Exhibit 10.38

 

EXECUTION COPY

 

[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.]

 

BMS-IMCLONE JAPAN AGREEMENT

 

THIS AGREEMENT (the “Agreement”), effective as of October 12, 2007 (the
“Effective Date”), is entered into by and among Bristol-Myers Squibb Company, a
corporation organized and existing under the laws of the State of Delaware,
having offices located at Route 206 & Province Line Road, Princeton, New Jersey
(“BMS”), E.R. Squibb & Sons, LLC, a limited liability company organized and
existing under the laws of the State of Delaware, having offices located at
Route 206 & Province Line Road, Princeton, New Jersey (“ERS”), Bristol-Myers K.
K., a Japanese corporation, with its principal place of business at Shinjuku
I-Land Tower, 5-1, Nishi-Shinjuku 6-chome, shinjuku-ku, Tokyo, 163-1328, Japan
(“BMKK”) (BMS, ERS and BMKK, sometimes collectively, “Bristol”), and ImClone
Systems Incorporated, a corporation organized under the laws of the State of
Delaware, having offices located at 180 Varick Street, New York, New York 10014
(“ImClone”).  BMS, ERS, BMKK and ImClone are each referred to as a “Party” (or,
collectively, as the “Parties”) to this Agreement.

 

PRELIMINARY STATEMENTS

 

WHEREAS, ImClone and Merck KGaA, a general partnership limited by shares
organized and existing under the laws of the Federal Republic of Germany, having
offices located at Frankfurter Straße 250, 64293 Darmstadt, Federal Republic of
Germany (“Merck”), entered into that certain Development and License Agreement,
dated December 14, 1998, as amended (hereinafter referred to as the
“Merck-ImClone Agreement”) with respect to the development and marketing of
Cetuximab; and

 

WHEREAS, ImClone has granted to Merck under the Merck-ImClone Agreement
worldwide outside of Canada, Japan and the United States of America (including
all territories and possessions thereof) exclusive rights to develop and market
Cetuximab; and

 

WHEREAS, with respect to Japan, the Merck-ImClone Agreement provides that Merck
has the co-exclusive rights to develop and market, with the right to sublicense,
Final Product in Japan; and

 

WHEREAS, ImClone, BMS and ERS entered into that certain Development, Promotion,
Distribution and Supply Agreement, dated September 19, 2001 (said agreement, as
amended heretofore by amendments thereto dated as of March 5, 2002 and July 27,
2007, and as the same may be hereafter amended, hereinafter referred to as the
“BMS-ImClone Commercial Agreement”), pursuant to which, among other things,
ImClone granted to ERS (i) the exclusive right to distribute, and a co-exclusive
right (together with ImClone) to develop

 

Confidential treatment has been requested by ImClone Systems Incorporated for
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and promote, ERBITUX (as defined in the BMS-ImClone Commercial Agreement) in
North America, and (ii)  a co-exclusive right to develop, distribute and promote
(together with the ImClone and the Merck Entities (as such term is defined in
the BMS-ImClone Commercial Agreement) in Japan; and

 

WHEREAS, BMS, ERS, BMKK, ImClone, Merck and Merck Ltd., a Japanese corporation,
with its principal place of business at ARCO Tower, 5 F, 8-1, Shimomeguro
1-chome, Meguro-ku, Tokyo 153-8927, Japan (“MJ”), entered into a Co-Development
Agreement for the Co-Development of Cetuximab in Japan effective as of
December 15, 2004 (the “Japan Co-Development Agreement”); and

 

WHEREAS, the parties to the Japan Co-Development Agreement have reached
agreement on terms of co-Commercialization of Final Product in Japan, and have
amended and restated the Co-Development Agreement, effective as of the effective
date of this Agreement, to reflect such understanding and agreement (said
amended and restated agreement referred to as the “Six-Party Japan Commercial
Agreement”); and

 

WHEREAS, ImClone, BMS, ERS and BMKK desire to enter into this Agreement in order
to reflect certain additional agreements among these three parties that are
related to each such Party’s willingness to enter into the Six-Party Japan
Commercial Agreement, all on the terms and conditions hereinafter set forth
below.

 

NOW, THEREFORE, in consideration of the foregoing Preliminary Statements and the
mutual agreements and covenants set forth herein, the parties hereto agree as
follows:

 

1.                                      DEFINITIONS.

 

Except as otherwise expressly defined in this Agreement, all capitalized terms
set forth in this Agreement shall have the meaning set forth in the Six-Party
Japan Commercial Agreement.  The following terms shall have the following
meaning for purposes of this Agreement:

 

1.1                                 “Adjusted Profit Or Loss” shall mean the sum
of a – (b + c), where:

 

a =                    BMS’ share of any Profit Or Loss determined under the
Six-Party Japan Commercial Agreement as set forth in Section 7.1 thereof with
respect to the applicable accounting period, after taking into account any
adjustments pursuant to Sections 4.5, 6.4(f)(ii) and 6.4(f)(iii) of said
Agreement;

 

b =                   the Unaccounted For Bristol Expenses with respect to the
applicable accounting period; and

 

c =                    the Unaccounted For ImClone Expenses with respect to the
applicable accounting period.

 

Adjusted Profit Or Loss, as set forth in this definition, shall be calculated in
accordance with GAAP (and IFRS, where used by Merck to calculate Profit Or Loss)
and the standard accounting practices that a Party customarily applies to other
products sold by it.  Items of cost

 

Confidential treatment has been requested by ImClone Systems Incorporated for
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or expense shall only be taken into account once in determining Adjusted Profit
Or Loss.  For example, if any cost or expense is already taken into account as
an Allowable Expense, such cost or expense shall not be taken into account again
as an Unaccounted For Bristol Expense or as an Unaccounted For ImClone Expense. 
“Adjusted Profit” means a positive Adjusted Profit Or Loss; “Adjusted Loss”
means a negative Adjusted Profit Or Loss.

