{"id":42231,"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-r.html"},"modified":"2015-09-17T11:25:58","modified_gmt":"2015-09-17T16:25:58","slug":"development-promotion-distribution-and-supply-agreement-e-r","status":"publish","type":"corporate_contracts","link":"https:\/\/corporate.findlaw.com\/contracts\/operations\/development-promotion-distribution-and-supply-agreement-e-r.html","title":{"rendered":"Development, Promotion, Distribution and Supply Agreement – E. R. Squibb & Sons LLC, Bristol-Myers Squibb Co., and ImClone Systems Inc."},"content":{"rendered":"
                   AMENDMENT NO. 1 TO DEVELOPMENT, PROMOTION,\n                       DISTRIBUTION AND SUPPLY AGREEMENT\n\n     AMENDMENT NO. 1 dated as of March 5, 2002 (this \"Amendment\"), by and among\nE. R. SQUIBB & SONS, LLC, a limited liability company organized and existing\nunder the laws of the State of Delaware, having offices located at Route 206\nand 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 and Province Line Road,\nPrinceton, New Jersey (\"BMS\") and IMCLONE SYSTEMS INCORPORATED, a corporation\norganized under the laws of the State of Delaware, having offices located at\n180 Varick Street, New York, New York 10014 (the \"Company\").\n\n                             PRELIMINARY STATEMENTS\n\n     A. ERS, BMS and the Company are parties to the Development, Promotion,\nDistribution and Supply Agreement dated as of September 19, 2001 (the\n\"Commercial Agreement\") pursuant to which the Parties have agreed to\ncollaborate on the development and commercialization of Products in the\nTerritory.\n\n     B. On October 30, 2001, pursuant to the Commercial Agreement, the Company\nsubmitted a biologics license application for a Product under Section 351 of\nthe Public Health Service Act. On December 28, 2001, the FDA notified the\nCompany that it would refuse to file such biologics license application (the\n\"Refusal to File\").\n\n     C. In light of the Refusal to File and subsequent discussions with the\nFDA, the Parties have agreed to amend the Commercial Agreement as set forth in\nthis Amendment.\n\n     NOW, THEREFORE, in consideration of the foregoing preliminary statements\nand the mutual agreements and covenants set forth herein, the Parties hereby\nagree as follows:\n\n1.   DEFINITIONS.\n\n     1.1 Definitions in the Commercial Agreement. Capitalized terms used but\nnot defined in this Amendment (including the Preliminary Statements set forth\nabove) shall have the meanings set forth in the Commercial Agreement.\nReferences in the Commercial Agreement to \"this Agreement\" shall be deemed to\nrefer to the Commercial Agreement as amended by this Amendment. Notwithstanding\nthe foregoing, the date of the Commercial Agreement, as amended hereby, shall\nin all instances remain September 19, 2001, and references to \"the date\nhereof\", \"the date of this Agreement\" and \"the Effective Date\" in the\nCommercial Agreement shall continue to refer to September 19, 2001.\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n\n\n\n2.   MANAGEMENT.\n\n     2.1 Clinical and Regulatory Oversight. The Parties agree that Andrew\nBodnar (\"Bodnar\") shall, for so long as he is willing to serve, be entitled to\noversee the implementation of the Clinical Development Plan and the process for\nseeking Registration of Products pursuant to the Commercial Agreement. Bodnar\nshall be entitled to attend meetings of any Committee, and any Committee may\nfrom time to time consult with Bodnar with respect to any matter relating to\nthe Clinical Development Plan or Registration of the Product; provided that\nBodnar shall not have any powers, rights or responsibilities of a member of a\nCommittee (except to the extent he otherwise has such powers, rights or\nresponsibilities in his capacity as a member of such Committee), and Bodnar's\nauthority shall be subject to the authority of the Committees and the other\nprovisions of the Commercial Agreement. Bodnar shall also be entitled to attend\nany meetings between the Company and the FDA with respect to a Product.\n\n3.  CLINICAL DEVELOPMENT PLAN\/CLINICAL BUDGET\n\n     3.1  Product Development Committee Meeting.\n\n     (a) As soon as reasonably practicable after the date hereof, the PDC shall\nmeet to amend and modify the Clinical Development Plan pursuant to the\nCommercial Agreement to reflect the current strategy of the Parties with\nrespect to Registration of the Product. Such amended and modified Clinical\nDevelopment Plan (the \"Modified Clinical Plan\") shall include the matters\nreferred to in Section 4.3(b) of the Commercial Agreement, and shall be a\n\"Clinical Development Plan\" within the meaning of Section 1.20 of the\nCommercial Agreement.