Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

 

  x

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2012

 

  ¨

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM              TO             

Commission file number:            1-1136

 

 

BRISTOL-MYERS SQUIBB COMPANY

(Exact name of registrant as specified in its charter)

 

Delaware   22-0790350

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

345 Park Avenue, New York, N.Y. 10154

(Address of principal executive offices) (Zip Code)

 

 

(212) 546-4000

(Registrant’s telephone number, including area code)

 

 

(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to the filing requirements for the past 90 days.    Yes   x     No   ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   x     No   ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definition of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer   x     Accelerated filer   ¨     Non-accelerated filer   ¨     Smaller reporting company   ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes   ¨     No   x

APPLICABLE ONLY TO CORPORATE ISSUERS:

At September 30, 2012, there were 1,650,688,859 shares outstanding of the Registrant’s $0.10 par value common stock.

 

 

 


Table of Contents

BRISTOL-MYERS SQUIBB COMPANY

INDEX TO FORM 10-Q

SEPTEMBER 30, 2012

 

PART I—FINANCIAL INFORMATION

  

Item 1.

  

Financial Statements:

  

Consolidated Statements of Earnings

     3   

Consolidated Statements of Comprehensive Income

     4   

Consolidated Balance Sheets

     5   

Consolidated Statements of Cash Flows

     6   

Notes to Consolidated Financial Statements

     7   

Item 2.

  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     29   

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risk

     46   

Item 4.

  

Controls and Procedures

     46   

PART II—OTHER INFORMATION

  

Item 1.

  

Legal Proceedings

     46   

Item 1A.

  

Risk Factors

     46   

Item 2.

  

Issuer Purchases of Equity Securities

     46   

Item 6.

  

Exhibits

     47   

Signatures

     48   


Table of Contents

PART I—FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF EARNINGS

Dollars and Shares in Millions, Except Per Share Data

(UNAUDITED)

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
EARNINGS    2012     2011     2012     2011  

Net Sales

   $ 3,736     $ 5,345     $ 13,430     $ 15,790  
  

 

 

   

 

 

   

 

 

   

 

 

 

Cost of products sold

     987       1,407       3,535       4,231  

Marketing, selling and administrative

     1,071       1,019       3,077       2,987  

Advertising and product promotion

     167       205       585       672  

Research and development

     951       973       2,822       2,831  

Impairment charge for BMS-986094 intangible asset

     1,830              1,830         

Provision for restructuring

     29       8       71       92  

Litigation expense/(recoveries)

     50              (122       

Equity in net income of affiliates

     (40     (71     (150     (215

Other (income)/expense

     (50     (26     (45     (195
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Expenses

     4,995       3,515       11,603       10,403  
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings/(Loss) Before Income Taxes

     (1,259     1,830       1,827       5,387  

Provision for/(benefit from) income taxes

     (546     475       250       1,358  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings/(Loss)

     (713     1,355       1,577       4,029  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings/(Loss) Attributable to Noncontrolling Interest

     (2     386       542       1,172  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings/(Loss) Attributable to BMS

   $ (711   $ 969     $ 1,035     $ 2,857  
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings/(Loss) per Common Share Attributable to BMS

        

Basic

   $ (0.43   $ 0.57     $ 0.62     $ 1.67  

Diluted

   $ (0.43   $ 0.56     $ 0.61     $ 1.66  

Dividends declared per common share

   $ 0.34     $ 0.33     $ 1.02     $ 0.99  

The accompanying notes are an integral part of these consolidated financial statements.

 

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BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

Dollars in Millions

(UNAUDITED)

 

                                           
    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
COMPREHENSIVE INCOME   2012     2011     2012     2011  

Net Earnings/(Loss)

  $ (713   $ 1,355     $ 1,577     $ 4,029  

Other Comprehensive Income/(Loss):

       

Foreign currency translation

    21       (40     (1     (12

Foreign currency translation on net investment hedges

    (21     44       8       (13

Derivatives qualifying as cash flow hedges, net of taxes of $9 and $(23) for the three months ended September 30, 2012 and 2011, respectively; and $(8) and $3 for the nine months ended September 30, 2012 and 2011, respectively

    (26     60       1       3  

Derivatives qualifying as cash flow hedges reclassified to net earnings, net of taxes of $9 and $(9) for the three months ended September 30, 2012 and 2011, respectively; and $15 and $(16) for the nine months ended September 30, 2012 and 2011, respectively

    (13     18       (28     31  

Pension and postretirement benefits, net of taxes $(5) for the nine months ended September 30, 2012

                  14         

Pension and postretirement benefits reclassified to net earnings, net of taxes of $(12) and $(11) for the three months ended September 30, 2012 and 2011, respectively; and $(35) and $(30) for the nine months ended September 30, 2012 and 2011, respectively

    24       19       70       56  

Available for sale securities, net of taxes of $9 and $(3) for the three months ended September 30, 2012 and 2011, respectively; and $8 and $(6) for the nine months ended September 30, 2012 and 2011, respectively

    38       6       45       24  

Available for sale securities reclassified to net earnings, net of taxes of $2 for the nine months ended September 30, 2012

                  (8       
 

 

 

   

 

 

   

 

 

   

 

 

 

Total Other Comprehensive Income/(Loss)

    23       107       101       89  
 

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive Income/(Loss)

    (690     1,462       1,678       4,118  
 

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive Income/(Loss) Attributable to Noncontrolling Interest

    (2     386       542       1,172  
 

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive Income/(Loss) Attributable to Bristol-Myers Squibb Company

  $ (688   $ 1,076     $ 1,136     $ 2,946  
 

 

 

   

 

 

   

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED BALANCE SHEETS

Dollars in Millions, Except Share and Per Share Data

(UNAUDITED)

 

ASSETS    September 30,
2012
    December 31,
2011
 

Current Assets:

    

Cash and cash equivalents

   $ 1,503     $ 5,776  

Marketable securities

     1,427       2,957  

Receivables

     2,889       3,743  

Inventories

     1,697       1,384  

Deferred income taxes

     1,339       1,200  

Prepaid expenses and other

     423       258  
  

 

 

   

 

 

 

Total Current Assets

     9,278       15,318  
  

 

 

   

 

 

 

Property, plant and equipment

     5,297       4,521  

Goodwill

     7,498       5,586  

Other intangible assets

     9,217       3,124  

Deferred income taxes

     179       688  

Marketable securities

     3,698       2,909  

Other assets

     877       824  
  

 

 

   

 

 

 

Total Assets

   $ 36,044     $ 32,970  
  

 

 

   

 

 

 

LIABILITIES

    

Current Liabilities:

    

Short-term borrowings and current portion of long-term debt

   $ 751     $ 115  

Accounts payable

     2,085       2,603  

Accrued expenses

     2,759       2,791  

Deferred income

     689       337  

Accrued rebates and returns

     1,122       1,170  

U.S. and foreign income taxes payable

     193       167  

Dividends payable

     596       597  
  

 

 

   

 

 

 

Total Current Liabilities

     8,195       7,780  
  

 

 

   

 

 

 

Pension, postretirement and postemployment liabilities

     1,473       2,017  

Deferred income

     4,006       866  

U.S. and foreign income taxes payable

     650       573  

Deferred income taxes

     748       107  

Other liabilities

     464       384  

Long-term debt

     6,608       5,376  
  

 

 

   

 

 

 

Total Liabilities

     22,144       17,103  
  

 

 

   

 

 

 

Commitments and contingencies (Note 17)

    

EQUITY

    

Bristol-Myers Squibb Company Shareholders’ Equity:

    

Preferred stock, $2 convertible series, par value $1 per share: Authorized 10 million shares; issued and outstanding 5,189 in 2012 and 5,268 in 2011, liquidation value of $50 per share

              

Common stock, par value of $0.10 per share: Authorized 4.5 billion shares; 2.2 billion issued in both 2012 and 2011

     221       220  

Capital in excess of par value of stock

     2,717       3,114  

Accumulated other comprehensive loss

     (2,944     (3,045

Retained earnings

     32,381       33,069  

Less cost of treasury stock – 558 million shares in 2012 and 515 million in 2011

     (18,475     (17,402
  

 

 

   

 

 

 

Total Bristol-Myers Squibb Company Shareholders’ Equity

     13,900       15,956  

Noncontrolling interest

            (89
  

 

 

   

 

 

 

Total Equity

     13,900       15,867  
  

 

 

   

 

 

 

Total Liabilities and Equity

   $ 36,044     $ 32,970  
  

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF CASH FLOWS

Dollars in Millions

(UNAUDITED)

 

     Nine Months Ended September 30,  
     2012     2011  

Cash Flows From Operating Activities:

    

Net earnings

   $ 1,577     $ 4,029  

Adjustments to reconcile net earnings to net cash provided by operating activities:

    

Net earnings attributable to noncontrolling interest

     (542     (1,172

Depreciation and amortization

     482       482  

Impairment charges

     2,118       28  

Deferred income taxes

     (737     273  

Stock-based compensation

     108       120  

Other

     21       (138

Changes in operating assets and liabilities:

    

Receivables

     643       (152

Inventories

     (135     (150

Accounts payable

     (321     309  

Deferred income from diabetes collaboration

     3,570         

Other deferred income

     100       (7

U.S. and foreign income taxes payable

     82       (20

Other

     (861     (330
  

 

 

   

 

 

 

Net Cash Provided by Operating Activities

     6,105       3,272  
  

 

 

   

 

 

 

Cash Flows From Investing Activities:

    

Sale and maturities of marketable securities

     4,384       3,808  

Purchases of marketable securities

     (3,501     (5,344

Additions to property, plant and equipment and capitalized software

     (373     (233

Sale of businesses and other investing activities

     16       147  

Purchase of businesses, net of cash acquired

     (7,530     (310
  

 

 

   

 

 

 

Net Cash Used in Investing Activities

     (7,004     (1,932
  

 

 

   

 

 

 

Cash Flows From Financing Activities:

    

Short-term borrowings/(repayments)

     20       67  

Proceeds from issuance of long-term debt

     1,950         

Long-term debt repayments

     (2,108     (78

Interest rate swap terminations

     2       296  

Stock option exercises

     397       365  

Common stock repurchases

     (1,911     (859

Dividends paid

     (1,725     (1,694
  

 

 

   

 

 

 

Net Cash Used in Financing Activities

     (3,375     (1,903
  

 

 

   

 

 

 

Effect of Exchange Rates on Cash and Cash Equivalents

     1       1  
  

 

 

   

 

 

 

Decrease in Cash and Cash Equivalents

     (4,273     (562

Cash and Cash Equivalents at Beginning of Period

     5,776       5,033  
  

 

 

   

 

 

 

Cash and Cash Equivalents at End of Period

   $ 1,503     $ 4,471  
  

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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Note 1. BASIS OF PRESENTATION

Bristol-Myers Squibb Company (which may be referred to as Bristol-Myers Squibb, BMS or the Company) prepared these unaudited consolidated financial statements following the requirements of the Securities and Exchange Commission (SEC) and United States (U.S.) generally accepted accounting principles (GAAP) for interim reporting. Under those rules, certain footnotes and other financial information that are normally required for annual financial statements can be condensed or omitted. The Company is responsible for the consolidated financial statements included in this Form 10-Q. These consolidated financial statements include all normal and recurring adjustments necessary for a fair presentation of the financial position at September 30, 2012 and December 31, 2011, the results of operations for the three and nine months ended September 30, 2012 and 2011 and cash flows for the nine months ended September 30, 2012 and 2011. All intercompany balances and transactions have been eliminated. Material subsequent events are evaluated and disclosed through the report issuance date. These unaudited consolidated financial statements and the related notes should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2011 included in the Annual Report on Form 10-K.

Certain prior period amounts have been reclassified to conform to the current period presentation. The presentation of depreciation and amortization in the consolidated statements of cash flows includes the depreciation of property, plant and equipment and the amortization of intangible assets and deferred income.

Revenues, expenses, assets and liabilities can vary during each quarter of the year. Accordingly, the results and trends in these unaudited consolidated financial statements may not be indicative of full year operating results.

The preparation of financial statements requires the use of management estimates and assumptions, based on complex judgments that are considered reasonable, that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and contingent liabilities at the date of the financial statements. The most significant assumptions are employed in estimates used in determining the fair value and potential impairment of intangible assets; sales rebate and return accruals used in revenue recognition; legal contingencies; income taxes; and pension and postretirement benefits. Actual results may differ from estimated results.

Note 2. BUSINESS SEGMENT INFORMATION

BMS operates in a single segment engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of innovative medicines that help patients prevail over serious diseases. A global research and development organization and a global supply chain organization are utilized and responsible for the development and delivery of products to the market. Products are distributed and sold through regional organizations that serve the United States; Europe; Latin America, Middle East and Africa; Japan, Asia Pacific and Canada; and Emerging Markets defined as Brazil, Russia, India, China and Turkey. The business is also supported by global corporate staff functions. Segment information is consistent with the financial information regularly reviewed by the chief operating decision maker, the chief executive officer, for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting future periods.

Net sales of key products were as follows:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions   2012     2011     2012     2011  

Plavix* (clopidogrel bisulfate)

  $ 64     $ 1,788     $ 2,498     $ 5,415  

Avapro*/Avalide* (irbesartan/irbesartan-hydrochlorothiazide)

    95       216       419       757  

Eliquis (apixaban)

                  1         

Abilify* (aripiprazole)

    676       691       2,008       2,021  

Reyataz (atazanavir sulfate)

    363       391       1,127       1,153  

Sustiva (efavirenz) Franchise

    370       359       1,144       1,073  

Baraclude (entecavir)

    346       311       1,028       878  

Erbitux* (cetuximab)

    173       172       531       510  

Sprycel (dasatinib)

    263       211       738       576  

Yervoy (ipilimumab)

    179       121       495       216  

Orencia (abatacept)

    307       233       851       660  

Nulojix (belatacept)

    3              7       2  

Onglyza/Kombiglyze (saxagliptin/saxagliptin and metformin)

    178       127       511       320  

Byetta* (exenatide)

    55              55         

Bydureon* (exenatide extended-release for injectable suspension)

    20              20         

Mature Products and All Other

    644       725       1,997       2,209  
 

 

 

   

 

 

   

 

 

   

 

 

 

Net Sales

  $ 3,736     $ 5,345     $ 13,430     $ 15,790  
 

 

 

   

 

 

   

 

 

   

 

 

 

 

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Note 3. ALLIANCES AND COLLABORATIONS

BMS maintains alliances and collaborations with various third parties for the development and commercialization of certain products. Unless otherwise noted, operating results associated with the alliances and collaborations are generally treated as follows: product revenues from BMS sales are included in revenue; royalties, collaboration fees, profit sharing and distribution fees are included in cost of goods sold; post-approval milestone payments to partners are deferred and amortized over the useful life of the related products in cost of products sold; cost sharing reimbursements offset the intended operating expense; payments to BMS attributed to upfront, pre-approval milestone and other licensing payments are deferred and amortized over the estimated useful life of the related products in other income/expense; income and expenses attributed to a collaboration’s non-core activities, such as supply and manufacturing arrangements and compensation for opting-out of commercialization in certain countries, are included in other income/expense; partnerships and joint ventures are either consolidated or accounted for under the equity method of accounting and related cash receipts and distributions are treated as operating cash flow.

See the 2011 Annual Report on Form 10-K for a more complete description of the below agreements, including termination provisions, as well as disclosures of other alliances and collaborations.

Sanofi

BMS has agreements with Sanofi for the codevelopment and cocommercialization of Avapro*/Avalide* and Plavix* . The worldwide alliance operates under the framework of two geographic territories; one in the Americas (principally the U.S., Canada, Puerto Rico and Latin American countries) and Australia and the other in Europe and Asia. Accordingly, two territory partnerships were formed to manage central expenses, such as marketing, research and development and royalties, and to supply finished product to the individual countries. In general, at the country level, agreements either to copromote (whereby a partnership was formed between the parties to sell each brand) or to comarket (whereby the parties operate and sell their brands independently of each other) are in place.

BMS acts as the operating partner and owns a 50.1% majority controlling interest in the territory covering the Americas and Australia and consolidates all country partnership results for this territory with Sanofi’s 49.9% share of the results included in net earnings/(loss) attributable to noncontrolling interest. BMS recognizes net sales in this territory and in comarketing countries outside this territory (e.g. Germany, Italy for irbesartan only, Spain and Greece). Sanofi acts as the operating partner and owns a 50.1% majority controlling interest in the territory covering Europe and Asia and BMS has a 49.9% ownership interest in this territory which is included in equity in net income of affiliates.

BMS and Sanofi have a separate partnership governing the copromotion of irbesartan in the U.S. Sanofi paid BMS $350 million for their acquisition of an interest in the irbesartan license for the U.S. upon formation of the alliance.

Summarized financial information related to this alliance is as follows:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions   2012     2011     2012     2011  

Territory covering the Americas and Australia:

       

Net sales

  $ 95     $ 1,936     $ 2,690     $ 5,959  

Royalty expense

    19       430       527       1,229  

Noncontrolling interest – pre-tax

    (7     590       847       1,764  

Distributions to/(from) Sanofi

    (290     523       768       1,824  

Territory covering Europe and Asia:

       

Equity in net income of affiliates

    45       75       163       226  

Profit distributions to BMS

    54       97       183       224  

Other:

       

Net sales in Europe comarketing countries and other

    64       68       227       213  

Amortization (income)/expense – irbesartan license fee

    (8     (7     (24     (23

Supply activities and development and opt-out royalty (income)/expense

    (53     6       (98     21  
Dollars in Millions               September 30,
2012
    December 31,
2011
 

Investment in affiliates – territory covering Europe and Asia

      $ 17     $ 37  

Deferred income – irbesartan license fee

        5       29  

 

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The following is summarized financial information for interests in the partnerships with Sanofi for the territory covering Europe and Asia, which are not consolidated but are accounted for using the equity method:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions   2012     2011     2012     2011  

Net sales

  $ 248     $ 364     $ 886     $ 1,125  

Gross profit

    132       161       402       501  

Net income

    116       131       358       413  

In September 2012, BMS and Sanofi restructured the terms of the codevelopment and cocommercialization agreements discussed above. Effective as of January 1, 2013, subject in certain countries to the receipt of regulatory approvals, Sanofi will assume the worldwide operations of the alliance with the exception of Plavix* for the U.S. and Puerto Rico. The alliance for Plavix* in these two markets will continue unchanged through December 2019 under the same terms as in the original alliance arrangements. In exchange for the rights being assumed by Sanofi, BMS will receive quarterly royalties from January 1, 2013 until December 31, 2018 and a terminal payment from Sanofi of $200 million at the end of 2018. All ongoing disputes between the companies have been resolved, including a one-time payment of $80 million by BMS to Sanofi related to the Avalide* supply disruption in the U.S. in 2011 (accrued for in 2011).

Otsuka

BMS has a worldwide commercialization agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to codevelop and copromote Abilify* , for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder, excluding certain Asia Pacific countries. The U.S. portion of the amended commercialization and manufacturing agreement expires upon the expected loss of product exclusivity in April 2015. Beginning on January 1, 2012, the contractual share of revenue recognized by BMS in the U.S. was reduced from 53.5% in 2011 to 51.5% and will be further reduced in 2013.

In the UK, Germany, France and Spain, BMS receives 65% of third-party net sales. In these countries and the U.S., third-party customers are invoiced by BMS on behalf of Otsuka and alliance revenue is recognized when Abilify* is shipped and all risks and rewards of ownership have been transferred to third-party customers. In certain countries where BMS is presently the exclusive distributor for the product or has an exclusive right to sell Abilify* , BMS recognizes all of the net sales.

BMS purchases the product from Otsuka and performs finish manufacturing for sale to third-party customers by BMS or Otsuka. Under the terms of the amended agreement, BMS paid Otsuka $400 million, which is amortized as a reduction of net sales through the expected loss of U.S. exclusivity in April 2015. The unamortized balance is included in other assets. Otsuka receives a royalty based on 1.5% of total U.S. net sales. Otsuka is responsible for 30% of the U.S. expenses related to the commercialization of Abilify* from 2010 through 2012. BMS also reimburses Otsuka for its contractual share of the annual pharmaceutical company fee related to Abilify* .

BMS and Otsuka also have an oncology collaboration for Sprycel and Ixempra (ixabepilone) (the “Oncology Products”) in the U.S., Japan and the EU. The Company pays a collaboration fee to Otsuka equal to 30% of the first $400 million annual net sales of the Oncology Products in the Oncology Territory (U.S., Japan and Europe), 5% of annual net sales between $400 million and $600 million, and 3% of annual net sales between $600 million and $800 million with additional trailing percentages of annual net sales over $800 million. Annually, Otsuka contributes 20% of the first $175 million of certain commercial operational expenses relating to the Oncology Products in the Oncology Territory and 1% of such costs in excess of $175 million. In addition, Otsuka has the right to co-promote Sprycel in the U.S., Japan, and the top five markets in the EU.

Summarized financial information related to this alliance is as follows:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions   2012     2011     2012     2011  

Abilify* net sales, including amortization of extension payment

  $ 676     $ 691     $ 2,008     $ 2,021  

Oncology Products collaboration fee expense

    36       30       103       100  

Royalty expense

    18       18       55       52  

Commercialization expense reimbursement to/(from) Otsuka

    (2     (15     (34     (37

Amortization (income)/expense – extension payment

    16       16       49       49  

Amortization (income)/expense – upfront, milestone and other licensing payments

    1       1       5       5  
Dollars in Millions               September 30,
2012
    December 31,
2011
 

Other assets – extension payment

      $ 170     $ 219  

Other intangible assets – upfront, milestone and other licensing payments

               5  

 

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Lilly

BMS has an Epidermal Growth Factor Receptor (EGFR) commercialization agreement with Lilly through Lilly’s November 2008 acquisition of ImClone Systems Incorporated (ImClone) for the codevelopment and promotion of Erbitux* and necitumumab (IMC-11F8) in the U.S. which expires as to Erbitux* in September 2018. BMS also has codevelopment and copromotion rights to both products in Canada and Japan. Erbitux * is indicated for use in the treatment of patients with metastatic colorectal cancer and for use in the treatment of squamous cell carcinoma of the head and neck. Under the EGFR agreement, with respect to Erbitux* sales in North America, Lilly receives a distribution fee based on a flat rate of 39% of net sales in North America plus reimbursement of certain royalties paid by Lilly.

In Japan, BMS shares rights to Erbitux* under an agreement with Lilly and Merck KGaA and receives 50% of the pre-tax profit from Merck KGaA’s net sales of Erbitux* in Japan which is further shared equally with Lilly.

With respect to necitumumab, the companies will share in the cost of developing and potentially commercializing necitumumab in the U.S., Canada and Japan. Lilly maintains exclusive rights to necitumumab in all other markets. BMS will fund 55% of development costs for studies that will be used only in the U.S., 50% for Japan studies and 27.5% for global studies.

BMS is amortizing $500 million of license acquisition costs associated with the EGFR commercialization agreement through 2018.

Summarized financial information related to this alliance is as follows:

 

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
Dollars in Millions   2012     2011     2012     2011  

Net sales

  $ 173     $ 172     $ 531     $ 510  

Distribution fees and royalty expense

    71       72       220       212  

Research and development expense reimbursement to Lilly – necitumumab

    5       4       13       10  

Amortization (income)/expense – upfront, milestone and other licensing payments

    9       9       28       28  

Commercialization expense reimbursements to/(from) Lilly

    (4     (9     (14     (12

Japan commercialization profit sharing (income)/expense

    (9     (9     (28     (24

 

Dollars in Millions           September 30,
2012
    December 31,
2011
 

Other intangible assets – upfront, milestone and other licensing payments

      $ 221     $ 249  

BMS acquired Amylin Pharmaceuticals, Inc. (Amylin) on August 8, 2012 (see “—Note 4. Acquisitions” for further information). Amylin had previously entered into a settlement and termination agreement with Lilly regarding their collaboration for the global development and commercialization of Byetta* and Bydureon * (exenatide products) under which the parties agreed to transition full responsibility of these products to Amylin. Although the transition of the U.S. operations was completed, Lilly had not yet transitioned the non-U.S. operations to Amylin. In September 2012, BMS provided notification to Lilly that BMS will assume essentially all non-U.S. operations of the exenatide products during the first half of 2013 and therefore terminate Lilly’s exclusive right to non-U.S. commercialization of the exenatide products, subject to certain regulatory and other conditions. BMS is responsible for any non-U.S. losses incurred by Lilly during 2012 and 2013 up to a maximum of $60 million and is entitled to tiered royalties until the transition is complete.

Gilead

BMS and Gilead Sciences, Inc. (Gilead) have a joint venture to develop and commercialize Atripla* (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily single tablet three-drug regimen for the treatment of human immunodeficiency virus (HIV) infection, combining Sustiva , a product of BMS, and Truvada* (emtricitabine and tenofovir disoproxil fumarate), a product of Gilead, in the U.S., Canada and Europe.

Net sales of the bulk efavirenz component of Atripla* are deferred until the combined product is sold to third-party customers. Net sales for the efavirenz component are based on the relative ratio of the average respective net selling prices of Truvada* and Sustiva .

Summarized financial information related to this alliance is as follows:

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions    2012     2011     2012     2011  

Net sales

   $ 305     $ 289     $ 950     $ 858  

Equity in net loss of affiliates

     (6     (3     (14     (11

 

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AstraZeneca

BMS and AstraZeneca Pharmaceuticals LP, a wholly-owned subsidiary of AstraZeneca, entered into a collaboration regarding the worldwide development and commercialization of Amylin’s portfolio of products. The arrangement is based on the framework of the existing diabetes alliance agreements discussed further below, including the equal sharing of profits and losses arising from the collaboration. AstraZeneca has indicated its intent to establish equal governance rights over certain key strategic and financial decisions regarding the collaboration pending required anti-trust approvals in certain international markets.

BMS received preliminary proceeds of $3.8 billion from AstraZeneca as consideration for entering into the collaboration during the current period, including $190 million which is included in accrued expenses and expected to be reimbursed back to AstraZeneca. The remaining $3.6 billion was accounted for as deferred income and is amortized as a reduction to cost of products sold on a pro-rata basis over the estimated useful lives of the related long-lived assets assigned in the purchase price allocation (primarily intangible assets with a weighted-average estimated useful life of 12 years and property, plant and equipment with a weighted-average estimated useful life of 15 years). The net proceeds that BMS will receive from AstraZeneca as consideration for entering into the collaboration are subject to certain other adjustments including the right to receive an additional $135 million when AstraZeneca exercises its option for equal governance rights.

BMS and AstraZeneca agreed to share in certain tax attributes related to the Amylin collaboration. The preliminary proceeds of $3.8 billion that BMS received from AstraZeneca included $207 million related to sharing of certain tax attributes.

In addition, BMS continues to maintain two worldwide codevelopment and cocommercialization agreements with AstraZeneca for Onglyza , Kombiglyze XR (saxagliptin and metformin hydrochloride extended-release), Komboglyze (saxagliptin and metformin immediate-release marketed in the EU) and Forxiga (dapagliflozin). The agreements for saxagliptin exclude Japan which is not covered by the alliance. Onglyza , Kombiglyze and Komboglyze are indicated for use in the treatment of diabetes. In this document unless specifically noted, we refer to both Kombiglyze and Komboglyze as Kombiglyze . Forxiga is currently being studied for the treatment of diabetes. Onglyza and Forxiga were discovered by BMS. Kombiglyze was codeveloped with AstraZeneca. Both companies jointly develop the clinical and marketing strategy and share commercialization expenses and profits and losses equally on a global basis and also share in development costs, with the exception of Forxiga development costs in Japan, which are borne by AstraZeneca. BMS manufactures both products. BMS has opted to decline involvement in cocommercialization for both products in certain countries not in the BMS global commercialization network and instead receives compensation based on net sales recorded by AstraZeneca in these countries. Opt-out compensation recorded by BMS was not material in the three and nine months ended September 30, 2012.

BMS received $300 million in upfront, milestone and other licensing payments related to saxagliptin as of September 30, 2012 and $170 million in upfront, milestone and other licensing payments related to dapagliflozin as of September 30, 2012.

Summarized financial information related to this alliance is as follows:

 

    Three Months  Ended
September 30,
    Nine Months  Ended
September 30,
 
Dollars in Millions           2012                     2011             2012     2011  

Net sales

  $ 266     $ 127     $ 599     $ 320  

Profit sharing expense

    118       58       268       148  

Commercialization expense reimbursements to/(from) AstraZeneca

    (43     (11     (62     (30

Research and development expense reimbursements to/(from) AstraZeneca

    (17     4       (7     33  

Amortization (income)/expense – upfront, milestone and other licensing
payments recognized in:

       

Cost of products sold

    (50            (50       

Other (income)/expense

    (9     (10     (30     (28

Upfront, milestone and other licensing payments received:

       

Amylin-related products

    3,570              3,570         

Dapagliflozin

                         120  
Dollars in Millions               September 30,
2012
    December 31,
2011
 

Deferred income – upfront, milestone and other licensing payments:

       

Amylin-related products

      $ 3,520     $   

Saxagliptin

        213       230  

Dapagliflozin

        129       142  

 

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Pfizer

BMS and Pfizer Inc. (Pfizer) maintain a worldwide codevelopment and cocommercialization agreement for Eliquis , an anticoagulant discovered by BMS for the prevention and treatment of atrial fibrillation and other arterial thrombotic conditions. Pfizer funds 60% of all development costs under the initial development plan effective January 1, 2007. The companies jointly develop the clinical and marketing strategy and share commercialization expenses and profits equally on a global basis. In certain countries not in the BMS global commercialization network, Pfizer will commercialize Eliquis alone and will pay compensation to BMS based on a percentage of net sales. BMS manufactures the product globally.

BMS has received $559 million in upfront, milestone and other licensing payments for Eliquis as of September 30, 2012.

Summarized financial information related to this alliance is as follows:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions           2012                     2011                     2012                     2011          

Net sales

  $      $      $ 1     $   

Commercialization expense reimbursement to/(from) Pfizer

    (6     (2     (14     (5

Research and development reimbursements to/(from) Pfizer

    (1     (16     10       (74

Amortization (income)/expense – upfront, milestone and other
licensing payments

    (10     (8     (29     (24
Dollars in Millions               September 30,
2012
    December 31,
2011
 

Deferred income – upfront, milestone and other licensing payments

      $ 405     $ 434  

Note 4. ACQUISITIONS

Amylin Pharmaceuticals, Inc. Acquisition

On August 8, 2012, BMS completed its acquisition of the outstanding shares of Amylin, a biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines to treat diabetes and other metabolic diseases. Acquisition costs of $29 million were included in other expenses.

BMS obtained full U.S. commercialization rights to Amylin’s two primary commercialized assets, Bydureon* , a once-weekly diabetes treatment and Byetta* , a daily diabetes treatment, both of which are glucagon-like peptide-1 (GLP-1) receptor agonists approved in certain countries to improve glycemic control in adults with type 2 diabetes. BMS also obtained full commercialization rights to Symlin* (pramlintide acetate), an amylinomimetic approved in the U.S. for adjunctive therapy to mealtime insulin to treat diabetes. Goodwill generated from this acquisition was primarily attributed to the expansion of our diabetes franchise.

The fair value of acquired intangible assets, including in-process research and development (IPRD), was estimated utilizing the income method which risk adjusted the expected future net cash flows estimated to be generated from the compounds based upon estimated probabilities of technical and regulatory success (PTRS). All acquired intangible assets were valued utilizing a global view that considered all potential jurisdictions and indications. Actual cash flows are likely to be different than those assumed.

IPRD was attributed to metreleptin, an analog of the human hormone leptine being studied and developed for the treatment of diabetes and/or hypertriglyceridemia in pediatric and adult patients with inherited or acquired lipodystrophy. The estimated useful life and the cash flows utilized to value metreleptin assumed initial positive cash flows to commence shortly after the expected receipt of regulatory approvals, subject to trial results.

The results of Amylin’s operations are included in the consolidated financial statements from August 9, 2012.

 

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Inhibitex, Inc. Acquisition

On February 13, 2012, BMS completed its acquisition of the outstanding shares of Inhibitex, Inc. (Inhibitex), a clinical-stage biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. Acquisition costs of $12 million were included in other expense. BMS obtained Inhibitex’s lead asset, INX-189, an oral nucleotide polymerase (NS5B) inhibitor in Phase II development for the treatment of chronic hepatitis C infections. Goodwill generated from this acquisition was primarily attributed to the potential to offer a full portfolio of therapy choices for hepatitis infections as well as to provide additional levels of sustainability to BMS’s virology pipeline.

The fair value of IPRD was estimated utilizing the income method which risk adjusted the expected future net cash flows estimated to be generated from the compounds based upon estimated PTRS and a global view that considered all potential jurisdictions and indications.

IPRD was primarily attributed to INX-189. INX-189 was expected to be most effective when used in combination therapy and it was assumed all market participants would inherently maintain franchise synergies attributed to maximizing the cash flows of their existing virology pipeline assets. The cash flows utilized to value INX-189 included such synergies and also assumed initial positive cash flows to commence shortly after the expected receipt of regulatory approvals, subject to trial results.

In August 2012, the Company discontinued development of INX-189 in the interest of patient safety. As a result, the Company recognized a non-cash, pre-tax impairment charge of $1.8 billion related to the IPRD intangible asset in the third quarter of 2012. For further information discussion of the impairment charge, see “—Note 12. Goodwill and Other Intangible Assets.”

The results of Inhibitex’s operations are included in the consolidated financial statements from February 13, 2012.

Significant estimates utilized at the time of the valuations to support the fair values of the commercial assets and compounds within the acquisitions include:

 

Dollars in Millions    Fair value      Discount
rate utilized
    Estimated
useful life
(in years)
   Phase of
Development as
of acquisition date
   PTRS
Rate
utilized
  Year of first
projected positive
cash flow

Commercialized products:

               

Bydureon*

   $ 5,240        11.1   13    N/A    N/A   N/A

Byetta*

     750        10.0   7    N/A    N/A   N/A

Symlin*

     300        10.0   9    N/A    N/A   N/A

IPRD:

               

BMS-986094 (formerly INX-189)

     1,830        12.0   11    Phase II    38%   2017

Metreleptin

     370        12.0   12    Phase III    75%   2014

The components of the cash paid to acquire Amylin and Inhibitex were as follows:

 

                                       
Dollars in Millions    Amylin      Inhibitex  

Total consideration transferred

   $ 5,218      $ 2,539  

Stock-based compensation expense

     94          
  

 

 

    

 

 

 

Total cash paid

   $ 5,312      $ 2,539  
  

 

 

    

 

 

 

The preliminary purchase price allocation for Amylin (pending final valuation of intangible assets and deferred income taxes) and the final purchase price allocation for Inhibitex were as follows:

 

                                       
Dollars in Millions             
Identifiable net assets:    Amylin     Inhibitex  

Cash

   $ 179     $ 46  

Marketable securities

     108       17  

Inventory

     178         

Property, plant and equipment

     773         

Developed technology rights

     6,290         

IPRD

     370       1,875  

Other assets

     136         

Debt obligations

     (2,020     (23

Other liabilities

     (339     (10

Deferred income taxes

     (1,156     (579
  

 

 

   

 

 

 

Total identifiable net assets

     4,519       1,326  
  

 

 

   

 

 

 

Goodwill

   $ 699     $ 1,213  
  

 

 

   

 

 

 

 

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Cash paid for the acquisition of Amylin included payments of $5,093 million to its outstanding common stockholders and $219 million to holders of its stock options and restricted stock units (including $94 million attributed to accelerated vesting that was accounted for as stock compensation expense in the third quarter of 2012).

Pro forma supplemental financial information is not provided as the impacts of the acquisitions were not material to operating results in the year of acquisition. Goodwill, IPRD and all intangible assets valued in these acquisitions are non-deductible for tax purposes.

 

Note 5. RESTRUCTURING

The following is the provision for restructuring:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions   2012     2011     2012     2011  

Employee termination benefits

  $ 21     $   4     $ 56     $ 72  

Other exit costs

    8       4       15       20  
 

 

 

   

 

 

   

 

 

   

 

 

 

Provision for restructuring

  $ 29     $ 8     $ 71     $ 92  
 

 

 

   

 

 

   

 

 

   

 

 

 

Restructuring charges included termination benefits for workforce reductions of manufacturing, selling, administrative, and research and development personnel across all geographic regions of approximately 185 and 50 for the three months ended September 30, 2012 and 2011, respectively, and approximately 480 and 700 for the nine months ended September 30, 2012 and 2011, respectively.

The following table represents the activity of employee termination and other exit cost liabilities:

 

    Nine Months Ended September 30,  
Dollars in Millions   2012     2011  

Liability at January 1

  $ 77     $ 126  
 

 

 

   

 

 

 

Charges

    77       94  

Changes in estimates

    (6     (2
 

 

 

   

 

 

 

Provision for restructuring

    71       92  

Foreign currency translation

    (1     1  

Amylin acquisition

    26         

Spending

    (66     (119
 

 

 

   

 

 

 

Liability at September 30

  $  107     $ 100  
 

 

 

   

 

 

 

Note 6. INCOME TAXES

The effective tax benefit rate was 43.4% on the pretax loss during the third quarter of 2012 compared to an effective tax rate of 26.0% on pretax earnings during the third quarter of 2011. The effective income tax rates were 13.7% and 25.2% during the nine months ended September 30, 2012 and 2011, respectively. The overall tax benefit rate of 43.4% attributed to the pretax loss in the current quarter was due to the mix of earnings in low tax jurisdictions and pretax loss in the higher U.S. tax jurisdiction resulting from a $1,830 million intangible asset impairment charge. The impact of the impairment charge reduced the effective tax rate by 11 percentage points during the nine months ended September 30, 2012. The effective tax rate is typically lower than the U.S. statutory rate of 35% primarily attributable to undistributed earnings of certain foreign subsidiaries that have been considered or are expected to be indefinitely reinvested offshore. If these earnings are repatriated to the U.S. in the future, or if it was determined that such earnings are to be remitted in the foreseeable future, additional tax provisions would be required. Reforms to U.S. tax laws related to foreign earnings have been proposed and if adopted, may increase taxes, which could reduce the results of operations and cash flows.

The decrease in the effective tax rate in the nine months ended September 30, 2012 was due to:

 

   

Favorable earnings mix between high and low tax jurisdictions primarily attributed to the $1,830 million IPRD impairment charge in the U.S.

Partially offset by:

 

   

Lower tax benefits from contingent tax matters ($30 million charge in 2012 and $75 million benefit in 2011);

 

   

An unfavorable impact on the current year rate from the research and development tax credit, which was not extended as of September 30, 2012; and

 

   

Changes in prior period estimates upon finalizing U.S. tax returns resulting in a $54 million benefit in 2011.

 

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BMS is currently under examination by a number of tax authorities which have proposed adjustments to tax for issues such as transfer pricing, certain tax credits and the deductibility of certain expenses. BMS estimates that it is reasonably possible that the total amount of unrecognized tax benefits at September 30, 2012 could decrease in the range of approximately $20 million to $50 million in the next twelve months as a result of the settlement of certain tax audits and other events resulting in the payment of additional taxes, the adjustment of certain deferred taxes and/or the recognition of tax benefits. It is also reasonably possible that new issues will be raised by tax authorities which may require adjustments to the amount of unrecognized tax benefits; however, an estimate of such adjustments cannot reasonably be made at this time. BMS believes that it has adequately provided for all open tax years by tax jurisdiction.

Note 7. EARNINGS/(LOSS) PER SHARE

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
Amounts in Millions, Except Per Share Data    2012     2011     2012     2011  

Net Earnings/(Loss) Attributable to BMS

   $ (711   $ 969     $ 1,035     $ 2,857  

Earnings attributable to unvested restricted shares

            (2     (1     (6
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings/(Loss) Attributable to BMS common shareholders

   $ (711   $ 967     $ 1,034     $ 2,851  
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings/(Loss) per share – basic

   $ (0.43   $ 0.57     $ 0.62     $ 1.67  
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares outstanding – basic

     1,666       1,698       1,679       1,703  

Contingently convertible debt common stock equivalents

            1       1       1  

Incremental shares attributable to share-based compensation plans

            16       17       13  
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares outstanding – diluted

     1,666       1,715       1,697       1,717  
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings/(Loss) per share – diluted

   $ (0.43   $ 0.56     $ 0.61     $ 1.66  
  

 

 

   

 

 

   

 

 

   

 

 

 

Anti-dilutive weighted-average equivalent shares – stock incentive plans

            11       2       28  
  

 

 

   

 

 

   

 

 

   

 

 

 

Contingently convertible debt common stock equivalents and incremental shares attributable to share-based compensation plans of 17 million were excluded from the per share calculation for the three months ended September 30, 2012 because of the net loss in that period.

Note 8. FINANCIAL INSTRUMENTS

Financial instruments include cash and cash equivalents, marketable securities, accounts receivable and payable, debt instruments and derivatives. Due to their short-term maturity, the carrying amount of account receivables and payables approximate fair value. Cash equivalents primarily consist of highly liquid investments with original maturities of three months or less at the time of purchase and are recorded at cost, which approximates fair value.

BMS has exposure to market risk due to changes in currency exchange rates and interest rates. As a result, certain derivative financial instruments are used when available on a cost-effective basis to hedge the underlying economic exposure. These instruments qualify as cash flow, net investment and fair value hedges upon meeting certain criteria, including initial and periodic assessments of the effectiveness in offsetting hedged exposures. Changes in fair value of derivatives that do not qualify for hedge accounting are recognized in earnings as they occur. Derivative financial instruments are not used for trading purposes.

All financial instruments, including derivatives, are subject to counterparty credit risk which is considered as part of the overall fair value measurement. Counterparty credit risk is monitored on an ongoing basis and is mitigated by limiting amounts outstanding with any individual counterparty, utilizing conventional derivative financial instruments and only entering into agreements with counterparties that meet high credit quality standards. The consolidated financial statements would not be materially impacted if any counterparty failed to perform according to the terms of its agreement. Under the terms of the agreements, posting of collateral is not required by any party whether derivatives are in an asset or liability position.

Fair Value Measurements – The fair values of financial instruments are classified into one of the following categories:

Level 1 inputs utilize quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. These instruments include U.S. treasury securities.