 

1.2           “Unaccounted For Bristol Expenses” means those expenses, whether
paid or payable, incurred by BMS, BMKK and their Affiliates with respect to an
applicable accounting period in connection with the performance of any
obligations or covenants required of BMS, BMKK and their Affiliates under
(i) the BMS-ImClone Commercial Agreement (with respect to Japan) and (ii) the
Six-Party Japan Commercial Agreement for each of the following categories of
expenses, but only where, in each case (i) and (ii), such expenses: (A) are not
already taken into account as an Allowable Expense in determining Profit Or Loss
for such accounting period, (B) are reasonably contemplated by and/or reasonably
incurred in connection with the performance of any such obligations or covenants
(and, where reasonably contemplated by a given Approved Plan, are incurred
consistent with such Approved Plan after taking into account any permitted cost
overruns under the BMS-ImClone Commercial Agreement (with respect to Japan)
and/or the Six-Party Japan Commercial Agreement or that are approved by the SCJ,
the JEC or the JCC), and (C) are specifically identifiable or reasonably
allocable to the performance of the applicable activities set forth below:

 

[**]

 

As promptly as reasonably practicable following approval by the SCJ of an
Approved Plan, ImClone and Bristol shall meet to arrive at an agreed upon number
of FTEs that Bristol is anticipated to devote to the tasks assigned to it in the
Approved Plan (the “Bristol FTE Budget”).  Unaccounted For Bristol Expenses
shall be calculated using the Bristol FTE Budget for the costs set forth in
Sections 1.2.1-1.2.5 regardless of the actual FTEs devoted by Bristol to such
tasks in the relevant period; provided, that, if and where Bristol also tracks
the actual number of FTEs in the ordinary course of its business operations
devoted to such FTE task, then, if the actual number of such FTEs devoted by
Bristol deviates (higher or lower) from the Bristol FTE Budget by [**], the
Unaccounted For Bristol Expenses shall be calculated using [**].  By way of
example, if the Bristol FTE Budget is [**] FTEs and the number of FTEs actually
devoted is [**], the number used in calculating Unaccounted For Bristol Expenses
is [**].  By way of further example, if the Bristol FTE Budget is [**] FTEs and
the number of FTEs actually devoted is [**], the number used in calculating
Unaccounted For Bristol Expenses is [**].

 

For clarification, no payments made by Bristol pursuant to Section 6.2(v) or
6.4(f)(i)(2)(x) or (y) of the Six-Party Japan Commercial Agreement shall be
included in Unaccounted for Bristol Expenses.

 

1.3           “Unaccounted for ImClone Expenses” means those expenses, whether
paid or payable, incurred by ImClone and its Affiliates with respect to an
applicable accounting period in connection with the performance of any
obligations or covenants required of ImClone and its Affiliates under (i) the
BMS-ImClone Commercial Agreement (with respect to Japan) and (ii) the Six-Party
Japan Commercial Agreement for each of the following categories of

 

Confidential treatment has been requested by ImClone Systems Incorporated for
certain portions of this document.

 

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expenses, but only where, in each (i) and (ii), such expenses: (a) are not
already taken into account as an allowable expense in determining Profit Or Loss
or in determining unaccounted for ImClone payments for such accounting period,
(b) are reasonably contemplated by and/or reasonably incurred in connection with
the performance of any such obligations or covenants (and, where reasonably
contemplated by a given Approved Plan, are consistent with such Approved Plan
after taking into account any permitted cost overruns under the BMS-ImClone
Commercial Agreement (with respect to Japan) and/or the Six-Party Japan
Commercial Agreement or that are approved by the SCJ, the JEC or the JCC), and
(c) are specifically identifiable or reasonably allocable to the performance of
the applicable activities set forth below:

[**]

 

As promptly as reasonably practicable following approval by the SCJ of an
Approved Plan, ImClone and Bristol shall meet to arrive at an agreed upon number
of FTEs that ImClone is anticipated to devote to the tasks assigned to it in the
Approved Plan (the “ImClone FTE Budget”).  Unaccounted For ImClone Expenses
shall be calculated using the ImClone FTE Budget for the costs set forth in
Sections 1.3.1-1.3.3 regardless of the actual FTEs devoted by ImClone to such
tasks in the relevant period; provided, that, if and where ImClone also tracks
the actual number of FTEs in the ordinary course of its business operations
devoted to such FTE task, then, if the actual number of FTEs devoted by ImClone
deviates (higher or lower) from the ImClone FTE Budget by [**], the Unaccounted
For ImClone Expenses shall be calculated using [**].  By way of example, if the
ImClone FTE Budget is [**] FTEs and the number of FTEs actually devoted is [**],
the number used in calculating Unaccounted For ImClone Expenses is [**].  By way
of further example, if the ImClone FTE Budget is [**] FTEs and the number of
FTEs actually devoted is [**], the number used in calculating Unaccounted For
ImClone Expenses is [**].

 

2.                                      SHARING OF ADJUSTED PROFIT OR LOSS;
OTHER PAYMENTS.

 

2.1                                 Sharing and Payment of Adjusted Profit Or
Loss.  Subject to Sections 2.3 and 3.5 of this Agreement:

 

2.1.1                        ImClone and BMS shall each receive one-half of the
Adjusted Profit and each shall bear one-half of the Adjusted Loss determined
hereunder.  BMS shall pay ImClone fifty percent (50%) of Adjusted Profits, and
ImClone shall pay to BMS fifty percent (50%) of the Adjusted Loss, determined on
a calendar year basis.  Payment shall be made under this Agreement on a
Quarterly basis, it being agreed that Quarterly payments shall be reconciled as
part of the year-end final determination of Adjusted Profit Or Loss for a given
year concurrently with the determination of the amount of any reconciliation
payments for a calendar year under Section 4.5(d) of the Six-Party Japan
Commercial Agreement.

 

2.1.2                        Within 30 days of the end of each Quarter, Bristol
shall provide to ImClone its calculated value for variable 1.1b and ImClone
shall provide to Bristol its calculated value for variable 1.1c, along with
sufficient documentation to reasonably establish the accuracy of these numbers. 
Following receipt of such values and documentation, a Party will have 15
Business Days to determine whether each of the components included in such

 

Confidential treatment has been requested by ImClone Systems Incorporated for
certain portions of this document.

 

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value are properly included therein pursuant to this Agreement and to
communicate any findings to the other Party.  Each Party shall also furnish the
other with (i) any information provided to Merck or MJ, or by Merck or MJ to one
of the Parties hereto, that is used to determine the calculation of Profit Or
Loss for such Quarter, and/or which otherwise accompany Merck’s payment of
Profits to Bristol or invoice to Bristol for its share of Loss; and (ii) all
documents concerning costs and/or expenses which were furnished by Bristol or
ImClone to the SCJ and/or the appropriate subcommittee in connection with the
formulation, verification and/or reconciliation of Approved Plans.  Each of
ImClone and Bristol shall have the right to further request any other documents
to which it would otherwise be entitled under the BMS-ImClone Commercial
Agreement with respect to enabling ImClone to verify the accuracy and validity
of any payment made to or by Bristol or ImClone pursuant to this Agreement or
the Six-Party Japan Commercial Agreement.

