-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, IMPDUxGtxPDT8WdN1csE0nNt4fokYVuuCI2NZEHz5QKCmof6nKBWSxyt1EzpRpdX sAoQRa64v4MUAF+FkqcT8Q== 0001047469-07-008776.txt : 20071108 0001047469-07-008776.hdr.sgml : 20071108 20071108172939 ACCESSION NUMBER: 0001047469-07-008776 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20070930 FILED AS OF DATE: 20071108 DATE AS OF CHANGE: 20071108 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENZYME CORP CENTRAL INDEX KEY: 0000732485 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 061047163 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-14680 FILM NUMBER: 071227135 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQ CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6172527500 MAIL ADDRESS: STREET 1: ONE KENDALL SQUARE CITY: CAMBRIDGE STATE: MA ZIP: 02139 10-Q 1 a2180321z10-q.htm FORM 10-Q

Use these links to rapidly review the document
GENZYME CORPORATION AND SUBSIDIARIES FORM 10-Q, SEPTEMBER 30, 2007 TABLE OF CONTENTS



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


FORM 10-Q

(Mark One)

ý   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2007
or

o

 

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 0-14680

GENZYME CORPORATION
(Exact name of registrant as specified in its charter)

Massachusetts
(State or other jurisdiction of
incorporation or organization)
  06-1047163
(I.R.S. Employer Identification No.)

500 Kendall Street,
Cambridge, Massachusetts

(Address of principal executive offices)

 

02142
(Zip Code)

(617) 252-7500
(Registrant's telephone number, including area code)


        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 such filing requirements for the past 90 days. Yes ý        No o

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

Large accelerated filer ý        Accelerated filer o        Non-accelerated filer o

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

        The number of shares of Genzyme Stock outstanding as of October 31, 2007: 265,975,721




NOTE REGARDING REFERENCES TO OUR COMMON STOCK

        Throughout this Form 10-Q, the words "we," "us," "our" and "Genzyme" refer to Genzyme Corporation as a whole, and "our board of directors" refers to the board of directors of Genzyme Corporation. We have one outstanding series of common stock, which we refer to as "Genzyme Stock."

NOTE REGARDING FORWARD-LOOKING STATEMENTS

        This Form 10-Q contains forward-looking statements, including statements regarding:

    our plans to seek marketing approvals for our products in additional jurisdictions, including Myozyme and Thymoglobulin;

    our plans and our anticipated timing for pursuing additional indications and uses for our products and services, including Synvisc, Campath and Clolar and for pursuing approvals of Renvela and Synvisc-One;

    our expectations for Renvela, including our ability to use it to expand the market for our phosphate binder to patients with chronic kidney disease, or CKD, not yet on dialysis;

    the timing and availability of data from clinical trials;

    the anticipated drivers for the future growth of our products, including Renvela, Hectorol and Synvisc-One;

    our estimates of the capacity of, and the projected timetable of approvals for, manufacturing and other facilities and production methods to support our products and services, including the larger-scale manufacturing process for Myozyme;

    our assessment of competitors and potential competitors and the anticipated impact of potentially competitive products on our revenues;

    our estimates of the potential markets for our products and services;

    our ability to meet the expected demand for our products, including Thymoglobulin and our ability to optimize the U.S. supply of Myozyme;

    Cerezyme's future contribution to revenues;

    our intention to pursue our rights with respect to insurance coverage for our settlement of a class action lawsuit under a director and officer liability insurance program;

    our assessment of the outcome, timetables and financial impact of litigation and other governmental proceedings and the potential impact of unasserted claims;

    the sufficiency of our cash, cash equivalents, short- and long-term investments and cash flows from operations;

    our U.S. and foreign income tax audits, including our provision for liabilities and our assessment of the impact of settlement of the Internal Revenue Service, commonly referred to as the IRS, and foreign tax disputes;

    our estimates of the cost to complete and estimated commercialization dates for our in-process research and development, or IPR&D, programs;

    our expected future revenues, operations, expenditures, allocations and expenses, and the assumptions underlying those estimates;

    our projected future earnings and earnings per share;

2


    our assessment of the impact of recent accounting pronouncements, including Financial Accounting Standards Board, or FASB, Statement of Financial Accounting Standards No., or FAS, 157, regarding fair value measurements, FAS 159, regarding the fair value option for financial assets and financial liabilities and Emerging Issues Task Force, or EITF, Issue No. 07-3, regarding accounting for nonrefundable advance payments for goods or services used in future research and development activities;

    our sales and marketing plans;

    our assessment of certain lots of Thymoglobulin finished goods inventory to determine if they meet product specifications and the expected timing of the completion of this review;

    our acquisition of Bioenvision, Inc., or Bioenvision, and the expected timing and payments related to the acquisition;

    our planned acquisition of the diagnostics division of Diagnostic Chemicals Limited, or DCL, and the expected timing and payments related to the acquisition;

    our expected future contingent payments due to Synpac (North Carolina), Inc., or Synpac; and

    our expected future payments related to our acquisitions, including milestone and royalty payments to the former shareholders of Surgi.B Chirugie et Medicine SAS, or Surgi.B, Wyeth, and Verigen AG, or Verigen, and employee benefits and leased facilities acquired from AnorMED Inc., or AnorMED, and the expected timing of these payments.

        These statements are subject to risks and uncertainties, and our actual results may differ materially from those that are described in this report. These risks and uncertainties include:

    our ability to successfully complete preclinical and clinical development of our products and services;

    our ability to secure regulatory approvals for our products, services and manufacturing facilities, and to do so in the anticipated timeframes;

    the content and timing of submissions to and decisions made by the United States Food and Drug Administration, commonly referred to as the FDA, the European Agency for the Evaluation of Medicinal Products, or EMEA, and other regulatory agencies related to our products and the facilities and processes used to manufacture our products (including FDA approval of larger-scale manufacturing of Myozyme);

    our ability to satisfy the post-marketing commitments made as a condition of the marketing approvals of Fabrazyme, Aldurazyme and Myozyme;

    our ability to manufacture sufficient amounts of our products for development and commercialization activities and to do so in a timely and cost-effective manner, including our ability to manufacture Thymoglobulin that meets product specifications and in quantities to meet projected market demand;

    our reliance on third parties to provide us with materials and services in connection with the manufacture of our products;

    our ability to obtain and maintain adequate patent and other proprietary rights protection for our products and services and successfully enforce these proprietary rights;

    the scope, validity and enforceability of patents and other proprietary rights held by third parties and their impact on our ability to commercialize our products and services;

    the accuracy of our estimates of the size and characteristics of the markets to be addressed by our products and services, including growth projections;

3


    market acceptance of our products and services in expanded areas of use and new markets;

    our ability to identify new patients for our products and services;

    our ability to increase market penetration both outside and within the United States of our products and services;

    the accuracy of our information regarding the products and resources of our competitors and potential competitors;

    the availability of reimbursement for our products and services from third party payors, the extent of such coverage and the accuracy of our estimates of the payor mix for our products;

    our ability to effectively manage wholesaler inventories of our products and the levels of their compliance with our inventory management programs;

    our ability to establish and maintain strategic license, collaboration and distribution arrangements and to successfully manage our relationships with licensors, collaborators, distributors and partners;

    the continued funding and operation of our joint ventures by our partners;

    our use of cash in business combinations or other strategic initiatives;

    the resolution of the dispute with our insurance carriers regarding our claim for coverage under a director and officer liability insurance program;

    the initiation of legal proceedings by or against us;

    the impact of changes in the exchange rate for the Euro and other currencies on our product and service revenues in future periods;

    our ability to successfully integrate the business we acquired from AnorMED;

    our ability to successfully integrate the business we acquired from Bioenvision effective October 23, 2007;

    our ability to complete the planned acquisition of the diagnostics division of DCL on the anticipated terms and timeline;

    the number of diluted shares of our stock considered outstanding, which will depend on business combination activity, our stock price and any further changes in the accounting rules for the calculation of earnings per share;

    the estimates and input variables used in accounting for stock options and the related stock-based compensation expense;

    the outcome of our IRS and foreign tax audits; and

    the possible disruption of our operations due to terrorist activities, armed conflict, severe climate change or outbreak of diseases such as severe acute respiratory syndrome (SARS) or avian influenza, including as a result of the disruption of operations of regulatory authorities, our subsidiaries, manufacturing facilities, customers, suppliers, distributors, couriers, collaborative partners, licensees and clinical trial sites.

        We provide more detailed descriptions of these and other risks and uncertainties under the heading "Risk Factors," included in this report. We encourage you to read those descriptions carefully. We caution investors not to place substantial reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report

4



(unless another date is indicated), and we undertake no obligation to update or revise the statements in light of future developments.

NOTE REGARDING INCORPORATION BY REFERENCE

        The U.S. Securities and Exchange Commission, commonly referred to as the SEC, allows us to disclose important information to you by referring you to other documents we have filed or will file with them. The information that we refer you to is "incorporated by reference" into this Form 10-Q. Please read that information.

NOTE REGARDING TRADEMARKS

        Genzyme®, Cerezyme®, Ceredase®, Fabrazyme®, Thyrogen®, Myozyme®, Renagel®, Campath®, Clolar®, Thymoglobulin®, Synvisc®, Seprafilm® and Hectorol® are registered trademarks, and Lymphoglobuline™, Sepra™, Mozobil™, Renvela™ and Synvisc-One™ are trademarks, of Genzyme or its subsidiaries. WelChol® is a registered trademark of Sankyo Pharma, Inc. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC. All rights reserved.

5



GENZYME CORPORATION AND SUBSIDIARIES

FORM 10-Q, SEPTEMBER 30, 2007

TABLE OF CONTENTS

 
   
PART I.   FINANCIAL INFORMATION
ITEM 1.   Financial Statements
    Unaudited, Consolidated Statements of Operations and Comprehensive Income for the Three and Nine Months Ended September 30, 2007 and 2006
    Unaudited, Consolidated Balance Sheets as of September 30, 2007 and December 31, 2006
    Unaudited, Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2007 and 2006
    Notes to Unaudited, Consolidated Financial Statements
ITEM 2.   Management's Discussion and Analysis of Financial Condition and Results of Operations
ITEM 3.   Quantitative and Qualitative Disclosures About Market Risk
ITEM 4.   Controls and Procedures
PART II.   OTHER INFORMATION
ITEM 1.   Legal Proceedings
ITEM 1A.   Risk Factors
ITEM 2.   Unregistered Sales of Equity Securities and Use of Proceeds
ITEM 6.   Exhibits
Signatures

6



PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS


GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Statements of Operations and Comprehensive Income

(Unaudited, amounts in thousands, except per share amounts)

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
 
  2007
  2006
  2007
  2006
 
Revenues:                          
  Net product sales   $ 867,682   $ 734,231   $ 2,511,354   $ 2,110,301  
  Net service sales     83,177     71,153     241,533     210,987  
  Research and development revenue     9,300     3,190     23,874     11,484  
   
 
 
 
 
    Total revenues     960,159     808,574     2,776,761     2,332,772  
   
 
 
 
 
Operating costs and expenses:                          
  Cost of products sold     190,475     134,140     508,451     388,609  
  Cost of services sold     54,137     50,536     156,222     148,350  
  Selling, general and administrative     270,306     239,700     878,807     743,849  
  Research and development     175,800     162,293     540,362     483,557  
  Amortization of intangibles     49,819     50,542     149,301     156,117  
  Charge for impaired goodwill         219,245         219,245  
   
 
 
 
 
    Total operating costs and expenses     740,537     856,456     2,233,143     2,139,727  
   
 
 
 
 
Operating income (loss)     219,622     (47,882 )   543,618     193,045  
   
 
 
 
 
Other income (expenses):                          
  Equity in income (loss) of equity method investments     (12,648 )   4,530     (1,091 )   10,630  
  Minority interest     5     2,545     3,932     7,741  
  Gains on investments in equity securities, net     1,105     128     14,036     75,037  
  Other     913     (873 )   110     (1,331 )
  Investment income     18,222     16,760     51,687     39,401  
  Interest expense     (1,474 )   (3,772 )   (9,283 )   (12,245 )
   
 
 
 
 
    Total other income     6,123     19,318     59,391     119,233  
   
 
 
 
 
Income (loss) before income taxes     225,745     (28,564 )   603,009     312,278  
(Provision for) benefit from income taxes     (66,432 )   44,530     (201,715 )   (60,841 )
   
 
 
 
 
Net income   $ 159,313   $ 15,966   $ 401,294   $ 251,437  
   
 
 
 
 
Net income per share:                          
  Basic   $ 0.61   $ 0.06   $ 1.52   $ 0.96  
   
 
 
 
 
  Diluted   $ 0.58   $ 0.06   $ 1.45   $ 0.93  
   
 
 
 
 
Weighted average shares outstanding:                          
  Basic     262,775     261,541     263,387     260,565  
   
 
 
 
 
  Diluted     279,206     278,271     279,898     277,130  
   
 
 
 
 
Comprehensive income, net of tax:                          
Net income   $ 159,313   $ 15,966   $ 401,294   $ 251,437  
   
 
 
 
 
Other comprehensive income (loss):                          
  Foreign currency translation adjustments     76,836     7,914     98,082     85,647  
   
 
 
 
 
  Other, net of tax     (274 )   (129 )   (540 )   (406 )
   
 
 
 
 
  Unrealized gains (losses) on securities, net of tax:                          
    Unrealized gains arising during the period, net of tax     7,450     7,066     12,812     43,004  
    Reclassification adjustment for (gains) losses included in net income, net of tax     (991 )   242     (8,839 )   (45,490 )
   
 
 
 
 
    Unrealized gains (losses) on securities, net of tax     6,459     7,308     3,973     (2,486 )
   
 
 
 
 
Other comprehensive income     83,021     15,093     101,515     82,755  
   
 
 
 
 
Comprehensive income   $ 242,334   $ 31,059   $ 502,809   $ 334,192  
   
 
 
 
 

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

7



GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Balance Sheets

(Unaudited, amounts in thousands, except par value amounts)

 
  September 30,
2007

  December 31,
2006

 
ASSETS  
Current assets:              
  Cash and cash equivalents   $ 849,864   $ 492,170  
  Short-term investments     87,503     119,894  
  Accounts receivable, net     879,163     746,746  
  Inventories     438,872     374,644  
  Prepaid expenses and other current assets     137,793     119,122  
  Deferred tax assets     131,772     136,925  
   
 
 
    Total current assets     2,524,967     1,989,501  

Property, plant and equipment, net

 

 

1,850,754

 

 

1,610,593

 
Long-term investments     512,181     673,540  
Note receivable—related party         7,290  
Goodwill, net     1,299,946     1,298,781  
Other intangible assets, net     1,389,180     1,492,038  
Deferred tax assets—noncurrent     78,243      
Investments in equity securities     107,734     66,563  
Other noncurrent assets     79,296     52,882  
   
 
 
    Total assets   $ 7,842,301   $ 7,191,188  
   
 
 

LIABILITIES AND STOCKHOLDERS' EQUITY

 
Current liabilities:              
  Accounts payable   $ 77,823   $ 98,063  
  Accrued expenses     569,559     477,442  
  Income taxes payable         54,853  
  Deferred revenue and other income     39,307     14,855  
  Current portion of long-term debt and capital lease obligations     6,519     6,226  
   
 
 
    Total current liabilities     693,208     651,439  

Long-term debt and capital lease obligations

 

 

115,096

 

 

119,803

 
Convertible notes     690,000     690,000  
Deferred revenue—noncurrent     5,574     6,675  
Deferred tax liabilities         10,909  
Other noncurrent liabilities     54,652     51,651  
   
 
 
    Total liabilities     1,558,530     1,530,477  
   
 
 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 
  Preferred stock, $0.01 par value          
  Common stock, $0.01 par value     2,635     2,630  
  Additional paid-in capital     5,193,116     5,106,274  
  Notes receivable from stockholders     (15,516 )   (15,057 )
  Accumulated earnings     747,816     312,659  
  Accumulated other comprehensive income     355,720     254,205  
   
 
 
    Total stockholders' equity     6,283,771     5,660,711  
   
 
 
    Total liabilities and stockholders' equity   $ 7,842,301   $ 7,191,188  
   
 
 

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

8



GENZYME CORPORATION AND SUBSIDIARIES

Consolidated Statements of Cash Flows

(Unaudited, amounts in thousands)

 
  Nine Months Ended
September 30,

 
 
  2007
  2006
 
Cash Flows from Operating Activities:              
  Net income   $ 401,294   $ 251,437  
  Reconciliation of net income to cash flows from operating activities:              
    Depreciation and amortization     246,556     246,651  
    Stock-based compensation     146,441     160,219  
    Provision for bad debts     7,045     6,329  
    Charge for impaired goodwill         219,245  
    Equity in income (loss) of equity method investments     1,091     (10,630 )
    Minority interest     (3,932 )   (7,741 )
    Gains on investments in equity securities, net     (14,036 )   (75,037 )
    Deferred income tax benefit     (81,629 )   (92,815 )
    Tax benefit from employee stock-based compensation     12,459     20,751  
    Excess tax benefits from stock-based compensation     (1,229 )   (8,979 )
    Other     5,585     (2,511 )
    Increase (decrease) in cash from working capital changes (excluding impact of acquired assets and assumed liabilities):              
      Accounts receivable     (103,285 )   (77,211 )
      Inventories     (32,559 )   (29,092 )
      Prepaid expenses and other current assets     (16,790 )   (1,519 )
      Income taxes payable     (17,419 )   13,545  
      Accounts payable, accrued expenses and deferred revenue     61,235     4,290  
   
 
 
        Cash flows from operating activities     610,827     616,932  
   
 
 
Cash Flows from Investing Activities:              
  Purchases of investments     (602,451 )   (750,855 )
  Sales and maturities of investments     796,612     643,594  
  Purchases of equity securities     (20,362 )   (6,115 )
  Proceeds from sales of investments in equity securities     20,712     137,806  
  Purchases of property, plant and equipment     (281,309 )   (236,917 )
  Acquisition of Bioenvision stock     (72,229 )    
  Distributions from equity method investments     17,100     12,000  
  Payment of note receivable from Dyax Corp.     7,771     370  
  Purchases of other intangible assets     (45,821 )   (67,793 )
  Other     658     4,292  
   
 
 
        Cash flows from investing activities     (179,319 )   (263,618 )
   
 
 
Cash Flows from Financing Activities:              
  Proceeds from issuance of common stock     100,276     112,012  
  Repurchase of common stock     (181,210 )    
  Excess tax benefits from stock-based compensation     1,229     8,979  
  Payments of debt and capital lease obligations     (4,606 )   (3,155 )
  Increase (decrease) in bank overdrafts     19,259     (16,285 )
  Minority interest contributions     4,136     8,265  
  Other     3,525     2,610  
   
 
 
        Cash flows from financing activities     (57,391 )   112,426  
   
 
 
Effect of exchange rate changes on cash     (16,423 )   5,187  
   
 
 
Increase in cash and cash equivalents     357,694     470,927  
Cash and cash equivalents at beginning of period     492,170     291,960  
   
 
 
Cash and cash equivalents at end of period   $ 849,864   $ 762,887  
   
 
 

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

9



GENZYME CORPORATION AND SUBSIDIARIES

Notes to Unaudited, Consolidated Financial Statements

1. Description of Business

        We are a global biotechnology company dedicated to making a major impact on the lives of people with serious diseases. Our broad product and service portfolio is focused on rare disorders, renal diseases, orthopaedics, transplant, and diagnostic and predictive testing. We are organized into five financial reporting units, which we also consider to be our reporting segments:

    Renal, which develops, manufactures and distributes products that treat patients suffering from renal diseases, including chronic renal failure. The unit derives substantially all of its revenue from sales of Renagel (including sales of bulk sevelamer) and Hectorol;

    Therapeutics, which develops, manufactures and distributes therapeutic products, with an expanding focus on products to treat patients suffering from genetic diseases and other chronic debilitating diseases, including a family of diseases known as lysosomal storage disorders, or LSDs, and other specialty therapeutics, such as Thyrogen. The unit derives substantially all of its revenue from sales of Cerezyme, Fabrazyme, Myozyme and Thyrogen;

    Transplant, which develops, manufactures and distributes therapeutic products that address pre-transplantation, prevention and treatment of rejection in organ transplantation and other auto-immune disorders. The unit derives substantially all of its revenue from sales of Thymoglobulin;

    Biosurgery, which develops, manufactures and distributes biotherapeutics and biomaterial-based products, with an emphasis on products that meet medical needs in the orthopaedics and broader surgical areas. The unit derives substantially all of its revenue from sales of Synvisc, the Sepra line of products, Carticel and Matrix-induced Autologous Chondrocyte Implantation, or MACI; and

    Genetics, which provides testing services for the oncology, prenatal and reproductive markets.

        We report the activities of our diagnostic products, oncology, bulk pharmaceuticals and cardiovascular business units under the caption "Other." We report our corporate, general and administrative operations and corporate science activities under the caption "Corporate."

2. Basis of Presentation and Significant Accounting Policies

Basis of Presentation

        Our unaudited, consolidated financial statements for each period include the statements of operations and comprehensive income, balance sheets and statements of cash flows for our operations taken as a whole. We have eliminated all intercompany items and transactions in consolidation. We have reclassified certain 2006 data to conform to our 2007 presentation. We prepare our unaudited, consolidated financial statements following the requirements of the SEC for interim reporting. As permitted under these rules, we condense or omit certain footnotes and other financial information that are normally required by accounting principles generally accepted in the United States.

        These financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of our financial position and results of operations. Since these are interim financial statements, you should also read our audited, consolidated financial statements and notes included in our 2006 Form 10-K. Revenues, expenses, assets and liabilities can vary from quarter to quarter. Therefore, the results and trends in these interim financial statements may not be indicative of results for future periods.

10



        Our unaudited, consolidated financial statements for each period include the accounts of our wholly-owned and majority-owned subsidiaries. As a result of our adoption of FIN 46R, "Consolidation of Variable Interest Entities," we also consolidate certain variable interest entities for which we are the primary beneficiary. For consolidated subsidiaries in which we have less than a 100% interest, we record minority interest in our consolidated statements of operations for the ownership interest of the minority owner. We use the equity method of accounting to account for our investments in entities in which we have a substantial ownership interest (20% to 50%) which do not fall in the scope of FIN 46R, or over which we exercise significant influence. Our consolidated net income includes our share of the earnings of these entities.

Income Taxes

        Effective January 1, 2007, we adopted the provisions of FIN 48, "Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement No. 109," which clarifies the accounting for income tax positions by prescribing a minimum recognition threshold that a tax position is required to meet before being recognized in the financial statements. FIN 48 also provides guidance on the derecognition of previously recognized deferred tax items, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. Under FIN 48, we recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities, based on the technical merits of the tax position. The tax benefits recognized in our financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution. For more information regarding the impact the adoption of FIN 48 had on our results of operations, financial condition and liquidity, see Note 13., "(Provision for) Benefit from Income Taxes," included in this report.

Recent Accounting Pronouncements

        FAS 157, "Fair Value Measurements." In September 2006, the FASB issued FAS 157, "Fair Value Measurements," which provides enhanced guidance for using fair value to measure assets and liabilities. FAS 157 establishes a common definition of fair value, provides a framework for measuring fair value under accounting principles generally accepted in the United States and expands disclosure requirements regarding fair value measurements. FAS 157 will be effective for us as of January 1, 2008. We are currently evaluating the impact, if any, the adoption of FAS 157 will have on our financial position and results of operations.

        FAS 159, "The Fair Value Option for Financial Assets and Financial Liabilities—Including an Amendment of FASB Statement No. 115." In February 2007, the FASB issued FAS 159, "The Fair Value Option for Financial Assets and Financial Liabilities—Including an Amendment of FASB Statement No. 115," which permits, but does not require, entities to measure certain financial instruments and other assets and liabilities at fair value on an instrument-by-instrument basis. Unrealized gains and losses on items for which the fair value option has been elected should be recognized in earnings at each subsequent reporting date. FAS 159 will be effective for us as of January 1, 2008 and cannot be adopted early unless FAS 157 is also adopted. We are currently evaluating the impact, if any, the adoption of FAS 159 may have on our financial position and results of operations.

11



        EITF Issue No. 07-3, "Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities." In June 2007, the FASB ratified the EITF consensus reached in EITF Issue No. 07-3, "Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities," which provides guidance for nonrefundable prepayments for goods or services that will be used or rendered for future research and development activities and directs that such payments should be deferred and capitalized. Such amounts should be recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. EITF 07-3 is effective for us January 1, 2008 and will be applied prospectively to new contracts we enter into on or after that date. Earlier application is not permitted. We are currently evaluating the impact, if any, the adoption of EITF No. 07-3 will have on our financial position, results of operations or cash flows.

3. Stockholders' Equity

Stock Repurchase

        In May 2007, our board of directors authorized a stock repurchase program to repurchase up to an aggregate maximum amount of $1.5 billion or 20,000,000 shares of our outstanding common stock over the next three years, beginning in June 2007. The repurchases are being made from time to time and can be effectuated through open market purchases, privately negotiated transactions, transactions structured through investment banking institutions, or by other means, subject to management's discretion and as permitted by securities laws and other legal requirements. As of September 30, 2007, we have repurchased a total of 2,808,738 shares of our common stock at an average price of $64.50 per share for a total of $181.2 million of cash, including fees. In July 2004, the Massachusetts Business Corporation Act, or MBCA, became effective and eliminated the concept of treasury shares. Under the MBCA, shares repurchased by Massachusetts corporations constitute authorized but unissued shares. As result, we recorded the repurchases in our consolidated balance sheet as of September 30, 2007, as a reduction to our common stock account for the par value of the repurchased shares and as a reduction to our additional paid-in capital account.

Equity Plans

        At our annual meeting of shareholders held on May 24, 2007, which we refer to as our 2007 Annual Meeting, our shareholders approved the merger of our 1997 Equity Incentive Plan into our 2004 Equity Incentive Plan and authorized an increase of 3,500,000 shares for issuance under our 2004 Equity Incentive Plan. Our 2004 Equity Incentive Plan authorizes the issuance of stock options, restricted stock and restricted stock units, or RSUs. We began issuing RSUs under our 2004 Equity Incentive Plan in connection with a general grant to employees in May 2007.

        Our 1998 Director Stock Option Plan was due to expire in March 2008. On February 28, 2007, our board of directors approved our 2007 Director Equity Plan which was created to amend, restate and replace our 1998 Director Stock Option Plan. At our 2007 Annual Meeting, our shareholders also approved the 2007 Director Equity Plan. Similar to our 2004 Equity Incentive Plan, our 2007 Director Equity Plan authorizes the issuance of stock options, restricted stock and RSUs to our directors.

12



Employee Stock Purchase Plan

        At our 2007 Annual Meeting, our shareholders approved an increase of 1,500,000 shares authorized for issuance under our 1999 Employee Stock Purchase Plan.

Stock-Based Compensation Expense, Net of Estimated Forfeitures

        We allocate pre-tax stock-based compensation expense, net of estimated forfeitures, based on the functional cost center of each employee as follows (amounts in thousands, except per share amounts):

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
 
  2007
  2006
  2007
  2006
 
Pre-tax stock-based compensation expense, net of estimated forfeitures charged to:                          
  Cost of products and services sold(1)   $ (5,779 ) $ (5,663 ) $ (18,540 ) $ (12,893 )
  Selling, general and administrative expense     (25,091 )   (24,421 )   (82,838 )   (96,560 )
  Research and development expense     (13,518 )   (14,556 )   (44,973 )   (50,682 )
   
 
 
 
 
    Total     (44,388 )   (44,640 )   (146,351 )   (160,135 )
Less: tax benefit from stock options     14,093     14,312     45,228     52,237  
   
 
 
 
 
    Total stock-based compensation expense, net of tax   $ (30,295 ) $ (30,328 ) $ (101,123 ) $ (107,898 )
   
 
 
 
 
Effect per common share:                          
  Basic   $ (0.12 ) $ (0.12 ) $ (0.38 ) $ (0.41 )
   
 
 
 
 
  Diluted   $ (0.11 ) $ (0.11 ) $ (0.36 ) $ (0.39 )
   
 
 
 
 

(1)
We also capitalized the following amounts of stock-based compensation expense to inventory, all of which is attributable to participating employees that support our manufacturing operations (amounts in thousands):

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
  2007
  2006
  2007
  2006
Stock-based compensation expense capitalized to inventory   $ 2,484   $ 3,377   $ 10,323   $ 11,640

        In July 2006, we began amortizing stock-based compensation expense capitalized to inventory based on inventory turns.

        At September 30, 2007, there was $292.6 million of pre-tax stock-based compensation expense, net of estimated forfeitures, related to unvested awards not yet recognized which are expected to be recognized over a weighted average period of 2.3 years.

13



4. Net Income Per Share

        The following table sets forth our computation of basic and diluted net income per share (amounts in thousands, except per share amounts):

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
  2007
  2006
  2007
  2006
Net income—basic   $ 159,313   $ 15,966   $ 401,294   $ 251,437
Effect of dilutive securities:                        
  Interest expense and debt fee amortization, net of tax, related to our 1.25% convertible senior notes     1,886     1,874     5,658     5,622
   
 
 
 
Net income—diluted   $ 161,199   $ 17,840   $ 406,952   $ 257,059
   
 
 
 
Shares used in computing net income per common
share—basic
    262,775     261,541     263,387     260,565
Effect of dilutive securities:                        
  Shares issuable upon the assumed conversion of our 1.25% convertible senior notes     9,686     9,686     9,686     9,686
  Stock options(1)     6,584     7,033     6,747     6,868
  Restricted stock units(2)     150         67    
  Warrants and stock purchase rights     11     11     11     11
   
 
 
 
    Dilutive potential common shares     16,431     16,730     16,511     16,565
   
 
 
 
Shares used in computing net income per common
share—diluted(1,2)
    279,206     278,271     279,898     277,130
   
 
 
 
Net income per common share:                        
  Basic   $ 0.61   $ 0.06   $ 1.52   $ 0.96
   
 
 
 
  Diluted   $ 0.58   $ 0.06   $ 1.45   $ 0.93
   
 
 
 

(1)
We did not include the securities described in the following table in the computation of diluted earnings per share because these securities were anti-dilutive during the corresponding period (amounts in thousands):

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
  2007
  2006
  2007
  2006
Shares issuable upon exercise of outstanding options   17,689   14,278   15,408   11,199
(2)
We began issuing RSUs under our 2004 Equity Incentive Plan in connection with a general grant to employees in May 2007.

14


5. Mergers and Acquisitions

Pending Acquisition of the Diagnostics Division of Diagnostic Chemicals Limited

        On November 2, 2007, we entered into an agreement with DCL, a privately-held diagnostics and biopharmaceutical company based in Charlottetown, Prince Edward Island, Canada, to acquire DCL's diagnostics division, including DCL's line of over 50 formulated clinical chemistry reagents and its diagnostics operations in Prince Edward Island, Canada and Connecticut, for an aggregate purchase price of approximately $53 million Canadian dollars, or approximately $57 million U.S. dollars (based on the November 2, 2007 spot rate for the Canadian dollar), in cash. We expect to close the transaction in December 2007.

Acquisition of Bioenvision

        On May 29, 2007, we entered into an agreement and plan of merger with Bioenvision, a publicly-traded biopharmaceutical company based in New York City and Edinburgh, Scotland, and Wichita Bio Corporation, one of our wholly-owned subsidiaries, to acquire Bioenvision in an all-cash transaction valued at $11.20 per outstanding share of Bioenvision Series A Preferred Stock (plus accrued but unpaid dividends) and $5.60 per outstanding share of Bioenvision Common Stock, or approximately $345 million in aggregate. Bioenvision is focused on the acquisition, development and marketing of compounds and technologies for the treatment of cancer, autoimmune disease and infection. Effective October 23, 2007, we completed the acquisition of Bioenvision. This acquisition was completed through a two step process consisting of a tender offer completed in July 2007, and a merger approved in October 2007.

        The acquisition of Bioenvision provides us with the exclusive, worldwide rights to clofarabine. We currently market clofarabine in the United States and Canada under the brand name Clolar for relapsed and refractory pediatric acute lymphoblastic leukemia, or ALL, patients. In Europe, we co-developed clofarabine with Bioenvision and Bioenvision has been marketing the product under the brand name Evoltra, also for the treatment of relapsed and refractory pediatric ALL patients. We and Bioenvision have been developing clofarabine for diseases with significantly larger patient populations, including use as a first-line therapy for the treatment of adult acute myeloid leukemia, or AML. Clofarabine has been granted orphan drug status for ALL and AML in both the United States and European Union.

    Tender Offer

        On July 10, 2007, we completed the tender offer and purchased 2,250,000 shares of Bioenvision Series A Preferred Stock for $25.2 million, which we recorded as a component of investments in equity securities, and 8,398,098 shares of Bioenvision Common Stock for $47.0 million, which we recorded as a component of other noncurrent assets in our consolidated balance sheet. As a result of the tender offer, we acquired approximately 22% of the then outstanding shares of Bioenvision Common Stock on an as-converted basis, including 100% of the outstanding Bioenvision Series A Preferred Stock.

        We accounted for our investments in Bioenvision Series A Preferred Stock and Bioenvision Common Stock using two different methods. In the third quarter of 2007, we accounted for our investment in Bioenvision Series A Preferred Stock under the cost method of accounting because these shares did not qualify as similar or substantially similar to common stock (in-substance common stock) under the guidance of EITF Issue No. 02-14, "Whether the Equity Method of Accounting Applies When an Investor Does Not Have an Investment in Voting Stock of an Investee but Exercises

15



Significant Influence through Other Means." Our initial investments in Bioenvision Common Stock and Bioenvision Series A Preferred Stock gave us significant influence over Bioenvision and, as a result, we accounted for our investment in Bioenvision Common Stock under the equity method of accounting. Accordingly, in July 2007, we recorded our initial $47.0 million investment in Bioenvision Common Stock as a single amount in other noncurrent assets in our consolidated balance sheet. Of this amount, we attributed $7.1 million to our 15% proportional share of the assets and liabilities of Bioenvision and $39.9 million, representing the excess of the purchase price over our proportional share of the net assets of Bioenvision, to the underlying intangible assets, IPR&D and goodwill based on their fair values, including $16.8 million, net of tax, to intangible assets, $19.1 million to IPR&D and $4.0 million to goodwill. Equity in income (loss) of equity method investments for the three and nine months ended September 30, 2007 reflects a total of $20.5 million of charges related to our initial investment in Bioenvision Common Stock, including a $19.1 million charge for IPR&D and a total of $1.4 million of charges for the period from July 10, 2007 through September 30, 2007, of which $1.0 million represents our portion of the losses of Bioenvision for that period and $0.4 million represents amortization expense, net of tax, related to the value assigned to technology and other intangible assets. As of September 30, 2007, other noncurrent assets in our consolidated balance sheet includes a net balance of $26.5 million for our initial investment in Bioenvision Common Stock including $47.0 million for the cash consideration we paid, which was offset by the $20.5 million of charges described above.

    Stockholder Approval of the Merger

        On October 22, 2007, a special meeting of the Bioenvision stockholders was held to seek approval for the merger. Holders of a majority of the issued and outstanding shares of Bioenvision Common Stock and Bioenvision Series A Preferred Stock, voting together as a single class on an as converted basis, approved the merger. On October 23, 2007, we paid approximately $245 million in cash consideration to the former Bioenvision stockholders and Bioenvision Common Stock ceased trading and was delisted from The Nasdaq Stock Market, Inc., or NASDAQ. In the fourth quarter of 2007, we will pay approximately $11 million of cash for the outstanding options to purchase shares of Bioenvision Common Stock. The full purchase accounting for our acquisition of Bioenvision, including the impact of our merger in October 2007, will be reflected in our consolidated financial statements as of December 31, 2007 and for the year ended December 31, 2007.

        In connection with the merger, holders of 2,880,000 shares of Bioenvision Common Stock, representing less than 5% of the outstanding shares of Bioenvision Common Stock on an as-converted basis immediately before the merger became effective, submitted written demands for appraisal of their shares and have, as a result, elected not to accept the $5.60 per share merger consideration. We refer to these stockholders as dissenting stockholders.

Acquisition of AnorMED

        In November 2006, we acquired AnorMED, a publicly-held chemical-based biopharmaceutical company based in Langley, British Columbia, Canada, with a focus on the discovery, development and commercialization of new therapeutic products in the area of hematology, oncology and human immunodeficiency virus, or HIV. We paid gross consideration of $589.2 million in cash, including $584.2 million for the shares of AnorMED's common stock outstanding on the date of acquisition and $5.0 million for acquisition costs. Net consideration was $569.0 million as we acquired AnorMED's cash and cash equivalents totaling $20.2 million. We accounted for the acquisition as a business combination

16



and accordingly, included AnorMED's results of operations in our consolidated statements of operations from November 7, 2006, the date of acquisition.

