Document:

Exhibit 10.40

 

[NOTE: CERTAIN PORTIONS
OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED FOR SUCH PORTIONS BY IMCLONE SYSTEMS INCORPORATED. THESE
PORTIONS HAVE BEEN MARKED WITH TWO ASTERISKS ENCLOSED IN BRACKETS (i.e. [**]).
THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.]

 

SETTLEMENT AGREEMENT AND MUTUAL RELEASE

 

THIS SETTLEMENT AGREEMENT AND MUTUAL RELEASE (the “Settlement
Agreement”), is executed and entered on this day, December 7, 2007 (the “Execution
Date”), by and among AVENTIS PHARMACEUTICALS, INC., a corporation duly
organized and existing under the laws of the State of Delaware and having its
principal office at 55 Corporate Drive, Bridgewater, NJ 08807 (hereinafter
collectively referred to as “API”), AVENTIS, INC., a corporation duly organized
and existing under the laws of the State of Pennsylvania and having its
principal office at 3711 Kennett Pike, Suite 200, Greenville, DE 19807,
successor-in-interest to RHONE-POULENC RORER INTERNATIONAL (HOLDINGS), INC.,
(hereinafter collectively referred to as “AI”), and AVENTIS HOLDINGS INC., a corporation duly
organized and existing under the laws of the State of Delaware and having its
principal office at 3711 Kennett Pike, Suite 200, Greenville, DE 19807 (hereinafter
collectively referred to as “AHI”, and together with API and AI, collectively
referred to as “SANOFI”), IMCLONE SYSTEMS INCORPORATED, a corporation duly
organized under the laws of the STATE OF DELAWARE and having its principal
office at 180 Varick Street, New York, NY 10014 (hereinafter referred to as “IMCLONE”),
and YEDA RESEARCH AND DEVELOPMENT CO. LTD. a corporation duly organized and
existing under the laws of the State of Israel and having its principal office
at Rehovot, Israel (hereinafter referred to as “YEDA”). (SANOFI, IMCLONE and
YEDA are referred to herein individually as a “Party” and collectively as the “Parties”).

 

WITNESSETH

 

WHEREAS, YEDA is the Plaintiff-Counter Defendant and IMCLONE and SANOFI are
the Defendants-Counter Claimants in the action entitled  Yeda Research and Development Company, Ltd. v. ImClone Systems, Inc.
and Aventis Pharmaceuticals, Inc.; Civil Action No. 03 cv 8484, in the United States
District Court for the Southern District of New York, with appeal 2007-1010-012
pending in the United States Court of Appeals for the Federal Circuit
(collectively, the “X Action”), IMCLONE is the Plaintiff-Counter Defendant and YEDA is
the Defendant-Counter Claimant in the action entitled  ImClone Systems Inc. v. Yeda Research and Development
Co., Ltd., Civil
Action No. 06 cv 7190, pending in the United States District Court for the
Southern District of New York (the “Y Action” collectively
together with the X Action, the “U.S. Litigation”), YEDA is the Plaintiff
and Aventis Holdings Inc. is the Defendant in the actions entitled Yeda
Research and Development Company, Ltd. v. Aventis Holdings, Inc., File Nos.  N 7/2005, N
18/2005 and N 19/2005, each pending in Austria (the “Austrian Actions”), YEDA
has asserted a patent office entitlement action in the United Kingdom against Rhone-Poulenc
Rorer International (Holdings) Inc., entitled In
the matter of European Patent No. EP (UK) 0 667 165 B 1 in the name of
Rhone Poulenc Rorer International (Holdings) Inc.

 

 

and a
reference under s 37 (1) (the
“UK Action”), YEDA is the Plaintiff in two actions pending in Munich District Court I (File No. 21
O 12091/06) and Federal Court of Justice (no file number to date) against Aventis Holdings Inc. and Rhone-Poulenc Rorer International (Holdings), Inc.
respectively, each with ImClone
Systems Inc. as intervener (the “German Actions”), YEDA is the Plaintiff and
Rhone-Poulenc Rorer International (Holdings) Inc, Aventis Holdings Inc. and
IMCLONE are Defendants in an action pending in the Paris First Instance Court
under Docket No. 07/12587 (the “French Action,” collectively
together with the U.S. Litigation, Austrian Actions, UK Actions and German
Actions, “All Litigation Matters”).

 

WHEREAS, the Parties now wish to resolve all existing and
potential claims and outstanding obligations in connection with All Litigation
Matters and desire to settle All Litigation Matters on the terms stated herein,
without any admission
of liability or wrongdoing, in order to avoid the time and expense of continuing to
litigate All Litigation Matters.

 

NOW, THEREFORE, in consideration of the mutual covenants and
agreements contained herein, and for other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, and intending to be
legally bound hereby, the Parties hereby agree as follows:

 

1.             Closing.  Upon the
completion of the payments required under Sections 5(a) and (b), this
Settlement Agreement shall become effective, such date being the “Closing Date”
hereunder.

 

2.             Correction of Inventorship; Confirmation
and Transfer of Ownership.

 

(a)           SANOFI and IMCLONE shall withdraw their
pending appeal in the X Action and will cooperate with YEDA in the
implementation of: (i) the naming of Drs. Michael Sela, Esther
Hurwitz and Esther Aboud-Pirak (the “Weizmann Inventors”) as inventors on United
States Patent No. 6,217,866 (the “‘866 Patent”) and the removal of George
A. Ricca, Christopher Cheadle, Victoria J. South and Joseph Schlessinger as inventors
on the ‘866 Patent; (ii) the amendment of the ‘866 Patent to remove
Francoise Bellot, Richard Kris and David Givol as inventors thereof; (iii) the
consequential one hundred percent (100%) ownership of all right, title and
interest in and to the ‘866 Patent by YEDA; and (iv) unopposed
intervention by SANOFI in the Y Action for the limited purpose of enforcing
this Settlement Agreement and the request to the court in the Y Action for a
stipulated order of dismissal with prejudice.

 

(b)                                 From and after the Closing Date, SANOFI
and YEDA shall [**] ownership interest in each of the patents, patent
applications, supplemental protection certificates and applications for
supplemental protection certificates listed on Schedule 1 and any other
non-U.S. patents and patent applications that claim priority to any one or more
of the patent applications for the ‘866 Patent (the “Non-U.S. Patents” and,
collectively with the ‘866 Patent, “All Patents”), and each shall make whatever
transfers to the other that may be required to effectuate such ownership.

 

(c)                                  From and after the Closing Date, the
Parties shall execute and jointly seek entry of stipulated consent judgments or
orders from the relevant patent office (or equivalent judicial orders or
consents) that (i) name YEDA the owner of [**] interest in all rights and
title in

 

Confidential
Treatment has been requested with respect to certain portions.

 

2

 

all Non-U.S. Patents, (ii) name inventors
designated by YEDA as inventors on each of the Non-U.S. Patents, (iii) are
consistent with continuing to have Joseph Schlessinger as inventor on each of
the Non-U.S. Patents, (iv) remove George A. Ricca, Christopher Cheadle,
Victoria J. South, Francoise Bellot, Richard Kris and David Givol as inventors on
the Non-U.S. Patents to the extent permitted by the laws of each country
involved and (v) dismiss with prejudice all other claims and counterclaims
in All Litigation Matters.

 

(d)           SANOFI and IMCLONE shall not contest (i) the
rights granted under All Patents by YEDA in the License Agreement between YEDA
and Amgen Inc. (“Amgen”) and the Patent License Agreement between YEDA and Merck
KGaA (“Merck”), as such agreements exist as of the Execution Date, or (ii) such
grants of such rights by YEDA. YEDA shall be entitled to retain for its own
benefit and disposition all payments made and to be made under those agreements
without any duty of accounting whatsoever.

 

(e)           From and after the Closing Date, SANOFI
and IMCLONE consent and agree that YEDA shall have the free right to dispose of,
encumber or mortgage its interest in any or all All Patents either in whole or
in part, and shall also have the free right to grant licenses under any or all
All Patents that are either exclusive or nonexclusive (subject, however, to the
licenses granted to IMCLONE in Paragraph 4 as well as any sublicenses granted
thereunder, including the IMCLONE-BMS Agreement and the IMCLONE-Merck Agreement)
without the need to obtain further consent of SANOFI or IMCLONE. From and after
the Closing Date, all prosecution, maintenance (including defending oppositions
brought by third parties) and enforcement activities with respect to All
Patents shall be in the sole discretion of YEDA and YEDA shall be entitled to
retain all recoveries achieved in connection therewith; provided however
to the extent BMS has rights of enforcement under the IMCLONE-BMS Agreement to
the extent relating to Erbitux®, BMS shall have the right to exercise such
rights; provided further that YEDA shall use all commercially reasonable
efforts to prosecute patent applications and extensions and reissues of issued
patents within the All Patents. IMCLONE, SANOFI and YEDA shall reasonably
cooperate with one another to seek SPCs and patent term extensions with respect
to All Patents.

 

(f)            SANOFI agrees that although it is a
co-owner of the Non-U.S. Patents, from and after the Closing Date it will not
exploit in any fashion the Non-U.S. Patents other than SANOFI’s license with
IMCLONE and subject to any separate agreement entered into between YEDA and
SANOFI.