 

2.1.3        Either Party may object to the calculated values of variables 1.1b
and 1.1c within 15 Business Days of receipt of said calculated values and
related documentation.  If there is any objection to the calculation provided,
the Parties will promptly confer and endeavor to resolve any differences.  If
there is an objection to any component of these calculated variables, the
Parties shall promptly confer to resolve the objections.  In the case of an
objection, the payments due on the remainder of the Adjusted Profit or Adjusted
Loss for which there is no objection will still be due as provided in
Section 2.1.4 below, with any balance with respect to the disputed portion to be
paid within 30 days following resolution of the dispute.

 

2.1.4        Within five Business Days after receipt by Bristol of its share of
any Profit (in Quarters where there is a Profit) from Merck/MJ pursuant to
Section 4.5 of the Six-Party Japan Commercial Agreement, either Bristol will pay
to ImClone its share of Adjusted Profit determined pursuant to this Section 2.1
or ImClone will pay to Bristol its share of Adjusted Loss determined pursuant to
this Section 2.1.  Within five Business Days after payment by Bristol of its
share of any Loss (in Quarters where there is a Loss) to Merck/MJ pursuant to
Section 4.5 of the Six-Party Japan Commercial Agreement, either Bristol will pay
to ImClone its share of Adjusted Profit determined pursuant to this Section 2.1
or ImClone will pay to Bristol its share of Adjusted Loss determined pursuant to
this Section 2.1.

 

2.2                                 Japan Development Costs.

 

2.2.1                        ImClone and BMS shall each bear one-quarter of the
total Development Costs determined under the Six-Party Japan Commercial
Agreement.  ImClone or BMS shall make a reconciling payment to the other with
respect to such Development Costs, at the same time as BMS/BMKK and Merck/MJ are
determining and making a payment to share same pursuant to Sections 4.4 and 4.5
of the Six-Party Japan Commercial Agreement.

 

2.2.2                        BMS and ImClone shall also each reimburse the other
for one-half of any Development Costs (as such term is defined in the
BMS-ImClone Commercial Agreement) that are incurred by such Party or its
Affiliates pursuant to and in accordance with the BMS-ImClone Commercial
Agreement with respect to development of Erbitux and Final Product in Japan and
that are not taken into account in determining Development Costs (as such term
is defined in the Six-Party Japan Commercial Agreement) under Section 2.2.1
above in the Six-Party Japan Commercial Agreement.  ImClone and BMS shall report
to one another such costs

 

Confidential treatment has been requested by ImClone Systems Incorporated for
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and remit the amount due the other under this Section 2.2.1 for a given Quarter
in accordance with the BMS-ImClone Commercial Agreement.

 

2.3           Royalty Cap.  Under Section 9.4(c) of the BMS-ImClone Commercial
Agreement, the sharing of certain Third Party Payments for damages, milestones,
royalties, license fees and similar payments by BMS and its Affiliates is capped
at certain levels with respect to Japan, after which ImClone is responsible for
the payment of any such Third Party Payments.  Accordingly, BMS and ImClone
agree that should the damages, awards and Third Party Payments that are
attributable to the manufacture (by any Party, its Affiliates or a Third Party)
of Cetuximab or Final Product for use and sale in Japan or to the use or
Commercialization (by any Party or its Affiliates, by Merck and its Affiliates,
or by any Third Party) of Cetuximab or Final Product in Japan and that are taken
into determining Profit Or Loss for a given accounting period exceed [**] of Net
Sales in such accounting period, then, to the extent that BMS/BMKK is not
otherwise being indemnified for such damages, awards and Third Party Payments
pursuant to the Six-Party Japan Commercial Agreement, ImClone shall pay to BMS
such amount as equals the difference between (x) what BMS’ share of Adjusted
Profit Or Loss would have been if the damages, awards and Third Party Payments
taken into account in determining Profit Or Loss for such Accounting Period had
only been [**] and (y) the Adjusted Profit Or Loss determined using all the
damages, awards and Third Party Payments that were taken into account for such
accounting period (“Royalty Cap Payment”).  Any such Royalty Cap Payment may be
taken into account by BMS to offset any payment of Adjusted Profit otherwise
required to be made by BMS to ImClone pursuant to Section 2.2.1 or to increase
ImClone’s share of Adjusted Loss payable by it to BMS; if not so offset or added
by BMS, such payment shall be paid by ImClone within 30 days after receipt of an
invoice from BMS for same.

 

2.4           Minimum Spend.  The Parties agree that, for 2004, 2005, 2006 and
thereafter, for so long as the Six-Party Japan Commercial Agreement remains in
force and effect with respect to BMS, any specific required amounts that BMS
would otherwise be or have been required to spend under the BMS-ImClone
Commercial Agreement with respect to Japan for Registrational Study Spend,
Non-Registrational Study Spend, Marketing Budget and A&P spend (as such terms
were defined in the BMS-ImClone Commercial Agreement prior to the execution of
Amendment No. 2 thereto dated as of July 27, 2007), and any specific number of
Sales Force Representatives that BMS would otherwise be required to devote under
the BMS-ImClone Commercial Agreement with respect to Japan, shall be of no force
and effect.  In the event of termination of the Six-Party Japan Commercial
Agreement, such contract required amounts shall be reinstated, but any specific
required amounts that BMS would otherwise be required to spend under the
BMS-ImClone Commercial Agreement with respect to Japan for the year of
termination (if other than effective as of December 31), shall be prorated for
the year of termination based on the number of days remaining in the year of
termination.  This Section 2.4 shall not otherwise affect or vary any diligence
or efforts obligations with which BMS would otherwise be required to satisfy
with respect to Japan under the Six-Party Japan Commercial Agreement or the
BMS-ImClone Commercial Agreement.