        The purchase price was allocated to the estimated fair value of the acquired tangible and intangible assets and assumed liabilities as follows (amounts in thousands, except share data):

Purchase of 43,272,085 shares of AnorMED common stock   $ 584,173  
Acquisition costs     5,000  
   
 
Total purchase price   $ 589,173  
   
 

Cash and cash equivalents

 

$

20,220

 
Other current assets     6,340  
Property, plant and equipment     758  
Goodwill     31,703  
Other intangible assets (to be amortized over 10 years)     3,500  
In-process research and development     552,900  
Deferred tax assets—noncurrent     27,380  
Other noncurrent assets     573  
Assumed liabilities:        
  Deferred tax liability     (25,288 )
  Liabilities for exit activities     (7,733 )
  Other liabilities     (21,180 )
   
 
Allocated purchase price   $ 589,173  
   
 

        The allocation of the purchase price was adjusted in 2007 to:

    write off $2.1 million of fixed assets associated with the acquisition;

    revise the estimated liabilities related to exit activities by $1.2 million; and

    adjust the deferred taxes by $(0.7) million.

        The purchase price, as adjusted, was allocated to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values at the date of acquisition. The excess of the purchase price over the estimated fair value of the assets acquired and liabilities assumed amounted to $31.7 million, which was allocated to goodwill. We expect that substantially all of the amount allocated to goodwill will be deductible for tax purposes.

        The allocation of the purchase price remains subject to potential adjustments, including adjustments for liabilities associated with certain exit activities and tax restructuring activities.

In-Process Research and Development

        In connection with five of our acquisitions completed between January 1, 2004 and September 30, 2007, we have acquired various IPR&D projects. Substantial additional research and development costs will be required prior to any of our acquired IPR&D programs and technology platforms reaching technological feasibility. In addition, once research is completed, each product candidate acquired will need to complete a series of clinical trials and receive FDA or other regulatory approvals prior to

17



commercialization. Our current estimates of the time and investment required to develop these products and technologies may change depending on the different applications that we may choose to pursue. We cannot give assurances that these programs will ever reach technological feasibility or develop into products that can be marketed profitably. In addition, we cannot guarantee that we will be able to develop and commercialize products before our competitors develop and commercialize products for the same indications. If products based on our acquired IPR&D programs and technology platforms do not become commercially viable, our results of operations could be materially adversely affected.

        The following table sets forth IPR&D projects for companies and certain assets we have acquired between January 1, 2004 and September 30, 2007 (amounts in millions):

Company/Assets Acquired

  Purchase
Price

  IPR&D(1)
  Programs Acquired

  Discount Rate
Used in
Estimating
Cash
Flows(1)

  Year of
Expected
Launch

AnorMED (2006)   $ 589.2   $ 526.8   Mozobil (stem cell transplant)   15%   2009-2014
            26.1   AMD070 (HIV)(2)   15%  
         
           
          $ 552.9            
         
           

Avigen, Inc. (2005)

 

$

12.0

 

$

7.0

 

AV201 (Parkinson's disease)

 

N/A

 

2016
         
           

Bone Care International, Inc. (2005)

 

$

712.3

 

$

12.7

 

LR-103 (secondary

 

 

 

 
         
  hyperparathyroidism)(3)   25%  

Verigen (2005)

 

$

12.7

 

$

9.5

 

MACI (cartilage repair)

 

24%

 

2012-2014
         
           

ILEX Oncology, Inc. (2004)

 

$

1,080.3

 

$

96.9

 

Campath(4)

 

11%

 

2009-2011
            113.4   Clolar(4)   12%   2008-2011
            44.2   Tasidotin   16%   2011-2014
         
           
          $ 254.5            
         
           

(1)
Management assumes responsibility for determining the valuation of the acquired IPR&D projects. The fair value assigned to IPR&D for each acquisition is estimated by discounting, to present value, the cash flows expected once the acquired projects have reached technological feasibility. The cash flows are probability-adjusted to reflect the risks of advancement through the product approval process. In estimating the future cash flows, we also considered the tangible and intangible assets required for successful exploitation of the technology resulting from the purchased IPR&D projects and adjusted future cash flows for a charge reflecting the contribution to value of these assets.

(2)
Year of expected launch is not provided for AMD070 at this time because we are assessing our future plans for this program.

(3)
Year of expected launch is not provided for LR-103 at this time because this program is in its early stages and we are evaluating several potential applications for LR-103 to determine which application we will pursue. Therefore, the year of expected launch cannot be determined.

(4)
Campath is currently marketed for the treatment of B-cell chronic lymphocytic leukemia and Clolar is marketed for the treatment of relapsed and refractory pediatric ALL. The IPR&D projects for Campath and Clolar are related to the development of these products for the treatment of other medical issues.

        In addition, we account for our investment in Bioenvision Common Stock under the equity method of accounting and, accordingly, we recorded a charge of $19.1 million in equity in income (loss) of equity method investments in our consolidated statement of operations for the three and nine months ended September 2007 for the portion of the purchase price for this investment that we allocated to IPR&D. The full purchase accounting for our acquisition of Bioenvision, including the impact of our merger in October 2007, will be reflected in our consolidated financial statements as of December 31, 2007 and for the year ended December 31, 2007.

18


Exit Activities

        In connection with several of our acquisitions, we initiated integration plans to consolidate and restructure certain functions and operations, including the relocation and termination of certain personnel of these acquired entities and the closure of certain of the acquired entities' leased facilities. These costs have been recognized as liabilities assumed in connection with the acquisition of these entities in accordance with EITF Issue No. 95-3, "Recognition of Liabilities in Connection with a Purchase or Business Combination," and are subject to potential adjustments as certain exit activities are confirmed or refined. The following table summarizes the liabilities established for exit activities related to these acquisitions (amounts in thousands):

 
  Employee
Related
Benefits

  Closure of
Leased
Facilities

  Other Exit
Activities

  Total
Exit
Activities

 
Balance at December 31, 2005   $ 2,249   $ 199   $ 8,117   $ 10,565  
  Acquisition(1)     6,478             6,478  
  Revision of estimates     (165 )   (132 )   (750 )   (1,047 )
  Payments     (2,457 )   (43 )   (7,367 )   (9,867 )
   
 
 
 
 
Balance at December 31, 2006     6,105     24         6,129  
  Revision of estimates     (75 )   1,307         1,232  
  Payments     (4,870 )           (4,870 )
   
 
 
 
 
Balance at September 30, 2007   $ 1,160   $ 1,331   $   $ 2,491  
   
 
 
 
 

(1)
We expect to pay employee related benefits related to the acquisition of AnorMED through 2008.

Pro Forma Financial Summary

        The following pro forma financial summary is presented as if the acquisition of AnorMED was completed as of January 1, 2006. These pro forma combined results are not necessarily indicative of the actual results that would have occurred had the acquisition been consummated on that date, or of the future operations of the combined entities. Material nonrecurring charges related to the acquisition of AnorMED, such as IPR&D charges of $552.9 million, are included in the following pro forma financial summary as of January 1, 2006 (amounts in thousands, except per share amounts):

 
  Three Months Ended
September 30, 2006

  Nine Months Ended
September 30, 2006

 
Total revenues   $ 823,078   $ 2,347,514  
   
 
 
Net income (loss)   $ 17,783   $ (168,271 )
   
 
 
Net income (loss) per share:              
  Basic   $ 0.07   $ (0.65 )
   
 
 
  Diluted   $ 0.07   $ (0.65 )
   
 
 
Weighted average shares outstanding:              
  Basic     261,541     260,565  
   
 
 
  Diluted     278,271     260,565  
   
 
 

19


6. Inventories

 
  September 30,
2007

  December 31,
2006

 
  (Amounts in thousands)

Raw materials   $ 125,841   $ 100,698
Work-in-process     120,735     119,510
Finished goods     192,296     154,436
   
 
  Total   $ 438,872   $ 374,644
   
 

        We capitalize inventory produced for commercial sale, which may result in the capitalization of inventory prior to regulatory approval of a product. In no event is inventory capitalized prior to the completion of a phase 3 clinical trial. If a product is not approved for sale, it would result in the write off of the inventory and a charge to earnings. Our total inventories at September 30, 2007, included $17.4 million of inventory for Renvela that had not yet been approved for sale. On October 22, 2007, the FDA granted marketing approval for Renvela.

        As of June 30, 2007, we had placed four lots of Thymoglobulin finished goods inventory, valued at $11.8 million, under review pending investigation and resolution of out of trend assay results we observed during quality testing. In September 2007, we determined that these lots did not meet our specifications for saleable product and recorded a charge of $11.8 million to cost of products sold to write off the inventory for these lots. Currently, we have three additional finished lots of Thymoglobulin, valued at approximately $8 million, which are under review to determine whether they meet product specifications. If we determine that any of these lots do not meet the specifications for saleable product, we will write off that inventory as a charge to earnings.

7. Goodwill and Other Intangible Assets

Goodwill

        The following table contains the change in our net goodwill during the nine months ended September 30, 2007 (amounts in thousands):

 
  December 31,
2006

  Adjustments
  September 30,
2007

Renal(1)   $ 305,528   $ (1,577 ) $ 303,951
Therapeutics     354,709         354,709
Transplant(2)     157,591     2,563     160,154
Biosurgery     7,585         7,585
Other     473,368     179     473,547
   
 
 
  Net goodwill   $ 1,298,781   $ 1,165   $ 1,299,946
   
 
 

    (1)
    The adjustments to Renal goodwill include adjustments associated with our acquisition of Bone Care International, Inc., or Bone Care, in July 2005.

    (2)
    The adjustments to Transplant goodwill represent purchase accounting adjustments related to our November 2006 acquisition of AnorMED, including increases of $2.1 million from the write off of certain fixed assets associated with the acquisition and $1.2 million of revisions to the estimates of liabilities related to exit activities, offset by a decrease of $(0.7) million to adjust deferred taxes.

20


        We are required to perform impairment tests related to our goodwill under FAS 142, "Goodwill and Other Intangible Assets," annually and whenever events or changes in circumstances suggest that the carrying value of an intangible asset may not be recoverable. We completed the required annual impairment tests for our $1.3 billion of net goodwill in the third quarter of 2007 and determined that no impairment charge was required.

Other Intangible Assets

        The following table contains information about our other intangible assets for the periods presented (amounts in thousands):

 
  September 30, 2007
  December 31, 2006
 
  Gross
Other
Intangible
Assets

  Accumulated
Amortization

  Net
Other
Intangible
Assets

  Gross
Other
Intangible
Assets

  Accumulated
Amortization

  Net
Other
Intangible
Assets

Technology   $ 1,506,998   $ (512,594 ) $ 994,404   $ 1,505,748   $ (424,650 ) $ 1,081,098
Patents     194,561     (100,076 )   94,485     194,560     (87,063 )   107,497
Trademarks     60,227     (35,445 )   24,782     60,227     (31,439 )   28,788
License fees(1)     90,084     (26,477 )   63,607     77,807     (20,597 )   57,210
Distribution rights(2)     293,217     (117,994 )   175,223     260,073     (85,543 )   174,530
Customer lists(3)     67,082     (30,984 )   36,098     90,783     (48,760 )   42,023
Other     2,050     (1,469 )   581     2,045     (1,153 )   892
   
 
 
 
 
 
  Total   $ 2,214,219   $ (825,039 ) $ 1,389,180   $ 2,191,243   $ (699,205 ) $ 1,492,038
   
 
 
 
 
 

(1)
Includes a $9.9 million payment to Sanofi Pasteur, or Sanofi, in September 2007 in connection with an amendment to an existing license agreement in which we acquired manufacturing expertise related to the production of bulk Thymoglobulin and a $2.5 million milestone payment to Synpac in June 2007 for the approval of Myozyme in Japan.

(2)
Includes an additional $32.4 million of intangible assets resulting from additional payments made or accrued in 2007 in connection with our reacquisition of the Synvisc sales and marketing rights from Wyeth in January 2005.

(3)
Reflects the write off, during the first quarter of 2007, of $23.7 million of fully amortized customer lists, related to our acquisition of Bone Care.

        All of our other intangible assets are amortized over their estimated useful lives. Total amortization expense for our other intangible assets was:

    $49.8 million for the three months ended September 30, 2007;

    $50.5 million for the three months ended September 30, 2006;

    $149.3 million for the nine months ended September 30, 2007; and

    $156.1 million for the nine months ended September 30, 2006.

21


        The estimated future amortization expense for other intangible assets for the remainder of fiscal year 2007, the four succeeding fiscal years and thereafter is as follows (amounts in thousands):

Year ended December 31,

  Estimated
Amortization
Expense(1)

2007 (remaining three months)   $ 49,878
2008     209,387
2009     215,620
2010     227,665
2011     238,507
Thereafter     625,327

      (1)
      Includes estimated future amortization expense for the Synvisc distribution rights based on the forecasted future sales of Synvisc and the resulting future contingent payments we will be required to make to Wyeth, and for the Myozyme patent and technology rights pursuant to a license agreement with Synpac based on forecasted future sales of Myozyme and the milestone payments we will be required to make to Synpac related to regulatory approvals. These contingent payments will be recorded as intangible assets when the payments are accrued. Estimated future amortization expense also includes estimated amortization expense for other arrangements involving contingent payments.

8. Investments in Equity Securities

        We recorded the following gains on investments in equity securities, net of charges for impairment of investments, for the three and nine months ended September 30, 2007 and 2006 (amounts in thousands):

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
 
  2007
  2006
  2007
  2006
 
Gross gains on investments in equity securities:                          
  Therapeutic Human Polyclonals, Inc. (THP)   $   $   $ 10,848   $  
  Cambridge Antibody Technology Group plc (CAT)                 69,359  
  BioMarin Pharmaceutical Inc. (BioMarin)                 6,417  
  Other     1,105     128     3,188     2,154  
   
 
 
 
 
    Total     1,105     128     14,036     77,930  
Less: charges for impairment of investments                 (2,893 )
   
 
 
 
 
Gains on investments in equity securities, net   $ 1,105   $ 128   $ 14,036   $ 75,037  
   
 
 
 
 

Unrealized Gains (Losses)

        At September 30, 2007, our stockholders' equity included $23.3 million of unrealized gains and $0.4 million of unrealized losses related to our investments in equity securities.

22


9. Payment of Note Receivable from Dyax Corp.

        In 2007, we received cash payments totaling $7.8 million from Dyax Corp., or Dyax, to settle the secured promissory note receivable from Dyax, including $7.0 million to satisfy the outstanding principal balance due under the note and $0.8 million of accrued interest.

10. Joint Venture with BioMarin

        We and BioMarin formed BioMarin/Genzyme LLC to develop and commercialize Aldurazyme, a recombinant form of the human enzyme alpha-L-iduronidase, used to treat an LSD known as mucopolysaccharidosis I, or MPS I. We record our portion of the income of BioMarin/Genzyme LLC in equity in income of equity method investments in our unaudited, consolidated statements of operations. Our portion of BioMarin/Genzyme LLC's net income was:

    $8.2 million for the three months ended September 30, 2007, as compared to $5.0 million for the same period of 2006; and

    $20.8 million for the nine months ended September 30, 2007, as compared to $13.0 million for the same period of 2006.

        During the nine months ended September 30, 2007, we received $17.1 million of cash distributions from BioMarin/Genzyme LLC.

        Condensed financial information for BioMarin/Genzyme LLC is summarized below (amounts in thousands):

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
 
  2007
  2006
  2007
  2006
 
Revenue   $ 32,322   $ 25,029   $ 88,270   $ 69,891  
Gross margin     25,284     18,883     68,241     51,674  
Operating expenses     (8,709 )   (9,110 )   (26,743 )   (26,209 )
Net income     16,793     9,959     42,029     25,953  

11. Revolving Credit Facility

        As of September 30, 2007, no amounts were outstanding under our five-year $350.0 million senior unsecured revolving credit facility with JPMorgan Chase Bank, N.A., as administrative agent, Bank of America, N.A., as syndication agent, ABN AMRO Bank N.V., Citizens Bank of Massachusetts and Wachovia Bank, National Association, as co-documentation agents, and a syndicate of lenders, which we refer to as our 2006 revolving credit facility. The terms of our 2006 revolving credit facility include various covenants, including financial covenants that require us to meet minimum interest coverage ratios and maximum leverage ratios. As of September 30, 2007, we were in compliance with these covenants.

12. Other Commitments and Contingencies

    Legal Proceedings

        We periodically become subject to legal proceedings and claims arising in connection with our business.

23


        Through June 30, 2003, we had three outstanding series of common stock, which we referred to as tracking stocks; Genzyme General Stock (which we now refer to as Genzyme Stock), Biosurgery Stock and Molecular Oncology Stock. Four lawsuits were filed against us regarding the exchange of all of the outstanding shares of Biosurgery Stock for shares of Genzyme Stock in connection with the elimination of our tracking stocks in July 2003. Each of the lawsuits was a purported class action on behalf of holders of Biosurgery Stock. The first case, filed in the Massachusetts Superior Court (MSC) in May 2003, alleged a breach of the implied covenant of good faith and fair dealing in our charter and a breach of our board of directors' fiduciary duties. The plaintiff in this case sought an injunction to adjust the exchange ratio for the tracking stock exchange. The MSC dismissed the complaint in its entirety in November 2003. Upon appeal, the Massachusetts Appeals Court upheld the dismissal by the MSC of the fiduciary duty claim, but reversed the earlier decision to dismiss the implied covenant claim. The Massachusetts Supreme Judicial Court (SJC) granted our petition for further appellate review. On June 4, 2007, the SJC reversed the Appeals Court's decision and affirmed dismissal of the complaint in its entirety. On July 25, 2007, the SJC denied the plaintiff's petition for rehearing. Two substantially similar cases were filed in the MSC in August and October 2003. These cases were consolidated in January 2004, and in July 2004, the consolidated case was stayed pending disposition of a fourth case, which was filed in the U.S. District Court for the Southern District of New York in June 2003. As amended, this complaint alleged violations of federal securities laws, as well as various state law claims, related to the exchange, on behalf of a certified class of holders of Biosurgery Stock as of May 8, 2003. On August 6, 2007, we reached an agreement-in-principle with counsel for the plaintiff class to settle and dismiss this case for approximately $64 million. A definitive settlement agreement was approved by the court on October 26, 2007. Because the members of the class in the New York action released all claims, the settlement has, as a practical matter, resolved the consolidated case in the MSC. We have submitted claims to our insurers for reimbursement of portions of the expenses incurred and to be incurred in connection with these cases; the insurer has purported to deny coverage. We intend to vigorously pursue our rights with respect to insurance coverage. As a result, we recorded a liability for the settlement payment of approximately $64 million as a charge to selling, general and administrative expense, or SG&A, in our consolidated statement of operations in June 2007, which we subsequently paid in August 2007.

        We are not able to predict the outcome of other legal proceedings, to which we may become subject in the normal course of business or estimate the amount or range of any reasonably possible loss we might incur if we do not prevail in the final, non-appealable determinations of such matters. Therefore, we have no current accruals for these potential contingencies. We cannot provide you with assurance that other legal proceedings will not have a material adverse impact on our financial condition or results of operations.

13. (Provision for) Benefit from Income Taxes

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
(Provision for) benefit from income taxes   $ (66,432 ) $ 44,530   $ (201,715 ) $ (60,841 )
Effective tax rate     29 %   (156 )%   33 %   19 %

24


Our effective tax rate for all periods presented varies from the U.S. statutory tax rate as a result of:

    our provision for state income taxes;

    the tax benefits from export sales;

    the tax benefits from domestic production activities;

    benefits related to tax credits;

    income and expenses taxed at rates other than the U.S. statutory tax rate;

    non-deductible stock-based compensation expenses; and

    non-deductible expenses associated with the settlement of litigation related to the consolidation of our former tracking stocks.

Our effective tax rate for the three and nine months ended September 30, 2006, was also impacted by a charge for impaired goodwill of $219.2 million of which $29.5 million was not deductible for tax purposes.

        Effective January 1, 2007, we adopted FIN 48 and recognized a cumulative effect adjustment of $33.9 million to increase our retained earnings balance as of January 1, 2007, which consisted of $25.8 million to record the combined effect of our gain contingency and the change in the recognition standard pursuant to the settlement criteria of FASB Staff Position, or FSP, FIN 48-1, "Definition of Settlement in FASB Interpretation No. 48," or FSP FIN 48-1, and $8.1 million resulting from our settlement of the IRS audit for tax years 2002 to 2003. After these adjustments, as of January 1, 2007, we had approximately $36.5 million of total gross unrealized tax benefits, of which approximately $26.6 million represents the amount of unrecognized tax benefits that, if recognized, would favorably affect our effective income tax rate in future periods. These gross unrealized tax benefits did not change significantly during the nine months ended September 30, 2007.

        We continue to recognize interest relating to unrecognized tax benefits within our provision for income taxes but have not recorded any amounts related to potential penalties. The amount of accrued interest related to unrecognized tax benefits within our provision for income taxes for the three and nine months ended September 30, 2007, and our accrued interest related to unrecognized tax benefits as of January 1, 2007 and September 30, 2007 were not significant.

        We are subject to U.S. federal income tax and various state, local and international income taxes in numerous jurisdictions, however, our only significant tax jurisdiction is the United States. We record liabilities for income tax contingencies based on our best estimate of the underlying exposures. We are currently under IRS audit for tax years 2004 to 2005, and in certain state and foreign jurisdictions from 2003 forward. We believe that we have provided sufficiently for all audit exposures and assessments. Settlement of these audits or the expiration of the statute of limitations on the assessment of income taxes for any tax year may result in an increase or reduction of future tax provisions. Any such tax or tax benefit would be recorded upon final resolution of the audits or expiration of the applicable statute of limitations.

25



14. Segment Information

        In accordance with FAS 131, "Disclosures about Segments of an Enterprise and Related Information," we present segment information in a manner consistent with the method we use to report this information to our management. Applying FAS 131, we have five reporting segments as described in Note 1., "Description of Business," to these consolidated financial statements.

        We have provided information concerning the operations in these reporting segments in the following tables (amounts in thousands):

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
 
  2007
  2006
  2007
  2006
 
Revenues:                          
  Renal   $ 184,424   $ 160,204   $ 522,350   $ 446,774  
  Therapeutics     471,351     388,267     1,365,617     1,107,262  
  Transplant     42,881     39,241     127,582     114,719  
  Biosurgery     106,146     93,449     312,428     286,386  
  Genetics     73,050     61,360     212,922     179,853  
  Other     81,841     66,043     234,693     197,674  
  Corporate     466     10     1,169     104  
   
 
 
 
 
    Total   $ 960,159   $ 808,574   $ 2,776,761   $ 2,332,772  
   
 
 
 
 

Income (loss) before income taxes:

 

 

 

 

 

 

 

 

 

 

 

 

 
  Renal   $ 75,706   $ 52,243   $ 201,796   $ 126,313  
  Therapeutics(1)     304,376     259,137     870,706     741,124  
  Transplant(2)     (19,902 )   4,809     (33,645 )   15,160  
  Biosurgery(2)     15,526     10,773     41,577     28,021  
  Genetics(3)     4,277     (220,778 )   19,909     (224,995 )
  Other(4)     (32,330 )   (11,273 )   (51,079 )   (35,253 )
  Corporate(5)     (121,908 )   (123,475 )   (446,255 )   (338,092 )
   
 
 
 
 
    Total   $ 225,745   $ (28,564 ) $ 603,009   $ 312,278  
   
 
 
 
 

      (1)
      Includes a $25.0 million upfront payment made to Ceregene, Inc., or Ceregene, in June 2007 in connection with a collaboration agreement for the development and commercialization of CERE-120, a gene therapy product for the treatment of Parkinson's disease.

      (2)
      The results of operations of acquired companies and assets and the amortization expense related to acquired intangible assets are included in segment results beginning on the date of acquisition.

      (3)
      Includes a charge for impaired goodwill of $219.2 million in September 2006 to write off the goodwill related to our Genetics reporting unit in accordance with FAS 142.

      (4)
      Includes $20.5 million of charges recorded against our initial $47.0 million investment in Bioenvision Common Stock, including a $19.1 million charge for IPR&D and a total of $1.4 million of charges for the period from July 10, 2007 through September 30, 2007, of

26


        which $1.0 million represents our portion of the losses of Bioenvision for that period and $0.4 million represents amortization expense, net of tax, related to the value assigned to Bioenvision's technology and other intangible assets.

      (5)
      Loss before income taxes for Corporate includes our corporate, general and administrative and corporate science activities, all of the stock-based compensation expense, as well as net gains on investments in equity securities, interest income, interest expense and other income and expense items that we do not specifically allocate to a particular reporting segment. Loss before income taxes for Corporate for the nine months ended September 30, 2007, includes a charge of $64.0 million for the settlement of the litigation related to the consolidation of our former tracking stocks.

    Segment Assets

        We provide information concerning the assets of our reportable segments in the following table (amounts in thousands):

 
  September 30,
2007

  December 31,
2006

Segment Assets(1):            
  Renal   $ 1,439,908   $ 1,380,003
  Therapeutics     1,221,528     1,094,520
  Transplant     411,530     410,436
  Biosurgery     470,765     477,334
  Genetics     148,311     133,839
  Other     854,763     851,343
  Corporate(2)     3,295,496     2,843,713
   
 
    Total   $ 7,842,301   $ 7,191,188
   
 

      (1)
      Assets for our five reporting segments and Other include primarily accounts receivable, inventory and certain fixed and intangible assets, including goodwill.

      (2)
      Includes the assets related to our corporate, general and administrative operations, and corporate science activities that we do not allocate to a particular segment, including cash, cash equivalents, short-and long-term investments, net property, plant and equipment and net deferred tax assets.

        Segment assets for Corporate consist of the following (amounts in thousands):

 
   
  September 30,
2007

  December 31,
2006

    Cash, cash equivalents, short- and long-term investments   $ 1,449,548   $ 1,285,604
    Deferred tax assets, net     210,015     136,925
    Property, plant & equipment, net     1,180,890     1,036,182
    Investments in equity securities     107,734     66,563
    Other     347,309     318,439
       
 
        Total   $ 3,295,496   $ 2,843,713
       
 

27


ITEM 2.    MANAGEMENT'S DISCUSSION AND ANALYSIS OF GENZYME CORPORATION AND SUBSIDIARIES' FINANCIAL CONDITION AND RESULTS OF OPERATIONS

        When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that characterize our business. In particular, we encourage you to review the risks and uncertainties described under the caption "Risk Factors" below. These risks and uncertainties could cause actual results to differ materially from those forecasted in forward-looking statements or implied by past results and trends. Forward-looking statements are statements that attempt to project or anticipate future developments in our business; we encourage you to review the examples of forward-looking statements included under the heading "Note Regarding Forward-Looking Statements" at the beginning of this report. These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated), and we undertake no obligation to update or revise the statements in light of future developments.

INTRODUCTION

        We are a global biotechnology company dedicated to making a major impact on the lives of people with serious diseases. Our broad product and service portfolio is focused on rare disorders, renal diseases, orthopaedics, organ transplant, and diagnostic and predictive testing. We are organized into five financial reporting units, which we also consider to be our reporting segments:

    Renal, which develops, manufactures and distributes products that treat patients suffering from renal diseases, including chronic renal failure. The unit derives substantially all of its revenue from sales of Renagel (including sales of bulk sevelamer) and Hectorol;

    Therapeutics, which develops, manufactures and distributes therapeutic products, with an expanding focus on products to treat patients suffering from genetic diseases and other chronic debilitating diseases, including a family of diseases known as LSDs, and other specialty therapeutics, such as Thyrogen. The unit derives substantially all of its revenue from sales of Cerezyme, Fabrazyme, Myozyme and Thyrogen;

    Transplant, which develops, manufactures and distributes therapeutic products that address pre-transplantation, prevention and treatment of rejection in organ transplantation and other auto-immune disorders. The unit derives substantially all of its revenue from sales of Thymoglobulin;

    Biosurgery, which develops, manufactures and distributes biotherapeutics and biomaterial-based products, with an emphasis on products that meet medical needs in the orthopaedics and broader surgical areas. The unit derives substantially all of its revenue from sales of Synvisc, the Sepra line of products, Carticel and MACI; and

    Genetics, which provides testing services for the oncology, prenatal and reproductive markets.

        We report the activities of our diagnostic products, oncology, bulk pharmaceuticals and cardiovascular business units under the caption "Other." We report our corporate, general and administrative operations and corporate science activities under the caption "Corporate."

MERGERS AND ACQUISITIONS

Pending Acquisition of the Diagnostics Division of Diagnostic Chemicals Limited

        On November 2, 2007, we entered into an agreement with DCL, a privately-held diagnostics and biopharmaceutical company based in Charlottetown, Prince Edward Island, Canada, to acquire DCL's diagnostics division, including DCL's line of over 50 formulated clinical chemistry reagents and its diagnostics operations in Prince Edward Island, Canada and Connecticut, for an aggregate purchase price of approximately $53 million Canadian dollars, or approximately $57 million U.S. dollars (based

28



on the November 2, 2007 spot rate for the Canadian dollar), in cash. We expect to close the transaction in December 2007.

Acquisition of Bioenvision

        On May 29, 2007, we entered into an agreement and plan of merger with Bioenvision, a publicly-traded biopharmaceutical company based in New York City and Edinburgh, Scotland, and Wichita Bio Corporation, one of our wholly-owned subsidiaries, to acquire Bioenvision in an all-cash transaction valued at $11.20 per outstanding share of Bioenvision Series A Preferred Stock (plus accrued but unpaid dividends) and $5.60 per outstanding share of Bioenvision Common Stock, or approximately $345 million in aggregate. Bioenvision is focused on the acquisition, development and marketing of compounds and technologies for the treatment of cancer, autoimmune disease and infection. Effective October 23, 2007, we completed the acquisition of Bioenvision. This acquisition was completed through a two step process consisting of a tender offer completed in July 2007, and a merger approved in October 2007.

        The acquisition of Bioenvision provides us with the exclusive, worldwide rights to clofarabine. We currently market clofarabine in the United States and Canada under the brand name Clolar for relapsed and refractory pediatric ALL patients. In Europe, we co-developed clofarabine with Bioenvision and Bioenvision has been marketing the product under the brand name Evoltra, also for the treatment of relapsed and refractory pediatric ALL patients. We and Bioenvision have been developing clofarabine for diseases with significantly larger patient populations, including use as a first-line therapy for the treatment of adult acute myeloid leukemia, or AML. Clofarabine has been granted orphan drug status for ALL and AML in both the United States and European Union.

    Tender Offer

        On July 10, 2007, we completed the tender offer and purchased 2,250,000 shares of Bioenvision Series A Preferred Stock for $25.2 million, which we recorded as a component of investments in equity securities, and 8,398,098 shares of Bioenvision Common Stock for $47.0 million, which we recorded as a component of other noncurrent assets in our consolidated balance sheet. As a result of the tender offer, we acquired approximately 22% of the then outstanding shares of Bioenvision Common Stock on an as-converted basis, including 100% of the outstanding Bioenvision Series A Preferred Stock.

        We accounted for our investments in Bioenvision Series A Preferred Stock and Bioenvision Common Stock using two different methods. In the third quarter of 2007, we accounted for our investment in Bioenvision Series A Preferred Stock under the cost method of accounting because these shares did not qualify as similar or substantially similar to common stock (in-substance common stock) under the guidance of EITF Issue No. 02-14, "Whether the Equity Method of Accounting Applies When an Investor Does Not Have an Investment in Voting Stock of an Investee but Exercises Significant Influence through Other Means." Our initial investments in Bioenvision Common Stock and Bioenvision Series A Preferred Stock gave us significant influence over Bioenvision and, as a result, we accounted for our investment in Bioenvision Common Stock under the equity method of accounting. Accordingly, in July 2007, we recorded our initial $47.0 million investment in Bioenvision Common Stock as a single amount in other noncurrent assets in our consolidated balance sheet. Of this amount, we attributed $7.1 million to our 15% proportional share of the assets and liabilities of Bioenvision and $39.9 million, representing the excess of the purchase price over our proportional share of the net assets of Bioenvision, to the underlying intangible assets, IPR&D and goodwill based on their fair values, including $16.8 million, net of tax, to intangible assets, $19.1 million to IPR&D and $4.0 million to goodwill. Equity in income (loss) of equity method investments for the three and nine months ended September 30, 2007, reflects a total of $20.5 million of charges related to our initial investment in Bioenvision Common Stock, including a $19.1 million charge for IPR&D and a total of $1.4 million of charges for the period from July 10, 2007 through September 30, 2007, of which $1.0 million represents

29



our portion of the losses of Bioenvision for that period and $0.4 million represents amortization expense, net of tax, related to the value assigned to technology and other intangible assets. As of September 30, 2007, other noncurrent assets in our consolidated balance sheet includes a net balance of $26.5 million for our initial investment in Bioenvision Common Stock, consisting of the $47.0 million cash consideration we paid, which was offset by the $20.5 million of charges described above.

    Stockholder Approval of the Merger

        On October 22, 2007, a special meeting of the Bioenvision stockholders was held to seek approval for the merger. Holders of a majority of the issued and outstanding shares of Bioenvision Common Stock and Bioenvision Series A Preferred Stock, voting together as a single class on an as converted basis, approved the merger. On October 23, 2007, we paid approximately $245 million in cash consideration to the former Bioenvision stockholders and Bioenvision Common Stock ceased trading and was delisted from NASDAQ. In the fourth quarter of 2007, we will pay approximately $11 million of cash for the outstanding options to purchase shares of Bioenvision Common Stock. The full purchase accounting for our acquisition of Bioenvision, including the impact of our merger in October 2007, will be reflected in our consolidated financial statements as of December 31, 2007 and for the year ended December 31, 2007.

        In connection with the merger, holders of 2,880,000 shares of Bioenvision Common Stock, representing less than 5% of the outstanding shares of Bioenvision Common Stock on an as-converted basis immediately before the merger became effective, submitted written demands for appraisal of their shares and have, as a result, elected not to accept the $5.60 per share merger consideration. We refer to these stockholders as dissenting stockholders.

Acquisition of AnorMED

        In November 2006, we acquired AnorMED, a publicly-traded chemical-based biopharmaceutical company based in Langley, British Columbia, Canada, with a focus on the discovery, development and commercialization of new therapeutic products in the area of hematology, oncology and human immunodeficiency virus, or HIV. We paid gross consideration of $589.2 million in cash, including $584.2 million for the shares of AnorMED's common stock outstanding on the date of acquisition and $5.0 million for acquisition costs. Net consideration was $569.0 million as we acquired AnorMED's cash and cash equivalents totaling $20.2 million. As part of the transaction, we acquired Mozobil, a late-stage product candidate in development for hematopoietic stem cell transplantation, which we have added to our Transplant business. Multiple early studies showed that Mozobil rapidly increases the number of stem cells that move out of the bone marrow and into a patient's blood, which is an important step in preparing a patient for a stem cell transplant. On July 19, 2007, we announced the successful completion of a phase 3 clinical trial of Mozobil in treating non-Hodgkin's lymphoma and on August 2, 2007, we announced the successful completion of a second phase 3 clinical trial of Mozobil in treating multiple myeloma. The trials met their respective primary and secondary endpoints. We accounted for the acquisition as a business combination and accordingly, we included AnorMED's results of operations in our consolidated statements of operations from November 7, 2006, the date of acquisition.

        The purchase price, as adjusted, was allocated to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values at the date of acquisition. The excess of the purchase price over the estimated fair value of the assets acquired and liabilities assumed amounted to $31.7 million, which was allocated to goodwill. We expect that substantially all of the amount allocated to goodwill will be deductible for tax purposes. The allocation of the purchase price remains subject to potential adjustments, including adjustments for liabilities associated with certain exit activities and tax restructuring activities.

30



CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

        Our critical accounting policies and significant judgments and estimates are set forth under the heading "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates" in Exhibit 13 to our 2006 Form 10-K. Additional information regarding significant judgments, estimates and updates to our policies for Revenue Recognition, Income Taxes and Inventories are included below. Excluding these additional disclosures, there have been no significant changes to our other critical accounting policies or significant judgments and estimates since December 31, 2006.

Revenue Recognition

Product Sales

        The timing of product shipments and receipts by the customer can have a significant impact on the amount of revenue recognized in a particular period. A significant portion of our products are sold at least in part through wholesalers and specialty distributors, along with direct sales to hospitals, homecare providers, government agencies and physicians. Consequently, our net sales and quarterly growth comparisons may be affected by fluctuations in the buying patterns of our major distributors and other trade buyers, which may result from seasonality, pricing, wholesaler buying decisions or other factors. Inventory in the distribution channel consists of inventory held by wholesalers and specialty distributors, who are our customers, and inventory held by their retail customers, such as pharmacies and hospitals. Our revenue in a particular period can be impacted by increases or decreases in channel inventories. Significant increases in wholesaler or retail inventories could result in reduced purchases in subsequent periods, or product returns from the distribution channel due to overstocking, low end-user demand or product expiration.