 

3.             Concession of Validity, Enforceability
and Infringement.

 

(a)           IMCLONE and SANOFI irrevocably consent
and agree that: (i) the ‘866 Patent is valid and enforceable; and (ii) [**]
 IMCLONE and SANOFI further irrevocably consent
and agree that: (A) the Non-U.S. Patents are valid and enforceable; and (B) [**]
 IMCLONE and SANOFI acknowledge that YEDA
is waiving its claims for damages in the Y Action and other All Litigation
Matters and any other claims it may have for damages of any type on any theory on
account of both past and future activities of IMCLONE and SANOFI and as such
the foregoing acknowledgment is binding and irrevocable regardless of any
determination with respect to the ‘866 Patent or the Non-U.S. Patents in any
other or subsequent matter. For avoidance of doubt, neither SANOFI nor IMCLONE
is making any warranty or any

 

Confidential Treatment
has been requested with respect to certain portions.

 

3

 

covenant with respect to the validity or
enforceability of any of the All Patents and shall have no cause of action in
case any of those patents is invalidated through no act of SANOFI or IMCLONE.

 

(b)           IMCLONE
and SANOFI are hereby enjoined and restrained from challenging the validity or
enforceability of any or all All Patents and from supporting or assisting
others in challenging such validity or enforceability, and consent to such
injunction and restraint.

 

4.             Patent License.

 

(a)                                  Subject to the rights previously granted
by YEDA to Merck outside the U.S. relating to Erbitux® and worldwide relating
to EMD72000, in each case pursuant to the Merck Agreement, but in any event not
with respect to IMC-11F8: YEDA hereby grants to IMCLONE from and after the Closing
Date an exclusive license for monetary consideration, with the right to
sublicense [**] (in accordance with the terms set forth in Paragraph 4(b)),
under All Patents to make, have made, use, sell, offer for sale and import cetuximab
(IMC-C225) (“Erbitux®”), IMC-11F8 and all product incorporating the humanized
antibody of Merck, EMD72000 (“EMD72000”), (collectively referred to as “Licensed
Products”), but in any event Licensed Products shall not include panitumumab
(Vectibix®), nimotuzumab or HuMax-EGFr, which license shall be worldwide for
Erbitux®” and IMC-11F8, and only outside the United States and Canada for
EMD72000.

 

(b)                                 IMCLONE shall have the right to grant
sublicenses under All Patents solely with respect to Licensed Products (“Sublicenses”),
provided that each Sublicense granted by IMCLONE shall contain terms set forth
on Exhibit A and shall extend to YEDA auditing rights of the sublicensee
consistent with those contained in Paragraph 5(j). Within thirty (30) days
after execution of each Sublicense, IMCLONE shall notify YEDA of the existence
of such Sublicense together with providing a redacted version of the
Sublicense, with such redactions having been made in such a manner as to permit
YEDA to ascertain payments due to it, the identity of the sublicensee, the
identity of the Licensed Product and compliance with the sublicensing terms and
conditions set forth in this Paragraph 4(b). In the event of an audit pursuant
to Paragraph 5(j), IMCLONE shall also make available to YEDA on a confidential basis
an unredacted copy of each such Sublicense. IMCLONE shall remain responsible
for the full and complete performance of all of IMCLONE’s obligations and
duties under this Settlement Agreement as well as those of any sublicensees of
IMCLONE, whose actions under each Sublicense shall be deemed to be those of
IMCLONE, and whose default under the Sublicense shall not relieve IMCLONE of
any obligations under this Settlement Agreement. Notwithstanding the foregoing,
this subsection (b) shall not apply with respect to the IMCLONE-BMS
Agreement or the IMCLONE-Merck Agreement or any of the sublicences granted
thereunder.

 

(c)                                  YEDA shall not contest (i) the
rights granted under All Patents for Licensed Products (A) by IMCLONE in
the Development, Promotion, Distribution & Supply Agreement (the “IMCLONE-BMS
Agreement”) among E.R. Squibb & Sons, LLC, Bristol-Myers Squibb
Company (collectively, “BMS”) and IMCLONE, and the Development and License
Agreement (the “IMCLONE-Merck Agreement”) between IMCLONE and Merck, (B)

 

Confidential Treatment has
been requested with respect to certain portions.

 

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all
further sublicenses granted under such agreements, and (C) such grants of
such rights by IMCLONE, and that as a consequence, BMS and Merck have the
rights under All Patents that are provided under those agreements. In no event
shall BMS or Merck have rights as sublicensees of IMCLONE broader than the
rights granted to IMCLONE under Paragraph 4(a).

 

5.             Settlement Payments.

 

(a)           On or before December 10, 2007, IMCLONE
shall pay YEDA by wire transfer to the account listed below in Paragraph 5(g),
a single lump sum payment of Sixty Million United States Dollars
(US$60,000,000).

 

(b)           On or before December 14, 2007, SANOFI
will pay YEDA by wire transfer to the account listed below in Paragraph 5(g), a
single lump sum payment of Sixty Million United States Dollars (US$60,000,000).

 

(c)           Contingent
Payment Obligation.  During the Contingent Payment Term,
IMCLONE shall pay to YEDA contingent payment amounts based on the following
rates for Net Sales (as defined below) of Licensed Products by IMCLONE or its sublicensees
and other amounts received in connection with Licensed Products, on a
country-by-country basis:

 

(i)            for Erbitux®, a rate of [**] on Net Sales
of Erbitux® in the U.S. (including its territories and possessions) and Canada and
[**] on Net Sales of Erbitux® outside the U.S. and Canada;

 

(ii)           for IMC-11F8, [**]; and

 

(iii)          for
EMD72000, [**].

 

The
Parties acknowledge that it would be impractical to calculate contingent
payments based solely on sales of Licensed Products that are used in connection
with anti-neoplastic agents and as such for convenience have adopted a
contingent payment arrangement based on sales of all Licensed Products, whether
or not sold in connection with or instructed for use in connection with
anti-neoplastic agents. They agree and acknowledge that the above contingent
payments have been reduced with the intent to reflect the value of All Patent
Rights and are not an attempt to collect contingent payments for activities not
covered by All Patent Rights.

 

For
purposes of this Settlement Agreement, “Net Sales” with respect to particular
Licensed Product(s), shall mean [**]

 

(d)           Contingent
Payment Term.  IMCLONE’s obligation to pay contingent
payments on Net Sales of Licensed Products shall commence around the world on October 1,
2007, and shall expire in the United States and its territories and possessions
and Canada on January 17, 2017 (however, in the event there is a patent
extension of the ‘866 Patent, such date shall expire in the United States and
its territories and possessions and Canada on February 12, 2018) and
everywhere else in the world on September 15, 2014 (the “Contingent
Payment Term”).

 

Confidential Treatment has
been requested with respect to certain portions.

 

5

 

(e)                                  Contingent
Payments.  During the Contingent Payment Term, IMCLONE
shall prepare and deliver to YEDA:

 

(i)            within sixty (60) days of the end of each
calendar quarter, a report broken down by country of sale, currency and
identity of seller (i.e., either IMCLONE or its sublicensee) that: (a) lists
gross and net sales of each Licensed Product; and (b) details any
deductions included in the calculation of Net Sales in accordance with the
breakdown of deductions set forth in Paragraph 5(c); and

 

(ii)           within thirty (30) days after a request
from YEDA, complete copies of any contingent payment reports or records
submitted to IMCLONE by its sublicensees with respect to Licensed Products.

 

The
relevant payments shall be made at the same time as the aforedescribed report
in subsection (e)(i) above. Interest shall accrue on payments made more
than sixty (60) days after such payments were due. Such interest will be
calculated using an arithmetic average of the daily fixings for the three-month
London InterBank Offering Rate (LIBOR) as reported by the British Bankers
Association for the calendar quarters in which the payments were due plus [**].
IMCLONE shall use reasonable efforts in detailing the breakdown of deductions,
provided, however, that the mischaracterization of any deduction(s) shall
not affect IMCLONE’s right to claim such deduction(s) in accordance with
the definition of Net Sales hereunder.

 

(f)            The payments set forth in Paragraphs 5(a)-5(c) will
be net amounts and not subject to withholding or offset of any kind.

 

(g)           YEDA bank account for payments:

 

	
  Bank
  Name:

  

  [**]

  	
  Name
  on Account:

  

  Yeda Research and Development Co. Ltd.

  

  [**]

  

 

(h)           U.S. Dollars. 
All payments to be made under this Settlement Agreement shall be made in
United States Dollars by wire transfer as designated by YEDA, or by such other
method as YEDA shall reasonably notify IMCLONE from time to time.

 

(i)            Currency Conversion. Net Sales received in currencies other
than U.S. dollars shall be converted into the U.S. dollar equivalent using an
arithmetic average rate of exchange for buying funds as reported in Bloomberg
Professional, a service of Bloomberg L.P., for the calendar quarter in which
such Net Sales were made, or in the event Bloomberg Professional is not
available then the Wall Street Journal for the currency of the country in which
the sale is made.

 

Confidential Treatment has
been requested with respect to certain portions.

