[* * *] REDACTED CONFIDENTIAL TREATMENT REQUESTED
SUPPLY AGREEMENT
between
SUPERGEN, INC.
and
XXXXXX-XXXXXXX COMPANY
TABLE OF CONTENTS
PAGE
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ARTICLE I DEFINITIONS........................................................1
1.1 Definitions..........................................................1
ARTICLE II PURCHASE AND SUPPLY...............................................3
2.1 Supply...............................................................3
2.3 Purchase Price.......................................................3
2.4 Payment..............................................................3
2.5 Title and Risk of Loss...............................................4
2.6 Conflicting Terms....................................................4
2.7 Regulatory Requirements..............................................4
2.8 Orders and Inventory.................................................5
2.9 Forecasts............................................................5
2.10 Force Majeure........................................................6
2.11 Warranties...........................................................6
2.12 Claims...............................................................7
2.13 Indemnification......................................................8
2.14 Limitation to the Territory.........................................10
ARTICLE III Confidentiality and Non-Compete.................................10
3.1 Confidentiality.....................................................10
3.2 Non-Compete.........................................................10
ARTICLE IV Term and Termination.............................................12
4.1 Term................................................................12
4.2 Termination.........................................................12
4.3 Effect of Termination...............................................12
ARTICLE V Adverse Reaction Reporting - Recalls..............................12
5.1 Notification of Complaints..........................................12
5.2 Notification of Threatened Action...................................12
5.3 Recalls.............................................................13
5.4 Recall Costs........................................................13
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TABLE OF CONTENTS
(CONTINUED)
PAGE
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ARTICLE VI General Provisions...............................................13
6.1 Notices.............................................................13
6.2 Assignability to AHP................................................14
6.3 Assignability and Amendments........................................14
6.4 Governing Law.......................................................14
6.5 Entire Agreement....................................................15
6.6 Other Agreements....................................................15
6.7 Waivers.............................................................15
6.8 Counterparts and Headings...........................................15
6.9 Absence of Third Party Beneficiary Rights...........................15
6.10 Severability........................................................15
6.11 Limitation of Liability.............................................16
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SUPPLY AGREEMENT
SUPPLY AGREEMENT, dated October 20, 1997, between SuperGen, Inc., a
California corporation having its principal place of business at Xxx Xxxxxxx
Xxxx, Xxxxx 000, Xxx Xxxxx, Xxxxxxxxxx 00000 ("Supplier"), and Xxxxxx-Xxxxxxx
Company, a Delaware corporation having its principal place of business at 000
Xxxxx Xxxx, Xxxxxx Xxxxxx, Xxx Xxxxxx 00000 ("Purchaser").
WITNESSETH:
WHEREAS, the parties entered into an agreement ("Asset Purchase
Agreement"), dated September 30, 1996, pursuant to which Supplier acquired
certain assets and rights of Purchaser relating to the Product (as hereinafter
defined); and
WHEREAS, pursuant to the Asset Purchase Agreement Supplier, among other
things, acquired know-how relating to the manufacture of the Product; and
WHEREAS, under the agreement ("AHP Agreement"), dated June 1, 1992 and last
revised on February 6, 1996, between Purchaser and American Home Products
("AHP"), Purchaser has been supplying and is obligated to supply AHP with its
requirements of the Product for countries outside of North America and Japan;
and
WHEREAS, the parties desire to enter into a supply agreement pursuant to
which Supplier shall manufacture and sell to Purchaser and Purchaser shall
purchase from the Supplier the Product for resale outside of North America and
Japan, all upon the terms and conditions recited hereinafter.
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants
contained herein, Supplier and Purchaser hereby agree as follows:
ARTICLE I
DEFINITIONS
1.1 DEFINITIONS. As used in this Agreement, the following defined terms
shall have the meanings set forth below:
"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.
"APPROVED COUNTRY" means those countries in the Territory in which the
Product has been approved for marketing as of the date of this Agreement, such
countries are shown on EXHIBIT A which is attached hereto and made a part
hereof.
"EX WORKS" has the meaning ascribed to it in INCOTERMS 1990, published by
the International Chamber of Commerce.
"GOVERNMENTAL OR REGULATORY AUTHORITY" means any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of the U.S.A.,
the European Union or any other relevant country, state, province, county, city
or other political subdivision.
"LOSSES" means any and all liabilities, damages, fines, 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).
"MANUFACTURING AGREEMENT" means that certain Manufacturing and Packaging
Agreement, of even date herewith, between the parties.