\n\n     (b) At the meeting referred to in Section 3.1(a), the PDC shall also modify\nthe Clinical Budget relating to the Registrational Studies pursuant to the\nCommercial Agreement to reflect the Modified Clinical Plan; provided that such\nmodified Clinical Budget (the \"Modified Clinical Budget\") shall (i) be equal in\nthe aggregate to the Clinical Budget in effect as of the date hereof (the\n\"Existing Clinical Budget\") and (ii) in respect of any year prior to 2005, not\nbe less than 80% of the budget for such year under the Existing Clinical\nBudget. Unless and until the Modified Clinical Budget is approved in accordance\nwith the Commercial Agreement, the Existing Clinical Budget shall remain in\neffect.\n\n     3.2 Joint Manufacturing Committee Meeting. As soon as reasonably\npracticable after the meeting referred to in Section 3.1(a), the JMC shall meet\nto amend Exhibit 8.12 (B)(i) to the Commercial Agreement to reflect the\nModified Clinical Budget.\n\n4.   PAYMENTS.\n\n     4.1  Payments to the Company.\n\n     (a) As partial consideration to the Company for the rights granted to ERS\nunder the Commercial Agreement and for entering into this Amendment, ERS shall\npay to the Company a non-refundable and non-creditable payment of $140,000,000\non March 7, 2002 in immediately available funds by wire transfer to an account\nspecified by the Company.\n\n     (b) Section 6.2 of the Commercial Agreement is amended by deleting\nparagraph (a) thereof in its entirety and replacing it with the following:\n\n                  \"(a) As further consideration to the Company for the rights\n                  granted to ERS\n\n\n                                       2\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n\n\n\n                  under this Agreement, ERS shall pay to the\n                  Company the following non-refundable and non-creditable\n                  payments on the date or upon the occurrence of the events, as\n                  the case may be, set forth below:\n\n\n                  Date\/Event                                      Payment   \n                  -------------------------------------------  --------------\n                  March 5, 2003                                  $60,000,000 \n                  -------------------------------------------  --------------\n                  Upon receipt of written Registration in\n                  the US from the FDA with respect to any\n                  indication for a Product (the \"First          $250,000,000\n                  Indication\").\n                  -------------------------------------------  --------------\n                  Upon receipt of written Registration in\n                  the US from the FDA with respect to any\n                  indication relating to a different tumor\n                  type from the First Indication (the           $250,000,000\n                  \"Second Indication\").\n                  -------------------------------------------  --------------\n                  \n                  The Party who receives notice of Registration from the FDA\n                  shall be responsible for promptly informing the other Parties\n                  when such event occurs. The payments required with respect to\n                  receipt of Registration pursuant to this Section 6.2(a) shall\n                  be paid within 30 days (by wire transfer in immediately\n                  available funds to an account specified by the Company) after\n                  the earlier to occur of: (i) ERS receiving notice of the\n                  Registration from the FDA or (ii) the Company notifying ERS\n                  of such Registration. The Parties understand that the First\n                  Indication and the Second Indication may be included in the\n                  same Registration; provided that any indication or series of\n                  indications relating to the same tumor type (e.g., colorectal\n                  cancer) shall, for all purposes under this Section 6.2,\n                  constitute one indication and no subsequent indication in\n                  respect of the tumor type for which the First Indication was\n                  received shall be considered a Second Indication.\"\n\n     4.2   Distribution Fees.\n\n     (a) Section 6 of the Commercial Agreement is amended by deleting Sections\n6.3 and 6.4 in their entirety and replacing them with the following:\n\n                  \"Section 6.3 Distribution Fees for North America. As further\n                  consideration to the Company for the rights granted to ERS in\n                  North America under this Agreement, ERS shall pay to the\n                  Company a Distribution Fee for North America equal to 39% of\n                  Net Sales in North America during each calendar year (or\n                  portion thereof).