{"id":42232,"date":"2015-09-17T11:25:58","date_gmt":"2015-09-17T16:25:58","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-legal\/contracts\/uncategorized\/development-promotion-distribution-and-supply-agreement-e-r2.html"},"modified":"2015-09-17T11:25:58","modified_gmt":"2015-09-17T16:25:58","slug":"development-promotion-distribution-and-supply-agreement-e-r2","status":"publish","type":"corporate_contracts","link":"https:\/\/corporate.findlaw.com\/contracts\/operations\/development-promotion-distribution-and-supply-agreement-e-r2.html","title":{"rendered":"Development, Promotion, Distribution and Supply Agreement &#8211; E. R. Squibbs &#038; Sons LLC, Bristol-Myers Squibb Co. and ImClone Systems Inc."},"content":{"rendered":"<pre>\n                            DEVELOPMENT, PROMOTION,\n\n\n                       DISTRIBUTION AND SUPPLY AGREEMENT\n\n\n                                     AMONG\n\n\n                           E. R. SQUIBB &amp; SONS, LLC,\n\n\n                         BRISTOL-MYERS SQUIBB COMPANY,\n\n\n                                      AND\n\n\n                          IMCLONE SYSTEMS INCORPORATED\n\n\n                                  DATED AS OF\n\n\n                               September 19, 2001\n\n\n\n\n\n\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n                               TABLE OF CONTENTS\n\n\n                                                                            Page\n\n1.       DEFINITIONS...........................................................2\n         1.1      Accelerated Arbitration Provisions...........................2\n         1.2      Acquiring Party..............................................2\n         1.3      Acquisition Agreement........................................2\n         1.4      Acquisition Subsidiary.......................................2\n         1.5      Affiliate....................................................2\n         1.6      Alliance Manager.............................................2\n         1.7      Allocable Overhead...........................................2\n         1.8      Allowable Failure Rate.......................................2\n         1.9      Antitrust Injunction.........................................2\n         1.10     API..........................................................2\n         1.11     Audited Party................................................2\n         1.12     Auditing Party...............................................2\n         1.13     Base Case Projections........................................2\n         1.14     BLA Filing Date..............................................2\n         1.15     BMS..........................................................2\n         1.16     BMS Dilution Event...........................................3\n         1.17     BMS Sell-Down................................................3\n         1.18     Breaching Party..............................................3\n         1.19     Clinical Budget..............................................3\n         1.20     Clinical Development Plan....................................3\n         1.21     Committee....................................................3\n         1.22     Common Stock.................................................3\n         1.23     Company......................................................3\n         1.24     Company SEC Documents........................................3\n         1.25     cGMP.........................................................3\n         1.26     Competing Product............................................3\n         1.27     Compound.....................................................3\n         1.28     Confidential Information.....................................3\n         1.29     Co-Promotion Option..........................................3\n         1.30     Co-Promotion Problem.........................................3\n         1.31     Cost of Goods Sold...........................................3\n         1.32     Critical Issue...............................................3\n         1.33     Current Forecast.............................................3\n         1.34     Development Costs............................................4\n         1.35     Distribution Costs...........................................4\n         1.36     Distribution Fee.............................................4\n         1.37     Effective Date...............................................4\n         1.38     Equity Agreements............................................4\n         1.39     ERS..........................................................4\n\n                                      -i-\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n         1.40     ERS Inventions...............................................4\n         1.41     ERS Obligations..............................................4\n         1.42     ERS Proposed Terms...........................................4\n         1.43     FDA..........................................................4\n         1.44     Field........................................................4\n         1.45     Finance Committee............................................4\n         1.46     Financial Appendix...........................................4\n         1.47      Finished Product............................................4\n         1.48     First Commercial Sale........................................4\n         1.49     First Offer Termination Date.................................4\n         1.50     Fully Burdened Manufacturing Cost............................4\n         1.51     GAAP.........................................................5\n         1.52     General and Administrative Costs.............................5\n         1.53     Gross Profit.................................................5\n         1.54     Inability to Supply..........................................5\n         1.55     IND..........................................................5\n         1.56     Indemnitee...................................................5\n         1.57     infringement.................................................5\n         1.58     Indicative Marketing Budget..................................5\n         1.59     Initial Regulatory Filing....................................5\n         1.60     Invention....................................................5\n         1.61     Joint Commercialization Committee or JCC.....................5\n         1.62     Joint Executive Committee or JEC.............................5\n         1.63     Joint Manufacturing Committee or JMC.........................5\n         1.64     Know-How.....................................................5\n         1.65     knowledge of the Company.....................................5\n         1.66     Letter of Intent.............................................6\n         1.67     Long-Term Inability to Supply................................6\n         1.68     Low Case Projections.........................................6\n         1.69     Manufacturing Standards......................................6\n         1.70     Marketing Budget.............................................6\n         1.71     Marketing Costs..............................................6\n         1.72     Marketing Plans..............................................6\n         1.73     Merck Agreement..............................................6\n         1.74     Merck Entities...............................................6\n         1.75     Net Sales....................................................6\n         1.76     Non-Acquiring Party..........................................6\n         1.77     Non-Breaching Party..........................................6\n         1.78     Non-Registrational Studies...................................6\n         1.79     North America................................................6\n         1.80     Number of Days to Make Payment...............................6\n         1.81     Offer........................................................6\n         1.82     Operating Profit or Loss.....................................6\n         1.83     Other Compound...............................................7\n         1.84     Other Operating Income\/Expense...............................7\n\n                                      ii\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n         1.85     Partnering Relationships.....................................7\n         1.86     Party........................................................7\n         1.87     Patents......................................................7\n         1.88     Person.......................................................7\n         1.89     Product......................................................7\n         1.90     Product Development Committee or PDC.........................7\n         1.91     Proposed Terms...............................................7\n         1.92     Q1, Q2, Q3 and Q4............................................7\n         1.93     Registration.................................................7\n         1.94     Registration Application.....................................7\n         1.95     Registrational Studies.......................................7\n         1.96     Regulatory Authority.........................................8\n         1.97     Restricted Period............................................8\n         1.98     Sales Costs..................................................8\n         1.99     Sales Force Guidelines.......................................8\n         1.100    Shares.......................................................8\n         1.101    Short-Term Inability to Supply...............................8\n         1.102    Specifications...............................................8\n         1.103    Stockholder Agreement........................................8\n         1.104    Subsidiary...................................................8\n         1.105    Summary Clinical Development Plan............................8\n         1.106    Technology...................................................8\n         1.107    Termination Date.............................................8\n         1.108    Territory....................................................8\n         1.109    Testing Methods..............................................8\n         1.110    Third Party..................................................8\n         1.111    Third Party Change of Control Transaction....................8\n         1.112    Third Party Manufacturer.....................................8\n         1.113    Trademarks...................................................9\n         1.114    United States or U.S.........................................9\n         1.115    Valid Claim..................................................9\n2.       MANAGEMENT............................................................9\n         2.1      Joint Executive Committee....................................9\n         2.2      Finance Committee...........................................11\n         2.3      Product Development Committee...............................12\n         2.4      Joint Commercialization Committee...........................13\n         2.5      Joint Manufacturing Committee...............................15\n         2.6      Minutes of Committee Meetings...............................16\n         2.7      Term........................................................17\n         2.8      Expenses....................................................17\n         2.9      Alliance Managers...........................................17\n3.       GRANT OF RIGHTS......................................................18\n         3.1      Rights Granted to ERS.......................................18\n         3.2      Restrictions on the Company.................................18\n         3.3      License to ERS Inventions...................................18\n\n                                      iii\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n\n         3.4      Trademarks; Logos...........................................18\n         3.5      Right of First Offer to ERS Regarding the Other Compound....19\n         3.6      Right of First Negotiation of ERS Regarding Partnering\n                     Transactions.............................................20\n         3.7      Negotiation of Services.....................................20\n         3.8      Restrictions on Competing Products..........................20\n         3.9      The Company's Right to Develop and Market Products..........21\n4.       DEVELOPMENT AND REGULATORY MATTERS...................................22\n         4.1      Exchange of Data and Know-How...............................22\n         4.2      Product Registrations.......................................22\n         4.3      Scope of Clinical Development Plans and Clinical Budget.....23\n         4.4      Transition of Clinical Studies..............................24\n         4.5      Conduct of Clinical Development Plans.......................25\n         4.6      Funding of Clinical Development Plans.......................26\n         4.7      IT Support..................................................26\n         4.8      Delay of Initial Regulatory Filing..........................27\n         4.9      Suspension of Clinical Development Activities...............27\n         4.10     Liability...................................................27\n5.       DISTRIBUTION AND PROMOTION...........................................28\n         5.1      Generally...................................................28\n         5.2      Scope of Marketing Budget...................................28\n         5.3      ERS Responsibilities; Rights................................28\n         5.4      Marketing Plans.............................................29\n         5.5      Promotional Materials and Activities........................29\n         5.6      The Company's Co-Promotion Right............................29\n         5.7      Distribution and Marketing Costs............................31\n6.       PAYMENTS.............................................................31\n         6.1      Upfront Payments to the Company.............................31\n         6.2      Milestone Payments to the Company...........................31\n         6.3      Distribution Fees for North America.........................32\n         6.4      Reduction in Distribution Fee for North America.............32\n         6.5      Distribution Fees for Japan.................................32\n         6.6      Allocation of Sales.........................................32\n7.       PAYMENTS AND REPORTS.................................................32\n         7.1      Payments....................................................32\n         7.2      Reports.....................................................33\n         7.3      Mode of Payment.............................................33\n         7.4      Records Retention...........................................33\n         7.5      Audit Request...............................................33\n         7.6      Cost of Audit...............................................34\n         7.7      No Non-Monetary Consideration for Sales.....................34\n         7.8      Taxes.......................................................34\n8.        MANUFACTURE AND SUPPLY..............................................35\n         8.1      Supply Obligations..........................................35\n         8.2      Supply of API; Processing of Finished Product...............35\n         8.3      Forecasts...................................................36\n\n                                       iv\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n         8.4      Orders for API..............................................36\n         8.5      Delivery....................................................36\n         8.6      Purchase Price..............................................37\n         8.7      Conformity; Specifications; Quality Control.................38\n         8.8      Acceptance\/Rejection; Interim Replacement...................38\n         8.9      Third Party Manufacturers...................................40\n         8.10     Inventory Management........................................41\n         8.11     Shortage of Supply..........................................41\n         8.12     Inability to Supply.........................................41\n9.       OWNERSHIP; PATENTS; TRADEMARKS.......................................43\n         9.1      Ownership...................................................43\n         9.2      Maintenance of the Patents..................................43\n         9.3      Patent Enforcement..........................................44\n         9.4      Infringement Action by Third Parties........................45\n10.      PUBLICATION; CONFIDENTIALITY.........................................47\n         10.1     Notification................................................47\n         10.2     Review......................................................47\n         10.3     Confidentiality; Exceptions.................................47\n         10.4     Exceptions to Obligation....................................47\n         10.5     Limitations on Use..........................................48\n         10.6     Remedies....................................................48\n11.      REPRESENTATIONS AND WARRANTIES.......................................48\n         11.1     Representations and Warranties of the Parties...............48\n         11.2     Representations and Warranties of the Company...............49\n         11.3     Representations and Warranties of ERS and BMS...............49\n         11.4     Representations and  Warranties of BMS......................50\n12.      RECALL; INDEMNIFICATION..............................................50\n         12.1     Investigation; Recall.......................................50\n         12.2     Indemnification by ERS and BMS..............................50\n         12.3     Indemnification by the Company..............................50\n         12.4     Notice of Indemnification...................................51\n         12.5     Complete Indemnification....................................51\n13.      TERM; TERMINATION....................................................51\n         13.1     Term........................................................51\n         13.2     Termination for Cause.......................................51\n         13.3     Termination by ERS..........................................52\n         13.4     Termination by the Company..................................52\n         13.5     Termination in Connection With Additional Studies...........52\n         13.5     Effect of Expiration or Termination.........................52\n         13.6     Accrued Rights; Surviving Obligations.......................53\n14.      FORCE MAJEURE........................................................53\n         14.1     Events of Force Majeure.....................................53\n15.      ADDITIONAL COVENANTS OF BMS AND BMS GUARANTEE........................53\n         15.1     Additional Covenants of BMS.................................53\n         15.2     BMS Guarantee...............................................54\n\n                                       v\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n16.      MISCELLANEOUS........................................................54\n         16.1     Relationship of Parties.....................................54\n         16.2     Assignment..................................................54\n         16.3     Books and Records...........................................54\n         16.4     Further Actions.............................................55\n         16.5     Notice......................................................55\n         16.6     Use of Name.................................................56\n         16.7     Public Announcements........................................56\n         16.8     Waiver......................................................56\n         16.9     Compliance with Law.........................................56\n         16.10    Severability................................................56\n         16.11    Amendment...................................................56\n         16.12    Governing Law...............................................56\n         16.13    Arbitration.................................................57\n         16.14    Entire Agreement............................................58\n         16.15    Parties in Interest.........................................58\n         16.16    Descriptive Headings........................................58\n         16.17    Counterparts................................................58\nExhibit 1.13      BASE CASE PROJECTIONS.......................................60\nExhibit 1.46      FINANCIAL APPENDIX..........................................61\nExhibit 1.68      LOW CASE PROJECTIONS........................................67\nExhibit 1.87      PATENTS.....................................................68\nExhibit 2.1       JOINT EXECUTIVE COMMITTEE AND ALLIANCE MANAGERS.............69\nExhibit 4.3(A)    CLINICAL BUDGET.............................................70\nExhibit 4.3(B)    SUMMARY CLINICAL DEVELOPMENT PLAN FOR 2001-2004.............71\nExhibit 5.2(A)    MARKETING BUDGET FOR 2001-2004..............................72\nExhibit 5.2(B)    INDICATIVE MARKETING BUDGET FOR 2005-2017...................73\nExhibit 8.12(B)(i)BASE CASE CLINICAL SUPPLY AMOUNT............................74\nExhibit 8.12(B)(ii)BASE CASE COMMERCIAL SUPPLY AMOUNT.........................75\n\n                                      vi\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n\n\n                            DEVELOPMENT, PROMOTION,\n                       DISTRIBUTION AND SUPPLY AGREEMENT\n\n         THIS DEVELOPMENT, PROMOTION, DISTRIBUTION AND SUPPLY AGREEMENT (this\n\"Agreement\"), dated as of September 19, 2001, is entered into by and among E.\nR. SQUIBB &amp; SONS, LLC, a limited liability company organized and existing under\nthe laws of the State of Delaware, having offices located at Route 206 &amp; Province Line Road, Princeton, New Jersey (\"ERS\"), BRISTOL-MYERS SQUIBB\nCOMPANY, a corporation organized and existing under the laws of the State of\nDelaware, having offices located at Route 206 &amp; Province Line Road, Princeton,\nNew Jersey (\"BMS\") and IMCLONE SYSTEMS INCORPORATED, a corporation organized\nunder the laws of the State of Delaware, having offices located at 180 Varick\nStreet, New York, New York 10014 (the \"Company\").\n\n\n                             PRELIMINARY STATEMENTS\n\n\n         A. The Company owns, and\/or has exclusive rights to, the Patents and\nKnow-How in existence as of the Effective Date relating to the Compound.\n\n         B. ERS and the Company desire to collaborate on the development and\ncommercialization of Products using the Compound for application in the Field.\n\n         C. ERS wishes to: (i) obtain the exclusive right to distribute, and\nthe co-exclusive right to develop and promote (together with the Company), the\nProducts in North America; (ii) obtain the co-exclusive right to develop,\ndistribute and promote (together with the Company and the Merck Entities), the\nProducts in Japan; and (iii) use the Company's registered trademarks for the\nProducts in the Territory in connection with the foregoing, and the Company\ndesires to grant such rights to ERS, on the terms and conditions set forth in\nthis Agreement.\n\n         D. ERS also wishes to purchase from the Company, and the Company\nwishes to supply to ERS, ERS's entire bulk requirements of API, on the terms\nand conditions set forth in this Agreement.\n\n         E. Simultaneously with the execution of this Agreement, the Company,\nBMS and Bristol-Myers Squibb Biologics Company, a Delaware corporation and\nwholly owned subsidiary of BMS (\"Acquisition Subsidiary\"), are entering into an\nAcquisition Agreement (the \"Acquisition Agreement\"), pursuant to which, among\nother things, BMS and Acquisition Subsidiary shall commence a tender offer to\nacquire approximately 19.9% of the Company's outstanding Common Stock.\n\n         F. Simultaneously with the execution of this Agreement, the Company,\nBMS and Acquisition Subsidiary are entering into a Stockholder Agreement (the\n\"Stockholder Agreement\", and together with the Acquisition Agreement, the\n\"Equity Agreements\"), pursuant to which, among other things, the Company, BMS\nand Acquisition Subsidiary have established certain governance arrangements\namong the Company, BMS and Acquisition Subsidiary.\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n         NOW, THEREFORE, in consideration of the foregoing preliminary\nstatements and the mutual agreements and covenants set forth herein, the\nParties hereby agree as follows:\n\n1.       DEFINITIONS.\n\n         As used in this Agreement, the following terms shall have the meanings\nset forth in this Section 1 unless context dictates otherwise:\n\n         1.1 \"Accelerated Arbitration Provisions\" shall have the meaning\nassigned to such term in Section 16.13(b).\n\n         1.2 \"Acquiring Party\" shall have the meaning assigned to such term in\nSection 3.8.\n\n         1.3 \"Acquisition Agreement\" shall have the meaning assigned to such\nterm in the preliminary statements.\n\n         1.4 \"Acquisition Subsidiary\" shall have the meaning assigned to such\nterm in the preliminary statements.\n\n1.5 \"Affiliate\" of any Person means any other Person directly or indirectly\ncontrolling, controlled by or under common control with such Person; provided\nthat for purposes of this Agreement, neither the Company nor any of its\nSubsidiaries shall be deemed an Affiliate of ERS or BMS. For the purposes of\nthis definition, \"control\" when used with respect to any Person, means the\npossession, directly or indirectly, of the power to direct or cause the\ndirection of the management and policies of such Person, whether through the\nownership of voting securities, by contract or otherwise; and the terms\n\"controlling\" and \"controlled\" have meanings correlative to the foregoing.\n\n         1.6 \"Alliance Manager\" shall have the meaning assigned to such term in\nSection 2.9.\n\n         1.7 \"Allocable Overhead\" shall have the meaning assigned to such term\nin the Financial Appendix.\n\n         1.8 \"Allowable Failure Rate\" shall have the meaning assigned to such\nterm in Section 8.8(c).\n\n         1.9 \"Antitrust Injunction\" shall have the meaning assigned to such\nterm in the Acquisition Agreement.\n\n         1.10 \"API\" shall mean any Compound, in bulk form, for use as an active\ningredient in the manufacture of Finished Products.\n\n         1.11 \"Audited Party\" shall have the meaning assigned to such term in\nSection 7.5.\n\n         1.12 \"Auditing Party\" shall have the meaning assigned to such term in\nSection 7.5.\n\n         1.13 \"Base Case Projections\" shall mean those base case financial\nprojections for the Products for each of calendar years 2005 through 2017\nattached to this Agreement as Exhibit 1.13.\n\n         1.14 \"BLA Filing Date\" shall have the meaning assigned to such term in\nSection 4.1.\n\n         1.15 \"BMS\" shall have the meaning assigned to such term in the\nintroductory paragraph.\n\n                                       2\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n         1.16 \"BMS Dilution Event\" shall have the meaning assigned to such term\nin the Stockholder Agreement.\n\n         1.17 \"BMS Sell-Down\" shall have the meaning assigned to such term in\nthe Stockholder Agreement.\n\n         1.18 \"Breaching Party\" shall have the meaning assigned to such term in\nSection 13.2(a).\n\n         1.19 \"Clinical Budget\" shall have the meaning assigned to such term in\nSection 4.3(a).\n\n         1.20 \"Clinical Development Plan\" shall mean the definitive clinical\ndevelopment plan approved by the PDC pursuant to Section 4.3(b), and each\nsubsequent definitive clinical development plan approved by the PDC pursuant to\nSection 4.3(e).\n\n         1.21 \"Committee\" shall mean any of the JEC, the PDC, the JCC, the JMC\nand the Finance Committee and, when used in the plural, shall mean all of them\nor more than one of them, as the case may be.\n\n         1.22 \"Common Stock\" shall mean the common stock, $.001 par value, of\nthe Company.\n\n         1.23 \"Company\" shall have the meaning assigned to such term in the\nintroductory paragraph.\n\n         1.24 \"Company SEC Documents\" shall have the meaning assigned to such\nterm in the Acquisition Agreement.\n\n         1.25 \"cGMP\" shall mean current Good Manufacturing Practice as defined\nin Parts 210 and 211 of Title 21 of the U.S. Code of Federal Regulations, as\nmay be amended from time to time, or any successor thereto.\n\n         1.26 \"Competing Product\" shall mean a product which has as its only\nmechanism of action an antagonism of the EGF receptor.\n\n         1.27 \"Compound\" shall mean the compound known as IMC-C225, including\nwithout limitation all fully humanized or human version thereof, and all\nanalogs, derivatives and\/or improvements of any of the foregoing.\n\n         1.28 \"Confidential Information\" shall have the meaning assigned to\nsuch term in Section 10.3.\n\n         1.29 \"Co-Promotion Option\" shall have the meaning assigned to such\nterm in Section 5.6.\n\n         1.30 \"Co-Promotion Problem\" shall have the meaning assigned to such\nterm in Section 5.6(e).\n\n         1.31 \"Cost of Goods Sold\" shall have the meaning assigned to such term\nin the Financial Appendix.\n\n         1.32 \"Critical Issue\" shall mean any matter that is subject to the\ndecision-making authority of any Committee that is material and would cause a\nsignificant delay or inability to be responsive which would have a material\nadverse consequence to the clinical development, distribution, promotion or\nsale of the Products.\n\n         1.33 \"Current Forecast\" shall have the meaning assigned to such term\nin Section 8.4.\n\n                                       3\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n         1.34 \"Development Costs\" shall have the meaning assigned to such term\nin the Financial Appendix.\n\n         1.35 \"Distribution Costs\" shall have the meaning assigned to such term\nin the Financial Appendix.\n\n         1.36 \"Distribution Fee\" shall mean the fees to be paid by ERS to the\nCompany pursuant to Sections 6.3 and 6.5 in consideration for the rights\ngranted to ERS by the Company with respect to North America and Japan,\nrespectively.\n\n         1.37 \"Effective Date\" shall mean the date set forth in the\nintroductory paragraph of the Agreement.\n\n         1.38 \"Equity Agreements\" shall have the meaning assigned to such term\nin the preliminary statements.\n\n         1.39 \"ERS\" shall have the meaning assigned to such term in the\nintroductory paragraph.\n\n         1.40 \"ERS Inventions\" shall have the meaning assigned to such term in\nSection 9.1.\n\n         1.41 \"ERS Obligations\" shall have the meaning assigned to such term in\nSection 15.2.\n\n         1.42 \"ERS Proposed Terms\" shall have the meaning assigned to such term\nin Section 3.5(c).\n\n         1.43 \"FDA\" shall mean the United States Food and Drug Administration,\nor any successor thereto.\n\n         1.44 \"Field\" shall mean all pharmaceutical applications for human\nhealth.\n\n         1.45 \"Finance Committee\" shall have the meaning assigned to such term\nin Section 2.1(b)(vii).\n\n         1.46 \"Financial Appendix\" shall mean Exhibit 1.46 attached to this\nAgreement.\n\n         1.47 \"Finished Product\" shall mean any formulation or dosage of\nProduct in finished form, including, without limitation, any product labeling\nor other package inserts or materials required by the applicable Regulatory\nAuthority(ies) and, when used in the plural, shall mean all formulations and\ndosages of Product in finished form, including, without limitation, all product\nlabeling and other package inserts and materials required by the applicable\nRegulatory Authority(ies).\n\n         1.48 \"First Commercial Sale\" shall mean the first sale of a Product to\na Third Party by ERS or its Affiliates in any country in the Territory after\nall Registrations required to permit such sale have been granted, or such sale\nis otherwise permitted, by the Regulatory Authority in such country.\n\n         1.49 \"First Offer Termination Date\" shall mean the earlier to occur of\n(i) the date which is the fifth anniversary of the Effective Date, and (ii) the\ndate which is the first anniversary of a BMS Dilution Event.\n\n         1.50 \"Fully Burdened Manufacturing Cost\" shall have the meaning\nassigned to such term in the Financial Appendix.\n\n                                       4\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n         1.51 \"GAAP\" shall mean generally accepted accounting principles in the\nUnited States, consistently applied by the Party at issue.\n\n         1.52 \"General and Administrative Costs\" shall have the meaning\nassigned to such term in the Financial Appendix.\n\n         1.53 \"Gross Profit\" shall have the meaning assigned to such term in\nthe Financial Appendix.\n\n         1.54 \"Inability to Supply\" shall have the meaning assigned to such\nterm in Section 8.12(b).\n\n         1.55 \"IND\" shall mean any filing made with the Regulatory Authority in\nany country in the Territory for initiating clinical trials in such country,\nwith respect to a Product.\n\n         1.56 \"Indemnitee\" shall have the meaning assigned to such term in\nSection 12.4.\n\n         1.57 \"infringement\" shall have the meaning assigned to such term in\nSection 9.3(a).\n\n         1.58 \"Indicative Marketing Budget\" shall mean the indicative marketing\nbudget attached as Exhibit 5.2(B).\n\n         1.59 \"Initial Regulatory Filing\" shall mean the completed and\nsubmitted initial Registration Application for the initial Product with the\nFDA.