"PERSON" means any natural person, corporation, general partnership,
limited partnership, proprietorship, other business organization, trust, union,
association or Governmental or Regulatory Authority.
"PRODUCT" means the pharmaceutical preparation for human use containing
between 9.5 and 10.5 mg of (R)-3-(2-deoxy-SS-D-erythro-pento-furanosyl)-3,6,
7,8-tetrahydroimidazo[4,5-d] [1,3] diazepin-8-o1, (identified by Supplier
as pentostatin) as the sole active ingredient, in unlabeled sterile filled
vials.
"PURCHASER'S DESIGNEE" means any Person designated by Purchaser to act on
its behalf or in lieu of itself with respect to the purchase of the Product.
"SPECIFICATIONS" means the specifications and procedures currently utilized
by Supplier or its designee in manufacturing and testing the Product as set
forth on EXHIBIT B which is attached hereto and made a part hereof or such other
manufacturing specifications as are mutually agreed upon in writing by the
parties hereto, including all stability requirements set forth therein.
"SUPPLIER'S DESIGNEE" means any Person designated by Supplier to act on its
behalf or in lieu of itself with respect to the supply of the Product.
"TERRITORY" means all countries of the world where the Product has been or
may be approved for sale with the exception of the U.S.A., Canada, Japan and
Mexico.
"U.S.A." means the United States of America, including its territories and
possessions, the District of Columbia and the Commonwealth of Puerto Rico.
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ARTICLE II
PURCHASE AND SUPPLY
2.1 SUPPLY. During the term of this Agreement, Supplier or Supplier's
Designee shall supply the Product to Purchaser or Purchaser's Designee in the
Territory in accordance with the terms and conditions set forth herein,
including without limitation the Price Schedule set forth in Exhibit C.
Purchaser agrees to, and shall cause Purchaser's Designees to, buy its total
requirements of the Product for the Territory from Supplier or Supplier's
Designee, subject to the terms and conditions herein specified. The Product
shall be manufactured by Supplier or Supplier's Designee in accordance with the
Specifications. The Product shall be supplied to Purchaser or Purchaser's
Designee in unit sizes as Supplier or Supplier's Designee shall indicate from
time to time. An order shall consist of not less than 1,900 (10 mg) vials of
Product and a sufficient number not to exceed 100 (10mg) vials as reasonably
necessary for quality control purposes. Supplier or Supplier's Designee shall
ship unlabeled vials of the Product to (SEE EXHIBIT D) (the
"Designated Destination") for acceptance by Purchaser or Purchaser's Designee.
It is understood that the Product as delivered shall consist of unlabeled vials
and Purchaser or Purchaser's Designee shall label and package the Product in
accordance with the Specifications and the laws and regulations of any relevant
Governmental or Regulatory Authorities.
2.2 SPECIFICATION CHANGES. Supplier and Supplier's Designee shall follow
the Specifications. Neither Supplier nor Supplier's Designee shall implement
any changes relating to the Product without obtaining Purchaser's prior written
approval; PROVIDED, HOWEVER, that Supplier and Supplier's Designee may, without
prior notice to or written approval from Purchaser, implement changes relating
to the Product that (i) do not impact the regulatory commitments for the
Product, (ii) do not require revalidation, (iii) do not affect the quality,
purity, identity or strength of the Product, or (iv) would not result in a
change or modification to the Specifications.
2.3 PURCHASE PRICE. Supplier or Supplier's Designee shall sell the
Product to Purchaser at the prices set forth on EXHIBIT C. Such prices shall be
Ex Works at the point where the Product is presented for customs clearance of
the country of the Designated Destination. Notwithstanding the foregoing, the
parties acknowledge that the prices and terms set forth in this Section 2.3
shall only apply to purchases made by the Purchaser or AHP or Xxxxx Xxxxx
Xxxxxxx ("SK") Italy for sales within Italy as Purchaser's Designee. In the
event that the Purchaser designates a Purchaser's Designee other than AHP or SK
or assigns this Agreement to another Person in accordance with Section 6.3, the
relevant parties shall renegotiate this Section 2.3.
