Exhibit 10.37

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

AMENDED AND RESTATED

CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT FOR

ERBITUX ® IN JAPAN

AMONG

1.          BRISTOL-MYERS SQUIBB COMPANY

2.          E.R. SQUIBB & SONS, LLC

3.          BRISTOL-MYERS K.K.

4.          MERCK KGAA

5.          MERCK SERONO JAPAN COMPANY, LIMITED
           AND

6.          IMCLONE SYSTEMS INCORPORATED

DATED AS OF

October 12, 2007

Table of Contents

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THIS AMENDED AND RESTATED CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT FOR ERBITUX® IN JAPAN (this “ Agreement ”), effective as of October 12, 2007 (the “ Restatement 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 (“ Bristol ”), 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 and ERS, collectively, “ BMS ”), 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 ”), Merck KGaA, a German corporation with general partners 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 ”), Merck Serono Japan Company, Limited, a Japanese corporation, with its principal place of business at 6F Meguro Tokyu Bldg., 2-13-17 Kamiosaki, Meguro-ku, Tokyo, 141-0021, Japan (“ MJ ”), 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 ”).

PRELIMINARY STATEMENTS

WHEREAS, ImClone and Merck entered into that certain Development and License Agreement, dated December 14, 1998 (and, as amended heretofore or hereafter, hereinafter referred to as the “ Merck-ImClone Agreement ”), with respect to the development and marketing of ImClone’s chimerized monoclonal antibody to EGFR, known as C-225 (IMC-225, cetuximab), which is the active pharmaceutical ingredient in the product sold under the Erbitux® trademark;

WHEREAS, ImClone has granted to Merck under such 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;

WHEREAS, with respect to Japan, the Merck-ImClone Agreement provides that ImClone and Merck have co-exclusive rights to develop and market, with certain rights to sublicense, Cetuximab in Japan;

WHEREAS, ImClone, BMS and ERS entered into that certain Development, Promotion, Distribution and Supply Agreement, dated September 19, 2001 and as heretofore amended, pursuant to which, among other things, ImClone and BMS shall (i) co-develop and co-promote Cetuximab in the United States of America and Canada, and (ii) co-develop and co-promote Final Product in Japan, together with Merck (such agreement, as amended heretofore or hereafter, and hereinafter referred to as the “ BMS-ImClone Agreement ” and collectively with the Merck-ImClone Agreement, the Merck-ImClone Japan Agreement and the BMS-ImClone Japan Agreement, the “ Existing Agreements ”);

WHEREAS, MJ, a fully owned subsidiary of Merck, has expertise, amongst other fields, in the development and marketing of drugs in Japan;

WHEREAS, BMKK, a fully owned subsidiary of BMS, has expertise, amongst other fields, in the development and marketing of drugs in Japan and has a substantial presence in Japan with which to do so;

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WHEREAS, the Parties (as hereinafter defined), recognizing that drafting, negotiating and concluding the terms and conditions of a full and complete co-development and co-commercialization agreement for Final Product in Japan would be time consuming, entered into a Co-Development Agreement for Cetuximab in Japan effective as of December 15, 2004 (the “ Co-Development Agreement ”), which the Parties acknowledge and agree remained in full force and effect until amended and restated by this Agreement; and

WHEREAS, the Parties would like to amend and restate the Co-Development Agreement in order to provide for co-commercialization by the Parties of Final Product in Japan on the terms and conditions hereinafter set forth.

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

1.              DEFINITIONS.

1.1            Defined Terms .  As used in this Agreement, the following terms shall have the meanings set forth in this Article 1 unless context clearly and unambiguously dictates otherwise:

“ Affiliate ” with respect to any Party, shall mean any Person directly or indirectly controlling, controlled by or under common control with, such Party, for only so long as such control exists; provided that for purposes of this Agreement, neither ImClone nor any of its subsidiaries shall be deemed an Affiliate of BMS or its subsidiaries.  For the purposes of this definition, “ control ” when used with respect to any Person, means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities, by contract or otherwise; and the terms “ controlling ” and “ controlled ” have meanings correlative to the foregoing.

“ Allowable Expenses ” means, subject to the terms and conditions of this Agreement (including Section 3.1(c)), the following expenses that are specifically identifiable or reasonably allocable to the Commercialization of the Final Product in Japan:

[**]

“ Alternative Final Product ” means a product that incorporates the drug IMC-C225 (C225, cetuximab), in all forms, dosages, and presentations, and that is formulated, packaged, finished, labeled, and released for commercial sale and distribution in Japan under the Alternative Trademark.

“ Antibody ” means any antibody, or fragment thereof, whether human, humanized, chimeric, murine or from any other source (and including bispecific antibodies, single chain antibodies, and immunoconjugated antibodies), that (a) has been raised, engineered or otherwise optimized to bind specifically and directly to the Target (whether exclusively or in addition to any other target to which such Antibody may directly bind), and (b) once bound to the Target, competitively inhibits the binding of epidermal growth factor (EGF) (and other ligands, such as transforming growth factor-alpha) to the Target.  For clarification, any fusion protein comprised of a fragment of an Antibody and that uses such fragment in order to bind to the Target shall be considered an Antibody for purposes of this Agreement.  For sake of clarity and avoidance of doubt, Merck’s EMD72000 antibody and ImClone’s IMC-11F8 antibody are Antibodies within the meaning of this definition.

“ API ” means bulk cetuximab drug substance.

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“ Applicable Law ” means the applicable laws, rules and regulations, including any rules, regulations, guidelines, or other requirements of the Japanese Regulatory Authorities or other Regulatory Authorities, that may be in effect from time to time and apply to the activities contemplated under this Agreement.

“ Approval ” means receipt from the Japanese Regulatory Authorities of any and all approvals, licenses, registrations or authorizations necessary to market Final Product, including receipt of pricing/reimbursement approval, where applicable.

“ Approved Commercialization Plan ” means the then current Annual Commercialization Plan and Budget and the then current Long-Term Commercialization Plan and Budget, in each case as adopted or approved hereunder, as the case may be.

“ Approved Indications ” means those indications for which Final Product has received Approval in Japan.

“ Approved Plan ” means any of the then current Annual Commercialization Plan and Budget, the Long-Term Commercialization Plan and Budget, the Japan Manufacturing Plan and Budget, the Long-Term Development Plan, and the Annual Development Plan and Budget, in each case as adopted or approved by the SCJ hereunder, as the case may be and as the context may require. “ Approved Plans ” means all of the foregoing.  Where references in this Agreement refer to the conduct or performance of activities in accordance with an Approved Plan, such references shall be deemed not to refer to those non-binding components of the Long-Term Development Plan.

“ Bad Debts ” means amounts actually written off by MJ by reason of uncollectible Net Sales.  Should a Bad Debt which was written off be collected, such amount shall be included in Net Sales in the Quarter in which received.

“BMS-ImClone Japan Agreement” means that separate agreement executed between ImClone, BMKK and BMS dated as of the Restatement Effective Date, as the same may be amended or supplemented hereafter.

 “ Business Day ” means a day that is not a Saturday, Sunday or a day on which banking institutions in Tokyo, Japan are required by law to remain closed.

“ Call Center ” means the customer support center established in Japan by the Parties under the direction of the SCJ.

“ Canada ” shall mean Canada, including its possessions and territories.

“ Cetuximab ” shall mean a product that incorporates the chimeric antibody IMC-C225 (C225, cetuximab), in all forms of administration, dosages, and presentations.  For clarity, Cetuximab does not include humanized or human forms of C225.

