationally
recognized common carrier's overnight courier to the parties at the following
addresses or facsimile numbers:
If to X-X. addressed to:
Xxxxxx-Xxxxxxx Company
000 Xxxxx Xxxx
Xxxxxx Xxxxxx, Xxx Xxxxxx 00000
Attention: Vice President and President,
Pharmaceutical Sector
Facsimile No.: 000-000-0000
with a copy to: Vice President and General Counsel
Facsimile No.: 000-000-0000
If to SuperGen, addressed to:
SuperGen, Inc.
0000 Xxxxxx Xxxxxx
Xxxxxxxxxx, Xxxxxxxxxx 00000
Attention: Chief Executive Officer
Facsimile No.: (000) 000-0000
All such notices, requests and other communications shall (i) if delivered
personally to the address as provided in this Section, be deemed given upon
delivery, (ii) if delivered by facsimile transmission to the facsimile number
provided in this Section, be deemed given upon receipt, and (iii) if delivered
by registered or certified mail or overnight courier in the manner described
above at the address provided in this Section, be deemed given upon receipt (in
each case regardless of whether such notice, request or other communication is
received by any other Person to whom a copy of such notice is to be
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delivered pursuant to this Section). Either party from time to time may change
its address, facsimile number upon written notice to the other party.
8.09 RECALLS OR WITHDRAWALS. X-X shall have the right to control and
direct any recall or withdrawal with respect to any Product sold by X-X prior to
the Closing Date or any Product bearing the name of X-X after the Closing Date.
SuperGen shall have the right to control and direct any other recall or
withdrawal of any other Product. With respect to any recall or withdrawal,
SuperGen and X-X shall cooperate fully with each other but all final decisions,
including, without limitation, the necessity of the recall or withdrawal, the
manner in which the recall or withdrawal is conducted and the duration of the
recall or withdrawal, shall be made by X-X with respect to recalls or
withdrawals it controls and by SuperGen with respect to recalls or withdrawals
it controls, in accordance with this Section 8.09. Each party shall bear its
own costs in connection with any recall or withdrawal that it controls in
accordance with this provision and any liability resulting therefrom shall be
limited to direct damages.
8.10 FDA REPORTING. After the Closing Date, SuperGen shall be responsible
for compliance with all applicable laws and regulations relating to reporting to
the FDA or similar Governmental or Regulatory Authorities in Mexico and Canada
with respect to Products, including, but not limited to, the filing of annual
reports and the filing and/or monitoring of adverse events or complaints
reported to X-X or SuperGen. In the event that such reports relate to Product
bearing the X-X name, SuperGen shall provide X-X of a copy of all related
documents to be filed with the FDA or similar Governmental or Regulatory
Authorities in Mexico and Canada 10 days prior to filing, and SuperGen agrees to
incorporate X-X's reasonable comments and to discuss with X-X any comments that
SuperGen believes to be unreasonable.
8.11 GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the State of Delaware.
8.12 ENTIRE AGREEMENT. This Agreement (including the Exhibits) contains
the entire agreement between the parties with respect to the transactions
contemplated hereby and supersedes all previous oral negotiations, commitments,
understandings and agreements executed and delivered prior to the respective
dates thereof.
8.13 CONFIDENTIALITY. Each party hereby agrees, and shall cause its
Affiliates to agree, that after the Closing Date, such party and its Affiliates
shall hold in confidence and not disclose to any third Person, nor use for its
own benefit any confidential or proprietary information of the other party or
its Affiliates that is disclosed to or discovered by such party or its
Affiliates in connection with the transactions contemplated hereby, unless (i)
such information becomes known to the public generally through no fault of such
party or its Affiliates or (ii) disclosure is required by law or the order of
any Governmental and Regulatory Authority under color of law.
8.14 TO THE BEST KNOWLEDGE. Notwithstanding any other term or provision of
this Agreement, whenever any representation or warranty is made by one of the
parties hereto "to the best
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of its knowledge," such party shall not be required to have conducted any
specific investigation with respect to the matter to which the representation or
warranty relates.
8.15 WAIVERS. Any waiver must be explicitly in writing. A waiver of any
breach or failure to enforce any of the terms or conditions of this Agreement
shall not in any way affect, limit, or waive a party's rights at any time to
enforce strict compliance thereafter with every term or condition of this
Agreement.
8.16 COUNTERPARTS AND HEADINGS. This Agreement may be executed in
counterparts, each of which shall be deemed an original and all of which
together shall constitute one and the same instrument. All headings in this
Agreement are inserted for convenience of reference only and shall not affect
its meaning or interpretation.
8.17 SEVERABILITY. If any provision of this Agreement is held to be
illegal, invalid or unenforceable under any applicable present or future law,
and if the rights or obligations of any party hereto under this Agreement will
not be materially and adversely affected thereby, (a) such provision will be
fully severable, (b) this Agreement will be construed and enforced as if such
illegal, invalid or unenforceable provision had never comprised a part hereof,
(c) the remaining provisions of this Agreement will remain in full force and
effect and will not be affected by the illegal, invalid or unenforceable
provision or by its severance herefrom and (d) in lieu of such illegal, invalid
or unenforceable provision, there will be added automatically as a part of this
Agreement, a legal, valid and enforceable provision as similar in terms to such
illegal, invalid or unenforceable provision as may be possible.
