-----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, WYeLvzRgyT3antF8AjG6Stbd+4E96sjjzqgIre1pF/trqgxjIdl6yYnKyH/C540B hxgT4FpSwvpY/0vsyGESjg== 0000318771-07-000004.txt : 20070223 0000318771-07-000004.hdr.sgml : 20070223 20070223145209 ACCESSION NUMBER: 0000318771-07-000004 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20061231 FILED AS OF DATE: 20070223 DATE AS OF CHANGE: 20070223 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENENTECH INC CENTRAL INDEX KEY: 0000318771 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 942347624 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09813 FILM NUMBER: 07645344 BUSINESS ADDRESS: STREET 1: 1 DNA WAY CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-225-1000 MAIL ADDRESS: STREET 1: 1 DNA WAY STREET 2: . CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 10-K 1 form10-k_2006.htm GENENTECH, INC. FORM 10-K FOR THE PERIOD ENDED 12/31/2006 Genentech, Inc. Form 10-K for the Period Ended 12/31/2006



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

FORM 10-K

(Mark One)
þ
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2006
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: 1-9813

GENENTECH, INC.
(Exact name of registrant as specified in its charter)

A Delaware Corporation
(State or other jurisdiction of incorporation or organization)
94-2347624
(I.R.S. Employer Identification No.)

1 DNA Way, South San Francisco, California
(Address of principal executive offices)
94080
(Zip Code)

(650) 225-1000
(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Name of Each Exchange on Which Registered
Common Stock, $0.02 par value
New York Stock Exchange

Securities registered pursuant to Section 12(g) of the Act:
               None              
(Title of class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes þ No o

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  Yes o No þ

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 þ No o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  þ 

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 þ
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 Act).  Yes o No þ

The aggregate market value of Common Stock held by non-affiliates as of June 30, 2006 was $38,078,024,827.(A) All executive officers and directors of the registrant and Roche Holdings, Inc. have been deemed, solely for the purpose of the foregoing calculation, to be “affiliates” of the registrant.

Number of shares of Common Stock outstanding as of February 9, 2007:  1,053,185,944

Documents incorporated by reference:
Portions of the Definitive Proxy Statement with respect to the 2006 Annual Meeting of Stockholders to be filed by Genentech, Inc. with the Securities and Exchange Commission (hereinafter referred to as “Proxy Statement”)
Part III
________________________
(A)
Excludes 587,254,604 shares of Common Stock held by directors and executive officers of Genentech and Roche Holdings, Inc.
 







GENENTECH, INC.

2006 Form 10-K Annual Report

Table of Contents

Page  
Item 1
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Item 1A
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Item 1B
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Item 2
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Item 4
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Item 5
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Item 6
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Item 7
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Item 7A
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Item 8
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Item 9
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Item 9A
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Item 9B
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Item 10
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Item 11
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Item 12
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Item 13
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Item 14
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Item 15
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113  

In this report, “Genentech,” “we,” “us” and “our” refer to Genentech, Inc. “Common Stock” refers to Genentech’s Common Stock, par value $0.02 per share, “Special Common Stock” refers to Genentech’s callable putable common stock, par value $0.02 per share, all of which was redeemed by Roche Holdings, Inc. (or “Roche”) on June 30, 1999.

We own or have rights to various copyrights, trademarks and trade names used in our business including the following: Activase® (alteplase, recombinant) tissue-plasminogen activator; Avastin® (bevacizumab) anti-VEGF antibody; Cathflo® Activase® (alteplase for catheter clearance); Herceptin® (trastuzumab) anti-HER2 antibody; Lucentis® (ranibizumab, rhuFab V2) anti-VEGF antibody fragment; Nutropin® (somatropin (rDNA origin) for injection) growth hormone; Nutropin AQ® and Nutropin AQ Pen® (somatropin (rDNA origin) for injection) liquid formulation growth hormone; Nutropin Depot® (somatropin (rDNA origin) for injectable suspension) encapsulated sustained-release growth hormone; Omnitarg™ (pertuzumab) HER dimerization inhibitor; Pulmozyme® (dornase alfa, recombinant) inhalation solution; Raptiva® (efalizumab) anti-CD11a antibody; and TNKase® (tenecteplase) single-bolus thrombolytic agent. Rituxan® (rituximab) anti-CD20 antibody is a registered trademark of Biogen Idec Inc.; Tarceva® (erlotinib) is a trademark of OSI Pharmaceuticals, Inc.; and Xolair® (omalizumab) anti-IgE antibody is a trademark of Novartis AG. This report also includes other trademarks, service marks and trade names of other companies.

i





Item 1.

Overview

Genentech is a leading biotechnology company that discovers, develops, manufactures, and commercializes biotherapeutics for significant unmet medical needs. A number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products, and receives royalties from companies that are licensed to market products based on our technology. See “Marketed Products” and “Licensed Products” below. Genentech was organized in 1976 as a California corporation and was reincorporated in Delaware in 1987.

Marketed Products

We commercialize in the United States (or “U.S.”) the biotechnology products listed below:

Avastin (bevacizumab) is an anti-VEGF humanized antibody approved for use in combination with intravenous 5-fluorouracil based chemotherapy as a treatment for patients with first- or second-line metastatic cancer of the colon or rectum. It is also approved for use in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer.

Rituxan (rituximab) is an anti-CD20 antibody which we commercialize with Biogen Idec Inc. It is approved for:

 
·
The treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma, including retreatment and bulky disease;

 
·
The first-line treatment of patients with diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy;

 
·
The first-line treatment of previously untreated patients with follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisone) chemotherapy regimens;

 
·
The treatment of patients with low-grade, CD20-positive, B-cell non-Hodgkin’s lymphoma in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy; and

 
·
Use in combination with methotrexate for reducing signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (or “RA”) who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

Herceptin (trastuzumab) is a humanized anti-HER2 antibody approved for use as an adjuvant treatment of node-positive breast cancer as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel for patients who have tumors that overexpress the human epidermal growth factor receptor 2 (or “HER2”) protein. It is approved for use as a first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy for patients with HER2-positive metastatic breast cancer.

Lucentis (ranibizumab) is an anti-VEGF antibody fragment approved for the treatment of neovascular (wet) age-related macular degeneration.

1



Xolair (omalizumab) is a humanized anti-IgE antibody, which we commercialize with Novartis Pharma AG (or “Novartis”). Xolair is approved for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

Tarceva (erlotinib), which we commercialize with OSI Pharmaceuticals, Inc., is a small-molecule tyrosine kinase inhibitor of the HER1/epidermal growth factor receptor (or “EGFR”) signaling pathway. Tarceva is approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (or “NSCLC”) after failure of at least one prior chemotherapy regimen. It is also approved, in combination with gemcitabine chemotherapy, for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Nutropin (somatropin [rDNA origin] for injection) and Nutropin AQ are growth hormone products approved for the treatment of growth hormone deficiency in children and adults, growth failure associated with chronic renal insufficiency prior to kidney transplantation, short stature associated with Turner syndrome and long-term treatment of idiopathic short stature.

Activase (alteplase, recombinant) is a tissue plasminogen activator (or “t-PA”) approved for the treatment of acute myocardial infarction (heart attack), acute ischemic stroke (blood clots in the brain) within three hours of the onset of symptoms and acute massive pulmonary embolism (blood clots in the lungs).

TNKase (tenecteplase) is a modified form of t-PA approved for the treatment of acute myocardial infarction (heart attack).

Cathflo Activase (alteplase, recombinant) is a t-PA approved in adult and pediatric patients for the restoration of function to central venous access devices that have become occluded due to a blood clot.

Pulmozyme (dornase alfa, recombinant) is an inhalation solution of deoxyribonuclease (rhDNase) I, approved for the treatment of cystic fibrosis.

Raptiva (efalizumab) is a humanized anti-CD11a antibody approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults age 18 or older who are candidates for systemic therapy or phototherapy.

See “Total Product Sales” under Results of Operations in Part II, Item 7 of this Form 10-K for a discussion of the sales of each of our products in the last three years, including those that accounted for 10% or more of our consolidated revenues.

2



Licensed Products

Royalty Revenue

We receive royalty revenue under license agreements with companies that sell and/or manufacture products based on technology developed by us or intellectual property to which we have rights. These licensed products are sometimes sold under different trademarks or trade names. Significant licensed products, including all related party licenses, representing approximately 92% of our royalty revenues in 2006, are presented in the following table:

Product
Trade Name
Licensee
Licensed Territory
Trastuzumab
 
Herceptin
 
F. Hoffmann-La Roche
 
Worldwide excluding U.S.
 
Rituximab
 
Rituxan/MabThera®
 
F. Hoffmann-La Roche
 
Worldwide excluding U.S. and Japan
 
Bevacizumab
 
Avastin
 
F. Hoffmann-La Roche
 
Worldwide excluding U.S.
 
Dornase alfa, recombinant
 
Pulmozyme
 
F. Hoffmann-La Roche
 
Worldwide excluding U.S.
 
Alteplase and Tenecteplase
 
Activase and TNKase
 
F. Hoffmann-La Roche
 
Canada
 
Somatropin
 
Nutropin
 
F. Hoffmann-La Roche
 
Canada
 
Etanercept
 
ENBREL®
 
Immunex Corporation (whose rights were acquired by Amgen Inc.)
 
Worldwide
 
D2E7/adalimumab
 
Humira®
 
Abbott Laboratories
 
Worldwide
 
Infliximab
 
Remicade®
 
Celltech Pharmaceuticals plc (which transferred rights to Centocor, Inc. / Johnson & Johnson)
 
Worldwide
 
Cetuximab
 
ERBITUX®
 
ImClone Systems, Inc.
 
Worldwide
 
Antihemophilic factor, recombinant
 
Kogenate®/Helixate®
 
Bayer Corporation
 
Worldwide
 

See Item 3, “Legal Proceedings” below for information regarding certain patent litigation matters.

Other Revenues

We have granted a license to Zenyaku Kogyo Co., Ltd. (or “Zenyaku”), a Japanese pharmaceutical company, for the manufacture, use and sale of rituximab in Japan. Zenyaku co-promotes rituximab in Japan with Chugai Pharmaceutical Co., Ltd., a Japanese subsidiary of F. Hoffmann-La Roche, under the trademark Rituxan. The revenue earned from our sales of rituximab to Zenyaku is included in product sales.

3



Products in Development

Our product development efforts, including those of our collaborators, cover a wide range of medical conditions, including cancer and immune diseases. Below is a summary of products, current stages of development, and the estimated completion of the current phase of development. For additional information on our development pipeline, please visit our website at http://www.gene.com.
Product
Description
Estimated Completion of Current Phase(1)
Awaiting U.S. Food and Drug Administration (or FDA) Action
 
   
Herceptin
 
A supplemental Biologics Licensure Application (or “sBLA”) was submitted to the FDA on December 21, 2006 for the use of Herceptin for the treatment of patients with early-stage HER2-positive breast cancer based on the HERA study to enable a broader label. This product is being developed in collaboration with F. Hoffmann-La Roche.
 
2007-2008
 
Preparing for Filing
 
   
Avastin
 
We are preparing to resubmit an sBLA to the FDA for the use of Avastin in combination with paclitaxel chemotherapy for the treatment of patients who have not previously received chemotherapy for their locally recurrent or metastatic breast cancer. This product is being developed in collaboration with F. Hoffmann-La Roche.
 
2007
 
Avastin
 
We are in discussions with the FDA regarding the submission requirements for a potential sBLA for the use of Avastin in combination with interferon alpha-2a for the treatment of patients with previously untreated advanced renal cell carcinoma. This product is being developed in collaboration with F. Hoffmann-La Roche.
 
2007-2008
 
Herceptin
 
We are preparing to submit an sBLA to the FDA for the use of Herceptin for the treatment of patients with early-stage HER2-positive breast cancer based on the BCIRG 006 study to enable a broader label. This product is being developed in collaboration with F. Hoffmann-La Roche.
 
2007
 
Rituxan Immunology
 
We and our collaborator Biogen Idec are preparing to submit an sBLA to the FDA seeking expansion of the rheumatoid arthritis (anti-tumor necrosis factor inadequate responders) indication to include radiographic data demonstrating inhibition of joint damage in Rituxan treated patients. This product is being developed in collaboration with F. Hoffmann-La Roche and Biogen Idec.
 
2007
 


4



Phase III
 
   
2nd Generation anti-CD20
 
2nd Generation anti-CD20 is being evaluated in rheumatoid arthritis. This product is being developed in collaboration with F. Hoffmann-La Roche and Biogen Idec(2).
 
2009-2010
 
Avastin
 
Avastin is being evaluated in adjuvant colon cancer, adjuvant rectal cancer, first- and second-line metastatic breast cancer in combination with several chemotherapy regimens, first-line non-squamous NSCLC, first-line ovarian cancer, and hormone refractory prostate cancer. This product is being developed in collaboration with F. Hoffmann-La Roche.
 
2007-2012
 
Avastin +/- Tarceva
 
Avastin and Tarceva are being evaluated as combination therapy in first-line NSCLC in combination with several chemotherapy regimens. This product is being developed in collaboration with F. Hoffmann-La Roche and OSI.
 
2009
 
Rituxan Hematology/Oncology
 
Rituxan is being evaluated in first-line follicular non-Hodgkin’s lymphoma with several chemotherapy regimens and in relapsed chronic lymphocytic leukemia. This product is being developed in collaboration with F. Hoffmann-La Roche and Biogen Idec.
 
2010
 
Rituxan Immunology
 
Rituxan is being evaluated in rheumatoid arthritis (DMARD inadequate responders) in collaboration with F. Hoffmann-La Roche and Biogen Idec. Rituxan is also being evaluated in primary progressive multiple sclerosis, systemic lupus erythematosus, lupus nephritis, and ANCA-associated vasculitis in collaboration with Biogen Idec.
 
2007-2009
 
Tarceva
 
Tarceva is being evaluated in adjuvant NSCLC with several chemotherapy regimens and first-line NSCLC. This product is being developed in collaboration with F. Hoffmann-La Roche and OSI.
 
2013
 
Tarceva +/- Avastin
 
Tarceva and Avastin are being evaluated as combination therapy in first-line metastatic pancreatic cancer and second-line NSCLC. This product is being developed in collaboration with F. Hoffmann-La Roche and OSI.
 
2008
 
TNKase
 
TNKase is being evaluated in the treatment of dysfunctional hemodialysis and central venous access catheters.
 
2008
 
Xolair
 
Xolair is being evaluated in pediatric asthma. This product is being developed in collaboration with Novartis and Tanox, Inc. (or “Tanox”).
 
2008
 


5



Preparing for Phase III
 
   
2nd Generation anti-CD20
 
We are preparing Phase III clinical trials in lupus nephritis and systemic lupus erythematosus. This product is being developed in collaboration with F. Hoffmann-La Roche and Biogen Idec(2).
 
2007
 
ALTU-238
 
Altus is preparing a Phase III clinical trial in adult growth hormone deficiency. We have entered into an agreement to develop this product in collaboration with Altus, and this transaction is subject to closing conditions.
 
(3)
 
Avastin
 
We are preparing for Phase III clinical trials in adjuvant breast cancer, first-line metastatic breast cancer in combination with antihormonal therapy, adjuvant NSCLC, gastrointestinal stromal tumors, and second-line ovarian cancer. This product is being developed in collaboration with F. Hoffmann-La Roche.
 
2007
 
Herceptin +/- Avastin
 
We are preparing for a Phase III clinical trial of Herceptin and Avastin as combination therapy in first-line HER2-positive metastatic breast cancer. This product is being developed in collaboration with F. Hoffmann-La Roche.
 
2007
 
Lucentis
 
We are preparing for Phase III clinical trials in diabetic macular edema and retinal vein occlusion. This product is being developed in collaboration with Novartis Ophthalmics.
 
2007
 
Phase II
 
   
Anti-CD40
 
Anti-CD40 is being evaluated in non-Hodgkin’s lymphoma. We are developing this product in collaboration with Seattle Genetics Inc.
 
2008-2009
 
Avastin
 
Avastin is being evaluated in adjuvant HER2-negative breast cancer, relapsed glioblastoma multiforme, and non-squamous NSCLC with previously treated central nervous system metastases. This product is being developed in collaboration with F. Hoffmann-La Roche.
 
2007
 
HAE1
 
HAE1 is being evaluated in moderate-to-severe allergic asthma.
 
2008-2009
 
Omnitarg
 
Our Phase II clinical trial evaluating Omnitarg in combination with chemotherapy in platinum-resistant ovarian cancer showed encouraging results. Roche is conducting a clinical trial evaluating Omnitarg in combination with chemotherapy in platinum-sensitive ovarian cancer. This product is being developed in collaboration with F. Hoffmann-La Roche.
 
2007
 
Topical VEGF
 
Topical VEGF is being evaluated for the treatment of diabetic foot ulcers.
 
2007
 


6



Preparing for Phase II
 
   
2nd Generation anti-CD20
 
We are preparing for a Phase II clinical trial in relapsing remitting multiple sclerosis. This product is being developed in collaboration with F. Hoffmann-La Roche and Biogen Idec(2).
 
2007-2008
 
ALTU-238
 
Altus is preparing for a Phase II clinical trial in pediatric growth hormone deficiency. We have entered into an agreement to develop this product in collaboration with Altus, and this transaction is subject to closing conditions.
 
(3)
 
Avastin
 
We are preparing to initiate a Phase II clinical trial in extensive small cell lung cancer. This product is being developed in collaboration with F. Hoffmann-La Roche.
 
2007
 
Phase I and Preparing for Phase I
 
We have multiple new molecular entities in Phase I or preparing for Phase I.
 
 
________________________
(1)
For those projects preparing for a Phase, the estimated date of completion refers to the date the project is expected to enter the Phase for which it is preparing.
(2)
Our collaborator Biogen Idec disagrees with certain of our development decisions under our 2003 collaboration agreement with them. We continue to pursue a resolution of our differences with Biogen Idec, and the disputed issues have been submitted to arbitration. See Part I, Item 3, “Legal Proceedings,” of this Form 10-K for further information.
(3)
Our collaborator is conducting the trial(s) and we are unable to provide the estimated date of completion for the current phase.

Related Party Arrangements

See “Relationship with Roche” and “Related Party Transactions” sections below in Part II, Item 7 of this Form 10-K for information on our collaboration arrangements with Roche, F. Hoffmann-La Roche and Novartis.

Distribution and Commercialization

We have a U.S.-based marketing, sales and distribution organization. Our sales efforts are focused on specialist physicians in private practice or at hospitals and major medical centers in the U.S. In general, our products are sold largely to wholesalers, specialty distributors or directly to hospital pharmacies. We utilize common pharmaceutical company marketing techniques, including sales representatives calling on individual physicians and distributors, advertisements, professional symposia, direct mail, public relations and other methods.

The Genentech Access to Care Foundation provides free product to eligible uninsured patients and those deemed uninsured due to payer denial in the U.S. We have the Genentech Endowment for Cystic Fibrosis to assist cystic fibrosis patients in the U.S. with obtaining Pulmozyme. We also provide customer service programs relating to our products. We maintain a physician-related product waste replacement program for Rituxan, Avastin, Herceptin, Activase, TNKase and Lucentis, that, subject to specific conditions, provides physicians the right to return these products to us for replacement. We also maintain expired product programs for all our products that, subject to certain specific conditions, provide customers the right to return expired products to us for replacement or credit at a price based on a 12-month rolling average. To further support patient access to therapies for various diseases we donate to various independent, public charities that offer financial assistance, such as co-pay assistance, to eligible patients. We maintain the right to renew, modify or discontinue any of the patient programs described above.

In October 2006, we announced our plan to launch the Avastin Patient Assistance Program in the first quarter of 2007, which is a voluntary program that enables eligible patients who receive greater than 10,000 milligrams of Avastin over a 12-month period to receive free Avastin during the remainder of the 12-month period. Eligible patients include those who are being treated for an FDA-approved indication and who meet the household income criteria for this program. The program will be available for eligible patients who enroll regardless of whether they are insured.

7



As discussed in Note 12, “Segment, Significant Customer and Geographic Information,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K, our combined sales to three major wholesalers provided approximately 85% in 2006, 82% in 2005, and 79% in 2004, of our total net U.S. product sales. Also discussed in the note are material net foreign revenues by country in 2006, 2005 and 2004.

Manufacturing and Raw Materials

Manufacturing biotherapeutics is difficult and complex, and requires facilities specifically designed and validated for this purpose. It can take longer than five years to design, construct, validate, and license a new biotechnology manufacturing facility. Production problems in any of our operations or our contractors’ manufacturing plants could result in failure to produce adequate product supplies or could result in product defects which could require us to delay shipment of products, recall products previously shipped or be unable to supply products at all. In addition, we may need to record period charges associated with manufacturing or inventory failures or other production-related costs or incur costs to secure additional sources of capacity. Furthermore, there are inherent uncertainties associated with forecasting future demand, especially for newly introduced products of ours or of those for whom we produce products, and as a consequence we may have inadequate capacity to meet our own actual demands and/or the actual demands of those for whom we produce product.

Raw materials and supplies required for the production of our principal products are available, in some instances from one supplier and in other instances, from multiple suppliers. In those cases where raw materials are only available through one supplier, such supplier may be either a sole source (the only recognized supply source available to us) or a single source (the only approved supply source for us among other sources). We have adopted policies to attempt, to the extent feasible, to minimize raw material supply risks to the Company, including maintenance of greater levels of raw materials inventory and coordination with our collaborators to implement raw materials sourcing strategies.

For risks associated with manufacturing and raw materials, see “Difficulties or delays in product manufacturing or in obtaining materials from our suppliers could harm our business and/or negatively affect our financial performance” under “Risk Factors.”

Proprietary Technology — Patents and Trade Secrets

We seek patents on inventions originating from our ongoing research and development (or “R&D”) activities. We have either been issued patents or have patent applications pending that relate to a number of current and potential products, including products licensed to others. Patents, issued or applied for, cover inventions ranging from basic recombinant DNA techniques to processes relating to specific products and to the products themselves. Our issued patents extend for varying periods according to the date of patent application filing or grant and the legal term of patents in the various countries where patent protection is obtained. The actual protection afforded by a patent, which can vary from country to country, depends upon the type of patent, the scope of its coverage as determined by the patent office or courts in the country, and the availability of legal remedies in the country. We consider that in the aggregate our patent applications, patents and licenses under patents owned by third parties are of material importance to our operations. Significant legal issues remain to be resolved as to the extent and scope of available patent protection for biotechnology products and processes in the U.S. and other important markets outside of the U.S. We expect that litigation will likely be necessary to determine the validity and scope of certain of our proprietary rights. We are currently involved in a number of legal proceedings relating to the scope of protection and validity of our patents and those of others. These proceedings may result in a significant commitment of our resources in the future and, depending on their outcome, may adversely affect the validity and scope of certain of our patent or other proprietary rights. We cannot assure that the patents we obtain or the unpatented proprietary technology we hold will afford us significant commercial protection.

We have obtained licenses from various parties that we deem to be necessary or desirable for the manufacture, use or sale of our products. These licenses (both exclusive and non-exclusive) generally require us to pay royalties to the parties on product sales. In conjunction with these licenses, disputes sometimes arise regarding whether royalties are

8



owed on certain product sales or the amount of royalties that are owed. The resolution of such disputes may cause us to incur significant additional royalty expenses or other expenses.

Our trademarks, Activase, Avastin, Cathflo, Herceptin, Lucentis, Nutropin, Nutropin AQ, Nutropin AQ Pen, Omnitarg, Pulmozyme, Raptiva, Rituxan (licensed from Biogen Idec), TNKase, Xolair (licensed from Novartis) and Tarceva (licensed from OSI), in the aggregate are considered to be of material importance. All are covered by registrations or pending applications for registration in the U.S. Patent and Trademark Office and in other countries. Trademark protection continues in some countries for as long as the mark is used and, in other countries, for as long as it is registered. Registrations generally are for fixed, but renewable, terms.

Our royalty income for patent licenses, know-how and other related rights amounted to $1,354 million in 2006, $935 million in 2005, and $641 million in 2004. Royalty expenses were $568 million in 2006, $462 million in 2005, and $355 million in 2004.

Competition

We face competition from pharmaceutical companies and biotechnology companies. The introduction of new competitive products or follow-on biologics or new information about existing products or pricing decisions by us or our competitors may result in lost market share for us, reduced utilization of our products, and/or lower prices, even for products protected by patents. For risks associated with competition, see “We face competition” under “Risk Factors” below in Part I, Item 1A of this Form 10-K.

Government Regulation

Regulation by governmental authorities in the U.S. and other countries is a significant factor in the manufacture and marketing of our products and in ongoing research and product development activities. All of our products require regulatory approval by governmental agencies prior to commercialization. Our products are subject to rigorous preclinical and clinical testing and other premarket approval requirements by the FDA and regulatory authorities in other countries. Various statutes and regulations also govern or influence the manufacturing, safety, labeling, storage, record keeping and marketing of such products. The lengthy process of seeking these approvals, and the subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources.

The activities required before a pharmaceutical product may be marketed in the U.S. begin with preclinical testing. Preclinical tests include laboratory evaluation of product chemistry and required animal studies to assess the potential safety and efficacy of the product and its formulations. The results of these studies must be submitted to the FDA as part of an Investigational New Drug Application, which must be reviewed by the FDA before proposed clinical testing in humans can begin. Typically, clinical testing involves a three-phase process. In Phase I, clinical trials are conducted with a small number of subjects to determine the early safety profile and the pattern of drug distribution and metabolism. In Phase II, clinical trials are conducted with groups of patients afflicted with a specified disease in order to provide enough data to evaluate the preliminary efficacy, optimal dosages and expanded evidence of safety. In Phase III, large scale, multicenter clinical trials are conducted with patients afflicted with a target disease in order to provide enough data to statistically evaluate the efficacy and safety of the product, as required by the FDA. The results of the preclinical and clinical testing of a chemical pharmaceutical product are then submitted to the FDA in the form of a New Drug Application (or “NDA”), or for a biological pharmaceutical product in the form of a Biologics License Application (or “BLA”), for approval to commence commercial sales. In responding to an NDA or a BLA, the FDA may grant marketing approval, request additional information or deny the application if it determines that the application does not provide an adequate basis for approval. Most R&D projects fail to produce data sufficiently compelling to enable progression through all the stages of development and to obtain FDA approval for commercial sale. See also “The successful development of biotherapeutics is highly uncertain and requires significant expenditures and time” under “Risk Factors.”

Among the conditions for an NDA or a BLA approval is the requirement that the prospective manufacturer’s quality control and manufacturing procedures conform on an ongoing basis with current Good Manufacturing Practices (or “GMP”). Before approval of a BLA, the FDA will usually perform a preapproval inspection of the facility to

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determine its compliance with GMP and other rules and regulations. Manufacturers must continue to expend time, money and effort in the area of production and quality control to ensure full compliance with GMP. After the establishment is licensed for the manufacture of any product, manufacturers are subject to periodic inspections by the FDA.

The requirements that we and our collaborators must satisfy to obtain regulatory approval by governmental agencies in other countries prior to commercialization of our products in such countries can be as rigorous, costly and uncertain.

We are also subject to various laws and regulations relating to safe working conditions, clinical, laboratory and manufacturing practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research.

The levels of revenues and profitability of biopharmaceutical companies may be affected by the continuing efforts of government and third-party payers to contain or reduce the costs of health care through various means. For example, in certain foreign markets, pricing or profitability of therapeutic and other pharmaceutical products is subject to governmental control. In the U.S. there have been, and we expect that there will continue to be, a number of federal and state proposals to implement similar governmental control.

In addition, in the U.S. and elsewhere, sales of therapeutic and other pharmaceutical products are dependent in part on the availability of reimbursement to the physician or consumer from third-party payers, such as the government or private insurance plans. Government and private third-party payers are increasingly challenging the prices charged for medical products and services, through class action litigation and otherwise. For example, the Medicare Prescription Drug Improvement and Modernization Act, enacted in December 2003 (or “Medicare Act”), revised the Medicare reimbursement rate for many drugs, including our oncology products, which resulted in a decrease in the revised reimbursement rate of several of our products and which was possibly offset to some extent by increased physician payment rates for drug administration services related to certain of our oncology products. To date, we have not seen any detectable effects of the new rules on our product sales, and we anticipate minimal effects on our revenues in 2007. See also “Decreases in third party reimbursement rates may affect our product sales, results of operations and financial condition” under “Risk Factors.”

We are also subject to various federal and state laws pertaining to health care fraud and abuse, including anti-kickback laws and false claims laws. For risks associated with health care fraud and abuse, see “If there is an adverse outcome in our pending litigation or other legal actions our business may be harmed” under “Risk Factors.”

Research and Development

A significant portion of our operating expenses is related to R&D. Generally, R&D expenses consist of independent R&D costs and costs associated with collaborative R&D and in-licensing arrangements. R&D expenses were $1,773 million in 2006, $1,262 million in 2005, and $948 million in 2004. We intend to maintain our strong commitment to R&D. Biotechnology products generally take 10 to 15 years to research, develop and bring to market in the U.S. As discussed above, clinical development typically involves three phases of study: Phase I, II, and III. The most significant costs associated with clinical development are the Phase III trials as they tend to be the longest and largest studies conducted during the drug development process. Product completion dates and completion costs vary significantly by product and are difficult to predict.

Human Resources

As of December 31, 2006, we had 10,533 employees.

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Environment

We have made, and will continue to make, expenditures for environmental compliance and protection. Expenditures for compliance with environmental laws have not had, and are not expected to have, a material effect on our capital expenditures, results of operations, or competitive position.

Available Information

The following information can be found on our website at http://www.gene.com or can be obtained free of charge by contacting our Investor Relations Department at (650) 225-1599 or by sending an e-mail message to investor.relations@gene.com:

 
·
our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with the Securities and Exchange Commission;

 
·
our policies related to corporate governance, including Genentech’s Principles of Corporate Governance, Good Operating Principles (Genentech’s code of ethics applying to Genentech’s directors, officers and employees) as well as Genentech’s Code of Ethics applying to our CEO, CFO and senior financial officials; and

 
·
the charters of the Audit Committee and the Compensation Committee of our Board of Directors.


Item 1A.

This Form 10-K contains forward-looking information based on our current expectations. Because our actual results may differ materially from any forward-looking statements we make or that are made on our behalf, this section includes a discussion of important factors that could affect our actual future results, including, but not limited to, our product sales, royalties, contract revenues, expenses, net income and earnings per share.

The successful development of biotherapeutics is highly uncertain and requires significant expenditures and time

Successful development of biotherapeutics is highly uncertain. Products that appear promising in research or development may be delayed or fail to reach later stages of development or the market for several reasons including:

 
·
Preclinical tests may show the product to be toxic or lack efficacy in animal models.

 
·
Clinical trial results may show the product to be less effective than desired or to have harmful or problematic side effects.

 
·
Failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, extended length of time to achieve study endpoints, additional time requirements for data analysis or Biologic Licensing Application (or “BLA”) preparation, discussions with the U.S. Food and Drug Administration (or “FDA”), FDA requests for additional preclinical or clinical data, analyses or changes to study design, or unexpected safety, efficacy or manufacturing issues.

 
·
Difficulties formulating the product, scaling the manufacturing process or in getting approval for manufacturing.

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·
Manufacturing costs, pricing or reimbursement issues, or other factors that make the product uneconomical.

 
·
The proprietary rights of others and their competing products and technologies that may prevent the product from being developed or commercialized.

 
·
The contractual rights of our collaborators or others that may prevent the product from being developed or commercialized.

Success in preclinical and early clinical trials does not ensure that large-scale clinical trials will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly and may be difficult to predict. If our large-scale clinical trials are not successful, we will not recover our substantial investments in the product.

Factors affecting our research and development (or “R&D”) productivity and the amount of our R&D expenses include, but are not limited to:

 
·
The number of and the outcome of clinical trials currently being conducted by us and/or our collaborators. For example, our R&D expenses may increase based on the number of late-stage clinical trials being conducted by us and/or our collaborators.

 
·
The number of products entering into development from late-stage research. For example, there is no guarantee that internal research efforts will succeed in generating a sufficient number of candidate products that are ready to move into development or that product candidates will be available for in-licensing on terms acceptable to us and permitted under the anti-trust laws.

 
·
Decisions by F. Hoffmann-La Roche (or “Hoffmann-La Roche”) whether to exercise its options to develop and sell our future products in non-U.S. markets and the timing and amount of any related development cost reimbursements.

 
·
Our ability to in-license projects of interest to us and the timing and amount of related development funding or milestone payments for such licenses. For example, we may enter into agreements requiring us to pay a significant upfront fee for the purchase of in-process R&D, which we may record as an R&D expense.

 
·
Participation in a number of collaborative research arrangements. On many of these collaborations, our share of expenses recorded in our financial statements is subject to volatility based on our collaborators’ spending activities as well as the mix and timing of activities between the parties.

 
·
Charges incurred in connection with expanding our product manufacturing capabilities, as described in “Difficulties or delays in product manufacturing or in obtaining materials from our suppliers could harm our business and/or negatively affect our financial performance” below.

 
·
Future levels of revenue.

We may be unable to obtain or maintain regulatory approvals for our products

We are subject to stringent regulation with respect to product safety and efficacy by various international, federal, state and local authorities. Of particular significance are the FDA’s requirements covering R&D, testing, manufacturing, quality control, labeling and promotion of drugs for human use. A biotherapeutic cannot be marketed in the United States (or “U.S.”) until it has been approved by the FDA, and then can only be marketed for the indications approved by the FDA. As a result of these requirements, the length of time, the level of expenditures and the laboratory and clinical information required for approval of a BLA or NDA, are substantial and can require a number of years. In addition, even if our products receive regulatory approval, they remain subject to ongoing FDA

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regulation, including, for example, changes to the product label, new or revised regulatory requirements for manufacturing practices, written advisements to physicians and/or a product recall or withdrawal.

We may not obtain necessary regulatory approvals on a timely basis, if at all, for any of the products we are developing or manufacturing or we may not maintain necessary regulatory approvals for our existing products, and all of the following could have a material adverse effect on our business:

 
·
Significant delays in obtaining or failing to obtain approvals as described in “The successful development of biotherapeutics is highly uncertain and requires significant expenditures and time” above.

 
·
Loss of, or changes to, previously obtained approvals, including those resulting from post-approval safety or efficacy issues.

 
·
Failure to comply with existing or future regulatory requirements.

 
·
Changes to manufacturing processes, manufacturing process standards or Good Manufacturing Practices (or “GMP”) following approval or changing interpretations of these factors.

In addition, the current regulatory framework could change or additional regulations could arise at any stage during our product development or marketing, which may affect our ability to obtain or maintain approval of our products or require us to make significant expenditures to obtain or maintain such approvals.

We face competition

We face competition from pharmaceutical companies and biotechnology companies.

The introduction of new competitive products or follow-on biologics, new information about existing products or pricing decisions by us or our competitors may result in lost market share for us, reduced utilization of our products, reduced product sales, and/or lower prices, even for products protected by patents.

Avastin: Avastin competes with Erbitux® (Imclone/Bristol-Myers Squibb), which is an EGFR-inhibitor approved for the treatment of irinotecan refractory or intolerant metastatic colorectal cancer (or “CRC”) patients, Nexavar® (sorafenib Bayer Corporation/Onyx Pharmaceuticals, Inc.) for the treatment of patients with advanced renal cell carcinoma (or “RCC”) or kidney cancer (an unapproved use of Avastin), Sutent® (sunitinib malate, Pfizer, Inc.) for use in advanced RCC (an unapproved use of Avastin), Gleevec® (imatinib mesylate, Novartis) for use in refractory/intolerant gastrointestinal stromal tumor (an unapproved use of Avastin), and Vectibix™ (panitumumab, Amgen), for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Avastin could face competition from products in development that currently do not have regulatory approval. Amgen has stated that it will initiate head-to-head clinical trials comparing AMG 706 and Avastin. There are also head-to-head clinical trials that have recently begun comparing both Sutent and AZD2171 (AstraZeneca) to Avastin. Additionally, there are more than 65 molecules that target VEGF inhibition, and over 130 companies that are developing molecules that, if approved, may compete with Avastin.

Rituxan: Rituxan’s primary competitor is Bexxar® (GlaxoSmithKline (or “GSK”)) which is radioimmunotherapy indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma (or “NHL”). Other potential competitors include Campath® in relapsed CLL (an unapproved use of Rituxan), Velcade® (Millennium Pharmaceuticals, Inc.) which is indicated for multiple myeloma and more recently, mantle cell lymphoma (both unapproved uses of Rituxan). Ofatumumab (Humax CD20™), an anti-CD20 antibody being co-developed by Genmab and GSK is in late-stage development for refractory CLL and NHL. In addition to the products detailed above, we are aware of other anti-CD20 molecules in development that, if successful in clinical trials, may compete with Rituxan.

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Rituxan’s current biologic competitors in rheumatoid arthritis (or “RA”) include Enbrel® (Amgen/Wyeth), Humira® (Abbott), Remicade® (Johnson & Johnson), Orencia® (Bristol-Myers Squibb), and Kineret® (Amgen). These products are approved for use in a broader RA patient population than the approved population for Rituxan.

Herceptin: Herceptin could face competition in the future from experimental drugs and products in development that do not currently have regulatory approval for use outside of clinical trials, including lapatinib ditosylate (Tykerb®), a tyrosine kinase inhibitor being developed by GSK. On April 3, 2006, GSK announced that it stopped enrollment in its Phase III clinical trial to evaluate lapatinib ditosylate because of positive results in treating HER2-positive metastatic breast cancer in women whose disease had progressed following a Herceptin-containing regimen and other cancer therapies. Results from this trial showed that lapatinib ditosylate in combination with capecitabine increased time to disease progression compared to capecitabine alone. GSK filed for regulatory approval of lapatinib ditosylate in the third quarter of 2006 and was granted priority review with approval expected in the first quarter of 2007.

Lucentis: We are aware that retinal specialists are currently using Avastin to treat the wet form of age-related macular degeneration, an unapproved use for Avastin, which results in significantly less revenue to us per treatment as compared to Lucentis. We expect Avastin use to continue in this setting. Additionally, the National Eye Institute and National Institute of Health have announced a head-to-head trial of Avastin and Lucentis in this setting. Lucentis also competes with Macugen® (Pfizer/OSI Pharmaceuticals), and Visudyne® (Novartis) alone, or in combination with the off-label steroid triamcinolone in wet AMD.

Xolair: Xolair faces competition from other asthma therapies, including inhaled corticosteroids, long-acting beta agonists, combination products such as fixed dose inhaled corticosteroids/long-acting beta agonists and leukotriene inhibitors, as well as oral corticosteroids and immunotherapy.

Tarceva: Tarceva competes with the chemotherapy agents Taxotere® (Sanofi-Aventis) and Alimta® (Eli Lilly and Company), both of which are indicated for the treatment of relapsed non-small cell lung cancer (or “NSCLC”). Recent increases in the off-label use of Avastin in combination with chemotherapy in second-line NSCLC have also had an impact in this setting. In front-line pancreatic cancer, Tarceva primarily competes with Gemzar® (Eli Lilly) monotherapy and Gemzar® in combination with other chemotherapeutic agents. Tarceva could also face competition in the future from products in late-phase development that currently do not have regulatory approval for use in NSCLC or pancreatic cancer. Examples of potential competitors in NSCLC include Erbitux® (Bristol-Myers Squibb), Xyotax® (Cell Therapeutics Inc.), Telcyta® (Telik, Inc.), Nexavar® (sorafenib, Bayer/Onyx) and Zactima® (Astra Zeneca). Examples of potential competitors in Phase III pancreatic cancer trials are Xeloda® (F. Hoffmann-La Roche) and Erbitux® (Bristol-Myers Squibb).

Nutropin: In the growth hormone market, we face competition from other companies currently selling growth hormone products. Nutropin’s current competitors are Genotropin® (Pfizer), Norditropin® (Novo Nordisk), Humatrope® (Eli Lilly and Company), Tev-Tropin® (Teva Pharmaceutical Industries Ltd.), and Saizen® (Serono, Inc.). In addition, follow-on biologics are beginning to enter the growth hormone market. The FDA recently approved the first follow-on version of a protein product, Omnitrope® (Sandoz), as a biologic similar to Genotropin® (Pfizer). Furthermore, as a result of multiple competitors, we have experienced, and may continue to experience, a loss of patient share and increased competition for managed care product placement. Obtaining placement on the preferred product lists of managed care companies may require that we discount the price of Nutropin.

Thrombolytics: We face competition in our acute myocardial infarction market, with sales of TNKase and Activase affected by the adoption by physicians of mechanical reperfusion strategies. We expect that the use of mechanical reperfusion in lieu of thrombolytic therapy for the treatment of acute myocardial infarction will continue to grow. TNKase, for acute myocardial infarction, also faces competition from Retavase® (PDL BioPharma Inc.), which engages in competitive price discounting.

Pulmozyme: Pulmozyme faces competition from the use of hypertonic saline, an emerging, inexpensive approach to clearing the lungs of cystic fibrosis patients.

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Raptiva: Raptiva competes with established therapies for moderate-to-severe psoriasis including oral systemics such as methotrexate and cyclosporin, as well as ultraviolet light therapies. In addition, Raptiva competes with biologic agents Amevive® (Astellas), Enbrel® (Amgen), and Remicade® (Centocor, Inc.). Raptiva also competes with the biologic agent Humira® (Abbott Laboratories), which is currently used off-label in the psoriasis market.

In addition to the commercial and late stage development products listed above, there are numerous products in earlier stages of development at other biotechnology and pharmaceutical companies that, if successful in clinical trials, may compete with our products.

Decreases in third party reimbursement rates may affect our product sales, results of operations and financial condition

Sales of our products will depend significantly on the extent to which reimbursement for the cost of our products and related treatments will be available to physicians from government health administration authorities, private health insurers and other organizations. Third party payers and governmental health administration authorities increasingly attempt to limit and/or regulate the reimbursement for medical products and services, including branded prescription drugs. Changes in government legislation or regulation, such as the Medicare Act, or changes in private third-party payers’ policies toward reimbursement for our products may reduce reimbursement of our products’ costs to physicians. Decreases in third-party reimbursement for our products could reduce physician usage of the product and may have a material adverse effect on our product sales, results of operations and financial condition.

Difficulties or delays in product manufacturing or in obtaining materials from our suppliers could harm our business and/or negatively affect our financial performance

Manufacturing biotherapeutics is difficult and complex, and requires facilities specifically designed and validated for this purpose. It can take longer than five years to design, construct, validate, and license a new biotechnology manufacturing facility. We currently produce our products at our manufacturing facilities located in South San Francisco, California and Vacaville, California and through various contract-manufacturing arrangements. Maintaining an adequate supply to meet demand for our products depends on our ability to execute on an aggressive production plan. Any significant problem in the operations of our or our contractors’ manufacturing facilities could result in cancellations of shipments, loss of product in the process of being manufactured, a shortfall or stock-out or recall of available product inventory, or unplanned increases in production costs, any of which could have a material adverse effect on our business. A number of factors could cause significant production problems or interruptions, including:

 
·
the inability of a supplier to provide raw materials used for manufacture of our products;

 
·
equipment obsolescence, malfunctions or failures;

 
·
product quality or contamination problems;

 
·
damage to a facility, including our warehouses and distribution facilities, due to natural disasters, including, but not limited to, earthquakes as our South San Francisco, Oceanside and Vacaville facilities are located in areas where earthquakes occur;

 
·
changes in FDA regulatory requirements or standards that require modifications to our manufacturing processes;

 
·
action by the FDA or by us that results in the halting or slowdown of production of one or more of our products or products we make for others;

 
·
a contract manufacturer going out of business or failing to produce product as contractually required;

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·
failure to maintain an adequate state of GMP compliance; and

 
·
successful implementation and integration of our new enterprise resource planning system, including the portions relating to manufacturing and distribution.

In addition, there are inherent uncertainties associated with forecasting future demand, especially for newly introduced products of ours or of those for whom we produce products, and as a consequence we may have inadequate capacity to meet our own actual demands and/or the actual demands of those for whom we produce product. Increasing our manufacturing capacity to keep pace with growing demand will depend, in part, on our ability to successfully implement key capacity enhancement projects, including the following:  (i) licensure of 90,000 liters of capacity at our Oceanside, California manufacturing facility during the first half of 2007 to produce Avastin, and (ii) completion of construction, qualification and licensure of our new plant in Vacaville, California in 2009.

Furthermore, certain of our raw materials and supplies required for the production of our principal products or products we make for others are available only through sole-source suppliers (the only recognized supplier available to us) or single-source suppliers (the only approved supplier for us among other sources), and we may not be able to obtain such raw materials without significant delay or at all. If such sole-source or single-source suppliers were to limit or terminate production or otherwise fail to supply these materials for any reason, such failures could also have a material adverse effect on our product sales and our business.

Because our manufacturing processes and those of our contractors are highly complex and are subject to a lengthy FDA approval process, alternative qualified production capacity may not be available on a timely basis or at all. Difficulties or delays in our or our contractors’ manufacturing and supply of existing or new products could increase our costs, cause us to lose revenue or market share, damage our reputation and could result in a material adverse effect on our product sales, financial condition and results of operations.

Protecting our proprietary rights is difficult and costly

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions. Accordingly, we cannot predict with certainty the breadth of claims allowed in these companies’ patents. Patent disputes are frequent and can preclude the commercialization of products. We have in the past been, are currently, and may in the future be, involved in material litigation and other legal proceedings relating to our proprietary rights, such as the Cabilly reexaminations discussed in Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K. Such litigation and other legal proceedings are costly in their own right and could subject us to significant liabilities to third-parties. An adverse decision could force us to either obtain third-party licenses at a material cost or cease using the technology or commercializing the product in dispute. An adverse decision with respect to one or more of our patents or other intellectual property rights could cause us to incur a material loss of royalties and other revenue from licensing arrangements that we have with third-parties, and could significantly interfere with our ability to negotiate future licensing arrangements.

The presence of patents or other proprietary rights belonging to other parties may lead to our termination of the R&D of a particular product, or to a loss of our entire investment in the product and subject us to infringement claims.

If there is an adverse outcome in our pending litigation or other legal actions our business may be harmed

Litigation or other legal actions to which we are currently or have been subjected relates to, among other things, our patent and other intellectual property rights, licensing arrangements and other contracts with third parties, and product liability. We cannot predict with certainty the eventual outcome of pending proceedings, which may include an injunction against the development, manufacture or sale of a product or potential product or a judgment with significant monetary award, including the possibility of punitive damages, or a judgment that certain of our patent or other intellectual property rights are invalid or unenforceable. Furthermore, we may have to incur substantial expense in these proceedings and such matters could divert management’s attention from ongoing business concerns.

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Our activities relating to the sale and marketing of our products are subject to regulation under the U.S. Federal Food, Drug and Cosmetic Act and other federal statutes. Violations of these laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as the possibility of exclusion from federal health care programs (including Medicare and Medicaid). In 1999 we agreed to pay $50 million to settle a federal investigation relating to our past clinical, sales and marketing activities associated with human growth hormone. We are currently being investigated by the Department of Justice with respect to our promotional practices, and may in the future be investigated for our promotional practices relating to any of our products. If the government were to bring charges against or convict us of violating these laws, or if we were subject to third party litigation relating to the same promotional practices, there could be a material adverse effect on our business, including our financial condition and results of operations.

We are subject to various U.S. federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback and false claims laws. Anti-kickback laws make it illegal for a prescription drug manufacturer to solicit, offer, receive, or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase or prescription of a particular drug. Due to the breadth of the statutory provisions and the absence of guidance in the form of regulations or court decisions addressing some of our practices, it is possible that our practices might be challenged under anti-kickback or similar laws. False claims laws prohibit anyone from knowingly and willingly presenting, or causing to be presented for payment to third-party payers (including Medicare and Medicaid) claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as the possibility of exclusion from federal health care programs (including Medicare and Medicaid). If a court were to find us liable for violating these laws, or if the government were to allege against or convict us of violating these laws, there could be a material adverse effect on our business, including on our stock price.

We may be unable to manufacture certain of our products if there is BSE contamination of our bovine source raw material

Most biotechnology companies, including Genentech, have historically used bovine source raw materials to support cell growth in our production processes. Bovine source raw materials from within or outside the U.S. are increasingly subject to greater public and regulatory scrutiny because of the perceived risk of contamination with bovine spongiform encephalopathy (or “BSE”). Should BSE contamination occur during the manufacture of any of our products that require the use of bovine source raw materials, it would negatively affect our ability to manufacture those products for an indefinite period of time (or at least until an alternative process is approved), negatively affect our reputation and could result in a material adverse effect on our product sales, financial condition and results of operations.

We may be unable to retain skilled personnel and maintain key relationships

The success of our business depends, in large part, on our continued ability to (i) attract and retain highly qualified management, scientific, manufacturing and sales and marketing personnel, (ii) successfully integrate large numbers of new employees into our corporate culture, and (iii) develop and maintain important relationships with leading research and medical institutions and key distributors. Competition for these types of personnel and relationships is intense. We cannot be sure that we will be able to attract or retain skilled personnel or maintain key relationships or that the costs of retaining such personnel or maintaining such relationships will not materially increase.

Other factors could affect our product sales

Other factors that could affect our product sales include, but are not limited to:

 
·
The timing of FDA approval, if any, of competitive products.

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·
Our pricing decisions, including a decision to increase or decrease the price of a product, the pricing decisions of our competitors, as well as our Avastin Patient Assistance Program, which is a voluntary program that enables eligible patients who receive greater than 10,000 milligrams of Avastin over a 12-month period to receive free Avastin during the remainder of the 12-month period. Eligible patients include those who are being treated for an FDA-approved indication.

 
·
Government and third-party payer reimbursement and coverage decisions that affect the utilization of our products and competing products.

 
·
Negative safety or efficacy data from new clinical studies conducted either in the U.S. or internationally by any party could cause the sales of our products to decrease or a product to be recalled or withdrawn.

 
·
Negative safety or efficacy data from post-approval marketing experience or production quality problems could cause sales of our products to decrease or a product to be recalled.

 
·
Efficacy data from clinical studies conducted by any party in the U.S. or internationally, showing or perceived to show, a similar or an improved treatment benefit at a lower dose or shorter duration of therapy could cause the sales of our products to decrease.

 
·
The degree of patent protection afforded our products by patents granted to us and by the outcome of litigation involving our patents.

 
·
The outcome of litigation involving patents of other companies concerning our products or processes related to production and formulation of those products or uses of those products.

 
·
The increasing use and development of alternate therapies.

 
·
The rate of market penetration by competing products.

 
·
Our distribution strategy, including the termination of, or change in, an existing arrangement with any major wholesalers who supply our products.

Any of these factors could have a material adverse effect on our sales and results of operations.

Our results of operations are affected by our royalty and contract revenues, and sales to collaborators

Royalty and contract revenues, and sales to collaborators in future periods could vary significantly. Major factors affecting these revenues include, but are not limited to:

 
·
Hoffmann-La Roche’s decisions whether to exercise its options and option extensions to develop and sell our future products in non-U.S. markets and the timing and amount of any related development cost reimbursements.

 
·
Variations in Hoffmann-La Roche’s sales and other licensees’ sales of licensed products.

 
·
The expiration or termination of existing arrangements with other companies and Hoffmann-La Roche, which may include development and marketing arrangements for our products in the U.S., Europe and other countries outside the U.S.

 
·
The timing of non-U.S. approvals, if any, for products licensed to Hoffmann-La Roche and to other licensees.

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·
Government and third-party payer reimbursement and coverage decisions that affect the utilization of our products and competing products.

 
·
Fluctuations in foreign currency exchange rates.

 
·
The initiation of new contractual arrangements with other companies.

 
·
Whether and when contract milestones are achieved.

 
·
The failure of or refusal of a licensee to pay royalties.

 
·
The expiration or invalidation of our patents or licensed intellectual property. For example, patent litigations, interferences, oppositions, and other proceedings involving our patents often include claims by third-parties that such patents are invalid, unenforceable, or unpatentable. If a court, patent office, or other authority were to determine that a patent under which we receive royalties and/or other revenues is invalid, unenforceable, or unpatentable, that determination could cause us to suffer a loss of such royalties and/or revenues, and could cause us to incur other monetary damages.

 
·
Decreases in licensees’ sales of product due to competition, manufacturing difficulties or other factors that affect the sales of product.

Our affiliation agreement with Roche Holdings, Inc. could adversely affect our cash position

Our affiliation agreement with Roche provides that we establish a stock repurchase program designed to maintain Roche’s percentage ownership interest in our Common Stock based on an established Minimum Percentage. For more information on our stock repurchase program, see discussion in “Liquidity and Capital Resources—Cash Used in or Provided by Financing Activities.” See Note 9, “Relationship with Roche and Related Party Transactions,” in the Notes to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K for information regarding the Minimum Percentage.

Roche’s ownership percentage is diluted by the exercise of stock options to purchase shares of our Common Stock by our employees and the purchase of shares of our Common Stock through our employee stock purchase plan. In order to maintain Roche’s Minimum Percentage, we repurchase shares of our Common Stock under the stock repurchase program. See Note 3, “Employee Stock-Based Compensation,” in the Notes to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K for information regarding employee stock plans. While the dollar amounts associated with future stock repurchase programs cannot currently be determined, future stock repurchases could have a material adverse effect on our liquidity, credit rating and ability to access additional capital in the financial markets.

Our affiliation agreement with Roche could limit our ability to make acquisitions

The affiliation agreement between us and Roche contains provisions that:

 
·
Require the approval of the directors designated by Roche to make any acquisition or any sale or disposal of all or a portion of our business representing 10% or more of our assets, net income or revenues.

 
·
Enable Roche to maintain its percentage ownership interest in our Common Stock.

 
·
Require us to establish a stock repurchase program designed to maintain Roche’s percentage ownership interest in our Common Stock based on an established Minimum Percentage. For information regarding Minimum Percentage, see Note 9, “Relationship with Roche and Related Party Transactions,” in the Notes to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K.

19



These provisions may have the effect of limiting our ability to make acquisitions.

Future sales of our Common Stock by Roche could cause the price of our Common Stock to decline

As of December 31, 2006, Roche owned 587,189,380 shares of our Common Stock, or 55.8% of our outstanding shares. All of our shares owned by Roche are eligible for sale in the public market subject to compliance with the applicable securities laws. We have agreed that, upon Roche’s request, we will file one or more registration statements under the Securities Act in order to permit Roche to offer and sell shares of our Common Stock. Sales of a substantial number of shares of our Common Stock by Roche in the public market could adversely affect the market price of our Common Stock.

Roche Holdings, Inc., our controlling stockholder, may seek to influence our business in a manner that is adverse to us or adverse to other stockholders who may be unable to prevent actions by Roche

Roche, as our majority stockholder, controls the outcome of most actions requiring the approval of our stockholders. Our bylaws provide, among other things, that the composition of our board of directors shall consist of at least three directors designated by Roche, three independent directors nominated by the nomination committee and one Genentech executive officer nominated by the nominations committee. Our bylaws also provide that Roche will have the right to obtain proportional representation on our board until such time that Roche owns less than 5% of our stock. Currently, three of our directors, Mr. William Burns, Dr. Erich Hunziker and Dr. Jonathan K.C. Knowles, also serve as officers and employees of Roche Holding Ltd and its affiliates. As long as Roche owns in excess of 50% of our Common Stock, Roche directors will comprise two of the three members of the nominations committee. Our certificate of incorporation includes provisions relating to competition by Roche affiliates with us, offering of corporate opportunities, transactions with interested parties, intercompany agreements, and provisions limiting the liability of specified employees. We cannot assure that Roche will not seek to influence our business in a manner that is contrary to our goals or strategies or the interests of other stockholders. Moreover, persons who are directors and/or officers of Genentech and who are also directors and/or officers of Roche may decline to take action in a manner that might be favorable to us but adverse to Roche.

Additionally, our certificate of incorporation provides that any person purchasing or acquiring an interest in shares of our capital stock shall be deemed to have consented to the provisions in the certificate of incorporation relating to competition with Roche, conflicts of interest with Roche, the offer of corporate opportunities to Roche and intercompany agreements with Roche. This deemed consent might restrict the ability to challenge transactions carried out in compliance with these provisions.

We may incur material product liability costs

The testing and marketing of medical products entail an inherent risk of product liability. Liability exposures for biotherapeutics could be extremely large and pose a material risk. Our business may be materially and adversely affected by a successful product liability claim or claims in excess of any insurance coverage that we may have.

Insurance coverage is increasingly more difficult and costly to obtain or maintain

While we currently have a certain amount of insurance to minimize our direct exposure to certain business risks, premiums are generally increasing and coverage is narrowing in scope. As a result, we may be required to assume more risk in the future or make significant expenditures to maintain our current levels of insurance. If we are subject to third-party claims or suffer a loss or damages in excess of our insurance coverage, we will incur the cost of the portion of the retained risk. Furthermore, any claims made on our insurance policies may affect our ability to obtain or maintain insurance coverage at reasonable costs.

We are subject to environmental and other risks

We use certain hazardous materials in connection with our research and manufacturing activities. In the event such hazardous materials are stored, handled or released into the environment in violation of law or any permit, we could

20



be subject to loss of our permits, government fines or penalties and/or other adverse governmental or private actions. The levy of a substantial fine or penalty, the payment of significant environmental remediation costs or the loss of a permit or other authorization to operate or engage in our ordinary course of business could materially adversely affect our business.

We also have acquired, and may continue to acquire in the future, land and buildings as we expand our operations. Some of these properties are “brownfields” for which redevelopment or use is complicated by the presence or potential presence of a hazardous substance, pollutant or contaminant. Certain events which could occur may require us to pay significant clean-up or other costs in order to maintain our operations on those properties. Such events include, but are not limited to, changes in environmental laws, discovery of new contamination, or unintended exacerbation of existing contamination. The occurrence of any such event could materially affect our ability to continue our business operations on those properties.

Fluctuations in our operating results could affect the price of our Common Stock

Our operating results may vary from period to period for several reasons including:

 
·
The overall competitive environment for our products as described in “We face competition” above.

 
·
The amount and timing of sales to customers in the U.S. For example, sales of a product may increase or decrease due to pricing changes, fluctuations in distributor buying patterns or sales initiatives that we may undertake from time to time.

 
·
The amount and timing of our sales to Hoffmann-La Roche and our other collaborators of products for sale outside of the U.S. and the amount and timing of sales to their respective customers, which directly affects both our product sales and royalty revenues.

 
·
The timing and volume of bulk shipments to licensees.

 
·
The availability and extent of government and private third-party reimbursements for the cost of therapy.

 
·
The extent of product discounts extended to customers.

 
·
The efficacy and safety of our various products as determined both in clinical testing and by the accumulation of additional information on each product after the FDA approves it for sale.

 
·
The rate of adoption by physicians and use of our products for approved indications and additional indications. Among other things, the rate of adoption by physicians and use of our products may be affected by results of clinical studies reporting on the benefits or risks of a product.

 
·
The potential introduction of new products and additional indications for existing products.

 
·
The ability to successfully manufacture sufficient quantities of any particular marketed product.

 
·
Pricing decisions that we or our competitors have adopted or may adopt, as well as our Avastin Patient Assistance Program.

Our integration of new information systems could disrupt our internal operations, which could harm our revenues and increase our expenses

Portions of our information technology infrastructure may experience interruptions, delays or cessations of service or produce errors. As part of our Enterprise Resource Planning efforts, we are implementing new information systems, but we may not be successful in implementing all of the new systems, and transitioning data and other aspects of the

21



process could be expensive, time consuming, disruptive and resource intensive. Any disruptions that may occur in the implementation of new systems or any future systems could adversely affect our ability to report in an accurate and timely manner the results of our consolidated operations, our financial position and cash flows. Disruptions to these systems also could adversely affect our ability to fulfill orders and interrupt other operational processes. Delayed sales, lower margins or lost customers resulting from these disruptions could adversely affect our financial results.

Our stock price, like that of many biotechnology companies, is volatile

The market prices for securities of biotechnology companies in general have been highly volatile and may continue to be highly volatile in the future. In addition, the market price of our Common Stock has been and may continue to be volatile.
The following factors may have a significant effect on the market price of our Common Stock.

 
·
Announcements of technological innovations or new commercial products by us or our competitors.

 
·
Publicity regarding actual or potential medical results relating to products under development or being commercialized by us or our competitors.

 
·
Concerns about the pricing of our products, or our pricing initiatives (including our Avastin Patient Assistance Program), and the potential effect of such on their utilization or our product sales.

 
·
Developments or outcome of litigation, including litigation regarding proprietary and patent rights.

 
·
Regulatory developments or delays concerning our products in the U.S. and foreign countries.

 
·
Issues concerning the safety of our products or of biotechnology products generally.

 
·
Economic and other external factors or a disaster or crisis.

 
·
Period to period fluctuations in our financial results.

Our effective income tax rate may vary significantly

Various internal and external factors may have favorable or unfavorable effects on our future effective income tax rate. These factors include but are not limited to changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, changes in estimates of prior years’ items, past and future levels of R&D spending, and changes in overall levels of income before taxes.

To pay our indebtedness will require a significant amount of cash and may adversely affect our operations and financial results

As of December 31, 2006, we had approximately $2.0 billion of long-term debt. Our ability to make payments on and to refinance our indebtedness, including our long-term debt obligations, and to fund planned capital expenditures, R&D, as well as stock repurchases and expansion efforts will depend on our ability to generate cash in the future. This, to a certain extent, is subject to general economic, financial, competitive, legislative, regulatory and other factors that are and will remain beyond our control. Additionally, our indebtedness may increase our vulnerability to general adverse economic and industry conditions, require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, which would reduce the availability of our cash flow to fund working capital, capital expenditures, R&D, expansion efforts and other general corporate purposes, and limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate.

22



Accounting pronouncements may affect our future financial position and results of operations

Under Financial Accounting Standards Board (or “FASB”) Interpretation No. 46R (or “FIN 46R”), a revision to Interpretation 46, “Consolidation of Variable Interest Entities,” we are required to assess new business development collaborations as well as to reassess, upon certain events, some of which are outside our control, the accounting treatment of our existing business development collaborations based on the nature and extent of our variable interests in the entities as well as the extent of our ability to exercise influence over the entities with which we have such collaborations. Our continuing compliance with FIN 46R may result in our consolidation of companies or related entities with which we have a collaborative arrangement and this may have a material effect on our financial condition and/or results of operations in future periods.

In June 2006, the FASB issued FASB Interpretation (or “FIN”) No. 48, “Accounting for Uncertainty in Income Taxes.” FIN 48 clarifies the application of FASB Statement 109, “Accounting for Income Taxes,” by defining criteria that must be met for any part of a benefit related to an individual tax position to be recognized in the financial statements. FIN 48 also provides guidance on measurement, derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition and is effective for us beginning January 1, 2007. We are currently evaluating the effect that the adoption of FIN 48 will have on our consolidated results of operations and financial position, but we do not expect the effect to be material.



None.


Item 2.

Our headquarters facilities are located in a research and industrial area in South San Francisco, California where we currently occupy 30 owned and 8 leased buildings which house our research and development, marketing and administrative activities, as well as bulk manufacturing facilities, a fill and finish facility and a warehouse. We have made and will continue to make improvements to these properties to accommodate our growth. We also have a commitment to lease an additional eight buildings in South San Francisco, California. We occupied one of these buildings in 2006, and we will occupy additional buildings beginning in 2007. In addition, we own other properties in South San Francisco for future expansion.

We own a manufacturing facility in Vacaville, California, which is licensed to produce commercial quantities of select products. We are currently expanding our Vacaville site by constructing an additional manufacturing facility adjacent to the existing facility as well as office buildings to support the added manufacturing capacity. We expect completion of construction, qualification and licensure of our new Vacaville plant by the end of 2009.

In June 2005, we acquired a biologics manufacturing facility in Oceanside, California. In 2006 we began manufacturing Avastin bulk product at the plant and we anticipate FDA licensure in the first half of 2007.

In September 2006, we acquired land in Hillsboro, Oregon for the construction of a new fill, finish, warehousing and related office facility. Construction is expected to begin in 2007 with completion and FDA licensure in early 2010.

In December 2006, Lonza acquired the warehouse and cell culture manufacturing facility that we owned in Porriño, Spain and at which Lonza will continue to manufacture Avastin for us through December 31, 2009. We also have an agreement under which we can elect to purchase Lonza’s manufacturing facility currently under construction in Singapore. Such facility is expected to be licensed for the production of Avastin in 2010.

We also lease additional office facilities as regional offices for sales and marketing and other functions in several locations throughout the United States.

23



In general, our existing facilities, owned or leased, are in good condition and adequate for all present and near term uses and we believe our capital resources are sufficient to purchase, lease or construct any additional facilities required to meet our long-term growth needs.



We are a party to various legal proceedings, including patent infringement litigation and licensing and contract disputes, and other matters.

On October 4, 2004, we received a subpoena from the U.S. Department of Justice, requesting documents related to the promotion of Rituxan, a prescription treatment now approved for five indications:  (1) the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma, (2) the first-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens (approved on February 10, 2006), (3) the first-line treatment of previously untreated patients with follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma in combination with cyclophosphamide, vincristine, prednisone (or “CVP”) chemotherapy (approved September 29, 2006), (4) the treatment of low-grade, CD20-positive, B-cell non-Hodgkin’s lymphoma in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy (approved on September 29, 2006), and (5) for use in combination with methotrexate to reduce signs and symptoms in adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies (approved on February 28, 2006). We are cooperating with the associated investigation, which we have been advised is both civil and criminal in nature. The government has called and will likely continue to call former and current Genentech employees to appear before a grand jury in connection with this investigation. The outcome of this matter cannot be determined at this time.

On July 29, 2005, a former Genentech employee, whose employment ended in April 2005, filed a qui tam complaint under seal in the United States District Court for the District of Maine against Genentech and Biogen Idec, alleging violations of the False Claims Act and retaliatory discharge of employment. On December 20, 2005, the United States filed notice of its election to decline intervention in the lawsuit. The complaint was subsequently unsealed and we were served on January 5, 2006. Genentech filed a motion to dismiss the complaint and on December 14, 2006, the Magistrate Judge assigned to the case issued a Recommended Decision on that motion, which is subject to review by the District Court Judge. The Magistrate Judge recommended that the False Claims Act portion of the complaint be dismissed, leaving as the only remaining claim against Genentech the plaintiff’s retaliatory discharge claim. Plaintiff, Biogen Idec, and Genentech each subsequently filed objections with the District Court Judge concerning certain aspects of the Magistrate Judge’s Recommended Decision. We are awaiting the District Court’s decision on the Recommended Decision and the objections. The outcome of this matter cannot be determined at this time.

We and the City of Hope National Medical Center (or “COH”) are parties to a 1976 agreement relating to work conducted by two COH employees, Arthur Riggs and Keiichi Itakura, and patents that resulted from that work, which are referred to as the “Riggs/Itakura Patents.” Since that time, we have entered into license agreements with various companies to make, use and sell the products covered by the Riggs/Itakura Patents. On August 13, 1999, the COH filed a complaint against us in the Superior Court in Los Angeles County, California, alleging that we owe royalties to the COH in connection with these license agreements, as well as product license agreements that involve the grant of licenses under the Riggs/Itakura Patents. On June 10, 2002, a jury voted to award the COH approximately $300 million in compensatory damages. On June 24, 2002, a jury voted to award the COH an additional $200 million in punitive damages. Such amounts were accrued as an expense in the second quarter of 2002 and are included in the accompanying Consolidated Balance Sheets in “litigation-related and other long-term liabilities” at December 31, 2006 and December 31, 2005. We filed a notice of appeal of the verdict and damages awards with the California Court of Appeal. On October 21, 2004, the California Court of Appeal affirmed the verdict and damages awards in all respects. On November 22, 2004, the California Court of Appeal modified its opinion without changing the verdict and denied Genentech’s request for rehearing. On November 24, 2004, we filed a petition seeking review by the California Supreme Court. On February 2, 2005, the California Supreme Court granted that petition. The appeal to the California Supreme Court has been fully briefed and we are waiting to be

24



assigned an oral argument date. The amount of cash paid, if any, or the timing of such payment in connection with the COH matter will depend on the outcome of the California Supreme Court’s review of the matter, however, it may take longer than one year to resolve the matter.

We recorded accrued interest and bond costs of $54 million in 2006 and 2005 related to the COH trial judgment. In conjunction with the COH judgment, we posted a surety bond and were required to pledge cash and investments of $735 million at December 31, 2005 to secure the bond. During the third quarter of 2006, COH requested that we increase the surety bond value by $50 million to secure the accruing interest, and we correspondingly increased the pledge amount to secure the bond by $53 million to $788 million. These amounts are reflected in “restricted cash and investments” in the accompanying Consolidated Balance Sheets. We expect that we will continue to incur interest charges on the judgment and service fees on the surety bond each quarter through the process of appealing the COH trial results.

On April 11, 2003, MedImmune, Inc. (or “MedImmune”) filed a lawsuit against Genentech, COH, and Celltech R & D Ltd. in the U.S. District Court for the Central District of California (Los Angeles). The lawsuit relates to U.S. Patent No. 6,331,415 (or “the ‘415 patent” or “Cabilly patent”) that we co-own with COH and under which MedImmune and other companies have been licensed and are paying royalties to us. The lawsuit includes claims for violation of antitrust, patent, and unfair competition laws. MedImmune is seeking a ruling that the ‘415 patent is invalid and/or unenforceable, a determination that MedImmune does not owe royalties under the ‘415 patent on sales of its Synagis® antibody product, an injunction to prevent us from enforcing the ‘415 patent, an award of actual and exemplary damages, and other relief. On January 14, 2004 (amending a December 23, 2003 Order), the U.S. District Court granted summary judgment in our favor on all of MedImmune’s antitrust and unfair competition claims. On April 23, 2004, the District Court granted our motion to dismiss all remaining claims in the case. On October 18, 2005, the U.S. Court of Appeals for the Federal Circuit affirmed the judgment of the District Court in all respects. MedImmune filed a petition for certiorari with the United States Supreme Court on November 10, 2005, seeking review of the decision to dismiss certain of its claims. The Supreme Court granted MedImmune’s petition and the oral argument of this case before the Supreme Court occurred on October 4, 2006. On January 9, 2007, the Supreme Court issued a decision reversing the Federal Circuit’s decision and remanding the case to the lower courts for further proceedings in connection with the patent and contract claims. The outcome of this matter cannot be determined at this time.

On May 13, 2005, a request was filed by a third party for reexamination of the ‘415 or Cabilly patent. The request sought reexamination on the basis of non-statutory double patenting over U.S. Patent No. 4,816,567. On July 7, 2005, the U.S. Patent Office ordered reexamination of the ‘415 patent. On September 13, 2005, the Patent Office mailed an initial non-final Office action rejecting the claims of the ‘415 patent. We filed our response to the Office action on November 25, 2005. On December 23, 2005, a second request for reexamination of the ‘415 patent was filed by another third party, and on January 23, 2006, the Patent Office granted that request. On June 6, 2006, the two reexaminations were merged into one proceeding. On August 16, 2006, the Patent Office mailed a non-final Office action in the merged proceeding, rejecting the claims of the ‘415 patent based on issues raised in the two reexamination requests. We filed our response to the Office action on October 30, 2006. On February 16, 2007, the Patent Office mailed a final Office action rejecting all thirty-six claims of the ‘415 patent. We intend to respond to the final Office action, and, if necessary, appeal the decision. The ‘415 patent, which expires in 2018, relates to methods we and others use to make certain antibodies or antibody fragments, as well as cells and DNA used in these methods. We have licensed the ‘415 patent to other companies and derive significant royalties from those licenses. The claims of the ‘415 patent remain valid and enforceable throughout the reexamination and appeals process. Because the above-described proceeding is ongoing, the outcome of this matter cannot be determined at this time.

In 2006, we made development decisions involving our humanized anti-CD20 program. Our collaborator, Biogen Idec, disagrees with certain of our development decisions under our 2003 collaboration agreement with Biogen Idec relating to humanized anti-CD20 products. We believe that we are permitted under the agreement to proceed with further trials of certain humanized anti-CD20 antibodies, and Biogen Idec disagrees with our position. We continue to pursue a resolution of our differences, and the disputed issues have been submitted to arbitration. In the arbitration, Biogen Idec has filed motions for a preliminary injunction and summary judgment seeking to stop us from proceeding with certain development activities, including planned clinical trials. A hearing on the motion for a

25



preliminary injunction was held on January 30, 2007 and we are waiting on a decision by the arbitrators on that motion. Briefing relating to the motion for summary judgment is ongoing. Resolution of the arbitration could require that both parties agree to certain development decisions before moving forward with humanized anti-CD20 antibody clinical trials, in which case we may have to alter or cancel planned trials in order to obtain Biogen Idec’s approval. The outcome of this matter cannot be determined at this time.

On March 24, 2004, Dr. Kourosh Dastgheib filed a lawsuit against Genentech in the U.S. District Court for the Eastern District of Pennsylvania. The lawsuit stems from Dastgheib’s claim that, based on a purported relationship with Genentech in the mid-1990’s, he is entitled to profits or proceeds from Genentech’s Lucentis product. Dastgheib has asserted multiple claims for monetary damages, including a claim under an unjust enrichment theory that he is entitled to the entire net present value of projected Lucentis sales, which he claims is between approximately $1.4 billion and $4.1 billion. On November 8, 2006, a unanimous jury ruled against Dastgheib and in favor of Genentech on all claims, and final judgment was entered in Genentech’s favor. On January 30, 2007, Dastgheib’s motion for a new trial was denied in its entirety. Because Dastgheib may still seek to appeal the judgment to the court of appeals, the final outcome of this matter cannot be determined at this time.



Not applicable.