“ Change of Control ” means, with respect to a Party, any of the following transactions with a Third Party (a “ Third Party Acquirer ”):  (a) a merger or consolidation of such Party (or of any of its Affiliates) with the Third Party Acquirer which results in the holders of the voting securities of such Party outstanding immediately prior thereto (other than the Third Party Acquirer, its “affiliates” and “associates” (as such terms are used in the Securities Exchange Act of 1934, as amended)) ceasing to represent, directly or indirectly, at least fifty percent (50%) of the combined voting power of the surviving entity (or, if applicable, its parent company) immediately after such merger or consolidation; (b) the sale to the Third Party Acquirer of all or substantially all of the business of such Party to which this Agreement relates

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(whether by merger, consolidation, sale of stock, sale of assets or other similar transaction); or (c) the Third Party Acquirer (which shall not be any trustee or other fiduciary holding securities under an employee benefit plan of such Party, or any corporation owned directly or indirectly by the stockholders of such Party, in substantially the same proportion as their ownership of stock of such Party), together with any of the Third Party Acquirer’s “affiliates” or “associates”, as such terms are used in the Securities Exchange Act of 1934, as amended, becoming the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Party (or, if applicable, its parent company.  For purposes of this definition only, a Third Party, (i) with respect to BMS or BMKK, includes Merck, ImClone and their respective Affiliates, (ii) with respect to Merck or MJ, includes BMS, ImClone and their respective Affiliates, and (iii) with respect to ImClone, includes BMS, Merck and their respective Affiliates.

“ Clinical Trial ” means, with respect to Cetuximab or Final Product, a Phase I Clinical Trial, a Phase II Clinical Trial, a Phase III Clinical Trial (including a Phase IIIb Clinical Trial), or a Phase IV Clinical Trial, as the case may be, that (x) is conducted in Japan pursuant to an Annual Development Plan and Budget or (y) is conducted outside of Japan pursuant to an Annual Development Plan and Budget in support of registration of Cetuximab or Final Product in Japan and whose principal objective is to support registration in Japan as opposed to other geographies.  A Clinical Trial involving study subjects shall be deemed to have commenced when the first patient in such study has been enrolled.

“ Commercialize ” means to promote, market, distribute, sell (and offer for sale or contract to sell), import, provide product support for Final Product, or otherwise commercially exploit or use Final Product in Japan, including by way of example:

(a)           detailing and other promotional activities in support of Final Product;

(b)          advertising and public relations in support of Final Product, including market research, development and distribution of selling, advertising and promotional materials, field literature, direct-to-consumer advertising campaigns, media/journal advertising, and exhibiting at seminars and conventions;

(c)           developing reimbursement programs and information and data specifically intended for national accounts, large health care organizations, governmental agencies ( e.g ., federal, state and local), and other group purchasing organizations, including pull-through activities;

(d)          Co-Promotion activities not included in the above; and

(e)           conducting journal advertising.

“ Commercializing ”, “ Commercialization ” and “ Commercial ” shall be interpreted accordingly.  To “Commercialize” is exclusive of manufacturing activities.

“ Competing Product ” means any pharmaceutical product (other than Final Product) for which marketing authorization has been filed with the Japanese Regulatory Authorities for an oncology Indication that is the same as any oncology Indication for which a marketing authorization is or has been filed or received for Final Product in Japan, and wherein such pharmaceutical product is comprised in whole or in part of any (i) Antibody or (ii) any compound or other substance that (A) has been developed, synthesized, engineered or optimized to bind specifically and directly to the Target and (B) once bound to the Target, competitively inhibits the binding of epidermal growth factor (EGF) (and other ligands, such as transforming growth factor-alpha) to the Target.  For sake of clarity and avoidance of doubt, (1)

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the conduct of preclinical research and clinical development are not activities that, for purposes of this definition and this Agreement only, would cause a product to be treated as a Competing Product; and (2) the determination of whether a product is a Competing Product shall be made without regard to the timing of the filing or Approval of such Competing Product and the Final Product (i.e., it shall not be affected by whether the Competing Product or the Final Product was the first to file or receive approval for an overlapping oncology Indication).

“ Co-Promote ” means to perform jointly those activities normally undertaken by a pharmaceutical company’s sales force to implement marketing plans and strategies aimed at encouraging the appropriate use of a product under such product’s Trademark.  It is agreed that this definition is not intended to alter the Diligent Efforts obligations that a Party is or may be required to devote under this Agreement or any Existing Agreement.  “Co-Promotion” shall be interpreted accordingly.

 “ Corporate Names ” means (a) in the case of ImClone, the Trademark ImClone® and the ImClone corporate logo or such other names and logos as ImClone may designate in writing from time to time, and (b) in the case of BMS, the Trademarks Bristol-Myers Squibb®, E.R. Squibb®, and the BMS corporate logo or such other names and logos as BMS may designate in writing from time to time, and (c) in the case of Merck, the Trademark Merck® and the Merck corporate logo or such other names and logos as Merck may designate in writing from time to time, and, in each case ((a), (b) and (c)), together with any variations and derivatives thereof.

“ CRO ” means a Third Party clinical research organization.

“ Detail ” means, with respect to Final Product, a face-to-face contact (including a live video presentation or a group presentation, if in accordance with an Annual Commercialization Plan and Budget) between a Sales Representative and a physician or other medical professional licensed in Japan to prescribe drugs, during which a Primary Position Detail or Secondary Position Detail is made to such person, in each case as measured by each Party’s internal recording of such activity in accordance with Section 6.4(e); provided , that such meeting is in compliance with Applicable Law and this Agreement.  When used as a verb, “ Detail ” shall mean to engage in a Detail.  For the avoidance of doubt, any contact or presentation between a Sales Representative and a large health care organization (as distinguished from calls on individual physicians or other medical professionals licensed to prescribe drugs who may be affiliated with a large health care organization, in connection with their professional prescribing decisions (but not with respect to the large health care organization’s formulary)) shall not be considered a Detail for purposes of this Agreement.

“ Develop ” means, with respect to Cetuximab or Final Product, those activities that, in general, are necessary for the development of Cetuximab and Final Product for registration in Japan (including as encompassed by the definition of Clinical Trials under this Agreement), to obtain and maintain Approval(s) for Final Product in Japan (including to support pricing/reimbursement), and to support appropriate usage for Final Product in Japan, including analysis, testing, any necessary pre-clinical studies required by Japanese Regulatory Authorities, and development activities pertaining to lifecycle management (including the conduct of Phase IIIb Clinical Trials and Phase IV Clinical Trials not explicitly for registrational purposes), new indications, and, if applicable, new formulations developed specifically for the Japan market, including, by way of example, the activities listed in the definition of Development Costs below.  “ Developing ” and “ Development ” shall have correlative meanings.

“ Development Costs ” has the meaning set forth in Section 4.2(a).

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“ Diligent Efforts ” means, for a Party, the performance of obligations in a sustained manner consistent with the efforts such Party devotes to a product of similar market potential  resulting from its own research efforts, based on conditions then prevailing and taking into account the terms of this Agreement, but without regard to whether such Party is also developing a potential Competing Product or commercializing a Competing Product; provided , however , if, with respect to the Commercialization or manufacture of Final Product, a Party does not have any such product of similar market potential, such Party shall use commercially reasonable efforts in the performance of its obligations hereunder.  Notwithstanding the forgoing, the applicable Diligent Efforts that a Party is required to apply under this Agreement shall not alter or supersede, or modify the interpretation of, the Diligent Efforts that a Party may be required to exercise under the Existing Agreements.  For emphasis, the diligence obligation owed to ImClone under this Agreement by Merck, on the one hand, and by BMS, on the other, shall be determined by the diligence obligations owed to ImClone by Merck and BMS, respectively, under the Existing Agreements.