\n\n         1.60 \"Invention\" shall mean any new or useful process, manufacture,\ncompound, composition of matter, improvements, discoveries, claims, formulae,\nprocesses, trade secrets, technologies and know-how (including confidential\ndata and Confidential Information), to the extent relating to, derived from and\nuseful for the manufacture, use or sale of a Compound or a Product (including,\nwithout limitation, the formulation, delivery or use thereof in the Field),\nincluding, without limitation, synthesis, preparation, recovery and\npurification processes and techniques, control methods and assays, chemical\ndata, toxicological and pharmacological data and techniques, clinical data,\nmedical uses, product forms and product formulations and specifications,\nwhether patentable or unpatentable, that (except for purposes of the\ndefinitions of Know-How and Patents set forth herein in Sections 1.64 and 1.87,\nrespectively) is conceived or first reduced to practice or demonstrated to have\nutility during the term of this Agreement.\n\n         1.61 \"Joint Commercialization Committee\" or \"JCC\" shall have the\nmeaning assigned to such term in Section 2.4(a).\n\n         1.62 \"Joint Executive Committee\" or \"JEC\" shall have the meaning\nassigned to such term in Section 2.1(a).\n\n         1.63 \"Joint Manufacturing Committee\" or \"JMC\" shall have the meaning\nassigned to such term in Section 2.5(a).\n\n         1.64 \"Know-How\" shall mean any and all unpatented Inventions that are\ngenerated, owned or controlled by the Company at any time before or during the\nterm of this Agreement to the extent relating to, derived from and useful for\nthe manufacture of Finished Products from API, manufacture of API, or the use\nor sale of the Compounds or the Products in the Field in any country in the\nTerritory.\n\n         1.65 \"knowledge of the Company\" shall mean the knowledge, after\nreasonable inquiry, of Samuel Waksal, Ph.D., Harlan Waksal, M.D., Daniel Lynch\nor John Landes.\n\n                                       5\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n\n         1.66 \"Letter of Intent\" shall have the meaning assigned to such term\nin Section 3.5(b).\n\n         1.67 \"Long-Term Inability to Supply\" shall have the meaning assigned\nto such term in Section 8.12(d).\n\n         1.68 \"Low Case Projections\" shall mean those low case financial\nprojections for the Products for each of calendar years 2005 through 2017\nattached to this Agreement as Exhibit 1.68.\n\n         1.69 \"Manufacturing Standards\" shall mean, with respect to the API or\nany Finished Product, cGMP and such additional manufacturing specifications or\nstandards as may be established by mutual agreement of the Company and ERS from\ntime to time.\n\n         1.70 \"Marketing Budget\" shall mean the definitive marketing budget\nattached as Exhibit 5.2(A) and each subsequent marketing budget approved by the\nJCC in accordance with Section 5.2(c).\n\n         1.71 \"Marketing Costs\" shall have the meaning assigned to such term in\nthe Financial Appendix.\n\n         1.72 \"Marketing Plans\" shall have the meaning assigned to such term in\nSection 5.4.\n\n         1.73 \"Merck Agreement\" shall mean that certain Development and License\nAgreement entered into by the Company and Merck KGaA on December 14, 1998, as\namended and modified as of the date of this Agreement.\n\n         1.74 \"Merck Entities\" shall mean Merck KGaA and its permitted\naffiliates, successors and assigns under the Merck Agreement.\n\n         1.75 \"Net Sales\" shall have the meaning assigned to such term in the\nFinancial Appendix.\n\n         1.76 \"Non-Acquiring Party\" shall have the meaning assigned to such\nterm in Section 3.8(b).\n\n         1.77 \"Non-Breaching Party\" shall have the meaning assigned to such\nterm in Section 13.2(b).\n\n         1.78 \"Non-Registrational Studies\" shall have the meaning assigned to\nsuch term in Section 4.3(b).\n\n         1.79 \"North America\" shall mean Canada and the United States.\n\n         1.80 \"Number of Days to Make Payment\" shall mean (i) until the end of\ncalendar year 2002, [**] days, (ii) during calendar year 2003, [**] days [**],\nas determined by the JCC prior to the end of calendar year 2002 making use of\nthe previous 12 months data available as of October 31, 2002 and (iii)\nbeginning with calendar year 2004 and thereafter, [**] days [**], as determined\nby the JCC prior to the end of each preceding calendar year making use of 12\nmonths data available as of the end of the month of October of such preceding\ncalendar year.\n\n         1.81 \"Offer\" shall have the meaning assigned to such term in the\nAcquisition Agreement.\n\n         1.82 \"Operating Profit or Loss\" shall have the meaning assigned to\nsuch term in the Financial Appendix.\n\n                                       6\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n         1.83 \"Other Compound\" shall mean that compound known as 2C6 anti-VEGF\nreceptor monoclonal antibody (or any human, humanized or chimeric version\nthereof, or any substitute therefor).\n\n         1.84 \"Other Operating Income\/Expense\" shall have the meaning assigned\nto such term in the Financial Appendix.\n\n         1.85 \"Partnering Relationships\" shall have the meaning assigned to\nsuch term in Section 3.6.\n\n         1.86 \"Party\" shall mean the Company, ERS, or BMS, as the case may be,\nand, when used in the plural, shall mean the Company, ERS, and BMS.\n\n         1.87 \"Patents\" shall mean the patents and patent applications set\nforth on Exhibit 1.87, together with any patents that may issue therefrom in\nany country in the Territory, and any other patents or patent applications in\nany country in the Territory owned by or exclusively licensed to the Company\nduring the term of this Agreement that cover any Inventions to the extent\nrelating to, derived from and useful for the manufacture, use or sale of the\nCompounds or the Products in the Field in any country in the Territory,\nincluding any and all extensions, renewals, continuations,\ncontinuations-in-part, divisions, patents-of-additions, reissues, supplementary\nprotection certificates or foreign counterparts of any of the foregoing.\n\n         1.88 \"Person\" shall mean an mean an individual or a corporation,\npartnership, association, trust, or any other entity or organization, including\na government or political subdivision or an agency or instrumentality thereof.\n\n         1.89 \"Product\" shall mean any prescription pharmaceutical product\ncomprising a Compound, including any strength and packaging configuration of\nthe final finished dosage form presentation, and any line extension thereof\nand, when used in the plural, shall mean all prescription pharmaceutical\nproducts comprising Compounds, including all strengths and packaging\nconfigurations of the final finished dosage form presentations, and any line\nextensions thereof.\n\n         1.90 \"Product Development Committee\" or \"PDC\" shall have the meaning\nassigned to such term in Section 2.3(a).\n\n         1.91 \"Proposed Terms\" shall have the meaning assigned to such term in\nSection 3.5(b).\n\n         1.92 \"Q1,\" \"Q2,\" \"Q3,\" and \"Q4\" shall have the meaning assigned to\nsuch term in Section 8.3.\n\n         1.93 \"Registration\" shall mean, with respect to each country in the\nTerritory, approval of the Registration Application for any Product filed in\nsuch country, including, where applicable outside of the United States, pricing\nor reimbursement approval by the Regulatory Authority in such country.\n\n         1.94 \"Registration Application\" shall mean a Biologics License\nApplication under the United States Federal Food, Drug and Cosmetics Act and\nthe regulations promulgated thereunder, or a comparable filing for Registration\nin a country, in each case with respect to a Product for application in the\nField in the Territory.\n\n         1.95 \"Registrational Studies\" shall have the meaning assigned to such\nterm in Section 4.3(b).\n\n                                       7\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n         1.96 \"Regulatory Authority\" shall mean the FDA in the U.S., and any\nhealth regulatory authority(ies) in any country in the Territory that is a\ncounterpart to the FDA and holds responsibility for granting regulatory\nmarketing approval for a Product in such country, and any successor(s) thereto.\n\n         1.97 \"Restricted Period\" shall have the meaning assigned to such term\nin the Stockholder Agreement.\n\n         1.98 \"Sales Costs\" shall have the meaning assigned to such term in the\nFinancial Appendix.\n\n         1.99 \"Sales Force Guidelines\" shall have the meaning assigned to such\nterm in Section 5.6(d).\n\n         1.100 \"Shares\" shall mean shares of Common Stock.\n\n         1.101 \"Short-Term Inability to Supply\" shall have the meaning assigned\nto such term in Section 8.12(c).\n\n         1.102 \"Specifications\" shall mean, with respect to API, the\nspecifications for such API as agreed upon by the Company and ERS, in\nconsideration of the regulatory requirements in each country in the Territory,\nas may be amended from time to time.\n\n         1.103 \"Stockholder Agreement\" shall have the meaning assigned to such\nterm in the preliminary statements.\n\n         1.104 \"Subsidiary\" means, with respect to any Person, any corporation\nor other entity of which a majority of the capital stock or other ownership\ninterests having ordinary voting power to elect a majority of the board of\ndirectors or other persons performing similar functions are at the time\ndirectly or indirectly owned by such Person.\n\n         1.105 \"Summary Clinical Development Plan\" shall mean the summary\nclinical development plan attached as Exhibit 4.3(B), and each subsequent\nsummary clinical development plan approved by the PDC pursuant to Section\n4.3(d).\n\n         1.106 \"Technology\" shall mean the Valid Claims and Know-How,\ncollectively.\n\n         1.107 \"Termination Date\" shall have the meaning assigned to such term\nin the Acquisition Agreement.\n\n         1.108 \"Territory\" shall mean the United States, Canada and Japan.\n\n         1.109 \"Testing Methods\" shall have the meaning assigned to such term\nin Section 8.7(c).\n\n         1.110 \"Third Party\" shall mean any Person who or which is neither a\nParty nor an Affiliate of a Party.\n\n         1.111 \"Third Party Change of Control Transaction\" shall have the\nmeaning assigned to such term in the Stockholder Agreement.\n\n         1.112 \"Third Party Manufacturer\" shall mean Third Parties who have\nbeen engaged by the Company to perform services or supply facilities or goods\n(including, without limitation, the API and\/or Finished Product) in connection\nwith the manufacture, testing and\/or packaging of the API and\/or Finished\nProduct by the Company.\n\n                                       8\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n         1.113 \"Trademarks\" shall mean the trademarks registered to the Company\nfor the marketing of the Products in any country in the Territory, and the\ntrademarks selected by the JCC for use in the marketing of the Products in any\ncountry in the Territory.\n\n         1.114 \"United States\" or \"U.S.\" shall mean the United States of\nAmerica, including its possessions and territories.\n\n         1.115 \"Valid Claim\" shall mean any claim of any Patents issued or\npending in a country in the Territory relating to, derived from or useful for\nthe use and sale of the Compounds or the Products in the Field, which claim has\nnot been held invalid or unenforceable by decision of a court or other\ngovernmental agency of competent jurisdiction, unappealable or unappealed\nwithin the time allowed for appeal, and which is not admitted to be invalid\nthrough disclaimer or otherwise not admitted by the Company to be invalid.\n\n2.       MANAGEMENT.\n\n         2.1 Joint Executive Committee.\n\n              (a) Members; Officers. Immediately after the Effective Date, the\nParties shall establish a joint executive committee (the \"Joint Executive\nCommittee\" or \"JEC\"), which shall consist of six members, three members from\neach of the Company and BMS. The initial members of the JEC are set forth on\nExhibit 2.1. Each of the Company and BMS may replace any or all of its\nrepresentatives on the JEC at any time upon written notice to the other in\naccordance with Section 16.5 of this Agreement. Such representatives shall at\nall times include each such Party's [**] and most senior pharmaceutical\nbusiness officer and one other senior officer of each such Party. Any member of\nthe JEC may designate a substitute to temporarily attend and perform the\nfunctions of that member at any meeting of the JEC. The Company and BMS each\nmay, in its discretion, invite non-member representatives of such Party to\nattend meetings of the JEC. The JEC shall be co-chaired by a representative of\neach of the Company and BMS. The co-chairpersons shall appoint a secretary of\nthe JEC, and such secretary shall serve for such term as designated by the\nco-chairpersons. The initial co-chairpersons and the initial secretary are\ndesignated on Exhibit 2.1.\n\n              (b) Responsibilities. The JEC shall perform the following\nfunctions:\n\n                   (i) manage and oversee the development and commercialization\nof the Compounds and Products pursuant to the terms of this Agreement;\n\n                   (ii) review and approve the annual budgets and multi-year\nexpense forecasts formulated by the PDC;\n\n                   (iii) at each meeting of the JEC, review a comparison of\nactual expenses to the budgeted expenses for the year-to-date, as current as\npracticable to a date immediately prior to the date of the meeting;\n\n                   (iv) review and evaluate the progress of the other\nCommittees;\n\n                   (v) review and approve \"go\/no-go\" decisions and other\nmatters referred to the JEC by any other Committee;\n\n                                       9\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n                   (vi) review and, if determined to be necessary, reallocate\nspending between the Clinical Budget and the relevant Marketing Budget;\n\n                   (vii) establish and empower a finance committee, which shall\nconsist of an equal number of representatives from each of the Company and BMS\n(the \"Finance Committee\") to advise the JEC and make recommendations to the\nJEC, for the areas it has responsibility as provided in Section 2.2, for which\nthe JEC has decision making authority;\n\n                   (viii) at least once each year, meet with each of the other\nCommittees (which meetings do not need to include all of the other Committees\nat the same meeting);\n\n                   (ix) in accordance with the procedures established in\nSection 2.1(d), resolve disputes, disagreements and deadlocks unresolved by the\nother Committees;\n\n                   (x) determine, in response to the PDC's findings regarding a\nmaterial delay of an Initial Regulatory Filing, whether or not it is in the\nbest interest of the Parties to go forward with the conduct of any additional\nclinical studies required by the FDA; and\n\n                   (xi) have such other responsibilities as may be assigned to\nthe JEC pursuant to this Agreement or as may be mutually agreed upon by the\nParties from time to time.\n\n              (c) Meetings. The JEC shall meet in person at least three times\nduring every calendar year, and more frequently as the Company and BMS deem\nappropriate or as required to resolve disputes, disagreements or deadlocks in\nthe other Committees, on such dates, and at such places and times, as such\nParties shall agree. Meetings of the JEC that are held in person shall\nalternate between the offices of the Company and BMS, or such other place as\nsuch Parties may agree. The members of the JEC also may convene or be polled or\nconsulted from time to time by means of telecommunications, video conferences,\nelectronic mail or correspondence, as deemed necessary or appropriate.\n\n              (d) Decision-making.\n\n                   (i) The JEC may make decisions with respect to any subject\nmatter that is subject to the JEC's decision-making authority and functions as\nset forth in Section 2.1(b). Except as specified in Section 2.1(d)(ii), (iii)\nor (iv), all decisions of the JEC shall be made by unanimous vote or written\nconsent, with the Company and BMS each having, collectively, one vote in all\ndecisions. The JEC shall use reasonable best efforts to resolve the matters\nwithin its roles and functions or otherwise referred to it.\n\n                   (ii) With respect to any Critical Issue, if the JEC cannot\nreach consensus within five business days after the matter has been brought to\nthe JEC's attention, the matter shall be referred on the sixth business day:\n(A) if the matter is the subject of a deadlock arising in the PDC and is not\nthe subject of Section 4.8 or 4.9, to the co-chairperson of the JEC designated\nby the Company for resolution, provided that any decision made by the\nco-chairperson of the JEC designated by the Company may not increase the\nClinical Budget for any one year by more than [**]; (B) if the matter is the\nsubject of a deadlock arising in the JCC (other than a matter under Section\n2.4(b)(xiv) with respect to Trademarks), to the co-chairperson of the JEC\ndesignated by BMS for resolution, provided that any decision made by the\nco-chairperson of the JEC designated by BMS may only increase or decrease the\noverall amount of the relevant Marketing Budget within the ranges provided in\n\n                                      10\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \nand otherwise in accordance with Section 5.2; (C) if the matter is under\nSection 2.4(b)(xiv) with respect to Trademarks and is the subject of a deadlock\narising in the JCC, to the co-chairperson of the JEC designated by the Company\nfor resolution; and (D) except as provided in Section 8.12(f), if the matter is\nthe subject of a deadlock arising in the JMC, to the co-chairperson of the JEC\ndesignated by the Company for resolution. In the event that the co-chairperson\ndesignated to resolve a dispute under this Section 2.1(d)(ii) is not\nimmediately available, then such matter shall be referred to the senior\nexecutive officer of such Party in the area to which the matter relates and who\nhas been designated by such Party for such resolution.\n\n                   (iii) With respect to all other matters that are subject to\nthe JEC's decision-making authority, if the JEC cannot reach consensus within\n20 business days after it has met and attempted to reach such consensus, the\nmatter shall be referred on the twenty-first business day: (A) if the matter is\nthe subject of a deadlock arising in the PDC and is not the subject of Section\n4.8 or 4.9, to the co-chairperson of the JEC designated by the Company for\nresolution, provided that any decision made by the co-chairperson of the\nCompany may not increase the Clinical Budget for any one year by more than\n[**]; (B) if the matter is the subject of a deadlock arising in the JCC (other\nthan a matter under Section 2.4(b)(xiv) with respect to Trademarks), to the\nco-chairperson of the JEC designated by BMS for resolution, provided that any\ndecision made by the co-chairperson of BMS may not increase or decrease the\noverall amount of the relevant Marketing Budget within the ranges provided in\nand otherwise in accordance with Section 5.2; (C) if the matter is under\nSection 2.4(b)(xiv) with respect to Trademarks and is the subject of a deadlock\narising in the JCC, to the co-chairperson of the JEC designated by the Company\nfor resolution; and (D) except as provided in Section 8.12(f), if the matter is\nthe subject of a deadlock arising in the JMC, to the co-chairperson of the JEC\ndesignated by the Company for resolution.\n\n                   (iv) In the event of a deadlock of the JEC with respect to a\nCritical Issue that is not resolved pursuant to clause (ii) and the matters\nunderlying such deadlock fall into the class of disputes that may be arbitrated\nby the Parties in accordance with Section 16.13, then such matters shall be\nresolved pursuant to the Accelerated Arbitration Provisions of Section\n16.13(b). In the event of a deadlock of the JEC with respect to any other\nmatters that are not resolved pursuant to clause (iii) and such matters fall\ninto the class of disputes that may be arbitrated by the Parties in accordance\nwith Section 16.13, then such matters shall be resolved pursuant to Section\n16.13(a).\n\n                   (v) For all purposes under this Agreement, any decision made\npursuant to this Section 2.1(d) shall be deemed to be the decision of the JEC.\n\n2.2      Finance Committee.  The Finance Committee shall perform the following \n         functions:\n\n              (a) clarify questions and ambiguities arising from the use or\napplication, as appropriate, in the relevant Territory of the accounting terms\nused in this Agreement, including without limitation, Fully Burdened\nManufacturing Costs, Net Sales, Cost of Goods Sold, Development Costs,\nDistribution Costs, Marketing Costs, Sales Costs, General and Administrative\nExpense, Other Operating Income\/Expense, Gross Profit and Operating Profit or\nLoss;\n\n              (b) set up systems necessary to capture such costs and profits or\nlosses (including, without limitation, developing the methodology to be used to\ndetermine Other Operating Income\/Expense in accordance with the Financial\nAppendix);\n\n              (c) establish parameters and mechanisms for management and\nfinancial reporting;\n\n                                      11\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n              (d) assist in reviewing manufacturing and marketing options;\n\n              (e) assist in developing and overseeing allocation of the\nClinical Budget and the Marketing Budgets for each of the Clinical Development\nPlans and Marketing Plans, respectively, and reviewing the actual expenditure\nof such allocated funds to ensure consistency with such Clinical Development\nPlans and Marketing Plans;\n\n              (f) have such other responsibilities as may be assigned by the\nJEC to the Finance Committee pursuant to this Agreement or as may be mutually\nagreed upon by the Parties from time to time.\n\n2.3      Product Development Committee.\n\n              (a) Members; Officers. Immediately after the Effective Date, the\nParties shall establish a product development committee (the \"Product\nDevelopment Committee\" or \"PDC\"), which shall consist of an equal number of\nrepresentatives from each of the Company and BMS, up to a maximum total of\neight members on such Committee. Each of the Company and BMS may replace any or\nall of its representatives on the PDC at any time upon written notice to the\nother in accordance with Section 16.5 of this Agreement. Such representatives\nshall include individuals within the senior management of each such Party, and\nthose representatives of each such Party shall, individually or collectively,\nhave expertise in pharmaceutical drug development and\/or marketing. Any member\nof the PDC may designate a substitute to temporarily attend and perform the\nfunctions of that member at any meeting of the PDC. The Company and BMS each\nmay, in its discretion, invite non-member representatives of such Party to\nattend meetings of the PDC. The PDC shall be chaired by a representative of the\nCompany. The secretary of the PDC shall be a representative of BMS.\n\n              (b) Responsibilities. The PDC shall perform the following\nfunctions:\n\n                   (i) manage and oversee the implementation of the Clinical\nDevelopment Plans, except the Non-Registrational Studies; \n\n                   (ii) review and approve each subsequent summary clinical\ndevelopment plan in accordance with Section 4.3(d); \n\n                   (iii) review and approve each subsequent clinical\ndevelopment plan in accordance with Section 4.3(e);\n\n                   (iv) review and approve any amendments or modifications of\nthe Clinical Development Plans or the Clinical Budget; \n\n                   (v) at each meeting of the PDC, review a comparison of\nactual clinical development and regulatory expenses to the budgeted expenses in\nthe Clinical Budget for the year-to-date, as current as practicable to a date\nimmediately prior to the date of the meeting;\n\n                   (vi) review and evaluate progress of the Registrational\nStudies; provided that the PDC shall not have authority to make any\ndetermination that any Party is in breach of this Agreement;\n\n                                      12\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n                   (vii) review and approve all compassionate use of Products;\n\n                   (viii) review and approve the joint publication strategy\ntogether with the JCC;\n\n                   (ix) review and approve \"go\/no-go\" decisions; and\n\n                   (x) have such other responsibilities as may be assigned to\nthe PDC pursuant to this Agreement or as may be mutually agreed upon by the\nParties from time to time.\n\n              (c) Meetings. The PDC shall meet in person at least once during\nevery calendar quarter, and more frequently as the Company and BMS deem\nappropriate or as reasonably requested by either such Party, on such dates, and\nat such places and times, as such Parties shall agree. Meetings of the PDC that\nare held in person shall alternate between the offices of the Company and BMS,\nor such other place as such Parties may agree. The members of the PDC also may\nconvene or be polled or consulted from time to time by means of\ntelecommunications, video conferences, electronic mail or correspondence, as\ndeemed necessary or appropriate.\n\n              (d) Decision-making. The PDC may make decisions with respect to\nany subject matter that is subject to the PDC's decision-making authority and\nfunctions as set forth in Section 2.3(b). All decisions of the PDC shall be\nmade by unanimous vote or written consent, with the Company and BMS each\nhaving, collectively, one vote in all decisions. If, with respect to a Critical\nIssue that is subject to the PDC's decision-making authority, the PDC cannot\nreach consensus within five business days after it has first met and attempted\nto reach such consensus, the matter shall be referred on the sixth business day\nto the Joint Executive Committee for resolution. If, with respect to any other\nmatter that is subject to the PDC's decision-making authority, the PDC cannot\nreach consensus within 20 days after it has first met and attempted to reach\nsuch consensus, the matter shall be referred on the twenty-first day to the\nJoint Executive Committee for resolution. For all purposes under this\nAgreement, any decision made pursuant to this Section 2.3(d) shall be deemed to\nbe the decision of the PDC.\n\n         2.4 Joint Commercialization Committee.\n\n              (a) Members; Officers. Immediately after the Effective Date, the\nParties shall establish a joint commercialization committee (the \"Joint\nCommercialization Committee\" or \"JCC\"), which shall consist of an equal number\nof representatives from each of the Company and BMS, up to a maximum total of\neight members on such Committee. Each of the Company and BMS may replace any or\nall of its representatives on the JCC at any time upon written notice to the\nother in accordance with Section 16.5 of this Agreement. Such representatives\nshall include individuals within the senior management of each such Party, and\nthose representatives of each such Party shall, individually or collectively,\nhave clinical experience and expertise in marketing and sales. Any member of\nthe JCC may designate a substitute to temporarily attend and perform the\nfunctions of that member at any meeting of the JCC. The Company and BMS each\nmay, in its discretion, invite non-member representatives of such Party to\nattend meetings of the JCC. The JCC shall be chaired by a representative of\nBMS. The secretary of the JCC shall be a representative of the Company.\n\n              (b) Responsibilities. The JCC shall perform the following\nfunctions:\n\n                   (i) oversee the preparation and implementation of the\nMarketing Plans;\n\n                                      13\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n                   (ii) oversee and coordinate the sales efforts of ERS and the\nCompany;\n\n                   (iii) review and approve Marketing Plans;\n\n                   (iv) discuss the state of the markets for Products in the\nTerritory and opportunities and issues concerning the commercialization of the\nProducts, including consideration of marketing and promotional strategy,\nmarketing research plans, labeling, Product positioning and Product profile\nissues, to determine in which countries in the Territory to launch Products,\nthe priority for same and the amount and kind of marketing and selling effort\nappropriate, in accordance with the Marketing Plans;\n\n                   (v) review and approve Non-Registrational Studies, taking\ninto consideration the appropriateness in the context of the overall marketing\nand promotional strategy for the Products;\n\n                   (vi) review and approve all pricing decisions and managed\ncare contracting strategies, in accordance with the Marketing Plans;\n\n                   (vii) review and approve all indigent care use of Products;\n\n                   (viii) periodically review sales mix of Products sold by ERS\nthrough various customer channels;\n\n                   (ix) review and approve allocations within the Marketing\nBudgets, from time to time;\n\n                   (x) review and approve each subsequent marketing budget in\naccordance with Section 5.2(c);\n\n                   (xi) review data and reports arising from and generated in\nconnection with the commercialization of the Products, including, but not\nlimited to the Marketing Plans, Marketing Budgets and sales forecasts;\n\n                   (xii) at each meeting of the JCC, review a comparison of\nactual sales and marketing expenses to the budgeted expenses in the relevant\nMarketing Budget for the year-to-date, as current as practicable to a date\nimmediately prior to the date of the meeting;\n\n                   (xiii) review and approve the general guidelines applicable\nto particular Products to be followed by ERS in its development of promotional\nmaterials and promotional activities to be used by ERS and the Company in the\npromotion of such Products (such guidelines to be consistent with the then\ncurrent Marketing Plan applicable to such Products);\n\n                   (xiv) consider and select Trademarks to be used for the\nmarketing and sale of the Products in each country in the Territory;\n\n                   (xv) review and approve the joint publication strategy\ntogether with the PDC;\n\n                                      14\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n                   (xvi) evaluate and determine the existence or non-existence\nof a Co-Promotion Problem referred to the JCC in accordance with Section\n5.6(e); and\n\n                   (xvii) have such other responsibilities as may be assigned\nto the JCC pursuant to this Agreement or as may be mutually agreed upon by the\nParties from time to time.\n\n              (c) Meetings. The JCC shall meet in person at least once during\nevery calendar quarter, and more frequently as the Company and BMS deem\nappropriate or as reasonably requested by either such Party, on such dates, and\nat such places and times, as such Parties shall agree. Meetings of the JCC that\nare held in person shall alternate between the offices of the Company and BMS,\nor such other place as such Parties may agree. The members of the JCC also may\nconvene or be polled or consulted from time to time by means of\ntelecommunications, video conferences, electronic mail or correspondence, as\ndeemed necessary or appropriate.\n\n              (d) Decision-making. The JCC may make decisions with respect to\nany subject matter that is subject to the JCC's decision-making authority and\nfunctions as set forth in Section 2.4(b). All decisions of the JCC shall be\nmade by unanimous vote or written consent, with the Company and BMS each\nhaving, collectively, one vote in all decisions. If, with respect to a Critical\nIssue that is subject to the JCC's decision-making authority, the JCC cannot\nreach consensus within five business days after it has first met and attempted\nto reach such consensus, the matter shall be referred on the sixth business day\nto the Joint Executive Committee for resolution. If, with respect to any other\nmatter that is subject to the JCC's decision-making authority, the JCC cannot\nreach consensus within 20 days after it has first met and attempted to reach\nsuch consensus, the matter shall be referred on the twenty-first day to the\nJoint Executive Committee for resolution. For all purposes under this\nAgreement, any decision made pursuant to this Section 2.4(d) shall be deemed to\nbe the decision of the JCC.\n\n         2.5      Joint Manufacturing Committee.\n\n              (a) Members; Officers. Immediately after the Effective Date, the\nParties shall establish a joint manufacturing committee (the \"Joint\nManufacturing Committee\" or \"JMC\"), which shall consist of an equal number of\nrepresentatives from each of the Company and BMS, up to a maximum total of\neight members on such Committee. Each of the Company and BMS may replace any or\nall of its representatives on the JMC at any time upon written notice to the\nother in accordance with Section 16.5 of this Agreement. Such representatives\nshall be comprised of members of senior management of each such Party with\nexpertise in manufacturing. Any member of the JMC may designate a substitute to\ntemporarily attend and perform the functions of that member at any meeting of\nthe JMC. The Company and BMS each may, in its discretion, invite non-member\nrepresentatives of such Party to attend meetings of the JMC. Except as provided\nin Section 8.12(f), the JMC shall be chaired by a representative of the\nCompany. The secretary of the JMC shall be a representative of BMS.