2.4 PAYMENT. Supplier or Supplier's Designee shall issue an invoice with
each shipment of the Product hereunder and Purchaser agrees to pay such invoice
in United States dollars to an account designated by Supplier or Supplier's
Designee within 45 days from the date of invoice. Such invoice shall include
any freight, taxes or other applicable costs initially paid by Supplier or
Supplier's Designee but to be borne by Purchaser or Purchaser's Designee. If
any amount due to Supplier or Supplier's Designee hereunder has not been paid by
Purchaser or Purchaser's Designee for more than 120 days from the date of the
invoice, Supplier or Supplier's Designee may refuse to
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ship any further Product to Purchaser or Purchaser's Designee unless there is a
good faith dispute regarding such invoice.
2.5 TITLE AND RISK OF LOSS. Title to the Product sold to Purchaser or
Purchaser's Designee hereunder and risk of loss shall pass to Purchaser or
Purchaser's Designee when the Product is presented for customs clearance of the
country of the Designated Destination. Purchaser or Purchaser's Designee shall
be responsible for such customs clearance and all expenses related thereto,
including, but limited to, the payment of all duties, taxes and any other
attendant charges.
2.6 CONFLICTING TERMS. In ordering and delivering the Product, Purchaser
and Purchaser's Designee and Supplier and Supplier's Designee may use their
standard forms, but nothing in such forms, purchase orders or any other
documents shall be construed to amend or modify the terms of this Agreement and
in case of conflict, the terms of this Agreement shall control.
2.7 REGULATORY REQUIREMENTS.
(a) The parties acknowledge that each party shall be responsible for
obtaining and maintaining certain registrations, approvals, permits and licenses
("Registrations") required by Governmental or Regulatory Authorities of the
United States and of the countries in the Territory in the following manner:
(i) Supplier, with the good faith assistance of the
Purchaser and at the Supplier's sole cost and expense, shall be responsible for
maintaining and obtaining all Registrations required by any Governmental or
Regulatory Authority of the United States. Supplier shall use all reasonable
efforts to file and maintain all such Registrations. With respect to all
Registrations required prior to the manufacture of the Product (the "Start-Up
Registrations"), Supplier shall use all reasonable efforts to file such
Registrations at the earliest possible date, but no later than 6 months from the
date hereof. Unless due to the failure to use reasonable efforts, Supplier
shall have no liability hereunder for not supplying the Product before it has
obtained all necessary Start-Up Registrations in the United States.
(ii) Purchaser, with the good faith assistance of the
Supplier and at the Purchaser's sole cost and expense, shall be responsible for
obtaining and maintaining all Registrations required by any Governmental or
Regulatory Authority of any country in the Territory. Specifically, it is
recognized that it is necessary for Purchaser to amend or modify Registrations
(the "Amendments") in the Territory regarding the manufacture of the Product to
qualify Supplier and/or Supplier Designee(s) as manufacturer(s) of the Product.
Supplier and Supplier's Designee(s) shall, at the Purchaser's sole cost and
expense, fully cooperate with Purchaser with respect to the Amendments and all
other Registrations necessary from time to time such that the Purchaser is able
to obtain or maintain Registrations from the corresponding Governmental or
Regulatory Authorities at the earliest possible date. Without limiting the
generality of Supplier's obligations under this Section 2.7(a)(ii), Supplier and
Supplier's Designee(s) shall furnish Purchaser with whatever documentation is
needed for such Governmental or Regulatory Authorities of the countries in the
Territory and to the extent required by applicable law, permit representatives
of the Governmental or
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Regulatory Authorities involved to inspect, during reasonable times and
operating hours, the facilities at which the Product may be tested, manufactured
stored and/or shipped, during reasonable times and operations hours. Purchaser
shall have the right to be present at the particular facility during any such
inspection. Unless due to the failure of Supplier to fully cooperate, Supplier
shall have no liability hereunder for not supplying the Product in accordance
with the Agreement before Purchaser has obtained all necessary Registrations in
the Territory. Purchaser or Purchaser's Designee shall perform the necessary
release testing on the Product in order to enable Purchaser or Purchaser's
Designee to sell the Product in each country of the Territory. Purchaser or
Purchaser's Designee shall be responsible for the release testing in accordance
with the Product release Specifications and all laws and regulations of any
relevant Governmental or Regulatory Authorities.
(b) Supplier and Supplier's Designee shall comply with all
Registrations required by any applicable Governmental or Regulatory Authority of
the United States. Supplier and Supplier's Designee shall use all reasonable
best efforts to comply with all Registrations required by any applicable
Governmental or Regulatory Authority of any country in the Territory, provided,
however that Purchaser shall inform Supplier and Supplier's Designee in writing
of all requirements necessary to comply with such Registrations. Supplier shall
have no liability hereunder for not supplying the Product due to the Purchaser's
failure to inform Supplier and Supplier's Designee in writing of such
requirements.