        We use a variety of data sources to determine the amount of inventory in the distribution channel. For most product lines, we receive data on sales and inventory levels directly from our primary customers. For key product lines in our Renal and Therapeutics areas, our data sources also include prescription and wholesaler data purchased from external data providers. As part of our efforts to limit the amount of Renal and Therapeutics inventory held by distributors and to gain improved visibility into the distribution channel, we have executed agreements to limit the amounts of inventory they carry and to provide us ongoing reports to verify distributor inventory levels and sales data.

Product Sales Allowances

        Sales of many biotechnology products in the United States are subject to increased pricing pressure from managed care groups, institutions, government agencies, and other groups seeking discounts. We and other biotechnology companies in the U.S. market are also required to provide statutorily defined rebates and discounts to various U.S. government agencies in order to participate in the Medicaid program and other government-funded programs. In most international markets, we operate in an environment where governments may and have mandated cost-containment programs, placed restrictions on physician prescription levels and patient reimbursements, emphasized greater use of generic drugs and enacted across-the-board price cuts as methods to control costs. The sensitivity of our estimates can vary by program, type of customer and geographic location. Estimates associated with Medicaid and other government allowances may become subject to adjustment in a subsequent period due to the time delay between the recording of the accrual and its ultimate settlement.

        We record product sales net of the following significant categories of product sales allowances:

    Contractual adjustments—We offer chargebacks and contractual discounts and rebates, which we collectively refer to as contractual adjustments, to certain private institutions and various

31


      government agencies in both the United States and international markets. We record chargebacks and contractual discounts as allowances against accounts receivable in our consolidated balance sheets. We account for rebates by establishing an accrual for the amounts payable by us to these agencies and institutions, which is included in accrued liabilities in our consolidated balance sheets. We estimate the allowances and accruals for our contractual adjustments based on historical experience and current contract prices, using both internal data as well as information obtained from external sources, such as independent market research agencies and data from wholesalers. We continually monitor the adequacy of these estimates and adjust the allowances and accruals periodically throughout each quarter to reflect our actual experience. In evaluating these allowances and accruals, we consider several factors, including significant changes in the sales performance of our products subject to contractual adjustments, inventory in the distribution channel, changes in U.S. and foreign healthcare legislation impacting rebate or allowance rates, changes in contractual discount rates and the estimated lag time between a sale and payment of the corresponding rebate;

    Discounts—In some countries, we offer cash discounts for certain products as an incentive for prompt payment, which are generally a stated percentage off the sales price. We account for cash discounts by reducing accounts receivable by the full amounts of the discounts. We consider payment performance and adjust the accrual to reflect actual experience; and

    Sales returns—We record allowances for product returns at the time product sales are recorded. The product returns reserve is estimated based on the returns policies for our individual products and our experience of returns for each of our products. If the price of a product changes or if the history of product returns changes, the reserve is adjusted accordingly. We determine our estimates of the sales return accrual for new products primarily based on the historical sales returns experience of similar products, such as those within the same line of product or those within the same or similar therapeutic category.

        Our provisions for product sales allowances reduced gross product sales as follows:

 
  Three Months Ended
September 30,

   
  Nine Months Ended September 30,
   
 
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
Product sales allowances:                                  
  Contractual adjustments   $ 66,931   $ 49,661   35 % $ 180,622   $ 144,384   25 %
  Discounts     45,065     33,384   35 %   126,547     90,202   40 %
  Sales returns     1,827     2,570   (29 )%   9,248     9,458   (2 )%
   
 
     
 
     
    Total product sales allowances   $ 113,823   $ 85,615   33 % $ 316,417   $ 244,044   30 %
   
 
     
 
     
Total gross product sales   $ 981,505   $ 819,846   20 % $ 2,827,771   $ 2,354,345   20 %
   
 
     
 
     
Total product sales allowances as a percent of total gross product sales     12 %   10 %       11 %   10 %    

        Product sales allowances for contractual adjustments and discounts increased for the three and nine months ended September 30, 2007, as compared to the same periods of 2006, primarily due to growth in overall gross product sales.

        Total estimated product sales allowance reserves and accruals in our consolidated balance sheets, increased 23% to approximately $159 million as of September 30, 2007, as compared to approximately $129 million as of December 31, 2006, primarily due to increased product sales. Historically, our actual results have not differed materially from amounts estimated. The annual variation has been less than 0.5% of total product sales for each of the last three years.

32



Distributor Fees

        EITF Issue No. 01-09, "Accounting for Consideration given by a Vendor to a Customer (including a Reseller of a Vendor's Products)" specifies that cash consideration (including a sales incentive) given by a vendor to a customer is presumed to be a reduction of the selling prices of the vendor's products or services and, therefore, should be characterized as a reduction of revenue. We include such fees in contractual adjustments, which are recorded as a reduction to product sales. That presumption is overcome and the consideration should be characterized as a cost incurred if, and to the extent that, both of the following conditions are met:

    the vendor receives, or will receive, an identifiable benefit (goods or services) in exchange for the consideration; and

    the vendor can reasonably estimate the fair value of the benefit received.

        We record service fees paid to our distributors as a charge to SG&A, a component of operating expenses, only if the criteria set forth above are met. The following table sets forth the distributor fees recorded as a reduction to product sales and charged to SG&A:

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
  2007
  2006
  2007
  2006
 
  (Amounts in thousands)

Distributor fees:                        
  Included in contractual adjustments and recorded as a reduction to product sales   $ 2,948   $ 2,151   $ 9,238   $ 6,784
  Charged to SG&A     3,210     2,826     9,644     7,860
   
 
 
 
    Total distributor fees   $ 6,158   $ 4,977   $ 18,882   $ 14,644
   
 
 
 

Income Taxes

        Effective January 1, 2007, we adopted the provisions of FIN 48, which clarifies the accounting for income tax positions by prescribing a minimum recognition threshold that a tax position is required to meet before being recognized in the financial statements. FIN 48 also provides guidance on the derecognition of previously recognized deferred tax items, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. Under FIN 48, we recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities, based on the technical merits of the tax position. The tax benefits recognized in our financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution.

        We operate in numerous countries where our income tax returns are subject to audit and adjustment by local tax authorities. Because we operate globally, the nature of the uncertain tax positions is often very complex and subject to change and the amounts at issue can be substantial. We develop our cumulative probability assessment of the measurement of uncertain tax positions using internal expertise, experience, judgment and assistance from professional advisors. Estimates are refined as additional information becomes known. Any outcome upon settlement that differs from our current estimate may result in additional or lower tax expense in future periods.

        As of January 1, 2007, we had approximately $36.5 million of total gross unrealized tax benefits, of which approximately $26.6 million represents the amount of unrecognized tax benefits that, if recognized, would favorably affect our effective income tax rate in future periods. These gross unrealized tax benefits did not change significantly during the nine months ended September 30, 2007.

        We continue to recognize interest related to unrecognized tax benefits within our provision for income taxes but have not recorded any amounts related to potential penalties. The amount of accrued interest related to unrecognized tax benefits included in our provision for income taxes for the three and nine months ended September 30, 2007, and our accrued interest related to unrecognized tax benefits as of January 1, 2007 and September 30, 2007, were not significant.

33


Inventories

        We value inventories at cost or, if lower, fair value. We determine cost using the first-in, first-out method. We analyze our inventory levels quarterly and write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. Expired inventory is disposed of and the related costs are written off. If actual market conditions are less favorable than those projected by management, additional inventory write-downs may be required.

        We capitalize inventory produced for commercial sale, which may result in the capitalization of inventory prior to regulatory approval. In no event is inventory capitalized prior to the completion of a phase 3 clinical trial. If a product is not approved for sale, it would result in the write off of the inventory and a charge to earnings. Our total inventories at September 30, 2007 included $17.4 million of inventory for Renvela that had not yet been approved for sale. On October 22, 2007, the FDA granted marketing approval for Renvela.

        As of June 30, 2007, we had placed four lots of Thymoglobulin finished goods inventory, valued at $11.8 million, under review pending investigation and resolution of out of trend assay results we observed during quality testing. In September 2007, we determined that these lots did not meet our specifications for saleable product and recorded a charge of $11.8 million to cost of products sold to write off the inventory for these lots. Currently, we have three additional finished lots of Thymoglobulin, valued at approximately $8 million, which are under review to determine whether they meet product specifications. If we determine that any of those lots do not meet the specifications for saleable product, we will write off that inventory as a charge to earnings. Even with the four finished lots of Thymoglobulin that have been written off and the possibility of lots under review being written off, we currently expect to be able to meet projected market demand. We will continue to closely monitor our inventory levels and intend to manage production in order to maintain adequate supply levels in 2008.

A.    RESULTS OF OPERATIONS

        The following discussion summarizes the key factors our management believes are necessary for an understanding of our consolidated financial statements.

REVENUES

        The components of our total revenues are described in the following table:

 
  Three Months Ended
September 30,

   
  Nine Months Ended September 30,
   
 
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
Product revenue   $ 867,682   $ 734,231   18 % $ 2,511,354   $ 2,110,301   19 %
Service revenue     83,177     71,153   17 %   241,533     210,987   14 %
   
 
     
 
     
  Total product and service revenue     950,859     805,384   18 %   2,752,887     2,321,288   19 %
Research and development revenue     9,300     3,190   >100 %   23,874     11,484   >100 %
   
 
     
 
     
  Total revenues   $ 960,159   $ 808,574   19 % $ 2,776,761   $ 2,332,772   19 %
   
 
     
 
     

Product Revenue

        We derive product revenue from sales of:

    Renal products, including Renagel for the reduction of elevated serum phosphorus levels in end-stage renal disease patients on hemodialysis, Hectorol for the treatment of secondary

34


      hyperparathyroidism in patients on dialysis and those with chronic kidney disease, or CKD, and bulk sevelamer;

    Therapeutics products, including Cerezyme for the treatment of Gaucher disease, Fabrazyme for the treatment of Fabry disease, Myozyme for the treatment of Pompe disease and Thyrogen, which is an adjunctive diagnostic agent used in the follow-up treatment of patients with well-differentiated thyroid cancer;

    Transplant products for the treatment of immune-mediated diseases, primarily Thymoglobulin, which induces immunosuppression of certain types of cells responsible for organ rejection in transplant patients;

    Biosurgery products, including orthopaedic products, such as Synvisc, and the Sepra line of products, such as Seprafilm; and

    Other products, including:

    diagnostic products, including infectious disease and cholesterol testing products;

    oncology products, including Campath for the treatment of B-cell chronic lymphocytic leukemia, and Clolar for the treatment of relapsed and refractory pediatric ALL after at least two prior regimens; and

    bulk pharmaceuticals, including WelChol, which is a mono and adjunctive therapy for the reduction of LDL cholesterol in patients with primary hypercholesterolemia.

        The following table sets forth our product revenue on a segment basis:

 
  Three Months Ended
September 30,

   
  Nine Months Ended
September 30,

   
 
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
Renal:                                  
  Renagel (including sales of bulk sevelamer)   $ 154,159   $ 134,722   14 % $ 436,497   $ 379,976   15 %
  Hectorol     30,265     25,482   19 %   85,853     66,798   29 %
   
 
     
 
     
    Total Renal     184,424     160,204   15 %   522,350     446,774   17 %
   
 
     
 
     

Therapeutics:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
  Cerezyme     286,071     252,227   13 %   832,841     745,225   12 %
  Fabrazyme     104,610     93,170   12 %   309,623     262,714   18 %
  Thyrogen     26,828     22,396   20 %   82,706     69,112   20 %
  Myozyme     53,568     20,402   >100 %   138,232     28,984   >100 %
  Other Therapeutics     153     72   >100 %   1,025     227   >100 %
   
 
     
 
     
    Total Therapeutics     471,230     388,267   21 %   1,364,427     1,106,262   23 %
   
 
     
 
     

Transplant:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
  Thymoglobulin/ Lymphoglobuline     41,036     37,619   9 %   121,854     110,291   10 %
  Other Transplant     1,845     1,622   14 %   5,548     4,428   25 %
   
 
     
 
     
    Total Transplant     42,881     39,241   9 %   127,402     114,719   11 %
   
 
     
 
     

Biosurgery:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
  Synvisc     61,175     55,929   9 %   179,634     172,782   4 %
  Sepra products     26,381     21,054   25 %   74,572     62,430   19 %
  Other Biosurgery     7,107     7,067   1 %   26,065     21,277   23 %
   
 
     
 
     
    Total Biosurgery     94,663     84,050   13 %   280,271     256,489   9 %
   
 
     
 
     
Other product revenue     74,484     62,469   19 %   216,904     186,057   17 %
   
 
     
 
     
    Total product revenues   $ 867,682   $ 734,231   18 % $ 2,511,354   $ 2,110,301   19 %
   
 
     
 
     

35


Renal

        Sales of Renagel, including sales of bulk sevelamer, increased 14% to $154.2 million for the three months ended September 30, 2007, as compared to the same period of 2006. Renagel price increases in the United States in December 2006 and April 2007 accounted for $9.5 million of the additional revenue while increased end-user demand worldwide accounted for $9.9 million of additional revenue. The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar for the three months ended September 30, 2007, as compared to the same period of 2006, positively impacted Renagel revenue by $3.7 million. Sales of Renagel, including sales of bulk sevelamer, were 16% of our total revenue for the three months ended September 30, 2007, compared to 17% of our total revenue for the same period of 2006.

        Sales of Renagel, including sales of bulk sevelamer, increased 15% to $436.5 million for the nine months ended September 30, 2007, as compared to the same period of 2006. Price increases for Renagel in the United States in December 2006 and April 2007 accounted for $25.1 million of additional revenue, while increased end-user demand worldwide accounted for $31.4 million of the additional revenue. The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar for the nine months ended September 30, 2007, as compared to the same period of 2006, positively impacted Renagel revenue by $10.8 million. Sales of Renagel, including sales of bulk sevelamer, were 16% of our total revenue for both the nine months ended September 30, 2007 and 2006.

        Hectorol, used to treat secondary hyperparathyroidism in patients on dialysis and those with CKD, is sold to nephrologists in the United States. Sales of Hectorol increased 19% to $30.3 million for the three months ended and increased 29% to $85.9 million for the nine months ended September 30, 2007, as compared to $25.5 million for the three months ended and $66.8 million for the nine months ended September 30, 2006, primarily due to price increases for the 0.5 and 2.5 microgram tablets in July and December 2006 and a price increase for Hectorol IV in April 2006, as well as higher end-user demand during both periods.

        We expect sales of Renagel and Hectorol to continue to increase, driven primarily by growing patient access to these products, including through the Medicare Part D program in the United States, and the continued adoption of the products by nephrologists worldwide. We expect adoption rates for Renagel to trend favorably as a result of our DCOR trial and the growing acceptance of the National Kidney Foundation's 2003 Kidney Disease Outcome Quality Initiative, or K/DOQI, Guidelines for Bone Metabolism and Disease in CKD and the RIND study. Renagel and Hectorol compete with several other products and our future sales may be impacted negatively by these products. We discuss some of these competitors under the heading "Risk Factors—Our future success will depend on our ability to effectively develop and market our products and services against those of our competitors," included in this report. In addition, our ability to continue to increase sales of Renagel and Hectorol will depend on many other factors, including our ability to optimize dosing and improve patient compliance with Renagel dosing, the availability of reimbursement from third-party payors and the extent of coverage, including under the Medicare Part D program. Also, the accuracy of our estimates of fluctuations in the payor mix and our ability to effectively manage wholesaler inventories and the levels of compliance with the inventory management programs we implemented for Renagel and Hectorol with our wholesalers, could impact the revenue from our Renal reporting segment that we record from period to period.

        On October 22, 2007, the FDA granted marketing approval for Renvela, a second-generation buffered form of Renagel for the control of serum phosphorus in patients with CKD on dialysis. We expect to launch Renvela for dialysis patients in the United States during the first quarter of 2008 and are pursuing regulatory approvals in Europe, South America and in other markets internationally. We will continue to make Renagel available, with the long-term goal of transitioning patients to Renvela.

36



        We expect Renvela will enable us to expand the market for our phosphate binder by reaching patients with CKD who have not progressed to dialysis. In October 2007, an FDA advisory committee voted to recommend that the agency extend the indications for phosphate binders to include pre-dialysis patients with hyperphosphatemia. During the first half of 2008, we plan to file a supplemental New Drug Application with the FDA seeking approval of Renvela for hyperphosphatemic patients with CKD who are not on dialysis. In addition, we expect to file for approval of a powder form of Renvela that may make it easier for patients to comply with their prescribed treatment program.

Therapeutics

        Therapeutics product revenue increased 21% to $471.2 million for the three months ended and 23% to $1.4 billion for the nine months ended September 30, 2007, as compared to the same periods of 2006, due to continued growth in sales of Cerezyme, Fabrazyme and Thyrogen and to the launch of Myozyme in the European Union, the United States and Canada in 2006.

        The 13% growth in sales of Cerezyme to $286.1 million for the three months ended and 12% growth in sales to $832.8 million for the nine months ended September 30, 2007, as compared to the same periods of 2006, is attributable to our continued identification of new Gaucher disease patients, particularly in international markets. Through October 2007, our price for Cerezyme has remained consistent from period to period. However, effective November 1, 2007, we implemented a 3% price increase for Cerezyme. Although we expect Cerezyme to continue to be a substantial contributor to revenues in the future, it is a mature product, and as a result, we do not expect that the current new patient growth trend will continue. The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar positively impacted Cerezyme revenue by $8.4 million for the three months ended and by $25.0 million for the nine months ended September 30, 2007, as compared to the same periods of 2006.

        Our results of operations are highly dependent on sales of Cerezyme and a reduction in revenue from sales of this product would adversely affect our results of operations. Sales of Cerezyme were approximately 30% of our total revenue for the three months ended September 30, 2007, as compared to 31% for the same period of 2006, and 30% of our total revenue for the nine months ended September 30, 2007, as compared to 32% for the same period of 2006. Revenue from Cerezyme would be impacted negatively if competitors developed alternative treatments for Gaucher disease, and the alternative products gained commercial acceptance, if our marketing activities are restricted, or if coverage, pricing or reimbursement is limited. Although orphan drug status for Cerezyme, which provided us with exclusive marketing rights for Cerezyme in the United States for seven years, expired in May 2001, we continue to have patents protecting our method of manufacturing Cerezyme until 2010 and the composition of Cerezyme as made by that process until 2013. The expiration of market exclusivity and orphan drug status will likely subject Cerezyme to increased competition, which may decrease the amount of revenue we receive from this product or the growth of that revenue. We are aware of companies that have developed or have initiated efforts to develop competitive products, and other companies may do so in the future. We discuss these competitors under the heading "Risk Factors—Our future success will depend on our ability to effectively develop and market our products and services against those of our competitors," in this report.

        The 12% increase to $104.6 million for the three months ended and the 18% increase to $309.6 million for the nine months ended September 30, 2007 in sales of Fabrazyme, as compared to the same periods of 2006, is primarily attributable to increased patient identification worldwide as Fabrazyme is introduced into new markets. The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar positively impacted Fabrazyme revenue by $2.9 million for the three months ended and by $8.3 million for the nine months ended September 30, 2007, as compared to the same periods of 2006.

37



        Sales of Thyrogen increased 20% to $26.8 million for the three months ended and 20% to $82.7 million for the nine months ended September 30, 2007, as compared to the same periods of 2006, due to worldwide volume growth which impacted sales by $2.7 million in the three month period and $11.5 million in the nine month period. The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar did not have a material impact on Thyrogen revenue for the three months ended but positively impacted Thyrogen revenue by $2.0 million for the nine months ended September 30, 2007, as compared to the same periods of 2006. We expect to receive FDA approval for the use of Thyrogen in thyroid cancer remnant ablation procedures by the end of 2007.

        Sales of Myozyme were $53.6 million for the three months ended and $138.2 million for the nine months ended September 30, 2007, as compared to $20.4 million for the three months ended and $29.0 million for the nine months ended September 30, 2006. In March 2006, we received marketing authorization for Myozyme in the European Union. In April 2006, the FDA granted marketing approval for Myozyme in the United States. We launched Myozyme in the United States in May 2006, in Europe a month later and in Canada in September 2006. We are introducing Myozyme on a country-by-country basis in the European Union, as pricing and reimbursement approvals are obtained. Myozyme has received orphan drug designation in the United States, which provides seven years of market exclusivity, and in the European Union, which provides ten years of market exclusivity. In April 2007, Myozyme was approved for commercial sale in Japan and in June 2007 we launched the product after we received reimbursement approval. We expect to file for approval in several additional countries in 2007. The 8% increase in the Euro against the U.S. dollar for the three months ended September 30, 2007, as compared to the same period of 2006, positively impacted Myozyme revenue by $1.2 million. The 8% increase in the Euro against the U.S. dollar for the nine months ended September 30, 2007, as compared to the same period of 2006, positively impacted Myozyme revenue by $1.7 million. The positive impact of the increase in the Euro against the U.S. dollar on Myozyme revenue for both the three and nine months ended September 30, 2007, is driven by the growth in sales volume of Myozyme in Europe, in each such period, as compared to the same periods of 2006.

        We currently manufacture Myozyme in the United States and have begun Myozyme fill-finish at our facility in Waterford, Ireland. We expect to commence Myozyme engineering runs at our protein manufacturing facility in Geel, Belgium later this year. In addition, in October 2007, we submitted an application to the FDA seeking approval of a larger-scale manufacturing process, based in Allston, Massachusetts, to enable us to meet the expected demand for Myozyme in the U.S. market going forward. We currently anticipate a decision from the FDA on the application for our larger-scale manufacturing process in the first quarter of 2008. In the meantime, we are continuing our efforts to optimize supply for the U.S. market, including temporarily transitioning some patients to a clinical access program through which they may receive Myozyme until the FDA approves the larger-scale manufacturing process. Production at this larger scale is already approved in 33 countries. We discuss the risks involved in manufacturing Myozyme and other products under the heading "Risk Factors—Manufacturing problems may cause product launch delays, inventory shortages, recalls and unanticipated costs," in this report.

Transplant

        Transplant product revenue increased 9% to $42.9 million for the three months ended and 11% to $127.4 million for the nine months ended September 30, 2007, as compared to the same periods of 2006. The increases are primarily due to a $5.6 million increase for the three month period and an $11.9 million increase for the nine month period in sales of Thymoglobulin as a result of its increased utilization in transplant procedures worldwide.

        We received a warning letter from the FDA on September 19, 2007 that addresses certain of our manufacturing procedures in our Thymoglobulin production facility in Lyon, France. There is no

38



current impact to product supply as a result of the FDA warning letter and we are in ongoing discussions with the FDA to resolve the issues described in the letter.

        Additionally, we determined that four lots of Thymoglobulin finished goods inventory did not meet our internal specifications for saleable product which caused those lots to be written off. Currently, we have three additional finished lots of Thymoglobulin, valued at approximately $8 million, which are under review to determine whether they meet product specifications. If we determine that any of those lots do not meet the specifications for saleable product, we will write off that inventory as a charge to earnings. Even with the four finished lots of Thymoglobulin that have been written off and the possibility of lots under review being written off, we currently expect to be able to meet projected market demand. We will continue to closely monitor our inventory levels and intend to manage production to maintain adequate supply levels in 2008.

        We discuss the risks involved in manufacturing Thymoglobulin and our other products under the heading "Risk Factors—Manufacturing problems may cause product launch delays, inventory shortages, recalls and unanticipated costs," in this report.

Biosurgery

        Biosurgery product revenue increased 13% to $94.7 million for the three months ended and increased 9% to $280.3 million for the nine months ended September 30, 2007, as compared to the same periods of 2006. There was a $5.5 million increase for the three month period and a $13.5 million increase for the nine month period, in sales of Seprafilm primarily due to greater penetration into the United States, Japanese and European markets.

        Synvisc sales increased $5.2 million for the three months ended and $6.9 million for the nine months ended September 30, 2007, as compared to the same periods of 2006, primarily due to a $2.5 million adjustment recorded in September 2007 to accruals related to our reacquisition of the sales and marketing rights to Synvisc in January 2005. Currently, Synvisc is delivered through three injections administered at one-week intervals. In November 2006 we completed a pivotal trial evaluating Synvisc-One, a single-injection regimen of Synvisc, which showed that patients who received a single-injection regimen of Synvisc achieved a statistically significant improvement in the pain caused by osteoarthritis of the knee in 26 weeks compared to those using placebo. We filed for marketing approval of Synvisc-One in the United States in June 2007 and in the European Union in July 2007. We anticipate receiving U.S. and European regulatory action this year on our marketing applications. The clinical advantages of Synvisc-One have the potential to expand the market for Synvisc.

        We are aware of several products that compete with Synvisc, several companies that have initiated efforts to develop competitive products and several companies that market products designed to relieve the pain of osteoarthritis. We discuss some of these competitors under the heading "Risk Factors—Our future success will depend on our ability to effectively develop and market our products and services against those of our competitors," included in this report.

39


Other Product Revenue

        Other product revenue increased 19% to $74.5 million for the three months ended and 17% to $216.9 million for the nine months ended September 30, 2007, as compared to the same periods of 2006, primarily due to:

    a 14% increase to $15.3 million for the three months ended and a 37% increase to $46.1 million for the nine months ended September 30, 2007, in the combined sales of Campath and Clolar;

    a 5% increase in sales of diagnostic products to $29.4 million for the three months ended and a 7% increase to $89.1 million for the nine months ended September 30, 2007, due to increased demand; and

    a 37% increase to $29.0 million for the three months ended and an 18% increase to $80.4 million in sales of bulk pharmaceuticals for the nine months ended September 30, 2007, due to bulk sales of and royalties earned on WelChol as a result of increased demand from our U.S. marketing partner, Sankyo Pharma, Inc., or Sankyo.

        In September 2007, the FDA approved expanded labeling for Campath to include first-line treatment of patients with B-cell chronic lymphocytic leukemia, significantly increasing the number of patients eligible to receive the product. We expect to receive European approval for an expanded indication by the end of 2007, following the positive opinion issued in October 2007 by the Committee for Medicinal Products for Human Use.

        In October 2007, we obtained European Union marketing approval for and subsequently launched Cholestagel in Europe. Cholestagel is a new, non-absorbed, cholesterol-lowering agent aimed at treating patients with primary hypercholesterolemia who cannot meet their targeted cholesterol levels with standard therapies alone.

Service Revenue

        We derive service revenue primarily from the following sources:

    sales of MACI, a proprietary cell therapy product for cartilage repair, in Europe and Australia, Carticel for the treatment of cartilage damage, and Epicel for the treatment of severe burns, all of which are included in our Biosurgery reporting segment; and

    genetic and pathology/oncology testing services, which are included in our Genetics reporting segment.

        The following table sets forth our service revenue on a segment basis:

 
  Three Months Ended
September 30,

   
  Nine Months Ended
September 30,

   
 
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
Biosurgery   $ 9,786   $ 9,399   4 % $ 27,486   $ 29,892   (8 )%
Genetics     73,050     61,360   19 %   212,922     179,853   18 %
Other     341     394   (13 )%   1,125     1,242   (9 )%
   
 
     
 
     
  Total service revenue   $ 83,177   $ 71,153   17 % $ 241,533   $ 210,987   14 %
   
 
     
 
     

        Service revenue attributable to our Biosurgery segment increased 4% to $9.8 million for the three months ended September 30, 2007, as compared to the same period of 2006. The increase is primarily due to higher demand for Carticel, offset, in part, by a decline in sales of Epicel due to a decrease in patients requesting this service.

40



        Service revenue attributable to our Biosurgery segment decreased 8% to $27.5 million for the nine months ended September 30, 2007, as compared to the same period of 2006 as a result of a decline in the sales of Epicel due to a decrease in patients requesting this service.

        Service revenue attributable to our Genetics reporting segment increased 19% to $73.1 million for the three months ended and 18% to $212.9 million for the nine months ended September 30, 2007, as compared to the same periods of 2006. These increases were primarily attributable to continued growth in sales of DNA and cancer testing services as well as growth in the prenatal screening and diagnosis market.

International Product and Service Revenue

        A substantial portion of our revenue is generated outside of the United States. The following table provides information regarding the change in international product and service revenue as a percentage of total product and service revenue during the periods presented:

 
  Three Months Ended
September 30,

   
  Nine Months Ended
September 30,

   
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
  2007
  2006
  2007
  2006
 
  (Amounts in thousands)

International product and service revenue   $ 451,881   $ 375,211   20%   $ 1,302,797   $ 1,057,507   23%
% of total product and service revenue     48%     47%         47%     46%    

        The 20% increase to $451.9 million for the three months ended and the 23% increase to $1.3 billion for the nine months ended September 30, 2007, in international product and service revenue, as compared to the same periods of 2006, is primarily due to a $71.5 million increase for the three month period and a $284.7 million increase for the nine month period, in the combined international sales of Renagel, Cerezyme, Fabrazyme and Myozyme primarily due to an increase in the number of patients using these products in the European Union and the Asia-Pacific rim.

        The strengthening of foreign currencies, primarily the Euro and British pound sterling, against the U.S. dollar positively impacted total product and service revenue by $19.8 million for the three months ended and $57.5 million for the nine months ended September 30, 2007, as compared to the same periods of 2006.

Research and Development Revenue

        The following table sets forth our research and development revenue on a segment basis:

 
  Three Months Ended
September 30,

   
  Nine Months Ended
September 30,

   
 
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
Therapeutics   $ 121   $   N/A   $ 1,190   $ 1,000   19 %
Transplant           N/A     180       N/A  
Biosurgery     1,697       N/A     4,671     5   >100 %
Other     7,016     3,180   >100 %   16,665     10,376   61 %
Corporate     466     10   >100 %   1,168     103   >100 %
   
 
     
 
     
  Total research and development revenue   $ 9,300   $ 3,190   >100 % $ 23,874   $ 11,484   >100 %
   
 
     
 
     

41


        Total research and development revenue increased $6.1 million for the three months ended and $12.4 million for the nine months ended September 30, 2007, as compared to the same periods of 2006, primarily due to increases in revenue recognized by our Biosurgery reporting segment and Other research and development revenue. Biosurgery research and development revenue primarily represents work done related to dermal filler products as a result of new contracts entered into with Mentor Corporation in September 2006 and February 2007, for which there were no comparable amounts for the three and nine months ended September 30, 2006. Other research and development revenue includes $2.9 million of revenue for the three months ended and $8.7 million for the nine months ended September 30, 2007, for research and development work related to alemtuzumab for the treatment of multiple sclerosis that we perform on behalf of Bayer Schering Pharma AG for which there were no comparable amounts for the same periods of 2006. Other research and development revenue also includes revenue related to our pharmaceuticals and cardiovascular businesses.

MARGINS

        The components of our total margins are described in the following table:

 
  Three Months Ended
September 30,

   
  Nine Months Ended
September 30,

   
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
  2007
  2006
  2007
  2006
 
  (Amounts in thousands)

Product margin   $ 677,207   $ 600,091   13%   $ 2,002,903   $ 1,721,692   16%
% of total product revenue     78 %   82 %       80 %   82 %  
Service margin   $ 29,040   $ 20,617   41%   $ 85,311   $ 62,637   36%
% of total service revenue     35 %   29 %       35 %   30 %  
Total product and service margin   $ 706,247   $ 620,708   14%   $ 2,088,214   $ 1,784,329   17%
% of total product and service revenue     74 %   77 %       76 %   77 %  

Product Margin

        Our overall product margin increased $77.1 million, or 13%, for the three months ended and $281.2 million, or 16%, for the nine months ended September 30, 2007, as compared to the same periods of 2006. This is primarily due to:

    improved margins for Hectorol and Renagel due to price increases, increased customer volume and increased efficiency at our global manufacturing facilities as well as the favorable foreign exchange rate for the Euro against the U.S. dollar;

    improved margins for Cerezyme, Fabrazyme and Thyrogen due to increased sales volume and improved unit costs;

    improved margins for Myozyme due to increased sales volume. We launched Myozyme in the European Union, the United States and Canada in 2006;

    an increase in product margin for Seprafilm due to increased sales; and

    an increase in product margin for our oncology business due to increased global sales of Campath and increased U.S. sales of Clolar.

These increases in product margin were partially offset by a $5.6 million increase in stock-based compensation expenses charged to cost of goods sold for the nine months ended September 30, 2007, as compared to the same period of 2006. In July 2006, we began amortizing stock-based compensation expense capitalized to inventory based on margin turns.

42



        Total product margin as a percentage of total product revenue for the three and nine months ended September 30, 2007, decreased as compared to the same periods of 2006, due to the change in product mix of the lower margin Myozyme and an $11.8 million manufacturing-related charge recorded in September 2007 to write off four finished lots of Thymoglobulin that did not meet product specifications for saleable product. Three additional finished lots of Thymoglobulin are currently under review to determine whether they meet product specifications.

        The amortization of product related intangible assets is included in amortization expense and, as a result, is excluded from cost of products sold and the determination of product margins.

Service Margin

        Our overall service margin increased $8.4 million, or 41%, for the three months ended and $22.7 million, or 36%, for the nine months ended September 30, 2007. This is primarily due to the increases in revenue recorded from our DNA and cancer testing services as well as the prenatal screening and diagnosis market for the three and nine months ended September 30, 2007.

        Total service margin as a percent of total service revenue increased for the three and nine months ended September 30, 2007, as compared to the same periods of 2006, primarily due to increased productivity and efficiencies in lab operations for our Genetics reporting segment.

OPERATING EXPENSES

Selling, General and Administrative Expenses

        The following table provides information regarding the change in SG&A during the periods presented:

 
  Three Months Ended
September 30,

   
  Nine Months Ended
September 30,

   
 
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
Selling, general and administrative expenses   $ 270,306   $ 239,700   13 % $ 878,807   $ 743,849   18 %
% of total revenue     28 %   30 %       32 %   32 %    

        SG&A increased $30.6 million for the three months ended and $135.0 million for the nine months ended September 30, 2007, as compared to the same periods of 2006, primarily due to spending increases of:

    $4.1 million for the three month period and $15.7 million for the nine month period for Renal, primarily due to continued support of the growth in Renal's international business operations;

    $6.6 million for the three month period and $23.3 million for the nine month period for Therapeutics, primarily due to costs incurred related to Myozyme's launch in additional countries during 2007;

    $2.7 million for the three month period and $8.2 million for the nine month period for Transplant, primarily due to expenses incurred for pre-launch activities for Mozobil. Also contributing to this increase is spending on additional personnel to support the expansion of Thymoglobulin into new markets;

    $4.3 million for the three month period and $9.8 million for the nine month period for Biosurgery, primarily due to sales force expansion;

    $4.1 million for the three month period and $8.2 million for the nine month period for Genetics, primarily due to headcount additions; and

43


    $7.2 million for the three month period and $85.7 million for the nine month period for Corporate SG&A primarily due to a charge of $64.0 million recorded in June 2007 related to the final court approved settlement agreement, subject to insurance coverage, of the litigation related to the consolidation of our former tracking stocks, and increased spending for information technology, legal expenses, employee recruiting and temporary help.

        These increases were partially offset in the nine month period by decreases of:

    $6.1 million for Genetics due to an adjustment in June 2007 to accruals related to our acquisition of the Physician Services and Analytical Services business units of IMPATH Inc. in May 2004; and

    $13.7 million attributable to a decrease in stock-based compensation expenses charged to SG&A. In May 2007, in connection with a general grant to employees, we issued a combination of stock options and RSUs, whereas in prior years we had only issued stock options for the general grant to employees.

Research and Development Expenses

        The following table provides information regarding the change in research and development expenses during the periods presented:

 
  Three Months Ended
September 30,

   
  Nine Months Ended
September 30,

   
 
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
Research and development expenses   $ 175,800   $ 162,293   8 % $ 540,362   $ 483,557   12 %
% of total revenue     18 %   20 %       19 %   21 %    

        Research and development expenses increased $13.5 million for the three months ended and $56.8 million for the nine months ended September 30, 2007, as compared to the same periods of 2006, primarily due to:

    increases of $7.3 million for the three month period and $47.0 million for the nine month period in spending on certain Therapeutics research and development programs, including a $25.0 million up-front payment paid to Ceregene in June 2007 in connection with our entry into a collaboration agreement for the development and commercialization of CERE-120, a gene therapy product for the treatment of Parkinson's disease;

    increases of $11.9 million for the three month period and $28.6 million for the nine month period in spending on Transplant research and development programs, primarily due to our acquisition of AnorMED in November 2006; and

    increases of $9.8 million for the three month period and $18.5 million for the nine month period in spending on Other research and development programs, primarily on alemtuzumab for the treatment of multiple sclerosis.

These increases were partially offset by decreases of:

    $3.3 million for the three month period and $13.9 million for the nine month period in spending on our Renal programs due to the termination of our collaboration with RenaMed Biologics, Inc., or RenaMed, in February 2007;

    $6.5 million in spending for the three month period and $7.6 million in spending for the nine month period on certain Therapeutics research and development programs, including a $4.6 million decrease in spending for the three month period and a $6.2 million decrease in

44


      spending for the nine month period due to the termination in February 2007 of our joint venture with Dyax for development of DX-88 for the treatment of HAE; and

    $3.5 million for the three month period and $12.3 million for the nine month period for our Corporate research and development programs, primarily due to decreases of $1.0 million for the three months ended and $5.7 million for the nine months ended September 30, 2007 in stock-based compensation expenses attributable to the issuance of a combination of stock options and RSUs in connection with a general grant to employees in May 2007. In prior years, only stock options were awarded in the general grant to employees.