 

2.5           Sharing of Penalties Paid by Merck for Failure to Provide Required
PDEs.  In the event that Merck/MJ fails to provide the PDEs required pursuant to
the Six-Party Japan Commercial Agreement such that Merck/MJ pays a penalty
pursuant to Section 6.4(f)(i)(2)(y)

 

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thereof (the “PDE Penalty”), then Bristol, within 30 days after upon receipt of
the PDE Penalty from Merck/MJ, shall pay [**] of the amount received to
ImClone.  However, to the extent that Bristol replaces any of the unprovided
PDEs then Bristol shall be entitled to retain such portion of ImClone’s share of
such PDE Penalty otherwise payable to ImClone that corresponds to the percentage
of the PDEs not provided by Merck/MJ that BMS replaces.  By way of example, if
Merck/MJ failed to provide [**] PDEs and Bristol replaced [**] of such PDEs,
then Bristol would receive [**] of the total PDE Penalty ([**])) and ImClone
would receive [**] of the total PDE Penalty.  If however, Bristol replaced all
[**] PDEs not provided by Merck/MJ, then Bristol would retain [**] of the total
PDE Penalty and ImClone would receive [**] of the PDE Penalty.  For
clarification, ImClone will not share in any payments made to Bristol pursuant
to Section 6.2(v), or 6.2(b)(v) or 6.4(f)(i)(2)(x) of the Six-Party Japan
Commercial Agreement, nor will ImClone be liable for any payments made by
Bristol pursuant to Section 6.2(v), or 6.4(f)(i)(2)(x) or (y) of the Six-Party
Japan Commercial Agreement.

 

3.                                      DILIGENCE, GOVERNANCE, REPORTING AND
MISCELLANEOUS MATTERS.

 

3.1           Diligence.  Neither this Agreement nor the Six-Party Japan
Commercial Agreement varies or supersedes the diligence that Bristol (or its
Affiliates) is required to exercise in Japan or elsewhere under the BMS-ImClone
Commercial Agreement.

 

3.2           Documents.  Bristol shall furnish ImClone, on a regular and
ongoing basis, with all material documents exchanged between Bristol and
Merck/MJ pursuant to the Six-Party Japan Commercial Agreement relating to the
performance of a Bristol or Merck/MJ obligation under the Agreement, which
documents ImClone would not otherwise have access to through ImClone’s
representation on the SCJ or any subcommittee thereof.

 

3.3           Voting.  Subject to Sections 3.5 and 3.7 below, the votes cast by
Bristol and ImClone on the SCJ and its subcommittees shall be determined by each
Party separately and shall be cast as provided in the Six-Party Japan Commercial
Agreement, provided, that any votes cast by BMS, BMKK or ImClone thereunder
shall be consistent with applicable terms of this Agreement and the BMS-ImClone
Commercial Agreement and any undisputed decisions by an applicable committee
under the BMS-ImClone Commercial Agreement not subject to further approval by a
higher committee (i.e., decisions that have not been submitted for approval or
dispute resolution to a higher committee to which it reports or for binding
arbitration as permitted by the BMS-ImClone Commercial Agreement).

 

3.4                                 Termination of Six-Party Japan Commercial
Agreement.

 

3.4.1                       Breach by Merck/MJ.

 

(a)                                  To the extent that the Six-Party Japan
Commercial Agreement gives either Bristol or ImClone the right to terminate such
agreement as to Merck/MJ pursuant to Section 14.3(a) or 14.4(a) thereof based on
an Uncured Material Default (as such term is defined in the Six-Party Japan
Commercial Agreement) by Merck or MJ (or their Affiliates), Bristol and ImClone
agree that neither shall exercise such termination right unless both Bristol and
ImClone agree to such termination.

 

Confidential treatment has been requested by ImClone Systems Incorporated for
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(b)           In the event that Section 14.3(a) or 14.4(a) of the Six-Party
Japan Commercial Agreement should apply such that Merck/MJ rights and
obligations under that Agreement are terminated, then, for so long as the
BMS-ImClone Commercial Agreement remains in force and effect thereafter, ImClone
will not grant any license or sublicense rights or any co-promotion or
co-marketing rights to any Third Party to develop or commercialize Cetuximab or
Final Product in Japan, nor shall ImClone or its Affiliates develop,
commercialize, co-promote or co-market Cetuximab or Final Product in Japan
except in accordance with the applicable provisions of the BMS-ImClone
Commercial Agreement.  Further, subject to Section 7.2 hereof and other
applicable terms and conditions of this Agreement that apply following such
termination and to those terms and conditions of the Six-Party Japan Commercial
Agreement that survive such termination, the Parties obligations with respect to
Japan following such termination shall be governed by the terms and conditions
of the BMS-ImClone Commercial Agreement thereafter with respect to Japan.

 

3.4.2        Termination by BMS/BMKK.  In the event that the BMS-ImClone
Commercial Agreement has expired and it is commercially unreasonable for ImClone
to continue to co-commercialize and co-develop Final Product in Japan under the
Six-Party Japan Commercial Agreement, BMS/BMKK shall voluntarily terminate the
Six-Party Japan Commercial Agreement pursuant to Section 14.5 thereof within 30
days following written notice by ImClone to BMS/BMKK requesting such
termination.  As part of such notice to BMS, ImClone shall provide to BMS in
writing its reasons for why it is commercially unreasonable for ImClone to so
continue.  If requested by BMS or BMKK within 30 days following receipt by BMS
of such notice and reasons from ImClone, BMS and ImClone will meet and confer
for up to 90 ninety days thereafter in an effort to determine if a mutually
acceptable agreement can be reached that would avoid the need for such
termination (during which time, BMS shall not be obligated to voluntarily
terminate the Six-Party Japan Commercial Agreement pursuant to Section 14.5
thereof).  It is further understood that the term “commercially unreasonable”
shall be based on the facts and circumstances then prevailing with respect to
Final Product in Japan (including, without limitation, the Parties’ experience
under the Six-Party Japan Commercial Agreement and the relative return on the
resources that ImClone is devoting to performing its obligations under the
Six-Party Japan Commercial Agreement) and shall not take into consideration more
financially favorable or beneficial commercial terms that would be available to
ImClone (whether by co-commercializing with a Third Party, granting Merck
exclusive co-commercialization rights, or co-commercializing itself with Merck)
if the Six-Party Japan Commercial Agreement were to terminate.  For the
avoidance of doubt, if the parties do not agree as to whether such commercially
unreasonable circumstances exist, the matter shall be settled by arbitration
pursuant to the terms of Section 16.13(a) of the BMS-ImClone Commercial
Agreement.