 

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Level 2 inputs include observable prices for similar instruments, quoted prices for identical or similar instruments in markets that are not active, and other observable inputs that can be corroborated by market data for substantially the full term of the assets or liabilities. These instruments include corporate debt securities, commercial paper, Federal Deposit Insurance Corporation (FDIC) insured debt securities, certificates of deposit, money market funds, foreign currency forward contracts, interest rate swap contracts, equity funds, fixed income funds and long-term debt. Additionally, certain corporate debt securities utilize a third-party matrix-pricing model that uses significant inputs corroborated by market data for substantially the full term of the assets. Equity and fixed income funds are primarily invested in publicly traded securities and are valued at the respective net asset value of the underlying investments. There were no significant unfunded commitments or restrictions on redemptions related to equity and fixed income funds as of September 30, 2012. Level 2 derivative instruments are valued using London Interbank Offered Rate (LIBOR) and Euro Interbank Offered Rate (EURIBOR) yield curves, less credit valuation adjustments, and observable forward foreign exchange rates at the reporting date. Valuations of derivative contracts may fluctuate considerably from period-to-period due to volatility in underlying foreign currencies and underlying interest rates, which are driven by market conditions and the duration of the contract. Credit adjustment volatility may have a significant impact on the valuation of interest rate swaps due to changes in counterparty credit ratings and credit default swap spreads.

Level 3 unobservable inputs are used when little or no market data is available. Valuation models for the Auction Rate Security (ARS) and Floating Rate Security (FRS) portfolio are based on expected cash flow streams and collateral values including assessments of counterparty credit quality, default risk underlying the security, discount rates and overall capital market liquidity. The fair value of the ARS was determined using an internally developed valuation which was based in part on indicative bids received on the underlying assets of the security and other evidence of fair value. The ARS is a private placement security rated ‘BBB’ by Standard and Poor’s and represents interests in insurance securitizations. Due to the current lack of an active market for the FRS and the general lack of transparency into its underlying assets, other qualitative analysis is relied upon to value the FRS including discussions with brokers and fund managers, default risk underlying the security and overall capital market liquidity.

Available-For-Sale Securities and Cash Equivalents

The following table summarizes available-for-sale securities at September 30, 2012 and December 31, 2011:

 

     Amortized
Cost
     Gross
Unrealized
Gain in
Accumulated
OCI
     Gross
Unrealized
Loss in
Accumulated
OCI
    Gain/(Loss)
in

Income
     Fair
Value
    

 

Fair Value

 
Dollars in Millions                  Level 1      Level 2      Level 3  

September 30, 2012

                      

Marketable Securities

                      

Certificates of Deposit

   $ 121      $       $      $       $ 121      $       $ 121      $   

Corporate Debt Securities

     4,337        94                       4,431                4,431          

Commercial Paper

     240                               240                240          

U.S. Treasury Securities

     150        1                       151        151                  

FDIC Insured Debt Securities

     50                               50                50          

Equity Funds

     51                       5        56                56          

Fixed Income Funds

     46                       1        47                47          

ARS

     9        1                       10                        10  

FRS

     21                (2             19                        19  
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total Marketable Securities

   $ 5,025      $ 96      $ (2   $ 6      $ 5,125      $ 151      $ 4,945      $ 29  
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

December 31, 2011

                      

Marketable Securities

                      

Certificates of Deposit

   $ 1,051      $       $      $       $ 1,051      $       $ 1,051      $   

Corporate Debt Securities

     2,908        60        (3             2,965                2,965          

Commercial Paper

     1,035                               1,035                1,035          

U.S. Treasury Securities

     400        2                       402        402                  

FDIC Insured Debt Securities

     302        1                       303                303          

ARS

     80        12                       92                        92  

FRS

     21                (3             18                        18  
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total Marketable Securities

   $ 5,797      $ 75      $ (6   $       $ 5,866      $ 402      $ 5,354      $ 110  
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

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The following table summarizes the classification of available for sale securities in the consolidated balance sheet:

 

Dollars in Millions    September 30,
2012
     December 31,
2011
 

Current Marketable Securities

   $ 1,427      $ 2,957  

Non-current Marketable Securities

     3,698        2,909  
  

 

 

    

 

 

 

Total Marketable Securities

   $ 5,125      $ 5,866  
  

 

 

    

 

 

 

Money market funds and other securities aggregating $1,203 million and $5,469 million at September 30, 2012 and December 31, 2011, respectively, were included in cash and cash equivalents and valued using Level 2 inputs. At September 30, 2012, $3,688 million of non-current available for sale corporate debt securities and FRS mature within five years.

The change in fair value for the investments in equity and fixed income funds are recognized in the results of operations and are designed to offset the changes in fair value of certain employee retirement benefits.

The following table summarizes the activity for financial assets utilizing Level 3 fair value measurements:

 

     2012     2011  

Fair value at January 1

   $ 110     $ 110  

Sales

     (81       
  

 

 

   

 

 

 

Fair value at September 30

   $ 29     $ 110  
  

 

 

   

 

 

 

Qualifying Hedges

The following table summarizes the fair value of outstanding derivatives:

 

          September 30, 2012     December 31, 2011  
Dollars in Millions   

Balance Sheet Location

   Notional      Fair Value
(Level 2)
    Notional      Fair Value
(Level 2)
 

Derivatives designated as hedging instruments:

             

Interest rate swap contracts

  

Other assets

   $ 573      $ 154     $ 579      $ 135  

Foreign currency forward contracts

  

Other assets

     953        47       1,347        88  

Foreign currency forward contracts

  

Accrued expenses

     993        (23     480        (29

Cash Flow Hedges— Foreign currency forward contracts are primarily utilized to hedge forecasted intercompany inventory purchase transactions in certain foreign currencies. These forward contracts are designated as cash flow hedges with the effective portion of changes in fair value being temporarily reported in accumulated other comprehensive income (OCI) and recognized in earnings when the hedged item affects earnings. As of September 30, 2012, significant outstanding foreign currency forward contracts were primarily attributed to Euro and Japanese yen foreign currency forward contracts in the notional amount of $1,130 million and $504 million, respectively.

The net gain on foreign currency forward contracts qualifying for cash flow hedge accounting is expected to be reclassified to cost of products sold within the next two years, including $33 million of pre-tax gains to be reclassified within the next 12 months. Cash flow hedge accounting is discontinued when the forecasted transaction is no longer probable of occurring on the originally forecasted date, or 60 days thereafter, or when the hedge is no longer effective. Assessments to determine whether derivatives designated as qualifying hedges are highly effective in offsetting changes in the cash flows of hedged items are performed at inception and on a quarterly basis. Any ineffective portion of the change in fair value is included in current period earnings. The earnings impact related to discontinued cash flow hedges and hedge ineffectiveness was not significant during the three and nine months ended September 30, 2012 and 2011.

Net Investment Hedges— Non-U.S. dollar borrowings of €541 million ($698 million) are designated to hedge the foreign currency exposures of the net investment in certain foreign affiliates. These borrowings are designated as net investment hedges and recognized in long-term debt. The effective portion of foreign exchange gains or losses on the remeasurement of the debt is recognized in the foreign currency translation component of accumulated OCI with the related offset in long-term debt.

Fair Value Hedges— Fixed-to-floating interest rate swap contracts are designated as fair value hedges and are used as part of an interest rate risk management strategy to create an appropriate balance of fixed and floating rate debt. The swaps and underlying debt for the benchmark risk being hedged are recorded at fair value. When the underlying swap is terminated prior to maturity, the fair value basis adjustment to the underlying debt instrument is amortized into earnings as an adjustment to interest expense over the remaining term of the debt.

 

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During the nine months ended September 30, 2011, fixed-to-floating interest rate swap agreements of $1.6 billion notional amount and €1.0 billion notional amount were terminated generating total proceeds of $356 million (including accrued interest of $66 million). The basis adjustment from the swap terminations is amortized as interest expense over the remaining life of the underlying debt.

The adjustment to debt from interest rate swaps that qualify as fair value hedges and other items was as follows:

 

Dollars in Millions    September 30,
2012
    December 31,
2011
 

Principal Value

   $ 6,601     $ 4,669  

Adjustments to Principal Value:

    

Fair value of interest rate swaps

     154       135  

Unamortized basis adjustment from swap terminations

     528       594  

Unamortized bond discounts

     (56     (22
  

 

 

   

 

 

 

Total

   $ 7,227     $ 5,376  
  

 

 

   

 

 

 

Current portion of long-term debt

   $ 619     $   

Long-term debt

     6,608       5,376  

During the three months ended September 30, 2012, $2.0 billion of senior unsecured notes were issued: $750 million in aggregate principal amount of 0.875% Notes due 2017, $750 million in aggregate principal amount of 2.000% Notes due 2022 and $500 million in aggregate principal amount of 3.250% Notes due 2042 in a registered public offering. Interest on the notes will be paid semi-annually on each February 1 and August 1 beginning February 1, 2013. The notes rank equally in right of payment with all of BMS’s existing and future senior unsecured indebtedness. BMS may redeem the notes, in whole or in part, at any time at a predetermined redemption price. The net proceeds of the note issuances were $1,950 million, which is net of a discount of $36 million and deferred loan issuance costs of $14 million.

Commercial paper was issued and matured during the three months ended September 30, 2012 with an average amount outstanding of $526 million at a weighted-average interest rate of 0.15%. There were no commercial paper borrowings at September 30, 2012.

Substantially all of the $2.0 billion debt obligations assumed in the acquisition of Amylin were repaid during the three months ended September 30, 2012, including a promissory note with Lilly with respect to a revenue sharing obligation and Amylin senior notes due 2014.

Debt repurchase activity was as follows:

 

     Nine Months Ended September 30,  
Dollars in Millions    2012      2011  

Principal amount

   $ 2,052      $      71  

Carrying value

     2,081        88  

Repurchase price

     2,108        78  

Notional amount of interest rate swaps terminated

     6        34  

Swap termination proceeds

     2        6  

Total (gain)/loss

     27        (10

The fair value of debt was $8,350 million at September 30, 2012 and $6,406 million at December 31, 2011 and was valued using Level 2 inputs. Interest payments were $125 million and $52 million for the nine months ended September 30, 2012 and 2011, respectively, net of amounts related to interest rate swap contracts.

In July 2012, BMS entered into a new $1.5 billion five year revolving credit facility. There are no financial covenants under the new facility. This revolving credit facility is in addition to the Company’s existing $1.5 billion revolving credit facility which was established in September 2011 with a syndicate of lenders. There were no borrowings under either revolving credit facility at September 30, 2012 and December 31, 2011.

 

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Note 9. RECEIVABLES

Receivables include:

 

Dollars in Millions    September 30,
2012
    December 31,
2011
 

Trade receivables

   $ 1,844     $ 2,397  

Less allowances

     (110     (147
  

 

 

   

 

 

 

Net trade receivables

     1,734       2,250  

Alliance partners receivables

     755       1,081  

Prepaid and refundable income taxes

     202       256  

Miscellaneous receivables

     198       156  
  

 

 

   

 

 

 

Receivables

   $ 2,889     $ 3,743  
  

 

 

   

 

 

 

Receivables are netted with deferred income related to alliance partners until recognition of income. As a result, alliance partner receivables and deferred income were reduced by $1,081 million and $901 million at September 30, 2012 and December 31, 2011, respectively. For additional information regarding alliance partners, see “—Note 3. Alliances and Collaborations.” Non-U.S. receivables sold on a nonrecourse basis were $734 million and $806 million for the nine months ended September 30, 2012 and 2011, respectively. In the aggregate, receivables due from three pharmaceutical wholesalers in the U.S. represented 39% and 55% of total trade receivables at September 30, 2012 and December 31, 2011, respectively.

Note 10. INVENTORIES

Inventories include:

 

Dollars in Millions    September 30,
2012
     December 31,
2011
 

Finished goods

   $ 533      $ 478  

Work in process

     868        646  

Raw and packaging materials

     296        260  
  

 

 

    

 

 

 

Inventories

   $ 1,697      $ 1,384  
  

 

 

    

 

 

 

Inventories of $374 million expected to remain on-hand beyond one year were included in non-current assets (including $29 million of inventories at risk). The status of the regulatory approval process and the probability of future sales were considered in assessing the recoverability of these costs.

Note 11. PROPERTY, PLANT AND EQUIPMENT

Property, plant and equipment includes:

 

Dollars in Millions    September 30,
2012
    December 31,
2011
 

Land

   $ 114     $ 137  

Buildings

     4,897       4,545  

Machinery, equipment and fixtures

     3,648       3,437  

Construction in progress

     623       262  
  

 

 

   

 

 

 

Gross property, plant and equipment

     9,282       8,381  

Less accumulated depreciation

     (3,985     (3,860
  

 

 

   

 

 

 

Property, plant and equipment

   $ 5,297     $ 4,521  
  

 

 

   

 

 

 

Depreciation expense was $274 million and $333 million for the nine months ended September 30, 2012 and 2011, respectively.

 

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Note 12. GOODWILL AND OTHER INTANGIBLE ASSETS

Changes in the carrying amount of goodwill during the nine months ended September 30, 2012 were as follows:

 

Dollars in Millions       

Balance at January 1, 2012

   $ 5,586  

Inhibitex acquisition

     1,213  

Amylin acquisition

     699  
  

 

 

 

Balance at September 30, 2012

   $ 7,498  
  

 

 

 

Qualitative factors were assessed in the first quarter in determining whether it was more likely than not that the fair value of our aggregated geographic reporting units exceeded its carrying value. Examples of qualitative factors assessed included our share price, our financial performance compared to budgets, long-term financial plans, macroeconomic, industry and market conditions as well as the substantial excess of fair value over the carrying value of net assets from the annual impairment test performed in the prior year. Positive and negative influences of each relevant factor were assessed both individually and in the aggregate and as a result it was concluded that no additional quantitative testing was required.

At September 30, 2012 and December 31, 2011, other intangible assets consisted of the following:

 

            September 30, 2012      December 31, 2011  
Dollars in Millions    Estimated
Useful Lives
     Gross
Carrying
Amount
     Accumulated
Amortization
     Net
Carrying
Amount
     Gross
Carrying
Amount
     Accumulated
Amortization
     Net
Carrying
Amount
 

Licenses

     2 – 15 years       $ 1,178      $ 526      $ 652      $ 1,218      $ 443      $ 775  

Developed technology rights

     7 – 15 years         8,777        1,439        7,338        2,608        1,194        1,414  

Capitalized software

     3 – 10 years         1,189        919        270        1,147        857        290  
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total finite-lived intangible assets

        11,144        2,884        8,260        4,973        2,494        2,479  
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

IPRD

        957                957        645                645  
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total other intangible assets

      $ 12,101      $ 2,884      $ 9,217      $ 5,618      $ 2,494      $ 3,124  
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

The changes in the carrying amount of other intangible assets for the nine months ended September 30, 2012 and 2011 were as follows:

 

Dollars in Millions    2012     2011  

Other intangible assets carrying amount at January 1

   $ 3,124     $ 3,370  

Capitalized software and other additions

     44       54  

Acquisitions

     8,535       160  

Amortization expense

     (394     (261

Impairment charges

     (2,092     (30

Other

            (97
  

 

 

   

 

 

 

Other intangible assets, net carrying amount at September 30

   $ 9,217     $ 3,196  
  

 

 

   

 

 

 

Annual amortization expense of other intangible assets is expected to be approximately $650 million in 2012, $900 million in 2013, $900 million in 2014, $800 million in 2015, $800 million in 2016 and an aggregate $4.6 billion beyond 2016.

On August 23, 2012, BMS announced that it has discontinued development of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor that was in Phase II development for the treatment of hepatitis C. The decision was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients in a Phase II study that was voluntarily suspended on August 1, 2012. BMS acquired BMS-986094 with its acquisition of Inhibitex in February 2012. As a result of the termination of this development program, BMS recognized a $1,830 million pre-tax impairment charge related to the IPRD intangible asset.

 

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Note 13. DEFERRED INCOME

Deferred income includes:

 

Dollars in Millions    September 30,
2012
     December 31,
2011
 

Upfront, milestone and other licensing payments

   $ 4,311      $ 882  

Atripla * deferred revenue

     211        113  

Gain on sale-leaseback transactions

     104        120  

Other

     69        88  
  

 

 

    

 

 

 

Total deferred income

   $ 4,695      $ 1,203  
  

 

 

    

 

 

 

Current portion

   $ 689      $ 337  

Non-current portion

     4,006        866  

For further information pertaining to upfront, milestone and other licensing payments, including $3.6 billion of proceeds received from AstraZeneca related to the Amylin collaboration during the third quarter of 2012, see “—Note 3. Alliances and Collaborations.”

Amortization of deferred income was $186 million and $112 million for the nine months ended September 30, 2012 and 2011.

Note 14. EQUITY

 

     Common Stock      Capital in  Excess
of Par Value
of Stock
    Retained
Earnings
    Treasury Stock     Noncontrolling
Interest
 
Dollars and Shares in Millions    Shares      Par Value          Shares     Cost    

Balance at January 1, 2011

     2,205      $ 220      $ 3,682     $ 31,636       501     $ (17,454   $ (75

Net earnings attributable to BMS

                            2,857                       

Cash dividends declared

                            (1,696                     

Stock repurchase program

                                   30       (858       

Employee stock compensation plans

                     (456            (20     923         

Net earnings attributable to noncontrolling interest

                                                 1,781  

Distributions

                                                 (1,842
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at September 30, 2011

     2,205      $ 220      $ 3,226     $ 32,797       511     $ (17,389   $ (136

Balance at January 1, 2012

     2,205      $ 220      $ 3,114     $ 33,069       515     $ (17,402   $ (89

Net earnings attributable to BMS

                            1,035                       

Cash dividends declared

                            (1,723                     

Stock repurchase program

                                   58       (1,914       

Employee stock compensation plans

     3        1        (397            (15     841         

Net earnings attributable to noncontrolling interest

                                                 854  

Distributions

                                                 (765
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at September 30, 2012

     2,208      $ 221      $ 2,717     $ 32,381       558     $ (18,475   $   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Treasury stock is recognized at the cost to reacquire the shares. Shares issued from treasury are recognized utilizing the first-in first-out method.

In June 2012, the Board of Directors increased its authorization for the repurchase of common stock by $3.0 billion. Repurchases may be made either in the open market or through private transactions, including under repurchase plans established in accordance with Rule 10b5-1 under the Securities Exchange Act of 1934. The stock repurchase program does not have an expiration date and is expected to take place over a couple of years. It may be suspended or discontinued at any time.

Noncontrolling interest is primarily related to the partnerships with Sanofi for the territory covering the Americas for net sales of Plavix *. Net earnings attributable to noncontrolling interest are presented net of a tax benefit of $2 million and taxes of $209 million for the three months ended September 30, 2012 and 2011, respectively, and taxes of $318 million and $609 million for the nine months ended September 30, 2012 and 2011, respectively, in the consolidated statements of earnings with a corresponding increase or decrease to the provision for income taxes. Distribution of the partnership profits to Sanofi and Sanofi’s funding of ongoing partnership operations occur on a routine basis. The above activity includes the pre-tax income and distributions related to these partnerships.

 

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The accumulated balances related to each component of other comprehensive income/(loss) (OCI), net of taxes, were as follows:

 

Dollars in Millions   Foreign
Currency
  Translation  
    Derivatives
Qualifying as
Effective Hedges
    Pension and Other
Postretirement
Benefits
    Available
for
Sale  Securities
    Accumulated
Other
Comprehensive
Income/(Loss)
 

Balance at January 1, 2011

  $ (222   $ (20   $ (2,163   $ 34     $ (2,371

Other comprehensive income/(loss)

    (25     34       56       24       89  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at September 30, 2011

  $ (247   $ 14     $ (2,107   $ 58     $ (2,282
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at January 1, 2012

  $ (238   $ 36     $ (2,905   $ 62     $ (3,045

Other comprehensive income/(loss)

    7       (27     84       37       101  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at September 30, 2012

  $ (231   $ 9     $ (2,821   $ 99     $ (2,944
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Note 15. PENSION AND POSTRETIREMENT BENEFIT PLANS

The net periodic benefit cost of defined benefit pension and postretirement benefit plans includes:

 

       Three Months Ended September 30,      Nine Months Ended September 30,  
       Pension Benefits      Other Benefits      Pension Benefits      Other Benefits  

Dollars in Millions

     2012      2011      2012      2011      2012      2011      2012      2011  

Service cost – benefits earned during the year

     $ 7      $ 11      $ 1      $ 2      $ 24      $ 32      $ 5      $ 6  

Interest cost on projected benefit obligation

       79        83        5        7        237        253        16        20  

Expected return on plan assets

       (125      (116      (6      (7      (377      (349      (19      (20

Amortization of prior service cost/(benefit)

       (1                      (1      (2              (1      (2

Amortization of net actuarial loss

       32        28        2        2        97        85        8        5  

Curtailments

                                               (1                

Settlements

       3        2                        3                          
    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total net periodic benefit cost

     $ (5    $ 8      $ 2      $ 3      $ (18    $ 20      $ 9      $ 9  
    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Contributions to the U.S. pension plans are expected to be approximately $340 million during 2012, of which $323 million was contributed in the nine months ended September 30, 2012. Contributions to the international plans are expected to range from $65 million to $80 million in 2012, of which $49 million was contributed in the nine months ended September 30, 2012.

The expense attributed to defined contribution plans in the U.S. was $47 million for both the three months ended September 30, 2012 and 2011, and $143 million and $133 million for the nine months ended September 30, 2012 and 2011, respectively.

Note 16. EMPLOYEE STOCK BENEFIT PLANS

Stock-based compensation expense was as follows:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions   2012     2011     2012     2011  

Stock options

  $ (1   $ 7     $ 4     $ 20  

Restricted stock

    9       19       46       59  

Market share units

    4       6       17       17  

Long-term performance awards

    14       7       41       24  

Amylin stock options and restricted stock units (See Note 4)

    94              94         
 

 

 

   

 

 

   

 

 

   

 

 

 

Total stock-based compensation expense

  $ 120     $ 39     $ 202     $ 120  
 

 

 

   

 

 

   

 

 

   

 

 

 

Income tax benefit

  $ 38     $ 13     $ 66     $ 41  
 

 

 

   

 

 

   

 

 

   

 

 

 

The acceleration of unvested stock options and restricted stock units in connection with the acquisition of Amylin resulted in stock-based compensation expense for the three and nine months ended September 30, 2012.

In the nine months ended September 30, 2012, 3.0 million restricted stock units, 1.1 million market share units and 1.7 million long-term performance share units were granted. The weighted-average grant date fair value for restricted stock units, market share units and long-term performance share units granted during the nine months ended September 30, 2012 was $32.70, $31.85 and $32.33, respectively.

 

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Substantially all restricted stock units vest ratably over a four year period based on share price performance. Market share units vest ratably over a four year period based on share price performance. The fair value of market share units was estimated on the date of grant using a model applying multiple input variables that determine the probability of satisfying market conditions. Long-term performance share units are determined based on the achievement of annual performance goals, but are not vested until the end of the three year plan period.

Total compensation costs related to nonvested awards not yet recognized and the weighted-average period over which such awards are expected to be recognized at September 30, 2012 were as follows:

 

Dollars in Millions    Stock
Options
     Restricted
Stock
     Market
Share Units
     Long-Term
Performance
Awards
 

Unrecognized compensation cost

   $ 4      $ 165      $ 39      $ 42  

Expected weighted-average period in years of compensation cost to be recognized

     0.4        2.8        2.9        1.4  

Note 17. LEGAL PROCEEDINGS AND CONTINGENCIES

The Company and certain of its subsidiaries are involved in various lawsuits, claims, government investigations and other legal proceedings that arise in the ordinary course of business. The Company recognizes accruals for such contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. These matters involve patent infringement, antitrust, securities, pricing, sales and marketing practices, environmental, commercial, health and safety matters, consumer fraud, employment matters, product liability and insurance coverage. Legal proceedings that are material or that the Company believes could become material are described below.

Although the Company believes it has substantial defenses in these matters, there can be no assurance that there will not be an increase in the scope of pending matters or that any future lawsuits, claims, government investigations or other legal proceedings will not be material. Unless otherwise noted, the Company is unable to assess the outcome of the respective litigation nor is it able to provide an estimated range of potential loss. Furthermore, failure to enforce our patent rights would likely result in substantial decreases in the respective product sales from generic competition.

INTELLECTUAL PROPERTY

Plavix* —Australia

As previously disclosed, Sanofi was notified that, in August 2007, GenRx Proprietary Limited (GenRx) obtained regulatory approval of an application for clopidogrel bisulfate 75mg tablets in Australia. GenRx, formerly a subsidiary of Apotex Inc. (Apotex), has since changed its name to Apotex. In August 2007, Apotex filed an application in the Federal Court of Australia (the Federal Court) seeking revocation of Sanofi’s Australian Patent No. 597784 (Case No. NSD 1639 of 2007). Sanofi filed counterclaims of infringement and sought an injunction. On September 21, 2007, the Federal Court granted Sanofi’s injunction. A subsidiary of the Company was subsequently added as a party to the proceedings. In February 2008, a second company, Spirit Pharmaceuticals Pty. Ltd., also filed a revocation suit against the same patent. This case was consolidated with the Apotex case and a trial occurred in April 2008. On August 12, 2008, the Federal Court of Australia held that claims of Patent No. 597784 covering clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate salts were valid. The Federal Court also held that the process claims, pharmaceutical composition claims, and claim directed to clopidogrel and its pharmaceutically acceptable salts were invalid. The Company and Sanofi filed notices of appeal in the Full Court of the Federal Court of Australia (Full Court) appealing the holding of invalidity of the claim covering clopidogrel and its pharmaceutically acceptable salts, process claims, and pharmaceutical composition claims which have stayed the Federal Court’s ruling. Apotex filed a notice of appeal appealing the holding of validity of the clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate claims. A hearing on the appeals occurred in February 2009. On September 29, 2009, the Full Court held all of the claims of Patent No. 597784 invalid. In November 2009, the Company and Sanofi applied to the High Court of Australia (High Court) for special leave to appeal the judgment of the Full Court. In March 2010, the High Court denied the Company and Sanofi’s request to hear the appeal of the Full Court decision. The case has been remanded to the Federal Court for further proceedings related to damages. It is expected the amount of damages will not be material to the Company.

Plavix* —EU

As previously disclosed, in 2007, YES Pharmaceutical Development Services GmbH (YES Pharmaceutical) filed an application for marketing authorization in Germany for an alternate salt form of clopidogrel. This application relied on data from studies that were originally conducted by Sanofi and BMS for Plavix* and were still the subject of data protection in the EU. Sanofi and BMS have filed an action against YES Pharmaceutical and its partners in the administrative court in Cologne objecting to the marketing authorization. This matter is currently pending, although these specific marketing authorizations now have been withdrawn from the market.

 

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Plavix* —Canada (Apotex, Inc.)

On April 22, 2009, Apotex filed an impeachment action against Sanofi in the Federal Court of Canada alleging that Sanofi’s Canadian Patent No. 1,336,777 (the ‘777 Patent) is invalid. On June 8, 2009, Sanofi filed its defense to the impeachment action and filed a suit against Apotex for infringement of the ‘777 Patent. The trial was completed in June 2011 and in December 2011, the Federal Court of Canada issued a decision that the ‘777 Patent is invalid. Sanofi is appealing this decision though generic companies have since entered the market.

OTHER INTELLECTUAL PROPERTY LITIGATION

Abilify *

As previously disclosed, Otsuka has filed patent infringement actions against Teva, Barr Pharmaceuticals, Inc. (Barr), Sandoz Inc. (Sandoz), Synthon Laboratories, Inc (Synthon), Sun Pharmaceuticals (Sun), Zydus Pharmaceuticals USA, Inc. (Zydus), and Apotex relating to U.S. Patent No. 5,006,528, (‘528 Patent) which covers aripiprazole and expires in April 2015 (including the additional six-month pediatric exclusivity period). Aripiprazole is comarketed by the Company and Otsuka in the U.S. as Abilify* . A non-jury trial in the U.S. District Court for the District of New Jersey (NJ District Court) against Teva/Barr and Apotex was completed in August 2010. In November 2010, the NJ District Court upheld the validity and enforceability of the ‘528 Patent, maintaining the main patent protection for Abilify* in the U.S. until April 2015. The NJ District Court also ruled that the defendants’ generic aripiprazole product infringed the ‘528 Patent and permanently enjoined them from engaging in any activity that infringes the ‘528 Patent, including marketing their generic product in the U.S. until after the patent (including the six-month pediatric extension) expires. Sandoz, Synthon, Sun and Zydus are also bound by the NJ District Court’s decision. In December 2010, Teva/Barr and Apotex appealed this decision to the U.S. Court of Appeals for the Federal Circuit (Federal Circuit). In May 2012, the Federal Circuit affirmed the NJ District Court’s decision. In June 2012, Apotex filed a petition for rehearing en banc which was denied .

Atripla *

In April 2009, Teva filed an abbreviated New Drug Application (aNDA) to manufacture and market a generic version of Atripla* . Atripla* is a single tablet three-drug regimen combining the Company’s Sustiva and Gilead’s Truvada* . As of this time, the Company’s U.S. patent rights covering Sustiva ’s composition of matter and method of use have not been challenged. Teva sent Gilead a Paragraph IV certification letter challenging two of the fifteen Orange Book-listed patents for Atripla* . Atripla* is the product of a joint venture between the Company and Gilead. In May 2009, Gilead filed a patent infringement action against Teva in the U.S. District Court for the Southern District of New York (SDNY). In January 2010, the Company received a notice that Teva has amended its aNDA and is challenging eight additional Orange Book-listed patents for Atripla* . In March 2010, the Company and Merck, Sharp & Dohme Corp. (Merck) filed a patent infringement action against Teva also in the SDNY relating to two U.S. Patents which claim crystalline or polymorph forms of efavirenz. In March 2010, Gilead filed two patent infringement actions against Teva in the SDNY relating to six Orange Book-listed patents for Atripla* . Trial is expected in 2013. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

Baraclude

In August 2010, Teva filed an aNDA to manufacture and market generic versions of Baraclude . The Company received a Paragraph IV certification letter from Teva challenging the one Orange Book-listed patent for Baraclude , U.S. Patent No. 5,206,244, which expires in 2015. In September 2010, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Teva for infringement of the listed patent covering Baraclude , which triggered an automatic 30-month stay of approval of Teva’s aNDA. A trial took place in mid-October 2012 and the Company is currently awaiting a decision. If Teva were to prevail, there could be a significant impact on sales of Baraclude in the U.S. In June 2012, the Company filed a patent infringement lawsuit against Sandoz following the receipt of a Paragraph IV certification letter challenging the same Orange-Book listed patent. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

Sprycel

In September 2010, Apotex filed an aNDA to manufacture and market generic versions of Sprycel . The Company received a Paragraph IV certification letter from Apotex challenging the four Orange Book listed patents for Sprycel , including the composition of matter patent. In November 2010, the Company filed a patent infringement lawsuit in the NJ District Court against Apotex for infringement of the four Orange Book listed patents covering Sprycel , which triggered an automatic 30-month stay of approval of Apotex’s aNDA. In October 2011, the Company received a Paragraph IV notice letter from Apotex informing the Company that it is seeking approval of generic versions of the 80 mg and 140 mg dosage strengths of Sprycel and challenging the same four Orange Book listed patents. In November 2011, BMS filed a patent infringement suit against Apotex on the 80 mg and 140 mg dosage strengths in the NJ District Court. This case has been consolidated with the suit filed in November 2010. Trial is currently scheduled for September 2013. Discovery in this matter is ongoing. It is not possible at this time to reasonably assess the outcome of this lawsuit or its impact on the Company.

 

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Sustiva —EU

In January 2012, Teva obtained a European marketing authorization for Efavirenz Teva 600 mg tablets. In February 2012, the Company and Merck filed lawsuits and requests for injunctions against Teva in the Netherlands, Germany and the U.K. for infringement of Merck’s European Patent No. 0582455 and Supplementary Protection Certificates expiring in November 2013. As of September 2012, requests for injunctions have been granted in the U.K. and denied in the Netherlands and Germany. The Company and Merck have are appealing the denial of injunctions in the Netherlands. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

GENERAL COMMERCIAL LITIGATION

Clayworth Litigation

As previously disclosed, the Company, together with a number of other pharmaceutical manufacturers, was named as a defendant in an action filed in California Superior Court in Oakland, James Clayworth et al. v. Bristol-Myers Squibb Company, et al ., alleging that the defendants conspired to fix the prices of pharmaceuticals by agreeing to charge more for their drugs in the U.S. than they charge outside the U.S., particularly Canada, and asserting claims under California’s Cartwright Act and unfair competition law. The plaintiffs sought trebled monetary damages, injunctive relief and other relief. In December 2006, the Court granted the Company and the other manufacturers’ motion for summary judgment based on the pass-on defense, and judgment was then entered in favor of defendants. In July 2008, judgment in favor of defendants was affirmed by the California Court of Appeals. In July 2010, the California Supreme Court reversed the California Court of Appeal’s judgment and the matter was remanded to the California Superior Court for further proceedings. In March 2011, the defendants’ motion for summary judgment was granted and judgment was entered in favor of the defendants. The plaintiffs appealed that decision and the California Court of Appeals affirmed summary judgment for the defendants. In October 2012, the plaintiffs filed a petition seeking review by the California Supreme Court, which is pending. It is not possible at this time to determine the outcome of the appeal.

Remaining Apotex Matters Related to Plavix *

As previously disclosed, in November 2008, Apotex filed a lawsuit in New Jersey Superior Court entitled, Apotex Inc., et al. v. sanofi-aventis, et al ., seeking payment of $60 million, plus interest calculated at the rate of 1% per month from the date of the filing of the lawsuit, until paid, related to the break-up of a March 2006 proposed settlement agreement relating to the-then pending Plavix* patent litigation against Apotex. In April 2011, the New Jersey Superior Court granted the Company’s cross-motion for summary judgment motion and denied Apotex’s motion for summary judgment. Apotex has appealed these decisions. It is not possible at this time to determine the outcome of any appeal from the New Jersey Superior Court’s decisions.

In January 2011, Apotex filed a lawsuit in Florida State Court, Broward County, alleging breach of contract relating to the May 2006 proposed settlement agreement with Apotex relating to the then pending Plavix* patent litigation. Discovery has concluded. The Company and Sanofi have moved for summary judgment.

PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION AND INVESTIGATIONS

Abilify* Federal Subpoena

In January 2012, the Company received a subpoena from the United States Attorney’s Office for the Southern District of New York requesting information related to, among other things, the sales and marketing of Abilify* . It is not possible at this time to assess the outcome of this matter or its potential impact on the Company.

Abilify* State Attorneys General Investigation

In March 2009, the Company received a letter from the Delaware Attorney General’s Office advising of a multi-state coalition investigating whether certain Abilify* marketing practices violated those respective states’ consumer protection statutes. It is not possible at this time to reasonably assess the outcome of this investigation or its potential impact on the Company.

Abilify* Co-Pay Assistance Litigation

In March 2012, the Company and its partner Otsuka were named as co-defendants in a putative class action lawsuit filed by union health and welfare funds in the SDNY. Plaintiffs are challenging the legality of the Abilify* co-pay assistance program under the Federal Antitrust and the Racketeer Influenced and Corrupt Organizations laws, and seeking damages. The Company and Otsuka have filed a motion to dismiss the complaint. It is not possible at this time to reasonably assess the outcome of this litigation or its potential impact on the Company.

 

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AWP Litigation

As previously disclosed, the Company, together with a number of other pharmaceutical manufacturers, has been a defendant in a number of private class actions as well as suits brought by the attorneys general of various states. In these actions, plaintiffs allege that defendants caused the Average Wholesale Prices (AWPs) of their products to be inflated, thereby injuring government programs, entities and persons who reimbursed prescription drugs based on AWPs. The Company remains a defendant in four state attorneys general suits pending in state courts around the country. Beginning in August 2010, the Company was the defendant in a trial in the Commonwealth Court of Pennsylvania (Commonwealth Court), brought by the Commonwealth of Pennsylvania. In September 2010, the jury issued a verdict for the Company, finding that the Company was not liable for fraudulent or negligent misrepresentation; however, the Commonwealth Court judge issued a decision on a Pennsylvania consumer protection claim that did not go to the jury, finding the Company liable for $28 million and enjoining the Company from contributing to the provision of inflated AWPs. The Company has moved to vacate the decision and the Commonwealth has moved for a judgment notwithstanding the verdict, which the Commonwealth Court denied. The Company has appealed the decision to the Pennsylvania Supreme Court. The Company has reached agreements in principle to resolve the suits brought by the Mississippi and Louisiana Attorneys General.

Qui Tam Litigation

In March 2011, the Company was served with an unsealed qui tam complaint filed by three former sales representatives in California Superior Court, County of Los Angeles. The California Department of Insurance has elected to intervene in the lawsuit. The complaint alleges the Company paid kickbacks to California providers and pharmacies in violation of California Insurance Frauds Prevention Act, Cal. Ins. Code § 1871.7. Discovery is ongoing. It is not possible at this time to reasonably assess the outcome of this lawsuit or its impact on the Company.

PRODUCT LIABILITY LITIGATION

The Company is a party to various product liability lawsuits. As previously disclosed, in addition to lawsuits, the Company also faces unfiled claims involving its products.

Plavix*

As previously disclosed, the Company and certain affiliates of Sanofi are defendants in a number of individual lawsuits in various state and federal courts claiming personal injury damage allegedly sustained after using Plavix* . Currently, more than 2,000 claims are filed in state and federal courts in various states including California, Illinois, New Jersey, New York, Alabama, Iowa and Pennsylvania. The defendants terminated the previously disclosed tolling agreement effective as of September 1, 2012. It is not possible at this time to reasonably assess the outcome of these lawsuits or the potential impact on the Company.

Reglan*

The Company is one of a number of defendants in numerous lawsuits, on behalf of approximately 2,700 plaintiffs, claiming personal injury allegedly sustained after using Reglan* or another brand of the generic drug metoclopramide, a product indicated for gastroesophageal reflux and certain other gastrointestinal disorders. The Company, through its generic subsidiary, Apothecon, Inc., distributed metoclopramide tablets manufactured by another party between 1996 and 2000. It is not possible at this time to reasonably assess the outcome of these lawsuits or the potential impact on the Company. The resolution of these pending lawsuits is not expected to have a material impact on the Company.

Hormone Replacement Therapy

The Company is one of a number of defendants in a mass-tort litigation in which plaintiffs allege, among other things, that various hormone therapy products, including hormone therapy products formerly manufactured by the Company ( Estrace *, Estradiol, Delestrogen* and Ovcon* ) cause breast cancer, stroke, blood clots, cardiac and other injuries in women, that the defendants were aware of these risks and failed to warn consumers. The Company has agreed to resolve the claims of approximately 400 plaintiffs. As of October 2012, the Company remains a defendant in approximately 35 actively pending lawsuits in federal and state courts throughout the U.S. All of the Company’s hormone therapy products were sold to other companies between January 2000 and August 2001. The resolution of these remaining lawsuits is not expected to have a material impact on the Company.

 

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Byetta*

Amylin, now a wholly-owned subsidiary of the Company (see “—Note 4. Acquisitions”), and Lilly are co-defendants in product liability litigation related to Byetta* . As of September 30, 2012, there were approximately 100 separate lawsuits pending on behalf of approximately 555 plaintiffs in various courts in the U.S. The vast majority of these cases have been brought by individuals who allege personal injury sustained after using Byetta* , primarily pancreatitis, and, in some cases, claiming alleged wrongful death. Of these, the Company has agreed in principle to resolve the claims of approximately 200 plaintiffs. The vast majority of cases are pending in California state court, where the Judicial Council has granted Amylin’s petition for a “coordinated proceeding” for all California state court cases alleging harm from the alleged use of Byetta* . Amylin and Lilly are currently scheduled for trial in two separate single plaintiff cases for the first half of 2013, the first of which is currently scheduled to begin in February. We cannot reasonably predict the outcome of any lawsuit, claim or proceeding. However, given that Amylin has product liability insurance coverage for existing claims and future related claims, it is expected the amount of damages, if any, will not be material to the Company.

BMS-986094

In August 2012, the Company announced that it had discontinued development of BMS-986094, an investigational compound which was being tested in clinical trials to treat hepatitis C due to the emergence of a serious safety issue. To date, five lawsuits have been filed against the Company in Texas State Court by plaintiffs, which have been removed to Federal Court, alleging that they participated in the Phase II study of BMS-986094 and suffered injuries as a result thereof. In total, slightly fewer than 300 patients were administered the compound at various doses and durations as part of the clinical trials. The resolution of these lawsuits is not expected to have a material impact on the Company.

ENVIRONMENTAL PROCEEDINGS

As previously reported, the Company is a party to several environmental proceedings and other matters, and is responsible under various state, federal and foreign laws, including the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), for certain costs of investigating and/or remediating contamination resulting from past industrial activity at the Company’s current or former sites or at waste disposal or reprocessing facilities operated by third-parties.

CERCLA Matters

With respect to CERCLA matters for which the Company is responsible under various state, federal and foreign laws, the Company typically estimates potential costs based on information obtained from the U.S. Environmental Protection Agency, or counterpart state or foreign agency and/or studies prepared by independent consultants, including the total estimated costs for the site and the expected cost-sharing, if any, with other “potentially responsible parties,” and the Company accrues liabilities when they are probable and reasonably estimable. The Company estimated its share of future costs for these sites to be $71 million at September 30, 2012, which represents the sum of best estimates or, where no best estimate can reasonably be made, estimates of the minimal probable amount among a range of such costs (without taking into account any potential recoveries from other parties).

New Brunswick Facility—Environmental & Personal Injury Lawsuits

Since May 2008, over 250 lawsuits have been filed against the Company in New Jersey Superior Court by or on behalf of current and former residents of New Brunswick, New Jersey who live or have lived adjacent to the Company’s New Brunswick facility. The complaints either allege various personal injuries damages resulting from alleged soil and groundwater contamination on their property stemming from historical operations at the New Brunswick facility, or are claims for medical monitoring. A portion of these complaints also assert claims for alleged property damage. In October 2008, the New Jersey Supreme Court granted Mass Tort status to these cases and transferred them to the New Jersey Superior Court in Atlantic County for centralized case management purposes. The Company intends to defend itself vigorously in this litigation. Discovery is ongoing. Since October 2011, over 100 additional cases have been filed in New Jersey Superior Court and removed by the Company to United States District Court, District of New Jersey. It is not possible at this time to reasonably assess the outcome of these lawsuits or the potential impact on the Company.