\n\n              (b) Responsibilities. The JMC shall perform the following\nfunctions:\n\n                   (i) oversee and coordinate the manufacturing and supply of\nAPI and Finished Products;\n\n                                      15\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n                   (ii) formulate and direct the manufacturing strategy for the\nProducts, including, without limitation, bulk drug production, formulation,\nfilling and finishing of the Products, and approve facilities to be used for\nsuch manufacture and production;\n\n                   (iii) evaluate and determine the existence of a Long-Term\nInability to Supply referred to the JMC in accordance with Section 8.12(e); and\n\n                   (iv) have such other responsibilities as may be assigned to\nthe JMC pursuant to this Agreement or as may be mutually agreed upon by the\nParties from time to time.\n\n              (c) Meetings. The JMC shall meet in person at least once during\nevery calendar quarter, and more frequently as the Company and BMS deem\nappropriate or as reasonably requested by either such Party, on such dates, and\nat such places and times, as such Parties shall agree. Meetings of the JMC that\nare held in person shall alternate between the offices of the Company and BMS,\nor such other place as such Parties may agree. The members of the JMC also may\nconvene or be polled or consulted from time to time by means of\ntelecommunications, video conferences, electronic mail or correspondence, as\ndeemed necessary or appropriate.\n\n              (d) Decision-making. The JMC may make decisions with respect to\nany subject matter that is subject to the JMC's decision-making authority and\nfunctions as set forth in Section 2.5(b). All decisions of the JMC shall be\nmade by unanimous vote or written consent, with the Company and BMS each\nhaving, collectively, one vote in all decisions. If, with respect to a Critical\nIssue that is subject to the JMC's decision-making authority, the JMC cannot\nreach consensus within five business days after it has first met and attempted\nto reach such consensus, the matter shall be referred on the sixth business day\nto the Joint Executive Committee for resolution. If, with respect to any other\nmatter that is subject to the JMC's decision-making authority, the JMC cannot\nreach consensus within 20 days after it has first met and attempted to reach\nsuch consensus, the matter shall be referred on the twenty-first day to the\nJoint Executive Committee for resolution. For all purposes under this\nAgreement, any decision made pursuant to this Section 2.5(d) shall be deemed to\nbe the decision of the JMC.\n\n         2.6      Minutes of Committee Meetings.\n\n              (a) Subject to Section 2.6(b), definitive minutes of all\nCommittee meetings shall be finalized no later than 30 days after the meeting\nto which the minutes pertain, as follows:\n\n                   (i) Within ten days after a Committee meeting, the secretary\nof such Committee shall prepare and distribute to all members of such Committee\nand each Alliance Manager draft minutes of the meeting. Such minutes shall\nprovide a list of any actions, decisions or determinations approved by such\nCommittee and a list of any issues yet to be resolved, either within such\nCommittee or through the relevant escalation process.\n\n                   (ii) The Alliance Managers shall then have ten days after\nreceiving such draft minutes to collect comments thereon from the members of\nits Party and provide them to the secretary of such Committee.\n\n                   (iii) Upon the expiration of such second ten-day period, the\nAlliance Managers and the secretary of such Committee shall have an additional\nten days to discuss each other's comments and finalize the minutes. The\nsecretary and chairperson(s) of such Committee shall each sign and date the\nfinal minutes. The signature of such chairperson(s) and secretary upon the\nfinal minutes shall indicate each Party's assent to the minutes.\n\n                                      16\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n              (b) If at any time during the preparation and finalization of\nCommittee meeting minutes, the secretary of such Committee and the Alliance\nManagers do not agree on any issue with respect to the minutes, such issue\nshall be resolved as provided in Section 2.3(d), 2.4(d) or 2.5(d), as the case\nmay be. The decision resulting from the foregoing process shall be recorded by\nthe secretary in amended finalized minutes for said meeting. All other issues\nin the minutes that are not subject to the foregoing process shall be finalized\nwithin the 30-day period as provided in Section 2.6(a).\n\n         2.7 Term. Each Committee shall exist until the termination or\nexpiration of this Agreement, or for such longer period as necessary to perform\nthe remaining responsibilities assigned to it under this Agreement.\n\n         2.8 Expenses. Each Party shall be responsible for all travel and\nrelated costs and expenses for its members and other representatives to attend\nmeetings of, and otherwise participate on, a Committee.\n\n         2.9 Alliance Managers. Each of the Company, on the one hand, and BMS\nand ERS collectively, on the other hand, shall appoint one senior\nrepresentative who possesses a general understanding of clinical, regulatory,\nmanufacturing and marketing issues to act as its respective alliance manager\nfor this relationship (each, an \"Alliance Manager\"). The initial Alliance\nManagers are set forth on Exhibit 2.1. Each of the Company, on the one hand,\nand BMS and ERS collectively, on the other hand, may replace its respective\nAlliance Manager at any time upon written notice to the other in accordance\nwith Section 16.5 of this Agreement. Any Alliance Manager may designate a\nsubstitute to temporarily perform the functions of that Alliance Manager. Each\nAlliance Manager shall be charged with creating and maintaining a collaborative\nwork environment within and among the Committees. Each Alliance Manager will\nalso be responsible for:\n\n              (a) Coordinating the relevant functional representatives of the\nParties, in developing and executing strategies and plans for the Products in\nan effort to ensure consistency and efficiency within the Territory;\n\n              (b) providing a single point of communication for seeking\nconsensus both internally within the respective Party's organizations and\ntogether regarding key strategy and plan issues;\n\n              (c) identifying and raising cross-country, cross-Party and\/or\ncross-functions disputes to the appropriate Committee in a timely manner; and\n\n              (d) planning and coordinating: (i) cooperative efforts in the\nTerritory; and (ii) internal and external communications.\n\n         The Alliance Managers shall be entitled to attend meetings of any of\nthe Committees, but shall not have, or be deemed to have, any rights or\nresponsibilities of a member of any Committee. Each Alliance Manager may bring\nany matter to the attention of any Committee where such Alliance Manager\nreasonably believes that such matter requires such attention.\n\n                                      17\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n3.       GRANT OF RIGHTS.\n\n         3.1 Rights Granted to ERS. Subject to the terms and conditions of this\nAgreement, the Company hereby grants to ERS:\n\n              (a) An exclusive right to distribute, and a co-exclusive right\n(together with the Company) to develop and promote, the Products in North\nAmerica.\n\n              (b) A co-exclusive right to develop, distribute and promote\n(together with the Company and the Merck Entities, in the case of the Merck\nEntities pursuant to the Merck Agreement) the Products in Japan.\n\n         3.2 Restrictions on the Company. The Company shall not, and shall not\ngrant any rights or licenses to any Third Party or otherwise permit any Third\nParty to, develop the Compounds for animal health or any other application\noutside the Field without the prior written consent of ERS, which shall not be\nunreasonably withheld.\n\n         3.3 License to ERS Inventions. ERS hereby grants to the Company and\nits Affiliates a [**] license, without the right to grant sublicenses (other\nthan to the Merck Entities for use in Japan and to any Person for use outside\nthe Territory), to use any ERS Inventions and any patents owned or controlled\nby ERS solely to the extent related to any ERS Inventions, solely for the\npurpose of developing, using, manufacturing, distributing, promoting and\nselling Compounds and Products in the Field; provided, however the license\ngranted under this Section 3.3 expressly [**] the right of (i) [**] to [**],\ndirectly or indirectly, any Compound or Product distributed or sold by [**], or\n(ii) [**], directly or indirectly, any Compound or Product distributed or sold\nby such [**].\n\n         3.4 Trademarks; Logos.\n\n              (a) The Company hereby grants ERS the non-exclusive right to use\nthe Trademarks in the Territory in connection with the Products, subject to the\nprovisions of this Agreement and for the term hereof. Solely in connection with\nERS's promotion, distribution and sale of Products in the Territory, ERS shall\nmarket the Products throughout the Territory under the applicable Trademarks\nfor the relevant country in the Territory. The use of the Trademarks by ERS\nshall be subject to the prior review and approval of the JCC as set forth in\nthis Section 3.4.\n\n              (b) ERS shall permit duly authorized representatives of the\nCompany to inspect, on the premises of ERS, at all reasonable times, the\nProducts, ERS's quality control records, and ERS's facilities used in or\nrelating to the manufacture, distribution or sale of the Products to insure\ncompliance with cGMP and the quality control standards set forth in the\napplicable Registration Application.\n\n              (c) Whenever ERS uses the Trademarks in advertising or in any\nother manner in connection with the Products, ERS shall clearly indicate the\nCompany's ownership of the Trademarks. At least ten business days prior to\nERS's use of the Trademarks, ERS shall provide the JCC with samples of all\nliterature and advertising using the Trademarks prepared by or for ERS and\nintended to be used by ERS for approval of such use by the JCC. If no objection\nis received from the JCC within five business days of receipt by the JCC of\nsuch samples, ERS may use the Trademarks in the manner used in the samples\nsubmitted to the JCC for approval. When using the Trademarks\n\n                                      18\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \nunder this Agreement, ERS undertakes to comply with all laws pertaining to\ntrademarks in force at any time in the Territory.\n\n              (d) If necessary in any country in the Territory to permit ERS to\nuse the Trademarks, the Company shall make application to register ERS as a\npermitted user or registered user of the Trademarks and, if necessary, or if\nrequested by the Company, ERS undertakes to join in such application and to\ntake such action as may be necessary or requested by the Company to implement\nsuch application or retain, enforce or defend the Trademarks. If necessary in\nany country in the Territory to maintain the Company's rights in the\nTrademarks, ERS shall enter into a registered user agreement or permitted user\nagreement regulating its use of the Trademarks.\n\n              (e) ERS acknowledges that the Company is the owner of the\nTrademarks. ERS shall not at any time do, cause to be done, or permit any act\nor thing inconsistent with, contesting or in any way impairing or tending to\nimpair such ownership. ERS agrees that all use of the Trademarks by ERS shall\ninure to the benefit of and be on behalf of the Company. ERS acknowledges that\nnothing in this Agreement shall give ERS any right, title or interest in the\nTrademarks other than the right to use the Trademarks in accordance with this\nAgreement. ERS agrees that it will not challenge the title or ownership of the\nCompany to the Trademarks or attack or contest the validity of the Trademarks.\n\n              (f) The Company shall register and maintain, or cause to be\nregistered and maintained, in consultation with ERS, the Trademarks in the\nTerritory during the term of this Agreement at the Company's sole expense. If\nany Party learns of any actual, alleged or threatened unauthorized use or other\ninfringement of the Trademarks by others in the Territory, such Party agrees to\npromptly notify the other Parties of such unauthorized use or other\ninfringement. The Company shall use reasonable efforts to retain, enforce or\ndefend the Trademarks.\n\n              (g) To the extent permitted by law, all labeling, packaging,\nliterature, promotional material and advertising for any Product to be\nmarketed, distributed or sold in any country in the Territory shall contain the\nCompany's name and logo with comparable prominence as the name and logo used by\nERS. To the extent practicable, or as required by applicable law to protect the\nTrademarks, ERS shall include on any material bearing any Trademarks an\nacknowledgement that such Trademark is the property of the Company.\n\n         3.5 Right of First Offer to ERS Regarding the Other Compound. During\nthe period of time commencing on the Effective Date and ending on the First\nOffer Termination Date, ERS shall have, and the Company hereby grants to ERS, a\nright of first offer to enter into a partnering arrangement with the Company\nfor the Other Compound, as follows:\n\n              (a) In the event that the Company is interested in seeking any\nThird Party partnering arrangement with respect to the Other Compound (whether\nby granting a license or other rights to a Third Party), the Company shall give\nwritten notice thereof to ERS, together with any and all materials and relevant\ninformation and data regarding the Other Compound that the Company has in its\npossession or control. ERS shall have 30 days after receipt of such written\nnotice and all such information and data to decide whether or not it is\ninterested in entering into negotiations for such a partnering arrangement with\nthe Company for the Other Compound.\n\n              (b) If ERS notifies the Company in writing within such 30-day\nperiod that it is interested in negotiating such a partnering arrangement, the\nCompany shall provide ERS with written notice of its proposed material terms\nand conditions of such arrangement (\"Proposed Terms\"). The Proposed Terms shall\ninclude all material terms and conditions of such arrangement, including,\n\n                                      19\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \nwithout limitation, the scope of the proposed arrangement, the financial terms\nand any technology or compound quid pro quo. ERS and the Company shall promptly\ncommence good faith negotiations (including a review of all relevant data and\ninformation of clinical significance relating to the Other Compound), for a\nperiod of up to 90 days after ERS receives such Proposed Terms from the\nCompany, in an effort to reach mutually acceptable material terms and\nconditions for such arrangement, which material terms and conditions shall be\nset forth in a written letter of intent (\"Letter of Intent\"). During such\n90-day period, the Company shall not negotiate with any Third Party a potential\npartnering arrangement with such Third Party with respect to the Other\nCompound.\n\n              (c) If, despite each of ERS's and the Company's good faith\nefforts, the Company and ERS are not able to agree on such material terms and\nconditions and do not execute a Letter of Intent by the end of such 90-day\nperiod, ERS shall provide to the Company (within five business days) a written\nnotice setting forth the terms ERS will agree to for such arrangement (the \"ERS\nProposed Terms\"). The Company shall then have 15 days to accept or reject the\nERS Proposed Terms. If the Company declines to accept the ERS Proposed Terms\nwithin such 15-day period, then the Company may enter into negotiations with\nany Third Party regarding the Other Compound, provided, however, that the terms\nand conditions of any agreement with a Third Party shall be no more favorable,\nin the aggregate, to such Third Party than the ERS Proposed Terms.\n\n         3.6 Right of First Negotiation of ERS Regarding Partnering\nTransactions. At any time during the Restricted Period, ERS shall have, and the\nCompany hereby grants to ERS, a right of first negotiation to enter into a\npartnering arrangement with the Company (including, without limitation, any\nco-development, co-promotion, research and development, commercialization or\nintellectual property license agreement, joint venture, partnership, or other\npartnering relationship) involving compounds or products not directly relating\nto the Other Compound, to the extent involving the out-licensing of any of\nintellectual property or know-how owned by the Company or to which the Company\nhas an exclusive license (\"Partnering Relationship\").\n\n              (a) In the event that the Company is interested in establishing a\nsuch Partnering Relationship with a Third Party, the Company shall give written\nnotice thereof to ERS, together with any and all materials and relevant\ninformation and data regarding the subject matter of such proposed Partnering\nRelationships that the Company has in its possession or control.\n\n              (b) With respect to each such Partnering Relationship, ERS shall\nhave 90 days after receipt of such written notice and all such information and\ndata to enter into a non-binding heads of agreement with the Company containing\nthe proposed material terms of an agreement regarding such Partnering\nRelationship. During such 90-day time period, the Company shall not negotiate\nsuch a Partnering Relationship with any Third Party. In the event that ERS and\nthe Company do not enter into a non-binding heads of agreement as aforesaid,\nthe Company shall be free to proceed to negotiate with Third Parties as it\ndeems appropriate without any further obligation to ERS.\n\n         3.7 Negotiation of Services. As soon as reasonably practicable after\nthe Effective Date, the Parties will negotiate in good faith the Company's\naccess to ERS's and BMS's research and development services, including\nmedicinal chemistry, high throughput screening, genomics, etc., and the extent\nto which and terms on which such services will be made available to the\nCompany.\n\n         3.8 Restrictions on Competing Products. Except as permitted by this\nSection 3.8, during the period from the Effective Date to the seventh\nanniversary of the Effective Date, each Party agrees not to, and to cause its\nAffiliates not to, directly or indirectly, develop or commercialize a Competing\nProduct in any country in the Territory. In the event that a Party (an\n\"Acquiring Party\") proposes to develop or commercialize a Competing Product or\npurchases or otherwise takes control of a Third Party which has developed or\ncommercialized (and is continuing to produce or sell), or is developing \n\n                                      20\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \nor commercializing, a Competing Product (directly or indirectly), in any such\ncase within the Territory, the Acquiring Party shall, at its option, either:\n\n              (a) divest, or cause its applicable Affiliate to divest, the\nCompeting Product within 12 months after such event; or\n\n              (b) offer to the Company (in the case of BMS or ERS) or ERS (in\nthe case of the Company), (the \"Non-Acquiring Party\"), the right to: (i)\nparticipate in 50% of the Acquiring Party's rights and obligations in\nconnection with the development and commercialization of the Competing Product;\nor (ii) acquire 50% of the Acquiring Party's interest in the Competing Product\nat a valuation which is in proportion to the price paid by the Acquiring Party\nfor the Competing Product. In such event, such Parties shall conduct good faith\ndiscussions regarding the terms of such arrangement. In the event that such\nParties do not reach agreement on such terms, or the Non-Acquiring Party\ndeclines to participate or acquire such an interest in the Competing Product,\nthen the Acquiring Party shall be required to divest, or cause its applicable\nAffiliate to divest, the Competing Product within 12 months after such event.\n\n         3.9 The Company's Right to Develop and Market Products.\n\n              (a) In the event that the Company believes that ERS is not\nadequately performing its obligations and responsibilities under the relevant\nClinical Development Plan or the Marketing Plan, the Company shall provide ERS\nwith written notice of such claim including specification of the respects in\nwhich the Company believes ERS is not meeting such obligations and\nresponsibilities with reasonable particularity. The PDC or the JCC, as the case\nmay be, shall promptly meet to discuss such claims. If the PDC or the JCC, as\nthe case may be, does not reach a consensus decision, then the matter shall be\nreferred to the JEC for resolution, provided that Sections 2.1(d)(ii), (iii)\nand (iv) shall not apply with respect to such matter. If the JEC does not reach\nconsensus decision on the matter, then the Company may submit the matter to\narbitration pursuant to the Accelerated Arbitration Provisions set forth in\nSection 16.13(b).\n\n              (b) If a determination is made pursuant to Section 3.9(a), by the\nPDC, the JCC, the JEC or the arbitrators, as the case may be, that ERS has\nfailed to adequately perform such obligations and responsibilities, then the\nCompany may perform such obligations and responsibilities to the extent it\nreasonably deems appropriate. The Company's performance of such obligations and\nresponsibilities pursuant to this Section shall be reasonably consistent with\nthe scope of performance of such obligations and responsibilities contemplated\nto be performed by ERS in the relevant Clinical Development Plan or Marketing\nPlan, as the case may be.\n\n              (c) Provided that the performance by the Company is in accordance\nwith the scope of such performance contemplated by Section 3.9(b), ERS shall\nreimburse the Company for all of the Company's Development Costs, Distribution\nCosts, Sales Costs, Marketing Costs and Other Operating Income\/Expense, as the\ncase may be, incurred by the Company with respect to such actions. In addition,\nif the Company elected to commence performance of such obligations and\nresponsibilities prior to a determination being made pursuant to Section\n3.9(a), and such determination is that ERS has failed to adequately perform\nsuch obligations and responsibilities, then ERS shall reimburse the Company for\nall such costs incurred by the Company prior to the date of such determination,\nbut only for such costs incurred by the Company that were necessary to satisfy\nthe performance obligations and responsibilities that it is determined ERS\nfailed to adequately provide.\n\n                                      21\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n\n              (d) If such failure to perform is in connection with ERS's\nobligations and responsibilities in Japan, then ERS shall have the right to\ninclude any amount paid to the Company pursuant to this Section as Development\nCosts, Distribution Costs, Sales Costs, Marketing Costs and\/or Other Operating\nIncome\/Expense, as the case may be, for purposes of calculating Operating\nProfit or Loss.\n\n              (e) In no event shall ERS be obligated pursuant to this Section\nto reimburse the Company for any costs incurred by the Company pursuant to this\nSection 3.9 unless: (i) the relevant Committee reaches a consensus decision, or\nthe arbitrators find, that ERS failed to adequately perform such obligations\nand responsibilities; or (ii) ERS otherwise consents in writing. The rights of\nthe Company under this Agreement shall not be affected in any way by the\nCompany's waiver or failure to take action pursuant to this Section 3.9. Any\nrights provided to the Company pursuant to this Section shall be in addition to\nany other rights or remedies available to the Company under this Agreement, at\nlaw or in equity.\n\n4.       DEVELOPMENT AND REGULATORY MATTERS.\n\n         4.1      Exchange of Data and Know-How.\n\n              (a) The Parties acknowledge that the Company is in the process of\nconducting clinical studies on the Product necessary to make the Initial\nRegulatory Filing. Therefore, until the Initial Regulatory Filing is made (the\n\"BLA Filing Date\"), the Company shall be primarily responsible for conducting\nthe clinical studies and all other regulatory matters, manufacturing matters\nand\/or pre-clinical studies necessary to support, prepare and file the Initial\nRegulatory Filing until the BLA Filing Date, and the Company shall use all\ncommercially reasonable efforts necessary to make the Initial Regulatory\nFiling. During such period, the Company shall keep ERS informed as to the\nstatus of such efforts, shall permit ERS to review and comment on the Initial\nRegulatory Filing during its preparation, and shall consult with ERS regarding\nthe preparation of the Initial Regulatory Filing.\n\n              (b) Promptly after the Effective Date, the Company shall deliver\nto ERS copies of all relevant and material data, studies and other written\nmaterials in the Company's possession as of the Effective Date relating to the\nCompounds and Products, including any such materials relating to Patents and\nKnow-How.\n\n              (c) During the term of this Agreement: (i) each Party shall\nprovide to the other Parties any material data or other information relating to\nthe Compounds and Products, including any such information relating to Patents\nand Know-How, from time to time as such data and information is developed or\nacquired by such Party; and (ii) each of the Parties shall deliver to the other\nParties all data and dossiers relating to the Compounds or any Product and\nresults from any studies being conducted by or on behalf of either of such\nParties in connection therewith promptly after such data and\/or dossiers become\navailable.\n\n              (d) All such data and information exchanged or required to be\nexchanged by the Parties pursuant to this Section 4.1 shall be owned by the\nCompany, whether in the Company's possession or control as of the Effective\nDate or developed by any Party during the term of this Agreement. The Company\nhereby grants BMS and ERS the right to use all such data and information for\nall purposes necessary to allow BMS and ERS to perform each of their\nobligations under this Agreement.\n\n         4.2 Product Registrations. Except as otherwise mutually agreed by the\nCompany and BMS, the Company shall own all Registrations in each country in the\nTerritory.\n\n                                      22\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n         4.3 Scope of Clinical Development Plans and Clinical Budget.\n\n              (a) A clinical budget containing the budget for the conduct of\nthe Clinical Development Plans for the development of Compounds and Products\nfor calendar years 2001 through and including 2017, on a calendar\nyear-by-calendar year basis, is attached to this Agreement as Exhibit 4.3(A)\n(such budget, as modified from time to time pursuant to this Agreement, the\n\"Clinical Budget\").\n\n              (b) A Summary Clinical Development Plan for calendar years 2001\nthrough 2004 is attached to this Agreement as Exhibit 4.3(B). As soon as\nreasonably possible after the Effective Date, the PDC shall meet to develop,\nfinalize and approve the definitive clinical development plan for the Compounds\nand the Products for calendar years 2001 through 2004 based on the Summary\nClinical Development Plan for such period. Such Clinical Development Plan shall\ninclude: (i) a plan for the rapid and orderly transition, after the BLA Filing\nDate, of those clinical and other studies ongoing with respect to the Compounds\nand Products which are identified in the initial Clinical Development Plan as\nbeing transferred to ERS from the Company's sole control to the control of ERS\nand the Company, as determined by the PDC in conformity with all applicable\nregulatory requirements and consistent with Section 4.1; (ii) the allocation\nand transition of regulatory strategy and responsibility for the Products;\n(iii) the research and development activities of any or all of the Parties\nunder this Agreement for the development of Compounds and Products for calendar\nyears 2001, 2002, 2003 and 2004, including the allocation of resources between\nthe Company and ERS, which shall be consistent with the Clinical Budget for\nsuch period; (iv) \"go\/no go\" decision criteria for each stage of development of\na Product; (v) target Product profiles; and (vi) timelines for scientific,\nmedical, regulatory and other activities to be undertaken by the Parties for\nthe purpose of obtaining Registrations for the Products in each country in the\nTerritory, providing marketing support and developing new indications and\nformulations for the Products. Every Clinical Development Plan for the relevant\nperiod shall comprise two components: (1) those clinical studies required for\napproval of new indications, other labeling changes or for any other purpose\nunder an IND (e.g., Phase I through Phase III studies (the \"Registrational\nStudies\"); and (2) those studies undertaken post-launch which are not\nRegistrational Studies (e.g., Phase IV studies) (\"Non-Registrational Studies\").\nThe PDC shall use all commercially reasonable efforts to finalize and approve\nthe initial Clinical Development Plan no later than 90 days after the Effective\nDate.\n\n              (c) Prior to Registration in any country in the Territory, the\nParties intend that the Company will be primarily responsible for implementing\nthe regulatory strategy for the Products in such country developed by the PDC.\nThe Parties intend that ERS will be primarily responsible for regulatory\nactivities in a country in the Territory after Registration in such country,\ncomprising regulatory compliance, worldwide safety surveillance, adverse event\nreporting and all other necessary support services.\n\n              (d) At least 12 months prior to the end of the last calendar year\nfor which a Clinical Development Plan has been approved (i.e., prior to the end\nof 2004, 2008 and 2012, respectively), the PDC shall develop, finalize and\napprove a summary clinical development plan for the Compounds and the Products\nfor the four (or, in the case of the last such period, five) calendar years\nnext succeeding such calendar year, comparable in scope and detail to the\nSummary Clinical Development Plan attached as Exhibit 4.3(B) (i.e., for the\nperiod from 2005 through and including 2008, 2009 through and including 2012,\n2013 through and including 2017) (each such approved summary clinical\ndevelopment plan is a Summary Clinical Development Plan).\n\n              (e) At least six months prior to the end of the last calendar\nyear for which a Clinical Development Plan has been approved (i.e., prior to\nthe end of 2004, 2008 and 2012, respectively),\n\n                                      23\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \nthe PDC shall develop, finalize and approve a definitive clinical development\nplan for the Compounds and the Products for the four calendar years (or, in the\ncase of the last such period, five calendar years) next succeeding such\ncalendar year, containing the information described in Section 4.3(b)(ii)\nthrough (vi) for the relevant period (i.e., for the period from 2005 through\nand including 2008, 2009 through and including 2012, 2013 through and including\n2017) based on the Summary Clinical Development Plan for such period (each such\napproved definitive clinical development plan is a Clinical Development Plan);\nprovided, however, that the Clinical Budget for each such calendar year shall\nbe no less than the amount set forth in the Clinical Budget attached as Exhibit\n4.3(A) with respect to such calendar year, except that:\n\n                   (i) if Net Sales of Products for the calendar year\nimmediately preceding such calendar year are less than the [**] for the\nimmediately preceding calendar year, but more than the [**] for the immediately\npreceding calendar year, then the Clinical Budget for the calendar year in\nquestion shall be no less than an amount equal to [**] of the amount set forth\nin the initial Clinical Budget for the calendar year in question, determined on\na [**] based upon the actual [**] for the calendar year immediately preceding\nthe calendar year in question and the [**] and [**], such that if the actual\nNet Sales were equal to the Low Case Projections, the amount would be equal\n[**] and if [**] were equal to the [**], the amount would be equal to [**] or\n\n                   (ii) if Net Sales of Products for the calendar year\nimmediately preceding such calendar year are less than the [**] for the\nimmediately preceding calendar year, then the Clinical Budget for the calendar\nyear in question shall be no less than an amount equal to [**] of the amount\nset forth in the initial Clinical Budget for the calendar year in question.\n\n              (f) As of the Effective Date, each of the Parties believes that\nthe Clinical Budget provides for sufficient funds to complete the execution of\nthe Clinical Development Plans that are to be developed by the Parties in\naccordance with this Section 4.3. ERS shall provide sufficient funds to\ncomplete the execution of the Clinical Development Plans provided they are\ndeveloped in accordance with this Section 4.3 (even if such funding is in\nexcess of the Clinical Budget). Any change to any Clinical Development Plan\nafter the development thereof in accordance with this Section 4.3 must be\napproved by the PDC, provided that any such change that (i) alters the number\nof patients being studied under the Clinical Development Plan or the type\nand\/or phase of such studies, or (ii) increases the amount of funding necessary\nto complete a Clinical Development Plan as a result of any change to (A) the\ntiming of entry of such patients into studies under such Clinical Development\nPlan, or (B) the procedures to be conducted in such studies, in each such case\nshall relieve ERS of the funding obligation set forth in the immediately\npreceding sentence with regard to such revised Clinical Development Plan only\nto the extent that such revised Clinical Development Plan requires funding\nwhich exceeds the Clinical Budget (after taking into account any increase in\nthe Clinical Budget in accordance with Sections 2.1(d)(ii) or (iii)).