Document:

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
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document.

 

 

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 

 

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document.

 

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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

 

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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

 

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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

 

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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.

 

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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

 

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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.

 

9

 

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.

 

10

 

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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document.

 

11

 

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.

 

12

 

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 certain portions of this
document.

 

13

 

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 certain portions of this
document.

 

14

 

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 

 

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

 

15

 

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.

 

16

 

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 certain
portions of this document.

 

17

 

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 certain portions of this
document.

 

18Exhibit 10.39

 

[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.]

 

[IMCLONE LETTERHEAD]

 

October 12,
2007

Merck KGaA

Dr. Wolfgang Wein

Frankfurter Strasse 250

64293 Darmstadt

Germany

 

RE:          Amended and Restated Co-Development and
Co-Commercialization Agreement for Erbitux in Japan (the “Japan Agreement”)

 

Dear Dr. Wein:

 

This letter agreement (this “Agreement”)
is intended to clarify the rights and responsibilities of Merck KGaA, a German
corporation with general partners (“Merck”), Merck Serono Japan
Company, Limited, a Japanese
corporation (“MJ”), and ImClone Systems Incorporated, a Delaware
corporation (“ImClone”), under the Japan Agreement and under that
certain Development and License Agreement, dated December 14, 1998,
between Merck and ImClone (as such agreement has been amended, modified and
supplemented, the “Existing Agreement”) with respect to Japan in light
of their entry into the Japan Agreement. 
This Agreement shall become effective upon the signing of the Japan
Agreement by all of the parties thereto (the “Effective Date”).  Unless otherwise indicated, initially
capitalized terms shall have the meanings given to them in the Japan Agreement.

 

1.             Royalties for Japan; Other Matters under Japan Agreement.

 

(a)           Royalties.  Except as otherwise provided in Section 1(c) hereof,
following the Effective Date until the expiration of the Japan Agreement or the
termination of Merck or MJ under Article 14 of the Japan Agreement, in
lieu or the royalties required to be paid by Merck to ImClone under the
Existing Agreement in respect of sales in Japan, Merck shall pay, or cause MJ
to pay, to ImClone a royalty equal to 4.75% of Net Sales.  Such royalty shall be paid on a quarterly
basis and at the same time as Merck is required to pay royalties to ImClone under
the Existing Agreement.

 

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

 

 

(b)                                 Adjustments upon Termination of BMS/BMKK as a Party to
the Japan Agreement.  If BMS/BMKK is terminated as a party to the
Japan Agreement prior to termination of this Agreement, then (i) Section 1(a) hereof
will not apply following such termination of BMS/BMKK as a party to the Japan
Agreement, and (ii) ImClone, Merck and MJ shall give effect to the
following provisions (the “Post-BMS Termination Adjustments”) under the
Japan Agreement and not to any contrary provisions thereof following such
termination of BMS/BMKK:

 

(A)          Profit Or Loss shall be shared as follows—[**];

 

(B)           Merck and MJ 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 Merck and MJ shall have a reasonable
time (not to exceed six months without good cause) in which to ramp up Sales
Force personnel and other internal FTE requirements following such termination
in order to perform the assumed Commercialization obligations of BMS/BMKK;

 

(C)           Commercialization Costs shall be deemed to include the costs of time
spent by employees of ImClone, Merck and MJ on the Commercialization of Final
Product in Japan on an equal FTE Cost basis, and Development Costs shall be
deemed to include the costs of time spent by employees of ImClone, Merck and MJ
on the Development of Final Product in Japan on a basis comparable to such
treatment of Commercialization Costs;

 

(D)          Merck, MJ and ImClone shall use the Long-Term Development Plan and the
Annual Development Plan and Budget and update them as appropriate to reflect
the termination of BMS/BMKK and other relevant circumstances, and will share
the Development effort and the Development Costs thereunder as follows— [**]

 

(E)           Merck/MJ and ImClone shall share all Losses arising under Section 13.2
of the Japan Agreement that otherwise would be allocated among the Parties
according to percentages set forth therein as follows—[**]

 

(F)           the SCJ will be eliminated and the Steering Committee (as defined in the
Existing Agreement) will serve as the SCJ under the Japan Agreement;

 

(G)           each of the Subcommittees will consist of five members, with three
members designated by Merck and two designated by ImClone, the JJCC will act by
majority vote with each member having one vote and the other Subcommittees will
act by unanimous vote; provided, however, that in the event that unanimity
cannot be achieved within 20 Business Days after a matter is first submitted to
the JJDC, then the representatives to the JJDC designated by Merck will decide
such matter; provided, further, that in the event that unanimity
cannot be achieved within 20 Business Days after a matter is first submitted to
the JJMC, the 

 

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

 

2

 

representatives of the
Party that is responsible for the applicable manufacturing activities will
decide such matter; and

 

(H)          the Alliance Managers will mean the Alliance Managers designated by
Merck/MJ and ImClone.