 

6

 

(j)            IMCLONE and its affiliates to which
IMCLONE grants a Sublicense under this Settlement Agreement shall keep complete
and accurate records of the underlying revenue and expense data relating to the
calculations of Net Sales and payments required by Paragraph 5(e) for no
less than [**] years after the relevant sales occurred. YEDA shall have the
right, once annually at its own expense, to review any such accounting records
of IMCLONE (including, without limitation, unredacted copies of each
Sublicense) in a single location upon reasonable notice (which shall be no less
than twenty (20) days prior written notice) and during regular business hours
and under obligations of strict confidence, for the sole purpose of verifying
the basis and accuracy of payments made under Paragraph 5(e). Should such
inspection lead to the discovery of a discrepancy to YEDA’s detriment in an
annual period, IMCLONE shall pay the amount of the discrepancy, and in the
event of an overpayment, IMCLONE shall have the right to apply such overpayment
against future payments due hereunder to YEDA or, if there is no such future
payment obligation of IMCLONE, then YEDA shall promptly refund the amount of
such overpayment to IMCLONE. YEDA shall pay the full cost of the inspection
unless the validated discrepancy for any period audited is, to YEDA’s
detriment, greater than [**] of the total amount due to be paid to YEDA for the
period audited, in which case IMCLONE shall pay the full cost of such
inspection and interest on the amount due in excess of the amount actually
paid. Interest will be calculated using an arithmetic average of the daily
fixings for the three-month London InterBank Offering Rate (LIBOR) as reported
by the British Bankers Association for the calendar quarters in which the
payments were due plus [**]. YEDA shall further have the right to cause IMCLONE
to exercise its right to audit royalty payments to be made by sublicensees with
respect to Licensed Products. YEDA shall pay the full cost of the audit so
caused unless the discrepancy for any period audited is greater than [**] of
the total amount due to be paid to IMCLONE for the period audited, in which
case the sublicensee or IMCLONE shall pay the full cost of such inspection and
interest on the amount due in excess of the amount actually paid. Within
fifteen (15) days after receiving such report from the entity conducting the
audit (whether or not at the request of YEDA), IMCLONE will provide YEDA a
complete copy of any final audit report obtained from auditing IMCLONE’s sublicensees.
For the avoidance of doubt, the delivery of any such report to YEDA shall not
constitute a waiver of any right or privilege of IMCLONE and/or its
representatives.

 

6.                                       Immediate Stay;  Dismissal of All Litigation Matters. 
As of the Execution Date, the Parties shall jointly through their
respective counsel execute and file such documents as necessary to immediately
stay All Litigation Matters.  Within five
(5) business days after the settlement payments are made in accordance
with Paragraphs 5(a) and 5(b) above, the Parties shall jointly
through their respective counsel: (a) execute and file papers to withdraw
the pending appeal in the X Action; (b) cause SANOFI to intervene in the Y
Action on consent for the limited purpose of enforcing this Settlement
Agreement; (c) execute and file stipulated orders of dismissal and final
decision that dismiss and finally resolve the Y Action with prejudice and
without costs to any Party, where such stipulated orders shall also provide
that the Southern District of New York will retain jurisdiction over the
Parties and the subject matter of All Litigation Matters in order to enforce
the terms of this Settlement Agreement if necessary and that this Settlement
Agreement is a binding obligation of each Party hereto; and (d) execute
and file appropriate documents for each jurisdiction outside of the United
States where there is ongoing litigation under any of the All Litigation
Matters, to discontinue such litigation and enter judgment by consent without
costs to any Party, except that the foregoing dismissal and the following
releases shall not prejudice YEDA’s right to recover its legal costs in the UK
Action.

 

Confidential Treatment has
been requested with respect to certain portions.

 

7

 

7.             Release by YEDA.  Effective
as of the Closing Date, under this Settlement Agreement, YEDA hereby forever
releases and fully discharges each of IMCLONE and SANOFI, as well as each of
their affiliates and with respect to IMCLONE, BMS and Merck (in their capacity
as sublicensees of IMCLONE), and each of their respective successors and
assigns, and the present or former officers, directors, agents, and employees
of any of them (in their capacities as such) (collectively, the “YEDA-Released
Parties”) from any and all actions, causes of action, suits, debts due, sums of
monies, covenants, contracts, controversies, agreements, promises, trespasses,
damages, judgments, claims, demands whatsoever, in law or in equity, whether in
tort or contract or otherwise, known or unknown, suspected or unsuspected,
which YEDA , as well as each of its affiliates (including, for the avoidance of
doubt, the Weizmann Institute of Science (the “Institute”)) and their
successors and assigns or, to the extent YEDA has the power to grant releases
hereunder, their present or former officers, directors, partners, members or
employees, in their capacities as such, ever had or now has against any of the
YEDA-Released Parties for, upon, or by reason of any matter, cause or thing
whatsoever from the beginning of the world to the Effective Date arising under
or relating in any way to (i) All Litigation Matters (or the facts
asserted in such All Litigation Matters by the Parties therein) or (ii) any
of the All Patents.  For the avoidance of
doubt, YEDA does not release Merck in any regard with respect to the Patent
License Agreement between Merck and YEDA. 
YEDA shall fully indemnify and hold harmless the YEDA-Released Parties
against any such claim except with respect to any claim by Joseph Schlessinger,
Francoise Bellot, Richard Kris and David Givol.

 

8.             Release by IMCLONE.  Effective
as of the Closing Date, under this Settlement Agreement, IMCLONE hereby fully
and forever releases and fully discharges each of YEDA and SANOFI, as well as,
each of their affiliates and with respect to YEDA, Merck and Amgen (in their
capacity as sublicensees of YEDA) and each of their respective successors, and
assigns, and the present or former officers, directors, agents, and employees
of any of them (in their capacities as such) (including, with respect to YEDA
and for the avoidance of doubt, the Institute and Weizmann Inventors)
(collectively, the “IMCLONE Released Parties”) from any and all claims, causes
of action, suits, debts due, sums of monies, covenants, contracts,
controversies, agreements, promises, trespasses, damages, judgments, claims,
demands whatsoever, in law or equity, whether in tort or contract or otherwise,
known or unknown, suspected or unsuspected, which IMCLONE, as well as each of
its affiliates, or their present or former officers, directors, partners,
members, employees, successors and assigns, in their capacities as such, ever
had or now has against any of the IMCLONE Released Parties for, upon, or by
reason of any matter, cause or thing whatsoever from the beginning of the world
to the Effective Date arising under or relating in any way to (i) All
Litigation Matters (or the facts asserted in such All Litigation Matters by the
Parties therein) or (ii) any of the All Patents.  For the avoidance of doubt, IMCLONE does not
release Merck in any regard with respect to the IMCLONE-Merck Agreement.

 

9.             Release by SANOFI.  Effective
as of the Closing Date, under this Settlement Agreement, SANOFI hereby fully
and forever releases and fully discharges each of YEDA and IMCLONE, as well as,
each of their affiliates and with respect to IMCLONE, BMS and Merck (in their
capacity as sublicensees of IMCLONE) and with respect to YEDA, Merck and Amgen
(in their capacity as sublicensees of YEDA) and each of their respective
successors, and assigns, and the present or former officers, directors, agents,
and employees of any of them (in their

 

Confidential Treatment
has been requested with respect to certain portions.

 

8

 

capacities as such) (including, with respect to YEDA
and for the avoidance of doubt, the Institute and Weizmann Inventors)
(collectively, the “SANOFI Released Parties”) from any and all claims, causes
of action, suits, debts due, sums of monies, covenants, contracts,
controversies, agreements, promises, trespasses, damages, judgments, claims,
demands whatsoever, in law or equity, whether in tort or contract or otherwise,
known or unknown, suspected or unsuspected, which SANOFI, as well as each of
its affiliates, or their present or former officers, directors, partners,
members, employees, successors and assigns, in their capacities as such, ever
had or now has against any of the SANOFI Released Parties for, upon, or by
reason of any matter, cause or thing whatsoever from the beginning of the world
to the Effective Date arising under or relating in any way to (i) All
Litigation Matters (or the facts asserted in such All Litigation Matters by the
Parties therein) or (ii) any of the All Patents.

 

10.           Release of Future Obligations. 
Nothing in Paragraphs 7-9 (inclusive) shall operate as a release of the Parties’
obligations or covenants under this Settlement Agreement, or with respect to
any agreements signed by or among the Parties contemporaneously herewith.

 

11.           No Admission of Wrongdoing. 
The Parties expressly acknowledge that this Settlement Agreement
represents a settlement of disputed rights and claims.  Nothing in the terms of this Settlement
Agreement or in its execution shall be construed as an admission of liability
or wrongdoing as to any matter by the Parties hereto.  IMCLONE and SANOFI affirmatively deny the
allegations of the other Parties with respect to the X Action, and YEDA
affirmatively denies the allegations of the other Parties with respect to the X
Action.  YEDA affirmatively denies the
allegations of the other Parties with respect to the Y Action, and IMCLONE
affirmatively denies the allegations of the other Parties with respect to the Y
Action.

 

12.           Confidentiality.  Without
limiting the Parties’ obligations under the Protective Order endorsed by Judge
Buchwald on June 29, 2004 in the X Action, the Stipulation and Order
Regarding the Use of Confidential Information endorsed by Judge Buchwald on September 6,
2007 in the X Action or the Protective Order endorsed by Judge Buchwald on July 24,
2007 in the Y Action, any non-public technical or business related information
or materials which any Party hereto may disclose to any other shall be treated
as confidential to the extent permitted by law. 
Written confidential information shall be identified as confidential
information.  Non-written confidential
information shall be reduced to writing and identified as confidential
information by the disclosing Party within forty-five (45) days of
disclosure.  Confidential information and
materials shall be maintained in confidence by the receiving Parties and shall
not be disclosed to any third party without prior written consent of the
disclosing Party, other than as contemplated by the terms of this Settlement
Agreement.  This obligation of
confidentiality shall not apply to information which:

 

(a)           is publicly known prior to the disclosure
through no fault of the receiving Parties;

 

(b)           becomes publicly known subsequent to
disclosure through no fault of the receiving Parties;

 

(c)           is lawfully disclosed to the receiving Parties
by a third party who is not obligated to retain such information in confidence;

 

Confidential Treatment has
been requested with respect to certain portions.