 

3.5           Bridging Studies.  In the event that positive data is obtained
from one or more Western Phase III registrational clinical trials for a given
line of therapy such that the Japan Pharmaceutical and Medical Devices Agency
(“PMDA”) acknowledges in writing that, based on such positive Western data, only
one or more successful Bridging Studies (as defined below) would be needed and
sufficient in order for the Parties to obtain approval in Japan for such line of
therapy using such Western data and the successful results of such Bridging
Study or Bridging Studies, then, so long as Merck/MJ is willing to co-fund and
co-develop all such needed Bridging Studies, neither Party will unreasonably
withhold, delay or condition its

 

Confidential treatment has been requested by ImClone Systems Incorporated for
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consent to funding its share of such Bridging Study or Bridging Studies;
provided, that (x) the foregoing shall not affect a Party’s consent rights with
respect to the scientific integrity, safety or design of such Bridging Study and
(y) the Parties reasonably expect that such studies will have been completed,
and that BMKK or MJ shall have received all data needed to be filed with the
PMDA following the completion of all such Bridging Studies, for a given
Indication by not later than December 31, 2014.  A “Bridging Study”, for
purposes of this Section 3.5, means a Phase I or Phase II study (usually
enrolling 20 to 50 patients), done in Japanese patients or other Asian patients
acceptable to the PMDA and conducted in Japan (and/or such other Asian countries
acceptable to the PMDA), whose purpose is to demonstrate the validity of said
positive Western clinical trial results in the Japanese population.  The design
and sample size of any such Bridging Study is generally discussed and agreed
upon by the study sponsor with the Japan Pharmaceutical and Medical Devices
Agency prior to the conduct of the Study.

 

3.6           Sublicense.  In the event that BMS should propose to sublicense
its rights under Section 10.3 of the Six-Party Japan Commercial Agreement, then
ImClone will not unreasonably withhold, delay or condition its consent to any
such Sublicense under Section 10.3(h) of said Agreement or to any sublicense of
BMS’ rights and obligations as they pertain to Japan under this Agreement and
any BMS-ImClone Commercial Agreement, provided, that (i) any terms and
conditions of Section 10.3 applicable to the grant of any such Sublicense are
satisfied, (ii) BMS guarantees the performance of the obligations pertaining to
Japan under this Agreement and any BMS-ImClone Commercial Agreement that are
sublicensed to such Sublicensee, and (iii) the grant of any such Sublicense or
any sublicense under this Agreement and the BMS-ImClone Commercial Agreement
shall not relieve BMS or BMKK of its obligations under this Agreement or the
BMS-ImClone Commercial Agreement as they pertain to Japan, except to the extent
they are satisfactorily performed by such Sublicensee.

 

3.7           Competing Product.  In the event that ImClone, any of its
Affiliates, or its or their licensees or sublicensees (other than BMS, Merck, or
their respective Affiliates) acting under the authority of such license or
sublicense should Develop (after the date that a product became a Competing
Product), promote or otherwise commercialize a Competing Product in Japan
(whether by itself, through an Affiliate, through co-promotion or co-marketing,
or through the grant of a license or sublicense to a Third Party to manufacture
or Commercialize a Competing Product) without the co-funding of, or
co-participation in, such activities by BMS/BMKK, then: (i) BMS will have the
deciding vote thereafter at the JEC level under the BMS-ImClone Commercial
Agreement with respect to the development and/or commercialization of Cetuximab,
Final Product or Alternative Final Product in Japan; and (ii) ImClone will, with
respect to the development of Cetuximab, Final Product and Alternative Final
Product in Japan, cast any votes to which it may be entitled at any committee or
subcommittee level under the Six-Party Japan Commercial Agreement consistent
with the vote cast by BMKK/BMS at such committee or subcommittee at the SCJ or
any Subcommittee; provided, that the foregoing shall not apply to any vote cast
by ImClone where ImClone believes in good faith that there are good grounds that
the proposed course of development activities are reasonably likely to be
significantly detrimental to the product profile or marketing of the Final
Product for existing Indications in Japan (by way of example and without
limitation because the proposed protocol is poorly designed or is likely to
yield poor results), or are reasonably likely to materially adversely impact the
Commercialization of the Final Product in the EU or the U.S., or that the
proposed course of activities presents a medical

 

Confidential treatment has been requested by ImClone Systems Incorporated for
certain portions of this document.

 

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risk/benefit that is so unfavorable as to be incompatible with the welfare of
patients.  Nothing in the foregoing shall, or is intended to, create or imply,
or is intended to create or imply, any additional right in ImClone to Develop
(after the date that a product became a Competing Product), promote or otherwise
commercialize a Competing Product in Japan without BMS’ consent thereto and
participation in the co-development, co-promotion and/or co-commercialization
thereof.

 

3.8           Co-Promotion Option.  For so long as the Six-Party Japan
Commercial Agreement remains in force and effect, and BMS remains a party
thereto, ImClone will not exercise any Co-Promotion Option with respect to Japan
under Section 5.6 of the BMS-ImClone Commercial Agreement nor exercise any
remedy with respect to Japan under Sections 3.9 or 5.6(e) of the BMS-ImClone
Commercial Agreement.

 

3.9           Conflict.  In the event of a conflict between the BMS-ImClone
Commercial Agreement and this Agreement, the terms of this Agreement shall
control as to the specific subject matter hereof.

 

4.                                      AUDIT RIGHTS.

 

4.1           Audit.  The respective audit rights of Bristol and ImClone under
this Agreement shall be governed by the same terms and conditions as apply to
audits permitted under the BMS-ImClone Commercial Agreement.

 

5.             REPRESENTATIONS AND WARRANTIES; DISCLAIMER OF WARRANTIES

 

5.1                                 Representations and Warranties.  Each of
Bristol and ImClone represents and warrants to the other, as of the Effective
Date, that:

 

5.1.1        It is duly organized and validly existing under the laws of the
jurisdiction of its incorporation and has full corporate power and authority to
enter into this Agreement and to carry out the provisions hereof, and the person
executing this Agreement on its behalf has been duly authorized to do so by all
requisite corporate action;

 

5.1.2        This Agreement is legally binding on it, and enforceable in
accordance with its terms.  The execution, delivery and performance of this
Agreement by it does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a party or by which it may be
bound, nor violate any Applicable Law or any order of any court, governmental
body or administrative or other agency having jurisdiction over it;

 

5.1.3        It has taken all corporate action necessary to authorize the
execution and delivery of this Agreement and the performance of its obligations
under this Agreement.

 

5.2           Disclaimer.  Except as expressly set forth in this agreement or in
the BMS-ImClone Commercial Agreement to which such Party is a party, no Party
makes any representations or extends any warranties of any kind, either express
or implied, and each Party expressly disclaims all implied warranties of
merchantability and of fitness for a particular purpose or use, with respect to
the subject matter of this agreement.