26


Executive Officers of the Company

The executive officers of the Company and their respective ages (as of December 31, 2006) and positions with the Company are as follows:

Name
Age
 
Position
Arthur D. Levinson, Ph.D.*
 
56 
 
 
Chairman and Chief Executive Officer
 
Susan D. Desmond-Hellmann, M.D., M.P.H.*
 
49 
 
 
President, Product Development
 
Ian T. Clark*
 
46 
 
 
Executive Vice President, Commercial Operations
 
David A. Ebersman*
 
37 
 
 
Executive Vice President and Chief Financial Officer
 
Stephen G. Juelsgaard, D.V.M., J.D.*
 
58 
 
 
Executive Vice President, Secretary and Chief Compliance Officer
 
Richard H. Scheller, Ph.D.*
 
53 
 
 
Executive Vice President, Research
 
Patrick Y. Yang, Ph.D.*
 
58 
 
 
Executive Vice President, Product Operations
 
Robert L. Garnick, Ph.D.
 
57 
 
 
Senior Vice President, Regulatory, Quality and Compliance
 
John M. Whiting
 
51 
 
 
Vice President, Finance and Chief Accounting Officer
 
________________________
*  Members of the Executive Committee of the Company.

The Board of Directors appoints all executive officers annually. There is no family relationship between or among any of the executive officers or directors.

Business Experience

Arthur D. Levinson, Ph.D. was appointed Chairman of the Board of Directors of Genentech, Inc. in September 1999 and was elected its Chief Executive Officer and a director of the Company in July 1995. Since joining the Company in 1980, Dr. Levinson has been a Senior Scientist, Staff Scientist and the Director of the Company’s Cell Genetics Department. Dr. Levinson was appointed Vice President of Research Technology in April 1989, Vice President of Research in May 1990, Senior Vice President of Research in December 1992, Senior Vice President of Research and Development in March 1993 and President in July 1995. Dr. Levinson also serves as a member of the Board of Directors of Apple Computer, Inc. and Google, Inc.

Susan D. Desmond-Hellmann, M.D., M.P.H. was appointed President, Product Development of Genentech in March 2004. She previously served as Executive Vice President, Development and Product Operations from September 1999 to March 2004, Chief Medical Officer from December 1996 to March 2004, and as Senior Vice President, Development from December 1997 to September 1999, among other positions, since joining Genentech in March 1995 as a Clinical Scientist. Prior to joining Genentech, she held the position of Associate Director at Bristol-Myers Squibb.

Ian T. Clark was appointed Executive Vice President, Commercial Operations of Genentech in December 2005. He previously served as Senior Vice President, Commercial Operations of Genentech from August 2005 to December 2005 and joined Genentech as Senior Vice President and General Manager, BioOncology and served in that role from January 2003 through August 2005. Prior to joining Genentech, he served as president for Novartis Canada from 2001 to 2003. Before assuming his post in Canada, he served as chief operating officer for Novartis United Kingdom from 1999 to 2001.

David A. Ebersman was appointed Executive Vice President of Genentech in December 2005 and Chief Financial Officer in March 2005. Previously, he served as Senior Vice President, Finance from January 2005 through March 2005 and Senior Vice President, Product Operations from May 2001 through January 2005. He joined Genentech in February 1994 as a Business Development Analyst and subsequently served as Manager, Business Development from February 1995 to February 1996, Director, Business Development from February 1996 to March 1998, Senior

27



Director, Product Development from March 1998 to February 1999 and Vice President, Product Development from February 1999 to May 2001. Prior to joining Genentech, he held the position of Research Analyst at Oppenheimer & Company, Inc.

Stephen G. Juelsgaard, D.V.M., J.D. was appointed Chief Compliance Officer of Genentech in June 2005, Executive Vice President in September 2002, and Secretary in April 1997. He joined Genentech in July 1985 as Corporate Counsel and subsequently served as Senior Corporate Counsel from 1988 to 1990, Chief Corporate Counsel from 1990 to 1993, Vice President, Corporate Law from 1993 to 1994, Assistant Secretary from 1994 to 1997, Senior Vice President from April 1998 to September 2002, and General Counsel from July 1994 to January 2007.

Richard H. Scheller, Ph.D. was appointed Executive Vice President, Research of Genentech in September 2003. Previously, he served as Senior Vice President, Research from March 2001 to September 2003. Prior to joining Genentech, he served as Professor of Molecular and Cellular Physiology and of Biological Sciences at Stanford University Medical Center from September 1982 to February 2001 and as an investigator at the Howard Hughes Medical Institute from September 1990 to February 2001. He received his first academic appointment to Stanford University in 1982. He was appointed to the esteemed position of professor of Molecular and Cellular Physiology in 1993 and as an investigator in the Howard Hughes Medical Institute in 1994.

Patrick Y. Yang, Ph.D. was appointed Executive Vice President, Product Operations of Genentech in December 2005. Previously, he served as Senior Vice President, Product Operations from January 2005 through December 2005 and Vice President, South San Francisco Manufacturing and Engineering from December 2003 to January 2005. Prior to joining Genentech, he worked for General Electric from 1980 to 1992 in manufacturing and technology and for Merck & Co. Inc. from 1992 to 2003 in manufacturing. At Merck, he held several executive positions including Vice President, Supply Chain Management from 2001 to 2003 and Vice President, Asia/Pacific Manufacturing Operations from 1997 to 2000.

Robert L. Garnick, Ph.D. was appointed Senior Vice President, Regulatory, Quality and Compliance of Genentech in February 2001. Previously, he served as Vice President, Regulatory Affairs from February 1998 to February 2001, Vice President, Quality from April 1994 to February 1998, Senior Director, Quality Control from 1990 to 1994 and Director, Quality Control from 1988 to 1990. He joined Genentech in August 1984 from Armour Pharmaceutical, where he held various positions.

John M. Whiting was appointed Vice President, Finance of Genentech in June 2006, and Chief Accounting Officer in October 1997. He served as Controller from October 1997 to June 2006 and as Vice President from January 2001 to June 2006. He previously served in a variety of financial positions at Genentech from 1989 to 1997. Prior to joining Genentech, he served as Senior Audit Manager at Arthur Young.

28


PART II



See “Liquidity and Capital Resources — Cash Used in or Provided by Financing Activities” in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of Part II, Item 7 of this Form 10-K, Note 1, “Description of Business — Redemption of Our Special Common Stock,” Note 9, “Relationship with Roche and Related Party Transactions,” and Note 10, “Capital Stock,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K.

Stock Exchange Listing

Our Common Stock trades on the New York Stock Exchange under the symbol “DNA.” No dividends have been paid on the Common Stock. We currently intend to retain all future income for use in the operation of our business and for future stock repurchases and, therefore, do not anticipate paying any cash dividends in the near future.

Common Stockholders

As of December 31, 2006, there were approximately 2,612 stockholders of record of our Common Stock, one of which is Cede & Co., a nominee for Depository Trust Company (or “DTC”). All of the shares of Common Stock held by brokerage firms, banks and other financial institutions as nominees for beneficial owners are deposited into participant accounts at DTC, and are therefore considered to be held of record by Cede & Co. as one stockholder.

Stock Prices

   
Common Stock
 
   
2006
 
2005
 
   
High
 
Low
 
High
 
Low
 
4th Quarter
 
$
86.93
 
$
79.65
 
$
100.20
 
$
79.87
 
3rd Quarter
   
86.65
   
76.80
   
94.99
   
79.71
 
2nd Quarter
   
84.72
   
75.58
   
84.10
   
54.68
 
1st Quarter
   
95.16
   
81.15
   
59.00
   
43.90
 

Stock Repurchases

See “Liquidity and Capital Resources — Cash Used in or Provided by Financing Activities” in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of Part II, Item 7 of this Form 10-K for information on our stock repurchases.

29



Performance Graph

We show below the cumulative total return to our stockholders during the period from December 31, 2001 through December 31, 2006 in comparison to the cumulative return on the Standard & Poor’s 500 Index, the Standard & Poor’s 500 Pharmaceuticals Index and the Standard & Poor’s 500 Biotechnology Index during that same period.(1) The results assume that $100 was invested on December 31, 2001.


   
Base Period
 
Years Ending
 
   
December
 
December
 
December
 
December
 
December
 
December
 
Company / Index
 
2001
 
2002
 
2003
 
2004
 
2005
 
2006
 
GENENTECH, INC
   
100
 
$
61.12
 
$
172.48
 
$
200.70
 
$
341.01
 
$
299.10
 
S&P 500 INDEX
   
100
   
77.90
   
100.25
   
111.15
   
116.61
   
135.03
 
S&P 500 PHARMACEUTICALS
   
100
   
79.96
   
86.98
   
80.51
   
77.81
   
90.14
 
S&P BIOTECHNOLOGY
   
100
   
79.59
   
102.55
   
110.35
   
130.52
   
126.94
 
________________________
(1)
The total return on investment (change in year end stock price plus reinvested dividends) assumes $100 invested on December 31, 2001 in our common stock, the Standard & Poor’s 500 Index, the Standard & Poor’s 500 Pharmaceuticals Index and the Standard & Poor’s 500 Biotechnology Index. The Standard & Poor’s 500 Pharmaceuticals Index was comprised at December 31, 2006 of Abbott Laboratories, Allergan, Inc., Barr Pharmaceuticals Inc., Bristol-Myers Squibb Company, Forest Laboratories, Inc., Johnson & Johnson, King Pharmaceuticals, Inc., Merck & Co., Inc., Mylan Laboratories Inc., Lilly (Eli) and Company, Pfizer Inc., Schering-Plough Corporation, Watson Pharmaceuticals, Inc. and Wyeth. The Standard & Poor’s 500 Biotechnology Index was comprised at December 31, 2006 of Amgen Inc., Biogen Idec Inc., Genzyme Corporation, Gilead Sciences, Inc. and MedImmune, Inc.
 
The information under “Performance Graph” is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference in any filing of Genentech under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this 10-K and irrespective of any general incorporation language in those filings.

30




The following selected consolidated financial information has been derived from the audited consolidated financial statements. The information below is not necessarily indicative of results of future operations, and should be read in conjunction with Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Item 1A, “Risk Factors” of this Form 10-K and the consolidated financial statements and related notes thereto included in Item 8 of this Form 10-K in order to fully understand factors that may affect the comparability of the information presented below.

SELECTED CONSOLIDATED FINANCIAL DATA
(in millions, except per share amounts)

   
2006
 
2005
 
2004
 
2003
 
2002
 
Total operating revenues
 
$
9,284
 
$
6,633
 
$
4,621
 
$
3,300
 
$
2,584
 
Product sales
   
7,640
   
5,488
   
3,749
   
2,621
   
2,164
 
Royalties
   
1,354
   
935
   
641
   
501
   
366
 
Contract revenue
   
290
   
210
   
231
   
178
   
54
 
                                 
Income before cumulative effect of accounting changes
 
$
2,113
 
$
1,279
 
$
785
 
$
610
 
$
64
 
Cumulative effect of accounting changes, net of tax
   
-
   
-
   
-
   
(47
)(3)
 
-
 
Net income
 
$
2,113
 (1)
$
1,279
 
$
785
 
$
563
 (3)
$
64
 (4)
                                 
Basic earnings per share
 
$
2.01
 
$
1.21
 
$
0.74
 
$
0.54
 
$
0.06
 
Diluted earnings per share
   
1.97
   
1.18
   
0.73
   
0.53
   
0.06
 
                                 
Total assets
 
$
14,842
 
$
12,147
 
$
9,403
 (2)
$
8,759
 (2)
$
6,776
 
Long-term debt
   
2,204
 (2)  
2,083
 (2)  
412
 (2)  
412
 (2)  
-
 
Stockholders’ equity
   
9,478
   
7,470
   
6,782
   
6,520
   
5,339
 
________________________
 
We have paid no dividends.
 
All per share amounts reflect the two-for-one stock split that was effected in 2004.
 
Certain prior year amounts have been reclassified to conform to the current year presentation.
(1)
Net income in 2006 includes employee stock-based compensation costs of $182 million, net of tax, due to our adoption of FAS 123R on a modified prospective basis on January 1, 2006. No employee stock-based compensation expense was recognized in reported amounts in any period prior to January 1, 2006.
(2)
Long-term debt in 2006 and 2005 includes $1.99 billion related to our debt issuance in July 2005, and includes $216 million in 2006 and $94 million in 2005 in construction financing obligations related to our agreements with Slough and Lonza. Long-term debt in 2005 also reflects the repayment of $425 million to extinguish the consolidated debt and noncontrolling interest of a synthetic lease obligation related to our manufacturing facility located in Vacaville, California. Upon adoption of the Financial Accounting Standards Board Interpretation No. 46 (or “FIN 46”), “Consolidation of Variable Interest Entities,” in 2003, we consolidated the entity from which we lease our manufacturing facility located in Vacaville, California. Accordingly, we included in property, plant and equipment assets with net book values of $326 million at December 31, 2004 and $348 million at December 31, 2003. We also consolidated the entity’s debt of $412 million and noncontrolling interest of $13 million, which amounts are included in long-term debt and litigation-related and other long-term liabilities, respectively, at December 31, 2004 and 2003.
(3)
Net income in 2003 includes the receipt of $113 million in pre-tax litigation settlements with Amgen Inc. and Bayer Inc. Net income in 2003 also reflects our adoption of FIN 46 on July 1, 2003, which resulted in a $47 million charge, net of $32 million in taxes, (or $0.05 per share) as a cumulative effect of an accounting change in 2003.
(4)
Net income in 2002 includes $544 million of pre-tax litigation-related special charges, which are comprised of the COH litigation judgment in 2002, and accrued interest and bond costs, and certain other litigation-related matters.

31




Overview

The Company

Genentech is a leading biotechnology company that discovers, develops, manufactures, and commercializes biotherapeutics for significant unmet medical needs. We commercialize multiple biotechnology products, and also receive royalties from companies that are licensed to market products based on our technology.

Major Developments in 2006

We primarily earn revenues and income and generate cash from product sales and royalty revenues. Our total operating revenues in 2006 were $9.28 billion, an increase of 40% from $6.63 billion in 2005. Product sales in 2006 were $7.64 billion, an increase of 39% from $5.49 billion in 2005. Product sales represented 82% of our operating revenues in 2006 and 83% in 2005. Royalty revenues were $1.35 billion in 2006, an increase of 45% from $935 million in 2005. Royalty revenues represented 15% of our operating revenues in 2006 and 14% in 2005. Our net income in 2006 was $2.11 billion, an increase of 65% from $1.28 billion in 2005. Net income in 2006 includes the effect of employee stock-based compensation expense related to employee stock options and employee stock purchases under Statement of Financial Accounting Standards No. 123 (revised 2004), “Share-Based Payment” (or “FAS 123R”), which decreased our net income by $182 million after taxes in 2006.

We received the following U.S. Food and Drug Administration (or FDA) approvals:

 
·
Lucentis for the treatment of neovascular (wet) age-related macular degeneration (or “AMD”);

 
·
Avastin in combination with intravenous 5-fluorouracil (or “5-FU”)-based chemotherapy for second-line metastatic colorectal cancer;

 
·
Avastin for use in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (or “NSCLC”);

 
·
Rituxan for the treatment of patients with active rheumatoid arthritis (or “RA”) who have had an inadequate response to tumor necrosis factor antagonist therapy;

 
·
Rituxan for use in first-line treatment of patients with diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma (or “DLBCL”);

 
·
Rituxan for the first-line treatment of previously untreated patients with follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma in combination with CVP (cyclophosphamide, vincristine, prednisone) chemotherapy;

 
·
Rituxan for the treatment of low-grade, CD20-positive, B-cell non-Hodgkin’s lymphoma in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy; and

 
·
Herceptin for the adjuvant treatment of HER2-positive node-positive breast cancer patients in combination with doxorubicin, cyclophosphamide, and paclitaxel.

32



In October 2006, we announced our plan to launch the Avastin Patient Assistance Program in the first quarter of 2007, which is a voluntary program that enables eligible patients who receive greater than 10,000 milligrams of Avastin over a 12-month period to receive free Avastin during the remainder of the 12-month period. Based on the current wholesale acquisition cost, the 10,000 milligrams is valued at $55,000 in gross revenue. Eligible patients include those who are being treated for an FDA-approved indication and who meet the household income criteria for this program. The program will be available for eligible patients who enroll regardless of whether they are insured. Because the program will apply retrospectively to patients currently on Avastin for all approved indications, we deferred approximately $9 million of our fourth quarter 2006 Avastin product sales to address our estimated free drug commitment to current patients. See “Critical Accounting Policies and the Use of Estimates - Revenue Recognition” below for further discussion.

On November 9, 2006 we and Tanox Inc. announced that we entered into an agreement to acquire Tanox, a biotechnology company specializing in the discovery and development of biotherapeutics based on monoclonal antibody technology, for $20 per share for a total cash value of approximately $0.9 billion. We and Tanox have been working together in collaboration with Novartis since 1996 to develop and commercialize Xolair. The terms of the acquisition have been unanimously approved by the Boards of Directors of both companies and approved by the stockholders of Tanox. We received a request for additional information from the U.S. Federal Trade Commission (or “second request”) in connection with the proposed acquisition. The second request extends the waiting period imposed by the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (or “Hart-Scott-Rodino Act”). The transaction is expected to be completed within the first half of 2007, subject to satisfaction of certain closing conditions, including the absence of a material adverse effect with respect to Tanox and the expiration or termination of the waiting period under the Hart-Scott-Rodino Act. Funds will be provided from Genentech’s cash on hand at the time of closing. We are currently evaluating the effects of the acquisition on our results of operations and financial condition and expect that if the transaction closes a substantial portion of the purchase price will be expensed as in-process research and development (or “R&D”).

On December 8, 2006, Lonza Group Ltd. (or “Lonza”) purchased all the outstanding shares of Genentech España, our wholly-owned subsidiary, for $150 million. Under the terms of the agreement, Lonza acquired from us the FDA-licensed Porriño facility, which has 40,000 liters of biologic manufacturing capacity and is currently dedicated to the production of Avastin. Lonza will continue to produce Avastin for us at the Porriño facility for the short-term. At the same time, we entered into a supply agreement with Lonza for the manufacture of certain of our products at Lonza’s facility under construction in Singapore, which is currently expected to receive FDA licensure in 2010. We are committed to fund the pre-commissioning production qualification costs at that facility, and, upon FDA licensure, we are committed to purchase 100 percent of products successfully manufactured at that facility for a period of three years after commissioning of the facility. The total estimated cost of these pre- and post-commissioning commitments is approximately $440 million. We also received an exclusive option to purchase the Lonza Singapore facility during the period from 2007 up to one year after FDA licensure for a purchase price of $290 million. Regardless of whether the purchase option is exercised, we will be obligated to make a milestone payment of approximately $70 million if certain performance milestones are met in connection with the construction of the facility.

In the fourth quarter of 2006, we received FDA approvals for yield improvement projects at our manufacturing plants in Vacaville, California related to the production of Rituxan and in South San Francisco, California related to the production of Avastin. In the fourth quarter of 2006, prior to the sale of our Porriño facility to Lonza, we received licensure of an additional 20,000 liters of capacity to manufacture bulk Avastin at that facility. In addition, in the first quarter of 2006, the FDA approved the production of bulk Xolair at Novartis’ production facility in Huningue, France and in the third quarter of 2006, the FDA approved the manufacture of bulk Herceptin at Wyeth’s Andover, Massachusetts facility. Our manufacturing plant in Oceanside, California, which currently has a total capacity of 90,000 liters, is expected to receive FDA licensure in the first half of 2007.

Our Strategy and Goals

Our business objectives for the years 2006 through 2010 include bringing at least 20 new molecules into clinical development, bringing at least 15 major new products or indications onto the market, becoming the number one U.S.

33



oncology company in sales, and achieving certain financial growth measures. These objectives are reflected in our revised Horizon 2010 strategy and goals summarized on our website at http://www.gene.com. At the end of 2006, we had 16 new molecules in the early development pipeline and approximately 30 projects in late stage research.

Our near-term growth will depend on our ability to execute on recent product approvals, including Lucentis for AMD and Avastin for lung cancer, and to successfully obtain FDA approvals for potential new indications for our existing products such as Avastin for breast cancer and Rituxan for immunological disorders. Continued long-term growth will depend on our ability to bring new molecules to the market that make a meaningful difference for patients and provide significant commercial opportunities. With the current highly competitive marketplace for licensing and mergers and acquisitions, particularly for late stage product opportunities, we expect the development of our internal products to provide the majority of our long-term growth.

Economic and Industry-wide Factors

Our long-term strategy and goals are challenged by economic and industry-wide factors that affect our business. The key factors that affect our future growth are discussed below:

 
·
We face significant competition in the diseases of interest to us from pharmaceutical companies and biotechnology companies. The introduction of new competitive products or follow-on biologics, new information about existing products or pricing decisions by us or our competitors may result in lost market share for us, reduced utilization of our products, reduced product sales, and/or lower prices, even for products protected by patents.

 
·
Our long-term business growth, commercial performance and clinical success depend upon our ability to continue to develop and commercialize important novel therapeutics to treat unmet medical needs, such as cancer. We recognize that the successful development of biotherapeutics is highly difficult and uncertain and that it will be challenging for us to continue to discover and develop innovative treatments. Our business requires significant investment in R&D over many years, often for products that fail during the R&D process. Once a product receives FDA approval, it remains subject to ongoing FDA regulation, including changes to the product label, new or revised regulatory requirements for manufacturing practices, written advisement to physicians, and/or product recalls or withdrawals.

 
·
We believe our business model is only sustainable with appropriate pricing and reimbursement for our products to offset the costs and risks of drug development. The pricing of our products has received negative press coverage and public scrutiny. We will continue to meet with patient groups, payers and other stakeholders in the healthcare system to understand their issues and concerns. However, the future reimbursement environment for our products is uncertain.

 
·
As the Medicare and Medicaid programs are the largest payers for our products, rules relating to coverage and reimbursement continue to represent an important area of focus. New regulations relating to hospital and physician payment continue to be implemented annually. To date, we have not seen any detectable effects of the new rules on our product sales, and we anticipate minimal effects on our revenues in 2007.

 
·
Manufacturing biotherapeutics is difficult and complex, and requires facilities specifically designed and validated to run biotechnology production processes. The manufacture of a biotherapeutic requires developing and maintaining a process to reliably manufacture and formulate the product at an appropriate scale, obtaining regulatory approval to manufacture the product, and is subject to changes in regulatory requirements or standards that may require modifications to the manufacturing process.

34



 
·
Our ability to attract and retain highly qualified and talented people in all areas of the company, and our ability to maintain our unique culture, will be critical to our success over the long-term. We are working diligently across the company to make sure that we successfully hire, train and integrate new employees into the Genentech culture and environment. In keeping with our desire to maintain and protect our culture, we continued our broad-based stock option program in 2006.

 
·
Intellectual property protection of our products is crucial to our business. Loss of effective intellectual property protection on one or more products could result in lost sales to competing products and may negatively affect our sales, royalty revenues and operating results. We are often involved in disputes over contracts and intellectual property and we work to resolve these disputes in confidential negotiations or litigation. We expect legal challenges in this area to continue. We plan to continue to build upon and defend our intellectual property position.

Critical Accounting Policies and the Use of Estimates

The accompanying discussion and analysis of our financial condition and results of operations are based upon our Consolidated Financial Statements and the related disclosures, which have been prepared in accordance with generally accepted accounting principles in the United States (or “GAAP”). The preparation of these Consolidated Financial Statements requires management to make estimates, assumptions and judgments that affect the reported amounts in our Consolidated Financial Statements and accompanying notes. These estimates form the basis for making judgments about the carrying values of assets and liabilities. We base our estimates and judgments on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, and we have established internal controls related to the preparation of these estimates. Actual results and the timing of the results could differ materially from these estimates.

We believe the following policies to be critical to understanding our financial condition, results of operations, and our expectations for 2007 because these policies require management to make significant estimates, assumptions and judgments about matters that are inherently uncertain.

Contingencies

We are currently, and have been, involved in certain legal proceedings, including patent infringement litigation. We are also involved in licensing and contract disputes, and other matters. Refer to Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K for further information on these matters. We assess the likelihood of any adverse judgments or outcomes for these legal matters as well as potential ranges of probable losses. We record an estimated loss as a charge to income if we determine that, based on information available at the time, the loss is probable and the amount of loss can be reasonably estimated.  Included in “litigation-related and other long-term liabilities” in the accompanying Consolidated Balance Sheet at December 31, 2006 is $726 million, which represents our estimate of the costs for the current resolution of these matters. The nature of these matters is highly uncertain and subject to change; as a result, the amount of our liability for certain of these matters could exceed or be less than the amount of our current estimates, depending on the final outcome of these matters. An outcome of such matters different than previously estimated could have a material effect on our financial position or our results of operations in any one quarter.

Revenue Recognition

In October 2006, we announced our plan to launch the Avastin Patient Assistance Program in the first quarter of 2007, which is a voluntary program that enables eligible patients who receive greater than 10,000 milligrams of Avastin over a 12-month period to receive free Avastin during the remainder of the 12-month period. Based on the current wholesale acquisition cost, the 10,000 milligrams is valued at $55,000 in gross revenue. Eligible patients include those who are being treated for an FDA-approved indication and who meet the household income criteria for this program. The program will be available for eligible patients who enroll regardless of whether they are insured. We defer a portion of the Avastin product sales revenue to reflect our estimate of the free Avastin commitment to those patients who elect to enroll in the program. A maximum amount of $55,000 of gross revenue earned from an

35



enrolled patient will be recognized ratably over the total number of product vials used for infusions from their physicians which were obtained through normal commercial channels as well as those vials we will deliver directly to their physician in conjunction with the Avastin Patient Assistance Program. As a result of our announced commitment to the program and because retroactive credit provisions are applicable for patients currently on Avastin for all FDA-approved indications, we deferred $9 million of our fourth quarter 2006 Avastin product sales to reflect our estimate of the free Avastin commitments we incurred for patients treated in the fourth quarter of 2006 who will receive free Avastin later in the course of their therapy.

In order to make our estimate of the amount of free Avastin to be provided to patients under the program, we need to estimate several factors, most notably: the number of patients who are currently being treated for FDA-approved indications and the start date for their treatment regimen, the extent to which doctors and patients may elect to enroll in the program, the number of patients who will meet the financial eligibility requirements of the program, and the duration and extent of treatment for the FDA-approved indications, among other factors. We have based our enrollment assumptions on physician surveys and other information that we consider relevant. We have analyzed a range of reasonably possible outcomes, and as of December 31, 2006, the range of reasonably possible outcomes was estimated to be between $3 million and $20 million, with $9 million as the most likely outcome in that range. We will continue to update our estimates in each reporting period as new information becomes available. If the actual results underlying this deferred revenue accounting vary significantly from our estimates, we will need to make adjustments to these estimates, which could have a material effect on revenue and earnings in the period of adjustment.

Product Sales Allowances

Revenues from U.S. product sales are recorded net of allowances and accruals for rebates, healthcare provider contractual chargebacks, prompt pay sales discounts, product returns, and wholesaler inventory management allowances, all of which are established at the time of sale. Sales allowances and accruals are based on estimates of the amounts earned or to be claimed on the related sales. The amounts reflected in our Consolidated Statements of Income as total product sales allowances, have been relatively consistent at approximately seven to eight percent of gross sales. In order to prepare our Consolidated Financial Statements, we are required to make estimates regarding the amounts earned or to be claimed on the related product sales.

Definitions for the product sales allowance types are as follows:

 
·
Rebate allowances and accruals are comprised of both direct and indirect rebates. Direct rebates are contractual price adjustments payable to direct customers, mainly to wholesalers and specialty pharmacies, that purchase products directly from us. Indirect rebates are contractual price adjustments payable to healthcare providers and organizations such as clinics, hospitals, pharmacies, Medicaid and group purchasing organizations that do not purchase products directly from us;

 
·
Prompt pay sales discounts are credits granted to wholesalers for remitting payment on their purchases within established cash repayment incentive periods;

 
·
Product return allowances are established in accordance with our Product Returns Policy. Our returns policy allows product returns within the period beginning two months prior to and six months following product expiration;

 
·
Wholesaler inventory management allowances are credits granted to wholesalers for compliance with various contractually-defined inventory management programs. These programs were created to align purchases with underlying demand for our products and to maintain consistent inventory levels, typically at two to three weeks of sales depending on the product; and

 
·
Healthcare provider contractual chargebacks are the result of contractual commitments by us to provide products to healthcare providers at specified prices or discounts.

36



We believe that our estimates related to product returns allowances and wholesaler inventory management payments are not material amounts, based upon the historical levels of credits and allowances as a percentage of product sales. We believe our estimates related to healthcare provider contractual chargebacks and prompt pay sales discounts do not have a high degree of estimation complexity or uncertainty as the related amounts are settled within a short period of time. We consider rebate allowances and accruals to be the only process that involves both material amounts, and requires a higher degree of subjectivity and judgment necessary to account for the rebate allowances or accruals. As a result of the uncertainties involved in estimating rebate allowances and accruals, there is a likelihood that materially different amounts could be reported under different conditions or using different assumptions.

Our rebates are based upon definitive agreements or legal requirements (such as Medicaid). These rebates are primarily estimated using historical and other data, including patient usage, customer buying patterns, applicable contractual rebate rates and contract performance by the benefit providers. Direct rebates are accrued at the time of sale and recorded as allowances against trade accounts receivable; indirect (including Medicaid) rebates are accrued at the time of sale and recorded as liabilities. Rebate estimates are evaluated quarterly and may require changes to better align our estimates with actual results. As part of this evaluation, we review changes to Medicaid legislation, changes to State rebate contracts, changes in the level of discounts, and significant changes in product sales trends. Although rebates are accrued at the time of sale, rebates are typically paid out, on average, up to six months after the sale. We believe our rebate allowances and accruals estimation process provides a high degree of confidence in the amounts established and that the annual allowance amounts provided for would not vary by more than approximately 3% based on our estimate that our changes in rebate allowances and accruals estimates related to prior years have not exceeded 3%. To illustrate our sensitivity to changes in the rebate allowances and accruals process, as much as a 10% change in the rebate allowances and accruals provision we recognized in 2006 (which is in excess of three times the level of variability we have recently observed for rebates) would have an approximately $13 million effect on our income before taxes (or less than $0.01 per share, after tax). The total rebate allowances and accruals recorded in our Consolidated Balance Sheets were $53 million as of December 31, 2006 and $50 million as of December 31, 2005.

All of the aforementioned categories of allowances and accruals are evaluated quarterly and adjusted when trends or significant events indicate that a change in estimate is appropriate. Such changes in estimate could materially affect our results of operations or financial position; however, to date they have not been material. However, it is possible that we may need to adjust our estimates in future periods. As of December 31, 2006, our Consolidated Balance Sheet reflected estimated product sales allowance reserves and accruals totaling approximately $139 million and for the year ended December 31, 2006, our net product sales were approximately $7,640 million.

Royalties

For substantially all of our agreements with licensees, we estimate royalty revenue and royalty receivables in the periods these royalties are earned, in advance of collection. Our estimate of royalty revenue and receivables in those instances is based upon communication with some licensees, historical information and forecasted sales trends. Differences between actual revenues and estimated royalty revenues are adjusted for in the period in which they become known, typically the following quarter. Historically, such adjustments have not been material to our consolidated financial condition or results of operations.

Income Taxes

Income tax expense is based on income before taxes and is computed using the liability method. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using tax rates projected to be in effect for the year in which the differences are expected to reverse. Significant estimates are required in determining our provision for income taxes. Some of these estimates are based on interpretations of existing tax laws or regulations. Various internal and external factors may have favorable or unfavorable effects on our future effective income tax rate. These factors include, but are not limited to, changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, changes in estimates of prior years’ items, past and future levels of R&D spending, and changes in overall levels of income before taxes.

37



Inventories

Inventories include currently marketed products manufactured under a new process or at facilities awaiting regulatory approval. These inventories are capitalized based on management’s judgment of probable near term regulatory approval. The valuation of inventory requires us to estimate the value of inventory that may become expired prior to use or that may fail to be released for commercial sale. The determination of obsolete inventory requires us to estimate the future demands for our products, and in the case of pre-approval inventories, to estimate the regulatory approval date for the product or for the licensure of either the manufacturing facility or the new manufacturing process. We may be required to expense previously capitalized inventory costs upon a change in our judgment, due to, among other potential factors, a denial or delay of approval of a product or the licensure of either a manufacturing facility or a new manufacturing process by the necessary regulatory bodies, or new information that suggests that the inventory will not be saleable.

Employee Stock-Based Compensation—Adoption of FAS 123R

On January 1, 2006, we began accounting for employee stock-based compensation in accordance with FAS 123R. Under the provisions of FAS 123R, employee stock-based compensation is estimated at the date of grant based on the employee stock award’s fair value using the Black-Scholes option-pricing model and is recognized as expense ratably over the requisite service period in a manner similar to other forms of compensation paid to employees. The Black-Scholes option-pricing model requires the use of certain subjective assumptions. The most significant of these assumptions are our estimates of the expected volatility of the market price of our stock and the expected term of the award. Due to the redemption of our Special Common Stock in June 1999 (or “Redemption”) by Roche Holdings, Inc. (or “Roche”), there is limited historical information available to support our estimate of certain assumptions required to value our stock options. When establishing an estimate of the expected term of an award, we consider the vesting period for the award, our recent historical experience of employee stock option exercises (including forfeitures), the expected volatility, and a comparison to relevant peer group data. As required under the accounting rules, we review our valuation assumptions at each grant date and, as a result, our valuation assumptions used to value employee stock-based awards granted in future periods may change. As of December 31, 2006, total compensation cost related to unvested stock options not yet recognized was $839 million, which is expected to be allocated to expense and production costs over a weighted-average period of 28 months. For the year ended December 31, 2006, employee stock-based compensation expense, net of tax, was approximately $182 million, or $0.17 per diluted share. For 2007, employee stock-based compensation is expected to be in the range of $0.23 to $0.25 per diluted share, of which $0.04 represents employee stock-based compensation expense as a component of cost of sales, which had previously been capitalized in inventory.

38



Results of Operations
(In millions, except per share amounts)

               
Annual Percentage Change
 
   
2006
 
2005
 
2004
 
2006/2005
 
 2005/2004
 
Product sales
 
$
7,640
 
$
5,488
 
$
3,749
   
39
%
 
46
%
Royalties
   
1,354
   
935
   
641
   
45
   
46
 
Contract revenue
   
290
   
210
   
231
   
38
   
(9
)
Total operating revenues
   
9,284
   
6,633
   
4,621
   
40
   
44
 
Cost of sales
   
1,181
   
1,011
   
673
   
17
   
50
 
Research and development
   
1,773
   
1,262
   
948
   
40
   
33
 
Marketing, general and administrative
   
2,014
   
1,435
   
1,088
   
40
   
32
 
Collaboration profit sharing
   
1,005
   
823
   
594
   
22
   
39
 
Recurring charges related to redemption
   
105
   
123
   
145
   
(15
)
 
(15
)
Special items: litigation-related
   
54
   
58
   
37
   
(7
)
 
57
 
Total costs and expenses
   
6,132
   
4,712
   
3,485
   
30
   
35
 
Operating income
   
3,152
   
1,921
   
1,136
   
64
   
69
 
Other income (expense):
                               
Interest and other income (expense), net
   
325
   
142
   
91
   
129
   
56
 
Interest expense
   
(74
)
 
(50
)
 
(7
)
 
48
   
614
 
Total other income, net
   
251
   
92
   
84
   
173
   
10
 
Income before taxes
   
3,403
   
2,013
   
1,220
   
69
   
65
 
Income tax provision
   
1,290
   
734
   
435
   
76
   
69
 
Net income
 
$
2,113
 
$
1,279
 
$
785
   
65
   
63
 
Earnings per share:
                               
Basic
 
$
2.01
 
$
1.21
 
$
0.74
   
66
   
64
 
Diluted
 
$
1.97
 
$
1.18
 
$
0.73
   
67
   
62
 
Pretax operating margin
   
34
%
 
29
%
 
25
%
           
COS as a % of product sales
   
15
   
18
   
18
             
R&D as a % of operating revenues
   
19
   
19
   
21
             
MG&A as a % of operating revenues
   
22
   
22
   
24
             
NI as a % of operating revenues
   
23
   
19
   
17
             
Tax rate
   
38
   
36
   
36
             
________________________
Percentages in this table and throughout our discussion and analysis of financial condition and results of operations may reflect rounding adjustments.

Total Operating Revenues

Total operating revenues increased 40% to $9,284 million in 2006 and increased 44% to $6,633 million in 2005. These increases were primarily due to higher product sales and royalty revenue, and are further discussed below.

39



Total Product Sales
(In millions)
               
Annual Percentage Change
 
Product Sales
 
2006
 
2005
 
2004
 
2006/2005
 
2005/2004
 
Net U.S. Product Sales
                     
Avastin
 
$
1,746
 
$
1,133
 
$
545
   
54
%
 
108
%
Rituxan
   
2,071
   
1,832
   
1,574
   
13
   
16
 
Herceptin
   
1,234
   
747
   
479
   
65
   
56
 
Lucentis
   
380
   
-
   
-
   
-
   
-
 
Xolair
   
425
   
320
   
188
   
33
   
70
 
Tarceva
   
402
   
275
   
13
   
46
   
*
 
Nutropin products
   
378
   
370
   
349
   
2
   
6
 
Thrombolytics
   
243
   
218
   
194
   
11
   
12
 
Pulmozyme
   
199
   
186
   
157
   
7
   
18
 
Raptiva
   
90
   
79
   
52
   
14
   
52
 
Total U.S. product sales
   
7,169
   
5,162
   
3,551
   
39
   
45
 
Net product sales to collaborators
   
471
   
326
   
198
   
44
   
65
 
Total product sales
 
$
7,640
 
$
5,488
 
$
3,749
   
39
   
46
 
________________________
*
Calculation not meaningful.
 
The values shown above are exact; therefore, the totals may not appear to sum due to rounding.

Total net product sales increased 39% to $7,640 million in 2006 and increased 46% to $5,488 million in 2005. Net U.S. sales increased 39% to $7,169 million in 2006 and increased 45% to $5,162 million in 2005. These increases in U.S. sales were due to higher sales across all products, in particular higher sales of our oncology products and sales of Lucentis in 2006. U.S. oncology sales accounted for 76% of U.S. product sales in 2006 compared to 77% in 2005. Increased U.S. sales volume accounted for 89%, or $1,785 million, of the increase in U.S. net product sales in 2006, and 88%, or $1,411 million in 2005. The increased U.S. sales volume in 2006 also included new product shipments of Lucentis. Changes in net U.S. sales prices across the portfolio accounted for most of the remainder of the increases in U.S. net product sales in 2006 and 2005.

Effective July 1, 2006, we made changes to our distribution model for Avastin, Herceptin and Rituxan and renegotiated our distribution agreements with a number of our major wholesalers. As part of these changes, the time at which we recognize products sales revenue for domestic product shipments changed from the time at which we ship our products to the time at which our products arrive at the designated receiving location. These distribution changes did not have a material effect on our 2006 results of operations.

Our references to market research and market adoption and penetration by treatment regimen are derived from our analyses of market tracking studies and surveys we undertake with physicians. We use statistical analyses to extrapolate the data we obtain.

Avastin

Net U.S. sales of Avastin increased 54% to $1,746 million in 2006 and 108% to $1,133 million in 2005. Net U.S. sales in 2006 reflect $9 million of deferred revenue resulting from the announcement of our Avastin Patient Assistance Program and our estimated free drug commitment for patients currently on Avastin for an FDA-approved indication. The increase in sales in 2006 was primarily a result of increased use of Avastin in metastatic NSCLC, approved on October 11, 2006, and metastatic breast cancer, an unapproved use of Avastin. In addition, the increase reflects modest gains in the treatment of first-line metastatic colorectal cancer (or “CRC”), for which Avastin is approved. Growth in the use of Avastin for the treatment of metastatic NSCLC was due to greater pre-launch adoption and post-launch penetration rates during 2006 as compared to 2005. In first-line metastatic NSCLC we estimate that Avastin penetration was 26% among all first-line NSCLC patients in the fourth quarter of 2006. In first-line metastatic CRC, we estimate that Avastin penetration was up slightly to 72% during 2006 as compared to

40



2005; however, over the course of 2006 we observed a flattening in penetration, duration and dose. These increases were partially offset by declining revenues in metastatic renal cell carcinoma (or “RCC”) and metastatic pancreatic cancer, both unapproved uses. As a result of competing products that have entered the market since the first quarter of 2006, we have seen a decline in the adoption of Avastin in metastatic RCC (an unapproved use). Revenues from metastatic pancreatic cancer have also declined following our June 2006 announcement that we halted a Phase III trial of Avastin in combination with chemotherapy for the first-line treatment of advanced pancreatic cancer because of failure to meet the primary endpoint of overall survival. Growth in 2005 relative to 2004 was primarily a result of increased use of Avastin in CRC. There were no price increases in 2006 or 2005.

We anticipate that the major driver of Avastin growth for 2007 will come from use in the first-line treatment of metastatic NSCLC.

In September 2006, we received a Complete Response Letter from the FDA for the sBLA for Avastin with chemotherapy in first-line metastatic breast cancer. The FDA has requested a substantial safety and efficacy update from the E2100 trial, including an independent review of patient scans for progression free survival, the study’s primary endpoint. We are currently addressing the FDA’s requests and based on the scope of their request, we anticipate we will be able to resubmit the application to the FDA in mid-2007. A new six-month review period will begin once the additional information is submitted to the FDA.

On February 21, 2007, we announced that a Roche-sponsored Phase III study evaluating two different doses of Avastin in combination with gemcitabine and cisplatin chemotherapy met the primary endpoint of prolonging progression-free survival (or “PFS”) in patients with previously untreated, advanced NSCLC. This study evaluated a 15 mg/kg/every 3 weeks dose of Avastin (the dose approved in the U.S. for use in combination with carboplatin and paclitaxel) and a lower dose of 7.5 mg/kg/every 3 weeks (a dose not approved for use in the U.S.). Both doses of Avastin significantly improved PFS compared to chemotherapy alone as assessed by trial investigators. Although the study was not designed to compare the Avastin doses, a similar treatment effect in PFS was observed between the two arms.

Rituxan

Net U.S. sales of Rituxan increased 13% to $2,071 million in 2006 and 16% to $1,832 million in 2005. Rituxan’s channel inventory finished the year at the upper level of our target range, adding approximately $10 million to $12 million to 2006 sales. Sales growth in 2006 resulted from increased use of Rituxan in rheumatoid arthritis, approved on February 28, 2006, as well as Rituxan following chemotherapy in combined NHL, including areas of unapproved use, and chronic lymphocytic leukemia (or “CLL”), an unapproved use. We estimate that Rituxan’s overall adoption rate in combined markets of NHL and CLL remained flat at 82% at the end of 2006 and at the end of 2005. Also contributing to the increases in product sales were price increases effective on July 6, 2005, October 5, 2005, March 29, 2006, and October 5, 2006.

The sales growth in 2005 resulted from increased physician adoption for treatment of indolent NHL with ongoing use of Rituxan following induction therapy, treatment of aggressive NHL, and treatment of CLL (unapproved uses of Rituxan in 2005). Net U.S. sales in 2005 included $10 million for a reorder to replace a shipment that was destroyed while in transit to a wholesaler. Also contributing to the increases in product sales were price increases in 2005 noted above.

Rituxan was approved for the treatment of adult patients with moderately-to-severely active RA in the first quarter of 2006. It remains difficult to precisely determine the sales split between Rituxan use in oncology and immunology settings since many treatment centers treat both types of patients.

Herceptin

Net U.S. sales of Herceptin increased 65% to $1,234 million in 2006 and 56% to $747 million in 2005. The sales growth in 2006 and 2005 was primarily the result of increased use of Herceptin in the treatment of early stage HER2-positive breast cancer (approved on November 16, 2006), increased use in the treatment of first-line HER2-positive

41



metastatic breast cancer, and increased cumulative duration of therapy relative to the comparable periods in 2005 and 2004. In first-line HER2-positive metastatic breast cancer patients, we estimate Herceptin’s penetration remained flat at 70% at the end of 2006 as adoption was also 70% at the end of 2005. While use in early stage breast cancer patients increased in 2006 relative to 2005, we believe usage in this setting flattened in the second half of 2006. We estimate Herceptin’s penetration in the adjuvant setting was 62% at the end of 2006 as compared to 43% adoption at the end of 2005. Also contributing, to a lesser extent, to the increases in product sales were price increases effective on February 24, 2005, March 29, 2006, and October 3, 2006.

Lucentis

We received FDA approval to market Lucentis for the treatment of AMD on June 30, 2006. Net U.S. sales of $380 million in 2006 were driven by high demand among existing AMD patients previously on other therapies and by newly diagnosed patients. We estimate that as of December 31, 2006 approximately 75 percent of Lucentis patients were AMD patients previously on other therapies that were switched to Lucentis and the remaining 25 percent were newly diagnosed patients. Our market research indicates that at six months post launch approximately 55 percent of newly diagnosed patients were treated with Lucentis. Sales growth in 2007 may be negatively impacted by (i) a decrease in existing AMD patients switching to Lucentis from other therapies, as we believe most of the existing AMD patients were switched to Lucentis or have chosen not to change therapies; (ii) less frequent dosing of existing patients who have completed their first four months of treatment; and (iii) continued use of Avastin in this setting.

Xolair

Net U.S. sales of Xolair increased 33% to $425 million in 2006 and 70% to $320 million in 2005. Sales growth in 2006 and 2005 were driven by increased penetration in the asthma market and, to a lesser extent, price increases effective on July 21, 2005, April 4, 2006, and October 17, 2006.

On February 21, 2007, the FDA announced it requested that Genentech strengthen the existing warning on the potential risk for anaphylaxis in patients receiving Xolair by adding a boxed warning to the product label and implementing a Risk Mitigation Action Plan, including providing a medication guide for patients. Genentech and Novartis will be working with FDA on its request.

Tarceva

Net U.S. sales of Tarceva increased 46% to $402 million in 2006. Net U.S. sales in 2005 were $275 million after the product launch in November 2004. The increase in product sales in 2006 was primarily due to price increases effective on April 5, 2005, November 9, 2005, and November 14, 2006. Also affecting our product sales was growth in penetration and duration of treatment in both second-line NSCLC and first-line pancreatic cancer; however, penetration in second-line NSCLC decreased in the second half of 2006. We estimate Tarceva’s penetration in second-line NSCLC averaged 30% in 2006 compared to 24% in 2005. We estimate Tarceva’s penetration in the first-line pancreatic cancer setting was 40% at the end of 2006 as compared to 24% at the end of 2005. Future sales growth in NSCLC will depend on gains in penetration against chemotherapy within select second-line NSCLC patient subsets, increased patient compliance with prescribed therapy, continuing recent gains in duration of therapy, and reducing obstacles for patient access to therapy.

Nutropin Products

Combined net U.S. sales of our Nutropin products increased 2% to $378 million in 2006 and 6% to $370 million in 2005. The increases in 2006 and 2005 were primarily due to price increases effective on March 3, 2005 and January 10, 2006. The 2006 increase in price was partially offset by a decrease in sales volume in 2006 compared to 2005, resulting from declining new patient market share and the loss of managed care product placement due to price discounting by competitors.

42



Thrombolytics

Combined net U.S. sales of our three thrombolytics products, Activase, Cathflo Activase, and TNKase, increased 11% to $243 million in 2006 and 12% to $218 million in 2005.  Sales growth in 2006 and 2005 was due to growth in Cathflo Activase sales in the catheter clearance market and increased Activase sales in the acute ischemic stroke market. Also contributing to the increases in product sales were price increases effective on January 11, 2005, February 14, 2006, and July 6, 2006.

Pulmozyme

Net U.S. sales of Pulmozyme increased 7% to $199 million in 2006 and 18% to $186 million in 2005. The sales growth in both 2006 and 2005 represents price increases effective on April 26, 2005 and June 29, 2006, as well as a focus on aggressive treatment of cystic fibrosis early in the course of the disease.

Raptiva

Net U.S. sales of Raptiva increased 14% to $90 million in 2006 and 52% to $79 million in 2005. The growth in 2006 was primarily due to price increases effective on April 21, 2005, November 17, 2005, and August 10, 2006.

Sales to Collaborators

Product sales to collaborators, the majority of which were for non-U.S. markets, increased 44% to $471 million in 2006 and 65% to $326 million in 2005. The increase in 2006 was primarily due to higher sales of Herceptin, Avastin and Rituxan to F. Hoffmann-La Roche. The increase in 2005 was primarily due to sales of Avastin and Rituxan to F. Hoffmann-La Roche and sales of product manufactured under a contract with a third party. In January 2007, Novartis received European Union approval for Lucentis for the treatment of patients with wet AMD. For 2007, we expect sales to collaborators to approximately double relative to 2006 levels.

Royalties

Royalty revenues increased 45% to $1,354 million in 2006 and 46% to $935 million in 2005. The increases were due to higher sales by F. Hoffmann-La Roche of Herceptin, Avastin and Rituxan in 2006, and Herceptin and Rituxan in 2005; and higher sales by various other licensees on other products. Of the overall royalties recognized, royalty revenue from F. Hoffmann-La Roche represented approximately 62% in 2006, 53% in 2005, and 52% in 2004. Also contributing to the increase in 2005 was a new license arrangement with ImClone Systems, Inc. under which we receive royalties on sales of ERBITUX®. We received a one-time payment in the first quarter of 2005 relating to royalties on ERBITUX® sales from the period between launch of the product in 2004 and the signing of the agreement in January 2005. Royalties from other licensees include royalty revenue on our patents, including our Cabilly patents noted below.

We have confidential licensing agreements with a number of companies on U.S. Patent No. 6,331,415 and No. 4,816,567 (or the “Cabilly patents”), under which we receive royalty revenue on sales of products that are covered by one or more of the Cabilly patents. The ‘567 patent expired in March 2006, while the ‘415 patent expires in December 2018. The licensed products for which we receive the most significant Cabilly royalties are Humira®, Remicade®, Synagis®, and ERBITUX®. Cabilly royalties affect three lines on our Consolidated Statement of Income:  (i) We record gross royalties we receive from Cabilly patent licensees as royalty revenue; (ii) On royalties we receive from Cabilly licensees, we in turn pay City of Hope National Medical Center (or “COH”) a percentage of our royalty revenue and these payments to COH are recorded with our marketing, general and administrative (or “MG&A”) expenses as royalty expense; (iii) We pay royalty expenses directly to COH on sales of our products that are covered by the Cabilly patents and these payments to COH are recorded in cost of sales. The overall net pre-tax contribution from revenues and expenses related to the Cabilly patents was approximately $105 million in 2006, or approximately $0.06 per diluted share, and $70 million in 2005, or approximately $0.04 per diluted share, excluding the effects of the one-time licensee payment we recorded in the first quarter of 2005 as discussed above. See also

43



Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K for further information on our Cabilly patent reexaminations.

Cash flows from royalty revenues include amounts denominated in foreign currencies. We currently enter into foreign currency option and forward contracts to hedge these foreign currency cash flows. These options and forwards are due to expire in 2007 through 2008. See also Note 2, “Summary of Significant Accounting Policies,” and Note 4, “Investments Securities and Financial Instruments — Derivative Financial Instruments,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K.

For 2007, we expect royalty revenue to increase approximately 25% over 2006 levels of $1,354 million; however, royalties are difficult to forecast because of the number of products involved.

Contract Revenues

Contract revenues increased 38% to $290 million in 2006, and decreased 9% to $210 million in 2005. The increase in 2006 was primarily due to higher contract revenues from Hoffmann-La Roche driven by higher reimbursements related to R&D development efforts on Avastin and manufacturing plant start-up costs, and a Herceptin milestone payment. Also contributing to the increase in 2006 were higher reimbursements from Biogen Idec related to R&D development efforts on Rituxan (RA and other immunology indications). The decrease in 2005 was mainly due to lower contract revenues from our collaborators, including OSI and XOMA, Ltd. (or “XOMA”). Due to the commercialization of Tarceva in November 2004, subsequent development efforts on this product were included in net operating profit sharing with OSI, which was reflected in the collaboration profit sharing line. In January 2005, we restructured our Raptiva collaboration arrangement with XOMA, whereby XOMA is no longer obligated to co-develop Raptiva, and we no longer earn contract revenue on the development of Raptiva. These decreases were partially offset by higher reimbursements in 2005 on R&D development efforts related to our Rituxan collaboration with Biogen Idec. See “Related Party Transactions” below for more information on contract revenue from F. Hoffmann-La Roche.

Contract revenues vary each quarter and are dependent on a number of factors, including the timing and level of reimbursements from ongoing development efforts, milestones and opt-in payments received, and new contract arrangements. For 2007, we expect contract revenues to decrease by approximately 15% as compared to $290 million in 2006.

Cost of Sales

Cost of sales (or “COS) as a percentage of net product sales was 15% in 2006 as compared to 18% in both 2005 and 2004. COS in 2006 and 2005 was favorably affected by increased sales of our higher margin products, primarily Lucentis, Avastin, Herceptin and Rituxan in 2006 and Avastin, Herceptin and Rituxan in 2005. COS in 2005 was also favorably affected by a reversal of a royalty accrual of $7 million, partially offset by charges of $41 million in payments to Amgen Inc. (or “Amgen”) and another collaborator to cancel and amend certain future manufacturing obligations, higher production costs, and a $20 million one-time royalty cost associated with a sales milestone that we owed a collaborator.

In 2007, we will begin recording employee stock-based compensation expense in the cost of sales line related to products sold for which employee stock-based compensation expense was previously capitalized as part of inventory costs upon implementation of FAS 123R on January 1, 2006.

Research and Development

Research and development (or “R&D”) expenses increased 40% to $1,773 million in 2006, and increased 33% to $1,262 million in 2005. R&D as a percentage of total operating revenues was 19% in 2006 and 2005, and 21% in 2004. The year-over-year decline in this ratio reflects the increase in operating revenues.

44



The major components of R&D expenses were as follows (in millions):

               
Annual Percentage Change
 
Research and Development
 
2006
 
2005
 
2004
 
2006/2005
 
2005/2004
 
Product development (including post-marketing)
 
$
1,269
 
$
935
 
$
668
   
36
%
 
40
%
Research
   
326
   
235
   
218
   
39
   
8
 
In-licensing
   
178
   
92
   
62
   
93
   
48
 
Total
 
$
1,773
 
$
1,262
 
$
948
   
40
   
33
 

Product development:  Product development expenses include costs of conducting clinical trials, activities to support regulatory filings, and post-marketing expenses, which include Phase IV and investigator-sponsored trials and product registries. Such costs include costs of personnel, drug supply costs, research fees charged by outside contractors, co-development costs, and facility expenses, including depreciation. Total development expenses increased 36% to $1,269 million in 2006 and 40% to $935 million in 2005. See “Products in Development” in the Business section of Part I, Item 1 of this Form 10-K for further information regarding our development pipeline.

The increase in 2006 expense was primarily driven by:  (i) $184 million higher development expenses due to increased activity across our entire product portfolio, including increased spending on clinical programs, including late-stage clinical trials for Avastin, Rituxan Immunology, humanized anti-CD20, and other programs, early stage projects and higher clinical manufacturing expenses in support of our clinical trials; and (ii) a $37 million increase in post-marketing expense related to studies of Avastin, Lucentis, Rituxan Immunology and Xolair. In addition, development expenses in 2006 included $113 million of employee stock-based compensation expense related to FAS 123R.

The increase in 2005 expense was primarily driven by: (i) $222 million higher development expenses due to an increase in clinical programs including our broad Avastin development program, Rituxan Immunology, Lucentis, anti-HER2 and BR3-Fc for rheumatoid arthritis; higher clinical manufacturing start-up costs associated with new contract sites, including costs related to testing the Herceptin manufacturing process at Wyeth, increased clinical manufacturing of our anti-CD20 molecule, and various new molecular entities including Apo2L/TRAIL; and increased headcount and related expenses and higher depreciation and facility expenses; and (ii) a $45 million increase in post-marketing expense related to studies of Avastin, Rituxan Immunology, Lucentis and Nutropin.

Research:  Research includes expenses associated with research and testing of our product candidates prior to reaching the development stage. Such expenses primarily include the costs of internal personnel, outside contractors, facilities, including depreciation, and lab supplies. Personnel costs primarily include salary, benefits, recruiting and relocation costs. Research expenses increased 39% to $326 million in 2006 and 8% to $235 million in 2005. The primary driver of the increase in both years was an increase in internal personnel and related expenses, and outside contractors for research and testing of product candidates. In addition, research expenses in 2006 included $27 million of employee stock-based compensation expense related to FAS 123R.

In-licensing:  In-licensing includes costs incurred to acquire licenses to develop and commercialize various technologies and molecules. In-licensing expenses increased 93% to $178 million in 2006 and 48% to $92 million in 2005. The increase in 2006 primarily related to new in-licensing collaborations with (i) Exelixis to co-develop a small-molecule inhibitor of methyl ethyl keyton (or “MEK”), (ii) AC Immune to research and develop anti-beta-amyloid antibodies for the potential treatment of Alzheimer’s and other diseases, (iii) Inotek Pharmaceuticals Corporation to discover, develop, manufacture and commercialize inhibitors of poly (ADP-ribose) polymerase (or “PARP”) for the potential treatment of cancer, and (iv) CGI Pharmaceuticals to research, develop, manufacture, and commercialize therapeutics for the potential treatment of cancer and immunological disorders. The increase in 2005 was primarily due to the expansion of research collaborations.

For 2007, we expect R&D absolute dollar spending to increase over 2006 levels due to continued investment in our late stage pipeline, and the addition of new molecules and indications to the early stage pipeline.

45



Marketing, General and Administrative

Overall marketing, general and administrative (or “MG&A”) expenses increased 40% to $2,014 million in 2006 and 32% to $1,435 million in 2005. MG&A as a percentage of total operating revenues was 22% in 2006 and 2005, and 24% in 2004. The decline in this ratio since 2004 primarily reflects the increase in operating revenues.

The increase in 2006 expense was primarily due to: (i) an increase of $149 million in marketing and sales spending primarily in support of launch activities related to Lucentis for AMD and Rituxan for RA; (ii) an increase of $84 million in marketing and sales spending on Avastin primarily in support of launch activities for NSCLC, a recently approved indication, and pre-launch activities for a potential breast cancer indication; (iii) a $47 million increase resulting from ongoing marketing efforts with established products, primarily Herceptin, partially offset by a $40 million decrease in Raptiva marketing costs; (iv) an increase of $131 million in support of our continued corporate growth including headcount growth and headcount related expenses, charitable donations, of which $26 million related to increased donations to independent public charities that provide co-pay assistance to eligible patients, and legal costs; and (v) an increase of $39 million in royalty expense, primarily to Biogen Idec resulting from higher Hoffmann-La Roche sales of Rituxan. In addition, MG&A expenses in 2006 included $169 million of employee stock-based compensation expense related to FAS 123R.

The increase in 2005 expense was primarily due to: (i) an increase of $121 million primarily in support of the launch of Tarceva and higher marketing costs for Avastin, Xolair and Raptiva; (ii) an increase of $89 million primarily due to pre-launch costs associated with pipeline products, including Rituxan RA and Lucentis and other pipeline product investments; (iii) an increase of $19 million resulting from ongoing marketing efforts with established products, primarily Herceptin; (iv) an increase of $79 million in general corporate expenses to support our continued growth and higher legal costs; and (v) $39 million in increased charitable donations, of which $21 million was donated to various independent, third party, public charities that provide co-pay assistance to eligible patients, and $13 million was donated to the Genentech Foundation, which primarily funds health science education.

For 2007, we expect MG&A expense to increase primarily driven by higher costs in support of recently launched products and anticipated launches of potential new product indications, including those for Avastin, and continued support of our corporate growth and infrastructure needs.

Collaboration Profit Sharing

Collaboration profit sharing expenses increased 22% to $1,005 million in 2006 and 39% to $823 million in 2005 due to higher sales of Rituxan, Tarceva and Xolair and the related profit sharing expenses. Our collaboration profit sharing expenses are expected to grow in 2007, consistent with our expectations of higher sales for the respective products.

The following table summarizes the amounts resulting from the respective profit sharing collaborations, for the periods presented (in millions):

               
Annual Percentage Change
 
   
2006
 
2005
 
2004
 
2006/2005
 
2005/2004
 
U.S. Rituxan profit sharing expense
 
$
672
 
$
603
 
$
518
   
11
%
 
16
%
U.S. Tarceva profit sharing expense
   
146
   
83
   
-
   
76
   
-
 
U.S. and ex-U.S. Xolair profit sharing expense
   
187
   
137
   
76
   
36
   
80
 
Total collaboration profit sharing expense
 
$
1,005
 
$
823
 
$
594
   
22
   
39
 

Currently, our most significant collaboration profit sharing agreement is with Biogen Idec, with whom we co-promote Rituxan in the U.S. Under the collaboration agreement, Biogen Idec granted us a worldwide license to develop, commercialize and market Rituxan in multiple indications. In exchange for these worldwide rights, Biogen Idec has co-promotion rights in the U.S. and a contractual arrangement under which we share a portion of the pretax U.S. co-promotion profits of Rituxan and royalty revenue on sales of Rituxan by collaborators. In June 2003, we

46



amended and restated the collaboration agreement with Biogen Idec to include the development and commercialization of one or more anti-CD20 antibodies targeting B-cell disorders, in addition to Rituxan, for a broad range of indications.

Under the amended and restated collaboration agreement, our share of the current pretax U.S. co-promotion profit sharing formula is approximately 60% of operating profits and Biogen Idec’s share is approximately 40% of operating profits. For each calendar year or portion thereof following the approval date of the first new anti-CD20 product, over a period of transition, our share of the pretax U.S. co-promotion profits will change to approximately 70% of operating profits and Biogen Idec’s share will be approximately 30% of operating profits.

Collaboration profit sharing expense, exclusive of research and development expenses, related to Biogen Idec for the years ended December 31, 2006, 2005 and 2004, consisted of the following commercial activity (in millions):

               
Annual Percentage Change
 
   
2006
 
2005
 
2004
 
2006/2005
 
2005/2004
 
Product sales, net
 
$
2,071
 
$
1,832
 
$
1,574
   
13
%
 
16
%
Combined commercial costs and expenses
   
489
   
390
   
316
   
25
   
23
 
Combined co-promotion profits
 
$
1,582
 
$
1,442
 
$
1,258
   
10
   
15
 
Amount due to Biogen Idec for their share of co-promotion profits - included in collaboration profit sharing expense
 
$
672
 
$
603
 
$
518
   
11
   
16
 

Biogen Idec’s relative share of combined commercial costs determines the amount shown as collaboration profit sharing expense, exclusive of research and development expenses.

Total revenue and expenses related to our collaboration with Biogen Idec included the following (in millions):

               
Annual Percentage Change
 
   
2006
 
2005
 
2004
 
2006/2005
 
2005/2004
 
Contract revenue
 
$
79
 
$
59
 
$
41
   
34
%
 
44
%
                                 
Co-promotion profit sharing expense
 
$
672
 
$
603
 
$
518
   
11
   
16
 
                                 
Royalty expense on ex-U.S. sales of Rituxan and other patent costs - included in MG&A expense
 
$
175
 
$
139
 
$
119
   
26
   
17
 

Recurring Charges Related to Redemption

We record recurring charges related to the June 1999 redemption of our Special Common Stock and push-down accounting (see discussion below in “Relationship with Roche — Redemption of Our Special Common Stock”). These charges were comprised of the amortization of Redemption-related other intangible assets in the periods presented.

Special Items: Litigation-Related

We recorded accrued interest and bond costs related to the COH trial judgment of $54 million each year in 2006, 2005 and 2004.  We expect that we will continue to incur interest charges on the judgment and service fees on the surety bond each quarter through the process of appealing the COH trial results. The amount of cash paid, if any, or the timing of such payment in connection with the COH matter will depend on the outcome of the California Supreme Court’s review of the matter; however, it may take longer than one year to resolve this matter. See Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K for further information regarding our litigation. Also included in this line in 2005 is a charge related

47



to a litigation settlement, net of amounts received on a separate litigation settlement. Also, included in this line in 2004 is a released accrual as a result of the resolution of a separate litigation matter.

Operating Income

Operating income increased 64% to $3,152 million in 2006 and increased 69% to $1,921 million in 2005. Our operating income as a percentage of operating revenues (or “pretax operating margin”) was 34% in 2006, 29% in 2005 and 25% in 2004.

Other Income (Expense)

The components of “other income (expense)” are as follows (in millions):

               
Annual Percentage Change
 
   
2006
 
2005
 
2004
 
2006/2005
 
 2005/2004
 
Gains on sales of biotechnology equity securities, net
 
$
93
 
$
9
 
$
13
   
933
%
 
(31
)%
Write-down of biotechnology debt and equity securities
   
(4
)
 
(10
)
 
(12
)
 
(60
)
 
(17
)
Interest income
   
230
   
143
   
90
   
61
   
59
 
Interest expense
   
(74
)
 
(50
)
 
(7
)
 
48
   
614
 
Other miscellaneous income
   
6
   
-
   
-
   
-
   
-
 
Total other income, net
 
$
251
 
$
92
 
$
84
   
173
   
10
 

Other income, net, increased 173% to $251 million in 2006, and increased 10% to $92 million in 2005. The components of other income (expense) have changed primarily due to gains on sales of biotechnology equity securities resulting from Amgen’s acquisition of Abgenix, Pfizer’s acquisition of Rinat, Stiefel Laboratories acquisition of Connetics Corporation, and Astra Zeneca’s acquisition of Cambridge Antibody and the effects of our debt issuance in July 2005. Interest expense increased in 2006 and 2005 due to the new debt service costs, and in 2006 investment income increased as a result of the higher average cash balances maintained and higher yields. In 2007, we expect other income, net, to be approximately 60% lower than 2006 levels, although this may vary with fluctuations in interest rates and unexpected acquisition-related gains from our biotechnology equity portfolio.

Income Tax Provision

The effective income tax rate was 38% in 2006 and 36% in 2005 and 2004. The effective tax rate in 2006 was higher than 2005 and 2004 primarily due to new Final Regulations issued by the U.S. Department of Treasury, which required a $34 million reduction in research credits claimed in prior years. The increase in the 2006 effective income tax rate also resulted from higher income before taxes in 2006. The effective income tax rate in 2005 was comparable to 2004 but included a $39 million benefit for increased research credits resulting from new Temporary Regulations issued by the U.S. Department of Treasury in 2005. The additional benefit in 2005 was partially offset by changes in estimates of prior years’ research credits and by higher income before taxes in 2005.

We anticipate that our annual 2007 effective income tax rate will be approximately 36%, excluding the effect of the potential Tanox acquisition. Various factors may have favorable or unfavorable effects on our effective income tax rate during 2007 and in subsequent years. These factors include, but are not limited to, interpretations of existing tax laws, changes in tax laws and rates, changes in estimates to prior years’ items, past and future levels of R&D spending, and changes in overall levels of income before taxes, all of which may result in periodic revisions to our effective income tax rate.

48


Relationship with Roche

As a result of the June 1999 redemption of our Special Common Stock (“the Redemption”) and subsequent public offerings, we amended our certificate of incorporation and bylaws, amended our licensing and marketing agreement with F. Hoffmann-La Roche Ltd (or “Hoffmann-La Roche”), an affiliate of Roche, and entered into or amended certain agreements with Roche, which are discussed below:

Affiliation Arrangements

Our board of directors consists of three Roche directors, three independent directors nominated by a nominating committee currently controlled by Roche, and one Genentech employee. However, under our bylaws, Roche has the right to obtain proportional representation on our board at any time.

Except as follows, the affiliation arrangements do not limit Roche’s ability to buy or sell our Common Stock. If Roche and its affiliates sell their majority ownership of shares of our Common Stock to a successor, Roche has agreed that it will cause the successor to agree to purchase all shares of our Common Stock not held by Roche as follows:

 
·
with consideration, if that consideration is composed entirely of either cash or equity traded on a U.S. national securities exchange, in the same form and amounts per share as received by Roche and its affiliates; and

 
·
in all other cases, with consideration that has a value per share not less than the weighted-average value per share received by Roche and its affiliates as determined by a nationally recognized investment bank.

If Roche owns more than 90% of our Common Stock for more than two months, Roche has agreed that it will, as soon as reasonably practicable, effect a merger of Genentech with Roche or an affiliate of Roche.

Roche has agreed, as a condition to any merger of Genentech with Roche or the sale of our assets to Roche, that either:

 
·
the merger or sale must be authorized by the favorable vote of a majority of non-Roche stockholders, provided no person will be entitled to cast more than 5% of the votes at the meeting; or

 
·
in the event such a favorable vote is not obtained, the value of the consideration to be received by non-Roche stockholders would be equal to or greater than the average of the means of the ranges of fair values for the Common Stock as determined by two nationally recognized investment banks.

We have agreed not to approve, without the prior approval of the directors designated by Roche:

 
·
any acquisition, sale or other disposal of all or a portion of our business representing 10% or more of our assets, net income or revenues;

 
·
any issuance of capital stock except under certain circumstances; or

 
·
any repurchase or redemption of our capital stock other than a redemption required by the terms of any security and purchases made at fair market value in connection with any deferred compensation plans.

49



Licensing Agreements

We have a July 1999 amended and restated licensing and marketing agreement with Hoffmann-La Roche and its affiliates granting an option to license, use and sell our products in non-U.S. markets. The major provisions of that agreement include the following:

 
·
Hoffmann-La Roche’s option expires in 2015;

 
·
Hoffmann-La Roche may exercise its option to license our products upon the occurrence of any of the following: (1) our decision to file an Investigational New Drug Application (or “IND”) for a product, (2) completion of the first Phase II trial for a product or (3) if Hoffmann-La Roche previously paid us a fee of $10 million to extend its option on a product, completion of a Phase III trial for that product;

 
·
if Hoffmann-La Roche exercises its option to license a product, it has agreed to reimburse Genentech for development costs as follows: (1) if exercise occurs at the time of our decision to file an IND is filed, Hoffmann-La Roche will pay 50% of development costs incurred prior to the filing and 50% of development costs subsequently incurred, (2) if exercise occurs at the completion of the first Phase II trial, Hoffmann-La Roche will pay 50% of development costs incurred through completion of the trial, 75% of development costs subsequently incurred for the initial indications, and 50% of subsequent development costs for new indications, formulations or dosing schedules, (3) if the exercise occurs at the completion of a Phase III trial, Hoffmann-La Roche will pay 50% of development costs incurred through completion of Phase II, 75% of development costs incurred through completion of Phase III, and 75% of development costs subsequently incurred, and $5 million of the option extension fee paid by Hoffmann-La Roche to preserve its right to exercise its option at the completion of a Phase III trial will be credited against the total development costs payable to Genentech upon the exercise of the option, and (4) each of Genentech and Hoffmann-La Roche have the right to “opt-out” of developing an additional indication for a product for which Hoffmann-La Roche exercised its option, and would not share the costs or benefits of the additional indication, but could “opt-back-in” within 30 days of decision to file for approval of the indication by paying twice what they would have owed for development of the indication if they had not opted out;

 
·
we agreed, in general, to manufacture for and supply to Hoffmann-La Roche its clinical requirements of our products at cost, and its commercial requirements at cost plus a margin of 20%; however, Hoffmann-La Roche will have the right to manufacture our products under certain circumstances;

 
·
Hoffmann-La Roche has agreed to pay, for each product for which Hoffmann-La Roche exercises its option upon either a decision to file an IND or completion of the first Phase II trial, a royalty of 12.5% on the first $100 million on its aggregate sales of that product and thereafter a royalty of 15% on its aggregate sales of that product in excess of $100 million until the later in each country of the expiration of our last relevant patent or 25 years from the first commercial introduction of that product; and

 
·
Hoffmann-La Roche will pay, for each product for which Hoffmann-La Roche exercises its option after completion of a Phase III trial, a royalty of 15% on its sales of that product until the later in each country of the expiration of our last relevant patent or 25 years from the first commercial introduction of that product; however, $5 million of any option extension fee paid by Hoffmann-La Roche will be credited against royalties payable to us in the first calendar year of sales by Hoffmann-La Roche in which aggregate sales of that product exceed $100 million.

We have further amended this licensing and marketing agreement with Hoffmann-La Roche to delete or add certain Genentech products under Hoffmann-La Roche’s commercialization and marketing rights for Canada.

We also have a July 1998 licensing and marketing agreement relating to anti-HER2 antibodies (Herceptin and Omnitarg) with Hoffmann-La Roche, providing them with exclusive marketing rights outside of the U.S. Under the agreement, Hoffmann-La Roche funds one-half the global development costs incurred in connection with developing

50



anti-HER2 antibody products under the agreement. Either Genentech or Hoffmann-La Roche has the right to “opt-out” of developing an additional indication for a product and would not share the costs or benefits of the additional indication, but could “opt-back-in” with 30 days of decision to file for approval of the indication by paying twice what would have been owed for development of the indication if no opt-out had occurred. Hoffmann-La Roche has also agreed to make royalty payments of 20% on aggregate net product sales outside the U.S. up to $500 million in each calendar year and 22.5% on such sales in excess of $500 million in each calendar year.

Research Collaboration Agreement

We have an April 2004 research collaboration agreement with Hoffmann-La Roche that outlines the process by which Hoffmann-La Roche and Genentech may agree to conduct and share in the costs of joint research on certain molecules. The agreement further outlines how development and commercialization efforts will be coordinated with respect to select molecules, including the financial provisions for a number of different development and commercialization scenarios undertaken by either or both parties.

Tax Sharing Agreement

We have a tax sharing agreement with Roche. If we and Roche elect to file a combined state and local tax return in certain states where we may be eligible, our tax liability or refund with Roche for such jurisdictions will be calculated on a stand alone basis.