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly
executed by their respective duly authorized officers, all as of the date first
above written.
XXXXXX-XXXXXXX COMPANY
/s/ Xxxxxxx X. Wild
-----------------------------------
Name: Xxxxxxx X. Wild
Title: President Pharmaceutical Sector
SUPERGEN, INC.
/s/ Xxxxx Xxxxxxx
-----------------------------------
Name: Xxxxx Xxxxxxx
Title: Vice President, Sales
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EXHIBIT A
BULK ACTIVE INGREDIENT
ITEM # DESCRIPTION LOT # QUANTITY
------------------ ----------------------------------- ------ -----------
002A041 Crude Concentrate 55151 400 KG
Pentostatin 55056 200 KG
55041 200 KG
Note: The above to be delivered in 8 drums.
EXHIBIT B
CLINICAL STUDY AGREEMENTS
Non-Governmental Clinical Study Agreement dated as of August 24, 1993 between
The University of Texas M.D. Xxxxxxxx Cancer Center and Xxxxxx-Xxxxxxx Company
relating to Cutaneous T-Cell Lymphoma.
Clinical Study Agreement dated as of December 16, 1993 between The University of
Chicago and Xxxxxx-Xxxxxxx Company relating to refractory rheumatoid arthritis.
Clinical Study Agreement dated as of November 11, 1992 between The University of
Chicago and Xxxxxx-Xxxxxxx Company relating to renal dysfunction.
Non-Governmental Clinical Study Agreement dated as of August 24, 1993 between
The University of Texas M.D. Xxxxxxxx Cancer Center and Xxxxxx-Xxxxxxx Company
relating to chronic lymphocytic leukemia.
EXHIBIT C
CUSTOMER LIST
HEALTH CARE SYSTEMS - DECISION SUPPORT SYSTEM
AWARDED CONTRACT PRICES FOR NIPENT 10MG (00071-4243-0100)
PRICES IN EFFECT ON: 08/31/1996
PRICE PRICE CONTRACT
MARKET SEGMENT CE NAME CONTRACT EFFECTIVE EXPIRES PRICE
-------------------------------------------------------------------------------------------------------------------------
ALTERNATE CARE AMERINET INC 00071-074 07/01/1995 06/30/1997 $1,176.00
HEALTHCARE PURCHASING PARTNERS 00014-009 04/12/1996 09/30/1998 $1,176.00
HLTH SERV CORP OF AMERICA 04446-048 10/01/1994 09/30/1998 $1,176.00
JOINT PURCHASING CORP 00044-155 07/01/1996 06/30/1998 $1,176.00
MANAGED HEALTHCARE ASSOC 04351-062 11/01/1996 06/30/1998 $1,176.00
MEDECON SERVICES INC 00195-058 05/17/1996 08/30/1998 $1,176.00
XXXX CO/COLUMBIA H.C.A. 00460-040 10/01/1995 03/31/1997 $1,176.00
PREMIER 00138-007 07/01/1996 06/30/1998 $1,173.00
PURCHASE CONNECTION CSS 00075-084 01/01/1995 01/31/1997 $1,178.00
SISTERS SORROWFUL MOTHER 00034-037 10/01/1994 08/30/1997 $1,176.00
XXXXX HEALTHCARE CORPORATION 00480-084 07/11/1996 08/31/1997 $1,176.00
VHA INC 00650-072 10/01/1995 09/30/1998 $1,176.00
CITY, XXX, XX XXXXXX XX XXX XXXXXXX 00000-000 02/01/1996 01/31/1997 $1,176.00
XXXXXXXXX XXXXX XXXX XXX 00000-000 01/30/1996 12/31/1996 $1,176.00
XXXXX XX XXXXXXXXXXX 00000-000 01/06/1996 12/31/1996 $1,176.00
XXXXX XX XXXXXXX 00000-000 12/01/1995 11/30/1996 $1,176.00
XXXXX XX XXXXXXXXX 00000-000 04/04/1996 03/31/1997 $1,176.00
XXXXX XX XXX XXXXXX 00000-000 04/01/1996 03/31/1997 $1,176.00
FED XXXX XXXXXX XX XXXXXXX/XXXXXX XXXX. 00000-000 01/15/1996 12/31/1996 $916.58
PUBLIC HEALTH SERVICE DEPOT 00316-005 01/15/1996 12/31/1996 $916.55
GRP PURCHASING ALLHEALTH 04054-080 03/01/1996 02/28/1998 $1,176.00
AMERINET INC 00071-073 07/01/1995 06/30/1997 $1,176.00
CATHOLIC MATERIAL MGMT ALL 00090-037 07/01/1994 06/30/1997 $1,176.00