Amortization of Intangibles

        The following table provides information regarding the change in amortization of intangibles expense during the periods presented:

 
  Three Months Ended
September 30,

   
  Nine Months Ended
September 30,

   
 
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
Amortization of intangibles   $ 49,819   $ 50,542   (1 )% $ 149,301   $ 156,117   (4 )%
% of total revenue     5 %   6 %       5 %   7 %    

        Amortization of intangibles expense decreased by $0.7 million for the three months ended and $6.8 million for the nine months ended September 30, 2007, as compared to the same periods of 2006, primarily due to $23.7 million of customer lists related to our acquisition of Bone Care in July 2005, which became fully amortized in the first quarter of 2007.

        As discussed in Note 7., "Goodwill and Other Intangible Assets," to our financial statements included in this report, we calculate amortization expense for the Synvisc sales and marketing rights we reacquired from Wyeth and the Myozyme patent and technology rights acquired pursuant to a licensing agreement with Synpac by taking into account forecasted future sales of Synvisc and Myozyme, respectively, and the resulting future contingent payments we will be required to make to Wyeth and Synpac. As a result, we expect amortization of intangibles to fluctuate over the next five years based on these future contingent payments.

Charge for Impaired Goodwill

        We are required to perform impairment tests related to our goodwill under FAS 142 annually and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. We completed the required annual impairment tests for our $1.3 billion of net goodwill in the third quarter of 2007 and determined that no impairment charges were required.

        As a result of the required annual impairment tests we performed on our $1.5 billion of net goodwill in the third quarter of 2006, we determined that the $219.2 million of goodwill assigned to our Genetics reporting unit was fully impaired and we recorded a pre-tax impairment charge of $219.2 million and $69.8 million of related tax benefits in September 2006.

Purchase of In-Process Research and Development

        In connection with five of our acquisitions completed between January 1, 2004 and September 30, 2007, we have acquired various IPR&D projects. Substantial additional research and development costs will be required prior to any of our acquired IPR&D programs and technology platforms reaching technological feasibility. In addition, once research is completed, each product candidate acquired will need to complete a series of clinical trials and receive FDA or other regulatory approvals prior to commercialization. Our current estimates of the time and investment required to develop these

45



products and technologies may change depending on the different applications that we may choose to pursue. We cannot give assurances that these programs will ever reach technological feasibility or develop into products that can be marketed profitably. In addition, we cannot guarantee that we will be able to develop and commercialize products before our competitors develop and commercialize products for the same indications. If products based on our acquired IPR&D programs and technology platforms do not become commercially viable, our results of operations could be materially adversely affected.

        The following table sets forth IPR&D projects for companies and certain assets we have acquired between January 1, 2004 and September 30, 2007 (amounts in millions):

Company/Assets Acquired

  Purchase
Price

  IPR&D(1)
  Programs Acquired

  Discount Rate
Used in
Estimating
Cash Flows(1)

  Year of
Expected
Launch

  Estimated
Cost to
Complete

AnorMED (2006)   $ 589.2   $ 526.8   Mozobil (stem cell transplant)   15%   2009-2014   $125
            26.1   AMD070 (HIV)(2)   15%     $—
         
               
          $ 552.9                
         
               
Avigen, Inc. (2005)   $ 12.0   $ 7.0   AV201 (Parkinson's disease)   N/A   2016   $100
         
               
Bone Care (2005)   $ 712.3   $ 12.7   LR-103 (secondary hyperparathyroidism)(3)   25%     $—
         
               
Verigen (2005)   $ 12.7   $ 9.5   MACI (cartilage repair)   24%   2012-2014   $20-$35
         
               
ILEX Oncology, Inc. (2004)   $ 1,080.3   $ 96.9   Campath(4)   11%   2009-2011   $194
            113.4   Clolar(4)   12%   2008-2011   $99
            44.2   Tasidotin   16%   2011-2014   $44
         
               
          $ 254.5                
         
               

(1)
Management assumes responsibility for determining the valuation of the acquired IPR&D projects. The fair value assigned to IPR&D for each acquisition is estimated by discounting, to present value, the cash flows expected once the acquired projects have reached technological feasibility. The cash flows are probability-adjusted to reflect the risks of advancement through the product approval process. In estimating the future cash flows, we also considered the tangible and intangible assets required for successful exploitation of the technology resulting from the purchased IPR&D projects and adjusted future cash flows for a charge reflecting the contribution to value of these assets.

(2)
Year of expected launch and estimated cost to complete data is not provided for AMD070 at this time because we are assessing our future plans for this program.

(3)
Year of expected launch and estimated cost to complete data is not provided for LR-103 at this time because this program is in its early stages and we are evaluating several potential applications for LR-103 to determine which application we will pursue. Therefore, the year of expected launch and cost to complete cannot be determined.

(4)
Campath is currently marketed for the treatment of B-cell chronic lymphoeytic leukemia and Clolar is marketed for the treatment of relapsed and refractory pediatric ALL. The IPR&D projects for Campath and Clolar are related to the development of these products for the treatment of other medical issues.

        In addition, we account for our investment in Bioenvision Common Stock under the equity method of accounting and, accordingly, we recorded a charge of $19.1 million in equity in income (loss) of equity method investments in our consolidated statement of operations for the three and nine months ended September 2007 for the portion of the purchase price for this investment that we allocated to IPR&D. The full purchase accounting for our acquisition of Bioenvision, including the impact of our merger in October 2007, will be reflected in our consolidated financial statements as of December 31, 2007 and for the year ended December 31, 2007.

46


OTHER INCOME AND EXPENSES

 
  Three Months Ended
September 30,

   
  Nine Months Ended
September 30,

   
 
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
Equity in income (loss) of equity method investments   $ (12,648 ) $ 4,530   >(100 )% $ (1,091 ) $ 10,630   >(100 )%
Minority interest     5     2,545   (100 )%   3,932     7,741   (49 )%
Gains on investments in equity securities, net     1,105     128   >100 %   14,036     75,037   (81 )%
Other     913     (873 ) >100 %   110     (1,331 ) >100 %
Investment income     18,222     16,760   9 %   51,687     39,401   31 %
Interest expense     (1,474 )   (3,772 ) (61 )%   (9,283 )   (12,245 ) (24 )%
   
 
     
 
     
  Total other income   $ 6,123   $ 19,318   (68 )% $ 59,391   $ 119,233   (50 )%
   
 
     
 
     

Equity in Income (Loss) of Equity Method Investments

        Under this caption, we record our portion of the results of our joint ventures with BioMarin and Medtronic, Inc., or Medtronic, and our investments in Peptimmune, Inc., or Peptimmune and, for the period from July 10, 2007 through September 30, 2007, Bioenvision, which we subsequently acquired in October 2007.

        Equity in income (loss) of equity method investments decreased $17.2 million, or more than 100%, for the three months ended and $11.7 million, or more than 100%, for the nine months ended September 30, 2007, as compared to the same periods of 2006, primarily due to $20.5 million of charges related to our investment in Bioenvision Common Stock, including a $19.1 million charge for IPR&D, representing our proportionate share of the fair value of IPR&D programs of Bioenvision. These decreases were offset in part by an increase of $3.2 million for the three months ended and $7.8 million for the nine months ended September 30, 2007 in our portion of the net income of BioMarin/Genzyme LLC attributable to increased sales of Aldurazyme.

Minority Interest

        Prior to February 20, 2007, as a result of our application of FIN 46R, "Consolidation of Variable Interest Entities," we consolidated the results of Dyax-Genzyme LLC and Excigen Inc. Effective February 20, 2007, we agreed with Dyax to terminate our participation and interest in Dyax-Genzyme LLC. In connection with this termination, we made a capital contribution of approximately $17 million in cash to Dyax-Genzyme LLC, and Dyax purchased our interest in the joint venture for 4.4 million shares of Dyax common stock, valued at $16.9 million, based on the closing price of Dyax common stock on February 23, 2007. Prior to February 20, 2007, in accordance with FIN 46R, we consolidated the assets related to Dyax-Genzyme LLC, which were not significant and consisted primarily of lab equipment net of their associated accumulated depreciation, and recorded Dyax's portion of this joint venture's losses as minority interest in our consolidated statements of operations through February 20, 2007. The results of Excigen Inc. were not significant.

47



Gains on Investments in Equity Securities, net

        We recorded the following gains on investments in equity securities, net of charges for impairment of investments, for the periods presented:

 
  Three Months Ended
September 30,

  Nine Months Ended
September 30,

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
Gross gains on investments in equity securities:                          
  THP   $   $   $ 10,848   $  
  CAT                 69,359  
  BioMarin                 6,417  
  Other     1,105     128     3,188     2,154  
   
 
 
 
 
    Total     1,105     128     14,036     77,930  
Less: charges for impairment of investments                 (2,893 )
   
 
 
 
 
Gains on investments in equity securities, net   $ 1,105   $ 128   $ 14,036   $ 75,037  
   
 
 
 
 

Unrealized Gains (Losses)

        At September 30, 2007, our stockholders' equity included $23.3 million of unrealized gains and $0.4 million of unrealized losses related to our investments in equity securities.

Investment Income

        Our investment income increased 9% to $18.2 million for the three months ended and 31% to $51.7 million for the nine months ended September 30, 2007, as compared to the same periods of 2006, primarily due to an increase in the average portfolio yield and higher average cash balances.

Interest Expense

        Our interest expense decreased 61% to $1.5 million for the three months ended September 30, 2007, as compared to the same period of 2006, primarily due to a $1.4 million increase in capitalized interest, which resulted in a decrease in interest expense, a $0.2 million decrease in interest related to our 2003 revolving credit facility, which was replaced in July 2006, and a $0.5 million decrease in interest expense related to asset retirement obligations, for which there was no similar amount in 2006.

        Our interest expense decreased 24% to $9.3 million for the nine months ended September 30, 2007, as compared to the same period of 2006, primarily due to a $4.3 million increase in capitalized interest, which resulted in a decrease in interest expense, and a $0.6 million decrease in interest related to our 2003 revolving credit facility, which was replaced in July 2006. These overall decreases were offset in part by a $2.3 million increase in interest expense related to asset retirement obligations, for which there was no similar amount in 2006.

(Provision for) Benefit from Income Taxes

 
  Three Months Ended
September 30,

   
  Nine Months Ended
September 30,

   
 
 
  Increase/
(Decrease)
% Change

  Increase/
(Decrease)
% Change

 
 
  2007
  2006
  2007
  2006
 
 
  (Amounts in thousands)

 
(Provision for) benefit from income taxes   $ (66,432 ) $ 44,530   >(100 )% $ (201,715 ) $ (60,841 ) >100 %
Effective tax rate     29 %   (156 )%       33 %   19 %    

48


Our effective tax rate for all periods presented varies from the U.S. statutory tax rate as a result of:

    our provision for state income taxes;

    the tax benefits from export sales;

    the tax benefits from domestic production activities;

    benefits related to tax credits;

    income and expenses taxed at rates other than the U.S. statutory tax rate;

    non-deductible stock-based compensation expenses; and

    non-deductible expenses associated with the settlement of litigation related to the consolidation of our former tracking stocks.

Our effective tax rate for the three and nine months ended September 30, 2006, was also impacted by a charge for impaired goodwill of $219.2 million of which $29.5 million was not deductible for tax purposes.

        Effective January 1, 2007, we adopted FIN 48 and recognized a cumulative effect adjustment of $33.9 million to increase our retained earnings balance as of January 1, 2007, which consisted of $25.8 million to record the combined effect of our gain contingency and the change in the recognition standard pursuant to the settlement criteria of FSP FIN 48-1 and $8.1 million resulting from our settlement of the IRS audit for tax years 2002 to 2003. After these adjustments, as of January 1, 2007, we had approximately $36.5 million of total gross unrealized tax benefits, of which approximately $26.6 million represents the amount of unrecognized tax benefits that, if recognized, would favorably affect our effective income tax rate in future periods. These gross unrealized tax benefits did not change significantly during the nine months ended September 30, 2007.

        We continue to recognize interest relating to unrecognized tax benefits within our provision for income taxes but have not recorded any amounts related to potential penalties. The amount of accrued interest related to unrecognized tax benefits within our provision for income taxes for the three and nine months ended September 30, 2007 and our accrued interest related to unrecognized tax benefits as of January 1, 2007 and September 30, 2007 were not significant.

        We are subject to U.S. federal income tax and various state, local and international income taxes in numerous jurisdictions, however, our only significant tax jurisdiction is the United States. We record liabilities for income tax contingencies based on our best estimate of the underlying exposures. We are currently under IRS audit for tax years 2004 to 2005, and in certain state and foreign jurisdictions from 2003 forward. We believe that we have provided sufficiently for all audit exposures and assessments. Settlement of these audits or the expiration of the statute of limitations on the assessment of income taxes for any tax year may result in an increase or reduction of future tax provisions. Any such tax or tax benefit would be recorded upon final resolution of the audits or expiration of the applicable statute of limitations.

        Management has concluded that it is not reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next 12 months.

B. LIQUIDITY AND CAPITAL RESOURCES

        We continue to generate cash from operations. At September 30, 2007, we had cash, cash equivalents and short- and long-term investments of $1.4 billion, an increase of $0.1 billion from $1.3 billion at December 31, 2006.

        The following is a summary of our statements of cash flows for the nine months ended September 30, 2007 and 2006.

49



Cash Flows from Operating Activities

        Cash flows from operating activities are as follows (amounts in thousands):

 
  Nine Months Ended
September 30,

 
 
  2007
  2006
 
Cash flows from operating activities:              
  Net income   $ 401,294   $ 251,437  
  Non-cash charges     318,351     455,482  
  Decrease in cash from working capital changes (excluding impact of acquired assets and assumed liabilities)     (108,818 )   (89,987 )
   
 
 
    Cash flows from operating activities   $ 610,827   $ 616,932  
   
 
 

        Cash provided by operating activities decreased $6.1 million for the nine months ended September 30, 2007, as compared to the same period of 2006, primarily due to a $149.9 million increase in earnings, excluding non-cash charges, offset by an $18.8 million increase in cash used for working capital.

Cash Flows from Investing Activities

        Cash flows from investing activities are as follows (amounts in thousands):

 
  Nine Months Ended
September 30,

 
 
  2007
  2006
 
Cash flows from investing activities:              
  Net sales (purchases) of investments, excluding investments in equity securities   $ 194,161   $ (107,261 )
  Net sales of investments in equity securities     350     131,691  
  Purchases of property, plant and equipment     (281,309 )   (236,917 )
  Acquisition of Bioenvision stock     (72,229 )    
  Distributions from equity method investments     17,100     12,000  
  Payment of note receivable from Dyax     7,771     370  
  Purchases of other intangible assets     (45,821 )   (67,793 )
  Other investing activities     658     4,292  
   
 
 
    Cash flows from investing activities   $ (179,319 ) $ (263,618 )
   
 
 

        For the nine months ended September 30, 2007, we used a total of $416.3 million of cash to fund capital expenditures and acquisitions including:

    approximately $17 million of cash for a capital contribution in connection with the termination of our participation and interest in Dyax-Genzyme LLC:

    $281.3 million of cash to fund the purchase of property, plant and equipment, primarily related to the ongoing expansion of our manufacturing capacity in the Republic of Ireland, the United Kingdom and Belgium, the construction of a new research and development facility in Framingham, Massachusetts and internally developed capitalized software costs related to our Genetics business, which is based at our facility in Westborough, Massachusetts;

    $72.2 million of cash to fund the acquisition of 22% of the outstanding shares of Bioenvision Common Stock on an as-converted basis. Effective October 23, 2007, we completed the acquisition of Bioenvision; and

50


    $45.8 million of cash for our reacquisition of the Synvisc sales and marketing rights from Wyeth and a milestone payment to Synpac.

        These decreases in cash were partially offset by:

    $194.2 million of cash received from the net sales of investments;

    $17.1 million of cash distributions from our joint venture with BioMarin; and

    $7.8 million of cash received from Dyax, including $7.0 million to satisfy the outstanding principal balance due under the note receivable from Dyax and $0.8 million of accrued interest due under the note.

Cash Flows from Financing Activities

        Our cash flows from financing activities are as follows (amounts in thousands):

 
  Nine Months Ended
September 30,

 
 
  2007
  2006
 
Cash flows from financing activities:              
  Proceeds from issuance of common stock   $ 100,276   $ 112,012  
  Repurchases of common stock     (181,210 )    
  Excess tax benefits from stock-based compensation     1,229     8,979  
  Payments of debt and capital lease obligations     (4,606 )   (3,155 )
  Increase (decrease) in bank overdrafts     19,259     (16,285 )
  Minority interest contributions     4,136     8,265  
  Other financing activities     3,525     2,610  
   
 
 
    Cash flows from financing activities   $ (57,391 ) $ 112,426  
   
 
 

        In May 2007, our board of directors authorized a stock repurchase program to repurchase up to an aggregate maximum amount of $1.5 billion or 20,000,000 shares of our outstanding common stock over the next three years, beginning in June 2007. The repurchases are being made from time to time and can be effectuated through open market purchases, privately negotiated transactions, transactions structured through investment banking institutions, or by other means, subject to management's discretion and as permitted by securities laws and other legal requirements. As of September 30, 2007, we had repurchased a total of 2,808,738 shares of our common stock at an average price of $64.50 per share for a total of $181.2 million of cash, including fees.

Payment of Note Receivable from Dyax

        In 2007, we received cash payments totaling $7.8 million from Dyax to settle the secured promissory note receivable from Dyax, including $7.0 million to satisfy the outstanding principal balance due under the note and $0.8 million of accrued interest.

Revolving Credit Facility

        As of September 30, 2007, no amounts were outstanding under our 2006 revolving credit facility. The terms of our 2006 revolving credit facility include various covenants, including financial covenants that require us to meet minimum interest coverage ratios and maximum leverage ratios. As of September 30, 2007, we were in compliance with these covenants.

51



Contractual Obligations

        The disclosure of payments we have committed to make under our contractual obligations is set forth under the heading "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations—Liquidity and Capital Resources" in Exhibit 13 to our 2006 Form 10-K. Excluding additional contingent payments to Wyeth for the reacquisition of the Synvisc sales and marketing rights as of September 30, 2007 there have been no material changes to our contractual obligations since December 31, 2006.

Financial Position

        We believe that our available cash, investments and cash flows from operations will be sufficient to fund our planned operations and capital requirements for the foreseeable future. Although we currently have substantial cash resources and positive cash flow, we have used or intend to use substantial portions of our available cash and may make additional borrowings for:

    product development and marketing;

    payments related to the cash consideration for our merger with Bioenvision, including the approximately $245 million of cash we paid in October 2007 upon completion of the merger, the approximately $11 million of cash we intend to pay in the fourth quarter of 2007 for the outstanding options to purchase shares of Bioenvision Common Stock;

    other business combinations and strategic business initiatives, including the approximately $53 million in Canadian dollars, or approximately $57 million in U.S. dollars (based on the November 2, 2007 spot rate for the Canadian dollar), of cash we intend to spend in December 2007 for our planned acquisition of the diagnostics division of DCL;

    our $1.5 billion stock repurchase program;

    expanding existing and constructing additional manufacturing facilities;

    upgrading our systems;

    contingent payments under license and other agreements;

    expanding staff; and

    working capital and satisfaction of our obligations under capital and operating leases.

        Our cash reserves may be further reduced to pay principal and interest on the $690.0 million in principal under our 1.25% convertible senior notes due December 1, 2023. The notes are initially convertible into Genzyme Stock at a conversion price of approximately $71.24 per share. Holders of the notes may require us to repurchase all or any part of the notes for cash, common stock, or a combination, at our option, on December 1, 2008, 2013 or 2018, at a price equal to 100% of the principal amount of the notes plus accrued and unpaid interest through the date prior to the date of repurchase. Additionally, upon a change of control, each holder may require us to repurchase for cash, at 100% of the principal amount of the notes plus accrued interest, all or a portion of the holder's notes. On or after December 1, 2008, we may redeem for cash at 100% of the principal amount of the notes plus accrued interest, all or part of the notes that have not been previously converted or repurchased.

        In addition, we have several outstanding legal proceedings. Involvement in investigations and litigation can be expensive and a court may ultimately require that we pay expenses and damages. As a result of legal proceedings, we also may be required to pay fees to a holder of proprietary rights in order to continue certain operations. We have provided you details on one set of pending legal proceedings in the notes to our consolidated financial statements.

52



        To satisfy these and other commitments, we may have to obtain additional financing. We cannot guarantee that we will be able to obtain any additional financing, extend any existing financing arrangement, or obtain either on favorable terms.

Off-Balance Sheet Arrangements

        We do not use special purpose entities or other off-balance sheet financing arrangements. We enter into guarantees in the ordinary course of business related to the guarantee of our own performance and the performance of our subsidiaries. In addition, we have joint ventures and certain other arrangements that are focused on research, development, and the commercialization of products. Entities falling within the scope of FIN 46R are included in our consolidated statements of operations if we qualify as the primary beneficiary. Entities not subject to consolidation under FIN 46R are accounted for under the equity method of accounting if our ownership percent exceeds 20% or if we exercise significant influence over the entity. We account for our portion of the income/losses of these entities in the line item "Equity in income (loss) of equity method investments" in our consolidated statements of operations. We also acquire companies in which we agree to pay contingent consideration based on attaining certain thresholds.

Recent Accounting Pronouncements

        FAS 157, "Fair Value Measurements." In September 2006, the FASB issued FAS 157, "Fair Value Measurements," which provides enhanced guidance for using fair value to measure assets and liabilities. FAS 157 establishes a common definition of fair value, provides a framework for measuring fair value under accounting principles generally accepted in the United States and expands disclosure requirements regarding fair value measurements. FAS 157 will be effective for us as of January 1, 2008. We are currently evaluating the impact, if any, the adoption of FAS 157 will have on our financial position and results of operations.

        FAS 159, "The Fair Value Option for Financial Assets and Financial Liabilities—Including an Amendment of FASB Statement No. 115." In February 2007, the FASB issued FAS 159, "The Fair Value Option for Financial Assets and Financial Liabilities—Including an Amendment of FASB Statement No. 115," which permits, but does not require, entities to measure certain financial instruments and other assets and liabilities at fair value on an instrument-by-instrument basis. Unrealized gains and losses on items for which the fair value option has been elected should be recognized in earnings at each subsequent reporting date. FAS 159 will be effective for us as of January 1, 2008 and cannot be adopted early unless FAS 157 is also adopted. We are currently evaluating the impact, if any, the adoption of FAS 159 will have on our financial position and results of operations.

        EITF Issue No. 07-3, "Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities." In June 2007, the FASB ratified the EITF consensus reached in EITF Issue No. 07-3, "Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities," which provides guidance for nonrefundable prepayments for goods or services that will be used or rendered for future research and development activities and directs that such payments should be deferred and capitalized. Such amounts should be recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. EITF 07-3 is effective for us January 1, 2008 and will be applied prospectively to new contracts we enter into on or after that date. Earlier application is not permitted. We are currently evaluating the impact, if any, the adoption of EITF No. 07-3 will have on our financial position, results of operations or cash flows.

53




RISK FACTORS

        Our future operating results could differ materially from the results described in this report due to the risks and uncertainties related to our business, including those discussed below.

Our financial results are highly dependent on sales of Cerezyme.

        We generate a significant portion of our revenue from sales of Cerezyme, our enzyme-replacement product for patients with Gaucher disease. Sales of Cerezyme totaled $832.8 million for the nine months ended September 30, 2007, representing approximately 30% of our consolidated total revenue. Because our business is highly dependent on Cerezyme, negative trends in revenue from this product could have a significant adverse effect on our results of operations and cause the value of our securities to decline substantially. We will lose revenue if alternative treatments gain commercial acceptance, if our marketing activities are restricted, or if reimbursement is limited. In addition, the patient population with Gaucher disease is not large. Because a significant percentage of that population already uses Cerezyme, opportunities for future sales growth are constrained. Furthermore, changes in the methods for treating patients with Gaucher disease, including treatment protocols that combine Cerezyme with other therapeutic products or reduce the amount of Cerezyme prescribed, could limit growth, or result in a decline, in Cerezyme sales.

If we fail to increase sales of several existing products and services, we will not meet our financial goals.

        Over the next few years, our success will depend substantially on our ability to increase revenue from our existing products and services. These products and services include Renagel, Renvela, Synvisc, Fabrazyme, Myozyme, Hectorol, Thymoglobulin, Thyrogen, Clolar, Campath and diagnostic testing services. Our ability to increase sales will depend on a number of factors, including:

    acceptance by the medical community of each product or service;

    the availability of competing treatments that are deemed more efficacious, more convenient to use, or more cost effective;

    our ability, and the ability of our collaborators, to efficiently manufacture sufficient quantities of each product to meet demand and to do so in a cost efficient manner;

    regulation by the U.S. Food and Drug Administration, commonly referred to as the FDA, and the European Agency for the Evaluation of Medicinal Products, or EMEA, and other regulatory authorities of these products and the facilities and processes used to manufacture these products;

    the scope of the labeling approved by regulatory authorities for each product and competitive products;

    the effectiveness of our sales force;

    the availability and extent of coverage, pricing and level of reimbursement from governmental agencies and third party payors; and

    the size of the patient population for each product or service and our ability to identify new patients.

        Part of our growth strategy involves conducting additional clinical trials to support approval of expanded uses of some of our products, including Clolar and alemtuzumab, pursuing marketing approval for our products in new jurisdictions and developing next generation products such as Renvela and Synvisc-One. The success of this component of our growth strategy will depend on the outcome of

54



these additional clinical trials, the content and timing of our submissions to regulatory authorities and whether and when those authorities determine to grant approvals.

        Because the healthcare industry is extremely competitive and regulatory requirements are rigorous, we spend substantial funds marketing our products and attempting to expand approved uses for them. These expenditures depress near-term profitability, with no assurance that the expenditures will generate future profits that justify the expenditures.

Our future success will depend on our ability to effectively develop and market our products and services against those of our competitors.

        The human healthcare products and services industry is extremely competitive. Other organizations, including pharmaceutical, biotechnology, device and diagnostic testing companies, have developed and are developing products and services to compete with our products, services, and product candidates. If healthcare providers, patients or payors prefer these competitive products or services or these competitive products or services have superior safety, efficacy, pricing or reimbursement characteristics, we will have difficulty maintaining or increasing the sales of our products and services.

        Renagel competes with two other products approved in the United States for the control of elevated phosphorus levels in patients with chronic kidney failure on hemodialysis. Fresenius Medical Care markets PhosLo®, a calcium-based phosphate binder. Shire Pharmaceuticals Group plc, or Shire, markets Fosrenol®, a non-calcium based phosphate binder. Amgen, Inc. recently acquired Ilypsa and its product candidate, ILY101, a polymeric phosphate binder that completed a phase 2 trial in CKD patients on dialysis. Renagel also competes with over-the-counter calcium carbonate products such as TUMS® and metal-based options such as aluminum and magnesium.

        UCB S.A. has developed Zavesca®, a small molecule drug for the treatment of Gaucher disease, the disease addressed by Cerezyme. Zavesca has been approved in the United States, European Union and Israel as an oral therapy for use in patients with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable. In addition, Shire reported top-line data from a phase 1/2 clinical trial for its gene-activated glucocerebrosidase program, also to treat Gaucher disease, and initiated phase 3 studies in July 2007. Protalix Biotherapeutics Ltd. initiated a phase 3 trial for plant-derived enzyme replacement therapy to treat Gaucher disease in the third quarter of 2007. Amicus Therapeutics, Inc., or Amicus, is conducting phase 2 trials for oral chaperone medication to treat Gaucher disease. We are also aware of other development efforts aimed at treating Gaucher disease.

        Outside the United States, Shire is marketing Replagal™, a competitive enzyme replacement therapy for Fabry disease which is the disease addressed by Fabrazyme. In addition, while Fabrazyme has received orphan drug designation, which provides us with seven years of market exclusivity for the product in the United States, other companies may seek to overcome our market exclusivity and, if successful, compete with Fabrazyme in the United States. Amicus has initiated phase 2 trials for oral chaperone medication to treat Fabry disease. We are aware of other development efforts aimed at treating Fabry disease.

        Current competition for Synvisc includes Supartz®, a product manufactured by Seikagaku Kogyo that is sold in the United States by Smith & Nephew Orthopaedics and in Japan by Kaken Pharmaceutical Co. under the name Artz®; Hyalgan®, produced by Fidia Farmaceutici S.p.A. and marketed in the United States by Sanofi-Aventis; Orthovisc®, produced by Anika Therapeutics, Inc., and marketed in the United States by Johnson & Johnson and marketed outside the United States through distributors; Euflexxa™, a product manufactured and sold by Ferring Pharmaceuticals and marketed in the United States and Europe; and Durolane®, manufactured by Q-Med AB and distributed outside the United States by Smith & Nephew Orthopedics. We are aware of various viscosupplementation products on the market or in development, but are unaware of any products that

55


have physical properties of viscosity, elasticity or molecular weight comparable to those of Synvisc. Furthermore, several companies market products that are not viscosupplementation products but which are designed to relieve the pain associated with osteoarthritis. Synvisc will have difficulty competing with any of these products to the extent the competitive products are considered more efficacious, less burdensome to administer or more cost-effective.

        Several companies market products that, like Thymoglobulin and Lymphoglobuline, are used for the prevention and treatment of acute rejection in renal transplant. These products include Novartis' Simulect® and Pfizer Inc.'s ATGAM®. Competition in the acute transplant rejection market is driven largely by product efficacy due to the potential decreased long-term survival of transplanted organs as the result of an acute organ rejection episode.

        The examples above are illustrative and not exhaustive. Almost all of our products and services face competition. Furthermore, the field of biotechnology is characterized by significant and rapid technological change. Discoveries by others may make our products or services obsolete. For example, competitors may develop approaches to treating LSDs that are more effective, convenient or less expensive than our products and product candidates. Because a significant portion of our revenue is derived from products that address this class of diseases and a substantial portion of our expenditures is devoted to developing new therapies for this class of diseases, such a development would have a material negative impact on our results of operations.

If we fail to obtain and maintain adequate levels of reimbursement for our products from third party payors, the commercial potential of our products will be significantly limited.

        A substantial portion of our domestic and international revenue comes from payments by third party payors, including government health administration authorities and private health insurers. Governments and other third party payors may not provide adequate insurance coverage or reimbursement for our products and services, which could impair our financial results.

        Third party payors are increasingly scrutinizing pharmaceutical budgets and healthcare expenses and are attempting to contain healthcare costs by:

    challenging the prices charged for healthcare products and services;

    limiting both the coverage and the amount of reimbursement for new therapeutic products;

    reducing existing reimbursement rates for commercialized products and services;

    limiting coverage for the treatment of a particular patient to a maximum dollar amount or specified period of time;

    denying or limiting coverage for products that are approved by the FDA or other governmental regulatory bodies but are considered experimental or investigational by third party payors; and

    refusing in some cases to provide coverage when an approved product is used for disease indications in a way that has not received FDA or other applicable marketing approval.

        Attempts by third party payors to reduce costs in any of these ways could decrease demand for our products. In addition, in certain countries, including countries in the European Union and Canada, the coverage of prescription drugs, the pricing, and the level of reimbursement are subject to governmental control. Therefore, we may be unable to negotiate coverage, pricing and/or reimbursement on terms that are favorable to us. Government health administration authorities may also rely on analyses of the cost-effectiveness of certain therapeutic products in determining whether to provide reimbursement for such products. Our ability to obtain satisfactory pricing and reimbursement may depend in part on whether our products, the cost of some of which is high in comparison to other therapeutic products, are viewed as cost-effective.

56


        Furthermore, governmental regulatory bodies, such as the Centers for Medicare and Medicaid Services (CMS), may from time-to-time make unilateral changes to reimbursement rates for our products and services. These changes could reduce our revenues by causing healthcare providers to be less willing to use our products and services. Although we actively seek to assure that any initiatives that are undertaken by regulatory agencies involving reimbursement for our products and services do not have an adverse impact on us, we may not always be successful in these efforts. For example, in October 2006, the CMS announced a change to the billing code for viscosupplementation products effective January 2007 that, if unchanged, would have resulted in Medicare reimbursement for Synvisc at a rate that was lower than the price healthcare providers were paying for the product. In December 2006, the CMS reversed its decision. If the CMS billing code decision had been left unchanged, our Synvisc revenues would have been adversely affected because healthcare providers likely would have been less willing to use Synvisc. Although the CMS ultimately reversed its decision and left the mechanism for calculating Synvisc reimbursement in 2007 substantially similar to the reimbursement mechanism for 2006, we have no way of knowing whether, at some point in the future, the CMS will change the method for reimbursing Synvisc or any of our other products and services in a way that could have an adverse effect on our revenues.

The development of new biotechnology products involves a lengthy and complex process, and we may be unable to commercialize any of the products we are currently developing.

        We have numerous products under development and devote considerable resources to research and development, including clinical trials.

        Before we can commercialize our development-stage product candidates, we will need to:

    conduct substantial research and development;

    undertake preclinical and clinical testing;

    develop and scale-up manufacturing processes; and

    pursue marketing approvals and, in some jurisdictions, pricing and reimbursement approvals.

        This process involves a high degree of risk and takes many years. Our product development efforts with respect to a product candidate may fail for many reasons, including:

    failure of the product candidate in preclinical studies;

    difficulty enrolling patients in clinical trials, particularly for disease indications with small patient populations;

    patients exhibiting adverse reactions to the product candidate or indications of other safety concerns;

    insufficient clinical trial data to support the effectiveness of the product candidate;

    our inability to manufacture sufficient quantities of the product candidate for development or commercialization activities in a timely and cost-efficient manner;

    our failure to obtain the required regulatory approvals for the product candidate, the facilities or the process used to manufacture the product candidate; or

    changes in the regulatory environment, including pricing and reimbursement, that make development of a new product or indication no longer desirable.

        Few research and development projects result in commercial products, and success in preclinical studies or early clinical trials often is not replicated in later studies. For example, in our phase 3 trial known as the Polymer Alternative for CDAD treatment (PACT) study, tolevamer did not meet its

57


primary endpoint. In our pivotal study of hylastan for treatment of patients with osteoarthritis of the knee, hylastan did not meet its primary endpoint. We may decide to abandon development of a product or service candidate at any time or we may be required to expend considerable resources repeating clinical trials or conducting additional trials, either of which would increase costs of development and delay any revenue from those product candidates.

        Our efforts to expand the approved indications for our products and to gain marketing approval in new jurisdictions and to develop next generation products also may fail. These expansion efforts are subject to many of the risks associated with completely new products and accordingly, we may fail to recoup the investments we make pursuing these strategies.

We may encounter substantial difficulties managing our growth.

        Several risks are inherent to our plans to grow our business. Achieving our goals will require substantial investments in research and development, sales and marketing, and facilities. For example, we have spent considerable resources building and seeking regulatory approvals for our manufacturing plants. We cannot assure you that these facilities will prove sufficient to meet demand for our products or that we will not have excess capacity at these facilities. In addition, building our facilities is expensive, and our ability to recover these costs will depend on increased revenue from the products produced at the facilities.

        We produce relatively small amounts of material for research and development activities and pre-clinical trials. Even if a product candidate receives all necessary approvals for commercialization, we may not be able to successfully scale-up production of the product material at a reasonable cost or at all.

        If we are able to grow sales of our products, we may have difficulty managing inventory levels. Marketing new therapies is a complicated process, and gauging future demand is difficult. With Renagel, for example, we have encountered problems in the past managing inventory levels at wholesalers. Comparable problems may arise with any of our products, particularly during market introduction.

        Growth in our business may also contribute to fluctuations in our operating results, which may cause the price of our securities to decline. Our revenue may fluctuate due to many factors, including changes in:

    wholesaler buying patterns;

    reimbursement rates;

    physician prescribing habits;

    the availability or pricing of competitive products; and

    currency exchange rates.

        We may also experience fluctuations in our quarterly results due to price changes and sales incentives. For example, purchasers of our products, particularly wholesalers, may increase purchase orders in anticipation of a price increase and reduce order levels following the price increase. We occasionally offer sales incentives and promotional discounts on some of our products and services that could have a similar impact. In addition, some of our products, including Synvisc, are subject to seasonal fluctuation in demand.

58



Our operating results and financial position may be impacted when we attempt to grow through business combination transactions.

        We may encounter problems assimilating operations acquired in business combination transactions. These transactions often entail the assumption of unknown liabilities, the loss of key employees, and the diversion of management attention. Furthermore, in any business combination, including our acquisitions of AnorMED Inc. and Bioenvision, there is a substantial risk that we will fail to realize the benefits we anticipated when we decided to undertake the transaction. We have in the past taken significant charges for impaired goodwill and for impaired assets acquired in business combination transactions. We may be required to take similar charges in the future.

