AMENDMENT NO. 2 TO DEVELOPMENT, PROMOTION, DISTRIBUTION AND SUPPLY AGREEMENT

Exhibit 10.41

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

AMENDMENT NO. 2 TO DEVELOPMENT, PROMOTION,
DISTRIBUTION AND SUPPLY AGREEMENT

        This AMENDMENT NO. 2 dated as of July 27, 2007 (this " Amendment No. 2 "), is entered into by and among 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 and Province Line Road, Princeton, New Jersey 08543 (" ERS "), BRISTOL-MYERS SQUIBB COMPANY, a corporation organized and existing under the laws of the State of Delaware, having offices located at Route 206 and Province Line Road, Princeton, New Jersey 08543 (" BMS ") 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 (the " Company ").

        WHEREAS ERS, BMS and the Company (collectively, the " Parties ") are parties to the Development, Promotion, Distribution and Supply Agreement among ERS, BMS and the Company dated as of September 19, 2001, as amended by Amendment No. 1 dated as of March 5, 2002 (" Amendment No. 1 "), by and among the Parties (the agreement as so amended, the " Agreement "), pursuant to which the Parties have agreed to collaborate on the development and commercialization of Products in the Territory;

        WHEREAS simultaneously with the execution of this Amendment No. 2, and as a condition to the effectiveness of this Amendment No. 2, the Parties are entering into a Letter of Intent Regarding the Japan Co-Commercialization Agreements (as defined below) and the Side Letter (as defined below), and executing the Release and Waiver (as defined below);

        NOW THEREFORE, in consideration of the mutual agreements herein contained and other good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, and subject to the conditions set forth herein, the Parties hereby agree to amend the Agreement as follows:

         Definitions.     Capitalized terms used but not defined in this Amendment No. 2 shall have the meanings set forth in the Agreement. References in the Agreement to "this Agreement" shall be deemed to refer to the Agreement as amended by this Amendment No. 2. Notwithstanding the foregoing, the date of the Agreement, as amended hereby, shall in all instances remain September 19, 2001, and references to "the date hereof", "the date of this Agreement" and "the Effective Date" in the Agreement shall continue to refer to September 19, 2001.

Confidential Treatment Requested

        SECTION 1.     Amendments to Section 1 and Exhibits.

•         (a)   Sections 1.78 and 1.95 of the Agreement are hereby deleted in their entirety.

          (b)   Sections 1.19 and 1.20 of the Agreement are hereby deleted in their entirety and replaced with the following:

  • • "1.19 "Clinical Budget" shall mean (i) the budget for Development Costs for each Approved Study and Contingent Approved Study that is included in Exhibit B or C of the 2007-2009 Clinical Development Plan as of the date of this Amendment No. 2, as set forth in such Exhibit B or C, as the case may be, (ii) subject to Sections 4.3(b)(ii) and 4.3(h)(ii), each budget for Development Costs for each Approved Study and Contingent Approved Study that is included in Exhibit A of the 2007-2009 Clinical Development Plan as of the date of this Amendment No. 2 as set forth in such Exhibit A; and (iii) each budget for Development Costs for each Proposed Study or Emergency Study that becomes an Approved Study or a Contingent Approved Study that is not set forth in the 2007-2009 Clinical Development Plan as of the date of this Amendment No. 2 that is included in a subsequent Clinical Development Plan and that is approved in accordance with the provisions of this Agreement, in each case as such Clinical Budget may be modified or amended from time to time in accordance with the provisions of this Agreement. Each Clinical Budget shall set forth the approved aggregate Development Costs through completion for each Approved Study and each Contingent Approved Study included in the Clinical Development Plan (including the budgeted Development Costs for each such Approved Study and Contingent Approved Study for each calendar year included in the applicable Clinical Development Plan and the estimated Development Costs, if any, for each subsequent calendar year through completion) and shall include the other cost information required by Exhibit 1.20 for each Approved Study and each Contingent Approved Study included in the Clinical Development Plan.

      1.20 "Clinical Development Plan" shall mean (a) the 2007-2009 Clinical Development Plan and (b) each subsequent Clinical Development Plan prepared and approved in accordance with the provisions of Sections 4.3(c) and 4.3(f), in each case as such Clinical Development Plan may be modified or amended from time to time to add or delete an Approved Study or a Contingent Approved Study or otherwise modified or amended in accordance with the provisions of Sections 2.1(b)(ii), (iii), (iv) and (v). Each Clinical Development Plan shall include for each Approved Study and Contingent Approved Study (other than any Clinical Study that was included in a Clinical Development Plan prior to the date of this Amendment No. 2), all the information required by Exhibit 1.20 including a Clinical Budget.

      1.20A " 2007-2009 Clinical Development Plan" shall mean the Clinical Development Plan set forth in Exhibit 1.20A that has been agreed to among the Parties as of the date of this Amendment No. 2, as the same may be amended or modified in accordance with the provisions of this Agreement."

          (c)   Section 1 of the Agreement is further amended by inserting the following definitions in alphabetical order:

  • • "1.5A " Alliance Committee" shall have the meaning assigned to such term in Section 2.10(a).