\"\n\n     (b) Section 6 of the Commercial Agreement is further amended by\nrenumbering Section 6.5 as \"Section 6.4\" and Section 6.6 as \"Section 6.5\".\n\n     (c) Section 16.2 of the Commercial Agreement is amended by deleting \",\nsubject to Section 6.4\" from the first sentence thereof.\n\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\n5.  PROJECTIONS.\n\n     5.1 Base Case Projections. Exhibit 1.13 to the Commercial Agreement is\ndeleted in its entirety and replaced by Exhibit 1.13 to this Amendment.\n\n     5.2 Low Case Projections. Exhibit 1.68 to the Commercial Agreement is\ndeleted in its entirety and replaced by Exhibit 1.68 to this Amendment.\n\n     5.3 Marketing Budget. Exhibits 5.2(A) and 5.2(B) to the Commercial\nAgreement are deleted in their entirety and replaced by Exhibits 5.2(A) and\n5.2(B) to this Amendment.\n\n     5.4 Commercial API Supply. Exhibit 8.12(B)(ii) to the Commercial Agreement\nis deleted in its entirety and replaced by Exhibit 8.12(B)(ii) to this\nAmendment.\n\n     5.5 Non-Registrational Clinical Budget. The portion of Exhibit 4.3(A) to\nthe Commercial Agreement related to Non-Registrational Studies is deleted in\nits entirety and replaced by Exhibit 4.3(A) to this Amendment\n\n6.   REPRESENTATIONS AND WARRANTIES.\n\n     Each Party represents and warrants to each of the other Parties, as of the\ndate of this Amendment, that:\n\n     (a) such Party is duly organized, validly existing and in good standing\nunder the laws of the jurisdiction of its incorporation and has full corporate\npower and authority to enter into this Amendment and to carry out the\nprovisions hereof;\n\n     (b) such Party has taken all corporate action necessary to authorize the\nexecution and delivery of this Amendment and the performance of its obligations\nunder this Amendment and has full power and authority to enter into this\nAmendment and perform its obligations under this Amendment; and\n\n     (c) this Amendment has been duly executed by such Party and constitutes a\nvalid and legally binding obligation of such Party, enforceable in accordance\nwith its terms, subject to and limited by: (i) applicable bankruptcy,\ninsolvency, reorganization, moratorium, and other laws generally applicable to\ncreditors' rights; and (ii) judicial discretion in the availability of\nequitable relief.\n\n7.   MISCELLANEOUS.\n\n     7.1 Prior Events. Each Party hereby acknowledges and agrees that a\nrequirement by the FDA that the Company (i) reformat and reanalyze the clinical\ndata from the two clinical studies (Nos.9923 and 0141) conducted by the Company\nin connection with the Registration Application submitted to the FDA on October\n30, 2001 and (ii) submit data from clinical study No. 007 currently being\nconducted by Merck KGaA in Europe for the use of the Product to treat\nrefractory colorectal cancer to support a resubmission of the Registration\nApplication, does not constitute, in and of itself without further FDA\nrequirements, a \"material delay\" under Section 4.8 of the Commercial Agreement\nor give rise, as of the date hereof, to \"a significant concern regarding a\nregulatory or patient safety issue that would seriously impact the long term\nviability of all Products\" under Section 13.3 of the Commercial Agreement;\nprovided that this Section 7.1 does not, and shall in no circumstances be\nconstrued as, an admission of the occurrence of, or as an indication of what\nmay constitute or be considered in the determination of the existence of, a\n\"material delay\" under Section 4.8 of the Commercial Agreement or such a\n\"significant concern\" under Section 13.3 of the Commercial Agreement.\n\n\n                                       4\n\n\n\nConfidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers\nSquibb Biologics Company and ImClone Systems Incorporated.\n\n\n\n     7.2 Manufacturing Facility. As soon as reasonably practicable after the\ndate hereof, the Company shall resume construction of the BB-50 plant (the\n\"Plant\"), and use its commercially reasonable efforts to pursue diligently the\nconstruction of the Plant, substantially in accordance with the plans and\nspecifications previously provided to BMS. The Company shall use its\ncommercially reasonable efforts to complete such construction by [**].\n\n     7.3 Press Release. Immediately following execution of this Amendment, the\nParties shall issue a joint press release in the form previously agreed by the\nParties.\n\n     7.4 Rights. Except as specifically set forth herein, the Commercial\nAgreement shall remain unchanged and in full force and effect. The Parties\nacknowledge and agree that there are no amendments, modifications or waivers in\nrespect of the Commercial Agreement other than those specifically set forth in\nthis Amendment.