“ Distribution Costs ” means the [**] as an expense by a Party or any of its Affiliates after the Restatement Effective Date that are specifically identifiable or reasonably allocable to the Commercial distribution of Final Product in Japan by a Party during the Co-Promotion Term, including: [**].

“ Existing Committees ” shall mean the Joint Executive Committee established under the BMS-ImClone Agreement and the Merck/ImClone Steering Committee established pursuant to the Merck-ImClone Agreement.

“ Experienced Arbitrator ” means a mutually acceptable, disinterested, conflict-of-interest-free individual not affiliated with any of the Parties or their Affiliates who (a) with respect to disputes of a primarily legal, scientific, technical or regulatory nature hereunder shall be an individual with appropriate legal, scientific, technical or regulatory expertise to resolve such disputes, or (b) with respect to disputes of a primarily business or financial nature ( e.g. , disputes referred for resolution pursuant to “baseball arbitration” under Section 16.13(a)) shall be an individual who possesses appropriate expertise to resolve such disputes.  The arbitrator shall not be or have been at any time an Affiliate, employee, officer or director of any of the Parties or any of their respective Affiliates, or, at any time within the five years preceding the arbitration, a consultant of any of the Parties or any of their respective Affiliates.

“ FDA ” shall mean the United States Food and Drug Administration, or any successor thereto.

“ Final Product ” means a product that incorporates Cetuximab, in all forms, dosages, and presentations, and that is formulated, packaged, finished, labeled, and released for commercial sale and distribution in Japan under the Erbitux® Trademark.

“ Fully Burdened Manufacturing Costs ” for any component or item comprising API or Final Product means 100% of a Party’s fully burdened manufacturing cost (as defined in the Party’s generally accepted accounting policies consistently applied) that is (x) supplied by a Third Party and/or (y) directly manufactured or supplied by a Party or an Affiliate of such Party, determined as follows:

In the case of clause (x) above, Fully Burdened Manufacturing Costs means those amounts that are payable to a Third Party and incurred by a Party or its Affiliates in connection with the manufacture or supply of API or Final Product, including [**].

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Fully-Burdened Manufacturing Costs incurred by a Party or its Affiliates (other than Fully-Burdened Manufacturing Costs that are payable to a Third Party, as discussed above) shall comprise the sum of:

(a)           For API:

Cost of Raw Materials

The purchase unit cost of raw materials multiplied by [**].

Direct Labor and Allocable Overhead Costs :

The cost of direct labor and manufacturing overhead resources consumed in the production process [**].

Costs will include any efficiency, activity and spending variances from standards as well as any underabsorbed overhead expenses incurred during the startup of the biologic operation for the Final Product or caused by subsequent evolution of the Final Product’s volumes sold in Japan, [**].

Manufacturing overhead includes the following costs:

-                Normal depreciation of building, machinery and equipment

-                Plant management

-                Plant services and utilities

-                Plant maintenance

-                Quality control at all stages

-                Freight and storage costs at all stages

-                Cost accounting and data processing services

-                Any taxes and duties other than VAT and income tax

(b)           For the Processing of API into Final Product:

Cost of Raw Materials

The purchase unit cost of any materials and packaging components necessary to make the finished goods (including the API) [**].

Direct Labor and Overhead Costs

The cost of direct labor and overhead resources consumed in the manufacturing process, [**].

[**]

The manufacturing overhead will include:

-                Normal depreciation of fixed assets

-                Plant management

-                Plant common services and utilities

-                Plant maintenance

-                Quality control at all stages

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-                Subject to Section 8.6(b), reasonable manufacturing plant capacity reservation fees to the extent reasonably allocable to binding forecasts of production of Final Product for sale or use in Japan

-                Freight and storage costs at all stages

-                Cost accounting and data processing services

-                Any taxes and duties other than VAT and income tax.

For the avoidance of doubt, Fully Burdened Manufacturing Cost shall in both cases described in subsections (a) and (b) above (as well as for purposes of item (x) in the first paragraph of this definition of Fully Burdened Manufacturing Cost), [**].

“ FTE ” means the equivalent of the work of one (1) employee full time for one (1) year (consisting of at least a total of [*] hours per year, or such other number as may be agreed by the SCJ) of work directly related to the Commercialization of Final Product or any other activities contemplated under this Agreement.  No additional payment shall be made with respect to any person who works more than [*] hours per year (or such other number as may be agreed by the SCJ), and any person who devotes less than [*] hours per year (or such other number as may be agreed by the SCJ) shall be treated as an FTE on a pro-rata basis, to be calculated upon the actual number of hours worked divided by [*] (or such other number as may be agreed by the SCJ).

“ FTE Cost ”, for a given employee performing services under this Agreement, means the FTE Rate for such category of employee as established under Section 4.1(e) and as adjusted subsequently in accordance with Section 4.1(e), multiplied by the percentage of time devoted by such employee to the applicable task.

“ GAAP ” shall mean generally accepted accounting principles in the United States, consistently applied by ImClone or BMS, as the case may be.

“ Good Manufacturing Practices ” or “ cGMP ” means current good manufacturing practices for biological and other pharmaceutical products (and components thereof) as described in regulations promulgated by the Japanese Regulatory Authorities or other Regulatory Authorities (such as FDA), as updated and applicable  from time to time.

“ IFRS ” shall mean International Financial Reporting Standards, consistently applied by Merck.

“Indication ” shall mean a specific disease indication and which, in the case of oncology, shall be differentiated by tumor type (e.g., colorectal cancer, non-small cell lung cancer and the like are separate Indications).  Any lines of therapy within a given tumor type shall not be deemed separate Indications.  For the sake of clarity, approval of new lines of therapy within a given tumor type (e.g., 1 ^st line, 2 ^nd line, 3 ^rd line or adjuvant) shall not be considered as new Indications for purposes of this Agreement, including for purposes of Section 3.1(c) and Article 6 of this Agreement (including Section 6.4(b)(i)).

“ Invention ” shall mean any new or useful process, compound, composition of matter, improvements, discoveries, claims, formulae, processes, trade secrets, technologies and know-how (including confidential data and Confidential Information), to the extent relating to, derived from and useful for the manufacture, use or sale of Final Product (including the formulation, delivery or use thereof in pharmaceutical applications for human health), including synthesis, preparation, recovery and purification processes and techniques, control methods and assays, chemical data, toxicological and pharmacological data and techniques, clinical data, medical uses, product forms and product formulations and specifications, whether

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patentable or unpatentable; and in each case, limited to those Inventions conceived or first reduced to practice or demonstrated to have utility in the performance of activities undertaken under, and in direct connection with the co-development and/or co-commercialization activities undertaken by or on behalf of a Party or two or more Parties pursuant to and during the term of, this Agreement, as contemplated herein.

“ Japan ” shall mean Japan, including its possessions and territories.

“ Japanese Regulatory Authorities ” shall mean the health regulatory authority(ies) in Japan, and any successor(s) thereto.

“ JNDA ” means a regulatory filing made with the Japanese Regulatory Authorities that seeks Approval to market and sell a Final Product in Japan for a given Indication.