 

Confidential treatment has been requested by ImClone Systems Incorporated for
certain portions of this document.

 

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6.                                      CONFIDENTIALITY; EXCEPTIONS.

 

6.1           Reference to Commercial Agreement.  The confidentiality provisions
of the BMS-ImClone Commercial Agreement shall apply to any Confidential
Information exchanged between the parties under this Agreement.

 

6.2           Use of Confidential Information.  Each of Bristol and ImClone
shall use, and cause each of its Affiliates to use, any Confidential Information
obtained pursuant to this Agreement solely in connection with the activities or
transactions contemplated under this Agreement, the Six-Party Japan Commercial
Agreement, and the BMS-ImClone Commercial Agreement.

 

7.                                      TERM.

 

7.1           Term; Termination.   This Agreement shall become effective as of
the Restatement Effective Date. This Agreement shall continue until (a) the
Six-Party Japan Commercial Agreement expires as provided in
Section 14.1(a) thereof (without being terminated prior to expiration); (b) BMS,
BMKK or ImClone ceases to be a party to the Six-Party Japan Commercial Agreement
pursuant to Section 14.2, 14.3(b) or 14.4 of the Six-Party Japan Commercial
Agreement; (c) termination by BMS/BMKK pursuant to Section 14.5 of the Six-Party
Japan Commercial Agreement; or (e) the Six-Party Japan Commercial Agreement
terminates for any other reason than those in (a), (b) or (c) of this
Section 7.1, and BMS (and/or BMKK as the case may be) and ImClone have entered
into a New Agreement as provided in Section 7.2 below.  The Parties agree that
Section 13.1 of the BMS-ImClone Commercial Agreement shall not apply so as to
trigger termination of the Six-Party Japan Commercial Agreement, unless such
termination is triggered by reason of Section 13.2 or 13.3 of the BMS-ImClone
Commercial Agreement.

 

7.2                                 Effect of Certain Terminations.

 

7.2.1        If the Six-Party Japan Commercial Agreement is terminated based on
either termination of the Merck-ImClone Agreement for any reason, for breach by
Merck, MJ or their Affiliates pursuant to Section 14.3(a) or 14.4 or voluntary
termination by Merck or MJ under Section 14.5 of the Six-Party Japan Commercial
Agreement, then BMS/BMKK and ImClone shall promptly begin good faith
negotiations to enter into a new agreement (“New Agreement”) with a view to
finalizing within six months thereafter, with such New Agreement to cover the
development and Commercialization of Erbitux/Final Product for, and the
manufacture of Final Product for use and sale in, Japan only, with the
understanding that the framework for such New Agreement will be the BMS-ImClone
Commercial Agreement as it applies to Japan, except for those provisions of the
Six-Party Japan Commercial Agreement that survive any termination of such
Agreement and except as follows:

 

(a)           BMKK will provide all of the sales force detailing, marketing, and
promotional effort for Final Product in Japan, and will use Diligent Efforts to
provide such efforts and support as required by, and in accordance with, those
Approved Commercialization Plans then agreed upon as of such termination date;
provided, that BMKK shall have a reasonable time (not to exceed six months
without good cause) in which to ramp up Sales Force

 

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personnel and other internal FTE requirements following such termination in
order to perform the assumed Commercialization obligations of Merck/MJ.
 Following the expiration of the time period covered by such Approved
Commercialization Plans, BMS/BMKK shall exercise such Commercialization efforts
obligations with respect to Japan as it would otherwise be required to devote
under the BMS-ImClone Commercial Agreement;

 

(b)           Except for any adjustments as may be required to reflect
Section 3.1(c) of the Six-Party Japan Commercial Agreement, BMS/BMKK and ImClone
will evenly provide the Development effort and evenly share the Development
Costs with respect to Erbitux and Final Product in Japan in accordance with the
then approved Annual Development Plan and Budget and Long-Term Development Plan
(and will evenly share what would otherwise have been Merck/MJ’s share of such
Development Costs thereunder). Following the expiration of such Annual
Development Plan and Budget and Long-Term Development Plan, or with respect to
any new clinical studies to be added thereto for Japan, BMS and ImClone shall
exercise such Development efforts obligations as would otherwise apply to each
such Party under the BMS-ImClone Commercial Agreement with respect to Japan;
provided, that there shall be no specific required amounts for BMS to spend
under the BMS-ImClone Commercial Agreement with respect to Japan for
Registrational Study Spend and Non-Registrational Study Spend (as such terms
were defined in the BMS-ImClone Commercial Agreement prior to the execution of
Amendment No. 2 thereto dated as of July 27, 2007);

 

(c)           Except as needed (i) to reflect Section 3.1(c) of the Six-Party
Japan Commercial Agreement and BMS’ cap under Section 9.4(c) of the BMS-ImClone
Commercial Agreement on the royalties or damages to be taken into account that
are attributable to Net Sales in Japan, and (ii) to exclude from the calculation
of Profit Or Loss amounts for which BMS and its Affiliates are not responsible
pursuant to the first two sentences of the second paragraph of Section 1 of the
Release, Waiver and Covenant Not to Sue, dated as of July 27, 2007, among
ImClone, BMS, and E.R. Squibb & Sons, LLC, the New Agreement will provide for
equal sharing of Profit Or Loss;

 

(d)           Sharing of Third Party Payments with respect to Japan will be as
set forth in Section 9.4(c) of the BMS-ImClone Commercial Agreement;

 

(e)           Sections 3.7 of this Agreement and Section 10.2 of the Six-Party
Japan Commercial Agreement will no longer apply;

 

(f)            Indemnification shall be addressed substantially as provided in
Sections 12.2 and 12.3 of the BMS-ImClone Commercial Agreement; provided, that
the foregoing shall not affect or supersede the application of any
indemnification obligations that survive termination of the Six-Party Japan
Commercial Agreement or the application of any provisions in Sections 14.2,
14.3, 14.4, 14.5, 14.6, 14.7 or 14.8 thereof, as applicable;

 

(g)           ImClone would supply Final Product to BMKK for use and sale in
Japan, in accordance with the terms of the BMS-ImClone Commercial Agreement, as
modified by applicable provisions of the Six-Party Japan Commercial Agreement
and BMKK will provide, or arrange through a Third Party to provide, fill/finish
and/or Packaging and Release services for Final Product for Japan; provided,
that the Parties will cooperate to ensure

 

Confidential treatment has been requested by ImClone Systems Incorporated for
certain portions of this document.