North Brunswick Township Board of Education

As previously disclosed, in October 2003, the Company was contacted by counsel representing the North Brunswick, NJ Board of Education (BOE) regarding a site where waste materials from E.R. Squibb and Sons may have been disposed from the 1940’s through the 1960’s. Fill material containing industrial waste and heavy metals in excess of residential standards was discovered during an expansion project at the North Brunswick Township High School, as well as at a number of neighboring residential properties and adjacent public park areas. In January 2004, the New Jersey Department of Environmental Protection (NJDEP) sent the Company and

 

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others an information request letter about possible waste disposal at the site, to which the Company responded in March 2004. The BOE and the Township, as the current owners of the school property and the park, are conducting and jointly financing soil remediation work and ground water investigation work under a work plan approved by NJDEP, and have asked the Company to contribute to the cost. The Company is actively monitoring the clean-up project, including its costs. To date, neither the school board nor the Township has asserted any claim against the Company. Instead, the Company and the local entities have negotiated an agreement to attempt to resolve the matter by informal means, and avoid litigation. A central component of the agreement is the provision by the Company of interim funding to help defray cleanup costs and assure the work is not interrupted. The Company transmitted interim funding payments in December 2007 and November 2009. The parties commenced mediation in late 2008; however, those efforts were not successful and the parties moved to a binding allocation process. The parties are expected to conduct fact and expert discovery, followed by formal evidentiary hearings and written argument. Hearings likely will be scheduled for late 2012 or early 2013. In addition, in September 2009, the Township and BOE filed suits against several other parties alleged to have contributed waste materials to the site. The Company does not currently believe that it is responsible for any additional amounts beyond the two interim payments totaling $4 million already transmitted. Any additional possible loss is not expected to be material.

OTHER PROCEEDINGS

Italy Investigation

In July 2011, the Public Prosecutor in Florence, Italy (Italian Prosecutor) initiated a criminal investigation against the Company’s subsidiary in Italy (BMS Italy). The allegations against the Company relate to alleged activities of a former employee who left the Company in the 1990s. The Italian Prosecutor also had requested interim measures that a judicial administrator be appointed to temporarily run the operations of BMS Italy. In October 2012, the parties reached an agreement to resolve the request for interim measures which resulted in the Italian Prosecutor withdrawing the request and this request was accepted by the Florence Court. It is not possible at this time to assess the outcome of the underlying investigation or its potential impact on the Company.

SEC Germany Investigation

In October 2006, the SEC informed the Company that it had begun a formal inquiry into the activities of certain of the Company’s German pharmaceutical subsidiaries and its employees and/or agents. The SEC’s inquiry encompasses matters formerly under investigation by the German prosecutor in Munich, Germany, which have since been resolved. The Company understands the inquiry concerns potential violations of the Foreign Corrupt Practices Act (FCPA). The Company is cooperating with the SEC.

FCPA Investigation

In March 2012, the Company received a subpoena from the SEC. The subpoena, issued in connection with an investigation under the FCPA, primarily relates to sales and marketing practices in various countries. The Company is cooperating with the government in its investigation of these matters.

 

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

EXECUTIVE SUMMARY

Bristol-Myers Squibb Company (which may be referred to as Bristol-Myers Squibb, BMS, the Company, we, our or us) is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We license, manufacture, market, distribute and sell pharmaceutical products on a global basis.

The following key events and transactions occurred during the current quarter as discussed in further detail in the Strategy, Product and Pipeline Developments and Results of Operations sections of Management’s Discussion and Analysis:

 

   

Overall sales continued to decline as a result of the loss of exclusivity of Plavix * (clopidogrel bisulfate) and Avapro* / Avalide* (irbesartan/irbesartan-hydrochlorothiazide).

   

The development of BMS-986094 (formerly INX-189), a compound which we acquired as part of our acquisition of Inhibitex, Inc. (Inhibitex) to treat hepatitis C, was discontinued in the interest of patient safety resulting in a $1.8 billion pre-tax impairment charge.

   

We acquired Amylin Pharmaceuticals, Inc (Amylin) and expanded our existing alliance arrangement with AstraZeneca PLC (AstraZeneca) to include Amylin-related products.

   

We had regulatory developments pertaining to Eliquis (apixaban), Forxiga (dapagliflozin) and Orencia (abatacept).

The following table is a summary of our financial highlights:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions, except per share data   2012     2011     2012     2011  

Net Sales

  $ 3,736     $ 5,345     $ 13,430     $ 15,790  

Total Expenses

    4,995       3,515       11,603       10,403  

Earnings/(Loss) before Income Taxes

    (1,259     1,830       1,827       5,387  

Provision for/(Benefit from) Income Taxes

    (546     475       250       1,358  

Effective tax rate

    43.4     26.0     13.7     25.2

Net Earnings/(Loss) Attributable to BMS

       

GAAP

    (711     969       1,035       2,857  

Non-GAAP

    685       1,044       2,587       3,015  

Diluted Earnings/(Loss) Per Share

       

GAAP

    (0.43     0.56       0.61       1.66  

Non-GAAP

    0.41       0.61       1.52       1.75  

Cash, Cash Equivalents and Marketable Securities

        6,628       11,012  

Our non-GAAP financial measures, including non-GAAP earnings and related earnings per share (EPS) information, are adjusted to exclude specified items which represent certain costs, expenses, gains and losses and other items impacting the comparability of financial results. For a detailed listing of all specified items and further information and reconciliations of non-GAAP financial measures see “—Non-GAAP Financial Measures” below.

Strategy

Over the past few years, we transformed our Company into a focused biopharmaceutical company. We continue to focus on sustaining our business and building a foundation for the future. We plan to achieve this foundation by growing our newer key marketed products, advancing our pipeline portfolio and managing our costs. We also plan to expand our presence in emerging markets, with a tailored approach to each market. We expect that our portfolio will become increasingly diversified across products and geographies over the next few years.

We experienced substantial exclusivity losses this year for Plavix* and Avapro* / Avalide* , which together had more than $8 billion of net sales in 2011. We will also face additional exclusivity losses in the coming years. We had been preparing for this for a number of years. As expected, we have experienced a rapid, precipitous, and material decline in Plavix* and Avapro* / Avalide* net sales and a reduction in net income and operating cash flow. Such events are the norm in the industry when companies experience the loss of exclusivity of a significant product. We also face significant challenges with an increasingly complex global and regulatory environment and global economic uncertainty, particularly in the European Union (EU). We believe our strategy to grow our newer marketed products and our robust research and development (R&D) pipeline, particularly within the therapeutic areas of immuno-oncology, cardiovascular/metabolic disease and virology, position us well for the future.

 

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We continue to expand our biologics capabilities. We still rely significantly on small molecules as our strongest, most reliable starting point for discovering potential new medicines, but large molecules, or biologics, which are derived from recombinant DNA technologies, are becoming increasingly important. Currently, more than one in three of our pipeline compounds are biologics, as are four of our key marketed products, including Yervoy (ipilimumab).

We also continue to support our pipeline with our licensing and acquisitions strategy, referred to as our “string of pearls.” During the third quarter of 2012, we acquired Amylin, a biopharmaceutical company dedicated to the discovery, development and commercialization of innovative medicines for patients with diabetes and other metabolic diseases. Following the completion of our acquisition of Amylin, we entered into a collaboration with AstraZeneca Pharmaceuticals LP, a wholly-owned subsidiary of AstraZeneca, which builds upon our existing alliance, further expanding our collaboration strategy. We are currently integrating the Amylin business into our development, manufacturing and commercial operations. We are also seeking to build relationships with academic organizations that have innovative programs and capabilities that complement our own internal efforts.

Product and Pipeline Developments

We manage our R&D programs on a portfolio basis, investing resources in each stage from early discovery through late-stage development. Our portfolio of R&D assets is evaluated continually to ensure that there is an appropriate balance of early-stage and late-stage programs to support future growth. We consider our R&D programs that have entered into Phase III development to be significant, as these programs constitute our late-stage development pipeline. These Phase III development programs include both investigational compounds in Phase III development for initial indications and marketed products that are in Phase III development for additional indications or formulations. Spending on these programs represents approximately 30-40% of our annual R&D expenses. No individual investigational compound or marketed product represented 10% or more of our R&D expenses in any of the last three years. While we do not expect all of our late-stage development programs to make it to market, our late-stage development programs are the R&D programs that could potentially have an impact on our revenue and earnings within the next few years. The following are the recent significant developments in our marketed products and our late-stage pipeline:

Eliquis —an oral Factor Xa inhibitor indicated in the EU for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery and in development for stroke prevention in patients with atrial fibrillation (AF) and the prevention and treatment of venous thromboembolic disorders that is part of our strategic alliance with Pfizer, Inc. (Pfizer)

 

   

In October 2012, the Company announced in a publication in The Lancet that the reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with Eliquis compared to warfarin in the ARISTOTLE trial were consistent across a wide range of stroke and bleeding risk scores in patients with nonvalvular atrial fibrillation (NVAF).

   

In September 2012, the Food and Drug Administration (FDA) acknowledged receipt of the resubmission of the New Drug Application (NDA) for Eliquis to reduce the risk of stroke and systemic embolism in patients with NVAF. The FDA deemed the application a complete response to its June 2012 Complete Response Letter that requested additional information on data management and verification from the ARISTOTLE trial. The FDA assigned a new Prescription Drug User Fee Act goal date of March 17, 2013.

   

In September 2012, the Company and Pfizer received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The CHMP recommended that Eliquis be granted approval for the prevention of stroke and systemic embolism in adult patients with NVAF and one or more risk factors for stroke. The CHMP’s positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the EU.

Forxiga —an oral SGLT2 inhibitor for the treatment of diabetes that is part of our alliance with AstraZeneca

 

   

The Company has met with the FDA and now has a path forward for potential approval for Forxiga in the U.S. The Company will provide additional data from ongoing studies to the FDA and expects to be able to resubmit the NDA for Forxiga in mid-2013. At this time, the Company expects that the FDA will have a six–month period in which to review the resubmission and will hold an Advisory Committee meeting.

Brivanib—an investigational anti-cancer agent

 

   

In July 2012, the Company announced that brivanib did not meet its primary overall survival objective based upon a non-inferiority statistical design in the Phase III BRISK-FL clinical trial of brivanib versus sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma.

 

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Erbitux* (cetuximab)—a monoclonal antibody designed to exclusively target and block the Epidermal Growth Factor Receptor, which is expressed on the surface of certain cancer cells in multiple tumor types as well as normal cells and is currently indicated for use against colorectal cancer and head and neck cancer. Erbitux* is part of our alliance with Eli Lilly and Company (Lilly).

 

   

In July 2012, the FDA granted full approval of Erbitux* in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for the first-line treatment of patients with KRAS mutation-negative epidermal growth factor receptor-expressing metastatic colorectal cancer as determined by FDA-approved tests for the use.

Yervoy —a monoclonal antibody for the treatment of patients with unresectable (inoperable) or metastatic melanoma

 

   

In September 2012, the Company announced at the European Society for Medical Oncology 2012 Congress long-term follow-up data of the 024 study which evaluated newly-diagnosed patients treated with Yervoy 10mg/kg in combination with dacarbazine versus dacarbazine alone and five-year follow-up data from the rollover 025 study which evaluated patients with Yervoy 0.3 mg/kg or 10 mg/kg. The survival rates observed in study 024 at years three and four were not only stable but higher in patients treated with Yervoy plus dacarbazine versus patients who received dacarbazine alone. The estimated survival rates in the 025 study remained unchanged or relatively stable at five years compared to four years in newly-diagnosed patients and previously-diagnosed patients.

Onglyza/Kombiglyze (saxagliptin/once daily combination of saxagliptin and metformin hydrochloride extended-release)—a treatment for type 2 diabetes that is part of our strategic alliance with AstraZeneca

 

   

In July 2012, the Company and AstraZeneca announced at the 17 th World Congress on Heart Disease the results of analyses showing that Onglyza 5mg demonstrated improvements across key measures of blood sugar control (glycosylated hemoglobin levels, or HbA1c; fasting plasma glucose, or FPG and post-prandial glucose, or PPG) compared to placebo in adult patients with type 2 diabetes at high risk for cardiovascular disease.

   

Marketing authorization for Komboglyze , the twice daily, fixed dose combination of saxagliptin and immediate-release metformin, was granted by the European Commission in November 2011. Due to a technical manufacturing issue, launches will begin in the fourth quarter of 2012.

Orencia —a fusion protein indicated for rheumatoid arthritis (RA)

 

   

In October 2012, the European Commission granted marketing authorization for a subcutaneous formulation of Orencia in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adults.

Baraclude (entecavir)—an oral antiviral agent for the treatment of chronic hepatitis B

 

   

In October 2012, a labeling update for Baraclude was approved by the FDA to include data on African Americans and liver transplant recipients with chronic hepatitis B infection.

In addition, in August 2012, the Company discontinued development of BMS-986094. This decision was made in the interest of patient safety. See “Item 1. Financial Statements—Note 12. Goodwill and Other Intangible Assets” for further information.

RESULTS OF OPERATIONS

Net Sales

The composition of the change in net sales was as follows:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
                2012 vs. 2011                 2012 vs. 2011  
    Net Sales     Analysis of % Change     Net Sales     Analysis of % Change  
Dollars in Millions   2012     2011     Total
Change
    Volume     Price     Foreign
Exchange
    2012     2011     Total
Change
    Volume     Price     Foreign
Exchange
 

United States

  $ 1,985     $ 3,477       (43)%        (45)%        2%             $ 8,029     $ 10,289       (22)%        (28)%        6%          

Europe

    800       916       (13)%        2%        (4)%        (11)%        2,548       2,738       (7)%        4%        (3)%        (8)%   

Japan, Asia Pacific and Canada

    438       464       (6)%               (4)%        (2)%        1,281       1,375       (7)%        (3)%        (3)%        (1)%   

Latin America, the Middle East
and Africa

    208       230       (10)%        (4)%               (6)%        654       664       (2)%        1%        2%        (5)%   

Emerging Markets

    230       238       (3)%        2%               (5)%        686       659       4%        9%        (1)%        (4)%   

Other

    75       20       **        N/A        N/A               232       65       **        N/A        N/A          
 

 

 

   

 

 

           

 

 

   

 

 

         

Total

  $ 3,736     $ 5,345       (30)%        (28)%        1%        (3)%      $ 13,430     $ 15,790       (15)%        (16)%        3%        (2)%   
 

 

 

   

 

 

           

 

 

   

 

 

         

 

**

Change in excess of 100%

 

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Our total net sales decreased in 2012 primarily due to declines in sales of Plavix* and Avapro*/Avalide* following the losses of exclusivity of these products in the U.S. and unfavorable foreign exchange, partially offset by higher average net selling prices, continued growth in most key products and sales of Byetta* (exenatide) and Bydureon* (exenatide extended-release for injectable suspension) from our Amylin acquisition.

The change in U.S. net sales attributed to volume reflects the recent exclusivity losses of Plavix* and Avapro*/Avalide* , partially offset by increased demand for most key products and the addition of Byetta and Bydureon . The change in U.S. net sales attributed to price was a result of higher average net selling prices for Abilify* (aripiprazole) and Plavix* , partially offset by the reduction in our contractual share of Abilify* net sales. See “—Key Products” for further discussion of sales by key product.

Net sales in Europe decreased primarily due to unfavorable foreign exchange and lower sales of certain mature brands from divestitures and generic competition as well as generic competition for Plavix* and Avapro*/Avalide* partially offset by sales growth of most key products. The change in net sales was negatively impacted by continuing fiscal challenges in many European countries as healthcare payers, including government agencies, have reduced and are expected to continue to reduce healthcare costs through actions that directly or indirectly impose additional price reductions. These measures include, but are not limited to, mandatory discounts, rebates, other price reductions and other restrictive measures.

Net sales in Japan, Asia Pacific and Canada decreased due to generic competition for Plavix* and Avapro*/Avalide* in Canada as well as lower mature brand sales from generic competition and divestitures partially offset by higher demand for Baraclude (entecavir), Sprycel (dasatinib), and Orencia .

Other increased due to additional sales of bulk active pharmaceutical ingredient to our alliance partner as well as enhanced royalty-related revenue.

No single country outside the U.S. contributed more than 10% of total net sales during the three and nine months ended September 30, 2012 and 2011.

In general, our business is not seasonal. For information on U.S. pharmaceutical prescriber demand, reference is made to the table within “—Estimated End-User Demand” below, which sets forth a comparison of changes in net sales to the estimated total prescription growth (for both retail and mail order customers) for certain of our key products. U.S. and non-U.S. net sales are categorized based upon the location of the customer.

We recognize revenue net of gross-to-net adjustments that are further described in “—Critical Accounting Policies” in the Company’s 2011 Annual Report on Form 10-K. Our contractual share of Abilify* and Atripla* sales is reflected net of all gross-to-net sales adjustments in gross sales.

The reconciliation of our gross sales to net sales by each significant category of gross-to-net sales adjustments was as follows:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions   2012     2011     2012     2011  

Gross Sales

  $ 4,225     $ 6,081     $ 15,127     $ 17,761  

Gross-to-Net Sales Adjustments

       

Charge-Backs Related to Government Programs

    (137     (206     (505     (571

Cash Discounts

    (36     (71     (154     (210

Managed Healthcare Rebates and Other Contract Discounts

    (98     (233     (182     (514

Medicaid Rebates

    (93     (137     (296     (404

Sales Returns

    6       (7     (228     (27

Other Adjustments

    (131     (82     (332     (245
 

 

 

   

 

 

   

 

 

   

 

 

 

Total Gross-to-Net Sales Adjustments

    (489     (736     (1,697     (1,971
 

 

 

   

 

 

   

 

 

   

 

 

 

Net Sales

  $ 3,736     $ 5,345     $ 13,430     $ 15,790  
 

 

 

   

 

 

   

 

 

   

 

 

 

Gross-to-Net Adjustments as a Percentage of Gross Sales

    12%        12%        11%        11%   
 

 

 

   

 

 

   

 

 

   

 

 

 

 

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The activities and ending balances of each significant category of gross-to-net sales reserve adjustments were as follows:

 

Dollars in Millions   Charge-Backs
Related to
Government
Programs
    Cash
Discounts
    Managed
Healthcare
Rebates and
Other Contract
Discounts
    Medicaid
Rebates
    Sales
Returns
    Other
Adjustments
    Total  

Balance at January 1, 2012

  $ (51   $ (28   $ (417   $ (411   $ (161   $ (181   $ (1,249

Provision related to sales made in current period

    (505     (153     (249     (333     (234     (338     (1,812

Provision related to sales made in prior periods

           (1     67       37       6       6       115  

Returns and payments

    522       166       422       354       60       323       1,847  

Amylin acquisition

    (2     (1     (34     (13     (23     (3     (76

Impact of foreign currency translation

                                (1     1         
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at September 30, 2012

  $ (36   $ (17   $ (211   $ (366   $ (353   $ (192   $ (1,175
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Changes in the gross-to-net sales adjustment rates are primarily a function of changes in sales mix and contractual and legislative discounts and rebates. Gross-to-net sales adjustments decreased due to:

 

   

Managed healthcare rebates and other contract discounts decreased due to a reduction in prior period rebate and discount accruals based upon actual invoices received, the nonrenewal of Plavix* contract discounts in the Medicare Part D program as of January 1, 2012, and the decrease in sales of Plavix* following the loss of exclusivity.

   

Medicaid rebates decreased primarily due to a reduction in prior period managed Medicaid accruals based upon actual invoices received.

   

The provision for sales returns increased as a result of the loss of exclusivity in the U.S. of Plavix* in May 2012 and Avapro* / Avalide* in March 2012. The U.S. sales return reserves for these products at September 30, 2012 were $191 million and were determined after considering several factors including estimated inventory levels in the distribution channels. In accordance with Company policy, these products are eligible to be returned between six months prior to and twelve months after product expiration. Additional adjustments to these reserves might be required in the future for revised estimates to various assumptions including actual returns which are generally not expected to occur until 2014.

 

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Net sales of key products represent 83% and 86% of total net sales for the three months ended September 30, 2012 and 2011, respectively, and 85% and 86% of total net sales for the nine months ended September 30, 2012 and 2011, respectively. The following table presents U.S. and international net sales by key product, the percentage change from the prior period and the foreign exchange impact when compared to the prior period. Commentary detailing the reasons for significant variances for key products is provided below:

 

     Three Months Ended September 30,      Nine Months Ended September 30,  
Dollars in Millions    2012      2011      %
Change
     % Change
Attributable
to Foreign
Exchange
     2012      2011      %
Change
     % Change
Attributable
to Foreign
Exchange
 

Key Products

                       

Plavix* (clopidogrel bisulfate)

   $   64      $   1,788        (96)%               $   2,498      $   5,415        (54)%           

U.S.

     41        1,672        (98)%                 2,372        5,060        (53)%           

Non-U.S.

     23        116        (80)%                 126        355        (65)%         (2)%   

Avapro*/Avalide*

(irbesartan/irbesartan-hydrochlorothiazide)

     95        216        (56)%         (3)%         419        757        (45)%         (2)%   

U.S.

     7        121        (94)%                 127        414        (69)%           

Non-U.S.

     88        95        (7)%         (4)%         292        343        (15)%         (3)%   

Eliquis (apixaban)

                     N/A         N/A         1                N/A         N/A   

U.S.

                                                               

Non-U.S.

                     N/A         N/A         1                N/A         N/A   

Abilify* (aripiprazole)

     676        691        (2)%         (2)%         2,008        2,021        (1)%         (3)%   

U.S.

     502        505        (1)%                 1,472        1,482        (1)%           

Non-U.S.

     174        186        (6)%         (9)%         536        539        (1)%         (9)%   

Reyataz (atazanavir sulfate)

     363        391        (7)%         (4)%         1,127        1,153        (2)%         (3)%   

U.S.

     194        184        5%                 577        554        4%           

Non-U.S.

     169        207        (18)%         (7)%         550        599        (8)%         (7)%   

Sustiva (efavirenz) Franchise

     370        359        3%         (3)%         1,144        1,073        7%         (2)%   

U.S.

     245        222        10%                 752        665        13%           

Non-U.S.

     125        137        (9)%         (9)%         392        408        (4)%         (7)%   

Baraclude (entecavir)

     346        311        11%         (4)%         1,028        878        17%         (2)%   

U.S.

     61        51        20%                 175        150        17%           

Non-U.S.

     285        260        10%         (4)%         853        728        17%         (3)%   

Erbitux* (cetuximab)

     173        172        1%         1%         531        510        4%           

U.S.

     166        168        (1)%                 512        497        3%           

Non-U.S.

     7        4        75%         (2)%         19        13        46%         (2)%   

Sprycel (dasatinib)

     263        211        25%         (6)%         738        576        28%         (5)%   

U.S.

     107        78        37%                 290        207        40%           

Non-U.S.

     156        133        17%         (10)%         448        369        21%         (8)%   

Yervoy (ipilimumab)

     179        121        48%         (5)%         495        216        **         (6)%   

U.S.

     123        109        13%                 361        204        77%           

Non-U.S.

     56        12        **         **         134        12        **         **   

Orencia (abatacept)

     307        233        32%         (3)%         851        660        29%         (2)%   

U.S.

     209        154        36%                 575        444        30%           

Non-U.S.

     98        79        24%         (9)%         276        216        28%         (6)%   

Nulojix (belatacept)

     3                                7        2        **           

U.S.

     3                                6        2        **           

Non-U.S.

                     N/A         N/A         1                N/A         N/A   

Onglyza/Kombiglyze (saxagliptin/saxagliptin

and metformin)

     178        127        40%         (3)%         511        320        60%         (3)%   

U.S.

     127        91        40%                 368        228        61%           

Non-U.S.

     51        36        42%         (9)%         143        92        55%         (12)%   

 

**

Change in excess of 100%.

 

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    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions   2012     2011     %
Change
    % Change
Attributable
to Foreign
Exchange
    2012     2011     %
Change
    % Change
Attributable
to Foreign
Exchange
 

Key Products (continued)

               

Byetta* (exenatide)

  $   55     $   —        N/A        N/A      $   55     $   —        N/A        N/A   

U.S.

    55              N/A               55              N/A          

Non-U.S.

                                                       

Bydureon* (exenatide extended-release for
injectable suspension)

    20              N/A        N/A        20              N/A        N/A   

U.S.

    20              N/A               20              N/A          

Non-U.S.

                                                       

Mature Products and All Other

    644       725       (11)%        (6)%        1,997       2,209       (10)%        (5)%   

U.S.

    125       122       2%               367       382       (4)%          

Non-U.S.

    519       603       (14)%        (5)%        1,630       1,827       (11)%        (4)%   

 

**

Change in excess of 100%.

Plavix* —a platelet aggregation inhibitor that is part of our alliance with Sanofi

 

   

U.S. net sales decreased due to the loss of exclusivity in May 2012. Estimated total U.S. prescription demand decreased 95% and 48% for the three and nine months ended September 30, 2012, respectively. Net sales included the impact of a $30 million reduction of inventory in the distribution channel that resulted in a reduction of sales returns reserve during the three months ended September 30, 2012.

 
   

International net sales continue to be negatively impacted by generic clopidogrel products in the EU, Canada, and Australia.

Avapro*/Avalide* (known in the EU as Aprovel*/Karvea* )—an angiotensin II receptor blocker for the treatment of hypertension and diabetic nephropathy that is also part of the Sanofi alliance

 

   

U.S. net sales decreased due to the exclusivity loss of Avapro*/Avalide* in March 2012. Total estimated U.S. prescription demand decreased 89% and 65% for the three and nine months ended September 30, 2012, respectively.

   

International net sales decreased due to lower demand including generic competition in certain EU markets and Canada.

Eliquis —an oral Xa inhibitor for the prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery and in development for the prevention and treatment of venous thromboembolic disorders and stroke prevention in patients with AF that is part of our strategic alliance with Pfizer

 

   

Eliquis is approved in the EU and several other international countries for VTE prevention with launches continuing in many of those countries.

Abilify* —an antipsychotic agent for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder that is part of our strategic alliance with Otsuka

 

•      U.S. net sales decreased as fluctuations in retail buying patterns and the reduction in our contractual share of net sales recognized from 53.5% in 2011 to 51.5% in 2012 more than offset higher average net selling prices. Estimated total U.S. prescription demand decreased 1% for the three months ended September 30, 2012 and increased 1% for the nine months ended September 30, 2012.

   

International net sales decreased primarily due unfavorable foreign exchange partially offset by higher prescription demand.

Reyataz —a protease inhibitor for the treatment of HIV

 

   

U.S. net sales increased due to higher average net selling prices. Estimated total U.S. prescription demand decreased 6% and 3% for the three and nine months ended September 30, 2012, respectively.

   

International net sales decreased due to lower demand resulting from competing products, the timing of government purchases in certain countries and unfavorable foreign exchange.

 

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Sustiva Franchise—a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV, which includes Sustiva , an antiretroviral drug, and bulk efavirenz, which is also included in the combination therapy, Atripla* (efavirenz 600mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a product sold through a joint venture with Gilead Sciences, Inc. (Gilead)

 

   

U.S. net sales increased due to higher average net selling prices. Estimated total U.S. prescription demand decreased 2% and 1% for the three and nine months ended September 30, 2012.

   

International net sales decreased due to unfavorable foreign exchange.

Baraclude —an oral antiviral agent for the treatment of chronic hepatitis B

 

   

Worldwide net sales increased primarily due to continued strong demand in international markets.

Erbitux* —a monoclonal antibody designed to exclusively target and block the Epidermal Growth Factor Receptor, which is expressed on the surface of certain cancer cells in multiple tumor types as well as normal cells and is currently indicated for use against colorectal cancer and head and neck cancer. Erbitux* is part of our strategic alliance with Lilly.

 

   

Sold by us almost exclusively in the U.S., net sales increased primarily due to higher demand.

Sprycel —an oral inhibitor of multiple tyrosine kinases, for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate) and first-line treatment of adults. Sprycel is part of our strategic alliance with Otsuka.

 

   

U.S. net sales increased due to higher demand and higher average net selling prices. Estimated total U.S. demand increased 22% and 33% for the three and nine months ended September 30, 2012, respectively.

   

International net sales increased due to higher demand partially offset by unfavorable foreign exchange.

Yervoy —a monoclonal antibody for the treatment of patients with unresectable (inoperable) or metastatic melanoma

 

   

Yervoy was launched in the U.S. in the second quarter of 2011 and continues to be launched in a number of international countries since the second quarter of 2011.

Orencia —a fusion protein indicated for adult patients with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more currently available treatments, such as methotrexate or anti-tumor necrosis factor therapy

 

   

U.S. net sales increased due to demand for the subcutaneous formulation of Orencia launched in the fourth quarter of 2011.

   

International net sales increased primarily due to increased demand partially offset by unfavorable foreign exchange.

Nulojix —a fusion protein with novel immunosuppressive activity targeted at prevention of kidney transplant rejection

 

   

Nulojix was approved and launched in the U.S. and the EU during 2011.

Onglyza/Kombiglyze (known in the EU as Onglyza / Komboglyze )—a once-daily oral tablet for the treatment of type 2 diabetes that is part of our strategic alliance with AstraZeneca

 

   

U.S. net sales increased primarily due to higher overall demand.

   

International net sales increased primarily due to higher overall demand partially offset by unfavorable foreign exchange.

Byetta* —a twice daily glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes

 

   

Byetta* was acquired from our acquisition of Amylin in August 2012.

Bydureon* —a once-weekly GLP-1 receptor agonist for the treatment of type 2 diabetes

 

   

Bydureon* was acquired from our acquisition of Amylin in August 2012.

Mature Products and All Other—includes all other products, including those which have lost exclusivity in major markets, over-the-counter brands and royalty-related revenue

 

   

U.S. net sales decreased as the continued generic erosion of certain products was partially offset by higher average net selling prices.

   

International net sales decreased due to continued generic erosion of certain brands and unfavorable foreign exchange.

 

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The estimated U.S. prescription change data provided throughout this report includes information only from the retail and mail order channels and does not reflect product demand within other channels such as hospitals, home health care, clinics, federal facilities including Veterans Administration hospitals, and long-term care, among others. The data is provided by Wolters Kluwer Health, except for Sprycel and Orencia subcutaneous formulation, and is based on the Source Prescription Audit. As of December 31, 2011, Sprycel and Orencia subcutaneous formulation demand is based upon information from the Next-Generation Prescription Service version 2.0 of the National Prescription Audit provided by IMS Health (IMS). The data is a product of each respective service providers’ own recordkeeping and projection processes and therefore subject to the inherent limitations of estimates based on sampling and may include a margin of error.

Prior to December 31, 2011, Sprycel demand was calculated based upon data obtained from the IMS National Sales Perspectives Audit. Since management believes information from the IMS National Prescription Audit more accurately reflects subscriber demand trends versus pill data from the IMS National Sales Perspectives Audit, all prior year Sprycel data has been restated to reflect information from the IMS National Prescription Audit.

We continuously seek to improve the quality of our estimates of prescription change amounts and ultimate patient/consumer demand by reviewing the calculation methodologies employed and analyzing internal and third-party data. We expect to continue to review and refine our methodologies and processes for calculation of these estimates and will monitor the quality of our own and third-party data used in such calculations.

We calculated the estimated total U.S. prescription change on a weighted-average basis to reflect that mail order prescriptions include a greater volume of product supplied, compared to retail prescriptions. Mail order prescriptions typically reflect a 90-day prescription whereas retail prescriptions typically reflect a 30-day prescription. The calculation is derived by multiplying mail order prescription data by a factor of approximately three and adding to this the retail prescriptions. We believe that a calculation of estimated total U.S. prescription change based on this weighted-average approach provides a superior estimate of total prescription demand in retail and mail order channels. We use this methodology for our internal demand reporting.

Estimated End-User Demand

The following table sets forth each of our key products sold by the U.S. for the three and nine months ended September 30, 2012 compared to the same period in the prior year: (i) change in reported U.S. net sales for each period; (ii) estimated total U.S. prescription change for the retail and mail order channels calculated by us based on third-party data on a weighted-average basis and (iii) months of inventory on hand in the wholesale distribution channel.

 

     Three Months Ended September 30,      Nine Months Ended September 30,      At September 30,  
     % Change in U.S.
Net Sales
     % Change in U.S.
Total Prescriptions
     % Change in U.S.
Net Sales
     % Change in U.S.
Total Prescriptions
     Months on Hand  
Dollars in Millions    2012      2011      2012      2011      2012      2011      2012      2011      2012      2011  

Plavix *

     (98)%         9%         (95)%         (6)%         (53)%         11%         (48)%         (5)%         1.6        0.5  

Avapro * /Avalide *

     (94)%         (28)%         (89)%         (42)%         (69)%         (21)%         (65)%         (38)%         0.9        0.5  

Abilify *

     (1)%         9%         (1)%         4%         (1)%         4%         1%         5%         0.4        0.4  

Reyataz

     5%         (3)%         (6)%         1%         4%         (1)%         (3)%         2%         0.5        0.4  

Sustiva Franchise (a)

     10%         (2)%         (2)%         7%         13%         2%         (1)%         8%         0.5        0.4  

Baraclude

     20%         11%         12%         8%         17%         15%         11%         9%         0.5        0.5  

Erbitux * (b)

     (1)%         8%         N/A         N/A         3%         2%         N/A         N/A         0.5        0.5  

Sprycel

     37%         66%         22%         27%         40%         63%         33%         19%         0.7        0.6  

Yervoy (b)(d)

     13%         N/A         N/A         N/A         77%         N/A         N/A         N/A         0.6        0.6  

Orencia (c)

     36%         12%         N/A         N/A         30%         11%         N/A         N/A         0.5        0.4  

Nulojix (b)(d)

             N/A         N/A         N/A         **         N/A         N/A         N/A         1.0        9.8  

Onglyza/Kombiglyze

     40%         **         42%         **         61%         **         56%         **         0.4        0.4  

Byetta * (e)

     N/A         N/A         N/A         N/A         N/A         N/A         N/A         N/A         0.8        N/A   

Bydureon * (e)

     N/A         N/A         N/A         N/A         N/A         N/A         N/A         N/A         0.7        N/A   

 

(a)

The Sustiva Franchise includes sales of Sustiva , as well as revenue of bulk efavirenz included in the combination therapy Atripla* . The months on hand relates only to Sustiva .

(b)

Erbitux* , Yervoy and Nulojix are parenterally administered products and do not have prescription-level data as physicians do not write prescriptions for these products.

(c)

Orencia intravenous formulation is a parenterally administered product and does not have prescription-level data as physicians do not write prescriptions for this product. The Orencia subcutaneous formulation is not parenterally administered and was launched in the U.S. in the fourth quarter of 2011.

(d)

Yervoy and Nulojix were launched in the U.S. in the second quarter of 2011.

(e)

Byetta* and Bydureon* were acquired from our acquisition of Amylin in the third quarter of 2012.

 

**

Change in excess of 100%.

 

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Pursuant to the Securities and Exchange Commission (SEC) Consent Order described in our 2011 Annual Report on Form 10-K, we monitor the level of inventory on hand in the U.S. wholesaler distribution channel and outside of the U.S. in the direct customer distribution channel. We are obligated to disclose products with levels of inventory in excess of one month on hand or expected demand, subject to a de minimis exception. Estimated levels of inventory in the distribution channel in excess of one month on hand for these products were not material as of the dates indicated. Below are U.S. products that had estimated levels of inventory in the distribution channel in excess of one month at September 30, 2012, and international products that had estimated levels of inventory in the distribution channel in excess of one month on hand at June 30, 2012:

Plavix* had 1.6 months of inventory on hand in the U.S. compared to 2.2 months of inventory on hand at June 30, 2012 due to the loss of exclusivity in May 2012. We expect a gradual decrease in inventory on hand of Plavix* to occur over the next few years as product in the wholesale distribution channel begins to be worked down or returned following the rapid, precipitous, and material decline in sales of Plavix* . Levels of inventory on hand in the wholesale and retail distribution channels were considered in assessing the sales return reserves established as of September 30, 2012.

Dafalgan , an analgesic product sold principally in Europe, had 1.2 months of inventory on hand at direct customers compared to 1.0 month of inventory on hand at December 31, 2011. The level of inventory on hand was due to the ordering patterns of private pharmacists in France.

Efferalgan , an analgesic product sold principally in Europe, had 1.1 months of inventory on hand at direct customers at June 30, 2012 and December 31, 2011. The level of inventory on hand was due to the ordering patterns of private pharmacists in France.

Luftal , an antacid product, had 1.1 months of inventory on hand at direct customers compared to 1.9 months of inventory on hand at December 31, 2011. The level of inventory on hand decreased as inventory was worked down following the relaunch of an alternate form.

Fervex , a cold and flu product, had 3.8 months of inventory on hand internationally at direct customers compared to 5.3 months of inventory on hand at December 31, 2011. The level of inventory on hand decreased following the peak flu season, but remained above average due to the ordering pattern of pharmacists in France.

In the U.S., for all products sold exclusively through wholesalers or through distributors, we generally determined our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers and our distributors. Our three largest wholesalers account for approximately 90% of total gross sales of U.S. products. Factors that may influence our estimates include generic competition, seasonality of products, wholesaler purchases in light of increases in wholesaler list prices, new product launches, new warehouse openings by wholesalers and new customer stockings by wholesalers. In addition, these estimates are calculated using third-party data, which may be impacted by their recordkeeping processes.

For our businesses outside of the U.S., we have significantly more direct customers. Limited information on direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information, where available, varies widely. In cases where direct customer product level inventory, ultimate patient/consumer demand or out-movement data does not exist or is otherwise not available, we have developed a variety of other methodologies to estimate such data, including using factors such as historical sales made to direct customers and third-party market research data related to prescription trends and end-user demand. Accordingly, we rely on a variety of methods to estimate direct customer product level inventory and to calculate months on hand. Factors that may affect our estimates include generic competition, seasonality of products, direct customer purchases in light of price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations. As a result, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. businesses for the quarter ended September 30, 2012 is not available prior to the filing of this quarterly report on Form 10-Q. We will disclose any product with levels of inventory in excess of one month on hand or expected demand for the current quarter, subject to a de minimis exception, in the next annual report on Form 10-K.

 

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Expenses

 

     Three Months Ended September 30,      Nine Months Ended September 30,  
Dollars in Millions    2012      2011      % Change      2012      2011      % Change  

Cost of products sold

   $       987      $       1,407        (30)%       $       3,535      $       4,231        (16)%   

Marketing, selling and administrative

     1,071        1,019        5%         3,077        2,987        3%   

Advertising and product promotion

     167        205        (19)%         585        672        (13)%   

Research and development

     951        973        (2)%         2,822        2,831          

Impairment charge for BMS-986094 intangible asset

     1,830                N/A         1,830                N/A   

Provision for restructuring

     29        8        **         71        92        (23)%   

Litigation expense/(recoveries)

     50                N/A         (122)                 N/A   

Equity in net income of affiliates

     (40)         (71)         44%         (150)         (215)         30%   

Other (income)/expense

     (50)         (26)         92%         (45)         (195)         (77)%   
  

 

 

    

 

 

       

 

 

    

 

 

    

Total Expenses

   $ 4,995      $ 3,515        42%       $ 11,603      $ 10,403        12%   
  

 

 

    

 

 

       

 

 

    

 

 

    

 

**

Change in excess of 100%.

Cost of products sold decreased primarily due to lower sales volume following the loss of exclusivity of Plavix* and Avapro* / Avalide* which resulted in lower royalties in connection with our Sanofi alliance and favorable foreign exchange partially offset by impairment charges in the second quarter of 2012 and higher amortization costs resulting from the Amylin acquisition (net of the amortization of Amylin collaboration proceeds). Cost of products sold as a percentage of net sales was 26.4% and 26.3% in the three months ended September 30, 2012 and 2011, respectively, and 26.3% and 26.8% in the nine months ended September 30, 2012 and 2011.

Impairment charges of $147 million were recognized during the second quarter of 2012, of which $120 million was related to a partial write-down to fair value of developed technology costs related to a non-key product acquired in the acquisition of ZymoGenetics, Inc. (ZymoGenetics). The developed technology impairment charge resulted from continued competitive pricing pressures and a reduction in the undiscounted projected cash flows to an amount less than the carrying value of the intangible asset at June 30, 2012. The impairment charge was calculated as the difference between the fair value of the asset based on the discounted value of the estimated future cash flows and the carrying value of the intangible asset. The remaining $27 million impairment charge related to the abandonment of a manufacturing facility resulting from the outsourcing of a manufacturing process.

Marketing, selling and administrative expenses increased in 2012 primarily as a result of the Amylin acquisition ($86 million, including $67 million related to the accelerated vesting of stock options and restricted stock units), which was partially offset by a reduction in sales-related activities for Plavix* and Avapro* / Avalide*. Marketing, selling and administrative expenses were also impacted by favorable foreign exchange.

Research and development expenses decreased primarily from the net impact of upfront, milestone, and other licensing payments and IPRD impairment charges. Refer to “Specified Items” included in “—Non-GAAP Financial Measures” for amounts attributed to each period. Other licensing payments included $88 million in the first quarter of 2011 associated with the amendment of an intellectual property license agreement for Yervoy prior to its approval. IPRD impairment charges relate to projects previously acquired in the Medarex, Inc. (Medarex) acquisition and Inhibitex acquisition (including $45 million in the second quarter of 2012 related to FV-100, a nucleoside inhibitor for the reduction of shingles-associated pain) resulting from unfavorable clinical trial results and decisions to cease further development. Research and development expenses also included $59 million of expenses related to the Amylin acquisition (including $27 million related to the accelerated vesting of Amylin stock options and restricted stock units) and favorable foreign exchange.

A $1.8 billion impairment charge was recognized when the development of BMS-986094 (formerly INX-189), a compound which we acquired as part of our acquisition of Inhibitex to treat hepatitis C, was discontinued in the interest of patient safety. See “Item 1. Financial Statements—Note 12. Goodwill and Other Intangible Assets” for further information.

Provision for restructuring was primarily attributable to employee termination benefits.

Litigation recoveries, in the nine months ended September 30, 2012, included $172 million for our share of the Apotex damages award concerning Plavix* partially offset by increases in reserves.

Equity in net income of affiliates decreased due to the continued impact of generic competition on international Plavix* net sales, the conversion of certain territories to opt-out markets and unfavorable foreign exchange.

 

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Other (income)/expense includes:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions   2012     2011     2012     2011  

Interest expense

  $ 48     $ 40     $ 131     $ 103  

Investment income

    (27     (23     (85     (69

Out-licensed intangible asset impairment

                  38         

Gain on sale of product lines, businesses and assets

           (25     (3     (36

Other income received from alliance partners, net

    (96     (44     (225     (107

Pension curtailments and settlements

    3       2       3       (1

Litigation charges/(recoveries)

           1       22       (105

Product liability charges

           10              36  

Other

    22       13       74       (16
 

 

 

   

 

 

   

 

 

   

 

 

 

Other (income)/expense

  $ (50   $ (26   $ (45   $ (195
 

 

 

   

 

 

   

 

 

   

 

 

 

 

 

Interest expense increased due to the termination of interest rate swap contracts in 2011 and higher borrowings in 2012.