Roche’s Ability to Maintain Its Percentage Ownership Interest in Our Stock 

We issue additional shares of Common Stock in connection with our stock option and stock purchase plans, and we may issue additional shares for other purposes. Our affiliation agreement with Roche provides, among other things, that with respect to any issuance of Common Stock by us in the future, we will repurchase a sufficient number of shares so that immediately after such issuance the percentage of our Common Stock owned by Roche will be no lower than 2% below the “Minimum Percentage” (as defined below), provided however, as long as Roche’s percentage ownership is greater than 50%, prior to issuing any shares, we will repurchase a sufficient number of shares of our Common Stock such that, immediately after our issuance of shares, Roche’s percentage ownership will be greater than 50%. The Minimum Percentage equals the lowest number of shares of Genentech Common Stock owned by Roche since the July 1999 offering (to be adjusted in the future for dispositions of shares of Genentech Common Stock by Roche as well as for stock splits or stock combinations) divided by 1,018,388,704 (to be adjusted in the future for stock splits or stock combinations), which is the number of shares of Genentech Common Stock outstanding at the time of the July 1999 offering, as adjusted for stock splits. We have repurchased shares of our Common Stock since 2001 (see discussion below in Liquidity and Capital Resources). The affiliation agreement also provides that, upon Roche’s request, we will repurchase shares of our Common Stock to increase Roche’s ownership to the Minimum Percentage. In addition, Roche will have a continuing option to buy stock from us at prevailing market prices to maintain its percentage ownership interest. The Minimum Percentage at December 31, 2006 was 57.7% and, under the terms of the affiliation agreement, Roche’s ownership percentage is to be no lower than 55.7%. At December 31, 2006, Roche’s ownership percentage was 55.8%.

Related Party Transactions

We enter into transactions with our related parties, Roche and other Roche affiliates (including Hoffmann-La Roche) and Novartis AG and other Novartis affiliates (or “Novartis”), under existing agreements in the ordinary course of business. The accounting policies we apply to our transactions with our related parties are consistent with those applied in transactions with independent third-parties and all related party agreements are negotiated on an arm’s-length basis.

In our royalty and supply arrangements with related parties, we are the principal, as defined under Emerging Issues Task Force (or “EITF”) Issue No. 99-19, “Reporting Revenue Gross as a Principal Versus Net as an Agent” (or “EITF 99-19”), because we bear the manufacturing risk, general inventory risk, and the risk to defend our intellectual

51



property. In circumstances where we are the principal in the transaction, we record the transaction gross in accordance with EITF 99-19. Otherwise our transactions are recorded net.

Hoffmann-La Roche

We recognized royalty revenue of 20% of net sales of Herceptin made by Hoffmann-La Roche outside of the U.S. of up to $500 million, and 22.5% of net sales outside of the U.S. in excess of $500 million, a sales plateau which was exceeded in 2006, 2005 and 2004. For all other products distributed by Hoffmann-La Roche outside of the U.S., we recognize royalty revenue at rates ranging from 8% to 20%.

In July 2006, we signed two new product supply agreements with Hoffmann-La Roche. The Umbrella Manufacturing Supply Agreement (or “Umbrella Agreement”) supersedes our existing product supply agreements with Hoffmann-La Roche. The Short-Term Supply Agreement (or “Short-Term Agreement”) supplements the terms of the Umbrella Agreement. Under the Short-Term Agreement, Hoffmann-La Roche has agreed to purchase specified amounts of Herceptin, Avastin and Rituxan through 2008. Under the Umbrella Agreement, Hoffmann-La Roche has agreed to purchase specified amounts of Herceptin and Avastin through 2012 and, on a perpetual basis, either party may order other collaboration products from the other party, including Herceptin and Avastin after 2012, pursuant to certain forecast terms. The Umbrella Agreement also provides that either party may terminate its obligation to purchase and/or supply Avastin and/or Herceptin with six years notice on or after December 31, 2007.

We currently have no active profit sharing arrangements with Hoffmann-La Roche.

Under our existing arrangements with Hoffmann-La Roche, including our licensing and marketing agreement, we recognized the following amounts (in millions):

   
2006
 
2005
 
2004
 
Ex-U.S. product sales to Hoffmann-La Roche
 
$
359
 
$
177
 
$
111
 
                     
Royalties received from Hoffmann-La Roche
 
$
846
 
$
500
 
$
334
 
                     
Cost of sales on ex-U.S. product sales to Hoffmann-La Roche
 
$
268
 
$
154
 
$
95
 
                     
Contract revenue from Hoffmann-La Roche
 
$
125
 
$
65
 
$
73
 

R&D expenses include amounts related to Hoffmann-La Roche of $213 million in 2006, $144 million in 2005, and $125 million in 2004. These amounts represent R&D development expenses we incurred on joint development projects, but are reimbursable to us by Hoffmann-La Roche. In addition, these amounts include R&D expenses resulting from the net settlement of amounts owed to Hoffmann-La Roche on R&D development expenses it incurred on joint development products/projects, less amounts reimbursable to us on these respective projects.

Novartis

Based on information available to us at the time of filing this Form 10-K, we believe that the Novartis Group holds approximately 33.3% of the outstanding voting shares of Roche Holding Ltd. As a result of this ownership, the Novartis Group is deemed to have an indirect beneficial ownership interest under FAS 57, “Related Party Disclosures,” of more than 10% of our voting stock.

We have an agreement with Novartis Pharma AG (a wholly-owned subsidiary of Novartis AG) under which Novartis Pharma AG has the exclusive right to develop and market Lucentis outside of the U.S. for indications related to diseases or disorders of the eye. As part of this agreement, the parties share the cost of certain of our ongoing development expenses for Lucentis.

We, along with Novartis Pharma AG and Tanox, Inc., are co-developing Xolair in the U.S., and we and Novartis are co-promoting Xolair in the U.S. and both make certain joint and individual payments to Tanox; our joint and

52



individual payments are in the form of royalties. We record all sales and cost of sales in the U.S. and Novartis markets the product in and records all sales and cost of sales in Europe. We and Novartis share the resulting U.S. and European operating profits, respectively, according to prescribed profit-sharing percentages. On January 20, 2006, Novartis received FDA approval to manufacture bulk supply of Xolair at their Huningue production facility in France. We now acquire bulk supply of Xolair from Novartis and compensate them on a cost plus mark up basis.

Under our existing arrangements with Novartis, we recognized the following amounts from Novartis (in millions):

   
2006
 
2005
 
2004
 
Ex-U.S. product sales to Novartis
 
$
5
 
$
7
 
$
1
 
                     
Royalties received from Novartis
 
$
3
 
$
1
 
$
1
 
                     
Cost of sales on ex-U.S. product sales to Novartis
 
$
4
 
$
17
 
$
1
 
                     
Contract revenue from Novartis
 
$
40
 
$
50
 
$
48
 
                     
Novartis’ share of co-promotion profits - included in collaboration profit sharing expense
 
$
187
 
$
136
 
$
75
 

Under the Xolair collaboration agreement, we contractually share a portion of the pretax U.S. and European co-promotion profits earned on the commercial sales of Xolair. Our U.S. and European profit sharing expenses are recorded as collaboration profit sharing expense.

R&D expenses include amounts related to Novartis of $38 million in 2006, $39 million in 2005, and $44 million in 2004.

Liquidity and Capital Resources

Liquidity and Capital Resources
 
2006
 
2005
 
2004
 
December 31:
 
(in millions)
 
Unrestricted cash, cash equivalents, short-term investments and long-term marketable debt and equity securities
 
$
4,325
 
$
3,814
 
$
2,781
 
Net receivable — equity hedge instruments
   
50
   
73
   
21
 
Total unrestricted cash, cash equivalents, short-term investments, long-term marketable debt and equity securities, and equity hedge instruments
 
$
4,375
 
$
3,887
 
$
2,802
 
Working capital
 
$
3,547
 
$
2,726
 
$
2,187
 
Current ratio
   
2.6:1
   
2.6:1
   
2.8:1
 
Year Ended December 31:
                   
Cash provided by (used in):
                   
Operating activities
 
$
2,138
 
$
2,363
 
$
1,195
 
Investing activities
   
(1,681
)
 
(1,776
)
 
(450
)
Financing activities
   
(432
)
 
368
   
(847
)
Capital expenditures (included in investing activities above)
   
(1,214
)
 
(1,400
)
 
(650
)

Total unrestricted cash, cash equivalents, short-term investments and long-term marketable securities, including the estimated fair value of the related equity hedge instruments, were approximately $4.4 billion at December 31, 2006, an increase of approximately $488 million, or 13%, from December 31, 2005. This increase primarily reflects cash generated from operations; partially offset by cash used for capital expenditures, payments of taxes, purchases of marketable securities, and repurchases of our Common Stock. To mitigate the risk of market value fluctuations, certain of our biotechnology equity securities are hedged with zero-cost collars and forward contracts, which are carried at estimated fair value. See Note 2, “Summary of Significant Accounting Policies — Comprehensive

53



Income,” in the Notes to the Consolidated Financial Statements of Part II, Item 8 of this Form 10-K for further information regarding activity in our marketable investment portfolio and derivative instruments.

See “Leases” below for a discussion of our leasing arrangements. See “Our affiliation agreement with Roche could limit our ability to make acquisitions” and “To pay our indebtedness will require a significant amount of cash and may adversely affect our operations and financial result,” above in Part I, Item 1A “Risk Factors” and below in Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K for factors that could negatively affect our cash position.

Cash Provided by Operating Activities

Cash provided by operating activities is primarily driven by increases in our net income. However, operating cash flows differ from net income as a result of non-cash charges or differences in the timing of cash flows and earnings recognition. Significant components of cash provided by operating activities are as follows:

Receivables and other assets increased $628 million in 2006. This increase is primarily due to an increase in “accounts receivable - product sales” of $411 million in 2006 from 2005, which is primarily due to sales of our new product, Lucentis, on which we offer extended payment terms. The average collection period of our “accounts receivable — product sales” as measured in days sales outstanding (or “DSO”) was 46 days as of December 31, 2006, 37 days as of December 31, 2005, and 58 days as of December 31, 2004. The increase in DSO in 2006 over 2005 is primarily due to the extended payment terms we offered to certain wholesalers in conjunction with the launch of Lucentis on June 30, 2006. This program will be in effect for 12 months following the launch date; therefore, we expect our DSO to continue to increase in the first half of 2007 due to these extended payment terms. The decline in DSO in 2005 over 2004 reflects the termination in the first quarter of 2005 of our extended payment term incentive program that was put into place during the first quarter of 2004 for sales of new products at that time, in particular Avastin. The level of accounts receivable with extended dating declined steadily in 2005 as customer payments were received. The DSO as of December 31, 2005 also decreased by an additional four days, primarily due to favorable collections.

Our inventory balance increased $408 million in 2006. The increase is primarily due to bulk production of our Avastin and Herceptin products. We expect that our inventory levels will continue to rise in 2007 in support of sales growth, in particular, sales growth related to our recently approved indications.

Accounts payable, other accrued liabilities and other long-term liabilities increased $683 million in 2006. This increase is mainly due to an increase in taxes payable, accrued compensation, accrued royalties and accrued collaboration expenses, which are mainly due to the growth in the business.

Cash Used in Investing Activities

Cash used in investing activities primarily relates to purchases, sales and maturities of investments and capital expenditures. Capital expenditures were $1.21 billion during 2006, compared to $1.40 billion during 2005, and $650 million during 2004. Capital expenditures in 2006 included ongoing construction of our second manufacturing facility in Vacaville, California, validation costs at our manufacturing facility in Oceanside, California, the purchase of a second facility in Oceanside, purchase of equipment and information systems, and ongoing expenditures to support our corporate infrastructure needs. Capital expenditures in 2005 included the purchase of the Oceanside plant for $408 million in cash plus $9 million in closing costs, ongoing construction of our second manufacturing facility in Vacaville, California, $160 million repayment of our synthetic lease obligation on a research facility in South San Francisco, California, the purchase of land, equipment and information systems, and ongoing construction costs in support of our manufacturing and corporate infrastructure needs. Capital expenditures in 2004 were made to purchase land and office buildings in South San Francisco, including the repayment of two of our synthetic leases, and for equipment and information systems purchases and ongoing construction costs in support of our manufacturing and corporate infrastructure needs.

54



Restricted cash increased by $53 million in 2006 and in 2005 due to the additional cash and investments we were required to pledge to secure the COH surety bond. Total cash and investments pledged to secure the COH surety bond were $788 million at December 31, 2006 and $735 million at December 31, 2005 and were reflected in the Consolidated Balance Sheets in “restricted cash and investments”. See the Contingencies section of Note 8, “Leases, Commitments and Contingencies” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K for further information regarding the COH litigation and related surety bond.

We anticipate that our capital expenditures for 2007 will stay relatively flat at approximately $1.2 billion, primarily driven by manufacturing expansion, in particular ongoing construction of our second manufacturing facility in Vacaville, and for projects related to existing facilities, increases in office space, and land purchases.

Cash Used in or Provided by Financing Activities

Cash used in or provided by financing activities includes activity under our stock repurchase program and our employee stock plans. We used cash for stock repurchases of approximately $1.0 billion in 2006, $2.02 billion during 2005, and $1.35 billion during 2004 pursuant to our stock repurchase program approved by our Board of Directors. We also received $385 million during 2006, $821 million during 2005, and $505 million during 2004, related to stock option exercises and stock issuances under our employee stock purchase plan.

Prior to our adoption of FAS 123R, the tax benefit from stock option exercises was reported as operating cash flows. FAS 123R requires excess tax benefits be reported as a financing cash inflow rather than as a reduction of cash used in operating activities. At December 31, 2006, the excess tax benefit from stock-based compensation arrangements was $179 million.

In July 2005, we received proceeds of $1.99 billion from our debt issuance, and we used a portion of those proceeds in the third quarter of 2005 to extinguish our remaining $425 million total lease obligation with respect to our Vacaville, California manufacturing facility.

Under a stock repurchase program approved by our Board of Directors in December 2003 and most recently extended in April 2006, we are authorized to repurchase up to 100,000,000 shares of our Common Stock for an aggregate price of up to $6.0 billion through June 30, 2007. In this program, as in previous stock repurchase programs, purchases may be made in the open market or in privately negotiated transactions from time to time at management’s discretion. We also may engage in transactions in other Genentech securities in conjunction with the repurchase program, including certain derivative securities. As of December 31, 2006, we have not engaged in any such transactions. We intend to use the repurchased stock to offset dilution caused by the issuance of shares in connection with our employee stock plans. Although there are currently no specific plans for the shares that may be purchased under the program, our goals for the program are (i) to address provisions of our affiliation agreement with Roche relating to maintaining Roche’s minimum ownership percentage; (ii) to make prudent investments of our cash resources; and (iii) to allow for an effective mechanism to provide stock for our employee stock plans. See above in “Relationship with Roche” for more information on Roche’s minimum ownership percentage.

We have entered into Rule 10b5-1 trading plans to repurchase shares in the open market during those periods each quarter when trading in our stock is restricted under our insider trading policy. The trading plan covers approximately four million shares and the current plan is effective through June 30, 2007.

Under our current stock repurchase program, we repurchased 12 million shares for $1.0 billion in 2006, 24 million shares for $2.02 billion in 2005 and 26 million shares for $1.35 billion in 2004.

55



Our shares repurchased during 2006 were as follows (shares in millions):

   
Total Number of
Shares Purchased
 
Average Price Paid
per Share
 
January 1-31
   
0.9
 
$
88.37
 
February 1-28
   
0.7
   
85.31
 
March 1-31
   
1.0
   
84.24
 
April 1-30
   
0.7
   
80.31
 
May 1-31
   
2.1
   
78.83
 
June 1-30
   
1.2
   
79.30
 
July 1-31
   
0.9
   
79.39
 
August 1-31
   
0.9
   
80.89
 
September 1-30
   
0.9
   
79.84
 
October 1-31
   
0.3
   
83.97
 
November 1-30
   
1.4
   
80.81
 
December 1-31
   
1.2
   
82.11
 
Total
   
12.2
 
$
81.45
 

As of December 31, 2006, 62 million shares have been purchased under our stock repurchase program for $4.37 billion, and a maximum of 38 million additional shares may be purchased under the program through June 30, 2007.

The par value method of accounting is used for common stock repurchases. The excess of the cost of shares acquired over the par value is allocated to additional paid-in capital with the amounts in excess of the estimated original sales price charged to accumulated deficit.

Off-Balance Sheet Arrangements

We have certain contractual arrangements that create potential risk for us and are not recognized in our Consolidated Balance Sheets. Discussed below are those off-balance sheet arrangements that have or are reasonably likely to have a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

We lease various real properties under operating leases that generally require us to pay taxes, insurance, maintenance and minimum lease payments. Some of our leases have options to renew.

In December 2004, we entered into a Master Lease Agreement with Slough SSF, LLC for the lease of property adjacent to our South San Francisco campus. The property is being developed into eight buildings and two parking structures. The lease of the property is taking place in two phases pursuant to separate lease agreements for each building as contemplated by the Master Lease Agreement. Phase I building leases began in 2006 and Phase II building leases begin in 2007 and 2008. For accounting purposes, due to the nature of our involvement with the construction of the buildings subject to the Master Lease Agreement, we are considered to be the owner of the assets during the construction period through the lease commencement date, even though the funds to construct the building shell and some infrastructure costs are paid by the lessor. As such, as of December 31, 2006, we have capitalized $205 million of construction costs, including capitalized interest, in property, plant and equipment, excluding approximately $150 million in leasehold improvements that we have installed at the property to date. We have recognized $198 million as a construction financing obligation, which is primarily included in “long-term debt” in the accompanying Consolidated Balance Sheets. As of December 31, 2005, we had capitalized $94 million of construction costs in property, plant and equipment and recognized the same amount as a construction financing obligation in “long-term debt” in the accompanying Consolidated Balance Sheets. Concurrent with the commencement of the rental period, during the third quarter of 2006, we began repayment of the construction financing obligation. We expect at the time of completion of the project, if all the buildings and infrastructure were completed by the lessor, our construction asset and related obligation may be as much as $365 million, excluding costs related to leasehold improvements.

56



In November 2006, we entered into a series of agreements with Lonza Group Ltd (or “Lonza”), including a supply agreement to purchase product produced by Lonza at their Singapore manufacturing facility, which is currently under construction. For accounting purposes, due to the nature of the supply agreement and our involvement with the construction of the buildings, we are considered to be the owner of the assets during the construction period, even though the funds to construct the building shell and some infrastructure costs are paid by Lonza. As such, during 2006, we capitalized $20 million in construction-in-progress and have also recognized a corresponding amount as a construction financing obligation in “long-term debt” in the accompanying Consolidated Balance Sheets. We also entered into a loan agreement with Lonza to advance $290 million to Lonza for the construction of this facility and approximately $9 million for a related land lease option, the majority of which is not expected to be advanced until 2008. See Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K for further discussion of the agreements.

During the third quarter of 2005, we paid $160 million to exercise our right to purchase a research facility in South San Francisco, California, which was subject to a synthetic lease with BNP Paribas Leasing Corporation (or “BNP”). As a result, the value of the property in South San Francisco was included in the accompanying Consolidated Balance Sheets at December 31, 2005. Prior to the purchase of this facility, we evaluated our accounting for this lease under the provisions of FASB Interpretation No. 46R (or “FIN 46R”), a revision to Interpretation 46, “Consolidation of Variable Interest Entities,” and determined we were not required to consolidate either the leasing entity or the specific assets leased under the BNP lease.

During the third quarter of 2005, we paid $425 million to extinguish the debt and acquire the noncontrolling interest related to a synthetic lease obligation on our manufacturing plant in Vacaville, California. Prior to the extinguishment of the debt, we were required to consolidate the entity from which we leased the Vacaville facility as it qualified as a variable interest entity (or “VIE”) under the provisions of FIN 46R and because we were determined to be the primary beneficiary of the VIE as we absorb the majority of the entity’s expected losses.

Commitments

See Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K.

57



Contractual Obligations

In the table below, we set forth our enforceable and legally binding obligations and future commitments and obligations related to all contracts that we are likely to continue regardless of the fact that they were cancelable as of December 31, 2006. Some of the figures we include in this table are based on management’s estimate and assumptions about these obligations, including their duration, the possibility of renewal, anticipated actions by third parties, and other factors. Because these estimates and assumptions are necessarily subjective, the obligations we will actually pay in future periods may vary from those reflected in the table.

   
Payments due by period (in millions)
 
Contractual Obligations
 
Total
 
2007
 
2008 and 2009
 
2010 and 2011
 
2012 and beyond
 
Operating lease obligations and other(1)
 
$
218
 
$
24
 
$
50
 
$
45
 
$
99
 
Slough(2) (Financing lease)
   
541
   
19
   
67
   
75
   
380
 
Lonza(3) (Singapore facility agreement)
   
510
   
-
   
75
   
293
   
142
 
Purchase obligations(4)
   
1,567
   
958
   
532
   
64
   
13
 
Long-term debt(5)
   
2,000
   
-
   
-
   
500
   
1,500
 
Litigation-related and other long-term liabilities(6)
   
768
   
-
   
748
   
-
   
20
 
Interest expense on long-term debt(7)
   
1,254
   
101
   
198
   
161
   
794
 
Total
 
$
6,858
 
$
1,102
 
$
1,670
 
$
1,138
 
$
2,948
 
________________________
(1)
Operating lease obligations include Owner Association Fees on buildings we own. See further discussion of our operating leases above in “Off-Balance Sheet Arrangements.”
(2)
See further discussion related to the Slough lease above in “Off-Balance Sheet Arrangements.”
(3)
Included in 2010 is a manufacturing milestone payment. See further discussion of the agreements with Lonza above in “Off-Balance Sheet Arrangements” and in Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K.
(4)
Purchase obligations include commitments related to capital expenditures, clinical development, collaborations, manufacturing and research operations and other significant purchase commitments. Purchase obligations exclude capitalized labor and capitalized interest on construction projects. Included in this line are our purchase obligations under our contract manufacturing arrangements with Lonza Biologics, a subsidiary of Lonza Group Ltd, for commercial quantities of Rituxan and with Wyeth Pharmaceuticals, a division of Wyeth, for bulk supply of Herceptin, and Novartis for the manufacture of Xolair and Lucentis. See also Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K.
(5)
See also Note 7, “Long-Term Debt,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K.
(6)
Litigation-related and other long-term liabilities include our litigation liabilities and other similar items which are reflected on our balance sheet. The amount of cash paid, if any, or the timing of such payment in connection with the COH matter will depend on the outcome of the California Supreme Court’s review of the matter; this item is captured in the “2008 and 2009” category in the table above.
(7)
Interest expense includes the effects of an interest rate swap agreement. See also, Note 4 “Investment Securities and Financial Instruments,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K.
Excludes payment obligations associated with deferred tax liabilities.

In addition to the above, we have committed to make potential future “milestone” payments to third-parties as part of in-licensing and product development programs. Payments under these agreements generally become due and payable only upon achievement of certain developmental, regulatory and/or commercial milestones. Because the achievement of these milestones is neither probable nor reasonably estimable, such contingencies have not been recorded on our Consolidated Balance Sheets. We also entered into a loan agreement, subject to certain mutually acceptable conditions of securitization, with Lonza to advance up to $290 million to Lonza for the construction of their Singapore facility and approximately $9 million for a related land lease option, the majority of which is not expected to be advanced until 2008. See Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial Statements of Part II, Item 8 of this Form 10-K for further information on these matters.

58



Stock Options

Option Program Description

Our employee stock option program is a broad-based, long-term retention program that is intended to attract and retain talented employees and to align stockholder and employee interests. Our program primarily consists of our 2004 Equity Incentive Plan (the “Plan”), a broad-based plan under which stock options, restricted stock, stock appreciation rights and performance shares and units may be granted to employees, directors and other service providers. Substantially all of our employees participate in our stock option program. In the past, we granted options under our amended and restated 1999 Stock Plan, 1996 Stock Option/Stock Incentive Plan, our amended and restated 1994 Stock Option Plan and our amended and restated 1990 Stock Option/Stock Incentive Plan. Although we no longer grant options under these plans, exercisable options granted under these plans are still outstanding.

All stock option grants are made with the approval of the Compensation Committee of the Board of Directors or an authorized delegate. See “Compensation Discussion and Analysis” appearing in our 2007 Proxy Statement for further information concerning the policies and procedures of the Compensation Committee regarding the use of stock options.

General Option Information

Summary of Option Activity
(Shares in millions)

       
Options Outstanding
 
   
Shares
Available
for Grant
 
Number of
Shares
 
Weighted
Average
Exercise Price
 
December 31, 2004
   
102
   
94
 
$
32.32
 
Grants
   
(20
)
 
20
   
84.01
 
Exercises
   
-
   
(29
)
 
25.88
 
Cancellations
   
2
   
(2
)
 
42.16
 
December 31, 2005
   
84
   
83
 
$
46.64
 
Grants
   
(17
)
 
17
   
79.85
 
Exercises
   
-
   
(9
)
 
30.42
 
Cancellations
   
3
   
(3
)
 
62.09
 
December 31, 2006
   
70
   
88
 
$
54.53
 

In-the-Money and Out-of-the-Money Option Information
(Shares in millions)

   
Exercisable
 
Unexercisable
 
Total
 
As of December 31, 2006
 
Shares
 
Wtd. Avg.
Exercise
Price
 
Shares
 
Wtd. Avg.
Exercise
Price
 
Shares
 
Wtd. Avg.
Exercise
Price
 
In-the-Money
   
42
 
$
32.16
   
27
 
$
66.70
   
69
 
$
45.81
 
Out-of-the-Money(1)
   
5
   
86.02
   
14
   
85.97
   
19
   
85.99
 
Total Options Outstanding
   
47
         
41
         
88
       
________________________
(1)
Out-of-the-money options are those options with an exercise price equal to or greater than the fair market value of Genentech Common Stock, which was $81.13 at the close of business on December 29, 2006.


59



Distribution and Dilutive Effect of Options

Employee and Executive Officer Option Grants

   
2006*
 
 2005*
 
 2004*
 
Net grants during the year as % of outstanding shares
   
1.43
%
 
1.70
%
 
1.83
%
Grants to Executive Officers during the period as % of outstanding shares
   
0.14
%
 
0.18
%
 
0.25
%
Grants to Executive Officers during the year as % of total options granted
   
8.60
%
 
9.44
%
 
12.29
%
________________________
*
Executive officers as of December 31 for the years presented.

Equity Compensation Plan Information

Our stockholders have approved all of our equity compensation plans under which options are outstanding.

******

This report contains forward-looking statements regarding completion of phases for, and regulatory approval of, development projects; our Horizon 2010 strategy of brining 20 new molecules into clinical development, bringing at least 15 major new products or indications onto the market, becoming the number one U.S. oncology company in sales, and achieving certain financial growth measures; the development of our internal products providing the majority of our long-term growth; an Avastin sBLA submission; construction, qualification and licensure of our new Vacaville, Hillsboro facilities and Oceanside facility, and Lonza’s Singapore facility; manufacturing of Avastin and Rituxan by Lonza; the adequacy of our capital resources to meet long-term growth; Wyeth’s manufacture of Herceptin; the Avastin Patient Assistance program; new product indication launches for Avastin; Avastin sales growth and sales growth in recently approved indications; sales to collaborators; royalty and contract revenue; collaboration profit sharing and sales for collaborative products; the effects of the Medicare Prescription Drug Improvement and Modernization Act on our revenues; expenditures to comply with environmental laws; stock-based compensation, R&D and MG&A expenses; other income, net; effective income tax rate; inventory levels; capital expenditures; extending a loan to Lonza; the effect of FIN 48 on our results of operations and financial position; and the acquisition of Tanox and closing certain licensing transactions.

These forward-looking statements involve risks and uncertainties, and the cautionary statements set forth below and those contained in “Risk Factors” in this Form 10-K identify important factors that could cause actual results to differ materially from those predicted in any such forward-looking statements. Such factors include, but are not limited to, additional time requirements for data analysis; BLA preparation and decision making; FDA actions or delays; failure to obtain FDA approval; difficulty in obtaining materials from suppliers; unexpected safety, efficacy or manufacturing issues for us or our contract/collaborator manufacturers; the ability to supply product and meet demand for our products; increased capital expenditures including greater than expected construction and validation costs; product withdrawals; competition; pricing decisions by us or our competitors; our ability to protect our proprietary rights; the outcome of, and expenses associated with, litigation or legal settlements; the level of patient participation in the Avastin Patient Assistance Program; increased R&D, MG&A and environmental expenses, and increased cost of sales; variations in collaborator sales and expenses; our indebtedness and ability to pay our indebtedness; actions by Roche that are adverse to our interests; decreases in third party reimbursement rates; greater than expected income tax rate; the ability of management and others to integrate new employees into our culture; the number of options granted to employees, Genentech’s stock price and certain valuation assumptions concerning Genentech stock; and the extent to which all closing conditions are met for our proposed acquisition of Tanox and certain licensing transactions, including the absence of a material adverse effect with respect to Tanox, the extent to which such transactions are permitted under the antitrust laws, and the extent to which we have cash on hand to consummate such transactions. We disclaim and do not undertake any obligation to update or revise any forward-looking statement in this Form 10-K.

60




We are exposed to market risk, including changes to interest rates, foreign currency exchange rates and equity investment prices. To reduce the volatility relating to these exposures, we enter into various derivative hedging transactions pursuant to our investment and risk management policies and procedures. We do not use derivatives for speculative purposes.

We maintain risk management control systems to monitor the risks associated with interest rates, foreign currency exchange rates and equity investment price changes. The risk management control systems use analytical techniques, including sensitivity analysis and market values. Though we intend for our risk management control systems to be comprehensive, there are inherent risks that may only be partially offset by our hedging programs should there be unfavorable movements in interest rates, foreign currency exchange rates or equity investment prices.

The estimated exposures discussed below are intended to measure the amount we could lose from adverse market movements in interest rates, foreign currency exchange rates and equity investment prices, given a specified confidence level, over a given period of time. Loss is defined in the value-at-risk (or “VAR”) estimation as fair market value loss. Our VAR model utilizes historical simulation of daily market data over the past three years and calculates market data changes using a 21-trading day holding period to estimate expected loss in fair value at a 95% confidence level. The VAR model is not intended to represent actual losses but is used as a risk estimation and management tool.

Actual future gains and losses associated with our investment portfolio and derivative positions may differ materially from the VAR analyses performed due to the inherent limitations associated with predicting the timing and amount of changes to interest rates, foreign currency exchanges rates and equity investment prices, and our actual exposures and positions.

Interest Rate Risk

Our interest-bearing assets, or interest-bearing portfolio, consisted of cash, cash equivalents, restricted cash and investments, short-term investments, marketable debt securities, long-term investments and interest-bearing forward contracts. The balance of our interest-bearing portfolio, including restricted and unrestricted cash and investments, was $4,747 million or 32% of total assets at December 31, 2006 and $4,169 million or 34% of total assets at December 31, 2005. Interest income related to this portfolio was $230 million in 2006 and $143 million in 2005. Our interest income is sensitive to changes in the general level of interest rates, primarily U.S. interest rates. In this regard, changes in U.S. interest rates affect the interest-bearing portfolio.

Our long-term debt is comprised of the following debt instruments: $500 million principal amount of 4.40% Senior Notes due 2010, $1.0 billion principal amount of 4.75% Senior Notes due 2015 and $500 million principal amount of 5.25% Senior Notes due 2035. To protect the fair value of our 2010 Notes against fluctuations in the benchmark U.S. interest rates, we entered into a series of interest rate swap agreements with respect to the 2010 Notes. See Note 7, “Long-Term Debt,” and Note 4, “Investment Securities and Financial Instruments — Derivative Financial Instruments,” section in the Notes to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K.

Based on our overall interest rate exposure, which includes the net effect of our interest rate exposures on our interest-bearing assets and our Senior Note debt instruments, using a 21-trading day holding period with a 95% confidence level, the potential loss in estimated fair value of our interest rate sensitive instruments was $24 million at December 31, 2006 and $34 million at December 31, 2005. A significant portion of the potential loss in estimated fair value at both December 31, 2006 and 2005 was attributed to the longer duration of our Senior Notes.

Foreign Currency Exchange and Foreign Economic Conditions Risk

We receive royalty revenues from licensees selling products in countries throughout the world. As a result, our financial results could be significantly affected by factors such as changes in foreign currency exchange rates or weak economic conditions in the foreign markets in which our licensed products are sold. Our exposure to foreign

61



exchange rates is most significant relative to the Swiss Franc, though we are also exposed to changes in exchange rates elsewhere in Europe, Asia (primarily Japan) and Canada. When the dollar strengthens against the currencies in these countries, the dollar value of foreign-currency denominated revenue decreases; when the dollar weakens, the dollar value of the foreign-currency denominated revenues increases. Accordingly, changes in exchange rates, and in particular a strengthening of the dollar, may adversely affect our royalty revenues as expressed in dollars. Currently, our foreign currency royalty revenues exceed our foreign currency expenses. In addition, as part of our overall investment strategy, a portion of our portfolio is in non-dollar denominated investments. As a result, we are exposed to changes in the exchange rates of the currencies in which these non-dollar investments are denominated.

To mitigate our net foreign exchange exposure, our policy allows us to hedge certain of our anticipated royalty revenues by entering into option or forward contracts with one to five year expiration dates and amounts of currency that are based on up to 90% of forecasted future revenues so that the potential adverse effect of movements in currency exchange rates on the non-dollar denominated revenues will be at least partly offset by an associated increase in the value of the option or forward. As of December 31, 2006, these options and forwards are due to expire in 2007 through 2008.

Based on our overall currency rate exposure, using a 21-trading day holding period with a 95% confidence level, the potential loss in the estimated fair value of our foreign currency sensitive instruments was $17 million at December 31, 2006 and $18 million at December 31, 2005. Because we use foreign currency instruments to hedge anticipated future cash flows, losses incurred on those instruments are generally offset by increases in the fair value of the underlying future cash flows they were intended to hedge.

Equity Security Risks

As part of our strategic alliance efforts, we invest in publicly traded equity instruments of biotechnology companies. Our biotechnology equity investment portfolio totaled $360 million or 2% of total assets at December 31, 2006 and $375 million or 3% of total assets at December 31, 2005. Impairment charges on our biotechnology equity investments were $4 million in 2006 and $5 million in 2005. These investments are subject to fluctuations from market value changes in stock prices. To mitigate the risk of market value fluctuation, certain equity securities are hedged with zero-cost collars and forward contracts. A zero-cost collar is a purchased put option and a written call option in which the cost of the purchased put and the proceeds of the written call offset each other; therefore, there is no initial cost or cash outflow for these instruments at the time of purchase. The purchased put protects us from a decline in the market value of the security below a certain minimum level (the put “strike” level), while the call effectively limits our potential to benefit from an increase in the market value of the security above a certain maximum level (the call “strike” level). A forward contract is a derivative instrument where we lock-in the termination price we receive from the sale of stock based on a pre-determined spot price. The forward contract protects us from a decline in the market value of the security below the spot price and limits our potential benefit from an increase in the market value of the security above the spot price. Throughout the life of the forward contract, we receive interest income based on the notional amount and a floating-rate index. Depending on market conditions, we may determine that in future periods certain of our other unhedged equity security investments are impaired, which would result in additional write-downs of those equity security investments.

Based on our overall exposure to fluctuations from market value changes in marketable equity prices, using a 21-trading day holding period with a 95% confidence level, the potential loss in estimated fair value of our equity securities portfolio was $24 million at December 31, 2006 and $19 million at December 31, 2005.

Also, as part of our strategic alliance efforts, we invest in privately held biotechnology companies, some of which are in the startup stage. These investments are primarily carried at cost, which were $33 million at December 31, 2006 and $29 million at December 31, 2005, and are recorded in “other long-term assets” in the Consolidated Balance Sheets. Our impairment charges on investments in privately held companies was $5 million in 2005. Our evaluation of investments in private companies is based on the fundamentals of the businesses, including, among other factors, the nature and success of their R&D efforts.

62



Counterparty Credit Risks

We could be exposed to losses related to the financial instruments described above should one of our counterparties default. We attempt to mitigate this risk through credit monitoring procedures.

63





Report of Independent Registered Public Accounting Firm


The Board of Directors and Stockholders of Genentech, Inc.


We have audited the accompanying consolidated balance sheets of Genentech, Inc. as of December 31, 2006 and 2005, and the related consolidated statements of income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2006. Our audits also included the financial statement schedule listed in the Index at Item 15(a). These financial statements and schedule are the responsibility of Genentech, Inc.’s management. Our responsibility is to express an opinion on these financial statements and schedule based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Genentech, Inc. at December 31, 2006 and 2005, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 2006, in conformity with U.S. generally accepted accounting principles. Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material respects the information set forth therein.

As discussed in Note 2 to the consolidated financial statements, in 2006 Genentech, Inc. changed its method of accounting for stock-based compensation in accordance with guidance provided in Statement of Financial Accounting Standards No. 123(R), “Share-Based Payment”.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the effectiveness of Genentech, Inc.’s internal control over financial reporting as of December 31, 2006, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 5, 2007 expressed an unqualified opinion thereon.

/s/ ERNST & YOUNG LLP

Palo Alto, California
February 5, 2007

64



CONSOLIDATED STATEMENTS OF INCOME
(in millions, except per share amounts)

   
Year Ended December 31,
 
   
2006
 
2005
 
2004
 
Revenues
             
Product sales (including amounts from related parties: 2006-$364; 2005-$184; 2004-$112)
 
$
7,640
 
$
5,488
 
$
3,749
 
Royalties (including amounts from related parties: 2006-$849; 2005-$501; 2004-$335)
   
1,354
   
935
   
641
 
Contract revenue (including amounts from related parties: 2006-$165; 2005-$115; 2004-$121)
   
290
   
210
   
231
 
Total operating revenues
   
9,284
   
6,633
   
4,621
 
                     
Costs and expenses
                   
Cost of sales (including amounts for related parties: 2006-$272; 2005-$171; 2004-$96)
   
1,181
   
1,011
   
673
 
Research and development (including amounts for related parties: 2006-$251; 2005-$183; 2004-$169)
(including contract related: 2006-$185; 2005-$144; 2004-$132)
   
1,773
   
1,262
   
948
 
Marketing, general and administrative
   
2,014
   
1,435
   
1,088
 
Collaboration profit sharing (including amounts for a related party: 2006-$187; 2005-$136; 2004-$75)
   
1,005
   
823
   
594
 
Recurring charges related to redemption
   
105
   
123
   
145
 
Special items: litigation-related
   
54
   
58
   
37
 
Total costs and expenses
   
6,132
   
4,712
   
3,485
 
                     
Operating income
   
3,152
   
1,921
   
1,136
 
Other income (expense):
                   
Interest and other income (expense), net
   
325
   
142
   
91
 
Interest expense
   
(74
)
 
(50
)
 
(7
)
Total other income, net
   
251
   
92
   
84
 
Income before taxes
   
3,403
   
2,013
   
1,220
 
Income tax provision
   
1,290
   
734
   
435
 
Net income
 
$
2,113
 
$
1,279
 
$
785
 
                     
Earnings per share
                   
Basic
 
$
2.01
 
$
1.21
 
$
0.74
 
Diluted
 
$
1.97
 
$
1.18
 
$
0.73
 
                     
Shares used to compute basic earnings per share
   
1,053
   
1,055
   
1,055
 
Shares used to compute diluted earnings per share
   
1,073
   
1,081
   
1,079
 

See Notes to Consolidated Financial Statements.

65



CONSOLIDATED STATEMENTS OF CASH FLOWS
(in millions)

   
Year Ended December 31,
 
   
2006
 
2005
 
2004
 
Cash flows from operating activities
             
Net income
 
$
2,113
 
$
1,279
 
$
785
 
Adjustments to reconcile net income to net cash provided by operating activities:
                   
Depreciation and amortization
   
407
   
370
   
353
 
Employee stock-based compensation
   
309
   
-
   
-
 
Deferred income taxes
   
(112
)
 
(110
)
 
(74
)
Deferred revenue
   
(3
)
 
(49
)
 
(15
)
Litigation-related liabilities
   
51
   
51
   
35
 
Excess tax benefit from stock-based compensation arrangements
   
(179
)
 
-
   
-
 
Tax benefit from employee stock options
   
-
   
632
   
329
 
Gain on sales of securities available-for-sale and other
   
(94
)
 
(12
)
 
(15
)
Loss on sales and write-downs of securities available-for-sale and other
   
5
   
13
   
14
 
Loss on fixed asset dispositions
   
23
   
10
   
5
 
Changes in assets and liabilities:
                   
Receivables and other assets
   
(628
)
 
(128
)
 
(363
)
Inventories
   
(408
)
 
(112
)
 
(121
)
Investments in trading securities
   
(29
)
 
(17
)
 
(76
)
Accounts payable, other accrued liabilities, and other long-term liabilities
   
683
   
436
   
338
 
Net cash provided by operating activities
   
2,138
   
2,363
   
1,195
 
Cash flows from investing activities
                   
Purchases of securities available-for-sale
   
(1,036
)
 
(1,000
)
 
(890
)
Proceeds from sales of securities available-for-sale
   
256
   
148
   
687
 
Proceeds from maturities of securities available-for-sale
   
357
   
574
   
462
 
Capital expenditures
   
(1,214
)
 
(1,400
)
 
(650
)
Change in other intangible and long-term assets
   
9
   
(45
)
 
(64
)
Transfer (to) from restricted cash, net
   
(53
)
 
(53
)
 
5
 
Net cash used in investing activities
   
(1,681
)
 
(1,776
)
 
(450
)
Cash flows from financing activities
                   
Stock issuances
   
385
   
821
   
505
 
Stock repurchases
   
(996
)
 
(2,016
)
 
(1,352
)
Excess tax benefit from stock-based compensation arrangements
   
179
   
-
   
-
 
Repayment of long-term debt and noncontrolling interest
   
-
   
(425
)
 
-
 
Proceeds from issuance of long-term debt
   
-
   
1,988
   
-
 
Net cash (used in) provided by financing activities
   
(432
)
 
368
   
(847
)
Net increase (decrease) in cash and cash equivalents
   
25
   
955
   
(102
)
Cash and cash equivalents at beginning of year
   
1,225
   
270
   
372
 
Cash and cash equivalents at end of year
 
$
1,250
 
$
1,225
 
$
270
 
Supplemental cash flow data
                   
Cash paid during the year for:
                   
Interest
 
$
68
 
$
8
 
$
7
 
Income taxes
   
1,038
   
312
   
132
 
Non-cash investing and financing activities
                   
Capitalization of construction in progress related to financing lease transaction
   
128
   
94
   
-
 
Sale of subsidiary in exchange for note receivable
   
135
   
-
   
-
 
Exchange of XOMA note receivable for a prepaid royalty and other long-term asset
   
-
   
29
   
-
 

See Notes to Consolidated Financial Statements.

66



CONSOLIDATED BALANCE SHEETS
(in millions, except par value)

   
December 31,
 
   
2006
 
2005
 
Assets
         
Current assets
         
Cash and cash equivalents
 
$
1,250
 
$
1,225
 
Short-term investments
   
1,243
   
1,140
 
Accounts receivable - product sales (net of allowances: 2006-$92; 2005-$84;
including amounts from related parties: 2006-$57; 2005-$4)
   
965
   
554
 
Accounts receivable - royalties (including amounts from related parties: 2006-$316; 2005-$173)
   
453
   
297
 
Accounts receivable - other (including amounts from related parties: 2006-$150; 2005-$132)
   
248
   
199
 
Inventories
   
1,178
   
703
 
Deferred tax assets
   
278
   
167
 
Prepaid expenses and other current assets
   
89
   
101
 
Total current assets
   
5,704
   
4,386
 
Long-term marketable debt and equity securities
   
1,832
   
1,449
 
Property, plant and equipment, net
   
4,173
   
3,349
 
Goodwill
   
1,315
   
1,315
 
Other intangible assets
   
476
   
574
 
Restricted cash and investments
   
788
   
735
 
Deferred tax assets
   
183
   
146
 
Other long-term assets
   
371
   
193
 
Total assets
 
$
14,842
 
$
12,147
 
Liabilities and stockholders’ equity
             
Current liabilities
             
Accounts payable (including amounts to related parties: 2006-$7; 2005-$1)
 
$
346
 
$
339
 
Deferred revenue
   
62
   
44
 
Other accrued liabilities (including amounts to related parties: 2006-$136; 2005-$132)
   
1,749
   
1,277
 
Total current liabilities
   
2,157
   
1,660
 
Long-term debt
   
2,204
   
2,083
 
Deferred revenue
   
199
   
220
 
Litigation-related and other long-term liabilities
   
804
   
714
 
Total liabilities
   
5,364
   
4,677
 
Commitments and contingencies (Note 8)
             
Stockholders’ equity
             
Preferred stock, $0.02 par value; authorized: 100 shares; none issued
   
-
   
-
 
Common Stock, $0.02 par value; authorized: 3,000 shares; outstanding: 2006-1,053 shares; 2005-1,054 shares
   
21
   
21
 
Additional paid-in capital
   
10,091
   
9,263
 
Accumulated other comprehensive income
   
204
   
253
 
Accumulated deficit, since June 30, 1999
   
(838
)
 
(2,067
)
Total stockholders’ equity
   
9,478
   
7,470
 
Total liabilities and stockholders’ equity
 
$
14,842
 
$
12,147
 

See Notes to Consolidated Financial Statements.

67



CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in millions)

                   
Accumulated
     
           
Additional
     
Other
     
   
Common Stock
 
Paid-in
 
Accumulated
 
Comprehensive
     
   
Shares
 
Amounts
 
Capital
 
Deficit
 
Income
 
Total
 
Balance December 31, 2003
   
1,049
 
$
21
 
$
7,360
 
$
(1,157
)
$
297
 
$
6,521
 
Comprehensive income
                                     
Net income
   
-
   
-
   
-
   
785
   
-
   
785
 
Increase in unrealized gain on securities available-for-sale, net of tax
   
-
   
-
   
-
   
-
   
11
   
11
 
Changes in fair value of cash flow hedges, net of tax
   
-
   
-
   
-
   
-
   
(17
)
 
(17
)
Comprehensive income
                                 
779
 
Issuance of stock upon exercise of options
   
22
   
1
   
446
   
-
   
-
   
447
 
Income tax benefits realized from employee stock option exercises
   
-
   
-
   
329
   
-
   
-
   
329
 
Issuance of stock under employee stock purchase plan
   
2
   
-
   
58
   
-
   
-
   
58
 
Repurchase of Common Stock
   
(26
)
 
(1
)
 
(191
)
 
(1,160
)
 
-
   
(1,352
)
Balance December 31, 2004
   
1,047
   
21
   
8,002
   
(1,532
)
 
291
   
6,782
 
Comprehensive income
                                     
Net income
   
-
   
-
   
-
   
1,279
   
-
   
1,279
 
Decrease in unrealized gain on securities available-for-sale, net of tax
   
-
   
-
   
-
   
-
   
(75
)
 
(75
)
Changes in fair value of cash flow hedges, net of tax
   
-
   
-
   
-
   
-
   
37
   
37
 
Comprehensive income
                                 
1,241
 
Issuance of stock upon exercise of options
   
29
   
1
   
745
   
-
   
-
   
746
 
Income tax benefits realized from employee stock option exercises
   
-
   
-
   
642
   
-
   
-
   
642
 
Issuance of stock under employee stock purchase plan
   
2
   
-
   
75
   
-
   
-
   
75
 
Repurchase of Common Stock
   
(24
)
 
(1
)
 
(201
)
 
(1,814
)
 
-
   
(2,016
)
Balance December 31, 2005
   
1,054
   
21
   
9,263
   
(2,067
)
 
253
   
7,470
 
Comprehensive income
                                     
Net income
   
-
   
-
   
-
   
2,113
   
-
   
2,113
 
Decrease in unrealized gain on securities available-for-sale, net of tax
   
-
   
-
   
-
   
-
   
(16
)
 
(16
)
Changes in fair value of cash flow hedges, net of tax
   
-
   
-
   
-
   
-
   
(27
)
 
(27
)
Change in post-retirement benefit obligation, net of tax
   
-
   
-
   
-
   
-
   
(6
)
 
(6
)
Comprehensive income
                                 
2,064
 
Issuance of stock upon exercise of options
   
9
   
-
   
288
   
-
   
-
   
288
 
Income tax benefits realized from employee stock option exercises
   
-
   
-
   
179
   
-
   
-
   
179
 
Issuance of stock under employee stock purchase plan
   
2
   
-
   
97
   
-
   
-
   
97
 
Stock-based compensation expense
   
-
   
-
   
376
   
-
   
-
   
376
 
Repurchase of Common Stock
   
(12
)
 
-
   
(112
)
 
(884
)
 
-
   
(996
)
Balance December 31, 2006
   
1,053
 
$
21
 
$
10,091
 
$
(838
)
$
204
 
$
9,478
 

See Notes to Consolidated Financial Statements.

68



NOTES TO CONSOLIDATED FINANCIAL STATEMENTS


In this Annual Report, “Genentech,” “we,” “us” and “our” refer to Genentech, Inc. “Common Stock” refers to Genentech’s Common Stock, par value $0.02 per share, “Special Common Stock” refers to Genentech’s callable putable common stock, par value $0.02 per share, all of which was redeemed by Roche Holdings, Inc. (or “Roche”) on June 30, 1999 (or “the Redemption”).


Note 1.
DESCRIPTION OF BUSINESS

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. We commercialize multiple biotechnology products, and also receive royalties from companies that have licensed our technology.

Redemption of Our Special Common Stock

On June 30, 1999, Roche exercised its option to cause us to redeem all of our Special Common Stock held by stockholders other than Roche. The Redemption was reflected as a purchase of a business, which under U.S. generally accepted accounting principles required push-down accounting to reflect in our financial statements the amounts paid for our stock in excess of our net book value. The aggregate purchase price for the acquisition of all of Genentech’s outstanding shares, including Roche’s estimated transaction costs of $10 million, was $6,605 million.


Note 2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Principles of Consolidation

The consolidated financial statements include the accounts of Genentech and all wholly owned subsidiaries. Material intercompany accounts and transactions have been eliminated.

Use of Estimates and Reclassifications

The preparation of financial statements in conformity with GAAP requires management to make judgments, assumptions and estimates that affect the amounts reported in our consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates.

Certain reclassifications of prior period amounts have been made to our consolidated financial statements to conform to the current period presentation.

Recent Accounting Pronouncements

On June 28, 2006, the Financial Accounting Standards Board (or “FASB”) ratified the consensus reached by the Emerging Issues Task Force (or “EITF”) on EITF Issue No. 06-2, “Accounting for Sabbatical Leave and Other Similar Benefits Pursuant to FASB Statement No. 43, Accounting for Compensated Absences” (or “EITF 06-2”). EITF 06-2 states that if all the conditions of paragraph 6 of FASB 43 are met, compensation costs for sabbatical and other similar benefit arrangements should be accrued over the requisite service period. Paragraph 6 of FASB 43 states that a liability should be accrued for employees’ future absences if the following are met:  (a) the employer’s obligation is attributable to employees’ services already rendered; (b) the obligation relates to rights that vest or accumulate; (c) payment of the compensation is probable; and (d) the amount can be reasonably estimated. EITF 06-2 is effective for us beginning January 1, 2007. Upon adoption of EITF 06-2, we expect to record a one-time charge as a cumulative effect of a change in accounting principle of approximately $26 million, net of tax. We will also begin to record an annual sabbatical expense that will reduce diluted net income per share by approximately $0.01 to $0.02 per share in 2007.

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In June 2006, the FASB issued FASB Interpretation (or “FIN”) No. 48, “Accounting for Uncertainty in Income Taxes.” FIN 48 clarifies the application of FASB Statement 109, “Accounting for Income Taxes,” by defining criteria that must be met for any part of a benefit related to an individual tax position taken or expected to be taken in an enterprise’s tax returns to be recognized in its consolidated financial statements. FIN 48 also provides guidance on measurement, derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition and is effective for us beginning January 1, 2007. We are currently evaluating the effect that the adoption of FIN 48 will have on our consolidated results of operations and financial position, but we do not expect the effect to be material.

Revenue Recognition

We recognize revenue from the sale of our products, royalties earned and contract arrangements. Our revenue arrangements which contain multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. The consideration we receive is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units. Advance payments received in excess of amounts earned are classified as deferred revenue until earned.

 
·
We recognize revenue from product sales when there is persuasive evidence that an arrangement exists, title passes, the price is fixed and determinable, and collectibility is reasonably assured. Allowances are established for estimated rebates, healthcare provider contractual chargebacks, prompt pay sales discounts, product returns, and wholesaler and distributor inventory management allowances. In our domestic commercial collaboration agreements, we have primary responsibility for the United States (or “U.S.”) product sales commercialization efforts, including selling and marketing, customer service, order entry, distribution, shipping and billing. We record net product sales and related production and selling cost in our income statement line items on a gross basis since we have the manufacturing risk and/or inventory risk, and credit risk, and meet the criteria as a principal under EITF Issue No. 99-19, “Reporting Revenue Gross as a Principal Versus Net as an Agent” (or “EITF 99-19”).

Avastin product sales subject to the Avastin Patient Assistance Program and the free Avastin that we expect to provide to eligible patients represent separate units of accounting under the provisions of EITF Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables,” (or “EITF 00-21”). The Avastin Patient Assistance Program is a voluntary program that enables eligible patients who receive greater than 10,000 milligrams of Avastin over a 12-month period to receive free Avastin during the remainder of the 12-month period. Based on the current wholesale acquisition cost, the 10,000 milligrams is valued at $55,000 in gross revenue. We defer a portion of the Avastin product sales revenue to reflect our estimate of the free Avastin commitment to those patients who elect to enroll in the program. A maximum amount of $55,000 of gross revenue earned from an enrolled patient will be recognized ratably over the total number of product vials used for infusions from their physicians, which were obtained through normal commercial channels as well as those vials we will deliver directly to their physician in conjunction with the Avastin Patient Assistance Program.

 
·
We recognize revenue from royalties based on licensees’ sales of our products or products using our technologies. Royalties are recognized as earned in accordance with the contract terms when royalties from licensees can be reasonably estimated and collectibility is reasonably assured. For the majority of our royalty revenues, estimates are made using historical and forecasted sales trends and used as a basis to record amounts in advance of amounts collected.

70



 
·
Contract revenue generally includes upfront and continuing licensing fees, manufacturing fees, milestone payments and net reimbursements from collaborators on development, post-marketing and commercial costs. Most of our contract arrangements with up-front license fees were entered into prior to the effective date of July 1, 2003 for EITF 00-21. Accordingly, our accounting policy on contract revenue, as described below, is focused on describing transactions entered into prior to the effective date of EITF 00-21.

 
·
Nonrefundable upfront fees, including product opt-ins, for which no further performance obligations exist, are recognized as revenue on the earlier of when payments are received or collection is assured.

 
·
Nonrefundable upfront licensing fees, including product opt-ins, and certain guaranteed, time-based payments that require our continuing involvement in the form of development, manufacturing or other commercialization efforts by us are recognized as revenue:

 
·
ratably over the development period if development risk is significant, or

 
·
ratably over the manufacturing period or estimated product useful life if development risk has been substantially eliminated.

 
·
Upfront manufacturing fees are recognized as revenue as the related manufacturing services are rendered, generally on a straight-line basis over the performance period of the longer of the manufacturing obligation period or the expected product life. Manufacturing profit is recognized when the product is shipped and title passes.

 
·
Fees associated with substantive milestones, which are contingent upon future events for which there is reasonable uncertainty as to their achievement at the time the agreement was entered into, are recognized as revenue when these milestones, as defined in the contract, are achieved.

 
·
Multiple element agreements, or amendments to such agreements, entered into after July 1, 2003, are evaluated under the provisions of EITF 00-21. We evaluate whether there is stand-alone value for the delivered elements and objective evidence of fair value to allocate revenue to each element in multiple element agreements. When the delivered element does not have stand-alone value or there is insufficient evidence of fair value for the undelivered element(s), we recognize the consideration for the combined unit of accounting in the same manner as the revenue is recognized for the final deliverable, which is generally ratably over the longest period of involvement.

 
·
Commercial collaborations resulting in a net reimbursement of development, post-marketing and commercial costs are recognized as revenue as the related costs are incurred. The corresponding development and post-marketing expenses are included in research and development (or “R&D”) expenses and the corresponding commercial costs are included in marketing, general and administrative (or “MG&A”) expenses in the Consolidated Statements of Income.

Product Sales Allowances

Revenues from product sales are recorded net of allowances for estimated rebates, healthcare provider contractual chargebacks, prompt pay sales discounts, product returns, and wholesaler and distributor inventory management allowances, all of which are established at the time of sale. These allowances are based on estimates of the amounts earned or to be claimed on the related sales. These estimates take into consideration our historical experience, current contractual and statutory requirements, specific known market events and trends such as competitive pricing and new product introductions, and forecasted customer buying patterns and inventory levels, including the shelf lives of our products. Rebates, healthcare provider contractual chargebacks, inventory management allowances, prompt pay sales discounts and product returns are product-specific, which can be affected by the mix of products sold in any given period. All our product sales allowances are based on estimates. If actual future results vary, we

71



may need to adjust these estimates, which could have an effect on earnings in the period of the adjustment. Our product sales allowances and accruals are as follows:

 
·
Rebate allowances and accruals are comprised of both direct and indirect rebates. Direct rebates are contractual price adjustments payable to wholesalers and specialty pharmacies that purchase products directly from us. Indirect rebates are contractual price adjustments payable to healthcare providers and organizations, such as payers, clinics, hospitals, pharmacies and group purchasing organizations that do not purchase products directly from us. Both types of allowances are based upon definitive contractual agreements or legal requirements (such as Medicaid) related to the dispensing of the product by a pharmacy, clinic or hospital to a benefit plan participant. Rebate accruals are recorded in the same period the related revenue is recognized resulting in a reduction to product sales revenue and the recognition of a contra asset (if due to a wholesaler or specialty pharmacy) or a liability (if due to a third party, such as a healthcare provider) as appropriate, which are included in accounts receivable allowances or other accrued liabilities, respectively. Rebates are estimated using historical and other data, including patient usage, customer buying patterns, applicable contractual rebate rates and contract performance by the benefit providers. Rebate estimates are evaluated quarterly and may require adjustments to better align our estimates with actual results. As part of this evaluation, we review changes to federal legislation, changes to rebate contracts, changes in the level of discounts, and changes in product sales trends. Although rebates are accrued at the time of sale, rebates are typically paid out, on average, up to six months after the sale.

 
·
Healthcare provider contractual chargebacks are the result of contractual commitments by us to provide products to healthcare providers at specified prices or discounts. These contracted health care providers include (i) hospitals that service a disproportionately high share of economically indigent and Medicaid patients for which they receive little or no reimbursement (i.e. Disproportionate Share Hospitals or “DSH”), (ii) government-owned hospitals that receive discounts, and (iii) hospitals that have contract pricing for certain products usually through a group purchasing agreement. Chargebacks occur when a contracted health care provider purchases our products through an intermediary wholesaler at fixed contract prices that are lower than the list prices we charge the wholesalers. The wholesaler, in turn, charges us back for the difference between the price initially paid by the wholesaler and the contract price paid to the wholesaler by the healthcare providers. Chargebacks are accrued at the time of sale and are estimated based on historical trends, which closely approximate actual results as we generally issue credits within a few weeks of the time of sale.

 
·
Prompt pay sales discounts are credits granted to wholesalers for remitting payment on their purchases within contractually defined cash repayment incentive periods. The contractually defined cash repayment periods are generally 30 days; however, for newly launched products, we have offered and we may offer in the future, for a limited period of time, extended payment terms to wholesalers. In connection with the launch of Lucentis we have offered an extended payment terms program to certain of our wholesalers. This program will be in effect for 12 months ending June 30, 2007. Based upon our experience that it is rare that a wholesaler does not comply with the contractual terms to earn the prompt pay sales discount, we accrue 100 percent of the prompt pay sales discounts at the time of original sale.

 
·
Wholesaler and distributor inventory management allowances are credits granted to wholesalers and distributors for compliance with various contractually-defined inventory management programs. These programs provide monetary incentives in the form of a credit for wholesalers and distributors to maintain consistent inventory levels at approximately two to three weeks of sales depending on the product. These wholesaler inventory management credits are calculated based on quarterly product purchases multiplied by a factor to determine the maximum possible credit for a product for the preceding quarter. Adjustments to reduce the maximum credit are made if the wholesaler does not meet and/or comply with the contractually defined metrics. These metrics include data timeliness, completeness and accuracy and deviations outside of the contracted inventory days on hand for each product. The maximum credits are accrued at the time of sale, and are typically granted to wholesaler accounts within 90 days after the sale.

72



 
·
Product returns allowances are established in accordance with our returns policy, which allows buyers to return our products within two months prior to and six months following product expiration. Most of our products are sold to our wholesalers with at least six months of dating prior to expiration. As part of our estimation process, we calculate historical return data on a production lot basis. Historical rates of return are determined by product and are adjusted for known or expected changes in the marketplace specific to each product. In addition, we review expiration dates to determine the remaining shelf life of each product not yet returned. Although product return allowances are accrued at the time of sale, the majority of returns take place up to two years after the sale.

Allowances against receivable balances primarily relate to product returns, wholesaler-related direct rebates, prompt pay sales discounts, and wholesaler inventory management allowances, and are recorded in the same period the related revenue is recognized, resulting in a reduction to product sales revenue and the reporting of product sales receivable net of allowances. Accruals related to indirect rebates and contractual chargebacks for healthcare providers are recognized in the same period the related revenue is recognized, resulting in a reduction to product sales revenue, and are recorded as other accrued liabilities.

Commercial Collaboration Accounting

We have domestic commercial collaboration profit sharing agreements with Biogen Idec Inc. on Rituxan, Novartis Pharma AG on Xolair, and with OSI Pharmaceuticals, Inc. on Tarceva. In these agreements, we have primary responsibility for the U.S. commercialization including sales and/or marketing, customer support, order entry, distribution, shipping and billing. In addition to being primarily responsible for providing the product or service to the customer, we have general inventory risk prior to the customer placing an order or upon customer return and we are exposed to customer credit risk. We record net product sales and related production and selling costs for our domestic collaborations in our Consolidated Statements of Income on a gross basis since we are the principal in the sales transaction, as defined under EITF 99-19. The collaboration profit sharing expense line in our Consolidated Statements of Income primarily includes the profit sharing results with Biogen Idec on Rituxan, with Novartis Pharma AG on Xolair, and with OSI Pharmaceuticals on Tarceva.

We have a European commercial collaboration profit sharing agreement with Novartis Pharma AG on Xolair. We do not record the net product sales and related production and selling costs for our European collaboration in our Consolidated Statements of Income on a gross basis since we do not meet the criteria as a principal under EITF 99-19, and instead record our net share of the European collaboration profits as contract revenue (or collaboration losses as collaboration profit sharing expense). See also Note 9, “Relationship with Roche and Related Party Transactions,” regarding Novartis related collaboration cost and profit sharing expenses.

Research and Development Expenses

Research and development (or “R&D”) expenses include salaries, benefits and other headcount related costs, clinical trial and related clinical manufacturing costs, contract and other outside service fees, and facilities and overhead costs. R&D expenses consist of independent R&D costs and costs associated with collaborative R&D and in-licensing arrangements. In addition, we acquire R&D services from other companies and fund research institutions under agreements which we can generally terminate at will. R&D expenses also include post-marketing activities such as Phase IV and investigator-sponsored trials and product registries. R&D costs, including upfront fees and milestones paid to collaborators, are expensed as incurred. The costs of the acquisition of technology is capitalized if it has alternative future uses in other R&D projects or otherwise. R&D collaborations resulting in a net payment of development and post-marketing costs are recognized as R&D expense as the related costs are incurred.

Royalty Expenses

Royalty expenses and milestones directly related to product sales are classified in cost of sales (or “COS”). Other royalty expenses, relating to royalty revenue, are classified in MG&A expenses and totaled $221 million in 2006, $182 million in 2005, and $174 million in 2004.

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Advertising Expenses

We expense the costs of advertising, which also includes promotional expenses, as incurred. Advertising expenses were $439 million in 2006, $345 million in 2005, and $257 million in 2004.

Research and Development Arrangements

To gain access to potential new products and technologies and to utilize other companies to help develop our potential new products, we establish strategic alliances with various companies. These strategic alliances often include the acquisition of marketable and nonmarketable equity investments or debt of companies developing technologies that complement or fall outside our research focus and include companies having the potential to generate new products through technology licensing and/or investments. Potential future payments may be due to certain collaborators achieving certain benchmarks as defined in the collaborative agreements. We also entered into product-specific collaborations to acquire development and marketing rights for products. See Note 8, “Leases, Commitments and Contingencies,” and Note 9, “Relationship with Roche and Related Party Transactions,” below for a discussion of our more significant collaborations.

Under FIN 46R, we are required to assess new business development collaborations as well as to, upon certain events, some of which are outside our control, reassess the accounting treatment of our existing business development collaborations based on the nature and extent of our financial interests as well as our ability to exercise influence in such collaborations. While this standard has not had any material effect on our financial results during 2005 and 2006, our continuing compliance may result in our consolidation of companies or related entities with which we have a collaborative arrangement and this may have a material effect on our financial condition and/or results of operation in future periods.

Cash and Cash Equivalents

We consider all highly liquid available-for-sale debt securities purchased with an original maturity of three months or less to be cash equivalents.

Inventories

Inventories are stated at the lower of cost or market value. Cost is determined using a weighted-average approach. If inventory costs exceed expected market value due to obsolescence or lack of demand, reserves are recorded for the difference between the cost and the estimated market value. These reserves are determined based on significant estimates. Inventories may include products awaiting regulatory approval or products manufactured at facilities awaiting regulatory approval and are capitalized based on management’s judgment of probable near term regulatory approval. In addition, inventories include employee stock-based compensation expenses capitalized under FAS 123R.

Investments in Marketable and Nonmarketable Securities

We invest in short-term and long-term marketable securities, primarily corporate notes, government agencies, preferred stock, asset-backed securities and municipal bonds. As part of our strategic alliance efforts, we may also invest in equity securities, dividend-bearing convertible preferred stock and interest-bearing debt of other biotechnology companies. Each of our equity investments represent less than a 13% ownership position in the collaborator company.

We classify marketable equity and debt securities into one of two categories: available-for-sale or trading. Trading securities are bought, held and sold with the objective of generating returns. We have established maximum amounts of our total investment portfolio that can be included in our trading portfolio, the majority of which is managed by investment management firms that operate within investment policy guidelines we provide. Trading securities are classified as short-term investments and are carried at estimated fair market value. Unrealized holding gains and

74



losses on trading securities are included in “interest and other income (expense), net”. Debt securities and marketable equity securities not classified as trading are considered available-for-sale. These securities are carried at estimated fair value (see Note 4, “Investment Securities and Financial Instruments,” below) with unrealized gains and losses included in accumulated other comprehensive income in stockholders’ equity. Available-for-sale equity securities and available-for-sale debt securities with remaining maturities of greater than one year are classified as long-term.

If the estimated fair value of a security is below its carrying value, we evaluate whether we have the intent and ability to retain our investment for a period of time sufficient to allow for any anticipated recovery in market value and whether evidence indicating that the cost of the investment is recoverable within a reasonable period of time outweighs evidence to the contrary. Some of the factors we consider in determining whether an impairment is other-than-temporary include, among other things, unfavorable clinical trial results and the diminished prospect for new products, failure to receive product approval from a regulatory body, the termination of a major collaborative relationship and the liquidity position and financing activities of the issuer. If the impairment is considered to be other-than-temporary, the security is written down to its estimated fair value. Other-than-temporary declines in estimated fair value of all marketable securities are charged to “interest and other income (expense), net.” The cost of all securities sold is based on the specific identification method. We recognized charges of $4 million in 2006, $5 million in 2005, and $12 million in 2004 related to other-than-temporary declines in the estimated fair values of certain of our marketable equity and debt securities.

Nonmarketable equity securities are carried at cost, less any write-downs for impairment. We periodically monitor the liquidity and financing activities of the respective issuers to determine if impairment write downs to our nonmarketable equity securities are necessary.

Derivative Instruments

We use derivatives to manage our market exposure to fluctuations in foreign currencies, U.S. interest rates and marketable equity investments. We record all derivatives on the balance sheet at estimated fair value. For derivative instruments that are designated and qualify as a fair value hedge (i.e., hedging the exposure to changes in the estimated fair value of an asset or a liability or an identified portion thereof that is attributable to a particular risk), the gain or loss on the derivative instrument, as well as the offsetting loss or gain on the hedged item attributable to the hedged risk, is recognized in current earnings during the period of the change in estimated fair values. For derivative instruments that are designated and qualify as a cash flow hedge (i.e., hedging the exposure to variability in expected future cash flows that is attributable to a particular risk), the effective portion of the gain or loss on the derivative instrument is reported as a component of other comprehensive income and reclassified into earnings in the same period or periods during which the hedged transaction affects earnings. The gain or loss on the derivative instruments in excess of the cumulative change in the present value of future cash flows of the hedged transaction, if any, is recognized in current earnings during the period of change. We do not use derivative instruments for speculative purposes. See Note 4, “Investment Securities and Financial Instruments — Derivative Financial Instruments,” below for further information on our accounting for derivatives.

Property, Plant and Equipment

The costs of buildings and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, but not more than:

 
Useful Lives
Buildings
25 years
Certain manufacturing equipment
15 years
Other equipment
3 to 8 years
Leasehold improvements
length of applicable lease

75



Depreciation expense on biologics manufacturing facilities constructed or purchased begins once production activities have commenced at the facility, which is generally at the point at which qualification lots are being produced. The point at which depreciation is commenced best represents the point at which the asset is ready for its intended use, and generally precedes U.S. Food and Drug Administration (or “FDA”) licensure of the facility.

FDA Validation Costs

FDA validation costs are capitalized as part of the effort required to acquire and construct long-lived assets, including readying them for their intended use, and are amortized over the estimated useful life of the asset or the term of the lease, whichever is shorter, and charged to cost of sales. These costs are included in “other long-term assets” in the accompanying Consolidated Balance Sheets.

Goodwill and Other Intangible Assets

Goodwill represents the difference between the purchase price and the estimated fair value of the net assets acquired when accounted for by the purchase method of accounting and arises from Roche’s purchases of our Special Common Stock and push-down accounting (refer to the “Redemption of Our Special Common Stock” note above). In accordance with FAS 142, “Goodwill and Intangible Assets,” we do not amortize goodwill. Also in accordance with FAS 142, we perform an annual impairment test of goodwill every September at the Company level, which is the sole reporting unit, and have found no impairment. We will continue to evaluate our goodwill for impairment annually and whenever events and changes in circumstances suggest that the carrying amount may not be recoverable.

We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from five to 15 years, and review for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. We capitalize costs of patents and patent applications related to products and processes of significant importance to us and amortize these on a straight-line basis over their estimated useful lives of approximately 12 years.

Restricted Cash and Investments

We have entered into an arrangement with third-party insurance companies to post a bond in connection with the City of Hope trial judgment. As part of this arrangement, we were required to pledge cash and investments to secure this bond. We are periodically required to increase the surety bond to secure the accruing interest. As of December 31, 2006 and 2005, we held restricted cash and investments of $788 million and $735 million, respectively, related to the surety bond. These amounts are reflected in the Consolidated Balance Sheets in “restricted cash and investments.”

Impairment of Long-Lived Assets

Long-lived assets and certain identifiable intangible assets to be held and used are reviewed for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values. Long-lived assets and certain identifiable intangible assets to be disposed of are reported at the lower of carrying amount or fair value less cost to sell.

Accounting for Employee Stock-Based Compensation

On January 1, 2006, we adopted Statement of Financial Accounting Standards No. 123(R), “Share-Based Payment” (or “FAS 123R”), which supersedes our previous accounting under Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” (or “APB 25”). FAS 123R requires the recognition of compensation

76



expense, using a fair-value based method, for costs related to all share-based payments including stock options and stock issued under our employee stock purchase plan. FAS 123R requires companies to estimate the fair value of share-based payment awards on the date of grant using an option-pricing model. We adopted FAS 123R using the modified prospective transition method, which requires that compensation expense be recognized in the financial statements for all awards granted after the date of adoption as well as for existing awards for which the requisite service has not been rendered as of the date of adoption. The modified prospective transition method does not require restatement of prior periods to reflect the effect of FAS 123R.

In November 2005, the FASB issued FASB Staff Position No. 123R-3, “Transition Election Related to Accounting for the Tax Effects of Share-Based Payment Awards.” We have adopted the simplified method to calculate the beginning balance of the additional paid-in-capital (or “APIC”) pool of the excess tax benefit, and to determine the subsequent effect on the APIC pool and Consolidated Statements of Cash Flows of the tax effects of employee stock-based compensation awards that were outstanding upon our adoption of FAS 123R.

Prior to the adoption of FAS 123R, we accounted for stock-based awards to employees and directors using the intrinsic value method in accordance with APB 25 as allowed under FAS No. 123, “Accounting for Stock-Based Compensation” (or “FAS 123”). Under the intrinsic value method, no employee stock-based compensation expense had been recognized in our Consolidated Statements of Income for any period prior to our adoption of FAS 123R on January 1, 2006, as the exercise price of the stock options granted to employees and directors equaled the fair market value of the underlying stock at the date of grant. See Note 3, “Employee Stock-Based Compensation” for further discussion of employee stock-based compensation.

401(k) Plan and Other Postretirement Benefits

Our 401(k) Plan (or “the Plan”) covers substantially all of our employees. We match a portion of employee contributions, up to a maximum of 5% of each employee’s eligible compensation. Historically, the match was effective and fully vested at December 31 of each year. Effective October 1, 2006, the match is funded concurrently with a participant’s semi-monthly contribution to the Plan. Additionally, we annually contributed to every employee’s account 1% of his or her eligible compensation, regardless of whether the employee actively participates in the Plan. In the third quarter of 2006, we increased the contribution to 2% of the employee’s compensation, beginning with the 2006 annual contribution. We recorded expense of $68 million in 2006, $46 million in 2005, and $34 million in 2004 for our contributions under the Plan.