      1.10A " Approved Study " shall mean a study that the Parties have agreed shall be conducted and jointly funded in accordance with Section 4.6, which comprises (a) each study designated as an Approved Study in the 2007-2009 Clinical Development Plan as of the date of this Amendment No. 2 and (b) each other study that shall be designated as

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      an Approved Study in a subsequent Clinical Development Plan in accordance with the procedures set forth in Section 4.3(f), each Proposed Study or Emergency Study that is added to the then-current Clinical Development Plan as an Approved Study in accordance with the provisions of Sections 4.3 (f) or 4.3 (i), as the case may be, and each Contingent Approved Study that shall be designated as an Approved Study in accordance with the provisions of Section 4.3(h).

      1.10B " Attributable Other Party SFI Expenses " shall have the meaning assigned to such term in Section 7.2(b).

      1.20A " Clinical Study " shall mean (a) any clinical study undertaken (i) for approval of new indications for the Product, (ii) to obtain a compendial listing, (iii) for the purpose of providing data that will result in a labeling change for the Product, or (iv) for any other purpose under an IND for the Product (e.g., Phase I through Phase III studies), (b) any Phase IIIb Clinical Trial or Phase IV Clinical Trial for the Product, and (c) any non-clinical study that is (1) required, requested or advised by a Regulatory Authority or (2) undertaken with the intention to obtain or maintain a regulatory approval or compendial listing, or to develop and provide additional information for inclusion in the label for the Product. A clinical study shall be deemed to have commenced when the first patient in such study is enrolled. For clarity, for purposes of this Agreement, Clinical Studies do not include clinical trials or other studies where a Product is used in such study as provided in Section 4.3(a)(iii).

      1.28A " Contingencies" shall mean, with respect to any Contingent Approved Study, the specific contingencies, decision points, and "go/no go" criteria for the commencement or continuation of such Contingent Approved Study as set forth in the Clinical Development Plan for each such Contingent Approved Study.

      1.28B " Contingent Approved Study " shall mean a study that the Parties have unanimously agreed shall be conducted if the Contingencies related to such study are satisfied in which event the commencement of such study shall be jointly funded in accordance with Section 4.6, which comprises (a) each study designated as a Contingent Approved Study in the 2007-2009 Clinical Development Plan as of the date of this Amendment No. 2 and (b) each other study that shall be designated as a Contingent Approved Study in a subsequent Clinical Development Plan in accordance with the procedures set forth in Section 4.3(f) or each Proposed Study that is added to the then-current Clinical Development Plan as a Contingent Approved Study in accordance with the provisions of Section 4.3(f).

      1.37A " Emergency Study " shall mean a Clinical Study that is to be performed to respond to a significant patient safety issue, a significant toxicity management issue or a request from a Regulatory Authority to conduct a Clinical Study relating to a significant patient safety issue or a significant toxicity management issue.

      1.54A "Incremental SFI Profit Or Loss" means Net Sales in North America of the Products that are attributable to a given Successful Indication for a given period, less the following costs, if any, incurred by the applicable Non-Proposing Party or any of its Affiliates for such Products that are attributable or reasonably allocable to such Successful Indication with respect to such period, including without limitation: [*]. For purposes of this Section 1.54A, where the definition of [*] refers to "Japan", such reference to "Japan" will be replaced by North America.

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Omitted and filed separately pursuant to a request for confidential treatment submitted to the Securities and Exchange Commission.

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• • • 1.60A " Japan Co-Commercialization Agreements" shall mean the Amended and Restated Co-Development and Co-Commercialization Agreement for Erbitux in Japan among Bristol-Myers Squibb Company, Bristol-Myers K.K., E.R. Squibb & Sons, LLC, Merck KGaA, Merck Ltd. and ImClone Systems Incorporated and the BMS-ImClone Japan Agreement among Bristol-Myers Squibb Company, Bristol-Myers K.K., E.R. Squibb & Sons, LLC and ImClone Systems Incorporated, in each case as referenced in the Letter of Intent Regarding the Japan Co-Commercialization Agreements.

      1.60B " Letter of Intent Regarding the Japan Co-Commercialization Agreements " means the letter executed by the Parties as of the date of this Amendment No. 2 with respect to certain matters related to the co-development and co-promotion of the Compound in Japan, including the negotiation and agreement of the Japan Co-Commercialization Agreements.

      1.72A "Material Modification" shall have the meaning assigned to such term in Section 2.1(b)(v).

      1.77A "Non-Proposing Party" shall have the meaning assigned to such term in Section 4.3(g)(i).

      1.88A " Phase IIIb Clinical Trial " means a human clinical trial of a Compound or Product for an indication that (a) is not required for receipt of Regulatory Approval for such indication for a country but which may be useful in providing additional drug profile data in support of such Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval), or (b) is required, requested or advised by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining such Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval). For clarity, for purposes of this Agreement, Phase IIIb Clinical Trials do not include clinical trials or other studies where a Product is used in such study as provided in Section 4.3(a)(iii).