\n\n         4.4 Transition of Clinical Studies. As soon as practicable after the\nBLA Filing Date, and consistent with the transition plan adopted by the PDC and\ncontained in the initial Clinical Development Plan, the Company shall\ntransition such clinical and other studies ongoing with respect to the Products\nwhich have been identified in such Clinical Development Plan as being\ntransferred to ERS in such transition plan from the Company's sole control to\nthe control of the Party(ies) set forth in the initial Clinical Development\nPlan. Thereafter, ERS shall be primarily responsible for performing such\nstudies designated therefor in the Clinical Development Plans through\ncompletion, and the Company shall be primarily responsible for performing such\nstudies designated therefor in the Clinical Development Plans through\ncompletion. During the transition period, the Company shall continue to be\ninvolved in the ongoing clinical studies in order to assure an orderly transfer\nof responsibility.\n\n                                      24\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n         4.5 Conduct of Clinical Development Plans. Under the auspices of, and\nsubject to review and approval by, the PDC, the Parties shall have the\nfollowing responsibilities relating to the conduct of the Clinical Development\nPlans:\n\n              (a) Each of ERS and the Company shall be responsible for the\npreparation of all protocols and the conduct of all Registrational Studies and\nNon-Registrational Studies for which such Party is designated as the Party\nresponsible for such studies in the Clinical Development Plans. Each such Party\nshall submit all protocols for Registrational Studies to the PDC and, in the\ncase of the Non-Registrational Studies, to the JCC, for its or their approval,\nas the case may be.\n\n              (b) Each of ERS and the Company shall be responsible for\npreparing all Regulatory Applications necessary or desirable to register the\nProducts in all countries in the Territory for which such Party is designated\nas the Party responsible for such preparation in the Clinical Development\nPlans. The Company shall be responsible for filing all Regulatory Applications\n(whether prepared by the Company or ERS) and, thereafter, to conduct all\ncommunications with the Regulatory Authorities during the registration process\n(provided that, if ERS is the responsible Party for the preparation of such\nRegulatory Application, it will work with the Company with respect to all such\nregulatory activities). Each such Party shall submit all proposed filings to\nthe PDC for its approval. The other such Party shall provide all technical data\nand support necessary to assist the responsible Party to prepare such\nRegulatory Applications. The responsible Party shall keep the PDC informed as\nto the status of such efforts, permit the PDC to review any revisions to any\nfilings or communications with Regulatory Authorities during their preparation,\nand shall confer with the PDC regarding the preparation of such filings and\ncommunications and the registration process. During such process, such Parties\nshall collaborate and cooperate in the preparation and filing of all documents\nnecessary therefor and all regulatory interactions and compliance with\nRegulatory Authorities in the Territory. All regulatory activities (including\nwithout limitation adverse event reporting) to be performed by ERS in\naccordance with this Agreement and the Clinical Development Plans shall be\nconducted on behalf of the Company. The Company shall appoint ERS as its agent\nfor regulatory compliance and all other regulatory activities for which ERS is\nresponsible.\n\n              (c) The Company shall supply all API necessary and\/or desirable\nfor all studies to be conducted pursuant to the Clinical Development Plans,\nincluding, without limitation all Registrational Studies and Non-Registrational\nStudies. Such API shall be supplied in accordance with, in all material\nrespects, the Specifications, in accordance with cGMP, and in accordance with\nforecasts therefor provided by the PDC at least 180 days prior to the\nanticipated delivery date for each shipment thereof. Such API shall be supplied\nat the Company's Fully Burdened Manufacturing Cost. The Company's obligation to\nsupply API for Non-Registrational Studies shall be subject, first, to\nfulfilling all requirements for API for the supply of Products for commercial\nsales pursuant to Section 8. Except as otherwise provided in this Section\n4.5(c), all of the provisions of Section 8, to the extent applicable, shall\napply to the supply of API for all such clinical studies (including the\nreference to the relevant payment terms contained in Section 7).\n\n              (d) In connection with performing its obligations pursuant to the\nClinical Development Plans, each of ERS and the Company shall use all\ncommercially reasonable efforts to perform such responsibilities diligently,\nwith the objective of maximizing the sales potential of the Products and\npromoting the therapeutic profile and benefits of the Products in the most\ncommercially beneficial manner. Without limiting the generality of the\nforegoing, each such Party shall:\n\n                   (i) cooperate with the other Party to implement the Clinical\nDevelopment Plans, and such other activities that, from time to time, the PDC\ndecides are necessary for the commercial success of the Products;\n\n                                      25\n\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n                                                  \n                   (ii) use commercially reasonable efforts to perform the work\nset out for such Party to perform in the Clinical Development Plans;\n\n                   (iii) conduct all work pursuant to the Clinical Development\nPlans in good scientific manner, and in compliance in all material respects\nwith all requirements of applicable laws, rules and regulations, and all other\nrequirements of any applicable cGMP, good laboratory practice and current good\nclinical practice to attempt to achieve the objectives of the Clinical\nDevelopment Plans efficiently and expeditiously; and\n\n                   (iv) maintain records, in sufficient detail and in good\nscientific manner, which shall be complete and accurate and shall fully and\nproperly reflect all work done and results achieved in connection with the\nClinical Development Plans in the form required under all applicable laws and\nregulations. The other such Party shall have the right, during normal business\nhours and upon reasonable prior written notice, to inspect and copy all such\nrecords at its own expense, so long as doing so is not unreasonably disruptive.\nThe other such Party shall maintain such records and information contained\ntherein in confidence in accordance with Section 10 and shall not use such\nrecords or information except to the extent otherwise permitted by this\nAgreement.\n\n         4.6      Funding of Clinical Development Plans.\n\n              (a) From and after the Effective Date, each of the Company and\nERS shall be responsible for the Development Costs listed below its name in the\nfollowing table:\n<\/pre>\n<table>\n<s>                    <c>                                            <c><br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<br \/>\n                            The Company                                     ERS<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<br \/>\n  North America        50% of the Development Costs for the            50% of the Development Costs for the<br \/>\n                       Non-Registrational Studies.                     Non-Registrational Studies, and<\/p>\n<p>                                                                       100% of the Development Costs for the<br \/>\n                                                                       Registrational Studies.<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<br \/>\n  Japan                50% of the Development Costs for each of        50% of the Development Costs for each of<br \/>\n                       the Registrational Studies and the              the Registrational Studies and the<br \/>\n                       Non-Registrational Studies.                     Non-Registrational Studies.<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<br \/>\n<\/c><\/c><\/s><\/table>\n<p>         4.7 IT Support. From and after the Effective Date, ERS shall provide<br \/>\nsoftware and technical assistance to the Company which are reasonably necessary<br \/>\nto enable the Company to fulfill its obligations under this Agreement by<br \/>\nallowing the Company&#8217;s information systems to communicate and exchange data<br \/>\nwith ERS&#8217;s and BMS&#8217;s information systems to a degree and in a manner mutually<br \/>\nagreed upon by the Parties. Such software and technical assistance will enable<br \/>\nsecure information flow among the Parties with respect to clinical, regulatory,<br \/>\nmanufacturing, marketing and sales information. It is understood that such<br \/>\nsoftware and technical assistance shall not include providing any hardware<br \/>\nnecessary for the Company to permit such information flow or incurring the<br \/>\ncosts associated with such hardware by ERS. ERS and BMS shall be responsible<br \/>\nfor all costs they incur in connection with providing the foregoing software<br \/>\nand technical assistance to the Company, which <\/p>\n<p>                                      26<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>shall include, without limitation, ERS&#8217;s and BMS&#8217;s internal costs of providing<br \/>\ninformation technology personnel to provide such software and technical<br \/>\nassistance and all applicable allocable overhead. Each of the Parties shall be<br \/>\nresponsible for their respective internal information technology maintenance<br \/>\ncosts associated with or arising from the foregoing, which shall include,<br \/>\nwithout limitation, each such Party&#8217;s internal costs of providing information<br \/>\ntechnology personnel to provide such maintenance and all applicable allocable<br \/>\noverhead. This Section 4.7 is not intended to address software or hardware<br \/>\nupgrades unilaterally undertaken by the Company without ERS&#8217;s consent after the<br \/>\nforegoing communication and data exchange systems have been established. In the<br \/>\nevent that the Parties cannot agree with respect to any of the foregoing, such<br \/>\nmatter shall be referred to the relevant Committee for resolution.<\/p>\n<p>         4.8 Delay of Initial Regulatory Filing. In the event that Registration<br \/>\nof the Initial Regulatory Filing is denied or is materially delayed by the FDA,<br \/>\nthen the PDC shall (a) immediately meet to discuss in good faith a reassessment<br \/>\nof the relevant Clinical Development Plan to address the FDA&#8217;s objections and<br \/>\nquestions, (b) immediately give the JEC notice of such developments, (c) from<br \/>\ntime to time as additional such developments arise, promptly give the JEC<br \/>\nnotice of such additional developments, and (d) keep the JEC reasonably<br \/>\ninformed of the PDC&#8217;s deliberations regarding all such developments. As used in<br \/>\nthis Section 4.8, a material delay is a delay arising from a requirement set<br \/>\nforth by the FDA that the Company conduct additional clinical studies not<br \/>\nconducted in connection with the submission of the Initial Regulatory Filing.<br \/>\nIn the event of a material delay, the PDC shall apply its sound scientific,<br \/>\ncommercial and regulatory judgment with all deliberate speed to determine<br \/>\nwhether or not it is in the best interest of both of ERS and the Company to go<br \/>\nforward with the conduct of any additional clinical studies required by the<br \/>\nFDA. Upon reaching such determination, the PDC shall make a formal<br \/>\nrecommendation of its conclusions to the JEC and shall await direction from the<br \/>\nJEC regarding what, if any, further action is to be taken with respect to such<br \/>\nmatters. Upon receiving the approval of the JEC to undertake the additional<br \/>\nclinical studies required by the FDA, the PDC shall be authorized to, and is<br \/>\nhereby directed to, redirect (without increasing) the existing overall Clinical<br \/>\nBudget as necessary to undertake such studies and to cause such studies to be<br \/>\nundertaken.<\/p>\n<p>         4.9 Suspension of Clinical Development Activities. Any Party shall<br \/>\nhave the right to immediately suspend the relevant clinical development<br \/>\nactivities with respect to a Product or Compound for a particular indication,<br \/>\nformulation or dosage form in the event that such Party, in good faith,<br \/>\ndetermines that there exists significant and urgent concerns relating to<br \/>\npatient safety with respect to such clinical studies. The Party making the<br \/>\ndetermination to suspend such clinical activities shall notify the other<br \/>\nParties in writing immediately of any such suspension and the reasons therefor.<br \/>\nThe PDC shall then promptly determine what actions should be taken with respect<br \/>\nto such clinical activities. Once a determination is made by the PDC with<br \/>\nrespect to the appropriate actions to be taken, the PDC shall review and<br \/>\nre-evaluate the relevant Clinical Development Plan and the Clinical Budget and<br \/>\nmake any changes necessary to implement such actions.<\/p>\n<p>         4.10 Liability. Each Party shall be responsible for, and hereby<br \/>\nassumes, any and all risks of personal injury or property damage attributable<br \/>\nto the negligent or willful acts or omissions of such Party or its Affiliates,<br \/>\nand their respective directors, officers, employees and agents and for the<br \/>\nRegistrational Studies and the Non-Registrational Studies that the Party is<br \/>\nresponsible for conducting and the other responsibilities of such Party<br \/>\npursuant to this Section 4.<\/p>\n<p>                                      27<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>5.       DISTRIBUTION AND PROMOTION.<\/p>\n<p>         5.1 Generally. ERS shall use all commercially reasonable efforts to<br \/>\nlaunch, promote and sell the Products in each country in the Territory (without<br \/>\nregard to other products of BMS and its Subsidiaries) and to perform such<br \/>\nresponsibilities diligently, with the objective of maximizing the sales<br \/>\npotential of the Products and promoting the therapeutic profile and benefits of<br \/>\nthe Products in the most commercially beneficial manner.<\/p>\n<p>         5.2 Scope of Marketing Budget.<\/p>\n<p>              (a) The Marketing Budget for the marketing and sales of Products<br \/>\nin each country in the Territory for calendar years 2001 through 2004 is<br \/>\nattached to this Agreement as Exhibit 5.2(A).<\/p>\n<p>              (b) The Indicative Marketing Budget for the marketing and sales<br \/>\nof Products in each country in the Territory for calendar years 2005 through<br \/>\nand including 2017 is attached to this Agreement as Exhibit 5.2(B).<\/p>\n<p>              (c) At least 12 months prior to the end of the last calendar year<br \/>\nfor which a Marketing Budget has been approved (i.e., prior to the end of 2004,<br \/>\n2008 and 2012, respectively), the JCC shall develop, finalize and approve a<br \/>\nmarketing budget for the Products for the four calendar years (or, in the case<br \/>\nof the last such period, five calendar years) next succeeding such calendar<br \/>\nyear, comparable in scope and detail to the Marketing Budget attached as<br \/>\nExhibit 5.2(A) (i.e., for the period from 2005 through and including 2008, 2009<br \/>\nthrough and including 2012, 2013 through and including 2017), on a calendar<br \/>\nyear-by-calendar year basis (each such approved marketing budget is a Marketing<br \/>\nBudget); provided, however, that such marketing budget for each such calendar<br \/>\nyear shall be no less than the amount set forth in the Indicative Marketing<br \/>\nBudget with respect to such calendar year, except that:<\/p>\n<p>                   (i) if Net Sales of Products for the calendar year<br \/>\nimmediately preceding such calendar year are less than the [**] for the<br \/>\nimmediately preceding calendar year, but more than the [**] for the immediately<br \/>\npreceding calendar year, then the Marketing Budget for the calendar year in<br \/>\nquestion shall be no less than an amount equal to [**] of the amount set forth<br \/>\nin the initial Marketing Budget for the calendar year in question, determined<br \/>\non [**] based upon [**] for the calendar year immediately preceding the<br \/>\ncalendar year in question and the [**] and [**], such that if the actual Net<br \/>\nSales were equal to the [**], the amount would be equal to [**] and if the<br \/>\nactual Net Sales were equal to the [**], the amount would be equal to [**]; or<\/p>\n<p>                   (ii) if Net Sales of Products for the calendar year<br \/>\nimmediately preceding such calendar year are less [**] for the immediately<br \/>\npreceding calendar year, then the Marketing Budget for the calendar year in<br \/>\nquestion shall be no less than an amount equal to [**] of the amount set forth<br \/>\nin the initial Marketing Budget for the calendar year in question.<\/p>\n<p>         5.3      ERS Responsibilities; Rights.<\/p>\n<p>              (a) Except as provided in Section 5.5 and subject to the overall<br \/>\ndirection and control of the JCC, ERS, either itself and\/or by and through its<br \/>\nAffiliates shall be responsible for, and shall have the rights granted under<br \/>\nSection 3.1.<\/p>\n<p>                                      28<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>              (b) In connection with its responsibilities for distribution,<br \/>\nmarketing and sales of the Products in the Territory, ERS shall provide all<br \/>\nsales force (including, without limitation, sales administration and training),<br \/>\norder entry, customer service, reimbursement management, medical affairs,<br \/>\nmedical information, marketing (including all advertising and promotional<br \/>\nexpenditures), warehousing, physical distribution, invoicing, credit and<br \/>\ncollections, production forecasting and other related facilities and services<br \/>\nnecessary or desirable for such distribution, marketing and sales.<\/p>\n<p>         5.4 Marketing Plans. In accordance with the direction provided by the<br \/>\nJCC, ERS shall prepare proposed-marketing and promotional plans for each of the<br \/>\nProducts and for each country in the Territory, which shall include plans<br \/>\nrelated to the prelaunch, launch, promotion and sales of the Product and which<br \/>\nshall include but not be limited to pricing strategy, sales targets, forecasts<br \/>\nfor the number of sales representatives, copies of promotional materials, a<br \/>\nsummary of Phase IV clinical studies and a reasonably descriptive overview of<br \/>\nthe marketing and advertising campaigns proposed to be conducted (the<br \/>\n&#8220;Marketing Plans&#8221;). The Marketing Plans shall be designed to be consistent with<br \/>\nthe Marketing Budget for such calendar year. ERS shall provide copies of the<br \/>\nproposed Marketing Plans to the Company for the Company&#8217;s review and comment as<br \/>\nsoon as practicable after preparation and as frequently as may be required<br \/>\nbased upon ERS&#8217;s usual marketing campaign cycles, but in no case less that once<br \/>\neach calendar year during the term of this Agreement. ERS shall in good faith<br \/>\ngive due consideration to comments received from the Company on any such<br \/>\nMarketing Plan, and will provide the Company with a copy of the final Marketing<br \/>\nPlan as soon as it is available. The Parties intend and expect that the<br \/>\nMarketing Plan for each calendar year will be finalized no later than the first<br \/>\nday of December of the immediately preceding calendar year. Any such final<br \/>\nMarketing Plan may be reviewed and revised in accordance with ERS&#8217;s usual<br \/>\ninternal practices, provided that the Company shall be provided copies of the<br \/>\nproposed revisions, and given the same opportunity to comment and consideration<br \/>\nas provided to the Company for the initial Marketing Plans.<\/p>\n<p>         5.5 Promotional Materials and Activities. The Company shall be<br \/>\nentitled to participate (through the JCC) in the planning of promotional<br \/>\nmaterials and promotional activities with respect to the Products in the<br \/>\nTerritory. All promotional materials and promotional activities shall be<br \/>\ndeveloped by ERS, with input from the Company, following the general guidelines<br \/>\nestablished by the JCC and consistent with the then current Marketing Plan<br \/>\napplicable to the Products being promoted. Such activities may include<br \/>\nsymposia, key opinion leader events, and similar such events. Prior to<br \/>\nfinalizing such promotional materials and promotional activities, ERS shall<br \/>\ninclude the Company in its internal circulation of information regarding such<br \/>\npromotional materials and events during the development of such promotional<br \/>\nmaterials and any event related materials and upon the finalization of such<br \/>\nmaterials.<\/p>\n<p>         5.6 The Company&#8217;s Co-Promotion Right. The Company shall have the<br \/>\nright, at its election and at its sole expense, at any time during the term of<br \/>\nthe Agreement, to promote any or all Products in the Territory (the<br \/>\n&#8220;Co-Promotion Option&#8221;).<\/p>\n<p>              (a) In the event that the Company exercises its Co-Promotion<br \/>\nOption, the Company shall be entitled, at its sole expense, to have its sales<br \/>\nforce and medical liaison personnel participate in the promotion of the<br \/>\nProducts in the Territory. In such event, the JCC shall determine the targets,<br \/>\nroles and assignments of the Company&#8217;s and ERS&#8217;s sales representatives within<br \/>\nsuch selling effort in a manner generally consistent with the then current<br \/>\nMarketing Plan. In order to exercise the Co-Promotion Option, the Company must<br \/>\ngive ERS written notice of such exercise at least six months prior to the date<br \/>\nthe Company intends to begin its co-promotion activities.<\/p>\n<p>              (b) The Company will be included in, and be allowed to<br \/>\nparticipate in, all promotional activities being conducted by ERS pursuant to<br \/>\nthe then current Marketing Plan, <\/p>\n<p>                                      29<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>including participation in symposia, key opinion leader events, and the like.<br \/>\nERS shall provide the Company&#8217;s sales force with all promotional materials and<br \/>\nsupport services to the same extent available to ERS&#8217;s sales force. The Company<br \/>\nshall reimburse ERS for ERS&#8217;s incremental costs and expenses associated with<br \/>\nproviding such materials and services to the Company&#8217;s sales force.<\/p>\n<p>              (c) Should the Company exercise its Co-Promotion Option, it is<br \/>\nunderstood that ERS will retain the exclusive rights to sell and distribute the<br \/>\nProducts in North America, so that the Company&#8217;s right and obligation to<br \/>\npromote would be in the nature of a co-promotion arrangement in which the<br \/>\nCompany promotes such Products, but sales continue to be made by ERS.<\/p>\n<p>              (d) ERS has provided the Company a copy of the Code of Conduct<br \/>\nfor Sales Representatives, Sales Force Management and Others Promoting USPG<br \/>\nPharmaceuticals dated December 17, 1998 (the &#8220;Sales Force Guidelines&#8221;)<br \/>\ngoverning the professional conduct of its sales representatives. From time to<br \/>\ntime when such Sales Force Guidelines are to be updated or changed, ERS (i)<br \/>\nshall provide the Company a reasonable opportunity to comment on such proposed<br \/>\nSales Force Guidelines, (ii) shall give reasonable consideration to any<br \/>\ncomments made by the Company regarding such proposed Sales Force Guidelines,<br \/>\nand (iii) shall provide the final updated or changed versions of the same to<br \/>\nthe Company upon being finalized. In undertaking its co-promotion activities,<br \/>\nthe Company shall use its reasonable efforts to ensure that its sales force<br \/>\npersonnel abide by all such Sales Force Guidelines, as they are updated or<br \/>\nchanged in accordance with this Section 5.6(d) from time to time, including<br \/>\npromptly disciplining any sales representatives violating such Sales Force<br \/>\nGuidelines. the Company may use the information and\/or materials disclosed by<br \/>\nERS to the Company in connection with such Sales Force Guidelines only for the<br \/>\npurpose of performing its co-promotion activities in accordance with this<br \/>\nAgreement. ERS shall, at all times, maintain ownership (copyright and<br \/>\notherwise) of all information and\/or materials comprising the Sales Force<br \/>\nGuidelines.<\/p>\n<p>              (e) In the event that ERS reasonably believes the Company has (i)<br \/>\nmaterially failed to competently co-promote the Product(s), (ii) materially<br \/>\nfailed to promote the Product(s) consistent with the direction provided by the<br \/>\nJCC and\/or then current Marketing Plan, or (iii) experienced a pattern of<br \/>\nviolating any Sales Force Guidelines, applicable laws, and\/or applicable<br \/>\nregulations in connection with its promotion of the Product(s), where there is<br \/>\na reasonable chance of reoccurrence of one or more of the violations comprising<br \/>\nsuch pattern, where such violations (to the degree such violations are not due<br \/>\nto the Company&#8217;s lawful use of promotional materials approved by the JCC), when<br \/>\ntaken in the aggregate, exceed BMS&#8217;s and its Subsidiaries&#8217;s collective history<br \/>\nof such violations in the applicable time period (each a &#8220;Co-Promotion<br \/>\nProblem&#8221;), then ERS shall provide the Company with written notice of such claim<br \/>\nincluding specification of the respects in which ERS believes such a<br \/>\nCo-Promotion Problem has occurred with reasonable particularity. The JCC shall<br \/>\npromptly meet to discuss such claims and to determine whether or not such a<br \/>\nCo-Promotion Problem has occurred. If the JCC does not reach a consensus<br \/>\ndecision, then the matter shall be referred to the JEC for resolution, provided<br \/>\nthat Sections 2.1(d)(ii), (iii) and (iv) shall not apply with respect to such<br \/>\nmatter. If the JEC does not reach consensus decision on the matter, then ERS<br \/>\nmay submit the matter to arbitration pursuant to the Accelerated Arbitration<br \/>\nProvisions set forth in Section 16.13(b).<\/p>\n<p>              (f) Upon reaching a determination that a Co-Promotion Problem has<br \/>\noccurred pursuant to Section 5.6(e), the JCC, the JEC, or the arbitrators, as<br \/>\nthe case may be, reaching such determination must order the suspension of all<br \/>\nof the Company&#8217;s rights to co-promote Products under this Section 5.6 for a<br \/>\nperiod of time which shall last for a minimum of three months but shall not<br \/>\nexceed six months. Upon the receipt of such an order, the Company shall suspend<br \/>\nall activities relating to its co-promotion of Products for the period of time<br \/>\nspecified in such order.<\/p>\n<p>                                      30<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>         5.7 Distribution and Marketing Costs. From and after the Effective<br \/>\nDate, each of the Company and ERS shall be responsible for those Distribution<br \/>\nCosts, Sales Costs, Marketing Costs, General and Administrative Costs, and\/or<br \/>\nOther Operating Income\/Expense listed below its name in the following table, as<br \/>\napplicable in North America and\/or Japan:<\/p>\n<table>\n<s>                     <c>                                             <c>    <\/p>\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;<br \/>\n                         The Company                                    ERS<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;<\/p>\n<p>  North America          0% of the Distribution  Costs,  Sales          100%  of the  Distribution  Costs,  Sales<br \/>\n  &#8212;&#8212;&#8212;&#8212;           Costs and Marketing Costs.                     Costs and Marketing Costs.<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;<br \/>\n  Japan                  50% of the Distribution  Costs, Sales          50%  of  the  Distribution  Costs,  Sales<br \/>\n  &#8212;&#8211;                  Costs,  Marketing Costs,  General and          Costs,   Marketing  Costs,   General  and<br \/>\n                         Administrative   Costs,   and   Other          Administrative     Costs,    and    Other<br \/>\n                         Operating Income\/Expense.                      Operating Income\/Expense.<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;<br \/>\n<\/c><\/c><\/s><\/table>\n<p>6.       PAYMENTS.<\/p>\n<p>         6.1 Upfront Payments to the Company. As partial consideration to the<br \/>\nCompany for the rights granted to ERS under this Agreement, ERS shall pay to<br \/>\nthe Company a non-refundable, non-creditable up-front payment of $200,000,000,<br \/>\non the date hereof.<\/p>\n<p>         6.2 Milestone Payments to the Company.<\/p>\n<p>              (a) As further consideration to the Company for the rights<br \/>\ngranted to ERS under this Agreement, ERS shall pay to the Company the following<br \/>\nnon-refundable and non-creditable milestone payments upon the first occurrence<br \/>\nof each event set forth below with respect to the Products:<\/p>\n<table>\n<s>                                                                                    <c><\/p>\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<br \/>\n  Milestone Event                                                                      Milestone Payment<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<br \/>\n    Upon the earlier of: (i) the written acceptance by the FDA of the complete<br \/>\n    filing with the FDA of a Registration Application for a Product, or (ii)              $300,000,000<br \/>\n    expiration of the statutory period (60 days) without receipt of a notice of<br \/>\n    non-acceptance from the FDA regarding a Registration Application for a<br \/>\n    Product.<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<br \/>\n    Upon receipt of the written Registration for a Product in the US from the FDA.        $500,000,000<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<br \/>\n<\/c><\/s><\/table>\n<p>                                      31<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>              The Party who receives the written acceptance, or the<br \/>\nRegistration, as the case may be, from the FDA for a milestone event shall be<br \/>\nresponsible for promptly informing the other Parties when such milestone has<br \/>\nbeen achieved. The payments required pursuant to this Section 6.2(a) shall be<br \/>\npaid within 30 days after the earlier to occur of: (i) ERS receiving the<br \/>\nwritten acceptance, or the Registration, as the case may be, from the FDA for a<br \/>\nmilestone event, or (ii) the Company notifying ERS of the achievement of the<br \/>\nrelevant milestone.<\/p>\n<p>              (b) In the event that the Company terminates this Agreement<br \/>\npursuant to clause (i) or (ii) of Section 13.4, all payments made by ERS to the<br \/>\nCompany pursuant to Section 6.2(a) shall be refunded by the Company, without<br \/>\ninterest, within 30 days after such termination.<\/p>\n<p>         6.3 Distribution Fees for North America. As further consideration to<br \/>\nthe Company for the rights granted to ERS in North America under this<br \/>\nAgreement, and subject to Section 6.4, ERS shall pay to the Company a<br \/>\nDistribution Fee for North America equal to the sum of a percentage of annual<br \/>\nNet Sales of the Products in North America as follows:<\/p>\n<p>              (a) 39% of that portion of Net Sales in North America in the<br \/>\nrelevant calendar year that is less than or equal to [**];<\/p>\n<p>              (b) [**] of that portion of Net Sales in North America in the<br \/>\nrelevant calendar year that is greater than [**] and less than or equal to<br \/>\n[**]; and<\/p>\n<p>              (c) [**] of that portion of Net Sales in North America in the<br \/>\nrelevant calendar year that is greater than [**].<\/p>\n<p>         6.4 Reduction in Distribution Fee for North America. In the event that<br \/>\na Third Party Change of Control Transaction is announced and consummated prior<br \/>\nto, or announced prior to and consummated after, the earliest to occur of (i)<br \/>\nthe fifth anniversary of the Effective Date, (ii) a BMS Dilution Event, and<br \/>\n(iii) a BMS Sell-Down; the Distribution Fee for North America shall be<br \/>\nadjusted, commencing in the calendar month in which such Third Party Change of<br \/>\nControl Transaction is consummated, and continuing until the expiration or<br \/>\ntermination of this Agreement, to be equal to 39% of Net Sales of the Products<br \/>\nin North America.<\/p>\n<p>         6.5 Distribution Fees for Japan. As further consideration to the<br \/>\nCompany for the rights granted to ERS in Japan under this Agreement, the<br \/>\nCompany&#8217;s Distribution Fee for Japan shall be equal to the sum of 50% of<br \/>\nOperating Profit or Loss from the sale of Products in Japan. Such amount shall<br \/>\nbe paid to the Company or credited to ERS, as the case may be, in accordance<br \/>\nwith Section 7.<\/p>\n<p>         6.6 Allocation of Sales. ERS shall allocate or reallocate sales of<br \/>\nProducts to Net Sales received in a specific calendar month or calendar year in<br \/>\naccordance with ERS&#8217;s usual and customary sales allocation practices that ERS<br \/>\napplies to its other therapeutic oncology products.<\/p>\n<p>7.       PAYMENTS AND REPORTS.<\/p>\n<p>         7.1 Payments. Beginning the Number of Days to Make Payment after the<br \/>\nend of the calendar month in which the First Commercial Sale is made in the<br \/>\nTerritory and for each calendar month thereafter (no later than the Number of<br \/>\nDays to Make Payment after the end of such calendar month),<\/p>\n<p>                                      32<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>ERS shall submit a statement, which shall set forth the amount of Net Sales in<br \/>\nNorth America and Operating Profit or Loss in Japan, Product-by-Product, during<br \/>\nsuch month, and the calculation of Distribution Fees due on such Net Sales in<br \/>\nNorth America and on such Operating Profit or Loss in Japan, for such month.