“ Launch ” means the first commercial sale of a Final Product to the general public in Japan after Approval for the marketing and sale of such Final Product has been obtained for its first Indication in Japan.

“ Long-Term Development Plan ” means the written Development plan then approved by the SCJ for Development in Japan, which plan shall include:

(A)           a binding section, which shall indicate those specific Clinical Trials that the Parties have agreed to conduct under this Agreement with respect to Japan, and which shall include, where agreed upon:  (i) a budget for such Clinical Trials (or a good faith estimate if a firm budget is not reasonably practicable), (ii) any plans involving a CRO for such Clinical Trials, (iii) to the extent known, estimated timelines for the initiation and completion of such Clinical Trials, (iv) to the extent known, key endpoints for such Clinical Trials, (v) to the extent known, any specific allocation of responsibilities among the Parties with respect to the implementation of such Clinical Trials, (vi) if applicable, any go/no-go criteria for a given study, and (vii) if applicable, any clinical studies being conducted outside the Development Plan (and which will not be shared as Development Costs under this Agreement) that will be used to bridge to or support the Clinical Trials; and

(B)            a non-binding section, which shall indicate those Indication(s), new line(s) of therapy within an Indication, preclinical studies and/or Clinical Trials that the Parties are contemplating but have not yet agreed to conduct with respect to Japan, which section may include (i) a good faith estimate of the budget for the Development of the Indications, lines of therapy, and/or conduct of those studies, (ii) any other or related significant Development related activities contemplated for Japan, (iii) any plans involving a CRO, (iv) to the extent known, estimated timelines, (v) to the extent known, key regulatory activities and any material regulatory strategies relating to such Indications, lines of therapy, and/or studies, and (vi) any contemplated allocation of responsibilities among the Parties with respect to the implementation of the Long-Term Development Plan.

Where references in this Agreement refer to the implementation of, or the conduct or performance of activities in accordance with, or subject to, an Approved Plan or a Long-Term Development Plan, such references shall be deemed to refer only to the binding components of the Long-Term Development Plan and not to those non-binding components of the Long-Term Development Plan.

“ Marketing Costs ” means, subject to Sections 4.1, 4.3(a) and 4.3(b), [**].

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“ Medical Education Activities ” means activities designed to ensure or improve appropriate medical use of, conduct medical education of, or further research regarding, Final Product sold in Japan, including by way of example:

[**]

“ Medical Education Costs ” means, subject to Sections 4.1, 4.3(a) and 4.3(c), [**] an expense by BMKK, MJ or any of their Affiliates after the Restatement Effective Date that are approved by the SCJ or incurred in accordance with an Annual Commercialization Plan and Budget and that are specifically identifiable or reasonably allocable to Medical Education Activities with respect to Final Product Commercialization efforts of MJ and BMKK in Japan during the Co-Promotion Term, together with any such costs incurred in excess of the budget set forth in the Annual Commercialization Plan and Budget for same that are approved by the JJCC or SCJ.

“Merck-ImClone Japan Agreement” means that separate agreement executed between ImClone and Merck, dated as of the Restatement Effective Date, as the same may be amended or supplemented hereafter.

“ Net Sales ” means the amount billed or otherwise charged by the final billing Party, an Affiliate or any permitted (sub)licensee for sales or other dispositions of Final Product to a Third Party, less (to the extent not reimbursed or refunded to the final billing Party):

(a)            normal and customary discounts (including cash discounts and quantity discounts), retroactive price reductions, charge-back payments (or their equivalent) and rebates allowed, paid, or granted to managed health care organizations or to national, state/provincial, local and other governments in Japan, their agencies, and purchasers and reimbursers or to trade customers as accrued by such Party in accordance with its customary practices in accordance with GAAP or IFRS, as applicable to such Party;

(b)            credits or allowances accrued for claims, damaged goods, rejections or returns of such Final Product, including Final Product returns in connection with recalls or withdrawals (to the extent the recall or withdrawal is not attributable to the negligence of the Party booking the Net Sale);

(c)            freight out, postage, shipping and insurance charges for delivery of Final Product (excluding such charges that are included in Distribution Costs), to the extent that such items are included in the gross amount billed; and

(d)            taxes or duties levied on, absorbed or otherwise imposed on sale of such Final Product, including value-added taxes, tariffs, excise taxes, or other governmental charges otherwise imposed upon the billed amount, as adjusted for rebates and refunds, to the extent not paid by the Third Party or otherwise reimbursed (but not including taxes assessed against the income derived from such sale.

Net Sales shall not include sales between a Party and its Affiliates, but shall arise upon the sale by a Party or its Affiliates to unrelated Third Parties, such as end users, wholesalers and retailers.  Net Sales, as set forth in this definition, shall be calculated applying, in accordance with GAAP or IFRS, as applicable to such Party, the standard accounting practices that a Party customarily applies to other products sold by it.  [**].

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“ Other Operating Expenses ” means other operating costs recorded as an expense by BMKK, MJ or any of their Affiliates after the Restatement Effective Date that relate to the manufacture or Commercialization of Final Product by a Party in Japan, that fall within the following cost categories, and that are specifically identifiable to or reasonably allocable to the manufacture of Final Product by a Party for use or sale in Japan or to Final Product Commercialization efforts of a Party in Japan:

[**]

The methodology used to determine the amount of each item set forth above shall be developed by the JJFC and approved by the SCJ.

“ Packaging and Release ” means those activities undertaken in connection with this Agreement to place a label on filled vials, package (both primary and secondary packaging) such vials, conduct QA/QC, and release Cetuximab or Final Product for use or sale in Japan.  Packaging and Release also includes the conduct of a market life stability program, whether performed in or outside of Japan, including, without limitation, the timely preparation and delivery of summary tables and reports to support regulatory filing submissions for Finished Product for Commercialization in Japan according to stability protocols and other requirements that are agreed to by the JJMC and as may be modified by the JJMC from time to time.

“ Party ” shall mean, as applicable, Merck, MJ, ImClone, BMS, or BMKK and, when used in the plural, shall mean Merck, MJ, ImClone, BMS, and BMKK.

“ Party Group ” shall mean either (i) Merck and MJ, or (ii) ImClone, BMS, and BMKK.

“ PDC ” shall mean the Product Development Committee established pursuant to the BMS-ImClone Agreement.

“ PDE ” or “ Primary Detail Equivalent ” means a primary Detail equivalent where (a) a Primary Position Detail has a value of [**] PDE, and (b) a Secondary Position Detail has the value of [**] PDE.  The procedures for determining PDEs in a group presentation are set forth on Exhibit 1.1(b)   hereto.

“ PDE Rate ” means the fully-burdened cost of providing an oncology PDE in Japan, as initially established and thereafter adjusted in accordance with Section 6.3(b).

“Person ” shall mean an individual or a corporation, partnership, association, trust, or any other entity or organization, including a government or political subdivision or an agency or instrumentality thereof.

“ Phase IIIB Clinical Trial ” means (a) a product support human clinical trial of Final Product ( i.e. , a clinical trial that is not required for receipt of Approval for an Indication in Japan or new line of therapy within an Indication, but which may be useful in providing additional drug profile data in support of such Approval in Japan for such Indication or new line of therapy) that is commenced before receipt of Approval for such Indication (or new line of therapy) in Japan, or (b) a clinical trial that is required or advised by a Japanese Regulatory Authorities as a condition of or in connection with obtaining or maintaining a regulatory approval for an Indication  or new line of therapy (and that is commenced after receipt of such regulatory approval).