      1.88B "Phase IV Clinical Trial" means a product support human clinical trial, or other test or study, of a Compound or Product for an indication that is either (a) commenced after receipt of the initial Regulatory Approval for such indication in the country for which such trial is being conducted and that is conducted within the parameters of the Regulatory Approval for the Compound or Product for such indication (and which may include investigator-sponsored clinical trials (" ISTs ")), but shall not include any Phase IIIb Clinical Trial or (b) is an IST that does not fall within the approved label for a Product. Phase IV Clinical Trials may include trials or studies conducted in support of pricing/reimbursement, epidemiological studies, life cycle management, modeling and pharmacoeconomic studies, post-marketing surveillance studies, outcome research studies and health economics studies. For clarity, for purposes of this Agreement, Phase IV Clinical Trials do not include clinical trials or other studies where a Product is used in such study as provided in Section 4.3(a)(iii).

      1.91A " Proposed Study" shall have the meaning assigned to such term in Section 4.3(e).

      1.91B "Proposing Party" shall have the meaning assigned to such term in Section 4.3(g)(i).

      1.95 " Release and Waiver " shall mean the Release and Waiver between the Parties dated as of the date of this Amendment No. 2.

      1.96A " Responsible Party" shall mean (a) with respect to any Approved Study or Contingent Approved Study, the Party responsible for conducting such study or, if such study is to be conducted by a CRO, the Party responsible for overseeing the conduct of

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      such study, in each case as set forth in the Clinical Development Plan and (b) with respect to any Sole-Funded SFI Registrational Study, the Proposing Party for such Sole-Funded SFI Registrational Study.

      1.99A " Scientific Expert" means a disinterested individual without any conflict-of-interest who is not affiliated with either Party and who has appropriate scientific, technical or regulatory expertise to resolve any disputes referred to him or her under this Agreement. A Scientific Expert shall not be or have been at any time within the previous five years an Affiliate, employee, consultant, officer or director of either Party or any of its respective Affiliates.

      1.99B "Selected Scientific Expert" shall have the meaning assigned to such term in Section 2.1(d)(vi).

      1.99C "SFI" shall have the meaning assigned to such term in Section 4.3(g)(ii).

      1.99D " SFI Net Canadian Sales " shall have the meaning assigned to such term in Section 7.2(b).

      1.99E " SFI Net U.S. Sales " shall have the meaning assigned to such term in Section 7.2(b).

      1.101A " Side Letter" shall mean the Side Letter between the Parties dated as of the date of this Amendment No. 2.

      1.101C " Sole-Funded SFI Registrational Study" shall mean a Clinical Study solely funded individually by either the Company or ERS subject to the provisions of Section 4.3(g).

      1.102A " Specified Phase III Study " shall have the meaning assigned to such term in 4.3(g)(i).

      1.102B " Specified Signal Finding Study " shall have the meaning assigned to such term in 4.3(g)(i).

      1.104A "Successful Indication" shall have the meaning assigned to such term in Section 4.3(g)(ii)."

          (d)   Exhibits 4.3(A), 4.3(B), 8.12(b)(i) and 8.12(b)(ii) are hereby deleted in their entirety.

          (e)   New Exhibits 1.20 and 1.20(A) and Schedule 4.3(g)(i) are hereby added to the Agreement in the form of Exhibits 1.20 and 1.20(A) and Schedule 4.3(g)(i) to this Amendment No. 2.

          (f)    The definition of "Development Costs" included in the Financial Appendix is hereby deleted in its entirety and replaced with the following:

  • "' Development Costs '

            (a)   In each of North America and Japan, " Development Costs " means the development costs incurred by each Party with respect to a Product in North America or Japan, as the case may be, from the Effective Date of the Agreement through the later of (i) the date of Registration (including thereafter costs to maintain or expand such Registration) of such Product in the Field in North America or Japan, as the case may be, or (ii) the date of termination of development efforts of such Product in the Field, as applicable in North America or Japan. Such costs shall comprise those costs incurred to obtain, maintain and/or expand the relevant authorization and/or ability to manufacture, formulate, fill, use, ship, sell and/or distribute the relevant Product in commercial quantities to Third Parties in North America or Japan, as the case may be.

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            (b)   In each of North America and Japan, " Development Costs " shall include, without limitation, costs of research or development including costs of studies on the toxicological, pharmacokinetical, metabolical or clinical aspects of a Product conducted internally or by individual investigators or consultants necessary for the purpose of obtaining, maintaining and/or expanding marketing/ pricing approval of a Product (including costs of Clinical Studies), costs for preparing, submitting, reviewing or developing data or information for the purpose of submission to a governmental authority to obtain, maintain and/or expand marketing/pricing approval of a Product, and applicable Allocable Overhead.

            (c)   In each of North America and Japan, " Development Costs " shall also include, without limitation, expenses for data management, statistical designs and studies, document preparation, and other administration expenses associated with the clinical testing program or post-marketing studies required to maintain product approvals.