<br \/>\nEach such statement shall be accompanied by the payment, if any, due to the<br \/>\nCompany or shall indicate that a credit is being issued to ERS. Any amounts<br \/>\ncredited to ERS may, in ERS&#8217;s sole discretion, be set off against to<br \/>\ncorrespondingly reduce any amount due the Company.<\/p>\n<p>         7.2 Reports. Beginning with the month in which the First Commercial<br \/>\nSale is made in the Territory and for each month thereafter, (a) ERS shall<br \/>\nsubmit on the fifth business day following the close of such month (closed in<br \/>\naccordance with ERS&#8217;s then standard practices), a net sales report regarding<br \/>\nsuch month&#8217;s Net Sales in the United States; (b) ERS shall submit on the<br \/>\ntwentieth business day following the close of such month (closed in accordance<br \/>\nwith ERS&#8217;s then standard practices), a net sales report regarding such month&#8217;s<br \/>\nNet Sales in Canada; and (c) each of ERS and the Company shall submit to the<br \/>\nother on the twentieth business day following the close of such month (closed<br \/>\nin accordance with such Party&#8217;s own then standard practices), an expense report<br \/>\nseparately detailing, for such month, such Party&#8217;s Development Costs for<br \/>\nRegistrational and Non-Registrational Studies in each of North America and<br \/>\nJapan, and Operating Profit and Loss detailed and broken down into its<br \/>\nconstituent components in accordance with the Financial Appendix. Such reports<br \/>\nare to be made in support of the payments to be made pursuant to this Agreement<br \/>\nand in accordance with the Financial Appendix. For the avoidance of doubt, the<br \/>\nParties shall also fulfill any additional reporting requirements, if any, set<br \/>\nforth elsewhere in this Agreement.<\/p>\n<p>         7.3 Mode of Payment. ERS shall make all payments required under this<br \/>\nAgreement as directed by the Company from time to time in U.S. Dollars.<br \/>\nWhenever conversion of payments from any foreign currency shall be required,<br \/>\nsuch conversion shall be at the rate of exchange used by ERS for its own<br \/>\nfinancial reporting purposes at such time without taking into account the<br \/>\neffect of any hedging transactions by ERS or its Affiliates.<\/p>\n<p>         7.4 Records Retention. ERS, the Company and each such Party&#8217;s<br \/>\nrespective Affiliates shall keep complete and accurate records pertaining to<br \/>\nthe sale of Products and the Product-by-Product and Product-consolidated<br \/>\ncalculation of Net Sales in North America, Net Sales in Japan and Operating<br \/>\nProfit or Loss in Japan, including without limitation the determination of<br \/>\nFully Burdened Manufacturing Cost of API and of Finished Product, Development<br \/>\nCosts, Distribution Costs, Sales Costs, Marketing Costs, General and<br \/>\nAdministrative Costs and Other Operating Income\/Expense for a period of three<br \/>\ncalendar years after the year in which such sales or costs occurred, and in<br \/>\nsufficient detail to permit the Company to confirm the accuracy of each of the<br \/>\nforegoing and of the aggregate Distribution Fees provided by ERS under this<br \/>\nAgreement.<\/p>\n<p>         7.5 Audit Request. During the term of this Agreement and for a period<br \/>\nof three years thereafter, at the request and expense of any Party (the<br \/>\n&#8220;Auditing Party&#8221;), the Company (in the case of a request by BMS or ERS) or ERS<br \/>\nand BMS (in the case of a request by the Company), (the &#8220;Audited Party&#8221;), and<br \/>\nits Affiliates shall permit an independent, certified public accountant<br \/>\nappointed by the Auditing Party and reasonably acceptable to the Audited Party,<br \/>\nat reasonable times and upon reasonable notice but not more often than two<br \/>\ntimes each calendar year, to examine such records as may be necessary to<br \/>\ndetermine the correctness of any report or payment made under this Agreement,<br \/>\nto determine the consistency of actual expenditures versus the budgeted<br \/>\nexpenditures set forth in the Clinical Budget and\/or any Marketing Budget, as<br \/>\nthe case may be, or obtain information as to the determination of Fully<br \/>\nBurdened Manufacturing Cost of API (including, without limitation, the records<br \/>\nof when during API production API batches failed, the cost and nature of such<br \/>\nfailures), the determination of Fully Burdened Manufacturing Cost of processing<br \/>\nAPI into Finished Product, <\/p>\n<p>                                      33<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>and the aggregate Net Sales, Operating Profit or Loss and Distribution Fees<br \/>\npayable for any calendar month, including without limitation, Development<br \/>\nCosts, Distribution Costs, Sales Costs, Marketing Costs, General and<br \/>\nAdministrative Costs and Other Operating Income\/Expense. Results of any such<br \/>\nexamination shall be made available to all Parties except that said<br \/>\nindependent, certified public accountant shall verify to the Auditing Party<br \/>\nsuch amounts and shall disclose no other information revealed in such audit.<\/p>\n<p>         7.6 Cost of Audit. The Auditing Party shall bear the full cost of the<br \/>\nperformance of any audit requested by the Auditing Party except as hereinafter<br \/>\nset forth. If, as a result of any inspection of the books and records of the<br \/>\nAudited Party and\/or its Affiliates, it is shown that payments made by ERS to<br \/>\nthe Company under this Agreement were less than the amount which should have<br \/>\nbeen paid, then ERS shall make all payments required to be made to eliminate<br \/>\nany discrepancy revealed by said inspection within 30 days after the Company&#8217;s<br \/>\ndemand therefor. Furthermore, if the payments made were less than 95% of the<br \/>\namount that should have been paid during the period in question, ERS shall also<br \/>\nreimburse the Company for the reasonable costs of such audit; provided,<br \/>\nhowever, that no such reimbursement of such audit costs shall be made in the<br \/>\nevent such audit determines that, in the period in question, the Company<br \/>\nmisstated the financial data it reported to ERS pursuant to Section 7.1 and the<br \/>\nFinancial Appendix by such an amount as to cause an increase in the<br \/>\nunderpayment by ERS great enough to trigger the threshold set forth above,<br \/>\nwithout which ERS would be within such threshold. In the event that the audit<br \/>\nshows that an overpayment has been made by ERS, such amounts shall be deducted<br \/>\nfrom Distribution Fees owed to the Company. If such overpayment amounts have<br \/>\nnot been settled by such deductions from Distribution Fees within one year from<br \/>\nthe date originally overpaid, then the Company shall make all payments required<br \/>\nto be made to ERS to eliminate any such overpayment. Furthermore, if (i) the<br \/>\noverpayment made was more than 105% of the amount that should have been paid<br \/>\nduring the period in question and (ii) the costs invoiced by the Company were<br \/>\nmore than 105% of the audited costs during the period in question, then the<br \/>\nCompany shall also reimburse ERS for the reasonable costs of such audit;<br \/>\nprovided, however, that no such reimbursement of such audit costs shall be made<br \/>\nin the event such audit determines that, in the period in question, ERS<br \/>\nmisstated the financial data it reported to the Company pursuant to Section 7.1<br \/>\nand the Financial Appendix by such an amount as to cause an increase in the<br \/>\ncosts invoiced by the Company and\/or the overpayment by ERS great enough to<br \/>\ntrigger the thresholds set forth above, without which the Company would be<br \/>\nwithin such thresholds.<\/p>\n<p>         7.7 No Non-Monetary Consideration for Sales. Without the prior written<br \/>\nconsent of the Company, ERS and its Affiliates shall not accept or solicit any<br \/>\nnon-monetary consideration of the sale of the Products. Subject to the<br \/>\napplicable oversight and approval responsibilities of the PDC and the JCC set<br \/>\nforth in Sections 2.3(b)(vii) and 2.4(b)(vii), the use by ERS and its<br \/>\nAffiliates of a commercially reasonable amount of the Products for promotional<br \/>\nsampling, compassionate use and indigent care shall not violate this Section<br \/>\n7.7.<\/p>\n<p>         7.8 Taxes. In the event that ERS is required to withhold any tax to<br \/>\nthe tax or revenue authorities in any country in the Territory regarding any<br \/>\npayment to the Company due to the laws of such country, such amount shall be<br \/>\ndeducted from the payment to be made by ERS, and ERS shall promptly notify the<br \/>\nCompany of such withholding and, within a reasonable amount of time after<br \/>\nmaking such deduction, furnish the Company with copies of any tax certificate<br \/>\nor other documentation evidencing such withholding. Each Party agrees to<br \/>\ncooperate with the other Parties in claiming exemptions from such deductions or<br \/>\nwithholdings under any agreement or treaty from time to time in effect.<\/p>\n<p>                                      34<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>8.       MANUFACTURE AND SUPPLY.<\/p>\n<p>         8.1 Supply Obligations. Under the auspices of, and subject to review<br \/>\nand approval by, the JMC, and except as mutually agreed by ERS and the Company,<br \/>\nthe Parties shall have the following responsibilities relating to the<br \/>\nmanufacture and supply of API and Finished Products:<\/p>\n<p>              (a) Commencing on the Effective Date, and thereafter during the<br \/>\nterm of this Agreement, the Company (or its Affiliates) shall be responsible<br \/>\nfor the manufacture or supply of all requirements of API for clinical and<br \/>\ncommercial use in the Territory pursuant to this Agreement.<\/p>\n<p>              (b) Prior to expiration, termination or assignment (pursuant to<br \/>\nSection 8.9) of any existing agreement between the Company and a Third Party<br \/>\nManufacturer for the manufacture of Finished Products, the Company shall be the<br \/>\nParty responsible for processing the API into Finished Products pursuant to<br \/>\nsuch agreement. Commencing upon the expiration, termination or assignment<br \/>\n(pursuant to Section 8.9) of any existing agreement between the Company and a<br \/>\nThird Party Manufacturer for the manufacture of Finished Products, ERS shall<br \/>\nbecome and thereafter shall remain the Party responsible for processing the API<br \/>\ninto Finished Products.<\/p>\n<p>         8.2      Supply of API; Processing of Finished Product.<\/p>\n<p>              (a) Commencing on the commercial launch of Product and thereafter<br \/>\nduring the term of this Agreement, subject to the terms and conditions of this<br \/>\nSection 8, the Company shall supply ERS with all of ERS&#8217;s requirements for API<br \/>\nfor commercial use in the Territory pursuant to this Agreement (which shall be<br \/>\ndeemed to include all of the requirements of ERS&#8217;s Affiliates), and ERS shall<br \/>\npurchase from the Company all of such requirements for API. ERS shall place<br \/>\norders for the requirements of its Affiliates, and either have the Company ship<br \/>\ndirectly to such Affiliates or to ERS for its reshipment to such Affiliates.<\/p>\n<p>              (b) Except to the extent that the Company is responsible for<br \/>\nprocessing API into Finished Products pursuant to Section 8.1(b), ERS (or its<br \/>\nAffiliates) shall be responsible for processing the API into Finished Product,<br \/>\nincluding, without limitation, all product labeling and other package inserts<br \/>\nand materials required by the applicable Regulatory Authorities. The<br \/>\nresponsible party shall use commercially reasonable efforts to ensure that all<br \/>\nservices, facilities and goods used in connection with such manufacture comply<br \/>\nwith the applicable Manufacturing Standards in effect from time to time.<\/p>\n<p>              (c) ERS and the Company shall cooperate in good faith and shall<br \/>\nestablish the Specifications for this Agreement. In order to facilitate<br \/>\nmanufacture of the API and the Finished Products, as ERS and the Company deem<br \/>\nappropriate, such Parties shall cooperate in good faith with Third Parties to<br \/>\nestablish Specifications and Manufacturing Standards for this Agreement that<br \/>\nconform to the extent practicable to the specifications and standards<br \/>\napplicable to the Company&#8217;s manufacture of the API and products containing the<br \/>\nAPI for such Third Parties, and the Company shall use all reasonable efforts to<br \/>\ncause such Third Parties to do the same.<\/p>\n<p>              (d) The Parties intend that the Company will use BMS&#8217;s Hopewell<br \/>\nfacility to provide certain services in connection with establishing a<br \/>\nnon-commercial supply of API. As soon as reasonably practicable after the<br \/>\nEffective Date, BMS and the Company will negotiate in good faith the Company&#8217;s<br \/>\nuse of BMS&#8217;s process development and analytical services at BMS&#8217;s Hopewell<br \/>\nfacility for the support of pre-clinical and clinical supplies of API for use<br \/>\nin the development of Products, and the extent to which and terms on which such<br \/>\nservices will be made available to the Company.<\/p>\n<p>                                      35<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>         8.3 Forecasts. Commencing 12 months prior to the anticipated<br \/>\ncommercial launch of the Product in any country in the Territory, no later than<br \/>\n180 days prior to the first day of each calendar quarter (&#8220;Q1&#8221;), ERS shall<br \/>\nprovide the Company with a non-binding (except with respect to Q1), good faith<br \/>\nrolling forecast of estimated quantities in kilograms and anticipated delivery<br \/>\nschedules for API for the following 12-month period (i.e., Q1 and the next<br \/>\nthree calendar quarters (&#8220;Q2,&#8221; &#8220;Q3&#8221; and &#8220;Q4,&#8221; respectively)), by calendar<br \/>\nquarters. The quantity indicated for Q1 shall be considered a firm order, in<br \/>\naccordance with Section 8.4. Such forecasts shall be revised and updated<br \/>\nquarterly, including firm orders for the next succeeding quarter.<\/p>\n<p>         8.4 Orders for API.<\/p>\n<p>              (a) Together with each forecast provided under Section 8.3 (the<br \/>\n&#8220;Current Forecast&#8221;), ERS shall place its firm order on a quarterly basis with<br \/>\nthe Company, setting forth kilograms, delivery dates and shipping instructions<br \/>\nwith respect to each shipment of API for delivery in Q1. The Company shall<br \/>\naccept such orders from ERS, subject to the other terms and conditions of this<br \/>\nAgreement, to the extent such quantity of API is: (i) no more than the least<br \/>\nof: (A) the quantity thereof reflected in the Current Forecast for Q1; (B) 110%<br \/>\nof the quantity thereof reflected for Q2 in the forecast that next preceded the<br \/>\nCurrent Forecast; and (C) 125% of the quantity thereof reflected for Q3 in the<br \/>\nforecast that next preceded the forecast referred to in clause (i)(B); and (ii)<br \/>\nno less than the greatest of: (A) the quantity thereof reflected in the Current<br \/>\nForecast for Q1; (B) 90% of the quantity thereof reflected for Q2 in the<br \/>\nforecast that next preceded the Current Forecast; and (C) 75% of the quantity<br \/>\nthereof reflected for Q3 in the forecast that next preceded the forecast<br \/>\nreferred to in clause (ii)(B). ERS&#8217;s orders shall be made pursuant to purchase<br \/>\norders which are in a form mutually acceptable to the ERS and the Company, to<br \/>\nthe extent that such form is not inconsistent with the terms of this Agreement.<\/p>\n<p>              (b) The Company shall not be obligated to accept orders for Q1 to<br \/>\nthe extent the quantity of API ordered exceeds the foregoing limitations, but<br \/>\nshall use good faith efforts to fill such orders for such excess quantities<br \/>\nfrom available supplies. In the event that the Company, despite the use of good<br \/>\nfaith efforts, is unable to supply such excess quantities to ERS, such<br \/>\ninability to supply shall not constitute a breach of the Company&#8217;s obligations<br \/>\nunder this Section 8 or a Short-Term Inability to Supply or Long-Term Inability<br \/>\nto Supply. The Company shall use all reasonable efforts to notify ERS within<br \/>\nten days after receipt of an order of the Company&#8217;s ability to fill any amounts<br \/>\nof such orders in excess of the quantities that the Company is obligated to<br \/>\nsupply. ERS shall notify the Company as soon as possible of an increase in<br \/>\nERS&#8217;s requirements for API materially in excess of the limits set forth in<br \/>\nSection 8.4(a).<\/p>\n<p>              (c) In the event that ERS submits orders for API with respect to<br \/>\nany Q1 for less than the minimum quantity of API that ERS is required to<br \/>\npurchase under this Section 8, the Company nevertheless shall have the right to<br \/>\nsupply and ship to ERS (in accordance with the shipping instructions most<br \/>\nrecently supplied by ERS), and ERS shall have the obligation to purchase and<br \/>\naccept from the Company, such minimum quantity of API. ERS shall notify the<br \/>\nCompany as soon as possible of a decrease in ERS&#8217;s requirements for API<br \/>\nmaterially below the limits set forth in Section 8.4(a). In the event of such a<br \/>\ndecrease, the Company shall use all reasonable efforts, but shall not be<br \/>\nrequired, to reduce accordingly the orders for API that the Company has placed<br \/>\nwith its Third Party Manufacturers or to allocate to other purchasers API that<br \/>\nERS would have purchased but for such decrease.<\/p>\n<p>              8.5 Delivery. With respect to exact shipping dates, the Company<br \/>\nshall use all reasonable commercial efforts to ship or cause to be shipped<br \/>\nquantities of API that the Company is obligated to supply pursuant to Section<br \/>\n8.4 on the dates specified in ERS&#8217;s purchase orders submitted and accepted in<br \/>\naccordance with Section 8.4. Notwithstanding any Incoterm that may be specified<br \/>\non <\/p>\n<p>                                      36<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>ERS&#8217;s API purchase order, all API to be delivered pursuant to this Agreement<br \/>\nshall be delivered in accordance with this Section 8.5, suitably packed in bulk<br \/>\ncontainers for shipment, and marked for shipment to the final destination point<br \/>\nindicated in ERS&#8217;s purchase order. The shipping packaging used in connection<br \/>\nwith such API deliveries shall be in accordance with cGMP with respect to<br \/>\nprotection of the API during transportation, taking into consideration the<br \/>\nmode(s) of transport ERS has elected to use for each such shipment, the final<br \/>\ndestination point of each such shipment and reasonable expectations regarding<br \/>\nshipment time duration and possible delays associated therewith. Transportation<br \/>\nof API may be made by rail, road, air, sea, inland waterway or by a combination<br \/>\nof such modes of transport. The Company will deliver or cause to be delivered<br \/>\nall API, cleared for export (if applicable based on the final destination point<br \/>\nand expected travel route indicated in ERS&#8217;s purchase order), to the carrier<br \/>\nnominated by ERS at a point selected by the Company. If such delivery occurs at<br \/>\nthe Company&#8217;s or a Third Party&#8217;s premises, the Company or such Third Party<br \/>\nshall be responsible for loading. If delivery occurs at any other place, the<br \/>\nCompany or such Third Party shall not be responsible for unloading. If ERS<br \/>\nnominates a Person other than a carrier to receive the API, the Company shall<br \/>\nbe deemed to have fulfilled its obligation to deliver the API when the API is<br \/>\ndelivered to that Person. Title and risk of loss shall transfer to ERS upon<br \/>\ndelivery to the carrier or Person designated by ERS.<\/p>\n<p>         8.6 Purchase Price.<\/p>\n<p>              (a) The purchase price for all API supplied by the Company to ERS<br \/>\npursuant to this Section 8 for commercial use in North America shall be the<br \/>\nCompany&#8217;s Fully Burdened Manufacturing Cost for such API plus a mark-up of 10%;<br \/>\nprovided, however process development, process improvement, scale-up, recovery,<br \/>\nand qualification lots costs (although components of Fully Burdened<br \/>\nManufacturing Cost) shall not be subject to the mark-up of 10%.<\/p>\n<p>              (b) For all API supplied by the Company to ERS pursuant to this<br \/>\nSection 8 for commercial use in Japan, the Company&#8217;s Fully Burdened<br \/>\nManufacturing Cost for such API shall be included in the calculation of<br \/>\nOperating Profit or Loss, pursuant to the Financial Appendix. Similarly, ERS&#8217;s<br \/>\nFully Burdened Manufacturing Cost for the processing API into Finished Product<br \/>\nfor commercial use in Japan shall be included in the calculation of Operating<br \/>\nProfit or Loss, pursuant to the Financial Appendix.<\/p>\n<p>              (c) For API supplied to ERS for the clinical studies and for<br \/>\ncommercial use in North America, the Company shall submit invoices to ERS for<br \/>\nAPI promptly after shipment. Payments shall be made by ERS within 60 days after<br \/>\nERS&#8217;s receipt of the invoice. ERS has no obligation to pay for any shipment of<br \/>\nAPI that (i) ERS and the Company agree does not to meet the Specifications<br \/>\nand\/or Manufacturing Standards, or (ii) in accordance with Section 8.8(b), ERS<br \/>\nhas found not to meet the Specifications and\/or Manufacturing Standards while<br \/>\nsuch findings have not been contradicted by independent laboratory testing.<br \/>\nUpon the Company&#8217;s receipt of a notice from ERS claiming that a shipment of API<br \/>\ndoes not meet the Specifications and\/or applicable Manufacturing Standards, the<br \/>\ntime period for payment of such shipment or such batch shall toll until such<br \/>\ntime as such non-conformity questions regarding such shipment or such batch are<br \/>\nresolved in accordance with Section 8.8. All relevant terms of Section 7 with<br \/>\nrespect to payments of Distribution Fees shall apply to the payment of invoices<br \/>\nfor the supply of API.<\/p>\n<p>              (d) Once the Company begins manufacturing API itself, it shall<br \/>\nuse its commercially reasonable efforts to reduce the Fully Burdened<br \/>\nManufacturing Cost of manufacturing API itself to an amount equal to or less<br \/>\nthan [**] before the end of calendar year [**]. The foregoing sentence shall<br \/>\napply only to API for the initial Product, and not to any other Products or<br \/>\nline extensions. If, in order to achieve the reduction referred to in the first<br \/>\nsentence of this Section 8.6(d), the Company reasonably determines that it must<br \/>\nchange the cell line and\/or manufacturing process for the Product, <\/p>\n<p>                                      37<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>the JMC shall approve such change and ERS shall assume all costs of any<br \/>\ntesting, qualification, scale-up, regulatory filings, and additional clinical<br \/>\ntrials which are reasonably necessary to support such changes in addition to,<br \/>\nand not as part of, the Development Costs assumed elsewhere in this Agreement.<br \/>\nIn the event that the Company does not achieve the target Fully Burdened<br \/>\nManufacturing Cost set forth in the first sentence of this Section 8.6(d), any<br \/>\nexcess of Fully Burdened Manufacturing Cost above such target cost shall be<br \/>\n[**] by ERS and the Company, after the end of calendar year [**].<\/p>\n<p>         8.7 Conformity; Specifications; Quality Control<\/p>\n<p>              (a) All quantities of API supplied by the Company pursuant to<br \/>\nthis Section 8 will comply in all material respects with the Specifications and<br \/>\napplicable Manufacturing Standards and shall adhere in all material respects to<br \/>\nall applicable governmental laws and regulations relating to the manufacture,<br \/>\nsale and shipment of each shipment of API at the time it is shipped by the<br \/>\nCompany hereunder.<\/p>\n<p>              (b) Changes to the Specifications shall be made only by the JMC.<\/p>\n<p>              (c) The Company shall conduct, or cause to be conducted, quality<br \/>\ncontrol testing of API prior to shipment, in accordance with the Specifications<br \/>\nand applicable Manufacturing Standards as are in effect from time to time and<br \/>\nsuch other quality control testing procedures adopted by the JMC from time to<br \/>\ntime (collectively, the &#8220;Testing Methods&#8221;). Initially and until decided<br \/>\notherwise by the JMC, the Testing Methods shall include all FDA required<br \/>\nrelease testing and the Company shall undertake all such tests. The Company<br \/>\nshall retain records pertaining to such testing. Each shipment of API hereunder<br \/>\nshall be accompanied by a certified quality control protocol and certificate of<br \/>\nanalysis for each lot of API therein as well as such customs and other<br \/>\ndocumentation as is necessary or appropriate.<\/p>\n<p>              (d) ERS shall have the right, at reasonable times and upon<br \/>\nreasonable notice, to inspect all facilities at which API is manufactured<br \/>\npursuant to this Section 8 for compliance with cGMP, subject to existing<br \/>\nagreements with Third Party Manufacturers.<\/p>\n<p>              (e) All units of Finished Product manufactured pursuant to this<br \/>\nAgreement will comply in all material respects with the applicable<br \/>\nManufacturing Standards and specifications for Finished Products determined by<br \/>\nthe JMC and shall adhere in all material respects to all applicable<br \/>\ngovernmental laws and regulations relating to the manufacture, sale and<br \/>\nshipment of each Finished Product at the time it is manufactured and<br \/>\ndistributed hereunder.<\/p>\n<p>              (f) The Party responsible for processing the API into Finished<br \/>\nProducts (either ERS or the Company to the extent that the Company is<br \/>\nresponsible for processing API into Finished Products pursuant to Section<br \/>\n8.1(b)) shall conduct, or cause to be conducted, quality control testing of<br \/>\neach Finished Product prior to shipment, in accordance with the applicable<br \/>\nManufacturing Standards and specifications for Finished Products determined by<br \/>\nthe JMC, as are in effect from time to time and such other quality control<br \/>\ntesting procedures adopted by the JMC from time to time. Such Party shall<br \/>\nretain records pertaining to such testing.<\/p>\n<p>         8.8 Acceptance\/Rejection; Interim Replacement.<\/p>\n<p>              (a) ERS may test or cause to be tested API supplied under this<br \/>\nSection 8 in accordance with ERS&#8217;s customary procedures within 30 days of its<br \/>\nreceipt at ERS&#8217;s plant or that of <\/p>\n<p>                                      38<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>its designee. ERS or its designee shall have the right to reject any shipment<br \/>\nof API made to it under this Agreement that does not meet the Specifications<br \/>\nand applicable Manufacturing Standards in any material respects when received<br \/>\nby it at such destination when tested in accordance with the Testing Methods.<br \/>\nAll claims by ERS of non-conforming API shall be deemed waived unless made by<br \/>\nERS in writing and received by the Company within such 30-day period.<\/p>\n<p>              (b) All claims of non-conforming API shall be accompanied by a<br \/>\nreport of analysis (including a sample of the API from the batch analyzed) of<br \/>\nthe allegedly non-conforming API that shall have been made by ERS or its<br \/>\ndesignee, using the Testing Methods. The Company shall promptly undertake its<br \/>\nown analysis of such sample after receiving such claim and report from ERS. If,<br \/>\nafter its own analysis, the Company does not confirm such non-conformity, the<br \/>\nJMC shall agree to retest the shipment or otherwise in good faith attempt to<br \/>\nagree upon a settlement of the issue. In the event that the JMC cannot resolve<br \/>\nthe issue, the JMC shall submit the disputed API to an independent testing<br \/>\nlaboratory, to be agreed upon by the JMC, for testing in accordance with the<br \/>\nTesting Methods. Notwithstanding Section 16.13, the findings of such laboratory<br \/>\nshall be binding on the Parties, absent manifest error. Expenses of such<br \/>\nindependent testing shall be borne by either ERS or the Company depending on<br \/>\nwhich such Party is adversely affected by such findings. In the event that any<br \/>\nAPI shipment or batch thereof is ultimately agreed or found not to meet the<br \/>\nSpecifications and\/or applicable Manufacturing Standards, the Company agrees to<br \/>\nreplace such shipment or batch with conforming API and pay for all reasonable<br \/>\nout of pocket expenses incurred by ERS and the Company in connection with<br \/>\nshipping and\/or storing such replacement API and storing the non-conforming<br \/>\nAPI. Such replacement shipment of API shall be treated as a new, additional<br \/>\nshipment of API (that will be separately invoiced by the Company) for all<br \/>\npurposes, including measuring its conformity to the Specifications and<br \/>\napplicable Manufacturing Standards and ERS&#8217;s payment for such additional<br \/>\nshipment. ERS shall return any such rejected shipment to the Company if so<br \/>\ninstructed by the Company, at the Company&#8217;s expense. In the event that any API<br \/>\nshipment or batch thereof is ultimately agreed or found to meet the<br \/>\nSpecifications and applicable Manufacturing Standards, ERS shall accept and pay<br \/>\nfor such shipment or batch in accordance with Section 8.6(c).<\/p>\n<p>              (c) Within 30 business days following December 31st of each<br \/>\ncalendar year after the first shipment of API by the Company in the Territory<br \/>\n(or upon such other times agreed to by the Finance Committee), the Finance<br \/>\nCommittee shall undertake a series of calculations to determine the amount, if<br \/>\nany, of overpayment by ERS to the Company of Fully Burdened Manufacturing Cost<br \/>\nfor API during the preceding calendar year, as follows:<\/p>\n<p>                   (i) The Finance Committee shall review and determine the<br \/>\nfollowing information regarding the previous calendar year&#8217;s production of API:<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>      Total Number of All Batches = total number of all (including successful,<br \/>\n      failed and non-conforming batches) API batches manufactured by the<br \/>\n      Company or attempted to be manufactured by the Company<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>      Total Number of Failed Batches = total number of all failed or<br \/>\n      non-conforming API batches manufactured by the Company or attempted to be<br \/>\n      manufactured by the Company<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>                                      39<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<br \/>\n      Total Cost of Failed Batches = total cost of all failed or non-conforming<br \/>\n      API batches manufactured by the Company or attempted to be manufactured<br \/>\n      by the Company (as such are reported as part of Fully Burdened<br \/>\n      Manufacturing Cost for API during such calendar year)<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>                   (ii) The Finance Committee shall undertake the following<br \/>\ncalculations:<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>      Average Cost Per Failed Batch  =  Total Cost of Failed Batches  \/  Total<br \/>\n      Number of Failed Batches<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>      Allowable Number of Failures = Total Number of All Batches x Allowable<br \/>\n      Failure Rate applicable to the calendar year under review<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>      Number of Excess Failed Batches  =  Total Number of Failed Batches  &#8211;<br \/>\n      Allowable Number of Failures<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>                   (iii) If the Number of Excess Failed Batches is greater than<br \/>\nzero, then the Finance Committee shall undertake the following calculation:<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>      Amount of Overpayment  =  Average Cost Per Failed Batch  x  Number of<br \/>\n      Excess Failed Batches<\/p>\n<p>      &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>If the Number of Excess Failed Batches is greater than zero, the Company shall<br \/>\nreimburse ERS for the Amount of Overpayment within 3 business days after the<br \/>\ncompletion of the calculation of such amount. Prior to receiving any such<br \/>\npayment, ERS may elect to credit any such amount due against any payment owed<br \/>\nto the Company under this Agreement. For purposes of such determinations, the<br \/>\n&#8220;Allowable Failure Rate&#8221; for the manufacture of API, in the aggregate, in<br \/>\ncalendar years 2001 and 2002 shall be [**]; in calendar years 2003 and 2004,<br \/>\nthe &#8220;Allowable Failure Rate&#8221; for the manufacture of API shall be [**]; and in<br \/>\ncalendar year 2005 and in all subsequent calendar years, the &#8220;Allowable Failure<br \/>\nRate&#8221; for the manufacture of API shall be [**]. In the event the Finance<br \/>\nCommittee does not agree on the Amount of Overpayment, such matter shall be<br \/>\nreferred to the JEC for resolution. <\/p>\n<p>                   (d) Upon the Company&#8217;s receipt of a claim that a shipment or<br \/>\nbatch thereof of API does not meet the Specifications and\/or applicable<br \/>\nManufacturing Standards, the Company shall use commercially reasonable efforts<br \/>\nto replace such shipment or batch thereof with an additional shipment of API<br \/>\nthat does conform to such standards as soon as practicable.