 

 

Investment income included a $10 million gain from the sale of auction rate securities in the first quarter of 2012.

 

 

Out-licensed intangible asset impairment charges are related to assets that were previously acquired in the Medarex and ZymoGenetics acquisitions and resulted from unfavorable clinical trial results and/or the abandonment of the programs. Similar charges of $15 million were included in research and development in 2011.

 

 

Other income from alliance partners, net increased due to lower sales-based development royalties payable to Sanofi, a new supply agreement related to the Sanofi partnership and amortization of certain upfront, milestone and other licensing payments.

 

 

Product liability charges in 2011 were for additional reserves in connection with the breast implant settlement program.

 

 

Additional pension settlement charges may be recognized in the future, particularly with the U.S. pension plans due to a lower threshold resulting from the elimination of service costs and potentially higher lump sum payments.

 

   

Other includes acquisition-related expenses and losses on debt repurchases.

Non-GAAP Financial Measures

Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude certain costs, expenses, gains and losses and other specified items that due to their significant and/or unusual nature, are evaluated on an individual basis. Similar charges or gains for some of these items have been recognized in prior periods and it is reasonably possible that they could reoccur in future periods. Non-GAAP information is intended to portray the results of our baseline performance which include the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceutical products on a global basis and to enhance an investor’s overall understanding of our past financial performance and prospects for the future. For example, non-GAAP earnings and EPS information is an indication of our baseline performance before items that are considered by us not to be reflective of our ongoing results. In addition, this information is among the primary indicators we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP.

 

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Specified items were as follows:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions, except per share data   2012     2011     2012     2011  

Accelerated depreciation, asset impairment and other shutdown costs

  $      $ 19     $ 147     $ 60  

Amortization of acquired Amylin intangible assets

    91              91         

Amortization of Amylin collaboration proceeds

    (46            (46       

Amortization of Amylin inventory adjustment

    9              9         
 

 

 

   

 

 

   

 

 

   

 

 

 

Cost of products sold

    54       19       201       60  

Stock compensation from accelerated vesting of Amylin awards

    67              67         

Process standardization implementation costs

    3       5       16       19  
 

 

 

   

 

 

   

 

 

   

 

 

 

Marketing, selling and administrative

    70       5       83       19  

Stock compensation from accelerated vesting of Amylin awards

    27              27         

Upfront, milestone and other licensing payments

    21       69       21       207  

IPRD impairment

           13       103       28  
 

 

 

   

 

 

   

 

 

   

 

 

 

Research and development

    48       82       151       235  

Impairment charge for BMS-986094 intangible asset

    1,830              1,830         

Provision for restructuring

    29       8       71       92  

Litigation expense/(recoveries)

    50              (122       

Gain on sale of product lines, businesses and assets

           (12            (12

Acquisition-related expenses

    29              42         

Litigation charges/(recoveries)

                  22       (102

Product liability charges

           10              36  

Out-licensed intangible asset impairment

                  38         

Loss on debt repurchase

    8              27         
 

 

 

   

 

 

   

 

 

   

 

 

 

Other (income)/expense

    37       (2     129       (78

Decrease to pretax income

    2,118       112       2,343       328  

Income tax on items above

    (722     (37     (791     (99

Specified tax benefit*

                         (71
 

 

 

   

 

 

   

 

 

   

 

 

 

Income taxes

    (722     (37     (791     (170
 

 

 

   

 

 

   

 

 

   

 

 

 

Decrease to net earnings

  $ 1,396     $ 75     $ 1,552     $ 158  
 

 

 

   

 

 

   

 

 

   

 

 

 

 

*

The 2011 specified tax benefit relates to releases of tax reserves that were specified in prior periods.

The reconciliations from GAAP to Non-GAAP were as follows:

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions, except per share data    2012     2011     2012     2011  

Net Earnings/(Loss) Attributable to BMS – GAAP

   $ (711   $ 969     $ 1,035     $ 2,857  

Earnings attributable to unvested restricted shares

            (2     (1     (6
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings/(Loss) used for Diluted EPS Calculation – GAAP

   $ (711   $ 967     $ 1,034     $ 2,851  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings/(Loss) – GAAP

   $ (711   $ 969     $ 1,035     $ 2,857  

Less Specified Items

     1,396       75       1,552       158  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings – Non-GAAP

     685       1,044       2,587       3,015  

Earnings attributable to unvested restricted shares

            (2     (1     (6
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings used for Diluted EPS Calculation – Non-GAAP

   $ 685     $ 1,042     $ 2,586     $ 3,009  
  

 

 

   

 

 

   

 

 

   

 

 

 

Average Common Shares Outstanding – Diluted – GAAP

     1,666       1,715       1,697       1,717  

Contingently convertible debt common stock equivalents

     1                       

Incremental shares attributable to share-based compensation plans

     16                       
  

 

 

   

 

 

   

 

 

   

 

 

 

Average Common Shares Outstanding – Diluted – Non-GAAP

     1,683       1,715       1,697       1,717  

Diluted Earnings/(Loss) Per Share – GAAP

   $ (0.43   $ 0.56     $ 0.61     $ 1.66  

Diluted EPS Attributable to Specified Items

     0.84       0.05       0.91       0.09  
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted Earnings/(Loss) Per Share – Non-GAAP

   $ 0.41     $ 0.61     $ 1.52     $ 1.75  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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Common stock equivalents were included in the calculation of GAAP earnings per share for all periods presented above except for the three months ended September 30, 2012, because they were anti-dilutive due to the loss.

Income Taxes

The effective tax benefit rate was 43.4% on the pretax loss during the third quarter of 2012 compared to an effective tax rate of 26.0% on pretax earnings during the third quarter of 2011. The effective income tax rates were 13.7% and 25.2% during the nine months ended September 30, 2012 and 2011, respectively. The overall tax benefit rate of 43.4% attributed to the pretax loss in the current quarter was due to the mix of earnings in low tax jurisdictions and pretax loss in the higher U.S. tax jurisdiction resulting from a $1.8 billion intangible asset impairment charge. The impact of the impairment charge reduced the effective tax rate by 11 percentage points during the nine months ended September 30, 2012. The effective tax rate is typically lower than the U.S. statutory rate of 35% due to our decision to indefinitely reinvest the earnings for certain of our manufacturing operations in Ireland and Puerto Rico. See “Item 1. Financial Statements—Note 6. Income Taxes” for further discussion.

Noncontrolling Interest

Noncontrolling interest is primarily related to our partnerships with Sanofi for the territory covering the Americas related to Plavix* and Avapro*/Avalide* net sales. See “Item 1. Financial Statements—Note 3. Alliances and Collaborations.” The decrease in noncontrolling interest resulted from the May 2012 exclusivity loss of Plavix* in the U.S and the March 2012 exclusivity loss of Avapro*/Avalide* in the U.S. A summary of noncontrolling interest is as follows:

 

                                                                                                   
    Three Months Ended September 30,     Nine Months Ended September 30,  
Dollars in Millions   2012     2011     2012     2011  

Sanofi partnerships

  $ (7   $ 590     $ 847     $ 1,764  

Other

    3       5       12       17  
 

 

 

   

 

 

   

 

 

   

 

 

 

Noncontrolling interest-pre-tax

    (4     595       859       1,781  

Income taxes

    (2     209       317       609  
 

 

 

   

 

 

   

 

 

   

 

 

 

Net earnings attributable to noncontrolling interest-net of taxes

  $ (2   $ 386     $ 542     $ 1,172  
 

 

 

   

 

 

   

 

 

   

 

 

 

FINANCIAL POSITION, LIQUIDITY, AND CAPITAL RESOURCES

Our net cash position was as follows:

 

                                                                          
Dollars in Millions        September 30,
2012
    December 31,
2011
 

Cash and cash equivalents

     $ 1,503     $ 5,776  

Marketable securities – current

       1,427       2,957  

Marketable securities – non-current

       3,698       2,909  
    

 

 

   

 

 

 

Total cash, cash equivalents and marketable securities

       6,628       11,642  

Short-term borrowings and current portion of long-term debt

       (751     (115

Long-term debt

       (6,608     (5,376
    

 

 

   

 

 

 

Net cash/(debt) position

     $ (731   $ 6,151  
    

 

 

   

 

 

 

Working capital

     $ 1,083     $ 7,538  

The reduction in net cash and working capital during 2012 resulted primarily from net cash used in connection with the acquisitions of Amylin and Inhibitex. Cash, cash equivalents and marketable securities held in the U.S. were approximately $2.0 billion at September 30, 2012. Most of the remaining $4.6 billion is held primarily in low-tax jurisdictions and is attributable to earnings that are expected to be indefinitely reinvested offshore. Cash repatriations are subject to restrictions in certain jurisdictions and may be subject to withholding and additional U.S. income taxes. During the third quarter of 2012, we began to issue commercial paper to meet near-term domestic liquidity requirements following the Amylin acquisition. The average commercial paper outstanding during the three months ended September 30, 2012 was $526 million with a weighted-average interest rate of 0.15%. There were no month-end commercial paper borrowings outstanding during the third quarter of 2012. We may continue to issue commercial paper to meet domestic liquidity requirements in the future.

Our investment portfolio includes non-current marketable securities which are subject to changes in fair value as a result of interest rate fluctuations and other market factors, which may impact our results of operations. Our investment policy places limits on these investments and the amount and time to maturity of investments with any institution. The policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards. See “Item 1. Financial Statements—Note 8. Financial Instruments.”

 

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In July 2012, BMS entered into a new $1.5 billion five-year revolving credit facility from a syndicate of lenders which contains customary terms and conditions and is extendable on any anniversary date with the consent of the lenders. This revolving credit facility is in addition to the Company’s existing $1.5 billion five-year revolving credit facility. There are no financial covenants under either facility. There were no borrowings outstanding under either revolving credit facility at September 30, 2012 and December 31, 2011.

In July 2012, in connection with the Amylin acquisition, BMS issued $2.0 billion of senior unsecured notes in a registered public offering consisting of $750 million in aggregate principal amount of 0.875% Notes due 2017, $750 million in aggregate principal amount of 2.000% Notes due 2022 and $500 million in aggregate principal amount of 3.250% Notes due 2042.

In August 2012, BMS completed its acquisition of Amylin for an aggregate purchase price of $5.3 billion. BMS also assumed Amylin’s net debt and a contractual payment obligation to Eli Lilly & Company, together totaling $2.0 billion (substantially all of which was repaid during the three months ended September 30, 2012). The acquisition was financed through the use of existing cash balances, the issuance of commercial paper and long-term debt borrowings described above.

BMS received preliminary proceeds of $3.8 billion from AstraZeneca as consideration for entering into the collaboration during the current period, including $190 million which is recorded in accrued expenses and expected to be reimbursed back to AstraZeneca during the fourth quarter. The net proceeds that BMS will receive from AstraZeneca as consideration for entering into the collaboration are subject to certain other adjustments including the right to receive an additional $135 million when AstraZeneca exercises its option for equal governance rights.

As discussed in “—Strategy” above, we lost exclusivity in the U.S. for our largest product, Plavix* , in May 2012 which has resulted in a rapid, precipitous, and material decline in operating cash flow. Additional regulations in the U.S. could be passed in the future which could further reduce our results of operations, operating cash flow, liquidity and financial flexibility. We also continue to monitor the potential impact of the economic conditions in certain European countries and the related impact on prescription trends, pricing discounts, creditworthiness of our customers, and our ability to collect outstanding receivables from our direct customers. Currently, we believe these economic conditions in the EU will not have a material impact on our liquidity, cash flow or financial flexibility.

Although not material, certain European government-backed entities with a higher risk of default were identified by monitoring economic factors including credit ratings, credit-default swap rates and debt-to-gross domestic product ratios in addition to entity specific factors. Our credit exposure to government-backed trade receivables in Greece, Portugal, Italy and Spain is limited by factoring receivables, deferring revenues until the collection of cash and accruing additional bad debt reserves. Our net receivables in these countries were approximately $233 million at September 30, 2012, of which approximately 75% was from government-backed entities. During 2012, counterparties in our factoring arrangements suspended factoring of receivables from Spanish and Portuguese government-backed entities and limited factoring of receivables from certain Italian government-backed entities. Sales of trade receivables in Italy, Portugal and Spain were $250 million in 2012 and $384 million in 2011. Our credit exposures in Europe may increase in the future due to further reductions in our factoring arrangements and the ongoing sovereign debt crisis. Sales of receivables in Japan were $484 million in 2012 and $422 million in 2011. Our sales agreements do not allow for recourse in the event of uncollectibility and we do not retain interest to the underlying assets once sold.

We continue to manage our operating cash flows with initiatives designed to improve working capital items that are most directly affected by changes in sales volume, such as receivables, inventories, and accounts payable. During 2012, the following changes in receivables, inventories and accounts payable resulted primarily from the rapid reduction of Plavix* sales, the acquisition of Amylin and timing of expenditures in the ordinary course of business. The following summarizes these components expressed as a percentage of trailing twelve months’ net sales:

 

Dollars in Millions   September 30,
2012
    % of Trailing
Twelve Month
Net Sales
    December 31,
2011
    % of Trailing
Twelve Month
Net Sales
 

Net trade receivables

  $ 1,734       9.2   $ 2,250       10.6

Inventories

    1,697       9.0     1,384       6.5

Accounts payable

    (2,085     (11.0 )%      (2,603     (12.2 )% 
 

 

 

     

 

 

   

Total

  $ 1,346       7.1   $ 1,031       4.9
 

 

 

     

 

 

   

 

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Credit Ratings

Moody’s Investors Service long-term and short-term credit ratings are currently A2 and Prime-1, respectively, and their long-term credit outlook remains stable. Standard & Poor’s (S&P) long-term and short-term credit ratings are currently A+ and A-1+, respectively, and their long-term credit outlook remains stable. S&P upgraded our short-term credit rating from A-1 to A-1+ in May 2012. Fitch Ratings (Fitch) long-term and short-term credit ratings are currently A and F1, respectively, and their long-term credit outlook remains negative. Fitch lowered our long-term credit rating from A+ to A in July 2012. Our credit ratings are considered investment grade. These long-term ratings designate that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions. These short-term ratings designate that we have the strongest capacity for timely repayment.

Cash Flows

The following is a discussion of cash flow activities:

 

    Nine Months Ended
September 30,
 
Dollars in Millions   2012     2011  

Cash flow provided by/(used in):

   

Operating activities

  $ 6,105     $ 3,272  

Investing activities

    (7,004     (1,932

Financing activities

    (3,375     (1,903

Operating Activities

Cash flow from operating activities represents the cash receipts and cash disbursements from all of our activities other than investing activities and financing activities. Operating cash flow is derived by adjusting net earnings for noncontrolling interest, non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash and when the transactions are recognized in our results of operations. As a result, changes in cash from operating activities reflect the timing of cash collections from customers and alliance partners; payments to suppliers, alliance partners and employees; pension contributions and tax payments in the ordinary course of business. Preliminary proceeds of $3.8 billion were received in 2012 from AstraZeneca as consideration for entering into the Amylin collaboration.

Investing Activities

 

   

Cash was used to fund the acquisition of Amylin for $5.0 billion and Inhibitex for $2.5 billion in 2012.

   

Net sales and maturities of marketable securities of $883 million in 2012 were primarily attributed to the Amylin acquisition. Net purchases of marketable securities of $1.5 billion in 2011 were primarily attributable to the timing of investments in time deposits and highly-rated corporate debt securities with maturities greater than 90 days.

   

Other investing activities included litigation recoveries of $102 million in 2011.

Financing Activities

 

   

Dividend payments were $1.7 billion in both 2012 and 2011. Dividends declared per common share totaled $1.02 for the nine months ended September 30, 2012 and $0.99 for the nine months ended September 30, 2011. Dividend decisions are made on a quarterly basis by our Board of Directors.

   

Proceeds of $2.0 billion were received from the issuance of senior unsecured notes.

   

Repayments of debt assumed in the Amylin acquisition were $2.0 billion.

   

Management periodically evaluates potential opportunities to repurchase certain debt securities and terminate certain interest rate swap contracts prior to their maturity. Cash outflows related to the repurchase of debt were $109 million in 2012 and $78 million in 2011.

   

In June 2012, the Board of Directors increased its authorization for the repurchase of common stock by $3.0 billion. There is $2.3 billion of common stock repurchase capacity remaining as of September 30, 2012. Common stock was repurchased in the amount of $1.9 billion in 2012 and $859 million in 2011.

   

Proceeds from stock option exercises were $397 million in 2012 and $365 million in 2011 and will vary from period to period based upon fluctuations in the market value of our stock relative to the exercise price of the stock options and other factors.

 

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Table of Contents

CRITICAL ACCOUNTING POLICIES

For a discussion of our critical accounting policies, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2011 Annual Report on Form 10-K.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by the fact they use words such as “should”, “expect”, “anticipate”, “estimate”, “target”, “may”, “project”, “guidance”, “intend”, “plan”, “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements are likely to relate to, among other things, our goals, plans and projections regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products and the outcome of contingencies such as legal proceedings and financial results, which are based on current expectations that involve inherent risks and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years. We have included important factors in the cautionary statements included in this report and in the 2011 Annual Report on Form 10-K, particularly under “Item 1A. Risk Factors,” that we believe could cause actual results to differ materially from any forward-looking statement.

Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. We undertake no obligation to release publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.

 

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Table of Contents

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

For a discussion of our market risk, see “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in our 2011 Annual Report on Form 10-K.

Item 4. CONTROLS AND PROCEDURES

Management, with the participation of the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures. Based on their evaluation, as of the end of the period covered by this Form 10-Q, the Chief Executive Officer and Chief Financial Officer have concluded that such disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) are effective.

In August 2012, Bristol-Myers Squibb Company (the Company) completed its acquisition of Amylin Pharmaceuticals, Inc. (Amylin) which represents a material change in the internal control over financial reporting since management’s last assessment of effectiveness. Amylin’s operations utilize separate information and accounting systems and processes and it was not possible to complete an evaluation and review of the internal controls over financial reporting since the completion of the acquisition. Management intends to complete its assessment of the effectiveness of internal control over financial reporting for Amylin within one year of the acquisition date. Excluding the Amylin acquisition, there were no changes in our internal control over financial reporting that have or are reasonably likely to materially affect the Company’s internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1. LEGAL PROCEEDINGS

Information pertaining to legal proceedings can be found in “Item 1. Financial Statements—Note 17. Legal Proceedings and Contingencies,” to the interim consolidated financial statements, and is incorporated by reference herein.

Item 1A. RISK FACTORS

There have been no material changes from the risk factors disclosed in the Company’s 2011 Annual Report on Form 10-K.

Item 2. ISSUER PURCHASES OF EQUITY SECURITIES

The following table summarizes the surrenders of our equity securities during the nine months ended September 30, 2012:

 

Period

       Total Number    
of Shares
Purchased (a)
     Average
    Price Paid    
per Share (a)
     Total Number of
    Shares Purchased as     
Part of Publicly
Announced Plans or
Programs (b)
     Approximate Dollar
    Value of Shares that     
May Yet Be
Purchased Under the
Plans or Programs (b)
 
Dollars in Millions, Except Per Share Data                            

January 1 to 31, 2012

     5,482,912      $ 33.35        5,477,200      $ 1,005  

February 1 to 29, 2012

     4,372,415      $ 32.22        4,360,900      $ 864  

March 1 to 31, 2012

     1,750,695      $ 32.51              $ 864  
  

 

 

       

 

 

    

Three months ended March 31, 2012

     11,606,022           9,838,100     
  

 

 

       

 

 

    

April 1 to 30, 2012

     5,613,737      $ 33.42        5,606,834      $ 677  

May 1 to 31, 2012

     5,876,829      $ 33.14        5,858,755      $ 483  

June 1 to 30, 2012

     4,912,492      $ 34.52        4,906,631      $ 3,313  
  

 

 

       

 

 

    

Three months ended June 30, 2012

     16,403,058           16,372,220     
  

 

 

       

 

 

    

July 1 to 31, 2012

     6,304,273      $ 35.30        6,299,644      $ 3,091  

August 1 to 31, 2012

     16,960,023      $ 32.36        16,949,219      $ 2,543  

September 1 to 30, 2012

     8,052,099      $ 33.36        8,045,000      $ 2,274  
  

 

 

       

 

 

    

Three months ended September 30, 2012

     31,316,395           31,293,863     
  

 

 

       

 

 

    

Nine months ended September 30, 2012

     59,325,475           57,504,183     
  

 

 

       

 

 

    

 

(a)

The difference between total number of shares purchased and the total number of shares purchased as part of publicly announced programs is due to shares of common stock withheld by us from employee restricted stock awards in order to satisfy our applicable tax withholding obligations.

(b)

In June 2012, the Board of Directors increased its authorization for the repurchase of common stock by $3.0 billion. The repurchase program does not have an expiration date and is expected to take place over a couple of years.

 

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Table of Contents

Item 6. EXHIBITS

Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).

 

Exhibit No.

  

Description

10a.    Master Restructuring Agreement by and between Bristol-Myers Squibb Company and Sanofi dated as of September 27, 2012.†
  12.    Computation of Earnings to Fixed Charges.
31a.    Section 302 Certification Letter.
31b.    Section 302 Certification Letter.
32a.    Section 906 Certification Letter.
32b.    Section 906 Certification Letter.
101.    The following financial statements from the Bristol-Myers Squibb Company Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, formatted in Extensible Business Reporting Language (XBRL): (i) consolidated statements of earnings, (ii) consolidated statements of comprehensive income and retained earnings, (iii) consolidated balance sheets, (iv) consolidated statements of cash flows, and (v) the notes to the consolidated financial statements.

 

† Confidential treatment has been requested for certain portions which are omitted in the copy of the exhibit electronically filed with the Commission. The omitted information has been filed separately with the Commission pursuant to the Company’s application for confidential treatment.

*             Indicates, in this Form 10-Q, brand names of products, which are registered trademarks not solely owned by the Company or its subsidiaries. Byetta, Bydureon, and Symlin are trademarks of Amylin Pharmaceuticals, LLC and AstraZeneca Pharmaceuticals LP; Erbitux is a trademark of Eli Lilly and Company; Avapro/Avalide (known in the EU as Aprovel/Karvea ) and Plavix are trademarks of Sanofi; Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd.; Truvada is a trademark of Gilead Sciences, Inc.; Gleevec is a trademark of Novartis AG; Atripla is a trademark of Bristol-Myers Squibb and Gilead Sciences, LLC; Estrace and Ovcon are trademarks of Warner-Chilcott Company, LLC; Reglan is a trademark of Alaven Pharmaceutical LLC; Humira is a trademark of Abbott Laboratories; and Delestrogen is a trademark of JHP Pharmaceuticals, Inc.

 

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Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

BRISTOL-MYERS SQUIBB COMPANY

(REGISTRANT)

Date: October 24, 2012

 

By:

 

/s/ Lamberto Andreotti

   

Lamberto Andreotti

   

Chief Executive Officer

Date: October 24, 2012

 

By:

 

/s/ Charles Bancroft

   

Charles Bancroft

   

Executive Vice President and Chief Financial Officer

 

48

Exhibit 10a

EXECUTION VERSION

MASTER RESTRUCTURING AGREEMENT

BY AND BETWEEN

BRISTOL-MYERS SQUIBB COMPANY

AND

SANOFI

DATED AS OF SEPTEMBER 27, 2012

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION


TABLE OF CONTENTS

 

ARTICLE I

  CERTAIN DEFINED TERMS      2   

ARTICLE II

  RESTRUCTURING OF TERRITORY PARTNERSHIPS AND LOCAL COUNTRY COMMERCIALIZATION ARRANGEMENTS      16   

2.1

  Territory B Partnership      16   

2.2

  U.S. Irbesartan Partnership      20   

2.3

  Territory A Partnership      22   

2.4

  Opt-out Agreements      26   

2.5

  Autogenerics and Other Sanofi Generic Products      27   

2.6

  Clinical Trial Supplies      30   

2.7

  Initial Closing      30   

2.8

  Initial Closing Date Deliveries      30   

2.9

  Additional Closing Deliveries      31   

2.10

  Inventory Purchase      31   

2.11

  Remuneration Payments      33   

2.12

  Market Withdrawal      35   

2.13

  Other Alliance Agreements      36   

ARTICLE III

  FINISHED PRODUCT MANUFACTURING AND IRBESARTAN API MANUFACTURING      36   

3.1

  Irbesartan Products and Clopidogrel Products      36   

3.2

  Irbesartan API Manufacturing      37   

3.3

  Supply/Tolling Agreements      38   

3.4

  Resolution of Inconsistencies      38   

3.5

  Industrial Committee      38   

ARTICLE IV

  REPRESENTATIONS AND WARRANTIES      38   

4.1

  Representations and Warranties of the Parties      38   

4.2

  Additional Representation and Warranty of BMS      40   

ARTICLE V

  CERTAIN REGULATORY MATTERS      41   

5.1

  Marketing Authorizations      41   

5.2

  Pharmacovigilance      41   

ARTICLE VI

  DILIGENCE OBLIGATIONS      43   

6.1

  No Obligations Generally      43   

6.2

  Certain Limitations      44   

6.3

  Regulatory Filings      44   

6.4

  Restricted Countries      44   

ARTICLE VII

  INTELLECTUAL PROPERTY      44   

7.1

  Trademark Transition      44   

7.2

  Intellectual Property Damages      46   

ARTICLE VIII

  COVENANTS      47   

8.1

  Antitrust Filings      47   

8.2

  ICC Disputes      48   

8.3

  Non-Competition      48   

8.4

  Works Council Notifications and TUPE Matters      50   

 

i

 

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION


8.5

  Third Party Contracts      50   

8.6

  Payment of Pharma Fee      51   

8.7

  NDC Codes      51   

8.8

  Confidentiality; Public Announcements      51   

8.9

  Notification of Certain Matters      52   

8.10

  Additional Closings      52   

8.11

  Books and Records      53   

8.12

  Further Assurances; Cooperation      53   

8.13

  Alliance Agreement Amendments      54   

8.14

  Discontinuation in Brazil      54   

8.15

  Conduct of Business Prior to the Initial Closing Date      54   

8.16

  Termination of Alliance Agreements      54   

ARTICLE IX

  INDEMNIFICATION      55   

9.1

  Generally      55   

ARTICLE X

  CLOSING CONDITIONS      59   

10.1

  Initial Closing Date Conditions to Each Party’s Obligation      59   

10.2

  Additional Closing Date Conditions to Each Party’s Obligation      59   

ARTICLE XI

  TERMINATION      60   

11.1

  Termination      60   

11.2

  Effect of Termination      60   

ARTICLE XII

  MISCELLANEOUS      61   

12.1

  Notices      61   

12.2

  Governing Law      62   

12.3

  Specific Performance      62   

12.4

  Dispute Resolution      62   

12.5

  No Third Party Beneficiaries      63   

12.6

  Severability      63   

12.7

  Assignment      63   

12.8

  Waivers and Amendments      64   

12.9

  Expenses; Currency of Payments      64   

12.10

  Waiver of Jury Trial      64   

12.11

  Counterparts      65   

12.12

  Entire Agreement      65   

12.13

  Performance of Affiliates’ Obligations      65   

12.14

  Indirect Taxes      65   

LIST OF SCHEDULES

 

  Schedule 1.1(a)

             Closing Date Agreements

  Schedule 1.1(c)

             Territory A

  Schedule 1.1(d)

             Territory B1

  Schedule 2.10

             Inventory Purchase

  Schedule 4.1(c)

             Ownership

  Schedule 4.2(b)

             Assigned Contracts

  Schedule 5.1(a)

             Marketing Authorizations

 

ii

 

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION


Schedule 6.4

   Restricted Country List

Schedule 7.2(b)

   Intellectual Property Actions

Schedule 8.1

   Antitrust Filings

Schedule 8.10

   Modified Designated Country Structure

Schedule 8.16

   Termination of Alliance Agreements

Schedule 9.1

   Pending Claims
LIST OF EXHIBITS

Exhibit 1.1(a)

   China Opt-out Letter

Exhibit 1.1(b)

   FDC Intellectual Property License

Exhibit 2.1(a)(i)

   Territory B1 Assignment Agreement

Exhibit 2.1(a)(ii)

   Amended and Restated Territory B Clopidogrel License

Exhibit 2.1(a)(iii)

   Amended and Restated Territory B Know-How License

Exhibit 2.1(a)(iv)

   Amended and Restated Territory B1 Know-How License

Exhibit 2.1(a)(vii)[1]

   Amended Territory B Alliance Support Agreement

Exhibit 2.1(a)(vii)[2]

   Amendment to JVB Partnership Agreement

Exhibit 2.1(h)(ii)

   Agreed Upon Principles for Terminating Co-Promotion Distribution Agreements

Exhibit 2.1(h)(iii)

   Agreed Upon Principles for Terminating Co-Marketing Distribution Agreements

Exhibit 2.1(h)(iv)

   Agreed Upon Principles for Terminating Marketing and Operating Services Agreements

Exhibit 2.1(i)

   Agreed Upon Principles for the Winding-up of Local Partnerships

Exhibit 2.1(m)

   Cash Flow Principles Amendment

Exhibit 2.2(a)(i)

   USIrbeJV Acquisition Agreement

Exhibit 2.2(a)(iii)

   USIrbeJV Alliance Support Agreement Termination Agreement

Exhibit 2.2(a)(iv)

   Amended USIrbeJV Partnership Agreement

Exhibit 2.2(c)

   Amended and Restated USIrbeJV Irbesartan License

Exhibit 2.3(a)(i)

   Business Lease

Exhibit 2.3(h)(ii)[1]

   Amended and Restated Territory A Clopidogrel License

Exhibit 2.3(h)(ii)[2]

   Amended and Restated Territory A Irbesartan License

Exhibit 2.3(h)(iii)

   Amended and Restated Territory A Know-How License

Exhibit 2.3(h)(iv)

   Territory A Alliance Support Agreement Termination Agreement

Exhibit 2.3(h)(v)[1]

   Amended and Restated Statuts

Exhibit 2.3(h)(v)[2]

   Amended and Restated Règlement Intérieur

Exhibit 2.3(h)(vi)

   Share Forward Purchase Agreement

Exhibit 3.1(c)

   Agreed Upon Principles for Termination of the Existing Supply Agreements

Exhibit 3.3(a)[1]

   Irbesartan API Supply Agreement

Exhibit 3.3(a)[2]

   Irbesartan Crude Toll Manufacturing Agreement

Exhibit 3.3(a)[3]

   Irbesartan Intermediates Supply Agreement

 

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Exhibit 3.3(a)[4]

   Plavix Finished Product Supply Agreement

Exhibit 3.3(a)[5]

   Toll Packaging Agreement

Exhibit 5.2(d)

   Amended Irbesartan SDEA

Exhibit 5.2(g)

   Amended Clopidogrel SDEA

Exhibit 8.2

   Settlement Agreement

 

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MASTER RESTRUCTURING AGREEMENT

This MASTER RESTRUCTURING AGREEMENT (this “ Agreement ”) is entered into as of September 27, 2012, by and between BRISTOL-MYERS SQUIBB COMPANY , a Delaware corporation (“ BMS ”), and SANOFI , a société anonyme organized under the laws of the French Republic (“ Sanofi ”, and together with BMS, the “ Parties ” and individually, each, a “ Party ”).

WHEREAS, the Parties have entered into certain alliance arrangements relating to two chemical entities discovered and patented by Sanofi, one known as SR 47436, with the international non-proprietary name Irbesartan (“ Irbesartan ”) and one known as SR 25990C with the international non-proprietary name Clopidogrel Hydrogenosulphate (“ Clopidogrel ”);

WHEREAS , the Parties desire to simplify the overall governance, operating and financial principles of their alliance arrangements with respect to (i) Irbesartan Products worldwide (other than in Japan, which is not covered by the Parties’ alliance) and (ii) Clopidogrel Products worldwide (other than in Japan, which is not covered by the Parties’ alliance, and in the U.S.).

WHEREAS , the Parties desire to settle on the date hereof the “ ICC Disputes ” (as such term is defined in the Settlement Agreement attached hereto as Exhibit 8.2 );

WHEREAS , the Parties desire to:

(a) maintain their partnership and related alliance arrangements with respect to Clopidogrel Products in the U.S.; and

(b) transition the operations of the alliance to Sanofi in the U.S. (with respect to Irbesartan Products) and in Territory A and Territory B1 (with respect to Irbesartan Products and Clopidogrel Products).

WHEREAS , the Parties desire (i) to transfer to Sanofi the responsibility for global pharmacovigilance for Irbesartan Products and (ii) Sanofi to assume the pharmacovigilance and safety reporting obligations for Clopidogrel Products (in all Co-Marketing markets);

WHEREAS , with respect to Territory A, the Parties desire to cause JVA to lease the business of JVA to an Affiliate of Sanofi;

WHEREAS , with respect to Territory B, the Parties desire to cause JVB to transfer to an Affiliate of Sanofi JVB’s rights with respect to the Products (other than with respect to Clopidogrel in the U.S.);

WHEREAS , with respect to Irbesartan in the U.S., the Parties desire for BMS to cause its Affiliate to sell, assign and transfer, and for Sanofi’s Affiliate to purchase, BMS’s Affiliate’s interest in USIrbeJV; and

 

 

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WHEREAS , the Parties desire that Sanofi will assume at an agreed upon time the entire manufacture and supply of Irbesartan API and Irbesartan and Clopidogrel Products in finished forms that are currently manufactured by BMS.

NOW, THEREFORE , in consideration of the mutual covenants and the terms and conditions contained herein, and for other good, valuable and binding consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE I

CERTAIN DEFINED TERMS

Except where expressly stated otherwise in this Agreement, the following rules of interpretation apply to this Agreement: (a) “includes” and “including” are not limiting; (b) “hereof,” “hereto,” “hereby,” “herein” and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement; (c) “date hereof” refers to the date set forth in the initial caption of this Agreement; (d) “extent” in the phrase “to the extent” means the degree to which a subject or other thing extends, and such phrase does not mean simply “if”; (e) descriptive headings and the table of contents are inserted for convenience only and do not affect in any way the meaning or interpretation of this Agreement; (f) definitions contained in this Agreement are applicable to the singular as well as the plural forms of such terms; (g) references to a Person or entity are also to its permitted successors and assigns; (h) references to an “Article,” “Section,” “Exhibit” or “Schedule” refer to an Article or Section of, or an Exhibit or Schedule to, this Agreement; (i) references to “$” or otherwise to dollar amounts refer to the lawful currency of the United States; and (j) references to a specific statute are also to all the applicable rules, regulations and interpretations promulgated thereunder. The language used in this Agreement shall be deemed to be the language chosen by the Parties hereto to express their mutual intent, and no rule of strict construction shall be applied against any Party. Except as otherwise noted, any agreement, instrument or statute defined or referred to herein or in any agreement or instrument that is referred to herein means such agreement, instrument or statute as from time to time amended, modified or supplemented, including (in the case of agreements or instruments) by waiver or consent and (in the case of statutes) by succession of comparable successor statutes and references to all attachments thereto and instruments incorporated therein. References to a Person are also to its permitted assigns and successors.

The terms below shall have the corresponding meanings ascribed to them below when used in this Agreement:

Additional Closing ” has the meaning set forth in Section 8.10(a) .

Affiliate ” when used with reference to any Person, means any other Person controlling, controlled by, or under common control with, such Person; provided, however, that, with respect to Sanofi, the definition of Affiliate shall exclude L’Oréal, a société anonyme organized and existing under the laws of the French Republic. For the purposes of this definition, “control” shall refer to (a) the possession, directly or indirectly, of the power to direct the management or

 

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policies of a Person or to veto any material decision relating to the management or policies of a Person, in each case whether through the ownership of voting securities, by contract or otherwise; (b) the beneficial ownership, directly or indirectly, of securities (excluding general partnership interests) representing at least 50% of the voting power of all outstanding voting securities of a Person; or (c) the beneficial ownership of at least 50% of the partnership interests of a general partnership.

Agreement ” has the meaning set forth in the Preamble to this Agreement.

Alliance Agreements ” means all agreements entered into by BMS, Sanofi or any Affiliate of BMS or Sanofi, as the case may be, in furtherance of the development, manufacturing and/or commercialization of any Product in the U.S. (only with respect to Irbesartan), and Territory A, Territory B, Territory B1, the Territory A Opt-out Countries and the Territory B1 Opt-out Countries.

Amended and Restated Règlement Intérieur ” means the amended and restated Règlement Intérieur of JVA substantially in the form attached hereto as Exhibit 2.3(h)(v)[2] .

Amended and Restated Statuts ” means the amended and restated statuts of JVA substantially in the form attached hereto as Exhibit 2.3(h)(v)[1] .

Amended and Restated Territory A Clopidogrel License ” means the Territory A Clopidogrel License, as amended and restated in substantially the form attached hereto as Exhibit 2.3(h)(ii)[1].

Amended and Restated Territory A Irbesartan License ” means the Territory A Irbesartan License, as amended and restated in substantially the form attached hereto as Exhibit 2.3(h)(ii)[2].

Amended and Restated Territory A Know-How License ” means the Territory A Know-How License, as amended and restated in substantially the form attached hereto as Exhibit 2.3(h)(iii) .

Amended and Restated Territory B Clopidogrel License ” means the non-assigned portion of the Territory B Clopidogrel License, as amended, in substantially the form attached hereto as Exhibit 2.1(a)(ii).

Amended and Restated Territory B Know-How License ” means the non-assigned portion of the Territory B Know-How License, as amended, in substantially the form attached hereto as Exhibit 2.1(a)(iii) .

Amended and Restated Territory B1 Clopidogrel License ” means the Territory B Clopidogrel License, as amended and assigned in part with respect to Territory B1, pursuant to the Territory B1 Assignment Agreement.

 

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Amended and Restated Territory B1 Irbesartan License ” means the Territory B Irbesartan License, as amended and assigned in part with respect to Territory B1, pursuant to the Territory B1 Assignment Agreement.

Amended and Restated Territory B1 Know-How License ” means the Territory B Know-How License, as amended and assigned in part with respect to Territory B1, in substantially the form attached hereto as Exhibit 2.1(a)(iv) .

Amended and Restated USIrbeJV Irbesartan License ” means the USIrbeJV Irbesartan License, as amended and restated in substantially the form attached hereto as Exhibit 2.2(c) .

“Amended Clopidogrel SDEA” has the meaning set forth in Section 5.2(g).

“Amended Irbesartan SDEA” has the meaning set forth in Section 5.2(d)

Amended JVB Partnership Agreement ” means the amended JVB Partnership Agreement, substantially in the form attached hereto as Exhibit 2.1(a)(vii)[2] .

Amended Territory B Alliance Support Agreement ” means the amended Territory B Alliance Support Agreement, substantially in the form attached hereto as Exhibit 2.1(a)(vii)[1].

Amended USIrbeJV Partnership Agreement ” means the amended USIrbeJV Partnership Agreement, substantially in the form attached hereto as Exhibit 2.2(a)(iv) .

Antitrust Filings ” has the meaning set forth in Section 8.1(a) .

Antitrust Laws ” means all laws and orders that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or attempted monopolization, restraint of trade, or lessening of competition.

API ” means an active pharmaceutical ingredient.

Assigned Contract ” has the meaning set forth in Section 4.2(b) .

Autogeneric Agreements ” means each of the following agreements by and between BMS and Sanofi: (a) Agreement, dated June 22, 2010, regarding a generic version of Clopidogrel monotherapy in Australia; (b) Agreement, dated August 2, 2010, regarding a generic version of Clopidogrel monotherapy in Germany; (c) Agreement, dated October 7, 2009, regarding a generic version of Clopidogrel monotherapy in France; (d) Agreement, dated April 6, 2010, regarding a generic version of Clopidogrel monotherapy in Switzerland; (e) Clopidogrel Autogeneric Agreement for Portugal, dated January 23, 2012; (f) Clopidogrel Autogenerics Agreement for Mexico, dated January 31, 2012; (g) Irbesartan Autogenerics Agreement for the United States, dated March 30, 2012; (h) Consent Agreement for Zentiva and Medley generics, dated March 21, 2012 and (i) Irbesartan Autogeneric Agreement dated July 30, 2012 (with respect to those countries in Europe set forth on Attachment A of said agreement).

 

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“Baseline Net Sales” has the meaning set forth in Section 2.5(a)(xi).

beneficial owner ” has the meaning set forth in Rule 13d-3 of the U.S. Securities Exchange Act of 1934, as amended.

BMS ” has the meaning set forth in the Preamble to this Agreement.

BMS Brands ” has the meaning set forth in Section 7.1(a) .

BMS Employees ” has the meaning set forth in Section 8.4(b) .

BMS Permitted FDC ” means an FDC that includes at least the following active ingredients: (a) either Irbesartan or Clopidogrel and (b) a BMS Proprietary Compound, excluding, for the period beginning on the Effective Date and ending on December 31, 2020, FDCs containing any of the following combinations of active ingredients only: Irbesartan and Amlodipine, Irbesartan and Atorvastatin, Irbesartan and Hydrochlorothiazide, and Clopidogrel and acetylsalicylic acid (collectively, the “ Excluded FDCs ”). For the avoidance of doubt, the foregoing exclusion does not apply to any Excluded FDC which also includes a BMS Proprietary Compound.

BMS JVA Partner ” means BMS Investco S.A.S., a société par actions simplifiée organized under the laws of the French Republic and an indirect wholly owned subsidiary of BMS.

BMS Proprietary Compound ” means any compound that is either owned, in whole or in part, by BMS or its Affiliates, or is licensed exclusively or co-exclusively to or by BMS or its Affiliates, and, at the time of the initial inclusion of such compound in a combination with Irbesartan or Clopidogrel, is covered by one or more claims of a patent or patent application in any country.

Business Day ” means any day other than: (a) a Saturday or Sunday; or (b) a day on which banking institutions located in New York, New York or Paris, France are permitted or required by applicable law, executive order or governmental decree to remain closed.

Business Lease ” has the meaning set forth in Section 2.3(a) .

Cash Flow Principles ” has the meaning set forth in Section 2.1(m) .

“Cash Flow Principles Amendment” has the meaning set forth in Section 2.1(m).

China Opt-out Letter ” means the letter agreement by and between BMS and Sanofi dated the date hereof and attached hereto as Exhibit 1.1(a) .