“ Phase IV Clinical Trial ” means (a) a human clinical trial, or other test or study, of Final Product commenced after receipt of initial Approval for an Indication (or for a new line of therapy within an Indication) in Japan that is conducted within the parameters of the labeling

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approved for the Final Product, other than Phase IIIB Clinical Trials, and (b) investigator sponsored clinical trials of Final Product that are not set forth in the Annual Development Plan.  Phase IV Studies may include clinical trials, or other tests and studies, conducted in support of pricing/reimbursement for an initial Approval, epidemiological studies, modeling and pharmacoeconomic studies, and post-marketing surveillance studies.  For clarity, the funding, the design, and the scientific integrity (and related matters) of any Phase IV studies are to be approved by the JJDC and not the JJCC.

“ Primary Position Detail ” means a Detail in which [**].

“ Profit Or Loss ” means, subject to Sections 3.1(c), 6.4(f), 7.2 and 7.3, Net Sales of Final Product in Japan, less Allowable Expenses in Japan.  For sake of clarity, Profit Or Loss shall be determined prior to application of any income taxes, and if such terms are used individually, “Profit” shall mean a positive Profit Or Loss, and “Loss” shall mean a negative Profit Or Loss .

“ QA ” means quality assurance activities conducted in accordance with Good Manufacturing Practices.

“ QC ” means quality control activities conducted in accordance with Good Manufacturing Practices.

“ Quarter ” means each of the three (3) month periods ending on March 31, June 30, September 30 and December 31; provided that the first Quarter during the term of this Agreement shall commence on the Restatement Effective Date and end on December 31, 2007.

“Regulatory Authority ” means any national (for example, the FDA in the United States) or supra-national (for example, the European Agency for the Evaluation of Medicinal Products) agency or other governmental entity authorized and empowered to grant regulatory approvals necessary to market Cetuximab outside of Japan.

“ Regulatory Costs ” means [**] an expense by a Party or any of its Affiliates after the Restatement Effective Date (including filing, user, maintenance and other fees paid to Japanese Regulatory Authorities) (i) that are incurred in accordance with an Approved Commercialization Plan, the Japan Manufacturing Plan and Budget, or an Approved Annual Development Plan and Budget, or are otherwise approved by the SCJ, and (ii) that are specifically identifiable or reasonably allocable to the preparation of regulatory submissions for, and the obtaining and maintenance of any Approval of, any Final Product in Japan, including [**].  Such Regulatory Costs shall be appropriately allocated between the Approved Commercialization Plan and the Approved Development Plan.  For sake of clarity, Regulatory Costs relating to Development activities for the purpose of obtaining regulatory Approval for an Indication (or new line of therapy within an existing approved Indication) for Cetuximab or Final Product in Japan to be considered Development Costs, while Regulatory Costs incurred in connection with obtaining pricing or reimbursement approval, maintenance of Approvals, or Phase IV Clinical Trials to be considered Allowable Expenses.

“ Representative ” means such individual as a Party is entitled to and has appointed to the SCJ, a Subcommittee or Working Group from time to time in accordance with this Agreement.  Each Party will endeavor to appoint individuals who are appropriate to, and have pertinent experience with respect to, the functions of the SCJ, Subcommittee or Working Group.  For clarity, the appointment or qualifications of a Party’s Representatives are not subject to approval by the other Parties.

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“ Results ” shall mean all data and information discovered or developed under or in connection with a Study, the Annual Development Plan and Budget, and/or the Development activities contemplated under this Agreement.

“ Sales Costs ” means [**] an expense by a Party or any of its Affiliates after the Restatement Effective Date that are approved by the SCJ or incurred in accordance with the then Approved Commercialization Plan and Budget and that are specifically identifiable or reasonably allocable to the sales efforts during the Co-Promotion Term for Final Product to all markets in Japan, together with any such costs incurred in excess of the budget set forth in the Annual Commercialization Plan and Budget for same that are approved by the JJCC or SCJ.  Subject to the foregoing, for sake of clarity, Sales Costs shall include the following costs paid or incurred by a Party associated with the following:

[**]

“ Sales Representative ” of a Party means (a) an employee of such Party or an Affiliate of such Party or (b) an individual independent contractor engaged by such Party or Affiliate (but only to the extent expressly permitted by Section 6.9(b) of this Agreement or by agreement of the BMKK/BMS and MJ/Merck members of the JJCC) to Co-Promote Final Product on behalf of such Party, in either case (i) who is responsible for meeting in person with customers and others who can buy or prescribe (or influence the buying or prescribing process and decisions regarding buying or prescribing) the Final Product in Japan, and (ii) whose success at such activities is a significant factor in the ongoing employment or engagement, and compensation, of the individual, excluding in each case (x) those employees or independent contractors of either Party or such an Affiliate that are solely engaged in telemarketing, professional education or other indirect activities in support of direct selling and (y) Medical Liaisons.

“ Secondary Position Detail ” means a Detail in which [**].

“ Semi-Annual Period ” means any period consisting of two (2) consecutive Quarters; provided that each Semi-Annual Period shall begin on the day following the last day of a previous Semi-Annual Period.

“ Specifications ” means the specifications for the manufacture, labeling, packaging, storage, shipment, and release of the Final Product, as set forth in an applicable JNDA or other regulatory filing ( e.g. , a drug master file (as defined in the Code of Federal Regulations)) or Approval then in effect from time to time.

“ Target ” means the extracellular domain of the human epidermal growth factor receptor (EGFR, HER1, c-ErbB-1).

“ Third Party ” shall mean any Person who or which is neither a Party nor an Affiliate of a Party.

“ Third Party Milestone Payments ” means up-front fees (including any fees paid in installments) and milestones and other payments  payable to a Third Party in consideration for rights necessary or useful for (i) the Commercialization or use of the Final Product in Japan, or (ii) the manufacture of the API or Final Product anywhere in the world for the purpose of, but only to the extent fairly and reasonably allocable to, the Commercialization or use of the Final Product in Japan, but excluding amounts paid in the form of Third Party Royalties.

“ Third Party Payments ” means Third Party Milestone Payments and Third Party Royalties.  The Third Party Payments as of the Restatement Effective Date are listed on Exhibit 1.1(a).

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“ Third Party Royalties ” means royalties (but excluding any royalties or other payments that are not tied to sales of Final Product) payable to a Third Party in consideration for rights necessary or useful for (i) the Commercialization or use of the Final Product in Japan, or (ii) the manufacture of Final Product anywhere in the world for the purpose of, and to the extent fairly and reasonably allocable to, the Commercialization or use of the Final Product in Japan.

“ Trademark ” shall include any word, name, symbol, color, designation or device or any combination thereof, including any trademark, trade dress, service mark, service name, brand mark, trade name, brand name, logo or business symbol, that is used in connection with distribution, marketing, promotion and sale of the Final Product in Japan, but excluding the Corporate Names of any Party and its Affiliates and variants thereof.

“ United States ” or “ U.S. ” shall mean the United States of America, including its possessions and territories.

1.2            Additional Defined Terms .  The following additional defined terms shall have the meanings set forth in the sections of this Agreement listed below:

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

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2.              MANAGEMENT OF COLLABORATION.