2.8 ORDERS AND INVENTORY. Purchaser understands that Supplier anticipates
that it will need 8 months from the receipt of an order for the Product and the
date on which it will be able to deliver the Product in response to that order.
To assure continuity of supply and adequate lead time, Purchaser shall place
firm binding orders for Product for not less than the minimum number of vials of
Product set forth in Section 2.1 above and for the first calendar quarter of
each forecast given pursuant to Section 2.9 hereof shall not be less than 75% of
the amount forecasted, and unless it agrees to otherwise in writing, Supplier
shall not be obligated to supply the Product pursuant to any order in less than
8 months from receipt of the order. As soon as it is able to do so, Supplier
will be responsible for maintaining adequate inventory of Product to fill
expected orders. Promptly after receipt of a firm order and subject to Sections
2.7, 2.10 and the Price Schedule set forth in Exhibit C, Supplier or Supplier's
Designee will notify Purchaser or Purchaser's Designee of Supplier or Supplier's
Designee's firm commitment to ship such Product by the date agreed upon to the
Designated Destination. Without the prior written consent of Supplier, which
consent will not be unreasonably withheld, no firm order for any amount of
Product may exceed the most recent order for Product by more than 25%. Once
Purchaser or Purchaser's Designee has placed a firm binding order, Purchaser or
Purchaser's Designee may not cancel, reschedule or modify any of the terms of
such order without the prior written consent of Supplier.
2.9 FORECASTS. After execution of this Agreement and the start of each
calendar quarter thereafter on a country-by-country basis, Purchaser and/or
Purchaser's Designee shall furnish Supplier or Supplier's Designee with a
forecast of the quantity of the Product that Purchaser or Purchaser's Designee
anticipates ordering hereunder for the 12 month period commencing 4 months after
the date of such forecast and for the initial calendar quarter of such forecast.
While Purchaser
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agrees that such forecasts are to be as accurate as possible, they shall be
non-binding, except as set forth in Section 2.8 above, and are to be furnished
to Supplier for planning purposes only.
2.10 FORCE MAJEURE. If the performance of any obligation under this
Agreement, other than payment of money, is prevented or delayed for any cause
beyond the control of the defaulting party, such defaulting party shall be
excused from performance so long as and to the extent that such cause continues
to prevent or delay performance; provided, however, that such defaulting party
shall promptly notify the other party of the existence of such cause and shall
at all times use its reasonable efforts to promptly resume and complete
performance. As clarification and not in limitation to the foregoing, the
parties acknowledge that Supplier shall be excused from performance if the
Supplier ceases or delays its obligations hereunder (a) in order to avoid an
infringement or violation of the patent or any other proprietary rights of a
third party; (b) due to a failure or delay by a third party in supplying any key
materials necessary to perform its obligations hereunder, including the
Purchaser's failure to perform under the Manufacturing Agreement; and (c) in
order to avoid a violation of any law, rule or regulation of any Governmental or
Regulatory Authority.
2.11 WARRANTIES.
(a) Supplier warrants only that the Product purchased by Purchaser or
Purchaser's Designee hereunder shall: (i) be manufactured in accordance with
current Good Manufacturing Practices; (ii) conform to the Specifications made
known to the Supplier in writing at the time of shipment; (iii) have a minimum
expiry period of 24 months from the time of manufacture and 18 months from the
time of delivery; and (iv) at time of shipment, shall not be a product, the
manufacture, use or sale of which, infringes or violates the patent or any other
proprietary rights of a third party, provided, however, that the foregoing
warranty shall not apply to any infringement or violation resulting from the use
of the Intellectual Property, NDA or NDS (as such terms are defined in the Asset
Purchase Agreement) as conveyed to Supplier by Purchaser pursuant to the Asset
Purchase Agreement.
(b) The warranties in Section 2.11(a) shall not apply to Products
that have been modified or altered in any manner after shipment by Supplier, or
to defects caused (i) through no fault of Supplier or Supplier's Designee after
shipment by Supplier; (ii) by the use or operation in any application or
environment other than that intended or recommended by Supplier; or (iii) by
accident, negligence, misuse or other causes beyond normal use. Supplier shall
not be liable for misbranding with respect to any product labeling or package
insert text provided or used by Purchaser or Purchaser's Designee or any
translation thereof and Supplier shall not be liable for any adulteration or
failure to meet the Specifications due to handling or packaging of Product by
Purchaser, Purchaser's Designee(s) or their Affiliates.