Claims Made ” means: (a) all lawsuits served or regulatory or other actions commenced; (b) written demands for money or services made; and/or (c) identification of individuals by name or other identifying information (such as but not limited to a social security number) in an agreement tolling the period of limitations for a claim.

 

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Clopidogrel ” has the meaning set forth in the Recitals to this Agreement.

Clopidogrel BMS Permitted FDC ” means a BMS Permitted FDC with respect to Clopidogrel.

Clopidogrel Product ” means: (a) a product with the sole active ingredient Clopidogrel, in finished form, marketed under the trademarks Plavix ® and Iscover ® or any trademark that is confusingly similar to or that is a replacement for any such trademark; and (b) a product (an “ Identified Clopi FDC ”) which contains as the only active ingredients the combination of Clopidogrel with acetylsalicylic acid, in finished form, marketed under the trademarks DuoPlavin ® , CoPlavix ® and DuoCover ® or any trademark that is confusingly similar to or that is a replacement for any such trademark. Clopidogrel Products shall exclude any other fixed dose combinations containing Clopidogrel.

Clopidogrel SDEA ” means the Safety Data Exchange Agreement by and between BMS and Sanofi, effective as of January 23, 2012, regarding Clopidogrel and Clopidogrel with acetylsalicylic acid.

Closing Date Agreements ” mean those agreements to be executed and delivered on the Initial Closing Date listed on Schedule 1.1(a) .

Co-Marketing ” or “ Co-Marketed ” means, for each Product and for any country in Territory A or Territory B1, the marketing of such Product in such country under two (2) or more trademarks by the applicable Marketing Entities.

Co-Promotion ” means, for each Product and for any country in Territory A, Territory B1 and the U.S. for Irbesartan, the marketing of such Product in such country under one (1) trademark by the applicable Marketing Entity.

“Covered Liabilities” has the meaning set forth in Section 9.1(c)(vi).

“Current Liability Allocation” has the meaning set forth in Section 9.1(a).

Damage ” means any liability (whether arising out of [*] or otherwise), obligation, loss, fine, damage, arbitration award, settlement amount, penalty, claim, cost or expense (including, without limitation, [*], fees and expenses [*], but excluding [*]). Damages shall include, without limitation, [*] liability, [*] liability (including, without limitation, any liability relating to the [*]) and damages for [*].

Designated Claims ” has the meaning set forth in Section 9.1(e) .

 

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Designated Country ” means, as of the Initial Closing Date, any jurisdiction listed in Schedule 8.1 attached hereto, as to which a Requisite Competition Law Approval has not been obtained on or prior to such date.

Designated Exchange Rate ” means the exchange rate applicable for each calendar month based on the prior month’s daily average EUR/USD rate set by the European Central Bank each day.

Dispute ” has the meaning set forth in Section 12.4(a) .

“Dispute Resolution Notice” has the meaning set forth in Section 12.4(a).

Dollars ,” “ dollars ,” “ U.S. dollars ,” “ USD ,” or any similar term, means the currency of the U.S. as in effect at the time of the applicable payment.

Estimated Future Sales ” means, for each Product, the sales forecasts agreed upon between Sanofi and BMS (or the relevant Selling Company and Purchasing Company) pursuant to Section 2.10(a) , concerning the [*] following the Initial Closing Date, an estimate of which is set forth on Schedule 2.10 .

“Estimated Market Withdrawal Adjustment” has the meaning set forth in Section 2.12(c).

“Estimated Market Withdrawal Notice” has the meaning set forth in Section 2.12(c)

EU ” has the meaning set forth in Section 2.5(a)(i) .

Excluded Country ” has the meaning set forth in Section 8.10(b) .

Excluded FDC ” has the meaning set forth in the definition of BMS Permitted FDC.

Existing Supply Agreements ” means, collectively, (a) the Irbesartan Supply Agreement, dated as of January 1, 1997 among Sanofi, BMS, JVA and JVB; (b) the Supply Letter Agreements dated as of January 30, 2004, October 7, 2005, December 21, 2007, June 28, 2010 and April 19, 2012 between Sanofi and BMS; (c) the Irbesartan Finished Product Purchase and Sale Agreement, dated as of October 17, 2001, among USIrbeJV and E.R. Squibb & Sons, LLC; and (d) the Irbesartan Finished Product Purchase and Sale Agreement, dated as of January 1, 2007, between JVA and SWIND.

FDC ” or “ fixed dose combination ” means a pharmaceutical dosage form containing fixed doses of more than one active ingredient in which all active ingredients are present in a single tablet, capsule or other form and shall expressly exclude so-called “co-packaging” in which separate drugs in separate dosage forms are sold in a single unit or bundle.

FDC Intellectual Property License ” means the FDC Intellectual Property License Agreement between Sanofi and BMS, substantially in the form attached hereto as Exhibit 1.1(b)

Generic Products ” has the meaning set forth in Section 2.5(a) .

 

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Governmental Authority ” means any federal, state or local or any foreign or supranational government, governmental, regulatory or administrative authority, agency or commission or any court, tribunal or judicial or arbitral body, in each case, of competent jurisdiction.

High Value ” has the meaning set forth in Section 2.12(d) .

ICC ” has the meaning set forth in Section 12.4(b) .

ICC Disputes ” has the meaning set forth in the Settlement Agreement attached hereto as Exhibit 8.2 .

Identified Clopi FDC ” has the meaning set forth in the definition of Clopidogrel Product.

Identified Irbe FDC ” has the meaning set forth in the definition of Irbesartan Product.

IFRS ” has the meaning set forth in the definition of IFRS Net Sales.

IFRS Net Sales ” means, with respect to a Product, net sales of Sanofi (or its Affiliates or their respective licensees or sublicensees) as audited and reported in Euros by Sanofi (or its Affiliates or licensees) in accordance with International Financial Reporting Standards (“ IFRS ”), as IFRS may be modified from time to time. For the avoidance of doubt: (a) IFRS Net Sales shall not include samples, compassionate use of the Products and the like; provided that revenue from Products sold to third parties for clinical trial purposes shall be included in IFRS Net Sales; and (b) any Damages paid by Sanofi pursuant to Article IX hereof shall not be treated as a deduction for purposes of calculating IFRS Net Sales. In calculating IFRS Net Sales, the Parties shall disregard any related Know-How, Discovery or other royalties paid to Sanofi after [*] on Clopidogrel Products or Irbesartan Products.

“Indemnified Party” has the meaning set forth in Section 9.1(c)(vii).

“Indemnifying Party” has the meaning set forth in Section 9.1(h)(ii).

Independent Expert ” has the meaning set forth in Section 2.12(e) .

Industrial Committee ” has the meaning set forth in Section 3.5 .

Initial Closing Date ” means the later of January 1, 2013 or the first date upon which all of the JVA Closing, the JVB Closing, and the USIrbeJV Closing may occur.

Irbesartan ” has the meaning set forth in the Recitals to this Agreement.

Irbesartan API Supply Agreement ” means the Supply Agreement to be entered into by Swords Laboratories, as supplier, and SWIND, as purchaser, in substantially the form attached hereto as Exhibit 3.3(a)[1] .

 

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Irbesartan BMS Permitted FDC ” means a BMS Permitted FDC with respect to Irbesartan.

Irbesartan Crude Toll Manufacturing Agreement ” means the Manufacturing Agreement to be entered into by SWIND, as Contractor, and Swords Laboratories, as Principal, in substantially the form attached hereto as Exhibit 3.3(a)[2] .

Irbesartan Intermediates Supply Agreement ” means the Supply Agreement to be entered into by SWIND, as supplier, and Swords Laboratories, as purchaser, in substantially the form attached hereto as Exhibit 3.3(a)[3] .

Irbesartan Product ” means: (a) a product with the sole active ingredient Irbesartan, in finished form, marketed under the trademarks Aprovel ® , Karvea ® and Avapro ® or any trademark that is confusingly similar to or that is a replacement for any such trademark; and (b) a product (an “ Identified Irbe FDC ”) which contains as the only active ingredients the combination of Irbesartan with Hydrochlorothiazide, in finished form, marketed under the trademarks CoAprovel ® , Avalide ® and Karvezide ® or any trademark that is confusingly similar to or that is a replacement for any such trademark. Irbesartan Products shall exclude any other fixed dose combinations containing Irbesartan.

Irbesartan SDEA ” means the Safety Data Exchange Agreement by and between BMS and Sanofi, effective as of April 15, 2008, as amended, effective as of November 15, 2009, regarding Irbesartan and Irbesartan with Hydrochlorothiazide, in finished form.

JVA ” means Sanofi Pharma Bristol-Myers Squibb, a société en nom collectif organized under the laws of the French Republic.

JVA Closing ” means the closing of the transactions set forth in Section 2.3 .

JVB ” means Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership, a Delaware general partnership.

JVB Closing ” means the closing of the transactions set forth in Section 2.1 .

JVB Partnership Agreement ” means the Partnership Agreement of Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership, by and between sanofi-aventis US LLC (as successor in interest to Sanofi Pharmaceuticals, Inc.) and Bristol-Myers Squibb Investco, Inc., dated as of January 1, 1997.

Knowledge ,” when used with respect to BMS, means the actual knowledge, without need for independent inquiry, of BMS’s Senior Vice President for Regulatory Affairs, BMS’s in-house legal counsel with responsibility for the Sanofi alliance and BMS’s Alliance Manager.

Lease Payment ” has the meaning set forth in Section 2.3(a) .

“Liability Allocation” has the meaning set forth in Section 9.1(c).

 

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License Agreements ” has the meaning set forth in Section 7.2(a) .

Low Value ” has the meaning set forth in Section 2.12(d) .

Market Withdrawal ” means a withdrawal of a Product from the market in a country or countries which has or is reasonably expected to have an adverse effect (which is material) on sales of such Product respectively, in Territory A, or all the Territory A Opt-out Country(ies), as a whole, and is (a) mandated by a Governmental Authority; (b) implemented by Sanofi or its Affiliates in anticipation of a withdrawal that Sanofi believes in good faith to be reasonably likely to be mandated in the future by a Governmental Authority (either by reason of statements from such Governmental Authority, mandated withdrawals in other jurisdictions or other objective facts); or (c) implemented by Sanofi or its Affiliates in lieu of complying with new requirements or conditions imposed by a Governmental Authority, which requirements or conditions are reasonably expected by Sanofi to have an adverse effect (which is material) on sales of such Product in such country or result in material costs and other burdens to Sanofi or its Affiliates in respect of such Product in such country, which expectation is reasonably supported by available facts; in each case, to the extent such Governmental Authority mandated withdrawal or the imposition of such requirements or conditions by a Governmental Authority is not attributable to acts or omissions of Sanofi or its Affiliates that constitute negligence or willful misconduct. For purposes of this Agreement, Sanofi’s or its Affiliate’s withdrawal or decision to withdraw a Product by Sanofi (instead of complying with a new requirement or condition of a Governmental Authority contemplated under clause (c) above) shall not in and of itself be deemed to be negligent or willful misconduct.

Market Withdrawal Adjustment ” means, in the event of a Market Withdrawal occurring prior to the Termination Date, an adjustment (or adjustments, in the event of more than one (1) Market Withdrawal) to the payment owed by Sanofi to BMS or any of its Affiliates under Section 2.3(g) if the country(ies) in which a Market Withdrawal occurred is within Territory A, determined in accordance with the Share Forward Purchase Agreement and/or under Section 2.4(b) if the country(ies) in which a Market Withdrawal occurred is(are) Territory A Opt-out Country(ies), determined in accordance with Section 2.12 . Such adjustment shall be a percentage corresponding to the remuneration received by BMS and its Affiliates attributable to the Product(s) which have been the subject of a Market Withdrawal in the country in which such Market Withdrawal occurred divided by the total remuneration received by BMS and its Affiliates for either: (a) Territory A if the country in which a Market Withdrawal occurred is within Territory A (in which case the remuneration received by BMS and its Affiliates shall be understood as the remuneration received by BMS and its Affiliates from JVA (whether through distributions resulting from its share of profits in JVA or royalties)); or (b) Territory A Opt-out Countries if the country in which the Market Withdrawal occurred is a Territory A Opt-out Country, in each case during the four (4) calendar quarters preceding the occurrence of the Market Withdrawal.

“Market Withdrawal Adjustment Resolution Date” has the meaning set forth in Section 2.12(c).

 

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Marketing Entity ” has the meaning set forth under the definition Entité de Marketing in the Règlement Intérieur of JVA.

“Modified Designated Country Structure” has the meaning set forth in Section 8.10(a).

Monetary Claim ” has the meaning set forth in Section 9.1(h)(ii) .

Net Sales ” (with respect to Clopidogrel Product in the U.S.) has the meaning ascribed to it in the Territory B Alliance Support Agreement. For the sake of clarity, the U.S. Pharma Fee will be deducted from such Net Sales in computing the royalties due in 2012 and thereafter under the Territory B Clopidogrel License.

“New Liability Claims” has the meaning set forth in Section 9.1(g).

Notices ” has the meaning set forth in Section 12.1 .

Opt-out Agreements ” means each of the: (a) “Opt-out” Letter dated November 24, 1998, as modified by a letter dated December 15, 1998; (b) “TMC A” Letter Agreement dated November 15, 2006 (Irbesartan in Denmark, Finland, Norway/Iceland, Sweden and Ireland); (c) Letter regarding Change of Commercial Structure for Clopidogrel in Malaysia, dated November 19, 2010; (d) Letter regarding Change of Commercial Structure for Clopidogrel in Singapore, dated December 17, 2010; (e) Letter regarding Change of Commercial Structure for Clopidogrel in Turkey, dated December 17, 2010 and (f) the China Opt-Out Letter.

Opt-out Countries ” means the Territory A Opt-out Countries and the Territory B1 Opt-out Countries.

Outside Date ” means [*].

Party ” or “ Parties ” has the meaning set forth in the Preamble to this Agreement.

Payment Report ” has the meaning set forth in Section 2.11(a) .

Permitted Sublicensees ” means entities: (a) that will be manufacturing, developing or registering Products on behalf of BMS, including pursuant to co-commercialization or co-development agreements (for the purpose of manufacturing, development or registration); or (b) to whom BMS sublicenses a Qualified FDC (but, in the case of this clause (b), only for use with such Qualified FDC).

Person ” means any individual, partnership, firm, corporation, société anonyme , société en nom collectif , societé par actions simplifieé , société en participation , limited liability company, joint venture, association, trust or other entity or any government or any agency or political subdivision thereof, as well as any syndicate or group that would be deemed to be a person under Section 13(d)(3) of the U.S. Securities Exchange Act of 1934, as amended.

“Pharma Activities” has the meaning set forth in Section 9.1(c)(vi).

 

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Plavix Finished Product Supply Agreement ” means the Supply Agreement to be entered into by sanofi-aventis U.S. LLC, as supplier, and JVB, as purchaser, in substantially the form attached hereto as Exhibit 3.3(a)[4] .

Previous SKU ” means a SKU of a Product which, as a result of the implementation of a regulatory change, is no longer approved by the relevant Regulatory Authority but is still authorized for sale during a limited period after the Initial Closing Date.

Purchasing Companies ” means a Party or its Affiliate that is purchasing Products pursuant to Section 2.10(b) .

Products ” means Irbesartan Products and/or Clopidogrel Products.

“Quality Agreement Amendments” has the meaning set forth in Section 3.3(a).

Qualified FDC ” means a BMS Permitted FDC with respect to which either (a) Phase II clinical trials have been completed by BMS and/or its Affiliates or the entities defined in clause (a) of the definition of “Permitted Sublicensees,” or (b) Phase III clinical trials have been commenced by BMS and/or its Affiliates or the entities defined in clause (a) of the definition of “Permitted Sublicensees.”

Regulatory Materials ” means regulatory applications, submissions, dossiers, notifications, registrations, regulatory approvals and/or other filings made to or with, or other approvals granted by, a Governmental Authority that are necessary or reasonably desirable in order to develop, manufacture or commercialize a Product in a particular country or regulatory jurisdiction.

Requisite Competition Law Approval ” means, in respect of a jurisdiction, all antitrust and competition law-related approvals (whether by the consent or waiver of the applicable governmental authorities or the expiration of the applicable waiting periods) necessary or appropriate to be obtained in such jurisdiction in order for the Parties to complete the transactions contemplated under this Agreement, and the relevant local country agreements, and perform their respective obligations hereunder and thereunder.

“Resolution Accounting Firm” has the meaning set forth in Section 2.10(b)(iv).

“Restricted Countries List” has the meaning set forth in Section 6.4.

Sanofi ” has the meaning set forth in the Preamble to this Agreement.

Sanofi JVA Partner ” means Sanofi Participations, a société par actions simplifée à associé unique organized under the laws of the French Republic and an indirect wholly owned subsidiary of Sanofi.

Sanofi Permitted Clopidogrel FDCs ” means an FDC that includes at least the following active ingredients: (a) Clopidogrel and (b) a Sanofi Proprietary Compound.

 

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Sanofi Proprietary Compound ” means any compound that is either owned, in whole or in part, by Sanofi or its Affiliates, or is licensed exclusively or co-exclusively to or by Sanofi or its Affiliates, and, at the time of the initial inclusion of such compound in a combination with Clopidogrel, is covered by one or more claims of a patent or patent application in any country.

“Seller’s Premises” has the meaning set forth in Section 2.10(b)(i).

Selling Companies ” means a Party or its Affiliate that is selling Products pursuant to Section 2.10 .

Settlement Agreement ” means the Settlement Agreement, by and between Sanofi and BMS, dated the date hereof, attached hereto as Exhibit 8.2 .

Share Forward Purchase Agreement ” means the Share Forward Purchase Agreement substantially in the form attached hereto as Exhibit 2.3(h)(vi) .

SKU ” means for each product the Stock Keeping Unit.

“Specified Prior Claims” has the meaning set forth in Section 9.1(a).

Supply Agreements ” has the meaning set forth in Section 3.3(a) .

SWIND ” means Sanofi Winthrop Industrie, an Affiliate of Sanofi and a société anonyme organized under the laws of the French Republic.

Technical Agreement ” has the meaning set forth in Section 5.2(f) .

Termination Date ” means December 31, 2018.

Territory ” means Territory A, Territory B1 or the U.S. (with respect to Irbesartan Products) and, with respect to Schedule 2.10 , as regards each Product in finished and packaged form set forth on Schedule 2.10 , the country indicated in Schedule 2.10 – Column “Territory.”

Territory A ” means the countries set forth on Schedule 1.1(c ).

Territory A Alliance Support Agreement ” means the Territory A Alliance Support Agreement by and between Sanofi and BMS, dated as of January 1, 1997, as amended.

Territory A Alliance Support Agreement Termination Agreement ” means the agreement to terminate the Territory A Alliance Support Agreement, in substantially the form attached hereto as Exhibit 2.3(h)(iv) .

Territory A Clopidogrel License ” means the Clopidogrel Intellectual Property License Agreement, by and between Sanofi and JVA, dated as of January 1, 1997.

Territory A Irbesartan License ” means the Irbesartan Intellectual Property License Agreement, by and between Sanofi and JVA, dated as of January 1, 1997.

 

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Territory A Know-How License ” means the Product Know-How License Agreement, by and between Sanofi, BMS and Sanofi Pharma Bristol-Myers Squibb, dated as of January 1, 1997.

Territory A Opt-out Countries ” mean those countries in Europe, Asia and Africa and their overseas territories (other than countries in Territory A or Japan).

Territory B ” means the U.S. with respect to Clopidogrel.

Territory B Alliance Support Agreement ” means the Territory B Alliance Support Agreement by and between Sanofi and BMS, dated as of January 1, 1997, as amended.

Territory B Clopidogrel License ” means the Territory B Clopidogrel Intellectual Property License and Supply Agreement, by and between JVB and Sanofi, dated as of January 1, 1997.

Territory B Irbesartan License ” means the Territory B Irbesartan Intellectual Property License Agreement, by and between JVB and Sanofi, dated as of January 1, 1997.

Territory B Know-How License ” means the Territory B Product Know-How License Agreement, by and among JVB, Sanofi and BMS, dated as of January 1, 1997.

Territory B1 ” means the countries set forth on Schedule 1.1(d) .

Territory B1 Assignment Agreement ” means the agreement substantially in the form attached hereto as Exhibit 2.1(a)(i) .

Territory B1 Know-How License ” means the Territory B Know-How License, as assigned with respect to Territory B1.

Territory B1 Opt-out Countries ” mean those countries in North and South America and Oceania and their overseas territories (other than the U.S., countries in Territory B1 and Japan).

Third Party ” means any Person or Governmental Authority, in each case that is not an Affiliate of BMS or Sanofi, as the case may be.

“Third Party Claim” has the meaning set forth in Section 9.1(c)(vii).

Toll Packaging Agreement ” means the Toll Packaging Agreement to be entered into by Bristol-Myers Squibb de Mexico, S. de R.L. de C.V., as contractor, and Sanofi-Aventis de Mexico SA de CV, as principal, in substantially the form attached hereto as Exhibit 3.3(a)[5] .

“Transaction Documents” has the meaning set forth in Section 4.1(a).

Transferred Inventory ” means such quantities of Products in finished and packaged form, as determined pursuant to the provisions of Section 2.10 , owned at the Initial Closing Date by each of the relevant Selling Companies, ready for commercial sale in the relevant Territories and which will be transferred to the corresponding Purchasing Company under this Agreement;

 

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provided , however , that Transferred Inventory shall exclude: (i) any quantities of Product in excess of [*] of Estimated Future Sales coverage; (ii) any quantities of Product for which the remaining shelf life is less than [*] measured as of the expected date of sale to wholesalers and/or customers; (iii) any quantities of Previous SKU that, according to the Estimated Future Sales and the date of implementation of the regulatory change, is not saleable under applicable law and/or customary business practices; (iv) any quantities of Product in incomplete or unsealed shipping cases; and (v) any quantities of Product that have been returned by wholesalers or customers.

“Transferred Inventory Purchase Price” has the meaning set forth in Section 2.10(b)(ii).

TUPE and Analogs ” has the meaning set forth in Section 8.4(b) .

Unit Cost ” means the legal entity cost for each SKU of the Products as recorded by the Selling Company. Such Unit Costs shall be communicated by each Selling Company to the corresponding Purchasing Company no later than [*] Days prior to the Initial Closing Date with corresponding relevant documents. The parties agree that, in the case of the countries or jurisdictions listed on Schedule 2.10 hereto, the Unit Cost includes a local country markup equal to the percentage appearing opposite the name of such country or jurisdiction in Schedule 2.10 (the “ Unit Cost Markup Percentage ”).

Unit Cost Markup ” means the amount equal to the Unit Cost of inventory purchased multiplied by the applicable Unit Cost Markup Percentage.

Unit Cost Markup Percentage ” has the meaning set forth in the definition of Unit Cost.

U.S. ” means any State or Commonwealth of the United States of America, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa and any other territory, possession or military base of the United States of America.

U.S. Sanctions Laws ” has the meaning set forth in Section 6.4 .

USIrbeJV ” means Bristol-Myers Squibb Sanofi-Synthelabo Partnership, a Delaware general partnership.

USIrbeJV Acquisition Agreement ” means the agreement substantially in the form attached hereto as Exhibit 2.2(a)(i) .

USIrbeJV Alliance Support Agreement ” means the U.S. Irbesartan Alliance Support Agreement between Sanofi and BMS, dated as of October 17, 2001, as amended.

USIrbeJV Alliance Support Agreement Termination Agreement ” means the agreement to terminate the USIrbeJV Alliance Support Agreement, substantially in the form attached hereto as Exhibit 2.2(a)(iii) .

USIrbeJV Closing ” means the closing of the transactions set forth in Section 2.2 .

 

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USIrbeJV Irbesartan License ” means the Irbesartan Intellectual Property License Agreement by and among Sanofi (as successor to Sanofi-Synthélabo), BMS and USIrbeJV, dated as of October 17, 2001.

USIrbeJV Partnership Agreement ” means the Amended and Restated Partnership Agreement of USIrbeJV dated as of October 17, 2001.

ARTICLE II

RESTRUCTURING OF TERRITORY PARTNERSHIPS AND LOCAL COUNTRY

COMMERCIALIZATION ARRANGEMENTS

2.1 Territory B Partnership .

(a) On the Initial Closing Date:

(i) The Parties shall cause JVB to transfer and assign to sanofi-aventis U.S. LLC, all of JVB’s rights and obligations under each of: (A) the Territory B Clopidogrel License; (B) the Territory B Irbesartan License; and (C) the Territory B Know-How License, in each case solely with respect to Territory B1, pursuant to the Territory B1 Assignment Agreement in substantially the form of Exhibit 2.1(a)(i) attached hereto;

(ii) The Parties shall cause JVB to, and Sanofi shall, amend the Territory B Clopidogrel License, pursuant to the agreement in substantially the form of Exhibit 2.1(a)(ii) attached hereto, to form the Amended and Restated Territory B Clopidogrel License;

(iii) BMS and Sanofi shall, and shall cause JVB to, amend the Territory B Know-How License pursuant to the agreement in substantially the form of Exhibit 2.1(a)(iii) attached hereto, to form the Amended and Restated Territory B Know-How License;

(iv) BMS and Sanofi shall, and shall cause JVB to, amend the assigned portion of the Territory B Know-How License pursuant to the agreement in substantially the form of Exhibit 2.1(a)(iv) attached hereto, to form the Amended and Restated Territory B1 Know-How License;

(v) Sanofi and sanofi-aventis U.S. LLC shall amend the assigned portion of the Territory B Clopidogrel License to form the Amended and Restated Territory B1 Clopidogrel License, such that, among other things, BMS shall no longer be a party thereto; and

(vi) Sanofi and sanofi-aventis U.S. LLC shall amend the assigned portion of the Territory B Irbesartan License to form the Amended and Restated Territory B1 Irbesartan License, such that, among other things, BMS shall no longer be a party thereto;

(vii) Sanofi and BMS shall, and shall cause their relevant Affiliates to, amend the Territory B Alliance Support Agreement and JVB Partnership Agreement to, among other things; (A) consent to the transfer of rights and obligations in Territory B1 to sanofi-aventis

 

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U.S. LLC; (B) reflect the removal of Territory B1 from Territory B; and (C) provide that the term of the Territory B Alliance Support Agreement shall expire on December 10, 2019, pursuant to the agreements in substantially the form of Exhibits 2.1(a)(vii)[1] and 2.1(a)(vii)[2] , respectively, attached hereto;

with the consequence that rights to the Products and associated obligations under such agreements in Territory B1 will be transferred solely to sanofi-aventis U.S. LLC and JVB’s business will remain only with respect to Clopidogrel Product in the U.S.; and

(i) BMS and Sanofi shall execute the FDC Intellectual Property License, in substantially the form attached hereto as Exhibit 1.1(b) .

(b) JVB’s overall remuneration for the transfer to sanofi-aventis U.S. LLC and forbearance of certain rights under the foregoing agreements in Territory B1 will be payment (on a quarterly basis and payable in the following quarter) by sanofi-aventis U.S. LLC to JVB in an amount such that the BMS Partner’s allocable share thereof is equal to the applicable percentage as set forth in Table 2.1(b) below (and subject to the provisions in Sections 2.1(d) and (e)  herein) of IFRS Net Sales in Territory B1 of:

(i) Irbesartan Products; and

(ii) Clopidogrel Products;

in the countries within Territory B1 between the date of the JVB Closing and the Termination Date;

Table 2.1(b)

 

Clopidogrel (% of IFRS Net Sales):

     2013       2014       2015       2016       2017       2018  
   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

 

Irbesartan (% of IFRS Net Sales):

     2013       2014       2015       2016       2017       2018  
   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

which percentages shall not be subject to any generic penetration/market share or parallel trade adjustments (and any changes in such percentages in Table 2.1(b) above from one year to the next shall be with effect as of January 1 of the year in which the new percentage applies). The remuneration amount shall be declared in Euros based on IFRS Net Sales and shall be paid to JVB in U.S. dollars and converted from Euros to U.S. dollars at the Designated Exchange Rate applicable for the month in which the payment is made.

 

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(c) Following the JVB Closing, the Parties shall record such payments in a separate account of JVB and shall endeavor in accordance with applicable law to cause JVB to make distributions of such amounts in accordance with each Party’s respective allocable ownership interest in JVB at or promptly after the time such payments are made to JVB.

(d) Sanofi and BMS (or their respective Affiliates), as applicable, shall continue to receive the amounts of the royalties (on a quarterly basis and payable in the following quarter) in accordance with the terms and provisions of the Amended and Restated Territory B1 Clopidogrel License, the Amended and Restated Territory B1 Irbesartan License and the Amended and Restated Territory B1 Know-How License, from sanofi-aventis U.S. LLC; provided , that with respect to Territory B1, the amounts of payments contemplated in the table above shall be reduced by the royalty paid by sanofi-aventis U.S. LLC to BMS under the Amended and Restated Territory B1 Know-How License.

(e) For the avoidance of doubt, remuneration based on the sale of Generic Products in Territory B1 shall be as provided in Section 2.5 and remuneration based on sales of the Products in Territory B1 Opt-out Countries shall be as provided in Section 2.4 .

(f) Sanofi or an Affiliate designated by Sanofi shall purchase JVB’s inventory of Products for Territory B1 at the Initial Closing Date for a purchase price (payable in U.S. dollars) equal to the Unit Cost of such inventory as further described in Section 2.10 .

(g) BMS’s interest in the amount of profit recorded by JVB prior to the JVB Closing pursuant to the Alliance Agreements in respect of Products comprised in any inventory on the JVB Closing related to Territory B1 (whether such inventory is owned by local Co-Promotion partnerships in Territory B1 and/or local Co-Marketing Affiliates of BMS in Territory B1) and transferred to Sanofi or its Affiliates pursuant to Section 2.1(j) shall be deducted until fully recouped (without double counting) from the remuneration ultimately due to BMS contemplated in Table 2.1(b) above; provided that such deduction shall be limited to the extent of BMS’s interest in the JVB profits attributable to Territory B1 sales, in a manner consistent with past practice for opt-out countries.

(h) The following actions shall be taken as of the JVB Closing, in each case, subject to the receipt of any Requisite Competition Law Approval in a given country in Territory B1:

(i) Sanofi and BMS and their respective Affiliates shall cause (A) Sanofi and its Affiliates to assume control of the distribution and commercialization of the Products in Territory B1 and have control over all decisions relating to distribution, commercialization and medical affairs of the Products in Territory B1, in each case, subject to the receipt of any Requisite Competition Law Approval in a given country in Territory B1; and (B) BMS and its Affiliates to cease all distribution, commercialization and medical affairs of the Products existing at the JVB Closing in Territory B1;

 

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(ii) The existing Co-Promotion distribution agreements in Territory B1 between JVB and the local Co-Promotion partnerships shall be terminated by mutual agreement of all of the parties to each such agreement pursuant to agreements prepared in accordance with Exhibit 2.1(h)(ii) attached hereto. No Products shall continue to be sold through such partnerships (with respect to Territory B1) after the JVB Closing;

(iii) The existing Co-Marketing distribution agreements in Territory B1 between JVB and local BMS entities and between JVB and local Sanofi entities shall be terminated by mutual agreement of all the parties to each such agreement pursuant to agreements prepared in accordance with Exhibit 2.1(h)(iii) attached hereto. As necessary, the Affiliates of Sanofi and BMS shall enter into transitional distribution agreements as described in Section 2 of Exhibit 2.1(h)(iii) attached hereto, to undertake an orderly transition pending the transfer of local Product registrations; and

(iv) The existing Marketing and Operating Services Agreements in Territory B1 by and among the local Co-Promotion partnerships, the local BMS entities and the local Sanofi entities shall be terminated by mutual agreement of all the parties to each such agreement pursuant to the agreements prepared in accordance with Exhibit 2.1(h)(iv) .

(i) The local country Co-Promotion partnerships (or similar vehicles) in Territory B1 shall be wound up in an orderly manner pursuant to agreed upon principles set forth on Exhibit 2.1(i) attached hereto and in accordance with Article 12 ( i.e ., “Termination”) of the applicable partnership agreement. Notwithstanding the foregoing, the Parties shall maintain, as of the Initial Closing Date and for such longer period as is necessary, the legal existence of any such local country Co-Promotion partnership (or similar vehicle) as a non-operating entity for the sole purpose of participating in, and preserving the rights of the Parties or any of their Affiliates with respect to, any litigation involving such local country Co-Promotion partnership (or similar vehicle). The Parties agree to determine prior to the Initial Closing Date which local country Co-Promotion partnerships (or similar vehicles) will survive in accordance with the foregoing sentence.

(j) Inventory held by either the local country Co-Promotion partnerships (or similar vehicles) or by the local BMS Co-Marketing entities in Territory B1 shall be sold by the entity (for a purchase price payable in the local currency of the applicable country) which legally owns such inventory to relevant Affiliates of Sanofi pursuant to the terms of Section 2.10 .

(k) In connection with the wind-up and termination of the local country Co-Promotion partnerships or any deemed buy-out of a BMS local country Affiliate’s interest in the Products where Co-Marketing occurs, except as expressly provided below, neither Party shall be obligated to indemnify the other [*]. If any such wind-up and termination is challenged or a buy-out transaction is deemed to have taken place [*], regardless of whether a Product was commercialized through Co-Promotion or Co-Marketing. In Co-Promotion countries, if BMS and Sanofi (on behalf of the local JVB-related entity) prevail, then the matter shall be deemed closed; [*]

 

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The foregoing shall apply equally to the local country Co-Promotion partnership entities and the local Affiliates engaged in Co-Marketing, and shall not apply to any other liability coverage or issue (which shall be governed by Article IX ) and shall be strictly limited to the [*] for local country [*].

(l) BMS and Sanofi agree that a timely election pursuant to U.S. Internal Revenue Code Section 754 will be made with the JVB tax return for the taxable year in which the JVB interest is transferred.

(m) On the Initial Closing Date, BMS and Sanofi agree to execute an amendment (the “ Cash Flow Principles Amendment ”), substantially in the form attached hereto as Exhibit 2.1(m) , to the BMS/Sanofi Joint Venture Summary of Cash Flow Principles, approved on December 11, 1997 (“ Cash Flow Principles ”), to: (1) terminate the Cash Flow Principles with respect to Territory B1 and Territory A and (2) change Section 4 thereof as to Co-Promotion partnerships from monthly to quarterly.

(n) The Unit Cost Markup of Transferred Inventory in countries in Territory B1 shall be deducted until fully recouped from the remuneration ultimately due to BMS contemplated in Table 2.1(b) .

2.2 U.S. Irbesartan Partnership .

(a) On the Initial Closing Date:

(i) Pursuant to the USIrbeJV Acquisition Agreement substantially in the form of Exhibit 2.2(a)(i) attached hereto, BMS shall cause its Affiliate to sell, assign and transfer, and Sanofi shall cause sanofi-aventis U.S. LLC to purchase and acquire, BMS’s 50.1% interest in USIrbeJV.

(ii) Sanofi and BMS and their respective Affiliates shall cause Sanofi and its Affiliates to assume control of, and BMS to cease, activities relating to the distribution, commercialization and medical affairs of the Irbesartan Products existing at the USIrbeJV Closing and any other activities currently handled by BMS under the Avapro Simplification Agreement;

(iii) Sanofi and BMS shall cause their respective Affiliates to terminate the USIrbeJV Alliance Support Agreement, pursuant to the agreement attached hereto substantially in the form of Exhibit 2.2(a)(iii) .

(iv) Sanofi and BMS shall cause their respective Affiliates to amend the USIrbeJV Partnership Agreement, pursuant to the agreement attached hereto substantially in the form of Exhibit 2.2(a)(iv) .

 

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(b) BMS’s overall remuneration for the sale of its interest in USIrbeJV, forbearance of certain rights under the Alliance Agreements relating to USIrbeJV, and continuing use of the BMS Brands in accordance with Article VI hereof, shall consist of (i) the payment set forth in subsection (e) below, and (ii) payment (on a quarterly basis and payable in the following quarter) of the applicable percentage (as set forth in Table 2.2(b) below and subject to the provisions of Sections 2.2(c) and (d)  herein) of IFRS Net Sales in the U.S. of Irbesartan Products between the Initial Closing Date and the Termination Date. Such payment will be made to such U.S.-organized BMS Affiliate as designated by BMS as follows:

Table 2.2(b)

 

Irbesartan (% of IFRS Net Sales):

     2013       2014       2015       2016       2017       2018  
   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

which percentages shall not be subject to any generic penetration/market share or parallel trade adjustments (and any changes in such percentages in Table 2.2(b) above from one year to the next shall be with effect as of January 1 of the year in which the new percentage applies). The remuneration amount shall be declared in Euros based on IFRS Net Sales and shall be paid to BMS in USD and converted from Euros to USD at the Designated Exchange Rate applicable for the month in which payment is made.

(c) BMS and Sanofi (or their respective Affiliates), as applicable, shall continue to receive from USIrbeJV the amounts of royalties (on a quarterly basis and payable in the following quarter) in accordance with the terms and provisions of the Amended and Restated USIrbeJV Irbesartan License, which is attached hereto substantially in the form of Exhibit 2.2(c) . The amounts of payments contemplated in Table 2.2(b) shall be reduced by the royalty paid by USIrbeJV to BMS under the Amended and Restated USIrbeJV Irbesartan License.

(d) For the avoidance of doubt, remuneration based on the sale of Irbesartan Generic Products in the U.S. shall be as provided in Section 2.5 .

(e) The initial portion of the purchase price payable on the USIrbeJV Closing for the sale of BMS’s interest in USIrbeJV shall be the Unit Cost with respect to BMS’s share of the inventory owned by USIrbeJV at the USIrbeJV Closing, denominated in U.S. dollars, pursuant to Section 2.10 .

(f) BMS and Sanofi agree that a timely election pursuant to U.S. Internal Revenue Code Section 754 will be made with the USIrbeJV tax return for the taxable year in which USIrbeJV interest is transferred.

(g) The existing distribution agreement between USIrbeJV and the local Co-Promotion partnership in Puerto Rico shall be terminated by mutual agreement of all of the parties to such agreement pursuant to an agreement prepared in accordance with Exhibit 2.1(h)(ii) attached hereto. No Products shall continue to be sold through such partnership in Puerto Rico after the USIrbeJV Closing.

 

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2.3 Territory A Partnership .

(a) On the Initial Closing Date, the Parties shall cause JVA to lease the business ( location-gérance ) of JVA to SWIND, so that SWIND shall benefit from the rights to produce, distribute and commercialize the Products. In return for such lease, SWIND shall pay to JVA a lease payment (the “ Lease Payment ”) in accordance with the terms of the agreement (the “ Business Lease ”) substantially in the form of Exhibit 2.3(a)(i) attached hereto, which Lease Payment shall constitute the income of JVA and therefore be included in the distributable profits to be distributed to the current JVA members in accordance with their respective ownership interests. Such distributions will be made in Euros on a quarterly basis and paid in the second month of the following quarter.

(b) The Lease Payment shall be determined so that it is the sum of (x) royalty payable pursuant to the Amended and Restated Territory A Clopidogrel License, the Amended and Restated Territory A Irbesartan License and the Amended and Restated Territory A Know-How License plus (y) an amount, such that the BMS JVA Partner’s total allocable share in the distribution of associated profits of JVA corresponds to the applicable percentage (as set forth in Table 2.3(b) below and subject to the provisions of Sections 2.3(c) and (d) ) of IFRS Net Sales of:

(i) Irbesartan Products; and

(ii) Clopidogrel Products;

in each case, in the countries within Territory A between the date of the JVA Closing and the Termination Date.

Table 2.3(b)

 

Clopidogrel (% of IFRS Net Sales):

     2013       2014       2015       2016       2017       2018  
   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

 

Irbesartan (% of IFRS Net Sales):

     2013       2014       2015       2016       2017       2018  
   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

which percentages shall not be subject to any generic penetration/market share or parallel trade adjustments.

 

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(c) BMS and Sanofi, as applicable, shall continue to receive the amounts of the royalties (on a quarterly basis and payable in the following quarter) in accordance with the terms and provisions of the Amended and Restated Territory A Clopidogrel License, the Amended and Restated Territory A Irbesartan License, and the Amended and Restated Territory A Know-How License, from JVA; provided , that the amounts of payments contemplated in the table above shall be reduced by the royalty paid by JVA to BMS under the Amended and Restated Territory A Know-How License. Sanofi shall cause SWIND to provide JVA with the funds necessary to pay any discovery or know-how royalty due to Sanofi, and BMS shall not be responsible for funding such payment.

(d) For the avoidance of doubt, remuneration based on the sale of Generic Products in Territory A shall be as provided in Section 2.5 and remuneration based on sales of the Products in Territory A Opt-out countries shall be as provided in Section 2.4 .

(e) The purchase price payable on the Initial Closing Date for the inventory owned by JVA to be sold to SWIND shall equal the Unit Cost (payable in Euros) for such inventory, pursuant to the terms set forth in Section 2.10 .

(f) BMS’s interest in the amount of profit recorded by JVA prior to the JVA Closing pursuant to the Alliance Agreements in respect of Products comprised in any inventory on the JVA Closing (whether such inventory is owned by Territory A local Co-Promotion partnerships and/or Territory A local Co-Marketing Affiliates of BMS) and transferred to Sanofi or its Affiliates pursuant to Section 2.3(j) ), shall be deducted until fully recouped (without double counting) from the remuneration ultimately due to BMS in Table 2.3(b) above; provided that such deduction shall be limited to the extent of BMS’s interest in the JVA profits, and the calculation of such deduction shall be made in a manner consistent with past practice. Prior to the JVA Closing, Sanofi shall provide BMS with a good-faith estimate of such profits, and BMS shall have an opportunity to review such estimate.

(g) Pursuant to the Share Forward Purchase Agreement to be delivered at the Initial Closing Date, Sanofi’s Affiliate shall be required to acquire, and the BMS JVA Partner shall be required to sell, the BMS JVA Partner’s interest in JVA, using either a new Sanofi entity organized and resident in France for tax purposes or the existing JVA Sanofi Partner, on the Termination Date, or if the Termination Date is not a Business Day, on the first Business Day following the Termination Date, for a purchase price payable at such date for such interest equal to an amount equal to 70 million Euros, minus the Market Withdrawal Adjustment (if any), in each case being calculated as provided in the Share Forward Purchase Agreement. [*] which may be due and payable on the JVA Closing Date and/or the Termination Date shall be shared equally between the seller and the purchaser of the shares of JVA.