Manufacturing problems may cause product launch delays, inventory shortages, recalls and unanticipated costs.

        In order to generate revenue from our approved products, we must be able to produce sufficient quantities of the products. Many of our products are difficult to manufacture. Our products that are biologics, for example, require product characterization steps that are more onerous than those required for most chemical pharmaceuticals. Accordingly, we employ multiple steps to attempt to control the manufacturing processes. Minor deviations in these manufacturing processes could result in unacceptable changes in the products that result in lot failures, product recalls, product liability claims and insufficient inventory.

        Certain of the raw materials required in the commercial manufacturing and the formulation of our products are derived from biological sources, including mammalian sources and human plasma. Such raw materials may be subject to contamination or recall. Also, some countries in which we market our products may restrict the use of certain biologically derived substances in the manufacture of drugs. A material shortage, contamination, recall, or restriction of the use of certain biologically derived substances in the manufacture of our products could adversely impact or disrupt our commercial manufacturing of our products or could result in a mandated withdrawal of our products from the market. This too, in turn, could adversely affect our ability to satisfy demand for our products, which could materially and adversely affect our operating results.

        In addition, we may only be able to produce certain of our products at a very limited number of facilities and, in some cases, we rely on third parties to formulate and manufacture our products. For example, we manufacture all of our Cerezyme and a portion of our Fabrazyme and Myozyme products at our facility in Allston, Massachusetts. A number of factors could cause production interruptions at our facilities or the facilities of our third party providers, including equipment malfunctions, labor problems, natural disasters, power outages, terrorist activities, or disruptions in the operations of our suppliers.

        Manufacturing is also subject to extensive government regulation. Regulatory authorities must approve the facilities in which human healthcare products are produced and those facilities are subject to ongoing inspections. In addition, changes in manufacturing processes may require additional regulatory approvals. Obtaining and maintaining these regulatory approvals could cause us to incur significant additional costs and lose revenue. For example, we are currently working with the FDA to obtain approval of a larger-scale Myozyme manufacturing process. We anticipate a decision from the FDA in the first quarter of 2008 and, until that time, are taking actions to optimize our U.S. Myozyme supply, including making Myozyme available to some patients through a clinical access program. Furthermore, any third party we use to manufacture, fill-finish or package our products to be sold must also be licensed by the applicable regulatory authorities. As a result, alternative third party providers may not be readily available on a timely basis.

        Additionally, we determined that four lots of Thymoglobulin finished goods inventory did not meet our internal specifications for saleable product which caused those lots to be written off. Currently, we

59



have three additional finished lots of Thymoglobulin, valued at approximately $8 million, which are under review to determine whether they meet product specifications. If we determine that any of those lots do not meet the specifications for saleable product, we will write off that inventory as a charge to earnings. Even with the four finished lots of Thymoglobulin that have been written off and the possibility of lots under review being written off, we currently expect to be able to meet projected market demand. We will continue to closely monitor our inventory levels and intend to manage production to maintain adequate supply levels in 2008.

Guidelines and recommendations published by various organizations can reduce the use of our products.

        Professional societies, practice management groups, private health/science foundations, and organizations involved in various diseases may publish guidelines or recommendations to the healthcare and patient communities from time to time. Recommendations of government agencies or these other groups/organizations may relate to such matters as usage, dosage, route of administration, cost-effectiveness, and use of related therapies. Organizations like these have in the past made recommendations about our products and products of our competitors. Recommendations or guidelines that are followed by patients and healthcare providers could result in decreased use of our products. The perception by the investment community or shareholders that recommendations or guidelines will result in decreased use of our products could adversely affect prevailing market price for our common stock. In addition, our success also depends on our ability to educate patients and healthcare providers about our products and their uses. If these education efforts are not effective, then we may not be able to increase the sales of our existing products or successfully introduce new products to the market.

We rely on third parties to provide us with materials and services in connection with the manufacture of our products.

        Certain materials necessary for commercial production of our products, including specialty chemicals and components necessary for manufacture, fill-finish and packaging, are provided by unaffiliated third party suppliers. In some cases, such materials are specifically cited in our marketing application with regulatory authorities so that they must be obtained from that specific source unless and until the applicable authority approved another supplier. In addition, there may only be one available source for a particular chemical or component. For example, we acquire polyalylamine (PAA), used in the manufacture of Renagel, Renvela, Cholestagel and WelChol, from Cambrex Charles City, Inc., the only source for this material currently qualified in our FDA drug applications for these products. Our suppliers also may be subject to FDA regulations or the regulations of other governmental agencies outside the United States regarding manufacturing practices. We may be unable to manufacture our products in a timely manner or at all if these third party suppliers were to cease or interrupt production or otherwise fail to supply these materials or products to us for any reason, including due to regulatory requirements or actions, adverse financial developments at or affecting the supplier, or labor shortages or disputes.

        We also source some of our manufacturing, fill-finish, packaging and distribution operations to third party contractors. The manufacture of products, fill-finish, packaging and distribution of our products requires successful coordination among these third party providers and Genzyme. Our inability to coordinate these efforts, the lack of capacity available at a third party contractor or any other problems with the operations of these third party contractors could require us to delay shipment of saleable products, recall products previously shipped or could impair our ability to supply products at all. This could increase our costs, cause us to lose revenue or market share and damage our reputation.

60



If our strategic alliances are unsuccessful, our operating results will be negatively impacted.

        Several of our strategic initiatives involve alliances with other biotechnology and pharmaceutical companies, including a joint venture with BioMarin Pharmaceutical Inc. with respect to Aldurazyme. The success of these and similar arrangements is largely dependent on technology and other intellectual property contributed by our strategic partners or the resources, efforts, and skills of our partners. Disputes and difficulties in such relationships are common, often due to conflicting priorities or conflicts of interest. Merger and acquisition activity may exacerbate these conflicts. The benefits of these alliances are reduced or eliminated when strategic partners:

    terminate the agreements or limit our access to the underlying intellectual property;

    fail to devote financial or other resources to the alliances and thereby hinder or delay development, manufacturing or commercialization activities;

    fail to successfully develop, manufacture or commercialize any products; or

    fail to maintain the financial resources necessary to continue financing their portion of the development, manufacturing, or commercialization costs of their own operations.

        Furthermore, payments we make under these arrangements may exacerbate fluctuations in our financial results. In addition, under some of our strategic alliances, we make milestone payments well in advance of commercialization of products with no assurance that we will ever recoup these payments. We also may make equity investments in our strategic partners, as we did with RenaMed Biologics, Inc., or RenaMed, in June 2005. Our strategic equity investments are subject to market fluctuations, access to capital and other business events, such as initial public offerings, the completion of clinical trials and regulatory approvals, which can impact the value of these investments. For example, in October 2006, RenaMed suspended clinical trials of its renal assist device which was being developed to treat patients with acute renal failure, causing us to write off our entire investment in RenaMed. If any of our other strategic equity investments decline in value and remain below cost for an extended duration, we may incur additional financial statement charges.

Government regulation imposes significant costs and restrictions on the development and commercialization of our products and services.

        Our success will depend on our ability to satisfy regulatory requirements. We may not receive required regulatory approvals on a timely basis or at all. Government agencies heavily regulate the production and sale of healthcare products and the provision of healthcare services. In particular, the FDA and comparable regulatory agencies in foreign jurisdictions must approve human therapeutic and diagnostic products before they are marketed, as well as the facilities in which they are made. This approval process can involve lengthy and detailed laboratory and clinical testing, sampling activities and other costly and time-consuming procedures. Several biotechnology companies have failed to obtain regulatory approvals because regulatory agencies were not satisfied with the structure or conduct of clinical trials. Similar problems could delay or prevent us from obtaining approvals. Furthermore, regulatory authorities, including the FDA, may not agree with our interpretations of our clinical trial data, which could delay, limit or prevent regulatory approvals.

        Therapies that have received regulatory approval for commercial sale may continue to face regulatory difficulties. If we fail to comply with applicable regulatory requirements, regulatory authorities could take actions against us, including:

    issuing warning letters;

    issuing fines and other civil penalties;

    suspending regulatory approvals;

61


    refusing to approve pending applications or supplements to approved applications;

    suspending product sales, imports and/or exports;

    requiring us to communicate with physicians and other customers about concerns related to potential safety, efficacy, and other issues involving Genzyme products;

    mandating product recalls; and

    seizing products.

        Furthermore, the FDA and comparable foreign regulatory agencies may require post-marketing clinical trials or patient outcome studies. We have agreed with the FDA, for example, to a number of post-marketing commitments as a condition to U.S. marketing approval for Fabrazyme, Aldurazyme and Myozyme. In addition, regulatory agencies subject a marketed therapy, its manufacturer and the manufacturer's facilities to continual review and periodic inspections. The discovery of previously unknown problems with a therapy or the facility or process used to produce the therapy could prompt a regulatory authority to impose restrictions on us, or could cause us to voluntarily adopt such restrictions, including withdrawal of one or more of our products or services from the market. For example, we received a warning letter from the FDA on September 19, 2007 that addresses certain of our manufacturing procedures in our Thymoglobulin production facility in Lyon, France. There is no current impact to product supply as a result of the FDA warning letter and we are in ongoing discussions with the FDA to resolve the issues described in the letter.

We may incur substantial costs as a result of litigation or other proceedings.

        A third party may sue us or one of our strategic collaborators for infringing the third party's patent or other intellectual property rights. Likewise, we or one of our strategic collaborators may sue to enforce intellectual property rights or to determine the scope and validity of third party proprietary rights. If we do not prevail in this type of litigation, we or our strategic collaborators may be required to:

    pay monetary damages;

    stop commercial activities relating to the affected products or services;

    obtain a license in order to continue manufacturing or marketing the affected products or services; or

    compete in the market with a different product.

        We are also currently involved in litigation matters and investigations that do not involve intellectual property claims and may be subject to additional actions in the future. For example, the federal government, state governments and private payors are investigating and have begun to file actions against numerous pharmaceutical and biotechnology companies, including Genzyme, alleging that the companies have overstated prices in order to inflate reimbursement rates. Domestic and international enforcement authorities also have instituted actions under healthcare "fraud and abuse" laws, including anti-kickback and false claims statutes. Moreover, individuals who use our products or services, including our diagnostic products and genetic testing services, sometimes bring product and professional liability claims against us or our subsidiaries.

        We may also become subject to investigations by government authorities in connection with our business activities. For example, we are currently cooperating with an investigation of Bone Care by the United States Attorney for the Eastern District of New York which was initiated in October 2004, when Bone Care received a subpoena requiring it to provide a wide range of documents related to numerous aspects of its business.

62



        We believe some of our products are prescribed by physicians for uses not approved by the FDA or comparable regulatory agencies outside the United States. Although physicians may lawfully prescribe our products for off-label uses, any promotion by us of off-label uses would be unlawful. Some of our practices intended to make physicians aware of off-label uses of our products without engaging in off-label promotion could nonetheless be construed as off-label promotion. Although we have policies and procedures in place designed to help assure ongoing compliance with regulatory requirements regarding off-label promotion, some non-compliant actions may nonetheless occur. Regulatory authorities could take enforcement action against us if they believe we are promoting, or have promoted, our products for off-label use.

        We have only limited amounts of insurance, which may not provide coverage to offset a negative judgment or a settlement payment. We may be unable to obtain additional insurance in the future, or we may be unable to do so on acceptable terms. Our insurers may dispute our claims for coverage. For example, we have submitted claims to our insurers for reimbursement of portions of the expenses incurred in connection with the litigation and settlement related to the consolidation of our tracking stock and are seeking coverage for the settlement. The insurer has purported to deny coverage. Any additional insurance we do obtain may not provide adequate coverage against any asserted claims.

        Regardless of merit or eventual outcome, investigations and litigations can result in:

    diversion of management's time and attention;

    expenditure of large amounts of cash on legal fees, expenses, and payment of damages;

    limitations on our ability to continue some of our operations;

    decreased demand for our products and services; and

    injury to our reputation.

Our international sales, clinical activities, manufacturing and other operations are subject to the economic, political, legal and business environments of the countries in which we do business, and our failure to operate successfully or adapt to changes in these environments could cause our international sales and operations to be limited or disrupted.

        Our international operations accounted for approximately 47% of our consolidated product and service revenues for the nine months ended September 30, 2007. We expect that international product and service sales will continue to account for a significant percentage of our revenues for the foreseeable future. In addition, we have direct investments in a number of subsidiaries outside of the United States, primarily in the European Union, Latin America and Japan. Our international sales and operations could be limited or disrupted, and the value of our direct investments may be diminished, by any of the following:

    economic problems that disrupt foreign healthcare payment systems;

    the imposition of governmental controls;

    less favorable intellectual property or other applicable laws;

    the inability to obtain any necessary foreign regulatory or pricing approvals of products in a timely manner;

    the inability to obtain third party reimbursement support for products;

    product counterfeiting and intellectual property piracy;

    parallel imports;

    anti-competitive trade practices;

63


    import and export license requirements;

    political instability;

    terrorist activities, armed conflict, or outbreak of diseases such as severe acute respiratory syndrome (SARS) or avian influenza;

    restrictions on direct investments by foreign entities and trade restrictions;

    changes in tax laws and tariffs;

    difficulties in staffing and managing international operations; and

    longer payment cycles.

        Our operations and marketing practices are also subject to regulation and scrutiny by the governments of the other countries in which we operate. In addition, the United States Foreign Corrupt Practices Act prohibits U.S. companies and their representatives from offering, promising, authorizing or making payments to foreign officials for the purpose of obtaining or retaining business abroad. Failure to comply with domestic or foreign laws could result in various adverse consequences, including possible delay in approval or refusal to approve a product, recalls, seizures, withdrawal of an approved product from the market, and/or the imposition of civil or criminal sanctions.

Our international sales are subject to fluctuations in currency exchange rates.

        A significant portion of our business is conducted in currencies other than our reporting currency, the U.S. dollar. We recognize foreign currency gains or losses arising from our operations in the period in which we incur those gains or losses. As a result, currency fluctuations among the U.S. dollar and the currencies in which we do business have caused foreign currency translation gains and losses in the past and will likely do so in the future. Because of the number of currencies involved, the variability of currency exposures and the potential volatility of currency exchange rates, we may suffer significant foreign currency translation losses in the future due to the effect of exchange rate fluctuations.

We may fail to adequately protect our proprietary technology, which would allow competitors or others to take advantage of our research and development efforts.

        Our long-term success largely depends on our ability to market technologically competitive products. If we fail to obtain or maintain adequate intellectual property protection in the United States or abroad, we may not be able to prevent third parties from using our proprietary technologies. Our currently pending or future patent applications may not result in issued patents. Patent applications are confidential for 18 months following their filing, and because third parties may have filed patent applications for technology covered by our pending patent applications without us being aware of those applications, our patent applications may not have priority over patent applications of others. In addition, our issued patents may not contain claims sufficiently broad to protect us against third parties with similar technologies or products, or provide us with any competitive advantage. If a third party initiates litigation regarding our patents, our collaborators' patents, or those patents for which we have license rights, and is successful, a court could declare our patents invalid or unenforceable or limit the scope of coverage of those patents. Governmental patent offices and courts have not consistently treated the breadth of claims allowed in biotechnology patents. If patent offices or the courts begin to allow or interpret claims more broadly, the incidence and cost of patent interference proceedings and the risk of infringement litigation will likely increase. On the other hand, if patent offices or the courts begin to allow or interpret claims more narrowly, the value of our proprietary rights may be reduced. Any changes in, or unexpected interpretations of, the patent laws may adversely affect our ability to enforce our patent position.

64


        We also rely upon trade secrets, proprietary know-how, and continuing technological innovation to remain competitive. We attempt to protect this information with security measures, including the use of confidentiality agreements with employees, consultants, and corporate collaborators. These individuals may breach these agreements and any remedies available to us may be insufficient to compensate for our damages. Furthermore, our trade secrets, know-how and other technology may otherwise become known or be independently discovered by our competitors.

We may be required to license technology from competitors or others in order to develop and commercialize some of our products and services, and it is uncertain whether these licenses would be available.

        Third party patents may cover some of the products or services that we or our strategic partners are developing or producing. A patent is entitled to a presumption of validity and accordingly, we face significant hurdles in any challenge to a patent. In addition, even if we are successful in challenging the validity of a patent, the challenge itself may be expensive and require significant management attention.

        To the extent valid third party patent rights cover our products or services, we or our strategic collaborators would be required to seek licenses from the holders of these patents in order to manufacture, use, or sell these products and services, and payments under them would reduce our profits from these products and services. We may not be able to obtain these licenses on acceptable terms, or at all. If we fail to obtain a required license or are unable to alter the design of our technology to fall outside the scope of a third party patent, we may be unable to market some of our products and services, which would limit our profitability.

Importation of products may lower the prices we receive for our products.

        In the United States and abroad, many of our products are subject to competition from lower-priced versions of our products and competing products from other countries where government price controls or other market dynamics result in lower prices for such products. Our products that require a prescription in the United States may be available to consumers in markets such as Canada, Mexico, Taiwan and the Middle East without a prescription, which may cause consumers to further seek out these products in these lower priced markets. The ability of patients and other customers to obtain these lower priced imports has grown significantly as a result of the Internet, an expansion of pharmacies in Canada and elsewhere that target American purchasers, the increase in U.S.-based businesses affiliated with Canadian pharmacies marketing to American purchasers, and other factors. Most of these foreign imports are illegal under current United States law. However, the volume of imports continues to rise due to the limited enforcement resources of the FDA and the United States Customs Service, and there is increased political pressure to permit such imports as a mechanism for expanding access to lower priced medicines. The importation of lower-priced versions of our products into the United States and other markets adversely affects our profitability. This impact could become more significant in the future.

Legislative or regulatory changes may adversely impact our business.

        The United States government and other governments have shown significant interest in pursuing healthcare reform. Any government-adopted reform measures could adversely impact:

    the pricing of healthcare products in the United States or internationally; and

    the amount of reimbursement available from governmental agencies or other third party payors.

        New laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, that relate to healthcare availability, methods of delivery or payment for products and

65



services, or sales, marketing or pricing may cause our revenue to decline, and we may need to revise our research and development programs.

        On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (the "FDAAA") was enacted, giving the FDA enhanced post-market authority, including the authority to require post-market studies and clinical trials, labeling changes based on new safety information, and compliance with risk evaluation and mitigation strategies approved by the FDA. The FDA's exercise of its new authority could result in delays or increased costs during the period of product development, clinical trials and regulatory review and approval, increased costs to assure compliance with new post-approval regulatory requirements, and potential restrictions on the sale of approved products.

We may require significant additional financing, which may not be available to us on favorable terms, if at all.

        As of September 30, 2007, we had $1.4 billion in cash, cash equivalents and short- and long-term investments, excluding our investments in equity securities.

        We intend to use substantial portions of our available cash for:

    product development and marketing;

    payments related to the cash consideration for our merger with Bioenvision, including the approximately $245 million of cash we paid in October 2007 upon completion of the merger, the approximately $11 million of cash we intend to pay in the fourth quarter of 2007 for the outstanding options to purchase shares of Bioenvision Common Stock;

    other business combinations and strategic business initiatives, including the approximately $53 million in Canadian dollars, or approximately $57 million U.S. dollars (based on the November 2, 2007 spot rate for the Canadian dollar), of cash we intend to spend in December 2007 for our planned acquisition of the diagnostics division of DCL;

    our $1.5 billion stock repurchase program;

    upgrading our systems;

    expanding existing and constructing additional manufacturing facilities;

    expanding staff; and

    working capital and satisfaction of our obligations under capital and operating leases.

        We may further reduce available cash reserves to pay principal and interest on outstanding debt, including our $690.0 million in principal of 1.25% convertible senior notes.

        To satisfy our cash requirements, we may have to obtain additional financing. We may be unable to obtain any additional financing or extend any existing financing arrangements at all or on terms that we or our investors consider favorable.

Our level of indebtedness may harm our financial condition and results of operations.

        As of September 30, 2007, we had $697.9 million of outstanding indebtedness, excluding capital leases. We may incur additional indebtedness in the future. Our level of indebtedness will have several important effects on our future operations, including:

    increasing our vulnerability to adverse changes in general economic and industry conditions; and

    limiting our ability to obtain additional financing for capital expenditures, acquisitions and general corporate and other purposes.

66


        Our ability to make payments and interest on our indebtedness depends upon our future operating results and financial performance.


ITEM 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Market Risk

        We are exposed to potential loss from market risks represented principally by changes in foreign exchange rates, interest rates and equity prices. At September 30, 2007, we held derivative contracts in the form of foreign exchange forward contracts. We also held a number of other financial instruments, including investments in marketable securities and debt securities outstanding. We do not hold derivatives or other financial instruments for speculative purposes.

Foreign Exchange Risk

        As a result of our worldwide operations, we face exposure to potential adverse movements in foreign currency exchange rates, primarily to the Euro, British pound and Japanese yen. Exposures to currency fluctuations that result from sales of our products in foreign markets are partially offset by the impact of currency fluctuations on our international expenses. We use forward foreign exchange contracts to further reduce our exposure to changes in exchange rates. We also hold a limited amount of foreign cash and equity securities.

        As of September 30, 2007, we estimate the potential loss in fair value of our foreign currency contracts, foreign cash, and foreign equity holdings that would result from a hypothetical 10% adverse change in exchange rates to be $18.8 million, as compared to $34.2 million as of December 31, 2006. The change from the prior period is primarily due to a reduction in forward contracts and to a decrease in foreign currency being held.

Interest Rate Risk

        We are exposed to potential loss due to changes in interest rates. Our principal interest rate exposure is to changes in U.S. interest rates. Instruments with interest rate risk include short- and long-term investments in fixed income securities. Other exposures to interest rate risk include the fair value of fixed rate convertible debt and other fixed rate debt. To estimate the potential loss due to changes in interest rates, we performed a sensitivity analysis using the instantaneous adverse change in interest rates of 100 basis points across the yield curve.

        We used the following assumptions in preparing the sensitivity analysis for our convertible notes:

    notes that are "in-the-money" at September 30, 2007 are considered equity securities and are excluded;

    notes that are "out-of-the-money" at September 30, 2007 are analyzed by taking into account both fixed income and equity components; and

    notes will mature on the first available put or call date.

        On this basis, we estimate the potential loss in fair value that would result from a hypothetical 1% (100 basis points) decrease in interest rates to be $2.6 million as of September 30, 2007, as compared to $4.2 million as of December 31, 2006.

Equity Price Risk

        We hold investments in a limited number of U.S. and European equity securities. We estimate the potential loss in fair value due to a 10% decrease in equity prices of marketable securities held at September 30, 2007 to be $6.0 million, as compared to $4.2 million at December 31, 2006. The increase

67



is due to the acquisition of 4.4 million additional shares of Dyax common stock. This estimate assumes no change in foreign exchange rates from quarter-end spot rates and excludes any potential risk associated with securities that do not have a readily determinable market value.


ITEM 4.    CONTROLS AND PROCEDURES

        At the direction of our Chief Executive Officer and Chief Financial Officer, we evaluated our disclosure controls and procedures and internal control over financial reporting and concluded that (1) our disclosure controls and procedures were effective as of September 30, 2007, and (2) no change in internal control over financial reporting occurred during the quarter ended September 30, 2007 that has materially affected, or is reasonably likely to materially affect, such internal control over financial reporting.

68



PART II.    OTHER INFORMATION

ITEM 1.    LEGAL PROCEEDINGS

    Legal Proceedings

        We periodically become subject to legal proceedings and claims arising in connection with our business.

        Through June 30, 2003, we had three outstanding series of common stock, which we referred to as tracking stocks; Genzyme General Stock (which we now refer to as Genzyme Stock), Biosurgery Stock and Molecular Oncology Stock. Four lawsuits were filed against us regarding the exchange of all of the outstanding shares of Biosurgery Stock for shares of Genzyme Stock in connection with the elimination of our tracking stocks in July 2003. Each of the lawsuits was a purported class action on behalf of holders of Biosurgery Stock. The first case, filed in the MSC in May 2003, alleged a breach of the implied covenant of good faith and fair dealing in our charter and a breach of our board of directors' fiduciary duties. The plaintiff in this case sought an injunction to adjust the exchange ratio for the tracking stock exchange. The MSC dismissed the complaint in its entirety in November 2003. Upon appeal, the Massachusetts Appeals Court upheld the dismissal by the MSC of the fiduciary duty claim, but reversed the earlier decision to dismiss the implied covenant claim. The Massachusetts Supreme Judicial Court (SJC) granted our petition for further appellate review. On June 4, 2007, the SJC reversed the Appeals Court's decision and affirmed dismissal of the complaint in its entirety. On July 25, 2007, the SJC denied the plaintiff's petition for rehearing. Two substantially similar cases were filed in the MSC in August and October 2003. These cases were consolidated in January 2004, and in July 2004, the consolidated case was stayed pending disposition of a fourth case, which was filed in the U.S. District Court for the Southern District of New York in June 2003. As amended, this complaint alleged violations of federal securities laws, as well as various state law claims, related to the exchange, on behalf of a certified class of holders of Biosurgery Stock as of May 8, 2003. On August 6, 2007, we reached an agreement-in-principle with counsel for the plaintiff class to settle and dismiss this case for approximately $64 million. A definitive settlement agreement was approved by the court on October 26, 2007. Because the members of the class in the New York action released all claims, the settlement has, as a practical matter, resolved the consolidated case in the MSC. We have submitted claims to our insurers for reimbursement of portions of the expenses incurred and to be incurred in connection with these cases; the insurer has purported to deny coverage. We intend to vigorously pursue our rights with respect to insurance coverage. As a result, we recorded a liability for the settlement payment of approximately $64 million as a charge to SG&A in our consolidated statements of operations in June 2007, which we subsequently paid in August 2007.

        We are not able to predict the outcome of other legal proceedings, to which we may become subject in the normal course of business or estimate the amount or range of any reasonably possible loss we might incur if we do not prevail in the final, non-appealable determinations of such matters. Therefore, we have no current accruals for these potential contingencies. We cannot provide you with assurance that other legal proceedings will not have a material adverse impact on our financial condition and results of operations.


ITEM 1A.    RISK FACTORS

        We incorporate by reference our disclosure related to risk factors which is set forth under the heading "Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations—Risk Factors" in Part I., Item 2. of this Quarterly Report on Form 10-Q.

69




ITEM 2.    UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

    Stock Repurchase Program

        In May 2007, our board of directors authorized a stock repurchase program to repurchase up to an aggregate maximum amount of $1.5 billion or 20,000,000 shares of our outstanding common stock over the next three years. The repurchases are being made from time to time and can be effectuated through open market purchases, privately negotiated transactions, transactions structured through investment banking institutions, or by other means, subject to management's discretion and as permitted by securities laws and other legal requirements. The manner of the purchase, the amount that we spend and the number of shares we ultimately purchase will vary based on a range of factors, including share price. The program does not obligate us to acquire any particular amount of common stock and the program may be suspended at any time at our discretion.

        The following table provides information about certain repurchases of equity securities that are registered under Section 12 of the Exchange Act during the quarter ended September 30, 2007:

Period

  Total
Number
of Shares
Purchased

  Average
Price
Paid
per
Share

  Total
Number of
Shares
Purchased
as Part of
Publicly
Announced
Plans or
Programs

  Approximate
Dollar Value
of Shares that
May Yet Be
Purchased
Under the
Plans or
Programs

July 1, 2007-July 31, 2007   803,300   $ 63.72   803,300   $ 1,385,400,672
August 1, 2007-August 31, 2007   1,036,953   $ 64.18   1,036,953     1,318,846,790
September 1, 2007-September 30, 2007             1,318,846,790
   
 
 
     
  Total   1,840,253 (1) $ 63.98 (2) 1,840,253      
   
 
 
     

(1)
During the third quarter of fiscal 2007, we repurchased 1,840,253 shares of our common stock under the stock repurchase program for $117.8 million of cash, including fees.

(2)
Represents the weighted average price paid per share for stock repurchases made during the third quarter of fiscal 2007.


ITEM 6.    EXHIBITS

(a)
Exhibits

        See the Exhibit Index following the signature page to this report on Form 10-Q.

70



GENZYME CORPORATION AND SUBSIDIARIES
FORM 10-Q, SEPTEMBER 30, 2007
SIGNATURES

        Pursuant to the requirements of Section 13 or 15(d) 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.

    GENZYME CORPORATION

Date: November 8, 2007

 

By:

/s/  
MICHAEL S. WYZGA      
Michael S. Wyzga
Executive Vice President, Finance, Chief
Financial Officer, and Chief Accounting Officer

71



GENZYME CORPORATION AND SUBSIDIARIES
FORM 10-Q, SEPTEMBER 30, 2007
EXHIBIT INDEX

EXHIBIT NO.
  DESCRIPTION
*3.1   Restated Articles of Organization of Genzyme, as amended. Filed as Exhibit 3.1 to Genzyme's Form 10-Q for the quarter ended June 30, 2006.

*3.2

 

By-laws of Genzyme, as amended. Filed as Exhibit 3.1 to Genzyme's Form 8-K filed May 24, 2007.

**10.1

 

Amended and Restated Contract Purchase and Supply Agreement between Invitrogen Corporation and Genzyme Corporation effective December 31, 2007.

10.2

 

Form of Severance Agreement between Genzyme and its executive officers.

31.1

 

Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith.

31.2

 

Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith.

32.1

 

Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Furnished herewith.

32.2

 

Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Furnished herewith.

*
Indicates exhibit previously filed with the SEC and incorporated herein by reference. Exhibits filed with Forms 10-K, 10-Q, 8-K, 8-A, 8-B or Schedule 14A of Genzyme Corporation were filed under Commission File No. 0-14680.

**
Confidential treatment has been requested for the deleted portions of Exhibit 10.1.

72



EX-10.1 2 a2180321zex-10_1.htm EXHIBIT 10.1

Exhibit 10.1

 

Amended and Restated Purchase and Supply Agreement

 

Between

 

Genzyme Corporation & Invitrogen Corporation

 

Contract # SPM-254-3

 

January 1, 2008 to December 31, 2011

 

1



 

Table of Contents:

 

 

 

1. Definitions

 

 

 

2. Scope

 

 

 

3. Term

 

 

 

4. Payment Terms

 

 

 

5. Products and Pricing

 

 

 

6. Release of Orders

 

 

 

7. Forecasting, Purchase Orders and Supply Obligations

 

 

 

8. Biosurgery Products

 

 

 

9. Security of Supply

 

 

 

10. Acceptance; Rejection; Pre-shipment Samples

 

 

 

11. Certificate of Analysis; Other Documentation

 

 

 

12. Storage; Delivery

 

 

 

13. Manufacturing Obligations; Warranties

 

 

 

14. Other Obligations

 

 

 

15. Termination

 

 

 

16. SBA Socio-Economic Reporting

 

 

 

17. Confidentiality

 

 

 

18. Insurance

 

 

 

19. Force Majeure

 

 

 

20. Research Product Warranties

 

 

 

21. Authorized use of Research Products

 

 

 

22. [**]/Transmissible Spongiform Encephalopathy Compliance

 

 

 

23. Export Control

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

2



 

 

24. Indemnification

 

 

 

25. Compliance Laws

 

 

 

26. Limitation of Liability

 

 

 

27. Assignment

 

 

 

28. Jurisdiction

 

 

 

29. Severability; Remedies; Waiver;

 

 

 

30. Notices

 

 

 

31. Advertising

 

 

 

32. Statutes and Executive Orders

 

 

 

33. Survival

 

 

 

34. Additional or Inconsistent Terms

 

 

 

35. Entire Agreement

 

 

 

36. General Provisions

 

 

The following Attachments are attached to this Purchase and Sale Agreement and made a part hereof:

 

 

 

Attachment A: Genzyme Global Buying Entities.

 

 

 

Attachment B1: Listing and prices of Custom Manufactured Products.

 

 

 

Attachment B2: Listings and prices of Biosurgery Products.

 

 

 

Attachment B3: Listing and prices of Research Products.

 

 

 

Attachment B4: Listing and prices of Genetics Products

 

 

 

Attachment C: Specifications, Certificates of Analysis,

 

 

 

Attachment D: List of Account Managers

 

 

 

Attachment E: Genzyme Accounts Payable Contacts

 

 

 

Attachment F: Supplemental Product Amendment for Biosurgery Products

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

3



 

 

Attachment G: Genzyme Materials and Materials Specifications

 

 

 

Attachment H: [**] Protocols

 

 

 

Attachment I: Biosurgery Refrigeration & Transportation Requirements

 

 

 

Attachment J: Supplemental Product Amendments

 

 

 

Attachment K: Change or Discontinuation Notification Process

 

 

 

Attachment L: Certification of Suitability of Monographs of the European Pharmacopoeia

 

 

 

Attachment M: Reserve Requirements

 

 

 

Attachment N: Disaster Recovery Plan

 

 

 

Attachment O: Belgium Amendment No. 1 to Supply Agreement No SPM 254

 

 

 

Attachment P: Genzyme On-Site Stockroom Programs

 

AMENDED AND RESTATED PURCHASE AND SUPPLY AGREEMENT

 

This Purchase and Supply Agreement (the “Agreement”) effective December 31, 2007 (“Effective Date”) is between Invitrogen Corporation (“Supplier”), a Delaware corporation with a principal place of business at 1600 Faraday Avenue, Carlsbad, CA 92008 and Genzyme Corporation,  a Massachusetts corporation with a principal place of business at 500 Kendall Street , Cambridge, MA 02142 and Genzyme Therapeutics Products Limited Partnership, C/O Genzyme Center, 500 Kendall Street, Cambridge, MA 02142 (“Genzyme”)

 

Recitals:

 

A.    Genzyme and Supplier previously entered into a purchase and supply agreement effective January 1st, 2005 (the “Prior Agreement”). For good and valuable consideration the receipt and sufficiency of which are hereby acknowledged, the parties wish to amend and restate in its entirety the  Purchase and Supply Agreement with this Amended and Restated Purchase and Supply Agreement

 

NOW THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties intending to be legally bound agree as follows:

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

4



 

1.             Definitions:

 

1.1.                  “Affected Product” shall mean Changed Products and discontinued Products, as defined in Attachment K.

 

1.2.                  “Affected Product Effective Date” shall mean the date on which the change or discontinuation giving rise to an Affected Product Notice is to be implemented. In the case of multiple changes to a Changed Product, the Affected Product Effective Date shall be the date of the first such change.

 

1.3.                  Affiliate” shall mean any entity or person that, directly or indirectly, controls, is controlled by, or is under common control with another person. A person shall be deemed to control another person if the controlling person possesses, directly or indirectly, the power to direct or cause the direction of the management or policies of the controlled person, whether through ownership of stock, the power to elect or appoint the board of directors or trustees, by contract, or otherwise.

 

1.4.                  “Authorized Buying Entities” shall have the meaning set forth in Section 2.2 hereof.

 

1.5.                  BioProduction” means any materials that are procured to a Genzyme part number and specification as contained in Attachment B1 and B2.

 

1.6.                  “[**] Product” shall mean any Product that contains, or is defined as being, a [**].

 

1.7.                  “Certificate of Suitability” shall have the meaning set forth in European Pharmacopoeia Monograph 2001:1483, Products With Risk of Transmitting Agents of Animal Spongiform Encephalopathies. A sample Certificate of Suitability is set forth on Attachment A hereto.

 

1.8.                  “Changed Product” shall mean any (i) Product, a component, element or ingredient of which has changed, or (ii) Product for which the process used for manufacturing such Product has changed.

 

1.9.                  Consigned Inventory” shall mean Products owned by Supplier and stored in a Stockroom as specified in Attachment P hereof.

 

1.10.                “Core Product” shall mean any franchised Product that Supplier maintains in its catalog.

 

1.11.                [**].

 

1.12.                [**].

 

1.13.                “Custom-Manufactured Products” shall mean non-catalog-based Products manufactured according to Material Specifications provided by Genzyme for Genzyme use only and not for sale to any other third party.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

5



 

1.14.                “Disaster” shall mean any unplanned interruption of the operations of, or inaccessibility to, Supplier’s manufacturing, shipping or storage facilities during which Supplier requires relocation of any or all of its operations relating to Products (the “Product Operations”) to an alternative facility or facilities (each a “Recovery Location”).

 

1.15.                “Disaster Recovery Plan” shall mean a document defining the resources, actions, tasks and data required for Supplier to continue its operations in the event of a business interruption. [**]

 

1.16.                [**].

 

1.17.                FDA” means the U.S. Food and Drug Administration.

 

1.18.                [**].

 

1.19.                “Lead Time” shall mean the period of time between submission of an Order by Genzyme and delivery to Genzyme of the Products included in such Order. A description of Lead Times for each category of Product is set forth in Section 3.1 hereto.

 

1.20.                “List Price” shall mean [**].

 

1.21.                “Manufacturer” shall mean the manufacturer of a Product, but shall not include Supplier or any Affiliate of Supplier.