<\/p>\n<p>         8.9 Third Party Manufacturers. The Parties acknowledge and agree that<br \/>\nthe Company currently obtains Finished Products through written contractual<br \/>\narrangements with Third Party Manufacturers. Upon the execution and delivery of<br \/>\nthis Agreement, the Company shall use <\/p>\n<p>                                      40<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>commercially reasonable efforts to assign all such written contracts to ERS,<br \/>\nand upon such assignment, the Company shall and hereby does represent and<br \/>\nwarrant that, as of the Effective Date, to the knowledge of the Company it is<br \/>\nnot in breach under any such contracts and that data and information provided<br \/>\nto ERS by the Company relating to such contracts is accurate and complete in<br \/>\nall material respects and contains no material errors or omissions. If any of<br \/>\nsuch contracts are not assigned (after the Company&#8217;s use of commercially<br \/>\nreasonable efforts to secure their assignment under such contracts), ERS will<br \/>\nreimburse the Company for the cost of producing Finished Product. The JMC shall<br \/>\nprepare a strategy and transition plan for transitioning the production of<br \/>\nFinished Products from such Third Party Manufacturers to ERS, which shall<br \/>\nprovide for a reasonably sufficient amount of time for ERS to be able to<br \/>\nmanufacture all of its requirements of Finished Products. The JMC may, from<br \/>\ntime to time, determine that the Company may use Third Party Manufacturers to<br \/>\nsupply all or some of the API it is required to supply to ERS under this<br \/>\nAgreement.<\/p>\n<p>         8.10 Inventory Management ERS shall maintain inventory of Finished<br \/>\nProduct and API in accordance with ERS&#8217;s usual and customary inventory<br \/>\nmanagement practices that ERS applies to its other therapeutic oncology<br \/>\nproducts.<\/p>\n<p>         8.11 Shortage of Supply.<\/p>\n<p>              (a) The Company shall notify ERS: (i) as promptly as possible,<br \/>\nbut in no event more than ten days after the Company&#8217;s receipt of a firm order<br \/>\nfrom ERS as provided in Section 8.4, or (ii) immediately upon becoming aware<br \/>\nthat the Company is unable to supply the quantity of API to ERS that the<br \/>\nCompany is required to supply hereunder, if the Company is unable to supply<br \/>\nsuch quantities of API. In such event, the Company shall implement all<br \/>\ncommercially reasonable efforts to remedy such shortage, including through the<br \/>\nuse of Third Party Manufacturers for all or a portion of such quantities of<br \/>\nAPI, as determined are necessary by the JMC.<\/p>\n<p>              (b) In the event that the Company is unable to supply both ERS&#8217;s<br \/>\nrequirements of API and the Company&#8217;s and Third Parties&#8217; requirements for the<br \/>\nAPI due to force majeure or otherwise, the Company shall allocate the API that<br \/>\nthe Company has in inventory and that the Company is able to produce among the<br \/>\nquantities of all such requirements, so that ERS receives at least its<br \/>\nproportionate share of such available supplies, as determined from reasonable<br \/>\nforecasts (taking into consideration past sales and sales performance against<br \/>\nforecast) and orders, for the API.<\/p>\n<p>         8.12     Inability to Supply.<\/p>\n<p>              (a) In the event of any Short-Term Inability to Supply or<br \/>\nLong-Term Inability to Supply, ERS shall be entitled in proportion to the<br \/>\nsupply shortfall to delay the incurrence of the Development Costs and\/or the<br \/>\nDistribution Costs, Sales Costs and\/or Marketing Costs for the relevant period,<br \/>\nuntil such Short-Term Inability to Supply or Long-Term Inability to Supply<br \/>\nends. The Clinical Budget and\/or the relevant Marketing Budget shall be<br \/>\nadjusted accordingly. Any issues relating to the application of this provision<br \/>\nshall be subject to review by the relevant Committee, and any resolution of<br \/>\nsuch matters shall require a consensus decision by such Committee, not subject<br \/>\nto the tie-break mechanisms of the relevant Sections of this Agreement.<\/p>\n<p>              (b) An &#8220;Inability to Supply&#8221; shall mean: (i) with respect to the<br \/>\nsupply of API for Registrational Studies or Non-Registrational Studies, the<br \/>\nCompany&#8217;s failure for any reason, including without limitation force majeure<br \/>\nreasons or otherwise, to supply ERS with quantities of API meeting the<br \/>\nSpecifications and Manufacturing Standards equal to at least [**] of the<br \/>\nquantity of API set forth in the applicable time period on Exhibit 8.12(B)(i);<br \/>\nand (ii) with respect to the supply of API for commercial sales, the Company&#8217;s<br \/>\nfailure for any reason, including without limitation force majeure reasons or<br \/>\notherwise, to supply ERS with quantities of API meeting the Specifications and<\/p>\n<p>                                      41<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>Manufacturing Standards equal to at least [**] of the quantity of API set forth<br \/>\nin the applicable time period on Exhibit 8.12(B)(ii).<\/p>\n<p>              (c) A &#8220;Short-Term Inability to Supply&#8221; is an Inability to Supply<br \/>\nthat is reasonably expected to continue for no more than a six-month period of<br \/>\ntime.<\/p>\n<p>              (d) A &#8220;Long-Term Inability to Supply&#8221; shall mean any Inability to<br \/>\nSupply that is reasonably expected to exceed or actually exceeds a six-month<br \/>\nperiod of time.<\/p>\n<p>              (e) In the event that ERS believes that any Long-Term Inability<br \/>\nto Supply exists, ERS shall provide the Company with written notice of such<br \/>\nclaim and the JMC shall promptly meet to discuss such claims and to determine<br \/>\nwhether the alleged Long-Term Inability to Supply exists and whether it is due<br \/>\nsolely to a force majeure event. If the JMC does not reach a consensus decision<br \/>\nin its deliberations regarding such claims, then the matter shall be referred<br \/>\nto the JEC for resolution, provided that Sections 2.1(d)(ii), (iii) and (iv)<br \/>\nshall not apply with respect to such matter. If the JEC does not reach<br \/>\nconsensus decision on the matter, then ERS may submit the matter to arbitration<br \/>\npursuant to the Accelerated Arbitration Provisions set forth in Section<br \/>\n16.13(b). The Parties shall reasonably and promptly cooperate with the JMC,<br \/>\nJEC, and arbitrators, as the case may be, during their proceedings regarding<br \/>\nsuch claims.<\/p>\n<p>              (f) If a determination is made pursuant to Section 8.12(e), by<br \/>\nthe JMC, the JEC, or the arbitrators, as the case may be, that a Long-Term<br \/>\nInability to Supply exists, the JEC shall re-evaluate the Clinical Development<br \/>\nPlans, Marketing Plans, Clinical Budget and\/or the Marketing Budgets in view of<br \/>\nsuch Long-Term Inability to Supply. If a determination is made pursuant to<br \/>\nSection 8.12(e), by the JMC, the JEC, or the arbitrators, as the case may be,<br \/>\nthat a Long-Term Inability to Supply exists and is not due solely to a force<br \/>\nmajeure event, then: (i) for so long as such Long-Term Inability to Supply<br \/>\ncontinues, the JMC shall be co-chaired by representatives of ERS and the<br \/>\nCompany and matters that are the subject of a deadlock arising in the JMC shall<br \/>\nbe resolved in accordance with the Accelerated Arbitration Provisions of<br \/>\nSection 16.13(b); (ii) the Company shall reasonably cooperate with ERS to<br \/>\nestablish an alternative supply, including locating qualified third party<br \/>\nmanufacturers and sources of materials; and (iii) the JMC shall (with the<br \/>\nunderstanding that the goal of the Parties shall be to transition the<br \/>\nmanufacture and supply of API back to the Company as soon as practicable, to<br \/>\nthe extent that such Long-Term Inability to Supply ceases to exist) authorize<br \/>\nthe taking of one or more the following actions to make up for the API supply<br \/>\nshortfall, in the order of preference listed below, and with the understanding<br \/>\nthat performance of API supply obligations and responsibilities under each of<br \/>\nthe actions listed below shall be reasonably consistent with the scope of<br \/>\nperformance of such obligations and responsibilities contemplated to be<br \/>\nperformed by the Company as the primary source of API supply:<\/p>\n<p>                    first, make use of the internal capacity of BMS and\/or ERS<br \/>\n                    to fill the API supply shortfall;<\/p>\n<p>                    second, contract with a third party manufacturer to fill<br \/>\n                    the API supply shortfall; and<\/p>\n<p>                    third, take such other actions as may be necessary for<br \/>\n                    purposes of filling the API supply shortfall.<\/p>\n<p>              (g) The Company shall reimburse ERS for all reasonable<br \/>\nout-of-pocket costs incurred in connection with making up for a shortfall in<br \/>\nAPI supply pursuant to Section 8.12(f); provided, <\/p>\n<p>                                      42<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>however that such reimbursable costs shall not include the costs of purchasing<br \/>\nAPI from a third party manufacturer or the costs of purchasing any component<br \/>\nused to manufacture API for purposes of calculating Fully Burdened<br \/>\nManufacturing Cost as defined in Exhibit 1.35 (as applied to ERS) other than<br \/>\nthose directly relating to the startup of biologic operation for the Product,<br \/>\nincluding any efficiency, activity and spending variances from standards as<br \/>\nwell as any underabsorbed overhead expenses incurred during such startup,<br \/>\nincluding, without limitation, capital investments undertaken by ERS that are<br \/>\nauthorized by the JMC which relate to ERS&#8217;s use, dedication, expansion, and\/or<br \/>\ncreation of ERS&#8217;s internal capability to supply API. The rights of ERS pursuant<br \/>\nto this Section 8.12 shall not be affected in any way by ERS&#8217;s waiver or<br \/>\nfailure to take action with respect to any previous failure by the Company. Any<br \/>\nrights provided to ERS pursuant to this Section shall be in addition to any<br \/>\nother rights or remedies available to ERS at law or in equity.<\/p>\n<p>              (h) If a determination is made pursuant to Section 8.12(e), by<br \/>\nthe JMC, the JEC, or the arbitrators, as the case may be, that a Long-Term<br \/>\nInability to Supply exists and is due solely to a force majeure event, then the<br \/>\nJMC shall meet to determine how to rectify such Long-Term Inability to Supply.<br \/>\nIf the JMC does not reach a consensus decision, then the matter shall be<br \/>\nreferred to the JEC for resolution, provided that Sections 2.1(d)(ii), (iii)<br \/>\nand (iv) shall not apply with respect to such matter. If the JEC does not reach<br \/>\nconsensus decision on the matter, then any Party may submit the matter to<br \/>\narbitration pursuant to the Accelerated Arbitration Provisions set forth in<br \/>\nSection 16.13(b). The Parties shall reasonably and promptly cooperate with the<br \/>\nJMC, JEC, and arbitrators, as the case may be, during their proceedings<br \/>\nregarding such Long-Term Inability to Supply.<\/p>\n<p>              (i) In the event that ERS or a third party manufacturer is to<br \/>\nsupply API in accordance with Section 8.12(f), the Company shall fully<br \/>\ncooperate with ERS or such third party manufacturer, as the case may be, and<br \/>\ntake all actions necessary to qualify them as a manufacturer of API, including,<br \/>\nwithout limitation: (i) providing them with copies of all documentation within<br \/>\nthe Company&#8217;s possession and control that is reasonably necessary for them to<br \/>\nmanufacture API; (ii) providing such technical assistance as is reasonably<br \/>\nnecessary to enable them to manufacture API in accordance with the<br \/>\nSpecifications and the applicable Manufacturing Standards; and (iii) to the<br \/>\nextent that ERS or a third party manufacturer supplies API pursuant to Section<br \/>\n8.12(f), ERS shall be relieved of its obligation to purchase from the Company<br \/>\nsuch quantities of API.<\/p>\n<p>9.       OWNERSHIP; PATENTS; TRADEMARKS.<\/p>\n<p>         9.1 Ownership. All Inventions developed by any Party or jointly by the<br \/>\nCompany, ERS, and\/or BMS shall be owned by the Company, except for Inventions<br \/>\ndeveloped solely by ERS and\/or BMS which have general utility in connection<br \/>\nwith other products and\/or compounds in addition to the Compounds and\/or<br \/>\nProducts, in which case ERS shall own such Inventions (&#8220;ERS Inventions&#8221;). To<br \/>\nthe extent necessary to effectuate the foregoing, ERS shall take any action<br \/>\nreasonably necessary to effectuate the Company&#8217;s ownership pursuant to the<br \/>\nforegoing. The Company shall have all right, title and interest in and to the<br \/>\nPatents, Know-How, and Trademarks, whether in existence on the Effective Date<br \/>\nor developed during the term of this Agreement, subject to the rights granted<br \/>\nto ERS and BMS pursuant to this Agreement.<\/p>\n<p>         9.2      Maintenance of the Patents.<\/p>\n<p>              (a) The Company shall have full responsibility for, and shall<br \/>\ncontrol the preparation and prosecution of, all patent applications and the<br \/>\nmaintenance of all patents relating to the Technology (including the Patents)<br \/>\nthroughout the Territory. In connection therewith, the Company shall generally<br \/>\nconsult with ERS on all future filings with respect to the Patents and the<br \/>\nprosecution <\/p>\n<p>                                      43<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>and maintenance of such Patents, including where appropriate or reasonably<br \/>\nrequested by ERS, providing copies to ERS of any such filings made to, and<br \/>\nwritten communications received from, any patent office relating, in whole or<br \/>\nin part, to the Patents. The Company shall pay all costs and expenses of<br \/>\nfiling, prosecuting and maintaining the Patents and the patents covering<br \/>\nInventions arising from the Technology. ERS shall have full responsibility for,<br \/>\nand shall control the preparation and prosecution of, all patent applications<br \/>\nand the maintenance of all patents relating to ERS Inventions throughout the<br \/>\nTerritory. In connection therewith, ERS shall generally consult with the<br \/>\nCompany on all future filings with respect to such patents and the prosecution<br \/>\nand maintenance of such patents, including where appropriate or reasonably<br \/>\nrequested by the Company, providing copies to the Company of any such filings<br \/>\nmade to, and written communications received from, any patent office relating,<br \/>\nin whole or in part, to such patents. ERS shall pay all costs and expenses of<br \/>\nfiling, prosecuting and maintaining patents covering ERS Inventions.<br \/>\nNotwithstanding the foregoing, the Company shall not have the right to file<br \/>\npatent applications or maintain patents for ERS Inventions, regardless of<br \/>\nwhether such ERS Inventions relate to the Technology. Upon a determination by<br \/>\nthe PDC that a patent application should be filed for an Invention relating to<br \/>\na Product that the PDC intends to commercialize in a particular country, the<br \/>\nCompany shall, at it sole cost and expense, file patent applications for such<br \/>\nInvention in such country.<\/p>\n<p>              (b) Each Party agrees to cooperate with the other Parties to<br \/>\nexecute all lawful papers and instruments, to make all rightful oaths and<br \/>\ndeclarations and to provide consultation and assistance as may be necessary in<br \/>\nthe preparation, prosecution, maintenance and enforcement of all such patents<br \/>\nand patent applications pursuant to this Agreement.<\/p>\n<p>         9.3      Patent Enforcement.<\/p>\n<p>              (a) If any Party learns of an infringement, unauthorized use,<br \/>\nmisappropriation or ownership claim or threatened infringement or other such<br \/>\nclaim (any of the foregoing, an &#8220;infringement&#8221;) by a Third Party with respect<br \/>\nto any Technology or any Trademark within the Territory, such Party shall<br \/>\npromptly notify the other Parties and shall provide such other Parties with<br \/>\navailable evidence of such infringement.<\/p>\n<p>              (b) The Company shall have the first right, but not the duty, to<br \/>\ninstitute patent or trademark infringement actions against Third Parties based<br \/>\non any Technology or Trademark in the Territory. If the Company does not<br \/>\ninstitute an infringement proceeding against an offending Third Party within<br \/>\n180 days of learning of such infringement or, in the event that a Third Party<br \/>\nfiles a paragraph IV certification relating to any Patent pursuant to 21 U.S.C.<br \/>\nss.355(j)(2)(A)(vii)(IV) of the Hatch\/Waxman Act (or any successor statute), if<br \/>\nthe Company does not institute an infringement proceeding against such Third<br \/>\nParty within 30 days of receipt of notice of such paragraph IV certification,<br \/>\nERS shall have the right, but not the duty, to institute such an action with<br \/>\nrespect to any infringement by such Third Party; provided that ERS may not<br \/>\nenter into any settlement, consent judgment or other voluntary final<br \/>\ndisposition of such action which adversely effects any Technology or Trademark<br \/>\nwithout the prior written consent of the Company, which will not be<br \/>\nunreasonably withheld. The costs and expenses of any such action (including<br \/>\nfees of attorneys and other professionals) shall be borne by the Party<br \/>\ninstituting the action, or, if the Parties elect to cooperate in instituting<br \/>\nand maintaining such action, such costs and expenses shall be borne by the<br \/>\nParties in such proportions as they may agree in writing. Each Party shall<br \/>\nexecute all necessary and proper documents, take such actions as shall be<br \/>\nappropriate to allow the other Party(ies) to institute and prosecute such<br \/>\ninfringement actions and shall otherwise cooperate in the institution and<br \/>\nprosecution of such actions (including, without limitation, consenting to being<br \/>\nnamed as a nominal party thereto). Each Party prosecuting any such infringement<br \/>\nactions shall keep the other Parties reasonably informed as to the status of<br \/>\nsuch actions. Any award paid by Third Parties as a result of such an<\/p>\n<p>                                      44<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>infringement action (whether by way of settlement or otherwise) shall be<br \/>\napplied first to reimburse the Parties for all costs and expenses incurred by<br \/>\nthe Parties with respect to such action on a pro rata basis and, if after such<br \/>\nreimbursement any funds shall remain from such award, they shall be allocated<br \/>\nas follows: (i) if the Company has instituted and maintained such action alone,<br \/>\nthe Company shall be entitled to retain such remaining funds; (ii) if ERS<br \/>\nand\/or BMS has instituted and maintained such action alone, ERS and\/or BMS, as<br \/>\nthe case may be, shall be entitled to retain such remaining funds; or (iii) if<br \/>\nthe Parties have cooperated in instituting and maintaining such action, the<br \/>\nParties shall allocate such remaining funds between themselves in the same<br \/>\nproportion as they have agreed to bear the expenses of instituting and<br \/>\nmaintaining such action.<\/p>\n<p>              (c) ERS shall have the first right, but not the duty, to<br \/>\ninstitute patent infringement actions against Third Parties based on the use of<br \/>\nERS Inventions which are used in the development, use, manufacture,<br \/>\ndistribution, promotion and\/or sale of Compounds and\/or Products in the Field.<br \/>\nIf ERS does not institute an infringement proceeding against an offending Third<br \/>\nParty within 180 days of learning of such infringement or, in the event that a<br \/>\nThird Party files a paragraph IV certification relating to any ERS Inventions<br \/>\npursuant to 21 U.S.C. ss.355(j)(2)(A)(vii)(IV) of the Hatch\/Waxman Act (or any<br \/>\nsuccessor statute), if ERS does not institute an infringement proceeding<br \/>\nagainst such Third Party within 30 days of receipt of notice of such paragraph<br \/>\nIV certification, the Company shall have the right, but not the duty, to<br \/>\ninstitute such an action with respect to any infringement by such Third Party;<br \/>\nprovided that the Company may not enter into any settlement, consent judgment<br \/>\nor other voluntary final disposition of such action which adversely effects any<br \/>\nERS Inventions without the prior written consent of ERS, which will not be<br \/>\nunreasonably withheld. The costs and expenses of any such action (including<br \/>\nfees of attorneys and other professionals) shall be borne by the Party<br \/>\ninstituting the action, or, if the Parties elect to cooperate in instituting<br \/>\nand maintaining such action, such costs and expenses shall be borne by the<br \/>\nParties in such proportions as they may agree in writing. Each Party shall<br \/>\nexecute all necessary and proper documents, take such actions as shall be<br \/>\nappropriate to allow the other Party(ies) to institute and prosecute such<br \/>\ninfringement actions and shall otherwise cooperate in the institution and<br \/>\nprosecution of such actions (including, without limitation, consenting to being<br \/>\nnamed as a nominal party thereto). Each Party prosecuting any such infringement<br \/>\nactions shall keep the other Party(ies) reasonably informed as to the status of<br \/>\nsuch actions. Any award paid by Third Parties as a result of such an<br \/>\ninfringement action (whether by way of settlement or otherwise) shall be<br \/>\napplied first to reimburse the Parties for all costs and expenses incurred by<br \/>\nthe Parties with respect to such action on a pro rata basis and, if after such<br \/>\nreimbursement any funds shall remain from such award, they shall be allocated<br \/>\nas follows: (i) if ERS and\/or BMS has instituted and maintained such action<br \/>\nalone, ERS and\/or BMS, as the case may be, shall be entitled to retain such<br \/>\nremaining funds; (ii) if the Company has instituted and maintained such action<br \/>\nalone, the Company shall be entitled to retain such remaining funds; or (iii)<br \/>\nif the Parties have cooperated in instituting and maintaining such action, the<br \/>\nParties shall allocate such remaining funds between themselves in the same<br \/>\nproportion as they have agreed to bear the expenses of instituting and<br \/>\nmaintaining such action.<\/p>\n<p>         9.4      Infringement Action by Third Parties.<\/p>\n<p>              (a) In the event of the institution or threatened institution of<br \/>\nany suit by a Third Party against ERS for patent or trademark infringement<br \/>\ninvolving the manufacture, use, distribution, sale or marketing of a Product in<br \/>\nthe Territory, ERS shall promptly notify the Company in writing of such suit.<br \/>\nUnless otherwise covered by Section 12.3(c), the Company shall be required to<br \/>\ndiligently defend such suit at its own expense shall control the defense of<br \/>\nsuch action and, subject to Section 9.4(c), shall be responsible for all<br \/>\ndamages incurred as a result thereof and shall indemnify ERS in connection<br \/>\ntherewith. ERS hereby agrees to assist and cooperate with the Company, at the<br \/>\nCompany&#8217;s reasonable request and expense, in the defense of any suit related to<br \/>\nthe Technology or Trademark (including, without limitation, consenting to being<br \/>\nnamed as a nominal party thereto). <\/p>\n<p>                                      45<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>During the pendency of such action and thereafter, ERS shall continue to make<br \/>\nall payments due under this Agreement. If the Company finally prevails and<br \/>\nreceives an award from such Third Party as a result of such action (whether by<br \/>\nway of judgment, award, decree, settlement or otherwise), such award shall be<br \/>\nretained entirely by the Company.<\/p>\n<p>              (b) In the event of the institution or threatened institution of<br \/>\nany suit by a Third Party against ERS for patent infringement involving the ERS<br \/>\nInventions which are used in the development, use, manufacture, distribution,<br \/>\npromotion and\/or sale of Compounds and\/or Products in the Field, ERS shall<br \/>\npromptly notify the Company in writing of such suit. ERS shall be required to<br \/>\ndiligently defend such suit at its own expense, shall control the defense of<br \/>\nsuch action and shall be responsible for all payment of damages incurred as a<br \/>\nresult thereof (or payment of any license fees incurred in connection with any<br \/>\nlicense obtained by the Parties from such Third Party); provided that (A) to<br \/>\nthe extent that such suit relates to ERS Inventions used solely by the Company,<br \/>\nthe Company shall diligently defend such suit at its own expense, shall control<br \/>\nthe defense of such action and shall be responsible for all payment of damages<br \/>\nincurred as a result thereof (or payment of any license fees incurred in<br \/>\nconnection with any license obtained by the Company from such Third Party) and<br \/>\n(B) to the extent that such suit relates to ERS Inventions used by both ERS and<br \/>\nthe Company, the Parties shall cooperate in the defense of such action and<br \/>\nshall be responsible for payment of damages incurred as a result thereof (or<br \/>\npayment of any license fees incurred in connection with any license obtained by<br \/>\nthe Parties from such Third Party) on a basis which is proportionate to their<br \/>\nrelative usage of such ERS Inventions. In the event that a Party is solely<br \/>\nresponsible for defending an action involving ERS Inventions, the other<br \/>\nParty(ies) shall assist and cooperate with such Party, at such Party&#8217;s<br \/>\nreasonable request and expense. If a Party which is solely responsible for<br \/>\ndefending an action involving ERS Inventions finally prevails and receives an<br \/>\naward from such Third Party as a result of such action (whether by way of<br \/>\njudgment, award, decree, settlement or otherwise), such award shall be retained<br \/>\nentirely by such Party. If the Parties cooperate in the defense of an action<br \/>\ninvolving ERS Inventions pursuant to (B) above and such Parties finally prevail<br \/>\nand receive an award from such Third Party as a result of such action (whether<br \/>\nby way of judgment, award, decree, settlement or otherwise), such award shall<br \/>\nbe shared on an equitable basis by the Parties.<\/p>\n<p>              (c) Unless otherwise covered by Section 12.3(c), (A) in the event<br \/>\nthat the PDC determines that a license under Third Party patents or trademarks<br \/>\nshould be obtained to avoid infringement of such Third Party patents or<br \/>\ntrademarks in order to make, have made, use or sell any Product in any<br \/>\ncountry(ies) in North America or in Japan, or royalties should be paid to such<br \/>\nThird Party in respect of sales of such Products in such country(ies) in North<br \/>\nAmerica or in Japan (provided that the Parties agree for the purposes of this<br \/>\nSection 9.4(c), that the PDC shall be deemed to have determined that licenses<br \/>\nobtained prior to the execution of this Agreement that are held by the Company<br \/>\nshould have been so obtained), or (B) if the Company or ERS finally loses and<br \/>\nis required to pay damages or an award to a Third Party as a result of an<br \/>\naction commenced under Section 9.4(a) (whether by way of judgment, award,<br \/>\ndecree, settlement or otherwise); then: (i) the Distribution Fees due from ERS<br \/>\nto the Company pursuant to Sections 6.3 with respect to rights in North America<br \/>\nshall be increased by an amount equal to [**] of any royalties or damages<br \/>\nattributable to Net Sales in North America, up to a maximum increase equal to:<br \/>\n(1) [**] of Net Sales of Products in North America during any calendar quarter<br \/>\nduring calendar years 2002 through and including 2006; and (2) [**] of Net<br \/>\nSales of Products in North America during any calendar quarter following 2006;<br \/>\nand (ii) with respect to rights in Japan, the Company shall be entitled to<br \/>\nallocate an amount equal to any royalties or damages attributable to Net Sales<br \/>\nin Japan against Cost of Goods Sold (in accordance with the Financial Appendix)<br \/>\nup to a maximum amount equal to: (1) [**] of Net Sales of Products in Japan<br \/>\nduring any calendar quarter during calendar years 2002 through and including<br \/>\n2006; and (2) [**] of Net Sales of Products in the Japan during any calendar<br \/>\nquarter following 2006.<\/p>\n<p>                                      46<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>10.      PUBLICATION; CONFIDENTIALITY<\/p>\n<p>         10.1 Notification. The Parties recognize that each may wish to publish<br \/>\nthe results of their wor k relating to the subject matter of this Agreement.<br \/>\nHowever, the Parties also recognize the importance of acquiring patent<br \/>\nprotection. Consequently, subject to any applicable laws or regulations<br \/>\nobligating any Party to do otherwise, any proposed publication by any Party<br \/>\nshall comply with this Section 10. All publications, whether written or oral,<br \/>\nshall be prepared in accordance with the joint publication strategy established<br \/>\nand approved by the PDC. At least 45 days before a manuscript is to be<br \/>\nsubmitted to a publisher, the publishing Party will provide the PDC with a copy<br \/>\nof the manuscript. If the publishing Party wishes to make an oral presentation,<br \/>\nit will provide the PDC with a summary of such presentation at least 30 days<br \/>\nbefore such oral presentation and, if an abstract is to be published, 30 days<br \/>\nbefore such abstract is to be submitted. Any oral presentation, including any<br \/>\nquestion period, shall not include any Confidential Information unless the<br \/>\nParties otherwise mutually agree in writing in advance of such oral<br \/>\npresentation.<\/p>\n<p>         10.2 Review. The PDC will review the manuscript, abstract, text or any<br \/>\nother material provided to it under Section 10.1 to determine whether<br \/>\npatentable subject matter is disclosed. The PDC will notify the publishing<br \/>\nParty within 30 days of receipt of the proposed publication if the PDC, in good<br \/>\nfaith, determines that patentable subject matter is or may be disclosed, or if<br \/>\nthe PDC, in good faith, believes Confidential Information is or may be<br \/>\ndisclosed. If it is determined by the PDC that patent applications should be<br \/>\nfiled, the publishing Party shall delay its publication or presentation for a<br \/>\nperiod not to exceed 60 days from the PDC&#8217;s receipt of the proposed publication<br \/>\nor presentation to allow time for the filing of patent applications covering<br \/>\npatentable subject matter. In the event that the delay needed to complete the<br \/>\nfiling of any necessary patent application will exceed the 60-day period, the<br \/>\nPDC will discuss the need for obtaining an extension of the publication delay<br \/>\nbeyond the 60-day period. If it is determined in good faith by the PDC that<br \/>\nConfidential Information or proprietary information is being disclosed, the<br \/>\nParties will consult in good faith to arrive at an agreement on mutually<br \/>\nacceptable modifications to the proposed publication or presentation to avoid<br \/>\nsuch disclosure.<\/p>\n<p>         10.3 Confidentiality; Exceptions. Except to the extent expressly<br \/>\nauthorized by this Agreement or otherwise agreed in writing, the Parties agree<br \/>\nthat, during the term of this Agreement and for ten years thereafter, the<br \/>\nreceiving Party, its Affiliates and its licensees shall, and shall ensure that<br \/>\ntheir respective employees, officers, directors and other representatives<br \/>\nshall, keep completely confidential and not publish or otherwise disclose and<br \/>\nnot use for any purpose any information furnished to it or them by the<br \/>\ndisclosing Party, its Affiliates or its licensees or developed under or in<br \/>\nconnection with this Agreement, except to the extent that it can be established<br \/>\nby the receiving Party by competent proof that such information: (i) was<br \/>\nalready known to the receiving Party, other than under an obligation of<br \/>\nconfidentiality, at the time of disclosure by the disclosing Party; (ii) was<br \/>\ngenerally available to the public or otherwise part of the public domain at the<br \/>\ntime of its disclosure to the receiving Party; (iii) became generally available<br \/>\nto the public or was otherwise part of the public domain after its disclosure<br \/>\nand other than through any act or omission of the receiving Party in breach of<br \/>\nthis Agreement; or (iv) was disclosed to the receiving Party, other than under<br \/>\nan obligation of confidentiality, by a Third Party who had no obligation to the<br \/>\ndisclosing Party not to disclose such information to others (all such<br \/>\ninformation to which none of the foregoing exceptions applies, shall be deemed<br \/>\n&#8220;Confidential Information&#8221;).