In addition, we provide certain postretirement benefits, primarily healthcare related, to employees who meet certain eligibility criteria. As of December 31, 2005, the accrued benefit costs and the accumulated benefit obligation related to these postretirement benefits were not material. In 2006, we adopted FAS 158, “Employers’ Accounting for Defined Benefit Pension and Other Postretirement Plans - an amendment of FASB Statements No. 87, 88, 106, and 132(R)” (or “FAS 158”). FAS 158 requires companies to recognize the funded status of their postretirement benefit plan in the statement of financial position. As of December 31, 2006, our postretirement benefit plan was not funded. The accumulated postretirement benefit obligation was $21 million, of which $20 million is included in “litigation-related and other long-term liabilities” and $1 million is included in “other current liabilities” in the Consolidated Balance Sheets.

Income Taxes

Our income tax provision is based on pretax financial accounting income computed under the liability method. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Significant estimates are required in determining our provisions for income taxes. Some of these estimates are based on interpretations of existing tax laws or regulations. We believe that our estimates are reasonable and that our reserves for income tax related uncertainties are adequate. Various internal and external factors may have favorable or unfavorable effects on our future effective income tax rate. These factors include, but are not limited to, changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, changes in estimates of prior years’ items, future levels of R&D spending, and changes in overall levels of income before tax.

77



Effective with the consummation of the public offering of our common stock by Roche on October 26, 1999, we ceased to be a member of the consolidated federal income tax group (and certain consolidated or combined state and local income tax groups) of which Roche is the common parent. Accordingly, our tax sharing agreement with Roche now pertains only to the state and local tax returns in which we are consolidated or combined with Roche. We will continue to calculate our tax liability or refund with Roche for these state and local jurisdictions as if we were a stand-alone entity.

Earnings Per Share

Basic earnings per share (or “EPS”) are computed based on the weighted-average number of shares of our Common Stock outstanding. Diluted earnings per share are computed based on the weighted-average number of shares of our Common Stock and other dilutive securities.

All information in this report relating to the number of shares, price per share and per share amounts of Common Stock gives retroactive effect to the May 2004 two-for-one stock split of our Common Stock.

The following is a reconciliation of the numerators and denominators of the basic and diluted earnings per share computations (in millions):

   
2006
 
2005
 
2004
 
Numerator:
             
Net income
 
$
2,113
 
$
1,279
 
$
785
 
Denominator:
                   
Weighted-average shares outstanding used to compute basic earnings per share
   
1,053
   
1,055
   
1,055
 
Effect of dilutive stock options
   
20
   
26
   
24
 
Weighted-average shares outstanding and dilutive securities used to compute diluted earnings per share
   
1,073
   
1,081
   
1,079
 

Outstanding employee stock options to purchase approximately 24 million shares of our Common Stock for 2006 were excluded from the computation of diluted EPS because the effect would have been anti-dilutive. See Note 3, “Employee Stock-Based Compensation,” for information on option exercise prices and expiration dates.

Comprehensive Income

Comprehensive income is comprised of net income and other comprehensive income (or “OCI”). OCI includes certain changes in stockholders’ equity that are excluded from net income. Specifically, we include in OCI changes in the estimated fair value of derivatives designated as effective cash flow hedges and unrealized gains and losses on our available-for-sale securities. In accordance with our adoption of FAS 158 in 2006, the gains or losses and prior service costs or credits that arise during the period but are not recognized as components of net periodic benefit cost have been recognized in other comprehensive income. Comprehensive income for the years ended December 31, 2006, 2005 and 2004 has been reflected in the Consolidated Statements of Stockholders’ Equity.

The components of accumulated other comprehensive income, net of taxes, at December 31, 2006 and 2005 were as follows (in millions):

   
2006
 
2005
 
Net unrealized gains on securities available-for-sale
 
$
214
 
$
230
 
Net unrealized gains (losses) on cash flow hedges
   
(4
)
 
23
 
Change in post-retirement benefit obligation
   
(6
)
 
-
 
Accumulated other comprehensive income
 
$
204
 
$
253
 


78



The activity in OCI was as follows (in millions):

   
2006
 
2005
 
2004
 
(Decrease) increase in unrealized gains on securities available-for-sale (net of tax: 2006-$(11); 2005-$(49); 2004-$7)
 
$
(13
)
$
(74
)
$
10
 
Reclassification adjustment for net (gains) losses on securities available-for-sale included in net income (net of tax: 2006-$(2); 2005-$(1); 2004-$1)
   
(3
)
 
(1
)
 
1
 
(Decrease) increase in unrealized gains on cash flow hedges (net of tax: 2006-$(12); 2005-$32; 2004-($14))
   
(18
)
 
48
   
(21
)
Reclassification adjustment for net (gains) losses on cash flow hedges included in net income (net of tax: 2006-$(6); 2005-$(7); 2004-$3)
   
(9
)
 
(11
)
 
4
 
Change in post-retirement benefit obligation (net of tax: 2006-$(4))
   
(6
)
 
-
   
-
 
Other comprehensive loss
 
$
(49
)
$
(38
)
$
(6
)


Note 3.
Employee Stock-Based Compensation

On January 1, 2006, we adopted FAS 123R, which supersedes our previous accounting under APB 25. FAS 123R requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based payments including stock options and stock issued under our employee stock purchase plan. Under FAS 123R, the value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service periods in our Consolidated Statements of Income. Also, certain of these costs are capitalized into inventory on our Consolidated Balance Sheets, and generally will be recognized as an expense when the related products are estimated to be sold.

Employee Stock Plans

We currently have an employee stock purchase plan, adopted in 1991 and amended thereafter (or “the 1991 Plan”). The 1991 Plan allows eligible employees to purchase Common Stock at 85% of the lower of the fair market value of the Common Stock on the grant date or the fair market value on the purchase date. The offering period under the 1991 Plan is currently 15 months, and the purchase price is established during each new offering period. Purchases are limited to 15% of each employee’s eligible compensation and subject to certain Internal Revenue Service restrictions. In general, all of our regular full-time employees are eligible to participate in the 1991 Plan. Of the 52,400,000 shares of Common Stock reserved for issuance under the 1991 Plan, 47,022,857 shares have been issued as of December 31, 2006.

We currently grant options under the Genentech, Inc. 2004 Equity Incentive Plan, which allows for the granting of non-qualified stock options, incentive stock options and stock appreciation rights, restricted stock, performance units or performance shares to our employees, directors and consultants. Incentive stock options may only be granted to employees under this plan. Generally, stock options granted to employees have a maximum term of 10 years, and vest over a four year period from the date of grant; 25% vest at the end of one year, and 75% vest monthly over the remaining three years. We may grant options with different vesting terms from time to time. When an employee over the age of 65 retires, the portion of the option that would have vested in the 12-month period following the retirement date, if the retiree had remained an employee, automatically becomes fully vested. The expiration date of the exercisable portion of the option remains the original expiration date at the time the option was granted. Unless an employee’s termination of service is due to retirement, disability or death, upon termination of service, any unexercised vested options will be forfeited at the end of three months or the expiration of the option, whichever is earlier.

79



Adoption of FAS 123R

Employee stock-based compensation expense recognized in 2006 was calculated based on awards ultimately expected to vest and has been reduced for estimated forfeitures. FAS 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

Employee stock-based compensation expense recognized under FAS 123R was as follows (in millions, except for per share data):

   
2006
 
Research and development
 
$
140
 
Marketing, general and administrative
   
169
 
Total employee stock-based compensation expense
   
309
 
Tax benefit related to employee stock-based compensation expense
   
(127
)
Net effect on net income
 
$
182
 
Effect on earnings per share:
       
Basic
 
$
0.17
 
Diluted
 
$
0.17
 

As of December 31, 2006, total compensation cost related to unvested stock options not yet recognized was $839 million, which is expected to be allocated to expense and production costs over a weighted-average period of 28 months.

The carrying value of inventory on our Consolidated Balance Sheet as of December 31, 2006 includes employee stock-based compensation costs of $67 million. Substantially all of the products sold during 2006 were manufactured in previous periods when we did not include employee stock-based compensation expense in our production costs.

The following pro forma net income and EPS were determined as if we had accounted for employee stock-based compensation expense for our employee stock plans under the fair value method prescribed by FAS 123 in prior periods and had capitalized certain costs into inventory manufactured in those prior periods, with the resulting effect on cost of sales for 2006 when previously manufactured products were sold. (In millions, except for per share data):

   
2006
 
Net income as reported
 
$
2,113
 
Deduct: Total employee stock-based compensation expense includable in cost of sales, net of related tax effects
   
(34
)
Pro forma net income
 
$
2,079
 
Earnings per share:
       
Basic-as reported
 
$
2.01
 
Basic-pro forma
 
$
1.97
 
         
Diluted-as reported
 
$
1.97
 
Diluted-pro forma
 
$
1.94
 


80



Pro Forma Information for Periods Prior to Adoption of FAS 123R

The following pro forma net income and EPS were determined as if we had accounted for employee stock-based compensation for our employee stock plans under the fair value method prescribed by FAS 123. (In millions, except for per share data):

   
2005
 
2004
 
Net income as reported
 
$
1,279
 
$
785
 
Deduct: Total employee stock-based compensation expense determined under the fair value based method for all awards, net of related tax effects
   
(175
)
 
(191
)
Pro forma net income
 
$
1,104
 
$
594
 
Earnings per share:
             
Basic-as reported
 
$
1.21
 
$
0.74
 
Basic-pro forma
 
$
1.05
 
$
0.56
 
               
Diluted-as reported
 
$
1.18
 
$
0.73
 
Diluted-pro forma
 
$
1.02
 
$
0.54
 

Valuation Assumptions

The employee stock-based compensation expense recognized under FAS 123R and presented in the pro forma disclosure required under FAS 123 was determined using the Black-Scholes option valuation model. Option valuation models require the input of subjective assumptions and these assumptions can vary over time. The weighted-average assumptions used are as follows:

   
2006
 
2005
 
2004
 
Risk-free interest rate
   
4.6
%
 
4.2
%
 
3.4
%
Dividend yield
   
0.0
%
 
0.0
%
 
0.0
%
Expected volatility
   
27.2
%
 
29.3
%
 
33.3
%
Expected term (years)
   
4.6
   
4.2
   
4.3
 

Due to the redemption of our Special Common Stock in June 1999 by Roche, there is limited historical information available to support our estimate of certain assumptions required to value our employee stock options. In developing our estimate of expected term, we have assumed that our recent historical stock option exercise experience is a relevant indicator of future exercise patterns. We base our determination of expected volatility predominantly on the implied volatility of our traded options with consideration of our historical volatilities and volatilities of comparable companies.

81



Stock Option Activity

The following is a summary of option activity (shares in millions):

       
Options Outstanding
 
   
Shares Available for Grant
 
Number of Shares
 
Weighted-Average Exercise Price
 
December 31, 2003
   
41
   
96
 
$
25.18
 
Grants
   
(21
)
 
21
   
53.04
 
Exercises
   
-
   
(21
)
 
20.81
 
Cancellations
   
2
   
(2
)
 
29.92
 
Additional shares reserved(1)
   
80
   
-
   
-
 
December 31, 2004
   
102
   
94
   
32.32
 
Grants
   
(20
)
 
20
   
84.01
 
Exercises
   
-
   
(29
)
 
25.88
 
Cancellations
   
2
   
(2
)
 
42.16
 
December 31, 2005
   
84
   
83
   
46.64
 
Grants
   
(17
)
 
17
   
79.85
 
Exercises
   
-
   
(9
)
 
30.42
 
Cancellations
   
3
   
(3
)
 
62.09
 
December 31, 2006
   
70
   
88
 
$
54.53
 
________________________
(1)
Additional shares have been reserved for issuance under the 2004 Equity Incentive Plan approved by stockholders on April 16, 2004.

The intrinsic value of options exercised during 2006, 2005, and 2004 was $500 million, $1,473 million, and $694 million, respectively. The estimated fair value of shares vested during 2006, 2005, and 2004 was $376 million, $276 million, and $305 million, respectively. The weighted-average estimated fair value of stock options granted during 2006, 2005, and 2004 was $24.95, $25.00, and $17.14 per option, respectively, based on the assumptions in the Black-Scholes valuation model discussed above.

The following table summarizes outstanding and exercisable options at December 31, 2006 (in millions, except exercise price data):

   
Options Outstanding
 
Options Exercisable
 
Range of
Exercise Prices
 
Number
of Shares
Outstanding
 
Weighted-Average
Remaining
Contractual Life
(in years)
 
Weighted-Average
Exercise Price
 
Number
of Shares
Exercisable
 
Weighted-Average
Remaining
Contractual Life
(in years)
 
Weighted-Average
Exercise Price
 
$6.27 - $8.89
   
0.4
   
5.04
 
$
7.62
   
0.4
   
5.04
 
$
7.62
 
$10.00 - $14.35
   
11.2
   
4.86
 
$
13.68
   
11.2
   
4.86
 
$
13.68
 
$15.04 - $22.39
   
7.8
   
4.34
 
$
20.85
   
7.8
   
4.33
 
$
20.86
 
$22.88 - $33.00
   
0.2
   
4.49
 
$
26.52
   
0.2
   
4.49
 
$
26.52
 
$35.63 - $53.23
   
32.5
   
6.77
 
$
46.85
   
21.5
   
6.43
 
$
45.45
 
$53.95 - $75.90
   
1.4
   
7.79
 
$
59.23
   
0.7
   
7.73
 
$
58.39
 
$78.99 - $98.80
   
34.8
   
9.20
 
$
82.94
   
5.6
   
8.73
 
$
85.99
 
     
88.3
               
47.4
             

At December 31, 2006, the aggregate intrinsic value of the outstanding options was $2,444 million and the aggregate intrinsic value of the exercisable options was $2,049 million.

82



Stock Repurchase Program

Under a stock repurchase program approved by our Board of Directors in December 2003 and most recently extended in April 2006, we are authorized to repurchase up to 100 million shares of our Common Stock for an aggregate amount of up to $6.0 billion through June 30, 2007. During 2006, we repurchased approximately 12 million shares at an aggregate cost of $996 million. Since the program’s inception, we have repurchased approximately 62 million shares at a total price of $4.4 billion. We intend to use the repurchased stock to offset dilution caused by the issuance of shares in connection with our employee stock plans and also to maintain Roche’s minimum percentage ownership interest in our stock. See Note 9, “Relationship with Roche and Related Party Transactions,” for further discussion about Roche’s minimum percentage ownership interest in our stock.


Note 4.
INVESTMENT SECURITIES AND FINANCIAL INSTRUMENTS

Investment Securities

Securities classified as trading and available-for-sale at December 31, 2006 and 2005 are summarized below (in millions). Estimated fair value is based on quoted market prices for these or similar investments.

December 31, 2006
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Estimated
Fair
Value
 
TOTAL TRADING SECURITIES
 
$
639
 
$
12
 
$
(10
)
$
641
 
SECURITIES AVAILABLE-FOR-SALE
                         
Equity securities
 
$
9
 
$
354
 
$
(3
)
$
360
 
Preferred stock
   
226
   
8
   
(3
)
 
231
 
Debt securities maturing:
                         
within 1 year
   
1,350
   
-
   
(1
)
 
1,349
 
between 1-5 years
   
1,491
   
7
   
(3
)
 
1,495
 
between 5-10 years
   
545
   
4
   
(7
)
 
542
 
TOTAL SECURITIES AVAILABLE-FOR-SALE
 
$
3,621
 
$
373
 
$
(17
)
$
3,977
 

December 31, 2005
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Estimated
Fair
Value
 
TOTAL TRADING SECURITIES
 
$
615
 
$
11
 
$
(14
)
$
612
 
SECURITIES AVAILABLE-FOR-SALE
                         
Equity securities
 
$
(3
)
$
381
 
$
(3
)
$
375
 
Preferred stock
   
201
   
8
   
(3
)
 
206
 
Debt securities maturing:
                         
within 1 year
   
1,617
   
-
   
(1
)
 
1,616
 
between 1-5 years
   
1,195
   
4
   
(4
)
 
1,195
 
between 5-10 years
   
467
   
7
   
(5
)
 
469
 
TOTAL SECURITIES AVAILABLE-FOR-SALE
 
$
3,477
 
$
400
 
$
(16
)
$
3,861
 

The gain or loss on derivative instruments designated as fair value hedges, as well as the offsetting loss or gain on the corresponding hedged marketable equity investment, is recognized currently in earnings. As a result, the cost basis of our equity securities in the table above includes adjustments related to gains and losses on fair value hedges.

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Unrealized loss positions for which other-than-temporary impairments have not been recognized at December 31, 2006 and 2005, are summarized below (in millions):

   
Less Than 12 Months
 
12 Months or Greater
 
Total
 
December 31, 2006
 
Fair
Value
 
Unrealized
Losses
 
Fair
Value
 
Unrealized
Losses
 
Fair
Value
 
Unrealized
Losses
 
Equity securities
 
$
9
 
$
(3
)
$
-
 
$
-
 
$
9
 
$
(3
)
Preferred stock
   
34
   
(1
)
 
53
   
(2
)
 
87
   
(3
)
Debt securities
   
470
   
(1
)
 
490
   
(10
)
 
960
   
(11
)
Total
 
$
513
 
$
(5
)
$
543
 
$
(12
)
$
1,056
 
$
(17
)

   
Less Than 12 Months
 
12 Months or Greater
 
Total
 
December 31, 2005
 
Fair
Value
 
Unrealized
Losses
 
Fair
Value
 
Unrealized
Losses
 
Fair
Value
 
Unrealized
Losses
 
Equity securities
 
$
7
 
$
(3
)
$
-
 
$
-
 
$
7
 
$
(3
)
Preferred stock
   
33
   
(1
)
 
41
   
(2
)
 
74
   
(3
)
Debt securities
   
846
   
(5
)
 
221
   
(5
)
 
1,067
   
(10
)
Total
 
$
886
 
$
(9
)
$
262
 
$
(7
)
$
1,148
 
$
(16
)

Unrealized losses in the portfolio relate to various debt securities, including corporate bonds, U.S. government agency bonds, municipal bonds and asset-backed securities, and investment-grade preferred securities. For these securities, the unrealized losses are primarily due to increases in interest rates. Because we have the ability and intent to hold these investments until a forecasted recovery of fair value, which may be maturity or call date, we do not consider these investments to be other-than-temporarily impaired as of December 31, 2006. See Note 2, “Summary of Significant Accounting Policies — Investments in Marketable and Nonmarketable Securities,” for further discussion of the criteria used to determine impairment of our equity securities.

The carrying amount, which approximates fair value, of all cash, cash equivalents and investment securities held at December 31, 2006 and 2005 (see sections “Cash and Cash Equivalents” and “Investments in Marketable and Nonmarketable Securities” in Note 2, “Summary of Significant Accounting Policies”) is summarized below (in millions):

Security
 
2006
 
2005
 
Cash
 
$
495
 
$
76
 
Cash equivalents
   
755
   
1,149
 
Total cash and cash equivalents
 
$
1,250
 
$
1,225
 
               
Trading securities
 
$
641
 
$
612
 
Securities available-for-sale maturing within one year
   
371
   
322
 
Preferred stock
   
231
   
206
 
Total short-term investments
 
$
1,243
 
$
1,140
 
               
Securities available-for-sale maturing after one year
 
$
1,472
 
$
1,074
 
Equity securities
   
360
   
375
 
Total long-term marketable debt and equity securities
 
$
1,832
 
$
1,449
 
               
Cash
 
$
-
 
$
1
 
Securities available-for-sale maturing within one year
   
223
   
144
 
Securities available-for-sale maturing between 1-10 years
   
565
   
590
 
Total restricted cash and investments
 
$
788
 
$
735
 


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In 2006, proceeds from the sales and maturities of available-for-sale securities totaled $613 million and gross realized gains totaled $61 million. In 2005, proceeds from the sales and maturities of available-for-sale securities totaled $722 million; gross realized gains totaled $9 million and gross realized losses totaled $3 million. In 2004, proceeds from the sales and maturities of available-for-sale securities totaled $1,149 million; gross realized gains totaled $13 million and gross realized losses totaled $2 million.

Net change in unrealized holding (losses) gains on trading securities included in net income totaled $5 million in 2006, ($22) million in 2005, and ($18) million in 2004.

The marketable debt securities we hold are issued by a diversified selection of corporate and financial institutions with strong credit ratings. Our investment policy limits the amount of credit exposure with any one institution. Other than asset-backed and mortgage-backed securities, these debt securities are generally not collateralized. In 2006, 2005, and 2004, there were no charges for credit impairment on marketable debt securities.

Our nonmarketable investment securities were based upon cost less write-downs for impairments, which approximates fair value. Our nonmarketable investment securities were $33 million at December 31, 2006 and $29 million at December 31, 2005, and are classified as “other long-term assets” on our Consolidated Balance Sheets.

Derivative Financial Instruments

Foreign Currency Instruments

We have an established foreign currency hedging program to protect against currency risks, primarily driven by forecasted foreign currency denominated royalties from licensees’ product sales over a five year period. Other foreign currency exposures include collaboration development expenses. We hedge portions of our forecasted foreign currency revenues with option or forward contracts. When the dollar strengthens significantly against the foreign currencies, the decline in value of future foreign currency revenues or expenses is offset by gains or losses, respectively, in the value of the option or forward contracts designated as hedges. Conversely, when the dollar weakens, the increase in the value of future foreign currency revenues or expenses is offset by losses or gains, respectively, in the value of the forward contracts. In accordance with FAS 133, hedges related to anticipated transactions are designated and documented at the hedge’s inception as cash flow hedges and evaluated for hedge effectiveness at least quarterly.

During the years ended December 31, 2006, 2005, and 2004, we had no ineffectiveness with respect to our foreign currency hedging instruments. Gains and losses related to option and forward contracts that hedge future cash flows are classified in the same manner as the underlying hedged transaction in the Consolidated Statements of Income.

At December 31, 2006, net losses on derivative instruments expected to be reclassified from accumulated other comprehensive income to earnings during the next twelve months due to the receipt of the related net revenues denominated in foreign currencies were $9 million.

Interest Rate Swaps

In July 2005, we entered into a series of interest-rate swap agreements with a total notional value of $500 million to protect the 4.40% Senior Notes due 2010 against changes in estimated fair value due to changes in U.S. interest rates. In these swaps, we pay a floating rate and receive a fixed rate that matches the coupon rate of the 5 year Notes due in 2010. See also Note 7, “Long-Term Debt” below.

Equity Instruments

Our marketable equity securities portfolio consists primarily of investments in biotechnology companies whose risk of market fluctuations is greater than the stock market in general. To manage a portion of this risk, we enter into derivative instruments such as zero-cost collar instruments and equity forward contracts to hedge equity securities

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against changes in market value. We have zero-cost collars that expire in 2007 and may require settlement in equity securities. A zero-cost collar is a purchased put option and a written call option on a specific equity security such that the cost of the purchased put and the proceeds of the written call offset each other; therefore, there is no initial cost or cash outflow for these instruments. At December 31, 2006, our zero-cost collars were designated and qualified as cash flow hedges.

As part of our fair value hedging strategy, we have also entered into equity forward contracts that mature in 2008 through 2009. An equity forward is a derivative instrument where we pay the counterparty the total return of the security above the current spot price and receive interest income on the notional amount for the term of the equity forward. A forward contract is a derivative instrument where we lock-in the termination price we receive from the sale of stock based on a pre-determined spot price. The forward contract protects us from a decline in the market value of the security below the spot price and limits our potential benefit from an increase in the market value of the security above the spot price. Throughout the life of the contract, we receive interest income based on the notional amount and a floating-rate index.

During the years ended December 31, 2006, 2005, and 2004, we had no ineffectiveness with respect to our equity hedging instruments. Gains and losses related to zero-cost collar instruments that hedge future cash flows are recorded against the gains or losses from the sale of the underlying hedged marketable equity investment in the Consolidated Statements of Income.

At December 31, 2006, net gains on derivative instruments expected to be reclassified from accumulated other comprehensive income to earnings during the next twelve months due to the cash receipt from the sales of the underlying equity instruments were $4 million.

As part of our hedging transactions, we have entered, and may in the future enter, into security lending agreements with our counterparties. For an equity forward contract, in exchange for lending the hedged shares to the counterparty, we receive additional interest income throughout the life of the agreement based on the notional amount and a floating-rate index. For an equity collar, the benefit is embedded in the call strike price. The total estimated fair value of the securities lent under these agreements was $145 million at December 31, 2006 and $138 million at December 31, 2005.

Estimated Fair Value

The estimated fair value of the foreign exchange options and forwards was based on the forward exchange rates as of December 31, 2006 and 2005. The estimated fair value of the equity forward contracts and zero-cost collar instruments was determined based on the closing market prices of the underlying securities at each year-end. The estimated fair value of our interest rate swap agreements was based on forward interest rates at each year-end. The table below summarizes the estimated fair value, which is also the carrying value, of our financial instruments at December 31, 2006 and 2005 (in millions):

   
2006
 
2005
 
Assets:
         
Foreign exchange forward contracts
 
$
-
 
$
5
 
Foreign exchange options
   
1
   
38
 
Equity forwards
   
47
   
58
 
Equity collars
   
4
   
15
 
Liabilities:
             
Foreign exchange forwards contracts
   
3
   
-
 
Interest rate swap agreements
   
12
   
10
 

The financial instruments we hold are entered into with a diversified selection of institutions with strong credit ratings, which minimizes the risk of loss due to nonpayment from the counterparty. Credit exposure is limited to the unrealized gains on our contracts. We have not experienced any material losses due to credit impairment of our financial instruments.

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Note 5.
CONSOLIDATED FINANCIAL STATEMENT DETAIL

Inventories

Inventories at December 31 are summarized below (in millions):

   
2006
 
2005
 
Raw materials and supplies
 
$
116
 
$
79
 
Work in process
   
818
   
438
 
Finished goods
   
244
   
186
 
Total
 
$
1,178
 
$
703
 

Included in work in process at December 31, 2006 are approximately $69 million of Avastin inventories that were manufactured at our Oceanside facility, at which we are awaiting FDA licensure, and $24 million of Rituxan and Avastin inventories that were manufactured through manufacturing processes awaiting regulatory licensure.

Property, Plant and Equipment

Property, plant and equipment balances at December 31 are summarized below (in millions):

   
2006
 
2005
 
At cost:
         
Land
 
$
399
 
$
376
 
Land improvements
   
38
   
43
 
Buildings
   
1,712
   
1,399
 
Equipment
   
1,953
   
1,614
 
Leasehold improvements
   
146
   
60
 
Construction-in-progress
   
1,291
   
965
 
     
5,539
   
4,457
 
Less: accumulated depreciation and amortization
   
1,366
   
1,108
 
Net property, plant and equipment
 
$
4,173
 
$
3,349
 

On December 8, 2006, we completed the sale of all of the outstanding capital stock of our wholly owned subsidiary, Genentech España, to Lonza Group, Inc. The assets of Genentech España at the time of the sale consisted of a manufacturing facility located in Porriño, Spain, cash, accounts receivable and certain liabilities. The net book value of the assets sold were approximately $159 million, resulting in a loss on sale of approximately $13 million, which has been included in our MG&A expenses in 2006. Our total consideration received from the sale consisted of cash of $11 million, a non-interest bearing, unsecured note, and other receivables, which had a present value of $135 million at the close of the sale. The net assets disposed of consisted of $153 million in property, plant and equipment, $13 million of other assets and $7 million of other liabilities.

In November 2006, we entered into a series of agreements with Lonza Group Ltd (or “Lonza”), including a supply agreement to purchase product produced by Lonza at their Singapore manufacturing facility, which is currently under construction. For accounting purposes, due to the nature of the supply agreement and our involvement with the construction of the buildings, we are considered to be the owner of the assets during the construction period, even though the funds to construct the building shell and some infrastructure costs are paid by Lonza. As such, during 2006, we capitalized $20 million in construction-in-progress and have also recognized a corresponding amount as a construction financing obligation in “long-term debt” in the accompanying Consolidated Balance Sheets.

Included in construction-in-progress at December 31, 2006 and 2005 are $355 million and $94 million, respectively, in capitalized costs pursuant to our Master Lease Agreement with Slough SSF, LLC (or “Slough”) for the construction of buildings in South San Francisco, California. See Note 8, “Leases, Commitments and Contingencies,” for further discussion of the Slough Master Lease Agreement.

87



In June 2005, we acquired Biogen Idec’s Oceanside, California biologics manufacturing facility (or “Oceanside plant”) for $408 million in cash plus $9 million in closing costs. The purchase price allocation for this acquisition was as follows: land and land improvements of $42 million, building of $110 million, equipment of $37 million and construction-in-progress (or “CIP”) of $228 million. These assets were included in CIP at December 31, 2005 as we continued to expend efforts to ready the facility for its intended use. We began to produce qualification lots at the plant during the second quarter of 2006, at which time the related assets were transferred to the appropriate property, plant and equipment categories and we began to depreciate the plant assets. We expect FDA licensure of our Oceanside plant during the first half of 2007, following which we will be able to commercially sell products manufactured at the facility.

Depreciation expense was $279 million in 2006, $226 million in 2005, and $171 million in 2004.

Other Accrued Liabilities

Other accrued liabilities at December 31 are as follows (in millions):

   
2006
 
2005
 
Accrued compensation
 
$
385
 
$
253
 
Accrued royalties
   
224
   
161
 
Accrued clinical and other studies (including to related parties: 2006-$67; 2005-$77)
   
218
   
221
 
Accrued marketing and promotion costs
   
155
   
161
 
Taxes payable
   
258
   
62
 
Accrued collaborations (including to a related party: 2006-$53; 2005-$42)
   
291
   
228
 
Other (including to related parties: 2006-$16; 2005-$13)
   
218
   
191
 
Total other accrued liabilities
 
$
1,749
 
$
1,277
 

Interest and Other Income (Expense), Net

Interest and other income (expense), net for the years ended December 31 are as follows (in millions):

   
2006
 
2005
 
2004
 
Gains on sales of biotechnology equity securities, net
 
$
93
 
$
9
 
$
13
 
Write-downs of biotechnology debt, equity securities and other
   
(4
)
 
(10
)
 
(12
)
Interest income
   
230
   
143
   
90
 
Other miscellaneous income
   
6
   
-
   
-
 
Total interest and other income (expense), net
 
$
325
 
$
142
 
$
91
 


88



Note 6.
OTHER INTANGIBLE ASSETS

The components of our other intangible assets including those arising from the Redemption and push-down accounting at December 31 are as follows (in millions):

   
2006
 
2005
 
   
Gross
Carrying
Amount
 
Accumulated
Amortization
 
Net
Carrying
Amount
 
Gross
Carrying
Amount
 
Accumulated
Amortization
 
Net
Carrying
Amount
 
Developed product technology
 
$
1,194
 
$
1,003
 
$
191
 
$
1,194
 
$
926
 
$
268
 
Core technology
   
444
   
393
   
51
   
444
   
372
   
72
 
Tradenames
   
144
   
91
   
53
   
144
   
84
   
60
 
Patents
   
197
   
78
   
119
   
167
   
64
   
103
 
Other intangible assets
   
98
   
36
   
62
   
122
   
51
   
71
 
Total
 
$
2,077
 
$
1,601
 
$
476
 
$
2,071
 
$
1,497
 
$
574
 

Amortization expense of our other intangible assets is as follows (in millions):

   
2006
 
2005
 
2004
 
Acquisition-related intangible assets amortization
 
$
105
 
$
123
 
$
145
 
Patents amortization
   
13
   
11
   
9
 
Other intangible assets amortization
   
10
   
10
   
28
 
Total amortization expense
 
$
128
 
$
144
 
$
182
 

Included in amortization expense in 2004 is a $19 million charge to MG&A expense related to the unamortized portion of a license fee that was paid to Alkermes, Inc. in 2000 upon FDA approval of Nutropin Depot. This license fee was being amortized over a 10 year estimated life and such expense was included in MG&A expense. Our decision to discontinue commercialization of Nutropin Depot resulted in an impairment to this license, as we did not anticipate any significant future cash flows attributable to this license.

The expected future annual amortization expense of our other intangible assets is as follows (in millions):

For the Year Ending December 31,
     
2007
 
$
129
 
2008
   
127
 
2009
   
78
 
2010
   
28
 
2011
   
26
 
Thereafter
   
88
 
Total expected future annual amortization
 
$
476
 


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Note 7.
LONG-TERM DEBT

On July 18, 2005, we completed a private placement of the following debt instruments: $500 million principal amount of 4.40% Senior Notes due 2010, $1.0 billion principal amount of 4.75% Senior Notes due 2015 and $500 million principal amount of 5.25% Senior Notes due 2035 (collectively, the “Notes”). Interest on each series of the Notes is payable on January 15 and July 15 of each year, beginning on January 15, 2006. Net proceeds resulting from issuance of the Notes, after debt discount and issuance costs, were approximately $1.99 billion. The Notes contain certain restrictive covenants on incurring property liens and entering into sale and lease-back transactions, all of which we were in compliance with at December 31, 2006. Interest expense related to the debt issuance, net of amounts capitalized of $27 million in 2006 and $2 million in 2005, was $69 million for 2006 and $41 million for 2005. As of December 31, 2006, the future minimum principal payments under the Notes are as follows (in millions):

2010
 
$
500
 
2011
   
-
 
Thereafter
   
1,500
 
Total
 
$
2,000
 

At December 31, 2006 and 2005, the carrying value of the Notes was $2.0 billion, and the estimated fair value was $1.91 billion and $1.95 billion, respectively. The fair value of debt was estimated based on the then current rates offered to us for debt instruments with the same remaining maturities. In July 2005, we entered into a series of interest rate swap agreements, which reduced the debt obligation by the fair value of the interest rate swap by $12 million and $10 million at December 31, 2006 and 2005, respectively. See “Derivative Financial Instruments” in Note 4, “Investment Securities and Financial Instruments” for further discussion of the interest rate swaps.

Long-term debt at December 31, 2006 and 2005 included $216 million and $94 million, respectively, in construction in progress financing obligations related to our agreements with Slough and Lonza. See Note 5, “Consolidated Financial Statement Detail,” for further discussion of the Lonza agreements, and Note 8, “Leases, Commitments and Contingencies,” for further discussion of the Slough Master Lease Agreement.


Note 8.
LEASES, COMMITMENTS AND CONTINGENCIES

Leases

We lease various real properties under operating leases that generally require us to pay taxes, insurance, maintenance and minimum lease payments. Some of our leases have options to renew.

In December 2004, we entered into a Master Lease Agreement with Slough SSF, LLC for the lease of property adjacent to our South San Francisco campus. The property is being developed into eight buildings and two parking structures. The lease of the property is taking place in two phases pursuant to separate lease agreements for each building as contemplated by the Master Lease Agreement. Phase I building leases began in 2006 and Phase II building leases begin in 2007 and 2008. For accounting purposes, due to the nature of our involvement with the construction of the buildings subject to the Master Lease Agreement, we are considered to be the owner of the assets during the construction period through the lease commencement date, even though the funds to construct the building shell and some infrastructure costs are paid by the lessor. As such, as of December 31, 2006, we have capitalized $205 million of construction costs, including capitalized interest, in property, plant and equipment, excluding approximately $150 million in leasehold improvements that we have installed at the property to date. We have recognized $198 million as a construction financing obligation, which is primarily included in “long-term debt” in the accompanying Consolidated Balance Sheets. As of December 31, 2005, we had capitalized $94 million of construction costs in property, plant and equipment and recognized the same amount as a construction financing obligation in “long-term debt” in the accompanying Consolidated Balance Sheets. Concurrent with the

90



commencement of the rental period, during the third quarter of 2006, we began repayment of the construction financing obligation. We expect at the time of completion of the project, if all the buildings and infrastructure were completed by the lessor, our construction asset and related obligation may be as much as $365 million, excluding costs related to leasehold improvements.

During the third quarter of 2005, we paid $160 million to exercise our right to purchase a research facility in South San Francisco, California, which was subject to a synthetic lease with BNP Paribas Leasing Corporation (or “BNP”). As a result, the value of the property in South San Francisco was included in the accompanying Consolidated Balance Sheets at December 31, 2005. Prior to the purchase of this facility, we evaluated our accounting for this lease under the provisions of FASB Interpretation No. 46R (or “FIN 46R”), a revision to Interpretation 46, “Consolidation of Variable Interest Entities,” and determined we were not required to consolidate either the leasing entity or the specific assets leased under the BNP lease.

During the third quarter of 2005, we paid $425 million to extinguish the debt and acquire the noncontrolling interest related to a synthetic lease obligation on our manufacturing plant in Vacaville, California. Prior to the extinguishment of the debt, we were required to consolidate the entity from which we leased the Vacaville facility as it qualified as a variable interest entity (or “VIE”) under the provisions of FIN 46R and because we were determined to be the primary beneficiary of the VIE as we absorb the majority of the entity’s expected losses.

Future minimum lease payments under all leases, exclusive of the residual value guarantees and executory costs at December 31, 2006 are as follows (in millions). These minimum lease payments were computed based on interest rates current at that time, which are subject to fluctuations in certain market-based interest rates:

   
2007
 
2008
 
2009
 
2010
 
2011
 
Thereafter
 
Total
 
Operating leases
 
$
23
 
$
24
 
$
23
 
$
22
 
$
22
 
$
99
 
$
213
 
Slough leases
   
19
   
31
   
36
   
37
   
38
   
380
   
541
 
Total
 
$
42
 
$
55
 
$
59
 
$
59
 
$
60
 
$
479
 
$
754
 

Rental expenses for our operating leases were $33 million in 2006, $19 million in 2005, and $12 million in 2004.

Commitments

On December 8, 2006 Lonza purchased all the outstanding shares of Genentech España, our wholly-owned subsidiary, including the FDA-licensed Porriño facility which is currently dedicated to the production of Avastin. Under a concurrent supply agreement we are committed to purchase a specified number of batches of bulk Avastin produced at Porriño by Lonza at a projected total cost of approximately $138 million through December 31, 2009. We also entered into a supply agreement with Lonza for the manufacture of certain of our products at Lonza’s facility under construction in Singapore, which is currently expected to receive FDA licensure in 2010. We are committed to fund the pre-commissioning production qualification costs at that facility, and, upon FDA licensure, we are committed to purchase 100 percent of products successfully manufactured at that facility for a period of three years after commissioning of the facility. The total estimated cost of these pre- and post-commissioning commitments is approximately $440 million. We also received an exclusive option to purchase the Lonza Singapore facility during the period from 2007 up to one year after FDA licensure for a purchase price of $290 million. Regardless of whether the purchase option is exercised, we will be obligated to make a milestone payment of approximately $70 million if certain performance milestones are met in connection with the construction of the facility.

In addition, we entered into a loan agreement with Lonza to advance up to $290 million to Lonza for the construction of the Singapore facility, subject to certain mutually acceptable conditions of securitization, and approximately $9 million for a related land lease option, the majority of which is not expected to be advanced until 2008. If we exercise our option to purchase the facility, any outstanding advances may be offset against the purchase price. If we do not exercise our purchase option then the advances will be offset against supply purchases.

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In November 2006, we also amended the December 2003 non-exclusive long-term manufacturing agreement with Lonza Biologics, a subsidiary of Lonza, under which Lonza Biologics will manufacture commercial quantities of Rituxan for us for approximately $180 million through 2008 at their manufacturing plant in Portsmouth, New Hampshire. This amendment reduces the number of successful batches that Lonza Biologics is obligated to produce and which we are obligated to purchase.

In September 2004, we entered into a non-exclusive long-term manufacturing agreement for the production of Herceptin bulk product with Wyeth Pharmaceuticals, a division of Wyeth, (or “Wyeth”). Under this agreement, Wyeth will manufacture Herceptin bulk product for us for approximately $251 million through 2009 at their production facility in Andover, Massachusetts. In the third quarter of 2006, the FDA approved the manufacture of Herceptin bulk product at Wyeth’s facility.
 
On November 9, 2006 we and Tanox Inc. announced that we entered into an agreement to acquire Tanox, a biotechnology company specializing in the discovery and development of biotherapeutics based on monoclonal antibody technology, for $20 per share for a total cash value of approximately $0.9 billion. We and Tanox have been working together in collaboration with Novartis since 1996 to develop and commercialize Xolair. The terms of the acquisition have been unanimously approved by the Boards of Directors of both companies and approved by the stockholders of Tanox. We received a request for additional information from the U.S. Federal Trade Commission (or “second request”) in connection with the proposed acquisition. The second request extends the waiting period imposed by the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (or “Hart-Scott-Rodino Act”). The transaction is expected to be completed within the first half of 2007, subject to satisfaction of certain closing conditions, including the absence of a material adverse effect with respect to Tanox and the expiration or termination of the waiting period under the Hart-Scott-Rodino Act. Funds will be provided from Genentech’s cash on hand at the time of closing. We are currently evaluating the effects of the acquisition on our results of operations and financial condition and expect that if the transaction closes a substantial portion of the purchase price will be expensed as in-process R&D.

Contingencies

We are a party to various legal proceedings, including patent infringement litigation and licensing and contract disputes, and other matters.

On October 4, 2004, we received a subpoena from the U.S. Department of Justice, requesting documents related to the promotion of Rituxan, a prescription treatment now approved for five indications:  (1) the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma, (2) the first-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens (approved on February 10, 2006), (3) the first-line treatment of previously untreated patients with follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma in combination with cyclophosphamide, vincristine, prednisone (or “CVP”) chemotherapy (approved September 29, 2006), (4) the treatment of low-grade, CD20-positive, B-cell non-Hodgkin’s lymphoma in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy (approved on September 29, 2006), and (5) for use in combination with methotrexate to reduce signs and symptoms in adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies (approved on February 28, 2006). We are cooperating with the associated investigation, which we have been advised is both civil and criminal in nature. The government has called and will likely continue to call former and current Genentech employees to appear before a grand jury in connection with this investigation. The outcome of this matter cannot be determined at this time.

On July 29, 2005, a former Genentech employee, whose employment ended in April 2005, filed a qui tam complaint under seal in the United States District Court for the District of Maine against Genentech and Biogen Idec, alleging violations of the False Claims Act and retaliatory discharge of employment. On December 20, 2005, the United States filed notice of its election to decline intervention in the lawsuit. The complaint was subsequently unsealed and we were served on January 5, 2006. Genentech filed a motion to dismiss the complaint and on December 14, 2006,

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the Magistrate Judge assigned to the case issued a Recommended Decision on that motion, which is subject to review by the District Court Judge. The Magistrate Judge recommended that the False Claims Act portion of the complaint be dismissed, leaving as the only remaining claim against Genentech the plaintiff’s retaliatory discharge claim. Plaintiff, Biogen Idec, and Genentech each subsequently filed objections with the District Court Judge concerning certain aspects of the Magistrate Judge’s Recommended Decision. We are awaiting the District Court’s decision on the Recommended Decision and the objections. The outcome of this matter cannot be determined at this time.

We and the City of Hope National Medical Center (or “COH”) are parties to a 1976 agreement relating to work conducted by two COH employees, Arthur Riggs and Keiichi Itakura, and patents that resulted from that work, which are referred to as the “Riggs/Itakura Patents.” Since that time, we have entered into license agreements with various companies to make, use and sell the products covered by the Riggs/Itakura Patents. On August 13, 1999, the COH filed a complaint against us in the Superior Court in Los Angeles County, California, alleging that we owe royalties to the COH in connection with these license agreements, as well as product license agreements that involve the grant of licenses under the Riggs/Itakura Patents. On June 10, 2002, a jury voted to award the COH approximately $300 million in compensatory damages. On June 24, 2002, a jury voted to award the COH an additional $200 million in punitive damages. Such amounts were accrued as an expense in the second quarter of 2002 and are included in the accompanying Consolidated Balance Sheets in “litigation-related and other long-term liabilities” at December 31, 2006 and December 31, 2005. We filed a notice of appeal of the verdict and damages awards with the California Court of Appeal. On October 21, 2004, the California Court of Appeal affirmed the verdict and damages awards in all respects. On November 22, 2004, the California Court of Appeal modified its opinion without changing the verdict and denied Genentech’s request for rehearing. On November 24, 2004, we filed a petition seeking review by the California Supreme Court. On February 2, 2005, the California Supreme Court granted that petition. The appeal to the California Supreme Court has been fully briefed and we are waiting to be assigned an oral argument date. The amount of cash paid, if any, or the timing of such payment in connection with the COH matter will depend on the outcome of the California Supreme Court’s review of the matter, however, it may take longer than one year to resolve the matter.

We recorded accrued interest and bond costs of $54 million in 2006 and 2005 related to the COH trial judgment. In conjunction with the COH judgment, we posted a surety bond and were required to pledge cash and investments of $735 million at December 31, 2005 to secure the bond. During the third quarter of 2006, COH requested that we increase the surety bond value by $50 million to secure the accruing interest, and we correspondingly increased the pledge amount to secure the bond by $53 million to $788 million. These amounts are reflected in “restricted cash and investments” in the accompanying Consolidated Balance Sheets. We expect that we will continue to incur interest charges on the judgment and service fees on the surety bond each quarter through the process of appealing the COH trial results.

On April 11, 2003, MedImmune, Inc. (or “MedImmune”) filed a lawsuit against Genentech, COH, and Celltech R & D Ltd. in the U.S. District Court for the Central District of California (Los Angeles). The lawsuit relates to U.S. Patent No. 6,331,415 (or “the ‘415 patent” or “Cabilly patent”) that we co-own with COH and under which MedImmune and other companies have been licensed and are paying royalties to us. The lawsuit includes claims for violation of antitrust, patent, and unfair competition laws. MedImmune is seeking a ruling that the ‘415 patent is invalid and/or unenforceable, a determination that MedImmune does not owe royalties under the ‘415 patent on sales of its Synagis® antibody product, an injunction to prevent us from enforcing the ‘415 patent, an award of actual and exemplary damages, and other relief. On January 14, 2004 (amending a December 23, 2003 Order), the U.S. District Court granted summary judgment in our favor on all of MedImmune’s antitrust and unfair competition claims. On April 23, 2004, the District Court granted our motion to dismiss all remaining claims in the case. On October 18, 2005, the U.S. Court of Appeals for the Federal Circuit affirmed the judgment of the District Court in all respects. MedImmune filed a petition for certiorari with the United States Supreme Court on November 10, 2005, seeking review of the decision to dismiss certain of its claims. The Supreme Court granted MedImmune’s petition and the oral argument of this case before the Supreme Court occurred on October 4, 2006. On January 9, 2007, the Supreme Court issued a decision reversing the Federal Circuit’s decision and remanding the case to the lower courts for further proceedings in connection with the patent and contract claims. The outcome of this matter cannot be determined at this time.

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On May 13, 2005, a request was filed by a third party for reexamination of the ‘415 or Cabilly patent. The request sought reexamination on the basis of non-statutory double patenting over U.S. Patent No. 4,816,567. On July 7, 2005, the U.S. Patent Office ordered reexamination of the ‘415 patent. On September 13, 2005, the Patent Office mailed an initial non-final Office action rejecting the claims of the ‘415 patent. We filed our response to the Office action on November 25, 2005. On December 23, 2005, a second request for reexamination of the ‘415 patent was filed by another third party, and on January 23, 2006, the Patent Office granted that request. On June 6, 2006, the two reexaminations were merged into one proceeding. On August 16, 2006, the Patent Office mailed a non-final Office action in the merged proceeding, rejecting the claims of the ‘415 patent based on issues raised in the two reexamination requests. We filed our response to the Office action on October 30, 2006. On February 16, 2007, the Patent Office mailed a final Office action rejecting all thirty-six claims of the ‘415 patent. We intend to respond to the final Office action, and, if necessary, appeal the decision. The ‘415 patent, which expires in 2018, relates to methods we and others use to make certain antibodies or antibody fragments, as well as cells and DNA used in these methods. We have licensed the ‘415 patent to other companies and derive significant royalties from those licenses. The claims of the ‘415 patent remain valid and enforceable throughout the reexamination and appeals process. Because the above-described proceeding is ongoing, the outcome of this matter cannot be determined at this time.

In 2006, we made development decisions involving our humanized anti-CD20 program. Our collaborator, Biogen Idec, disagrees with certain of our development decisions under our 2003 collaboration agreement with Biogen Idec relating to humanized anti-CD20 products. We believe that we are permitted under the agreement to proceed with further trials of certain humanized anti-CD20 antibodies, and Biogen Idec disagrees with our position. We continue to pursue a resolution of our differences, and the disputed issues have been submitted to arbitration. In the arbitration, Biogen Idec has filed motions for a preliminary injunction and summary judgment seeking to stop us from proceeding with certain development activities, including planned clinical trials. A hearing on the motion for a preliminary injunction was held on January 30, 2007 and we are waiting on a decision by the arbitrators on that motion. Briefing relating to the motion for summary judgment is ongoing. Resolution of the arbitration could require that both parties agree to certain development decisions before moving forward with humanized anti-CD20 antibody clinical trials, in which case we may have to alter or cancel planned trials in order to obtain Biogen Idec’s approval. The final outcome of this matter cannot be determined at this time.

On March 24, 2004, Dr. Kourosh Dastgheib filed a lawsuit against Genentech in the U.S. District Court for the Eastern District of Pennsylvania. The lawsuit stems from Dastgheib’s claim that, based on a purported relationship with Genentech in the mid-1990’s, he is entitled to profits or proceeds from Genentech’s Lucentis product. Dastgheib has asserted multiple claims for monetary damages, including a claim under an unjust enrichment theory that he is entitled to the entire net present value of projected Lucentis sales, which he claims is between approximately $1.4 billion and $4.1 billion. On November 8, 2006, a unanimous jury ruled against Dastgheib and in favor of Genentech on all claims, and final judgment was entered in Genentech’s favor. On January 30, 2007, Dastgheib’s motion for a new trial was denied in its entirety.  Because Dastgheib may still seek to appeal the judgment to the court of appeals, the final outcome of this matter cannot be determined at this time.


Note 9.
RELATIONSHIP WITH ROCHE AND RELATED PARTY TRANSACTIONS

Licensing Agreements

We have a July 1999 amended and restated licensing and marketing agreement with F. Hoffmann-La Roche (or “Hoffmann-La Roche”) and its affiliates granting an option to license, use and sell our products in non-U.S. markets. The major provisions of that agreement include the following:

 
·
Hoffmann-La Roche’s option expires in 2015;

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·
Hoffmann-La Roche may exercise its option to license our products upon the occurrence of any of the following: (1) our decision to file an Investigational New Drug Application (or “IND”) for a product, (2) completion of the first Phase II trial for a product or (3) if Hoffmann-La Roche previously paid us a fee of $10 million to extend its option on a product, completion of a Phase III trial for that product;

 
·
if Hoffmann-La Roche exercises its option to license a product, it has agreed to reimburse Genentech for development costs as follows: (1) if exercise occurs at the time of our decision to file an IND is filed, Hoffmann-La Roche will pay 50% of development costs incurred prior to the filing and 50% of development costs subsequently incurred, (2) if exercise occurs at the completion of the first Phase II trial, Hoffmann-La Roche will pay 50% of development costs incurred through completion of the trial, 75% of development costs subsequently incurred for the initial indications, and 50% of subsequent development costs for new indications, formulations or dosing schedules, (3) if the exercise occurs at the completion of a Phase III trial, Hoffmann-La Roche will pay 50% of development costs incurred through completion of Phase II, 75% of development costs incurred through completion of Phase III, and 75% of development costs subsequently incurred, and $5 million of the option extension fee paid by Hoffmann-La Roche to preserve its right to exercise its option at the completion of a Phase III trial will be credited against the total development costs payable to Genentech upon the exercise of the option, and (4) each of Genentech and Hoffmann-La Roche have the right to “opt-out” of developing an additional indication for a product for which Hoffmann-La Roche exercised its option, and would not share the costs or benefits of the additional indication, but could “opt-back-in” within 30 days of decision to file for approval of the indication by paying twice what they would have owed for development of the indication if they had not opted out;

 
·
we agreed, in general, to manufacture for and supply to Hoffmann-La Roche its clinical requirements of our products at cost, and its commercial requirements at cost plus a margin of 20%; however, Hoffmann-La Roche will have the right to manufacture our products under certain circumstances;

 
·
Hoffmann-La Roche has agreed to pay, for each product for which Hoffmann-La Roche exercises its option upon either a decision to file an IND or completion of the first Phase II trial, a royalty of 12.5% on the first $100 million on its aggregate sales of that product and thereafter a royalty of 15% on its aggregate sales of that product in excess of $100 million until the later in each country of the expiration of our last relevant patent or 25 years from the first commercial introduction of that product; and

 
·
Hoffmann-La Roche will pay, for each product for which Hoffmann-La Roche exercises its option after completion of a Phase III trial, a royalty of 15% on its sales of that product until the later in each country of the expiration of our last relevant patent or 25 years from the first commercial introduction of that product; however, $5 million of any option extension fee paid by Hoffmann-La Roche will be credited against royalties payable to us in the first calendar year of sales by Hoffmann-La Roche in which aggregate sales of that product exceed $100 million.

We have further amended this licensing and marketing agreement with Hoffmann-La Roche to delete or add certain Genentech products under Hoffmann-La Roche’s commercialization and marketing rights for Canada.

In addition, we have a July 1998 licensing and marketing agreement relating to anti-HER2 antibodies (Herceptin and Omnitarg) with Hoffmann-La Roche, providing them with exclusive marketing rights outside of the U.S. Under the agreement, Hoffmann-La Roche funds one-half of the global development costs incurred in connection with developing anti-HER2 antibody products under the agreement. Either Genentech or Hoffmann-La Roche has the right to “opt-out” of developing an additional indication for a product and would not share the costs or benefits of the additional indication, but could “opt-back-in” within 30 days of decision to file for approval of the indication by paying twice what would have been owed for development of the indication if no opt-out had occurred. Hoffmann-La Roche has also agreed to make royalty payments of 20% on aggregate net product sales outside the U.S. up to $500 million in each calendar year and 22.5% on such sales in excess of $500 million in each calendar year.

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Research Collaboration Agreement

In April 2004, we entered into a research collaboration agreement with Hoffmann-La Roche that outlines the process by which Hoffmann-La Roche and Genentech may agree to conduct and share in the costs of joint research on certain molecules. The agreement further outlines how development and commercialization efforts will be coordinated with respect to select molecules, including the financial provisions for a number of different development and commercialization scenarios undertaken by either or both parties.

Tax Sharing Agreement

We have a tax sharing agreement with Roche. If we and Roche elect to file a combined state and local tax return in certain states where we may be eligible, our tax liability or refund with Roche for such jurisdictions will be calculated on a stand alone basis.

Roche’s Ability to Maintain Its Percentage Ownership Interest in Our Stock 

We issue additional shares of Common Stock in connection with our stock option and stock purchase plans, and we may issue additional shares for other purposes. Our affiliation agreement with Roche provides, among other things, that with respect to any issuance of our Common Stock in the future, we will repurchase a sufficient number of shares so that immediately after such issuance, the percentage of our Common Stock owned by Roche will be no lower than 2% below the “Minimum Percentage” (as defined below), provided however, as long as Roche’s percentage ownership is greater than 50%, prior to issuing any shares, we will repurchase a sufficient number of shares of our Common Stock such that, immediately after our issuance of shares, Roche’s percentage ownership will be greater than 50%. The Minimum Percentage equals the lowest number of shares of Genentech Common Stock owned by Roche since the July 1999 offering (to be adjusted in the future for dispositions of shares of Genentech Common Stock by Roche as well as for stock splits or stock combinations) divided by 1,018,388,704 (to be adjusted in the future for stock splits or stock combinations), which is the number of shares of Genentech Common Stock outstanding at the time of the July 1999 offering, as adjusted for stock splits. We have repurchased shares of our Common Stock since 2001 (see discussion above in Liquidity and Capital Resources). The affiliation agreement also provides that, upon Roche’s request, we will repurchase shares of our Common Stock to increase Roche’s ownership to the Minimum Percentage. In addition, Roche will have a continuing option to buy stock from us at prevailing market prices to maintain its percentage ownership interest. The Minimum Percentage at December 31, 2006 was 57.7% and, under the terms of the affiliation agreement, Roche’s ownership percentage is to be no lower than 55.7%. At December 31, 2006, Roche’s ownership percentage was 55.8%.

Related Party Transactions

We enter into transactions with our related parties, Roche and other Roche affiliates (including Hoffmann-La Roche) and Novartis AG and other Novartis affiliates (or “Novartis”), under existing agreements in the ordinary course of business. The accounting policies we apply to our transactions with our related parties are consistent with those applied in transactions with independent third-parties.

In our royalty and supply arrangements with related parties, we are the principal, as defined under EITF 99-19, because we bear the manufacturing risk, general inventory risk, and the risk to defend our intellectual property. In circumstances where we are the principal in the transaction, we record the transaction gross in accordance with EITF 99-19; otherwise, our transactions are recorded net.

Hoffmann-La Roche

We recognized royalty revenue of 20% of net sales of Herceptin made by Hoffmann-La Roche outside of the U.S. of up to $500 million and 22.5% of net sales outside of the U.S. in excess of $500 million, a sales plateau which was exceeded in 2006, 2005 and 2004.  For all other products distributed by Hoffmann-La Roche outside of the U.S., we recognize royalty revenue at rates ranging from 8% to 20%. 

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In July 2006, we signed two new product supply agreements with Hoffmann-La Roche. The Umbrella Manufacturing Supply Agreement (or “Umbrella Agreement”) supersedes our existing product supply agreements with Hoffmann-La Roche. The Short-Term Supply Agreement (or “Short-Term Agreement”) supplements the terms of the Umbrella Agreement. Under the Short-Term Agreement, Hoffmann-La Roche has agreed to purchase specified amounts of Herceptin, Avastin and Rituxan through 2008. Under the Umbrella Agreement, Hoffmann-La Roche has agreed to purchase specified amounts of Herceptin and Avastin through 2012 and, on a perpetual basis, either party may order other collaboration products from the other party, including Herceptin and Avastin after 2012, pursuant to certain forecast terms. The Umbrella Agreement also provides that either party may terminate its obligation to purchase and/or supply Avastin and/or Herceptin with six years notice on or after December 31, 2007.

We currently have no active profit sharing arrangements with Hoffmann-La Roche.

Under our existing arrangements with Hoffmann-La Roche, including our licensing and marketing agreements, we recognized the following amounts (in millions):

   
2006
 
2005
 
2004
 
Ex-U.S. product sales to Hoffmann-La Roche
 
$
359
 
$
177
 
$
111
 
                     
Royalties received from Hoffmann-La Roche
 
$
846
 
$
500
 
$
334
 
                     
Cost of sales on ex-U.S. product sales to Hoffmann-La Roche
 
$
268
 
$
154
 
$
95
 
                     
Contract revenue from Hoffmann-La Roche
 
$
125
 
$
65
 
$
73
 

R&D expenses include amounts related to Hoffmann-La Roche of $213 million in 2006, $144 million in 2005, and $125 million in 2004. These amounts represent R&D development expenses we incurred on joint development products/projects, but are reimbursable to us by Hoffmann-La Roche. In addition, these amounts include R&D expenses resulting from the net settlement of amounts owed to Hoffmann-La Roche on R&D development expenses it incurred on joint development products/projects, less amounts reimbursable to us on these respective products/projects.

Novartis

Based on information available to us at the time of filing this Form 10-K, we believe that the Novartis Group holds approximately 33.3% of the outstanding voting shares of Roche Holding Ltd. As a result of this ownership, the Novartis Group is deemed to have an indirect beneficial ownership interest under FAS 57 “Related Party Disclosures” of more than 10% of our voting stock.

We have an agreement with Novartis Pharma AG (a wholly-owned subsidiary of Novartis AG) under which Novartis Pharma AG has the exclusive right to develop and market Lucentis outside of the U.S. for indications related to diseases or disorders of the eye. As part of this agreement, the parties will share the cost of certain of our ongoing development expenses for Lucentis.

We, along with Novartis Pharma AG and Tanox, Inc., are co-developing Xolair in the U.S. and we and Novartis are co-promoting Xolair in the U.S. and both make certain joint and individual payments to Tanox; our joint and individual payments are in the form of royalties. We record all sales and cost of sales in the U.S. and Novartis markets the product in and records all sales and cost of sales in Europe. We and Novartis share the resulting U.S. and European operating profits, respectively, according to prescribed profit-sharing percentages. On January 20, 2006, Novartis received FDA approval to manufacture bulk supply of Xolair at their Huningue production facility in France. We now acquire bulk supply of Xolair from Novartis and compensate them on a cost plus mark up basis.

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Under our existing arrangements with Novartis, we recognized the following amounts from Novartis (in millions):

   
2006
 
2005
 
2004
 
Ex-U.S. product sales to Novartis
 
$
5
 
$
7
 
$
1
 
                     
Royalties received from Novartis
 
$
3
 
$
1
 
$
1
 
                     
Cost of sales on ex-U.S. product sales to Novartis
 
$
4
 
$
17
 
$
1
 
                     
Contract revenue from Novartis
 
$
40
 
$
50
 
$
48
 
                     
Collaboration profit sharing expense
 
$
187
 
$
136
 
$
75
 

Under the Xolair collaboration agreement, we contractually share a portion of the pretax U.S. and European co-promotion profits earned on the commercial sales of Xolair. Our U.S. and European profit sharing expenses are recorded as collaboration profit sharing expense.

R&D expenses include amounts related to Novartis of $38 million in 2006, $39 million in 2005, and $44 million in 2004.


Note 10.
CAPITAL STOCK

Common Stock and Special Common Stock

On June 30, 1999, we redeemed all of our outstanding Special Common Stock held by stockholders other than Roche. Subsequently, in July and October 1999, and March 2000, Roche consummated public offerings of our Common Stock. On January 19, 2000, Roche completed an offering of zero-coupon notes that were exchanged prior to the April 5, 2004 expiration for an aggregate of approximately 26 million shares of our Common Stock held by Roche. See “Redemption of Our Special Common Stock” and “Relationship with Roche” notes above for a discussion of our Redemption and the related transactions.

Stock Repurchase Program

Under a stock repurchase program approved by our Board of Directors on December 5, 2003 and most recently extended in April 2006, we are authorized to repurchase up to 100,000,000 shares of our Common Stock for an aggregate price of up to $6.0 billion through June 30, 2007. In this program, as in previous stock repurchase programs, purchases may be made in the open market or in privately negotiated transactions from time to time at management’s discretion. We also may engage in transactions in other Genentech securities in conjunction with the repurchase program, including certain derivative securities. We intend to use the repurchased stock to offset dilution caused by the issuance of shares in connection with our employee stock plans. Although there are currently no specific plans for the shares that may be purchased under the program, our goals for the program are (i) to address provisions of our affiliation agreement with Roche relating to maintaining Roche’s minimum ownership percentage (see above in Note 9, “Relationship with Roche and Related Party Transactions”); (ii) to make prudent investments of our cash resources; and (iii) to allow for an effective mechanism to provide stock for our employee stock plans.

We have entered into Rule 10b5-1 trading plans to repurchase shares in the open market during those periods each quarter when trading in our stock is restricted under our insider trading policy. The trading plan covers approximately four million shares and the current plan is effective through June 30, 2007.

The par value method of accounting is used for our common stock repurchases. The excess of the cost of shares acquired over the par value is allocated to additional paid-in capital with the amounts in excess of the estimated original sales price charged to accumulated deficit.

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Note 11.
INCOME TAXES

The income tax provision consists of the following amounts (in millions):

   
2006
 
2005
 
2004
 
Current:
             
Federal
 
$
1,306
 
$
723
 
$
444
 
State
   
96
   
121
   
64
 
Total current
   
1,402
   
844
   
508
 
Deferred:
                   
Federal
   
(155
)
 
(85
)
 
(50
)
State
   
43
   
(25
)
 
(23
)
Total deferred
   
(112
)
 
(110
)
 
(73
)
Total income tax provision
 
$
1,290
 
$
734
 
$
435
 

Tax benefits of $179 million in 2006, $641 million in 2005, and $330 million in 2004 related to employee stock options and stock purchase plans. These amounts reduced current income taxes payable and deferred income taxes and were credited to stockholders’ equity.

A reconciliation between our effective tax rate and the U.S. statutory tax rate follows:

   
2006
 
 2005
 
 2004
 
Tax at U.S. statutory rate
   
35.0
%
 
35.0
%
 
35.0
%
Research and other credits
   
(2.3
)
 
(1.5
)
 
(3.6
)
Prior years’ items
   
0.9
   
(0.7
)
 
-
 
Export sales benefit
   
(0.3
)
 
(0.4
)
 
(0.5
)
State taxes
   
5.0
   
5.0
   
5.0
 
Deduction for qualified production activities
   
(0.7
)
 
(0.8
)
 
-
 
Tax-exempt investment income
   
(0.2
)
 
(0.3
)
 
(0.3
)
Other
   
0.5
   
0.2
   
0.1
 
Effective tax rate
   
37.9
%
 
36.5
%
 
35.7
%

Prior years’ items in 2006 relate to decrease in research credits resulting from new income tax regulations issued by the U.S. Department of Treasury in 2006. Prior years’ items in 2005 include $39 million benefit for increased research credits resulting from new Temporary Regulations issued by the U.S. Department of Treasury during 2005, partially offset by other changes in estimates of prior years’ research credits.

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The components of deferred taxes consist of the following at December 31 (in millions):

   
2006
 
2005
 
Deferred tax liabilities:
         
Depreciation
 
$
(156
)
$
(189
)
Unrealized gain on securities available-for-sale
   
(144
)
 
(172
)
Intangibles - Roche transaction
   
(118
)
 
(160
)
Other intangible assets
   
(48
)
 
(41
)
Other
   
(46
)
 
(11
)
Total deferred tax liabilities
   
(512
)
 
(573
)
Deferred tax assets:
             
Capitalized R&D costs
   
14
   
19
 
Employee stock-based compensation costs
   
102
   
-
 
Expenses not currently deductible
   
492
   
431
 
Deferred revenue
   
101
   
106
 
Investment basis difference
   
203
   
209
 
State credit carryforwards
   
56
   
114
 
Other
   
5
   
7
 
Total deferred tax assets
   
973
   
886
 
Total net deferred tax assets
 
$
461
 
$
313
 

Total tax credit carryforwards of $56 million have no expiration date.

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Note 12.
SEGMENT, SIGNIFICANT CUSTOMER AND GEOGRAPHIC INFORMATION

Our chief operating decision-makers (or “CODMs”) are comprised of our executive management with the oversight of our board of directors. Our CODMs review our operating results and operating plans and make resource allocation decisions on a company-wide or aggregate basis. Accordingly, we operate as one segment.

Information about our product sales, major customers and material foreign sources of revenues is as follows (in millions):

Product Sales
 
2006
 
2005
 
2004
 
Net U.S. Product Sales
             
Avastin
 
$
1,746
 
$
1,133
 
$
545
 
Rituxan
   
2,071
   
1,832
   
1,574
 
Herceptin
   
1,234
   
747
   
479
 
Lucentis
   
380
   
-
   
-
 
Xolair
   
425
   
320
   
188
 
Tarceva
   
402
   
275
   
13
 
Nutropin products
   
378
   
370
   
349
 
Thrombolytics
   
243
   
218
   
194
 
Pulmozyme
   
199
   
186
   
157
 
Raptiva
   
90
   
79
   
52
 
Total U.S. product sales
   
7,169
   
5,162
   
3,551
 
                     
Net Product Sales to Collaborators
                   
Avastin
 
$
107
 
$
50
 
$
10
 
Rituxan
   
181
   
158
   
137
 
Herceptin
   
96
   
17
   
4
 
Lucentis
   
1
   
-
   
-
 
Xolair
   
4
   
7
   
1
 
Nutropin products
   
8
   
5
   
5
 
Thrombolytics
   
16
   
8
   
6
 
Pulmozyme
   
45
   
35
   
21
 
Raptiva
   
14
   
15
   
4
 
Enbrel
   
-
   
31
   
11
 
Total product sales to collaborators
   
471
   
326
   
198
 
Total product sales
 
$
7,640
 
$
5,488
 
$
3,749
 
________________________
The values shown above are exact; therefore, the totals may not appear to sum due to rounding.

Three major customers, AmerisourceBergen, Corp., Cardinal Health, Inc. and McKesson Corp. each contributed 10% or more of our U.S. product sales in each of the last three years. AmerisourceBergen Corp., a national wholesale distributor of all of our major products lines, represented 50% in 2006, 36% in 2005, and 33% in 2004 of our total net U.S. product sales. Cardinal Health, Inc., a national wholesale distributor of all our major product lines, represented 18% in 2006 and 23% in 2005 and 2004 of our total net U.S. product sales. McKesson Corp., a national wholesale distributor of all of our major product lines, represented 17% in 2006 and 23% in 2005 and 2004 of our total net U.S. product sales. The combined net accounts receivable balance for our three major customers was $778 million in as of December 31, 2006 and $478 million as of December 31, 2005.

We currently sell primarily to distributors and health care companies throughout the U.S. under an extension of trade credit terms based on an assessment of each customers’ financial condition. Trade credit terms are generally offered without collateral and may include a discount for prompt payment for specific customers. To manage our credit

101



exposure, we perform ongoing evaluations of our customers’ financial condition and also participate in third party contracts to significantly reduce the risk of financial loss. In 2006, 2005 and 2004, we did not record any material additions to, or losses against, our allowance for bad debts.

Net foreign revenues by country were as follows (in millions):

   
2006
 
2005
 
2004
 
Europe:
             
Switzerland
 
$
561
 
$
320
 
$
235
 
Germany
   
133
   
79
   
47
 
France
   
100
   
56
   
35
 
Italy
   
57
   
35
   
23
 
Great Britain
   
61
   
34
   
23
 
Spain
   
49
   
28
   
18
 
Others
   
121
   
73
   
51
 
Japan
   
119
   
117
   
92
 
Canada
   
64
   
39
   
28
 
Others
   
181
   
91
   
44
 
Total net foreign revenues
 
$
1,446
 
$
872
 
$
596
 

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QUARTERLY FINANCIAL DATA (unaudited)
(in millions, except per share amounts)

   
2006 Quarter Ended(3)
 
   
December 31
 
September 30
 
June 30
 
March 31
 
Total operating revenues
 
$
2,714
 
$
2,384
 
$
2,199
 
$
1,986
 
Product sales
   
2,244
   
1,941
   
1,810
   
1,644
 
Gross margin from product sales
   
1,906
   
1,644
   
1,526
   
1,382
 
Net income(1)
   
594
   
568
   
531
   
421
 
Earnings per share:
                         
Basic
   
0.56
   
0.54
   
0.50
   
0.40
 
Diluted
   
0.55
   
0.53
   
0.49
   
0.39
 

   
2005 Quarter Ended(3)
 
   
December 31
 
September 30
 
June 30
 
March 31
 
Total operating revenues
 
$
1,893
 
$
1,752
 
$
1,527
 
$
1,462
 
Product sales
   
1,577
   
1,451
   
1,274
   
1,186
 
Gross margin from product sales(2)
   
1,332
   
1,215
   
1,000
   
930
 
Net income
   
339
   
359
   
296
   
284
 
Earnings per share:
                         
Basic
   
0.32
   
0.34
   
0.28
   
0.27
 
Diluted
   
0.31
   
0.33
   
0.27
   
0.27
 
________________________
(1)
Net income in 2006 includes $182 million, net of tax, in employee stock-based compensation expense related to our adoption of FAS 123R on January 1, 2006.
(2)
Certain costs and expenses of $5 million, $5 million, and $6 million for the quarterly periods ended March 31, June 30, and September 30, 2005, respectively, have been reclassified from MG&A expenses to cost of sales to conform to the fourth quarter and full year presentation.
(3)
The 2006 and 2005 amounts were computed independently for each quarter, and the sum of the quarters may not total the annual amounts.


CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

Not applicable.


CONTROLS AND PROCEDURES

(a)  Evaluation of Disclosure Controls and Procedures:  The Company’s principal executive and financial officers reviewed and evaluated the Company’s disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e)) as of the end of the period covered by this Form 10-K. Based on that evaluation, the Company’s principal executive and financial officers concluded that the Company’s disclosure controls and procedures are effective in timely providing them with material information relating to the Company, as required to be disclosed in the reports the Company files under the Exchange Act.

(b)  Management’s Annual Report on Internal Control Over Financial Reporting:  The Company’s management is responsible for establishing and maintaining adequate internal control over the Company’s financial reporting. Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2006. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (or “COSO”) in Internal Control-Integrated Framework. Based on the assessment using those criteria, management concluded that, as of December 31, 2006, our internal control over financial reporting was effective. The Company’s independent registered public accountants, Ernst & Young LLP, audited the consolidated financial statements included in this Annual Report on Form 10-K and have issued an audit

103



report on management’s assessment of our internal control over financial reporting as well as on the effectiveness of the Company’s internal control over financial reporting. The report on the audit of internal control over financial reporting appears below.

104



Report of Independent Registered Public Accounting Firm


The Board of Directors and Stockholders of Genentech, Inc.

We have audited management’s assessment, included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting, that Genentech, Inc. maintained effective internal control over financial reporting as of December 31, 2006, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). Genentech, Inc.’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting. Our responsibility is to express an opinion on management’s assessment and an opinion on the effectiveness of Genentech, Inc.’s internal control over financial reporting based on our audit.
 
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, evaluating management’s assessment, testing and evaluating the design and operating effectiveness of internal control, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

A company’s internal control over financial reporting is a process designed 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. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

In our opinion, management’s assessment that Genentech, Inc. maintained effective internal control over financial reporting as of December 31, 2006, is fairly stated, in all material respects, based on the COSO criteria. Also, in our opinion, Genentech, Inc. maintained, in all material respects, effective internal control over financial reporting as of December 31, 2006, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of Genentech, Inc. as of December 31, 2006 and 2005, and the related consolidated statements of income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2006 and our report dated February 5, 2007 expressed an unqualified opinion thereon.

/s/ ERNST & YOUNG LLP

Palo Alto, California
February 5, 2007

105



(c) Changes in Internal Controls over Financial Reporting: There were no changes in the Company’s internal control over financial reporting that occurred during the Company’s last fiscal quarter that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.


OTHER INFORMATION

Not applicable.


106






(a) The sections labeled “Nominees for Directors,” “Board Committees and Meetings,” “Audit Committee Matters,” “Corporate Governance” and “Section 16(a) Beneficial Ownership Reporting Compliance” of our Proxy Statement in connection with the 2007 Annual Meeting of Stockholders are incorporated herein by reference.