2.1            General

(a)            General Scope .  The collaboration among the Parties set forth in this Agreement shall be composed of and limited to:

(i)             the co-Development and regulatory activities of the Parties undertaken with the intention to obtain marketing authorizations for Final Product in Japan.  The Clinical Trials described in detail in the Annual Development Plan and Budget and the binding portion of the Long-Term Development Plan attached as Exhibit 3.1(a)  hereto are those Clinical Trials with respect to which the Parties have currently agreed to pursue for Final Product in Japan;

(ii)            the co-Commercialization by BMKK and MJ of Final Product in Japan; and

(iii)           the manufacture and supply of Cetuximab for co-development, and of Final Product for co-Commercialization, in Japan.

(b)                             Committees and Subcommittees .  Subject to the terms and conditions of this Agreement, the Parties have established or shall establish (i) a joint steering committee (the “ Steering Committee Japan ” or “ SCJ ”) that will oversee the Parties’ activities under this Agreement (the “ Collaboration ”) and facilitate communications between the Parties with respect to the Development, Approval, manufacturing and Commercialization of the Final Products hereunder, and (ii) four (4) specialized joint subcommittees (“ Subcommittees ”) consisting of one to focus on each of the following areas:  Development and Approval and other regulatory matters (such Subcommittee, the “ Joint Japan Development and Regulatory Committee ” or “ JJDC ”), Commercialization (such committee, the “ Joint Japan Commercialization Committee ” or “ JJCC ”), manufacturing (such committee, the “ Joint Japan Manufacturing Committee ” or “ JJMC ”), and financial (such committee, the “ Joint Japan Financial Committee ” or “ JJFC ”), respectively, arising out of the Collaboration.  Each Committee shall have the responsibilities and authority allocated to it in this Article 2 and elsewhere in this Agreement.  The Parties intend that their respective organizations will work together to assure the success of the Collaboration.

(c)                              Reservation of Rights in a Party.  Notwithstanding the Committee structure established pursuant to Section 2.1(b) to oversee the Collaboration, each Party shall retain the rights, powers and discretion granted to it under this Agreement, and no such rights, powers, or discretion shall be delegated to or vested in the SCJ or a Subcommittee unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing.  The Parties hereby agree that the following matters are outside the jurisdiction and authority of the SCJ and the Subcommittees:  (i) the amendment, modification or waiver of compliance with this Agreement, which shall require mutual written agreement of the Parties, and (ii) such other matters as are expressly reserved to the consent, approval, agreement or other decision-making authority of any one or more Parties in this Agreement, whether or not required by this Agreement to be considered by the SCJ one or more Subcommittees prior to the exercise of such consent, approval or other decision-making authority.

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(d)                    No Effect on Existing Agreements .  Except as provided in Section 16.14(c), no decision by the SCJ or any Subcommittee may affect, alter or modify a Party’s obligations under any of the Existing Agreements, as amended by this Agreement.

2.2            Steering Committee Japan .  The Steering Committee Japan shall be responsible for overseeing and coordinating each Party’s co-Development and co-Commercialization activities as set forth in, and subject to the terms of, this Agreement. Subject to the terms of this Agreement, the SCJ shall have overall responsibility for the success of the Collaboration, and its general areas of responsibility shall be: (i) to determine the Development, regulatory, Commercialization, and manufacturing strategy for the Collaboration, (ii) to coordinate the Parties’ activities hereunder, and (iii) as applicable, to review, comment on, approve, and resolve disputes with respect to, plans and budgets for, and the implementation of, the Collaboration, including the specific responsibilities of the SCJ outlined below.  The SCJ shall have the membership and shall operate by the procedures set forth in Sections 2.4, 2.5 and 2.6.  In particular, and subject to Sections 3.1(c) and 10.2 and to Article 14 of this Agreement, the SCJ shall have the following specific responsibilities:

(a)                    Development and Regulatory Responsibilities .  Subject to Section 3.1(c), the SCJ shall:  (1) approve the Development and regulatory strategy for the Final Product, (2) provide a forum for coordination of the Parties’ Development and regulatory activities under this Agreement, and (3) as applicable, review, comment on, approve, and seek to resolve disputes with respect to, Development plans and budgets for, and the implementation of, the Development and regulatory strategy for, the Final Product.  The Long-Term Development Plan, as of the Restatement Effective Date, is as set forth in Exhibit 3.1(a)   hereto.  The SCJ may amend or supplement the Long-Term Development Plan, and make any decision necessary to fulfill the Long-Term Development Plan in accordance with this Agreement.  In particular, the SCJ shall have the following specific responsibilities with respect to the Development and registration of the Final Product in Japan:

(i)             subject to Section 3.1(c), review and approve all Annual Development Plans and Budgets, and all updates, amendments and modifications to, and waivers of provisions of, each Annual Development Plan and Budget and the Long-Term Development Plan, including whether to pursue the Development of an additional Indication (or a new line of therapy within an existing approved Indication), the termination of an Indication (or line of therapy) then being developed, or the initiation or cessation of other additional Development activities;

(ii)            review and approve each Annual Development Plan and Budget or any changes thereto approved by the JJDC, and resolve any disputes at the JJDC with respect to the Annual Development Plan and Budget or any changes thereto;

(iii)           monitor progress of the ongoing Clinical Trials and any future Clinical Trials added to the binding and non-binding sections of the Long-Term Development Plan, identify issues and provide necessary resources, tools and ideas to solve such issues;

(iv)           establish and develop common working structures (e.g., use of common databases, investigator brochures, exchange of safety information);

(v)            review and comment upon interactions with the Japanese Regulatory Authorities pursuant to Article 3 hereof;

(vi)           review, modify and approve, and ensure consistency between, draft JNDAs for Cetuximab proposed by BMKK, as agent for ImClone, and MJ;

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(vii)          create, monitor, oversee and direct working groups as necessary or useful to carry out the implementation of the binding portions of  the Long-Term Development Plan;

(viii)         determine a publication strategy and oversee publications pursuant to Sections 12.1 and 12.2;

(ix)            review and approve all key regulatory and key clinical Development strategies;

(x)             review, modify and approve (including funding for) compassionate use and early access programs; and

(xi)            approve Final Product labeling and all changes thereto.

(b)                             Commercialization and Manufacturing Responsibilities .  The SCJ shall:  (1) determine the Commercialization, and manufacturing, quality control and product release strategy for Final Product, (2) provide a forum for coordination of the Parties’ Commercialization activities under this Agreement, and (3) as applicable, review, comment on, approve, and seek to resolve disputes with respect to, plans and budgets for, and the implementation of, the Commercialization, manufacturing, quality control and product release aspects of and strategy for Final Product.  The Long-Term Commercialization Plan and Budget as of the Restatement Effective Date is as set forth in Exhibit 6.2(a)   hereto, and has been approved by the SCJ.  The manufacturing plan portion of the Manufacturing Plan and Budget as of the Restatement Effective Date is as set forth in Exhibit 8.1(a)   hereto, and has been approved by the SCJ.  Subject to applicable terms of this Agreement, the SCJ may amend or supplement the Long-Term Commercialization Plan and Budget and the Manufacturing Plan and Budget, and make any decision necessary to fulfill or implement same in accordance with this Agreement.   In particular, the SCJ shall have the following specific responsibilities with respect to the Commercialization of Final Product and the manufacture of API and Final Product for sale in Japan:

(i)             review and approve (1) each Long-Term Commercialization Plan and Budget, (2) each Annual Commercialization Plan and Budget, and (3) all updates, amendments and modifications thereto, and waivers of provisions thereof;

(ii)            review and approve (1) each Japan Manufacturing Plan and Budget, and (2) all updates, amendments and modifications thereto, and waivers of provisions thereof);

(iii)           determine whether to recall or withdraw Final Product in the circumstances set forth in Section 8.7;

(iv)           review and approve long-term ( i.e., for the ensuing three-to-five years) Commercial strategy for Final Product;

(v)            subject to the Existing Agreements and this Agreement, review and approve strategies for obtaining and maintaining patent and Trademark protection, enforcing such patents and Trademarks, and defending Third Party claims relating to patents and Trademarks;

(vi)           determine and approve pricing/reimbursement strategy with respect to large health care providers, governmental agencies ( e.g ., national, state, regional, and local), and other group purchasing accounts;

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(vii)          review and approve the parameters of any terms and conditions relating to or affecting the price at which Final Product will be sold in Japan, including discounts available to large health care providers, governmental agencies ( e.g ., federal, state and local), and other group purchasing accounts; discounts attributable to payments on receivables; and credits, price adjustments, other discounts and allowances to be granted or refused;

(viii)         subject to Section 10.2(a), review and approve the specific terms and conditions with respect to which MJ may offer Final Product for sale in Japan.