\n\n     7.5 Governing Law. This Amendment shall be governed by and interpreted in\naccordance with the laws of the State of New York without regard to conflicts\nof law principles.\n\n     7.6 Descriptive Headings. The descriptive headings of this Amendment are\nfor convenience only, and shall be of no force or effect in construing or\ninterpreting any of the provisions of this Amendment.\n\n     7.7 Counterparts. This Amendment may be executed simultaneously in any\nnumber of counterparts, any one of which need not contain the signature of more\nthan one Party but all such counterparts taken together shall constitute one\nand the same agreement.\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\n     IN WITNESS WHEREOF, each of the Parties has caused this Amendment to be\nexecuted by its duly authorized representative as of the day and year first\nabove written.\n\n\n\n                             IMCLONE SYSTEMS INCORPORATED\n\n\n                             By:      \/s\/ Samuel D. Waksal\n                                --------------------------------\n\n                             Name:    Samuel D. Waksal\n                                  ---------------------------------------\n\n                             Title:  President and Chief Executive Officer\n                                   ---------------------------------------\n\n\n\n                             E. R. SQUIBB & SONS, LLC\n\n\n                             By:      \/s\/ John L. McGoldrick\n                                -----------------------------------------\n\n                             Name:    John L. McGoldrick\n                                  ---------------------------------------\n\n                             Title:   Vice President\n                                   --------------------------------------\n\n\n\n                             BRISTOL-MYERS SQUIBB COMPANY\n\n\n                             By:      \/s\/ Sandra Leung\n                                -----------------------------------------\n\n                             Name:    Sandra Leung\n                                  ---------------------------------------\n\n                             Title:   Secretary\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--------------------------------------------------------------------------------\nExhibit 1.13 -- Base Case Projections\nUnited States and Japan C225 Sales\n($MM)\n                                 2002     2003    2004     2005    2006    2007\n--------------------------------------------------------------------------------\nBase Case\n--------------------------------------------------------------------------------\nU.S. Sales                          -     [**]    [**]     [**]    [**]    [**]\n--------------------------------------------------------------------------------\nJapan Sales                         -        -       -        -       -    [**]\n--------------------------------------------------------------------------------\nTotal C225 Sales                    -     [**]    [**]     [**]    [**]    [**]\n--------------------------------------------------------------------------------\n\n<\/pre>\n\n—————————————————————————————————————-
\nExhibit 1.13 — Base Case Projections
\nUnited States and Japan C225 Sales (continued)
\n($MM)
\n                                 2008     2009    2010     2011    2012     2013    2014    2015    2016    2017
\n—————————————————————————————————————-
\n                                                                              
\nBase Case
\n—————————————————————————————————————-
\nU.S. Sales                       [**]     [**]    [**]     [**]    [**]     [**]    [**]    [**]    [**]    [**]
\n—————————————————————————————————————-
\nJapan Sales                      [**]     [**]    [**]     [**]    [**]     [**]    [**]    [**]    [**]    [**]
\n—————————————————————————————————————-
\nTotal C225 Sales                 [**]     [**]    [**]     [**]    [**]     [**]    [**]    [**]    [**]    [**]
\n—————————————————————————————————————-
\n<\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/s><\/table>\n
Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers
\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n
——————————————————————————–
\nExhibit 1.68 — Low Case Projections
\nUnited States and Japan C225 Sales
\n($MM)
\n                                 2002     2003    2004     2005    2006    2007
\n——————————————————————————–
\nLow Case
\n——————————————————————————–
\nU.S. Sales                          –     [**]    [**]     [**]    [**]    [**]
\n——————————————————————————–
\nJapan Sales                         –        –       –        –       –    [**]