(h) On the Initial Closing Date:

(i) Sanofi and BMS and their respective Affiliates shall cause: (A) Sanofi and its Affiliates to assume control of the distribution and commercialization of the Products in Territory A and have control over all decisions relating to distribution, commercialization and medical affairs of the Products in Territory A, in each case, subject to the

 

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receipt of any Requisite Competition Law Approval in a given country in Territory A; and (B) BMS and its Affiliates to cease all distribution, commercialization and medical affairs of the Products existing at the JVA Closing in Territory A;

(ii) Sanofi shall, and BMS and Sanofi shall cause JVA to, amend the Territory A Clopidogrel License and the Territory A Irbesartan License, pursuant to the agreements substantially in the forms of Exhibits 2.3(h)(ii)[1] and 2.3(h)(ii)[2] , respectively, attached hereto;

(iii) BMS and Sanofi shall, and shall cause JVA to, amend the Territory A Know-How License, pursuant to the agreement substantially in the form of Exhibit 2.3(h)(iii) attached hereto;

(iv) BMS and Sanofi shall, and shall cause their respective Affiliates to, terminate the Territory A Alliance Support Agreement, as amended, pursuant to the agreement substantially in the form attached hereto as Exhibit 2.3(h)(iv) ;

(v) BMS and Sanofi shall cause their respective Affiliates to amend and restate the statuts and Règlement Intérieur of JVA in substantially the forms attached hereto as Exhibits 2.3(h)(v)[1] and (h)(v)[2] , respectively;

(vi) BMS and Sanofi shall cause their respective Affiliates to execute the Share Forward Purchase Agreement in substantially the form attached hereto as Exhibit 2.3(h)(vi) .

(vii) The existing Co-Promotion distribution agreements in Territory A between JVA and the local Co-Promotion partnerships (or the local Affiliates of BMS or Sanofi, as applicable) shall be terminated by mutual agreement of all of the parties to each such agreement pursuant to agreements prepared in accordance with Exhibit 2.1(h)(ii) attached hereto. No Products shall continue to be sold through such partnerships (with respect to Territory A) after the JVA Closing;

(viii) The existing Co-Marketing distribution agreements in Territory A between JVA and local BMS entities and between JVA and local Sanofi entities shall be terminated by mutual agreement of all the parties to each such agreement pursuant to agreements prepared in accordance with Exhibit 2.1(h)(iii) . As necessary, the Affiliates of Sanofi and BMS shall enter into transitional distribution agreements as described in Section 2 of Exhibit 2.1(h)(iii) attached hereto, to undertake an orderly transition pending for the transfer of local Product registrations;

(ix) The existing Marketing and Operating Services Agreements in Territory A by and among the local Co-Promotion partnerships, the local BMS entities and the local Sanofi entities shall be terminated by mutual agreement of all of the parties to each such agreement pursuant to agreements prepared in accordance with Exhibit 2.1(h)(iv) ; and

 

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(x) BMS and Sanofi shall execute the FDC Intellectual Property License, in substantially the form attached hereto as Exhibit 1.1(b).

(i) The local country Co-Promotion partnerships (or similar vehicles) in Territory A shall be wound up in an orderly manner pursuant to agreed-upon principles set forth on Exhibit 2.1(i) attached hereto and in accordance with Article 12 ( i.e ., “Termination”) of the applicable partnership agreement. Notwithstanding the foregoing, the Parties shall maintain, as of the Initial Closing Date and for such longer period as is necessary, the legal existence of any such local country Co-Promotion partnership (or similar vehicle) as a non-operating entity for the sole purpose of participating in, and preserving the rights of the Parties or any of their Affiliates with respect to, any litigation involving such local country Co-Promotion partnership (or similar vehicle). The Parties agree to determine prior to the Initial Closing Date which local country Co-Promotion partnerships (or similar vehicles) will survive in accordance with the foregoing sentence.

(j) Inventory held by either the local country Co-Promotion partnerships (or similar vehicles) or by the local BMS Co-Marketing entities in Territory A shall be sold by the entity (for a purchase price payable in the local currency of the applicable country) which legally owns such inventory to relevant Affiliates of Sanofi pursuant to the terms of Section 2.10 .

(k) In connection with the wind-up and termination of the local country Co-Promotion partnerships or any deemed buy-out of a BMS local country Affiliate’s interest in the Products where Co-Marketing occurs, except as expressly provided below neither Party shall be obligated to indemnify the other [*]. If any such wind-up and termination is challenged or a buy-out transaction is deemed to have taken place by [*], regardless of whether a Product was commercialized through Co-Promotion or Co-Marketing. In Co-Promotion countries, if BMS and Sanofi (on behalf of the local JVA-related entity) prevail, then the matter shall be deemed closed; [*] The foregoing shall apply equally to the local country Co-Promotion partnership entities and the local Affiliates engaged in Co-Marketing, and shall not apply to any other liability coverage or issue (which shall be governed by Article IX) and shall be strictly limited to the [*] for local country [*].

(l) After the Initial Closing Date, Sanofi agrees not, to the extent within its control, to impose any new costs or liabilities on JVA that would have the result of reducing the distributions to the JVA members in accordance with Section 2.3(a) .

(m) Each of BMS and Sanofi agree that it shall neither dissolve or liquidate nor permit to be dissolved or liquidated the BMS JVA Partner or the Sanofi JVA Partner, respectively, prior to the Termination Date, nor shall it take or permit to be taken any act which could negatively affect the full unencumbered ownership by the BMS JVA Partner or the Sanofi JVA Partner of their respective interests in JVA at any time prior to the Termination Date.

 

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(n) The Unit Cost Markup of Transferred Inventory in countries of Territory A shall be deducted until fully recouped from the remuneration ultimately due to BMS contemplated in Table 2.3(b) .

2.4 Opt-out Agreements .

(a) Other than as set forth in this Section 2.4(a) , the Opt-out Agreements shall remain in full force and effect in accordance with their current terms; provided, however, that the Opt-out Agreements are hereby amended, as of the Initial Closing Date, to: (i) replace the rates payable under them with the corresponding rates set out in Table 2.4(a) below for Territory A Opt-out Countries and/or Territory B1 Opt-out Countries; and (ii) replace any termination or expiration date referenced in such Opt-out Agreements with the Termination Date. For the avoidance of doubt, any indemnification and related damages payable to BMS thereunder shall continue and survive the Termination Date and remain in place and are not affected hereby. In addition, any Territory A Opt-out Countries and Territory B1 Opt-out Countries for which a Product is not subject to an Opt-out Agreement are hereby confirmed to be “opt-out” countries consistent with past practice for such Product with remuneration payable under this Section 2.4 for such Products sold in such countries (other than any of the countries listed on Schedule 6.4 , which Schedule 6.4 shall be deemed to be amended to include any country identified pursuant to the second sentence of Section 6.4 , for which remuneration is not due to BMS). With respect to Territory A Opt-out Countries, a termination payment shall be made on the Termination Date pursuant to Section 2.4(b) below.

Table 2.4(a)

Territory A Opt-out Countries:

 

Clopidogrel Products (% of IFRS Net Sales):

     2013       2014       2015       2016       2017       2018  

China:

   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

Turkey, Malaysia, Singapore:

   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

Other Territory A Opt-out Countries:

   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

 

Irbesartan Products (% of IFRS Net Sales):

     2013       2014       2015       2016       2017       2018  
   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

 

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Territory B1 Opt-out Countries:

 

Clopidogrel Products (% of IFRS Net Sales):

     2013       2014       2015       2016       2017       2018  
   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

 

Irbesartan Products (% of IFRS Net Sales):

     2013       2014       2015       2016       2017       2018  
   [*]%   [*]%   [*]%   [*]%   [*]%   [*]%

Notwithstanding the terms of the Opt-out Agreements, the applicable rates shall not be subject to any generic penetration/market share or parallel trade adjustments (and any changes in such percentages in Table 2.4(a) above from one year to the next shall be with effect as of January 1 of the applicable year). Payments required pursuant to this Section 2.4(a) shall be paid in Euros.

(b) Upon the termination of the Opt-out Agreements for Territory A Opt-out Countries pursuant to Section 2.4(a) above, Sanofi shall pay on the Termination Date, or if the Termination Date is not a Business Day, the first Business Day following the Termination Date, a termination lump sum of an amount in Dollars equal to (a) $200 million minus (b) the Market Withdrawal Adjustment (if any) calculated under Section 2.12 and minus (c) 70 million Euros converted into Dollars at the spot rate of exchange on December 31, 2018 using the fixing rate published by the European Central Bank which appears on the Bloomberg page EUCFUSD Index or whichever page may be substituted therefor (or, should the European Central Bank not make the rate available to Bloomberg for publication on December 31, 2018, the relevant rate shall be the one applicable for the immediate succeeding Business Day).

2.5 Autogenerics and Other Sanofi Generic Products .

(a) A specific royalty rate shall be payable by Sanofi to BMS (or to E.R. Squibb & Sons LLC with respect to the U.S. autogeneric Irbesartan Products) (on a quarterly basis and payable in the following quarter) on IFRS Net Sales of generic products with Clopidogrel as the sole active ingredient, Clopidogrel with acetylsalicylic acid as the sole active ingredients, Irbesartan as the sole active ingredient, and Irbesartan with Hydrochlorothiazide as the sole active ingredients in each case, in finished form, sold by Sanofi or its Affiliates or their licensees (collectively, “ Generic Products ”) from the Initial Closing Date until the Termination Date (and any other termination or expiration date referenced in an Autogeneric Agreement shall be deemed to be replaced with the Termination Date), as follows:

 

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(i) No royalty paid for Clopidogrel Generic Products in the European Union (the “ EU ”) and Switzerland. For the avoidance of doubt, no royalty shall be paid for Clopidogrel Generic Products in a country that is added to or exits from the EU unless, with respect to a country that is added to the EU, a royalty rate was paid prior to its addition, in which case the royalty rate shall be maintained.

(ii) Clopidogrel (mono and combo) Generic Products in Australia: [*]% of IFRS Net Sales.

(iii) U.S. Irbesartan Generic Products: [*]% of IFRS Net Sales.

(iv) EU Irbesartan (mono and combo) Generic Products: [*]% of IFRS Net Sales.

(v) Clopidogrel Generic Products in Mexico: [*]% of IFRS Net Sales.

(vi) Zentiva Clopidogrel Generic Products (Pingel ® ) in Turkey: [*]% of IFRS Net Sales.

(vii) Medley Clopidogrel Generic Products (Brazil): [*]% of IFRS Net Sales.

(viii) Zentiva Clopidogrel Generic Products (Trombex ® ) in Eastern Europe: [*]% of IFRS Net Sales.

(ix) Irbesartan (mono and combo) Generic Products in Australia, if any: rate applicable to the Irbesartan Products in Territory B1 (as reflected on Table 2.1(b) ).

(x) Irbesartan (mono and combo) Generic Products in Mexico, if any: rate applicable to the Irbesartan Products in Territory B1 (as reflected on Table 2.1(b) ).

(xi) All Generic Products acquired by Sanofi from a Third Party from and after the Initial Closing Date until the Termination Date (including (a) Generic Products in the territories and of the compounds described in clauses (i) through (x) above acquired from and after the Initial Closing Date and (b) any acquired business or product line then selling products with Clopidogrel as the sole active ingredient, Clopidogrel with acetylsalicylic acid as the sole active ingredients, Irbesartan as the sole active ingredient, and Irbesartan with Hydrochlorothiazide as the sole active ingredients, in each case, in finished form): that percentage of IFRS Net Sales equal to the rate resulting from the following formula = (A) + (B), where:

 

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A = (Baseline Net Sales) x (the [*] of (i) [*]% or (ii) in respect of sales in Territory A, the rate set forth in Section 2.3 , in respect of sales in Opt-out Countries, the rate set forth in Section 2.4 , and in respect of sales in Territory B1, the rate set forth in Section 2.1 , in each case that is applicable in the corresponding country(ies)); and

B = (Actual IFRS Net Sales – Baseline Net Sales) x (in respect of sales in Territory A, the rate set forth in Section 2.3 , in respect of sales in Opt-out Countries, the rate set forth in Section 2.4, and in respect of sales in Territory B1, the rate set forth in Section 2.1 , in each case that is applicable in the corresponding country(ies)).

Baseline = [*] of IFRS Net Sales of such acquired Generic Product(s) in the relevant country(ies) immediately preceding the date on which Sanofi acquired the Generic Product(s) (“ Baseline Net Sales ”).

If the Actual IFRS Net Sales are below the Baseline Net Sales, then the royalty rate shall be deemed to be the lower of (i) [*]% or (ii) in respect of sales in Territory A the rate set forth in Section 2.3 , in respect of sales in Opt-out Countries, the rate set forth in Section 2.4 , and in respect of sales in Territory B1, the rate set forth in Section 2.1 , in each case that is applicable in the corresponding country(ies). Sanofi shall begin to include sales of Generic Products acquired by Sanofi under clause (xi) above in IFRS Net Sales on which remuneration is paid hereunder on the later of (y) the date on which Sanofi acquired the Generic Products and (z) the date on which Sanofi consolidates the acquired business or product line in its financial reports so long as such date is not greater than thirty (30) days after the acquisition date.

Notwithstanding the foregoing, if, after the Initial Closing Date, Sanofi or any of its Affiliates acquires a business, or acquires or combines with a Person, which, at the time of such acquisition or combination, makes, sells, promotes or otherwise commercializes (i) a Generic Product containing Irbesartan or Clopidogrel outside of the U.S. or (ii) a Generic Product containing Irbesartan in the U.S. and Sanofi and its Affiliates disposes of the relevant portion of the business or securities of the Person which undertakes the foregoing activity within [*] after the completion of such acquisition or combination, then [*] shall be paid by Sanofi to BMS with respect to such Generic Product for the period of time from the date of such acquisition or combination until the disposal.

(xii) For all Generic Products (except for those covered in clauses (i) through (x) above, which shall be paid at the rates set forth therein) developed or launched by Sanofi from and after the Initial Closing Date until the Termination Date: the rate shall be the [*] of (A) [*]% or (B): (i) in respect of sales in Territory A, the rate set forth in Section 2.3 ; (ii) in respect of sales in Opt-out Countries, the rate set forth in Section 2.4 ; and (iii) in respect of sales in Territory B1, the rate set forth in Section 2.1 , in each case that is applicable in the corresponding country(ies).

 

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(b) [*] or other compensation (including any payments in respect of terminal value) will be due under the Autogeneric Agreements with respect to periods following the Termination Date. For the avoidance of doubt, any indemnification obligations and related damages payable to BMS thereunder shall survive the Termination Date and remain in place and are not affected hereby. The Autogeneric Agreements shall be amended hereby to: (i) replace any termination or expiration date referenced therein with the Termination Date, (ii) delete any provisions requiring the payment of terminal value and (iii) with respect to the Irbesartan Autogenerics Agreement, dated July 30, 2012, delete BMS’s prior approval to launch Irbesartan with Hydrochlorothiazide after the Initial Closing Date. All payments required to be made pursuant to this Section 2.5 shall be made in Euros, except that all such payments in respect of sales of Irbesartan Generic Product in the U.S. shall be made in U.S. Dollars.

2.6 Clinical Trial Supplies . With respect to clinical trial supplies, the applicable percentage of IFRS Net Sales for clinical supplies of Irbesartan Products or Clopidogrel Products (that is payable by Sanofi to BMS) shall be the relevant percentage of IFRS Net Sales as provided in Sections 2.1, 2.2, 2.3 or 2.4 that is applicable in the country of the relevant purchaser ( i.e ., the invoiced legal entity) of such clinical supplies.

2.7 Initial Closing .

(a) The Initial Closing Date shall take place at 10:00 a.m., Eastern time, on the second (2 nd ) Business Day following the satisfaction or waiver of the conditions set forth in Article X at the offices of Wilmer Cutler Pickering Hale and Dorr LLP, 7 World Trade Center, New York, New York 10007 (or remotely via the exchange of facsimile or “.pdf” signature pages with originals to follow). The Parties acknowledge that individual documents may be executed and delivered in other locations.

2.8 Initial Closing Date Deliveries .

(a) On the Initial Closing Date, each of the Parties shall deliver or cause to be delivered to the other Party all of the following, and in the case of executed agreements, documents or instruments, in each case executed by a duly authorized representative of such Party or such Party’s Affiliate(s) on such Party’s or its Affiliate’s behalf:

(i) Each of the Closing Date Agreements set forth on Schedule 1.1(a) .

(ii) Each of the applicable local agreements referenced in Sections 2.1(h)-(i) , Section 2.2(g) and Sections 2.3(h)-(i)  pursuant to agreements prepared in accordance with Exhibits 2.1(h)(ii) through 2.1(i) , as applicable, for each country in Territory B1 and Territory A, in each case other than for each Designated Country, and Puerto Rico, as applicable.

(b) On the Initial Closing Date, BMS shall perform or deliver or cause to be delivered to Sanofi, in each case executed by a duly authorized representative of BMS or BMS’s Affiliate(s) on BMS or its Affiliate’s behalf, certificate(s) representing BMS’s USIrbeJV interests acquired by sanofi-aventis U.S. LLC pursuant to the USIrbeJV Acquisition Agreement.

 

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2.9 Additional Closing Deliveries .

(a) After the Initial Closing Date, if a Requisite Competition Law Approval has been obtained prior to [*] for a Designated Country, Additional Closings shall occur on a country-by-country and quarterly basis, as applicable, in accordance with Section 8.10 .

(b) On the date of each Additional Closing, each of the Parties shall deliver or cause to be delivered to the other Party all of the following, and in the case of executed agreements, documents or instruments, in each case executed by a duly authorized representative of such Party or such Party’s Affiliate(s) on such Party’s or its Affiliate’s behalf:

(i) Evidence of receipt of the Requisite Competition Law Approval with respect to such country; and

(ii) Each of the applicable local agreements referenced in Sections 2.1(h)-(i) , Section 2.2(g) and Sections 2.3(h)-(i)  pursuant to agreements prepared in accordance with Exhibits 2.1(h)-(i) , as applicable, for the applicable country in Territory B1 or Territory A, which, in each case, shall be modified as necessary to apply to an Additional Closing.

2.10 Inventory Purchase .

(a) Information on Transferred Inventory. Schedule 2.10 – Part A Column “Estimated Inventory as of Initial Closing Date” contains an indicative list of the quantities of each Product in finished and packaged form in each Territory listed in Schedule 2.10 – Part A Column “Country,” as of the Initial Closing Date. No later than the [*] Day prior to the Initial Closing Date, the Parties shall agree upon Estimated Future Sales, 1 and BMS shall communicate to Sanofi an updated list of each Product (outlining Previous SKUs, if any) that BMS estimates to constitute Transferred Inventory on the Initial Closing Date, for each Territory. Such list shall be made available to Sanofi for information purposes only.

(b) Purchase and Sale of Inventory with Physical Transfer of the Inventory from the Location of an Affiliate of BMS to the Location of an Affiliate of Sanofi . Upon the terms and subject to the conditions of this Agreement, on the Initial Closing Date, BMS shall cause its Affiliates listed in Schedule 2.10 – Part A Column “Selling Companies” (the “ Selling Companies ”) to sell, transfer, and assign to the Affiliates of Sanofi listed in Schedule 2.10 – Part A Column “Purchasing Companies” (the “ Purchasing Companies ”) and Sanofi shall cause the Purchasing Companies to acquire and assume from the Selling Companies all right, title, and interest of the Selling Companies in the Transferred Inventory, in accordance with the following provisions.

 

 

1 Such Estimated Future Sales will be based on the estimated quantities set forth in Schedule 2.10 plus pending orders minus projected sales until Initial Closing Date.

 

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(i) The location of the Transferred Inventory in each Territory is set forth on Schedule 2.10 – Part A Column “Seller’s Premises” (the “ Seller’s Premises ”). As soon as practicable following the Initial Closing Date and no later than the [*] Day following the Initial Closing Date, the relevant Selling Company and Purchasing Company shall commonly perform a physical stock-take of the Transferred Inventory at the Seller’s Premises, and each Selling Company shall make available within [*] Days to the Purchasing Company the Transferred Inventory in accordance with Ex-Works Incoterms 2010 at the relevant Selling Company.

(ii) Within [*] Days following the date of the physical stock-take, the relevant Purchasing Company shall notify the Selling Company in writing regarding (a) the quantities of Products actually delivered to the Purchasing Company, it being specified that the Purchasing Company shall be entitled to return for each Product any quantities of such Product that do not meet the definition of Transferred Inventory and that such quantities of Products returned to the Selling Company (at the Selling Company’s sole expense) shall not be included in the Transferred Inventory and (b) the aggregate valuation of the Transferred Inventory calculated by multiplying (i) the Unit Cost of each item of the Transferred Inventory by (ii) the quantity of each item of such Transferred Inventory (the aggregate value of all such multiplications hereinafter the “ Transferred Inventory Purchase Price ”).

(iii) The Selling Company shall have the right to review all working papers and procedures used to determine the Transferred Inventory Purchase Price. Unless, within [*] Days after delivery of the notification referred to the paragraph (b) above, the Selling Company notifies to the Purchasing Company in writing that it objects to the Purchasing Company’s determination of the Transferred Inventory Purchase Price, then the Selling Company shall issue an invoice equal to the Transferred Inventory Purchase Price, plus VAT (or other similar taxes), as applicable, and, upon receipt, the Purchasing Company shall pay the amount of such invoice to the Selling Company by wire transfer of immediately available funds to the account indicated by the Selling Company within [*] Days following the receipt of such invoice.

(iv) In the event the Parties fail to agree on the Transferred Inventory Purchase Price within [*] Business Days after the notification referred to in Paragraph (c) above has been given, all remaining matters in dispute shall be submitted to the office of an internationally reputed accounting firm (other than the auditors of either Party) (the “ Resolution Accounting Firm ”). In the event the Parties are unable to agree upon the selection of the Resolution Accounting Firm within [*] Days after expiration of the [*] Day period referred to above, the Resolution Accounting Firm shall be appointed by the International Center for Expertise of the International Chamber of Commerce, Paris, France at the request of either Party (the first Party making such request being considered the “most diligent party” ( la partie la plus diligente )). The International Center for Expertise shall not, however, administer the dispute resolution procedure. The request to the International Center for Expertise shall include a copy of this Agreement. The Resolution Accounting Firm shall, acting as experts and not as arbitrators, make a final determination as to all remaining matters in dispute with respect to the Transferred Inventory Purchase Price, which determination shall be conclusive and binding on the Purchasing Company, the Selling Company, and the Parties in the absence of manifest error. The cost of retaining the Resolution Accounting Firm shall be borne equally by the Selling Company and the Purchasing Company. The Selling Company and the Purchasing Company agree to

 

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cooperate with each other in order to resolve any and all matters in dispute as soon as possible. The Transferred Inventory Purchase Price, as determined by the Resolution Accounting Firm, shall be paid by the Purchasing Company in accordance with the provisions of Section 2.10(b)(iii) above.

(c) Purchase and Sale of Inventory with no Physical Transfer of the Inventory.

(i) Upon the terms and subject to the conditions of Agreement, the Parties hereby agree that joint venture companies listed in Schedule 2.10 – Part B Column “Selling Companies” (the “ Selling Companies ”) shall sell, transfer, and assign to the Affiliates of Sanofi listed in Schedule 2.10 – Part B Column “Purchasing Companies” (the “ Purchasing Companies ”) on the Initial Closing Date, all right, title, and interest of the Selling Companies in the Transferred Inventory, in accordance with the following provisions.

(ii) In each Territory listed in Schedule 2.10 – Part B Column “Territory”, the Transferred Inventory owned by the Selling Company as of the Initial Closing Date shall be sold to the corresponding Purchasing Company at its net book value, as determined in accordance with the Selling Company’s accounting rules as consistently applied, as of the Effective Date. The Selling Company shall issue an invoice equal to the amount of the net book value of such Transferred Inventory, plus [*] and, upon receipt, the Purchasing Company shall pay the amount of such invoice to the Selling Company by wire transfer of immediately available funds to the account indicated by the Selling Company within thirty (30) Business Days following the receipt of such invoice.

2.11 Remuneration Payments .

(a) In consideration of the rights and licenses granted under this Agreement, Sanofi shall pay, or shall cause to be paid, all remuneration payments due to BMS under this Agreement, and whether under this Article II or otherwise, and any other Transaction Document on a quarterly basis within [*] days of the end of each calendar quarter. Each such payment shall be accompanied by an accurate statement of: (i) the amount of IFRS Net Sales of the Products (denominated in Euros), set forth on a [*], during such calendar quarter (together with the underlying calculations in reasonable detail for such amount); (ii) the remuneration payments due to BMS under this Agreement set forth on a [*] basis; and (iii) the calculation of all payments to be made to BMS for such calendar quarter (each a “ Payment Report ”)

(b) All payments to be made hereunder shall be made by wire transfer in immediately available funds to the respective bank accounts of BMS (or its designee) as designated in writing to Sanofi, unless the Parties agree to settle such payments through other means.

(c) Sanofi shall maintain: (i) books, records and accounts which accurately and fairly reflect, in reasonable detail, the IFRS Net Sales of the Products; and (ii) an adequate system of internal accounting controls. All books, records and accounts referred to in clause (i) above shall be maintained for not less than [*], or for such longer period if and as required by applicable law, following the date of the sales constituting the IFRS Net Sales and shall be made available for reasonable review upon request by BMS.

 

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(d) Sanofi shall provide to BMS: (i) Sanofi’s non-binding forecast of IFRS Net Sales for the current fiscal year and for the succeeding [*] no later than May 31 of each year until the Termination Date; and (ii) Sanofi’s non-binding re-forecast of IFRS Net Sales for current year and budgeted forecast of IFRS Net Sales for the succeeding 12 month period no later than October 31st of each year until the Termination Date, together with information and documentation supporting Sanofi’s calculations therefor. BMS shall have an opportunity to review with Sanofi its calculations and underlying assumptions in connection with such forecasts.

(e) At the request of BMS, Sanofi shall, and shall if applicable cause its Affiliates to, permit BMS or an independent, certified public accountant not having any significant relation to either BMS or Sanofi, as appointed by BMS, at reasonable times and upon reasonable notice, to examine the books and records of Sanofi (or its relevant Affiliate) as may be necessary to: (i) determine, with respect to any calendar quarter ending not more than [*] prior to the related request, the correctness of any Payment Report or payment made under this Agreement or any other Transaction Document; (ii) obtain information as to the amount payable for any such calendar quarter in the case of failure on the part of Sanofi or its relevant Affiliate to report or pay pursuant to this Agreement or on the part of any party to any other Transaction Document; or (iii) enforce any rights relating to audits and/or books and records under the Alliance Agreements as in effect prior to the date hereof; provided , however that BMS shall not have the right to make an audit request more than once every twelve (12) calendar months. The results of any such audit shall be promptly made available to the Parties. Further, for the avoidance of doubt, it is the Parties’ intent that the audit rights granted under the terms of the Alliance Agreements as in effect prior to the date hereof shall survive in accordance with their terms, notwithstanding any provision to the contrary herein or in any other Closing Date Agreement or Alliance Agreement. Each Party grants to the other Party the rights under the preceding sentence.

(f) BMS shall bear the full cost and expense of any such audit, unless such audit discloses that the amount due to BMS is more than the amount paid by more than [*] percent ([*]%) of the amount due, in which case Sanofi shall bear the full cost and expense of such audit.

(g) The determination by an independent, certified public accountant pursuant to this Section 2.11 as to the amount due and payable by Sanofi, or its relevant Affiliate, shall be conclusive and binding on the Parties.

(h) All payments due under this Agreement shall be paid in full without deduction, except for taxes (if any) required to be withheld by applicable law in Territory A or Territory B1, as applicable, with respect to such payments. If Sanofi is required under applicable law to withhold any tax to the revenue authorities in any country in Territory A or Territory B1, as applicable, regarding any payment to BMS, the amount of such tax shall be

 

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deducted by Sanofi and paid to the relevant revenue authority, and Sanofi shall notify BMS thereof, and shall promptly furnish to BMS all copies of any tax certificate or other documentation evidencing such withholding. If any such tax shall subsequently be found to be due, payment of such tax shall be the responsibility of Sanofi. Notwithstanding the foregoing, BMS and Sanofi shall cooperate reasonably to reduce or eliminate any such withholding tax under applicable law or treaty.

2.12 Market Withdrawal .

(a) The determination of a Market Withdrawal and the computation of any Market Withdrawal Adjustment in Territory A shall be made in accordance with the Share Forward Purchase Agreement.

(b) If Sanofi determines that a Market Withdrawal has occurred in one or more Territory A Opt-out Countries, Sanofi shall promptly provide written notice of such determination to BMS (including such records regarding sales, profitability, market share and other information from Sanofi for the applicable market as may be reasonably requested by BMS). BMS shall, within [*] days after receipt of such notice indicate to Sanofi whether it objects to Sanofi’s determination that a Market Withdrawal has occurred. If BMS objects to such a determination, the Parties shall resolve such dispute in accordance with the procedures set forth in Section 12.4 .

(c) If there has been a Market Withdrawal in one or more Territory A Opt-out Countries, each of BMS and Sanofi shall reach its own independent conclusion as to the amount of the Market Withdrawal Adjustment resulting from the Market Withdrawal (each, an “ Estimated Market Withdrawal Adjustment ”) and shall deliver to the other Party a written notice (each an “ Estimated Market Withdrawal Notice ”) on the [*] day following the earlier of the date on which: (i) BMS acknowledges that a Market Withdrawal has occurred; or (ii) the Dispute as to whether a Market Withdrawal has occurred is resolved (the earlier of (i) or (ii), the “ Market Withdrawal Adjustment Resolution Date ”). Each of BMS and Sanofi shall bear its own costs in connection with such determination. If one Party fails to deliver an Estimated Market Withdrawal Notice within [*] days of the date of the Market Withdrawal Adjustment Resolution Date, then the other Party’s determination of the Market Withdrawal Adjustment shall be considered final and binding on the Parties.

(d) If the highest figure (the “ High Value ”) provided by one Party on its Estimated Market Withdrawal Notice for the Market Withdrawal Adjustment is less than or equal to [*]% of the lower figure (“ Low Value ”) provided by the other on its Estimated Market Withdrawal Notice, then the Market Withdrawal Adjustment shall equal the arithmetical average of the High Value and the Low Value.

(e) If the High Value is more than [*]% of the Low Value (or, for the avoidance of doubt, an amount equal to [*] multiplied by the Low Value), BMS and Sanofi shall within [*] days after receipt of the Estimated Market Withdrawal Notice appoint [*] (“ Independent Expert ”) to determine the Market Withdrawal Adjustment. If [*] is unable or unwilling to act, or if it has provided services to either Party after the Initial Closing Date, then

 

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BMS and Sanofi shall cooperate in good faith to appoint an independent certified public accounting firm of international recognition mutually agreeable to BMS and Sanofi, in which event “ Independent Expert ” shall mean such firm. Within [*] days of its appointment, the Independent Expert shall, after having made its own estimate of the Market Withdrawal Adjustment, determine the Market Withdrawal Adjustment by selecting (a) the High Value or (b) the Low Value, whichever is closer to its own estimate of the Market Withdrawal Adjustment. Each Party shall provide the Independent Expert with the documentation in support of its Estimated Market Withdrawal Adjustment, and the Independent Expert shall keep such documentation confidential and shall not share it with the other Party. The expenses and fees of the Independent Expert shall be borne equally by BMS and Sanofi.

(f) The determination of the Independent Expert shall be final and binding on the Parties and may not be appealed, other than in cases of fraud or manifest error ( erreur grossière ).

(g) The final determination of the Market Withdrawal Adjustment by an Independent Expert shall be accompanied by a written report setting out the details of the determination by the Independent Expert of such value.

2.13 Other Alliance Agreements . If either Party or one of its Affiliates becomes aware of an Alliance Agreement that has not been amended, modified or terminated pursuant to the terms of this Agreement whose continued effectiveness would be inconsistent with the transactions contemplated hereby, then such Party shall notify the other Party and the Parties shall, or shall cause their Affiliates to, terminate such Alliance Agreement, effective as of the Initial Closing Date, unless such termination would have an adverse impact on either Party, in which case the Parties shall cooperate with each other to find a commercially reasonable alternative to termination.

ARTICLE III

FINISHED PRODUCT MANUFACTURING AND IRBESARTAN API

MANUFACTURING

3.1 Irbesartan Products and Clopidogrel Products .

(a) On and after the Initial Closing Date, Sanofi shall assume responsibility (with respect to for Territory A, Territory B and Territory B1) for:

(i) the manufacture of finished product tablets and packaging for Irbesartan Products; and

(ii) the manufacture of finished product tablets and packaging for Clopidogrel Products.

 

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(b) After the Initial Closing Date, and at the request of Sanofi, on a Product-by-Product basis and on a country-by-country basis, BMS shall continue packaging and releasing each of: (i) Clopidogrel Products currently Co-Marketed by BMS in Mexico; (ii) Clopidogrel Products currently Co-Marketed by BMS in Colombia; (iii) Irbesartan Products currently Co-Marketed by BMS in Mexico; (iv) Irbesartan Products currently Co-Marketed by Sanofi in Mexico; and (v) Irbesartan Products currently Co-Marketed by BMS in Argentina. Sanofi shall use commercially reasonable efforts to obtain such registrations to enable Sanofi to perform such packaging and releasing functions.

(c) The existing supply arrangements between the Parties regarding Clopidogrel in the U.S. shall be amended and replaced in accordance with the Supply Agreements. The Existing Supply Agreements shall be terminated on the Initial Closing Date pursuant to agreements prepared in accordance with Exhibit 3.1(c) .

3.2 Irbesartan API Manufacturing .

(a) The balancing mechanism applicable to the manufacturing of Irbesartan Products described in any agreement currently in force as between the Parties or their Affiliates shall terminate on the Initial Closing Date. There shall be no separate compensation to BMS for the termination of such balancing mechanism.

(b) BMS shall manufacture Irbesartan API for Irbesartan Products in each of the following calendar years in the following amounts set forth under the “BMS’s obligation to supply” row in Table 3.2 , and shall exclusively sell Irbesartan API to Sanofi during 2013 through 2015 (except that BMS may also use Irbesartan API for a fixed dose combination product permitted by Section 8.3(e) ). The price for such Irbesartan supplied by BMS shall equal [*]/ metric tonne.

Table 3.2

 

     2013   2014   2015

Forecasted total demand (in tonnes)

   [*]   [*]   [*]

BMS’s obligation to supply

   [*]   [*]   [*]

If forecasted total yearly demand, as determined by Sanofi, is lower than [*] tonnes in 2013, [*] tonnes in 2014 or [*] tonnes in 2015, then BMS will manufacture and supply [*] % of such total yearly demand for the applicable year. If BMS fails to supply Sanofi’s demanded quantity for any period in 2013, 2014 or 2015, Sanofi shall be relieved of the foregoing purchase obligation for such year to the extent provided in the Irbesartan API Supply Agreement.

(c) Sanofi shall manufacture and supply the Irbesartan intermediates known as “SR48001a,” “SR47563” and “Irbesartan crude” that are required by BMS to manufacture Irbesartan API until 2015 and in accordance with the pricing set forth on Exhibit 4.1 to the Irbesartan Intermediates Supply Agreement and Exhibit 4.1 to the Irbesartan Crude Toll Manufacturing Agreement. To the extent that Sanofi is able to meet BMS’s requirements, BMS shall be required to purchase from Sanofi: (i) all its “SR48001a” requirements, less [*] metric tons ([*] MT) that BMS is entitled to purchase from any other source; (ii) all of BMS’s “SR47563” requirements that BMS does not elect to manufacture by itself or through one of its Affiliates and (iii) all of BMS’s “Irbesartan crude” requirements.

 

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3.3 Supply/Tolling Agreements .

(a) Each of the Parties shall (i) cause their Affiliate(s) and/or their partnerships referenced herein, as applicable, to execute supply or tolling agreements in substantially the forms attached hereto as Exhibits 3.3(a)[1] to [5] and (ii) agree in good faith to amend the existing quality agreements prior to the Initial Closing Date to reflect changes in the underlying responsibilities of the Parties and their Affiliates (“ Quality Agreement Amendments ” and, together with the agreements referenced in clause (i) above, the “ Supply Agreements ”), in order to memorialize the supply or tolling arrangements for: (A) manufacturing finished Product tablets and packaging for Clopidogrel Products in the U.S.; (B) packaging and releasing Irbesartan Products and Clopidogrel Products for Mexico, Argentina and Colombia; and (C) manufacturing Irbesartan API and Irbesartan intermediates for Irbesartan Products throughout the world (other than in Japan) as described in this Article III.

(b) Each Supply Agreement for Irbesartan Products shall provide that the Parties will discuss in good faith adapting the quantities of Irbesartan API to be purchased by Sanofi from BMS in response to such adverse change in the demand in the event of:

(i) a material adverse change affecting Irbesartan demand (not attributable to acts or omissions of Sanofi that constitute negligence or willful misconduct); or

(ii) an intellectual property claim related to an Irbesartan product in any country which may result in the entry of an Irbesartan Generic Product in such country(ies) before the relevant patent expiry.

3.4 Resolution of Inconsistencies . To the extent there is any inconsistency between the provisions of Sections 3.2 or 3.3, on the one hand, and the Supply Agreements, on the other hand, the terms of the relevant Supply Agreement shall control.

3.5 Industrial Committee . The parties shall, by the Initial Closing Date, establish an industrial committee (the “Industrial Committee”) to manage the activities contemplated by the Supply Agreements. The Industrial Committee shall at all times consist of [*] representatives of BMS and Sanofi. All recommendations and decisions made by the Industrial Committee shall be made by a consensus of the representatives of Sanofi and BMS thereon. If the Industrial Committee is unable to reach a decision on any matter, the dispute shall be resolved as provided in Section 12.4.

ARTICLE IV

REPRESENTATIONS AND WARRANTIES

4.1 Representations and Warranties of the Parties . Each Party (with respect to itself and each of its Affiliates that is a party to one of the Closing Date Agreements) represents and warrants to the other Party as follows as of each of the date hereof, the Initial Closing Date and the date of each Additional Closing:

 

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(a) Organization; Authority . Such Person is a corporation or other business entity, as the case may be, duly organized, validly existing and in good standing (or the equivalent thereof, if applicable) under the laws of its respective jurisdiction of formation or organization (as applicable). Such Person has the requisite corporate or other applicable power and authority to own, lease and operate its material properties and to carry on its businesses as presently conducted. Such Person is duly qualified or licensed to transact business and is in good standing (if applicable) in each jurisdiction in which the property and assets owned, leased or operated by it, or the nature of the business conducted by it, makes such qualification or licensing necessary, except in such jurisdictions where the failure to be so duly qualified or licensed and in good standing would not reasonably be expected to have a material adverse effect on such Person’s ability to consummate the transactions contemplated by this Agreement and the Closing Date Agreements to which it is a party (together, the “ Transaction Documents ”).

(b) Consents . No notices to, filings with, or authorizations, consents or approvals of any Person or Governmental Authority are necessary for the execution, delivery or performance by such Person of this Agreement or the consummation by such Person of the transactions contemplated hereby, except for compliance with and filings pursuant to any Requisite Competition Law Approvals. Neither the execution, delivery or performance by such Person of this Agreement, or any other Transaction Document to which such Person is a party, nor the consummation by such Person of the transactions contemplated hereby or thereby will: (i) conflict with or result in any breach of any provision of such Person’s certificate of incorporation, bylaws or similar organizational documents; (ii) result in a violation or breach of, or constitute (with or without due notice or lapse of time or both) a default or give rise to any right of termination, cancellation or acceleration under, any of the terms, conditions or provisions of any contract or arrangement to which such Person is a party; or (iii) violate any law, rule or regulation of any Governmental Authority having jurisdiction over such Person or its properties or assets (except, with respect to the foregoing clauses (ii) or (iii), for such violations, breaches, defaults or violations that would not reasonably be expected to have a material adverse effect on such Person’s ability to consummate the transactions contemplated by this Agreement, or any other Transaction Document to which such Person is a party).

(c) Ownership . Each Party is the record and beneficial owner of the partnership interests set forth opposite such Party’s name on Schedule 4.1(c) . Such interests are held, and will be transferred to the other Party’s Affiliate, as applicable, hereunder, free and clear of all liens. Except as set forth in the Transaction Documents, neither Party (or any of its Affiliates) is a party to any option, warrant, purchase right, or other contract or commitment that requires such Party (or any of its Affiliates) to offer, sell, transfer or otherwise dispose of any partnership interests or other equity securities of JVA, JVB or USIrbeJV.

(d) Enforceability . This Agreement, and each other Transaction Document to which such Person is a party, constitutes the valid and binding obligation of such Person, enforceable against such Person in accordance with its terms, except as enforceability may be limited by applicable laws relating to bankruptcy, other similar laws affecting creditors’ rights and general principles of equity affecting the availability of specific performance and other equitable remedies.

 

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(e) No Brokers . No broker, finder, financial advisor or investment banker is entitled to any broker’s, finder’s, financial advisor’s or investment banker’s fee or commission or similar payment in connection with the transactions contemplated by this Agreement, or any other Transaction Document to which such Person is a party, based upon arrangements made by or on behalf of such Person.

(f) No Representations . None of Sanofi, BMS or any of their respective Affiliates has given any representations or warranties upon which the other Party is relying in connection with the transactions contemplated by this Agreement, other than the representations or warranties set forth in this Agreement.

4.2 Additional Representation and Warranty of BMS . BMS (on its and its Affiliates’ behalf) represents and warrants to Sanofi as follows (as of each of the date hereof and as of the Initial Closing Date) that, to BMS’s Knowledge:

(a) Regulatory Materials .

(i) (A) all Regulatory Materials filed with Governmental Authorities in the U.S. (with respect to Irbesartan), and in Territory A and Territory B1, by BMS with respect to the Products were, at the time of filing, true, complete and accurate in all material respects; and (B) no adverse event information is known by BMS that is materially different in terms of the incidence, severity or nature of such adverse events than any which were filed as safety updates to such Regulatory Materials for the Products;

(ii) BMS has made available to Sanofi all material books and records from the past [*] regarding the safety of the Products to the extent such books and records are in BMS’s possession;

(iii) BMS has made available to Sanofi copies of all material Regulatory Materials from the past [*] for the Products filed by BMS with Governmental Authorities in the U.S. (with respect to Irbesartan) and in Territory A and Territory B1; and

(iv) BMS has provided to Sanofi copies, to the extent received by BMS and relating to Products manufactured by BMS, of all material written: (A) reports of inspection observations, if any, in the past [*]; (B) establishment inspection reports from the [*]; and (C) Governmental Authority warning letters from the past [*], if any, that assert ongoing material lack of compliance with any applicable law or regulatory requirements.