 

9

 

(d)           is in the receiving Parties’ possession
prior to disclosure as shown by reasonable proof; or

 

(e)           lawfully becomes publicly known following
disclosure to a government patent agency in connection with the prosecution of
any All Patent or a regulatory agency responsible for the approval of
therapeutic products.

 

If any
subpoena or court order shall require the disclosure of confidential
information by way of document production and/or testimony, each Party shall
give the Party whose confidential information is at issue and its attorneys
reasonable and practicable prior written notice such that the noticed Party has
an opportunity to intervene and oppose the disclosure of such confidential
information.  The Parties agree to take
all reasonable measures to ensure that any confidential information sought by
any subpoena or court order is kept confidential until the objecting Party’s
opposition to the disclosure is considered and resolved by the Court or other
relevant governing authority.  This
provision shall survive expiration, termination and/or satisfaction of the
terms of this Settlement Agreement. 
Nothing herein shall preclude the Parties from disclosing such
information as required by law or to their officers, directors, accountants
and/or tax advisors, sublicensees or other agents, on a need-to-know basis,
provided such persons comply with the confidentiality requirements of this
Settlement Agreement.  Except as
permitted herein, the Parties shall not offer in evidence or in any way refer
to in any civil, criminal, administrative or other action or proceeding, any of
the confidential information other than as may be necessary to consummate or
enforce this Settlement Agreement.

 

13.           Representations, Warranties and Covenants of the
Parties.  The Parties hereby represent, warrant and
agree, as of the Closing Date, as follows:

 

(a)           YEDA represents and warrants that it has granted
no licenses under All Patents that would preclude or restrict the license
granted in Paragraph 4 above.  EXCEPT AS
SPECIFICALLY SET FORTH IN THIS PARAGRAPH 13(a), NOTHING IN THIS SETTLEMENT AGREEMENT
SHALL BE CONSTRUED AS:

 

(i)            A WARRANTY OR REPRESENTATION BY YEDA AS
TO THE VALIDITY OR SCOPE OF ANY PATENT OR APPLICATION THEREFOR;

 

(ii)           A WARRANTY OR REPRESENTATION THAT ANY
MANUFACTURE, SALE, USE OR OTHER DISPOSITION OF LICENSED PRODUCTS HEREUNDER WILL
BE FREE FROM INFRINGEMENT OF PATENTS AND APPLICATIONS THEREFOR OTHER THAN THOSE
UNDER WHICH LICENSES, RIGHTS AND PRIVILEGES HAVE BEEN GRANTED;

 

(iii)          AN
AGREEMENT TO BRING OR PROSECUTE ACTIONS OR SUITS AGAINST THIRD PARTIES FOR
INFRINGEMENT OR CONFERRING ANY RIGHT TO BRING OR PROSECUTE ACTIONS OR SUITS
AGAINST THIRD PARTIES FOR INFRINGEMENT;

 

Confidential Treatment has
been requested with respect to certain portions.

 

10

 

(iv)          CONFERRING BY IMPLICATION, ESTOPPEL OR
OTHERWISE, UPON ANY PARTY LICENSED HEREUNDER, ANY LICENSE, RIGHT OR PRIVILEGE
UNDER ANY PATENT OR APPLICATIONS THEREFOR EXCEPT THE LICENSES, RIGHTS AND
PRIVILEGES EXPRESSLY GRANTED HEREUNDER; OR

 

(v)           AN OBLIGATION TO FURNISH ANY TECHNICAL
INFORMATION OR KNOW-HOW.

 

(b)           Each Party represents and warrants that
it has relied upon its own judgment and that of its own legal counsel regarding
the proper, complete, and agreed-upon consideration for, and the terms and
provisions of, this Settlement Agreement and that no Party has relied on any
representation or warranty (express or implied) made by any other Party or any
of its agents, employees or legal counsel, other than as expressly set forth in
this Settlement Agreement, in entering into this Settlement Agreement.

 

(c)           This Settlement Agreement has been duly
executed and delivered on behalf of each Party and constitutes a legal, valid
and binding obligation of each Party and is enforceable against it in
accordance with its terms subject to the effects of bankruptcy, insolvency or
other laws of general application affecting the enforcement of creditor rights
and judicial principles affecting the availability of specific performance and
general principles of equity, whether enforceability is considered a proceeding
at law or equity.

 

14.           Indemnification and Limitation of
Liability.

 

(a)           Indemnification
by IMCLONE.  IMCLONE hereby agrees to defend,
hold harmless and indemnify YEDA, the Institute and their affiliates,
directors, officers and employees and the YEDA inventors of the All Patents
(such inventors being referred to as the “YEDA Inventors,” and all the
foregoing persons being referred to collectively as the “YEDA Indemnitees”)
from and against any and all claims, demands, liabilities, costs, fees,
damages, expenses and/or losses, including without limitation, reasonable legal
costs, expenses and attorneys’ fees for outside counsel (collectively, “Losses”)
resulting directly or indirectly from claims, suits, actions or demands by any person
or entity arising out of IMCLONE’s or its sublicensee’s making, using, selling,
offering for sale and/or importing Licensed Products and/or the granting of
Sublicenses.

 

(b)           Disclaimer of Liability.  In
no event shall any of the YEDA Indemnitees be liable for any Losses caused to
or suffered by any person or entity (including IMCLONE or any sublicensee) that
directly or indirectly arise out of or result from (i) claims of infringement
of the patents of any third party as a result of IMCLONE’s practice of All
Patents; (ii) making, using, selling, offering for sale and/or importing
of Licensed Products by IMCLONE or any sublicensee; (iii) the grant by
IMCLONE of any Sublicense; or (iv) the use by any customer of the Licensed
Products manufactured or sold by or on behalf of IMCLONE or any of its sublicensees;
provided, however, YEDA Indemnitees shall not be released from liability
pursuant to this Paragraph 14(b) to the extent any such Losses arise out
of or result from the gross negligence or willful misconduct of YEDA or any of
the YEDA Indemnitees.

 

Confidential
Treatment has been requested with respect to certain portions.

 

11

 

(c)           Insurance.  Within thirty (30) days after the Closing
Date, IMCLONE shall at its own expense procure and maintain during the entire
period that the
license under Paragraph 4 is in force in any country, plus an additional period
of seven (7) years, an insurance policy/policies (including products
liability and general liability insurance) adequate to cover its obligations
hereunder and which is/are consistent with normal business practices of prudent
companies similarly situated. Such insurance shall include a waiver of
subrogation in favor of the Yeda Indemnitees, to the extent Yeda is not liable
for any Losses under Paragraph 14(b). Upon request by YEDA, IMCLONE shall
provide certificates of insurance evidencing the insurance policies and
additional insured status as required under this Settlement Agreement.

 

(d)           Separate Obligations.  No obligation of either IMCLONE or SANOFI is
a joint obligation and the breach by any one of them shall not be considered a
breach by the other; IMCLONE and SANOFI are each responsible only for their own
commitments.  For the avoidance of doubt,
the release of SANOFI by YEDA is not dependent or conditional on IMCLONE’s
performance under this Settlement Agreement or its license with YEDA. With
respect to the license rights granted IMCLONE by YEDA and the financial and
other terms and conditions set forth in this Settlement Agreement relating
thereto, IMCLONE and YEDA shall have the right to modify or amend (or consent to modification or
amendment of) or terminate any and all such rights, terms and conditions as IMCLONE and
YEDA may agree from time to time in writing without any notice to or obtaining
the consent of SANOFI.

 

15.           Publicity. 
The Parties agree that no publicity release or announcement to third
parties concerning the provisions contemplated herein will be issued without
the advance written consent of the other Parties. Notwithstanding anything in
this Paragraph, and Paragraph 12 to the contrary, each Party may make filings
or disclosures that are required by applicable laws (as determined to be so
required by outside counsel for the disclosing Party), including filings or
disclosures required by or to the Securities and Exchange Commission (and any
other applicable securities exchanges) that discuss the subject matter of this
Settlement Agreement or otherwise make reference to other Parties consistent
with the terms of this Settlement Agreement; provided, however, that such
disclosing Party provides the other Parties with no less than five (5) business
days (except any filings with the Securities and Exchange Commission which
require filing within a period less than (5) business days) to review and
comment on such filings, or the relevant portions thereof, pertaining to the
provisions contemplated herein, and the other Parties do not unreasonably
reject the incorporation of such comments into such filings; provided further,
however, that the disclosing Party will agree to make a confidential treatment
request with the Securities and Exchange Commission in order to request the
redaction of any confidential information of the other Parties that, in the
opinion of such disclosing Party’s outside counsel, is not required by
applicable laws from such filings or disclosures; provided further, however,
that, the disclosing Party will use commercially reasonable efforts to obtain
confidential treatment by such security exchanges with respect thereto;
provided further, however, that IMCLONE shall be authorized to release the
press release attached hereto as Exhibit B upon the execution of this
Settlement Agreement. In addition, YEDA may, in its sole discretion, disclose
this Settlement Agreement with financial terms redacted to current or
prospective licensees under All Patents under the same terms of confidentiality
as provided for hereunder.

 

Confidential Treatment has
been requested with respect to certain portions.

 

12

 

16.           Attorneys’ Fees and Costs. 
Except to the extent provided in Paragraph 6 above, the Parties shall
bear their own respective attorneys’ fees and costs.

 

17.           Entire Agreement.  This
Settlement Agreement and the stipulations of dismissals filed by the Parties in
connection herewith, constitutes the entire, complete and integrated agreement
and understanding made among the three Parties hereto regarding the subject
matter hereof.  Any other express or
implied agreements and understandings among the three Parties hereto, either
oral or written, with regard to the subject matter hereof, are superseded by
the terms of this Settlement Agreement, along with the stipulations of
dismissals filed by the Parties in connection herewith. The Parties shall
confirm the accuracy of Schedules 1 and 2 within ten (10) days following
the Execution Date.