\n——————————————————————————–
\nTotal C225 Sales                    –     [**]    [**]     [**]    [**]    [**]
\n——————————————————————————–<\/p>\n
\n——————————————————————————————————————
\nExhibit 1.68 — Low Case Projections
\nUnited States and Japan C225 Sales (continued)
\n($MM)
\n                                 2008     2009    2010     2011    2012    2013     2014    2015     2016     2017
\n——————————————————————————————————————
\n                                                                              
\nLow Case
\n——————————————————————————————————————
\nU.S. Sales                       [**]     [**]    [**]     [**]    [**]    [**]     [**]    [**]     [**]     [**]
\n——————————————————————————————————————
\nJapan Sales                      [**]     [**]    [**]     [**]    [**]    [**]     [**]    [**]     [**]     [**]
\n——————————————————————————————————————
\nTotal C225 Sales                 [**]     [**]    [**]     [**]    [**]    [**]     [**]    [**]     [**]     [**]
\n——————————————————————————————————————
\n<\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/s><\/table>\n
Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers
\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n
————————————————————————-
\nExhibit 5.2A — Marketing Budget
\n2001-2004
\n($MM)
\n                                          2001    2002     2003     2004
\n————————————————————————
\nTotal A&P Expense                         [**]    [**]     [**]     [**]
\n————————————————————————
\nU.S.                                      [**]    [**]     [**]     [**]
\n————————————————————————
\nJapan                                        –       –        –        –
\n————————————————————————
\nDistribution & Other Fees                    –       –     [**]     [**]
\n————————————————————————
\nTotal Sales Force                            –       –     [**]     [**]
\n————————————————————————
\nU.S.                                         –       –     [**]     [**]
\n————————————————————————
\nJapan                                        –       –        –        –
\n————————————————————————
\n# Reps                                                     [**]     [**]
\n————————————————————————<\/p>\n
Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers
\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n
\n———————————————————————————-
\nExhibit 5.2B — Indicative Marketing Budget
\n2005-2017
\n($MM)
\n                                 2005     2006     2007     2008     2009     2010
\n———————————————————————————-
\n                                                            
\nTotal A&P Expense                [**]     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————-
\nU.S.                             [**]     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————-
\nJapan                               –     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————-
\nDistribution & Other Fees        [**]     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————-
\nTotal Sales Force                [**]     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————-
\nU.S.                             [**]     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————-
\nJapan                               –        –     [**]     [**]     [**]     [**]
\n———————————————————————————-<\/p>\n
\n——————————————————————————————-
\nExhibit 5.2B — Indicative Marketing Budget
\n2005-2017 (continued)
\n($MM)
\n                                 2011     2012     2013     2014     2015     2016     2017
\n——————————————————————————————-
\n                                                                  
\nTotal A&P Expense                [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n——————————————————————————————-
\nU.S.                             [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n——————————————————————————————-
\nJapan                            [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n——————————————————————————————-
\nDistribution & Other Fees        [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n——————————————————————————————-
\nTotal Sales Force                [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n——————————————————————————————-
\nU.S.                             [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n——————————————————————————————-
\nJapan                            [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n——————————————————————————————-
\n<\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/s><\/caption>\n
<\/c><\/c><\/c><\/c><\/c><\/c><\/s><\/table>\n
Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers
\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n\n———————————————————————————-