(ix)            approve the methodology used to determine the amount of each item of Operating Expenses;

(x)             resolve any disputes at the JJFC regarding the calculation of Profit and Loss or any other amount due a Party under this Agreement or the reconciliation of payments between the Parties;

(xi)            evaluate performance of the Parties under this Agreement;

(xii)           coordinate and oversee the activities of the Parties and Committees hereunder and resolve any disputes at the JJMC, JJDC and JJCC; and

(xiii)          review recommendations submitted by the JJCC concerning, and approve, patient assistance and indigent access programs and any changes thereto.

(c)                             Generally .  The SCJ shall also:

(i)             provide guidance to the JJDC, the JJCC, JJFC and the JJMC with respect to any other Development, Commercialization, financial, and manufacturing activities, strategies, plans and budgets (or portions thereof);

(ii)            review any matter that falls within the responsibilities of the JJDC, JJCC JJFC, or JJMC, if any Party’s members of such Subcommittee believe that a matter should be reviewed by the SCJ following review by such Subcommittee;

(iii)           perform such other responsibilities related to the Parties’ co-Development and co-Commercialization activities contemplated hereunder as have been or may be assigned to the SCJ pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time;

(iv)           periodically, as a Party may request, evaluate the performance of the Development, manufacturing and Commercialization activities against its related Plan goals;

(v)            coordinate the activities of the Parties hereunder, including oversight of the JJDC, JJCC, and JJMC as provided herein;

(vi)           seek to resolve any disputes or disagreements within or between the JJDC, JJCC, JJFC or JJMC;

(vii)          approve winning bids to manufacture Final Product (or any component thereof) pursuant to Section 8.1(c); and

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(viii)         review any matter that falls within the responsibilities of the JJDC, JJCC, JJFC or JJMC if a Party’s members of such Subcommittee (where such Party has a vote on such Subcommittee) believe that a matter should be reviewed by the SCJ following review by such Subcommittee.

2.3            Subcommittees .  Unless already established, the following Subcommittees shall also be established by the Parties within thirty (30) days after the Restatement Effective Date, each of which shall have, subject to Sections 3.1(c) and 10.2 and to Article 14, the following specific responsibilities:

(a)                              Joint Japan Commercialization Committee (JJCC) .  The JJCC shall be responsible for preparing and submitting to the SCJ for its approval, on an annual basis consistent with Article 6 hereof, each Annual Commercialization Plan and Budget and each Long-Term Commercialization Plan and Budget.   Each such Plan shall be consistent with applicable terms of this Agreement.  The JJCC shall be charged with taking any action and making any decision necessary to implement each such Annual Commercialization Plan and Budget approved by the SCJ.  In particular, the JJCC shall be responsible for the following Commercialization activities with respect to Final Product in Japan:

(i)             establish a strategy for Commercialization of Final Product in Japan, including product positioning, consistent where achievable with the Parties’ respective strategies in other major market countries in which they Commercialize ERBITUX;

(ii)            make recommendations to the SCJ with respect to the SCJ’s review and approval of each Long-Term Commercialization Plan and Budget, and all updates, amendments and modifications to, and waivers of provisions of, each such Long-Term Commercialization Plan and Budget;

(iii)           developing and recommending for approval by the SCJ each Annual Commercialization Plan and Budget, and all updates, amendments and modifications thereto, and waivers of provisions thereof, in each case consistent with the Long-Term Commercialization Plan and Budget;

(iv)           develop and provide to the JJMC market, unit sales, and Net Sales forecasts for Final Product, broken down by approved Indication and updated quarterly, in sufficient detail and length of time as to enable the JJMC to determine its own forecasts under Section 8.3(b);

(v)            determine and approve the allocation of responsibilities among the Parties applicable to the Development activities contemplated under this Agreement in a manner consistent with this Agreement and the Annual Commercialization Plan and Budget;

(vi)           monitor progress and compliance under, and oversee the implementation of, each Long-Term Commercialization Plan and Budget and each Annual Commercialization Plan and Budget;

(vii)          monitor, review and comment on costs incurred by the Parties in connection with their respective Commercialization activities, to the extent practicable, on an Indication-by-Indication basis;

(viii)         review and recommend for approval by the SCJ packaging designs and provide input to the SCJ regarding Product labeling;

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(ix)            review and approve Final Product marketing, advertising and promotional strategies and materials, including all Marketing Materials, developed by the Parties for the Parties’ Sales Representatives, for compliance with this Agreement and applicable Law;

(x)             endeavor to coordinate Final Product marketing, advertising and promotional activities, where practicable, on a worldwide basis;

(xi)            approve the selection of major or key marketing vendors ( e.g ., public relations agencies, advertising agencies and/or medical education agencies);

(xii)           recommend reimbursement strategies for approval by the SCJ;

(xiii)          review and approve strategies for, and key specific, market research plans and journal advertising, in each case in accordance with this Agreement, the applicable Annual Commercialization Plan and Budget and the Long-Term Commercialization Plan and Budget, and approve and assign responsibilities for implementation of same;

(xiv)         review and approve, assign responsibilities for, and coordinate all sales force activities, including Sales Representative training, the number of Sales Representatives to be assigned to Final Product promotion, the number of PDEs to be devoted to Final Product promotion, and the territory alignment of Sales Representatives, in each case in accordance with this Agreement, the applicable Annual Commercialization Plan and Budget and the Long-Term Commercialization Plan and Budget;

(xv)          plan and oversee promotional programs, including speaker and peer-to-peer activity programs, and the funding of educational and professional symposia, in each case in accordance with this Agreement, the applicable Annual Commercialization Plan and Budget and the Long-Term Commercialization Plan and Budget;

(xvi)         discuss and recommend to the SCJ for its approval a range of suggested prices and discount strategies for the sale of Final Product to unaffiliated Third Parties;

(xvii)        receive and review each Party’s sales, pricing, and financial reports pertaining to Sales Costs, Marketing Costs and other Allowable Expenses;

(xviii)       make recommendations to the SCJ with respect to patient assistance and indigent access programs, and provide input to the SCJ with respect to early access and compassionate use programs;

(xix)          review and approve any significant agreements (including any agreement or series or group of related agreements with an aggregate expense of more than one hundred thousand dollars ($100,000)) with Third Parties to be entered into by a Party with respect to the Commercialization of Final Product in Japan;

(xx)           facilitate the flow of Commercialization information;

(xxi)          review MJ’s or BMKK’s plans for detailing a product to be detailed in the third position, where Final Product is detailed in the first or second position;

(xxii)         coordinate with the Existing Committees and the JJDC, JJFC and JJMC as appropriate; and

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(xxiii)        provide updates to the SCJ on its activities no less frequently than once each Quarter after the Restatement Effective Date and during the term of this Agreement.