 

18.           Force Majeure. 
No Party shall be responsible or liable to the other for failure or
delay in performance of this Settlement Agreement due to any war, fire,
accident or other casualty or any changes in government laws or regulations,
labor disturbance or acts of God, or any other contingency beyond the Party’s
reasonable control. In the event of the applicability of this Paragraph 18, the
Party affected by such force majeure shall use its best efforts to eliminate,
cure, and overcome any of such causes and resume performance of its
obligations.

 

19.           Headings.  The captions
to the Paragraphs hereof are not a part of this Agreement, but are merely for
convenience to assist in locating and reading the Paragraphs hereof.

 

20.           Interpretive Rules. 
For the purpose of this Settlement Agreement, except as otherwise
expressly provided herein or unless the context otherwise requires: (a) defined
terms include the plural as well as the singular and the use of any gender
shall be deemed to include the other gender; (b) the use of the term “including”
means “including but not limited to”; and (c) the words “herein”, “hereof”,
“hereunder” and other words of similar import refer to this Settlement
Agreement in whole and not to any particular provision.

 

21.           No Waiver.  The failure of either Party to assert a right
hereunder or to insist upon compliance with any term or condition of this
Settlement Agreement shall not constitute a waiver of that right or excuse a
similar subsequent failure to perform any such term or condition by the other
Party.

 

22.           Further Assurances. 
All Parties hereto agree, without charge, to promptly execute and
deliver such further instruments and do and cause to be done such further acts
and things, including the filing of such assignments, agreements, documents,
registrations and instruments, as may be necessary or as a Party may reasonably
request in order to perfect any assignment or other transfer or any properties
or rights contemplated hereunder and otherwise cooperate with the other Parties
as may be reasonably necessary or desirable to effect the purpose of this
Settlement Agreement and carry out its provisions.

 

23.           Assignment and
Successors.  No Party may assign or transfer
this Settlement Agreement or any rights or obligations hereunder without the
prior written consent of the other parties, except that YEDA may freely assign
its right to receive payments under this Settlement Agreement and any Party may
make such an assignment or assumption without the other parties’ consent to an
entity that acquires all or substantially all of the business of such Party,
whether in 

 

Confidential Treatment has
been requested with respect to certain portions.

 

13

 

a
merger, consolidation, corporate or bankruptcy reorganization, acquisition,
sale or otherwise. Any assignment or attempted assignment by either Party in
violation of the terms of this Paragraph 23 shall be null and void and of no
legal effect. The assigning Party shall forward to the other parties a copy of
those portions of each fully executed assignment agreement which relate to the
assumption of the rights and responsibilities of the assigning Party, within
sixty (60) days of the execution of such assignment agreement. This Settlement
Agreement is binding upon, and shall inure to the benefit of, the Parties and
their respective affiliates, subsidiaries and each of their employees,
officers, directors, agents, successors and assigns.

 

24.           Governing Law. 
This Settlement Agreement shall be construed, governed, applied and interpreted
in accordance with the laws of the State of New York, notwithstanding any
conflict of laws analysis, except that questions affecting the construction and
effect of any patent shall be determined by the patent law of the country in
which such patent was granted. All claims hereunder shall be resolved
exclusively in the United States District Court for the Southern District of
New York (which is retaining jurisdiction to enforce this Settlement
Agreement).

 

25.           Amendments.  This Settlement Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by authorized
representatives of all Parties hereto.

 

26.           Severability.  If any one or more of the provisions contained in this
Settlement Agreement is held invalid, illegal or unenforceable in any respect,
the validity, legality and enforceability of the remaining provisions contained
herein shall not in any way be affected or impaired thereby.  In the event that the absence of the
invalidated provision(s) adversely affects the substantive rights of the
Parties, the Parties shall use their best efforts to replace the invalid,
illegal or unenforceable provision(s) with valid, legal and enforceable
provision(s) which, as much as legally possible, implement the purposes of
this Settlement Agreement as originally written.  To the extent permitted by applicable law,
IMCLONE, SANOFI, and YEDA hereby waive any provision of law that would render
any provision hereof prohibited or unenforceable in any respect.

 

27.           Notices.  Any notices
given hereunder shall be sent by overnight mail (confirmed receipt), facsimile
(confirmed receipt), or personally delivered as follows:

 

	
  If to IMCLONE:

  	
   

  	
  With a copy to:

  
	
   

  	
   

  	
   

  
	
  ImClone Systems
  Incorporated

  33 ImClone Drive

  Branchburg, NJ 08876

  Attention: General Counsel

  Tel: (908)
  218-9588

  Fax: (908) 704-2719

  	
   

  	
   

  

 

Confidential Treatment
has been requested with respect to certain portions.

 

14

 

	
  If to SANOFI:

  	
   

  	
  With a copy to:

  
	
   

  	
   

  	
   

  
	
  Aventis
  Pharmaceuticals, Inc.

  55 Corporate Drive

  Bridgewater, NJ 08807

  Attention: President

  Tel: (908)
  981-6400

  Fax: (908) 981-6405

  	
   

  	
  Proskauer
  Rose LLP

  1585 Broadway

  New York, New York 10036-8299

  Attention: Bruce Fader, Esq.

  Tel: (212) 969-3415

  Fax: (212) 969-2900

  
	
   

  	
   

  	
   

  
	
  If to YEDA:

  	
   

  	
  With a copy to:

  
	
   

  	
   

  	
   

  
	
  Yeda
  Research and Development Co. Ltd.

  Post Office Box 95

  Rehovot 76100 Israel

  Attention: CEO

  Tel: +972-8-947-0617

  Fax: +972-8-947-0739

  	
   

  	
  Weil
  Gotshal & Manges LLP

  767 5th Avenue

  New York, NY 10153

  Attention: Nicholas Groombridge, Esq.

  Tel: (212)
  310-8000

  Fax: (212)
  310-8007

  

 

28.           Construction.  Neither this Settlement Agreement nor any
provision in this Settlement Agreement shall be construed for or against any
Party because the Settlement Agreement as a whole, or any provision of this Settlement
Agreement, was requested or drafted by such Party.  Neither this Settlement Agreement nor any
provision in this Settlement Agreement nor evidence of any negotiations in
connection with it or them shall be offered or received in evidence or used in
any way in any action or proceeding between the Parties except to enforce the
terms and provisions hereof.

 

29.           Advice of Counsel. 
The Parties hereby acknowledge that they have read this Settlement
Agreement and have had an opportunity to obtain advice of counsel in connection
with the review, drafting and negotiation of this Settlement Agreement.

 

30.           365(n).  All rights
and licenses granted to IMCLONE by YEDA under or pursuant to any section of
this Settlement Agreement are and shall otherwise be deemed to be for purposes
of Section 365(n) of Title 11, United States Code (the “Bankruptcy
Code”) licenses of rights to “intellectual property” as defined in Section 101(56)
of the Bankruptcy Code.  IMCLONE shall
retain and may fully exercise all of their respective rights and elections
under the Bankruptcy Code.  Upon the
bankruptcy of YEDA, IMCLONE shall further be entitled to a complete duplicate
of, or complete access to all documents embodying, any such intellectual
property or relating to obtaining protection of or maintaining same, and such,
if not already in its possession, shall be promptly delivered to YEDA, unless
the bankrupt party elects to continue, and continues, to perform all of its
obligations under this Settlement Agreement.

 

31.           Execution and Counterparts. 
This Settlement Agreement may be executed in any number of counterparts,
each of which, when executed and delivered, shall be deemed an original, but
all of which together shall constitute one and the same instrument.  Any signatory hereto may indicate acceptance
of this Settlement Agreement with a facsimile signature or PDF copy, provided
that an original signature is provided to all other Parties thereafter.  The terms set forth herein will become effective
and binding upon the Parties once this Settlement Agreement has been fully and
duly executed.

 

Confidential Treatment has
been requested with respect to certain portions.

 

15

 

*  *  *

 

Confidential
Treatment has been requested with respect to certain portions.

 

16

 

THE
SIGNATORIES HERETO DECLARE THAT THEY ARE DULY AUTHORIZED TO EXECUTE THIS
AGREEMENT ON BEHALF OF THEIR RESPECTIVE ORGANIZATIONS, THE TERMS OF THIS
AGREEMENT HAVE BEEN FULLY UNDERSTOOD, AND ARE VOLUNTARILY ACCEPTED FOR THE
PURPOSE OF MAKING A FULL AND FINAL COMPROMISE AND SETTLEMENT.

 

IN
WITNESS WHEREOF, the Parties have executed this Settlement
Agreement:

 

	
  IMCLONE
  SYSTEMS INCORPORATED

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:     
  December 7, 2007

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  AVENTIS
  PHARMACEUTICALS, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:     
  December 7, 2007

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  AVENTIS,
  INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:     
  December 7, 2007

  	
   

  

 

Confidential Treatment
has been requested with respect to certain portions.

 

17

 

	
  AVENTIS
  HOLDINGS INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:     
  December 7, 2007

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  YEDA
  RESEARCH AND DEVELOPMENT CO. LTD.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:     
  December 7, 2007

  	
   

  

 

Confidential Treatment has been requested with respect
to certain portions.

 

18

 

SCHEDULE 1

 

Non-US Patents

 

[**]

 

 

SCHEDULE 2

 

Non-US Countries

 

[**]

 

Confidential Treatment has been requested with respect
to certain portions.