            (d)   For a given Approved Study or Contingent Study included in the Clinical Development Plan or a Sole-Funded SFI Registrational Study, Development Costs shall include the internal FTE Costs (for which a Party's internal FTE Rate shall be calculated based on the relevant Parties' costs set forth in Annex I to the Financial Appendix, which shall be reviewed and mutually agreed by ERS and the Company prior to the beginning of each new calendar year beginning with calendar year 2008) and direct out-of-pocket costs that are paid or incurred by a Party or any of its Affiliates that are attributable or reasonably allocable to such Approved Study, Contingent Approved Study or Sole-Funded SFI Registrational Study, including without limitation:

    •           (i)  the internal FTE Costs and direct out-of-pocket costs incurred in connection with the planning and conduct of any such Approved Study, Contingent Approved Study or Sole-Funded SFI Registrational Study, including grant costs and contract research organization ("CRO") costs;

               (ii)  the Fully-Burdened Manufacturing Cost for (1) Compound or Product used in such Approved Study, Contingent Approved Study or Sole-Funded SFI Registrational Study, and (2) the manufacture, purchase or packaging of comparators, placebo or other clinical supplies for use in such Approved Study, Contingent Approved Study or Sole-Funded SFI Registrational Study (with the manufacturing costs for such comparators, placebo or clinical supplies that are (A) manufactured by a Party or its Affiliates to be determined in the same manner as Manufacturing Costs are determined for such Product or (B) purchased by a Party or its Affiliates from a Third Party based on the actual cost of purchase), as well as the reasonable direct costs and expenses of disposal of drugs and other supplies used in such Approved Study, Contingent Approved Study or Sole-Funded SFI Registrational Study;

              (iii)  regulatory expenses (including internal FTE costs and direct out-of-pocket costs) incurred that directly relate to such Approved Study, Contingent Approved Study or Sole-Funded SFI Registrational Study;

              (iv)  costs of recruitment initiatives for such Approved Study, Contingent Approved Study or Sole-Funded SFI Registrational Study; and

               (v)  Allocable Overhead relating to such Approved Study, Contingent Approved Study or Sole-Funded SFI Registrational Study.

    If any cost or expense is specifically identifiable or reasonably allocable to more than one activity set forth above, such cost or expense shall only be counted as Development Costs with respect to one of such activities, provided that, other than with respect to any cost or expense incurred in connection with the obtaining, maintaining and/or expanding marketing/pricing

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• • approval of a Product, no expense that is specifically identifiable or reasonably allocable as a Marketing Cost may be counted as a Development Cost.

            (e)   Each Party will use its respective project accounting systems and will review and approve its respective project accounting systems and methodologies with the other Parties, provided that in determining the amount of Development Costs incurred in a given year for purposes of the cost sharing provisions of Section 4.6, the Parties will use the cash basis of accounting."

            (g)   New Annex I to the Financial Appendix is hereby added to the Agreement in the form of Annex I to this Amendment No. 2.

            (h)   The definition of "Marketing Costs" included in the Financial Appendix is hereby amended by inserting the following at the end thereof:

    •         "(d) " Marketing Costs " will specifically exclude the costs of [*]."

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Omitted and filed separately pursuant to a request for confidential treatment submitted to the Securities and Exchange Commission.

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        SECTION 2.     Amendments to Section 2 of the Agreement.

•         (a)   Section 2.1(b) is hereby deleted in its entirety and replaced with the following:

          "(b)  Responsibilities.     The JEC shall perform the following functions:

  •           (i)  oversee the development and commercialization of the Compounds and Products pursuant to the terms of this Agreement;

             (ii)  review and approve, pursuant to Section 4.3(f), each Clinical Development Plan, including the Clinical Budget for each Approved Study and Contingent Approved Study included in such Clinical Development Plan;

            (iii)  review and approve, pursuant to Section 4.3(f) or 4.3(i), as applicable, each Proposed Study and each Emergency Study proposed to be added as an Approved Study or a Contingent Approved Study to the then-current Clinical Development Plan pursuant to Section 4.3(e) or 4.3(i), as applicable, including the related Clinical Budget for such Proposed Study or Emergency Study;

            (iv)  (A) review and approve, pursuant to Section 4.3(h), the determination that either (1) each of the Contingencies applicable to a Contingent Approved Study has been satisfied and such Contingent Approved Study shall become an Approved Study or (2) at least one of the Contingencies related to a Contingent Approved Study has failed to be satisfied and such Contingent Approved Study shall be removed from the Clinical Development Plan; and (B) review and approve, pursuant to Section 4.3(h), the protocol and updated Clinical Budget for each Contingent Approved Study that shall become an Approved Study;

             (v)  review and approve (A) any amendments or modifications to any Approved Study or Contingent Approved Study included in the then-current Clinical Development Plan that would reasonably be expected to result in an increase in the aggregate Clinical Budget through the completion of such Approved Study or Contingent Approved Study, as applicable, of [*] or more or (B) any other material modification or amendment to any Approved Study or Contingent Approved Study, including (1) any delay in the expected start date of such Approved Study or Contingent Approved Study by more than [*], (2) any change of [*] or more in the number of patients enrolled or to be enrolled in such approved Study or Contingent Approved Study, (3) a change in the primary or secondary endpoints or any other key provisions of the study protocol design (including study power), publication strategy or data analysis relating to such Approved Study or Contingent Approved Study, (4) any modification or amendment to the Contingencies required to be satisfied for any Contingent Approved Study to become an Approved Study or (5) the early termination of an Approved Study or Contingent Approved Study (any such amendment or modification in clause (A) or (B) of this Section 2.1(b)(v), a "Material Modification"), provided that this Section 2.1(b)(v) shall not apply to the termination of a Contingent Approved Study as a result of failure to satisfy the Contingencies applicable to such Contingent Approved Study (which is the subject of Section 2.1(b)(iv)), provided further that, pending the JEC approval of early termination under this Section 2.1(b)(v)(B)(5), the Responsible Party for an Approved Study or Contingent Approved Study may suspend such Approved Study or Contingent Approved Study, as the case may be, if it believes that failure to do so would jeopardize the welfare or safety of patients;

            (vi)  at each meeting of the JEC review a comparison of the actual expenses to the budgeted expenses for the year-to-date (including Development Costs for each Approved

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Omitted and filed separately pursuant to a request for confidential treatment submitted to the Securities and Exchange Commission.