 

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an appropriate and reasonable transition period as needed to upgrade, prepare
and qualify any necessary facilities with applicable regulatory authorities
needed to implement same;

 

(h)           BMKK will provide forecasts for Japan in the manner as had been
established under the Six-Party Japan Commercial Agreement;

 

(i)            Regulatory matters shall be handled as provided in the
BMS-ImClone Commercial Agreement, as supplemented or modified by the BMS-ImClone
Japan Agency Agreement among BMS, BMKK, and ImClone, dated January 25, 2007, as
amended;

 

(j)            The New Agreement shall retain the committees and other decision
making bodies, approval rights and decision making processes and procedures of
the Six-Party Japan Commercial Agreement, except that (i) Merck/MJ shall not
have any representation on such committees and shall not have any approval
rights, (ii) Bristol and ImClone shall have equal numbers of representatives on
such committees, and (iii) decision making and tie-breaking votes shall follow
the procedures set forth in the then applicable BMS-ImClone Commercial Agreement
for the corresponding committees set forth therein;

 

(k)           The New Agreement will provide for the Erbitux® Trademark to be
exclusively licensed by ImClone to BMS/BMKK for use in connection with the
commercialization of Final Product in Japan during the term of the New
Agreement; and

 

(l)            The term of the New Agreement would continue until the earlier of
(i) the termination or expiration of the BMS-ImClone Commercial Agreement, and
(ii) the date that the Six-Party Japan Commercial Agreement would otherwise have
expired (without regard to early termination other than permitted terminations
under Section 14.5 thereof) pursuant to Section 14.1 thereof, subject to sooner
termination for Uncured Material Default by BMS or ImClone.

 

7.2.2                        Unless specifically modified by such New Agreement
(as mutually agreed by BMS/BMKK and ImClone, in its sole discretion, following
any termination that results in negotiation of a New Agreement), any such New
Agreement shall not affect, and each of ImClone and BMS/BMKK shall retain, all
rights separately granted to each them, and obligations that are retained by
them, under the Six-Party Japan Commercial Agreement that survive termination of
such Six-Party Japan Commercial Agreement, including the rights and obligations
set forth in Article 14 of the Six-Party Japan Commercial Agreement.  Pending
the execution of any such New Agreement, each Party shall continue to perform
any obligations that it may have with respect to Japan under this Agreement, the
BMS-ImClone Commercial Agreement, the Six-Party Japan Commercial Agreement, and
any other agreement (including manufacturing agreements) that such may at such
time have entered into with a Party or its Affiliates or with Third Parties
relating to Japan.

 

7.3           Other Terminations.  Upon termination of this Agreement pursuant
to any of Sections 7.1(a), 7.1(b) or 7.1(c) of this Agreement, the Parties’
obligations with respect to Japan following such termination shall be governed
by the terms and conditions of the BMS-ImClone Commercial Agreement thereafter
with respect to Japan, subject to and/or as amended by the terms and conditions
of this Agreement that apply following such termination and

 

Confidential treatment has been requested by ImClone Systems Incorporated for
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subject to those terms and conditions of the Six-Party Japan Commercial
Agreement that survive such termination.

 

7.4           Accrued Rights; Surviving Obligations.  Termination of this
Agreement for any reason shall be without prejudice to any rights that shall
have accrued to the benefit of any of the Parties prior to such termination or
expiration, including without limitation the payment of any amounts that have
accrued, or that remain to determined pursuant to Article 2 of this Agreement
and are reasonably allocable to the period, through the date of termination. 
Such termination shall not relieve any of the Parties from any obligation which
is expressly indicated to survive termination or expiration of this Agreement. 
All of the Parties’ rights and obligations under Articles 4, 6, 7 and 8 and
Sections 2.4, 3.6 and 5.2 shall survive termination of this Agreement.

 

8.                                      MISCELLANEOUS.

 

8.1           Relationship of Parties.  Nothing in this Agreement is intended or
shall be deemed to constitute a partnership, agency, employer-employee or joint
venture relationship among the Parties.  Neither ImClone nor Bristol shall incur
any debts or make any commitments for the other, except to the extent, if at
all, specifically provided herein.

 

8.2           Assignment.  Each Party may assign its rights and obligations
under this Agreement, to a Person to which such Party is permitted to assign,
and to which such Party has assigned, all of its rights and obligations under
the Six-Party Japan Commercial Agreement.  BMS, ERS and BMKK hereby consent to
any assignment by ImClone of the Six Party Japan Commercial Agreement and this
Agreement to an entity that is an Affiliate of ImClone (subject to the same
terms and conditions as are contained in Section 16.2 of the Six Party Japan
Commercial Agreement applying to the assignment of this Agreement), it being
understood that (a) ImClone will remain responsible (jointly and severally) with
such Affiliate for the performance of such assigned obligations (including for
the payment of any amounts owed by such Affiliate) under the Six Party Japan
Commercial Agreement and this Agreement (as either such agreement may be amended
or supplemented hereafter), and (b) ImClone will cause such assignment to
terminate if such entity ceases to be an Affiliate of ImClone and shall
immediately assume the performance of all such assigned obligations.  ImClone
agrees to take such action as may be necessary to keep itself informed as to the
scope and performance of such obligations.  ImClone’s joint and several
responsibility will not be discharged by any extension, amendment, modification,
or renewal by such ImClone Affiliate with respect to any obligation so assigned
to such ImClone Affiliate. All of the terms and provisions of this Agreement
shall be binding upon, inure to the benefit of and be enforceable by the parties
hereto and their respective permitted successors and assigns.

 

8.3           Affiliates of the Parties.  Each Party shall cause its applicable
Affiliates to take such actions as are necessary for such Party to fulfill its
obligations under this Agreement.

 

8.4           Books and Records.  Any books and records to be maintained under
this Agreement by a Party shall be maintained in accordance with GAAP.

 

Confidential treatment has been requested by ImClone Systems Incorporated for
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8.5           Further Actions.  Each Party shall execute, acknowledge and
deliver such further instruments, and do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.