 

1.22.                “Material Specifications” shall mean specific and detailed information regarding the composition, shipping, handling and storage guidelines and other information necessary to properly manufacture, ship and store a Product, including, without limitation, the identity of and contact information for the Manufacturer, Part Number, sampling plan, safety considerations, expiration date and retest instructions, Supplier certificate requirements, Genzyme test requirements, and storage conditions.

 

1.23.                “Materials of Animal Origin” shall mean material derived from animal tissues, cells, or body fluids; an “animal” is defined as a higher eukaryotic organism, including mammals (to include humans), fish, birds, reptiles, amphibians, insects, mollusks, etc. Materials of Animal Origin shall not include material derived from lower eukaryotic organisms (including without limitation higher plants, fungi, protozoa and algae); nor does it include material derived from prokaryotic organisms (including without limitation bacteria or blue-green algae).

 

1.24.                [**].

 

1.25.                “On-Site Personnel” shall mean employees, consultants, subcontractors or other personnel employed or engaged by Supplier to perform services on its behalf at a Genzyme facility.

 

1.26.                “Order” shall mean an order provided by Genzyme or an Authorized Buying Entity to Supplier for the purchase and delivery of Products to a location specified by Genzyme or an Authorized Buying Entity pursuant to this Agreement. An Order may

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

6



 

include, without limitation, (1) a purchase order, (2) a website order, and/or (3) a procurement card order. All Orders shall be accompanied by a corresponding control number and subject to the terms and conditions contained herein, whether such Order references this Agreement or not.

 

1.27.                PPL Schedule” – Product Price List – this is a categorization in which related product lines are placed and managed. This list carries detailed descriptions and packaging designations. The PPL also displays list price for the products within.

 

1.28.                “Part Number” shall mean a unique, Genzyme-issued number identifying a particular Product and the Manufacturing Specifications specific to such Product.

 

1.29.                “Person” shall mean any individual, partnership, corporation, firm, association, unincorporated organization, joint venture, trust or other entity.

 

1.30.                “Products” has the meaning set forth in Section 2.1 and may include (i) Custom-Manufactured Products; (ii) Capital Equipment; (iii) items listed in a catalog (“Catalog Products”); (iv) bulk catalog items (“Bulk Products”); or (v) custom-packaged items listed in a catalog, whether separately or in bulk (“Special Products”). “Products” does not include services, custom products not listed in Section 2.1 and software products.

 

1.31.                [**].

 

1.32.                “Product Transition Period” shall mean the period beginning on the date of Genzyme’s receipt of an Affected Product Notice and ending on (i) the Affected Product Effective Date or (ii) the date which is nine (9) months from such date, whichever is longer.

 

1.33.                Purchase Order” means any purchase order that Genzyme either itself or through a Buying Entity completes and delivers to Supplier either directly or through one of its Affiliates listed in Attachment __ in accordance with Section 6.

 

1.34.                QSR” means regulations set forth in FDA’s Quality System Regulations at 21 C.F.R. Part 820.

 

1.35.                “Quote” shall mean a quotation provided by Supplier to Genzyme [**].

 

1.36.                “Reference Price” shall mean, as of any particular date, the price of a Product in effect on such date in the previous year.

 

1.37.                “Special Handling” shall mean increased freight and delivery charges required to ship a Product (i) that has been classified as (a) hazardous material, (b) oversized, or (c) a direct factory shipment and has been labeled as such in any catalog, flyer or other promotional material of the Supplier; or (ii) on an expedited basis at Genzyme’s request.

 

1.38.                Specifications” means the procedures, test results, requirements, criteria, specifications, standards and other data relating to the manufacture and supply of Products, as more particularly set forth on Attachment C.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

7



 

1.39.                Sterile” means that any Product described as Sterile has been manufactured in compliance with medical device QSR’s through aseptic processing to a sterility assurance level of 10-3.

 

1.40.                “Summary Invoice” shall mean a monthly invoice in Microsoft Excel format sent by Supplier to Genzyme that shall include all Orders (including, without limitation, withdrawals of Consigned Inventory, Orders made using procurement cards and Supplier website Orders) filled by Supplier during the relevant monthly period.

 

1.41.                “Term” shall mean the Initial Term and all Extended Terms, if any.

 

1.42.                Third Party” means any person or entity other than Genzyme, Supplier, their respective Affiliates, and a Buying Entity.

 

2.             Scope:

 

2.1           Products. The Products, individually or collectively, to be bought and sold by Genzyme from Supplier are any of the following:

 

2.1.1        Custom Manufactured Products” as set forth more particularly on Attachment B 1, and which are:

 

[**].

 

2.1.2        Supplier’s research products, as set forth in Supplier’s then-current U.S. Catalog, and its Affiliates’ then-current written catalogs (“Research Products”), including research products supplied under on-site stocking programs.

 

2.1.3        Supplier’s Biosurgery products listed on Attachment B2 ([**]) (collectively, “Biosurgery Products”).

 

2.1.4        [**].

 

Products does not include services, custom products not listed above, and software products.

 

2.2           Buying Entities. Only Genzyme and an entity listed on Attachment A (each a “Buying Entity”) may place Purchase Orders for Products under this Agreement.

 

2.2.1        An entity not listed on Attachment A may not place Purchase Orders, either for itself or on behalf of any other party, and is not entitled to the benefits of this Agreement.

 

2.2.2        A Genzyme Affiliate or other entity may only become a Buying Entity by a written amendment of Attachment A signed by Supplier and Genzyme. Removal of an entity from Attachment A requires only written notice from Genzyme to that Buying Entity and to Supplier.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

8



 

2.2.3        Genzyme warrants and represents to Supplier that the Buying Entities listed on Attachment A, are Affiliates of Genzyme. If, at any time during this Agreement, any entity listed on Attachment A ceases to be a Genzyme Affiliate, then Genzyme shall so notify Supplier, and such entity shall be removed from Attachment A and shall no longer be a Buying Entity.

 

2.2.4        Removal of a Buying Entity from Attachment A shall not, alone, release such Buying Entity from its obligations hereunder.

 

2.2.5        Genzyme and Supplier each acknowledge and agree that the terms and conditions of this Agreement shall apply to all Purchase Orders submitted by Genzyme or any of the Buying Entities during the Term of this Agreement. Where the terms of this Agreement conflict with any such Purchase Order, this Agreement shall govern. All parties agree that Attachment O will specifically apply to Genzyme Belgium purchases.

 

2.2.6        The placement of a Purchase Order by a Buying Entity constitutes such Buying Entity’s acceptance that the terms and conditions of this Agreement govern such Purchase Order and agreement to abide by this Agreement.

 

2.2.7        Supplier shall provide Genzyme with a list of all Supplier Affiliates who are selling Products subject to this Agreement (together with Supplier, “Selling Entities”). The acceptance of a Purchase Order by a Selling Entity constitutes such Selling Entity’s agreement (i) that the terms and conditions of this Agreement govern such Purchase Order; and (ii) to abide by the applicable terms and conditions of Agreement. Supplier shall also provide Genzyme with written notice in due commercial course of any companies acquired by Supplier during the term of this Agreement, any new product offerings, and new discounts or other promotional offerings.

 

2.2.8        The only role of the Buying Entities and Selling Entities under this Agreement is to facilitate the ordering, delivery and payment process on a multinational level. No Buying Entity or Selling Entity shall be liable under this Agreement except as expressly stated herein. Genzyme and Supplier shall each be fully liable and responsible for all supply, delivery, quality, payment, warranty, security, insurance, use, indemnity, and other commitments under this Agreement, regardless of which Buying Entity or Selling Entity (respectively) placed or accepted a Purchase Order, or received or delivered Products.

 

3.             Term:

 

This Agreement shall be effective on the Effective Date and continue until December 31, 2011  (the “Initial Term”). Upon expiration of the Initial term, this Agreement shall automatically renew for successive one year terms unless it is terminated by either party pursuant to this Article 3 or as otherwise provided herein. Each party may terminate this Agreement after the Initial Term has expired by providing the other party with at least six (6) months written notice.

 

4.             Payment Terms:

 

4.1           Non-U.S. Purchases. Non-U.S. Buying Entities shall receive invoices from, and

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

9



 

payment on invoices shall be made to, the Selling Entity corresponding to the territory in which such Buying Entity is located. Such non-U.S. invoices shall be stated in the currency of the invoicing Selling Entity or the Buying Entity, as such parties may determine from time to time.

 

4.2           Currency Exchange. Prices for Custom Product purchases by non-U.S. Buying Entities will be based on the List Price for such Custom Products as set forth in this Agreement and adjusted to local currency using a currency exchange rate determined as follows:  at the beginning of each calendar year, the exchange rate for the applicable currency shall be set for such calendar year as the previous year’s average exchange rate for such currency as calculated from data published at Oanda.com.  For clarity, the exchange rate for a given currency shall be set at the beginning of the year and shall be applicable for the entire calendar year.

 

4.3           Payment. Except as described in Section 4.3, invoices shall be paid within thirty (30) days of receipt, provided that all invoices shall include at least the following information: Buying Entity account number, Purchase Order number, Product description, quantity of Product desired, unit cost and extended cost of Product, invoice number, and applicable Product part number.

 

4.4           Consolidated Invoices. Supplier shall provide upon Genzyme’s request consolidated monthly invoices for each U.S. Buying Entity. All such consolidated invoices shall be paid in full within the last date specified, provided that the parties agree on the amount invoiced. Consolidated invoices shall be submitted in Excel format and shall contain at least the following information: Buying Entity account number; Purchase Order number; Product description; quantity of Product; unit cost and extended cost of Product; invoice number; and applicable Product part number.

 

4.5           Invoice Disputes. In the event Genzyme disputes an invoice amount, Genzyme shall notify Supplier within fifteen (15) days of the date of receipt of such invoice, may withhold payment of the disputed amount, and shall pay the undisputed portion of such invoice by such fifteenth (15th) days. The parties shall negotiate in good faith how to address the disputed portion of the invoice.

 

5              Products and Pricing:

 

5.1           [**].

 

5.2           Process Development Genzyme & Supplier Support.

 

SUPPLIER understands that GENZYME needs the freedom to operate regarding the future development of mammalian cell base technologies. Therefore GENZYME may elect to work with Vendors whose skill set and know-how best suit Genzyme’s timelines and or other requirements. Genzyme may use a reasonable effort to provide Supplier an opportunity re: the above needs by using Supplier’s catalogue products, custom products, and or optimized IP platforms to address the cell culture needs of Genzyme during the course of this Agreement, so long as Supplier can meet Genzyme’s timelines, budgets and other requirements for the project. [**].

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

10



 

5.4           Price and Payment Terms for [**]Batches.

 

The pricing for the [**]is set forth in Attachment B 1. Delivery of the [**] will be consistent with terms outlined in Section 10.1 of the Supply Agreement. [**].

 

5.5           Price and Payment Terms for [**] Batches.

 

[**].

 

5.6           Pricing for Research Products.

 

5.6.1        Current US prices for Supplier Research Products are set forth in Supplier’s current catalog (“List Price”). Each Selling Entity has a different catalog and the List Prices may vary by country. [**].

 

5.6.2        [**].

 

5.6.3        [**]

 

5.6.4        [**].

 

5.6.5        [**]

 

5.7           Contingency Manufacturing Site and Disaster Recovery Plan. Will be reviewed annually during a Quarterly Business Review Meeting where [**].

 

5.7.1 Raw Material Safety Stock: [**]

 

6. Release of Orders:

 

6.1           Purchase Order Placement. Genzyme shall have no obligation to order any Product by virtue of this Agreement alone. In the event that Genzyme orders Products hereunder, Genzyme shall issue a Purchase Order to Supplier stating, at a minimum, the description and quantity of the Product(s) being ordered and the required date(s) for delivery of such Product(s). No Product shall be delivered prior to receipt of an applicable Purchase Order (whether electronically, by telephone, or fax). Purchase Orders for Custom Manufactured Products and Biosurgery Products shall be sent by hard copy or email only. In the event Genzyme does not receive a written notice of acceptance or rejection of a Purchase Order within five (5) business days of the Purchase Order date, acceptance of the Purchase Order by Supplier shall be conclusively presumed.

 

6.2           Electronic Orders. Purchase Orders placed and acknowledgments sent under this Agreement may be sent in writing or by electronic means in a mutually agreed

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

11



 

upon platform. The parties agree that:

 

6.2.1        The electronically transmitted Purchase Orders shall be deemed to satisfy any legal formalities requiring that agreements be in writing.

 

6.2.2        Neither party shall contest the validity or enforceability of any such electronic transmission under any applicable statute of frauds.

 

6.2.3        Computer maintained records when produced in hard copy form shall constitute business records and shall have the same validity as any other generally recognized business records.

 

6.3           21 CFR Part 11 Compliance. Supplier and Genzyme each represent and warrant to the other that each is developing its electronic transmission and computer maintained records/security to bring such transmission, records, and security into compliance with the requirements of 21 CFR Part 11.

 

7.             Forecasting. Purchase Orders and Supply Obligations:

 

7.1           Forecasts. [**].

 

7.2           Purchase Order Requirements: Supply Obligations.

 

7.2.1        Genzyme shall issue Purchase Orders for Products as follows: (i) for Custom Manufactured Products and [**] (after [**] has been approved by Genzyme for use in its BioProduction process) [**] prior to the requested delivery date(s); (ii) for [**],[**] prior to the requested delivery date(s); (iii) for Biosurgery Products (excluding [**]),[**] prior to the requested delivery dates.

 

7.2.2        Each Purchase Order shall specify at a minimum the amount of each Product required, the delivery dates and location and any other ordering terms. Each Purchase Order shall constitute a binding obligation on Genzyme to take and pay for the Product specified therein subject to the terms of this Agreement.

 

7.2.3        [**].

 

7.2.4        Delay of Delivery: Genzyme may delay deliveries under an outstanding Purchase Order upon providing written notice to Supplier no less than (i) [**] days before the scheduled delivery date for Custom Manufactured Products, and (ii) [**] days before the scheduled delivery date for Biosurgery Products. Such delays shall be at no additional charge to Genzyme. The maximum duration of any delay of [**] and Biosurgery Products shall be [**] months from the date of Genzyme’s notification of acceptance of the pre-shipment sample for the applicable Product (or, if no pre-shipment sample is sent, then from the original date of delivery of such Product); the maximum duration of any delay of [**] shall be [**] months from date of the Purchase Order.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

 

12



 

8.             Biosurgery Products:

 

8.1           Raw Materials for Biosurgery Products. Prior to or on even date with its submission of a Purchase Order for Biosurgery Products, Genzyme shall deliver to Supplier a sufficient amount of the materials set forth in Attachment G (“Materials”) to enable Supplier to manufacture the amount of Biosurgery Products set forth in such Purchase Order. In the event that Materials are lost or destroyed due to Supplier’s negligence or misconduct, Supplier will reimburse Genzyme for its direct out-of-pocket costs of the Materials and the associated shipping costs.

 

8.1.1        If Genzyme delays delivery of the necessary Materials, the affected Purchase Order delivery date(s) may be extended for the duration equal to such delay.

 

8.1.2        The parties acknowledge that Supplier’s manufacture of Biosurgery Products manufactured using Materials is conditional upon the Materials meeting certain specifications (“Materials Specifications”) as set forth on Attachment G. Genzyme shall accompany each delivery of Materials with Certificates of Analysis confirming that the delivered Materials meet the Materials Specifications, along with instructions for proper storage and handling of the Materials.

 

8.1.3        Genzyme acknowledges that if the Materials do not conform to the Materials Specifications upon their delivery to Supplier, then Supplier’s manufacture of the Biosurgery Products may be adversely affected. [**].

 

8.1.4        Upon the parties’ agreement with respect to the amount of Materials necessary to manufacture Biosurgery Products, Genzyme has the right to instruct Supplier that excess Materials be disposed of by Supplier, in which case Genzyme will reimburse Supplier a disposal fee to cover Supplier’s expense in destroying such Material and other reasonable costs associated with the disposal of the materials.

 

8.1.5        Supplier will provide reports to Genzyme prior to the close of each month with respect to delivered Material which will include: ending inventory, receipts, new reserves, and usage details.

 

8.2           Other Biosurgery Products. The parties may enter into future agreements from time to time to add additional Biosurgery Products to Attachment B2. Biosurgery Products may only be added to this Agreement by execution of the Amendment form attached hereto as Attachment F (“Supplemental Product Amendment” or “SPA”), to which a Certificate of Analysis and sample label for such product shall be attached. Supplemental Product Amendments that are currently effective between the parties as of the Effective Date are identified on Attachment J, are incorporated by reference herein, and the products described thereunder shall be Biosurgery Products hereunder, provided that where the terms of this Agreement conflict with the terms of any Supplemental Product Amendment, the terms of this Agreement shall govern. Each Supplemental Product Amendment entered into after the Effective Date shall be attached hereto as Attachments F1, F2, and so on.

 

8.3           Purchase Orders. Following receipt of a Purchase Order for a Biosurgery products that is not subject to a SPA, Supplier and Genzyme shall review execute an SPA

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

13



 

in the form attached hereto as Attachment F to incorporate such Biosurgery Product. Supplier will not manufacture and deliver to Genzyme any Biosurgery Product that is not subject to an executed SPA. Supplier shall use commercially reasonable and good faith efforts to meet Genzyme’s Purchase Orders and delivery requirements for Biosurgery Products. If Supplier is unable for any reason to supply any portion of the total demand for Biosurgery Products specified in a Purchase Order that exceeds the then-applicable, accepted Genzyme Forecast, Supplier may allocate its available supply among any or all customers on such basis as Supplier may deem fair and practical, without liability for any failure of performance that may result there from.

 

8.4           Termination of Supply of Biosurgery Products.

 

8.4.1        If Genzyme cannot offer its services as a result of action by the FDA, and the FDA’s requirements cannot be satisfied within [**], Genzyme may terminate Supplier’s supply of Biosurgery Products hereunder by providing [**].

 

8.4.2        Each party may terminate the supply of Biosurgery Products hereunder without cause upon [**] written notice to the other party. Such termination shall not affect the supply of Products other than Biosurgery Products.

 

9.             Security of Supply:

 

9.1           Custom Manufactured Products. Upon Genzyme’s request in a written or electronic Purchase Order, Supplier shall commence manufacture of an inventory of Custom Manufactured Products (in the quantity (ies) set forth below) that are Pre-Approved Finished Goods (defined below), custom manufactured and stored in accordance with the applicable Specifications, and held on reserve inventory for the purpose of security of supply (“Security of Supply”). Submission of such initial Purchase Order obligates Genzyme to take delivery of the Security of Supply. Upon completion of the manufacture of the Security of Supply, Supplier shall roll over such Security of Supply into its delivery of Custom Manufactured Products under the next-occurring Purchase Order on a first-in-first out basis. At all times during the term of this Agreement, Supplier shall maintain the inventory dedicated for Security of Supply in the following quantities and at the following locations or otherwise at Genzyme’s sole discretion:

 

[**]

 

9.1.1        Unapproved Finished Goods. “Unapproved Finished Goods” means a Custom Manufactured Product which is tested, approved, packaged and labeled in accordance with the applicable Specifications for delivery to Genzyme by Supplier, but which Genzyme has not tested to confirm conformity to the applicable Specifications.

 

9.1.2        Pre-Approved Finished Goods. For Genzyme to approve a lot of [**] as Security of Supply, Supplier shall send Genzyme a sample of such lot within [**] of receiving Genzyme’s Purchase Order requesting such Security of Supply. Upon receipt of Genzyme’s notification of acceptance of a pre-shipment sample of [**] as conforming to the applicable Specifications, the lot from which pre-shipment sample was taken shall be

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

14



 

Pre-Approved Finished Goods” for purposes of this Section 9.1.

 

9.1.3        Form of Packaging and Storage Conditions. The Security of Supply of [**] shall be maintained in [**] unless otherwise reasonably requested by Genzyme no less than [**] in advance. The Security of Supply of [**] shall be maintained in [**], unless otherwise reasonably requested by Genzyme no less than [**] in advance.

 

9.1.4        Ordering Security of Supply. Genzyme may, at any time, request delivery of all or part of the Security of Supply by placing a Purchase Order therefore (“Security Supply Order”). Supplier shall deliver such Security of Supply within [**] of receipt of such Security Supply Order.

 

9.1.5        Replenishment of Security of Supply. If Genzyme takes delivery of the entire inventory dedicated to Security of Supply pursuant to this Section 9.1  Supplier shall use fully replenish the Security of Supply as follows: [**].

 

9.2           Back-up Manufacturing Facility: Supplier has two manufacturing locations for [**]. In the event the primary manufacturing location becomes or would become incapable of manufacturing Custom Manufactured Products, Supplier will use every available opportunity to manufacture in the alternate location; provided however, that manufacture in the Scotland facility must be approved by Genzyme in advance.

 

9.3           [**].

 

10.           Acceptance: Rejection: Pre-shipment Samples:

 

10.1         [**]. Supplier will test a sample of each lot of [**] in accordance with its Specifications prior to shipment of the full lot of [**]. Supplier will provide Genzyme with a pre-shipment sample of [**] within [**] of the Purchase Order date. Such pre-shipment sample shall be [**] derived from one (1) lot of [**]. Upon receipt of such sample, Genzyme will have [**] to retest the sample in accordance with the [**] Specifications, and will notify Supplier within such time whether the sample complies with the [**] Specifications. Within [**] of receipt of Genzyme’s acceptance of such pre-shipment sample, Supplier shall ship the full order of [**] from its New Zealand facility to its U.S. facility, and Supplier’s U.S. facility will then deliver such [**] to the Genzyme location specified on the Purchase Order on or by the applicable delivery date. Genzyme’s failure to provide timely notice of acceptance or rejection of the sample may result in a delay in delivery, and if so, will relieve Supplier of breach with respect to a Purchase Order delivery late.

 

10.1.1      If Genzyme determines that the [**] sample does not comply with the [**] Specifications, Genzyme shall provide evidence to Supplier supporting the claim. If Supplier agrees that the [**] sample does not comply with the [**] Specifications, Supplier shall provide a sample from a replacement batch of [**] within [**] after written notification of such rejection.

 

10.1.2      If Supplier’s assays confirm that the [**] samples are in compliance with

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

15



 

the Specifications, but Genzyme’s assays determine that the samples are not in compliance with the Specifications, Supplier and Genzyme will investigate the discrepancy and attempt to reach a reasonable settlement.

 

10.1.3      Prior to the next-scheduled shipment of [**], Supplier will provide to Genzyme a Certificate of Analysis (COA) with respect to such shipment to allow Genzyme to determine the appropriate Genzyme location for the shipment to be shipped.

 

10.2         [**] as a Biosurgery Product.

 

10.2.1      Pre-Shipment Samples. Prior to delivering [**] as a Biosurgery Product under a Purchase Order, Supplier will use commercially reasonable efforts to provide Genzyme with a pre-qualification sample of [**] meeting the Specifications derived from at least one (1) lot of [**].

 

10.2.2      Inventory. In response to Genzyme’s Purchase Order for [**] as a Biosurgery Product, Supplier will maintain an inventory [**] equal to the amount set forth in such Purchase Order, at no obligation to Genzyme, for [**] from the date of delivery of the pre-shipment sample in accordance with Section 10.2.1.

 

10.2.3      Acceptance/Rejection of Sample. If Genzyme rejects the sample of [**] in such [**] period, then Supplier will provide a new sample of [**] from different lot; Genzyme acknowledges that such rejection may affect the delivery date of [**], notwithstanding any other provision herein. If Genzyme does not notify Supplier of acceptance or rejection of the sample of [**] within such time period, then Supplier shall have no obligation to fill the corresponding Purchase Order. If Genzyme notifies Supplier of acceptance of the sample within the time period, then Supplier shall ship the amount of [**] set forth in the Purchase Order, at Genzyme’s instruction, either:  (i) promptly in its entirety; or (ii) in installments over a period not to exceed [**]. If such installments are instructed by Genzyme to be delivered within [**] from notification of acceptance, then the price for such [**] shall be as the price existed on the date of the applicable Purchase Order; and if such installments are instructed by Genzyme to be delivered beyond [**] from notification of acceptance, then the price for [**] shall be subject to change as described in Section 5.6.

 

10.3         All Biosurgerv Products.

 

10.3.1      Shortages: Patent Defects. Immediately upon receipt of a Biosurgery Product, Genzyme shall inspect same, and notify Supplier of any claims for shortages, patent defects or damages, and shall hold any such Biosurgery Product pending receipt of Supplier’s written instructions regarding disposition. The failure of Genzyme to notify Supplier within five (5) days after receipt shall constitute confirmation that the Biosurgery Product delivered was in the correct quantity, and that there were no patent defects or damages in the packaging containers. Supplier will notify Genzyme if the delivery reflects an overage in excess of one hundred ten percent (110%) of the amount requested in the Purchase Order within thirty (30) days of the day of manufacture; and acceptance of such overage will be at

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

16



 

the sole discretion of Genzyme at the original Purchase Order price.

 

10.3.2      Compliance with the Specifications. Genzyme shall have thirty (30) days from the date of receipt of Biosurgery Products to confirm compliance of such Biosurgery Products with the Biosurgery Product Specifications (latent defects). The failure of Genzyme to notify Supplier in writing that any Biosurgery Product was not in compliance with the Biosurgery Product Specifications shall constitute Genzyme’s final acceptance of the Biosurgery Product.

 

10.3.3      Cure. If Genzyme rejects a Biosurgery Product as not complying with the Biosurgery Product Specifications subject to Section 8.1.3, then Supplier will use commercially reasonable efforts to deliver to Genzyme a replacement lot of the Biosurgery Product. The replacement lot( s) size will be the same size as the rejected lot, unless otherwise agreed to by the parties, and will be priced at the same unit price as the failed lot. Supplier will fully reimburse Genzyme for Genzyme’s out of pocket cost of any raw materials consumed in the failed lot.

 

10.4         Custom Manufactured Product Acceptance

 

10.4.1      Receipt and Testing of Custom Manufactured Product. All Custom Manufactured Product shipped shall be accompanied by quality control certificates of analysis (as set forth in Section 11) signed by a duly authorized official of Supplier confirming that each batch of Custom Manufactured Product covered by such certificate meets the Specification’s release requirements and shall be deemed accepted by Genzyme unless Genzyme, acting reasonably and in good faith, shall give written notice of rejection (hereafter referred to as a “Rejection Notice”) to Supplier within sixty (60) days after receipt of the Custom Manufactured Product by, on behalf of, or for the account of Genzyme.

 

10.4.2      Rejection Notice. The Rejection Notice shall state in reasonable detail (sufficient to enable) Supplier to identify the nature of the problem, the reason why the Custom Manufactured Product is not acceptable. Any Rejection Notice shall be accompanied by copies of all written reports relating to tests, studies or investigations performed to that date by or for Genzyme on the Custom Manufactured Product rejected. Genzyme shall have the right but not the obligation, to return the rejected Custom Manufactured Product to Supplier at Supplier’s cost, and title to and risk of loss associated with the rejected Custom Manufactured Product shall transfer to Supplier upon receipt by Supplier of the rejected Custom Manufactured Product.

 

10.4.3      Return of Custom Manufactured Product. Upon receipt of such Rejection Notice, Supplier may require Genzyme to return the rejected Custom Manufactured Product or samples thereof (at Supplier’s cost) to Supplier for further testing, in which event such Custom Manufactured Product or samples thereof as the case may be, shall be returned by Genzyme to Supplier. Upon receipt of the rejected Custom Manufactured Product title to and risk of loss associated with the rejected Custom Manufactured Product shall transfer to Supplier. If it is later determined that Genzyme

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

17



 

was not justified in rejecting the Custom Manufactured Product, Genzyme shall reimburse Supplier for the costs of the return, as well as any other costs or expenses incurred by Supplier as a result of the rejection or return and retest and title to and risk of loss associated with such Custom Manufactured Product shall transfer to Genzyme upon placement of the Custom Manufactured Product on the designated carrier by Supplier.

 

10.4.4      Dispute Resolution. Genzyme’s basis for rejection shall be conclusive unless Supplier notifies Genzyme, within thirty-five (35) days of receipt of the Rejection Notice that it disagrees with such rejection. In the event of Genzyme’s receipt of such a notice by Supplier, representative samples of the Custom Manufactured Product in question shall be submitted to a mutually acceptable independent laboratory or consultant for analysis or review, the costs of which shall ultimately be paid by the party that is determined by the independent laboratory or consultant to have been incorrect in its determination of whether the Product should be rejected. Should the fees associated with the work conducted by the independent laboratory or consultant be due upfront, each of Genzyme and Supplier shall each pay fifty percent (50%) of such upfront fees, and the party that is determined by the independent laboratory or consultant to have been incorrect in its determination shall then reimburse the other party.

 

10.4.5      Payment Obligations Suspended for Rejected Custom Manufactured Product. If any order of Custom Manufactured Products is rejected by Genzyme under Section 10.4, Genzyme’s duty to pay all amounts payable to Supplier in respect of the rejected Custom Manufactured Product shall be suspended until such time as it is determined by an independent laboratory or consultant that the Custom Manufactured Products in question should not have been rejected by Genzyme. If only a portion of an order is rejected, only the duty to pay the amount allocable to such portion shall be suspended.

 

11.           Certificate of Analysis: Other Documentation:

 

A Certificate of Analysis will accompany Custom Manufactured Products and Biosurgery Products. Supplier will accompany a Research Product with a Certificate of Analysis upon Genzyme’s reasonable advanced written request. [**] and [**] shipments will also be accompanied with a certificate of country of origin, expiration date, and batch number.

 

12.           Packaging, Storage and Delivery:

 

12.1         Packaging. All Products shall be packaged, marked and otherwise prepared for shipment by Supplier in accordance with the Specifications, or if there are no such specifications for a particular Product, Supplier will use reasonable commercial packaging practices. Supplier shall mark on containers all necessary handling, loading and shipping instructions. An itemized packing list setting forth all Products shipped shall be included with each shipment. Supplier shall store and transport Biosurgery Products in accordance with the specification set forth on Attachment I.

 

12.2         Storage. [**].

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

18



 

12.3         Shipment. With respect to Custom Manufactured Products and Biosurgery Products, Supplier shall arrange and prepay for shipping to Genzyme or the Buying Entity (as applicable), Genzyme or the Buying Entity shall reimburse Supplier for such shipping charges, and title and risk of loss for such Custom Manufactured Products and Biosurgery Products shall pass to Genzyme or the Buying Entity (as applicable) upon delivery to Genzyme or Buying Entity (as applicable). With respect to Research Products, Supplier shall ship such Research Products using the Genzyme Federal Express account number specified by Genzyme, and title and risk of loss for such Research Products shall pass to Genzyme or the Buying Entity (as applicable) upon delivery to Federal Express.

 

12.4         Delivery Dates. Delivery of Custom Manufactured Products and Biosurgery Products (subject to Section 8.3), shall be [**] late and no more than [**] early from agreed upon delivery date. If Supplier is unable to deliver a Custom Manufactured Product or Biosurgery Product within this agreed upon time frame, Supplier will, if requested by Genzyme or its Buying Entity, ship such product the fastest commercial manner available, at Supplier’s expense. Supplier will ship any Research Products not available at time of receipt of a Purchase Order by next-day delivery.

 

13.           Manufacturing Obligations: Warranties:

 

13.1         Custom Manufactured Products. Supplier shall manufacture each Custom Manufactured Product in accordance with the Custom Manufactured Product Specifications, as set forth on Attachment C1. C2. C3 and Attachment C4.

 

13.1.1      Manufacturing Change or Discontinuance Notification: Refer to Attachment K.

 

13.1.2      Reliability Analysis of Affected Products. Upon Genzyme’s request, Supplier shall provide to Genzyme a sample of sufficient quantity (as determined in Genzyme’s sole discretion), paid for by Genzyme for Genzyme to perform a reliability analysis on such Affected Product. Supplier acknowledges that such analysis may take up to nine (9) months to complete, and agrees to provide an appropriate sample of the Affected Product as soon as practical following a request from Genzyme.

 

13.1.3      Large Volume Orders and Storage. Supplier will continue to supply all of Genzyme’s requirements for any Affected Product during the Product Transition Period as described in Attachment K

 

13.2         Biosurgery Products. Biosurgery Products supplied to Genzyme shall be under a Genzyme label, as incorporated in the Specifications and/or applicable Supplemental Product Amendment. Genzyme shall have no rights to use any trademark or logo of Supplier in the promotion, sale or distribution of its products or services. Supplier does not warrant that Biosurgery Product labeling designated by Genzyme meets any applicable regulatory requirement.

 

13.3         Custom Manufactured Products Warranty. Each Custom Manufactured Product

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

19



 

shipped hereunder shall, at the time it is made delivered to Genzyme or any Buying Entity:

 

13.3.1      Meet such Custom Manufactured Product’s Specifications;

 

13.3.2      Be manufactured in accordance with all applicable laws and regulations;

 

13.3.3      Be conveyed to Genzyme or the Buying Entity with good title; and

 

13.3.4      Not be adulterated or misbranded.

 

EXCEPT AS OTHERWISE SET FORTH IN THIS AGREEMENT, INCLUDING IN SECTIONS 24 (INDEMNIFICATION) AND 26 (LIMITATION OF LIABILITY) HEREOF, GENZYME’S REMEDY FOR ANY BREACH OF THE FOREGOING WARRANTIES SHALL BE, AT GENZYME’S DISCRETION, EITHER REPLACEMENT OF THE NON-CONFORMING CUSTOM MANUFACTURED PRODUCT OR, IF SUPPLIER CANNOT REPLACE SUCH CUSTOM MANUFACTURED PRODUCT, REFUND OF THE CUSTOM MANUFACTURED PRODUCT PRICE.

 

13.4         Supplier Biosurgery Product Warranty. Supplier warrants to Genzyme that each Biosurgery Product shall at the time it is made available to Genzyme or a Buying Entity (as applicable):

 

13.4.1      Meet the relevant Biosurgery Specifications attached hereto as Attachment B2,  and Attachment G;

 

13.4.2      Be manufactured in substantial compliance with QSR or other similar requirements to the extent that such other applicable requirements have been incorporated into the Biosurgery Product Specifications at the time of manufacture of the Biosurgery Product;

 

13.4.3      Be packaged and shipped to Genzyme in a manner consistent with the Biosurgery Product Specifications attached hereto as Attachment B2 and G

 

13.4.4      Not to be sold by Supplier over a Genzyme label to Third Parties for any purpose.

 

13.5         Sterility. The determination as to whether each batch of a Biosurgery Product is Sterile by the procedures defined in the Biosurgery Product Specifications provides a small, but non-zero probability that each and every container of a Biosurgery Product produced as part of a batch of a Biosurgery Product, which batch is in compliance with the Biosurgery Product Specifications, is not Sterile. Biosurgery Product packaging and aseptic filling process has not been qualified by the Supplier to achieve or maintain a defined sterility assurance level.

 

SUPPLIER DISCLAIMS ANY WARRANTY THAT EACH AND EVERY CONTAINER OF BIOSURGERY PRODUCT SHALL BE STERILE.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

20



 

13.6         Genzyme Acknowledgments.

 

13.6.1      Genzyme acknowledges that Supplier has not qualified Biosurgery Products for any human or animal diagnostic or therapeutic application.

 

13.6.2      Genzyme acknowledges that Supplier has no responsibility with respect to whether components in the end product of any Genzyme therapeutic or diagnostic process are suitable for Genzyme’s intended use, or for use in any other process using a Biosurgery Product which is practiced by Genzyme or any other party and which involves the health of a human.

 

13.6.3      EXCEPT AS OTHERWISE SET FORTH IN SECTION 24 (INDEMNIFICATION) HEREOF, GENZYME’S SOLE REMEDY FOR ANY BREACH OF THE FOREGOING WARRANTIES REGARDING BIOSURGERY PRODUCTS SHALL BE, AT GENZYME’S -DISCRETION, EITHER REPLACEMENT OF THE NON-CONFORMING BIOSURGERY PRODUCT OR, IF SUPPLIER CANNOT REPLACE SUCH BIOSURGERY PRODUCT, REFUND OF THE BIOSURGERY PRODUCT PRICE PAID.

 

13.7         Biosurgery Product Issues. Supplier shall notify Genzyme or the applicable Buying Entity in writing immediately upon learning: (i) that a Biosurgery Product delivered hereunder fails to meet the Biosurgery Product Specifications; or (ii) of a deviation of the Biosurgery Product batch records which could impact product quality; and in each case initiate an investigation and implement corrective action where commercially reasonably appropriate.