(b) Information concerning our Executive Officers is set forth in Part I of this Form 10-K.



The sections labeled “Director Compensation for 2006,” “Compensation, Discussion and Analysis,” “Compensation of Named Executive Officers,” “Summary Compensation Table for 2006,” “Grants of Plan Based Awards in 2006,” “Outstanding Equity Awards at Fiscal 2006 Year End,” “ Option Exercises and Stock Vested in 2006,” “Non-Qualified Deferred Compensation for 2006,” “Compensation Committee Interlocks and Insider Participation” and “Compensation Committee Report” of our Proxy Statement in connection with the 2007 Annual Meeting of Stockholders are incorporated herein by reference.



The sections labeled “Relationship with Roche,” “Equity Compensation Plans” and “Beneficial Ownership of Principal Stockholders, Directors and Management” of our Proxy Statement in connection with the 2007 Annual Meeting of Stockholders are incorporated herein by reference.



The sections labeled “Relationship with Roche,” “Certain Relationships and Related Persons Transactions” and “Director Independence” of our Proxy Statement in connection with the 2007 Annual Meeting of Stockholders is incorporated herein by reference.



The section labeled “Audit Committee Matters” and “Principal Accounting Fees and Services” of our Proxy Statement in connection with the 2007 Annual Meeting of Stockholders is incorporated herein by reference.

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(a)  The following documents are included as part of this Annual Report on Form 10-K.

1.  Index to Financial Statements

Report of Independent Registered Public Accounting Firm 

Consolidated Statements of Income for the years ended December 31, 2006, 2005 and 2004

Consolidated Statements of Cash Flows for the years ended December 31, 2006, 2005 and 2004

Consolidated Balance Sheets at December 31, 2006 and 2005

Consolidated Statements of Stockholders’ Equity for the year ended December 31, 2006, 2005 and 2004

Notes to Consolidated Financial Statements

Quarterly Financial Data (unaudited)

2.  Financial Statement Schedule

The following schedule is filed as part of this Form 10-K:

Schedule II- Valuation and Qualifying Accounts for the years ended December 31, 2006, 2005 and 2004.

All other schedules are omitted as the information required is inapplicable or the information is presented in the consolidated financial statements or the related notes.
 
3.  Exhibits

The documents set forth below are filed herewith or incorporated by reference to the location indicated.

Exhibit No.
Description
Location
3.1
 
Amended and Restated Certificate of Incorporation
 
Filed as an exhibit to our Current Report on Form 8-K filed with the U. S. Securities and Exchange Commission (or “Commission”) on July 28, 1999 and incorporated herein by reference.
 
3.2
 
Certificate of Amendment of Amended and Restated Certificate of Incorporation
 
Filed as an exhibit to our Annual Report on Form 10-K for the year ended December 31, 2000 filed with the Commission and incorporated herein by reference.
 
3.3
 
Certificate of Amendment of Amended and Restated Certificate of Incorporation
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2001 filed with the Commission and incorporated herein by reference.
 
3.4
 
Certificate of Third Amendment of Amended and Restated Certificate of Incorporation
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2004 filed with the Commission and incorporated herein by reference.
 


108



3.5
 
Bylaws
 
Filed as an exhibit to our Annual Report on Form 10-K for the year ended December 31, 2005 filed with the Commission and incorporated herein by reference.
 
4.1
 
Form of Common Stock Certificate
 
Filed as an exhibit to Amendment No. 3 to our Registration Statement (No. 333-80601) on Form S-3 filed with the Commission on July 16, 1999 and incorporated herein by reference.
 
4.2
 
Indenture, dated as of July 18, 2005, between the Company and Bank of New York, as trustee
 
Filed on a Current Report on Form 8-K with the Commission on July 19, 2005 and incorporated herein by reference.
 
4.3
 
Officers’ Certificate of Genentech, Inc. dated July 18, 2005, including forms of the Company’s 4.40% Senior Notes due 2010, 4.75 Senior Notes due 2015 and 5.25% Senior Notes due 2035
 
Filed on a Current Report on Form 8-K with the Commission on July 19, 2005 and incorporated herein by reference.
 
4.4
 
Form of 4.40% Senior Note due 2010
 
Filed on a Current Report on Form 8-K with the Commission on July 19, 2005 and incorporated herein by reference.
 
4.5
 
Form of 4.75% Senior Note due 2015
 
Filed on a Current Report on Form 8-K with the Commission on July 19, 2005 and incorporated herein by reference.
 
4.6
 
Form of 5.25% Senior Note due 2035
 
Filed on a Current Report on Form 8-K with the Commission on July 19, 2005 and incorporated herein by reference.
 
4.7
 
Registration Rights Agreement, dated as of July 18, 2005, among Genentech, Inc. and Citigroup Global Markets, Inc. and Goldman, Sachs & Co. as representatives of the initial purchasers
 
Filed on a Current Report on Form 8-K with the Commission on July 19, 2005 and incorporated herein by reference.
 
10.1
 
Form of Affiliation Agreement, dated as of July 22, 1999, between Genentech and Roche Holdings, Inc.
 
Filed as an exhibit to Amendment No. 3 to our Registration Statement (No. 333-80601) on Form S-3 filed with the Commission on July 16, 1999 and incorporated herein by reference.
 
10.2
 
Amendment No. 1, dated October 22, 1999, to Affiliation Agreement between Genentech and Roche Holdings, Inc.
 
Filed as an exhibit to our Annual Report on Form 10-K for the year ended December 31, 1999 filed with the Commission and incorporated herein by reference.
 
10.3
 
Form of Amended and Restated Agreement, restated as of July 1, 1999, between Genentech and F. Hoffmann-La Roche Ltd regarding Commercialization of Genentech’s Products outside the United States
 
Filed as an exhibit to Amendment No. 3 to our Registration Statement (No. 333-80601) on Form S-3 filed with the Commission on July 16, 1999 and incorporated herein by reference.
 
10.4
 
Amendment dated March 10, 2000, to Amended and Restated Agreement between Genentech and F. Hoffmann-La Roche Ltd regarding Commercialization of Genentech’s Products outside the United States
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2004 filed with the Commission and incorporated herein by reference.
 
10.5
 
Amendment dated June 26, 2000, to Amended and Restated Agreement between Genentech and F. Hoffmann-La Roche Ltd regarding Commercialization of Genentech’s Products outside the United States
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2004 filed with the Commission and incorporated herein by reference.
 


109



10.6
 
Third Amendment dated April 30, 2004, to Amended and Restated Agreement between Genentech and F. Hoffmann-La Roche Ltd regarding Commercialization of Genentech’s Products outside the United States
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2004 filed with the Commission and incorporated herein by reference.
 
10.7
 
Form of Tax Sharing Agreement, dated as of July 22, 1999, between Genentech, Inc. and Roche Holdings, Inc.
 
Filed as an exhibit to Amendment No. 3 to our Registration Statement (No. 333-80601) on Form S-3 filed with the Commission on July 16, 1999 and incorporated herein by reference.
 
10.8
 
Collaborative Agreement, dated April 13, 2004, among Genentech, F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc.
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2004 filed with the Commission and incorporated herein by reference.
 
10.9
 
Genentech, Inc. Tax Reduction Investment Plan, as amended and restated †
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended October 31, 2006 filed with the Commission and incorporated herein by reference.
 
10.10
 
Genentech, Inc. 1990 Stock Option/Stock Incentive Plan, as amended effective October 16, 1996 †
 
Filed as an exhibit to our Registration Statement (No. 333-83157) on Form S-8 filed with the Commission on July 19, 1999 and incorporated herein by reference.
 
10.11
 
Genentech, Inc. 1994 Stock Option Plan, as amended effective October 16, 1996 †
 
Filed as an exhibit to our Registration Statement (No. 333-83157) on Form S-8 filed with the Commission on July 19, 1999 and incorporated herein by reference.
 
10.12
 
Genentech, Inc. 1996 Stock Option/Stock Incentive Plan, as amended effective October 16, 1996 †
 
Filed as an exhibit to our Registration Statement (No. 333-83157) on Form S-8 filed with the Commission on July 19, 1999 and incorporated herein by reference.
 
10.13
 
Genentech, Inc. 1999 Stock Plan, as amended and restated as of February 13, 2003 †
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2003 filed with the Commission and incorporated herein by reference.
 
10.14
 
Genentech, Inc. 1999 Stock Plan, Form of Stock Option Agreement
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2004 filed with the Commission and incorporated herein by reference.
 
10.15
 
Genentech, Inc. 1999 Stock Plan, Form of Stock Option Agreement (Director Version)
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2004 filed with the Commission and incorporated herein by reference.
 
10.16
 
Genentech, Inc. 2004 Equity Incentive Plan
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2004 filed with the Commission and incorporated herein by reference.
 
10.17
 
Form of Genentech, Inc. 2004 Equity Incentive Plan Nonqualified Stock Option Grant Agreement (Employee Version) †
 
Filed on a Current Report on Form 8-K with the Commission on September 26, 2006, and incorporated herein by reference.
 
10.18
 
Form of Genentech, Inc. 2004 Equity Incentive Plan Nonqualified Stock Option Grant Agreement (Director Version) †
 
Filed on a Current Report on Form 8-K with the Commission on September 26, 2006, and incorporated herein by reference.
 
10.19
 
Genentech, Inc. Supplemental Plan †
 
Filed on a Current Report on Form 8-K with the Commission on February 24, 2005 and incorporated herein by reference.
 
10.20
 
Genentech, Inc. 1991 Employee Stock Plan, as amended
 
Filed on a Current Report on Form 8-K with the Commission on April 25, 2006, and incorporated herein by reference.
 
10.21
 
Bonus Program
 
Incorporated by reference to the description under “Bonus Program” in the Current Report on Form 8-K filed with the Commission on December 21, 2006.
 
10.22
 
Form of Indemnification Agreement for Directors and Officers
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 filed with the Commission and incorporated herein by reference.
 


110



10.23
 
Promissory Note, dated as of April 5, 2001, issued to Genentech, Inc. by Richard H. Scheller
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2004 filed with the Commission and incorporated herein by reference.
 
10.24
 
Transition Agreement between Genentech, Inc. and Myrtle S. Potter dated August 3, 2005
 
Filed on a Current Report on Form 8-K with the Commission on August 16, 2005 and incorporated herein by reference.
 
10.25
 
First Amendment to Transition Agreement between Genentech, Inc. and Myrtle S. Potter dated December 29, 2005
 
Filed as an exhibit to our Annual Report on Form 10-K for the year ended December 31, 2005 filed with the Commission and incorporated herein by reference.
 
10.26
 
Master Lease Agreement dated as of November 1, 2004, between Genentech and Slough SSF, LLC
 
Filed as an exhibit to our Annual Report on Form 10-K for the year ended December 31, 2004 filed with the Commission and incorporated herein by reference.
 
10.27
 
First Amendment to Master Lease Agreement and First Amendment to Building Leases between Genentech and Slough SSF, LLC, dated October 2, 2006
 
Filed herewith
 
10.28
 
Purchase and Sale Agreement and Joint Escrow Instruction, dated as of June 16, 2005, between Genentech and Biogen Idec Inc. *
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2005 filed with the Commission and incorporated herein by reference.
 
10.29
 
Purchase Agreement, dated as of July 13, 2005, among Genentech, Inc. and Citigroup Global Markets, Inc. and Goldman, Sachs & Co. as representatives of the initial purchasers
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended October 31, 2005 filed with the Commission and incorporated herein by reference.
 
10.30
 
Manufacturing and Supply Agreement between Genentech, Inc. and Lonza Biologics, Inc. dated December 7, 2003 *
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended October 31, 2005 filed with the Commission and incorporated herein by reference.
 
10.31
 
First Amendment to the Manufacturing and Supply Agreement between Genentech, Inc. and Lonza Biologics, Inc. dated March 14, 2005 *
 
Filed as an exhibit to our Annual Report on Form 10-K for the year ended December 31, 2005 filed with the Commission and incorporated herein by reference.
 
10.32
 
Second Amendment to the Manufacturing and Supply Agreement between Genentech and Lonza Biologics PLC, effective as of 19 May 2006 *
 
Filed herewith
 
10.33
 
Third Amendment to the Manufacturing and Supply Agreement between Genentech and Lonza Biologics PLC, dated as of November 6, 2006 *
 
Filed herewith
 
10.34
 
Toll Manufacturing Agreement by and between Wyeth, acting through its Wyeth Pharmaceuticals Division, and Genentech, Inc. dated September 15, 2004 *
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended October 31, 2005 filed with the Commission and incorporated herein by reference.
 
10.35
 
First Amendment to the Toll Manufacturing Agreement by and between Wyeth, acting through its Wyeth Pharmaceuticals Division, and Genentech, Inc. dated December 8, 2004
 
Filed as an exhibit to our Annual Report on Form 10-K for the year ended December 31, 2005 filed with the Commission and incorporated herein by reference.
 
10.36
 
Amended and Restated Collaboration Agreement between Genentech, Inc. and Idec Pharmaceuticals Corporation dated as of June 19, 2003 *
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, filed with the Commission on August 3, 2006, and incorporated herein by reference.
 


111



10.37
 
Letter Amendment dated as of August 21, 2003, to the Amended and Restated Collaboration Agreement between Genentech, Inc. and Idec Pharmaceuticals Corporation
 
Filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, filed with the Commission on August 3, 2006, and incorporated herein by reference.
 
10.38
 
Agreement and Plan of Merger by and among Genentech, Inc., Green Acquisition Corporation and Tanox, Inc., dated as of November 9, 2006
 
Filed herewith
 
10.39
 
Form of Voting Agreement between Genentech, Inc. and Certain Stockholders of Tanox, Inc.
 
Filed herewith
 
23.1
 
Consent of Independent Registered Public Accounting Firm
 
Filed herewith
 
24.1
 
Power of Attorney
 
Reference is made to the signature page.
 
28.1
 
Description of the Company’s capital stock
 
Incorporated by reference to the description under the heading “Description of Capital Stock” relating to our Common Stock in the prospectus included in our Amendment No. 2 to the Registration Statement on Form S-3 (No. 333-88651) filed with the Commission on October 20, 1999, and the description under the heading “Description of Capital Stock” relating to the Common Stock in our final prospectus filed with the Commission on October 21, 1999 pursuant to Rule 424(b)(1) under the Securities Act of 1933, as amended, including any amendment or report filed for the purpose of updating that description.
 
31.1
 
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended
 
Filed herewith
 
31.2
 
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended
 
Filed herewith
 
32.1
 
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
Furnished herewith
 
________________________
*   Pursuant to a request for confidential treatment, portions of this Exhibit have been redacted from the publicly filed document and have been furnished separately to the Securities and Exchange Commission as required by Rule 24b-2 under the Securities Exchange Act of 1934.
†   Indicates a management contract or compensatory plan or arrangement.


112


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.

     
GENENTECH, INC.
Registrant
     
         
         
Date:
  February 23, 2007
 
By:
/s/ JOHN M. WHITING
       
John M. Whiting
       
Vice President, Finance and
Chief Accounting Officer


POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints David A. Ebersman, Executive Vice President and Chief Financial Officer, and John M. Whiting, Vice President, Finance and Chief Accounting Officer, and each of them, his or her true and lawful attorneys-in-fact and agents, with the full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any amendments to this report, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto each said attorney-in-fact and agent full power and authority to do and perform each and every act in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or either of them, or their or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:

Signature
 
Title
 
Date
         
Principal Executive Officer:
       
         
         
/s/ ARTHUR D. LEVINSON
 
Chairman and Chief Executive Officer
 
February 23, 2007
Arthur D. Levinson
       
         
         
Principal Financial Officer:
       
         
         
/s/ DAVID A. EBERSMAN
 
Executive Vice President and
 
February 23, 2007
David A. Ebersman
 
Chief Financial Officer
   
         
         
Principal Accounting Officer:
       
         
         
/s/ JOHN M. WHITING
 
Vice President, Finance and
 
February 23, 2007
John M. Whiting
 
Chief Accounting Officer
   


113



Signature
 
Title
 
Date
         
Directors:
       
         
         
         
         
/s/ HERBERT W. BOYER
 
Director
 
February 23, 2007
Herbert W. Boyer
       
         
         
         
         
/s/ WILLIAM M. BURNS
 
Director
 
February 23, 2007
William M. Burns
       
         
         
         
         
/s/ ERICH HUNZIKER
 
Director
 
February 23, 2007
Erich Hunziker
       
         
         
         
         
/s/ JONATHAN K.C. KNOWLES
 
Director
 
February 23, 2007
Jonathan K.C. Knowles
       
         
         
         
         
/s/ DEBRA L. REED
 
Director
 
February 23, 2007
Debra L. Reed
       
         
         
         
         
/s/ CHARLES A. SANDERS
 
Director
 
February 23, 2007
Charles A. Sanders
       


114



SCHEDULE II

GENENTECH, INC.
VALUATION AND QUALIFYING ACCOUNTS
Years Ended December 31, 2006, 2005 and 2004
(in millions)

   
Balance at
Beginning
of Period
 
Addition
Charged to
Cost and
Expenses
 
Deductions*
 
Balance at
End of
Period
 
Accounts receivable allowances:
                 
Year Ended December 31, 2006:
 
$
84
 
$
415
 
$
(407
)
$
92
 
Year Ended December 31, 2005:
 
$
62
 
$
307
 
$
(284
)
$
84
 
Year Ended December 31, 2004:
 
$
47
 
$
188
 
$
(173
)
$
62
 
Inventory reserves:
                         
Year Ended December 31, 2006:
 
$
55
 
$
29
 
$
(16
)
$
68
 
Year Ended December 31, 2005:
 
$
46
 
$
33
 
$
(24
)
$
55
 
Year Ended December 31, 2004:
 
$
21
 
$
57
 
$
(32
)
$
46
 
Rebate accruals:
                         
Year Ended December 31, 2006:
 
$
38
 
$
113
 
$
(104
)
$
47
 
Year Ended December 31, 2005:
 
$
35
 
$
77
 
$
(74
)
$
38
 
Year Ended December 31, 2004:
 
$
23
 
$
78
 
$
(66
)
$
35
 
________________________
 
Certain prior year amounts have been reclassified to conform with the current year presentation.
*
Represents amounts written off or returned against the allowance or reserves, or returned against earnings.


EX-10.27 2 dna-ex10_27.htm FIRST AMENDMENT TO MASTER LEASE AGREEMENT AND FIRST AMENDMENT TO BUILDING LEASES BETWEEN GENENTECH AND SLOUGH SSF, LLC, DATED OCTOBER 2, 2006

EXHIBIT 10.27

 
FIRST AMENDMENT TO MASTER LEASE AGREEMENT
 
AND FIRST AMENDMENT TO BUILDING LEASES
 
THIS FIRST AMENDMENT TO MASTER LEASE AGREEMENT AND FIRST AMENDMENT TO BUILDING LEASES (First Amendment) is entered into as of October 2, 2006 by SLOUGH SSF, LLC, a Delaware limited liability company (Landlord), and GENENTECH, INC., a Delaware corporation (Tenant), with reference to the following facts:
 
A.  Landlord and Tenant are parties to a Master Lease Agreement dated as of November 1, 2004 (the Agreement) which provides for, among other things, the construction of eight office and/or research and development buildings at the Britannia East Grand Business Park (the Center), commonly known as 450-660 East Grand Avenue, South San Francisco, California, and the leasing of such buildings to Tenant pursuant to individual building leases entered into or to be entered into by Landlord and Tenant pursuant to the Agreement (collectively, the Building Leases,” consisting of a Building 1 Lease dated as of November 1, 2004, a Building 3 Lease dated as of November 1, 2004, a Building 4 Lease dated as of November 1, 2004, a Building 5/6 Lease dated as of November 1, 2004, a Building 2 Lease dated as of July 1, 2005, a Building 7 Lease dated as of March 1, 2006, a Building 8 Lease dated as of March 1, 2006 and a Building 9 Lease dated as of March 1, 2006). The Building 7 Lease, Building 8 Lease and Building 9 Lease are being executed substantially concurrently with this Agreement, while the remaining Building Leases have already been executed by the parties). Terms used as defined terms in this First Amendment but not expressly defined herein shall have the meanings assigned to such terms in the Agreement.
 
B.  Landlord and Tenant wish to update or correct certain Exhibits attached to the Agreement and to amend or clarify certain other matters set forth in the Agreement and in the Building Leases, all as more particularly set forth in this First Amendment.
 
NOW, THEREFORE, in consideration of the mutual obligations set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Landlord and Tenant agree as follows:
 
1.  Phase II Construction Schedules. The construction schedule for the Phase II Buildings attached to the Agreement as part of Exhibit B thereto consisted of a single-line, non-detailed schedule for each Phase II Building, since the relevant dates were subject to the possible exercise of Tenant’s right under Section 1(b) of the Agreement to either defer or accelerate the construction of and Rent Commencement Date for any one or more of the Phase II Buildings. Tenant elected to accelerate the construction of and Rent Commencement Date for Building 2, and the resulting acceleration of dates is reflected in the terms of the individual Building Lease for Building 2, which has already been executed by the parties. Tenant did not exercise its right to elect any such deferral or acceleration for any of the other Phase II Buildings. Accordingly, the contemplated Rent Commencement Dates for all of the Phase II Buildings other than Building 2 remain as set forth in the Agreement and reiterated in Paragraph 3 of this First Amendment, below, except that as shown in Paragraph 3 below, the parties have agreed to extend the contemplated Rent Commencement Dates for Buildings 8 and 9 to May 1, 2008 and July 1, 2008, respectively. The individual Building Lease for Building 2 included a detailed
 



construction schedule approved by the parties at the time that Building Lease was signed. The construction schedules attached as Exhibit B to this First Amendment shall be the operative construction schedules for the remaining Phase II Buildings (Buildings 7, 8 and 9) as of the date of this First Amendment, shall replace and supersede the corresponding schedule attached to the Agreement, and shall be attached to the respective individual Building Leases for Buildings 7, 8 and 9 when such individual Building Leases are executed (which is intended to occur substantially concurrently with the execution of this First Amendment).
 
2.  Revised Rent Schedules; Building Square Footages. The rent schedules attached to the Agreement as Exhibits C-1 through C-5 (i) contained inadvertent clerical errors in the tables for a number of the Buildings, particularly in the “Total Base Rent” columns, and (ii) were based on estimated rather than actual square footages for the respective Buildings (since the actual square footages were not known at the time). Final, actual square footages as determined by Landlord’s architect and approved by Tenant’s architect are not yet available for any of the Phase II Buildings, but are now available for the Phase I Buildings and have been reviewed and approved by the parties and their respective architects as follows:
 
 
Building 1
107,733 sq ft
 
 
Building 3
118,981 sq ft
 
 
Building 4
78,200 sq ft
 
 
Building 5/6
151,874 sq ft
 

 
The “Acknowledgment of Rent Commencement Date” forms attached as Exhibit E to the respective individual Building Leases contemplate that a copy of the minimum rent schedule in effect for the applicable Building as of its Rent Commencement Date will be attached to the “Acknowledgment of Rent Commencement Date” form for the applicable Building. The rent schedules attached to the Agreement as Exhibits C-3 through C-5 dealt solely with rents for Phase II Buildings under various deferral or acceleration scenarios, and are therefore now irrelevant since Tenant did not elect any deferral or acceleration for any of the Phase II Buildings other than Building 2 (and the rent schedule set forth in the individual Building Lease already executed for Building 2 is correct). In light of all of the foregoing circumstances, Landlord and Tenant agree as follows:
 
(a)  The rent schedule attached hereto as Exhibit C-1 (the Phase I Master Rent Schedule) replaces and supersedes Exhibit C-1 to the Agreement, and the rent schedule attached hereto as Exhibit C-2 (the Phase II Master Rent Schedule) replaces and supersedes Exhibit C-2 to the Agreement. Such replacement schedules in each case incorporate any necessary corrections to clerical errors that were contained in the schedules originally attached to the Agreement, and the Phase I Master Rent Schedule also reflects the final, agreed square footages for the Phase I Buildings as set forth above. As noted above, Exhibits C-3 through C-5 to the Agreement have no further effect or significance under the Agreement, so the parties have deemed it unnecessary to prepare corrected versions of those schedules.
 
(b)  The rent schedules for Building 5/6 and Building 4 as shown on the Phase I Master Rent Schedule also reflect the Rent Commencement Dates which have already occurred for those two Buildings, and are therefore the final and effective rent schedules for those two Buildings. Accordingly, those rent schedules shall be attached to the
 

-2-


“Acknowledgment of Rent Commencement Date” forms for those respective Buildings, which are being executed substantially concurrently with this First Amendment, and upon the execution of such “Acknowledgment of Rent Commencement Date” form for the respective Building, such final schedule shall supersede (retroactively to the applicable Rent Commencement Date) the previously estimated rent schedule set forth in Section 3.1(a) of the respective Building Lease. To the extent there has been any overpayment or underpayment of rent since the applicable Rent Commencement Date (due to minor adjustments in square footage or for any other reason), any such overpayment shall be credited against Tenant’s next monthly rent payment under the applicable Building Lease and any such underpayment shall be paid by Tenant to Landlord within twenty (20) days after mutual execution of this First Amendment.
 
(c)  The rent schedules for the other Buildings as shown on the Phase I Master Rent Schedule or Phase II Master Rent Schedule, as applicable, are based on the presently estimated Rent Commencement Dates for such Buildings and, in the case of the Phase II Buildings, on the presently estimated square footages for such Buildings (the square footages used in the rent schedules for Buildings 1 and 3, however, are the final, agreed square footages for those Buildings as set forth above). Such rent schedules shall therefore be subject to further revision to reflect final Rent Commencement Dates and (in the case of the Phase II Buildings) final square footages, when determined, and as so revised shall be attached to the “Acknowledgment of Rent Commencement Date” forms for those respective Buildings when such forms are executed, and upon the execution of such “Acknowledgment of Rent Commencement Date” form for the respective Building, such final schedule shall supersede (retroactively to the applicable Rent Commencement Date) the previously estimated rent schedule set forth in Section 3.1(a) of the respective Building Lease. To the extent there has been any overpayment or underpayment of rent since the applicable Rent Commencement Date (due to minor adjustments in square footage or for any other reason), any such overpayment shall be credited against Tenant’s next monthly rent payment under the applicable Building Lease and any such underpayment shall be paid by Tenant to Landlord within twenty (20) days after mutual execution of the applicable Acknowledgment of Rent Commencement Date form.
 
3.  Revised Building Uses; TI Periods. Landlord and Tenant have agreed that the primary uses of certain Buildings as previously designated in the Agreement will, at Tenant’s request, be changed from office to lab use or vice versa, and have further agreed that notwithstanding such change in use for certain Buildings and notwithstanding the provisions in the Agreement and in certain individual Building leases for a longer TI Period (from Structural Completion to Rent Commencement Date) for lab buildings than for office buildings, (i) the calculation of the Rent Commencement Dates for the respective Buildings shall be based on the number of days after Structural Completion indicated in the following table (which replaces and supersedes the table in Section 1(b) of the Agreement), regardless of the actual use for which the applicable Building will be constructed; (ii) the actual (in the case of Buildings 5/6 and 4) or presently estimated Rent Commencement Dates for the respective Buildings are as set forth in the following table; (iii) the contemplated primary Building uses for the respective Buildings are as indicated in following table (however, reference to such primary uses shall not restrict Tenant from using part or all of any designated office Building for laboratory and research and development purposes in accordance with Section 10.1 of the Building Lease for such Building, or from using significant portions of any designated lab Building for ancillary office purposes in accordance with Section 10.1 of the Building Lease for such Building, subject in each instance to
 

-3-


Landlord’s approval of the tenant improvements in the applicable Building to the extent provided in the applicable Building Lease and related Workletter); and (iv) up to six (6) Buildings in total can be designated as lab buildings, notwithstanding anything to the contrary in Section 1(b) of the Agreement:

 
Phase I:
 
 
Building 5/6 (lab)
February 1, 2006 (180 days after Structural Completion)
 
Building 4 (lab)
March 1, 2006 (180 days after Structural Completion)
 
Building 1 (lab)
August 1, 2006 (300 days after Structural Completion)
 
Building 3 (office)
November 1, 2006 (300 days after Structural Completion)
     
 
Phase II:
 
 
Building 2 (office)
June 28, 2007 (180 days after Structural Completion)
 
Building 7 (lab)
March 1, 2008 (180 days after Structural Completion
 
Building 8 (lab)
May 1, 2008 (300 days after Structural Completion)
 
Building 9 (lab)
July 1, 2008 (300 days after Structural Completion)

Landlord and Tenant have further agreed that the second sentence of Section 8.1 of each of the respective Building Leases (Phase I and Phase II) shall be deleted in its entirety and replaced as follows:

Landlord and Tenant acknowledge that it would be unreasonable for Landlord to withhold consent to Alterations consisting of a conversion of up to one-half of any Building designated as office primary use to laboratory, research and/or development facilities; provided, however, that in all cases, Tenant shall obtain the advance written approval of Landlord to the extent such Alterations involve structural Alterations or require approval under the Site Management Plan or Environmental Deed Restrictions, which approval shall not be unreasonably withheld, conditioned or delayed.
 
4.  Funding of Tenant Improvement Allowances. The Agreement contemplated, and the individual Building Leases and workletters executed prior to this First Amendment provided, that funding of the Tenant Improvement Allowance for each respective Building would be made on a “Baseline Payment Schedule” of four (4) equal monthly installments, beginning on the date Structural Completion is achieved, subject to Tenant’s right to accelerate funding of the Tenant Improvement Allowance under certain conditions specified in the workletters under the applicable Building Leases. Landlord and Tenant agree that with respect to each Building Lease under which disbursement of the Tenant Improvement Allowance has not already been completed as of the date of mutual execution of this First Amendment, the “Baseline Payment Schedule” governing the disbursement of the Tenant Improvement Allowance with respect to such Building shall be deemed to be modified to provide for disbursement of such Tenant Improvement Allowance in four (4) equal monthly installments, beginning on the earlier to occur of (i) the date Structural Completion is achieved or (ii) the Rent Commencement Date under the applicable Building Lease, and continuing on the same day of each successive calendar month, still subject in each case to Tenant’s right to accelerate funding of the Tenant Improvement Allowance under the conditions already specified in the workletter under the applicable Building lease.
 

-4-



 
5.  Deed Restrictions. Subject to the terms of the Agreement, Landlord may record deed restrictions affecting the Center from time to time; provided, however, that during the Amenities Exclusivity Period, such deed restrictions shall be on a form approved by Tenant, which approval shall not be unreasonably withheld, conditioned or delayed. Tenant shall provide its approval or final comments to any request for approval within five (5) business days of a request from Landlord to provide its approval. Failure of Tenant to provide its approval or final comments to any request for approval within such five (5) business day period shall constitute and be deemed to be approval by Tenant.
 
6. Brokers. Each party represents and warrants that no broker represented such party or otherwise participated in the negotiation or consummation of this First Amendment, and each party agrees to indemnify, defend and hold the other party harmless against any liability, cost or expense, including, without limitation, reasonable attorneys’ fees, arising out of any claims for brokerage commissions or other similar compensation in connection with any conversations, prior negotiations or other dealings by the indemnifying party with any broker.
 
7. Notice. Confirming notices which have previously been sent by Tenant, the addresses for notices (and copies of notices) directed to Tenant under the Agreement and under any ancillary or related agreements have been modified by Tenant and are now as follows:
 
 
To Tenant:
Lisa Sullivan
Genentech, Inc.
1 DNA Way, Mail Stop 256A
South San Francisco, CA 94080
Fax: (650) 467-3412
     
 
with a copy to:
Corporate Secretary
Genentech, Inc.
1 DNA Way, Mail Stop 49
South San Francisco, CA 94080
Fax: (650) 467-9146
     
 
and a copy to:
Meg Fitzgerald, Esq.
Genentech, Inc. Legal Department
1 DNA Way, Mail Stop 49
South San Francisco, CA 94080
Fax: (650) 952-9881
 
8. Entire Agreement; Modification. This First Amendment constitutes the entire agreement between the parties relating to the subject matter hereof, and supersedes any and all prior agreements, promises, negotiations, letters of intent and representations between the parties with respect to such subject matter. This First Amendment may not be modified orally or in any manner other than by an agreement in writing signed by the parties hereto or their respective successors in interest.
 

-5-



 
9. Successors and Assigns. This First Amendment shall inure to the benefit of and be binding upon the parties hereto and their respective heirs, personal representatives, successors and assigns.
 
10. Attorneys’ Fees. In the event of any legal action or other proceeding arising out of this First Amendment, the party prevailing in such action or proceeding shall be entitled to recover its reasonable attorneys’ fees, expenses and costs of suit incurred in connection with such action or proceeding, including (but not limited to) any appellate proceedings relating thereto and any proceedings for the enforcement of any judgment entered in favor of such prevailing party in any such action or proceeding, from the non-prevailing party or parties.
 
11. Section Headings. The headings contained in this First Amendment are for convenience only and shall in no way enlarge or limit the scope or meaning of the various Sections hereof.
 
12. Gender and Number. Within this First Amendment, words of any gender shall be construed to include any other gender, words in the singular number shall be construed to include the plural and words in the plural number shall be construed to include the singular, unless the context otherwise requires.
 
13. Applicable Law. This First Amendment and the rights and duties of the parties hereunder shall be governed for all purposes by the laws of the State of California and the laws of the United States applicable to transactions within such state.
 
14. Time of the Essence. Time is of the essence of this First Amendment, and of the exercise of each of the rights and performance of each of the obligations set forth herein.
 
15. Further Assurances. The parties agree to execute any further documents that are reasonable and appropriate to carry out the purposes of this First Amendment in accordance with its terms.
 
16. Publicity; Authorized Disclosure. Neither party will make any press release or other public disclosure regarding this First Amendment or the transactions contemplated hereby without the other party's express prior written consent, except as required under applicable law or by any governmental agency. Without limiting the generality of the foregoing, each party agrees that the other party will have no less than five (5) business days to review and provide comment regarding any such proposed press release or publicity, unless a shorter review time is agreed to by both parties. In the event that one party reasonably concludes that a given disclosure is required by law and the other party would prefer not to make such disclosure, then the party seeking such disclosure shall either (i) limit said disclosure to address the concerns of the other party, or (ii) provide a written opinion from counsel stating that such disclosure is indeed required by law. With respect to complying with the disclosure requirements of the SEC or other securities regulatory bodies in other nations, in connection with any required securities filing of this First Amendment, the filing party shall seek confidential treatment of this First Amendment to the maximum extent permitted by such regulatory body and shall provide the other party with the opportunity, for at least fifteen (15) days, to review any such proposed filing. Each party agrees that it will obtain its own legal advice with regard to its compliance with securities laws
 

-6-


and regulations, and will not rely on any statements made by the other party relating to such securities laws and regulations.
 
17. Controlling Provisions. Except as modified by the terms of this First Amendment, the parties’ obligations under the Agreement and the provisions of the Agreement shall remain unchanged, in full force and effect, and enforceable in accordance with their respective terms. In the event of any conflict or ambiguity between the Agreement and this First Amendment, this First Amendment shall govern and control in all respects. The terms of this First Amendment apply to all of the Building Leases, whether executed prior to, contemporaneously with, or subsequent to the execution of this First Amendment. In the event of any conflict between this First Amendment and any of the Building Leases, whether executed prior to, contemporaneously with, or subsequent to the execution of this First Amendment (unless such subsequent Building Lease expressly states that it governs and controls with specific reference to this First Amendment), this First Amendment shall govern and control in all respects and the provisions of the applicable Building Lease(s) affected by such conflict shall be deemed to be amended accordingly.
 
18. Remedies Cumulative. All rights, privileges and elections or remedies of Landlord or Tenant contained in this First Amendment are cumulative and not alternative to the extent permitted by law and except as otherwise provided herein.
 
19. Counterparts. This First Amendment may be executed in multiple counterparts, and by the respective parties hereto in separate counterparts, each of which when so executed and delivered shall be deemed to be one and the same instrument with the same signatures as if all parties to this First Amendment had signed the same signature page. Signature pages may be detached from separate counterparts and attached to a single copy of this First Amendment to form one original document (or multiple original counterparts of this document with full signatures).
 
IN WITNESS WHEREOF, the parties hereto have executed this First Amendment as of the date first set forth above.
 
“Landlord”
 
“Tenant”
     
SLOUGH SSF, LLC, a Delaware limited liability company
 
GENENTECH, INC., a Delaware corporation
         
By:
Slough Estates USA Inc., a Delaware
corporation, Its Manager
 
By:
/s/  STEPHEN G. JUELSGAARD
     
Name:
Stephen G. Juelsgaard
By:
/s/  JONATHAN M. BERGSCHNEIDER
 
Its:
Executive Vice President,
General Counsel & Secretary
Name:
Jonathan M. Bergschneider
     
Its:
Senior Vice President
 
By:
/s/  DAVID A. EBERSMAN
     
Name:
David A. Ebersman
     
Its:
Executive Vice President, and
Chief Financial Officer

 
-7-


EXHIBITS


EXHIBIT B  Phase II Construction Schedules (Buildings 7, 8 & 9)

EXHIBIT C-1  Phase I Master Rent Schedule (Revised)

EXHIBIT C-2  Phase II Master Rent Schedule (Revised)



EXHIBIT LIST - PAGE 1



EXHIBIT B
 

REVISED PHASE II CONSTRUCTION SCHEDULES
(BUILDINGS 7, 8 & 9)



[See attached three schedules:
two pages for Building 7 and one page each for Buildings 8 & 9.]



EXHIBIT B TO FIRST AMENDMENT TO MASTER LEASE AGREEMENT
REVISED PHASE II CONSTRUCTION SCHEDULES, PAGE 1















 










 
EXHIBIT C-1

PHASE I MASTER RENT SCHEDULE (REVISED)

 
PHASE I BUILDING
                             
                             
       
Building 5/6
 
Building 1
Rentable Area:
Rent Commencement Date:
Original MLA Rent Schedule:
151,874 RSF
1-Feb-06
Schedule C-1
 
107,733 RSF
1-Aug-06
Schedule C-1
                             
Lease
     
Initial Base
Rent
Additional Rent
Total Base Rent
 
Initial Base
Rent
Additional Rent
Total Base Rent
Year
Months
(psf/pm)
(CGL)
(Seismic)
(psf/pm)
(pm)
 
(psf/pm)
(CGL)
(Seismic)
(psf/pm)
(pm)
                             
1
1
-
12
$2.500
$0.050
$0.070
$2.620
$397,910
 
$2.500
$0.050
$0.070
$2.620
$282,260
2
13
-
24
$3.000
$0.050
$0.072
$3.122
$474,219
 
$3.000
$0.050
$0.072
$3.122
$336,391
3
25
-
36
$3.400
$0.050
$0.075
$3.525
$535,364
 
$3.400
$0.050
$0.075
$3.525
$379,757
4
37
-
48
$3.519
$0.050
$0.078
$3.647
$553,825
 
$3.519
$0.050
$0.078
$3.647
$392,580
5
49
-
60
$3.642
$0.050
$0.080
$3.772
$572,943
 
$3.642
$0.050
$0.080
$3.772
$406,422
6
61
-
72
$3.770
$0.050
$0.083
$3.903
$592,731
 
$3.770
$0.050
$0.083
$3.903
$420,458
7
73
-
84
$3.902
$0.050
$0.086
$4.038
$613,210
 
$3.902
$0.050
$0.086
$4.038
$434,986
8
85
-
96
$4.038
$0.050
$0.089
$4.177
$634,407
 
$4.038
$0.050
$0.089
$4.177
$450,022
9
97
-
108
$4.179
$0.050
$0.092
$4.322
$656,345
 
$4.179
$0.050
$0.092
$4.322
$465,584
10
109
-
120
$4.326
$0.050
$0.095
$4.471
$679,052
 
$4.326
$0.050
$0.095
$4.471
$481,691
11
121
-
132
$4.477
$0.050
$0.099
$4.626
$702,553
 
$4.477
$0.050
$0.099
$4.626
$498,381
12
133
-
144
$4.634
$0.050
$0.102
$4.766
$726,876
 
$4.634
$0.050
$0.102
$4.786
$515,615
13
145
-
156
$4.795
$0.050
$0.106
$4.952
$752,051
 
$4.796
$0.050
$0.106
$4.952
$533,473
14
157
-
168
$4.964
$0.050
$0.109
$5.123
$778,107
 
$4.964
$0.050
$0.109
$5.123
$551,956
15
169
-
180
$5.138
$0.050
$0.113
$5.301
$805,075
 
$5.138
$0.050
$0.113
$5.301
$571,086
16
181
-
192
$5.317
$0.050
$0.117
$5.465
$832,967
 
$5.317
$0.050
$0.117
$5.485
$590,886
17
193
-
204
$5.504
$0.050
$0.121
$5.675
$861,876
 
$5.504
$0.050
$0.121
$5.675
$611,378
18
205
-
216
$5.696
$0.050
$0.128
$5.872
$891,776
 
$5.596
$0.050
$0.126
$5.872
$632,586
19
217
-
228
$5.896
$0.050
$0.130
$6.076
$922,722
 
$5.896
$0.050
$0.130
$6.078
$654,540
20
229
-
240
$6.102
$0.050
$0.135
$6.286
$954,752
 
$6.102
$0.050
$0.135
$6.286
$677,260

       
Building 4
 
Building 3
Rentable Area:
Rent Commencement Date:
Original MLA Rent Schedule:
78,200 RSF
1-Mar-06
Schedule C-1
 
118,981 RSF
1-Nov-05 (TBD)
Schedule C-1
                             
Lease
     
Initial Base Rent
Additional Rent
Total Base Rent
 
Initial Base Rent
Additional Rent
Total Base Rent
Year
Months
(psf/pm)
(CGL)
(Seismic)
(psf/pm)
(pm)
 
(psf/pm)
(CGL)
(Seismic)
(psf/pm)
(pm)
1
1
-
12
$3.000
$0.050
$0.070
$3.120
$243,984
 
$3.000
$0.050
$0.070
$3.120
$371,221
2
13
-
24
$3.105
$0.050
$0.072
$3.227
$252,387
 
$3.105
$0.050
$0.072
$3.227
$384,005
3
25
-
36
$3.400
$0.050
$0.075
$3.525
$275,654
 
$3.400
$0.050
$0.075
$3.525
$419,408
4
37
-
48
$3.519
$0.050
$0.078
$3.647
$285,165
 
$3.519
$0.050
$0.078
$3.647
$433,877
5
49
-
60
$3.642
$0.050
$0.080
$3.772
$295,009
 
$3.642
$0.050
$0.080
$3.772
$448,855
6
61
-
72
$3.770
$0.050
$0.083
$3.903
$305,197
 
$3.770
$0.050
$0.083
$3.903
$464,357
7
73
-
84
$3.902
$0.050
$0.088
$4.038
$315,742
 
$3.902
$0.050
$0.088
$4.038
$480,401
8
85
-
96
$4.038
$0.050
$0.089
$4.177
$326,658
 
$4.038
$0.050
$0.089
$4.177
$497,007
9
97
-
108
$4.179
$0.050
$0.092
$4.322
$337,953
 
$4.179
$0.050
$0.092
$4.322
$514,194
10
109
-
120
$4.326
$0.050
$0.095
$4.471
$349,644
 
$4.326
$0.050
$0.095
$4.471
$531,982
11
121
-
132
$4.477
$0.050
$0.099
$4.626
$361,745
 
$4.477
$0.050
$0.099
$4.626
$550,393
12
133
-
144
$4.634
$0.050
$0.102
$4.786
$374,269
 
$4.634
$0.050
$0.102
$4.786
$589,449
13
145
-
156
$4.796
$0.050
$0.106
$4.952
$387,232
 
$4.796
$0.050
$0.106
$4.952
$589,171
14
157
-
168
$4.964
$0.050
$0.109
$5.123
$400,648
 
$4.964
$0.050
$0.109
$5.123
$609,584
15
169
-
180
$5.138
$0.050
$0.113
$5.301
$414,534
 
$5.138
$0.050
$0.113
$5.301
$630,711
16
181
-
192
$5.317
$0.050
$0.117
$5.465
$428,905
 
$5.317
$0.050
$0.117
$5.485
$652,578
17
193
-
204
$5.504
$0.050
$0.121
$5.675
$443,780
 
$5.504
$0.050
$0.121
$5.675
$675,210
18
205
-
216
$5.696
$0.050
$0.126
$5.872
$459,176
 
$5.696
$0.050
$0.126
$5.872
$698,634
19
217
-
228
$5.896
$0.050
$0.130
$6.076
$475,110
 
$5.896
$0.050
$0.130
$6.076
$722,878
20
229
-
240
$6.102
$0.050
$0.135
$6.286
$491,602
 
$6.102
$0.050
$0.135
$6.286
$747,971
 

EXHIBIT C-1 TO FIRST AMENDMENT TO MASTER LEASE AGREEMENT
PHASE I MASTER RENT SCHEDULE (REVISED), PAGE 1



 
EXHIBIT C-2
 
PHASE II MASTER RENT SCHEDULE (REVISED)
 

PHASE 11 BUILDINGS
                             
       
Building 2
 
Building 7
Rentable Area:
Rent Commencement Date:
Original MLA Rent Schedule:
106,000 RSF
24-Jun-07 (TBD)
Schedule C-5
 
92,000 RSF
1-Mar-08 (TBD)
Schedule C-2
                             
Lease
     
Initial Base Rent
Additional Rent
Total Base Rent
 
Initial Base Rent
Additional Rent
Total Base Rent
Year
Months
(psf/pm)
(CGL)
(Seismic)
(psf/pm)
(pm)
 
(psf/pm)
(CGL)
(Seismic)
(ps/pm)
(pm)
1
1
-
12
$3.631
$0.050
$0.072
$3.754
$397,897
 
$3.763
$0.050
$0.075
$3.886
$357,685
2
13
-
24
$3.758
$0.050
$0.075
$3.883
$411,838
 
$3.895
$0.050
$0.078
$4.022
$370,053
3
25
-
36
$3.890
$0.050
$0.078
$4.016
$425,860
 
$4.031
$0.050
$0.080
$4.161
$382,544
4
37
-
48
$4.026
$0.050
$0.080
$4.158
$440,579
 
$4.172
$0.050
$0.083
$4.305
$396,082
5
49
-
60
$4.167
$0.050
$0.085
$4.300
$455,814
 
$4.318
$0.050
$0.086
$4.454
$409,784
6
61
-
72
$4.313
$0.050
$0.086
$4.449
$471,582
 
$4.460
$0.050
$0.089
$4.806
$423,988
7
73
-
84
$4.454
$0.050
$0.089
$4.603
$487,902
 
$4.628
$0.050
$0.092
$4.788
$438,644
8
85
-
96
$4.620
$0.050
$0.092
$4.762
$504,793
 
$4.788
$0.050
$0.095
$4.933
$453,835
9
97
-
108
$4.782
$0.050
$0.095
$4.927
$522,275
 
$4.955
$0.050
$0.099
$5.104
$459,558
10
109
-
120
$4.949
$0.050
$0.099
$5.096
$540,369
 
$5.129
$0.050
$0.102
$5.281
$485,832
11
121
-
132
$5.122
$0.050
$0.102
$5.274
$559,097
 
$5.306
$0.050
$0.106
$5.464
$502,675
12
133
-
144
$5.302
$0.050
$0.106
$5.457
$578,480
 
$5.494
$0.050
$0.109
$5.653
$520,108
13
145
-
156
$5.487
$0.050
$0.109
$5.647
$598,541
 
$5.686
$0.050
$0.113
$5.849
$538,150
14
157
-
168
$5.679
$0.050
$0.113
$5.842
$619,304
 
$5.885
$0.050
$0.117
$6.052
$556,825
15
169
-
180
$5.878
$0.050
$0.117
$6.045
$640,795
 
$6.091
$0.050
$0.121
$6.263
$576,152
16
181
-
192
$6.084
$0.050
$0.121
$6.255
$653,037
 
$6.304
$0.050
$0.126
$6.480
$595,157
17
193
-
204
$6.297
$0.050
$0.128
$6.472
$686,058
 
$6.525
$0.050
$0.130
$6.705
$616,861
18
205
-
216
$6.517
$0.050
$0.130
$6.697
$709,884
 
$6.753
$0.050
$0.135
$6.938
$638,290
19
217
-
228
$6.745
$0.050
$0.135
$6.930
$734,545
 
$6.990
$0.050
$0.139
$7.179
$660,470
20
229
-
240
$6.981
$0.050
$0.139
$7.170
$760,068
 
$7.234
$0.050
$0.144
$7.429
$683,425


       
Building 8
 
Building 9
Rentable Area:
Rent Commencement Date:
Original MLA Rent Schedule:
82,000 RSF
1-May-08 (TBD)
Schedule C-2
 
54,000 RSF
1-Jul-08 (TBD)
Schedule C-2
                             
Lease
     
Initial Base Rent
Additional Rent
Total Base Rent
 
Initial Base Rent
Additional Rent
Total Base Rent
Year
Months
(psf/pm)
(CGL)
(Seismic)
(psf/pm)
(pm)
 
(psf/pm)
(CGL)
(Seismic)
(psf/pm)
(pm)
1
1
-
12
$3.763
$0.050
$0.075
$3.888
$318,315
 
$3.763
$0.050
$0.075
$3.888
$209,951
2
13
-
24
$3.895
$0.050
$0.078
$4.022
$329,830
 
$3.895
$0.050
$0.078
$4.022
$217,205
3
25
-
36
$4.031
$0.050
$0.080
$4.151
$341,230
 
$4.031
$0.050
$0.080
$4.161
$224,713
4
37
-
48
$4.172
$0.050
$0.083
$4.305
$353,030
 
$4.172
$0.050
$0.083
$4.305
$232,483
5
49
-
60
$4.318
$0.050
$0.088
$4.454
$385,243
 
$4.318
$0.050
$0.086
$4.454
$240,526
6
61
-
72
$4.469
$0.050
$0.089
$4.608
$377,882
 
$4.469
$0.050
$0.089
$4.608
$248,849
7
73
-
84
$4.626
$0.050
$0.092
$4.768
$390,965
 
$4.626
$0.050
$0.092
$4.788
$257,465
8
85
-
96
$4.788
$0.050
$0.095
$4.933
$404,505
 
$4.788
$0.050
$0.095
$4.933
$268,381
9
97
-
108
$4.955
$0.050
$0.099
$5.104
$418,519
 
$4.955
$0.050
$0.099
$5.104
$275,610
10
109
-
120
$5.129
$0.050
$0.102
$5.281
$433,024
 
$5.129
$0.050
$0.102
$5.281
$285,162
11
121
-
132
$5.308
$0.050
$0.105
$5.464
$448,036
 
$5.308
$0.050
$0.108
$5.464
$295,048
12
133
-
144
$5.494
$0.050
$0.109
$5.853
$483,574
 
$5.494
$0.050
$0.109
$5.653
$305,281
13
145
-
156
$5.686
$0.050
$0.113
$5.849
$479,656
 
$5.686
$0.050
$0.113
$5.849
$315,871
14
157
-
168
$5.885
$0.050
$0.117
$6.052
$496,300
 
$5.885
$0.050
$0.117
$6.052
$328,832
15
169
-
180
$6.091
$0.050
$0.121
$6.283
$513,527
 
$6.091
$0.050
$0.121
$6.263
$338,176
16
181
-
192
$6.304
$0.050
$0.126
$6.480
$531,357
 
$6.304
$0.050
$0.126
$6.480
$349,918
17
193
-
204
$6.525
$0.050
$0.130
$6.705
$549,811
 
$6.526
$0.050
$0.130
$6.705
$362,071
18
205
-
216
$6.753
$0.050
$0.135
$6.938
$568,911
 
$6.753
$0.050
$0.136
$6.938
$374,649
19
217
-
228
$6.990
$0.050
$0.139
$7.179
$588,679
 
$6.990
$0.050
$0.139
$7.179
$387,687
20
229
-
240
$7.234
$0.050
$0.144
$7.429
$609,140
 
$7.234
$0.050
$0.144
$7.429
$401,141

 
EXHIBIT C-2 TO FIRST AMENDEMENT TO MASTER LEASE AGREEMENT
PHASE II MASTER RENT SCHEDULE (REVISED), PAGE 1


EX-10.32 3 dna-ex10_32.htm SECOND AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT BETWEEN GENENTECH AND LONZA BIOLOGICS PLC, EFFECTIVE AS OF 19 MAY 2006 Second Amendment to the Manufacturing and Supply Agreement between Genentech and Lonza Biologics PLC, effective as of 19 May 2006

EXHIBIT 10.32

 
SECOND AMENDMENT
 
TO THE
 
MANUFACTURING AND SUPPLY AGREEMENT OF DECEMBER 7 2003
 
THIS SECOND AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT DATED DECEMBER 7 2003 ("2nd Amendment") is made effective as of 19 May 2006 (the “2nd Amendment Effective Date”), by and between Lonza Biologics PLC, having its principal place of business at 228 Bath Road, Slough, Berkshire SL1 4DX, England ("LB"), Lonza Biologics, Inc. having its principal place of business at 101 International Drive Portsmouth, New Hampshire 03801 ("Lonza Inc") (collectively LB and Lonza Inc, hereinafter "Lonza"), and Genentech, Inc., a Delaware corporation, having its principal place of business at One DNA Way, South San Francisco, California 94080 ("Genentech").
 
BACKGROUND
 
The Parties have executed that certain Manufacturing and Supply Agreement by and between the Parties dated December 7, 2003, as amended 14 March 2005 (the “1st Amendment”), (collectively, the “Agreement”) and wish now to further amend said Agreement.
 
Lonza and Genentech desire to modify the Lonza Facility to [*], and in conjunction therewith, Lonza agrees to grant Genentech an option to implement such modification in accordance with the terms of this 2nd Amendment.
 
Lonza and Genentech also desire to amend the Purchase Price to be paid by Genentech for certain Batches of Product produced by Lonza, provide a means to estimate and true-up invoicing of the Purchase Price for Batches, amend the milestone payments to be paid by Genentech upon Lonza achievement of certain milestones, re-schedule certain Campaigns to be conducted by Lonza, provide for an alternative means of invoicing for Batches resulting from a Project, and amend the Manufacturing Process.
 
NOW, THEREFORE, IN CONSIDERATION OF the mutual covenants set forth in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
 
1.
[*]. Lonza hereby grants to Genentech an option to require Lonza to implement a project [*] (as further described in Exhibit 1 attached hereto, the “[*]”). Genentech may exercise such option by providing written notice to Lonza at any time during the Term. Upon Genentech’s exercise of such option, Lonza shall use its Commercially Reasonable Best Efforts to initiate and complete the [*] Project in accordance with the requirements, costs and timelines set forth in Exhibit 1.
 
2.
Adjustment to Purchase Price for Successful Commercial Batches. Section 6.4.3 of the Agreement is amended to add a new subsection (e) as follows:
 
(e) Notwithstanding Section 6.4.3(a) above, commencing with the first Successful Commercial Batch resulting from a Commercial Run that entered the [*] at the Lonza Facility in the [*] Campaign, and continuing thereafter for the remainder of the Term, for each such Successful Commercial Batch (up to the Campaign Maximum in a particular
 

1


 
Campaign) manufactured after commencement of the [*] Campaign in compliance with this Agreement and in conformance with cGMP and the Bulk Drug Specifications, the Target Yield, and the warranties provided in Section 7.1 hereof, Genentech shall pay Lonza an amount as set forth below. Such amount shall be the Purchase Price for such Successful Commercial Batches.
 
(i) If the Yield for such Successful Commercial Batch is [*], Genentech shall pay Lonza an amount for such Batch equal to [*];
 
(ii) If the Yield for such Successful Commercial Batch is [*], Genentech shall pay Lonza an amount for such Batch [*]; or
 
(iii) If the Yield for such Successful Commercial Batch is [*], Genentech shall pay Lonza an amount for such Batch [*]
 
The Yield for each such Successful Commercial Batch shall be determined from its Batch Record using the protein concentration as reported in its Certificate of Analysis.
 
3.
Invoicing the Purchase Price for Successful Commercial Batches. Section 6.4.4 shall be amended to revise the last three sentences of that Section as follows:
 
Such invoices shall reference the Acceptance Date, the Batch delivered and the total Purchase Price; provided, for the sake of administrative ease, with respect to invoices issued under Section 6.4.3(e), Lonza shall invoice all such Successful Commercial Batches at an estimated Purchase Price of [*], and, [*] after the end of each calendar year, Lonza shall send to Genentech a report comparing the actual Purchase Price for such Successful Commercial Batches and the estimated Purchase Price invoiced to Genentech for such calendar year. Any payment required by Lonza to Genentech or by Genentech to Lonza to compensate for such difference between the actual Purchase Price and estimated Purchase Price shall be made to the appropriate Party no later than [*] of year in which such report is delivered.
 
In addition, for invoices issued with respect to Section 6.4.2(c), such invoices shall also reference a complete list of the Successful Commercial Batches produced, shipped and accepted by Genentech during such calendar year.
 
Amounts due under undisputed correct invoices shall be due and payable in U.S. currency within [*] after receipt of such invoice.
 
4.
Process Validation Batches for [*]. With respect to that Qualification Batch identified internally by Lonza as “[*]”, notwithstanding Sections 6.4.2 and 6.4.3(c) of the Agreement, Lonza and Genentech agree that Genentech shall purchase such Batch from Lonza for an amount equal to [*] (the “Batch Payment”) [*]. Such Batch Payment and [*] shall be the Purchase Price for [*]. Genentech shall pay such amount within [*] of the 2nd Amendment Effective Date.
 
5.
Milestone Payments for Calendar Years 2005 and 2006. Section 6.4.3(d) is amended in entirety as follows:
 

2


 
(d) In consideration for Lonza’s success in manufacturing and supplying to Genentech Successful Commercial Batches during the calendar year 2005, Genentech shall pay to Lonza a [*] of the 2nd Amendment Effective Date. In addition, Lonza shall also be entitled to receive:
 
(i) [*] upon Lonza quality release of a [*], which Batches resulted from Campaign [*] or Campaign [*]. Such additional amount shall be payable upon [*] Commercial Batch resulting from such Campaigns; and
 
(ii) a [*] payment of [*] upon Lonza quality release by [*] of a [*] Successful Commercial Batches [*]. For the avoidance of doubt, no Successful Commercial Batches resulting from Campaign [*] shall count toward such milestone. Such additional amount shall be payable upon Genentech’s final release of such Commercial Batches.
 
For the avoidance of doubt, such amounts shall in no event be paid more than once each, and with respect to (i) and (ii) only on achievement of such milestone by the date indicated above. 
 
6.
[*]. As of the 2nd Amendment Effective Date, Genentech and Lonza are in the process of gathering additional data in order to [*] from Campaign [*]. Lonza and Genentech agree, that with respect to such [*], Genentech shall continue to use commercially reasonable efforts to perform certain activities and testing as necessary, in Genentech reasonable judgment and in conformance with the Quality Agreement, to determine [*]. Lonza and Genentech further agree:
 
(a) If Genentech determines that such Batch is a Successful Commercial Batch, Genentech shall pay to Lonza the amounts specified in Section 6.4.3(a) of the Agreement for such Successful Commercial Batch, less [*]. Such amounts shall be due and payable upon Genentech’s release of such Batch; or
 
(b) If Genentech rejects such Batch [*] and/or if such Batch expires prior to the completion of [*]: (i) Genentech shall have no obligation to pay Lonza any amounts for such Batch and (ii) Lonza shall pay to Genentech an amount equal to [*]. Such amount shall be due and payable upon Genentech’s written notice to Lonza.
 
[*]
 
7.
Rescheduling of Campaigns. Notwithstanding the Campaign, Campaign Minimum and Campaign Minimum Run schedule listed on Exhibit A of the Agreement (including any amendments thereof in the 1st Amendment):
 
(a) the [*] Campaigns scheduled to commence on [*], shall be conducted in [*], with: (i) [*], to continue for a Campaign Minimum of [*], during which time Lonza shall be obligated to perform [*] Campaign Minimum Runs; and (ii) such Campaign [*] and continue for a Campaign Minimum of [*], during which time Lonza shall be obligated to perform [*] Campaign Minimum Runs (with the expectation of the Parties that [*] Campaign Minimum Runs shall be allocated to conducting [*], as further described in Section 3 of the 1st Amendment); and
 

3


 
(b) the [*] Campaign and the [*] Campaign, scheduled to commence on [*], shall be [*] Campaign, and shall be rescheduled to commence on [*] and continue for a Campaign Minimum of [*] during which time Lonza shall be obligated to [*] Campaign Minimum Runs.
 
8.
Invoicing of Project Batches deemed releasable by Genentech but subject to Regulatory Approval.
 
Notwithstanding Section 5.4.6, but subject to Genentech's rights to make claims under Article 9 of the Agreement, for Batches manufactured as part of a mutually agreed project subject to Regulatory Approval, [*] (each a “Project Batch”), the Acceptance Date shall be defined as the date on which Lonza receives written notice from Genentech that such Batch has been released, or deemed releasable, by Genentech pursuant to applicable release testing standard operating protocols as described in the Quality Agreement.  For the avoidance of doubt, per Section 6.4.4, Lonza may issue invoices for such Project Batches on or after the related Acceptance Date.
 
9.
Amendment to the Manufacturing Process; Non-Conforming Bulk Drug Resulting from such amended Manufacturing Process.
 
The Parties agree to amend the Manufacturing Process to provide a [*]. Should any Non-Conforming Bulk Drug result from a Commercial Batch manufactured in accordance with such amended Manufacturing Process [*], and such non-conformity was not caused by Lonza (or its agents), the Parties agree that Genentech will pay to Lonza (a) [*] the Purchase Price that would have otherwise been due for such Bulk Drug if it resulted from a Successful Commercial Batch, and (b) [*] of the Acquisition Cost for the raw materials utilized to produce such Bulk Drug. Any investigation of such Non-Conforming Bulk Drug shall be completed in accordance with Article 9 of the Agreement.
 
10. All terms and conditions of the Agreement not modified by this 2nd Amendment shall continue in full force and effect in accordance with their terms. All capitalized terms not otherwise defined herein shall have the same definition as in the Agreement.
 
[the remainder of this page intentionally blank]
 

4


 
IN WITNESS WHEREOF, the Parties have caused this 2nd Amendment to be executed as of the Effective Date.
 
GENENTECH, INC.
 
     
By:
/s/  MARKUS GEMUEND
 
     
Name:
Markus Gemuend
 
     
Title:
Vice President, Manufacturing Collaborations & Contract Manufacturing
     
     
LONZA BIOLOGICS, INC.
 
     
By:
/s/  STEPHAN KUTZER
 
     
Name:
Stephan Kutzer
 
     
Title:
Chief Operating Officer
 
     
     
LONZA BIOLOGICS, PLC
 
     
By:
/s/  STEPHAN KUTZER
 
     
Name:
Stephan Kutzer
 
     
Title:
Chief Operating Officer
 
 

5

 

 
EXHIBIT 1
 
[*] Project
 
Upon Genentech’s exercise of its option set forth in Section 1 above of this 2nd Amendment, Lonza shall complete all activities required to implement [*] including those outlined below:
 
1. [*].
 
Feasibility of doing [*] is to be assessed by the parties first confirming the maximum buffer used if [*] were to be run. To perform [*], an additional capital investment will be required if, and only if, it can be determined that enough [*] is available to provide a safety level during processing. That determination can only be assessed after the [*] are run. Commercial terms for proceeding with capital investments or any other charges related to [*] will be mutually agreed upon prior to implementation.
 
It is estimated that an [*] will correlate to an increase of [*].
 
Furthermore, it is estimated that due to the associated changes required (see details below) [*].
 
Other improvements which have increased the reliability of operations in the plant should be considered as well.
 
1.1 Details of [*]
 
[*] is not currently validated for use in [*] but will be required for the additional supply of the [*]. The CIP and SIP code are in place but not validated. This change will require operations, process validation, documentation, controls and computer validation resources.
 
Also, [*] requires that[*] of the [*] be used to [*], there will [*] to allow for safety margins in respect to volume. Instead of using [*], the separately prepared [*] can be used for this step instead. This will also allow for [*] because the [*] can be retained [*] instead of the [*] in which the [*]. The extra [*] may increase the overall recovery [*]. This will require operations, process validation, documentation, controls and computer validation resources.
 
As a final change, [*] requested that [*]. This was requested to maintain consistency with the other [*] chromatography steps. This will require operations and documentation support.
 
Lonza assumes that all of these changes will require [*] to ensure the change has been completed as desired.
 
2. Actions/Activity Required.
 
1) [*]
 
a) Write change controls and route for approvals (OPS).
 

6


 
b) [*].
 
c) Add code to support [*] tanks of [*] (Con).
 
d) Validate any additional code required (CpV).
 
e) Rewrite [*] document to include [*] in BR (OPS).
 
f) Provide GMP documentation support (DOCS)
 
g) Rewrite [*] records (OPS).
 
2) Use [*] Equil. instead of [*] to equilibrate the skid prior to [*].
 
a) Code the change (CON)
 
b) Validate the code change (CpV)
 
c) Rewrite batch records (OPS)
 
d) Provide GMP documentation support (DOC)
 
3) Use [*] instead of [*] for flushing filters
 
a) Change batch records
 
b) Provide GMP documentation support
 
4) Provide [*] including buffer preparations.
 
a) [*] (upstream and downstream)
 
3. Schedule
 
It is estimated that [*] will be required to make the change from [*] from the time that Lonza initiates a change control to the [*] tests
 
Also [*] of down time during the campaign due to [*] and [*] tests are estimated for which we can provide more detail on the affect to the scheduling and batch output.
 
[*]
 
Genentech and Lonza agree that the time required to implement the project will [*].
 
4. Cost and Benefit
 
4.1 Costs.
 

7


 
(a) [*]. The loss [*] shall be borne by Genentech; provided such [*] shall in no event exceed [*] without Genentech’s prior written consent. Such [*] shall be invoiced to Genentech at a cost of [*]. Lonza shall invoice Genentech for such costs on a [*] basis. Genentech shall pay all true and correct invoices within [*]. For the avoidance of doubt, any loss of [*] in excess of [*] to implement the [*] shall be borne by Lonza, and the total amount that may be invoiced to Genentech by Lonza under this Section 4.1 of Exhibit 1 shall [*], in each case, without Genentech prior written consent.
 
(b) Reimbursement of Costs of [*]. Lonza shall reimburse all amounts paid by Genentech to Lonza for [*] in accordance with the following. Commencing with the first Successful Commercial Batch resulting from [*] at the Lonza Facility after Lonza commences the [*], and continuing thereafter until Lonza reimburses Genentech for all amounts paid by Genentech to Lonza for [*], for each such Successful Commercial Batch whose Yield is [*], Lonza shall reimburse to Genentech an amount [*]. In conjunction with the report Lonza is to send to Genentech under Section 6.4.4 of the Agreement in each calendar year (as described in Section 3 of this 2nd Amendment above), Lonza shall also provide a report of the Successful Commercial Batches for such calendar year which are subject to reimbursement by Lonza to Genentech. Any reimbursement required by Lonza to Genentech under this Section 4.1(b) of Exhibit 1 shall be made to Genentech no later than [*] of year in which such report is delivered.
 
(c) Activity Costs. The actual [*] costs to be incurred by Lonza to implement the [*] Project as currently projected by the Parties are [*] (the “Activity Costs”). Such Activity Costs shall be borne by Genentech. Lonza shall invoice Genentech for a) [*] of the expected Activity Costs prior to commencing the [*] Project and b) the balance of actual Activity Costs incurred upon completing the [*] Project and concurrent with such invoice, Lonza shall provide Genentech with a written report summarizing the activities completed and the Activity Costs incurred by Lonza in support of such activities. Genentech shall pay all undisputed invoices within [*] of receipt thereof. In the event that Genentech believes that an invoice is incorrect, it will inform Lonza within [*] of receipt and such disputed amount will be investigated by the parties. Once the dispute has been resolved, Genentech shall pay the corrected invoice within [*] of receipt thereof.
 
(d) Project Scope Changes. In the event that the scope of the [*] Project changes [*], the Parties shall agree in writing to both the scope changes and new estimates for the Activity Costs and [*] prior to Genentech exercising its option as outlined in Section 1 above of this 2nd Amendment.
 
 
8


EX-10.33 4 dna-ex10_33.htm THIRD AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT BETWEEN GENENTECH AND LONZA BIOLOGICS PLC, DATED AS OF NOVEMBER 6, 2006 Third Amendment to the Manufacturing and Supply Agreement between Genentech and Lonza Biologics PLC, dated as of November 6, 2006

 
EXHIBIT 10.33
 
THIRD AMENDMENT
 
TO THE
 
MANUFACTURING AND SUPPLY AGREEMENT OF DECEMBER 7 2003
 
THIS THIRD AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT DATED DECEMBER 7 2003 ("3rd Amendment") is dated as of 06 November 2006, by and between Lonza Biologics PLC, having its principal place of business at 228 Bath Road, Slough, Berkshire SL1 4DX, England ("LB"), Lonza Biologics, Inc. having its principal place of business at 101 International Drive Portsmouth, New Hampshire 03801 ("Lonza Inc") (collectively LB and Lonza Inc, hereinafter "Lonza"), and Genentech, Inc., a Delaware corporation, having its principal place of business at One DNA Way, South San Francisco, California 94080 ("Genentech").
 
BACKGROUND
 
The Parties have executed that certain Manufacturing and Supply Agreement by and between the Parties dated December 7, 2003, as amended 14 March 2005 (the “1st Amendment”), (collectively, the “Agreement”), as amended 19 May 2006 (the “2nd Amendment”) and wish now to further amend said Agreement.
 
Lonza and Genentech desire to (i) re-schedule certain Campaigns to be conducted by Lonza, (ii) amend the non-competition provisions, and (iii) remove Genentech’s [*] right to extend the Term of the Agreement in exchange for Lonza providing Genentech regular forecasts with respect to capacity at the Lonza Facility in the years [*].
 
NOW, THEREFORE, IN CONSIDERATION OF the mutual covenants set forth in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
 
1.
Condition Precedent. This 3rd Amendment shall only become effective upon the closing of the purchase and sale of the issued and outstanding units of Genentech España S.L., pursuant to the terms of the Sale Agreement (the “3rd Amendment Effective Date”). As of the signing of this 3rd Amendment, the expected closing date of the Sale Agreement is 08 December 06. As used herein, the “Sale Agreement” means that certain Stock Purchase Agreement by and among Lonza Europe B.V., a Dutch company incorporated in the Netherlands, having its principal place of business at Breda, Netherlands and Genentech, of even date herewith, pursuant to which Genentech has agreed to sell the “Shares” (as defined in the Sale Agreement) to Lonza, and Lonza has agreed to purchase the Shares from Genentech, as the same may be amended from time to time.
 
2.
Rescheduling of Campaigns. Notwithstanding the Campaign, Campaign Minimum and Campaign Minimum Run schedule listed on Exhibit A of the Agreement (including any amendments thereof in the 1st Amendment and/or 2nd Amendment):
 
(a) the combined [*] Campaigns scheduled to commence on [*], shall be rescheduled to commence on [*], and shall continue for a Campaign Minimum of [*] during which time Lonza shall be obligated to perform [*] Campaign Minimum Runs; and
 
 

1



 
(b) the [*] Campaigns shall each commence as currently scheduled; provided, the Parties shall discuss in good faith a rescheduling of such Campaigns in order to accommodate each Party’s requirements; provided further, with respect to such Campaigns, the Campaign Minimum Runs are amended as follows:
 
Campaign        Campaign Minimum Runs
 
[*] Campaign             [*]
 
[*] Campaign             [*]
 
[*] Campaign             [*]
 
3.
Competitive Products. A new Section 5.7.7 is hereby added to the Agreement as follows:
 
 
5.7.7
Competitive Products. Notwithstanding the non-compete provisions of Section 5.7.6, if any existing or new capacity becomes available at the Lonza Facility at any time [*], Lonza shall have the right to use such capacity to manufacture, either for commercial supply or clinical supply, an Existing Lonza Customer Product (including without limitation those Existing Lonza Customer Product that are Competing Products). Each Party agrees that the provisions of this Section 5.7.7 shall be binding upon the licensees, successors and/or assignees of a Party. As used herein this Section 5.7.7:
 
(i) [*], “Singapore Facility” and “Competing Product”, respectively, means as defined in that certain Exclusive Option Agreement (“Singapore Facility”) between Genentech and Lonza Group Ltd. and Lonza Holding Singapore PTE Ltd. of even date herewith; and
 
(ii) Existing Lonza Customer Product” means [*]
 
4.
Term. Section 20.1 of the Agreement is amended in its entirety to read as follows:
 
 
20.1
Term. Unless sooner terminated pursuant to the terms of this Agreement, the term of this Agreement (the "Term") shall commence on the Effective Date and shall continue until December 31, 2008.
 

2



 
5.
Capacity at the Lonza Facility in the [*]. A new Section 5.10 is hereby added to the Agreement as follows:
 
 
5.10
Capacity at the Lonza Facility in [*]. Lonza hereby agrees to provide to Genentech notice of any capacity (new or existing) at the Lonza Facility (and not already committed under written agreement with a Third Party as of the date of such notice), for so long as such capacity is available for production during [*]. This Section 5.10 shall survive the termination or expiration of this Agreement.
 
 
5.10.1
Forecast Notice. Commencing on [*], and continuing every six (6) months thereafter until [*], Lonza shall provide Genentech with a forecast of available capacity (including without limitation that portion of capacity, if any, under discussion by Lonza with a Third Party) at the Lonza Facility in [*]. Lonza shall offer such capacity to Genentech [*]. Genentech shall have [*] (as may be extended by mutual agreement) following its receipt of each such forecast to provide written notification to Lonza regarding its decision [*] with respect to any of such capacity.
 
 
5.10.2
Exercise. If written notice is given by Genentech to Lonza within such [*] period that Genentech may desire to obtain some or all of such capacity, Lonza shall provide Genentech with all information reasonably useful for Genentech to make a decision regarding such capacity. Following Genentech’s receipt of all such information, [*].
 