<\/p>\n<p>         10.4 Exceptions to Obligation. The restrictions contained in Section<br \/>\n10.3 shall not apply to Confidential Information that: (i) is submitted by the<br \/>\nrecipient to governmental authorities to facilitate the issuance of<br \/>\nRegistrations for the Product, provided that reasonable measures shall be <\/p>\n<p>                                      47<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>taken to assure confidential treatment of such information; (ii) is provided by<br \/>\nthe recipient to Third Parties under confidentiality provisions at least as<br \/>\nstringent as those in this Agreement, for consulting, manufacturing<br \/>\ndevelopment, manufacturing, external testing, or marketing trials; or (iii) is<br \/>\notherwise required to be disclosed in compliance with applicable laws or<br \/>\nregulations or order by a court or other regulatory body having competent<br \/>\njurisdiction; provided that if a Party is required to make any such disclosure<br \/>\nof disclosing Party&#8217;s Confidential Information such Party will, except where<br \/>\nimpracticable for necessary disclosures (for example, to physicians conducting<br \/>\nstudies or to health authorities), give reasonable advance notice to the<br \/>\ndisclosing Party of such disclosure requirement and, except to the extent<br \/>\ninappropriate in the case of patent applications, will use its best efforts to<br \/>\nsecure confidential treatment of such Confidential Information required to be<br \/>\ndisclosed.<\/p>\n<p>         10.5 Limitations on Use. Each Party shall use, and cause each of its<br \/>\nAffiliates and its licensees to use, any Confidential Information obtained by<br \/>\nsuch Party from the disclosing Party, its Affiliates or its licensees, pursuant<br \/>\nto this Agreement or otherwise, solely in connection with the activities or<br \/>\ntransactions contemplated hereby.<\/p>\n<p>         10.6 Remedies. Each Party shall be entitled, in addition to any other<br \/>\nright or remedy it may have, at law or in equity, to an injunction, without the<br \/>\nposting of any bond or other security, enjoining or restraining the disclosing<br \/>\nParty, its Affiliates and\/or its licensees from any violation or threatened<br \/>\nviolation of this Section 10.<\/p>\n<p>11.      REPRESENTATIONS AND WARRANTIES.<\/p>\n<p>         11.1 Representations and Warranties of the Parties. Each Party<br \/>\nrepresents and warrants to each of the other<br \/>\nParties, as of the Effective Date, that:<\/p>\n<p>              (a) Such Party is duly organized, validly existing and in good<br \/>\nstanding under the laws of the jurisdiction of its incorporation and has full<br \/>\ncorporate power and authority to enter into this Agreement and to carry out the<br \/>\nprovisions hereof;<\/p>\n<p>              (b) Such Party has taken all corporate action necessary to<br \/>\nauthorize the execution and delivery of this Agreement and the performance of<br \/>\nits obligations under this Agreement and has full power and authority to enter<br \/>\ninto this Agreement and perform its obligations under this Agreement; and<\/p>\n<p>              (c) This Agreement has been duly executed by such Party and<br \/>\nconstitutes a valid and legally binding obligation of such Party, enforceable<br \/>\nin accordance with its terms, subject to and limited by: (i) applicable<br \/>\nbankruptcy, insolvency, reorganization, moratorium, and other laws generally<br \/>\napplicable to creditors&#8217; rights; and (ii) judicial discretion in the<br \/>\navailability of equitable relief.<\/p>\n<p>              (d) Such Party is not required to obtain the consent, approval,<br \/>\norder, or authorization of any Third Party, or complete any registration,<br \/>\nqualification, designation, declaration or filing with, any federal, state,<br \/>\nlocal, or provincial governmental authority, in connection with the execution<br \/>\nand delivery of this Agreement and the performance by such Party of its<br \/>\nobligations under this Agreement, including, without limitation, <\/p>\n<p>                                      48<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>the grant of rights to the other Parties pursuant to this Agreement, or such<br \/>\nParty has done so (with respect to the Company, including, without limitation,<br \/>\nthat all consents, approvals and authorizations required pursuant to the Merck<br \/>\nAgreement have been secured by the Company); and<\/p>\n<p>              (e) The execution and delivery of this Agreement, and the<br \/>\nperformance by such other Party of its obligations under this Agreement,<br \/>\nincluding without limitation the grant of rights to the other Parties pursuant<br \/>\nto this Agreement, will not: (i) conflict with, nor result in any violation of<br \/>\nor default under any such instrument, judgment, order, writ, decree, contract<br \/>\nor provision; (ii) give rise to any event that results in the creation of any<br \/>\nlien, charge or encumbrance upon any assets of such Party or the suspension,<br \/>\nrevocation, impairment, forfeiture or non-renewal of any material permit,<br \/>\nlicense, authorization or approval that applies to such Party, its business or<br \/>\noperations or any of its assets or properties; or (iii) conflict with any<br \/>\nrights granted by such Party to any Third Party or breach any obligation that<br \/>\nsuch Party has to any Third Party.<\/p>\n<p>         11.2 Representations and Warranties of the Company. The Company<br \/>\nrepresents and warrants to each of ERS and BMS, as of the Effective Date, that,<br \/>\nexcept as disclosed in Company SEC Documents or in the disclosure letter<br \/>\npreviously delivered by the Company to BMS:<\/p>\n<p>              (a) The Company is the owner of, or has exclusive rights to, all<br \/>\nof the Patents and Trademarks in existence on the Effective Date, and has the<br \/>\nexclusive right to grant the rights granted under this Agreement therefor. To<br \/>\nthe knowledge of the Company, all of the Patents and Trademarks are valid, in<br \/>\nfull force and effect and have been maintained to date, and are not the subject<br \/>\nof any interference or opposition proceedings;<\/p>\n<p>              (b) To the knowledge of the Company, the Company (i) is not aware<br \/>\nof any asserted or unasserted claims, interferences, oppositions or demands of<br \/>\nany Third Party against the Technology or the Trademarks in existence as of the<br \/>\nEffective Date; and (ii) to the knowledge of the Company, the Parties&#8217; practice<br \/>\nof any invention claimed in the Patents or the exercise of any rights to the<br \/>\nTechnology or the Trademarks as contemplated by this Agreement will not<br \/>\ninfringe any patent or other intellectual property right of any Third Party;<\/p>\n<p>              (c) To the knowledge of the Company, the Company has rights to<br \/>\nall of the Know-How in existence on the Effective Date and the right to grant<br \/>\nall rights with respect thereto granted to ERS pursuant to this Agreement;<\/p>\n<p>              (d) To the knowledge of the Company, ERS&#8217;s use of the Compounds<br \/>\nand the Products in the Field, in accordance with the terms of this Agreement,<br \/>\nwould not infringe upon or conflict with any patent or other proprietary rights<br \/>\nin the Territory of any Third Party; and<\/p>\n<p>              (e) To the knowledge of the Company, all of the data and<br \/>\ninformation provided to ERS or BMS by the Company relating to the Technology<br \/>\nand the Trademarks is accurate and complete in all material respects and<br \/>\ncontains no material errors or omissions.<\/p>\n<p>         11.3 Representations and Warranties of ERS and BMS. Only to the extent<br \/>\nthe Company&#8217;s representations and warranties set forth in Section 11.2(e) are<br \/>\ntrue and correct, each of BMS and ERS represents and warrants to the Company,<br \/>\nas of the Effective Date, that it has utilized its own scientific, marketing<br \/>\nand distribution expertise and experience to analyze and evaluate both the<br \/>\nscientific and commercial value of the Compound and Product and has solely<br \/>\nrelied on such analysis and evaluations in deciding to enter into this<br \/>\nAgreement.<\/p>\n<p>                                      49<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>         11.4 Representations and Warranties of BMS . BMS represents and<br \/>\nwarrants to the Company, as of the Effective Date, that ERS is a wholly owned<br \/>\nsubsidiary of BMS and that ERS owns or controls all or substantially all of<br \/>\nBMS&#8217;s pharmaceutical business in the U.S.<\/p>\n<p>12.      RECALL; INDEMNIFICATION.<\/p>\n<p>         12.1 Investigation; Recall. In the event that the Regulatory Authority<br \/>\nin any country in the Territory shall allege or prove that a Product does not<br \/>\ncomply with applicable rules and regulations in such country, ERS shall notify<br \/>\nthe Company immediately. The JCC shall conduct any appropriate investigation<br \/>\nand shall make a determination as to the disposition of any such matter. If ERS<br \/>\nis required or if the JCC should deem it appropriate to recall any Product, the<br \/>\nCompany and ERS shall bear the costs and expenses associated with such recall,<br \/>\nin North America in the proportion of 39% for the Company and 61% for ERS, and<br \/>\nin Japan in the proportion for which such Party is entitled to receive<br \/>\nOperating Profit or Loss, as the case may be, unless: (i) the predominant cause<br \/>\nof such recall results from or also constitutes the Company&#8217;s breach of its<br \/>\nrepresentation and\/or warranty set forth in Section 11.2(e) and\/or ERS&#8217;s<br \/>\nreliance upon such breached representation and\/or warranty, or unless the<br \/>\npredominant cause of such recall results from the Company&#8217;s willful wrongdoing<br \/>\nor negligence, in each such case the Company shall bear all costs and expenses<br \/>\nassociated with such recall; or (ii) the predominant cause of such recall<br \/>\nresults from ERS&#8217;s willful wrongdoing or negligence, in which case ERS shall<br \/>\nbear all costs and expenses associated with such recall.<\/p>\n<p>         12.2 Indemnification by ERS and BMS. ERS and BMS shall indemnify,<br \/>\ndefend and hold harmless the Company and its Affiliates, and their respective<br \/>\ndirectors, officers, employees and agents, from and against any and all<br \/>\nliabilities, damages, losses, costs and expenses (including the reasonable fees<br \/>\nof attorneys and other professionals) to the extent arising out of or resulting<br \/>\nfrom:<\/p>\n<p>              (a) negligence, recklessness or wrongful intentional acts or<br \/>\nomissions of ERS or its Affiliates, and their respective directors, officers,<br \/>\nemployees and agents, in connection with the work performed by ERS or BMS under<br \/>\nthe Clinical Development Plans or the fulfillment of ERS&#8217;s or BMS&#8217;s obligations<br \/>\nunder the Marketing Plans;<\/p>\n<p>              (b) any manufacture, use, distribution or sale of the Products by<br \/>\nERS or its Affiliates or due to any negligence, recklessness, or wrongful<br \/>\nintentional acts or omissions by or strict liability of, ERS or its Affiliates<br \/>\nand their respective directors, officers, employees and agents.; or<\/p>\n<p>              (c) any breach of any representation or warranty made by ERS or<br \/>\nBMS under Sections 11.1, 11.3 or 11.4.<\/p>\n<p>         12.3 Indemnification by the Company. The Company shall indemnify,<br \/>\ndefend and hold harmless ERS, BMS and their respective Affiliates, and their<br \/>\nrespective directors, officers, employees and agents, from and against any and<br \/>\nall liabilities, damages, losses, costs and expenses (including the reasonable<br \/>\nfees of attorneys and other professionals) to the extent arising out of or<br \/>\nresulting from:<\/p>\n<p>              (a) negligence, recklessness or wrongful intentional acts or<br \/>\nomissions of the Company or its Affiliates, and their respective directors,<br \/>\nofficers, employees and agents, in connection with the Company&#8217;s fulfillment of<br \/>\nits obligations under the Clinical Development Plans or the fulfillment of the<br \/>\nCompany&#8217;s rights or obligations under the Marketing Plans;<\/p>\n<p>                                      50<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>              (b) failure of API to meet the Specifications and\/or applicable<br \/>\nManufacturing Standards or use of Products or promotion of Products not in<br \/>\nconformity with Product labeling, by the Company or its Affiliates, or due to<br \/>\nany negligence, recklessness or wrongful intentional acts or omissions by, or<br \/>\nstrict liability of, the Company or its Affiliates, and their respective<br \/>\ndirectors, officers, employees and agents; or<\/p>\n<p>              (c) any breach of any representation or warranty made by the<br \/>\nCompany under Section 11.1 or 11.2.<\/p>\n<p>         12.4 Notice of Indemnification. In the event that any Person (an<br \/>\n&#8220;Indemnitee&#8221;) entitled to indemnification under Section 12.2 or 12.3 is seeking<br \/>\nsuch indemnification, such Indemnitee shall inform the indemnifying Party of<br \/>\nthe claim as soon as reasonably practicable after such Indemnitee receives<br \/>\nnotice of such claim, shall permit the indemnifying Party to assume direction<br \/>\nand control of the defense of the claim (including the sole right to settle it<br \/>\nat the sole discretion of the indemnifying Party, provided that such settlement<br \/>\ndoes not impose any obligation on, or otherwise adversely affect, the<br \/>\nIndemnitee or any of the other Parties) and shall cooperate as requested (at<br \/>\nthe expense of the indemnifying Party) in the defense of the claim.<\/p>\n<p>         12.5 Complete Indemnification. As the Parties intend complete<br \/>\nindemnification, all costs and expenses incurred by an Indemnitee in connection<br \/>\nwith enforcement of Sections 12.2 and 12.3 shall also be reimbursed by the<br \/>\nindemnifying Party.<\/p>\n<p>13.      TERM; TERMINATION.<\/p>\n<p>         13.1 Term. This Agreement shall become effective as of the Effective<br \/>\nDate and, unless earlier terminated pursuant to the other provisions of this<br \/>\nSection 13, shall expire as follows:<\/p>\n<p>              (a) As to each Product in each country in the Territory, this<br \/>\nAgreement shall expire on the later of: (i) the seventeenth (17th) anniversary<br \/>\nof the Effective Date, or (ii) the date on which the sale of such Product<br \/>\nceases to be covered by Valid Claim in such country.<\/p>\n<p>              (b) This Agreement shall expire in its entirety upon the<br \/>\nexpiration of this Agreement with respect to all Products in all countries in<br \/>\nthe Territory pursuant to Section 13.1(a).<\/p>\n<p>13.2     Termination for Cause.<\/p>\n<p>              (a) The Company may, without prejudice to any other remedies<br \/>\navailable to it at law or in equity, terminate this Agreement in the event that<br \/>\neither BMS or ERS (as used in this subsection, the &#8220;Breaching Party&#8221;) shall<br \/>\nhave materially breached or defaulted in the performance of any of its material<br \/>\nobligations hereunder, and such default shall have continued for 60 days after<br \/>\nwritten notice thereof was provided to the Breaching Party by the Company (or,<br \/>\nif such default cannot be cured within such 60-day period, if the Breaching<br \/>\nParty does not commence and diligently continue actions to cure such default<br \/>\nduring such 60-day period). Any such termination shall become effective at the<br \/>\nend of such 60-day period unless the Breaching Party has cured any such breach<br \/>\nor default prior to the expiration of such 60-day period (or, if such default<br \/>\ncannot be cured within such 60-day period, if the Breaching Party has commenced<br \/>\nand diligently continued actions to cure such default). The right of the<br \/>\nCompany to terminate this Agreement, as provided in this <\/p>\n<p>                                      51<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>Section 13.2(a) shall not be affected in any way by its waiver or failure to<br \/>\ntake action with respect to any previous default.<\/p>\n<p>              (b) ERS or BMS (as used in this subsection, the &#8220;Non-Breaching<br \/>\nParty&#8221;) may, without prejudice to any other remedies available to them at law<br \/>\nor in equity, terminate this Agreement in the event the Company shall have<br \/>\nmaterially breached or defaulted in the performance of any of its material<br \/>\nobligations hereunder, and such default shall have continued for 60 days after<br \/>\nwritten notice thereof was provided to the Company by the Non-Breaching Party<br \/>\n(or, if such default cannot be cured within such 60-day period, if the Company<br \/>\ndoes not commence and diligently continue actions to cure such default during<br \/>\nsuch 60-day period). Any such termination shall become effective at the end of<br \/>\nsuch 60-day period unless the Company has cured any such breach or default<br \/>\nprior to the expiration of such 60-day period (or, if such default cannot be<br \/>\ncured within such 60-day period, if the Company has commenced and diligently<br \/>\ncontinued actions to cure such default). The right of either ERS or BMS to<br \/>\nterminate this Agreement, as provided in this Section 13.2(b) shall not be<br \/>\naffected in any way by such Party&#8217;s waiver or failure to take action with<br \/>\nrespect to any previous default.<\/p>\n<p>         13.3 Termination by ERS . ERS shall have the right, upon six months&#8217;<br \/>\nprior written notice to the Company setting forth the reasons therefor, to have<br \/>\nthe JEC determine whether or not there exists a significant concern regarding a<br \/>\nregulatory or patient safety issue that would seriously impact the long term<br \/>\nviability of all Products. If the JEC can not reach agreement regarding such a<br \/>\nquestion, then the matter shall be resolved in accordance with the Accelerated<br \/>\nArbitration Provisions of Section 16.13(b). The Agreement shall immediately<br \/>\nterminate upon a finding by the JEC or arbitrators, as the case may be, that<br \/>\nthere exists a significant concern regarding a regulatory or patient safety<br \/>\nissue that would seriously impact the long term viability of all Products.<\/p>\n<p>              13.4 Termination by the Company. The Company shall have the right<br \/>\nto terminate this Agreement effective immediately if: (i) (A) the Offer is not<br \/>\nconsummated on or before the Termination Date and (B) as of the Termination<br \/>\nDate the waiting period applicable to the Offer under the Hart-Scott-Rodino<br \/>\nAntitrust Improvements Act of 1976, as amended shall not have expired or been<br \/>\nterminated, or (ii) (A) the Offer is not consummated on or before the<br \/>\nTermination Date and (B) there exists on the Termination Date an Antitrust<br \/>\nInjunction; or (iii) BMS and Acquisition Subsidiary shall have failed to<br \/>\ncommence the Offer in the time required by the Acquisition Agreement; or (iv)<br \/>\nall of the conditions to the Offer set forth in the Acquisition Agreement shall<br \/>\nhave been satisfied and Acquisition Subsidiary shall have failed to accept for<br \/>\npayment or pay for Shares tendered in the Offer as required by the terms of the<br \/>\nAcquisition Agreement.<\/p>\n<p>              13.5 Termination in Connection With Additional Studies. If,<br \/>\npursuant to Section 4.8, the PDC does not receive the approval of the JEC to<br \/>\nundertake the additional clinical studies required by the FDA within 90 days of<br \/>\nmaking its formal recommendation of its conclusions to the JEC, then any Party<br \/>\nmay terminate this Agreement effective immediately upon giving the other<br \/>\nParties notice of such termination.<\/p>\n<p>              13.6 Effect of Expiration or Termination. If this Agreement<br \/>\nexpires pursuant to its terms or is terminated by any Party pursuant to this<br \/>\nSection 13, in addition to any other remedies available to the Parties at law<br \/>\nor in equity: (i) ERS and BMS shall promptly transfer to the Company copies of<br \/>\nall data, reports, records and materials in their possession or control that<br \/>\nrelate to the Products and return to the Company all relevant records and<br \/>\nmaterials in their possession or control containing Confidential Information of<br \/>\nthe Company (provided that ERS and BMS may keep one copy of such Confidential<br \/>\nInformation of the Company for archival purposes only); (ii) ERS and BMS shall<\/p>\n<p>                                      52<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>transfer to the Company, or shall cause its designee(s) to transfer to the<br \/>\nCompany, ownership of all INDs, Registration Applications, Registrations and<br \/>\nother regulatory filings made or filed for such Products (to the extent that<br \/>\nany are held in ERS&#8217;s, BMS&#8217;s or such designee(s)&#8217;s name), if permitted by<br \/>\napplicable laws and regulations; and (iii) the Company shall promptly return to<br \/>\nERS all relevant records and materials in the Company&#8217;s possession or control<br \/>\ncontaining Confidential Information of ERS or BMS (provided that the Company<br \/>\nmay keep one copy of such Confidential Information of ERS and BMS for archival<br \/>\npurposes only).<\/p>\n<p>         13.7 Accrued Rights; Surviving Obligations.<\/p>\n<p>              (a) Termination, relinquishment or expiration of this Agreement<br \/>\nfor any reason shall be without prejudice to any rights that shall have accrued<br \/>\nto the benefit of any Party prior to such termination, relinquishment or<br \/>\nexpiration. Such termination, relinquishment or expiration shall not relieve<br \/>\nany Party from obligations which are expressly indicated to survive termination<br \/>\nor expiration of this Agreement. All obligations which are not expressly<br \/>\nindicated to survive termination or expiration of this Agreement shall<br \/>\nterminate upon the termination or expiration of this Agreement.<\/p>\n<p>              (b) All of the Parties&#8217; rights and obligations under, and\/or the<br \/>\nprovisions contained in, Sections 1, 3.3(unless ERS or BMS terminates this<br \/>\nAgreement pursuant to Section 13.2(b)), 4.10, 6.2(b), 7, 9.1, 9.3, 9.4, 10.3,<br \/>\n10.4, 10.5, 10.6, 12, 13.6, 13.7, 15.2(only to the extent ERS&#8217;s obligations<br \/>\nunder this Agreement survive termination), and 16 shall survive termination,<br \/>\nrelinquishment or expiration of this Agreement.<\/p>\n<p>14.      FORCE MAJEURE.<\/p>\n<p>         14.1 Events of Force Majeure. None of the Parties shall be held liable<br \/>\nor responsible to the other Parties nor be deemed to be in default under, or in<br \/>\nbreach of any provision of, this Agreement for failure or delay in fulfilling<br \/>\nor performing any obligation of this Agreement when such failure or delay is<br \/>\ndue to force majeure, and without the fault or negligence of the Party so<br \/>\nfailing or delaying. For purposes of this Agreement, force majeure is defined<br \/>\nas causes beyond the control of the Party, including, without limitation, acts<br \/>\nof God; acts, regulations, or laws of any government; war; civil commotion;<br \/>\ndestruction of production facilities or materials by fire, flood, earthquake,<br \/>\nexplosion or storm; labor disturbances; epidemic; and failure of public<br \/>\nutilities or common carriers. In such event the Company or ERS, as the case may<br \/>\nbe, shall immediately notify the other Parties of such inability and of the<br \/>\nperiod for which such inability is expected to continue. The Party giving such<br \/>\nnotice shall thereupon be excused from such of its obligations under this<br \/>\nAgreement as it is thereby disabled from performing for so long as it is so<br \/>\ndisabled and the 30 days thereafter. To the extent possible, each Party shall<br \/>\nuse reasonable efforts to minimize the duration of any force majeure<\/p>\n<p>15.      ADDITIONAL COVENANTS OF BMS AND BMS GUARANTEE.<\/p>\n<p>         15.1 Additional Covenants of BMS. BMS hereby agrees that for so long<br \/>\nas ERS is a party to this Agreement (and ERS&#8217;s rights and obligations under<br \/>\nthis Agreement have not been assigned in accordance with Section 16.2), ERS<br \/>\nwill remain a wholly owned subsidiary of BMS. Each of BMS and ERS hereby agree<br \/>\nthat in the event that BMS or ERS sells, assigns or otherwise transfers all or<br \/>\nsubstantially all of the pharmaceutical business or pharmaceutical oncology<br \/>\nbusiness (or control thereof) held by BMS or ERS to any other Person, all of<br \/>\nBMS&#8217;s and ERS&#8217;s, as the case may be, rights and obligations under this<br \/>\nAgreement shall be included in such transfer and the transferee shall agree <\/p>\n<p>                                      53<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>in writing to be bound by the terms of this Agreement in form and substance<br \/>\nsatisfactory to the Company (and such transfer shall otherwise be in accordance<br \/>\nwith Section 16.2).<\/p>\n<p>         15.2 BMS Guarantee BMS hereby irrevocably and unconditionally<br \/>\nguarantees to the Company the prompt and full discharge by ERS of all of ERS&#8217;s<br \/>\ncovenants, agreements, obligations and liabilities under this Agreement<br \/>\nincluding, without limitation, the due and punctual payment of all amounts<br \/>\nwhich are or may become due and payable by ERS hereunder when and as the same<br \/>\nshall become due and payable (collectively, the &#8220;ERS Obligations&#8221;), in<br \/>\naccordance with the terms hereof. BMS acknowledges and agrees that, with<br \/>\nrespect to all ERS Obligations to pay money, such guaranty shall be a guaranty<br \/>\nof payment and performance and not of collection and shall not be conditioned<br \/>\nor contingent upon the pursuit of any remedies against ERS. If ERS shall<br \/>\ndefault in the due and punctual performance of any ERS Obligation, including<br \/>\nthe full and timely payment of any amount due and payable pursuant to any ERS<br \/>\nObligation, BMS will forthwith perform or cause to be performed such ERS<br \/>\nObligation and will forthwith make full payment of any amount due with respect<br \/>\nthereto at its sole cost and expense.<\/p>\n<p>16.      MISCELLANEOUS.<\/p>\n<p>         16.1 Relationship of Parties. Nothing in this Agreement is intended or<br \/>\nshall be deemed to constitute a partnership, agency, employer-employee or joint<br \/>\nventure relationship between the Parties. No Party shall incur any debts or<br \/>\nmake any commitments for the other, except to the extent, if at all,<br \/>\nspecifically provided herein.<\/p>\n<p>         16.2 Assignment. No Party shall be entitled to assign its rights or<br \/>\ndelegate its obligations hereunder without the express written consent of the<br \/>\nother Parties hereto, except that (i) ERS may assign its rights and transfer<br \/>\nits duties hereunder, without the consent of the Company, (A) to a directly or<br \/>\nindirectly wholly-owned subsidiary of BMS, or (B) to the extent that such<br \/>\nrights and duties solely relate to Japan, to a directly or indirectly<br \/>\nmajority-owned subsidiary of BMS (provided that, in the case of (A) and (B),<br \/>\nsuch subsidiary remains so owned, BMS guarantees the obligations of such<br \/>\nsubsidiary under this Agreement in form and substance satisfactory to the<br \/>\nCompany, and no such assignment shall relieve BMS or ERS of any of its<br \/>\nobligations under this Agreement), (ii) each of BMS and ERS may assign its<br \/>\nrights and transfer its duties hereunder, without the consent of the Company to<br \/>\nany assignee of all or substantially all of BMS&#8217;s business (or that portion of<br \/>\nits overall business of which this Agreement is a part (e.g. all of its<br \/>\npharmaceutical business, its pharmaceutical oncology business)) or in the event<br \/>\nof BMS&#8217;s merger, consolidation or involvement in a similar transaction;<br \/>\nprovided that, in the case of (i) or (ii), the assignee agrees in writing to be<br \/>\nbound by the terms of this Agreement; and (iii) the Company may assign its<br \/>\nrights and transfer its duties hereunder, without the consent of ERS or BMS, to<br \/>\n(A) a directly or indirectly wholly-owned subsidiary of the Company (provided<br \/>\nthat such subsidiary remains so owned, the Company guarantees the obligations<br \/>\nof such subsidiary under this Agreement in form and substance satisfactory to<br \/>\nBMS, and no such assignment shall relieve the Company of any of its obligations<br \/>\nunder this Agreement), or (B) to any assignee of all or substantially all of<br \/>\nits business (or that portion of its overall business of which this Agreement<br \/>\nis a part (e.g. all of its pharmaceutical business, its pharmaceutical oncology<br \/>\nbusiness)) or in the event of the Company&#8217;s merger, consolidation or<br \/>\ninvolvement in a similar transaction, subject to Section 6.4; provided that, in<br \/>\nthe case of (A) or (B), the assignee agrees in writing to be bound by the terms<br \/>\nof this Agreement. No assignment or transfer shall be valid or effective unless<br \/>\ndone in accordance with this Section 16.2.<\/p>\n<p>         16.3 Books and Records. Any books and records to be maintained under<br \/>\nthis Agreement by a Party or its Affiliates shall be maintained in accordance<br \/>\nwith GAAP.<\/p>\n<p>                                      54<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>         16.4 Further Actions. Solely to the extent necessary to allow any<br \/>\nParty to use it rights and perform its obligations under this Agreement, each<br \/>\nParty hereby grants to the other Parties and their Affiliates the rights to use<br \/>\nthe Patents, Know-How and ERS Inventions (as applicable) in the Territory in<br \/>\naccordance with this Agreement. Each Party shall execute, acknowledge and<br \/>\ndeliver such further instruments, and do all such other acts, as may be<br \/>\nnecessary or appropriate in order to carry out the purposes and intent of this<br \/>\nAgreement.<\/p>\n<p>         16.5 Notice.<\/p>\n<p>              (a) Any notice, request or other communication required or<br \/>\npermitted to be given under or in connection with this Agreement shall be<br \/>\ndeemed to have been sufficiently given if in writing and personally delivered<br \/>\nor sent by certified mail (return receipt requested), facsimile transmission<br \/>\n(receipt verified), or overnight express courier service (signature required),<br \/>\nprepaid, to the Party for which such notice is intended, at the address set<br \/>\nforth for such Party below:<\/p>\n<p>               In the case of the Company, to:<\/p>\n<p>                        ImClone Systems Incorporated<br \/>\n                        180 Varick Street<br \/>\n                        New York, New York 10014<br \/>\n                        Attention: John B. Landes, General Counsel<br \/>\n                        Facsimile No: (1 212) 645-2770<br \/>\n                        Telephone No.:(1 212) 645-1405<\/p>\n<p>               With a copy to:<\/p>\n<p>                        Davis Polk Wardwell<br \/>\n                        450 Lexington Avenue<br \/>\n                        New York, NY 10017<br \/>\n                        Attention: Phillip R. Mills, Esq.<br \/>\n                        Facsimile No: (1 212) 450-4800<br \/>\n                        Telephone No.:(1 212) 450-4000<\/p>\n<p>               In the case of BMS or ERS, to:<\/p>\n<p>                        Bristol-Myers Squibb Company<br \/>\n                        P.O.  Box 4000<br \/>\n                        Route 206 &amp; Province Line Road<br \/>\n                        Princeton, NJ 08543-4000 USA<br \/>\n                        Attention:       Vice President and Senior Counsel,<br \/>\n                                         Pharmaceutical Research Institute, and<br \/>\n                                         Worldwide Franchise Management and<br \/>\n                                         Business Development<br \/>\n                        Facsimile:       (1 609) 252-4232<br \/>\n                        Attention:       Vice President, Alliance Management<br \/>\n                        Facsimile:       (1 609) 252-7235<\/p>\n<p>                                      55<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>         or to such other address for such Parties as it shall have specified<br \/>\nby like notice to the other Parties, provided that notices of a change of<br \/>\naddress shall be effective only upon receipt thereof. Except where the express<br \/>\nlanguage of this Agreement indicates that BMS (and not ERS) is to be given<br \/>\nnotice, delivered materials and information or consulted with, notice given to,<br \/>\ndelivery of materials and information to or consultations with ERS hereunder<br \/>\nshall be deemed to have been given, delivered, and made, as the case may be,<br \/>\nwith each of BMS and ERS. If delivered personally or by facsimile transmission,<br \/>\nthe date of delivery shall be deemed to be the date on which such notice or<br \/>\nrequest was given. If sent by overnight express courier service, the date of<br \/>\ndelivery shall be deemed to be the next business day after such notice or<br \/>\nrequest was deposited with such service. If sent by certified mail, the date of<br \/>\ndelivery shall be deemed to be the third business day after such notice or<br \/>\nrequest was deposited with the U.S. Postal Service.<\/p>\n<p>         16.6 Use of Name. Except as otherwise provided herein, the Company, on<br \/>\nthe one hand, and ERS and BMS, on the other hand, shall not have any right,<br \/>\nexpress or implied, to use in any manner the name or other designation of the<br \/>\nother or any other trade name, trademark or logos of the other (including,<br \/>\nwithout limitation, the Trademarks) for any purpose in connection with the<br \/>\nperformance of this Agreement.<\/p>\n<p>         16.7 Public Announcements. Except as permitted by Section 10.4, none<br \/>\nof the Parties shall make any public announcement concerning this Agreement or<br \/>\nthe subject matter hereof without first consulting with the other Parties and<br \/>\nproviding such Party with a reasonable opportunity to comment on such proposed<br \/>\npublic announcement.