 

13.8         Genzyme Biosurgery Product Warranties. Genzyme warrants that:

 

13.8.1      It has now and will maintain the technical and other requisite competencies to determine the suitability of the Biosurgery Products for the uses to which Genzyme or its customers will put such Biosurgery Products;

 

13.8.2      The Biosurgery Product Specifications have been determined by Genzyme to be adequate to confirm the suitability of the Biosurgery Product, its packaging and labeling supplied hereunder for the uses to which such Biosurgery Product will be put by Genzyme or its customers;

 

13.8.3      It shall ship Biosurgery Products in furtherance of its provision of service to its customers only under Genzyme’s label;

 

13.8.4      Genzyme’s processes are structured and will be operated only in a manner in which the use of any Biosurgery Product which is not Sterile shall be detected by Genzyme prior to any use of the Biosurgery Product;

 

13.8.5      It shall perform diligently sufficient incoming inspection to satisfy its obligations under this Agreement and under all applicable laws, rules and regulations.

 

13.9         Limitation of Warranties. Supplier’s warranties herein are personal to the purchaser of Biosurgery Products, and shall not be construed as running to the benefit of any Buying Entity’s distributors or its or their customers.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

21



 

13.10         WARRANTY DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN, SUPPLIER MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO ANY PRODUCT, AND SUPPLIER DISCLAIMS ALL OTHER WARRANTIES, EXPRESS AND IMPLIED, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. SUPPLIER PROVIDES NO REPRESENTATIONS OR WARRANTIES THAT THE PRODUCTS ARE SUITABLE FOR USE IN ANY THERAPEUTIC OR DIAGNOSTIC PROCESS FOR HUMANS AND ANIMALS.

 

13.11         Herd Management. Supplier agrees to conduct its Herd Management in conformance with the [**] Processing Protocols attached hereto as Attachment H to this Agreement.

 

13.12        Traceability. Supplier will ensure traceability to the original manufacturer of each raw material used in the manufacture of Custom Manufactured Products and Biosurgery Products

 

13.13         Site Audit. Supplier will, within sixty (60) days of Genzyme’s reasonable written request, allow Genzyme to inspect that portion of Supplier’s manufacturing facilities in which Supplier manufactures Products, provided that Genzyme signs Supplier’s standard site visit confidentiality agreement. Supplier will work with Genzyme’s audit team to secure a mutually agreeable date for such audit, respond to any reasonable questions, and take any compliance issues that may arise into consideration.

 

13.14         Regulatory Inspection. Supplier shall provide written notification of all inspections from any regulatory agencies that specifically apply to Custom Manufactured Products and Biosurgery Products within thirty (30) days of Supplier’s receipt of notice of such inspections. These inspections include: ISO, FDA, EC, HPB, and MCA. Supplier shall inform Genzyme within twenty-four (24) hours should any regulatory or ISO approval be withdrawn for Custom Manufactured Products and Biosurgery Products, if there are any recalls of items provided to Genzyme, or if any regulatory agency initiates any enforcement action against the Supplier with respect to Custom Manufactured Products and Biosurgery Products.

 

14.           Other Obligations:

 

14.1     Technical Seminars. Supplier and Genzyme’s Science and Research Corporate Purchasing group will, from time to time, discuss the provision of technical seminars by Supplier at a central Genzyme location.

 

14.2    Quarterly Business Reviews. Supplier will conduct quarterly business reviews coordinated with designated Genzyme personnel, to monitor Genzyme’s forecasts, business progress, on-time delivery (of product listed in Attachments B 1, B2 and B4) and cost savings. Such business reviews will review all areas of Supplier’s business that is directly related to Genzyme. Supplier will supply such business reviews to Genzyme no later than forty-five (45) days after the close of the previous business quarter for international, and thirty (30) days after the close of the previous business quarter for domestic, and the parties will meet to discuss such business reviews at a Genzyme location no later than sixty (60) days after the close of each calendar quarter.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

22



 

14.3    Account Administration: Genzyme and Supplier will assign a primary individual to manage such party’s account established by this Agreement. Each party may request a change of the other party’s account manager upon written notice of at least ninety (90) days to the other party, at which point the parties shall attempt to resolve the issue.

 

14.4    Government Applications.

 

14.4.1  Supplier will cooperate with Genzyme by supporting any FDA applications with appropriate technical information available at that time to Supplier.

 

14.4.2 Genzyme shall have the sole responsibility to obtain any government authorizations necessary to test, distribute or sell materials that use or incorporate the Biosurgery Products.

 

14.4.3 To the extent that Genzyme determines that applications to and approval from the FDA or other governmental authority are necessary for a Biosurgery Product, Supplier will cooperate fully with Genzyme by providing available technical information about the Biosurgery Product to Genzyme for incorporation in Genzyme’s application

 

14.4.4 Should Genzyme request Supplier to provide proof of manufacture of a Biosurgery Product to a regulatory authority, Supplier shall cooperate and supply information in response to such request. Genzyme shall reimburse any reasonable out of pocket expenses incurred by Supplier in complying with Genzyme’s request.

 

14.4.5 With respect to supply of Biosurgery Products for use in a European or other non-U.S. country, all of the provisions of this Section 14.4 and of Section 13.5 shall be construed to encompass the various equivalent (or most nearly equivalent) regulatory agencies and regulations applicable, to the extent that any requirements of such other authorities which are different than those of the U.S. government have been incorporated by mutual written agreement in amended Biosurgery Product Specifications. The parties shall negotiate in good faith using reasonable efforts any modifications to the provisions hereof occasioned by virtue of the supply of Biosurgery Products to a European country. The parties acknowledge and agree that because Biosurgery Products to be supplied to European countries pursuant to this Agreement is to be under a Genzyme label, the primary responsibility lies with Genzyme to identify the requirements of the laws and regulations of each such country, and to communicate such requirements to Supplier in order to amend the Biosurgery Product Specifications appropriately.

 

15.           Termination:

 

15.1 Term. The term of this Agreement is set forth in Section 3.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

23



 

15.2 Termination for Cause. Either Party may terminate this Agreement in the event the other Party refuses, declines or fails to perform or otherwise breaches its material obligations under this Agreement and such breach is not cured within thirty (30) days after receiving written notice from the non-breaching Party specifying the nature of the failure to perform or breach. If more than thirty (30) days is reasonably required to cure the failure to perform or breach, and the defaulting Party diligently pursues the cure during such thirty (30)-day period, the period to cure shall be extended a minimum of an additional thirty (30) days prior to the termination being effective.

 

15.3     Termination for Bankruptcy. Each party may terminate this Agreement effective immediately without liability upon written notice to the other if anyone of the following events occurs:

 

15.3.1 the other files a voluntary petition in bankruptcy or an involuntary petition is filed against it;

15.3.2 the other is adjudged bankrupt;

15.3.3 a court assumes jurisdiction of the assets of the other under federal reorganization act;

15.3.4 a trustee or receiver is appointed by a court for all or a substantial portion of the assets of the other;

15.3.5 the other becomes insolvent or suspends business; or

15.3.6  the other makes an assignment of its assets for the benefit of its creditors.

 

15.4     Termination for Infringement or Violation of Law. Each party may terminate this Agreement, or may terminate supply of a particular Product under this Agreement, upon sixty (60) days written notice to the other party if it would constitute a violation of law for the terminating party or its relevant Affiliate (i.e., a Buying Entity or Selling Entity, as applicable) to fulfill its obligations hereunder without (i) infringing the intellectual property of a Third Party, breaching federal or other governmental regulations, including but not limited to FDA requirements; or (ii) violating any law.

 

15.5     Effect of Termination or Expiration.

 

15.5.1      Purchase Orders. Upon termination or expiration of this Agreement, Genzyme either itself or through its Buying Entities shall (i) take delivery of and pay for all Products under any Purchase Order outstanding as of the date of termination; (ii) take delivery of and pay for all Biosurgery Products manufactured in reliance upon the binding portion of the relevant forecast; (iii) each Buying Entity shall not be relieved of the obligation to purchase all Products for which it has placed Purchase Orders; (iv) purchase all Products held in inventory as of the date of termination by or for Supplier pursuant to the security of supply provision in Sections 9.1 or 10.2; and (v) Supplier either itself or through its Selling Entity will fulfill all Purchase Orders submitted to Supplier either itself or through its Selling Entity prior to the effective date of termination. In the event of any termination of this Agreement, Genzyme shall be responsible for taking delivery of Custom Manufactured Products and Biosurgery Products under any outstanding Purchase Order only if such Custom Manufactured Product or Biosurgery Product has entered the manufacturing process at the time of termination.

 

15.5.2      Supply Stock and Raw Materials. If this Agreement is terminated by Genzyme for any reason, or if the Agreement is terminated by Supplier on account of breach by Genzyme,

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

24



 

Genzyme will purchase (i) all Custom Manufactured Products and Biosurgery Products that may reside in Supplier inventory under outstanding Purchase Orders and as set forth in Sections 9.1 or 10.2; and (ii) any raw material (including without [**]) purchased by or for Supplier specifically for manufacture of any Custom Manufactured Product or Biosurgery Product in accordance with an outstanding Purchase Order and/or, in the case of Biosurgery Products, in accordance with the the-binding portion of Genzyme’s forecast. Genzyme may request that Supplier provide cost justification to support such reimbursement. No termination shall relieve Genzyme of its obligation to purchase all Products for which it has placed Purchase Orders.

 

15.5.3      Biosurgery Products. In the event of Genzyme’s termination of this Agreement for reason other than Supplier’s breach or bankruptcy, and unless otherwise agreed to by the parties, Genzyme shall accept delivery and pay for all Biosurgery Products for which Supplier has commenced manufacture under the then-current Genzyme Forecast, and Genzyme shall reimburse Supplier for its direct, out-of-pocket costs of raw materials purchased to manufacture such Biosurgery Products to the extent such costs were authorized in writing by Genzyme and Supplier cannot reasonably use raw materials.

 

16.           SBA Socio-Economic Reporting:

 

Genzyme is an equal employment opportunity employer and is a federal contractor. Consequently, the parties agree that, to the extent applicable, they will comply with Executive Order 11246, the Vietnam Era Veterans Readjustment Assistance Act of 1974 and Section 503 of the Vocational Rehabilitation Act of 1973 and also agree that these laws are incorporated herein by this reference.  Supplier also agrees to comply with the provisions of Executive Order 13201 Compliance (29 CFR Part 470), relating to the notice of employee rights concerning payment of union dues.

 

17. Confidentiality:

 

17.1     Nonuse and Nondisclosure Obligations. Each party shall maintain as confidential and shall not disclose, copy nor use for purposes other than the performance of this Agreement, any information which relates to the other party’s business affairs, trade secrets, technology, research and development, pricing, or the terms of this Agreement (“Confidential Information”) and each agrees to protect that Confidential Information of the other with the same degree of care it exercises to protect its own confidential information.

 

17.2         Exceptions. “Confidential Information” shall not include any information that:

 

17.2.1  is within the public domain prior to the time of the disclosure hereunder or thereafter becomes within the public domain other than as a result of disclosure by the receiving party in violation of this Agreement;

 

17.2.2  was in the possession of the receiving party on or before the date of disclosure hereunder, as evidenced by records, however maintained;

 

17.2.3  is acquired by a party hereto from a Third Party not under an obligation of confidentiality;

 

17.2.4  the receiving Party must disclose by law, order, subpoena, or regulation of a governmental agency or a court of competent jurisdiction, provided the other party receives prior written notice of such disclosure; or

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

25



 

17.2.5  is hereafter independently developed by a party without reference to or reliance upon the other party’s Confidential Information, as evidenced by records, however maintained.

 

17.3  Injunctive Relief. Breach of this Section 17 by one party may cause irreparable damage to the other party and, therefore, the injured party shall have the right to seek equitable and injunctive relief, and to recover the amount of damages (including reasonable attorney’s fees and expense) incurred in connection with such disclosure and/or unauthorized use.

 

17.4  Effect Upon Termination or Expiration. Upon expiration or termination of this Agreement, each party agrees to return to the other or destroy all Confidential Information of the other, as the other party may request. The obligations of confidentiality and nonuse set forth in this Section 17 shall survive expiration or termination of this Agreement.

 

18.           Insurance:

 

18.1         Minimal Insurance Coverage Limits.  Without limiting the scope of its aforementioned defense, hold harmless and indemnity duties, Provider shall maintain at its sole cost and expense the following insurance coverage:

 

[**]

 

 

18.2         Certificates of InsuranceAt the request of Genzyme, Supplier will furnish Genzyme a true copy of a certificate of coverage issued by the responsible insurance carrier.

 

18.3         [**].

 

18.4         [**].

 

 

18.5         [**].

 

 

18.6         [**].

 

19.           FORCE MAJEURE

 

19.1         General.  No failure or omission by a Party (the “Incapacitated Party”) in the performance of any obligation of this Agreement shall create any liability to the other Party (the “Affected Party”) if such failure or omission arises from any unforeseeable cause(s) beyond the reasonable control of the Incapacitated Party, including without limitation the following: acts of God; fire; storm; flood; earthquake; war; terrorism, sabotage; quarantine restrictions; labor strike; and freight embargo (collectively, “Force Majeure”). In the event of any delay or inability to perform arising pursuant to Force Majeure, the Incapacitated Party shall notify the Affected Party within eight (8) business hours following the occurrence of any qualifying event.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

26



 

19.2         Response by Supplier. Upon the occurrence of a Force Majeure where Supplier is the Incapacitated Party and such Force Majeure continues for five (5) consecutive days following its initial occurrence, the Supplier shall provide Genzyme with a proposal to remedy the situation (“Contingency Plan Proposal”). Genzyme shall then have five (5) days to review and approve the Contingency Plan Proposal or suggest changes to the Contingency Plan Proposal which Supplier shall have one (1) day to review and approve or amend which the above time frame will govern. If Supplier is unwilling or unable to make the changes to the Contingency Plan Proposal suggested by Genzyme, Genzyme may terminate this agreement on ten (10) days written notice.

 

19.3         Response by Genzyme. Upon the occurrence of a Force Majeure where Genzyme is the Incapacitated Party, Genzyme’s performance shall be postponed by such length of time (the “Suspension Period”) as may be reasonably necessary to compensate for the delay or inability to perform and Supplier’s performance shall be postponed by a length of time equal to the Suspension Period.

 

19.4         Contingency Plan. Supplier shall put into place, with Genzyme’s written approval, a contingency plan based on the Contingency Plan Proposal and Genzyme instructions (“Contingency Plan”) to be used in the event of Force Majeure conditions such as those described above. The purpose of the Contingency Plan is to maintain, as consistently as possible and with complete integrity in respect of quality and to Genzyme’s reasonable satisfaction, Supplier’s supply of Products to Genzyme.

 

19.5         Disaster Recovery. Supplier represents and warrants that it has adopted and will maintain a complete integrity in respect of quality and to Genzyme’s reasonable satisfaction, Supplier’s supply of Products to Genzyme in the event of a Disaster. Supplier shall notify Genzyme immediately after Supplier deems an event to be a Disaster. Immediately following a Disaster, Supplier shall move the affected Product Operations to a Recovery Location as expeditiously as possible to ensure the uninterrupted supply of Products to Genzyme.

 

19.5.1      Communications. Supplier shall work with Genzyme to establish a plan for alternative communications in the event of a Disaster.

 

19.5.2      No Warranty. Genzyme acknowledges that the Disaster Recovery Plan is designed to minimize, but may not eliminate, risks associated with a Disaster affecting Product Operations. Supplier does not warrant that Product Operations will be uninterrupted in the event of a Disaster.

 

19.5.3      Reporting Obligations. A current and complete copy of the Disaster Recovery Plan in effect on the Effective Date is set forth on Attachment N hereto. On June 30 and December 31 of each year during the Term, Supplier shall deliver to Genzyme a copy of the then-current Disaster Recovery Plan with a statement describing any changes made to the Disaster Recovery Plan during the previous six month period.

 

20.           Research Product Warranties:

 

The Supplier warrants to Genzyme that each Research Product shall conform substantially to the

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

27



 

description of such Research Product as provided in the applicable catalog as referenced in Section 2.1.2 above and literature accompanying the Research Products until their respective expiration dates or, if no expiration date is provided, for six (6) months from the date of the Buying Entity’s receipt of the Research Products. Supplier warrants that all Research Products delivered hereunder will be new, of the grade and quality specified by Supplier, free from material defects in design, material and workmanship, will conform to delivered samples and written descriptions, and will be free of liens and encumbrances. The warranties shall survive any delivery, inspection, payment or acceptance of the Products. At its expense, Supplier shall replace Research Products not conforming to the foregoing warranties. GENZYME’S SOLE REMEDY FOR ANY BREACH OF THE FOREGOING WARRANTIES SHALL BE REPLACEMENT OF THE NON-CONFORMING RESEARCH PRODUCT OR, IF SUPPLIER CANNOT REPLACE SUCH RESEARCH PRODUCT, REFUND OF THE RESEARCH PRODUCT PRICE PAID.

 

21.           Authorized Uses of Research Products:

 

21.1         Except as otherwise agreed in writing by an authorized representative of Supplier, the purchase and sale of Research Products hereunder only conveys to Genzyme the non-transferable right for only Genzyme to use the purchased quantity of Research Products in compliance with the applicable intended use statement, limited use statement or limited label license, if any, in Supplier’s written catalogs or more recent Research Product literature or on the label or other documentation accompanying the Research Products (all such statements or licenses being incorporated herein by reference as if set forth herein in their entirety). Unless otherwise expressly indicated in Supplier’s written catalogs or more recent Research Product literature, or on the label or other documentation accompanying the Research Products, Genzyme may use the Research Products for research use only and not for any other purpose including, but not limited to, commercial purposes, in vitro diagnostic purposes, ex vivo or in vivo therapeutic purposes, investigational use, in foods, drugs, devices or cosmetics of any kind, or for consumption by or use in connection with or administration or application to humans or animals.

 

21.2         Genzyme acknowledges that the Research Products have not been tested by or for Supplier for safety or efficacy except as expressly stated in Supplier’s written catalogs or more recent product literature, or on the label or other documentation accompanying the Research Products. Without limiting the foregoing restrictions, Genzyme warrants to Supplier that should Genzyme use the goods for any use other than research, Genzyme shall conduct all necessary tests, comply with all applicable regulatory requirements, issue all appropriate warnings and information to subsequent purchasers and/or users and be responsible for obtaining any required intellectual property rights.

 

21.3         Genzyme agrees to comply with instructions for use of the Research Products, if any, and not to misuse the Research Products. Genzyme also agrees to inform its employees of the risks, if any, involved in using or handling the Research Products and to train and equip them to handle the Research Products safely. Supplier will label all hazardous shipments in accordance with HAZMA T standards.

 

21.4         Genzyme realizes that because Supplier’s goods are intended primarily for research purposes, they may not be on the Toxic Substances Control Act (TSCA) inventory. Genzyme assumes responsibility to ensure that purchased Research Products are approved for use under TSCA, if applicable.

 

21.5         Genzyme has the responsibility to conduct any research necessary to learn the hazards involved for any of Genzyme’s uses of Research Products and to warn Genzyme’s customers, employees and any auxiliary personnel (such as freight handlers, etc.) of any risks involved in Genzyme’s use or handling of the Research Products. Genzyme agrees to comply with instructions

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

28



 

for use of the Research Products, if any, and not to misuse the Research Products. If Genzyme is to repackage, re-label or use a Research Product as a starting material or component of other products, Genzyme will make commercially reasonable efforts to qualify the Research Products for such applications, and comply with all applicable laws and regulations relating to labeling or providing other communications to customers. Genzyme also agrees to make commercially reasonable efforts to inform its employees of the risks, if any, involved in using or handling the Research Products and to train and equip them to handle the Research Products safely. Supplier will label all hazardous shipments in accordance with HAZMA T standards.

 

22.           [**]/Transmissible Spongiform Encephalopathy Compliance.

 

Supplier warrants that in the event that any Product that contains or is defined as being a ruminant derived material( s) and/or material( s) derived from animals which are susceptible to infection with transmissible spongiform encephalopathy through the oral route, it shall provide Genzyme with a current Certificate of Suitability (as defined in European Pharmacopoeia Monograph 2001: 1483, Products With Risk of Transmitting Agents of Animal Spongiform Encephalopathies - - a sample of which is contained in Attachment L). Supplier shall be responsible for advising Genzyme of any changes to the Certificate of Suitability in writing, and shall also provide an updated copy of the Certificate of Suitability as soon as it becomes available. Supplier shall be responsible for identifying the Certificate of Suitability 10 number and its expiration date on any Certificate of Analysis for materials of Animal Origin (defined below). Within a commercially reasonable time after receipt of Genzyme’s written request, Supplier shall provide Genzyme with a Letter of Origin stating whether raw materials used in the manufacture of a Product are synthetic or plant derived, or if Animal Origin, whether the raw materials meet the Certificate of Suitability requirements. Material shall be deemed of “Animal Origin” if it is derived from animal tissues, cells, or body fluids; an “animal” is defined as a higher eukaryotic organism, including mammals (to include humans), fish, birds, reptiles, amphibians, insects, mollusks, etc. Animal Origin does not include lower eukaryotic organisms (including without limitation higher plants, fungi, protozoa and algae); nor does it include prokaryotic organisms (including without limitation bacteria or blue-green algae).

 

23.           Export Control:

 

Neither Supplier nor Genzyme shall export or re-export, either directly or indirectly, any technical data relating to Products, incorporating the other party’s Confidential Information or any Product in contravention of any laws or regulations of the United States, including but not limited to the United States Export Administration Act of 1979 as amended, the Trading With the Enemy Act, and the regulations of the U.S. Departments of Commerce, Defense, State, Energy and Treasury, pursuant thereto.

 

24.           Indemnification:

 

24.1 [**].

 

24.2 [**].

 

24.3 [**].

 

24.4 [**].

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

29



 

25.          Compliance with Laws:

 

Each party represents and warrants that in the performance of this Agreement, it and its relevant Affiliates (i.e., Selling Entities and Buying Entities) shall comply with all applicable federal, state and local laws, ordinances, rules, and regulations (including without limitation, and if applicable, 40 CFR 720.3(ee)). Each party agrees to indemnify and hold harmless the other from any and all liabilities, claims, demands, losses, costs, damages or expenses regardless of the nature of same to the extent they arise from any Third Party claim against such party for its or its relevant Affiliate’s failure to comply with such laws, ordinances, rules or regulations.

 

26.          Limitation of Liability:

 

Except for claims arising under Sections 17 (Confidentiality), neither party shall be liable to the other for any indirect, incidental, special or consequential damages (including, without limitation, any damages arising from loss of use or lost business revenue, profits or goodwill) arising in connection with this Agreement, whether in an action in contract, tort, strict liability, warranty, or negligence even if advised of the possibility of such damages. [**].

 

27.           Assignment:

 

The terms and provisions of this Agreement shall inure to the benefit of, and be binding upon, Genzyme, Supplier, and their respective successor and assigns, including pursuant to a merger or consolidation; further, each party may, without the consent of the other, assign its rights and interests, and delegate its obligations hereunder, effective upon written notice thereof to the other party: (a) to an Affiliate if such Affiliate assumes all of the obligations of the assigning party hereunder and this Agreement remains binding upon the assignor, or (b) to any entity that acquires all or substantially all of the assets of a party to which this Agreement pertains, or which is the surviving entity in a merger or consolidation, if such entity assumes in writing all of the obligations of a party hereunder. Any attempt to assign or delegate any portion of this Agreement in violation of this Section 27 shall be null and void. Subject to the foregoing, any reference to Genzyme or Supplier hereunder shall be deemed to include the successors thereto and assigns thereof.

 

28.           Jurisdiction:

 

This Agreement is deemed to be made under and shall be interpreted in accordance with the laws of the Commonwealth of Massachusetts.

 

29.           Severability; Remedies; Waiver:

 

In the event that anyone or more provisions contained in this Agreement shall be held by a court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby.

 

The remedies contained herein are cumulative and in addition to, any other remedies at law or equity. A failure to enforce, or waiver of a breach of, any provision of this Agreement shall not constitute a waiver of any other breach or of such provisions.

 

30.           Notices:

 

All notices under this Agreement shall be in writing, properly addressed and shall be deemed to have been duly given or received upon the earlier of (i) if by personal service, when actually received, (ii) five business days after sending by registered or certified mail, return receipt requested, (iii) one business day after sending via a next business day commercial delivery service, and such service

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

30



 

obtains the signature of a representative of the recipient; or (iv) one (1) day after transmission by facsimile. Any notices not addressed as follows shall be deemed not to have been give or received.

 

For notices to Supplier regarding forecasts or operation of this Agreement:

 

To Supplier (Custom Manufactured Products):

 

Invitrogen Corporation 3175 Staley Road Grand Island, NY 14072

Attention: Beth Webb Tel: 617-630-0242

Fax: 617-630-0243

 

To Genzvme:

Emily Nault

Supply Management Genzyme Corporation

PO Box 9322

Framingham, MA 01701-9322

 

To Supplier (Biosurgery Products):

Invitrogen Corporation 3175 Staley Road

Grand Island, NY 14072 Attention: Rick McAvoy Tel: 716-774-6959

Fax: 716-774-6811

 

With a Copy to:

Legal Department of Genzyme One Kendall Square Cambridge, MA 02139

 

For notices to Supplier regarding interpretation, terms, termination, or breach of this Agreement, all notices shall be sent via mail or commercial delivery service:

 

To Invitrogen:

 

With a Copy to:

Invitrogen Corporation

 

Invitrogen Corporation

1600 Faraday Avenue

 

1600 Faraday Avenue

Carlsbad, CA 92008

 

Carlsbad, CA 92008

Attention: Contracts Department

 

Attention: General Counsel

Tel: 760-603-7200

 

Tel: 760-603-7200

Fax: 760-476-6326

 

Fax: 760-476-6326

 

To Genzvme:

Emily Nault

Supply Management Genzyme Corporation

PO Box 9322.

Framingham, MA 01701-9322

 

With a Copy to:

Legal Department of Genzyme

500 Kendall Street

Cambridge, MA 02142

 

Notices to Buying Entities under this Agreement shall be delivered to those entities at the locations and addresses identified on Attachment A.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

31



 

31.          Advertising:

 

Without the prior written consent of each party’s representative as designated in Section 30, and except as permitted under Section 17, neither Genzyme nor Supplier shall in any manner advertise, publish, or disclose to any Third Party the terms of this Agreement.

 

32.          Statutes and Executive Orders:

 

The following statutes and Executive Orders (“EO’s”) together with Regulations issued hereunder are made a part of this Agreement:

      Equal Opportunity (41 C.R.R. 60-14, EO 11246),

      Employment of Disabled Veterans, and Veterans of Vietnam ERA (Sec. 60-250.4 of Title 41 C.F.R.)

      Employment of the handicapped (sec. 60-741.4 of title 41 C.F.R., EO 11758)

 

33.           Survival:

 

All rights and obligations of the parties set forth herein that expressly or by their nature survive the expiration or termination of this Agreement (including, without limitation, rights and obligations under outstanding Purchase Orders) shall continue in full force and effect subsequent to and notwithstanding the expiration or termination of this Agreement until they are satisfied or by their nature expire and shall bind the parties and their legal representatives, successors, and permitted assigns. Without limiting the foregoing, any of the provisions of this Agreement and/or its Attachments dealing with Delivery, Payment, Warranty, Authorized Use, Confidential Information and Advertising, Intellectual Property Indemnity, Compliance with Laws, and Sections 2.2.8, 26, 28, 30, 34, 35, 36.4, 36.5 and 36.6 shall survive termination of this Agreement.

 

34.           Additional or Inconsistent Terms:

 

Any terms or conditions set forth in any invoice provided to Genzyme by Supplier or in any order provided to Supplier by Genzyme (including, without limitation, Purchase Orders) which is in any way different from, inconsistent with or in addition to the terms and conditions set forth herein will not become a part of this Agreement or be binding upon Genzyme or Supplier.

 

35.           Entire Agreement:

 

This Agreement and its Attachments constitute the entire agreement between the parties relating to the subject matter hereof, and supersedes and replaces all prior agreements, written or oral; between the parties regarding Products (including, without limitation, the Biosurgery Agreement). Any modification or waiver of any provision must be made in writing and signed by authorized representatives of each party.

 

36.           General Provisions.

 

36.1         Non-Exclusivity. Supplier is not, and nothing in this Agreement shall imply that Supplier or Selling Entities are Genzyme’s or Buying Entities’ exclusive manufacturer or Supplier of Products. Genzyme and Buying Entities are not, and nothing in this Agreement shall imply that Genzyme or Buying Entities are, Supplier’s exclusive purchaser of Products.

 

36.2         Force Majeure Refer to section 19.

 

36.3         Independent Contractor. Supplier shall furnish Products to Genzyme as an independent contractor and not as an employee or agent of Genzyme. Except as expressly stated

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

32



 

herein, Supplier may not act for, bind, or represent Genzyme in any manner.

 

36.4         Headings. Headings used herein are for descriptive purposes only and shall not control or alter the meaning of this Agreement as set forth in the text.

 

36.5         Severability. Should one or more of the provisions contained in this Agreement be held invalid, illegal or unenforceable by a court or tribunal with jurisdiction to do so, then the validity, legality and enforceability of the remaining provisions contained herein shall not be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affect the parties’ substantive rights. In such instance, the parties shall use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.

 

36.6         No Amendment: Waiver. This Agreement shall not be amended except by an instrument in writing executed by both parties. Failure of either party at any time to enforce any of the provisions of this Agreement shall not be deemed to be a waiver of such or any other provision hereof.

 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives.

 

INVITROGEN CORPORATION (SUPPLIER)

 

By:

 

Name: Bernd Brust

 

Title:  Sr. VP. Worldwide Sales

 

 

GENZYME CORPORATION (GENZYME)

 

By:

 

Name: Mark Bamforth

 

Title:  Sr. VP. Corporate Operations and Pharmaceuticals

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

 

33



 

Attachment A

 

Genzyme Global Buying Entities

 

Corporations

Genzyme Corporation * (Headquarters)

500 Kendall Street
Cambridge, MA 02142
Telephone: 617-252-7500
Fax: 617-252-7600

 

Authorized Buying Entities

Genzyme Corporation
80 New York Avenue
Framingham, MA  01701-9322
Telephone:  508-424-4300
Fax:  508-424-4066

 

Genzyme Corporation
74 New York Avenue
Framingham, MA  01701-9322
Telephone:  508-424-4300
Fax:  508-424-4066

 

Genzyme Corporation
31 New York Avenue
Framingham, MA  01701-9322
Telephone:  508-424-4300
Fax:  508-872-4091

 

Genzyme Corporation
11 Pleasant Street Connector
PO Box 9322
Framingham, MA  01701-9322
Telephone:  508-872-8400
Fax:  508-872-9080

 

Genzyme Corporation
78 New York Avenue
Framingham, MA  01701-9322
Telephone:  508-424-4300
Fax:  508-872-4091

 

Genzyme Corporation
51 New York Avenue
Framingham, MA  01701-9322
Telephone:  508-424-4300
Fax:  508-872-4091

 

Genzyme Corporation
One Mountain Road
Framingham, MA  01701-9322
Telephone:  508-872-8400
Fax:  508-872-9080

 

Genzyme Corporation
15 Pleasant Street Connector
PO Box 9322
Framingham, MA  01701-9322
Telephone:  508-872-8400
Fax:  508-872-9080

 

Genzyme Corporation
76 New York Avenue
Framingham, MA  01701-9322
Telephone:  508-424-4300
Fax:  508-424-4066

 

Genzyme Corporation
45 New York Avenue
Framingham, MA  01701-9322
Telephone:  508-424-4300
Fax:  508-872-4091

 

Genzyme Corporation
5 Mountain Road
Framingham, MA  01701-9322
Telephone:  508-872-8400
Fax:  508-872-9080

 

Genzyme Corporation
(Diagnostics Business Unit Headquarters)
One Kendall Square
Cambridge, MA  02139
Telephone:  617-252-7500
Fax:  617-252-7600

 

Genzyme Corporation
(Diagnostics Business Unit Location)
6659 Top Gun
San Diego, CA 92121
Telephone:   858-452-3198
Fax:  858-452-3258

 

Genzyme Corporation
(Pharmaceuticals Business Unit Headquarters)
500 Kendall Street
Cambridge, MA 02142
Telephone: 617-252-7500
Fax: 617-252-7600

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

34



 

Genzyme Corporation
(Molecular Oncology Division Headquarters)
MetroWest Place
15 Pleasant Street Connector
PO Box 9322
Framingham, MA  01701-0322
Telephone:  505-271-2627
Fax:  508-271-2604

 

Genzyme Corporation
(Therapeutics Business Unit Headquarters)
500 Kendall Street
Cambridge, MA 02142
Telephone: 617-252-7500
Fax: 617-252-7600

 

Genzyme Corporation
(Biosurgery Division Headquarters)
500 Kendall Street
Cambridge, MA 02142
Telephone: 617-252-7500
Fax: 617-252-7600

 

Genzyme Corporation
(Biosurgery Division Location)
64 Sidney Street
Cambridge, MA  02139
Telephone:  617-494-8484
Fax:  617-494-6561

 

Genzyme Corporation
(Biosurgery Division Location)
65 Railroad Avenue
Ridgefield, NJ  07657

 

Genzyme Corporation
(Genetics Business Unit Headquarters)
MetroWest Place
15 Pleasant Street Connector
PO Box 9322
Framingham, MA  01701-9322
Telephone:  508-872-8400
Fax:  508-872-5663

 

Genzyme Corporation
(Genetics Business Unit Location)
6991 E. Camelback Road
Suite B295
Scottsdale, AZ  85251
Telephone:  602-675-0250
Fax:  602-675-0210

 

Genzyme Corporation
(Genetics-Pasadena)
11 West Del Mar
Pasadena, CA 91105
Telephone: 800-255-1616

 

Genzyme Corporation
(Genetics Business Unit Location)
2000 Vivigen Way
Santa Fe, NM  87505
Telephone:  505-438-1111
Fax:  505-438-1120

 

(Genetics Business Unit Location)
10421 University Center Drive #100
Tampa, FL  33612-6422
Telephone:  813-979-9442
Fax:  813-972-4632

 

Diagnostic Testing
4310 E. Cotton Center Blvd
Suite 120
Phoenix, AZ 85040
Tel: 602-254-6620
Fax: 602-254-7340
Toll free: 800-645-6626

 

Diagnostic Testing
655 East Huntington Drive
Monrovia, CA 91016
Tel: 626-471-9922
Fax: 626-471-7510
Toll free: 800-255-1616

 

(Genetics Business Unit Location)
1054 Town & Country Road
Orange, CA  92868
Telephone:  714-245-9259
Fax:  714-245-9259

 

Genzyme Genetics | Impath
521 West 57th St.
New York NY 10019

 

Genzyme Genetics | Impath
Receiving Location
625 West 55th St.
5th Floor
New York, NY 10019

 

Genzyme Genetics | Impath
Receiving Location
5340 Alla Rd.
Los Angeles CA 90066

 

Genzyme Genetics | Impath
Receiving Location
518 West 58th St.
5th Floor
New York, NY 10019

 

Genzyme Genetics | Impath
Receiving Location
5300 McConnell Ave.
Los Angeles, CA 90066

 

Genzyme Genetics | Impath
Receiving Location
810 East Hammond Ln.
Phoenix, AZ 85034

 

Genzyme Drug Discovery and Development
153 Second Avenue
Waltham, MA  01254

Telephone:  781-290-5890
Fax:  781-290-5890

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

35



 

Genzyme Glycobiology Research Institute
800 Research Parkway, Suite 200
Oklahoma City, OK  73104
Telephone:  405-271-8144
Fax:  405-271-1030

 

GBL West Malling
50 Gibson Drive
Kings Hill, West Malling
Kent  ME19 4AF
UNITED KINGDOM
Telephone:  011-44-1732-22-0022
Fax:  011-44-1732-22-0024

 

Genzyme Flanders NV
Cipalstraat 8
B-2440 Geel
BELGIUM
Telephone:  011-32-1456-4911
Fax:  011-32-1456-4916

 

Genzyme Pharmaceuticals
Sygena Facility
Eichenweg 1
CH 4410 Liestal
SWITZERLAND
Telephone:  011-41-061-906-5959
Fax:  011-41-061-906-5958

 

Genzyme Ltd
37 Hollands Road
Haverhill
Suffolk CB9 8PU
UNITED KINGDOM
Telephone:  011-44-1440-703-522
Fax:  011-44-1440-707-783

 

Genzyme (formerly Sangstat)
58, Avenue Debourg
B.P. 7055
F-69348 Lyon Cedex 07
FRANCE
Telephone: +33 (0)4 37 28 16 88
Fax: +33 (0)4 37 28 16 95

 

Genzyme Virotech GmbH
Lowenplatz 5
D-65428 Ruesselsheim
GERMANY
Telephone:  011-49-6142-69-0963
Fax:  011-49-6142-82-621

 

Genzyme Waterford
IDA Business Park
Kilmeadan Road
Waterford
IRELAND
Telephone:  011-353-51-594-100
Fax:  011-353-51-594-105

 

Genzyme (formerly Sangstat)
1541, Avenue Marcel Mérieux
69280 Marcy L’Etoile
FRANCE
Telephone: +33 (0)4 37 22 58 10
Fax +33 (0)4 37 22 58 98

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

36



 

Attachment B-1

 

Bioproduction Pricing

 

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

37



 

Attachment B2

 

Biosurgery Products

 

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

38



 

Attachment B3

 

Research Pricing

 

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

39



 

Attachment B4

 

GENETICS PRICING

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

40



 

Attachment C

 

SPECIFICATIONS

 

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

41



 

Attachment D

 

LIST OF ACCOUNT MANAGERS FOR INVITROGEN

 

WILL BE PROVIDED AT THE YEARLY BUSINESS REVIEW

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

42



 

Attachment E

 

GENZYME ACCOUNTS PAYABLE CONTACTS

 

US Invoices. Unless otherwise specified, all US invoices (with the exception of EDI invoices as referenced below) shall be sent by mail to the following address:

 

Genzyme Corporation
P.O. Box 9322
Framingham, MA  01701-9322
USA

 

International Invoices. Unless otherwise specified, all non-US (International) Invoices shall be sent to applicable Genzyme locations at the appropriate address specified in Attachment A.