 
5.10.3
Failure to Exercise; Election to Not Exercise. If written notice is given that Genentech does not want to accept some or all of such capacity, or written notice is not given by Genentech within [*] (as may be extended by mutual agreement), Genentech will have waived its right to [*] capacity (or, as applicable, that portion thereof that it specifies in such written notice that it does not want [*]) unless and until Lonza notifies Genentech in a subsequent forecast that such capacity is available.
 
 
5.10.4
Additional Rights/Obligations.
 
(a) With respect to capacity subject to this Section 5.10 and under written proposal by Lonza with a Third Party prior to the date of Lonza’s notice Genentech under Section 5.10.1 above, during said [*],
 

 
3



 
Lonza shall be free to talk with and enter into an agreement to sell such capacity to such Third Party;
 
(b) With respect to all other capacity subject to this Section 5.10 and under a written proposal by Lonza with Genentech, during [*], Lonza shall be free to talk to any Third Party; provided Lonza does not [*].
 
6.
Milestone Payment for Calendar Year 2006. Section 6.4.3(d)(ii) is amended in entirety as follows:
 
(ii) a one-time additional payment of [*] upon Lonza quality release by [*] of a total number of Successful Commercial Batches greater than or equal to [*] of the total Commercial Runs commenced by Lonza during the [*] Campaign and [*] Campaign (it being understood that the [*] Campaign consists of the [*] of the [*] Campaign). For the avoidance of doubt, no Successful Commercial Batches resulting from the [*] Campaign shall count toward such milestone. Such additional amount shall be payable upon Genentech’s final release of such Commercial Batches.
 
7.
All terms and conditions of the Agreement not modified by this 3rd Amendment shall continue in full force and effect in accordance with their terms. All capitalized terms not otherwise defined herein shall have the same definition as in the Agreement.
 
[the remainder of this page intentionally blank]
 
 

4



 
IN WITNESS WHEREOF, the Parties have caused this 3rd Amendment to be executed as of the Effective Date.
 
GENENTECH, INC.
 
     
By:
/s/  MARKUS GEMUEND
 
     
Name:
Markus Gemuend
 
     
Title:
Vice President, Manufacturing Collaborations
 
     
     
LONZA BIOLOGICS, INC.
 
     
By:
/s/  STEPHAN KUTZER
 
     
Name:
Stephan Kutzer
 
     
Title:
Chief Operating Officer
 
     
     
LONZA BIOLOGICS, PLC
 
     
By:
/s/  STEPHAN KUTZER
 
     
Name:
Stephan Kutzer
 
     
Title:
Chief Operating Officer
 

 
5


EX-10.38 5 dna-ex10_38.htm AGREEMENT AND PLAN OF MERGER BY AND AMONG GENENTECH, INC., GREEN ACQUISITION CORPORATION AND TANOX, INC., DATED AS OF NOVEMBER 9, 2006 Agreement and Plan of Merger by and among Genentech, Inc., Green Acquisition Corporation and Tanox, Inc., dated as of November 9, 2006


EXHIBIT 10.38
 
 
AGREEMENT AND PLAN OF MERGER
 
BY AND AMONG
 
GENENTECH, INC.
 
GREEN ACQUISITION CORPORATION
 
and
 
TANOX, INC.
 
Dated as of November 9, 2006
 
 


 
 
TABLE OF CONTENTS
 

 
Page
ARTICLE I THE MERGER
1
 
    1.1
The Merger
1
    1.2
Effective Time; Closing
1
    1.3
Effect of the Merger
2
    1.4
Certificate of Incorporation and Bylaws of Surviving Corporation
2
    1.5
Directors and Officers of Surviving Corporation
2
    1.6
Effect on Capital Stock
2
    1.7
Dissenting Shares
3
    1.8
Surrender of Certificates
4
    1.9
No Further Ownership Rights in Company Common Stock
5
    1.10
Lost, Stolen or Destroyed Certificates
5
    1.11
Adjustments
5
    1.12
Taking of Necessary Action; Further Action
5
 
ARTICLE II REPRESENTATIONS AND WARRANTIES OF COMPANY
5
 
    2.1
Organization and Qualification; Subsidiaries
6
    2.2
Certificate of Incorporation and Bylaws; Minutes
6
    2.3
Capitalization
7
    2.4
Authority Relative to this Agreement
8
    2.5
No Conflict; Required Filings and Consents
8
    2.6
Compliance with Health Care Laws
9
    2.7
Permits
10
    2.8
FDA; Global Regulation Compliance; Company Products and Company Research Programs
10
    2.9
SEC Filings; Financial Statements
12
    2.10
No Undisclosed Liabilities
15
    2.11
Absence of Certain Changes or Events
15
    2.12
Absence of Litigation
16
    2.13
Employee Benefit Plans
16
    2.14
Proxy Statement
21
    2.15
Title to Property
21
    2.16
Taxes
23
    2.17
Environmental Matters
25
    2.18
Brokers; Third Party Expenses
26
    2.19
Intellectual Property
26
    2.20
Contracts
32
    2.21
Product Liability Claims
34
    2.22
Insurance
34
    2.23
Opinion of Financial Advisor
35
    2.24
Board Approval
35
    2.25
Rights Agreement
35
    2.26
State Takeover Statutes
35
    2.27
Interested Party Transactions
35
 
ARTICLE III REPRESENTATIONS AND WARRANTIES OF PARENT AND MERGER SUB
36
 
    3.1
Corporate Organization
36
    3.2
Authority Relative to this Agreement
36
    3.3
No Conflict; Required Filings and Consents
36
    3.4
Proxy Statement
37
    3.5
Sufficient Funds
37
 
 
i


 
   
Page
    3.6
No Prior Merger Sub Operations
37
     
ARTICLE IV CONDUCT PRIOR TO THE EFFECTIVE TIME
37
     
    4.1
Conduct of Business by Company
37
     
ARTICLE V ADDITIONAL AGREEMENTS
 
     
    5.1
Proxy Statement
41
    5.2
Meeting of Company Stockholders
42
    5.3
Confidentiality; Access to Information
43
    5.4
No Solicitation
43
    5.5
Public Disclosure
46
    5.6
Reasonable Efforts; Regulatory Matters
47
    5.7
Notification
48
    5.8
Third Party Consents and Notices
48
    5.9
Indemnification
49
    5.10
Termination of Certain Benefit Plans
49
    5.11
Section 16 Matters
50
    5.12
Disqualified Individuals
50
    5.13
Company Rights Agreement
50
    5.14
Takeover Statutes
50
    5.15
FIRPTA Compliance
50
     
ARTICLE VI CONDITIONS TO THE MERGER
51
     
    6.1
Conditions to Obligations of Each Party to Effect the Merger
51
    6.2
Additional Conditions to Obligations of the Company
51
    6.3
Additional Conditions to the Obligations of Parent and Merger Sub
51
     
ARTICLE VII TERMINATION, AMENDMENT AND WAIVER
52
     
    7.1
Termination
52
    7.2
Notice of Termination; Effect of Termination
54
    7.3
Fees and Expenses
54
    7.4
Amendment
56
    7.5
Extension; Waiver
56
     
ARTICLE VIII GENERAL PROVISIONS
56
     
    8.1
Non-Survival of Representations and Warranties
56
    8.2
Notices
56
    8.3
Interpretation; Knowledge
57
    8.4
Counterparts
58
    8.5
Entire Agreement; Third Party Beneficiaries
58
    8.6
Severability
59
    8.7
Other Remedies; Specific Performance
59
    8.8
Governing Law; Jurisdiction
59
    8.9
Rules of Construction
59
    8.10
Assignment
59
    8.11
Waiver of Jury Trial
60

INDEX OF EXHIBITS

Exhibit A
Form of Company Voting Agreement


ii



AGREEMENT AND PLAN OF MERGER
 
THIS AGREEMENT AND PLAN OF MERGER is made and entered into as of November 9, 2006 (the “Agreement”), by and among Genentech, Inc., a Delaware corporation (“Parent”), Green Acquisition Corporation, a Delaware corporation and a wholly-owned subsidiary of Parent (“Merger Sub”), and Tanox, Inc., a Delaware corporation (the “Company”).
 
RECITALS
 
WHEREAS, the Boards of Directors of Parent, Merger Sub and the Company have each determined that it is in the best interests of their respective stockholders for Parent to acquire the Company upon the terms and subject to the conditions set forth herein.
 
WHEREAS, the Board of Directors of the Company (the “Board”) has unanimously (i) determined that the Merger (as defined in Section 1.1) is advisable and fair to, and in the best interests of, the Company and its stockholders, (ii) approved this Agreement and the other transactions contemplated by this Agreement, including the Merger and the transactions contemplated by the Company Voting Agreements, and (iii) determined to recommend that the stockholders of the Company adopt this Agreement.
 
WHEREAS, the Board of Directors of Parent has (i) determined that the Merger is advisable and fair to, and in the best interest of, Parent and its stockholders, and (ii) approved this Agreement.
 
WHEREAS, concurrently with the execution of this Agreement, as a condition and inducement to Parent’s willingness to enter into this Agreement, certain stockholders of the Company are entering into Voting Agreements, dated as of the date hereof, in substantially the form attached hereto as Exhibit A (the “Company Voting Agreements”).
 
WHEREAS, Parent, Merger Sub and the Company desire to make certain representations, warranties, covenants and agreements in connection with the Merger and also to prescribe certain conditions to the Merger.
 
NOW, THEREFORE, in consideration of the covenants, promises and representations set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
 
ARTICLE I
THE MERGER
 
1.1 The Merger. At the Effective Time (as defined in Section 1.2) and subject to and upon the terms and conditions of this Agreement and the applicable provisions of the Delaware General Corporation Law (“Delaware Law”), Merger Sub shall be merged with and into the Company (the “Merger”), the separate corporate existence of Merger Sub shall cease and the Company shall continue as the surviving corporation. The Company, as the surviving corporation after the Merger, is hereinafter sometimes referred to as the “Surviving Corporation.”
 
1.2 Effective Time; Closing. Upon the terms and subject to the conditions of this Agreement, the parties hereto shall cause the Merger to be consummated by filing with the Secretary of State of the State of Delaware a certificate of merger (the “Certificate of Merger”) executed in accordance with the relevant provisions of Delaware Law (the time of such filing, or such later time as may be agreed in writing by the Company and Parent and specified in the Certificate of Merger, being the “Effective Time”) on, or as soon as practicable after, the Closing Date (as herein defined). The closing of the Merger (the “Closing”) shall take place at the offices of Wilson Sonsini Goodrich & Rosati, Professional Corporation, 650 Page Mill Road, Palo Alto, California, at a time and date to be specified by the parties hereto, which shall be no later than the second business day after the satisfaction or waiver of the conditions set forth in Article VI (other than those conditions which, by their terms,


1



are to be satisfied or waived on the Closing Date, but subject to the satisfaction or waiver thereof), or at such other time, date and location as the parties hereto agree in writing. The date on which the Closing occurs is referred to in this Agreement as the “Closing Date”.
 
1.3 Effect of the Merger. At the Effective Time, the effect of the Merger shall be as provided in this Agreement and the applicable provisions of Delaware Law. Without limiting the generality of the foregoing, and subject thereto, at the Effective Time, all of the assets, properties, rights, privileges, powers and franchises of the Company and Merger Sub shall vest in the Surviving Corporation, and all of the debts, liabilities, obligations, restrictions and duties of the Company and Merger Sub shall become the debts, liabilities, obligations, restrictions and duties of the Surviving Corporation.
 
1.4 Certificate of Incorporation and Bylaws of Surviving Corporation.
 
(a) Certificate of Incorporation. As of the Effective Time, by virtue of the Merger and without any action on the part of Merger Sub or the Company, the Certificate of Incorporation of the Surviving Corporation shall be amended and restated to read the same as the Certificate of Incorporation of Merger Sub, as in effect immediately prior to the Effective Time, subject to Section 5.9(a), until thereafter amended in accordance with Delaware Law and such Certificate of Incorporation; provided, however, that as of the Effective Time the Certificate of Incorporation shall provide that the name of the Surviving Corporation is “Tanox, Inc.”
 
(b) Bylaws. As of the Effective Time, by virtue of the Merger and without any action on the part of Merger Sub or the Company, the Bylaws of the Surviving Corporation shall be amended and restated to read the same as the Bylaws of Merger Sub, as in effect immediately prior to the Effective Time, subject to Section 5.9(a), until thereafter amended in accordance with Delaware Law, the Certificate of Incorporation of the Surviving Corporation and such Bylaws; provided, however, that all references in such Bylaws to Merger Sub shall be amended to refer to “Tanox, Inc.”
 
1.5 Directors and Officers of Surviving Corporation.
 
(a) Directors. The initial directors of the Surviving Corporation shall be the directors of Merger Sub as of immediately prior to the Effective Time, until their respective successors are duly elected or appointed and qualified or until their earlier death, resignation or removal in accordance with the Certificate of Incorporation and the Bylaws of the Surviving Corporation.
 
(b) Officers. The initial officers of the Surviving Corporation shall be the officers of Merger Sub as of immediately prior to the Effective Time, until their respective successors are duly appointed and qualified or until their earlier death, resignation or removal in accordance with the Certificate of Incorporation and the Bylaws of the Surviving Corporation.
 
1.6 Effect on Capital Stock. Upon the terms and subject to the conditions of this Agreement, at the Effective Time, by virtue of the Merger and without any action on the part of Merger Sub, the Company or the holders of any of the following securities, the following shall occur:
 
(a) Conversion of Shares. Each share of common stock, par value $0.01 per share, of the Company (“Company Common Stock”) issued and outstanding immediately prior to the Effective Time (other than any shares of Company Common Stock to be canceled pursuant to Section 1.6(b) and any Dissenting Shares, as defined in Section 1.7), will be canceled and extinguished and automatically converted into the right to receive, upon surrender of the certificate(s) representing such Company Common Stock in the manner provided in Section 1.8 (or in the case of a lost, stolen or destroyed certificate, upon delivery of an affidavit, and bond, if required, in the manner provided in Section 1.10), cash in an amount equal to $20.00 per share, without interest (the “Per Share Merger Consideration” and the aggregate of all Per Share Merger Consideration, the “Merger Consideration”).
 

2



(b) Cancellation of Treasury and Parent-Owned Shares. All Company Common Stock held by the Company or owned by Merger Sub, Parent or any direct or indirect wholly-owned subsidiary of the Company or of Parent immediately prior to the Effective Time shall be canceled and extinguished without any conversion thereof.
 
(c) Capital Stock of Merger Sub. Each share of common stock, par value $0.01 per share, of Merger Sub (the “Merger Sub Common Stock”) issued and outstanding immediately prior to the Effective Time shall be converted into one validly issued, fully paid and nonassessable share of common stock, par value $0.01 per share, of the Surviving Corporation. Each certificate evidencing ownership of shares of Merger Sub Common Stock outstanding immediately prior to the Effective Time shall evidence ownership of such shares of capital stock of the Surviving Corporation.
 
(d) Stock Options. Except as set forth on Section 1.6(d) of the Company Disclosure Letter (as defined in Article II), each option to purchase Company Common Stock (the “Company Stock Options”), whether vested or unvested, and all stock option plans or other equity-related plans of the Company (the “Company Stock Plans”), that are unexpired, unexercised and outstanding as of the Effective Time shall on the terms and subject to the conditions set forth in this Agreement, be cancelled in its entirety at the Effective Time, and the holder of each shall be fully vested in such Company Stock Options, and the Parent shall pay or cause to be paid, as soon as reasonably practicable after the Effective Time, to each such holder of Company Stock Options an amount of cash equal to the product of (i) the number of shares of Company Common Stock as to which such Company Stock Option remains unexercised immediately prior to the Effective Time, multiplied by (ii) the Per Share Merger Consideration minus the exercise price of such Company Stock Option immediately prior to the Effective Time (the “Option Merger Consideration”); provided, however, that if the Per Share Merger Consideration does not exceed the exercise price of such Company Stock Option immediately prior to the Effective Time, the Option Merger Consideration for such Company Stock Option shall be zero; and provided further, that nothing in this Section 1.6(d) shall prohibit the holder of a Company Stock Option from exercising such Company Stock Option prior to the Effective Time in accordance with its terms and applicable Legal Requirements. Prior to the Effective Time, the Company shall timely deliver any notices to holders of Company Stock Options as may be required by the terms of the Company Stock Plans and take any and all actions necessary or appropriate to effectuate the foregoing, including, without limitation, using all reasonable efforts to obtain any applicable consents or waivers from holders of Company Stock Options that were granted under the Company’s 2000 Non-Employee Directors’ Stock Option Plan. The payment of the Option Merger Consideration to the holder of a Company Stock Option shall be reduced by any income, employment or other Tax withholding required under the Code (as defined in Section 2.13(a)(ii)) or any provision of state, local or foreign Tax law.
 
1.7 Dissenting Shares.
 
(a) Notwithstanding any provision of this Agreement to the contrary, shares of Company Common Stock that are outstanding immediately prior to the Effective Time and that are held by stockholders who shall have not voted in favor of the Merger and who shall have demanded properly in writing appraisal for such Company Common Stock in accordance with Section 262 of Delaware Law (collectively, the “Dissenting Shares”) shall not be converted into, or represent the right to receive, the Per Share Merger Consideration payable for each such share of Company Common Stock. Such stockholders shall be entitled to receive payment of the appraised value of such Company Common Stock held by them in accordance with the provisions of such Section 262, except that all Dissenting Shares held by stockholders who shall have failed to perfect or who effectively shall have withdrawn or lost their rights to appraisal of such Company Common Stock under such Section 262 shall thereupon be deemed to have been converted into, and to have become exchangeable for, as of the Effective Time, the right to receive the Per Share Merger Consideration payable for each such share of Company Common Stock, without any interest thereon, upon surrender, in the manner provided in Section 1.8, of the certificate or certificates that formerly evidenced such Company Common Stock.
 

3



(b) The Company shall give Parent (i) prompt notice of any demands for appraisal received by the Company, withdrawals of such demands, and any other instruments served pursuant to Delaware Law and received by the Company and (ii) the opportunity to direct all negotiations and proceedings with respect to demands for appraisal under Delaware Law. The Company shall not, except with the prior written consent of Parent, make any payment with respect to any demands for appraisal or offer to settle or settle any such demands.
 
1.8 Surrender of Certificates.
 
(a) Paying Agent. At the Effective Time, Parent shall deposit or cause to be deposited with a bank or trust company reasonably acceptable to the Company to act as agent (the “Paying Agent”), for the benefit of the holders of Company Common Stock to receive the funds to which holders of Company Common Stock shall become entitled pursuant to Section 1.6(a), a cash amount sufficient to pay the Merger Consideration. Such funds shall be invested by the Paying Agent as directed by Parent; earnings from such investments shall be the sole and exclusive property of Parent and the Surviving Corporation, and no part of such earnings shall accrue to the benefit of holders of the shares of Company Common Stock.
 
(b) Payment Procedures. As soon as reasonably practicable after the Effective Time, Parent shall cause the Paying Agent to mail to each holder of record (as of the Effective Time) of a certificate or certificates (the “Certificates”), which immediately prior to the Effective Time represented the outstanding shares of Company Common Stock, (i) a letter of transmittal in customary form (which shall specify that delivery shall be effected, and risk of loss and title to the Certificates shall pass, only upon delivery of the Certificates to the Paying Agent and shall contain such other provisions as Parent shall reasonably specify) and (ii) instructions for use in effecting the surrender of the Certificates in exchange for the portion of the Merger Consideration payable upon surrender of said Certificates. Upon surrender of Certificates for cancellation to the Paying Agent or to such other agent or agents as may be appointed by Parent, together with such letter of transmittal, duly completed and validly executed in accordance with the instructions thereto, and such other documents as may be required pursuant to those instructions, the holders of such Certificates formerly representing the Company Common Stock shall be entitled to receive in exchange therefor the portion of the Merger Consideration payable for such shares of Company Common Stock, and the Certificates so surrendered shall forthwith be canceled. Until so surrendered, outstanding Certificates shall be deemed from and after the Effective Time, for all corporate purposes, to evidence only the ownership of the respective portion of the Merger Consideration to which the record holder of such Certificate is entitled by virtue thereof. Promptly following surrender of any such Certificates and the duly executed letters of transmittal, the Paying Agent shall deliver to the record holders thereof, without interest, the portion of the Merger Consideration to which such holder is entitled upon surrender of said Certificates, subject to the restrictions set forth herein.
 
(c) Payments with respect to Unsurrendered Company Common Stock; No Liability. At any time following the 180th day after the Effective Time, the Surviving Corporation shall be entitled to require the Paying Agent to deliver to it any funds which had been made available to the Paying Agent and not disbursed to holders of Company Common Stock (including all interest and other income received by the Paying Agent in respect of all funds made available to it), and, thereafter, such holders shall be entitled to look to Parent (subject to abandoned property, escheat and other similar laws) only as general creditors thereof with respect to any portion of the Merger Consideration that may be payable upon due surrender of the Certificates held by them. Notwithstanding the foregoing, none of Parent, the Surviving Corporation nor the Paying Agent shall be liable to any former holder of Company Common Stock for any portion of the Merger Consideration delivered in respect of such Company Common Stock to a public official pursuant to any abandoned property, escheat or other similar Legal Requirement.
 
(d) Transfers of Ownership. If the payment of the portion of the Merger Consideration to which such holder is entitled is to be paid to a person other than the person in whose name the Certificates surrendered in exchange therefor are registered, it will be a condition of payment that the Certificates so surrendered be properly endorsed and otherwise in proper form for transfer (including, if requested by Parent or the Paying


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Agent, a medallion guarantee), and that the persons requesting such payment will have paid to Parent or any agent designated by it any transfer or other Taxes required by reason of the payment of a portion of the Merger Consideration to a person other than the registered holder of the Certificates surrendered, or established to the satisfaction of Parent or any agent designated by it that such Tax has been paid or is not applicable.
 
(e) Required Withholding. Each of the Paying Agent, Parent and the Surviving Corporation shall be entitled to deduct and withhold from any consideration payable or otherwise deliverable pursuant to this Agreement to any holder or former holder of the Company Common Stock such amounts as may be required to be deducted or withheld therefrom under the Code or under any provision of state, local or foreign Tax law or under any other applicable Legal Requirement. To the extent such amounts are so deducted or withheld, such amounts shall be treated for all purposes under this Agreement as having been paid to the person to whom such amounts would otherwise have been paid.
 
1.9 No Further Ownership Rights in Company Common Stock. Payment of the Merger Consideration shall constitute payment in full satisfaction of all rights pertaining to the Company Common Stock. From and after the Effective Time, there shall be no further registration of transfers on the records of the Surviving Corporation of shares of the Company Common Stock which were outstanding immediately prior to the Effective Time. If, after the Effective Time, Certificates are presented to the Surviving Corporation for any reason, they shall be canceled and exchanged as provided in this Article I.
 
1.10 Lost, Stolen or Destroyed Certificates. In the event that any Certificates shall have been lost, stolen or destroyed, the Paying Agent shall pay in exchange for such lost, stolen or destroyed Certificates, upon the making of an affidavit of that fact by the holder thereof, the portion of the Merger Consideration payable with respect thereto; provided, however, that Parent or the Paying Agent may, in its discretion and as a condition precedent to the payment of such portion of the Merger Consideration, require the owner of such lost, stolen or destroyed Certificates to deliver a bond (at the sole expense of the holder of such Certificate) in such reasonable and customary amount as it may direct as indemnity against any claim that may be made against Parent, the Surviving Corporation or the Paying Agent with respect to the Certificates alleged to have been lost, stolen or destroyed.
 
1.11 Adjustments. In the event of any stock split, reverse stock split, stock dividend (including any dividend or distribution of securities convertible into Company Common Stock, whether directly or indirectly), reorganization, reclassification, combination, recapitalization or other like change with respect to the Company Common Stock occurring after the date of this Agreement and prior to the Effective Time, all references in this Agreement to specified numbers of shares of any class or series affected thereby, and all calculations provided for that are based upon numbers of shares of any class or series (or trading prices therefor) affected thereby, shall be equitably adjusted to the extent necessary to provide the parties the same economic effect as contemplated by this Agreement prior to such stock split, reverse stock split, stock dividend, reorganization, reclassification, combination, recapitalization or other like change.
 
1.12 Taking of Necessary Action; Further Action. If, at any time after the Effective Time, any further action is necessary or desirable to carry out the purposes of this Agreement and to vest the Surviving Corporation with full right, title and possession to all assets, property, rights, privileges, powers and franchises of the Company and Merger Sub, the officers and directors of the Company and Merger Sub will take all such lawful and necessary action.
 
ARTICLE II
REPRESENTATIONS AND WARRANTIES OF COMPANY
 
The Company hereby represents and warrants to Parent and Merger Sub, except as are specifically disclosed in writing in the disclosure schedule supplied by the Company to Parent (which such exceptions shall reference


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the specific section and, if applicable, subsection number of this Article II to which it applies, and, if applicable, any information disclosed in any such section or subsection shall also be deemed to be disclosed with respect to each other such section or subsection to the extent that it is reasonably apparent on its face that such disclosure should also apply to such other section or subsection), dated as of the date hereof and certified by a duly authorized officer of the Company (the “Company Disclosure Letter”), as follows:
 
2.1 Organization and Qualification; Subsidiaries.
 
(a) Each of the Company and its subsidiaries is a corporation duly organized, validly existing and in good standing (with respect to jurisdictions that recognize the concept of good standing) under the laws of its respective jurisdiction of organization and has the requisite corporate power and authority to own, lease and operate its assets and properties and to carry on its business as it is now being conducted, except for such failures to be so organized, existing and in good standing (with respect to such jurisdictions that recognize the concept of good standing) or to have such power and authority that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect on the Company.
 
(b) The Company has no subsidiaries except for the persons identified in Section 2.1(b) of the Company Disclosure Letter. Section 2.1(b) of the Company Disclosure Letter also sets forth the form of ownership and percentage voting and/or equity interest of the Company in its subsidiaries and, to the extent that a subsidiary set forth thereon is not wholly owned by the Company, lists the other persons that have an ownership interest in such subsidiary and sets forth the percentage of each such ownership interest. Neither the Company nor any of its subsidiaries has agreed to make nor is obligated to make nor is bound by any written, oral, express or implied agreement, contract, subcontract, lease, mortgage, indenture, understanding, arrangement, instrument, note, bond, warranty, purchase order, license, sublicense, benefit plan, franchise or other instrument, obligation, commitment or undertaking that is legally binding and with respect to which there are continuing obligations, rights, or liabilities, including any amendments thereto (a “Contract”) or Legal Requirement (as defined in Section 2.3(a) below), in effect as of the date hereof, to make any future investment in or capital contribution to any other person or any sale or other disposition of the capital stock or any of the assets or operations of any such person.
 
(c) Other than the subsidiaries set forth in Section 2.1(b) of the Company Disclosure Letter, neither the Company nor any of its subsidiaries directly or indirectly owns any equity or similar interest in or any interest convertible, exchangeable or exercisable for, any equity or similar interest in, any person.
 
(d) The Company and each of its subsidiaries is duly qualified to do business as a foreign corporation, and is in good standing (with respect to jurisdictions that recognize the concept of good standing), under the laws of all jurisdictions where the character of the properties owned, leased or operated by it or the nature of its activities makes such qualification necessary, except where the failure to be so qualified and in good standing has not had, and would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect on the Company. Section 2.1(d) of the Company Disclosure Letter sets forth a true and complete list of each state and other jurisdiction which the Company and each of its subsidiaries is qualified to do business as a foreign corporation.
 
2.2 Certificate of Incorporation and Bylaws; Minutes.
 
(a) The Company has previously furnished to Parent (i) a complete and correct copy of its Certificate of Incorporation and Bylaws as amended to date (together, the “Company Charter Documents”) and (ii) the equivalent organizational documents for each subsidiary of the Company, each as amended to date. The Company Charter Documents and equivalent organizational documents of each subsidiary of the Company are in full force and effect. The Company is not in violation of any of the provisions of the Company Charter Documents, and no subsidiary of the Company is in violation of its equivalent organizational documents.
 
(b) The Company has delivered to Parent and its representatives true and complete copies of the minutes (or, in the case of minutes that have not yet been finalized, the most recent drafts thereof) of all meetings of the stockholders, the Board of Directors and each committee of such Board of Directors of the Company and each of its subsidiaries held since January 1, 2000.


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2.3 Capitalization.
 
(a) The authorized capital stock of the Company consists of 120,000,000 shares of Company Common Stock and 10,000,000 shares of Preferred Stock, par value of $0.01 per share (“Company Preferred Stock”). At the close of business on the date of this Agreement (i) 45,258,927 shares of Company Common Stock were issued and outstanding, all of which are validly issued, fully paid and nonassessable; (ii) no shares of Company Common Stock were held by subsidiaries of the Company; (iii) 554,700 shares of Company Common Stock were held in treasury by the Company; (iv) 2,677,418 shares of Company Common Stock were reserved for issuance upon the exercise of outstanding options to purchase Company Common Stock under the Company Stock Plans and (v) 5,248,185 additional shares of Company Common Stock were reserved for future issuance pursuant to the Company Stock Plans. The Company does not have any employee stock purchase plan, as such term is defined in Section 423 of the Code. As of the date hereof, no shares of Company Preferred Stock were issued or outstanding and there are no outstanding shares of Company Common Stock that are subject to risk of forfeiture. All shares of Company Common Stock subject to issuance upon exercise of such Company Stock Options, upon issuance on the terms and conditions specified in the instrument pursuant to which they are issuable, will be duly authorized, validly issued, fully paid and nonassessable. Except as set forth in Section 2.3(a) of the Company Disclosure Letter, there are no Contracts to which the Company is bound obligating the Company to accelerate the vesting of any Company Stock Option as a result of the transactions contemplated hereby (the “Transactions”) or upon termination of employment or service with the Company or with any of its subsidiaries following the Merger (whether alone or in combination with any other events) or otherwise. All outstanding shares of Company Common Stock, all outstanding Company Stock Options and all outstanding shares of capital stock of each subsidiary of the Company have been issued and granted in compliance with all applicable securities laws and other applicable Legal Requirements (as defined below). The exercise price of each Company Stock Option is no less than the fair market value of a share of Company Common Stock as determined on the date of grant of such Company Stock Option. All grants of Company Stock Options were properly approved by the Board or a duly and validly appointed committee of the Board in compliance with all applicable Legal Requirements and recorded on the Financial Statements (as defined in Section 2.9(b)) in accordance with GAAP, and no such grants involved any inappropriate “back dating,” “forward dating” or similar practices with respect to the effective date of grant. All repurchases of Company securities have been made in compliance with all applicable Legal Requirements. For the purposes of this Agreement, “Legal Requirements” means any federal, state, local, municipal, foreign or other law, statute, legislation, constitution, principle of common law, binding resolution, ordinance, code, edict, order, injunction, judgment, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Entity (as defined in Section 2.5(b)) hereof. There are no declared or accrued but unpaid dividends with respect to any shares of Company Common Stock.
 
(b) Section 2.3(b) of the Company Disclosure Letter sets forth, as of the date of this Agreement the following information with respect to each Company Stock Option outstanding as of the date of this Agreement: (i) the name and address of the optionee; (ii) the particular plan pursuant to which such Company Stock Option was granted; (iii) the number of shares of Company Common Stock subject to such Company Stock Option; (iv) the exercise price of such Company Stock Option; (v) the date on which such Company Stock Option was granted; (vi) the applicable vesting schedule; (vii) the date on which such Company Stock Option expires; (viii) whether the exercisability of such Company Stock Option will be accelerated in any way by the transactions contemplated by this Agreement, and indicates the extent of acceleration; and (ix) whether such Company Stock Option is intended to qualify as an incentive stock option within the meaning of Section 422 of the Code.
 
(c) Except for the Company Stock Options and the rights designated in connection with the Rights Agreement, dated July 27, 2001 between the Company and American Stock Transfer & Trust Company as rights agent (the “Rights Agreement”), there are no subscriptions, options, warrants, equity securities, partnership interests or similar ownership interests, calls, rights (including preemptive rights), Contracts to


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which the Company or any of its subsidiaries is a party or by which the Company or any of its subsidiaries is bound obligating the Company or any of its subsidiaries to issue, deliver or sell, or cause to be issued, delivered or sold, or repurchase, redeem or otherwise acquire, or cause the repurchase, redemption or acquisition of, any shares of capital stock, partnership interests or similar ownership interests of the Company or any of its subsidiaries or obligating the Company or any of its subsidiaries to grant, extend, accelerate the vesting of or enter into any such subscription, option, warrant, equity security, call, right, commitment or agreement. There are no outstanding or authorized stock appreciation, phantom stock, profit participation, or other similar rights, contingent or accrued, to receive shares of Company Common Stock or benefits measured in whole or part by the value of a number of shares of Company Common Stock with respect to the Company or any of its subsidiaries. Except for the Company Stock Options, the Company Voting Agreements and the Rights Agreement, there are no voting trusts, proxies, rights plans, anti-takeover plans or Contracts to which the Company or any of its subsidiaries is a party or by which the Company or any of its subsidiaries is bound with respect to the voting, acquisition, disposition of or imposition of any Encumbrance on (i) any class of equity security of the Company or (ii) any equity security, partnership interest or similar ownership interest of any of its subsidiaries.
 
(d) True, correct and complete copies of (i) each of the Company Stock Plans, (ii) the standard form of all Contracts and instruments relating to or issued under the Company Stock Plans or Company Stock Option, (iii) each Contract or instrument relating to or issued under the Company Stock Plans or Company Stock Option where the terms of such grant differ in any material respect from such standard form agreements, and (iv) Contracts relating to unvested shares, have been made available to Parent, and such Contracts and instruments have not been amended, modified or supplemented since being made available to Parent, and, except as contemplated by this Agreement, there are no Contracts to amend, modify or supplement such agreements or instruments in any case from those made available to Parent.
 
2.4 Authority Relative to this Agreement. The Company has all necessary corporate power and authority to execute and deliver this Agreement, to perform its obligations hereunder and to consummate the Transactions, subject, with respect to the Merger, to the Company Stockholder Approval (as defined below). The execution and delivery of this Agreement by the Company and the consummation by the Company of the Transactions have been duly and validly authorized by all necessary corporate action on the part of the Company and no other corporate proceedings on the part of the Company are necessary to authorize this Agreement or to consummate the Transactions other than (i) with respect to the Merger, the filing with the Securities and Exchange Commission (the “SEC”) of a proxy statement with respect to, and the receipt of, the Company Stockholder Approval and (ii) the filing of the Certificate of Merger as required by Delaware Law, subject, in each case, to the receipt of the Required Consents. The affirmative vote of the holders of a majority of the shares of Company Common Stock issued and outstanding on the record date set for the meeting of the Company’s stockholders to adopt this Agreement is the only vote of the holders of capital stock of the Company necessary to adopt this Agreement and approve and adopt the Merger under applicable Legal Requirements and the Company Charter Documents (the “Company Stockholder Approval”). This Agreement has been duly and validly executed and delivered by the Company and, assuming the due authorization, execution and delivery by Parent and Merger Sub, constitutes a legal and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, moratorium, reorganization or similar Legal Requirements affecting the rights of creditors generally and the availability of equitable remedies (regardless of whether such enforceability is considered in a proceeding in equity or at law).
 
2.5 No Conflict; Required Filings and Consents.
 
(a) The execution and delivery of this Agreement by the Company does not, and the performance of this Agreement by the Company will not, (i) result in the creation of any material Encumbrance (as defined below) on any of the material properties or assets of the Company or any of its subsidiaries, (ii) conflict with or violate the Company Charter Documents or the equivalent organizational documents of any of the Company’s subsidiaries, (iii) subject, (A) with respect to the Merger, to the Company Stockholder Approval and (B) to compliance with the requirements set forth in Section 2.5(b), conflict with or violate in any


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material respect any Legal Requirements applicable to the Company or any of its subsidiaries or by which its or any of their respective properties is bound or affected, (iv) conflict with or violate, or result in any breach, impermissible assignment or non-transferability of or constitute a default (or an event that with notice or lapse of time or both would become a default) under, or materially impair the Company’s or any of its subsidiaries’ rights or alter the rights or obligations of any third party under, or give to others any rights of termination, amendment, acceleration or cancellation of any Company Contract (as defined in Section 2.20(a)) or (v) except to the extent that such conflicts, violations, breaches, defaults, impairments, rights of termination, cancellation, acceleration, Encumbrance or other effects would not in the aggregate have a material negative impact on the Company, conflict with or violate, or result in any breach, impermissible assignment or non-transferability of or constitute a default (or an event that with notice or lapse of time or both would become a default) under, or impair the Company’s or any of its subsidiaries’ rights or alter the rights or obligations of any third party under, or give to others any rights of termination, amendment, acceleration or cancellation of any Contract (other than a Company Contract) to which the Company or any of its subsidiaries is a party or by which the Company or any of its subsidiaries or its or any of their respective properties are bound or affected. “Encumbrance” means, with respect to any asset, mortgage, deed of trust, lien, pledge, charge, security interest, title retention device, conditional sale or other security arrangement, collateral assignment, claim, charge, adverse claim of title, third person ownership or right to use, restriction or other encumbrance of any kind in respect of such asset (including any restriction on (1) the voting of any security or the transfer of any security or other asset, (2) the receipt of any income derived from any asset, (3) the use of any asset, and (4) the possession, exercise or transfer of any other attribute of ownership of any asset, but excluding current Taxes not yet due and payable).
 
(b) The execution and delivery of this Agreement by the Company does not, and the performance of this Agreement by the Company shall not, require any consent, approval, authorization or permit of, or filing with or notification to, any supranational, national, state, municipal, local or foreign government, any instrumentality, subdivision, court, administrative agency or commission or other governmental authority or instrumentality, or any quasi-governmental or private body exercising any regulatory, taxing, importing or other governmental or quasi-governmental authority (a “Governmental Entity”), except (i) for applicable requirements, if any, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), state securities laws (“Blue Sky Laws”) and state takeover laws, such filings as may be required under, and compliance with the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”) and any other applicable Antitrust Law (as defined herein), the rules and regulations of Nasdaq, and the filing and recordation of the Certificate of Merger as required by Delaware Law, (ii) as set forth in Section 2.5(b) of the Company Disclosure Letter and (iii) where the failure to obtain such consents, approvals, authorizations or permits, or to make such filings or notifications, could not, individually or in the aggregate, be material to the Company or its subsidiaries or prevent or materially delay consummation of the Transactions or otherwise prevent the Company from performing its obligations under this Agreement (collectively, the “Required Consents”).
 
2.6 Compliance with Health Care Laws.
 
(a) Neither the Company nor any of its subsidiaries has been the subject of any investigation by a Governmental Entity as a result of or in connection with the Company’s or any of its subsidiaries’ research, development, clinical activities, production or distribution activities related to the Company Products.
 
(b) The Company and each of its subsidiaries are in material compliance and, except for any non-compliance that occurred prior to January 1, 2003 which, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect on the Company, have at all times been in material compliance with all relevant federal and other Legal Requirements applicable to the Company and its subsidiaries, including the federal Anti-kickback and Fraud and Abuse Prohibition Statutes (42 U.S.C. § 1320a-7b) and all other Legal Requirements prohibiting false statements and improper remuneration for purchasing products or services, the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Health Insurance Portability and


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Accountability Act of 1996 (42 U.S.C. § 1301 et seq. and implementing regulations), the exclusion laws, SSA § 1128 (42 U.S.C. 1320a-7) and the regulations promulgated pursuant to such laws and regulations, relating to the regulation of the Company and its subsidiaries (including the pertinent requirements of Good Laboratory Practices, Good Clinical Practices, Good Manufacturing Practices and the U.S. Food, Drug and Cosmetic Act and its implementing regulations, including 21 CFR Parts 50, 54, 56, 58, 210, and 211 and the respective counterparts thereof promulgated by Governmental Entities in countries outside the United States) (collectively, “Health Care Laws”). To its knowledge, the Company and each of its subsidiaries are in material compliance and have at all times been in material compliance with all Health Care Laws. Since January 1, 2003, neither the Company nor any of its subsidiaries has received any written notice or communication and, to the knowledge of the Company, prior to January 1, 2003, neither the Company nor any of its subsidiaries received a written notice or communication, in each case, from any Governmental Entity with respect to the Company regarding, and, to the knowledge of the Company, there are no facts or circumstances that would reasonably be expected to give rise to, any material violation of applicable Health Care Laws or any other applicable Legal Requirement. To the knowledge of the Company, no change in the current conduct of the Company or its subsidiaries, or their internal procedures or processes, is required in order to materially comply with Health Care Laws.
 
2.7 Permits. The Company and each of its subsidiaries have obtained all federal, state, county, local or foreign permits, authorizations, licenses, grants, variances certifications, clearances, consents, franchises, exemptions, orders and approvals (a) that are required by the Federal Food and Drug Administration (the “FDA”), any other Governmental Entity engaged in the regulation of the Company Research Programs, Company Products or the Company’s or its subsidiaries’ manufacturing and quality system or that are required by Health Care Laws or (b) that are otherwise material to the Company and its subsidiaries (other than those specified in Section 2.7(a) above) and that are required for operating the Company or its subsidiaries in the manner currently conducted in any location in which they currently operate (including those required to be obtained under Environmental and Safety Laws (as defined in Section 2.17(a)) (each, a “Company Permit” and collectively, the “Company Permits”). All such Company Permits are valid and in full force and effect. Section 2.7 of the Company Disclosure Letter lists all Company Permits. The Company and its subsidiaries are in compliance in all material respects with all covenants, terms and conditions of such Company Permits. Neither the Company nor any of its subsidiaries has received any written notice or communication with respect to the Company from any Governmental Entity regarding, and, to the knowledge of the Company, there are no facts or circumstances that could give rise to, (i) any violation of any Company Permit or (ii) any revocation, non-renewal, withdrawal, suspension, cancellation, limitation, termination or adverse modification of any Company Permit. No such Company Permit will be terminated or impaired, or will become terminable, in whole or in part, as a result of the consummation of the Transactions.
 
2.8 FDA; Global Regulation Compliance; Company Products and Company Research Programs.
 
(a) The operation of the Company and the operation of its subsidiaries, including the research, manufacture, import, export, testing, development, processing, packaging, labeling, storage and distribution of all Company Products, is in material compliance and, except for non-compliance prior to January 1, 2003 which, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect, have at all times been in material compliance with all applicable Health Care Laws and other applicable Legal Requirements, including to the extent applicable (1) those administered by the FDA and (2) those administered by Governmental Entities in countries outside the United States (including requirements for the manufacture of Company Products for administration in human subjects). To the Company’s knowledge, the operation of the Company and the operation of its subsidiaries are in material compliance and have at all times been in material compliance with all applicable Health Care Laws and other applicable Legal Requirements, including to the extent applicable (1) those administered by the FDA and (2) those administered by Governmental Entities in countries outside the United States (including requirements for the manufacture of Company Products for administration in human subjects). There is no pending or, to the knowledge of the Company, threatened Action in respect of the Company or Company Products by the FDA or any other Governmental Entity which has jurisdiction over the Company Products


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or the operations, properties or processes of the Company or the Company’s subsidiaries, or, to the knowledge of the Company, in respect of any third person’s activities on behalf of the Company or its subsidiaries (excluding Parent and Parent’s subsidiaries). The Company has no knowledge of any facts or circumstances that are likely to give rise to any such Action.
 
(b) (A) Except for non-compliance prior to January 1, 2003 which, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect on the Company, and (B) at all times to the Company’s knowledge, neither the Company nor any of its subsidiaries has had any Company owned or leased manufacturing site (nor, to the knowledge of the Company, has any third person (other than Parent and Parent’s subsidiaries) had any manufacturing site that produces Company Products) subject to a Governmental Entity (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 notice or similar notification from a Governmental Entity, “warning letters,” “untitled letter” or, to the knowledge of the Company, requests or requirements to make changes to the operations of the Company, a Company Research Program or the Company Products that have not been complied with and, if not complied with, would reasonably be expected to result in a material effect that is adverse to the Company’s or any of its subsidiaries’ ability to continue with the planned activities at that manufacturing site, and, to the knowledge of the Company, neither the FDA nor any Governmental Entity is considering such action. To the knowledge of the Company, no vigilance report or adverse event report is under investigation by any Governmental Entity with respect to any Company Products, the Company or its subsidiaries.
 
(c) All activities (including, without limitation, clinical trials and any studies, tests, and other preclinical activities the results of which have been or will be submitted to a Governmental Entity (such as the FDA or its counterparts worldwide), but excluding clinical trials conducted or being conducted by Parent or Parent’s subsidiaries) conducted by the Company in connection with any Company Product or Company Research Program, and, to the Company’s knowledge, all such activities conducted by third persons on behalf of the Company, which activities are required or purported to be conducted under statutory or regulatory “good practices” applicable to biopharmaceutical companies (e.g., Good Laboratory Practices, Good Clinical Practices and Good Manufacturing Practices), have been conducted in compliance in all material respects with the required experimental protocols required by applicable Institutional Review Boards, applicable Health Care Laws, and other applicable Legal Requirements.
 
(d) Neither the Company nor any of its subsidiaries has received any notices, correspondence or other communication in respect of the Company, any subsidiary, or any Company Product from the FDA or any other Governmental Entity requiring the termination or suspension of any clinical trials of any Company Product, or any clinical trials conducted by, or on behalf of, the Company or any of its subsidiaries and, to the knowledge of the Company, neither the FDA nor any other Governmental Entity is considering such action. Neither the Company nor any of its subsidiaries has received notification from a Governmental Entity of the rejection of data obtained from any clinical trials conducted by, or at the request of, the Company with respect to any Company Products, which data was submitted to the Governmental Entity and which was necessary to obtain regulatory approval of a particular Company Product or to move such Company Product to the next phase of clinical development.
 
(e) The manufacture of the Company Products by or, to the knowledge of the Company, on behalf of, the Company or any of its subsidiaries (other than by Parent or Parent’s subsidiaries) is being conducted in compliance in all material respects with all applicable Health Care Laws and other applicable Legal Requirements, including the FDA’s Good Manufacturing Practices at 21 CFR §§210-211 and applicable guidelines for products sold or used for clinical trials in the United States, and the respective counterparts thereof promulgated by Governmental Entities in countries outside the United States.
 
(f) Neither the Company nor any of its subsidiaries is the subject of any pending or, to the knowledge of the Company, threatened investigation in respect of the Company by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Neither the Company nor any of its subsidiaries has


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committed any act, made any statement, or failed to make any statement, in each case in respect of the Company or a subsidiary and that would provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities” and any amendments thereto. Neither the Company nor any of its subsidiaries nor any of their respective officers or, to the knowledge of the Company after reasonable inquiry by the Company of its Employees (other than Consultants) on or about the date of hire for each such Employee, its Employees (other than Consultants) has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) similar applicable Legal Requirement. The Company and its subsidiaries have implemented reasonable practices (consistent with prevailing industry standards) to determine whether any of its Employees (other than Consultants who are not Significant Consultants) have been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) similar applicable Legal Requirement. To the knowledge of the Company, no debarment or exclusionary claims, actions, proceedings or investigations in respect of the Company or any of its subsidiaries is pending or threatened against the Company, any of its subsidiaries or any of their respective officers, employees or agents. For purposes of this Agreement, a “Significant Consultant” is a Consultant (as defined in Section 2.13(a)(iv)) who (i) has responsibility for a function that is regulated by Health Care Laws (as opposed to advising a regular Company employee who has such responsibility) or (ii) devotes more than eighty (80) hours per month for three or more months, in each case performing functions for the Company or its subsidiaries.
 
(g) The Company has delivered or made available to Parent true and complete copies of all data, studies, results, and other information set forth in Section 2.8(g) of the Company Disclosure Letter. Such information provided or made available by the Company fairly represents all of the material ongoing research and development of the Company Products and Company Research Programs (as defined in Section 2.19), and, to the knowledge of the Company, there is no scientific information, data or results in the Company’s possession or control that have not been provided to Parent that a reasonable scientist would conclude is necessary to accurately assess or value such program or project.
 
(h) As of the date of this Agreement, the Company has in its control the amounts of each Company Product set forth in Section 2.8(g) of the Company Disclosure Letter (including TNX 355, TNX 650, TNX 234, and any other anti-CD4 product), in the form described therein (whether filled containers, drug product, bulk drug substance or otherwise) (“Product Inventory”). All such Product Inventory has stability sufficient (and, where applicable, approved by applicable Governmental Entities) such that it will not expire prior to use in the study or research for which it was manufactured, and all such Product Inventory has been manufactured and stored in accordance with Good Manufacturing Practices and applicable Health Care Laws.
 
(i) Where data with respect to a particular Company Product or a product candidate being studied in a Company Research Program has been provided to Parent (a) the underlying Company Product or product candidate is in Company’s possession and control as of the date hereof, along with any cell lines, reagents or other materials necessary to produce that Company Product or product candidate in its current form, and (b) the Company has in its possession and control the reagents and other materials required to reproduce the experiments that generated the data provided to Parent, except to the extent such reagents or other materials are readily commercially available and are identified as such.
 
2.9 SEC Filings; Financial Statements.
 
(a) Since January 1, 2004, the Company has filed or furnished each form, report, document, schedule, registration statement and definitive proxy statement with the SEC required to be filed or furnished by the Company with the SEC under the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, as then in effect (the “Company SEC Reports”). The Company SEC Reports (i) were filed or furnished on a timely basis, (ii) were prepared in accordance with the requirements of the Securities Act or the Exchange Act and the rules and regulations of the SEC then in effect, as the case may be, and (iii) did not at the time they were filed or furnished (and if amended or superseded by a filing prior to the date of this Agreement, then on the date of such amended or superseding filing) contain any untrue statement of a


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material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. None of the Company’s subsidiaries is required to file or furnish any reports or other documents with the SEC.
 
(b) Each set of consolidated financial statements (including, in each case, any related notes thereto) contained in the Company SEC Reports (the “Financial Statements”) (including any Company SEC Report filed after the date of this Agreement): (i) complied and will comply as to form in all material respects with the published rules and regulations of the SEC with respect thereto in effect at the time of such filing; (ii) was and will be prepared in accordance with United States generally accepted accounting principles (“GAAP”) applied on a consistent basis throughout the periods involved (except as may be indicated in the notes thereto or, in the case of unaudited statements, may not contain footnotes as permitted by Form 10-Q or Form 8-K) and fairly presented and will fairly present in all material respects the consolidated financial position of the Company and its consolidated subsidiaries at the respective dates thereof and the consolidated results of the Company’s and its subsidiaries’ operations and cash flows for the periods indicated. Except as reflected in the Financial Statements, neither the Company nor any of its subsidiaries is a party to any material off-balance sheet arrangement (as defined in Item 303 of Regulation S-K promulgated under the Securities Act (“Regulation S-K”)). All reserves that are set forth in or reflected in the Interim Balance Sheet (as defined below) have been established in accordance with GAAP consistently applied. At June 30, 2006 (the “Interim Balance Sheet Date”), there were no material loss contingencies (as such term is used in Statement of Financial Accounting Standards No. 5 (“Statement No. 5”) issued by the Financial Accounting Standards Board in March 1975) that are not adequately provided for in the balance sheet as of the Interim Balance Sheet Date (the “Interim Balance Sheet”) as required by Statement No. 5. The Company has not had any dispute with any of its auditors regarding accounting matters or policies during any of its past three full fiscal years or during the current fiscal year-to-date. The books and records of the Company and each of its subsidiaries have been, and are being maintained in all material respects in accordance with applicable legal and accounting requirements.
 
(c) To the Company’s knowledge, no fact, event or circumstance currently exists that will prevent any material amount of the cash, investments or securities represented by the line items “Cash and cash equivalents” and “Short-term investments” on the face of the Company’s Condensed Consolidated Balance Sheet included in the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2006 (collectively, the “Closing Cash Items”) from being available as cash in the United States and the repatriation to the Company of any such cash held outside of the United States will not result in the imposition of any material United States or foreign Tax Liability.
 
(d) Section 2.9(d) of the Company Disclosure Letter sets forth the Company’s forecasted expenses for Tanox West for the Company’s fiscal year 2006 as of the date hereof (the “Forecast”). The Company prepared the Forecast in good faith.
 
(e) The Company has previously furnished to Parent a complete and correct copy of any amendments or modifications, which have not yet been filed with the SEC but which are required to be filed, to agreements, documents or other instruments which previously had been filed by the Company with the SEC pursuant to the Securities Act or the Exchange Act.
 
(f) The Company has established and maintains “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) that are reasonably designed to ensure that material information (both financial and non-financial) relating to the Company and its subsidiaries required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to the Company’s principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure and to make the certifications of the principal executive officer and the principal financial officer of the Company required by Section 302 of the Sarbanes-Oxley Act of 2002 (“SOX”) with respect to such reports. For purposes of this Agreement, “principal executive officer” and “principal financial officer” shall have the meanings given to such terms in SOX.
 

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(g) The Company and each of its subsidiaries has established and maintains, adheres to and enforces a system of internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act) which is effective in providing reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with GAAP and SEC rules and regulations (including the Financial Statements), including policies and procedures that (i) require the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company and its subsidiaries, (ii) provide reasonable assurance that material information relating to the Company and its subsidiaries is promptly made known to the officers responsible for establishing and maintaining the system of internal controls; (iii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures of the Company and its subsidiaries are being made only in accordance with appropriate authorizations of management and the Board; (iv) provide reasonable assurance that access to assets is permitted only in accordance with management’s general or specific authorization; (v) provide reasonable assurance that the reporting of assets is compared with existing assets at regular intervals and appropriate action is taken with respect to any differences; (vi) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the assets of the Company and its subsidiaries; and (vii) provide reasonable assurance that any “significant deficiencies” or “material weaknesses” (as such terms are defined in Auditing Standard No. 2, promulgated by the Public Company Accounting Oversight Board, (“AS-2”) in the design or operation of internal controls which are reasonably likely to materially and adversely affect the ability to record, process, summarize and report financial information, and any fraud, whether or not material, that involves the Company’s management or other Employees (other than Consultants who are not Significant Consultants) who have a role in the preparation of financial statements or the internal controls used by the Company and its subsidiaries, are adequately and promptly disclosed to the Company’s independent auditors and the audit committee of the Board. There (i) are no significant deficiencies or material weaknesses in the system of internal control over financial reporting used by the Company and its subsidiaries, (ii) is no fraud, whether or not material, that involves the Company’s management or other Employees (other than Consultants who are not Significant Consultants) who have a role in the preparation of financial statements or the internal control over financial reporting used by the Company and its subsidiaries or (iii) is no claim or allegation regarding any of the foregoing. Section 2.9(g) of the Company Disclosure Letter summarizes each “control deficiency” (as defined in AS-2) identified by the Company’s independent auditors since January 1, 2004 through the date of this Agreement and not disclosed in the Company SEC Reports.
 
(h) Each of the principal executive officer of the Company and the principal financial officer of the Company (or each former principal executive officer of the Company and each former principal financial officer of the Company, as applicable) has made all certifications required by Sections 302 and 906 of SOX and the rules and regulations promulgated thereunder with respect to the Company SEC Reports. The Company’s management has completed an assessment of the effectiveness of the Company’s system of internal control over financial reporting in compliance with the requirements of Section 404 of SOX for the fiscal year ended December 31, 2005, and such assessment concluded that such controls were effective and the Company’s independent registered accountant has issued (and not subsequently withdrawn or qualified) and attestation report concluding the Company maintained effective internal control over financial reporting as of December 31, 2005. Since December 31, 2005 and through the date hereof, to the knowledge of the Company, no events, facts or circumstances have occurred, or exist, such that management would not be able to complete its assessment of the effectiveness of the Company’s system of internal control over financial reporting in compliance with the requirements of Section 404 of SOX for the fiscal year ended December 31, 2006, and conclude, after such assessment, that such controls were effective.
 
(i) To the Company’s knowledge, Ernst & Young LLP, which has expressed its opinion with respect to the financial statements of the Company and its subsidiaries as of December 31, 2005, December 31, 2004 and December 31, 2003 and for each of the fiscal years in the three fiscal year period ended December 31, 2005 included in the Company SEC Reports (including the related notes), is “independent” with respect to the Company and each of its subsidiaries within the meaning of Regulation S-X since the appointment of


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Ernst & Young LLP in that capacity. The Company is in compliance with the applicable criteria for continued listing of the Company Common Stock on Nasdaq and has not since January 1, 2004 received any written notice from Nasdaq asserting any non-compliance with such rules and regulations.
 
(j) The Company has timely responded to all comment letters of the staff of the SEC relating to the Company SEC Reports, and the SEC has not advised the Company that any final responses are inadequate, insufficient or otherwise non-responsive. The Company has made available to Parent true, correct and complete copies of all correspondence between the SEC, on the one hand, and the Company and any of its subsidiaries, on the other, since January 1, 2004, including all SEC comment letters and responses to such comment letters by or on behalf of the Company. To the Company’s knowledge, none of the Company SEC Reports is the subject of ongoing SEC review or outstanding SEC comment.
 
(k) No attorney representing the Company or any of its subsidiaries, whether or not employed by the Company or any of its subsidiaries, or Employee has reported to the Board or any committee thereof or to any director or officer of the Company evidence of a material violation of securities laws, breach of fiduciary duty, fraudulent conduct (whether or not material) or similar violation by an Employee or agent (while acting in that capacity).
 
2.10 No Undisclosed Liabilities. Neither the Company nor any of its subsidiaries has any liability, indebtedness, obligation, deficiency, guaranty or endorsement of any type (whether absolute, accrued, contingent, direct, indirect, or otherwise) (collectively, “Liabilities”) of a nature required to be disclosed on a balance sheet or in the related notes to the consolidated financial statements prepared in accordance with GAAP and which are, individually or in the aggregate with such other items, material to the business, assets, financial condition, results of operations or cash flows of the Company and its subsidiaries taken as a whole, except (i) Liabilities reflected or reserved in the Interim Balance Sheet, (ii) Liabilities incurred since the Interim Balance Sheet Date in the ordinary course of business consistent with past practices, (iii) Liabilities incurred since the Interim Balance Sheet date which, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect on the Company, or (iii) Liabilities permitted under Section 4.1 hereof or otherwise reasonably incurred in connection with the Company’s performance of its obligations hereunder.
 
2.11 Absence of Certain Changes or Events. From the Interim Balance Sheet Date through the date hereof, there has not been, occurred or arisen: (a) any event or condition of any character that has had or would be reasonably expected to have a Material Adverse Effect on the Company; (b) any declaration, setting aside or payment of any dividend on, or other distribution (whether in cash, stock or property) in respect of, any of the Company’s or any of its subsidiaries’ capital stock, or any purchase, redemption or other acquisition by the Company of any of the Company’s capital stock or any other securities of the Company or its subsidiaries or any options, warrants, calls or rights to acquire any such shares or other securities, except for repurchases from Employees following their termination pursuant to the terms of stock option or purchase agreements existing as of the Interim Balance Sheet Date; (c) any split, combination or reclassification of any of the Company’s or any of its subsidiaries’ capital stock; (d) any granting by the Company or any of its subsidiaries of any increase in compensation or fringe benefits to any Employee (other than Consultants who are not Significant Consultants) or any payment by the Company or any of its subsidiaries of any bonus or any entry by the Company or one of its subsidiaries into any Contract (or amendment of an existing Contract) to grant or provide severance, acceleration of vesting, termination pay or other similar benefits; (e) the execution of any employment Contract or service Contract, the extension of the term of any existing employment Contract or service Contract with any Employee, or any entry or other modification by the Company or any of its subsidiaries of any employment, severance, termination or indemnification Contract or any Contract the benefits of which are contingent, or the terms of which are materially altered, upon the occurrence of a transaction involving the Company of the nature contemplated hereby; (f) entry by the Company or any of its subsidiaries into (i) any licensing or other Contract providing for the use, acquisition or disposition of any Intellectual Property (as defined in Section 2.19 hereof) other than (A) licenses of commercially available third party software applications for internal use by the Company or otherwise in the Company’s ordinary course of business consistent with past practice and (B) confidentiality agreements in the ordinary course of business consistent with past practice, or (ii) any


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amendment or consent with respect to any material licensing or other Contract providing for the use, acquisition or disposition of any Intellectual Property, other than confidentiality agreements in the ordinary course of business consistent with past practice; (g) any change by the Company in its accounting methods, principles or practices (including any change in depreciation or amortization policies or rates or revenue recognition policies), except as required by concurrent changes in GAAP; (h) any revaluation by the Company of any of its assets, including writing off promissory notes or accounts receivable, or any sale of assets of the Company; (i) entry by the Company or any of its subsidiaries into any Contract (other than the Voting Agreements) filed or required to be filed by the Company with the SEC; (j) the incurrence, creation or assumption of any material Encumbrance (other than a Permitted Encumbrance) or any discharge of any material Encumbrance, any material Liability for borrowed money or any material Liability or obligation as guaranty or surety with respect to the obligations of others who are not wholly-owned subsidiaries of the Company, (k) any purchase, offer to purchase, sale, offer to sell, option to purchase or sell, agreement to transfer any interest in, or any lease, right to use, sublease or other occupancy, of any Company Real Estate (as defined in Section 2.15(a)) by the Company or its subsidiaries; and (l) any announcement of or any agreement by the Company, any of its subsidiaries, or any Employee on behalf of the Company, to do any of the things described in the preceding clauses (a) through (k) (other than negotiations or agreements with Parent and Merger Sub regarding the Transactions).
 
2.12 Absence of Litigation. Except as would not result in a material Liability, there are no claims, actions, charges, investigations or other proceedings pending or, to the knowledge of the Company, threatened against the Company or any of its subsidiaries, or any of their respective properties or any of the executive officers or directors of the Company or any of its subsidiaries before any Governmental Entity or otherwise (each, an “Action”). No investigation or review by any Governmental Entity is pending or, to the knowledge of the Company, threatened against the Company or any of its subsidiaries, or any of their respective properties or any of the executive officers or directors of the Company or any of its subsidiaries, nor has any Governmental Entity indicated to the Company an intention to conduct the same. The Company has provided or made available to Parent true, correct and complete copies of all complaints regarding the litigation referred to in Section 2.12 of the Company Disclosure Letter and has made available to Parent true, correct and complete copies of all pleadings, motions and non-privileged written correspondence regarding the litigation referred to in Section 2.12 of the Company Disclosure Letter. There has not been since January 1, 2000, nor are there currently any internal investigations being conducted by the Company, the Board (or any committee thereof) or any third party at the request of any of the foregoing concerning any financial, accounting, auditing, Tax, conflict of interest, illegal activity, fraudulent or deceptive conduct or other misfeasance or malfeasance issues with respect to the Company or any of its subsidiaries.
 
2.13 Employee Benefit Plans.
 
(a) Definitions. Except as otherwise provided for herein, for purposes of this Agreement, the following terms shall have the meanings set forth below:
 
(i) “COBRA” shall mean the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended and as codified in Section 4980B of the Code and Section 601 et. seq. of ERISA;
 
(ii) “Code” shall mean the Internal Revenue Code of 1986, as amended;
 
(iii) “Company Employee Plan” shall mean any Employee Plan, including all International Employee Plans;
 
(iv) “Consultant” shall mean any current or former independent contractor or leased employee who is (i) a natural person or (ii) a staffing agency or other entity that leases or otherwise supplies employees to third persons on a consulting, contract or project basis;
 
(v) “DOL” shall mean the U.S. Department of Labor;
 
(vi) “Employee” shall mean any current or former or retired employee, officer, Consultant or director of the Company or any ERISA Affiliate;
 

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(vii) “Employment Agreement” shall mean each management, employment, severance, change of control, retention, consulting (with a Consultant), relocation, repatriation, expatriation, visas, work permit or other agreement, contract or understanding, written or otherwise, between the Company or any ERISA Affiliate and any Employee under which the Company has current or future obligations;
 
(viii) “Employee Plan” shall mean any plan, program, policy, practice, Contract or other arrangement, providing for compensation, severance, termination pay, deferred compensation, performance awards, bonuses, stock or stock-related awards or purchases, fringe benefits, loans, or other employee benefits or remuneration of any kind, whether written or unwritten, funded or unfunded, including each “employee benefit plan,” within the meaning of Section 3(3) of ERISA which is or has been maintained, contributed to, or required to be contributed to, by the Company or any ERISA Affiliate for the benefit of any Employee, and with respect to which the Company or any ERISA Affiliate has or may have any Liability, including all International Employee Plans;
 
(ix) “ERISA” shall mean the Employee Retirement Income Security Act of 1974, as amended;
 
(x) “ERISA Affiliate” shall mean any other person or entity under common control with the Company within the meaning of Section 414(b), (c), (m) or (o) of the Code and the regulations issued thereunder;
 
(xi) “FMLA” shall mean the Family and Medical Leave Act of 1993, as amended;
 
(xii) International Employee Plan” shall mean each Employee Plan that has been adopted or maintained by the Company or any ERISA Affiliate pursuant to the laws of any country outside the United States, whether informally or formally, or with respect to which the Company or any ERISA Affiliate will or may have any Liability, for the benefit of Employees who perform services outside the United States;
 
(xiii) “IRS” shall mean the U.S. Internal Revenue Service;
 
(xiv) “Multiemployer Plan” shall mean any “Pension Plan” (as defined below) which is a “multiemployer plan,” as defined in Section 3(37) of ERISA;
 
(xv) “Pension Plan” shall mean each Company Employee Plan which is an “employee pension benefit plan,” within the meaning of Section 3(2) of ERISA.
 
(b) Schedule. Section 2.13(b) of the Company Disclosure Letter contains an accurate and complete list of each Company Employee Plan, and each Employment Agreement existing as of the date of this Agreement. Neither the Company nor any ERISA Affiliate has any plan or commitment to establish any new Company Employee Plan or Employment Agreement, to modify any Company Employee Plan or Employment Agreement (except to the extent required by applicable Legal Requirements, in each case as previously disclosed to Parent in writing, or as required by this Agreement), or to adopt or enter into any Company Employee Plan or Employment Agreement.
 
(c) Documents. The Company has provided or made available to Parent correct and complete copies of: (i) all material documents embodying each Company Employee Plan and each Employment Agreement including all amendments thereto and all related trust documents; (ii) the most recent annual actuarial valuations and annual and periodic accounting, if any, prepared for each Company Employee Plan; (iii) the three (3) most recent annual reports (Form Series 5500 and all schedules and financial statements attached thereto), if any, required under ERISA or the Code in connection with each Company Employee Plan; (iv) the most recent summary plan description together with the summary(ies) of material modifications thereto, if any, required under ERISA with respect to each Company Employee Plan; (v) the most recent IRS determination or opinion letter issued with respect to each Company Employee Plan, if applicable, and all applications and correspondence to or from the IRS or the DOL with respect to any such application or letter; (vi) all communications material to any Employee or Employees relating to any Company Employee Plan and any proposed Company Employee Plans, in each case, relating to any amendments, terminations, establishments, increases or decreases in benefits, acceleration of payments or vesting schedules or other


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events which would result in any material Liability to the Company; (vii) all correspondence to or from any Governmental Entity relating to any Company Employee Plan; (viii) all COBRA forms and related notices (or such forms and notices as required under comparable law); (ix) the three (3) most recent plan years discrimination tests for each Company Employee Plan, where applicable; (x) all material written agreements and contracts relating to each Company Employee Plan, including administrative service agreements and group insurance contracts and group annuity contracts; and (xi) all registration statements, annual reports (Form 11-K and all attachments thereto, if applicable to be filed) and prospectuses prepared in connection with each Company Employee Plan, as applicable.
 
(d) Employee Plan Compliance. Company and its ERISA Affiliates have performed, in all material respects, all obligations required to be performed by them under, are not in material default or violation of, and neither Company nor its ERISA Affiliates have any knowledge of any material default or violation by any other party to, any Company Employee Plan, and each Company Employee Plan has been established and maintained in all material respects (i) in accordance with its terms and (ii) in compliance with all applicable laws, statutes, orders, rules and regulations, including but not limited to ERISA and the Code. Any Company Employee Plan intended to be qualified under Section 401(a) of the Code and each trust intended to qualify under Section 501(a) of the Code (i) has either applied for, prior to the expiration of the requisite period under applicable U.S. Department of the Treasury (“Treasury”) Regulations or IRS pronouncements, or obtained a favorable determination, notification, advisory and/or opinion letter, as applicable, as to its qualified status from the IRS, and (ii) incorporates or has been amended to incorporate all provisions required to comply with the Tax Reform Act of 1986 and subsequent legislation. For each Company Employee Plan that is intended to be qualified under Section 401(a) of the Code, there has been no event, condition or circumstance that has adversely affected or would reasonably be expected to adversely affect the qualified status of such Company Employee Plan. No “prohibited transaction,” within the meaning of Section 4975 of the Code or Sections 406 and 407 of ERISA, and not otherwise exempt under Section 408 of ERISA, has occurred with respect to any Company Employee Plan. There are no Actions pending or, to Company’s or any ERISA Affiliates’ knowledge, threatened (other than routine claims for benefits) against any Company Employee Plan or against the assets of any Company Employee Plan. Each Company Employee Plan can be amended, terminated or otherwise discontinued after the Effective Time in accordance with its terms, and the act of amending, terminating or discontinuing any Company Employee Plan will not result in any Liability to Parent, Company or any of its ERISA Affiliates (other than routine administration expenses incurred with respect to any such amendment, termination or discontinuance). There are no audits, inquiries or proceedings pending or to Company’s or any of its ERISA Affiliates’ knowledge threatened by the IRS, DOL, or any other Governmental Entity with respect to any Company Employee Plan. Neither Company nor any ERISA Affiliate is subject to any penalty or Tax with respect to any Company Employee Plan under Section 502(i) of ERISA or Sections 4975 through 4980 of the Code. The Company and its ERISA Affiliates have, in all material respects, each timely made all contributions and other payments required by and due under the terms of each Company Employee Plan.
 
(e) No Pension or Funded Welfare Plans. Neither the Company nor any ERISA Affiliate has ever maintained, established, sponsored, participated in, or contributed to, or could have any obligation to, any (i) Pension Plan which is subject to Title IV of ERISA or Section 412 of the Code, or (ii) “funded welfare plan” within the meaning of Section 419 of the Code. Neither the Company nor any Company subsidiary or ERISA Affiliate has incurred or expects to incur any Liability under Title IV of ERISA or Section 412 of the Code. No Company Employee Plan provides health benefits that are not fully insured through an insurance contract.
 
(f) Collectively Bargained, Multiemployer and Multiple Employer Plans. At no time has the Company or any ERISA Affiliate contributed to or been obligated to contribute to any Multiemployer Plan. Neither the Company, nor any affiliate has at any time ever maintained, established, sponsored, participated in, or contributed to any multiple employer plan, or to any plan described in Section 413 of the Code.
 
(g) Deferred Compensation Compliance. The Company does not have a Company Benefit Plan that is a “nonqualified deferred compensation plan” (as defined in Section 409A(d)(1) of the Code).
 

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(h) Executive Loans. Neither the Company nor any ERISA Affiliate has violated the provisions of Section 402 of SOX applicable to loans to key executives, and the execution of this Agreement and the consummation of the transactions contemplated hereby will not, to the knowledge of the Company, cause such a violation of such provisions of Section 402 of SOX.
 
(i) Fair Market Value. No Company Stock Option or other right to acquire Company Common Stock or other equity of the Company (i) has an exercise price that has been or may be determined to be less than the fair market value of the underlying equity as of the date such Company Stock Option or other equity right was granted, (ii) has any feature for the deferral of compensation other than the deferral of recognition of income until the later of exercise or disposition of such Company Stock Options or other equity rights, or (iii) has been granted after December 31, 2004, with respect to any class of stock of the Company that is not “service recipient stock” (within the meaning of applicable regulations under Section 409A).
 
(j) Plan Contributions. With respect to the Company Employee Plans, there are no benefit or funding obligations for which contributions have not been made or properly accrued to the extent required by GAAP or will not be offset by insurance. The assets of each Company Employee Plan which is fully funded are reported at their fair market value in the books and records of such Company Plan, the applicable related trust as indicated on the Financial Statements and, if applicable, on Forms 5500, and/or the Company and its subsidiaries.
 
(k) No Post-Employment Obligations. No Company Employee Plan provides, or reflects or represents any Liability to provide retiree insurance or other retiree benefits to any person for any reason, except as may be required by COBRA or other applicable statute, and the Company has never represented, promised or contracted (whether in oral or written form) to any Employee (either individually or to Employees as a group) or any other person that such Employee(s) or other person would be provided with retiree insurance or other benefits, except to the extent required by applicable Legal Requirements.
 
(l) Effect of Transaction.
 
(i) The execution of this Agreement and the consummation of the Transactions or any termination of employment or service in connection therewith will not (either alone or upon the occurrence of any additional or subsequent events) constitute an event under any Company Employee Plan, Employment Agreement, trust or loan that will or may result in any payment (whether of severance pay or otherwise), acceleration, forgiveness of indebtedness, vesting, distribution, increase in benefits or obligation to fund benefits with respect to any Employee other than accrued payments.
 
(ii) No payment or benefit could give rise, directly or indirectly, to the payment of any amount that could reasonably be expected to be (i) non-deductible to Company under Section 280G of the Code, (ii) characterized as a “parachute payment” within the meaning of Section 280G of the Code or (iii) subject to the excise Tax under Section 4999 of the Code. The Company is not a party to or bound by any Tax indemnity agreement or any other agreement that will require Parent or the Surviving Corporation to “gross-up” or otherwise compensate any Employee because of the imposition of any excise Tax. Section 2.13(l)(ii) of the Company Disclosure Letter lists as of the date of this Agreement each person who the Company reasonably believes is, with respect to the Company, any Company subsidiary and/or any ERISA affiliate, a “disqualified individual” (within the meaning of Section 280G of the Code and the regulations promulgated thereunder).
 