<\/p>\n<p>         16.8 Waiver. A waiver by any Party of any of the terms and conditions<br \/>\nof this Agreement in any instance shall not be deemed or construed to be a<br \/>\nwaiver of such term or condition for the future, or of any subsequent breach<br \/>\nhereof. All rights, remedies, undertakings, obligations and agreements<br \/>\ncontained in this Agreement shall be cumulative and none of them shall be in<br \/>\nlimitation of any other remedy, right, undertaking, obligation or agreement of<br \/>\nany Party.<\/p>\n<p>         16.9 Compliance with Law. Nothing in this Agreement shall be deemed to<br \/>\npermit a Party to export, reexport or otherwise transfer any Product sold under<br \/>\nthis Agreement without compliance with applicable laws.<\/p>\n<p>         16.10 Severability. When possible, each provision of this Agreement<br \/>\nwill be interpreted in such manner as to be effective and valid under<br \/>\napplicable law, but if any provision of this Agreement is held to be prohibited<br \/>\nby or invalid under applicable law, such provision will be ineffective only to<br \/>\nthe extent of such prohibition or invalidity, without invalidating the<br \/>\nremainder of this Agreement.<\/p>\n<p>         16.11 Amendment. No amendment, modification or supplement of any<br \/>\nprovisions of this Agreement shall be valid or effective unless made in writing<br \/>\nand signed by a duly authorized officer of each Party.<\/p>\n<p>         16.12 Governing Law. This Agreement shall be governed by and<br \/>\ninterpreted in accordance with the laws of the State of New York without regard<br \/>\nto conflicts of law principles.<\/p>\n<p>                                      56<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>         16.13 Arbitration.<\/p>\n<p>              (a) Except as expressly otherwise provided in this Agreement, any<br \/>\ndispute arising out of or relating to the interpretation of any provisions of<br \/>\nthis Agreement or the failure of any Party to perform or comply with any<br \/>\nobligations or conditions applicable to such Party pursuant to this Agreement<br \/>\nshall be finally settled by arbitration under the then current commercial<br \/>\narbitration rules of the American Arbitration Association in accordance with<br \/>\nthe terms set forth in this Section 16.13(a):<\/p>\n<p>                   (i) The place of arbitration of any dispute shall be New<br \/>\nYork, New York. Such arbitration shall be conducted by three arbitrators, one<br \/>\nappointed by each of ERS and the Company and the third selected by the first<br \/>\ntwo appointed arbitrators. Each arbitrator shall be a person with relevant<br \/>\nexperience in the pharmaceutical industry. ERS and the Company shall instruct<br \/>\nsuch arbitrators to render a determination of any such dispute within four<br \/>\nmonths after the appointment of the third arbitrator.<\/p>\n<p>                   (ii) Any award rendered by the arbitrators shall be final<br \/>\nand binding upon the Parties. Judgment upon any award rendered may be entered<br \/>\nin any court having jurisdiction, or application may be made to such court for<br \/>\na judicial acceptance of the award and an order of enforcement, as the case may<br \/>\nbe. Each Party shall pay its own expenses of arbitration, and the expenses of<br \/>\nthe arbitrators shall be equally shared between ERS and the Company unless the<br \/>\narbitrators assess as part of their award all or any part of the arbitration<br \/>\nexpenses of a Party or Parties (including reasonable attorneys&#8217; fees) against<br \/>\nthe other Party or Parties, as the case may be.<\/p>\n<p>                   (iii) This Section 16.13(a) shall not prohibit a Party from<br \/>\nseeking injunctive relief from a court of competent jurisdiction in the event<br \/>\nof a breach or prospective breach of this Agreement by any other Party which<br \/>\nwould cause irreparable harm to the first Party.<\/p>\n<p>              (b) Whenever a dispute arising out of or relating to the<br \/>\ninterpretation of any provisions of this Agreement or the failure of any Party<br \/>\nto perform or comply with any obligations or conditions applicable to such<br \/>\nParty pursuant to this Agreement arises and such dispute is expressly<br \/>\ndesignated as one to be resolved through the Accelerated Arbitration<br \/>\nProvisions, then such dispute shall be finally settled by arbitration under the<br \/>\nthen current expedited procedures applicable to the then current commercial<br \/>\narbitration rules of the American Arbitration Association in accordance with<br \/>\nthe terms set forth in this subsection (b) (the &#8220;Accelerated Arbitration<br \/>\nProvisions&#8221;):<\/p>\n<p>                   (i) The place of arbitration of any dispute shall be New<br \/>\nYork, New York. Such arbitration shall be conducted by three arbitrators, one<br \/>\nappointed by each of ERS and the Company and the third selected by the first<br \/>\ntwo appointed arbitrators. Each arbitrator shall be a person with relevant<br \/>\nexperience in the pharmaceutical industry. ERS and the Company shall instruct<br \/>\nsuch arbitrators to render a determination of any such dispute within 15<br \/>\nbusiness days after the appointment of the third arbitrator. ERS and the<br \/>\nCompany must make their respective appointments within five business days of<br \/>\nnotice being given to a Party by the other Parties of its intention to resolve<br \/>\nsuch dispute through these arbitration provisions. Such appointed arbitrators<br \/>\nmust select the third arbitrator within five business days of the last to occur<br \/>\nof their respective appointments. The dispute shall be resolved by submission<br \/>\nof documents unless the arbitration panel determines that an oral hearing is<br \/>\nnecessary. The arbitration panel shall, within the overall 15 business day time<\/p>\n<p>                                      57<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>constraint, determine what shall be conclusively deemed to be fair and<br \/>\nappropriate deadlines for submitting documents and dates, if any, of oral<br \/>\nhearings.<\/p>\n<p>                   (ii) Any award rendered by the arbitrators shall be final<br \/>\nand binding upon the Parties. Judgment upon any award rendered may be entered<br \/>\nin any court having jurisdiction, or application may be made to such court for<br \/>\na judicial acceptance of the award and an order of enforcement, as the case may<br \/>\nbe. Each Party shall pay its own expenses of arbitration, and the expenses of<br \/>\nthe arbitrators shall be equally shared between ERS and the Company unless the<br \/>\narbitrators assess as part of their award all or any part of the arbitration<br \/>\nexpenses of a Party or Parties (including reasonable attorneys&#8217; fees) against<br \/>\nthe other Party or Parties, as the case may be.<\/p>\n<p>                   (iii) This Section 16.13(b) shall not prohibit a Party from<br \/>\nseeking injunctive relief from a court of competent jurisdiction in the event<br \/>\nof a breach or prospective breach of this Agreement by any other Party which<br \/>\nwould cause irreparable harm to the first Party.<\/p>\n<p>         16.14 Entire Agreement. This Agreement, the disclosure letter<br \/>\nreferenced in Section 11.2, the Confidentiality Agreement (as defined in the<br \/>\nAcquisition Agreement), the Acquisition Agreement and the Stockholder Agreement<br \/>\nconstitute the entire agreement among the Parties with respect to the subject<br \/>\nmatter of this Agreement and supersede all prior agreements and understandings,<br \/>\nboth oral and written, among the Parties with respect to the subject matter of<br \/>\nthis Agreement.<\/p>\n<p>         16.15 Parties in Interest. All of the terms and provisions of this<br \/>\nAgreement shall be binding upon, inure to the benefit of and be enforceable by<br \/>\nthe Parties hereto and their respective permitted successors and assigns.<\/p>\n<p>         16.16 Descriptive Headings. The descriptive headings of this Agreement<br \/>\nare for convenience only, and shall be of no force or effect in construing or<br \/>\ninterpreting any of the provisions of this Agreement.<\/p>\n<p>         16.17 Counterparts. This Agreement may be executed simultaneously in<br \/>\nany number of counterparts, any one of which need not contain the signature of<br \/>\nmore than one Party but all such counterparts taken together shall constitute<br \/>\none and the same agreement.<\/p>\n<p>                                      ***<\/p>\n<p>                                      58<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>       IN WITNESS WHEREOF, each of the Parties has caused this Agreement to<br \/>\nbe executed by its duly authorized representative as of the day and year first<br \/>\nabove written.<\/p>\n<p>                                        IMCLONE SYSTEMS INCORPORATED<\/p>\n<p>                                        By: \/s\/ Samuel D. Waksal<br \/>\n                                           &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<\/p>\n<p>                                        Name: Samuel D. Waksal<br \/>\n                                             &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>                                        Title: President and Chief Executive<br \/>\n                                                 Officer<br \/>\n                                              &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<\/p>\n<p>                                        E. R. SQUIBB &amp; SONS, LLC<\/p>\n<p>                                        By: \/s\/ Charles Linzner<br \/>\n                                           &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<\/p>\n<p>                                        Name: Charles Linzner<br \/>\n                                             &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>                                        Title: Vice President and Senior<br \/>\n                                                 Counsel &#8211; External Development\/<br \/>\n                                                 PRI<br \/>\n                                              &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<\/p>\n<p>                                        BRISTOL-MYERS SQUIBB COMPANY<\/p>\n<p>                                        By: \/s\/ Brian Markison<br \/>\n                                           &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<\/p>\n<p>                                        Name:  Brian Markison<br \/>\n                                             &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>                                        Title: Senior Vice President &#8211; External<br \/>\n                                                 Affairs, Worldwide Medicines<br \/>\n                                                 Group<br \/>\n                                              &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<\/p>\n<p>                                      59<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>                                  Exhibit 1.13<br \/>\n                             BASE CASE PROJECTIONS<\/p>\n<p>[**]<\/p>\n<p>                                  Exhibit 1.46<\/p>\n<p>                               FINANCIAL APPENDIX<\/p>\n<p>         This provides the definitions of certain financial terms applicable to<br \/>\nthe Parties for purposes of the Agreement; provided, however, that the<br \/>\ndefinition of &#8220;Fully Burdened Manufacturing Costs&#8221; shall apply to ERS or the<br \/>\nCompany to the extent it manufactures any Product (or component thereof) under<br \/>\nthe Agreement and the definition of &#8220;Development Costs&#8221; shall apply to the<br \/>\ndevelopment work of the Parties under the Agreement. All capitalized terms used<br \/>\nherein without definition shall have the meanings ascribed thereto in the<br \/>\nAgreement, unless otherwise expressly provided herein. References in this<br \/>\nExhibit 1.46 to a &#8220;Party&#8221; or &#8220;Parties&#8221; shall be construed to mean ERS or the<br \/>\nCompany, as the case may be, and in every case shall be deemed to include the<br \/>\nParty&#8217;s Affiliates under the Agreement.<\/p>\n<p>Principles of Reporting<\/p>\n<p>              The presentation of results of operations of ERS in North America<br \/>\nwill be based on ERS&#8217;s financial information for each Product presented<br \/>\nseparately by Product and on a consolidated basis across all Products in the<br \/>\nreporting format depicted as follows:<\/p>\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<br \/>\nNorth America                                               Total<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<br \/>\nNet Sales of [Product name \/ all Products]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n<p>         The presentation of results of operations of the Parties in Japan will<br \/>\nbe based on each Party&#8217;s respective financial information for each Product<br \/>\npresented separately, by Party and by Product, and on a consolidated basis, by<br \/>\nParty (across all Products), by Product (across the Parties) and across all<br \/>\nProducts and the Parties, in the reporting format depicted as follows:<\/p>\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n[**]                                   ERS          The Company        Total<br \/>\n                                       &#8212;          &#8212;&#8212;&#8212;&#8211;        &#8212;&#8211;<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n[**]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n[**]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n[**]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n                      [**]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n                      [**]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n                      [**]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n                      [**]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n                      [**]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8211; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n                      [**]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<br \/>\n[**]<br \/>\n&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212; &#8212;&#8212;&#8212;&#8212;&#8212;- &#8212;&#8212;&#8212;&#8212;-<\/p>\n<p>         It is the intention of the Parties that the interpretation of these<br \/>\ndefinitions will be consistent with GAAP.<\/p>\n<p>         If necessary, a Party will make the appropriate adjustments to the<br \/>\nfinancial information it supplies under the Agreement to conform to the above<br \/>\nformat of reporting results of operation.<\/p>\n<p>                                      61<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>Frequency of Reporting<\/p>\n<p>         The fiscal year will be a calendar year.<\/p>\n<p>         Reports of results compared to budget shall be made to the relevant<br \/>\nCommittee on a quarterly basis and on a year-to-date basis, for the entire<br \/>\nTerritory. After approval by the appropriate Committee as to amounts, such<br \/>\nCommittee shall forward the report to the JEC for its approval.<\/p>\n<p>         ERS will be responsible for the preparation of consolidated reporting<br \/>\nfor Japan, calculation of the profit\/loss sharing and determination of the cash<br \/>\nsettlement. ERS will provide the Finance Committee within 30 business days or<br \/>\nreceipt of each Party&#8217;s financial information, a statement showing the<br \/>\nconsolidated results and calculations of the sharing of Operating Profit or<br \/>\nLoss in Japan and cash settlement required in a format agreed to by the<br \/>\nParties.<\/p>\n<p>Definitions<\/p>\n<p>         &#8220;Allocable Overhead&#8221; means costs directly related to the [**]<br \/>\nincluding, but not limited to, those which are attributable to [**]. Allocable<br \/>\nOverhead shall not include any costs attributable to [**] including, by way of<br \/>\nexample, [**].<\/p>\n<p>         &#8220;Cost of Goods Sold&#8221; means Fully Burdened Manufacturing Costs (as<br \/>\ndefined below) of each Party relating to Finished Product for sales in [**].<\/p>\n<p>         &#8220;Development Costs&#8221;<\/p>\n<p>         (a) In each of North America and Japan, &#8220;Development Costs&#8221; means the<br \/>\ndevelopment costs incurred by each Party with respect to a Product in North<br \/>\nAmerica or Japan, as the case may be, from the Effective Date of the Agreement<br \/>\nthrough the later of (i) the date of Registration (including thereafter costs<br \/>\nto maintain or expand such Registration) of such Product in the Field in North<br \/>\nAmerica or Japan, as the case may be, or (ii) the date of termination of<br \/>\ndevelopment efforts of such Product in the Field for which Registration is<br \/>\nsought, as applicable in North America or Japan. Such costs shall comprise<br \/>\nthose costs required to obtain, maintain and\/or expand the relevant<br \/>\nauthorization and\/or ability to manufacture, formulate, fill, use, ship, sell<br \/>\nand\/or distribute such Product in commercial quantities to Third Parties in<br \/>\nNorth America or Japan, as the case may be.<\/p>\n<p>         (b) In each of North America and Japan, &#8220;Development Costs&#8221; shall<br \/>\ninclude, without limitation, costs of research or development including costs<br \/>\nof studies on the toxicological, pharmacokinetical, metabolical or clinical<br \/>\naspects of a Product conducted internally or by individual investigators or<br \/>\nconsultants necessary for the purpose of obtaining, maintaining and\/or<br \/>\nexpanding marketing approval of a Product, costs for preparing, submitting,<br \/>\nreviewing or developing data or information for the purpose of submission to a<br \/>\ngovernmental authority to obtain, maintain and\/or expand marketing approval of<br \/>\na Product, and applicable Allocable Overhead.<\/p>\n<p>         (c) In each of North America and Japan, &#8220;Development Costs&#8221; shall also<br \/>\ninclude, without <\/p>\n<p>                                      62<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>limitation, expenses for data management, statistical designs and studies,<br \/>\ndocument preparation, and other administration expenses associated with the<br \/>\nclinical testing program or post-marketing studies required to maintain product<br \/>\napprovals.<\/p>\n<p>         (d) In determining Development Costs chargeable under the Agreement,<br \/>\neach Party will use its respective project accounting systems and will review<br \/>\nand approve its respective project accounting systems and methodologies with<br \/>\nthe other Parties.<\/p>\n<p>         &#8220;Distribution Costs&#8221; means the costs, including applicable Allocable<br \/>\nOverhead, specifically identifiable to the distribution of a Product in North<br \/>\nAmerica or Japan, as the case may be, by a Party including customer services,<br \/>\ncollection of data about sales to hospitals and other end users, order entry,<br \/>\nbilling, shipping, bad debt, credit and collection and other such activities.<\/p>\n<p>         &#8220;Fully Burdened Manufacturing Costs&#8221; of an item or items, including,<br \/>\nwithout limitation, API or a Finished Product (in bulk or finished product<br \/>\nform, as the case may be) means 100% of a Party&#8217;s fully burdened manufacturing<br \/>\ncost (as defined in the Party&#8217;s generally accepted accounting policies<br \/>\nconsistently applied) which shall comprise the sum of:<\/p>\n<p>         (a)      For API:<\/p>\n<p>         Cost of Raw Materials<\/p>\n<p>                  The purchase unit cost of raw materials multiplied by [**]<br \/>\nincluding [**] and any [**].<\/p>\n<p>         Direct Labor and Allocable Overhead Costs<\/p>\n<p>                  The cost of direct labor and manufacturing overhead resources<br \/>\n         consumed in the production process.<\/p>\n<p>                  Costs will include any efficiency, activity and spending<br \/>\n         variances from standards as well as any underabsorbed overhead<br \/>\n         expenses incurred during the startup of the biologic operation for the<br \/>\n         Product or caused by subsequent evolution of the Product&#8217;s volumes<br \/>\n         sold in North America or Japan, as the case may be, including, without<br \/>\n         limitation, process development, process improvement, scale-up,<br \/>\n         recovery, and qualification lots costs.<\/p>\n<p>                  Manufacturing overhead includes the following costs:<\/p>\n<p>                           Normal depreciation of building, machinery and<br \/>\n                           equipment<br \/>\n                           Plant management Plant services and utilities<br \/>\n                           Plant maintenance Quality control at all stages<br \/>\n                           Freight and storage costs at all stages <\/p>\n<p>                                      63<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>                           Cost accounting and data processing services<br \/>\n                           Any taxes and duties other than VAT and income tax<\/p>\n<p>                  (b)      For the Processing of API into Finished Product:<\/p>\n<p>         Cost of Raw Materials<\/p>\n<p>                  The purchase unit cost of any materials and packaging<br \/>\n         components necessary to make the finished goods (including, without<br \/>\n         limitation, the API) multiplied by the actual quantity consumed in the<br \/>\n         manufacturing process including any usage variance and any write-offs<br \/>\n         caused by obsolescence, accident and book-to-physical differences.<\/p>\n<p>         Direct Labor and Overhead Costs<\/p>\n<p>                  The cost of direct labor and overhead resources consumed in<br \/>\nthe manufacturing process.<\/p>\n<p>                  Such costs will include any efficiency, activity and spending<br \/>\n         variances from standards as well as any unabsorbed overhead expenses<br \/>\n         caused by the start up of the dedicated manufacturing operation and\/or<br \/>\n         by the evolution of the Product sales volume in North America or<br \/>\n         Japan, as the case may be.<\/p>\n<p>                  The manufacturing overhead will include:<\/p>\n<p>                           The normal depreciation of fixed assets<br \/>\n                           The plant management<br \/>\n                           The plant common services and utilities<br \/>\n                           The plant maintenance<br \/>\n                           The quality control at all stages<br \/>\n                           The freight and storage costs at all stages<br \/>\n                           The cost accounting and data processing services<br \/>\n                           Any taxes and duties other than VAT and income tax<\/p>\n<p>         &#8220;General and Administrative Costs&#8221; means costs chargeable to the<br \/>\nProducts relating to Product sales efforts of a Party in Japan equal to a<br \/>\nportion of Net Sales set by the Finance Committee. The Finance Committee shall<br \/>\ndetermine such portion by calculating ERS&#8217;s general and administrative cost<br \/>\nbudget relating to Japan [**].<\/p>\n<p>         &#8220;Gross Profit&#8221; means Net Sales in Japan less Cost of Goods Sold in<br \/>\nJapan, for sales of Product by any Party to Third Parties in Japan.<\/p>\n<p>         &#8220;Marketing Costs&#8221;<\/p>\n<p>                                      64<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>         For purposes of this definition of Marketing Costs, the &#8220;Applicable<br \/>\nRegion&#8221; shall mean (i) Japan, when &#8220;Marketing Costs&#8221; is used in reference to<br \/>\npayments that are to be made in connection with Product sales in Japan, or (ii)<br \/>\nthe Territory, when &#8220;Marketing Costs&#8221; is used in reference to the Marketing<br \/>\nBudget.<\/p>\n<p>         (a) &#8220;Marketing Costs&#8221; means the direct or accrued costs of marketing,<br \/>\npromotion, advertising, Product promotional materials, professional education,<br \/>\nproduct related public relations, relationships with opinion leaders and<br \/>\nprofessional societies, market research (before and after product approval),<br \/>\nhealthcare economics studies, post-marketing studies not required to maintain<br \/>\nproduct approvals, and other similar activities, relating to Product sales<br \/>\nefforts of a Party in the Applicable Region and approved by the JCC. Such costs<br \/>\nof a Party will include [**].<\/p>\n<p>         (b) &#8220;Marketing Costs&#8221; shall also include, without limitation,<br \/>\nactivities related to [**].<\/p>\n<p>         (c) &#8220;Marketing Costs&#8221; will specifically exclude the costs of<br \/>\nactivities which [**].<\/p>\n<p>         &#8220;Net Sales&#8221; means the gross amount invoiced for sales of a Product by<br \/>\nERS or its Affiliates, in arm&#8217;s length sales to Third Parties, commencing with<br \/>\nthe First Commercial Sale, less the following deductions from such gross<br \/>\namounts which are actually incurred, allowed, accrued or specifically allocated<br \/>\n(ERS shall use commercially reasonable efforts to reconcile such amounts<br \/>\ninvoiced and deducted annually):<\/p>\n<p>         (a) credits or allowances for damaged products, returns or rejections<br \/>\nof Products and price adjustments;<\/p>\n<p>         (b) normal and customary trade, cash and quantity discounts,<br \/>\nallowances and credits;<\/p>\n<p>         (c) chargeback payments and rebates (or the equivalent thereof)<br \/>\ngranted to managed health care organizations or to federal, state\/provincial,<br \/>\nlocal and other governments, including their agencies, or to trade customers;<\/p>\n<p>         (d) any invoiced freight, postage, shipping, insurance and other<br \/>\ntransportation charges (excluding such charges that are included in<br \/>\nDistribution Costs); and<\/p>\n<p>         (e) sales, value-added (to the extent not refundable in accordance<br \/>\nwith applicable law), and excise taxes, tariffs and duties, and other taxes<br \/>\ndirectly related to the sale (but not including taxes assessed against the<br \/>\nincome derived from such sale).<\/p>\n<p>         Net Sales shall not include sales among ERS and its Affiliates, but<br \/>\nshall arise upon the sale by ERS or its Affiliates to unrelated Third Parties,<br \/>\nsuch as end users, wholesalers and retailers. Net Sales, as set forth in this<br \/>\ndefinition, shall be calculated applying, in accordance with GAAP, the standard<br \/>\naccounting practices ERS customarily applies to other products sold by it.<\/p>\n<p>         &#8220;Operating Profit or Loss&#8221; means Net Sales in Japan of all Products<br \/>\nless the following items with respect to each Product sold in Japan or relating<br \/>\nto Product sales efforts of a Party in Japan, all for a given period: [**].<\/p>\n<p>         &#8220;Other Operating Income\/Expense&#8221; means other operating income or<br \/>\nexpense from or to<\/p>\n<p>                                      65<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>Third Parties, relating to the manufacture or sales of Products by a Party in<br \/>\nJapan or Product sales efforts of a Party in Japan, which is not part of the<br \/>\nprimary business activity being conducted by the Parties under this Agreement,<br \/>\nbut is considered and approved by the Finance Committee or the JEC as income or<br \/>\nexpense for purposes of this activity and is limited to the following, each of<br \/>\nwhich is to be related to manufacturing or selling Products by a Party in Japan<br \/>\nor Product sales efforts of a Party in Japan:<\/p>\n<p>                  [**]<\/p>\n<p>The methodology used to determine the amount of each item set forth above shall<br \/>\nbe developed by the Finance Committee.<\/p>\n<p>         &#8220;Sales Costs&#8221; means costs, including Allocable Overhead, approved by<br \/>\nthe JCC with the Marketing Budgets, incurred by the Parties or for their<br \/>\naccount and specifically identifiable to the sales efforts of Products to all<br \/>\nmarkets in North America or Japan, as the case may be, including the managed<br \/>\ncare market.<\/p>\n<p>         (a) &#8220;Sales Costs&#8221; shall include, without limitation, costs associated<br \/>\nwith sales representatives for Products in North America or Japan, as the case<br \/>\nmay be, including compensation, benefits and travel, supervision and training<br \/>\nof such sales representatives, sales meetings, and other sales related<br \/>\nexpenses.<\/p>\n<p>         (b) &#8220;Sales Costs&#8221; will not include the start-up costs associated with<br \/>\nany Party&#8217;s sales force relating to that Party&#8217;s sales efforts in North America<br \/>\nor Japan, as the case may be, including recruiting, relocation and other<br \/>\nsimilar costs. the Company&#8217;s sales costs shall not be included in profit\/loss<br \/>\ncalculations.<\/p>\n<p>                                      66<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>                                  Exhibit 1.68<br \/>\n                              LOW CASE PROJECTIONS<\/p>\n<p>[**]<\/p>\n<p>                                      67<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>Exhibit 1.87<br \/>\n                                    PATENTS<\/p>\n<table>\n<s>               <c><br \/>\nTITLE:            Hybrid Cell Lines That Produce Monoclonal Antibodies to Epidermal Growth Factor Receptor<br \/>\nINVENTOR(S):      Mendelsohn et al.<br \/>\nUS PATENT NO.:    4,943,533<br \/>\nPRIORITY DATE:    March 9, 1987<\/p>\n<p>TITLE:            Monoclonal Antibodies Specific to Human Epidermal Growth Factor Receptor and Therapeutic<br \/>\n                  Methods of Employing Same<br \/>\nINVENTOR(S):      Schlessinger et al.<br \/>\nUS PATENT NO.:    6,217,866<br \/>\nPRIORITY DATE:    September 15, 1988<br \/>\nCA  PATENT NO:    1,340,417<br \/>\nJP SERIAL NO:     237397\/1989<\/p>\n<p>TITLE:            Antibody and Antibody Fragments for Inhibiting the Growth of Tumors<br \/>\nINVENTOR(S):      Goldstein et al.<br \/>\nUS SERIAL NO.:    08\/973,065<br \/>\nPRIORITY DATE:    June 7, 1995<br \/>\nCA SERIAL NO:     2,222,231<br \/>\nJP SERIAL NO:     9-502046<\/p>\n<p>TITLE:            Treatment of Human Tumors with Radiation and Inhibitors of Growth Factor Receptor Tyrosine<br \/>\n                  Kinases<br \/>\nINVENTOR(S):      Waksal et al.<br \/>\nUS SERIAL NO.:    09\/312,286<br \/>\nPRIORITY DATE:    May 15, 1998<br \/>\nCA SERIAL NO:     2,332,331<br \/>\nJP SERIAL NO:     2000-549641<\/p>\n<p>TITLE:            Treatment of Refractory Human Tumors with Epidermal Growth Factor Receptor Antagonists<br \/>\nINVENTOR(S):      Harlan W. Waksal<br \/>\nUS SERIAL NOS.:   09\/374,028; 09\/840,146<br \/>\nPRIORITY DATE:    May 14, 1999<br \/>\nPCT APPL:         PCT\/US00\/11756<br \/>\nPCT FILED:        May 1, 2000, to be nationalized in Canada and Japan November 14, 2001<br \/>\n<\/c><\/s><\/table>\n<p>                                      68<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>                                  Exhibit 2.1<br \/>\n                JOINT EXECUTIVE COMMITTEE AND ALLIANCE MANAGERS<\/p>\n<p>Initial Joint Executive Committee Members Designated by BMS:<\/p>\n<p>         [**]<\/p>\n<p>Initial Alliance Manager Designated by BMS and ERS:<\/p>\n<p>         [**]<\/p>\n<p>Initial Joint Executive Committee Members Designated by the Company:<\/p>\n<p>         [**]<\/p>\n<p>Initial Alliance Manager Designated by the Company:<\/p>\n<p>         [**]<\/p>\n<p>                                      69<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>                                 Exhibit 4.3(A)<br \/>\n                                CLINICAL BUDGET<\/p>\n<p>[**]<\/p>\n<p>                                      70<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>Exhibit 4.3(B)<br \/>\n                SUMMARY CLINICAL DEVELOPMENT PLAN FOR 2001-2004<\/p>\n<p>[**]<\/p>\n<p>                                      71<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>                                 Exhibit 5.2(A)<br \/>\n                         MARKETING BUDGET FOR 2001-2004<\/p>\n<p>[**]<\/p>\n<p>                                      72<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>Exhibit 5.2(B)<br \/>\n                   INDICATIVE MARKETING BUDGET FOR 2005-2017<\/p>\n<p>[**]<\/p>\n<p>                                      73<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>                               Exhibit 8.12(B)(i)<br \/>\n                        BASE CASE CLINICAL SUPPLY AMOUNT<\/p>\n<p>[**]<\/p>\n<p>                                      74<\/p>\n<p>Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers<br \/>\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n<p>                              Exhibit 8.12(B)(ii)<br \/>\n                       BASE CASE COMMERCIAL SUPPLY AMOUNT<\/p>\n<p>[**]<\/p>\n<p>                                      75<\/p>\n","protected":false},"template":"","meta":{"_acf_changed":false,"_stopmodifiedupdate":true,"_modified_date":"","_cloudinary_featured_overwrite":false},"corporate_contracts_companies":[6948,7835],"corporate_contracts_industries":[9405,9407],"corporate_contracts_types":[9613,9619],"class_list":["post-42232","corporate_contracts","type-corporate_contracts","status-publish","hentry","corporate_contracts_companies-bristol-myers-squibb-co","corporate_contracts_companies-imclone-inc","corporate_contracts_industries-drugs__biotech","corporate_contracts_industries-drugs__pharma","corporate_contracts_types-operations","corporate_contracts_types-operations__sales"],"acf":[],"_links":{"self":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts\/42232","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts"}],"about":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/types\/corporate_contracts"}],"wp:attachment":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/media?parent=42232"}],"wp:term":[{"taxonomy":"corporate_contracts_companies","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_companies?post=42232"},{"taxonomy":"corporate_contracts_industries","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_industries?post=42232"},{"taxonomy":"corporate_contracts_types","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_types?post=42232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}