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

43



 

ATTACHMENT F

 

SUPPLEMENTAL PRODUCT AMENDMENT FOR BIOSURGERY PRODUCTS

 

Pursuant to Section 8.2 of that certain PURCHASE AND SUPPLY AGREEMENT entered into by and between Genzyme Corporation (“Genzyme”) and Invitrogen Corporation (“Invitrogen”) dated December        , 2003.

 

Supplier agrees to manufacture for the Biosurgery Division of Genzyme the following Biosurgery product (referred to herein as the “Biosurgery Product,”                   , subject to the warranties and limitations set forth herein. The Biosurgery Product formulation and packaging components are attached.

 

Supplier will manufacture the Biosurgery Product in accordance with specifications attached here (the “Specifications”). Supplier’s warranty’s for the Biosurgery Products are as set forth in the Purchase and Supply Agreement. A copy of the Certificate of Analysis that defines the Specifications is attached.

 

In witness whereof each of the parties has caused its authorized representative to execute this Supplemental Product Amendment on the date specified below.

 

Invitrogen Corporation

Genzyme Corporation

 

 

Name:

 

 

Name:

 

 

 

 

Signature:

 

 

Signature:

 

 

 

 

Title:

 

 

Title:

 

 

 

 

Date:

 

 

Date:

 

 

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

44



 

ATTACHMENT G

 

GENZYME MATERIALS
AND MATERIALS SPECIFICATIONS

 

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

45



 

ATTACHMENT H

 

[**] PROTOCOLS

 

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

46



 

ATTACHMENT I

 

Biosurgery Refrigeration and Transportation Requirements

 

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

47



 

ATTACHMENT J

 

SUPPLEMENTAL PRODUCT AMENDMENTS

[**]

 

ATTACHMENT K

 

Change or Discontinuation Notification Process

 

[**]

 

ATTACHMENT L

 

CERTIFICATION OF SUITABILITY OF MONOGRAPHS OF THE EUROPEAN
PHARMACOPOEIA

 

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

48



 

ATTACHMENT M

 

RESERVE REQUIREMENTS

 

[**]

 

ATTACHMENT N

 

DISASTER RECOVERY PLAN

 

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

49



 

ATTACHMENT O

 

SPECIAL REQUIREMENTS for GENZYME’S BELGIUM FACILITY

 

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

50



 

ATTACHMENT P

 

GENZYME ON-SITE STOCKROOM PROGRAMS

 

[**]

 


[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.  An unredacted version of this exhibit has been filed separately with the Commission.

 

51



EX-10.2 3 a2180321zex-10_2.htm EXHIBIT 10.2

Exhibit 10.2

 

FORM OF

AMENDED AND RESTATED

EXECUTIVE SEVERANCE AGREEMENT

 

This Amended and Restated Executive Severance Agreement (the “Agreement”), entered into effective as of December 31, 2007 between Genzyme Corporation, a Massachusetts corporation with its principal executive offices at 500 Kendall Street, Cambridge, Massachusetts 02142, including its subsidiaries and affiliates (collectively, the “Company”), and Name (the “Executive”) residing at Address, amends and restates in its entirety the Executive Severance Agreement dated Date of Prior Agreement between the Company and the Executive (the “Prior Agreement”).

 

The Compensation Committee (the “Committee”) of the Board of Directors of Genzyme Corporation (the “Board”) has determined that it is in the best interests of the Company and its stockholders to ensure the continued dedication of the Executive, notwithstanding the possibility, threat or occurrence of a Change in Control (as defined in Section 3(i) hereof) of Genzyme Corporation. The Committee believes it is imperative to diminish the inevitable distraction of the Executive by virtue of the personal uncertainties and risks created by a pending or threatened Change in Control, to encourage the Executive’s full attention and dedication to the Company currently and in the event of any threatened or pending Change in Control, and to provide the Executive with severance benefits in certain circumstances after a Change in Control that provide the Executive with individual financial security and, in order to accomplish these objectives the Committee, pursuant to the authority delegated to it by the Board, has caused the Company to enter into this Agreement.

 

Accordingly, the parties agree as follows:

 

1.             Severance Benefits. In consideration of (i) the Executive’s continued employment with the Company; and (ii) the Executive’s agreement set forth in Section 3(iv) hereof, the Executive will be entitled to the benefits provided under this Agreement after a Change in Control (as defined in Section 3(i) hereof) and under the circumstances described below.

 

2.             Term of Agreement. This Agreement is effective as of the date specified above and will continue in effect through December 31, 2008. Commencing on December 31, 2008 and on each December 31 thereafter, the term of this Agreement will be extended automatically for one additional year unless, not later than September 30 of that year, the Company notifies the Executive that it does not wish to extend this Agreement. The Company may not, however, notify the Executive during the pendency of a Potential Change in Control that this Agreement will not be renewed. Any references herein to the “term” of this Agreement shall include both the initial term and any renewal terms. If a Change in Control occurs during the term of this Agreement, this Agreement will continue in effect for thirty-six (36) months after the month in which the Change in Control occurred; provided that this Agreement shall terminate automatically upon the Executive’s Date of Termination, subject to the last sentence of Section 9 hereof.

 



 

3.             Change in Control; Potential Change in Control.

 

(i)  No benefits are payable under this Agreement unless there shall have been a Change in Control of Genzyme Corporation followed by a Separation from Service of the Executive as described in Section 5(ii) hereof. For purposes of this Agreement, a “Change in Control” means any of the following:

 

(A)  any “person” (as defined below), other than Genzyme Corporation, any trustee or other fiduciary holding securities under an employee benefit plan of Genzyme Corporation or a corporation owned, directly or indirectly, by the stockholders of Genzyme Corporation in substantially the same proportions as their ownership of stock of Genzyme Corporation, is or becomes the “beneficial owner” (as defined below), directly or indirectly, of securities of Genzyme Corporation representing 50% or more of the combined voting power of Genzyme Corporation’s then outstanding securities;

 

(B)  during any period of twenty-four (24) consecutive months (not including any period prior to the date of this Agreement), individuals who at the beginning of such period constitute the Board and any new director (other than a director designated by a person who has entered into an agreement with Genzyme Corporation to effect a transaction described in paragraphs (A), (C) or (D) of this Section 3(i)) whose election by the Board or nomination for election by the Board or by the stockholders of Genzyme Corporation was approved by a vote of at least two-thirds (2/3) of the directors then still in office who either were directors at the beginning of such period or whose election or nomination for election was previously so approved (such directors in office from time to time, the “Continuing Directors”), cease for any reason to constitute a majority thereof;

 

(C)  there is consummated a merger, share exchange or consolidation of Genzyme Corporation with any other corporation or business entity or the sale or other disposition of all or substantially all of Genzyme Corporation’s assets (each, a “Business Combination”), other than (1) a Business Combination that would result in the voting securities of Genzyme Corporation outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of another entity) beneficial ownership, directly or indirectly, of a majority of the combined voting power of Genzyme Corporation or the surviving entity (including any person that, as a result of such transaction, owns all or substantially all of Genzyme Corporation’s assets either directly or through one or more subsidiaries) outstanding immediately after such Business Combination or (2) a merger, share exchange or consolidation effected to implement a recapitalization of Genzyme Corporation (or similar transaction) following which no person is or becomes the beneficial owner of 50% or more of the combined voting power of Genzyme Corporation’s then outstanding securities; or

 

(D)  the stockholders of Genzyme Corporation approve a plan of complete liquidation of Genzyme Corporation.

 

2



 

(ii) For purposes of this Agreement, a “Potential Change in Control” shall be deemed to have occurred if:

 

(A)  Genzyme Corporation enters into an agreement with any person, the consummation of which would result in the occurrence of a Change in Control;

 

(B)  any person, including Genzyme Corporation, publicly announces an intention to take or consider taking actions which if consummated would constitute a Change in Control, unless the Board adopts a resolution in good faith setting forth its determination that such announcement is not sufficiently credible to constitute a Potential Change in Control for purposes of this Agreement;

 

(C)  any person, other than Genzyme Corporation, any trustee or other fiduciary holding securities under an employee benefit plan of Genzyme Corporation or a corporation owned, directly or indirectly, by the stockholders of Genzyme Corporation in substantially the same proportions as their ownership of stock of Genzyme Corporation (1) is or becomes the beneficial owner, (2) discloses directly or indirectly to Genzyme Corporation or publicly a plan or intention to become the beneficial owner, or (3) makes a filing under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to securities to become the beneficial owner, directly or indirectly, of securities representing 50% or more of the combined voting power of the outstanding voting securities of Genzyme Corporation; or

 

(D)  the Board adopts a resolution to the effect that, for purposes of this Agreement, a Potential Change in Control of Genzyme Corporation has occurred.

 

(iii) For purposes of this Section 3, “person” shall have the same meaning as when used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and “beneficial owner” shall have the same meaning as when used in Rule 13d-3 under the Exchange Act.

 

(iv) The Executive agrees that, subject to the terms and conditions of this Agreement, in the event of a Potential Change in Control, he or she will remain in the employ of the Company until at least the earliest of (A) a date which is one (1) year after the occurrence of such Potential Change in Control, (B) the termination of the Executive’s employment by reason of death, (C) the date of the occurrence of a Change in Control, or (D) the determination in good faith by the Board that the event creating the Potential Change in Control has ceased to exist.

 

4.             Separation from Service Following Change in Control.

 

(i) In General. If any of the events described in Section 3(i) constituting a Change in Control occur during the Executive’s employment with the Company and while this Agreement is in effect, the Executive will be entitled to the benefits provided in Section 5(ii) upon a Separation from Service (as defined below) of the Executive during the term of this Agreement (A) by the Company without

 

3



 

Cause, or (B) by the Executive for Good Reason. For the avoidance of doubt, if the Executive experiences a Separation from Service because it is reasonably anticipated that the Executive will no longer perform services for the Company or that the level of bona fide services performed by the Executive for the Company will permanently decrease to less than 20% of the average level of bona fide services performed over the 36-month period (or the full period of services of the Executive if employed less than 36 months) immediately before that date, the Executive shall not be entitled to the benefits provided in Section 5(ii) upon that, or a subsequent, Separation from Service, unless such reasonable anticipation is caused by actions of the Company giving the Executive the right to provide notice of a Separation from Service for Good Reason, as defined in Section 4(iii).

 

(ii) Cause. Separation from Service for “Cause” shall mean Separation from Service upon (A) the willful and continued failure by the Executive to substantially perform his or her duties with the Company (other than any such failure resulting from his or her incapacity due to physical or mental illness or any such actual or anticipated failure after the issuance of a Notice of Termination by him or her for Good Reason (as defined below)) after a written demand for substantial performance is delivered to the Executive by the Board, which demand specifically identifies the manner in which the Board believes that he or she has not substantially performed his or her duties, or (B) the willful engaging by the Executive in conduct which is demonstrably and materially injurious to the Company, monetarily or otherwise. For purposes of this Section, no act, or failure to act, on the Executive’s part shall be deemed “willful” unless done, or omitted to be done, by him or her not in good faith and without reasonable belief that his or her action or omission was in the best interest of the Company. Notwithstanding the foregoing, the Executive shall not be deemed to have been terminated for Cause unless and until there shall have been delivered to him or her a copy of a resolution duly adopted by the affirmative vote of not less than three-quarters (3/4) of the entire membership of the Board at a meeting of the Board called and held for such purpose (after reasonable notice to the Executive and an opportunity for him, together with his or her counsel, to be heard before the Board), finding that in the good faith opinion of the Board the Executive was guilty of conduct set forth above in this Section and specifying the particulars thereof in detail.

 

(iii) Good Reason. For purposes of this Agreement, Separation from Service for Good Reason shall have the same meaning as the safe harbor set forth in Section 409 of the Internal Revenue Code of 1986, as amended (the “Code”), and the Treasury regulations §1.409A-1(n)(2). Any amendments or revisions made to such safe harbor by the Internal Revenue Service (“IRS”) and any interpretations of such safe harbor announced by the IRS after the effective date of this Amended and Restated Agreement shall automatically be incorporated herein at the time such amendments, revisions or interpretations become effective. As of the effective date of this Amended and Restated Agreement, the safe harbor Separation from Service for Good Reason means Separation from Service during the two (2) year period following a Change in Control and the initial existence of one or more of the following conditions arising without the Executive’s consent:

 

(1)     a material diminution in the Executive’s annual base compensation;

 

4



 

(2)     a material diminution in the Executive’s authority, duties, or responsibilities;

 

(3)     a material diminution in the authority, duties, or responsibilities of the Executive’s supervisor to whom the Executive is required to report;

 

(4)     a material change in the budget over which the Executive retains authority;

 

(5)       a material change in the geographic location where the Executive is required to perform services for the Company, from the Company’s offices at which he or she was principally employed except for required travel on the Company’s business to an extent substantially consistent with his or her present business travel obligations;

 

(6)     any other action or inaction that constitutes a material breach by the Company of this Agreement.

 

In all instances described above, the Executive must give the Company notice of the existence of the material diminution, change or breach described above within 90 days after the initial existence of the material diminution, change or breach, and the Company will have 30 days to remedy the material diminution, change or breach. A Separation from Service for Good Reason does not occur if the material diminution, change or breach is remedied. If the Company does not remedy the material diminution, change or breach, the Separation from Service for Good Reason shall occur on the 31st day after receiving notice from the Executive.

 

(iv) Notice of Termination. Any purported termination of the Executive’s employment by the Company or by the Executive following a Change in Control or while a Potential Change in Control is pending, shall be communicated by written Notice of Termination to the other party hereto in accordance with Sections 4 and 8 hereof. A “Notice of Termination” means a notice indicating the specific termination provision in this Agreement relied upon and shall set forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of the Executive’s employment under the provision so indicated.

 

(v) Date of Termination, Etc. “Date of Termination” means if the Executive’s employment is terminated pursuant to Section 4(ii) or (iii) above, the date specified in the Notice of Termination shall not be less than thirty (30) days nor more than sixty (60) days from the date such Notice of Termination is given; provided that if within fifteen (15) days after any Notice of Termination is given, or, if later, prior to the Date of Termination (as determined without regard to this proviso), the party receiving such Notice of Termination notifies the other party that a dispute exists concerning the termination, the Date of Termination shall be the date on which the dispute is finally determined, either by mutual written agreement of the parties or by a binding arbitration award; and provided further that the Date of Termination shall be extended by a notice of dispute only if such notice is given in good faith and the party giving such notice pursues the resolution of such dispute with reasonable diligence. Notwithstanding the foregoing sentence, if the Executive is entitled to the benefits provided in Section 5(ii) upon a Separation of Service, such benefits will be paid to the Executive no later than March 15th of the calendar year following the calendar year in which such Notice of

 

5



 

Termination is given. During the pendency of any such dispute, (1) the Executive shall not be required to report for work or otherwise continue to perform his or her duties with the Company and (2) the Company will continue to pay to the Executive his or her full compensation in effect when the notice giving rise to the dispute was given (including, but not limited to, base salary) and, to the extent permissible by law, continue the Executive and his or her dependents as a participant in all compensation, benefit and insurance plans in which he or she or they were participating when the notice giving rise to the dispute was given, until the dispute is finally resolved in accordance with this Section 4(v). Amounts paid under this Section 4(v) are in addition to all other amounts due under this Agreement and shall not reduce any other amounts due under this Agreement.

 

(vi) Separation from Service. For purposes of this Agreement, “Separation from Service” shall have the same meaning as the definition set forth in Section 409 of the Code, and the Treasury regulations §1.409A-1(h)(1)(i). Any amendments or revisions made to such definition by the IRS and any interpretations of such definition announced by the IRS after the effective date of this Amended and Restated Agreement shall automatically be incorporated herein at the time such amendments, revisions or interpretations become effective. “Separation from Service” means, regardless of the Date of Termination, the date on which the Executive retires, dies, or otherwise has a termination of employment with the Company, including the date it is reasonably anticipated that the Executive will no longer perform services for the Company or that the level of bona fide services performed by the Executive for the Company will permanently decrease to less than 20% of the average level of bona fide services performed over the 36-month period (or the full period of services of the Executive if employed less than 36 months) immediately before that date. But if the Executive has a bona fide leave of absence such that there is a reasonable expectation that the Executive will return to perform services for the Company, Separation of Service will occur on the first day following a six-month leave period unless the Executive retains the right to return to employment with the Company by statute or contract. Notwithstanding the foregoing sentence, for a leave of absence due to any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of six months or longer, Separation from Service will occur on the first day following the 29-month period of leave if the impairment causes the Executive to be unable to perform the duties of his or her position or any substantially similar position.

 

5.             Compensation Upon Separation from Service Following a Change in Control. The Executive will be entitled to the following benefits after a Change in Control under the circumstances described in this Section. To the extent that any of these benefits are subject to Section 409A of the Code and the Treasury regulations thereunder (“Treas. Reg.”) and the Executive is a “specified employee” pursuant to Treas. Reg. §1.409A-1(i) at Separation from Service (as defined in Section 4(vi)), such benefits will not be paid to the Executive before the six-month period that immediately follows the Executive’s Separation from Service. Any such suspended benefits will be paid immediately after the expiration of such six month period in a lump sum.

 

(i) Voluntary Separation from Service, Involuntary Separation from Service for Cause, or Death. If the Executive experiences a Separation from Service by death, by the Company

 

6



 

for Cause or by the Executive other than for Good Reason, the Company shall pay him or her, within 60 days after Separation from Service, his or her full base salary through the Separation from Service at the rate in effect at the time Notice of Termination is given, plus all other amounts to which he or she is entitled under any compensation or benefit plan of the Company at the time such payments are due, and the Company shall have no further obligations to the Executive under this Agreement.

 

(ii) Good Reason Separation from Service, Involuntary Separation from Service Other Than for Cause. If the Executive experiences a Separation from Service after a Change in Control (a) by the Company without Cause, or (b) by the Executive for Good Reason, then he or she will be entitled to the benefits described below:

 

(A) the Company shall pay the Executive, within 60 days after Separation from Service, his or her full base salary through the Separation from Service at the rate in effect at the time Notice of Termination is given, plus all other amounts to which he or she is entitled under any compensation or benefit plan of the Company, at the time such payments are due, except as otherwise provided below;

 

(B) in lieu of any further salary payments to the Executive for periods subsequent to the Separation from Service, the Company shall pay, not later than March 15 of the calendar year following the calendar year in which Separation from Service occurs, as severance pay to the Executive a lump sum severance payment (together with the payments provided in paragraphs (D), (E), and (F) below, the “Severance Payments”) equal to two (2) times the sum of (1) the greater of (a) his or her annual rate of base salary in effect on the Separation from Service or (b) his or her annual rate of base salary in effect immediately prior to the Change in Control and (2) the greatest of (a) the average of the last two annual bonuses (annualized in the case of any bonus paid with respect to a partial year) paid to him or her preceding the Separation from Service, (b) the average of the last two annual bonuses (annualized in the case of any bonus paid with respect to a partial year) paid to him or her preceding the Change in Control, (c) the most recent annual bonus (annualized in the case of any bonus paid with respect to a partial year) paid to him or her preceding the Separation from Service, or (d) the most recent annual bonus (annualized in the case of any bonus paid with respect to a partial year) paid to him or her preceding the Change in Control;

 

(C) the Company shall also pay to the Executive, within thirty (30) days after any such fees or expenses are incurred and substantiated to the Company, all legal fees and expenses incurred by him or her as a result of or in connection with termination of employment, including all such fees and expenses, if any, incurred in contesting or disputing the termination or in seeking to obtain or enforce any right or benefit provided by this Agreement (other than any such fees or expenses incurred in connection with any such claim which is determined by arbitration, in accordance with Section 12 of this Agreement, to be frivolous) or in connection with any tax audit or proceeding to the extent attributable to the application of Sections 4999 and 409A of the Code, to any payment or benefit provided hereunder, provided that such fees and expenses incurred and reimbursed in one calendar year will not impact fees or expenses eligible

 

7



 

for reimbursement in another calendar year;

 

(D) for a twenty-four (24) month period after Separation from Service, the Company shall arrange to provide, at its cost, the Executive and his or her dependents with life, disability, accident and health insurance benefits substantially similar to those which he or she and they are receiving immediately before the Separation from Service. Benefits otherwise receivable by the Executive pursuant to this Section 5(ii)(D) shall be reduced to the extent comparable benefits are actually received by him or her from a subsequent employer during the twenty-four (24) month period following his or her Separation from Service, and any such benefits actually received by him or her shall be reported to the Company;

 

(E) in addition to the retirement benefits to which the Executive is entitled under the provisions of the Company’s defined benefit plans (the “Benefit Plans”), any supplemental defined benefit retirement or excess defined benefit plan maintained by the Company or any of its subsidiaries or any successor plans thereto (hereinafter collectively referred to as the “Pension Plans”), the Company shall pay the Executive, not later than March 15 of the calendar year after Separation from Service, in cash a lump sum equal to the excess of (a) the actuarial equivalent of the retirement pension (taking into account any early retirement subsidies associated therewith and determined as a straight life annuity commencing at age sixty-five (65) or any earlier date, but in no event earlier than the second anniversary of the Separation from Service, whichever annuity the actuarial equivalent of which is greatest) which the Executive would have accrued under the terms of the Pension Plans (without regard to the limitations imposed by Section 401(a)(17) of the Code, any temporary freeze on benefit accruals under the Pension Plans pursuant to Internal Revenue Service Notice 88-131 or any amendment to the Pension Plans made subsequent to a Change in Control and on or prior to the Separation from Service, which amendment adversely affects in any manner the computation of retirement benefits thereunder), determined as if the Executive was fully vested thereunder and had continued to be employed by the Company (after the Separation from Service) for twenty-four (24) additional months and as if he or she had accumulated twenty-four (24) additional months of compensation (for purposes of determining his or her pension benefits thereunder), each in an amount equal to the sum of the amounts determined under clauses (1) and (2) of Section 5(ii)(B) hereof over (b) the actuarial equivalent of the vested retirement pension (taking into account any early retirement subsidies associated therewith and determined as a straight life annuity commencing at age sixty-five (65) or any earlier date, but in no event earlier than the Separation from Service, whichever annuity the actuarial equivalent of which is greatest) which the Executive had then accrued pursuant to the provisions of the Pension Plans. For purposes of this Section, “actuarial equivalent” shall be determined using the same actuarial assumptions utilized in determining the amount of alternate forms of benefits under the Benefit Plans immediately prior to the Change in Control;

 

(F) should the Executive move his or her residence in order to pursue other business opportunities within one (1) year after the Separation from Service, the Company shall pay him or her, within thirty (30) days after such expenses are incurred

 

8



 

and substantiated to the Company, an amount equal to the reasonable expenses incurred by him or her in connection with such relocation (including expenses incurred in selling his or her home to the extent such expenses were customarily reimbursed by the Company to transferred executives prior to the Change in Control) and which are not reimbursed by another employer; and

 

(G) the Company shall pay, within thirty (30) days after such fees and expenses are incurred and substantiated to the Company, all fees and expenses of any executive recruiting, counseling or placement firm selected by the Executive for the purpose of seeking new employment within one (1) year of the Separation from Service, provided that such cost shall not exceed $30,000.00.

 

(iv) Amounts payable to the Executive shall be reduced as set forth below.

 

(A) For purposes of this Section 5(iv), (1) “Payment” shall mean any Payment or distribution in the nature of compensation to or for the benefit of the Executive, whether paid or payable pursuant to this Agreement or otherwise; (2) “Agreement Payment” shall mean a Payment paid or payable pursuant to this Agreement (disregarding this Section 5(iv)); (3) “Net After Tax Receipt” shall mean the Present Value of a Payment net of all taxes imposed on the Executive with respect thereto under Sections 1 and 4999 of the Code, determined by applying the highest marginal rate under Section 1 of the Code which applied to the Executive’s taxable income for the immediately preceding taxable year; (4) “Present Value” shall mean such value determined in accordance with Section 280G(d)(4) of the Code; and (5) “Reduced Amount” shall mean the smallest aggregate amount of Payments which (a) is less than the sum of all Payments and (b) results in aggregate Net After Tax Receipts which are equal to or greater than the Net After Tax Receipts which would result if the aggregate Payments were any other amount less than the sum of all Payments.

 

(B) Anything in this Agreement to the contrary notwithstanding, in the event PricewaterhouseCoopers LLP or a successor accounting firm of national reputation (the “Accounting Firm”) shall determine the receipt of all Payments would subject the Executive to tax under Section 4999 of the Code, it shall determine whether some amount of Payments would meet the definition of a “Reduced Amount.”  If the Accounting Firm determines that there is a Reduced Amount, the aggregate Agreement Payments shall be reduced to such Reduced Amount; provided, however, that if the Reduced Amount exceeds the aggregate Agreement Payments, the aggregate Payments shall, after the reduction of all Agreement Payments, be reduced (but not below zero) in the amount of such excess.

 

(C) If the Accounting Firm determines that aggregate Agreement Payments or Payments, as the case may be, should be reduced to the Reduced Amount, the Company will promptly notify the Executive and provide a copy of the detailed calculation. In determining the Reduced Amount, the Company will reduce or eliminate the Agreement Payment or Payments in the following order:

 

(1)           the portion denominated and payable in cash (other than “24(c) Payments”), such as Severance Payments;

 

9



 

(2)           the portion payable in-kind, such as insurance coverage, or in cash as a reimbursement, such as for outplacement, legal fees, or moving expenses (other than “24(c) Payments”); and

 

(3)           by reducing or eliminating “24(c) Payments,” such as equity-based compensation and enhancements under any Pension Plans.

 

The Company has full discretionary authority to determine which payments to reduce within each of the three categories described in the preceding sentence. The Company cannot, however, reduce payments in the second or third category unless all Payments in the preceding category have been eliminated. A “24(c) Payment” is any Agreement Payment or Payments that are permitted to be valued under Treasury Regulation Section 1.280G-1, Q/A-24(c), or any successor provision. All determinations made by the Accounting Firm under this Section 5(iv) shall be binding upon the Company and the Executive, and shall be made within sixty (60) days after Separation from Service. As promptly as practicable following such determination and subject to the payment provisions applicable to all benefits payable under this Agreement, the Company shall pay to or distribute for the benefit of the Executive such Payments as are then due to the Executive under this Agreement and shall promptly pay to or distribute for the benefit of the Executive in the future such Payments as become due to the Executive under this Agreement.

 

(D) While it is the intention of the Company and the Executive to reduce the amounts payable or distributable to the Executive hereunder only if the aggregate Net After Tax Receipts to the Executive would thereby be increased, as a result of the uncertainty in the application of Section 4999 of the Code at the time of the initial determination by the Accounting Firm hereunder, it is possible that amounts will have been paid or distributed by the Company to or for the benefit of the Executive pursuant to this Agreement which should not have been so paid or distributed (“OverPayment”) or that additional amounts which will have not been paid or distributed by the Company to or for the benefit of the Executive pursuant to this Agreement could have been so paid or distributed (“UnderPayment”), in each case, consistent with the calculation of the Reduced Amount hereunder. In the event that the Accounting Firm, based either upon the assertion of a deficiency by the Internal Revenue Service against the Company or the Executive which the Accounting Firm believes has a high probability of success or controlling precedent or other substantial authority, determines that an OverPayment has been made, any such OverPayment paid or distributed by the Company to or for the benefit of the Executive shall be treated for all purposes as a loan ab initio to the Executive which the Executive shall repay to the Company (together with interest at the rate provided for in Section 1274(b)(2)(B) of the Code); provided, however, that no such loan shall be deemed to have been made and no amount shall be payable by the Executive to the Company if and to the extent such deemed loan and Payment would not either reduce the amount on which the Executive is subject to tax under Section 1 and Section 4999 of the Code or generate a refund of such taxes. In the event that the Accounting Firm, based upon controlling precedent or other substantial authority, determines that an UnderPayment has occurred, any such UnderPayment shall be promptly paid (subject to the payment provisions applicable to all benefits payable under this Agreement) by the Company to or for the benefit

 

10



 

of the Executive (together with interest at the rate provided for in Section 1274(b)(2)(B) of the Code).

 

(v) The Executive shall not be required to mitigate the amount of any payment provided for in this Section 5 by seeking other employment or otherwise, nor shall the amount of any payment or benefit provided for in this Section 5 be reduced by any compensation earned by the Executive as the result of employment by another employer, by retirement benefits or otherwise, except to the extent expressly so provided.

 

6.             Non-Compete and Non-Solicitation.

 

(i) The Executive acknowledges and agrees that the Company Agreement last executed by the Executive (the “Non-Compete Agreement”) remains in full force and effect in accordance with its terms. The Executive further acknowledges and agrees that the restrictions set forth in the Non-Compete Agreement shall apply and be binding regardless of any changes in the Executive’s position, duties, geographic location, responsibilities or compensation during the Executive’s employment with the Company.

 

(ii) By accepting this Agreement, the Executive consents to a deduction from any amounts the Company owes the Executive from time to time (including amounts owed to the Executive under this Agreement and any amounts owed to Executive as wages or other compensation, fringe benefits, or vacation pay) any amounts the Executive owes the Company as a result of a monetary award or settlement in favor of the Company arising out of Executive’s breach of the Non-Compete Agreement. Any deductions will be on an after-tax basis. Whether or not amounts are deducted, if the Company does not recover by means of deduction the full amount the Executive owes it, the Executive agrees to pay immediately the unpaid balance to the Company.

 

7.             Successors; Binding Agreement.

 

(i) Any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business or assets of the Company must expressly assume and agree to perform this Agreement in the same manner and to the same extent required if no succession had taken place. As used in this Agreement, “Company” shall mean the Company as defined above and any successor to its business or assets as aforesaid which assumes and agrees to perform this Agreement by operation of law, or otherwise.

 

(ii) This Agreement shall inure to the benefit of and be enforceable by the Executive’s personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees. If the Executive should die while any amount would still be payable to him or her hereunder if he or she had continued to live, all such amounts, unless otherwise provided herein, shall be paid in accordance with the terms of this Agreement to his or her devisee, legatee or other designee or, if there is no such designee, to his or her estate.

 

8.             Notice. Notices and all other communications provided for in the Agreement must be in writing and shall be delivered (a) in person, (b) by electronic mail, (c) by an

 

11



 

overnight delivery or courier service, or (d) by United States registered or certified mail, return receipt requested, postage prepaid, in each case addressed to the respective addresses on the first page of this Agreement. Notice shall be effective upon receipt if delivered in person, upon the sender’s notification of read receipt email tracking confirmation if by electronic mail, the first business day after delivery if delivered by overnight delivery or courier service, or three (3) business days after mailing if sent by certified or registered mail. Notwithstanding the foregoing sentence, the Company may not, however, notify the Executive that this Agreement will not be renewed by electronic mail. All notices to the Company must be directed to the attention of the Board with a copy to the Secretary of Genzyme Corporation, or to such other address as either party has furnished to the other in writing in accordance with this Agreement. Any notice of change of address will be effective only upon receipt.

 

9.             Miscellaneous. No provision of this Agreement may be modified, waived or discharged unless such waiver, modification or discharge is agreed to in writing and signed by the Executive and the officer specifically designated by the Board or the Committee. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any condition or provision of this Agreement to be performed by such other party will be deemed a waiver of similar or dissimilar provisions or conditions at the same or at any prior or subsequent time. Neither party has made any agreements or representations, oral or otherwise, express or implied, concerning the subject matter of this Agreement that are not expressly provided in this Agreement. The validity, interpretation, construction and performance of this Agreement is governed by the laws of the Commonwealth of Massachusetts, without giving effect to the conflicts of law principles thereof. All references to sections of the Exchange Act, the Code, or the Treas. Regs shall be deemed also to refer to any successor provisions to such sections. Any payments under this Agreement will be paid net of any applicable tax withholding required under federal, state or local law. Sections 5 through 13 of this Agreement will survive the expiration or termination (for any reason) of the term of this Agreement and the termination (for any reason) of the Executive’s employment with the Company and will survive for as long as necessary for any applicable obligations thereunder to be satisfied.

 

10.          Validity. The invalidity or unenforceability or any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement, which shall remain in full force and effect.

 

11.           Counterparts. This Agreement may be executed in several counterparts, each of which shall be deemed to be an original but all of which together will constitute one and the same instrument.

 

12.          Arbitration. Any dispute or controversy arising under or in connection with this Agreement shall be settled exclusively by arbitration conducted before a panel of three arbitrators in the Commonwealth of Massachusetts in accordance with the Employment Dispute Resolution rules of the American Arbitration Association then in effect. Judgment may be entered on the arbitrator’s award in any court having jurisdiction. Notwithstanding the foregoing, the Executive shall be entitled to seek specific performance of his or her right to be

 

12



 

paid until the Separation from Service during the pendency of any dispute or controversy arising under or in connection with this Agreement.

 

13.          Entire Agreement. This Agreement constitutes the entire agreement of the parties hereto in respect of the subject matter contained herein and supersedes the provisions of all prior agreements (including but not limited to the Prior Agreement, which is of no further force and effect; provided that the Non-Compete Agreement shall remain in full force and effect in accordance with Section 6 hereof), promises, covenants, arrangements, communications, representations or warranties, whether oral or written, by any officer, employee or representative of any party hereto with respect to the subject matter hereof.

 

14.          Effective Date. This Agreement is effective as of the date first set forth above.

 

IN WITNESS WHEREOF, the Company, pursuant to due authorization by its Board of Directors, and the Executive have caused this Agreement to be duly executed under seal as of the date first written above.

 

 

GENZYME CORPORATION

 

 

 

 

 

By:

 

 

 

 

 

 

 

 

 

 

 

 

EXECUTIVE

 

 

 

 

 

By:

 

 

 

 

 

13



EX-31.1 4 a2180321zex-31_1.htm EXHIBIT 31.1
QuickLinks -- Click here to rapidly navigate through this document


Exhibit 31.1


Certification Pursuant To
Rules 13a-14(a) and 15d-14(a) Under The Securities Exchange Act of 1934, as Amended

I, Henri A. Termeer, certify that:

1.
I have reviewed this quarterly report on Form 10-Q of Genzyme Corporation (the "Registrant");

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 quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and

(d)
disclosed in this quarterly report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter 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 the 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: November 8, 2007   /s/  HENRI A. TERMEER      
Henri A. Termeer
Chief Executive Officer



QuickLinks

Certification Pursuant To Rules 13a-14(a) and 15d-14(a) Under The Securities Exchange Act of 1934, as Amended
EX-31.2 5 a2180321zex-31_2.htm EXHIBIT 31.2
QuickLinks -- Click here to rapidly navigate through this document


Exhibit 31.2


Certification Pursuant To
Rules 13a-14(a) and 15d-14(a) Under The Securities Exchange Act of 1934, as Amended

I, Michael S. Wyzga, certify that:

1.
I have reviewed this quarterly report on Form 10-Q of Genzyme Corporation (the "Registrant");

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 quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and

(d)
disclosed in this quarterly report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter 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 the 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: November 8, 2007   /s/  MICHAEL S. WYZGA      
Michael S. Wyzga
Chief Financial Officer



QuickLinks

Certification Pursuant To Rules 13a-14(a) and 15d-14(a) Under The Securities Exchange Act of 1934, as Amended
EX-32.1 6 a2180321zex-32_1.htm EXHIBIT 32.1
QuickLinks -- Click here to rapidly navigate through this document


EXHIBIT 32.1


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, the undersigned Chief Executive Officer of Genzyme Corporation (the "Company"), hereby certify that the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2007 (the "Report") fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

/s/  HENRI A. TERMEER      
Henri A. Termeer
Chief Executive Officer
November 8, 2007
   



QuickLinks

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
EX-32.2 7 a2180321zex-32_2.htm EXHIBIT 32.2
QuickLinks -- Click here to rapidly navigate through this document


EXHIBIT 32.2


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, the undersigned Chief Financial Officer of Genzyme Corporation (the "Company"), hereby certify that the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2007 (the "Report") fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

/s/  MICHAEL S. WYZGA      
Michael S. Wyzga
Chief Financial Officer
November 8, 2007
   



QuickLinks

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
-----END PRIVACY-ENHANCED MESSAGE-----