 

20

 

EXHIBIT A

 

Sublicensing Terms

 

[**]

 

Confidential Treatment has been requested with respect
to certain portions.

 

 

EXHIBIT B

 

Press Release

 

Confidential Treatment has been requested with respect
to certain portions.Exhibit
10.41

 

[NOTE : CERTAIN PORTIONS OF THIS
DOCUMENT HAVE BEEN MARKED TO INDICATE THAT CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR SUCH PORTIONS BY IMCLONE SYSTEMS INCORPORATED.  THESE PORTIONS HAVE BEEN MARKED WITH TWO ASTERISKS
ENCLOSED IN BRACKETS (i.e. [**]).  THE
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.]

 

AMENDED AND RESTATED LICENSE AGREEMENT

 

 

by and between

 

 

AVENTIS HOLDINGS, INC.

 

 

and

 

 

IMCLONE SYSTEMS INCORPORATED

 

 

Dated December 7, 2007

 

 

TABLE OF CONTENTS

 

	
  Article No.

  	
   

  	
  Title

  	
   

  	
  Page

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  RECITALS

  	
   

  	
  2

  
	
   

  	
   

  	
  DEFINITIONS

  	
   

  	
  2

  
	
  1.

  	
   

  	
  LICENSE AND
  SUBLICENSES

  	
   

  	
  4

  
	
  2.

  	
   

  	
  DUE
  DILIGENCE

  	
   

  	
  4

  
	
  3.

  	
   

  	
  FEES AND
  ROYALTIES

  	
   

  	
  4

  
	
  3.

  	
   

  	
  FEES AND
  ROYALTIES

  	
   

  	
  6

  
	
  5.

  	
   

  	
  PATENT
  PROTECTION

  	
   

  	
  7

  
	
  6.

  	
   

  	
  TERMINATION

  	
   

  	
  7

  
	
  7.

  	
   

  	
  REPRESENTATIONS
  AND WARRANTIES

  	
   

  	
  8

  
	
  8.

  	
   

  	
  INFRINGEMENT

  	
   

  	
  8

  
	
  9.

  	
   

  	
  PRODUCT
  LIABILITY

  	
   

  	
  9

  
	
  10.

  	
   

  	
  ASSIGNMENT

  	
   

  	
  9

  
	
  11.

  	
   

  	
  NON-USE OF
  NAMES

  	
   

  	
  10

  
	
  12.

  	
   

  	
  PAYMENTS,
  NOTICES AND OTHER COMMUNICATIONS

  	
   

  	
  10

  
	
  13.

  	
   

  	
  CONFIDENTIALITY

  	
   

  	
  10

  
	
  14.

  	
   

  	
  MISCELLANEOUS
  PROVISIONS

  	
   

  	
  11

  

 

Confidential Treatment Requested by ImClone Systems Incorporated

 

 

AMENDED AND RESTATED LICENSE AGREEMENT

 

This
Amended and Restated License Agreement (this “Agreement”) is entered into and
effective as of December 7, 2007 (the “Effective Date”) by and between AVENTIS
HOLDINGS, INC., a corporation duly organized and existing under the laws of
Delaware and having its principal office at 3711 Kennett Pike, Suite 200,
Greenville, Delaware 19807 (hereinafter referred to as “AVENTIS”), and IMCLONE
SYSTEMS INCORPORATED, a corporation duly organized under the laws of the STATE
OF DELAWARE and having its principal office at 180 Varick Street, New York, NY
10014 (hereinafter referred to as “IMCLONE”).

 

WITNESSETH

 

WHEREAS,
Rhône Poulenc
Rorer Inc. (“RPR”) and IMCLONE have been parties to that
certain License Agreement entered into as of June 13, 1994 (the “License
Agreement”);

 

WHEREAS, RPR through a series of intercompany
agreements has assigned to AVENTIS the License Agreement since April 5,
2004;

 

WHEREAS,
AVENTIS and IMCLONE desire to amend the License Agreement and to restate the
same in its entirety, as provided in this Agreement;

 

WHEREAS,
Yeda Research and Development Co. Ltd. (“YEDA”) has initiated legal proceedings
in several countries seeking to change the inventorship and/or ownership of
certain of the U.S. and Non-U.S. Patents and Patent Applications assigned to
RPR (“the Inventorship and Ownership Proceedings”);

 

WHEREAS,
IMCLONE, Aventis and YEDA have reached an agreement settling the Inventorship
and Ownership Proceedings (the “Three-Way Settlement”)

 

WHEREAS,
IMCLONE desires to manufacture, use and sell products which include the use of
the Know-how and are covered by the claims of the Patent Rights, and is willing
to expend its good faith efforts and resources to do so in return for an
exclusive license by AVENTIS to whatever rights remain in AVENTIS after
implementation of the Three-Way Settlement.

 

NOW,
THEREFORE, in consideration of the premises and the mutual covenants contained
herein, the parties hereto, intending to be legally bound, agree as follows:

 

DEFINITIONS

 

For the
purposes of this Agreement, the following words and phrases shall have the
following meanings:

 

Confidential Treatment Requested by ImClone
Systems Incorporated

 

2

 

“Affiliate”
shall mean any corporation, company or other entity which directly or
indirectly controls or is controlled by, or is under common control with,
IMCLONE or AVENTIS.

 

“AVENTIS”
shall mean AVENTIS and any subsidiary or Affiliate of AVENTIS.

 

“Commercial
Sale” shall mean the sale for its intended use of a Licensed Product(s) to
a third party which is not an Affiliate.

 

“Erbitux®”
shall mean cetuximab (IMC-C225, and marketed as ‘Erbitux®’).

 

“IMCLONE”
shall mean IMCLONE and any subsidiary or Affiliate of IMCLONE.

 

“Know-how”
means AVENTIS owned or licensed information and materials useful for the
manufacture, use, regulatory approval of, or sale of the Licensed Product.

 

“Licensed
Product(s)” shall mean Erbitux®, IMC-11F8 and matuzumab (EMD-72000) as well as
all derivatives, analogs, fragments, improvements, conjugates and
bioequivalents of any of the foregoing.

 

“Net
Sales,” with respect to particular Licensed Product(s), shall mean the gross
amount received by IMCLONE, its Affiliates, or its sublicensees on all sales of
such Licensed Product(s) less:

 

[**]

 

“Patent
Rights” shall mean any and all non-U.S. patents and non-U.S. patent
applications that claim priority to (a) U.S. Patent No. 6,217,866 or (b) any
one or more of the patent applications for U.S. Patent No. 6,217,866, and
any continuations, continuations-in-part, and division applications thereof,
all foreign equivalents thereof, foreign patents and any reissues,
re-examinations or extensions based thereon or a Supplementary Protection
Certificate or the like in respect thereof.

 

“Royalty
Payment(s)” shall mean the royalties paid by IMCLONE to AVENTIS under this
Agreement.

 

“Supplementary
Protection Certificate” shall mean the supplementary protection certificate for
Medicinal products provided under Council Regulation (EEC) No. 1768/92 of June 18,
1992 and their equivalents.

 

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Systems Incorporated

 

3

 

ARTICLE 1 - LICENSE AND SUBLICENSES

 

1.1           AVENTIS
hereby grants to IMCLONE a worldwide exclusive right and license under
Know-how, with the right to sublicense others, to make, have made, use, sell,
offer for sale and import Licensed Product(s).

 

1.2           AVENTIS
hereby grants to IMCLONE an exclusive license under Patent Rights, with respect
to AVENTIS’ fifty percent ownership interest in such Patent Rights, with the
right to sublicense others, to make, have made, use, sell, offer for sale and
import Licensed Product(s) in all jurisdictions outside the United States.

 

1.3           In the event
IMCLONE sublicenses the rights granted to it under Sections 1.1 or 1.2, IMCLONE
shall remain responsible for all obligations hereunder.

 

1.4           The license
granted herein shall extend in a country until expiration in such country of
the IMCLONE royalty payment obligations as described in Sections 3.3 and 3.4.

 

1.5           Except as
expressly set forth pursuant to the foregoing in this ARTICLE 1, neither party
shall acquire any license or other intellectual property interest under this
Agreement, by implication or otherwise, including patents, know-how, trademarks
or copyrights owned or licensed by the other party or its respective
Affiliates.

 

ARTICLE 2 - DUE DILIGENCE

 

2.1           IMCLONE
shall use its good faith efforts to bring the Licensed Product(s) to
market.  This good faith efforts
requirement will be considered fulfilled if IMCLONE engages in a thorough,
vigorous, and diligent program to exploit Patent Rights in all appropriate
fields of use, which may include the sublicensing of Patent Rights to better
exploit Patent Rights, as long as such a program is justified as determined by
prudent business practice.

 

ARTICLE 3 - FEES AND ROYALTIES

 

3.1           With the
exception of IMCLONE paying a single lump sum payment of $3,000,000 U.S.
dollars to AVENTIS pursuant to the December 7, 2007 letter agreement
between IMCLONE and AVENTIS (the “Side Letter”), no upfront license fees shall
be due under this Agreement upon the execution of this Agreement.  AVENTIS shall retain all amounts already paid
to it under the License Agreement before the Effective Date.  For the avoidance of doubt, except as
expressly set forth in this ARTICLE 3, no other payments or any milestone or
other royalty or other license payments shall be due from IMCLONE to AVENTIS in
consideration for any licenses or other rights granted to IMCLONE under this
Agreement.