(b) Third Party Contracts . Schedule 4.2(b) is a list of each Third Party contract (each an, “ Assigned Contract ”) to which BMS or an Affiliate of BMS is a party and is in full force and effect as to BMS in accordance with its respective terms. BMS has the right to update Schedule 4.2(b) prior to the Initial Closing Date with Sanofi’s prior written consent.

 

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None of BMS or its Affiliates or, to the Knowledge of BMS, any other party thereto, is in default, violation or breach in any material respect under any such Assigned Contract, and no event has occurred and is continuing that constitutes or, with notice or the passage of time or both, would constitute, a default, violation or breach in any material respect under such Assigned Contract by BMS or its Affiliates or, to the Knowledge of BMS, any other party thereto. Except as set forth on Schedule 4.2(b) , BMS represents that there are no additional Third Party contracts the counterparty to which could compel an assignment of such contract to Sanofi or its Affiliates, JVA, JVB or USIrbeJV on or following the Initial Closing Date and agrees to indemnify Sanofi and its Affiliates in full for reasonable costs or obligations (that cannot be reasonably mitigated by Sanofi) that arise if such a counterparty claims that such contract should have been assigned to Sanofi as of the Initial Closing Date.

ARTICLE V

CERTAIN REGULATORY MATTERS

5.1 Marketing Authorizations .

(a) The transfer to Sanofi of marketing authorizations (which shall be held by a Sanofi legal entity) for the Products currently held by BMS or its Affiliates that are set forth on Schedule 5.1(a) shall be undertaken in accordance with the timelines and processes to effect the transfer of such marketing authorizations to be agreed to in good faith by the Parties prior to the Initial Closing Date. All external costs for such transfer of such marketing authorizations shall be shared equally between BMS and Sanofi.

(b) BMS shall withdraw all marketing authorizations held by BMS or its Affiliates for all Products not being marketed by BMS as of the date hereof within [*] of the Initial Closing Date and provide evidence to Sanofi thereof.

5.2 Pharmacovigilance .

(a) The transfer to Sanofi of the Irbesartan Product pharmacovigilance database to Sanofi shall be initiated on the Initial Closing Date and pursued in accordance with the timelines, processes and costs to be agreed upon by the Parties prior to the Initial Closing Date and set forth in the Technical Agreement. All external costs for the transfer of such database shall be shared equally between BMS and Sanofi. Prior to the Initial Closing Date, the Parties agree to comply with the provisions of the Irbesartan SDEA and the Clopidogrel SDEA.

(b) The Parties agree that all current safety surveillance responsibilities including, but not limited to, individual and periodic safety reports management, signal detection, risk management activities as well as the EU Qualified Person for Pharmacovigilance responsibilities for Irbesartan Products remain with BMS as long as the global safety database is not fully transferred to Sanofi.

 

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(c) BMS shall continue to provide to Sanofi through [*], at BMS’s cost, reasonable medical assistance solely for the purpose of supporting the transfer of the pharmacovigilance database for Irbesartan Products, in finished form, as reasonably requested by Sanofi. Sanofi shall use diligent efforts to accomplish the transfer as soon as practicable following the date hereof.

(d) Prior to the Initial Closing Date, duly qualified representatives of each of BMS and Sanofi shall work in good faith to prepare a revised or amended Safety Data Exchange Agreement (“ Amended Irbesartan SDEA ”) regarding Irbesartan Products, in finished form, for the period beginning on the Initial Closing Date or, with respect to an Irbesartan BMS Permitted FDC, as required by law. A working draft of the Amended Irbesartan SDEA, which shall be finalized and executed by the Parties on the Initial Closing Date, is attached hereto as Exhibit 5.2(d) . The Amended Irbesartan SDEA also defines safety reporting obligations to the regulatory authorities before and after the marketing authorizations held by BMS have been transferred to Sanofi as well as the procedures for the pharmacovigilance document transfer. The Amended Irbesartan SDEA shall remain in effect for as long as: (i) BMS is the holder of the marketing authorization for Irbesartan Products, in finished form, anywhere in the world; (ii) BMS is the sponsor of a clinical trial involving Irbesartan Products, in finished form; (iii) Irbesartan Products sold by BMS, its Affiliates or their licensees in Co-Marketing countries prior to the JVA Closing or the JVB Closing, as applicable, are on the market prior to the expiration date of such Irbesartan Products; and/or (iv) with respect to an Irbesartan BMS Permitted FDC that are under development or sold by BMS or its Affiliates or its Permitted Licensees, where and to the extent required by applicable law.

(e) BMS will notify its partners of the global safety database for Irbesartan Products transfer to Sanofi. Sanofi will be responsible to set-up new Safety Data Exchange Agreement(s) with these partners to enable Sanofi and its Affiliates to comply with all pharmacovigilance and safety reporting obligations.

(f) The Parties shall agree in good faith on the date that the global safety database for Irbesartan Products has been successfully and completely transferred to Sanofi. To the extent practicable, the transfer of the safety database will be done in conjunction with the transfers of the marketing authorizations from BMS to Sanofi. In connection with the foregoing, the Parties’ respective system support groups shall cooperate in good faith to prepare and execute a detailed pharmacovigilance transfer agreement (the “ Technical Agreement ”) to be executed on the Initial Closing Date to define the technical requirements for the transfer of the safety database.

(g) Prior to the Initial Closing Date, duly qualified representatives of each of BMS and Sanofi shall work in good faith to prepare a revised or amended Safety Data Exchange Agreement (“ Amended Clopidogrel SDEA ”) regarding Clopidogrel Products to set forth the Parties’ pharmacovigilance and safety reporting obligations to regulatory authorities prior to and after the transfer of BMS’s marketing authorizations to Sanofi. A working draft of the Amended Clopidogrel SDEA, which shall be finalized and executed by the Parties on the Initial Closing Date, is attached hereto as Exhibit 5.2(g) . The Amended Clopidogrel SDEA shall remain in effect for as long as (i) BMS is the holder of the marketing authorization for Clopidogrel Products anywhere in the world; (ii) Clopidogrel Products sold by BMS, its Affiliates or their

 

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licensees in Co-Marketing countries prior to the date of the JVA Closing or the JVB Closing, as applicable, are on the market; and/or (iii) with respect to a Clopidogrel BMS Permitted FDC that are sold by BMS or its Affiliates or Permitted Licensees, where and to the extent required by applicable law. When the U.S. is the only market where BMS is marketing Clopidogrel products, the Amended Clopidogrel SDEA shall be terminated and replaced with a Safety Data Exchange Agreement that covers exclusively the U.S.

(h) In addition, as of the Initial Closing Date until the Termination Date, Sanofi shall provide BMS with the following pharmacovigilance information with respect to the Products: (i) aggregate safety reports such as PSUR, DSUR and INDAR; (ii) Risk Management Plan; and (iii) Product Alert information ( e . g ., information from external sources which may have significant ethical (including new efficacy and/or safety finding) or legal repercussions, or which can otherwise materially affect patients and/or which can have a potential negative impact on Sanofi, its image, officers or financial situation)).

(i) Any obligation of BMS to serve as Sanofi’s agent for regulatory purposes will cease as of the Initial Closing Date, or as otherwise mutually agreed by the Parties but in any case not earlier than the date when the global safety database for Irbesartan Products has been successfully and completely transferred to Sanofi.

ARTICLE VI

DILIGENCE OBLIGATIONS

6.1 No Obligations Generally . None of JVA, USIrbeJV, Sanofi or any Affiliate of Sanofi shall be obligated to perform any specified level of commercialization efforts, promotional efforts, marketing efforts or research and development efforts with respect to the Products after the Initial Closing Date.

6.2 Certain Limitations . Without the prior written consent of BMS, neither Sanofi nor any of its Affiliates shall take any action, nor fail to take any action, with the specific intent of reducing the remuneration of BMS with respect to Clopidogrel Products or Irbesartan Products (or Generic Products subject to remuneration under Section 2.5 ) in either the U.S. (with respect to Irbesartan) or in Territory A or Territory B1; provided , however, that Sanofi or any of its Affiliates shall be entitled, without the prior written consent of BMS: (a) to take any such action, or fail to take action which is for purposes of adapting or adjusting the distribution and commercialization of Clopidogrel Products or Irbesartan Products in either the U.S. (with respect to Irbesartan) or in Territory A or Territory B1 to any changes in the market or demand for such Products resulting from or relating to the expiration (prior to or after the Initial Closing Date) of patents in respect thereof (including any launch of autogeneric Products); and (b) to terminate commercialization of any Clopidogrel Products or Irbesartan Products when IFRS Net Sales for such Product in a country during any calendar year fall below [*] % of 2012 IFRS Net Sales for such Product in such country. If Sanofi desires to terminate commercialization of any such Product in accordance with the foregoing clause (b), Sanofi shall provide BMS with at least sixty (60) days’ advance notice in writing thereof, including the details of the basis for such termination.

 

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6.3 Regulatory Filings . From the Initial Closing Date until the Termination Date, Sanofi shall make all pharmacovigilance and other regulatory filings legally required with respect to either Territory A or Territory B1 (with respect to Clopidogrel and Irbesartan) or in the U.S. (with respect to Irbesartan), on a timely basis in accordance with applicable law and consistent with past practice.

6.4 Restricted Countries . Schedule 6.4 contains a list of countries (the “Restricted Countries List”) in which the sale or commercialization of Products will cause BMS to be in violation of sanctions laws and regulations applicable to BMS, including the International Emergency Economic Powers Act and any laws, executive orders or regulations authorized under such Act (together, “U.S. Sanctions Laws”). BMS may update the Restricted Countries List from time to time both before and after the Initial Closing Date to add to such list any additional countries in which the sale or commercialization of Products will cause BMS to be in violation of U.S. Sanctions Laws. If BMS elects to update the Restricted Countries List, it shall provide notice to Sanofi as soon as reasonably practicable of such updates to the Restricted Countries List. With respect to any countries on the Restricted Countries List, (x) any license granted by BMS to Sanofi shall be deemed terminated with respect to such country when such country appears on the Restricted Countries List and (y) from and after Sanofi’s receipt of notice from BMS with respect to the addition of such country to the Restricted Countries List, Sanofi shall not thereafter pay to BMS any royalties or remuneration arising from the sale or commercialization of the Products in such country. No products, components or other materials supplied by BMS to Sanofi in connection with the transactions contemplated hereby will be designated or allocated by Sanofi to any country on the Restricted Countries List and such products, components or other materials cannot be sold or commercialized by Sanofi in any such country.

ARTICLE VII

INTELLECTUAL PROPERTY

7.1 Trademark Transition .

(a) BMS hereby grants to Sanofi a fully-paid, royalty-free, non-exclusive, non-sublicensable (except to its affiliates), non-transferable and non-assignable right and license to use BMS’s corporate names and logos currently used, as of the date hereof, in the operations of the alliance (the “ BMS Brands ”) for the purposes expressly set forth below in Section 7.1(b) until the Termination Date. All other uses by Sanofi and its Affiliates of BMS Brands not contemplated by Section 7.1(b) will be subject to BMS’s prior written consent, which consent may be withheld in BMS’s sole discretion.

(b) Sanofi will be permitted to use the BMS Brands pursuant to Section 7.1(a) , and in each case, solely in connection with the manufacture, distribution and sale of Products and to the extent either:

 

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(i) set forth on packaging materials for Products; or

(ii) as embedded in the legal entity name(s) of USIrbeJV or the holders of marketing authorizations, and on packaging where required to reflect such name(s).

(c) Sanofi agrees to conform to past practice with respect to manner of use of the BMS Brands as of the date hereof, and to maintain the same high quality standards as currently adhered to in connection with the use of the BMS Brands in connection with Products. From time to time, BMS may request that Sanofi submit to BMS materials bearing the BMS Brands for review. Sanofi may change its materials using the BMS Brands so long as the materials, as revised, are of the same high level of quality as that in effect as of the date hereof.

(d) Sanofi will not, directly or indirectly, challenge BMS’s sole and exclusive ownership of all right, title and interest in and to the BMS Brands, or the validity or distinctiveness thereof, including the goodwill associated therewith, and acknowledges that all goodwill arising from use of the BMS Brands will inure solely to the benefit of BMS. Nothing contained in this Agreement will be construed as an assignment to Sanofi of any right, title or interest in the BMS Brands; it being understood that all rights, title and interest relating to the BMS Brands are expressly reserved by BMS. Sanofi shall not use any trademark, logo, or similar intellectual property right that is substantially the same as or deceptively or confusingly similar to any BMS Brand.

(e) Sanofi will not use the BMS Brands other than as permitted hereunder and will not incorporate BMS Brands into Sanofi’s corporate or business name in any manner whatsoever. In using the BMS Brands, Sanofi will in no way represent that it has any right, title or interest in any of the BMS Brands other than those expressly granted under the terms of this Agreement.

(f) Sanofi will, at its expense, take all actions reasonably requested by BMS to assist BMS in defending or prosecuting any action, suit or administrative procedure relating to the BMS Brands as used in connection with this Section 7.1 . Sanofi will notify BMS promptly if Sanofi learns of any infringement of, or pending or threatened litigation involving, the BMS Brands

(g) From and after the Initial Closing Date, Sanofi will use its reasonably diligent efforts to: (i) discontinue, as promptly as is reasonably practicable, the use of the BMS Brands in (A) the packaging materials for Products and (B) as embedded in the legal entity name(s) of the holders of the marketing authorizations, and on packaging where required to reflect such name(s); and (ii) change, as promptly as is reasonably practicable, the name of USIrbeJV and the JVA legal entity to one that does not include a reference to the BMS Brands; provided , however , that Sanofi shall not be required to destroy any inventory of Products or packaging thereof (in each case, as existing or in production on the Initial Closing Date) or incur any other material costs in connection with the foregoing. In connection with clause (ii) above, BMS shall, and shall cause the BMS JVA Partner to, vote in favor of changing the name of the legal entity of JVA and USIrbeJV to a name of Sanofi’s choosing so long as such the name of the legal entity does not include the BMS Brands.

 

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7.2 Intellectual Property Damages .

(a) Prior to the Termination Date, if Sanofi or BMS become aware of the infringement or threatened infringement of any patents or trademarks licensed under any of the Amended and Restated Territory A Clopidogrel License, the Amended and Restated Territory A Irbesartan License, the Amended and Restated Territory A Know-How License, the Amended and Restated Territory B1 Know-How License, the Amended and Restated Territory B1 Clopidogrel License, the Amended and Restated Territory B1 Irbesartan License and the Amended and Restated USIrbeJV Irbesartan License, (including those license agreements that the foregoing amend and restate and collectively, the “ License Agreements ”), it shall promptly notify the other Party in writing of the same, giving particulars thereof.

(i) If Sanofi or its Affiliates own the patents or other intellectual property rights allegedly being infringed or misappropriated, Sanofi and its Affiliates shall have the right, but not the obligation, to initiate an action based on such infringement or threatened infringement and, if Sanofi or any of its Affiliates initiates such an action, shall have control over the conduct of, and shall control, any such action. BMS and its Affiliates shall assist and cooperate with Sanofi to the extent reasonably necessary in the conduct of such action. The costs and expenses of any such infringement action (including, without limitation, fees of attorneys and other professionals) shall be borne equally by Sanofi and BMS unless BMS irrevocably notifies Sanofi within [*] days of receipt of notice of such infringement that it elects not to participate in such action. Each Party shall execute all necessary and proper documents and take such actions as shall be appropriate to allow Sanofi to initiate and prosecute such infringement actions. Any award or other consideration paid by Third Parties as a result of an infringement action (whether by way of settlement or otherwise) shall be shared equally between Sanofi and BMS unless BMS has elected not to participate in such action in which case such award or other consideration shall be retained entirely by Sanofi.

(ii) With respect to Irbesartan in the U.S., if BMS or its Affiliates own the patents or other intellectual property rights allegedly being infringed or misappropriated, BMS and its Affiliates shall have the right, but not the obligation, to initiate an action based on such infringement or threatened infringement and, if BMS or any of its Affiliates initiates such an action, shall have control over the conduct of, and shall control, any such action. Sanofi and its Affiliates shall assist and cooperate with BMS to the extent necessary in the conduct of such action. The costs and expenses of any such infringement action (including, without limitation, fees of attorneys and other professionals) shall be borne equally by Sanofi and BMS unless (in the case of actions relating to Irbesartan in the U.S.) Sanofi irrevocably notifies BMS within [*] days of receipt of notice of such infringement that it elects not to participate in such action. Each Party shall execute all necessary and proper documents and take such actions as shall be appropriate to allow BMS to initiate and prosecute such infringement actions. Any award or other consideration paid by Third Parties as a result of an infringement action (whether by way of settlement or otherwise) shall be shared equally between Sanofi and BMS unless Sanofi has elected not to participate in such action in which case such award or other consideration shall be retained entirely by BMS.

 

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(b) Notwithstanding Section 7.2(a) , with respect to actions commenced under the License Agreements prior to the Initial Closing Date (including but not limited to those listed on Schedule 7.2(b) , which schedule shall be updated by Initial Closing Date to reflect additional actions commenced between the date hereof and the Initial Closing Date), each of BMS and Sanofi shall (i) bear half of all damages payable and out-of-pocket costs and expenses incurred after the Initial Closing Date and (ii) share equally in all awards payable after the Initial Closing Date arising out of such actions. Such actions shall be deemed to be ones in which BMS and Sanofi have elected to participate, and the conduct of such actions shall continue to be governed by the relevant License Agreement as it existed prior to the amendments contemplated in this Agreement.

(c) Infringement actions referred to in this Section 7.2 may be brought in the name of JVA, JVB, USIrbeJV or a winding-down Co-Promotion partnership as Sanofi may reasonably determine appropriate and BMS shall reasonably cooperate with Sanofi in facilitating the participation of the appropriate entity as plaintiff in any such action.

ARTICLE VIII

COVENANTS

8.1 Antitrust Filings .

(a) The Parties shall use their respective reasonable best efforts to promptly file or cause to be filed within [*] Days of the date hereof, all filings necessary or appropriate to be obtained under applicable Antitrust Laws in the jurisdictions as set forth on Schedule 8.1 attached hereto (collectively, the “ Antitrust Filings ”), shall consult and cooperate with each other in the preparation of such filings, and shall promptly inform the other Party of any material communication received by such Party from any Governmental Authority regarding the Antitrust Filings regarding the transactions contemplated by this Agreement. Each Party shall review and discuss in advance, and consider in good faith the views of the other Party in connection with any proposed written or material oral communication with any Governmental Authority. Neither Party shall participate in any meeting with any Governmental Authority unless it first consults with the other Party in advance, and to the extent permitted by the Governmental Authority, gives that Party the opportunity to be present thereat. Neither Party shall agree to any voluntary extension of any statutory deadline or waiting period or to any voluntary delay of the consummation of the transactions contemplated by this Agreement at the behest of any Governmental Authority without the prior written consent of the other Party. Each of the Parties shall be responsible for its own filing fees required to be paid in connection with any Antitrust Filing.

(b) The Parties’ obligations under this Section 8.1 to use reasonable best efforts shall include, as applicable, defending any judicial or administrative action or similar proceeding instituted (or threatened to be instituted) by any Person under any Antitrust Law or seeking to have any stay, restraining order, injunction or similar order entered by any Governmental Authority vacated, lifted, reversed or overturned.

 

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8.2 ICC Disputes . Sanofi and BMS shall settle and resolve the ICC Disputes pursuant to the Settlement Agreement attached hereto as Exhibit 8.2.

8.3 Non-Competition .

(a) Neither Party nor any of its Affiliates shall have any noncompetition restrictions in the U.S. (with respect to Irbesartan) or in Territory A, Territory B1, Territory A Opt-out Countries or Territory B1 Opt-out Countries after the Initial Closing Date, except as set forth in this Section 8.3 . For the avoidance of doubt, except as provided in Sections 8.3(c) - (f) below, the existing noncompetition commitments of the Parties (or their Affiliates) contained in the Territory B Alliance Support Agreement shall continue to apply with respect to Clopidogrel in the U.S. until such agreement terminates, and thereafter, shall apply for [*] following such termination date to the party or parties (and their Affiliates) whose interests are purchased pursuant to Section 7.07 or 7.08 of such agreement, as applicable.

(b) Except as set forth in Sections 8.3(c) - (f) below, neither BMS nor any of its Affiliates shall make, sell, promote or otherwise commercialize: (i) any product containing Clopidogrel or Irbesartan as an API; (ii) Clopidogrel API or Irbesartan API; or (iii) intermediates useful solely for production of Clopidogrel API or Irbesartan API, with respect to the U.S. (with respect to Irbesartan) or in Territory A, Territory B1, Territory A Opt-out Countries or Territory B1 Opt-out Countries; in each case until after [*] of the Termination Date.

(c) Nothing contained in this Section 8.3 shall prevent BMS or any of its Affiliates from acquiring a business, or being acquired by, or acquiring or combining with a Person, in each case which, at the time of such acquisition or combination, makes, sells, promotes or otherwise commercializes: (i) any product containing Clopidogrel or Irbesartan as an API; (ii) Clopidogrel API or Irbesartan API; or (iii) intermediates useful solely for production of Clopidogrel API or Irbesartan API; provided , that BMS and its Affiliates (which for these purposes would include an acquiror following the closing of the relevant transaction) either: (x) dispose of API and intermediates of the Products (other than API and intermediates purchased, used or manufactured in connection with BMS Permitted FDCs) and of the relevant portion of the business or securities of the Person which undertakes the foregoing activity within [*] after the completion of such acquisition or combination, or (y) market such product (other than API or intermediates) and pay Sanofi, for the period ending on the Termination Date, that [*], on a country-by-country basis, the [*] (except that no such [*] shall be payable on BMS Permitted FDCs);

provided , however , that neither BMS nor its Affiliates shall have the right to exercise the rights set forth in clause (c)(y) above with respect to Clopidogrel (other than BMS Permitted FDCs) in the U.S. and, following any acquisition or combination with respect to Clopidogrel in the U.S. described in this clause (c) (other than BMS Permitted FDCs), shall be required to make the disposition required in clause (c)(x) above in accordance with the time frame specified in such clause. In each case, BMS shall notify Sanofi as promptly as practicable after any such acquisition or combination. In the event BMS or any of its Affiliates makes a disposition in accordance with clause (c)(x) above within [*] of an acquisition or combination, no royalties shall be paid by BMS to Sanofi with respect to such product(s) for the period of time from the date of such acquisition or combination until the disposal.

 

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(d) Nothing contained in this Section 8.3 shall prevent Sanofi or any of its Affiliates from acquiring a business, or being acquired by, or acquiring or combining with a Person, in each case which, at the time of such acquisition or combination, makes, sells, promotes or otherwise commercializes, in the U.S.: (i) any product containing Clopidogrel as an API; (ii) Clopidogrel API; or (iii) intermediates useful solely for production of Clopidogrel API; provided , that Sanofi and its Affiliates (which for these purposes would include an acquiror following the closing of the relevant transaction) shall dispose of API and intermediates of such products (other than API and intermediates purchased, used or manufactured in connection with Sanofi Permitted Clopidogrel FDCs) in the U.S. and the relevant portion of the business or securities of the Person which undertakes the foregoing activity in the U.S. (other than with respect to Sanofi Permitted Clopidogrel FDCs) within [*] after the completion of such acquisition or combination.

(e) BMS and its Affiliates shall have a right to use, and to have its Permitted Sublicensees use, by cross-reference, or incorporation by reference, or any similar right or process, regulatory filings held (and any data contained therein) generated or owned, by Sanofi with respect to the Products (other than Excluded FDCs) prior to the Initial Closing Date, to enable BMS, its Affiliates or its Permitted Sublicensees to conduct clinical trials for, and to file and obtain registrations for and commercialize a BMS Permitted FDC, if BMS desires to develop or market a BMS Permitted FDC in a given country, and at BMS’s cost. Upon BMS’s reasonable request, Sanofi will, at BMS’s expense, promptly confirm such rights and/or answer questions that have been reasonably requested or required by an applicable regulatory authority.

(f) Nothing contained in this Section 8.3 (subject to Section 8.3(c) ) shall prevent BMS or its Affiliates from making, selling, promoting or otherwise commercializing, in each case either directly or through Permitted Sublicensees, a BMS Permitted FDC and none of them shall be required to pay any royalties or to obtain any consent from Sanofi for any such activities worldwide from and after the Initial Closing Date.

(g) Notwithstanding anything contained in any other Alliance Agreement, neither Sanofi nor any of its Affiliates shall be required to pay any royalties (except with respect to Identified Irbe FDCs or Identified Clopi FDCs) or obtain the consent from BMS to make, sell, promote or otherwise commercialize, either directly or indirectly through sublicensees, fixed dosed combinations with either Irbesartan and Clopidogrel, including Irbesartan and Amlodipine and Irbesartan and Atorvastatin.

(h) Nothing contained in this Section 8.3 shall prevent BMS or any of its Affiliates from performing the contracts identified in Section 8.5(b) .

(i) Nothing in this Section 8.3 shall be deemed to create or imply a license or right to or in the other Party or its Affiliates under any intellectual property owned or controlled by a Party or its Affiliates that covers or claims any of its proprietary compounds or molecules (except as otherwise provided in the Transaction Documents with respect to Irbesartan or Clopidogrel).

 

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8.4 Works Council Notifications and TUPE Matters .

(a) BMS shall notify the necessary local works council(s) on the same date the transactions contemplated by this Agreement are publicly announced or on such other date as required by applicable law; provided , that BMS shall notify the European works council on the Business Day preceding such public announcement.

(b) BMS shall reassign any of its employees whose current roles and responsibilities include matters related to the Products (“ BMS Employees ”) to other businesses of BMS sufficiently in advance of the JVA Closing or the JVB Closing, as applicable, to minimize so far as is possible the basis for any valid claim by any BMS Employee that his/her contract of employment has transferred to Sanofi pursuant to the operation of the Transfer of Undertakings (Protection of Employment) Regulations 2006 or similar laws in other jurisdictions (collectively, “ TUPE and Analogs ”). BMS will indemnify, keep indemnified and hold harmless Sanofi and its Affiliates fully in respect of losses of any kind arising from or in connection with (i) any claim by any BMS Employees arising out of or in connection with their employment by BMS or any act or omission, breach or default of BMS or any of its Affiliates, in any case on or prior to the Initial Closing Date; (ii) any breach by BMS or any of its Affiliates of its or their obligations with regard to any BMS Employees under TUPE and Analogs or works councils notifications; or (iii) costs incurred by Sanofi or its Affiliates (including payment of salary and benefits based on and limited to their terms and conditions of employment immediately prior to the transfer of their employment to Sanofi or its Affiliates) associated with any BMS Employees deemed to have transferred into the employment of Sanofi or its Affiliates until such time as Sanofi or its Affiliate may legally terminate such employment (in a manner that does not involve offering severance to Sanofi employees other than former BMS Employees) and in each case, except if attributable to the negligence of Sanofi or one of its Affiliates.

8.5 Third Party Contracts .

(a) Subject to Section 4.2(b) and Section 8.5(b) , BMS shall undertake to use commercially reasonable efforts to assign, and Sanofi shall use commercially reasonable efforts to assume by the Initial Closing Date, the Assigned Contracts, and BMS shall (i) be exclusively responsible for any other Third Party agreements which are not assigned to, and assumed by, Sanofi and (ii) cease to sell the Products to its Third Party subcontractors, customers or distributors and shall hold Sanofi harmless with respect to such termination.

(b) Sanofi acknowledges that BMS will, after the date hereof and prior to the Initial Closing Date, tender for certain supply contracts in the ordinary course of business in Co-Marketing countries. In the event that BMS is the winning bidder in such tender and the Initial Closing Date occurs, BMS will, to the extent possible, assign such contract to the relevant Sanofi Affiliate (but only with respect to the applicable Product) and, to the extent not possible, perform such contract for the benefit of Sanofi. To the extent that Sanofi supplied to BMS prior to the Initial Closing Date any materials necessary for BMS to perform any such contract, Sanofi will continue to supply such materials and information as are necessary for BMS to perform such contract on existing terms.

 

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8.6 Payment of Pharma Fee . Sanofi shall be responsible for paying (or reimbursing BMS for) the U.S. Pharma Fee invoiced in 2013 and any succeeding year for Irbesartan Products (regardless of which Party receives the applicable statement, and regardless of the sales year to which the invoice relates). The U.S. Pharma Fee invoiced in 2013 and any succeeding year for Plavix shall be paid under the terms of the Alliance Agreements.

8.7 NDC Codes . Sanofi shall obtain new National Drug Codes in Sanofi’s name for all Products (other than Clopidogrel Products in the U.S.) sold on or after the Initial Closing Date, and shall make any similar changes throughout Territory A and Territory B1 consistent with this Agreement such that returns, rebates and similar items for Products (other than Clopidogrel Products in the U.S.) sold after the Initial Closing Date will be billed and paid by Sanofi and its Affiliates.

8.8 Confidentiality; Public Announcements .

(a) Any press release announcing the execution of this Agreement shall be issued in such form as shall be mutually agreed upon by the Parties. Each Party shall consult with the other Party before issuing any other press release or otherwise making any public statement with respect to this Agreement or the transactions contemplated by this Agreement (except for communications and disclosures required by law, provided that the disclosing Party shall use commercially reasonable efforts to consult with the other Party in advance of such communication or disclosure).

(b) From and after the date hereof, the Parties shall, and shall cause their Affiliates and their employees, consultants, agents and advisors to, keep confidential and not use for its benefit or for the benefit of any other Person, any and all non-public information, which includes, without limitation, confidential information relating to or provided under the Alliance Agreements (including those Alliance Agreements that will terminate on the Initial Closing Date or thereafter in connection with an Additional Closing or pursuant to their respective terms), to the extent relating to such other Party or its Affiliates; provided , however , that the Parties shall not be liable hereunder with respect to any disclosure to the extent such disclosure is requested or required by law, including applicable rules of any securities exchange, or pursuant to a subpoena, civil investigative demand (or similar process), order, statute, rule or other legal or similar requirement promulgated or imposed by a court or by a Governmental Authority or otherwise in connection with any judicial, administrative or similar proceeding (including in response to oral questions, interrogatories or other requests for information or documents). If the Parties or any of their Affiliates are requested or required by any law to disclose any non-public information, the Parties shall, to the extent permissible by law, provide the other Party with prompt written notice of such request or requirement so that such other Party may seek a protective order or other appropriate remedy and/or waive compliance with the provisions of this Section 8.8 . If, in the absence of a protective order or other remedy or the receipt of a waiver from the other Party nonetheless, on the advice of counsel, are requested or required by law to disclose any non-public

 

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information, the Parties or their Affiliates may, without liability hereunder, disclose only that non-public information which such counsel advises such disclosing Party, that is requested or required by applicable law to be disclosed; provided that to the extent permissible by law, the Parties exercise their commercially reasonable efforts to preserve the confidentiality of the non-public information. Notwithstanding the foregoing, such non-public information shall not include information that: (i) is or becomes available to the public other than as a result of a disclosure by a Party in breach of this Section 8.8 ; (ii) becomes available to a Party or its Affiliates from a source other than the other Party or its respective Affiliates; provided that the source of such information is not known by the receiving Party or its Affiliates to be bound by a confidentiality agreement with, or other contractual, legal or fiduciary obligation of confidentiality to, the disclosing Party with respect to such information; or (iii) is independently developed by a Party without breach of this Agreement.

8.9 Notification of Certain Matters . Prior to the Initial Closing Date, the Parties shall give prompt notice to the other Party of: (a) the occurrence, or failure to occur, of any event, which occurrence or failure to occur is reasonably likely to cause any representation or warranty of such Party contained in this Agreement to be untrue or inaccurate in any material respect; (b) any material failure of such Party to comply with or satisfy any covenant, condition or agreement to be complied with or satisfied by it under this Agreement; (c) any notice or other communication from any Person alleging that the consent of such Person is or may be required in connection with the consummation of the transactions contemplated hereby; and (d) any legal proceeding pending or, to the applicable Party’s knowledge, threatened against the Party relating to the transactions contemplated hereby.

8.10 Additional Closings .

(a) Prior to the Initial Closing Date, the Parties shall agree on modifications to the transaction structure as defined in this Agreement to ensure that the Alliance Agreements (or equivalent arrangements) shall continue in each Designated Country until the Requisite Competition Law Approvals have been obtained in such Designated Country(ies) in accordance with the agreed-upon principles set forth on Schedule 8.10 attached hereto (the “ Modified Designated Country Structure ”). After the Initial Closing Date, and until [*], the Parties shall continue to diligently seek the Requisite Competition Law Approvals in the Designated Countries (and in accordance with Section 8.1 ). If the Parties obtain any Requisite Competition Law Approvals in respect of a Designated Country after the Initial Closing Date, and on or before [*], then the transactions contemplated hereby in respect of such Designated Country shall close on the last day of the quarter during which such Requisite Competition Law Approvals are obtained (such closing, an “ Additional Closing ”). From and after each Additional Closing with respect to a Designated Country, the Parties’ governance, economic and other contractual rights in respect of such country shall be those contemplated under this Agreement as if the Additional Closing for such country had occurred on the Initial Closing Date; provided , however, taking into account payments made and/or received until such Additional Closing by BMS or its Affiliates under the Modified Designated Country Structure in respect of such country, on [*], the Parties shall (to the extent permitted by applicable laws) pay such amounts to each other so that the overall economic effect for BMS and its Affiliates, collectively, contemplated under this Agreement in respect of such country shall be as if such Additional Closing had occurred on the Initial Closing Date. The Parties shall exchange any information needed to implement the Modified Designated Country Structure.

 

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(b) No Additional Closing shall occur with respect to any Designated Country for which the Requisite Competition Law Approvals have not been obtained on or by [*]. With respect to any such Designated Country for which the Requisite Competition Law Approvals have not been obtained on or by [*], from and after [*], the Modified Designated Country Structure will remain in effect with respect to such country (each such country, an “ Excluded Country ”) until the Termination Date unless and until otherwise agreed by the Parties pursuant to good faith negotiations requested by either Party to review and amend the Modified Designated Country Structure given the restructurings described in this Agreement for JVA, JVB and USIrbeJV. At the end of each calendar year following [*], and taking into account payments made and/or received during such calendar year by BMS or its Affiliates under the Modified Designated Country Structure in respect of each Excluded Country, the Parties (to the extent permitted by applicable laws) shall pay such amounts to each other so that the overall economic effect for BMS and its Affiliates, collectively, contemplated under this Agreement in respect of such Excluded Country shall be as if such Additional Closing had occurred on the Initial Closing Date. The Parties shall exchange any information needed to implement the Modified Designated Country Structure.

8.11 Books and Records .

(a) BMS shall provide Sanofi, upon its reasonable written request, with applicable copies of books and records to the extent: (a) relating to the period of [*] prior to the date hereof (and BMS shall cooperate in good faith with respect to Sanofi’s reasonable requests for books and records relating to periods beyond [*] prior to the date hereof); and (b) exclusively relating to JVA, JVB or USIrbeJV, and local Co-Marketing or Co-Promotion entities, as applicable; provided that BMS shall be entitled to retain copies of same in accordance with its internal document retention policies and applicable law.

(b) The rights relating to books and records granted under the terms of the Alliance Agreements as in effect prior to the date hereof shall survive in accordance with their terms, notwithstanding any provision to the contrary herein or in any other Closing Date Agreement or Alliance Agreement. Each Party grants to the other Party such rights under the preceding sentence.

8.12 Further Assurances; Cooperation . Subject to the terms and conditions of this Agreement, each of the Parties shall: (i) take, or cause to be taken, all reasonable actions, and do, or cause to be done, all things reasonably necessary, proper or advisable under applicable law to consummate the transactions contemplated hereby, including, without limitation, causing their respective Affiliates to perform all of their respective obligations under the applicable Alliance Agreements; and (ii) cooperate with each other to implement the transactions contemplated hereby; in each case as soon as is reasonably practicable following the date hereof both before and after the Initial Closing Date. In addition, subject to Antitrust Laws, other applicable laws

 

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restricting the provision of information and BMS’s confidentiality obligations with Third Parties, promptly after the date hereof and both before and after the Initial Closing Date, BMS shall cooperate with Sanofi and provide Sanofi with information (including in connection with BMS practices and commitments with third parties) reasonably necessary for Sanofi and its Affiliates to continue to market, sell and distribute the Products that were previously marketed, sold and distributed by BMS in Co-Marketing countries in order to avoid and minimize any disruption in the marketing and sale of such Products.

8.13 Alliance Agreement Amendments . The Alliance Agreements shall be amended and/or restated in accordance with the agreements in substantially the forms attached hereto as Exhibits, or as otherwise contemplated by this Agreement.

8.14 Discontinuation in Brazil . No later than [*], BMS shall, and shall cause its Affiliates to: (i) discontinue all sales and commercialization of Products in Brazil; and (ii) initiate the process to withdraw all Product registrations in Brazil. BMS shall use commercially reasonable efforts to pursue such withdrawals in accordance with applicable law.

8.15 Conduct of Business Prior to the Initial Closing Date . Between the date hereof and the Initial Closing Date, the Parties shall, and shall cause their respective Affiliates to, conduct the operations of their alliance with respect to Irbesartan Products and Clopidogrel Products in the ordinary course of business consistent with past practices (except for actions expressly permitted or contemplated by the Transaction Documents and such further matters as may be consented to by the Parties in advance in writing); provided that BMS and its Affiliates shall have the right to terminate certain Third Party contracts in the ordinary course of business prior to the Initial Closing Date, including, without limitation, as contemplated by Section 8.5(a) .

8.16 Termination of Alliance Agreements . All Alliance Agreements shall be terminated as of the Initial Closing Date other than the Alliance Agreements (i) necessary for Sanofi to market, sell and commercialize the Irbesartan Products worldwide (other than in Japan) and Clopidogrel Products worldwide (other than in Japan and in the U.S.) from and after the Initial Closing Date; (ii) as set forth on Schedule 8.16 ; (iii) contemplated by the Parties to survive or be amended in connection with the transactions contemplated by this Agreement, including the forms of agreements attached hereto as exhibits and all settlement agreements and other agreements entered into by or between the Parties that relate to litigation in connection with the Products; and (iv) that constitute Closing Date Agreements. For the avoidance of doubt, except as otherwise contemplated by the Parties, the Parties shall not terminate agreements between or among the Parties and/or their respective Affiliates and/or Third Parties to the extent related to Clopidogrel Products in the U.S. For the avoidance of doubt, notwithstanding any termination contemplated in this Section 8.16 , any provision relating to payments to be made to one of the Parties, their Affiliates or Third Parties under an agreement to be terminated shall survive with respect to amounts accrued but not yet paid prior to the Initial Closing Date, with such payments to be made in accordance with the terms of the relevant agreement after the Initial Closing Date.

 

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ARTICLE IX

INDEMNIFICATION

9.1 Generally .

(a) The Parties’ obligations under Article VI of the Territory A Alliance Support Agreement, Article VI of the Territory B Alliance Support Agreement, and Article VII of the USIrbeJV Alliance Support Agreement (the “ Current Liability Allocation ”) shall survive and continue to apply to (i) pending Claims Made prior to the Initial Closing Date based on acts or omissions that occurred on or prior to the Initial Closing Date, including those claims forth on Schedule 9.1 (which schedule may be amended by the Parties prior to the Initial Closing Date), and (ii) to any Claims Made after the Initial Closing Date, if (x) such claim is based on or arises from an act or omission occurring prior to the Initial Closing Date and (y) the claims or allegations made by a plaintiff (in written demands and, if applicable, its pleadings) in respect of such claim specifically limit such claim exclusively to actions or omissions occurring prior to the Initial Closing Date (collectively, “ Specified Prior Claims ”). Notwithstanding anything to the contrary in this Agreement, the provisions of Article VI of the Territory B Alliance Support Agreement shall continue to apply with respect to Clopidogrel Products in the U.S.

(b) The Parties’ obligations under the liability allocation and indemnification provisions of the Opt-out Agreements, and the autogeneric agreements contemplated in Section 2.5 , to the extent contained in such agreements, shall survive in accordance with their terms unaffected by the transactions contemplated hereby. To the extent any such Opt-out Agreements or autogeneric agreements do not contain provisions allocating liability between the Parties, the allocation of liability between the parties to such agreements shall be either: (x) the Current Liability Allocation for Claims Made prior to the Initial Closing Date or Specified Prior Claims; or (y) the Liability Allocation for Claims Made on or after the Initial Closing Date, in each case, with respect to the activities covered by such agreements.

(c) Subject to the time periods described in Sections 9.1(e) , (f)  and (g)  with respect to any Product sold or distributed anywhere in the world other than Clopidogrel Products in the U.S., the Parties shall share equally (i.e., on a “50/50” basis) (the “ Liability Allocation ”) Damages in respect of all Claims Made (other than Specified Prior Claims) that are based on or arise from:

(i) the development and preparation for the commercialization of a Product;

(ii) the manufacture of the active substance chemical bulk used in the Products;

(iii) the manufacture of the Products ( i.e. , the transformation of the active substance chemical bulk into finished, packaged and labeled Products);

 

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(iv) the labeling, marketing, promotion, sale and distribution of the Products;

(v) any other activity undertaken by either Party or its Affiliates in connection with the transactions contemplated in this Agreement; or

(vi) any Third Party generic version of a Product (collectively, “ Pharma Activities ”) (including defense costs, except as otherwise specified in Sections 9.1(h)(iii) (iv) ) (collectively, the “ Covered Liabilities ”).

The agreements referenced in Section 9.1(b) above shall not be subject to this Section 9.1(c) , except as expressly provided in Section 9.1(b) .

(vii) For each claim asserted or alleged by a Third Party (a “ Third Party Claim ”) against a Party or an Affiliate of a Party claiming indemnification under this Section 9.1(c) (the “ Indemnified Party ”) that is subject to the Liability Allocation: (A) in respect of claims asserted solely against Sanofi and/or its Affiliates, BMS shall indemnify Sanofi or its Affiliates from and against 50% of the associated Covered Liabilities; (B) in respect of claims asserted solely against BMS or BMS’s Affiliates, Sanofi shall indemnify BMS or its Affiliates from and against 50% of the associated Covered Liabilities; and (C) in respect of claims asserted against both Sanofi or its Affiliates, on the one hand, and against BMS or its Affiliates, on the other hand, each Party would indemnify the other Party (or its Affiliates) from and against 50% of the Covered Liabilities of such other Party (or its Affiliates). The Parties shall cooperate to determine the most efficient process to implement such indemnification, including by possibly netting payments if each Party is required to make payments to the other Party. The procedures described in Section 9.1(h) below shall apply to the control of defense of any Third Party Claims.