 

2.             Termination; Effect of Termination.

 

(a)           Termination.  This Agreement shall continue until (i) the
Japan Agreement expires as provided in Section 14.1(a) thereof; (ii) any
of Merck, MJ or ImClone is terminated as a party to the Japan Agreement
pursuant to Section 14.2(b), 14.3, 14.4 or 14.5 thereof; (iii) BMS/BMKK
is terminated as a party to the Japan Agreement and Merck and ImClone
have entered into a New Agreement (as defined below).

 

(b)           Survival.  Sections 2 and 3 hereof shall survive any
termination of this Agreement.  The
rights that have accrued to the benefit of any party hereto prior to any
termination of this Agreement, including, without limitation, the rights of
ImClone to payments from Merck under Section 1(a) hereof with respect
to the period prior to such termination, shall survive any termination of this
Agreement.

 

(c)           Effect of Termination.  Upon termination of this Agreement pursuant
to Sections 2(a)(i) or (ii) hereof, the rights and obligations of
Merck and ImClone to one another with respect to Japan following such
termination shall be governed by the terms and conditions of the Existing Agreement,
except for the rights and obligations under this Agreement that survive such
termination or the Japan Agreement that survive the events that provided the
basis for such termination.  Upon
termination of this Agreement pursuant to Section 2(a)(iii) hereof,
the rights and obligations of Merck and ImClone to one another with respect to
Japan following such termination shall be governed by the terms and conditions
of the New Agreement, except for the rights and obligations under this
Agreement that survive such termination.

 

(d)           New Agreement.  If BMS/BMKK is terminated as a party to the
Japan Agreement, then Merck and ImClone shall promptly begin good faith
negotiations (with a view to finalizing within six months thereafter) to enter
into a new agreement with respect to Japan that will replace and supersede the
Japan Agreement and this Agreement (“New Agreement”), with the
understanding that the framework for such New Agreement will be the Japan
Agreement as in effect following the termination of BMS/BMKK, except as required
to give effect to the Post-BMS Termination Adjustments.

 

3.             Miscellaneous.

 

(a)           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 hereto.

 

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

 

3

 

(b)           Assignment.  The ability
of each of the parties hereto to assign its rights and obligations under this
Agreement shall be governed by the terms of the Japan Agreement.  Merck and MJ hereby consent to any assignment
by ImClone of the Japan Agreement and this Agreement to an entity that is an
Affiliate of ImClone, it being understood that (a) ImClone will remain
responsible (jointly and severally) with such Affiliate for the performance of
such assigned obligations, and (b) ImClone will cause such assignment and
delegation to terminate if such entity ceases to be an Affiliate of
ImClone.  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

 

(c)           Notices.  Any notice or
request required or permitted to be given under or in connection with this
Agreement shall be provided in the manner specified in the Existing Agreement (except
that notices to MJ may be provided to Merck as agent for MJ) and the
effectiveness of such notices shall be governed by the terms thereof.

 

(d)           Amendment
and Waiver.  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
hereto.  No waiver of any term or
condition of this Agreement shall be valid or effective unless in writing and
signed by the party hereto against which such waiver is sought to be
enforced.  A waiver by any of the parties
hereto 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.

 

(e)           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.

 

(f)            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.

 

(g)           Disputes.  Except as
otherwise provided in this Agreement, any disputes under this Agreement shall
be addressed in the manner set forth in the Existing Agreement.

 

(h)           Entire
Agreement.  This Agreement, together with the Japan
Agreement and the Existing Agreement, and all exhibits, schedules or amendments
attached thereto, set forth the entire agreement and understanding between the
parties hereto as to the subject matter hereof and merges all prior discussions
and negotiations among them.  This Agreement
is intended to supplement and modify the Existing 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 Existing Agreement applicable to
other countries.

 

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

 

4

 

(i)            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.

 

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

 

*              *              *

 

Please sign in the space provided below to
indicate your agreement to the foregoing. Upon signing of this Agreement by all
of the parties hereto, each of such parties shall be legally bound.

 

	
   

  	
  IMCLONE SYSTEMS INCORPORATED

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
  Name:

  	
   

  
	
   

  	
  Title:

  	
   

  
	
   

  	
   

  
	
  ACKNOWLEDGED AND AGREED

  	
   

  
	
  AS OF OCTOBER 12, 2007 BY:

  	
   

  
	
   

  	
   

  
	
  MERCK KGAA

  	
   

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  MERCK SERONO JAPAN COMPANY, LIMITED

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  
						

 

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

 

5

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