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• • Study and each Contingent Approved Study), as current as practicable to a date immediately prior to the date of the meeting;

           (vii)  review and evaluate the progress of the other Committees;

          (viii)  review and take action on any other matters within the scope of the authority of another Committee that are referred to the JEC by such other Committee;

            (ix)  review and, if unanimously agreed, reallocate spending from the Marketing Budget to the Clinical Budget;

             (x)  establish and empower a finance committee, which shall consist of an equal number of representatives from each of the Company and BMS (the " Finance Committee " ) to advise the JEC and make recommendations to the JEC for the areas it has responsibility as provided in Section 2.2;

            (xi)  at least once each year, meet with each of the other Committees (which meetings do not need to include all of the other Committees at the same meeting);

           (xii)  in accordance with the procedures established in Section 2.1(d), resolve disputes, disagreements and deadlocks unresolved by the other Committees; and

          (xiii)  have such other responsibilities as may be assigned to the JEC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time."

          (b)   Section 2.1(d) of the Agreement is hereby deleted in its entirety and replaced with the following:

          "(d)  Decision-making .

  •           (i)  The JEC may make decisions with respect to any subject matter that is subject to the JEC's decision-making authority and functions as set forth in Section 2.1(b). Except as otherwise specified in Section 2.1(d)(ii), (iii), (iv), (v) or (vii), all decisions of the JEC shall be made by unanimous vote or written consent, with the Company and BMS each having, collectively, one vote in all decisions. The JEC shall use reasonable best efforts to resolve the matters within its roles and functions or otherwise referred to it.

             (ii)  Subject to the provisions of Section 2.1(d)(vii), with respect to any Critical Issue (other than a Critical Issue that relates to a decision to be made pursuant to Section 2.1(b)(ii), (iii), (iv), (v) or (ix)), if the JEC cannot reach consensus within five business days after the matter has been brought to the JEC's attention, the matter shall be referred on the sixth business day: (A) if the matter is the subject of a deadlock arising in the PDC and is not the subject of Section 4.8 or 4.9, to the co-chairperson of the JEC designated by the Company for resolution, provided that any decision made by the co-chairperson of the JEC designated by the Company may not increase the aggregate Clinical Budget for such Approved Study or Contingent Approved Study through completion by [*] or more; (B) if the matter is the subject of a deadlock arising in the JCC (other than a matter under Section 2.4(b)(xiv) with respect to Trademarks), to the co-chairperson of the JEC designated by BMS for resolution, provided that any decision made by the co-chairperson of the JEC designated by BMS may only increase or decrease the overall amount of the relevant Marketing Budget within the ranges provided in and otherwise in accordance with Section 5.2; (C) if the matter is under Section 2.4(b)(xiv) with respect to Trademarks and is subject of a deadlock arising in the JCC, to the co-chairperson of the JEC designated by the Company for resolution; and (D) except as provided in Section 8.12(f), if the matter is the subject of a deadlock arising in the JMC, to the co-chairperson of the JEC designated by the Company for resolution. In the event that the co-chairperson of a Party designated to resolve a dispute

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Omitted and filed separately pursuant to a request for confidential treatment submitted to the Securities and Exchange Commission.

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• • under this Section 2(d)(ii) is not immediately available, then such matter shall be referred to a senior executive officer of such Party who has been designated by such Party for such resolution.

            (iii)  Subject to the provisions of Section 2.1(d)(vii), with respect to all other matters that are subject to the JEC's decision-making authority (other than any matter that relates to a decision to be made pursuant to Section 2.1(b)(ii), (iii), (iv), (v) or (ix)), if the JEC cannot reach consensus within 20 business days after it has met and attempted to reach such consensus, the matter shall be referred on the twenty-first business day: (A) if the matter is the subject of a deadlock arising in the PDC and is not the subject of Section 4.8 or 4.9, to the co-chairperson of the JEC designated by the Company for resolution, provided that any decision made by the co-chairperson of the Company may not increase the aggregate Clinical Budget for such Approved Study or Contingent Approved Study through completion by [*] or more; (B) if the matter is the subject of a deadlock arising in the JCC (other than a matter under Section 2.4(b)(xiv) with respect to Trademarks), to the co-chairperson of the JEC designated by BMS for resolution, provided that any decision made by the co-chairperson of BMS may not increase or decrease the overall amount of the relevant Marketing Budget within the ranges provided in accordance and otherwise in accordance with Section 5.2; (C) if the matter is under Section 2.4(b)(xiv) with respect to Trademarks and is the subject of a deadlock arising in the JCC, to the co-chairperson of the JEC designated by the Company for resolution; and (D) except as provided in Section 8.12(f), if the matter is the subject of a deadlock arising in the JMC, to the co-chairperson of the JEC designated by the Company for resolution.