 

8.6           Notice.  Any notice or request required or permitted to be given
under or in connection with this Agreement shall be deemed to have been
sufficiently given if in writing and personally delivered or sent by facsimile
transmission (receipt verified) or overnight express courier service (signature
required), prepaid, to the Party for which such notice is intended, at the
address set forth for such Party below:

 

(i)            in the case of ImClone, to:

 

 

ImClone Systems Incorporated

 

 

180 Varick Street

 

 

New York, New York 10014 USA

 

 

Attention:

General Counsel

 

Facsimile:

(1 212) 645-2770

 

Telephone:

(1 646) 638-5027

 

 

 

with a copy to:

 

 

 

Attention:

Senior Vice President Regulatory Affairs,

 

 

Biostatistics and Quality Assurance

 

 

Facsimile:

(1 908) 218-0555

 

 

Telephone:

(1 908) 541-2250

 

(ii)           in the case of Bristol (either BMS or BMKK), to:

 

 

Bristol-Myers Squibb Company

 

 

 

P.O.  Box 4000

 

 

 

Route 206 & Province Line Road

 

 

 

Princeton, New Jersey 08543-4000 USA

 

Attention:

Vice President and Senior Counsel,

 

 

 

Worldwide Licensing and

 

 

 

Business Development

 

Facsimile:

(1 609) 252-6019

 

 

 

 

with a copy to:

 

 

 

 

 

Attention:

Vice President, Alliance Management

 

Facsimile:

(1 609) 252-7235

 

or to such other address for such Party as it shall have specified by like
notice to the other parties, provided that notices of a change of address shall
be effective only upon receipt thereof.  With respect to notices given pursuant
to this Section 8.6, (i) if delivered personally or by facsimile transmission,
the date of delivery shall be deemed to be the date on which such notice or
request was given; and (ii) if sent by overnight express courier service, the
date of

 

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delivery shall be deemed to be the next business day after such notice or
request was deposited with such service.

 

8.7           Use of Name.  Except as otherwise provided herein or in the
BMS-ImClone Commercial Agreement, none of the parties shall have any right,
express or implied, to use in any manner the name or other designation of the
other parties or any other trade name, Trademark, Corporate Name or logo of the
other parties for any purpose in connection with the performance of this
Agreement.

 

8.8           Public Announcements.  Except as required by law (including,
without limitation, disclosure requirements of the U.S. Securities and Exchange
Commission, Nasdaq or any other stock exchange on which securities issued by a
Party are traded), none of the parties shall make any public announcement
concerning this Agreement or the subject matter hereof without the prior written
consent of the other parties, which shall not be unreasonably withheld or
delayed; provided that it shall not be unreasonable for a Party to withhold
consent with respect to any public announcement containing any financial terms
or any of such Party’s Confidential Information.  In the event of a required
public announcement, to the extent practicable under the circumstances, the
Party making such announcement shall provide the other parties with a copy of
the proposed text prior to such announcement sufficiently in advance of the
scheduled release of such announcement to afford the other parties a reasonable
opportunity to review and comment upon the proposed text.

 

8.9           Waiver.  A waiver by any of the parties of any of the terms and
conditions of this Agreement in any instance shall not be deemed or construed to
be a waiver of such term or condition for the future, or of any subsequent
breach hereof.  All rights, remedies, undertakings, obligations and agreements
contained in this Agreement shall be cumulative and none of them shall be in
limitation of any other remedy, right, undertaking, obligation or agreement of
any of the parties.

 

8.10         Severability.  When possible, each provision of this Agreement will
be interpreted in such manner as to be effective and valid under Applicable Law,
but if any provision of this Agreement is held to be prohibited by or invalid
under Applicable Law, such provision will be ineffective only to the extent of
such prohibition or invalidity, without invalidating the remainder of this
Agreement.

 

8.11         Amendment.  No amendment, modification or supplement of any
provisions of this Agreement shall be valid or effective unless made in writing
and signed by a duly authorized officer of each of the parties.

 

8.12         Governing Law.  This Agreement shall be governed by and interpreted
in accordance with the laws of the United States and the State of New York
without regard to conflict of law principles.

 

8.13         Disputes.  Any disputes under this Agreement shall be addressed by
the JEC, the Finance Committee, the PDC, the JCC and/or the JMC of the
BMS-ImClone Commercial Agreement (as such terms are defined in the BMS-ImClone
Commercial Agreement).  Any dispute arising out of or relating to the
interpretation of any provisions of this Agreement or the

 

Confidential treatment has been requested by ImClone Systems Incorporated for
certain portions of this document.

 

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failure of either Bristol or ImClone to perform or comply with any obligations
or conditions applicable to them pursuant to this Agreement shall be finally
settled by arbitration pursuant to the terms of Section 16.13(a) of the
BMS-ImClone Commercial Agreement.

 

8.14         Entire Agreement.

 

(a)           This Agreement, together with the Six-Party Japan Commercial
Agreement and the BMS-ImClone Commercial Agreement, and all exhibits, schedules
or amendments attached thereto, set forth the entire agreement and understanding
between the parties as to the subject matter hereof and merges all prior
discussions and negotiations among them, and none of the parties shall be bound
by any conditions, definitions, warranties, understandings or representations
with respect to such subject matter other than as expressly provided herein or
therein or as duly set forth on or subsequent to the date hereof in writing and
signed by a proper and duly authorized officer or representative of the Parties
to be bound thereby.

 

(b)           This Agreement is intended to supplement and modify the
BMS-ImClone Commercial Agreement with respect to Japan only, and this Agreement
is not intended to and shall not in any way change or amend any other provisions
of the BMS-ImClone Commercial Agreement applicable to other countries within a
Party’s territory.

 

(c)           The rights of Bristol and ImClone under this Agreement are
cumulative to their rights under the BMS-ImClone Commercial Agreement.

 

(d)           Nothing in this Agreement shall, or is intended in any way to,
modify or supplement the Release, Waiver and Covenant Not to Sue, dated as of
July 27, 2007, among ImClone, BMS, and E.R. Squibb & Sons, LLC.

 

8.15         Descriptive Headings.  The descriptive headings of this Agreement
are for convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.

 

8.16         Counterparts.  This Agreement may be executed simultaneously in any
number of identical counterparts, any one of which need not contain the
signature of more than one Party, but all such counterparts taken together shall
constitute one and the same agreement.

 

[the next page is the signature page]

 

Confidential treatment has been requested by ImClone Systems Incorporated for
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IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed
by its duly authorized representative as of the date first above written.

 

 

BRISTOL-MYERS SQUIBB COMPANY

 

BRISTOL-MYERS K.K.

 

 

 

 

 

 

 

 

 

 

By:

 

 

By:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

IMCLONE SYSTEMS INCORPORATED

 

E.R. SQUIBB & SONS, LLC

 

 

 

 

 

 

 

 

 

 

By:

 

 

By:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Confidential treatment has been requested by ImClone Systems Incorporated for
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