(c) Each party warrants to the other that it has the full corporate
power and authority to enter into this Agreement and to consummate the
transactions contemplated hereunder,
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and the execution, delivery and performance of this Agreement and the
transactions contemplated hereby have been duly and validly authorized by proper
corporate action, and no other proceedings on the part of such party are
necessary to authorize this Agreement and the transactions contemplated hereby.
(d) Each party warrants to the other that this Agreement has been
duly executed and delivered by it and constitutes a legal, valid and binding
obligation of it, enforceable against it 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.
(e) EXCEPT AS EXPRESSLY PROVIDED IN THIS SECTION 2.11, SUPPLIER MAKES
NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AS TO PRODUCTS, AND SUPPLIER
HEREBY EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES,
INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE.
2.12 CLAIMS. (a) All claims for failure of any shipment of the Product to
conform to the Specifications must be made to Supplier, in writing, within 30
days from the date of initial receipt of the Product by Purchaser or Purchaser's
Designee. Such claims shall specify the manner in which such shipment fails to
meet the Specifications. Failure to make a timely claim in the manner
prescribed herein shall constitute acceptance of the shipment.
(b) Should Purchaser or Purchaser's Designee make a claim pursuant to
Section 2.12(a) regarding a shipment of Product, Supplier shall have a period
(the "Investigation Period") not to exceed ninety (90) days from the date of
Purchaser's written notice of its claim to investigate. Should Supplier, after
conclusion of such investigation and after good faith negotiation, fail to agree
that such claim is justified, Purchaser and Supplier shall mutually agree upon a
third party to test samples of such shipment and to review records and test data
and other relevant information developed by either of the parties relating
thereto to ascertain liability for the non-conformance. The findings of such
third party shall be binding on both parties. If the Product is found to meet
Specifications in all material respects, Purchaser shall pay the costs of such
tests and shall be deemed to have accepted such shipment. If the Product is not
found to meet Specifications in all material respects, Supplier shall pay the
costs of such tests.
(c) Neither Purchaser nor Purchaser's Designee shall dispose of any
non-conforming shipment without written authorization and instructions from
Supplier, which instructions shall be given promptly at the conclusion of any
investigation of Supplier or as the case may be, the conclusion of the testing
in accordance with Section 2.12(b). Supplier shall notify Purchaser at such
time as to such disposition, and Purchaser shall, at Supplier's cost, dispose of
or return such shipment as so instructed. If Supplier fails to notify Purchaser
within ten (10) days of the end of the Investigation Period or as the case may
be, of the end of the testing in accordance with Section 2.12(b), Purchaser may
return the non-conforming shipment to Supplier. Purchaser shall give Supplier
reasonable prior notice of such return.
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2.13 INDEMNIFICATION.
(a) Purchaser hereby agrees to indemnify and hold harmless Supplier
and its Affiliates and Designees and their respective directors, officers,
employees and agents from and against all Losses resulting from claims or suits
brought against them by any third parties or Purchaser's or Purchaser's
Designee's employees or agents resulting from or arising out of (i) the release
testing of the Product by or for Purchaser or Purchaser's Designee,
(ii) Purchaser's breach of any obligation, representation or covenant hereunder,
(iii) an act or omission on the part of Purchaser, Purchaser's Designee(s) or
any of their respective Affiliates or employees or agents in the performance of
this Agreement; (iv) personal injury (including death) or property damage
suffered by Purchaser's, Purchaser's Designee(s) or any of their respective
employees or agents while engaged in the performance of this Agreement; (v) the
promotion, distribution, sale, handling, possession or use of the Products by or
for Purchaser or Purchaser's Designee following its acceptance thereof, or
(iv) Purchaser's, Purchaser's Designee's or any of their respective employees'
or agents' negligence or wilful misconduct; except in each case to the extent
such liability results from or arises out of (a) Supplier's, Supplier's
Designee's or any of their respective employees' or agents' breach of any
obligation, representation or covenant hereunder, including any nonconformance
or defect of Products, or (b) Supplier's or Supplier's Designee's negligence or
willful misconduct.