(m) Employment Matters. The Company: (i) is in compliance in all material respects with all applicable foreign, federal, state and local laws, rules, regulations and ordinances respecting employment, employment practices, terms and conditions of employment, discrimination in employment, worker classification, wages, benefits, hours, working conditions and occupational safety and health and employment practices, in each case, with respect to Employees; (ii) has, in all material respects, withheld and reported all amounts required by Legal Requirements or by agreement to be withheld and reported with respect to wages, benefits, salaries and other payments to Employees (excluding Consultants); (iii) is not liable for any material arrears of wages, salaries, commissions, bonuses, benefits or other compensation due or any Taxes or any penalty for


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failure to comply with any of the foregoing; and (iv) is not liable for any payment to any trust or other fund governed by or maintained by or on behalf of any governmental authority, with respect to unemployment compensation benefits, social security or other retiree benefits, or other benefits or obligations for Employees (excluding Consultants) (other than routine payments to be made in the normal course of business and consistent with past practice). There are no pending or reasonably anticipated or, to the knowledge of the Company, threatened Actions, audits or administrative matters against the Company or any ERISA Affiliate relating to any Employee, Employee Agreement, or Company Employee Plan, or under any workers’ compensation policy or long-term disability policy. The employment or services of each of the Employees located in the United States is terminable at the will of the Company or its ERISA Affiliates and any such termination would result in no Liability to the Company or to any ERISA Affiliate. Neither the Company nor any ERISA Affiliate has direct or indirect material Liability with respect to any misclassification of any person as an independent contractor rather than as an employee, or with respect to any worker leased from another employer.
 
(n) Labor. No work stoppage or labor strike against the Company is pending or reasonably anticipated or, to the knowledge of the Company, threatened. The Company does not know of any current activities or proceedings of any labor union to organize any Employees (excluding Consultants) or of any such activities or proceedings within the preceding three (3) years. There are no Actions, audits, administrative matters, labor disputes or grievances pending, or, to the knowledge of the Company, threatened or reasonably anticipated relating to any wage, benefit, medical or family leave, labor, safety or discrimination matters involving any Employee, including charges of wage and/or hour violations, unfair labor practices, discrimination, or wrongful termination complaints. Neither the Company nor any ERISA Affiliate is party to a current conciliation agreement, consent decree, or other agreement or order with any federal, state, or local agency or Governmental Entity with regard to employment practices. Neither the Company nor any ERISA Affiliate has engaged in any unfair labor practices within the meaning of the National Labor Relations Act. The Company is not presently, nor has it been in the past, a party to, or bound by, any collective bargaining agreement or union contract with respect to Employees, no collective bargaining agreement is being negotiated by the Company or any of its subsidiaries and neither the Company or any of its subsidiaries has any duty to bargain with any labor organization.
 
(o) International Employee Plan. Each International Employee Plan has been established, maintained and administered in compliance with its terms and conditions and with the requirements prescribed by any and all statutory or regulatory laws that are applicable to such International Employee Plan. Furthermore, no International Employee Plan has unfunded liabilities, that as of the Effective Time, will not be offset by insurance or fully accrued. Except as required by applicable Legal Requirements, no condition exists that would prevent the Company or Parent from terminating or amending any International Employee Plan at any time for any reason without Liability to the Company or its affiliates (other than ordinary administration expenses or routine claims for benefits). Each International Employee Plan has obtained from the Governmental Entity having jurisdiction with respect to such International Employee Plan any required determinations, if any, that such International Employee Plan is in compliance with the laws of the relevant jurisdiction if such determinations are required in order to give effect to such International Employee Plan.
 
(p) WARN Act. The Company and any ERISA Affiliate have complied with the Workers Adjustment and Retraining Notification Act of 1988, as amended (“WARN Act”) and all similar state or local laws, including applicable provisions of state or local law. All Liabilities relating to the employment, termination or employee benefits of any former Employees (excluding Consultants) previously terminated by the Company or an affiliate including all termination pay, severance pay or other amounts in connection with the WARN Act and all similar state laws, have been paid, and no terminations prior to the Closing Date shall result in unsatisfied Liability under WARN or any similar state or local law.
 
(q) Employee Information. The Company and each of its subsidiaries has made available to Parent a true, correct and complete list of the names of all current officers, directors, and employees of the Company and each subsidiary showing each such person’s name, position, date of hire, work location, and each such person’s annualized salary and target commission (as applicable), status as exempt/non-exempt, status as


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full-/part-time, target bonus(es) and fringe benefits for the current fiscal year and the most recently completed fiscal year. The Company and each of its subsidiaries has made available to Parent the following additional information for each of its current international employees: city/country of employment; citizenship; date of hire; manager’s name and work location; date of birth; any material special circumstances; and whether the employee was recruited from a previous employer.
 
(r) True and Correct Copies. In addition to the documents referred to in Section 2.13(c) above, the Company and each of its subsidiaries has made available to Parent true, correct and complete copies of each of the following: (i) all affirmative action plans; (ii) all forms of offer letters currently in use; (iii) all forms of employment agreements and severance agreements for current Employees (excluding Consultants); (iv) all forms of consultant and/or independent contractor agreements currently in effect, (v) all forms of confidentiality, non-disclosure, non-solicitation, non-competition or inventions agreements between Employees and the Company or any of its subsidiaries currently in use for such matters (and a true, correct and complete list of current Employees not subject thereto); (vi) any agreements that deviate in any material respect from forms described in (i) through (v) above; (vi) all current management organization chart(s); (vii) all current, in force agreements and/or insurance policies providing for the indemnification of any officers or directors of the Company or any of its subsidiaries; (viii) summary of the Company’s current standard severance policy and any policy in existence or effect during the immediately preceding twelve (12) months; (ix) summary of outstanding Liability for termination payments and benefits to Employees; and (x) a schedule of bonus commitments made to Employees.
 
2.14 Proxy Statement. The proxy statement to be sent to the stockholders of the Company in connection with the Stockholders’ Meeting (as hereinafter defined) (such proxy statement, as amended or supplemented, being referred to herein as the “Proxy Statement”), shall not, at the date the Proxy Statement (or any amendment or supplement thereto) is first mailed to stockholders of the Company, at the time of the Stockholders’ Meeting and at the Effective Time, contain any statement which, at such time and in light of the circumstances under which it was made, is false or misleading with respect to any material fact, or which omits to state any material fact necessary in order to make the statements therein not false or misleading or necessary to correct any statement in any earlier communication with respect to the solicitation of proxies, if any, for the Stockholders’ Meeting which shall have become false or misleading. Notwithstanding the foregoing, the Company makes no representation or warranty with respect to any information supplied by Parent, Merger Sub or any of Parent’s or Merger Sub’s representatives in writing for inclusion in the Proxy Statement. The Proxy Statement shall comply in all material respects as to form with the requirements of the Exchange Act and the rules and regulations thereunder.
 
2.15 Title to Property.
 
(a) Section 2.15(a) of the Company Disclosure Letter sets forth a complete and accurate list as of the date of this Agreement of all real property owned by the Company or any of its subsidiaries, or in which the Company or any of its subsidiaries has an ownership interest, including, without limitation, any rights, contracts or options to acquire real property other than the Leased Real Estate defined below (the “Owned Real Estate”).
 
(b) Section 2.15(b) of the Company Disclosure Letter sets forth a list of all real property currently leased, subleased by or from the Company or any of its subsidiaries or otherwise used or occupied by the Company or any of its subsidiaries (the “Leased Real Estate” and together with the Owned Real Estate, the “Company Real Estate”), the name of the lessor, sublessor, master lessor and/or lessee, the date and term of the lease, sublease or other occupancy right and each amendment thereto, the aggregate annual rental payable thereunder, the size of the Leased Real Estate and a description of renewal options contained in such lease. The Company has provided or made available to Parent true, correct and complete copies of all leases, lease guaranties, subleases, agreements for the leasing, use or occupancy of, or otherwise granting a right in or relating to the Leased Real Estate, including all amendments, terminations and modifications thereof (the “Real Estate Leases”). All such Real Estate Leases are in full force and effect, are valid and enforceable in accordance with their respective terms, subject to bankruptcy, insolvency, reorganization,


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moratorium and similar state and federal laws affecting the rights of creditors generally and equitable limitations, and there is not, under any such leases, any existing material breach, default or event of default (or event which with notice or lapse of time, or both, would constitute a material default) of the Company or any of its subsidiaries, or to the Company’s knowledge, of any other party thereto.
 
(c) To the knowledge of the Company, neither the operations of the Company nor any of its subsidiaries on the Company Real Estate nor such Company Real Estate, violate in any material respect any Legal Requirement or Company Permit relating to the particular property or such operations. The Company or its subsidiaries currently occupies all of the Company Real Estate for the operation of its business and there are no other parties occupying, or with a right to occupy, the Company Real Estate. Section 2.15(c)(i) of the Company Disclosure Letter sets forth a list of all leasehold improvements to real property and improvements and other capital equipment used or held for use by the Company and its subsidiaries in their business operations as of September 30, 2006. Such list includes pertinent information related to property, plant and equipment (including leasehold improvements) such as asset identification, location, acquisition date, original cost, accumulated depreciation and net book value.
 
(d) To the knowledge of the Company, the covenants, conditions, rights-of-way, easements and similar restrictions affecting all or any portion of the Company Real Estate (the “Exceptions to Title”) do not, in each case, materially impair the ability to use any such Company Real Estate in the operation of the businesses of the Company or its subsidiaries as presently conducted, and no material default or breach exists thereunder by the Company or any of its subsidiaries.
 
(e) To the knowledge of the Company, there are no requirements (including any Legal Requirements) imposed on the Owned Real Estate that require the Company or any of its subsidiaries to construct or pay for the cost of construction of any off-site improvements or pay any other impact fee.
 
(f) Neither the Company, nor any subsidiary of the Company has received any written notice from any insurance company of any material defects or inadequacies in any Company Real Estate or any part thereof which could materially and adversely affect the insurability of such property or the premiums for the insurance thereof, nor has any written notice been given by any insurer of any such property requesting the performance of any repairs, alterations or other work with which substantial compliance has not been made.
 
(g) The Company has received no written notice with respect to pending, and, to the knowledge of the Company, there are no threatened, condemnation or eminent domain actions or proceedings, or any special assessments or other activities of any public or quasi-public body that would materially adversely affect the Company Real Estate for use in the operations of its business as currently conducted.
 
(h) The Company and each of its subsidiaries has good and indefeasible title to all Owned Real Estate, or, in the case of leased properties and assets, valid leasehold interests in or other valid contractual rights of use with respect to, all of its other properties and assets, used or held for use in its business, free and clear of all Encumbrances except for the Exceptions to Title and indebtedness that is reflected on the Interim Balance Sheet and (i) Encumbrances for Taxes (as herein defined) not yet due and payable, (ii) statutory Encumbrances which arise in the ordinary course of business, are not material in amount and do not materially impair the Company’s or its subsidiaries’ ownership or use of such properties and assets, (iii) liens securing indebtedness that are reflected on the Interim Balance Sheet or (iv) with respect to Owned Real Estate, minor imperfections of title, if any, and land use laws which do not materially impair the use, occupancy or value of the Company’s or its subsidiaries’ ownership of the Owned Real Estate for its current purpose (each of (i) through (iv), a “Permitted Encumbrance”).
 
(i) To the knowledge of the Company, all the Company Real Estate and material equipment of the Company and its subsidiaries, are in good operating condition and repair, in all material respects (subject to ordinary wear and tear), free from material defects which would adversely affect their use in the conduct of the business as currently conducted, and are otherwise suitable for the conduct of business as currently conducted.
 

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2.16 Taxes.
 
(a) Definition of Taxes. For the purposes of this Agreement, “Tax” or “Taxes,” means (i) any and all federal, state, local and foreign taxes, assessments and other governmental charges, duties and impositions, including taxes based upon or measured by gross receipts, income, profits, sales, use and occupation, and value added, ad valorem, transfer, franchise, withholding, payroll, recapture, employment, excise and property taxes, together with all interest, penalties and additions imposed with respect to such amounts; (ii) any Liability for the payment of any amounts of the type described in clause (i) as a result of being a member of an affiliated, consolidated, combined or unitary group for any period; and (iii) any Liability for the payment of any amounts of the type described in clause (i) or (ii) as a result of any express or implied obligation to indemnify any other person or as a result of any obligations under any agreements or arrangements with any other person with respect to such amounts and including any Liability for taxes of a predecessor entity.
 
(b) Tax Returns and Audits. 
 
(i) The Company and each of its subsidiaries have timely filed all federal, state, local and foreign returns, forms, estimates, information statements and reports (“Returns”) relating to Taxes required to be filed by the Company and each of its subsidiaries with any Tax authority, except such Returns which are not, individually or in the aggregate, material to the Company (“Company Returns”). The Company and each of its subsidiaries have paid all Taxes shown to be due on such Company Returns. All Company Returns were complete and accurate in all material respects and have been prepared in substantial compliance with all applicable Legal Requirements. The Company’s net operating losses and other Tax attributes are accurately reflected on the Company Returns and, to the knowledge of the Company, are not currently subject to any limitation under Sections 382 or 383 of the Code. The Company has made available to Parent correct and complete copies of all Company Returns, examination reports, closing agreements and statements of deficiencies assessed against or agreed to by the Company or any of its subsidiaries.
 
(ii) Neither the Company nor any of its subsidiaries is delinquent in the payment of any material Tax nor is there any material Tax deficiency outstanding, proposed or assessed against the Company or any of its subsidiaries, nor has the Company or any of its subsidiaries executed any unexpired waiver of any statute of limitations on or extension of any the period for the assessment or collection of any Tax.
 
(iii) No audit, or pending audit of, or other examination of any Company Return by any Tax authority is presently in progress, nor has the Company or any of its subsidiaries been notified of any request for such an audit or other examination.
 
(iv) No adjustment relating to any Company Returns has been proposed in writing, formally or informally, by any Tax authority to the Company or any of its subsidiaries or any representative thereof.
 
(v) Neither the Company nor any of its subsidiaries has any Liability for any material unpaid Taxes (whether or not shown to be due on any Company Return) which has not been accrued for or reserved on the Company’s Interim Balance Sheet in accordance with GAAP, whether asserted or unasserted, whether or not shown on any Company Return, contingent or otherwise, other than any Liability for unpaid Taxes that may have accrued since the Interim Balance Sheet Date in connection with the operation of the business of the Company and its subsidiaries in the ordinary course. There are no claims for Taxes being asserted against the Company or any of its subsidiaries that have resulted in, and there are no, Encumbrances with respect to Taxes on any of the assets of the Company or any of its subsidiaries, other than Encumbrances which are not, individually or in the aggregate, material, or customary Encumbrances for Taxes not yet due and payable.

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(vi) There is no Contract, plan or arrangement to which the Company or any of its subsidiaries is a party as of the date of this Agreement, including but not limited to the provisions of this Agreement, covering any Employee (other than a Consultant who is not a Significant Consultant) that, individually or collectively, would reasonably be expected to give rise to the payment of any amount that would not be deductible pursuant to Sections 280G, 404 or 162(m) of the Code or that would give rise to a penalty under Section 409A of the Code. There is no Contract, plan or arrangement to which the Company or any of its subsidiaries is a party or by which it is bound to compensate any individual for excise Taxes paid pursuant to Section 4999 of the Code.
 
(vii) Neither the Company nor any of its subsidiaries is party to or has any obligation under any Tax-sharing, Tax indemnity or Tax allocation agreement or arrangement, nor does the Company or any of its subsidiaries have any Liability or potential Liability to another party under any such agreement or arrangement. Neither the Company nor any of its subsidiaries has ever been a member of a group filing a consolidated, unitary, combined or similar Return (other than such Company Returns which include only the Company and any of its subsidiaries) under any federal, state, local or foreign law. Neither the Company nor any of its subsidiaries is party to any joint venture, partnership or other arrangement that could be treated as a partnership for federal and applicable state, local or foreign Tax purposes.
 
(viii) None of the Company’s or its subsidiaries’ assets are Tax exempt use property within the meaning of Section 168(h) of the Code.
 
(ix) Neither the Company nor any of its subsidiaries has constituted either a “distributing corporation” or a “controlled corporation” in a distribution of stock intended to qualify for tax-free treatment under Section 355 of the Code (x) in the two years prior to the date of this Agreement or (y) in a distribution which could otherwise constitute part of a “plan” or “series of related transactions” (within the meaning of Section 355(e) of the Code) in conjunction with the Transactions.
 
(x) Neither the Company nor any of its subsidiaries has consummated, has participated in, or is currently participating in any transaction which was or is a “Tax shelter,” “listed transaction” or “reportable transaction” as defined in Sections 6662, 6662A, 6011, 6012, 6111 or 6707A of the Code or the Treasury Regulations promulgated thereunder, including, but not limited to, transactions identified by the IRS by notice, regulation or other form of published guidance as set forth in Treasury Regulation Section 1.6011-4(b)(2).
 
(xi) Each of the Company and each of its subsidiaries has in its possession official foreign government receipts for any Taxes paid by it to any foreign Tax authorities.
 
(xii) The Company has made available to the Parent all documentation relating to any Tax holidays or incentives applicable to itself or its subsidiaries. The Company and its subsidiaries are in compliance with the requirements for any such Tax holidays or incentives.
 
(xiii) Neither the Company nor any of its subsidiaries is or has ever been a “United States real property holding corporation” within the meaning of Section 897 of the Code.
 
(xiv) The Company and each of its subsidiaries has complied (and until the Effective Time will comply) in all material respects with all applicable Legal Requirements relating to the payment and withholding of Taxes (including withholding of Taxes pursuant to Sections 1441, 1442, 1445 and 1446 of the Code or similar provisions under any foreign law), has, in all material respects within the time and in the manner prescribed by law, withheld from the wages or compensation of Employees (other than Consultants) and paid over to the proper Governmental Entities (or is properly holding for such timely payment) all amounts required to be so withheld and paid over under all applicable Legal Requirements, including federal and state income Taxes, Federal Insurance Contribution Act, Medicare Federal Unemployment Tax Act, relevant state income and employment Tax withholding laws, and has in all material respects timely filed all withholding Returns required to be filed.


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2.17 Environmental Matters.
 
(a) Hazardous Material. No underground storage tanks, nor to the knowledge of the Company, any sumps, vaults, clarifiers, wells or septic systems are present, in, on, under or about any property, including the land and the improvements, ground water and surface water thereof, that the Company or any of its subsidiaries has at any time owned, nor to the Company’s knowledge, on any property leased by the Company or any of its subsidiaries (all owned and leased facilities collectively referred to as the “Company Business Facilities”). Except as would not be reasonably expected to result in material Liability to the Company or its subsidiaries, no Hazardous Materials (as defined below) are present, in, on, under or about any property, including the land and the improvements, ground water and surface water thereof, that the Company or any of its subsidiaries has at any time owned or on any property leased by the Company or any of its subsidiaries. For purposes of this Section 2.17, “Environmental and Safety Laws” shall mean any applicable foreign, federal, state or local laws, ordinances, codes, regulations, rules, policies, directives, requirements, treaties, and orders and all other permits, approvals, clearances, consents and conditions associated therewith, which prohibit, regulate or control any Hazardous Material or that are intended to assure the protection of the environment, health or safety of Employees, workers or other persons, including the public. For the purposes of this Agreement, “Hazardous Materials” shall mean any material or substance that is prohibited or regulated by Environmental and Safety Laws or that has been designated by any Governmental Entity to be radioactive, toxic, hazardous, or otherwise a danger to health, reproduction or the environment, including PCBs, asbestos, petroleum, mold, and urea formaldehyde.
 
(b) Hazardous Materials Activities. Except in compliance in all material respects with all Environmental and Safety Laws and in a manner that would not reasonably be expected to result in a material Liability to the Company, neither the Company nor any of its subsidiaries has transported, transferred, recycled, treated, manufactured, distributed, stored, used, disposed of, released or exposed its Employees or others to Hazardous Materials or, to the knowledge of the Company, any product containing a Hazardous Material or any product manufactured with Ozone depleting substances (collectively “Hazardous Materials Activities”). The Hazardous Materials Activities of the Company prior to the Closing have not resulted in the exposure of any person to a Hazardous Material in a manner which has caused or could reasonably be expected to cause an adverse health effect to any such person.
 
(c) Environmental Liabilities; Compliance with Environmental and Safety Laws. No action, proceeding, revocation proceeding, amendment procedure, writ or injunction is pending, nor, to the Company’s knowledge, threatened by any Governmental Entity against the Company or any of its subsidiaries concerning any Company Environmental Permit, Hazardous Material or any Hazardous Materials Activity of the Company or any of its subsidiaries. The Company has no knowledge of any fact or circumstance which could reasonably be expected to involve the Company or any of its subsidiaries in any environmental litigation or impose upon the Company any material environmental Liability. Except as would not reasonably be expected to result in a material Liability to the Company, (i) neither the Company nor any of its subsidiaries has received any notice (verbal or written) of any past or present noncompliance of its operations, facilities, buildings or improvements located on any Company Business Facility with Environmental and Safety Laws, (ii) no notices, administrative actions or suits are pending or, to the knowledge of the Company, threatened against the Company or any of its subsidiaries or any such property relating to an actual or alleged violation of any Environmental and Safety Laws, (iii) neither the Company nor any of its subsidiaries is a potentially responsible party under the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. Section 9601 et seq. (“CERCLA”), or any analogous state, local or foreign laws arising out of events occurring prior to the Closing Date, and (iv) the operations, facilities, buildings or improvements located on any Company Business Facility have complied in all material respects with all Environmental and Safety Laws.
 
(d) Environmental Indemnities. Neither the Company nor any of its subsidiaries have entered into any agreement that may require it to guarantee, reimburse, pledge, defend, hold harmless or indemnify any other party with respect to liabilities arising out of Environmental and Safety Laws, or the Hazardous Materials Activities of the Company, any of its subsidiaries or any other individual or entity.


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(e) Decommissioning. The Company does not have any material Liabilities with respect to decommissioning associated with any use of or equipment using radioactive materials.
 
(f) Reports and Records. The Company has delivered or made available to Parent all environmental audits and environmental assessments of any facility that is in the possession or control of the Company or any of its subsidiaries.
 
2.18 Brokers; Third Party Expenses. Except for fees payable to Credit Suisse Securities (USA) LLC pursuant to an engagement letter between the Company and Credit Suisse Securities (USA) LLC dated as of January 31, 2006, a correct and complete copy of which has been provided to Parent, neither the Company nor any of its subsidiaries or affiliates has incurred, nor will it incur, directly or indirectly, any Liability for brokerage or finders fees or agent’s commissions or any similar charges in connection with this Agreement or the Transactions, and Parent will not incur any such Liability, either directly or indirectly, as a result of this Agreement or the Merger as a result of any Contract entered by the Company, any of its subsidiaries or affiliates or any of their respective directors, officers, employees, stockholders or agents. An itemized good faith estimate as of the date of this Agreement of the fees and expenses that may be payable to any investment banker, broker, advisor or similar party, and any accountant, legal counsel or other person retained by the Company in connection with this Agreement or the Transactions contemplated hereby, including the expenses of investment bank referenced above, is set forth on Section 2.18 of the Company Disclosure Letter, including a list of all Contracts with such persons that involve the payment by the Company or any of its subsidiaries of fees that are based on anything other than “time and materials” (which shall include a summary of the terms under which such fees are earned and become payable).
 
2.19 Intellectual Property.
 
(a) Definitions. For all purposes of this Agreement, the following terms shall have the following respective meanings:
 
Company Intellectual Property” shall mean (i) any and all Company-Owned Intellectual Property and/or (ii) any and all Company-Controlled Intellectual Property used or otherwise exploited by the Company or any of its subsidiaries in the Conduct of the Business of the Company, including in either of the foregoing (i) or (ii) any Intellectual Property covering anti-IgE products.
 
For purposes of this Section 2.19 and Section 2.20, “Conduct of the Business of the Company” shall mean (i) the conduct of the Company Research Programs and/or (ii) the research, discovery, development, manufacture or use of Company Products and/or (iii) the grant of license rights (including any option or other contingent right to obtain such rights) under Intellectual Property to third persons, in the case of clauses (i) and (ii), (a) as conducted on or before the date of this Agreement and/or (b) as conducted during from the date hereof to immediately prior to the Closing.
 
Company-Controlled Intellectual Property” shall mean any and all Intellectual Property to which the Company or any of its subsidiaries has valid rights granted by a third person to use or otherwise exploit for the application(s) for which such Intellectual Property is used or otherwise exploited in the Conduct of the Business of the Company, in each case other than Company-Owned Intellectual Property.
 
Company-Owned Intellectual Property” shall mean any and all Intellectual Property that is owned by the Company or any of its subsidiaries (whether solely or jointly with any third person).
 
Company Products” shall mean any and all products or service offerings of the Company or any of its subsidiaries that are the subject of the any of the following (whether by the Company or any of its subsidiaries or third person on behalf or under authority of or in cooperation with the Company or any of its subsidiaries) (A) an IND (as defined in 21 C.F.R. §312.3) filed with the United States FDA (or counterpart thereof filed with any ex-U.S. regulatory authority), or (B) other testing in human subjects in clinical studies anywhere in the world.


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Company Research Programs” shall mean any and all of the Company’s or its subsidiaries’ research programs ongoing immediately prior to the date of this Agreement in one or more specific therapeutic areas (i.e., immune-mediated diseases, infectious disease, inflammation and cancer) or one or more specific biological pathways or targets (regardless of whether the expected product is an agonist, antagonist or otherwise modulates the pathway or target which have been identified by Company to Parent (specifically, such programs that are related or directed to IL13, CD4, Tissue Factor, Factor D or Complement C5a)).
 
Company Registered Intellectual Property” shall mean all Registered Intellectual Property owned (in whole or part) by the Company or any of its subsidiaries.
 
Intellectual Property” shall mean any or all of the following and all rights (whether common law, statutory or otherwise) in, arising out of, or associated therewith existing anywhere in the world: (1) United States and foreign patents, inventor’s certificates and utility models (including any substitutions, extensions, confirmations, reissues, divisions, re-examinations, renewals and extensions thereof) and any and all applications (including any utility, continuation, divisional, substitution, continuations-in-part, provisional, reissue, or reexamination application) and registrations therefor, and equivalent or similar rights anywhere in the world in inventions and discoveries (“Patents”); (2) copyrights and any and all applications and registrations therefor; (3) domain names, uniform resource locators and other names and locators associated with the Internet, and any and all applications or registrations therefor (“Domain Names”); (4) trade names, logos, business symbols, trade dress, assumed names, fictitious names, corporate names, certification marks, collective marks, d/b/a’s, trademarks and service marks, (in each case together with any and all related goodwill) and any and all applications and registrations therefor (“Trademarks”); (5) all rights in databases and data collections; (6) all inventions (whether or not patentable), trade secrets, and other confidential information including technology, know how, data, processes, schematics, business methods, formulae, drawings, prototypes, models, designs, compositions of matter, techniques, improvements, methods (including manufacturing methods), clinical and regulatory strategies, formulations, manufacturing data and processes specifications, manuals, research and development/clinical proposals and customer and supplier lists and other industry information, and all documentation relating to any of the foregoing (“Trade Secrets and Confidential Information”), in each case to the extent recognized as intellectual property under applicable law.
 
IP Contracts” shall mean all Contracts to which the Company or any of its subsidiaries is a party and pursuant to which (1) Company-Owned Intellectual Property or Company-Controlled Intellectual Property is licensed (including by way of any sublicense, grant of an option or other future contingent right, covenant of non-assertion or covenant not to sue) or otherwise transferred (including as a result of assignment, novation or otherwise, provided that a non-disclosure or confidentiality agreement, without more, shall not be considered a “transfer”) to any third person, (2) any third person has licensed (including any sublicense) or otherwise transferred to the Company any rights under Intellectual Property used or otherwise exploited in the Conduct of the Business of the Company or (3) Company has an option or right to obtain a non-exclusive or exclusive license to or other transfer of Intellectual Property of a third person, or a third person has an option or right to obtain a non-exclusive or exclusive license to or other transfer of Company Intellectual Property.
 
Registered Intellectual Property” shall mean Intellectual Property that is duly registered with or issued by an appropriate Governmental Entity of which the rights conveyed by the registration or issuance are in effect as of the date hereof, and any application filed with an appropriate Governmental Entity for registration or issuance.
 
(b) Representations.
 
(i) Company Intellectual Property.
 
(1) Company Products and Company Research Programs. Section 2.19(b)(i)(1) of the Company Disclosure Letter contains a complete and accurate list of all Company Products and all Company Research Programs.


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(2) Company Registered Intellectual Property. 
 
a) Section 2.19(b)(i)(2) of the Company Disclosure Letter contains a complete and accurate list of all Company Registered Intellectual Property and lists, where applicable, (I) the jurisdictions in which each such item of Company Registered Intellectual Property has been issued or registered, or in which an application for registration or issuance is pending, (II) whether such Registered Intellectual Property is owned solely by Company or jointly with third persons, and (III) current actions for each Company Registered Intellectual Property that, to the knowledge of the Company, must be taken within ten (10) months after October 1, 2006 for the purposes of obtaining, maintaining, perfecting, preserving or renewing any Company Registered Intellectual Property to the maximum extent legally available, including the payment of any registration, maintenance, annuity or renewal fees, or the filing of any responses to formality requirements or office actions to avoid any derogation of rights under the Company Registered Intellectual Property, including preserving maximal patent term adjustment rights.
 
b) Section 2.19(b)(i)(2) of the Company Disclosure Letter contains a complete and accurate list by jurisdiction of any litigation, opposition, reexamination, interference proceeding, nullity action, reissue proceeding, cancellation, objection, claim or other equivalent proceeding or action pending, asserted or threatened against the Company or its subsidiaries with respect to the ownership, validity, registerability, enforceability, infringement or use of, or right to license, any Company Registered Intellectual Property. To the knowledge of the Company, no valid basis for any such litigation, opposition, reexamination, interference proceeding, nullity action, reissue proceeding, cancellation, objection, claim or other equivalent proceeding or action exists.
 
(3) IP Contracts. Neither the Company nor any of its subsidiaries is a party to or is bound by any IP Contracts that meet any of the following descriptions, except to the extent those IP Contracts are listed in Section 2.19(b)(i)(3) of the Company Disclosure Letter and are identified thereon using the categories below, in each case listing (i) the person(s) with whom such IP Contract is made, (ii) the date thereof, and (iii) the Company Product or Company Research Program to which such IP Contract applies, if applicable:
 
a) material transfer agreements under which the Company or any of its subsidiaries has received or has a right to receive information or materials related to actual or potential pharmaceutical products, biological pathways, disease states, research tools, or other scientific or medical information;
 
b) pursuant to which the Company or any of its subsidiaries has granted a third person the right to practice any Company Intellectual Property, except for rights to conduct internal research for a limited period of time or rights under a material transfer agreement where the Company owns any resulting inventions or intellectual property;
 
c) pursuant to which the Company or any of its subsidiaries has obtained any Intellectual Property (or has obtained any option to obtain any Intellectual Property or license thereto) required or used for research, discovery, development, manufacture, use, import, sale, offer for sale or other exploitation of any Company Product or for engaging in any Company Research Program;
 
d) pursuant to which the Company or any of its subsidiaries has granted any exclusive rights (or an option to obtain exclusive rights) to any third person under any Company Intellectual Property;
 
e) pursuant to which the Company or any of its subsidiaries is engaging in scientific research or other activities that are likely to create Intellectual Property, where that Intellectual Property is not solely owned by the Company or any of its subsidiaries, except


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where the research or other activities have been completed and, to the knowledge of the Company, no Intellectual Property was created;
 
f) pursuant to which the Company or any of its subsidiaries is obligated to pay any royalty, milestones, or other similar payments, including but not limited to profit sharing, manufacturing or similar payments (i) that are contingent on the occurrence of future events or (ii) that vary with the amount of any Company Product produced, sold or otherwise exploited;
 
g) pursuant to which a third person is obligated to pay to the Company or any of its subsidiaries any royalty, milestones, or make any other payments that are contingent on the occurrence of future events or that vary with the amount of product produced, sold or otherwise exploited (including sharing of profits).
 
In addition, Section 2.19(b)(i)(3) of the Company Disclosure Letter contains the Company’s and its subsidiaries’ current forms of the following (where “current” includes any of the following used by the Company or any of its subsidiaries during the 12-month period prior to the date of this Agreement): employment agreement, nondisclosure agreement, assignment of invention agreement or similar Contracts relating to the protection, ownership, development, use or transfer of Company Intellectual Property (collectively, “IPR Form Agreements”).
 
(ii) Validity. To the knowledge of the Company, the Company has materially complied with all the requirements of each applicable Governmental Entity (including the United States Patent and Trademark Office and foreign counterparts thereof) with respect to the filing and prosecution of the Company Registered Intellectual Property, including timely payment of all required fees and filing of all documents, recordations and certificates to such Governmental Entity. Neither the Company nor any of its subsidiaries has received written notice from a third person of or has obtained an opinion of counsel addressing and the Company has no knowledge of any (i) prior art or prior public uses, sales, offers for sale or disclosures which would invalidate any Company Registered Intellectual Property (in whole or in part) or (ii) conduct the result of which would render the Company Registered Intellectual Property (in whole or in part) invalid or unenforceable.
 
(iii) Ownership.
 
(1) To the knowledge of the Company no Company Intellectual Property, Company Research Program or Company Product is subject to, and the Company and its subsidiaries are not a party to, any proceeding or outstanding decree, order, judgment or settlement agreement or stipulation that (i) restricts or may restrict in any manner the use, transfer or licensing thereof by the Company or any of its subsidiaries or may adversely affect the validity, use or enforceability of such Company Intellectual Property, or (ii) restricts or may restrict the Conduct of the Business of the Company in order to accommodate Intellectual Property rights of any third person.
 
(2) To the knowledge of the Company (I) all Company-Owned Intellectual Property is fully transferable, alienable or licensable by Surviving Corporation without restriction and without payment of any kind to any person and (II) except as otherwise set forth in the respective IP Contract, all of the Company’s rights in Company-Controlled Intellectual Property are fully transferable, alienable or licensable by Surviving Corporation without restriction and without payment of any kind to any person.
 
(3) To the knowledge of the Company, the Company or its subsidiaries owns, and has good and exclusive title to, each item of Company-Owned Intellectual Property free and clear of any Encumbrance, except for any Encumbrance which would not reasonably be expected to have a material negative impact on (A) the Conduct of the Business of the Company, (B) the value or use of any material Company Intellectual Property or (C) the sale, offer for sale, importation or other commercial exploitation of any Company Product anywhere in the world. Without limiting the


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foregoing, to the knowledge of the Company: (i) the Company or a subsidiary of the Company is the exclusive owner of all registrations obtained by the Company for Trademarks that are used to designate the source or origin of the Company Products; and (ii) the Company or a subsidiary of the Company owns exclusively, and has good title to, or has the right to use, all copyrighted works that are embodied in any Company Product.
 
(4) To the knowledge of the Company, no person other than the Company or its subsidiaries has ownership rights or license rights granted by the Company or its subsidiaries to improvements made by or for the Company or its subsidiaries to any Company Intellectual Property, Company Product, or subject of any Company Research Program.
 
(5) To the knowledge of the Company, except where Patents claiming or covering the composition of matter of any pharmaceutically or biologically active ingredient incorporated into any Company Product is licensed or acquired from a third person, the Company or its subsidiaries has filed applications for one or more Patents claiming or covering patentable compositions of matter, in each case with respect to Company Products that are as of the date of this Agreement, the subject of an IND (or equivalent), or the subject of a clinical trial or other study involving human subjects.
 
(6) To the knowledge of the Company, within the twelve (12) months immediately prior to the date hereof, neither the Company nor any of its subsidiaries has (i) transferred ownership of, or granted any exclusive license of or exclusive right to use, Company Intellectual Property, to any third person, or (ii) permitted the Company’s rights in any Company Intellectual Property to lapse or enter the public domain, except to the extent such failure would not adversely affect the Conduct of the Business of the Company.
 
(7) To the knowledge of the Company, in each case in which the Company or any of its subsidiaries has acquired sole ownership of any Intellectual Property from any person, the Company or such subsidiary has obtained a valid and enforceable assignment sufficient to irrevocably transfer all rights in and to all such Intellectual Property and the associated rights therein (including the right to seek future damages with respect thereto) and has recorded each assignment of Registered Intellectual Property assigned to the Company or such subsidiary with the relevant Governmental Entity.
 
(8) To the knowledge of the Company, no employee, independent contractor or agent of the Company or any of its subsidiaries, past or present, is in material default or breach of any term relating to the protection, ownership, development, use or transfer of Company-Owned Intellectual Property in any Employment Agreement, nondisclosure agreement, assignment of invention agreement or similar Contracts. To the knowledge of the Company, all employees of, consultants to or vendors of the Company or any of its subsidiaries with permitted access to Trade Secrets and Confidential Information of the Company or any of its subsidiaries that are used in Conduct of the Business of the Company are a party to written Contracts under which, among other things, each such employee, consultant or vendor is obligated to maintain the confidentiality of such Trade Secrets and Confidential Information and, in the case of employees and consultants of the Company or any of its subsidiaries, assign to the Company or its subsidiary all Intellectual Property created by such employee or consultant in the scope of employment or consultancy with the Company or its subsidiaries. To the knowledge of the Company, none of the Company’s nor its subsidiaries’ current employees is the owner of any Patent for any device, process, design or invention of any kind that is now used or needed by the Company or any of its subsidiaries in the Conduct of the Business of the Company and was conceived during the course of his or her employment with the Company, which Patent has not been assigned or licensed to the Company or its subsidiary. To the knowledge of the Company, all Company-Owned Intellectual Property developed under Contract to the Company or its subsidiaries have been assigned to the Company or its subsidiary or are contractually obligated to be assigned. To the knowledge of the Company,


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the Company’s and its subsidiaries’ employees’ performance of their employment activities does not violate such employees’ contractual obligations to any third person.
 
(iv) Non-Infringement. 
 
(1) Neither the Company nor its subsidiaries has received a written notice from any third person alleging, or an opinion of counsel directed to, and the Company has no knowledge that, the Conduct of the Business of the Company or the manufacture, use, sale, offer for sale importation or other commercial exploitation, if occurring as of the date hereof, of any Company Product in its current form, infringes, without reference to any research or development exemption therefrom or misappropriates any Intellectual Property of any third person or constitutes unfair competition or trade practices under the laws of any jurisdiction.
 
(2) To the knowledge of the Company, all Intellectual Property incorporated into or embodied in any Company Product was developed solely by either (A) employees of the Company acting within the scope of their employment or (B) by third persons who have licensed to the Company or validly assigned or are under an obligation to assign all of their rights in or to such Intellectual Property to the Company. To the extent any such Intellectual Property comprises Company Registered Intellectual Property, the Company or its subsidiaries, to the knowledge of the Company, has recorded each such assignment with the relevant Governmental Entity.
 
(3) Neither the Company nor any of its subsidiaries have entered into any Contract that may require it to reimburse, defend, hold harmless or indemnify any third person with respect to Liabilities arising out of the infringement or misappropriation of any Intellectual Property, except to the extent those Contracts are listed in Section 2.19(b)(iv)(3) of the Company Disclosure Letter.
 
(v) IP Contracts.
 
(1) To the knowledge of the Company, all of the IP Contracts listed in Section 2.19(b)(i)(3) of the Company Disclosure Letter are in full force and effect.
 
(2) To the knowledge of the Company, the consummation of the transactions contemplated by this Agreement will neither violate nor result in the breach, modification, cancellation, termination or suspension of any IP Contract. Following the Effective Time, Surviving Corporation will be permitted to exercise all of the Company’s rights under all IP Contracts (including, without limitation, the right to receive royalties), to the same extent the Company would have been able to had the transactions contemplated by this Agreement not occurred and without being required to pay any additional amounts or consideration other than fees, royalties or payments which the Company would otherwise be required to pay had such transactions contemplated hereby not occurred.
 
(3) Neither this Agreement nor the transactions contemplated by this Agreement, will result in (A) Surviving Corporation granting to any third person any right in any Intellectual Property, or (B) Surviving Corporation being obligated to pay any royalties or other amounts to any third person in excess of those payable by Company prior to the Closing.
 
(vi) Sufficiency of Intellectual Property. To the knowledge of the Company as of the date hereof, the Company Intellectual Property constitutes (A) the Intellectual Property that is currently used or otherwise exploited by the Company in the Conduct of the Business of the Company and (B) the Intellectual Property that would be necessary for the manufacture, use, sale, offer for sale, importation or other commercial exploitation of any Company Product in its current form, if such manufacture, use, sale, offer for sale, importation or other commercial exploitation were occurring as of the date hereof.
 
(vii) Government Rights. To the knowledge of the Company, no government funding, facilities of a university, college, other educational institution or research center or funding from third persons was used in the development of any Company-Owned Intellectual Property that is material to the Conduct


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of the Business of the Company and would result in any march-in rights, ownership rights or any future obligation by the Company to make any payment or grant any license.
 
(viii) Third-Party Infringement. To the knowledge of the Company, no person has infringed or misappropriated, or is infringing or misappropriating, any Company-Owned Intellectual Property in a manner that would be expected to adversely affect the Conduct of the Business of the Company or the sale, offer for sale, importation or other commercial exploitation of any Company Product.
 
(ix) Trade Secret Protection. To the knowledge of the Company, the Company and its subsidiaries have taken all reasonable and customary steps to protect the rights of the Company and its subsidiaries in their Trade Secrets and Confidential Information, and any Trade Secrets and Confidential Information of third persons provided to the Company under an obligation of confidentiality.
 
(x) Maintenance of Invention Materials. To the knowledge of the Company, the Company and its subsidiaries have maintained and secured (or cause to be maintained and secured) all documentation and other materials (including signed, dated and witnessed laboratory notebooks) necessary or appropriate to establish conception, reduction to practice or other matters of inventorship (including timing thereof) or ownership with respect to Company-Owned Intellectual Property in accordance with practices standard and customary in the biopharmaceutical industry.
 
2.20 Contracts.
 
(a) Except for Contracts between the Company or its subsidiaries on the one hand and Parent or a subsidiary of Parent on the other hand, neither the Company nor any of its subsidiaries is a party to or is bound by any of the following Contracts as of the date of this Agreement, except to the extent those Contracts are listed in Section 2.20(a) of the Company Disclosure Letter and are identified thereon using the numbering below, in each case listing (i) the person(s) with whom such Contract is made and (ii) the date thereof:
 
(i) any employment or consulting Contract with any officer or director, or any Employee (excluding offer letters for “at-will” Employees) or any other type of Contract (whether or not such Contract is an Employment Agreement, as defined in Section 2.13(a)(vi)) with any Employee that is not terminable within thirty (30) days by the Company without Liability to the Company or Parent, including any Contract requiring it to make or accelerate a payment to any Employee on account of the Merger, any Transaction or any Contract that is entered into in connection with this Agreement;
 
(ii) any Contract or plan, including any stock option plan, stock appreciation right plan or stock purchase plan (A) relating to the sale, issuance, grant, exercise, award, purchase, repurchase or redemption of any shares of Company Common Stock or any other securities of the Company or any of its subsidiaries or any options, warrants, convertible notes or other rights to purchase or otherwise acquire any such shares of stock, other securities or options, warrants or other rights therefor, except for the Company Stock Plans, or (B) any of the benefits of which will be increased, or the vesting of benefits of which will be accelerated, by the occurrence of any of the Transactions or the value of any of the benefits of which will be calculated on the basis of any of the Transactions;
 
(iii) any Contract requiring the Company to engage in ongoing research or development, which obligations extend beyond January 1, 2007 and are not terminable by the Company (with or without penalty) on less than ninety (90) days prior notice;
 
(iv) any Contract (whether non-compete or otherwise) containing provisions which have or would reasonably be expected to have the effect of prohibiting or impairing any business practice of the Company or any of its subsidiaries (including engaging in research and development or the development or commercialization of any Company Product), any acquisition of property (tangible or intangible) by the Company or any of its subsidiaries, any other conduct of business by the Company or any of its subsidiaries, or otherwise limiting the freedom of the Company or any of its subsidiaries to engage in any line of business in any geographical area or to compete with any person. Without


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limiting the generality of the foregoing, neither the Company nor any of its subsidiaries has entered into any Contract under which the Company or any of its subsidiaries is prohibited or impaired from engaging in any areas of research or development or from the licensing, manufacturing, selling or distributing any Company Intellectual Property or exploiting any Technology of the Company;
 
(v) any Contract under which the Company has granted or is obligated to grant any person any “opt-in” rights, exclusive rights, rights of refusal or similar rights;
 
(vi) any Contract under which the Company is obliged to enter into any further agreement or license, under which the Company is obligated to accept or use manufacturing (including cell culture, bulk manufacturing or fill and finish) capacity or to pay for manufacturing capacity not used or accepted, or under which the Company has any material “take or pay” commitment;
 
(vii) any Contract relating to the disposition by the Company or any of its subsidiaries of a material amount of assets not in the ordinary course of business, or pursuant to which the Company or its subsidiaries has acquired a business or entity, or material assets of a person (other than purchases in the ordinary course of business that are customarily effected on a purchase order basis), whether by way of merger, consolidation, purchase of stock, purchase of assets, exclusive license or otherwise, or any Contract pursuant to which the Company or any of its subsidiaries has any material ownership interest in any person other than the Company’s subsidiaries;
 
(viii) any Contract currently in force under which the Company or any of its subsidiaries has continuing obligations to provide to a third person information about any Company Research Program or any other scientific or clinical data produced by the Company, including research, characterization, manufacturing, clinical, pre-clinical or other information and including information regarding the Company’s planned research and development activities;
 
(ix) any joint venture Contract, collaboration Contract or any other Contract that involves a sharing of revenues, profits, cash flows, expenses (including development expenses) or losses with other persons;
 
(x) any Contract requiring the Company or any of its subsidiaries to undertake a clinical trial (or to have a third person undertake a clinical trial on the Company’s or its subsidiaries’ behalf) of an existing Company Product or the subject of a Company Research Program;
 
(xi) any Contract that authorizes any third person to sell, offer for sale, market or otherwise distribute any Company Products or results of any Company Research Programs;
 
(xii) any mortgages, indentures, guarantees, promissory notes, loans or credit agreements, security Contracts or other Contracts or instruments relating to the borrowing of money or extension of credit, or any currency exchange, commodities or other hedging arrangement or any leasing transaction of the type required to be capitalized in accordance with GAAP;
 
(xiii) any settlement or litigation “standstill” Contract;
 
(xiv) any Contract of guarantee, support, assumption or endorsement of, or any similar commitment with respect to, the obligations, liabilities (whether accrued, absolute, contingent or otherwise) or indebtedness of any other person;
 
(xv) any Contract (including open purchase orders) under which the Company has a commitment to purchase goods, capital equipment, services or other items in excess of $50,000 for any Contract or series of Contracts;
 
(xvi) any Contract (i) pursuant to which any third person is required to make payments to the Company in excess of $20,000 per annum, (ii) pursuant to which the Company or any of its subsidiaries is obligated to pay any royalty or similar payments, including but not limited to profit sharing or similar payments, or (iii) pursuant to which the Company or any of its subsidiaries is obligated to pay any milestone payment or similar payment, including any payment of a


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pre-determined amount in excess of $100,000, which payment is contingent on the occurrence of a future event, but excluding any fee-for-service Contract;
 
(xvii) any Contract pursuant to which the Company or any of its subsidiaries is a lessor or lessee of any equipment or other fixed assets, including machinery, equipment, motor vehicles, office furniture, fixtures or other personal property involving payments in excess of $20,000 per annum or involving any manufacturing equipment with a value in excess of $10,000;
 
(xviii) any Contract with any person with whom the Company or any of its subsidiaries does not deal at arm’s length;
 
(xix) any Contract with any investment banker, broker, advisor or similar party, or any accountant, legal counsel or other person retained by the Company, in connection with this Agreement and the Transactions;
 
(xx) any Contract with any Governmental Entity (a “Government Contract”) or any material federal, state, county, local or foreign governmental consent, license, permit, grant, or other authorization of a Governmental Entity (excluding Company Permits) that is required for the operation in all material respects of the Company’s or any of its subsidiaries’ businesses;
 
(xxi) any Contract entitling a third person (other than an Employee) to a commission or “finder’s fee” payable by the Company or any of its subsidiaries; or
 
(xxii) any Contract not otherwise disclosed in Section 2.20 of the Company Disclosure Letter (i) under which the consequences of a default could reasonably be expected to be material to the Company, (ii) that is of the nature required to be filed by Company as an exhibit to an Annual Report on Form 10-K under the Exchange Act; (iii) involving in excess of $100,000 being paid by or to the Company over the term thereof, or (iv) that is otherwise material to the Company or any of its subsidiaries or their respective businesses, operations, properties, assets, financial condition, results of operations or cash flows; any such Contract listed or required to be listed in Section 2.19(b)(iii) or Section 2.20(a) of the Company Disclosure Letter being a “Company Contract”.
 
(b) Neither the Company nor any of its subsidiaries, nor, to the Company’s knowledge, any other person that is a party to a Company Contract, is in breach, violation or default under, and neither the Company nor any of its subsidiaries has received notice that it has breached, violated or defaulted under, any of the material terms or conditions of any Company Contract. The Company or the applicable Company subsidiary is entitled to all benefits under any Company Contract. Each of the Company Contracts is in full force and effect, and has not been amended in any material respect, except to the extent that such amendment is described in Section 2.20(a) of the Company Disclosure Letter. Except as noted in Section 2.20(b), the Company has delivered or made available to Parent or its representatives true, correct and complete copies of each of the Company Contracts required to be listed in Section 2.20(a) of the Company Disclosure Letter; provided that, to the extent that third party confidentiality restrictions expressly prohibit disclosure of such Company Contract to Parent, Section 2.20(b) of the Company Disclosure Letter sets forth a description of the subject matter of each such Company Contract and a general indication of the nature of the rights and obligations granted thereunder. The Company is not a party to any Government Contract (other than Company Permits).
 
2.21 Product Liability. The Company has made available to Parent a true and correct list of all serious adverse events reported to the Company in connection with clinical trials of any Company Product (other than Xolair). The Company has never made payments in respect of a product liability matter that relates to the administration of substances to humans. There is no current product liability claim made against the Company or its subsidiaries.
 
2.22 Insurance. Section 2.22 of the Company Disclosure Letter lists all insurance policies (including fire and casualty, general liability, director & officer liability, business interruption, product liability and sprinkler and water damage insurance policies) and/or fidelity bonds covering the assets, business, equipment, properties,


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operations, and Employees of the Company (collectively, the “Insurance Policies”) and includes for each such Insurance Policy, the amount of the annual premium and the maximum coverage amounts per incident and per year. The Company and each of its subsidiaries have made available to Parent true, correct and complete copies of all Insurance Policies. There is no claim by the Company or any of its subsidiaries pending under any of the Insurance Policies as to which coverage has been questioned, denied or disputed by the underwriters of such policies or bonds. All premiums due and payable under all such Insurance Policies have been paid, and the Company and each of its subsidiaries, as the case may be, is otherwise in material compliance with the terms of such Insurance Policies. The Company has not made any untrue statement about itself or its business in any application for insurance. All Insurance Policies remain in full force and effect, and neither the Company nor any of its subsidiaries has knowledge of any threatened termination of, or premium increase with respect to, any such Insurance Policies.
 
2.23 Opinion of Financial Advisor. The Board has received the opinion of Credit Suisse Securities (USA) LLC, to the effect that, as of the date of this Agreement, the Per Share Merger Consideration is fair, from a financial point of view, to the stockholders of Company Common Stock. A copy of the written opinion delivered by Credit Suisse Securities (USA) LLC shall be delivered to Parent following the signing of this Agreement.
 
2.24 Board Approval. The full Board, by resolutions duly adopted (and not thereafter modified or rescinded) as of the date of this Agreement, has unanimously (a) approved this Agreement and the Merger and determined that this Agreement and the Merger are advisable and fair to, and in the best interests of, the Company and its stockholders, (b) approved, subject to stockholder approval of this Agreement, the Transactions, and (c) directed that adoption of this Agreement be submitted to the Company stockholders for consideration and recommended that the stockholders of the Company adopt this Agreement.
 
2.25 Rights Agreement. The Company has taken all action so that (i) Parent shall not be an “Acquiring Person” under the Rights Agreement for so long as this Agreement is in effect and (ii) the entering into of this Agreement and the Merger and the other transactions contemplated hereby will not result in the grant of any rights to any person under the Rights Agreement or enable or require the Rights (as defined therein) to be exercised, distributed or triggered as a result thereof. The Rights Agreement shall terminate in accordance with its terms and be of no further force or effect at the Effective Time.
 
2.26 State Takeover Statutes. The Board has approved the Merger, this Agreement and the Company Voting Agreements and taken all actions sufficient to render inapplicable to the Merger, the execution, delivery and performance of this Agreement and the Company Voting Agreements and the Transactions and the transactions contemplated by the Company Voting Agreements, the provisions of Section 203 of Delaware Law applicable to a “business combination” (as defined in such Section 203). No other state takeover statute or similar statute or regulation or anti-takeover provision in the Company Charter Documents applies to, purports to apply or at the Effective Time will be applicable to the Merger, this Agreement and the Company Voting Agreements or the Transactions and the transactions contemplated by the Company Voting Agreements.
 
2.27 Interested Party Transactions. Except as set forth in the Company SEC Reports, since the date of the Company’s last proxy statement filed with the SEC, no event has occurred that would be required to be reported by the Company pursuant to Item 404 of Regulation S-K promulgated by the SEC. Section 2.27 of the Company Disclosure Letter identifies each person who is an “affiliate” (as that term is used in Rule 145 promulgated under the Securities Act) of the Company as of the date hereof.


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ARTICLE III
REPRESENTATIONS AND WARRANTIES OF PARENT
AND MERGER SUB
 
Parent and Merger Sub hereby jointly and severally represent and warrant to the Company, as follows:
 
3.1 Corporate Organization. Each of Parent and Merger Sub is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has the requisite corporate power and authority and all necessary governmental approvals to own, lease and operate its properties and to carry on its business as it is now being conducted, except where the failure to be so organized, existing or in good standing or to have such power, authority and governmental approvals would not prevent or materially delay consummation of the Transactions, or otherwise prevent Parent or Merger Sub from performing their respective material obligations under this Agreement.
 
3.2 Authority Relative to this Agreement. Each of Parent and Merger Sub has all necessary corporate power and authority to execute and deliver this Agreement, and to perform its obligations hereunder and to consummate the Transactions. The execution and delivery of this Agreement by Parent and Merger Sub and the consummation by Parent and Merger Sub of the Transactions have been duly and validly authorized by all necessary corporate action on the part of Parent and Merger Sub, and no other corporate proceedings on the part of Parent or Merger Sub are necessary to authorize this Agreement, or to consummate the Transactions (other than, with respect to the Merger, the filing of the Certificate of Merger as required by Delaware Law). This Agreement has been duly and validly executed and delivered by Parent and Merger Sub and, assuming the due authorization, execution and delivery by the Company, constitutes a legal and binding obligation of Parent and Merger Sub, enforceable against Parent and Merger Sub in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, moratorium, reorganization or similar Legal Requirements affecting the rights of creditors generally and the availability of equitable remedies (regardless of whether such enforceability is considered in a proceeding in equity or at law).
 
3.3 No Conflict; Required Filings and Consents. 
 
(a) The execution and delivery of this Agreement by Parent and Merger Sub does not, and the performance of this Agreement by Parent and Merger Sub will not, (i) conflict with or violate the Parent’s or Merger Sub’s Certificate of Incorporation or Bylaws, each as amended to date, (ii) subject to compliance with the requirements set forth in Section 3.3(b) hereof, conflict with or violate any Legal Requirements applicable to Parent, or (iii) conflict with or violate, result in any breach of or constitute a default (or an event that with notice or lapse of time or both would become a default) under, or impair Parent’s rights under, or give to others any rights of termination, amendment, acceleration or cancellation of, or result in the creation of a Encumbrance on any of the properties or assets of Parent pursuant to any Contract to which Parent is a party or by which Parent or its properties are bound or affected, except to the extent such conflict, violation, breach, default, impairment or other effect could not in the case of clause (ii) or (iii) individually or in the aggregate, prevent or materially delay consummation of the Transactions or otherwise prevent Parent or Merger Sub from performing their respective material obligations under this Agreement.
 
(b) The execution and delivery of this Agreement by Parent and Merger Sub does not, and the performance of this Agreement by Parent and Merger Sub shall not, require any consent, approval, authorization or permit of, or filing with or notification to, any Governmental Entity except (i) for applicable requirements, if any, of the Exchange Act, Blue Sky Laws and state takeover laws, the pre-merger notification requirements under the HSR Act and of foreign Governmental Entities, the rules and regulations of the NYSE, and the filing and recordation of the Certificate of Merger as required by Delaware Law and (ii) where the failure to obtain such consents, approvals, authorizations or permits, or to make such filings or notifications, could not, individually or in the aggregate, prevent or materially delay consummation of the Transactions or otherwise prevent Parent or Merger Sub from performing their respective material obligations under this Agreement.


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3.4 Proxy Statement. The information supplied by Parent and Merger Sub for inclusion in the Proxy Statement shall not, at the date the Proxy Statement (or any amendment or supplement thereto) is first mailed to stockholders of the Company, at the time of the Stockholders’ Meeting or at the Effective Time, contain any untrue statement of a material fact, or omit to state any material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not false or misleading, or necessary to correct any statement in any earlier communication with respect to the solicitation of proxies for the Stockholders’ Meeting which shall have become false or misleading. Notwithstanding the foregoing, Parent and Merger Sub make no representation or warranty with respect to any information supplied by the Company or any of its representatives for inclusion in the Proxy Statement.
 
3.5 Sufficient Funds. Parent will have at the Effective Time sufficient cash or cash-equivalent funds to consummate the Transactions, including acquiring all of the outstanding shares of Company Common Stock in the Merger.
 
3.6 No Prior Merger Sub Operations. Merger Sub was formed solely for the purpose of effecting the Merger and has not engaged in any business activities or conducted any operations other than in connection with the transactions contemplated hereby.
 
ARTICLE IV
CONDUCT PRIOR TO THE EFFECTIVE TIME
 
4.1 Conduct of Business by Company. During the period from the date of this Agreement and continuing until the earlier of the termination of this Agreement pursuant to its terms or the Effective Time, the Company and each of its subsidiaries shall, except to the extent that Parent shall otherwise consent in writing or as otherwise required by this Agreement or by applicable Legal Requirements, (i) carry on its business in the ordinary course in substantially the same manner as heretofore conducted and in compliance with all applicable Legal Requirements, (ii) pay its Liabilities and Taxes when due in the ordinary course in substantially the same manner as heretofore conducted and in compliance with all applicable Legal Requirements, (iii) pay or perform other obligations when due, (iv) use all reasonable efforts to assure that each such Contract entered into after the date hereof will not require the procurement of any consent, waiver or novation or provide for any material change in the obligations of any party hereto in connection with, or terminate as a result of the consummation of, the Merger, and shall give reasonable advance notice to Parent prior to allowing any Company Contract, IP Contract or material right thereunder to lapse or terminate by its terms (it being understood that, after the date of this Agreement, the Company may only enter into an IP Contract if the entry into such IP Contract is not otherwise prohibited by this Section 4.1, including Section 4.1(f) below), (v) maintain each of its leased premises in accordance with the terms of the applicable lease in all material respects, (vi) use all reasonable efforts to maintain in good condition, consistent with standard industry practices, Company’s procedures and Good Laboratory Practices, Good Clinical Practices and Good Manufacturing Practices, any and all Product Inventory (as defined in Section 2.8) not used in the ordinary course of business for clinical trials or compassionate use, (vii) use all reasonable efforts to maintain in accordance with standard industry practices and the Company’s procedures and pursuant to Company Contracts in effect as of the date of this Agreement, any DNA, protein, expression product, cell line, reagent, know-how or other material that constitutes a Company Product or product candidate, or that is necessary to produce any Company Product or product candidate or perform research or clinical trials with regard to any product candidate being pursued as of the date of this Agreement; (ix) notify and give Parent the opportunity to participate in the defense or settlement of any litigation to which the Company is a party, and (x) use all reasonable efforts to (A) preserve intact its present business organization, (B) keep available the services of any Employees identified in writing by Parent to the Company as a “key employee”, and (C) preserve its relationships with customers, suppliers, distributors, consultants, licensors, licensees and others with which it has business dealings.


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In addition, without the prior written consent of Parent, except as required by this Agreement or Legal Requirements and except as disclosed in Section 4.1 of the Company Disclosure Letter, during the period from the date of this Agreement and continuing until the earlier of the termination of this Agreement pursuant to its terms or the Effective Time, the Company shall not do any of the following and shall not permit its subsidiaries to do any of the following:
 
(a) Waive any stock repurchase rights, accelerate, amend or change the period of exercisability or vesting of any Company Stock Options or other rights granted under any Company Stock Plan or the vesting of the securities purchased or purchasable under such Company Stock Options or other rights or the vesting schedule or repurchase rights applicable to any unvested shares;
 
(b) Amend or change any other terms of Company Stock Options or other rights granted under the Company Stock Plans;
 
(c) Authorize cash payments in exchange for any Company Stock Options or other rights granted under Company Stock Plans or the securities purchased or purchasable under those Company Stock Options or rights;
 
(d) Grant or pay, or enter into any Contract or amendment to an existing Contract providing for the granting of, any severance or termination pay (whether in cash, stock, equity securities, or property) or the acceleration of vesting or other benefits to any Employee, except pursuant to written agreements outstanding on the date hereof and as identified in Section 4.1(d) of the Company Disclosure Letter, or adopt any new severance or termination plan, program or arrangement, or amend or modify or alter in any manner any severance or termination plan or Contract existing on the date hereof (including any retention, change of control or similar agreement), or grant any equity-based compensation, whether payable in cash or stock;
 
(e) Transfer or make available to a third person any research materials or product candidates owned by the Company except, with respect only to materials and product candidates that are not Company Products or necessary for manufacturing or use of Company Products, Company may distribute such research materials or product candidates under a material transfer agreement on the form provided to Parent;
 
(f) (i) sell, lease, license or transfer any right in or to any Company Intellectual Property (including by way of option) or take any action or enter into any option that would have the same effect, or otherwise take actions which would reasonably be expected to materially impair the value of any Company Intellectual Property, (ii) modify or amend any IP Contract existing as of the date of this Agreement (including any financial provision thereof) or enter into any IP Contract with any person which would have been required to be included on any schedule set forth in Section 2.19 of the Company Disclosure Letter, (iii) purchase, license or otherwise acquire any rights to any Intellectual Property of a third person (including through exercise of any option) or (iv) exercise any option to obtain a license to the Intellectual Property of a third person to the extent the exercise of such option would create a future payment obligation or other Liability on the part of Parent after the Closing;
 
(g) Except for non-capital purchases in the ordinary course of business that are customarily effected on a purchase order basis, enter into any Contract or series of Contracts involving commitments by the Company and its subsidiaries in excess of $250,000 over the life of such Contract or series of Contracts;
 
(h) Enter into any Contract requiring the Company to provide to any person any Intellectual Property, Company Product or a product candidate being studied in a Company Research Program (in any form, including antibodies, proteins, fragments or drug substances);
 
(i) Conduct the Company’s business such that its operating cash expenditures (excluding capital expenditures permitted under Section 4.1(bb) and expenditures for toxicology studies) exceed $4.5 million on a monthly basis;
 
(j) Declare, set aside or pay any dividends on or make any other distributions (whether in cash, stock, equity securities or property) in respect of any capital stock or split, combine or reclassify any capital stock or issue or authorize the issuance of any other securities in respect of, in lieu of or in substitution for any capital stock;


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(k) Purchase, redeem or otherwise acquire, directly or indirectly, any shares of capital stock of the Company or its subsidiaries, except repurchases of unvested shares at or below cost in connection with the termination of the employment relationship with any Employee pursuant to stock option or purchase Contracts in effect on the date of this Agreement, provided that no such repurchase shall be permitted in the event the per share repurchase price is greater than the Per Share Merger Consideration;
 
(l) Issue, deliver, sell, purchase, authorize, grant or designate (including by certificate of designation) or pledge or otherwise encumber, or propose any of the foregoing with respect to any shares of capital stock or any securities convertible into shares of capital stock, or subscriptions, rights, warrants or options to acquire any shares of capital stock or any securities convertible into shares of capital stock, or enter into other Contracts of any character obligating it to issue any such shares or convertible securities, other than the issuance, delivery and/or sale of Company Common Stock pursuant to the exercise of Company Stock Options outstanding as of the date of this Agreement;
 
(m) Cause, permit or submit to a vote of the Company’s stockholders any amendments to the Company Charter Documents (or similar governing instruments of any of its subsidiaries);
 
(n) Acquire or agree to acquire by merging or consolidating with, or by purchasing any equity interest in or a portion of the assets of, or by any other manner, any person or division thereof, or otherwise acquire or agree to enter into any joint ventures, strategic partnerships or similar alliances;
 
(o)(i) Sell or otherwise dispose of any physical properties or physical assets, except in the ordinary course of business and at no less than the fair market value of such physical assets or physical properties, (ii) lease, license or encumber any Company-owned or controlled physical properties or physical assets, or (iii) enter into any Contract for the purchase or sale of any interest in real property, grant any security interest in any real property, enter into any lease, sublease, license or other occupancy Contract with respect to any real property or violate (in any material respect), alter, amend, modify, or terminate any of the terms of any Real Estate Leases;
 
(p) Make any loan, advance or capital contribution to or investment in any person, incur any indebtedness for borrowed money or guarantee any such indebtedness or the indebtedness of another person, issue or sell any debt securities or options, warrants, calls or other rights to acquire any debt securities of the Company, enter into any “keep well” or other Contract to maintain any financial statement condition, forgive or discharge in whole or in part any outstanding loans or advances, modify any loan previously granted, enter into any hedging agreement or other financial Contract designed to protect the Company or its subsidiaries against fluctuations in commodities prices or exchange rates, or enter into any arrangement having the economic effect of any of the foregoing;
 
(q)(i) Adopt, terminate or amend any Company Employee Plan or enter into any Company Employee Plan, or amend any compensation, bonus, commission, insurance coverage (except (A) as contemplated by this Agreement and (B) for any Company Employee Plan with a Consultant, which shall be governed by Section 4.1(t) and any other applicable provisions of this Section 4.1), benefit, entitlement, grant or award provided or made under any Company Employee Plan; (ii) enter into any employment Contract or collective bargaining agreement; (iii) pay any special bonus, commission or special remuneration to any Employee (cash, equity or otherwise); (iv) increase the salaries, bonuses, commissions or wage rates or fringe benefits (including rights to severance or indemnification) of its Employees; (v) pay any benefit not provided for as of the date of this Agreement under any Company Employee Plan (provided that nothing herein is intended to preclude the accrual of benefits under the terms of such Company Employee Plans in effect as of the date of this Agreement); or (vi) add any new members to the Board or any scientific or other advisory board; (v) pay any benefit not provided for as of the date of this Agreement under any Company Employee Plan; or (vi) add any new members to the Board;
 
(r) discuss, announce or otherwise disseminate information to the Company’s employees regarding any severance plan or practice of the Company, whether or not the terms of such plan or practice would be triggered by the Closing, except for announcements or other communications regarding such matters as are provided by Parent;


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(s) (i) Pay, discharge, settle or satisfy any Liabilities, other than the payment, discharge, settlement or satisfaction of Liabilities (I) recognized or disclosed in the most recent financial statements (or the notes thereto) of the Company included in the Company SEC Reports, (II) incurred since the date of the Interim Balance Sheet in the ordinary course of business consistent with past practices or (III) incurred since the date of the Interim Balance Sheet pursuant to and in accordance with Contracts in effect as of the date hereof or permitted to be entered into pursuant to this Section 4.1; provided, however, that the payment, discharge, settlement or satisfaction of any Liability relating to or arising out of any Action shall be governed by Section 4.1(z));
 
(t) (i) Enter into (unless otherwise permitted by this Section 4.1), modify or amend (unless such amendment, if it were a new Contract, would be otherwise permitted by this Section 4.1), or terminate any Contract (including an IP Contract) of a nature required to be listed as a Company Contract in Section 2.19 or Section 2.20 of the Company Disclosure Letter or waive, delay the exercise of, release or assign any material rights or claims thereunder or knowingly fail to enforce any Company Contract (including the confidentiality or nondisclosure provisions of any such Company Contract), or (ii) enter into or amend any Contract pursuant to which any other person is granted exclusive rights or “most favored party” rights of any type or scope with respect to any Company Research Programs, Company Products or Company Intellectual Property or containing any non-competition covenants or other material restrictions relating to the Company’s, any of its subsidiaries or Parent’s business activities or the effect of which would be to grant to a third person following the Merger the actual or potential right to license any Intellectual Property owned by Parent or its subsidiaries or otherwise would have the effect of prohibiting or impairing any business practice of the Company, any of its subsidiaries or Parent or limiting the freedom of the Company, any of its subsidiaries or Parent to engage in any line of business or to compete with any person or in any market or geography;
 
(u) Except as required by GAAP or SEC rules and regulations as concurred with by its independent auditors and after notice to Parent, revalue any of its assets or make any change in accounting methods, principles or practices;
 
(v) (i) Enter into or materially modify any Contract relating to the distribution, sale, license, manufacture or marketing by third persons of the Company Products or any subject or product of a Company Research Program; or (ii) renew any Contract relating to the distribution, sale, license, manufacture or marketing by third persons of the Company Products or any subject or product of a Company Research Program, except to the extent that such renewals are on terms substantially similar to the terms of such Contracts in effect as of the date hereof;
 
(w) Make or change any material Tax election or accounting method, enter into any Tax sharing or similar agreement or closing agreement, settle or compromise any material Tax Liability or consent to any extension or waiver of any limitation period with respect to Taxes;
 
(x) (i) hire any officers or employees or enter into, or amend or extend the term of, any Employment Agreement with any officer or employee (except that, in the event an employee is terminated pursuant to clause (ii) hereof or voluntarily terminates, including by death or disability, his or her employment, a replacement may be engaged to fill such terminated employee’s position, provided (A) any consideration payable for services rendered by such replacement is of a kind and amount not otherwise prohibited by this Section 4.1 and substantially similar in kind and amount to the consideration paid for such terminated employee, and (B) any arrangement with any such replacement shall be terminable, at the sole option of Parent, without payment or penalty at the Effective Time, other than payment as may be required by applicable Legal Requirements or the Company’s employee handbook), (ii) terminate any Employee (other than Consultants who are not Significant Consultants) identified in writing by Parent to the Company as a “key employee” (except for termination for cause), or take any action that would allow any employee to claim a constructive termination or termination for “good reason”; or (iii) hire any consultants or independent contractors or enter into, or amend or extend the term of, any consulting Contract with any consultant or independent contractor unless any such Contract is on customary terms and rates and is either (A) scheduled to be completed within 90 days after the date of this Agreement or (B) terminable at the sole option of Parent, without payment or penalty at the Effective Time;


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(y) Make any individual or series of related payments outside of the ordinary course of business (including payments to legal, accounting or other professional service advisors) in excess of $100,000 in the aggregate, other than (i) pursuant to Contracts existing on the date hereof and made available to Parent prior to the date hereof and (ii) payment to legal counsel and other advisers as set forth in Section 2.18 of the Company Disclosure Letter;
 
(z) Commence or settle any threatened or pending Action (including material litigation or any other material disputes), whether or not commenced prior to the date of this Agreement;
 
(aa) Adopt, implement or amend any stockholder rights plan (including the Rights Agreement), “poison pill” anti-takeover plan or other similar plan, device or arrangement that, in each case, is applicable to Parent or any of its affiliates or the transactions contemplated by this Agreement;
 
(bb) Make any capital expenditures, capital additions, capital improvements or other expenditures in excess of $200,000 in the aggregate;
 
(cc) Materially change the amount of any insurance coverage;
 
(dd) Fail to timely file any of the forms, reports or documents required to be filed with the SEC;
 
(ee) Enter into any Contract or transaction in which any officer, director or Employee of the Company or any of its subsidiaries (or, to the knowledge of the Company, any member of their families) has an interest under circumstances that, if entered immediately prior to the date of this Agreement, would require that such Contract be listed on Section 2.20(a) of the Company Disclosure Letter; or
 
(ff) Agree to take any of the actions described in Section 4.1(a) through Section 4.1(ee).
 
ARTICLE V
ADDITIONAL AGREEMENTS
 
5.1 Proxy Statement.
 
(a) As promptly as practicable after the execution of this Agreement, the Company shall prepare, and file with the SEC, preliminary proxy materials relating to the Company Stockholder Approval; provided that the parties acknowledge that the parties’ goal is that the Company file the Proxy Statement within 15 days after execution of this Agreement and that if the Company does not file the Proxy Statement within such period, the Company’s senior executives shall discuss the reasons for the failure to meet such goals with Parent’s duly appointed representatives. Parent shall provide promptly to the Company such information concerning Parent as, in the reasonable judgment of Parent or its counsel, may be required or appropriate for inclusion in the Proxy Statement, or in any amendments or supplements thereto. At the earliest practicable time following the later of (i) receipt and resolution of SEC comments thereon, or (ii) the expiration of the 10-day waiting period provided in Rule 14a-6(a) promulgated under the Exchange Act, the Company shall file definitive proxy materials with the SEC and cause the Proxy Statement to be mailed to its stockholders. The Company will cause the Proxy Statement to comply with all applicable Legal Requirements. Prior to filing the preliminary proxy materials, definitive proxy materials or any other filing with the SEC or any other Governmental Entity, the Company shall provide Parent (which term shall in all instances in this Section 5.1 also include Parent’s counsel) with reasonable opportunity to review and comment on each such filing in advance and the Company shall in good faith consider including in such filings all comments reasonably proposed by Parent; provided that Parent shall have provided to the Company its comments as promptly as practicable after the Proxy Statement has been transmitted to Parent for its review.
 