 

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4

 

3.2           No other
payments or any milestone or other royalty or other license payments shall be
due from IMCLONE to AVENTIS (a) in respect of any Net Sales in the United
States, or (b) subject to the provisions of Section 3.3 hereunder,
with respect to Net Sales in a jurisdiction outside of the United States where
there is no issued patent in the Patent Right(s) licensed by AVENTIS to
IMCLONE hereunder.

 

3.3           IMCLONE
shall pay to AVENTIS a royalty rate of [**] of Net Sales of Erbitux® outside
the United States, in all oncological uses, and whether or not such sales are
for use as a single pharmaceutical agent or in combination with any
antineoplastic agent, including radiotherapy. 
Such royalty obligation shall apply to Net Sales in any and all
countries (other than the United States) in which there exists as of the
Effective Date an unexpired issued patent in the Patent Rights.  Such royalty obligation shall commence on the
Effective Date and thereafter terminate, on a country by country basis, on the
later of (i) January 17, 2017 or such later date secured by a patent
term extension for U.S. Patent No. 6,217,866, (ii) the expiration of
the applicable issued patent in the Patent Rights including any patent term
extension thereof, or (iii) ten (10) years from the grant of the
marketing approval for Erbitux® in that country (and in such case, whether or
not the marketing approval has been granted to Erbitux® by the competent
authorities in such country as of the Effective Date).

 

3.4           IMCLONE
shall pay to AVENTIS a royalty rate of [**] on Net Sales outside the U.S. for
all IMC-11F8 and matuzumab (EMD-72000), in each case in all oncological uses,
and whether or not such sales are for use as a single pharmaceutical agent or
in combination with any antineoplastic agent, including radiotherapy.  Such royalty obligation under this Section 3.4
shall apply to Net Sales in any and all countries in the world other than the
United States in which there exists as of the Effective Date an unexpired
issued or pending patent in the Patent Rights. 
Such royalty obligation under this Section 3.4 shall commence on
the Effective Date and thereafter terminate, on a country by country basis, on
expiration of the applicable issued patent in the Patent Rights including any
patent term extension thereof.

 

3.5           No multiple
royalties shall be payable because the Licensed Product(s), its manufacture,
lease or sale are or shall be covered by more than one patent application or
patent licensed under this Agreement.

 

3.6           Royalty
payments shall be paid in United States dollars at such place as AVENTIS may
reasonably designate consistent with the laws and regulations controlling in
any foreign country.  Any withholding
taxes that IMCLONE or any sublicensee shall be required by law to withhold on
remittance of the royalty payments shall be deducted from royalty paid to
AVENTIS.  IMCLONE shall furnish AVENTIS
the original copies of all official receipts for such taxes.  If any currency conversion shall be required
in connection with the payment of royalties hereunder, such conversion shall be
made by using the exchange rate reported in the Wall Street Journal for the
last day of the reporting period to which such royalty payments relate.

 

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3.7           The IMCLONE
obligations to pay royalties to AVENTIS under Sections 3.3 and 3.4 are absolute
and unconditional. IMCLONE shall have no right to withhold payments partially
or totally if and when there is a dispute on the application of any provision
of this Agreement.

 

ARTICLE 4 - REPORTS AND RECORDS

 

4.1(a)      IMCLONE
shall keep full, true and accurate books of account containing all particulars
that may be necessary for the purpose of showing the amount payable to AVENTIS
by way of royalty as aforesaid.  Said
books of account shall be kept at IMCLONE’s principal place of business or the
principal place of business of the appropriate division of IMCLONE to which
this Agreement relates.  Said books and
the supporting data shall be open at all reasonable times, but not exceeding
[**], for [**] years following the end of the calendar year to which they
pertain, to the inspection of AVENTIS and/or an independent certified public
accountant retained or employed by AVENTIS for the purpose of verifying IMCLONE’s
royalty statement or compliance in other respects with this Agreement.  AVENTIS shall keep information contained in
such reports confidential.

 

(b)      IMCLONE
shall require all sublicensees to keep reports sufficient to show the amount
payable to AVENTIS under this Agreement and to transmit such reports to IMCLONE
at periodic intervals.  Such sublicensee
reports shall be available to AVENTIS under the same conditions as the reports
described in Section 4.1(a) above.

 

4.2           IMCLONE,
within thirty (30) days after March 31, June 30, September 30
and December 31, of each year following the first Commercial Sale of a
Licensed Product, shall deliver to AVENTIS true and accurate reports, giving
such particulars of the business conducted by IMCLONE during the preceding
three-month period under this Agreement as shall be pertinent to a royalty
accounting hereunder.  These shall
include at least the following:

 

(a)                                  All Licensed
Products manufactured and sold.  Total
billings for Licensed Product sold.

 

(b)                                 Accounting
for all the Licensed Products used or sold.

 

(c)                                  Deductions
applicable as provided in the definition of Net Sales.

 

(d)                                 Total
royalties due.

 

(e)                                  Names and
addresses of all sublicensees hereunder.

 

4.3           With each
report submitted in accordance with Section 4.2, IMCLONE shall pay to
AVENTIS the royalties due and payable under this Agreement.  If no royalties shall be due, IMCLONE shall
so report.

 

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ARTICLE 5 - PATENT PROTECTION

 

5.1(a)      AVENTIS has
transferred to IMCLONE its complete files of Patent Rights.  IMCLONE shall retain such files until this
Agreement shall be terminated as hereinafter provided.  If this Agreement is so terminated, IMCLONE shall
return to AVENTIS its complete files of Patent Rights, and shall keep one
archive copy thereof.

 

(b)      As between
AVENTIS AND IMCLONE, IMCLONE shall pay for the filing, prosecution and
maintenance of all Patent Rights.

 

5.2           IMCLONE
shall promptly furnish to AVENTIS copies of:

 

(a)                                  Patent
applications within the Patent Rights filed in any Patent Office; and

 

(b)                                 Papers
pertaining to the Patent Rights filed in or received from a Patent Office.

 

5.3           IMCLONE
shall promptly inform AVENTIS of all matters concerning the filing, prosecution
and maintenance of the Patent Rights, and shall send copies to AVENTIS of any
relevant documents in connection with such Patent Rights.

 

ARTICLE 6 - TERMINATION

 

6.1           Upon any
material breach or default of this Agreement by IMCLONE or AVENTIS, the
non-breaching or non-defaulting party shall have the right to terminate this
Agreement and the rights, privileges and license granted hereunder, by ninety
(90) days written notice to the other party. 
Such termination shall become effective unless the breaching or
defaulting party shall have cured such breach or default prior to the
expiration of the ninety (90) day period from receipt of notice of breach or
default.

 

6.2           Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either party from any non-cancelable obligation that matured prior
to the effective date of such termination. 
IMCLONE and/or any sublicensee thereof may, however, after the effective
date of such termination, sell all Licensed Products, and complete Licensed
Products in the process of manufacture at the time of such termination and sell
the same, provided that IMCLONE shall pay to AVENTIS the royalties thereon as
required by ARTICLE 3 of this Agreement, and shall submit the reports required
by ARTICLE 4 hereof on the sales of Licensed Products.

 

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ARTICLE 7- REPRESENTATIONS AND WARRANTIES

 

7.1           AVENTIS
and IMCLONE each represents and warrants that it has the power and authority to
enter into and perform this Agreement.

 

7.2           AVENTIS
represents and warrants that, subject to the Three-Way Agreement and the
transactions contemplated thereunder, it has not granted or transferred and
shall not grant or transfer to a third party any right or interest in any
inventions, discoveries or improvements that would prevent IMCLONE from
exercising or exploiting any rights granted under this Agreement.

 

ARTICLE 8- INFRINGEMENT

 

8.1           IMCLONE
and AVENTIS shall promptly inform the other in writing of any alleged
infringement of which it shall have notice by a third party and provide such
other with any available evidence of infringement.

 

8.2           To
the extent AVENTIS has the right to do so under the Three-Way Settlement,
IMCLONE shall have the right, but shall not be obligated, to bring an action at
its own expense for any infringements of the Patent Rights and, in furtherance
of such right, AVENTIS hereby agrees to join IMCLONE as a nominal party
plaintiff in any such suit where required for jurisdictional purposes, and to
render to IMCLONE its best reasonable efforts to assist with such prosecution
of IMCLONE’s rights, such as, to the extent possible, having its employees
testify when requested and making available relevant records, papers,
information, samples, specimens, and the like. 
The total cost of any such infringement action commenced or defended
solely by IMCLONE with or without AVENTIS as a nominal party plaintiff shall be
borne by IMCLONE, and IMCLONE shall keep any recovery or damages for past
infringement derived therefrom, except for the payment to AVENTIS of [**], from
which costs and expenses of the infringement action have been deducted.

 

8.3           If
within six (6) months after having been notified by AVENTIS or after
notifying AVENTIS of any alleged infringement in accordance with Section 8.1,
IMCLONE shall have been unsuccessful in persuading the alleged infringer to
desist and shall not have brought and shall not be diligently prosecuting an
infringement action, or if IMCLONE shall notify AVENTIS at any time prior
thereto of its intention not to bring suit against any alleged infringer, then,
and in these events only, AVENTIS shall have the right, but shall not be
obligated, to prosecute at its own expense any infringement of the Patent
Rights.  No settlement, consent judgment
or other voluntary final disposition of the suit may be entered into without
the consent of IMCLONE, which consent shall not be unreasonably withheld.  The total cost of any such infringement
action commenced solely by AVENTIS shall by borne by AVENTIS and AVENTIS shall
keep any recovery or damages for past infringement derived therefrom, except
for the payment to IMCLONE of [**], from which costs and expenses of the
infringement action have been deducted. 
If IMCLONE joins

 

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AVENTIS in the enforcement of the Patent Rights
by litigation under this Section 8.3, [**].