(b) Supplier hereby agrees to indemnify and hold harmless Purchaser
and its Affiliates and Designees and their respective directors, officers,
employees and agents from and against all Losses resulting from claims or suits
brought against them by any third parties or Supplier's or Supplier's Designee's
employees or agents resulting from or arising out of (i) Supplier's breach of
any obligation, representation or covenant hereunder or (ii) Supplier's,
Supplier's Designee's or any of their respective employees' or agents'
negligence or willful misconduct; except in each case (a) to the extent such
liability results from or arises out of (x) Purchaser's or Purchaser's
Designee's breach of any obligation, representation or covenant hereunder or (y)
Purchaser's, Purchaser's Designee's or any of their respective employees' or
agents' negligence or willful misconduct or (b) to the extent of Purchaser's
indemnification obligations to Supplier under the Manufacturing Agreement.
(c) All Claims for indemnification under this Section 2.13 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 thirty (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 2.13, the Indemnified Party shall have
fifteen (15) days to respond in a written statement to the objection
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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 shall have thirty 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 the 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 claims, whether by failure of the Indemnifying
Party to give the Indemnified Party timely notice as provided above or
otherwise, then, the Indemnifying Party, without waiving any rights against the
Indemnifying Party, may settle or defend against 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 that 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.
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(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 provided that the Indemnifying Party
shows by clear and convincing evidence that the failure to give such notice did
not materially and adversely prejudice the Indemnifying Party.
2.14 LIMITATION TO THE TERRITORY. Purchaser agrees and shall cause its
Designees and Affiliates to agree that: (i) all of the Product purchased
hereunder shall be purchased for resale solely in the Territory; (ii) all of the
Product shall be resold or otherwise distributed solely in the Territory; (iii)
none of the Product purchased hereunder shall be reimported into the U.S.A.; and
(iv) none of the Products purchased hereunder shall be resold or otherwise
distributed in the U.S.A., Canada and Mexico.
ARTICLE III
CONFIDENTIALITY AND NON-COMPETE
3.1 CONFIDENTIALITY. Supplier and Purchaser hereby agree, and shall cause
their respective Designees and Affiliates to agree in writing prior to
disclosure of any confidential or proprietary information to such Persons, that
during the term of this Agreement and thereafter for a period of five (5) years,
each party and their respective Designees and 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 Designee(s) or
Affiliates that is disclosed to or discovered by such party or its Designee(s)
or 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 Designee(s) or Affiliates or (ii) disclosure is required by
law or the order of any Governmental and Regulatory Authority. Without limiting
the generality of the foregoing, the parties agree that the terms and
conditions of this Agreement, including the price, constitutes confidential and
proprietary information and shall be subject to the confidentiality and use
obligations contained in this Article, provided, however, that the Purchaser may
disclose the terms and conditions of this Agreement to an assignee of this
Agreement as long as such assignee has agreed to be bound to the confidentiality
and non use obligations of this Agreement.
3.2 NON-COMPETE.
(a) In furtherance of the transactions contemplated by this Agreement
and in order to secure the interests of the parties hereto, Purchaser agrees and
shall cause its Designees and Affiliates to agree in writing prior to disclosure
of any confidential or proprietary information to such Persons that it will not,
for the longer of (x) the term of this Agreement and thereafter for a period of
three (3) years or (y) a period of ten (10) years from the date of this
Agreement, for any reason whatsoever, directly or indirectly, for itself or on
behalf of or in conjunction with any other person:
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(i) sell pentostatin anywhere in the United States of
America, its territories and possessions, the Commonwealth of Puerto Rico and
the District of Columbia, Canada or Mexico (collectively, the "Non-Compete
Territory") or have any ownership interest in, or participate in the financing,
operation, management or control of any person selling pentostatin in the
Non-Compete Territory or enter into any partnership, joint venture or similar
collaborative arrangement with any person to sell pentostatin in the Non-Compete
Territory, or knowingly transfer pentostatin to a third person with the intent
to sell pentostatin in the Non-Compete Territory; provided, however, that
pentostatin shall not be deemed to be sold within the Non-Compete Territory if
ownership title passes within the Non-Compete Territory for resale and use
exclusively outside the Non-Compete Territory.
(ii) call upon or otherwise hire for its pentostatin related
business any person who is at that time an employee of Supplier or any of its
designees who is engaged in any aspect of Supplier's pentostatin related
business for the purpose or with the intent of enticing such employee away from
or out of the employ of Supplier or any of its designees.
(b) It is expressly understood and agreed that, if any of the
agreements contained in this Section 3.2 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 3.2 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 the Purchaser, its designee or its
Affiliates against Supplier, whether predicated on this Agreement or otherwise,
shall not constitute a defense to the enforcement by Supplier of such covenants.