HC PHARMACY CENTRAL INC 02190-038 07/24/1996 07/31/1997 $1,176.00
HEALTHCARE PURCHASING PARTNERS 00014-005 10/01/1995 09/30/1998 $1,176.00
HLTH SERV CORP OF AMERICA 04446-047 10/01/1994 09/30/1998 $1,176.00
HOSP CENTRAL SVC INC 00165-048 07/01/1996 06/30/1998 $1,176.00
HPI-VALUE RX 03265-092 01/07/1996 06/30/1997 $1,178.00
JOINT PURCHASING CORP 00044-154 07/01/1996 06/30/1998 $1,178.00
MANAGED HEALTHCARE ASSOC 04351-058 07/15/1995 06/30/1998 $1,178.00
MEDECON SERVICES INC 00195-057 05/17/1996 09/30/1998 $1,178.00
NATIONAL PURCH ALLINCE INC 00008-037 08/01/1996 06/30/1998 $1,176.00
HEALTH CARE SYSTEMS - DECISION SUPPORT SYSTEM
AWARDED CONTRACT PRICES FOR NIPENT 10MG (00071-4243-0100)
PRICES IN EFFECT ON: 08/31/1996
PRICE PRICE CONTRACT
MARKET SEGMENT CE NAME CONTRACT EFFECTIVE EXPIRES PRICE
-------------------------------------------------------------------------------------------------------------------------
GRP PURCHASING NEW JERSEY HOSP ASSOC 00200-053 12/01/1995 11/30/1996 $1,176.00
XXXX CO/COLUMBIA H.C.A. 00460-039 10/01/1995 03/31/1997 $1,176.00
PREMIER 00138-002 07/01/1996 06/30/1998 $1,173.00
SHARED SERVICES HEALTHCARE INC 00154-045 01/01/1998 12/31/1997 $1,176.00
SISTERS SORROWFUL MOTHER 00034-036 10/01/1994 09/30/1997 $1,176.00
XXXXX HEALTHCARE CORPORATION 00480-091 08/01/1995 08/31/1997 $1,176.00
UNIV HOSP CONSORT SVC CORP 02172-059 07/01/1995 06/30/1997 $1,176.00
VHA INC 00650-070 10/01/1995 09/30/1996 $1,176.00
HEALTH MAINT. FALLON CLINIC 02268-027 10/09/1993 03/31/1997 $1,176.00
HEALTH PARTNERS/GROUP HLTH INC 02953-048 01/01/1994 12/31/1996 $1,176.00
KAISER PRMNNTE MED CR PRGM 01038-059 10/09/1993 12/31/1998 $1,176.00
HOSPITAL HOSP PURCH SVC OF MICHIGAN 00280-055 01/01/1996 12/31/1996 $1,178.00
PURCHASE CONNECTION CSS 00075-083 01/01/1995 01/31/1997 $1,178.00
MILITARY MILITARY DEPOT (DPSC) 00312-015 05/07/1996 12/31/1996 $918.56
MILITARY MON DEPOT (OAPA) 02003-007 01/11/1994 11/30/1997 $912.00
02003-016 05/07/1996 11/30/1997 $915.56
VALUE RX INC. 00028-003 11/01/1995 10/31/1996 $912.00
NURSING HM SPL GERMED 02742-038 12/18/1995 10/30/1998 $1,176.00
02742-042 07/17/1996 10/30/1998 $1,176.00
02742-043 07/17/1996 10/30/1998 $1,176.00
MANAGED HEALTHCARE ASSOC 04351-054 07/15/1995 06/30/1998 $1,176.00
MEDECON SERVICES INC 00195-059 05/17/1996 09/30/1998 $1,178.00
PHARMACY CORP OF AMERICA (PCA) 02733-040 01/27/1995 09/30/1997 $1,178.00
XXXXX HEALTHCARE CORPORATION 00480-093 09/01/1995 08/31/1997 $1,176.00
VETERANS ADMIN VA DEPOT-DIRECT ONLY 00298-008 01/15/1996 12/31/1996 $916.58
VA STATE HOMES 00328-008 01/15/1998 12/31/1996 $916.58
VA-NON DEPOT 02004-018 01/15/1996 12/31/1996 $916.58
Total Number of Contracts: 59 Average contract Price: $1,136.17
EXHIBIT D
INVENTORY
ITEM # DESCRIPTION LOT # QUANTITY
---------------- ----------------------------------- ----- ---------------
4243A951 Nipent (unlabelled)
Vials 41900 1,383 vials
(unpackaged Product)
4243-01 Nipent (Pentostatin for inj. 5 mg/ml) 03905P 577 sales units
10 mg/vial -
one vial in a unit carton
packed into a 10 pack
accumulator carton
shippers of 100 vials
EXHIBIT E
TRADEMARKS
Trademarks Country Reg. No.
-------------------------------- ---------------------- ------------------
XXXXXX XXX 0000000
XXXXXX Xxxxxx TMA425513
XXXXXX Xxxxxx 000000
ONCOPENT Mexico 416729