 

ARTICLE 9– RELEASE AND INDEMNITY

 

9.1           IMCLONE
shall fully indemnify and hold harmless AVENTIS, as well as each of its
affiliates, successors, and assigns, and its present or former officers,
directors, agents, and employees (collectively, the “AVENTIS Released Parties”)
from and against any third party claim or expense or cost relating in any way
to any Patent Rights or to the manufacture, use or sale of Erbitux®.

 

9.2           IMCLONE
fully and broadly releases the Aventis Released Parties from any claim of any
kind, whether known or unknown, with respect to the License Agreement up to and
including the date of this Amended and Restated License Agreement.  AVENTIS fully and broadly releases each of
IMCLONE’s affiliates, successors, and assigns, and its present or former
officers, directors, agents, and employees from any claim of any kind, whether
known or unknown, with respect to the License Agreement up to and including the
date of this Amended and Restated License Agreement.  For the avoidance of doubt, nothing in this Section 9.2
shall affect IMCLONE’s royalty payment obligations set forth under this
Agreement going forward.

 

ARTICLE 10 - PRODUCT LIABILITY

 

10.1         IMCLONE
shall defend, indemnify, and hold AVENTIS harmless from and against all
liability, demands, damages, expense or losses for death, personal injury,
illness or property damage arising (a) out of use by IMCLONE or its
transferees of inventions licensed or Know-how furnished under this Agreement,
or (b) out of any use, sale or other disposition by IMCLONE or its
transferees of products made by use of such inventions or information, except
to the extent that such loss, claim, damage, or liability arises in whole or in
part from the gross negligence or willful misconduct of AVENTIS.  As used in this clause, “AVENTIS” includes
its Officers, Agents and Employees, and “IMCLONE” includes its Subsidiaries,
Contractors and Sub-contractors.

 

ARTICLE 11 - ASSIGNMENT

 

11.1         IMCLONE
may assign or otherwise transfer this Agreement and the license granted hereby
and the rights acquired by it hereunder so long as such assignment or transfer
shall be accompanied by a sale or other transfer of IMCLONE’s entire business
or of that part of IMCLONE’s business to which the license granted hereby
relates.  IMCLONE shall give AVENTIS
thirty (30) days prior notice of such assignment and transfer.

 

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ARTICLE 12 - NON-USE OF NAMES

 

12.1         IMCLONE
shall not use the name of AVENTIS nor any adaptation thereof in any
advertising, promotional or sales literature without prior written consent of
AVENTIS, in each case, except that IMCLONE may state that it is licensed by
AVENTIS under one or more of the patents and/or applications comprising the
Patent Rights.

 

ARTICLE 13 - PAYMENTS, NOTICES AND OTHER
COMMUNICATIONS

 

13.1         Any payment, notice or other
communication pursuant to this Agreement shall be sufficiently made or given on
the date of mailing if sent to such party by certified first class mail,
postage prepaid, or on the day it is received by such party if sent by any
other method, addressed to such party at its address below or as it shall
designate by written notice given to the other party:

 

In the
case of AVENTIS, to:

 

Aventis Holdings, Inc.

3711 Kennett Pike,

Suite 200, Greenville,

Delaware 19807

Attn: President

 

With a
copy to:

 

Sanofi-Aventis
U.S. LLC

55,
Corporate Drive

08807 Bridgewater

UNITED
STATES

Attention:
General Counsel

 

In the
case of IMCLONE, to:

 

ImClone Systems Incorporated

180 Varick Street

New York, NY 10014

Attention: General Counsel

 

ARTICLE 14 - CONFIDENTIALITY

 

14.1         While
this Agreement is in effect, and for a period of five (5) years
thereafter, any technical or business related information or materials which
AVENTIS or IMCLONE may disclose to each other shall be treated as confidential
to

 

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the
extent permitted by law.  Written
confidential information shall be identified as confidential information.  Non-written confidential information shall be
reduced to writing and identified as confidential information by the disclosing
party within forty-five (45) days of disclosure.  Confidential information and materials shall
be maintained in confidence by the receiving party and shall not be disclosed
to any third party without prior written consent of the disclosing party, other
than as contemplated by the terms of this Agreement.  This obligation shall not apply to
information which:

 

(a)                                  is in the
public domain prior to the disclosure through no fault of the receiving party;

 

(b)                                 becomes part
of the public domain subsequent to disclosure through no fault of the receiving
party;

 

(c)                                  is lawfully
disclosed to the receiving party by a third party who is not obligated to
retain such information in confidence;

 

(d)                                 is in the
receiving party’s possession prior to disclosure as shown by reasonable proof;

 

(e)                                  lawfully
becomes publicly known following disclosure to a government patent agency in
connection with the prosecution of any Patent Rights or a regulatory agency
responsible for the approval of therapeutic products; or

 

(f)                                    must be
publicly disclosed pursuant to any government statute or regulation or any
court order.

 

ARTICLE 15 - MISCELLANEOUS PROVISIONS

 

15.1         This
Agreement shall be construed, governed, interpreted and applied in accordance
with the laws of the State of New York, except that questions affecting the
construction and effect of any patent shall be determined by the patent law of
the country in which such patent was granted.

 

15.2         The
parties hereto acknowledge that this Agreement sets forth the entire Agreement
and understanding of the parties hereto as to the subject matter hereof except
for as set out in the Three-Way Settlement and the Side Letter.  Any other express or implied agreements and
understandings, either oral or written, with regard to the subject matter
hereof (including the License Agreement), are superseded by the terms of this
Agreement. This Agreement may be amended, or any term hereof modified, only by
a written instrument duly executed by authorized representatives of both parties
hereto.

 

15.3         If
any one or more of the provisions contained in this Agreement is held invalid,
illegal or unenforceable in any respect, the validity, legality and

 

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11

 

enforceability
of the remaining provisions contained herein shall not in any way be affected
or impaired thereby.  In the event that
the absence of the invalidated provision(s) adversely affects the
substantive rights of the parties, the parties shall use their best efforts to
replace the invalid, illegal or unenforceable provision(s) with valid,
legal and enforceable provision(s) which, insofar as practical, implement
the purposes of this Agreement.

 

15.4         All
Licensed Products shipped to or sold in countries other than the United States
shall be marked in such manner as to conform with the patent laws and practice
of the country of manufacture or sale.

 

15.5         The
failure of either party to assert a right hereunder or to insist upon
compliance with any term or condition of this Agreement shall not constitute a
waiver of that right or excuse a similar subsequent failure to perform any such
term or condition by the other party.

 

15.6         Neither
party shall be responsible or liable to the other for failure or delay in
performance of this Agreement due to any war, fire, accident or other casualty
or any changes in government laws or regulations, labor disturbance or acts of
God, or any other contingency beyond the Party’s reasonable control.  In the event of the applicability of this Section 15.6,
the party affected by such force majeure shall use its best efforts to
eliminate, cure, and overcome any of such causes and resume performance of its
obligations.

 

15.7         All
rights and licenses granted under or pursuant to any section of this Agreement
are and shall otherwise be deemed to be for purposes of Section 365(n) of
Title 11, United States Code (the “Bankruptcy Code”) licenses of rights to “intellectual
property” as defined in Section 101(56) of the Bankruptcy Code.  The parties shall retain and may fully
exercise all of their respective rights and elections under the Bankruptcy
Code.  Upon the bankruptcy of any party,
the non-bankrupt party shall further be entitled to a complete duplicate of, or
complete access to all documents embodying, any such intellectual property or
relating to obtaining protection of or maintaining same, and such, if not
already in its possession, shall be promptly delivered to the non-bankrupt
party, unless the bankrupt party elects to continue, and continues, to perform
all of its obligations under this Agreement.

 

15.8         The
captions to the Sections and Articles hereof are not a part of this Agreement,
but are merely for convenience to assist in locating and reading the Sections
and Articles hereof.

 

15.9         For
the purpose of this Agreement, except as otherwise expressly provided herein or
unless the context otherwise requires: (a) defined terms include the
plural as well as the singular and the use of any gender shall be deemed to
include the other gender; (b) references to Articles, Sections and other
subdivisions and to Schedules and Exhibits without reference to a document, are
to designated Articles, Sections and other subdivisions of and to Schedules and
Exhibits to this Agreement; (c) the use of the term “including” means “including
but not limited to”;

 

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12

 

and
(d) the words “herein”, “hereof”, “hereunder” and other words of similar
import refer to this Agreement in whole and not to any particular provision.

 

15.10       It
is expressly agreed that each of the parties shall be independent contractors
and that the relationship between the parties shall not constitute a
partnership, joint venture or agency. 
Neither of the parties shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on the other party, without the prior written consent of the other
party.

 

15.11       No
remedy referred to in this Agreement is intended to be exclusive, but each
shall be cumulative and in addition to any other remedy referred to in this
Agreement or otherwise available under law.

 

15.12       Each
party has had the opportunity to consult with counsel in connection with the
review, drafting and negotiation of this Agreement.  Accordingly, the rule of construction
that any ambiguity in this Agreement shall be construed against the drafting
party shall not apply.

 

15.13       This
Agreement may be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.

 

*  *  *

 

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IN
WITNESS WHEREOF, the parties hereto have hereunto set their hands and seals and
duly executed this License Agreement as of the Effective Date.

 

	
  Aventis Holdings, Inc.

  	
   

  	
  ImClone Systems Incorporated

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  
									

 

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