It is specifically agreed that the period stated at the beginning of this
Section 3.2, during which the agreements and covenants of Purchaser, its
designees and its affiliates made in this Section 3.2 shall be effective, shall
be computed by excluding from such computation any time during which Purchaser,
its designee or its Affiliates is found by a court of competent jurisdiction to
have been in violation of any provision of this Section 3.2. The covenants
contained in Section 3.2 shall not be affected by any breach of any other
provision hereof by a party hereto and shall have no effect if the transactions
contemplated by this Agreement are not consummated.
(d) Purchaser and Supplier hereby agree that the covenants set forth
in this Section 3.2 are a material and substantial part of the transactions
contemplated by this Agreement.
(e) Because of the difficulty of measuring economic losses to
Supplier as a result of a breach of the restrictive covenants set forth in this
Section 3.2, and because of the immediate and irreparable damage that would be
caused to Supplier for which monetary damages would not be
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a sufficient remedy, it is hereby agreed that in addition to all other remedies
that may be available to Supplier at law or in equity, Supplier 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.
ARTICLE IV
TERM AND TERMINATION
4.1 TERM. This Agreement shall become effective as of the date first
above written, and unless terminated sooner as provided herein, shall remain in
full force and effect thereafter for a period of 7 years following the day on
which Supplier or Supplier's Designee makes the initial shipment of the Product
to Purchaser or Purchaser's Designee hereunder.
4.2 TERMINATION. Supplier or Purchaser may terminate this Agreement upon
thirty (30) days' written notice to the other in the event of a failure by the
other to perform or observe an obligation imposed by this Agreement unless such
failure is cured within thirty (30) days after receipt of a notice specifying
failure to pay any amounts due under this Agreement and within ninety (90) days
after the receipt of a notice of any other failure. In addition, each of the
parties may terminate this Agreement in accordance with the Price Schedule set
forth in Exhibit C.
4.3 EFFECT OF TERMINATION. The termination of this Agreement shall not
operate to relieve Supplier from its obligations to supply Product ordered
through firm purchase orders received from Purchaser or Purchaser's Designee
prior to receipt of notice of such termination or of Purchaser's obligation to
accept delivery of Product and pay for such Product, unless such termination is
effected pursuant to Section 4.2. The provisions contained in Sections 2.13 and
2.14 hereof, Article III, Sections 5.1 and 5.2 and Article VI hereof shall
remain in full force and effect and survive any termination of this Agreement
and each party shall remain liable for any breach of this Agreement prior to
termination.
ARTICLE V
ADVERSE REACTION REPORTING - RECALLS
5.1 NOTIFICATION OF COMPLAINTS. Each party agrees that throughout the
duration of this Agreement, and with respect to all Product supplied and
purchased under this Agreement, after the termination of this Agreement, it will
notify the other party immediately of any information concerning any complaint
involving the possible failure of the Product to meet any Specifications, and
any serious or unexpected side effect, injury, toxicity or sensitivity reaction
or any unexpected incidence associated with the distribution of the Product,
whether or not determined to be attributable to the Product.
5.2 NOTIFICATION OF THREATENED ACTION. Throughout the duration of this
Agreement and with respect to all Product supplied and purchased under this
Agreement, after the termination of this
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Agreement, each party shall immediately notify the other party of any
information it receives regarding any threatened or pending action, inspection
or communication by or from a concerned Governmental or Regulatory agency which
may affect the safety or efficacy claims of Product or the continued marketing
of Product. Upon receipt of such information, the parties shall consult with
each other in an effort to arrive at a mutually acceptable procedure for taking
appropriate action.
5.3 RECALLS. If at any time or from time to time any Governmental or
Regulatory Authority of any country in the Territory requests either party to
recall the Product, or if a voluntary recall is contemplated, the party to whom
such request is made or the party contemplating such recall, as the case may be,
shall immediately notify the other party. The recall shall be carried out by
the Purchaser in as expeditious a manner as reasonably possible to preserve the
goodwill and reputation of Product and the goodwill and reputation of the
parties. Supplier shall cooperate as reasonably required in Purchaser's
efforts.
5.4 RECALL COSTS. With respect to any recall of Product pursuant to
Section 5.3, the Purchaser shall be responsible for all costs of such recall.
Notwithstanding the foregoing, Supplier shall reimburse Purchaser for all
reasonable costs associated with such recall to the extent of any failure of
Product to conform in all respects to the Specifications due to any action taken
by or omission of the Supplier, provided, however, that Supplier shall not be
liable for any such costs to the extent that Purchaser's release testing was not
performed in accordance with Product release Specifications and to the extent
that any release testing performed by Purchaser revealed any nonconformance with
the manufacturing Specifications at the time of the Product release.