Except as otherwise provided in Article  6, the JJCC shall, in allocating responsibilities between the Parties with respect to Commercialization activities:  (A) endeavor to take advantage of the respective resources, capabilities and expertise of MJ and BMKK, and (B) endeavor to (i) maintain, to the extent reasonably practical and commercially appropriate, continuity in functions and commitments of personnel and physical resources of MJ and BMKK, (ii) avoid duplication of efforts by the Parties, and (iii) foster efficient use by the Parties of resources and personnel, consistent with this Agreement, the applicable Annual Commercialization Plan and Budget and the Long-Term Commercialization Plan and Budget.

(b)                            Joint Japan Development and Regulatory Committee (JJDC) .  Subject to the terms of this Agreement, the JJDC shall be responsible, in consultation with the JJCC and the JJMC, as applicable, for preparing and submitting to the SCJ for its approval any key regulatory strategies for the Development and Commercialization of Final Product in Japan, for proposing amendments to the Long-Term Development Plan for review and approval by the SCJ, for approving an Annual Development Plan and Budget for review and/or modification by the SCJ, for overseeing and coordinating the Development of, and the making of regulatory filings for, Final Product in Japan, for facilitating the flow of information with respect to Development activities, for overseeing the conduct of Phase I-IIIA Clinical Trials, and, where necessary or appropriate, for collaborating with the JJCC  to oversee any Phase IIIB Clinical Trials and Phase IV Clinical Trials.  Subject to the terms of this Agreement, the JJDC shall be charged with taking any action and making any decision necessary to implement the binding portion of the Long-Term Development Plan and each approved strategy in cooperation with the Existing Committees, the JJCC, JJFC, and the JJMC, as applicable.  In particular, subject to the terms of this Agreement, the JJDC shall be responsible for the following Development and regulatory activities with respect to Final Product in Japan:

(i)             recommending a strategy for the Development and Approval of Final Product in Japan, on an Indication-by-Indication basis, for review and approval by the SCJ;

(ii)            making recommendations to the SCJ with respect to its review and approval of the Long-Term Development Plan and all updates, amendments and modifications thereto, and waivers of provisions thereof;

(iii)           preparing and recommending each Annual Development Plan and Budget for review and approval by the SCJ, and all updates, amendments and modifications thereto, and waivers of provisions thereof, in each case consistent with the binding portion of the Long-Term Development Plan;

(iv)           determine and approve the allocation of responsibilities among the Parties applicable to the Development activities contemplated under this Agreement in a manner consistent with this Agreement, the Annual Development Plan and Budget, and the binding portion of the Long-Term Development Plan;

(v)            overseeing the implementation of, and monitoring the progress of, the clinical and regulatory program, consistent with the Long-Term Development Plan, including making proposals to the SCJ whether to conduct, cease or suspend any Phase I-IIIA Clinical Trials;

(vi)           reviewing and approving the scientific integrity and protocols of all Clinical Trials included in the Annual Development Plan and Budget, and the binding

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portion of the Long-Term Development Plan, and supervising the use and dissemination of the resulting data;

(vii)          recommend for approval by the SCJ a budget for all Clinical Trials that is consistent with the binding portion of the Long-Term Development Plan and the Annual Development Plan and Budget;

(viii)         formulating and proposing for inclusion in the Long-Term Development Plan, a regulatory strategy, schedule, and plan for filing and obtaining Approvals, on an Indication-by-Indication basis (it being understood that any such inclusion shall not control or affect a Party’s decision as to whether it will agree (or not agree) to include a given Clinical Trial in the Annual Development Plan and Budget or the binding portion of the Long-Term Development Plan);

(ix)            overseeing and monitoring regulatory aspects of the Development with respect to obtaining Approval, including all regulatory actions, communications and filings and submissions (including filings and submissions of supplements and amendments to Approvals) to or with the Japanese Regulatory Authorities;

(x)             overseeing and making recommendations to the SCJ and JJCC with respect to Final Product labeling;

(xi)            coordinating preparation for and attendance at meetings of Japanese Regulatory Authorities with respect to Final Product;

(xii)           coordinating responses to additional requirements and inquiries of Japanese Regulatory Authorities with respect to Final Product;

(xiii)          drafting, or having drafted, the contents of the Chemistry, Manufacturing and Controls section of any JNDA with respect to Final Product;

(xiv)         facilitating the exchange of all critical Final Product regulatory information and data between the Parties, as well as ensuring that significant issues concerning Final Product adverse event information and safety issues are addressed in a timely manner, consistent where practicable, to the manner in which such issues are addressed by the Parties with Regulatory Authorities in other countries;

(xv)          reviewing and approving the content, strategies for, and other aspects (other than level of funding) for (A) Product labeling, (B) early access and compassionate use programs for a given Indication or line of therapy (prior to launch in Japan for such Indication or line of therapy), and (C) Medical Education Activities, as well as approve and assign responsibilities for implementation of same; and

(xvi)         providing updates at least quarterly on its activities to the SCJ, JJCC, and Existing Committees.

(c)                             Joint Japan Manufacturing Committee (JJMC).  The JJMC shall be responsible for preparing and submitting the Japan Manufacturing Plan and Budget annually to the SCJ for its approval.  The JJMC shall be charged with taking any action and making any decision necessary to implement each such Japan Manufacturing Plan and Budget approved by the SCJ.  As soon as practicable after the Restatement Effective Date, the first annual Japan Manufacturing Plan and Budget shall be prepared by the JJMC consistent with the long-term Japan Manufacturing Plan and Budget and forwarded to the SCJ for review, comment and approval.  In particular, subject to the terms of this Agreement and the Existing

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Agreements, the JJMC shall be responsible for the following manufacturing and supply activities with respect to Final Product in Japan:

(i)             delineate requirements and responsibilities for development and licensure of manufacturing processes and facilities for the supply of Final Product in Japan;

(ii)            develop a manufacturing strategy for the Long-Term Development Plan, the Long-Term Commercialization Plan and Budget and the Annual Commercialization Plan and Budget, to enable development and licensure of manufacturing processes and facilities for Final Product in Japan that includes all aspects of manufacture and release, including bulk drug substance (API), intermediate(s), dosage form (formulations), devices, product characterization studies, stability studies and manufacturing plans and forecasts;

(iii)           prepare and submit to the SCJ annually a long-term and annual Japan Manufacturing Plan and Budget, and allocate responsibilities for and oversee the implementation thereof;

(iv)           prepare and submit to the SCJ on a quarterly basis updated forecasts for requirements of API, Cetuximab, and Final Product for Commercialization in Japan in the manner set forth in Section 8.3;

(v)            oversee and approve process development plans prior to the manufacture of registration batches;

(vi)           review quality assurance efforts, including those efforts with respect to the establishment of Specifications and quality standards;

(vii)          approve the terms of any supply or quality agreement involving any Party or its Affiliates that affects (or may affect) the supply of bulk drug substance (API) , any intermediates or Final Product;

(viii)         approve the Chemistry, Manufacturing and Controls (CMC) section of each JNDA and any revisions to same, and coordinate with the JJDC the drafting and contents of the CMC section of each JNDA and any revisions to same;

(ix)            review and approve technology transfer plans for any changes in manufacturing