            (iv)  Subject to the provisions of Section 2.1(d)(vii), in the event of a deadlock of the JEC with respect to a Critical Issue (other than a Critical Issue that relates to a decision to be made pursuant to Section 2.1(b)(ii), (iii), (iv), (v) or (ix)) that is not resolved pursuant to Section 2.1(d)(ii) and the matters underlying such deadlock fall into the class of disputes that may be arbitrated by the Parties in accordance with Section 16.13, then such matters shall be resolved pursuant to the Accelerated Arbitration Provisions of Section 16.13(b). Subject to the provisions of Section 2.1(d)(vii), in the event of a deadlock of the JEC with respect to any other matters that are not resolved pursuant to Section 2.1(d)(iii) and such matters fall into the class of disputes that may be arbitrated by the Parties in accordance with Section 16.13, then such matters shall be resolved pursuant to Section 16.13(a).

             (v)  Subject to the provisions of Section 2.1(d)(vii), in the event of a deadlock of the JEC with respect to any matter that relates to a decision to be made pursuant to Section 2.1(b)(ii), (iii), (iv), (v) or (ix), such deadlock shall be resolved solely as follows:

    •         (A)  if the matter relates to a deadlock under Section 2.1(b)(ii), the new Clinical Development Plan shall be deemed to include only (1) Approved Studies, (2) Contingent Approved Studies for which there has not been a determination pursuant to Section 2.1(b)(iv) to remove such Contingent Approved Study from the Clinical Development Plan, and (3) any other studies that the Parties have agreed unanimously in accordance with the provisions of Section 4.3(f) should be included as an Approved Study or Contingent Approved Study in the new Clinical Development Plan;

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Omitted and filed separately pursuant to a request for confidential treatment submitted to the Securities and Exchange Commission.

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• • •         (B)  if the matter relates to a deadlock regarding an Emergency Study under Section 2.1(b)(iii), the Emergency Study shall become an Approved Study and shall be added to the then-current Clinical Development Plan, provided that if the deadlock relates to the scientific design of the Emergency Study, the Parties shall seek the advice of the Regulatory Authority on the appropriate scientific design of the Emergency Study and shall implement the Regulatory Authority's recommendations;

              (C)  if the matter relates to a deadlock regarding a Proposed Study under Section 2.1(b)(iii), the Proposed Study shall not become an Approved Study or a Contingent Approved Study;

              (D)  (1) if the matter relates to a deadlock under Section 2.1(b)(iv) (other than with respect to approval of an updated Clinical Budget), the matter shall be submitted to binding arbitration by a Scientific Expert pursuant to Section 2.1(d)(vi) and (2) if the matter relates to a deadlock under Section 2.1(b)(iv) with respect to approval of an updated Clinical Budget, such matter shall be resolved pursuant to the Accelerated Arbitration Provisions of Section 16.13(b) based on the agreed protocol for such Contingent Approved Study, provided that such arbitration may not result in an increase in the Clinical Budget of more than [*] in excess of the Clinical Budget for such Contingent Approved Study in the Clinical Development Plan as of the date of this Amendment No. 2;

              (E)  if the matter relates to a deadlock regarding a Material Modification under Section 2.1(b)(v), the amendment or modification shall not be made; and

              (F)  if the matter relates to a deadlock regarding the reallocation of funds under Section 2.1(b)(ix), the reallocation shall not be made.

      For the avoidance of doubt, a deadlock of the JEC with respect to any matter that relates to a decision to be made pursuant to Section 2.1(b)(ii), (iii), (iv), (v) or (ix) shall not be a dispute that may be arbitrated pursuant to Section 16.13.

            (vi)  In the event of a deadlock of the JEC with respect to a matter described in Section 2.1(d)(v)(D), the matter shall be referred for arbitration to a Scientific Expert who is mutually agreed by the Parties. If the Parties cannot agree on a mutually acceptable Scientific Expert within 30 calendar days after the JEC has determined that it can not reach agreement, then within five business days after the expiration of such 30-calendar day period, each of ERS and the Company shall appoint one Scientific Expert who shall jointly select a third Scientific Expert within five business days after the last to occur of their respective appointments to arbitrate the referred matter. The Scientific Expert mutually agreed by the Parties or, if the Parties cannot agree, the third Scientific Expert selected by the Party-appointed Scientific Experts is referred to as the " Selected Scientific Expert ". ERS and the Company shall instruct the Selected Scientific Expert to render a determination of any such dispute within 15 business days after his selection. The dispute shall be resolved by submission of documents unless the Selected Scientific Expert determines that an oral hearing is necessary. The Selected Scientific Expert shall, within the overall 15 business day time constraint, determine what shall be conclusively deemed to be fair and appropriate deadlines for submitting documents and dates, if any, of oral hearings. Each Party shall pay its own expenses of arbitration, and the expenses of the Scientific Experts shall be equally shared between ERS and the Company. Any decision rendered by the Selected Scientific Expert shall be final and binding upon the Parties. Application may be made to any court having

*

Omitted and filed separately pursuant to a request for confidential treatment submitted to the Securities and Exchange Commission.