\nExhibit 8.12B (ii)
\nUnited States and Japan C225 Commercial Volume
\nKilograms
\n                                 2002     2003     2004     2005     2006     2007
\n———————————————————————————-
\n                                                            
\nBase Case
\n———————————————————————————-
\nUnited States – Lonza            [**]     [**]        –        –        –        –
\n———————————————————————————-
\nUnited States – IMCL                –     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————-
\nJapan – Lonza                       –        –        –        –        –        –
\n———————————————————————————-
\nJapan – IMCL                        –        –        –        –        –     [**]
\n———————————————————————————-
\nTotal – Lonza                    [**]     [**]        –        –        –        –
\n———————————————————————————-
\nTotal – IMCL                        –     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————-<\/p>\n
\n———————————————————————————————————————-
\nExhibit 8.12B (ii)
\nUnited States and Japan C225 Commercial Volume (continued)
\nKilograms
\n                                 2008     2009     2010     2011     2012     2013     2014     2015     2016     2017
\n———————————————————————————————————————-
\n                                                                                    
\nBase Case
\n———————————————————————————————————————-
\nUnited States – Lonza               –        –        –        –        –        –        –        –        –        –
\n———————————————————————————————————————-
\nUnited States – IMCL             [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————————————————-
\nJapan – Lonza                       –        –        –        –        –        –        –        –        –        –
\n———————————————————————————————————————-
\nJapan – IMCL                     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————————————————-
\nTotal – Lonza                       –        –        –        –        –        –        –        –        –        –
\n———————————————————————————————————————-
\nTotal – IMCL                     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n———————————————————————————————————————-
\n<\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/s><\/caption>\n
<\/c><\/c><\/c><\/c><\/c><\/c><\/s><\/table>\n
Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers
\nSquibb Biologics Company and ImClone Systems Incorporated.<\/p>\n\n————————————————————————————————————-
\nExhibit 4.3A — C225 Clinical Spending
\nNon-Registrational Studies
\n($MM)
\n                                 2001     2002     2003     2004     2005     2006     2007     2008     2009
\n————————————————————————————————————-
\n                                                                             
\n Non-Registrational Studies      [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n————————————————————————————————————-
\n U.S.                            [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n————————————————————————————————————-
\nJapan                               –        –        –        –        –        –     [**]     [**]     [**]
\n————————————————————————————————————-<\/p>\n
\n————————————————————————————————————-
\nExhibit 4.3A — C225 Clinical Spending
\nNon-Registrational Studies (continued)
\n($MM)
\n                                 2010     2011     2012     2013     2014     2015     2016     2017    Total
\n————————————————————————————————————-
\n                                                                              
\n Non-Registrational Studies      [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n————————————————————————————————————-
\n U.S.                            [**]     [**]     [**]     [**]     [**]     [**]     [**]        –     [**]
\n————————————————————————————————————-
\nJapan                            [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]     [**]
\n————————————————————————————————————-<\/p>\n
<\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/s><\/caption>\n
<\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/c><\/s><\/table>\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-42231","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\/42231","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=42231"}],"wp:term":[{"taxonomy":"corporate_contracts_companies","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_companies?post=42231"},{"taxonomy":"corporate_contracts_industries","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_industries?post=42231"},{"taxonomy":"corporate_contracts_types","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_types?post=42231"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}