(d) Notwithstanding the foregoing, each Party shall bear full liability in respect of Claims Made during the period commencing on the Initial Closing Date through [*] and that: (x) are based on or arise from Pharma Activities (other than those described in clause (vi) of the definition thereof); and (y) relate to an act or omission of such Party (or its Affiliates) that constitutes negligence, bad faith or willful misconduct; provided that:

(i) an act or omission by a Party that is consistent with the Parties’ practices under the Alliance Agreements prior to the Initial Closing Date shall be presumed not to be negligent (as between the Parties for purposes of this Article IX ) absent evidence to the contrary;

(ii) an act by a Party that is mandated or recommended by health authorities shall be deemed not to be negligent (as between the Parties for purposes of this Article IX ); and

(iii) a failure by a Party to either (x) perform actions mandated or recommended by health Governmental Authorities with respect to a Product in a territory or (y) withdraw the affected Product in the affected territory shall be presumed to be negligent (as between the Parties for purposes of this Article IX ).

 

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(e) Except as expressly provided otherwise in Sections 9.1(a) , (b)  and (c) , the Liability Allocation shall remain in force with respect to Claims Made against either Party during the period commencing on the Initial Closing Date through (and including) [*] (collectively, the “ Designated Claims ”); provided , that all Designated Claims shall be identified as such on a list to be agreed to by the Parties, each acting reasonably and in good faith, promptly after [*] and the Liability Allocation in respect of Designated Claims shall apply until final resolution or settlement thereof.

(f) Subject to Section 9.1(g) : (i) the Liability Allocation shall terminate and cease to apply with respect to any Claims Made against either Party on or after [*]; and (ii) Sanofi shall be responsible for [*] % of all Damages in respect of all Claims Made with respect to Pharma Activities in the U.S. (with respect to Irbesartan) or in Territory A or Territory B1 on or after [*] and shall indemnify BMS in respect of such Damages; provided that BMS shall use reasonable efforts to have the case dismissed as to BMS and its Affiliates at the “motion to dismiss” or comparable stage and the Parties shall bear equally all out-of-pocket costs and expenses associated with such efforts. This Section 9.1(f) shall not apply to Claims Made prior to [*] and which continue to be disputed after [*], which Claims Made shall continue to be treated in accordance with Sections 9.1(e) and (h) .

(g) If either Party is subject to any Claims Made on or after [*] that are associated with use of a Product by a Third Party based on or arising from Pharma Activities where the underlying injury or damage incurred by such Third Party is of a type not consistent with the underlying injury or damage incurred by any Third Party and asserted as a Designated Claim, and the incurred liabilities associated therewith exceed [*] Dollars ($[*] (the “ New Liability Claims ”), then the Liability Allocation shall apply to the New Liability Claims until the final resolution or settlement thereof.

(h) All claims for indemnification described in Sections 9.1(c) and (g) , if any, shall be handled as follows:

(i) Subject to Sections 9.1(h)(ii) - (iv) below, all costs and expenses (including legal fees) associated with the defense of any Third Party Claims that are subject to the Liability Allocation, regardless of which Party incurs such costs and expenses and any amounts ordered to be paid or amounts agreed to be paid in settlement of any Third Party Claim subject to the Liability Allocation shall be shared and paid equally by Sanofi and BMS (with neither Party being required to advance funds to pay for the other Party’s share).

(ii) The Indemnified Party shall promptly notify the Party from whom indemnification is sought (the “ Indemnifying Party ”) of the existence of any Third Party Claim. With respect to any Third Party Claims asserted against BMS or its Affiliates that are subject to indemnification hereunder, Sanofi shall have the right to defend such Third Party Claim, on its own behalf and on behalf of BMS and its respective Affiliates, by all appropriate proceedings, which proceedings shall be prosecuted diligently by Sanofi to a final conclusion or settled at the discretion of Sanofi; provided , however, that Sanofi may not enter into any compromise or settlement that does not provide for an unconditional release of liability of BMS and its

 

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Affiliates, involves equitable relief, any non-monetary remedy or any imposition of any obligation upon BMS or monetary damages (exclusive of attorneys’ fees) in excess of [*] Dollars ($[*]) (a “ Monetary Claim ”), without the prior written consent of BMS. If BMS does not consent to a settlement of a Monetary Claim as contemplated in the immediately preceding sentence, BMS shall assume all of the liability and damages (including any defense costs that would not have been incurred if the Parties settled such claim at the time and in the amount proposed by Sanofi) incurred by the Parties in respect of such claim in excess of the monetary settlement amount proposed by Sanofi to which BMS did not consent. If requested by Sanofi, BMS and its Affiliates shall agree to reasonably cooperate with Sanofi and its counsel in contesting any Third Party Claim that Sanofi elects to contest, including, without limitation, the making of any related counterclaim against the Third Party asserting the Third Party Claim or any cross-complaint against such Third Party.

(iii) Notwithstanding Sanofi’s election to assume the defense of any Third Party Claim, BMS and its Affiliates shall have the right to employ separate counsel and to participate in the defense of such Third Party Claim if (A) the use of counsel chosen by Sanofi to represent both Sanofi and BMS would present such counsel with a conflict of interest; (B) the actual or potential defendants in, or targets of, any such Third Party Claims include both Sanofi or its Affiliates on the one hand, and BMS or its Affiliates on the other hand, and BMS shall have reasonably concluded that there may be a legal defense available to it which is different from or additional to the defenses available to Sanofi and its Affiliates (in which case Sanofi shall not have the right to assume the defense of such Third Party Claim on behalf of BMS and its Affiliates); (C) Sanofi shall not have employed counsel reasonably satisfactory to BMS to represent BMS and/or its Affiliates within a reasonable time after notice of the institution of such Third Party Claim; or (D) Sanofi authorizes BMS to employ separate counsel. All costs and expenses of any separate counsel retained by BMS in accordance with clause (B) or (D) of the immediately preceding sentence shall be assumed and paid for exclusively by BMS and all costs and expenses of any separate counsel retained by BMS in accordance with clause (A) or (D) of the immediately preceding sentence shall be shared equally by BMS and Sanofi.

(iv) If Sanofi fails to notify BMS within thirty (30) days after receipt of notice in accordance with Section 9.1(h)(ii) that Sanofi elects to defend BMS and its Affiliates pursuant to this Section 9.1(h) or if Sanofi elects to defend BMS and its Affiliates pursuant to this Section 9.1(h) but fails to defend or settle the Third Party Claim diligently and promptly, then BMS shall have the right to defend the Third Party Claim by all appropriate proceedings, which proceedings shall be promptly and vigorously defended by BMS or its Affiliate to a final conclusion or settled at the discretion of BMS or its Affiliate; provided , however, that BMS may not enter into any compromise or settlement that does not provide for an unconditional release of liability of Sanofi and its Affiliates, involves equitable relief, any non-monetary remedy or any imposition of any obligation upon Sanofi or a Monetary Claim, without the prior written consent of Sanofi. If Sanofi does not consent to a settlement of a Monetary Claim as contemplated in the immediately preceding sentence, Sanofi shall assume all of the liability and damages (including any defense costs that would not have been incurred if the Parties settled such claim at the time and in the amount proposed by BMS) incurred by the Parties in respect of such claim in excess of the monetary settlement amount proposed by BMS to which Sanofi did not consent. Indemnification pursuant to any other Transaction Document shall be deemed to be subject to the notification and resolution procedures set forth in this Article IX .

 

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ARTICLE X

CLOSING CONDITIONS

10.1 Initial Closing Date Conditions to Each Party’s Obligation . The respective obligations of each Party to this Agreement to consummate the transactions contemplated hereby on the Initial Closing Date shall be subject to the satisfaction on or prior to the Initial Closing Date of the following conditions:

(a) No Injunctions . No Governmental Authority shall have enacted, issued, promulgated, enforced or entered any order, executive order, stay, decree, judgment or injunction (preliminary or permanent) or statute, rule or regulation which is in effect and which has the effect of making the consummation of the transactions contemplated hereby on the Initial Closing Date illegal or otherwise prohibiting consummation of the transactions contemplated by this Agreement.

(b) Requisite Competition Law Approvals . Subject to Section 8.10 , all applicable waiting periods and clearances pursuant to any Requisite Competition Law Approval shall have been unconditionally expired, been terminated or been obtained or waived.

(c) Closing Date Agreements . The Parties and/or their applicable Affiliates shall have entered into and executed each of the Closing Date Agreements.

10.2 Additional Closing Date Conditions to Each Party’s Obligation . The respective obligations of each Party to this Agreement to consummate an Additional Closing pursuant to Section 2.9 shall be subject to the satisfaction on or prior to the such Additional Closing date of the following conditions:

(a) No Injunctions . No Governmental Authority shall have enacted, issued, promulgated, enforced or entered any order, executive order, stay, decree, judgment or injunction (preliminary or permanent) or statute, rule or regulation which is in effect and which has the effect of making the consummation of such Additional Closing on such Additional Closing date illegal or otherwise prohibiting consummation of the transactions contemplated by this Agreement.

(b) Requisite Competition Law Approvals . Subject to Section 8.10 , all Requisite Competition Law Approvals in respect of the Designated Country subject to the Additional Closing shall have been obtained or all applicable waiting periods shall have expired or been terminated.

(c) Additional Closing Date Agreements . The Parties and/or their applicable Affiliates shall have entered into and executed each of the applicable agreements referenced in Section 2.9(b)(ii) .

 

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ARTICLE XI

TERMINATION

11.1 Termination .

(a) This Agreement may be terminated by mutual written consent of the Parties (or by each Party) if the Initial Closing Date has not occurred prior to the Outside Date; provided that the failure of the Initial Closing Date to occur is not due to the breach of such terminating Party.

(b) Prior to the Initial Closing Date, this Agreement may be terminated by either BMS or Sanofi, upon notice to the other Party, following the first to occur of:

(i) Sanofi, BMS or any of their respective partners in JVA, JVB and USIrbeJV having: (A) voluntarily commenced any proceeding or filed any petition seeking relief under Title 11 of the United States Code, Book VI of the French Commercial Code (legislative part as well as regulatory part) or any other bankruptcy, insolvency or similar law of the U.S., any state thereof, the French Republic or any other applicable jurisdiction; (B) applying for or consenting to the appointment of a receiver, trustee, custodian, sequestrator, conciliator, administrator or similar official for it or for all or substantially all of its property; (C) filing an answer admitting the material allegations of a petition filed against or in respect of it in any such proceeding; (D) making a general assignment for the benefit of creditors of all or substantially all of its assets; (E) becoming unable generally, or admitted in writing its inability to, pay all or substantially all of its debts as they become due; or (F) taking corporate action for the purpose of effecting any of the foregoing; or

(c) an involuntary proceeding having been commenced or any involuntary petition having been filed in a court of competent jurisdiction seeking: (A) relief in respect of either Sanofi, BMS or any of their respective partners in JVA, JVB and USIrbeJV, or of its property, under Title 11 of the United States Code, Book VI of the French Commercial Code (legislative part as well as regulatory part) or any other bankruptcy, insolvency or similar law of the United States, any state thereof, the French Republic or any other applicable jurisdiction; (B) the appointment of a receiver, trustee, custodian, sequestrator, conciliator, administrator or similar official for either Sanofi, BMS or any of their respective partners in JVA, JVB and USIrbeJV or for all or substantially all of its property; or (C) the winding-up or liquidation of Sanofi or BMS; and such proceeding or petition having continued undismissed for sixty (60) days or an order or decree approving or ordering any of the foregoing having continued unstayed and in effect for thirty (30) days.

11.2 Effect of Termination . In the event of the termination of this Agreement as provided in Section 11.1 , this Agreement shall immediately become void and there shall be no liability or obligation on the part of the Parties or their respective officers, directors, managers, employees, agents, equity holders or Affiliates; provided that: (a) any such termination shall not relieve any Party from liability for damages for any fraud or breach or failure to perform under this Agreement (including such Party’s obligation to close if it was otherwise obligated to do so under the terms of this Agreement); and (b) the provisions of this Section 11.2 (Effect of Termination) and Article XII (Miscellaneous) shall remain in full force and effect and survive any termination of this Agreement.

 

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ARTICLE XII

MISCELLANEOUS

12.1 Notices . All notices, requests, claims, demands and other communications hereunder (collectively, “Notices”) shall be in writing, shall be in the English language and shall be given or made by delivery in person, by courier service or by registered or certified mail (return receipt requested, with postage prepaid), to the respective Parties at the following addresses:

 

if to BMS, to:       

Bristol-Myers Squibb Company

Route 206 & Province Line Road

Princeton, NJ 08543-4000 USA

Attn: Alliance Manager

 

with copies (which shall not constitute Notice) to:     

Wilmer Cutler Pickering Hale and Dorr LLP

7 World Trade Center

250 Greenwich Street

New York, NY 10007 USA

Attn: [omitted] and [omitted]

 

and

 

Bristol-Myers Squibb Company

Route 206 & Province Line Road

Princeton, NJ 08543-4000 USA

Attn: Vice President & Associate General Counsel – Transactions;

 

and

 

if to Sanofi, to:     

Sanofi

54, rue la Boétie

75008 Paris, FRANCE

Attns: Senior Vice President, Legal Affairs and General Counsel; and Vice President, Alliances & Partnerships

 

with a copy (which shall not constitute Notice) to:     

Weil, Gotshal & Manges LLP

767 Fifth Avenue

New York, NY 10153 USA

Attn: [omitted]

 

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Any Party may designate another addressee (and/or change its address) for Notices hereunder by a Notice given pursuant to this Section 12.1 . All Notices given to any Party in accordance with the provisions of this Section 12.1 shall be deemed to have been given on the date of receipt if delivered by hand or overnight courier service, or on the date ten (10) Business Days after dispatch by certified or registered mail (postage prepaid) if mailed.

12.2 Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of New York applicable to contracts executed and performed entirely in that state, without regarding to any principles of conflicts of laws thereof.

12.3 Specific Performance . Each Party hereby acknowledges and agrees that it and the other Party would be damaged irreparably if any of the provisions of this Agreement are not performed in accordance with their specific terms or otherwise are breached. Accordingly, each Party shall be entitled to seek specific performance and/or interim relief, and agrees that the arbitral tribunal constituted under Section 12.4(b) shall have the power to order specific performance or grant provisional, interim, or conservatory measures, including but not limited to provisional injunctive relief. The Parties undertake to comply forthwith with any such provisional, interim, or conservatory measures ordered by the arbitral tribunal and agree that such measures may, to the extent not precluded by applicable law, be enforceable as a final award in any court of competent jurisdiction. For the avoidance of doubt, nothing in this provision shall prevent any Party from seeking conservatory or interim measures, including, but not limited to, temporary restraining orders or preliminary injunctions or their equivalent, from any court of competent jurisdiction before the arbitral tribunal is constituted under Section 12.4(b) or, thereafter, upon the order of the arbitral tribunal.

12.4 Dispute Resolution .

(a) Negotiation and Notice . In the event of any dispute, claim, controversy or disagreement (each, a “ Dispute ”) arising out of, in connection with or relating to this Agreement including any question regarding this Agreement’s existence, validity or termination, the Parties shall first seek resolution of such Dispute by negotiation between their respective senior management. Such negotiation shall be deemed to commence upon the service by either Party upon the other of a written notice (a “ Dispute Resolution Notice ”) under this Section 12.4(a) .

(b) If a Dispute subject to negotiation under Section 12.4(a) is not finally resolved within thirty (30) days following receipt by one Party of a Dispute Resolution Notice, the Dispute shall be finally resolved by arbitration under the Rules of Arbitration of the International Chamber of Commerce (the “ ICC ”). The arbitral tribunal shall be composed of three (3) arbitrators. Each Party shall nominate one (1) arbitrator. The two arbitrators so nominated shall nominate the presiding arbitrator. If either Party fails to nominate an arbitrator in its Request for Arbitration or within thirty (30) days of receiving written notice of the nomination of an arbitrator by the other Party, such arbitrator shall be appointed by the ICC

 

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Court. If the two (2) arbitrators to be nominated by the Parties fail to agree upon a third arbitrator within thirty (30) days of the nomination of the second arbitrator, the third arbitrator shall be appointed by the ICC Court. The place of arbitration shall be Paris, France and the language of the arbitration shall be English. Notwithstanding any provision to the contrary in the ICC Rules of Arbitration, each Party shall bear its own costs and expenses relating to such arbitration and all related proceedings, including fees for legal representation. Each Party shall continue to perform its respective obligations under this Agreement and this Agreement shall remain in effect while the Dispute is being resolved. The Parties agree that any dispute arising out of or relating to this Agreement, the Settlement Agreement (including the China Opt-Out Letter), or any Alliance Agreement shall be resolved in a single arbitration before the ICC, regardless of how many parties or agreements are implicated, and specifically waive any argument that a dispute arising out of or relating to this Agreement shall be resolved in multiple arbitrations before the ICC.

12.5 No Third Party Beneficiaries . Except for the provisions of Article IX hereof relating to Indemnified Parties, this Agreement shall be binding upon, and inure solely to the benefit of, the Parties hereto and permitted assigns, and nothing herein, express or implied, is intended to, or shall, confer upon any other Person any legal or equitable right, benefit or remedy of any nature whatsoever.

12.6 Severability . If any term or other provision of this Agreement is held to be invalid, illegal or incapable of being enforced by any applicable law or public policy, all other terms and provisions of this Agreement shall nevertheless remain in full force and effect so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to either Party. Upon the determination that any term or other provision is invalid, illegal or incapable of being enforced, the Parties hereto shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in an acceptable manner in order that the transactions contemplated hereby are consummated as originally contemplated to the greatest extent possible.

12.7 Assignment .

(a) Neither Party may assign any of its rights or obligations to a Third Party under this Agreement without the prior written consent of the other Party and any assignment without such consent shall be null and void and of no effect. Either Party may assign any of its rights or obligations under this Agreement to an Affiliate of such Party without the written consent of the other Party, provided that the assigning Party shall remain liable for its Affiliate’s performance hereunder.

(b) Notwithstanding Section 12.7(a) , Sanofi and/or its Affiliates may divest a business or product lines with respect to any Products that are subject to compensation hereunder, provided that Sanofi and its Affiliates shall not divest all or substantially all of its business relating to Irbesartan Products or all or substantially all of its business relating to Clopidogrel Products [*] hereof, and in any event Sanofi and/or its Affiliates shall require the purchaser of any business or Product line with respect to Products that are subject to

 

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compensation hereunder to agree in a written instrument that is reasonably satisfactory to BMS, consent to such written instrument not to be unreasonably withheld or delayed, to continue paying BMS the specified percentage of IFRS Net Sales (and performing other obligations of Sanofi under this Agreement) attributable to the divested business or Product line until the Termination Date; and provided further that Sanofi shall remain responsible for causing such payments to be made and obligations to be fulfilled following any such divestiture, in each case pursuant to documentation that is reasonably satisfactory to BMS, consent to such documentation not to be unreasonably withheld or delayed. Sanofi may assign this Agreement, and any or all of the rights and obligations hereunder, and Sanofi’s Affiliates may assign any Alliance Agreement, without the prior written consent of BMS or any of its Affiliates to a Third Party in connection with a sale permitted under this Section 12.7(b) . BMS shall cause its Affiliates, including the BMS JVA Partner, to vote in favor of, or more generally take any necessary action, to authorize, when its consent is required, any such transfer of any Alliance Agreement or any or all of the rights and obligations thereunder, provided that such transfer is in connection with a sale permitted under this Section 12.7(b) .

(c) In no event shall Sanofi or its Affiliates be restricted in their ability to appoint distributors for Products or to sublicense their rights hereunder, so long as such appointment or sublicensing does not or would not reasonably be expected to result in an assignment in violation of this Section 12.7 .

12.8 Waivers and Amendments . No modification of or amendment to this Agreement shall be valid unless in a writing signed by both Parties referring specifically to this Agreement and stating the Parties’ intention to modify or amend the same. Any waiver of any term or condition of this Agreement shall be in a writing signed by the Party sought to be charged with such waiver referring specifically to the term or condition to be waived, and no such waiver shall be deemed to constitute the waiver of any other term or condition of this Agreement.

12.9 Expenses; Currency of Payments .

(a) Each Party shall bear its own expenses in connection with the negotiation and execution of this Agreement.

(b) To the extent any payment hereunder is required to be made in Euros, and in the event that the Euro is no longer available as a currency for payment in the country of the payor, such payment will be made to the extent required by applicable law, in the currency required by such applicable law, or if applicable law does not require a specific currency, in the currency that the payor uses in preparing its financial statements.

12.10 Waiver of Jury Trial . FOR THE AVOIDANCE OF DOUBT, AND WITHOUT PREJUDICE TO THE PARTIES’ RIGHTS AND OBLIGATIONS UNDER SECTION 12.4 , EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF, OR RELATING TO, THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.

 

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12.11 Counterparts . This Agreement may be executed in one or more counterparts (including by facsimile or e-mail “PDF” transmission), and by the different Parties in separate counterparts, each of which when executed shall be deemed to be an original but all of which when taken together shall constitute one and the same agreement.

12.12 Entire Agreement . This Agreement, including the exhibits and schedules hereto, together with the other instruments referred to herein, including the Settlement Agreement, the Alliance Agreements and the Closing Date Agreements, constitute the entire agreement, and supersede all other prior agreements and understandings, both oral and written, among the Parties and their Affiliates, or any of them, with respect to the subject matter hereof; provided , however, that this provision shall also be deemed to refer to such Additional Closing documents as may be entered into by the Parties and their Affiliates following the Initial Closing Date.

12.13 Performance of Affiliates’ Obligations .

(a) Sanofi and BMS shall each cause their respective Affiliates under the Alliance Agreements, the Transaction Documents, and all other documents or instruments entered into in connection with the transactions contemplated by this Agreement, to perform their respective obligations thereunder, including notably all payment obligations.

(b) Sanofi and BMS shall each be an intended third party beneficiary of each Alliance Agreement to which its Affiliate is a party, and shall be entitled to enforce its Affiliate’s rights under such Alliance Agreement.

(c) In each respect where this Agreement specifies an obligation of JVA (before or after the JVA Closing), JVB (before or after the JVA Closing), or USIrbeJV (after the USIrbeJV Closing), each of the Parties agrees to cause such entity, as applicable, to satisfy the relevant obligation contained in this Agreement; provided , that following the sale of its applicable interest in an entity, BMS shall not be bound by this Section 12.13(c) .

12.14 Indirect Taxes . Each Party undertakes to assume all obligations and liabilities in respect of VAT incurred by such Party in connection with the activities contemplated by this Agreement. Subject to Sections 2.1(k) , 2.3(k) and 2.11(h) of this Agreement and Section 9.1 of the Share Forward Purchase Agreement, indirect taxes (other than VAT) incurred by a Party or any of its Affiliates as a result of any change in the transactions contemplated by this Agreement or by the Transaction Documents, requested or made by the other Party that is not contemplated by this Agreement or the Transaction Documents shall be assumed by the Party requesting or making such change.

[ Signature Page Follows ]

 

65

 

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IN WITNESS WHEREOF , the Parties have caused this Agreement to be signed by their respective officers thereunto duly authorized as of the date first written above.

 

BRISTOL-MYERS SQUIBB COMPANY

 

By:

 

/s/ Charles Bancroft

Name:

Title:

 

Charles Bancroft

Executive Vice President

 

SANOFI

 

By:

 

/s/ David Alexandre Gros

Name:

Title:

 

David Alexandre-Gros

Chief Strategy Officer

[ Signature Page to Master Restructuring Agreement ]

 

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SCHEDULE 1.1(a)

CLOSING DATE AGREEMENTS

Amended and Restated Règlement Intérieur

Amended and Restated Statuts

Amended and Restated Territory A Clopidogrel License

Amended and Restated Territory A Irbesartan License

Amended and Restated Territory A Know-How License

Amended and Restated Territory B Clopidogrel License

Amended and Restated Territory B Know-How License

Amended and Restated Territory B1 Know-How License

Amended and Restated USIrbeJV Irbesartan License

Amended Irbesartan SDEA

Amended Clopidogrel SDEA

Amended JVB Partnership Agreement

Amended Territory B Alliance Support Agreement

Amended Territory B Partnership Agreement

Amended USIrbeJV Partnership Agreement

Business Lease

Cash Flow Principles Amendment

FDC Intellectual Property License

Irbesartan API Supply Agreement

Irbesartan Crude Toll Manufacturing Agreement

Irbesartan Intermediates Supply Agreement

Plavix Finished Product Supply Agreement

Share Forward Purchase Agreement

Technical Agreement

Termination of Existing Supply Agreements

Territory A Alliance Support Agreement Termination Agreement

Territory B1 Assignment Agreement

Toll Packaging Agreement

Quality Agreement Amendments

USIrbeJV Acquisition Agreement

USIrbeJV Alliance Support Agreement Termination Agreement

Minutes of the General Meeting of JVA adopting the Amended and Restated Règlement Intérieur, the Amended and Restated Statuts and authorizing entry into the Business Lease

Local agreements required pursuant to Sections 2.1 and 2.3 for each country within Territory A and Territory B1 (other than Designated Countries)

 

 

S-1

 

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SCHEDULE 1.1(c)

TERRITORY A

With respect to Clopidogrel Products and Irbesartan Products:

Belgium

Germany

Greece

Italy

United Kingdom

the Netherlands

Portugal

Spain

Switzerland

With respect to Clopidogrel Products, only:

Austria

Cyprus

Denmark

France (excluding overseas territories)

Hong-Kong

Iceland

Ireland

Israel

Finland

Korea

Norway

Sweden

Taiwan

With respect to Irbesartan Products, only:

France (including overseas territories)

 

S-2

 

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SCHEDULE 1.1(d)

TERRITORY B1

With respect to Irbesartan Products and Clopidogrel Products:

Argentina

Australia

Brazil

Canada

Mexico

With respect to Clopidogrel Products only:

Colombia

 

S-3

 

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[*][NOTE: TABLE CONTENT FOR SCHEDULE 2.10 HAS BEEN OMITTED.]

SCHEDULE 2.10

INVENTORY PURCHASE

Transferred Inventory – Territories

PART A

 

        Countries        

Products

                                    Products                                             SKU            

Estimated

Future

    Sales

(in unit)    

  

Estimated

Transferred

    Inventory as    

of Initial

Closing Date

(in units)

  

  Estimated

Unit  

Cost

in local

currency

(before unit cost

mark-up

percentage)

  

Unit Cost

Mark-up

  percentage  

  

Estimated

Unit

Cost

in local

currency

(after unit cost
mark-

up percentage)

  

Selling

    Companies    

  

Seller’s

    Premises    

  

Purchasing    

Companies

MEXICO Plant

                                     

Bristol-Myers

Squibb de

Mexico, S. de

R.L. de C.V.

         

1622

                                               
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
     TOTAL MEXICO Plant                                             

MEXICO Market

                                     

Bristol-Myers

Squibb de

Mexico, S. de

R.L. de C.V.

         

1624

                                               
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
     TOTAL MEXICO Market                                             

 

S-4

 

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ARGENTINA

1744

                                     

Bristol-Myers

Squibb Argentina

S. R. L

         
                                     
                                     
                                               
                        TOTAL ARGENTINA                                             

CANADA

                                     

Bristol-Myers

Squibb Canada

Co.

         

1728

                                               
                                                 
                                                 
                                                 
                                                 
                                                 
     TOTAL CANADA                                             

US

                                                 

1658

                                     

Bristol-Myers

Squibb Sanofi-

Synthelabo

Partnership

         

Bulk 1248

                                               
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
     TOTAL US                                             

    PUERTO RICO    

                                                 

1682

                                     

Bristol-Myers

Squibb Puerto

Rico/Sanofi-

Synthelabo

Puerto Rico

         
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                   
     TOTAL PUERTO RICO                                             

 

S-5

 

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    AUSTRALIA    

                                                 

1741

                                                 
                                                   
                                       

Bristol-Myers

Squibb Australia

Pty. Ltd

         
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                        TOTAL AUSTRLIA                                             

SPAIN

                                     

Bristol-Myers

Squibb, S.A.U.

         

1395

                                               
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
     TOTAL SPAIN                                             

GREECE

                                     

Bristol-Myers

Squibb A.E.

         

1597

                                               
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
     TOTAL GREECE                                             

GERMANY

                                     

Bristol-Myers

Squibb GmbH & Co.

KGaA

         

1332

                                               
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
     TOTAL GERMANY                                             

ITALY

                                     

Bristol-Myers

Squibb S.r.l.

         

1340

                                               
                                                 
                                                 
                                                 
                                                 
                                                 
                                                 
     TOTAL ITALY                                             

 

S-6

 

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PART B

 

                              

    Countries    

Products

          Products            SKU   

Selling

Companies

  

Purchasing

Companies

                              

Austria

  Clopidogrel               
                    

Belgium

  Clopidogrel               
                    
                    
                    
                    
                    
    Irbesartan               
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    

Denmark

  Clopidogrel               
                    
                    

Finland

  Clopidogrel               
                    
                    

France

  Clopidogrel               
                    

 

S-7

 

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    Countries    

Products

          Products            SKU   

Selling

Companies

  

Purchasing

Companies

                              
                    
                    
                    
                    
                    
    Irbesartan               
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
Hong Kong   Clopidogrel               
                    
                    

Ireland

  Clopidogrel               

 

S-8

 

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    Countries    

Products

          Products            SKU   

Selling

Companies

  

Purchasing

Companies

                              
                    
                    
    Irbesartan               
Italy   Clopidogrel               
                    
                    
                    
                    
The Netherlands   Clopidogrel               
                    
                    
                    
    Irbesartan               
                    
                    
                    
                    
                    
                    
                    
Norway/Iceland   Clopidogrel               
                    
                    
                    
Portugal   Clopidogrel               
                    
    Irbesartan               
                    

 

S-9

 

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    Countries    

Products

          Products            SKU   

Selling

Companies

  

Purchasing

Companies

                              
                    
                    
                    
                    
                    
                    
                    
Sweden   Clopidogrel               
                    
                    
                    
Switzerland   Clopidogrel               
                    
                    
                    
                    
                    
                    
    Irbesartan               
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    

 

S-10

 

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    Countries    

Products

          Products            SKU   

Selling

Companies

  

Purchasing

Companies

                              
                    
                    
                    
United Kingdom   Clopidogrel               
                    
    Irbesartan               
                    
                    
                    
                    
                    

 

S-11

 

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SCHEDULE 4.1(c)

OWNERSHIP

 

Territory  

BMS Affiliate

(Partnership Interest)

 

Sanofi Affiliate

(Partnership Interest)

JVA   49.9%   50.1%
JVB   50.1%   49.9%
USIrbeJV   50.1%   49.9%

 

 

S-12

 

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SCHEDULE 4.2(b)

ASSIGNED CONTRACTS

 

1. Consulting Agreement effective as of October 26, 2010 between [*] and [*].

 

2. Industry Support Agreement effective as of November 18, 2010 among [*], [*] and [*].

 

3. Services Agreement effective as of March 21, 2011 between [*] and [*].

 

4. Agreement effective April 1, 2009 between [*] and [*].

 

5. Amending Agreement No. 1 effective as of July 15, 2010 between [*] and [*].

 

6. Amending Agreement No. 2 effective as of April 26, 2011 between [*] and [*].

 

7. Additional [*] Contracts.

 

  a. Professional Services Agreement dated March 15, 2012, between [*] and [*] (each, a duly authorized representative of the [*]) of the first part, and [*] of the second part.
  b. Amendment to Professional Services Agreement (effective September 29, 2011, between [*] and [*]) entered into as of February 15, 2012, between [*] and [*] (each, a duly authorized representative of the [*]) of the first part, and [*] of the second part.
  c. Amendment to Services Agreement (effective March 21, 2011, as amended, between [*] and [*]) dated February 20, 2012, between [*] and [*] (each, a duly authorized representative of the [*]) of the first part, and [*] of the second part.
  d. Confidential Disclosure Agreement dated as of February 14, 2012 between [*] and [*].

 

S-13

 

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[*][NOTE: TABLE CONTENT FOR SCHEDULE 5.1(a) HAS BEEN OMITTED.]

SCHEDULE 5.1(a)

MARKETING AUTHORIZATIONS

Clopidogrel

MAs to be transferred to Sanofi

 

Country

 

 

Trade

Names

 

 

Pharmaceutical

Form

 

 

Strength

 

 

License
status

 

 

MAH

 

 

 

Marketing status

 

MA number

 

           

Marketed

 

 

Not marketed

 

 
                                 
                                 
                                 

MAs to be withdrawn by BMS

 

Country  

Trade

Names

 

 

Pharmaceutical

Form

 

 

Strength

 

 

License status

 

 

MAH

 

 

 

Marketing status

 

MA number

 

           

Marketed

 

 

Not marketed

 

 
                                 
                                 

 

S-14

 

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Country  

Trade

Names

 

Pharmaceutical

Form

  Strength   License status   MAH   Marketing status   MA number
            Marketed   Not marketed  
                                 

Note: In [*], Sanofi is the Marketing Authorization holder and BMS will transfer the regulatory documents related to local activities currently performed by BMS.

Clopidogrel ASA

MAs to be transferred to Sanofi

 

Country   Trade Names  

Pharmaceutical

Form

  Strength   License status   MAH   Marketing status   MA number
            Marketed   Not marketed  
                                 
                                 

 

S-15

 

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MAs to be withdrawn by BMS

 

Country   Trade Names  

Pharmaceutical

Form

  Strength   License status   MAH   Marketing status   MA number
            Marketed   Not marketed  
                                 
                                 

IRBESARTAN

MAs to be transferred to Sanofi

 

Country   Trade Names  

Pharmaceutical

Form

  Strength   License status   MAH   Marketing status   MA number
            Marketed   Not marketed  
                                 
                                 
                           

 

S-16

 

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MAs to be withdrawn by BMS

 

Country   Trade Names  

Pharmaceutical

Form

  Strength   License status   MAH   Marketing status   MA number
            Marketed   Not marketed  
                                 

Note: In the [*], regulatory documents related to local activities currently performed by BMS, will be transferred to Sanofi who is the Marketing Authorization holder in those countries.

Irbesartan HCTZ

MAs to be transferred to Sanofi

 

Country   Trade Names  

Pharmaceutical

Form

  Strength   License status   MAH   Marketing status   MA number
            Marketed   Not marketed  
                                 
                               
                                 
                                 

 

S-17

 

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Country   Trade Names  

Pharmaceutical

Form

  Strength   License status   MAH   Marketing status   MA number
            Marketed   Not marketed  
                                 
                                 
                                 
                             

MAs to be withdrawn by BMS

Country   Trade Names  

Pharmaceutical

Form

  Strength   License status   MAH   Marketing status   MA number
            Marketed   Not marketed  
                                 

Note: In the [*], regulatory documents related to local activities currently performed by BMS, will be transferred to Sanofi who is the Marketing Authorization holder in those countries.

 

S-18

 

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SCHEDULE 6.4

RESTRICTED COUNTRY LIST

Cuba

Iran

North Korea

Sudan

Syria

 

S-19

 

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[*][NOTE: TABLE CONTENT FOR SCHEDULE 7.2(b) HAS BEEN OMITTED.]

SCHEDULE 7.2(b)

INTELLECTUAL PROPERTY ACTIONS

Clopidogrel

 

 

 Type of 

Action 

  Brought    

 

 

 

Country/

    Jurisdiction/    

Court

 

 

 

Parties

  

 

Patents and Expiration

Dates, Including

Extensions (in each case,

if applicable)

 

  

 

Date

Suit

    Filed    

         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   

Irbesartan

 

 

 Type of 

Action 

  Brought    

 

 

 

Country/

    Jurisdiction/    

Court

 

 

 

Parties

  

 

Patents and Expiration

Dates, Including

Extensions (in each case,

if applicable)

 

  

 

Date

Suit

    Filed    

         
                   
         
                   
         
                   
         
                   

 

S-20

 

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 Type of 

Action 

  Brought    

 

 

 

Country/

    Jurisdiction/    

Court

 

 

 

Parties

  

 

Patents and Expiration

Dates, Including

Extensions (in each case,

if applicable)

 

  

 

Date

Suit

    Filed    

         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   

 

S-21

 

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SCHEDULE 8.1

ANTITRUST FILINGS

Argentina

Australia

Austria

Germany

Canada

 

S-22

 

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SCHEDULE 8.10

MODIFIED DESIGNATED COUNTRY STRUCTURE

For Designated Countries in Territory A:

 

   

The Parties agree that no Modified Designated Country Structure need be agreed for countries in Territory A, but the Parties shall cooperate in good faith to implement such Modified Designated Country Structures as may be required following the date hereof,

For each Designated Country in Territory B1:

 

   

The Territory B1 Assignment Agreement shall be modified such that the Territory B Clopidogrel License, the Territory B Irbesartan License and the Territory B Know-How License shall not be assigned to sanofi-aventis U.S. LLC with respect to the Designated Country.

 

   

The amendment and restatement of the Territory B Clopidogrel License and the Territory B Know-How License shall reflect the retention of the Designated Country in its territory (in addition to the U.S.).

 

   

JVB and Sanofi will enter into an amended and restated version of the non-assigned portion of the Territory B Irbesartan License to reflect the restriction of its territory to the Designated Country.

 

   

Sanofi and JVB will enter into an Irbesartan supply agreement which will have the same terms as the Supply Agreement for Clopidogrel but for changes to reflect the difference in product and differences required by law.

 

   

Any local Co-Marketing agreements, partnerships or other local agreements for the Designated Country will not be terminated.

 

   

The amendment to the Territory B Alliance Support Agreement will retain appropriate governance at JVB to support the Designated Country.

 

   

BMS shall have diligence obligations in the Designated Country consistent with those applicable to Sanofi under Section 6.2 of the Agreement.

 

S-23

 

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SCHEDULE 8.16

TERMINATION OF ALLIANCE AGREMENTS

The following Alliance Agreement shall not be terminated:

 

  1. Letter Agreement, between BMS and Sanofi, dated March 20, 2012, regarding Generic Sartan Waiver, Opt-Out Royalties for 2007-2008 and Colombia litigation.

 

  2. Co-Exclusive Patent Sublicense Agreement (“Patent Sublicense”) regarding Clopidogrel in Mexico, among JVB, as sublicensor, and Sanofi-Synthélabo S.A. de C.V., as sublicensee, and Bristol-Myers Squibb de Mexico, S. de R.L. de C.V., as sublicensee, dated February 22, 2005. The Parties agree that the Patent Sublicense shall be terminated upon the transfer of the relevant Marketing Authorization in Mexico from BMS or one of its Affiliates to Sanofi or one of its Affiliates.

 

S-24

 

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[*][NOTE: TABLE CONTENT FOR SCHEDULE 9.1 HAS BEEN OMITTED.]

SCHEDULE 9.1

PENDING CLAIMS

Claims set forth on Schedule 7.2(b) are incorporated by reference in all instances where either Sanofi or BMS or their respective Affiliates (including the alliance partnerships) face actual or threatened liability.

Clopidogrel

 

 Type of 

Action 

  Brought    

 

 

Country/

    Jurisdiction/    

Court

 

 

Parties

  

Description

  

 Date Suit 

Filed

         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   
         
                   

Irbesartan

 

 Type of 

Action 

  Brought    

 

 

Country/

    Jurisdiction/    

Court

 

 

Parties

  

Description

  

 Date Suit 

Filed

         
                   
         
                   

 

S-25

 

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EXHIBIT 12.

Computation of Earnings to Fixed Charges

 

Ratio of Earnings to Fixed Charges:   Nine Months Ended
September 30,
2012
    Year Ended December 31,  
    2011     2010     2009     2008  
Dollars in Millions                              

Earnings

         

Earnings from continuing operations before income taxes

  $ 1,827     $ 6,981     $ 6,071     $ 5,602     $ 4,776  

Less:

         

Noncontrolling interest in pre-tax income of subsidiaries that have not incurred fixed charges

    847       2,323       2,074       1,717       1,444  

Equity in net income of affiliates

    150       281       313       550       617  

Capitalized interest

                  8       13       21  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted income

    830       4,377       3,676       3,322       2,694  

Add:

         

Fixed charges

    165       190       201       242       387  

Distributed income of equity investments

    183       283       313       550       590  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Earnings

  $ 1,178     $         4,850     $         4,190     $         4,114     $         3,671  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Fixed Charges

         

Interest expense

  $ 131     $ 145     $ 145     $ 184     $ 310  

Capitalized interest

                  8       13       21  

One-third of rental expense (1)

    34       45       48       45       56  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Fixed Charges

  $ 165     $ 190     $ 201     $ 242     $ 387  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Ratio of Earnings to Fixed Charges

    7.14       25.53       20.85       17.00       9.49  

 

(1)

Rents included in the computation consist of one-third of rental expense which the Company believes to be a reasonable estimate of an interest factor in its leases.

 

E-12-1

EXHIBIT 31a.

CERTIFICATION BY THE CHIEF EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Lamberto Andreotti, certify that:

 

1.

I have reviewed Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012;

 

2.

Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

4.

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a.

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

  b.

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c.

evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d.

disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

 

  a.

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b.

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: October 24, 2012

 

/s/ Lamberto Andreotti

Lamberto Andreotti

Chief Executive Officer

 

E-31-1

EXHIBIT 31b.

CERTIFICATION BY THE CHIEF FINANCIAL OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Charles Bancroft, certify that:

 

1.

I have reviewed Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012;

 

2.

Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

4.

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a.

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

  b.

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c.

evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d.

disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

 

  a.

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b.

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: October 24, 2012

 

/s/ Charles Bancroft

Charles Bancroft

Executive Vice President and Chief Financial Officer

 

E-31-2

EXHIBIT 32a.

Certification by the Chief Executive Officer Pursuant to 18 U. S. C. Section 1350, as

Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. Section 1350, I, Lamberto Andreotti, hereby certify that, to the best of my knowledge, Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 (the Report), as filed with the Securities and Exchange Commission on October 24, 2012, fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Bristol-Myers Squibb Company.

 

/s/ Lamberto Andreotti

Lamberto Andreotti

Chief Executive Officer

October 24, 2012

 

E-32-1

EXHIBIT 32b.

Certification by the Chief Financial Officer Pursuant to 18 U. S. C. Section 1350, as

Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. Section 1350, I, Charles Bancroft, hereby certify that, to the best of my knowledge, Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 (the Report), as filed with the Securities and Exchange Commission on October 24, 2012, fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Bristol-Myers Squibb Company.

 

/s/ Charles Bancroft

Charles Bancroft

Executive Vice President and Chief Financial Officer

October 24, 2012

 

E-32-2