11

• • jurisdiction for a judicial acceptance of the decision and an order of enforcement, as the case may be. This Section 2.1(d)(vi) shall not prohibit a Party from seeking injunctive relief from a court of competent jurisdiction in the event of a breach or prospective breach of this Agreement by any other Party which would cause irreparable harm to the first Party.

           (vii)  If the JEC cannot reach consensus with respect to any matter that is subject to the JEC's decision-making authority, and the co-chairs of the JEC unanimously agree, the matter shall be referred first to the Alliance Committee for review in accordance with the provisions of Section 2.10 before the provisions of Section 2.1(d)(ii), (iii), (iv) or (v), as applicable, shall be invoked. In the event of such referral, the periods of time set forth in Section 2.1(d)(ii), (iii), (iv) or (v), as applicable, shall be tolled during the period of the Alliance Committee's review of the referred matter. If within five business days (in the case of any referred matter that is to be resolved pursuant to Section 2.1(d)(ii)) or 20 business days (in the case of any referred matter that is to be resolved pursuant to Section 2.1(d)(iii), (iv) or (v)) after having received the Alliance Committee's response, the JEC again cannot reach consensus, the matter shall be resolved in accordance with Section 2.1(d)(ii), (iii), (iv) or (v), as applicable.

          (viii)  For all purposes under this Agreement, any decision made pursuant to this Section 2.1(d) shall be deemed to be the decision of the JEC."

          (c)   Section 2.3(b) is hereby deleted in its entirety and replaced with the following:

          "(b)  Responsibilities.     The PDC shall perform the following functions:

  •           (i)  review and recommend, pursuant to Section 4.3(f), to the JEC for consideration and approval each Clinical Development Plan, including the related Clinical Budget for each Approved Study and Contingent Approved Study included in such Clinical Development Plan;

             (ii)  review and recommend, pursuant to Section 4.3(f) or 4.3(i), as applicable, to the JEC for consideration and approval each Proposed Study and each Emergency Study proposed to be added as an Approved Study or a Contingent Approved Study to the then-current Clinical Development Plan pursuant to Section 4.3(e) or 4.3(i), as applicable, including the proposed Clinical Budget for such Proposed Study or Emergency Study;

            (iii)  (A) review and recommend, pursuant to Section 4.3(h), to the JEC that either (1) each of the Contingencies applicable to a Contingent Approved Study has been satisfied and such Contingent Approved Study should become an Approved Study or (2) that at least one of the Contingencies related to a Contingent Approved Study has failed to be satisfied and such Contingent Approved Study should be removed from the Clinical Development Plan; and (B) review and recommend, pursuant to Section 4.3(h), the protocol and updated Clinical Budget for each Contingent Approved Study that shall become an Approved Study;

            (iv)  oversee the implementation of the Clinical Development Plans and any Sole-Funded SFI Registrational Studies;

             (v)  review and approve or, in the case of any Material Modification, recommend to the JEC for approval any amendment or modification to the Clinical Development Plan;

            (vi)  at each meeting of the PDC review a comparison of the actual Development Costs incurred to the budgeted Development Costs for the year-to-date for each Approved Study and each Contingent Approved Study, as current as practicable to a date immediately prior to the date of the meeting;

           (vii)  review and evaluate progress of each Approved Study or Contingent Approved Study and any Sole-Funded SFI Registrational Studies, provided that the PDC shall not have authority to make any determination that any Party is in breach of this Agreement;

12

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          (viii)  review and approve all compassionate use of Products;

            (ix)  review and approve the joint publication strategy together with the JCC, and take the lead in coordinating such joint review and approval; and

             (x)  have such other responsibilities as may be assigned to the PDC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time."

          (d)   Section 2.3(d) is hereby deleted in its entirety and replaced with the following:

          "(d)  Decision-making .

  •           (i)  The PDC may make decisions with respect to any subject matter that is subject to the PDC's decision-making authority and functions as set forth in Section 2.3(b). All decisions of the PDC shall be made by unanimous vote or written consent, with the Company and BMS each having, collectively, one vote in all decisions.

             (ii)  If, with respect to any matter related to a decision under Section 2.3(b)(iii) (other than with respect to approval of an updated Clinical Budget), the PDC cannot reach consensus within twenty business days after it has first met and attempted to reach such consensus, the matter shall be referred on the twenty-first business day to each Party's most senior scientific officer for review. If within 20 business days after having received the matter from the PDC, such officers cannot reach agreement, the matter shall be referred on the twenty-first business day to the Alliance Committee for review and comment in accordance with Section 2.10. If within twenty business days after having received the Alliance Committee's response, the PDC again cannot reach consensus, the matter should be referred on the twenty-first business day to the JEC for resolution.

13

• •         (iii)  If, with respect to a Critical Issue that is subject to the PDC's decision-making authority (other than a Critical Issue that relates to a decision pursuant to Section 2.3(b)(iii)(A)), the PDC cannot reach consensus within five business days after it has first met and attempted to reach such consensus, the matter shall be referred on the sixth business day to the Alliance Committee for review and comment in accordance with Section 2.10. If within five business days after having received the Alliance Committee's response the PDC again cannot reach consensus, the matter shall be referred on the sixth business day to the JEC.