ARTICLE VI
GENERAL PROVISIONS
6.1 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 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 Supplier, addressed to:
SuperGen, Inc.
Xxx Xxxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Attention: Chief Executive Officer
Facsimile No.: (000) 000-0000
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with a copy to:
Xxxxxx Xxxxxxx Xxxxxxxx & Xxxxxx
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, XX 00000-0000
Attention: Xxxx X. Xxxx
Facsimile No.: (000) 000-0000
If to Purchaser, 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
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 mail or overnight courier in the manner described above to 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 delivered pursuant to this
Section). Either party from time to time may change its address or facsimile
number upon written notice to the other party.
6.2 ASSIGNABILITY TO AHP. Supplier recognizes that Purchaser has entered
into this Agreement in order to satisfy its obligations to supply the Product to
AHP under the AHP Agreement and that Purchaser intends to either designate AHP
as Purchaser's Designee or to assign its rights and obligations under this
Agreement to AHP. Supplier agrees that Purchaser, upon written notice to
Supplier, may assign Purchaser's entire rights and obligations under this
Agreement to AHP, provided that AHP expressly agrees in writing to be bound by
the provisions of this Agreement; in which event Purchaser shall be relieved of
all of its liabilities hereunder other than any amounts due to the Supplier on
the date of the assignment and the provisions of Section 2.13 to the extent any
claims or suits result from or arise out of any actions or omissions of the
Purchaser prior to the date of the assignment and provided that Purchaser shall
be bound by the provisions of Article III and shall be subject to the provisions
of Section 2.13 for any claims or suits arising from the breach of such Article
III.
6.3 ASSIGNABILITY AND AMENDMENTS. Except as provided in Section 6.2
hereof, this Agreement may not be assigned by either party without the prior
written consent of the other party,
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except that 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. Except as provided in Section 6.2 hereof, 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.
6.4 GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the State of Delaware.
6.5 ENTIRE AGREEMENT. This Agreement 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.
6.6 OTHER AGREEMENTS.
(a) Notwithstanding anything to the contrary in this Agreement,
nothing contained in this Agreement shall be construed so as to limit, curtail,
modify, revise or amend the respective rights and obligations of the parties
hereto under the Asset Purchase Agreement or the Manufacturing Agreement.
(b) The Purchaser acknowledges that the supply of the Product to
Purchaser, its Designee or any assignees of this Agreement pursuant to this
Agreement is not and shall at no time be a violation of Section 6.17 of the
Asset Purchase Agreement, and the Purchaser covenants not to xxx Supplier or its
Designee pursuant to Section 6.17 of the Asset Purchase Agreement in connection
with this Agreement.
6.7 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.
6.8 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.
6.9 ABSENCE OF THIRD PARTY BENEFICIARY RIGHTS. Other than as specifically
provided for herein, no provision of this Agreement is intended, nor will be
interpreted, to provide or to create any third party beneficiary rights or any
other rights of any kind in any Person (including AHP).
6.10 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
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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.
6.11 LIMITATION OF LIABILITY. IN NO EVENT SHALL SUPPLIER OR ITS DESIGNEE
BE LIABLE HEREUNDER FOR INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES ARISING OUT
OF THIS AGREEMENT, EVEN IF SUPPLIER OR ITS DESIGNEE HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.
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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.
SUPERGEN, INC. XXXXXX-XXXXXXX COMPANY
Name: Name:
------------------------- -------------------------
Title: Title:
------------------------ ------------------------
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EXHIBIT A
APPROVED COUNTRIES
Belgium
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
Portugal
Spain
United Kingdom
[* * *] REDACTED CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT B
PRODUCT SPECIFICATION
PENTOSTATIN 5MG/ML, 10ML PER VIAL
[* * *]
[* * *] REDACTED CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT C
PRICE SCHEDULE
[* * *]
EXHIBIT D
Designated Destination
Vials for quality control purposes should be sent to:
Wyeth Lederle Italy
Xxx Xxxxxx Xxxxxxx
Xxxx Xxxxxxxxxxx
00000
Xxxxxxx, Xxxxx
The 1900 vials for packaging should be sent to:
Wyeth Medica Ireland
Xxxxxx Xxxxxxx
Xxxxxxxxx
Xxxxxx xx Xxxxxxx
Xxxxxxx