            (iv)  If, with respect to any other matter that is subject to the PDC's decision-making authority, the PDC cannot reach consensus within 20 business days after it has first met and attempted to reach such consensus, the matter shall be referred on the twenty-first business day to the Alliance Committee for review and comment in accordance with Section 2.10. If within 20 business days after having received the Alliance Committee's response, the PDC again cannot reach consensus, the matter shall be referred on the twenty-first business day to the JEC for resolution.

             (v)  For all purposes under this Agreement, any decision made pursuant to this Section 2.3(d) shall be deemed to be the decision of the PDC."

          (e)   Section 2.4(b) of the Agreement is hereby deleted in its entirety and replaced with the following:

          "(b)  Responsibilities.     The JCC shall perform the following functions:

  •           (i)  oversee the preparation and implementation of the Marketing Plans;

             (ii)  oversee and coordinate the sales efforts of ERS and the Company;

            (iii)  review and approve Marketing Plans;

            (iv)  discuss the state of the markets for Products in the Territory and opportunities and issues concerning the commercialization of the Products, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the priority for same and the amount and kind of marketing and selling effort appropriate, in accordance with the Marketing Plans;

             (v)  review and approve the total annual budget for all Phase IV Clinical Trials, but not the budget or protocol for the individual studies themselves which must be approved by the PDC and the JEC pursuant to Section 4.3(f);

            (vi)  review and approve all pricing decisions and managed care contracting strategies, in accordance with the Marketing Plans;

           (vii)  review and approve all indigent care use of Products;

          (viii)  periodically review sales mix of Products sold by ERS through various customer channels;

            (ix)  review and approve allocations within the Marketing Budgets, from time to time;

             (x)  review and approve each subsequent marketing budget in accordance with Section 5.2(c);

            (xi)  review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts;

14

• • 
    

           (xii)  at each meeting of the JCC, review a comparison of actual sales and marketing expenses to the budgeted expenses in the relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;

          (xiii)  review and approve the general guidelines applicable to particular Products to be followed in the development of promotional materials and promotional activities to be used by ERS and the Company in the promotion of such Products (such guidelines to be consistent with the then-current Marketing Plan applicable to such Products);

          (xiv)  consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory;

           (xv)  review and approve the joint publication strategy together with the PDC;

          (xvi)  evaluate and determine the existence or non-existence of a Co-Promotion Problem referred to the JCC in accordance with Section 5.6(e); and

         (xvii)  have such other responsibilities as may be assigned to the JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time."

          (f)    Section 2.4(d) is hereby deleted in its entirety and replaced with the following:

          "(d) Decision-making.

  •           (i)  The JCC may make decisions with respect to any subject matter that is subject to the JCC's decision-making authority and functions as set forth in Section 2.4(b). All decisions of the JCC shall be made by unanimous vote or written consent, with the Company and BMS each having, collectively, one vote in all decisions. If, with respect to a Critical Issue that is subject to the JCC's decision-making authority, the JCC cannot reach consensus within five business days after it has first met and attempted to reach such consensus, the matter shall be referred on the sixth business day to the Alliance Committee for review and comment in accordance with Section 2.10. If within five business days after having received the Alliance Committee's response, the JCC again cannot reach consensus, the matter shall be referred on the sixth business day to the JEC for resolution.

             (ii)  If, with respect to any other matter that is subject to the JCC's decision-making authority, the JCC cannot reach consensus within 20 business days after it has first met and attempted to reach such consensus, the matter shall be referred on the twenty-first business day to the Alliance Committee for review and comment in accordance with Section 2.10. If within 20 business days after having received the Alliance Committee's response, the JCC again cannot reach consensus, the matter shall be referred on the 21st business day to the JEC for resolution.

            (iii)  For all purposes under this Agreement, any decision made pursuant to this Section 2.4(d) shall be deemed to be the decision of the JCC."

          (g)   Section 2.5(d) is hereby deleted in its entirety and replaced with the following:

          "(d) Decision-making.

  •           (i)  The JMC may make decisions with respect to any subject matter that is subject to the JMC's decision-making authority and functions as set forth in Section 2.5(b). All decisions of the JMC shall be made by unanimous vote or written consent, with the Company and BMS each having, collectively, one vote in all decisions. If, with respect to a Critical Issue that is subject to the JMC's decision-making authority, the JMC cannot reach consensus within five business days after it has first met and attempted to reach such consensus, the matter shall be referred on the sixth business day to the Alliance Committee for review and comment in

15

• • accordance with Section 2.10. If within five business days after having received the Alliance Committee's response, the JMC again cannot reach consensus, the matter shall be referred on the sixth business day to the JEC for resolution.

             (ii)  If, with respect to any other matter that is subject to the JMC's decision-making authority, the JMC cannot reach consensus within 20 business days after it has first met and attempted to reach such consensus, the matter shall be referred on the twenty-first business day to the Alliance Committee for review and comment in accordance with Section 2.10. If within 20 business days after having received the Alliance Comm