(b) The Company will notify Parent promptly of the receipt of any comments from the SEC or its staff (or of notice of the SEC’s intent to review the Proxy Statement) and of any request by the SEC or its staff or any other government officials for amendments or supplements to the Proxy Statement or any other filing or for additional/supplemental information, and will supply Parent with copies of all correspondence between


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the Company or any of its representatives, on the one hand, and the SEC, or its staff or any other government officials, on the other hand, with respect to the Proxy Statement or other filing. The Company and its outside counsel shall permit Parent and its outside counsel to participate in all planned communications with the SEC and its staff (including all meetings and telephone conferences) relating to the Proxy Statement, this Agreement or the Merger. The Company shall consult with Parent prior to responding to any comments or inquiries by the SEC or any other Governmental Entity with respect to the Proxy Statement and shall provide Parent with reasonable opportunity to review and comment on any such written response in advance and shall include in such response all comments reasonably proposed by Parent (provided that Parent shall have provided its comments to the Company as promptly as practicable after such written response has been transmitted to Parent for its review). Whenever any event occurs prior to the Effective Time (including events relating to the Company or any of its affiliates, directors or officers) that is required to be set forth in an amendment or supplement to the Proxy Statement or any other filing, the Company shall promptly inform Parent of such occurrence, provide Parent with reasonable opportunity to review and comment on any such amendment or supplement in advance, shall in good faith consider including in such amendment or supplement all comments reasonably proposed by Parent, and shall cooperate in filing with the SEC or its staff or any other government officials, and/or mailing to the stockholders of the Company, such amendment or supplement; provided that Parent shall have provided to the Company its comments as promptly as practicable after the Proxy Statement has been transmitted to Parent for its review.
 
(c) If at any time prior to the Effective Time Parent should discover any information relating to itself or to any of its affiliates, directors or officers which should be set forth in an amendment or supplement to the Proxy Statement, so that the Proxy Statement would not include any misstatement of a material fact or omit to state any material fact necessary to make the statements therein, in light of the circumstances under which they are made, not misleading, Parent shall promptly notify the Company and an appropriate amendment or supplement describing such information shall be promptly filed with the SEC and, to the extent required by Legal Requirements, disseminated to the stockholders of the Company.
 
5.2 Meeting of Company Stockholders.
 
(a) Promptly after the date hereof, the Company shall take all action necessary in accordance with Delaware Law, the rules of Nasdaq and the Company Charter Documents to convene a special meeting of its stockholders for the purpose of considering and taking action with respect to the Company Stockholder Approval (the “Stockholders’ Meeting”), to be held as promptly as practicable after execution of this Agreement; provided that the parties acknowledge that the Company’s goal is (to the extent permissible under applicable law) to convene such special meeting within 45 days after the Proxy Statement is cleared by the SEC (or, if no SEC comments are received on or prior to the tenth day after the initial filing of the Proxy Statement, within 55 days after such initial filing), and that if the Stockholders’ Meeting is not convened within such period, the Company’s senior executives shall discuss the reasons for the failure to meet such goals with Parent’s duly appointed representatives. The Company shall use all reasonable efforts to solicit from its stockholders proxies in favor of the adoption of this Agreement and shall take all other action necessary or advisable to secure the vote or consent of its stockholders required by the rules of Nasdaq or Delaware Law to obtain such approvals. Notwithstanding anything to the contrary contained in this Agreement, the Company may adjourn or postpone the Stockholders’ Meeting to the extent necessary to ensure that any necessary supplement or amendment to the Proxy Statement is provided to the Company’s stockholders in advance of a vote on this Agreement or, if as of the time for which the Stockholders’ Meeting is originally scheduled (as set forth in the Proxy Statement) there are insufficient shares of Company Common Stock represented (either in person or by proxy) to constitute a quorum necessary to conduct the business of the Stockholders’ Meeting. The Company shall ensure that the Stockholders’ Meeting is called, noticed, convened, held and conducted, and that all proxies solicited by the Company in connection with the Stockholders’ Meeting are solicited, in compliance with Delaware Law, the Company Charter Documents, the rules of Nasdaq and all other applicable Legal Requirements.
 

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(b) Subject to the terms of Section 5.4(d): (i) the Board shall unanimously recommend that the Company’s stockholders adopt this Agreement at the Stockholders’ Meeting; (ii) the Proxy Statement shall include (A) the fairness opinion referred to in Section 2.23 and (B) a statement to the effect that the Board has unanimously recommended that the Company’s stockholders vote in favor of the Company Stockholder Approval at the Stockholders’ Meeting; and (iii) neither the Board nor any committee thereof shall withdraw, amend, change or modify, or propose or resolve to withdraw, amend, change or modify in any manner adverse to Parent, the unanimous recommendation of the Board that the Company’s stockholders vote in favor of the Company Stockholder Approval. For purposes of this Agreement, said recommendation of the Board shall be deemed to have been modified in a manner adverse to Parent if said recommendation shall no longer be unanimous.
 
5.3 Confidentiality; Access to Information. 
 
(a) The parties acknowledge that Parent and the Company have previously executed a mutual confidentiality agreement, dated as of June 22, 2006 (the “Confidentiality Agreement”), which Confidentiality Agreement will continue in full force and effect in accordance with its terms, and each of Parent and the Company will hold, and will cause their respective directors, officers, employees, agents and advisors (including attorneys, accountants, consultants, bankers, and financial advisors) to hold any Information (as defined in the Confidentiality Agreement) confidential in accordance with the terms thereof.
 
(b) The Company shall: (i) afford Parent and its accountants, counsel, advisors and other representatives reasonable access, upon reasonable notice, to the properties (including for the purpose of performing such environmental tests and due diligence review as Parent may desire), books, records and personnel of the Company during the period prior to the Effective Time to obtain all information concerning the business, including the status of product development efforts, properties, financial positions, results of operations and personnel of the Company, as Parent may reasonably request (it being understood that Parent shall use all reasonable efforts to conduct such access during normal business hours), and (ii) furnish Parent on a timely basis with such financial and operating data and other information with respect to the business, operations and properties of the Company and its subsidiaries as Parent may from time to time reasonably request, except for information covered by attorney-client privilege or subject to confidentiality (which information shall be treated in accordance with the procedures put in place by Parent and the Company on or prior to the date hereof). Except for disclosures expressly permitted by the terms of the Confidentiality Agreement, Parent shall hold, and shall cause its representatives to hold, all information received from the Company, directly or indirectly, in confidence in accordance with the Confidentiality Agreement.
 
(c) No information or knowledge obtained by Parent pursuant to this Section 5.3 will affect or be deemed to modify any representation or warranty contained herein or the conditions to the obligations of the parties to consummate the Transactions.
 
5.4 No Solicitation. 
 
(a) No Solicitation. The Company and its subsidiaries shall not, nor shall they permit any of their respective officers and directors (or affiliates of any of such officers or directors), controlled affiliates, or employees or any investment banker, attorney, accountant or other advisor or representative retained by (or otherwise working on behalf of) the Company or any of its subsidiaries (collectively, “Representatives”) to directly or indirectly: (i) solicit, initiate, knowingly encourage, knowingly facilitate, or induce any inquiry with respect to, or the making, submission or announcement of, any Acquisition Proposal (as defined in Section 5.4(g)(i)), (ii) participate or otherwise engage in any discussions or negotiations regarding, or furnish to any person any nonpublic information with respect to, or take any other action (including granting any person a waiver or release under any standstill or similar agreement with respect to any class of equity security of the Company or any of its subsidiaries or amending, waiving or terminating the Rights Agreement, other than as contemplated by this Agreement, or redeeming any rights under the Rights Agreement, other than as contemplated by this Agreement) to facilitate any inquiries or the making of any proposal that constitutes or may reasonably be expected to lead to, any Acquisition Proposal, (iii) engage in


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discussions with any person with respect to any Acquisition Proposal, except as to the existence of these provisions, (iv) approve, endorse or recommend any Acquisition Proposal (except to the extent specifically permitted pursuant to Section 5.4(d)), or (v) enter into any letter of intent or similar document or any Contract relating to an Acquisition Proposal (other than a confidentiality agreement entered into with a party making an Acquisition Proposal as permitted by Section 5.4(c)(i) below). The Company and its subsidiaries will immediately cease, and will cause its Representatives to immediately cease, any and all existing activities, discussions or negotiations with any third parties conducted heretofore with respect to any Acquisition Proposal.
 
(b) Notification of Unsolicited Acquisition Proposals. 
 
(i) As promptly as practicable (but in no event more than 36 hours thereafter) after receipt of any Acquisition Proposal or any request for nonpublic information or inquiry which it reasonably believes would lead to an Acquisition Proposal, the Company shall provide to Parent written notice of the material terms and conditions of such Acquisition Proposal, request or inquiry, and the identity of the person or group making any such Acquisition Proposal, request or inquiry, a copy of all written materials provided in connection with such Acquisition Proposal, request or inquiry and a written summary of any such Acquisition Proposal, request or inquiry, if it is not in writing. After receipt of the Acquisition Proposal, request or inquiry, the Company shall continue to provide to Parent as promptly as practicable (but in no event more than 48 hours thereafter) written notice setting forth all such information as is reasonably necessary to keep Parent informed in all material respects of the status and material terms (including material amendments or proposed material amendments) of any such Acquisition Proposal, request or inquiry and shall promptly provide to Parent a copy of all written materials provided in connection with such Acquisition Proposal, request or inquiry.
 
(ii) The Company shall provide Parent with at least 48 hours prior notice (or such lesser prior notice as is provided to the members of the Board) of any meeting at which the Board is reasonably expected to consider any Acquisition Proposal.
 
(c) Superior Offers. Notwithstanding anything to the contrary contained in Section 5.4, in the event that the Company or any of its subsidiaries receives a bona fide written Acquisition Proposal from a third party that is not solicited or otherwise procured in violation of Section 5.4(a) that the Board has in good faith concluded (following consultation with its outside legal counsel and its financial advisor) is, or is reasonably likely to be, a Superior Offer (as defined in Section 5.4(g)(ii)), it may then take the following actions:
 
(i) Furnish nonpublic information to the third party making such Acquisition Proposal (and its Representatives), provided that (A) (1) concurrently with furnishing any such nonpublic information to such party, it gives Parent at least one business day prior written notice of its intention to furnish nonpublic information and (2) it receives from the third party an executed confidentiality and standstill agreement, the terms of which are at least as restrictive as the terms contained in the Confidentiality Agreement and (B) contemporaneously with furnishing any such nonpublic information to such third party, the Company furnishes such nonpublic information to Parent (to the extent such nonpublic information has not been previously so furnished); and
 
(ii) Engage in negotiations with the third party with respect to the Acquisition Proposal, provided that concurrently with entering into negotiations with such third party, the Company gives Parent at least one business day prior written notice of its intention to enter into negotiations with such third party.
 
(d) Changes of Recommendation. In response to the receipt of a Superior Offer, the Board may withhold, withdraw, amend or modify its unanimous recommendation in favor of the Merger, and, in the case of a Superior Offer that is a tender or exchange offer made directly to its stockholders, may recommend that its stockholders accept the tender or exchange offer (any of the foregoing actions, whether by the Board or a committee thereof, a “Change of Recommendation”) or terminate this Agreement pursuant to Section 7.1(h) of this Agreement (provided, however, that the Company shall not terminate this Agreement


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pursuant to Section 7.1(h) and any purported termination pursuant to Section 7.1(h) shall be void and of no further force or effect, unless prior to or concurrently with such termination, the Company pays the Termination Fee), only if all of the following conditions in clauses (i) through (v) are met:
 
(i) A Superior Offer with respect to the Company has been made and has not been withdrawn;
 
(ii) The Stockholders’ Meeting has not occurred;
 
(iii) The Company shall have (A) provided to Parent five business days prior written notice which shall state expressly (1) that the Company has received a Superior Offer, (2) the material terms and conditions of the Superior Offer and the identity of the person or group making the Superior Offer, and (3) that the Board intends to effect a Change of Recommendation and the manner in which it intends to do so or terminate this Agreement and enter into a definitive agreement with respect to such Superior Offer, (B) provided to Parent a copy of all written materials delivered to the person or group making the Superior Offer in connection with such Superior Offer that have not already been provided to Parent, (C) made available to Parent all materials and information made available to the person or group making the Superior Offer in connection with such Superior Offer and (D) during such five business day period, engaged in good faith negotiations to amend this Agreement in a manner as would enable the Company to proceed with the Board’s recommendation to the Company’s stockholders in favor of the Company Stockholder Approval with respect to this Agreement, as it may be amended (and the Company shall make its Chairman and senior executives available for discussions with Parent and otherwise negotiate in good faith with Parent with respect thereto during such five business day period);
 
(iv) The Board has concluded in good faith, following consultation with its outside legal counsel and financial adviser, that, in light of such Superior Offer and notwithstanding any adjustments or negotiations pursuant to Section 5.4(d)(iii)(D), the failure of the Board to effect a Change of Recommendation is reasonably likely to constitute a breach of its fiduciary duties to the Company’s stockholders under applicable law; and
 
(v) It shall not have materially breached Section 5.2.
 
Provided however, that in the event of any material revisions to the Superior Offer, the Company shall deliver a new written notice to Parent and comply with the requirements of this Section 5.4(d), including the five-day good faith notice period provided for, with respect to such new written notice.
 
(e) Continuing Obligation to Call, Hold and Convene Stockholders’ Meeting; No Other Vote. Notwithstanding anything to the contrary contained in this Agreement, the obligation of the Company to call, give notice of, convene and hold the Stockholders’ Meeting shall not be limited or otherwise affected by the commencement, disclosure, announcement or submission to it of any Acquisition Proposal with respect to it, or by any Change of Recommendation. The Company shall not submit to the vote of its stockholders any Acquisition Proposal, or propose to do so.
 
(f) Compliance with Tender Offer Rules. Nothing contained in this Agreement shall prohibit the Board from taking and disclosing to its stockholders a position contemplated by Rules 14d-9 and 14e-2(a) promulgated under the Exchange Act. Without limiting the foregoing proviso, the Company shall not effect a Change of Recommendation unless specifically permitted pursuant to the terms of Section 5.4(d).
 
(g) Certain Definitions. For purposes of this Agreement, the following terms shall have the following meanings:
 
(i) “Acquisition Proposal” shall mean any offer or proposal (whether written, oral or otherwise), relating to any transaction or series of related transactions involving: (A) any purchase or acquisition by any person or “group” (as defined under Section 13(d) of the Exchange Act and the rules and regulations thereunder) of more than a fifteen percent (15%) interest in the total outstanding voting securities of the Company or any of its subsidiaries or any tender offer or exchange offer that if consummated would result in any person or group beneficially owning fifteen percent (15%) or more


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of the total outstanding voting securities of the Company or any of its subsidiaries or any merger, consolidation, business combination or similar transaction involving the Company or any of its subsidiaries, (B) any sale, lease (other than in the ordinary course of business), exchange, transfer, license (other than in the ordinary course of business) or disposition of more than fifteen percent (15%) of the assets of the Company (including its subsidiaries taken as a whole), or (C) any liquidation or dissolution of the Company, in each case other than the Transactions; and
 
(ii) “Superior Offer” shall mean a bona fide written offer that is made by a third party to acquire, directly or indirectly, pursuant to a tender offer, exchange offer, merger, consolidation or other business combination, all or substantially all of the assets of the Company or a majority of the total outstanding voting securities of the Company and as a result of which the stockholders of the Company immediately preceding such transaction would hold less than fifty percent (50%) of the equity interests in the surviving or resulting entity of such transaction or any direct or indirect parent or subsidiary thereof, on terms that the Board has in good faith concluded (following the receipt of advice of its outside legal counsel and its financial adviser), taking into account, among other things, all legal, financial, regulatory and other aspects of the offer and the person making the offer, to be more favorable, from a financial point of view, to the Company’s stockholders (in their capacities as stockholders) than the terms of the Merger (as they may be amended in accordance with Section 5.4(d)(iii)(D)) and is reasonably capable of being consummated and for which financing, to the extent required, is then fully committed or reasonably determined by the Board to be available to consummate such a transaction.
 
(h) Without limiting the foregoing, it is understood that (i) any violation of the restrictions set forth above by any officer or director of the Company and (ii) any violation of the restrictions set forth above by any agent or representative of the Company of which the Company has knowledge (prior to such violation) shall be deemed to be a breach of this Agreement by the Company. The Company and its subsidiaries shall not (A) authorize, direct or permit any of the persons identified in clauses (i) and (ii) of this Section 5.4(h) or (B) authorize or direct any affiliate of the Company to violate the provisions of this Section 5.4 and shall promptly inform all such Representatives of the restrictions set forth in this Section 5.4.
 
5.5 Public Disclosure. 
 
(a) The initial press release with respect to the execution of this Agreement shall be a joint press release to be reasonably agreed upon by Parent and the Company. Thereafter, the Company shall not issue or cause the publication of any press release or other public announcement (to the extent not previously issued or made in accordance with this Agreement) with respect to the Merger, this Agreement or the other Transactions without the prior consent of Parent, except: (a) as may be required by applicable Legal Requirements or by the rules and regulations of Nasdaq, in which case the Company shall not issue or cause the publication of such press release or other public announcement without prior consultation with Parent, to the extent practicable and (b) as may be consistent with actions taken by the Company or the Board (or any committee thereof) pursuant to Section 5.4(d).
 
(b) Subject to Parent’s compliance with applicable Legal Requirements or the rules and regulations of the New York Stock Exchange, from the date hereof until the earlier to occur of the Closing and the termination of this Agreement pursuant to Section 7.1 hereof, Parent shall inform the Company prior to issuing or causing the publication of any press release or other public announcement with respect to the Merger, this Agreement or the other Transactions; provided, however, that nothing in this Section 5.5(b) shall prohibit Parent from responding to questions and inquiries from third parties regarding the Merger, this Agreement or the other Transactions.
 
(c) The Company shall consult with Parent before issuing any press release or otherwise making any public statement with respect to the Company’s earnings or results of operations, and shall not issue any such press release or make any such public statement prior to such consultation.
 

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5.6 Reasonable Efforts; Regulatory Matters. 
 
(a) Other than taking any action permitted by Section 5.4(d) and subject to the limitations set forth in Section 5.6(d), upon the terms and subject to the conditions set forth in this Agreement, each of the parties agrees to use all reasonable efforts to take, or cause to be taken, all actions, and to do, or cause to be done, and to assist and cooperate with the other parties in doing, all things necessary, proper or advisable to consummate and make effective, in the most expeditious manner practicable, the Transactions, including using all reasonable efforts to accomplish the following: (i) the taking of all reasonable acts necessary to cause the conditions precedent set forth in Article VI to be satisfied, (ii) the obtaining of all necessary actions or non-actions, waivers, consents, approvals, orders and authorizations from Governmental Entities and the making of all necessary registrations, declarations and filings (including registrations, declarations and filings with Governmental Entities, if any) and the taking of all reasonable steps as may be necessary to avoid any suit, claim, action, investigation or proceeding by any Governmental Entity, (iii) the obtaining of all consents, approvals or waivers from third parties required as a result of the Transactions, (iv) responding to any investigations or proceedings related to this Agreement or the consummation of the Transactions, including a request for additional information or documents, and (v) the execution or delivery of any additional instruments reasonably necessary to consummate the Transactions, and to fully carry out the purposes of, this Agreement. In connection with and without limiting the foregoing, the Company and its Board shall, if any state takeover statute or similar statute or regulation is or becomes applicable to the Transactions or this Agreement, use all reasonable efforts to ensure that the Transactions may be consummated as promptly as practicable on the terms contemplated by this Agreement and otherwise to minimize the effect of such statute or regulation on the Transactions and this Agreement.
 
(b) Each of Parent and the Company shall, as soon as practicable, make any initial filings required under the HSR Act, and as promptly as practicable make any other additional filings required by any other applicable Antitrust Laws (as defined below). Subject to the limitations set forth in Section 5.6(d), each of Parent and the Company shall use all reasonable efforts to take such action as may be required to cause the expiration or early termination of the waiting or notice periods under the HSR Act or other Antitrust Laws with respect to the Transactions as promptly as possible after execution of this Agreement. To the extent permitted by applicable law, the parties shall consult and cooperate with one another, and consider in good faith the views of one another, in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto in connection with proceedings under or relating to the HSR Act or any foreign or other Antitrust Law; provided, that with respect to any such analyses, appearances, presentations, memoranda, briefs, arguments, opinions or proposals, each of Parent and the Company need not supply the other (or its counsel) with copies (or in case of oral presentations, a summary) to the extent that any law, treaty, rule or regulation of any Governmental Entity applicable to such party or confidentiality agreement to which such party is bound (which shall be governed in accordance with the procedures put in place by Parent and the Company on or prior to the date hereof) requires such party or its subsidiaries to restrict or prohibit access to any such properties or information. For purposes of this Agreement, “Antitrust Laws” shall mean the HSR Act and any other federal, state or foreign statutes, rules, regulations, orders or decrees that are designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade.
 
(c) Each party will notify the other promptly upon the receipt of: (i) any comments from any officials of any Governmental Entity in connection with any filings made pursuant to this Section 5.6, and (ii) any request by any officials of any Governmental Entity for amendments or supplements to any filings made pursuant to, or information provided to comply in all material respects with, any Legal Requirements. Whenever any event occurs that is required to be set forth in an amendment or supplement to any filing made pursuant to Section 5.6(b), each party will promptly inform the other of such occurrence and cooperate in filing with the applicable Governmental Entity such amendment or supplement. To the extent reasonably practicable, neither the Company nor Parent shall, nor shall they permit their respective representatives to, participate independently in any substantive meeting or discussion, either in person or by telephone, with any Governmental Entity in connection with the proposed Transactions unless it consults with the other party in advance and, to the extent not prohibited by such Governmental Entity, gives the other party the opportunity to attend and participate.
 

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(d) Notwithstanding anything in this Agreement to the contrary (including the other provisions of this Section 5.6), if any administrative or judicial action or proceeding is instituted (or threatened to be instituted) challenging any transaction contemplated by this Agreement as violative of any Antitrust Law, it is expressly understood and agreed that: (i) Parent shall not have any obligation to litigate or contest any administrative or judicial Action or any decree, judgment, injunction or other order, whether temporary, preliminary or permanent brought by or before an administrative tribunal, court or other similar tribunal or body; (ii) Parent shall be under no obligation to make proposals, execute or carry out agreements or submit to orders providing for a Divestiture and (iii) the Company may not conduct or agree to conduct a Divestiture without the prior written consent of Parent. “Divestiture” shall mean (1) the sale, license or other disposition or holding separate (through the establishment of a trust or otherwise) of any assets or categories of assets of Parent or any of its affiliates or the Company, (2) the imposition of any limitation or restriction on the ability of Parent or any of its affiliates to freely conduct their business or the Company’s business or own such assets, or (3) the holding separate of the shares of Company Common Stock or any limitation or regulation on the ability of Parent or any of its affiliates to exercise full rights of ownership of the shares of Company Common Stock.
 
5.7 Notification. Each party shall give prompt notice to the other party upon becoming aware that any representation or warranty made by it contained in this Agreement has become untrue or inaccurate or of any failure to comply with or satisfy in any respect any covenant, condition or agreement to be complied with or satisfied by it under this Agreement, in each case such that the conditions set forth in Section 6.2(a) or Section 6.2(b) (as it relates to knowledge acquired by Parent) or Section 6.3(a) or Section 6.3(b) (as it relates to knowledge acquired by the Company), as applicable, would not be satisfied; provided, however, that no such notification shall affect the representations, warranties, covenants or agreements of the parties or the conditions to the obligations of the parties under this Agreement. Each party shall promptly notify the other party of (i) any change, event, violation, inaccuracy, circumstance or effect that has had or would reasonably be expected to have a Material Adverse Effect on such party and (ii) any Actions commenced or, to such party’s knowledge, threatened against, relating to or involving or otherwise affecting such party or any of its subsidiaries that relate to the consummation of the Merger.
 
5.8 Third Party Consents and Notices. 
 
(a) As soon as practicable following the date hereof, the Company shall use all reasonable efforts to obtain any consents, waivers and approvals under any Company Contracts required to be obtained in connection with the consummation of the Transactions, as set forth on Section 5.8 of the Company Disclosure Letter; provided that neither the Company nor any of its subsidiaries shall, without the prior written consent of Parent, expend any material amount, assume any material Liability or suffer or permit the loss of any material right or benefit in connection with obtaining any of the foregoing consents, waivers or approvals.
 
(b) As soon as practicable following the date hereof, the Company shall deliver any notices required under any Company Contracts that are required to be provided in connection with the execution of this Agreement or prior to the effectiveness of the Merger.
 
(c) With respect to all Employees (other than Consultants), the Company and/or any of its subsidiaries shall be responsible for providing any notices required to be given and otherwise complying with WARN or similar statutes or regulations of any jurisdiction relating to any plant closing or mass layoff (or similar triggering event) caused by the Company or any of its subsidiaries, and Parent shall have no responsibility or Liability under WARN (or any other similar statute or regulation) with respect to such Employees. If Parent determines that an event would trigger WARN obligations (or obligations arising under similar statutes or regulations) within 60 days following the Effective Time, the Company or the Company’s subsidiaries shall, at Parent’s request, provide notices to all Employees (other than Consultants) as are required to be provided under WARN (or any similar statute or regulation), in a form approved by and as directed by Parent.


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5.9 Indemnification. 
 
(a) From and after the Effective Time, Parent shall, and shall cause the Surviving Corporation to fulfill and honor in all respects the obligations with respect to all rights to indemnification and exculpation from liabilities, including advancement of expenses, for acts or omissions occurring at or prior to the Effective Time now existing in favor of the current and former directors or officers of the Company pursuant to any indemnification agreements between the Company and its directors and officers (in each case, as in effect on the date hereof and listed on the Company Disclosure Letter), and any indemnification provisions under the Company Charter Documents as in effect on the date hereof in favor of the Company’s directors and officers and Employees (the “Indemnified Parties”), and such obligations shall survive the Merger and shall continue in full force and effect in accordance with their terms. The Certificate of Incorporation and Bylaws of the Surviving Corporation will contain provisions with respect to exculpation and indemnification that are at least as favorable to the Indemnified Parties as those contained in the Company Charter Documents as in effect on the date hereof, which provisions will not be amended, repealed or otherwise modified for a period of six (6) years from the Effective Time in any manner that would adversely affect the rights thereunder of individuals who, immediately prior to the Effective Time, were Employees or agents of the Company, unless such modification is required by applicable law.
 
(b) At any time prior to the Closing, Company may purchase, for a price (which shall in no event exceed the Cap Amount regardless of any amounts credited against premium payments previously paid by the Company) not to exceed the amount set forth on Section 5.9(b) of the Company Disclosure Letter (the “Cap Amount”), directors’ and officers’ liability tail coverage (for a period of six (6) years following the Effective Time), covering those persons who are currently covered by the Company’s directors’ and officers’ liability insurance policy, on terms comparable to those applicable to the current directors and officers of the Company, and covering all periods prior to the Effective Time (the “Tail Coverage”). Following the Closing, in the event Company shall not have purchased the Tail Coverage, Parent shall (or shall cause the Surviving Corporation to) purchase the Tail Coverage, provided that in no event shall Parent or the Surviving Corporation be required to expend in the aggregate in connection with the purchase of such Tail Coverage an amount in excess of the Cap Amount and, in the event a comparable level of directors’ and officers’ liability Tail Coverage is not readily available for the Cap Amount without undue effort or expense, Parent (or the Surviving Corporation, as the case may be) shall only be obligated to purchase such Tail Coverage as may be purchased for the Cap Amount.
 
(c) If the Surviving Corporation or any of its successors or assigns (i) consolidates with or merges into any other person and is not the continuing or surviving corporation or entity of such consolidation or merger or (ii) transfers or conveys all or substantially all of its properties and other assets to any person, then, and in each such case, Parent shall cause proper provision to be made so that the successors and assigns of the Surviving Corporation shall expressly assume the obligations set forth in this Section 5.9. If (A) the Surviving Corporation transfers any material portion of its assets, in a single transaction or in a series of transactions or (B) Parent takes any action to materially impair the financial ability of the Surviving Corporation to satisfy the obligations referred to in this Section 5.9, Parent will either guarantee such obligations or take such other action to insure that the ability of the Surviving Corporation, legal and financial, to satisfy such obligations will not be diminished in any material respect.
 
(d) This Section 5.9 is (i) intended for the irrevocable benefit of, and to grant third party rights to, the Indemnified Parties and shall be binding on all successors and assigns of Parent, the Company and the Surviving Corporation and (ii) in addition to, and not in substitution for, any other rights to indemnification or contribution that any such person may have by Contract or otherwise. Each of the Indemnified Parties shall be entitled to enforce the covenants contained in this Section 5.9.
 
5.10 Termination of Certain Benefit Plans. Except as set forth on Section 5.10 of the Company Disclosure Letter, effective no later than the day immediately preceding the Closing Date, the Company and its ERISA Affiliates, as applicable, shall each terminate any and all group severance, separation or salary continuation plans, programs or arrangements and any and all plans intended to include a Code Section 401(k) arrangement


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(unless Parent provides written notice to the Company that such 401(k) plans shall not be terminated) (collectively, for purposes of this Section 5.10Company Group Employee Plans”). Unless Parent provides such written notice to the Company, no later than five (5) business days prior to the Closing Date, the Company shall provide Parent with evidence that such Company Group Employee Plan(s) have been terminated (effective no later than the day immediately preceding the Closing Date) pursuant to resolutions of the Board. The form and substance of such resolutions shall be subject to advance review and approval of Parent. The Company also shall take such other actions in furtherance of terminating such Company Group Employee Plan(s) as Parent may reasonably require.
 
5.11 Section 16 Matters. The Company shall take all such steps as may be required (to the extent permitted under applicable law) to cause any disposition of Company Common Stock (including derivative securities with respect to Company Common Stock) resulting from the transactions contemplated by Article I of this Agreement by each Company Insider to be exempt under Rule 16b-3 promulgated under the Exchange Act. “Company Insiders” shall mean those individuals who are subject to the reporting requirement of Section 16(b) of the Exchange Act with respect to the Company.
 
5.12 Disqualified Individuals. At least five (5) business days prior to the Closing Date, the Company shall, to the extent not already disclosed on Section 2.13(l)(ii) of the Company Disclosure Letter, deliver to Parent a schedule which sets forth each person who the Company reasonably believes is, with respect to the Company or any ERISA Affiliate, a “disqualified individual” within the meaning of Section 280G of the Code and the regulations promulgated thereunder, as of the date such schedule is delivered to Parent.
 
5.13 Company Rights Agreement. The Company shall not redeem the Rights or amend or modify (including by delay of the “Distribution Date” thereunder) or terminate the Company Rights Agreement prior to the Effective Time unless, and only to the extent that: (i) it is required to do so by order of a court of competent jurisdiction or (ii) the Board has concluded in good faith, following consultation with its outside legal counsel, that the failure of the Board to effect such an amendment, modification or termination is reasonably likely to constitute a breach of its fiduciary duties to the Company’s stockholders under applicable law.
 
5.14 Takeover Statutes. 
 
(a) The Board shall take all actions sufficient to render inapplicable to the Merger, the execution, delivery and performance of this Agreement and the Company Voting Agreements and the Transactions and the transactions contemplated by the Company Voting Agreements, the provisions of Section 203 of Delaware Law applicable to a “business combination” (as defined in such Section 203 and any other state takeover statue or similar statute or regulation).
 
(b) If any “fair price”, “moratorium”, “control share acquisition” or other form of anti-takeover statute or regulation shall become applicable to the Transactions, the Company and the members of the Board shall grant such approvals and take such actions as are reasonably necessary so that the Transactions may be consummated as promptly as practicable on the terms contemplated hereby and otherwise act to eliminate or minimize the effects of such statute or regulation on the Transactions.
 
5.15 FIRPTA Compliance. On the Closing Date, the Company shall deliver to Parent a properly executed statement prepared in accordance with the certification requirements set forth in Treasury Regulations Section 1.1445-2(c)(3) certifying that the shares of Company Common Stock are not U.S. real property interests.


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ARTICLE VI
CONDITIONS TO THE MERGER
 
6.1 Conditions to Obligations of Each Party to Effect the Merger. The respective obligations of each party to this Agreement to effect the Merger shall be subject to the satisfaction at or prior to the Closing Date of each of the following conditions. any and all of which may be waived in whole or in part by Parent, Merger Sub and the Company, as the case may be, to the extent permitted by applicable Legal Requirements:
 
(a) Company Stockholder Approval. The Company Stockholder Approval shall have been obtained.
 
(b) No Order. No Governmental Entity shall have enacted, issued, promulgated, enforced or entered any statute, rule, regulation, executive order, decree, injunction or other order (whether temporary, preliminary or permanent) which is in effect and which has the effect of making the Merger illegal or otherwise prohibiting consummation of the Merger; provided, however, that the right to assert this condition shall not be available to any party whose breach of any provision of this Agreement results in the imposition of any such statute, rule, regulation, executive order, decree, injunction or other order or the failure of any the foregoing to be resisted, resolved or lifted, as applicable.
 
(c) Governmental Approvals. All applicable waiting periods under the HSR Act shall have expired or been terminated and all other material regulatory consents, approvals, expiration of waiting periods, and clearances of Governmental Entities under any applicable material foreign or other Legal Requirements (including other Antitrust Laws) in connection with this Agreement and the transactions contemplated hereby (including the Merger) (other than the filing of the Certificate of Merger) shall have been obtained, and if the SEC shall have reviewed and/or provided comments to the Proxy Statement, such comments and any related issues or matters with the SEC shall have been resolved.
 
6.2 Additional Conditions to Obligations of the Company. The obligation of the Company to consummate and effect the Merger shall be subject to the satisfaction at or prior to the Closing Date of each of the following conditions, any of which may be waived, in writing, exclusively by the Company:
 
(a) The representations and warranties of Parent and Merger Sub contained in this Agreement shall be (i) true and correct in all material respects at and as of the date of this Agreement (except for those representations and warranties that are qualified by the word “material”, “Material Adverse Effect” or a similar phrase, which shall be true and correct in all respects at and as of the date of this Agreement) and (ii) true and correct at and as of the Closing Date as though made at and as of the Closing Date, except for such failures to be true and correct at and as of the Closing Date as would not have, in each case or in the aggregate, a Material Adverse Effect on Parent (it being understood and agreed that, for purposes of this clause (ii), all materiality qualifications and other qualifications based on the word “material”, “Material Adverse Effect” or similar phrases contained in such representations and warranties shall be disregarded); provided, however, notwithstanding the foregoing, the representations and warranties that are made as of a particular date or period shall be true and correct only at and as of such date or period. The Company shall have received a certificate to such effect signed on behalf of Parent and Merger Sub by a duly authorized officer of Parent and Merger Sub.
 
(b) Agreements and Covenants. Parent and Merger Sub shall have performed or complied in all material respects with all agreements and covenants required by this Agreement to be performed or complied with by them on or prior to the Closing Date, and the Company shall have received a certificate to such effect signed on behalf of Parent and Merger Sub by an authorized officer of Parent and Merger Sub.
 
6.3 Additional Conditions to the Obligations of Parent and Merger Sub. The obligations of Parent and Merger Sub to consummate and effect the Merger shall be subject to the satisfaction at or prior to the Closing Date of each of the following conditions, any of which may be waived, in writing, exclusively by Parent:
 
(a) Representations and Warranties. The representations and warranties of the Company contained in this Agreement shall be (i) true and correct in all material respects at and as of the date of this Agreement


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(except for those representations and warranties that are qualified by the word “material”, “Material Adverse Effect” or a similar phrase, which shall be true and correct in all respects at and as of the date of this Agreement) and (ii) true and correct at and as of the Closing Date as though made at and as of the Closing Date, except for such failures to be true and correct at and as of the Closing Date as would not have, in each case or in the aggregate, a Material Adverse Effect on the Company (it being understood and agreed that, for purposes of this clause (ii), all materiality qualifications and other qualifications based on the word “material”, “Material Adverse Effect” or similar phrases contained in such representations and warranties shall be disregarded and any purported update of or modification to the Company Disclosure Letter made after the execution of this Agreement shall be disregarded); provided, however, notwithstanding the foregoing, (i) the representations and warranties that are made as of a particular date or period shall be true and correct only at and as of such date or period and (ii) the representations and warranties contained in Section 2.3(a), Section 2.4, Section 2.23 and Section 2.25 shall be true and correct in all material respects at and as of the date of this Agreement and at as of the Closing Date. Parent shall have received a certificate to such effect signed on behalf of the Company by the Chief Executive Officer and the Vice President of Finance of the Company.
 
(b) Agreements and Covenants. The Company shall have performed or complied in all material respects with all agreements and covenants required by this Agreement to be performed or complied with by it at or prior to the Closing Date, and Parent shall have received a certificate to such effect signed on behalf of the Company by the Chief Executive Officer and the Chief Financial Officer of the Company.
 
(c) Material Adverse Effect. No Material Adverse Effect with respect to the Company and its subsidiaries shall have occurred since the date of this Agreement and not been cured, and Parent shall have received a certificate to such effect signed on behalf of the Company by the Chief Executive Officer and the Vice President of Finance of the Company.
 
(d) No Governmental Restriction. There shall not be any pending or threatened Action by any Governmental Entity (i) challenging or seeking to restrain or prohibit the consummation of the Merger or any of the Transactions or (ii) seeking to require Parent or the Company, or any subsidiary or affiliate of either of them, to effect a Divestiture.
 
(e) Sarbanes-Oxley Certifications; No Restatement. With respect to any Company SEC Reports filed with the SEC after the date of this Agreement, neither the principal executive officer nor the principal financial officer of the Company shall have failed to provide the necessary certifications in the form required under Section 302 and Section 906 of the SOX. There shall not have been any restatement of the Company’s consolidated financial statements, and the Company shall not be aware of any event that would reasonably be expected to result in any such restatement. The Company’s auditors shall not have resigned or threatened to resign.
 
ARTICLE VII
TERMINATION, AMENDMENT AND WAIVER
 
7.1 Termination. This Agreement may be terminated at any time prior to the Effective Time, and the Merger may be abandoned, notwithstanding any requisite adoption of this Agreement by the stockholders of the Company:
 
(a) by mutual written consent of the Company and Parent;
 
(b) by either the Company or Parent if the Effective Time shall not have occurred on or before May 9, 2007 (the “Initial Termination Date”) for any reason; provided, however, that in the event that a condition to the Merger set forth in Section 6.1(b) (solely if such condition has not been satisfied as a result of an Action by a Governmental Entity to enforce Antitrust Laws), Section 6.1(c) or Section 6.3(d) (solely if such condition has not been satisfied as a result of an Action by a Governmental Entity to enforce Antitrust Laws) shall not have been satisfied on or prior to the Initial Termination Date and all of the other conditions


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to the Merger set forth in Article VI (other than those conditions that are capable of being waived by the party seeking to terminate) shall have been satisfied on or prior to the Initial Termination Date, either Parent or the Company may elect to extend the Initial Termination Date, by written notice to the other prior to or on the Initial Termination Date, until August 9, 2007 (the “Extended Termination Date”); provided, further, that, in each case, the right to terminate this Agreement under this Section 7.1(b) shall not be available to any party whose action or failure to act has been a principal cause of or resulted in the failure of the Effective Time to occur on or before such date and such action or failure to act constitutes a breach of this Agreement;
 
(c) by either the Company or Parent if any Legal Requirement makes consummation of the Merger illegal or if a Governmental Entity of competent jurisdiction shall have issued an order, decree or ruling or taken any other action, in any case having the effect of permanently restraining, enjoining or otherwise prohibiting the Merger, which order, decree, ruling or other action is final and nonappealable;
 
(d) by either the Company or Parent if the Company Stockholder Approval shall not have been obtained by reason of the failure to obtain the required vote at the Stockholders’ Meeting or at any adjournment or postponement thereof; provided, however, that the right to terminate this Agreement under this Section 7.1(d) shall not be available to a party where the failure to obtain the Company Stockholder Approval shall have been caused by the action or failure to act of such party and such action or failure to act constitutes a breach by such party of this Agreement;
 
(e) by the Company, upon a breach of any representation, warranty, covenant or agreement on the part of Parent set forth in this Agreement, or if any representation or warranty of Parent shall have become untrue, in either case such that the conditions set forth in Section 6.2(a) or Section 6.2(b) would not be satisfied as of the time of such breach or as of the time such representation or warranty shall have become untrue; provided, however, that if such inaccuracy in Parent’s representations and warranties or breach by Parent is capable of being cured by Parent through the exercise of all reasonable efforts, then the Company may not terminate this Agreement under this Section 7.1(e) until 30 days after delivery of written notice from the Company to Parent of such breach or inaccuracy, provided Parent continues to exercise all reasonable efforts to cure such breach or inaccuracy (it being understood that the Company may not terminate this Agreement pursuant to this Section 7.1(e) if it shall have materially breached this Agreement or if such breach or inaccuracy by Parent is cured during such 30-day period);
 
(f) by Parent, upon a breach of any representation, warranty, covenant or agreement on the part of the Company set forth in this Agreement, or if any representation or warranty of the Company shall have become untrue, in either case such that the conditions set forth in Section 6.3(a) or Section 6.3(b) would not be satisfied as of the time of such breach or as of the time such representation or warranty shall have become untrue; provided, however, that if such inaccuracy in the Company’s representations and warranties or breach by the Company is capable of being cured by the Company through the exercise of all reasonable efforts, then Parent may not terminate this Agreement under this Section 7.1(f) until 30 days after delivery of written notice from Parent to the Company of such breach or inaccuracy, provided the Company continues to exercise all reasonable efforts to cure such breach or inaccuracy (it being understood that Parent may not terminate this Agreement pursuant to this Section 7.1(f) if such breach or inaccuracy by the Company is cured during such 30-day period);
 
(g) by Parent, if a Material Adverse Effect on the Company shall have occurred since the date hereof and shall not have been cured;
 
(h) by the Company, in accordance with Section 5.4(d) of this Agreement, provided, that, in order for the termination of this Agreement pursuant to this Section 7.1(h) to be deemed effective, the Company shall have complied with Section 5.4(d) of this Agreement and paid the Termination Fee referred to in Section 7.3(b)(i) of this Agreement concurrently with or prior to such termination; or
 
(i) by Parent if a Triggering Event (as defined below) shall have occurred prior to obtaining the Company Stockholder Approval. For the purposes of this Agreement, a “Triggering Event” shall be deemed to have occurred if: (i) the Board or any committee thereof shall for any reason have withdrawn or


53



withheld, or shall have amended, changed, qualified or modified in a manner adverse to Parent the Board’s or committee’s unanimous recommendation in favor of the adoption of this Agreement (it being understood that the taking of a neutral position or no position with respect to an Acquisition Proposal beyond the Acquisition Proposal Assessment Period, as defined below, shall be considered an adverse modification), except in connection with a material breach of this Agreement by Parent or Merger Sub; (ii) the Company shall have failed to include in the Proxy Statement the unanimous recommendation of the Board that holders of Company Common Stock vote in favor of the adoption of this Agreement; (iii) the Board or any committee thereof shall have approved or recommended any Acquisition Proposal; (iv) the Company shall have entered into any letter of intent or similar document or any Contract accepting any Acquisition Proposal; (v) a tender or exchange offer relating to securities of the Company shall have been commenced by a person unaffiliated with Parent and the Company shall not have sent to its securityholders pursuant to Rule 14e-2 promulgated under the Securities Act, within ten (10) business days (such ten (10) business day period, the “Acquisition Proposal Assessment Period”) after such tender or exchange offer is first published sent or given, a statement disclosing that the Board recommends rejection of such tender or exchange offer; (vi) the Board shall have failed to reaffirm its approval or recommendation of this Agreement as promptly as practicable (but in any event within five (5) business days) after receipt of a written request to do so from Parent; or (vii) the Company shall have materially breached Section 5.2 or Section 5.4. 
 
7.2 Notice of Termination; Effect of Termination. Any termination of this Agreement under and in accordance with Section 7.1 will be effective immediately upon (subject to, in the case of Section 7.1(e) or Section 7.1(f), if the proviso therein is applicable, prior delivery of notice of the breach 30 days prior to notice of termination) the delivery of written notice of the terminating party to the other parties hereto. In the event of the termination of this Agreement as provided in Section 7.1, this Agreement shall be of no further force or effect and there shall be no Liability to any party hereunder in connection with the Agreement or the Transactions, except (i) as set forth in Section 5.3(a), this Section 7.2, Section 7.3 and Article VIII, each of which shall survive the termination of this Agreement, and (ii) nothing herein shall relieve any party from Liability for any intentional or willful breach of, or any intentional misrepresentation made in this Agreement. No termination of this Agreement shall affect the obligations of the parties contained in the Confidentiality Agreement, all of which obligations shall survive termination of this Agreement in accordance with their terms.
 
7.3 Fees and Expenses.
 
(a) General. Except as set forth in this Section 7.3, all fees and expenses incurred in connection with this Agreement and the Transactions shall be paid by the party incurring such expenses whether or not the Merger is consummated; provided that Parent and the Company shall share equally the filing fees for the Notification and Report Forms filed with the FTC and DOJ under the HSR Act and premerger notification and report forms under similar applicable Legal Requirements of other jurisdictions.
 
(b) Company Payments. 
 
(i) Provided no Termination Fee is payable pursuant to clauses (ii) or (iii) below, the Company shall pay to Parent in immediately available funds prior to or concurrently with such termination an amount equal to Thirty-Two Million Dollars ($32,000,000) (the “Termination Fee”) if this Agreement is terminated by the Company pursuant to Section 7.1(h).
 
(ii) Provided no Termination Fee is payable pursuant to clause (i) above or (iii) below, the Company shall pay to Parent in immediately available funds, within one (1) business day thereafter the Termination Fee if this Agreement is terminated by Parent or the Company and prior to such termination a Triggering Event shall have occurred.
 
(iii) Provided no Termination Fee is payable pursuant to clauses (i) or (ii) above, the Company shall pay to Parent in immediately available funds, within two (2) business days thereafter, an amount equal to the Termination Fee, if this Agreement is terminated by Parent or the Company pursuant to


54



Section 7.1(b) or the Company Stockholder Approval shall not have been obtained at the Stockholders’ Meeting or any adjournment or postponement thereof and any of the following shall occur:
 
(1) if following the date hereof and prior to the termination of this Agreement, a third party has announced an Acquisition Proposal, and within 12 months following the termination of this Agreement, any Company Acquisition (as defined below) is consummated; or
 
(2) if following the date hereof and prior to the termination of this Agreement, a third party has announced an Acquisition Proposal, and within 12 months following the termination of this Agreement, the Company enters into a letter of intent or similar document or any Contract providing for any Company Acquisition and a Company Acquisition is ultimately consummated (whether prior to or after such twelve-month period).
 
(iv) The Company hereby acknowledges and agrees that the agreements set forth in this Section 7.3(b) are an integral part of the transactions contemplated by this Agreement, and that, without these agreements, Parent would not enter into this Agreement. Accordingly, if the Company fails to pay in a timely manner the amounts due pursuant to this Section 7.3(b) and, in order to obtain such payment, Parent makes a claim that results in a judgment against the Company for the amounts set forth in this Section 7.3(b), the Company shall pay to Parent its reasonable costs and expenses (including reasonable attorneys’ fees and expenses) in connection with such suit, together with interest on the amounts set forth in this Section 7.3(b) at the prime rate of Citibank in effect on the date such payment was required to be made. Payment of the fees described in this Section 7.3(b) shall not be in lieu of damages incurred in the event of any intentional or willful breach of, or any intentional misrepresentation made in, this Agreement.
 
(v) No payment under this Section 7.3 shall limit in any respect any rights or remedies available to Parent and Merger Sub relating to any breach or failure to perform any representation, warranty, covenant or agreement set forth in this Agreement resulting, directly or indirectly, in the right to receive any payment under this Section 7.3. Notwithstanding any other provision of Section 7.3(b) (other than the immediately preceding sentence) to the contrary, in no event shall the Company be required to pay Parent any amounts under this Section 7.3(b) in excess of the Termination Fee.
 
(vi) For the purposes of this Agreement, “Company Acquisition” shall mean any of the following transactions (other than the transactions contemplated by this Agreement): (A) a merger, consolidation, business combination, recapitalization, liquidation, dissolution or similar transaction involving the Company pursuant to which the stockholders of the Company immediately preceding such transaction hold less than 80% of the aggregate equity interests in the surviving or resulting entity of such transaction or any direct or indirect parent thereof, (B) a sale or other disposition by the Company of assets representing in excess of 20% of the aggregate fair market value of the Company’s business immediately prior to such sale or (C) the acquisition by any person or group (including by way of a tender offer or an exchange offer or issuance by the Company), directly or indirectly, of beneficial ownership or a right to acquire beneficial ownership of shares representing in excess of 20% of the voting power of the then outstanding shares of capital stock of the Company.
 
(c) Parent Payment. In the event that (i) this Agreement is terminated by Parent or the Company pursuant to Section 7.1(b) or Section 7.1(c); provided, with respect to Section 7.1(c), solely to the extent such order, decree, ruling or other action is based on an Action brought by a Governmental Entity under Antitrust Laws and (ii) all of the conditions set forth in Section 6.1 are satisfied (other than (A) Section 6.1(b) solely to the extent the existence of such statute, rule, regulation, executive order, decree, injunction or other order is based upon Antitrust Laws in an Action brought by a Governmental Entity and (B) Section 6.1(c) solely to the extent such Legal Requirements are Antitrust Laws) and Section 6.3 (other than Section 6.3(d)) are satisfied, Parent shall promptly, but in no event later than three (3) business days following the receipt by Parent of documentation (in detail) of such expenses in form and substance reasonably satisfactory to Parent, reimburse the Company for its out-of-pocket fees and expenses, up to an aggregate of five million dollars ($5,000,000), incurred by Company after the filing of Company’s initial HSR notification and in connection with or relating


55



to the review pursuant to the HSR Act of the Transactions contemplated hereby (including fees and expenses of all attorneys, consultants, economists and other experts retained by Company and all duplicating and travel and related expenses), provided that Company will consult in advance with Parent, and consider in good faith the advice of Parent, regarding the retention of any consultants, economists and other experts.
 
7.4 Amendment. Subject to applicable law, this Agreement may be amended by the parties hereto at any time by execution of an instrument in writing signed on behalf of each of Parent and the Company.
 
7.5 Extension; Waiver. At any time prior to the Effective Time, the Company, on the one hand, or Parent and Merger Sub, on the other hand, may, to the extent legally allowed, (i) extend the time for the performance of any of the obligations or other acts of the other parties hereto, (ii) waive any inaccuracies in the representations and warranties made to such party contained herein or in any document delivered pursuant hereto and (iii) waive compliance with any of the agreements or conditions for the benefit of such party contained herein; provided that any condition set forth in Section 6.1(a) may not be waived without the express written consent of Parent and the Company. Any agreement on the part of a party hereto to any such extension or waiver shall be valid only if set forth in an instrument in writing signed on behalf of such party. Delay in exercising any right under this Agreement shall not constitute a waiver of such right.
 
ARTICLE VIII
GENERAL PROVISIONS
 
8.1 Non-Survival of Representations and Warranties. The representations and warranties of the Company, Parent and Merger Sub contained in this Agreement and the other agreements, certificates and documents contemplated hereby shall terminate and be of no further force or effect at, and as of, the Effective Time. The covenants and agreements in this Agreement and the other agreements, certificates and documents contemplated hereby shall terminate at the Effective Time unless such covenants or agreements by its terms contemplated performance after the Effective Time, it being understood this Section 8.1 shall not limit any covenant or agreement of the parties which by its terms contemplates performance after the Effective Time.
 
8.2 Notices. All notices and other communications hereunder shall be in writing and shall be deemed given if delivered personally or by commercial delivery service, or sent via telecopy (receipt confirmed) to the parties at the following addresses or telecopy numbers (or at such other address or telecopy numbers for a party as shall be specified by like notice):
 
(a) if to Parent or Merger Sub, to:
 
   Genentech, Inc.
   1 DNA Way
   South San Francisco, California 94080
   Attention: Corporate Secretary
   Telephone No.: (650) 225-1000
   Telecopy No.: (650) 467-9146
 
  with a copy to:
 
   Wilson Sonsini Goodrich & Rosati
   Professional Corporation
   650 Page Mill Road
   Palo Alto, California 94304
   Attention:   Martin W. Korman, Esq.
         Bradley L Finkelstein, Esq.
   Telephone No.: (650) 493-9300
   Telecopy No.: (650) 493-6811


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(b) if to the Company, to:
 
   Tanox, Inc.
   10555 Stella Link
   Houston, Texas 77025-5631
   Attention: General Counsel
   Telephone No.: (713) 578-4000
   Telecopy No.: (713) 578-5000
 
   with a copy to:
 
   Winstead Sechrest & Minick
   Professional Corporation
   919 Milam Street
   Houston, TX 77002
   Attention: Frank S. Wu, Esq.
   Telephone No.: (713) 650-8400
   Telecopy No.: (713) 650-2400
 
8.3 Interpretation; Knowledge.
 
(a) When a reference is made in this Agreement to Exhibits, such reference shall be to an Exhibit to this Agreement unless otherwise indicated. When a reference is made in this Agreement to Articles or Sections, such reference shall be to an Article or Section, respectively, of this Agreement unless otherwise indicated. Unless otherwise indicated the words “include,” “includes” and “including” when used herein shall be deemed in each case to be followed by the words “without limitation.” As used herein, an item shall be deemed to have been “furnished” to Parent if such item has been sent to Parent or its representatives, provided to Parent or its representatives or made available to Parent or its representatives for review, in a data room or otherwise. The table of contents and headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. When reference is made herein to “the business of” an entity, such reference shall be deemed to include the business of all direct and indirect subsidiaries of such entity. Reference to the subsidiaries of an entity shall be deemed to include all direct and indirect subsidiaries of such entity. Where a reference is made to a law, such reference is to such law, as amended, and all rules and regulations promulgated thereunder, unless the context requires otherwise.
 
(b) For purposes of this Agreement, the term “knowledge” means with respect to a party hereto, with respect to any matter in question, that any of the executive officers or directors of such party has actual knowledge of such matter; provided that with respect to any executive officer or director, such executive officer or director shall have made reasonable inquiry of the current Employees (other than Consultants who are not Significant Consultants) responsible for such matter in question.
 
(c) For purposes of this Agreement, the term “Material Adverse Effect” when used in connection with any entity, including the Company and its subsidiaries, means (1) any change, event, violation, inaccuracy, circumstance or effect, individually or when aggregated with other changes, events, violations, inaccuracies, circumstances or effects, that is or is reasonably expected to be materially adverse to (i) the business, assets (including intangible assets), liabilities, financial condition, or results of operations of such entity and its subsidiaries taken as a whole, (ii) the ability of such entity to perform its obligations under this Agreement and to timely consummate the Transactions, and (2) with respect to the Company or its subsidiaries, any event arising after the date of this Agreement relating to Omalizumab (Xolair) that would reasonably be expected to have a material adverse impact on the sales, future value or revenue of Omalizumab (Xolair); provided, however, that, except otherwise provided below, none of the following shall be deemed either alone or in combination to constitute, and none of the following shall be taken into account in determining whether there has been or will be, a Material Adverse Effect: (A) changes in the financial markets generally in the United States or that are the result of acts of war or terrorism; (B) general national or international


57



economic, financial, political or business conditions (including changes in Legal Requirements or GAAP or the interpretation thereof) in each case affecting generally the biopharmaceutical industry, which do not have a materially disproportionate effect (relative to other industry participants) on the Company and its subsidiaries taken as a whole; (C) the execution, announcement and performance of this Agreement by the Company or its subsidiaries, or any actions taken, delayed or omitted to be taken by the Company (and the results thereof) that are required or prohibited (but only in the event that the Company has sought a waiver from Parent, and Parent has failed to agree to such waiver within a reasonable period of time after such request), as the case may be, pursuant to this Agreement or at the specific request of Parent or Merger Sub (it being understood that the provision of consent contemplated under Section 5.1 hereof shall not be deemed to be at the specific request of Parent); (D) the failure of the applicable party to this Agreement to meet projections of earnings, cash burn rates, revenues or other financial measures (whether such projections were made by such party or independent third parties), in and of itself (it being understood that the facts or occurrences giving rise or contributing to such failure may be deemed to constitute, or be taken into account in determining whether there has been, or will be, a Material Adverse Effect); (E) any change in the stock price or trading volume of the applicable party to this Agreement, in and of itself (it being understood that the facts or occurrences giving rise or contributing to such failure may be deemed to constitute, or be taken into account in determining whether there has been, or will be, a Material Adverse Effect); (F) any item set forth on Schedule 8.3(F); (G) the results of any clinical trial (excluding Omalizumab (Xolair)); or (H) any change after the date hereof of Parent’s projections for the sale of Omalizumab (Xolair), in and of itself (it being understood that the facts or occurrences giving rise or contributing to such change may be deemed to constitute, or be taken into account in determining whether there has been, or will be, a Material Adverse Effect).
 
(d) For purposes of this Agreement, the term “person” shall mean any individual, corporation (including any non-profit corporation), general partnership, limited partnership, limited liability partnership, joint venture, estate, trust, company (including any limited liability company or joint stock company), firm or other enterprise, association, organization, entity or Governmental Entity.
 
(e) For purposes of this Agreement, the term “business day” shall mean each day that is not a Saturday, Sunday or other day on which banking institutions located in San Francisco, California are authorized or obligated by law or executive order to close, and the term “day” when not immediately preceded by the word “business” shall mean a calendar day.
 
(f) For purposes of this Agreement, the terms “subsidiary” and “subsidiaries” with respect to any party shall mean (i) solely with respect to the Company, Tanox Biotech (Shanghai) Co. Ltd. and (ii) any corporation, partnership, association, trust or other form of legal entity of which (A) more than 50% of the outstanding voting securities are directly or indirectly owned by such party, or (B) such party or any subsidiary of such party is a general partner (excluding partnerships in which such party or any subsidiary of such party does not have a majority of the voting interest of such partnership).
 
(g) Unless the context of this Agreement otherwise requires: (i) words of any gender include each other gender; (ii) words using the singular or plural number also include the plural or singular number, respectively; and (iii) the terms “hereof,” “herein,” “hereunder” and derivative or similar words refer to this entire Agreement.
 
8.4 Counterparts. This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement and shall become effective when one or more counterparts have been signed by each of the parties and delivered to the other party, it being understood that all parties need not sign the same counterpart.
 
8.5 Entire Agreement; Third Party Beneficiaries. This Agreement and the documents and instruments and other agreements among the parties hereto as contemplated by or referred to herein, including the Company Disclosure Letter, (a) constitute the entire agreement among the parties with respect to the subject matter hereof and supersede all prior agreements and understandings, both written and oral, among the parties with respect to


58



the subject matter hereof, it being understood that the Confidentiality Agreement shall continue in full force and effect and shall survive any termination of this Agreement as modified by Section 5.3(a) and Section 5.3(b) are not intended to confer, and shall not be construed as conferring, upon any other person any rights or remedies hereunder, except as specifically provided in Section 5.9(d).
 
8.6 Severability. In the event that any provision of this Agreement, or the application thereof, becomes or is declared by a court of competent jurisdiction to be illegal, void or unenforceable, the remainder of this Agreement will continue in full force and effect and the application of such provision to other persons or circumstances will be interpreted so as reasonably to effect the intent of the parties hereto. The parties further agree to replace such void or unenforceable provision of this Agreement with a valid and enforceable provision that will achieve, to the extent possible, the economic, business and other purposes of such void or unenforceable provision.
 
8.7 Other Remedies; Specific Performance. Except as otherwise provided herein, any and all remedies herein expressly conferred upon a party will be deemed cumulative with and not exclusive of any other remedy conferred hereby, or by law or equity upon such party, and the exercise by a party of any one remedy will not preclude the exercise of any other remedy, and nothing in this Agreement shall be deemed a waiver by any party of any right to specific performance or injunctive relief. The parties hereto agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties shall be entitled to seek an injunction or injunctions without the necessity of proving the inadequacy of money damages as a remedy and without the necessity of posting any bond or other security in order to prevent breaches of this Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity.
 
8.8 Governing Law; Jurisdiction. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, regardless of the laws that might otherwise govern under applicable principles of conflicts of law thereof. The parties hereto hereby irrevocably submit to the exclusive jurisdiction of the Court of Chancery in Newcastle County in the state of Delaware (and any appellate courts therefrom), or if such jurisdiction shall be unavailable, any court in the State of Delaware and the Federal courts of the United States of America, each located within Newcastle County in the State of Delaware., solely in respect of the interpretation and enforcement of the provisions of this Agreement and of the documents referred to in this Agreement, and in respect of the transactions contemplated hereby and thereby, and hereby waive, and agree not to assert, as a defense in any action, suit or proceeding for the interpretation or enforcement hereof or thereof, that it is not subject thereto or that such action, suit or proceeding may not be brought or is not maintainable in said courts or that the venue thereof may not be appropriate or that this Agreement or any such document may not be enforced in or by such courts, and the parties hereto irrevocably agree that all claims with respect to such action or proceeding shall be heard and determined in the Court of Chancery in the State of Delaware or, if jurisdiction is not available in the Court of Chancery, any other Delaware state court or Federal court, each located in Newcastle, County Delaware. The parties hereby consent to and grant any such court jurisdiction over the person of such parties and over the subject matter of such dispute and agree that mailing of process or other papers in connection with any such action or proceeding in the manner provided in Section 8.2 or in such other manner as may be permitted by applicable law, shall be valid and sufficient service thereof. With respect to any particular action, suit or proceeding, venue shall lie solely in Newcastle County, Delaware.
 
8.9 Rules of Construction. The parties hereto agree that they have been represented by counsel during the negotiation and execution of this Agreement and, therefore, waive the application of any law, regulation, holding or rule of construction providing that ambiguities in an agreement or other document will be construed against the party drafting such agreement or document.
 
8.10 Assignment. No party may assign or delegate, in whole or in part, by operation of law or otherwise, either this Agreement or any of the rights, interests, or obligations hereunder without the prior written approval of the other parties, and any such assignment without such prior written consent shall be null and void, except


59



that Parent may assign its rights (but not its obligations) under this Agreement to any direct or indirect wholly-owned subsidiary of Parent without the prior written consent of the Company. Subject to the preceding sentence, this Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns.
 
8.11 Waiver of Jury Trial. EACH OF PARENT, COMPANY AND MERGER SUB HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF PARENT, COMPANY OR MERGER SUB IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF.
 
[Remainder of Page Intentionally Left Blank]


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IN WITNESS WHEREOF, the parties hereto have caused this Agreement and Plan of Merger to be executed by their duly authorized respective officers as of the date first written above.


 
GENENTECH, INC.
     
 
By:
/s/  ARTHUR LEVINSON
   
Arthur Levinson, Chairman and
Chief Executive Officer
     
     
 
GREEN ACQUISITION CORPORATION
     
 
By:
/s/  STEPHEN JUELSGAARD
   
Stephen Juelsgaard, President and
Chief Executive Officer
     
     
 
TANOX, INC.
     
 
By:
/s/  NANCY T. CHANG
   
Nancy Chang,
Chairman of the Board of Directors

****Signature Page to Agreement and Plan of Merger****

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EX-10.39 6 dna-ex10_39.htm FORM OF VOTING AGREEMENT BETWEEN GENENTECH, INC. AND CERTAIN STOCKHOLDERS OF TANOX, INC. Form of Voting Agreement between Genentech, Inc. and Certain Stockholders of Tanox, Inc.

EXHIBIT 10.39
 
EXECUTION COPY
FORM OF VOTING AGREEMENT
THIS VOTING AGREEMENT (this “Agreement”) is made and entered into as of November 9, 2006, by and between Genentech, Inc., a Delaware corporation (“Parent”) and the undersigned stockholder (“Stockholder”) of Tanox, Inc. (the “Company”).
RECITALS
A. Concurrently with the execution of this Agreement, Parent and the Company have entered into an Agreement and Plan of Merger (the “Merger Agreement”), which provides for the merger (the “Merger”) of a wholly-owned subsidiary of Parent with and into the Company.
B. Pursuant to the Merger, all of the issued and outstanding shares of capital stock and options of the Company will be canceled and converted into the right to receive the consideration set forth in the Merger Agreement, all upon the terms and subject to the conditions set forth in the Merger Agreement.
C. As of the date hereof, Stockholder is the beneficial owner (as defined in Rule 13d-3 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) of the number of shares of outstanding capital stock of the Company (the “Shares”) and other securities convertible into, or exercisable or exchangeable for, shares of capital stock of the Company (the “Options”), all as set forth on the signature page of this Agreement; provided that for purposes of determining beneficial ownership pursuant to this Agreement, Stockholder shall in all cases be deemed to be the beneficial owner of any securities which may be acquired by such Stockholder pursuant to any agreement, arrangement or understanding or upon the exercise of conversion rights, exchange rights, warrants or options, or otherwise (irrespective of whether the right to acquire such securities is exercisable immediately or only after the passage of time, including the passage of time in excess of 60 days, the satisfaction of any conditions, the occurrence of any event or any combination of the foregoing).
D. As a material inducement to Parent to enter into and to consummate the transactions contemplated by the Merger Agreement, Parent has required that Stockholder agree, and Stockholder is willing to agree, to restrict the transfer or disposition of any Shares, Options and any New Shares (as defined in Section 1(b) hereof), and to vote the Shares and any New Shares as set forth in this Agreement.
NOW, THEREFORE, the parties hereto hereby agree as follows:
1. Agreement to Retain Shares and Options.
(a) Transfer. Stockholder agrees that, at all times during the period beginning on the date hereof and ending at the Expiration Time, Stockholder shall not Transfer (as defined below) any of the Shares, Options and any New Shares, or make any agreement or understanding regarding any Transfer, in each case without the prior written consent of Parent. Stockholder agrees that any Transfer in violation of this Agreement shall be void and of no force or effect.
As used herein, the term “Expiration Time” shall mean the earlier to occur of (i) such date and time as the Merger shall become effective in accordance with the terms and provisions of the Merger Agreement, or (ii) the termination of the Merger Agreement in accordance with the terms thereof. As used herein, the term “Transfer” shall mean, with respect to any security, the direct or indirect assignment, sale, transfer, tender, pledge, hypothecation, or the gift, placement in trust, or the Constructive Sale (as defined below) or other disposition of such security (excluding [exercises of Options and]1 transfers by testamentary or intestate succession or otherwise by operation of law) or any right, title or interest therein (including, but not limited to, any right or power to vote to which the holder thereof may be entitled, whether such right or power is granted by proxy or otherwise), or the record or beneficial ownership thereof, the offer to make such a sale, transfer, tender, pledge, hypothecation or Constructive Sale or other disposition, and each agreement, arrangement or understanding, whether or not in writing, to effect any of the foregoing, excluding any Transfer (A) pursuant to a court order, (B) pursuant to the Merger, (C) to any affiliate or family member of Stockholder if such transferee, prior to the Transfer, executes a binding agreement with Parent and the Company substantially in the form of this Agreement [or (D) that is a sale (other than a Constructive Sale) in the open market through a brokers’ transaction (as defined in Rule 144(g) under the Securities Act of 1933, as amended)]2. As used herein, the term “Constructive Sale” shall mean, with respect to any security, a short sale with respect to such security, entering into or acquiring an offsetting derivative contract with respect to such security, entering into or acquiring a futures or forward contract to deliver such security or entering into any other hedging or other derivative transaction that has the effect of materially changing the economic benefits and risks of ownership.
(b) New Shares. Stockholder agrees that any shares of capital stock of the Company that Stockholder purchases or with respect to which Stockholder otherwise acquires beneficial ownership after the date of this Agreement and prior to the Expiration Time, including, without limitation, shares issued or issuable upon the conversion, exercise or exchange, as the case may be, of any Options held by Stockholder (“New Shares”), shall be subject to the terms and conditions of this Agreement to the same extent as if they constituted Shares as of the date hereof.
2. Agreement to Vote Shares. Until the Expiration Time, at every meeting of stockholders of the Company called with respect to any of the following, and at every adjournment or postponement thereof, and on every action or approval by written consent of stockholders of the Company with respect to any of the following, Stockholder shall vote, to the extent not voted by the person(s) appointed under the Proxy (as defined in Section 3), the outstanding Shares and any outstanding New Shares (to the extent any such New Shares may be voted):
 
1This language was included in voting agreements executed by Julia Brown, Heinz Bull, Danong Chen, Gary Frashier, Osama Mikhail and Peter Traber, but was excluded from the voting agreements executed by Nancy Chang and Tse-Wen Chang.
2This language was included in voting agreements executed by Julia Brown, Heinz Bull, Danong Chen, Gary Frashier, Osama Mikhail and Peter Traber, but was excluded from the voting agreements executed by Nancy Chang and Tse-Wen Chang.
          (i) in favor of adoption of the Merger Agreement and in favor of any other action contemplated by the Merger Agreement or required in furtherance of the Merger and the transactions contemplated by the Merger Agreement (including one or more adjournments necessary to solicit additional proxies if there are insufficient votes to adopt the Merger Agreement and any such related proposals at the time of any meeting held for such purposes);
(ii) against approval of any proposal made in opposition to, or in competition with, consummation of the Merger and the transactions contemplated by the Merger Agreement;
(iii) against any of the following actions (other than those actions contemplated by the Merger Agreement): (A) any merger, consolidation, business combination, sale of assets, reorganization or recapitalization of the Company or any subsidiary of the Company with any party, (B) any sale, lease, license or transfer of any significant part of the assets of the Company or any subsidiary of the Company, (C) any reorganization, recapitalization, dissolution, liquidation or winding up of the Company or any subsidiary of the Company, (D) any amendment to the certificate of incorporation or bylaws of the Company or any subsidiary of the Company or any material change in the capitalization of the Company or any subsidiary of the Company, or the corporate structure of the Company or any subsidiary of the Company, or (E) any other action that is intended, or could reasonably be expected to, impede, frustrate, prevent, interfere with, delay, postpone, discourage, nullify or adversely affect the Merger, the Merger Agreement or any of the other transactions contemplated by the Merger Agreement; and
(iv) in favor of waiving any notice that may have been or may be required relating to any such meeting of stockholders or written consent, the Merger, the Merger Agreement or the transactions contemplated thereby.
Prior to the Expiration Time, Stockholder shall not enter into any agreement or understanding with any person to vote or give instructions in any manner inconsistent with this Section 2. Prior to the Expiration Time, to the extent not represented thereat by the person(s) appointed under the Proxy, Stockholder shall [cause the Shares and any New Shares to be counted as present thereat for purposes of establishing quorum.]3
3. Irrevocable Proxy. Concurrently with the execution of this Agreement, Stockholder agrees to deliver to Parent an irrevocable proxy in the form attached hereto as Appendix A (the “Proxy”), which shall be irrevocable to the fullest extent permitted by applicable law, covering the total number of Shares and New Shares.
4. Representations, Warranties and Covenants of Stockholder. Stockholder represents, warrants and covenants to Parent as follows:
(i) Stockholder is the beneficial owner of the Shares, with full power to vote or direct the voting of the Shares and to dispose of the Shares for and on behalf of any and all beneficial owners of the Shares, with no limitations, qualifications or restrictions on such rights.
 
3This language was included in voting agreements executed by Julia Brown, Heinz Bull, Danong Chen, Gary Frashier, Osama Mikhail and Peter Traber. In the voting agreements executed by Nancy Chang and Tse-Wen Chang, the following language was substituted for the highlighted language: “appear at any meeting of stockholders of the Company and cause the Shares and any New Shares to be counted as present thereat for purposes of establishing quorum.”
 
(ii) As of the date hereof, the Shares are, and at all times up until the Expiration Time the Shares will be, free and clear of any rights of first refusal, co-sale rights, security interests, liens, pledges, claims, options, charges or other encumbrances of any kind or nature, in each case that could impair Stockholder’s ability to fulfill its obligations under Section 2. The execution and delivery of this Agreement by Stockholder do not, and Stockholder’s performance of its obligations under this Agreement will not, conflict with or violate any order, decree, judgment or Contract applicable to Stockholder or by which Stockholder or any of Stockholder’s properties or Shares is bound.
(iii) Stockholder does not beneficially own any shares of capital stock of the Company, or any securities convertible into, or exchangeable or exercisable for, shares of capital stock of the Company, other than as set forth on the signature page hereto.
(iv) Stockholder has full power and authority to make, enter into and carry out the terms of this Agreement, the Proxy and any other related agreements to which Stockholder is a party.
(v) Stockholder shall not take any action that the Company is prohibited from authorizing or permitting any Representative (as defined in the Merger Agreement) from taking under Section 5.4(a) of the Merger Agreement, whether or not Stockholder is or remains a Representative.
(vi) Stockholder agrees that it will not bring, commence, institute, maintain, prosecute, participate in or voluntarily aid any Action before any Governmental Entity, which alleges that the execution and delivery of this Agreement by Stockholder, either alone or together with the other Company voting agreements and proxies to be delivered in connection with the execution of the Merger Agreement, or the approval of the Merger Agreement by the board of directors of the Company, breaches any fiduciary duty of the board of directors of the Company or any member thereof; provided, that Stockholder may defend against, contest or settle any such action, claim, suit or cause of action brought against Stockholder that relates solely to Stockholder’s capacity as a director or officer of the Company.
(vii) Stockholder shall not exercise any rights (including under Section 262 of the Delaware Law) to demand appraisal or dissenters’ rights with respect to any Shares or New Shares that may be available with respect to the Merger.
5. Further Assurances. Stockholder hereby covenants and agrees to take, or cause to be taken, all actions, and to do, or cause to be done, all things reasonably necessary to fulfill such Stockholder’s obligations under this Agreement, and to execute and deliver any additional documents reasonably necessary or desirable to carry out the purpose and intent of this Agreement.
 
6. Consents and Waivers. Stockholder hereby gives any consents or waivers that are reasonably required for the consummation of the Merger under the terms of any Contract or other instrument to which Stockholder is a party or subject or in respect of any rights Stockholder may have. Stockholder further consents to the Company placing a stop transfer order on the Shares and any New Shares with its transfer agent(s) in accordance with Section 8.
7. Termination. This Agreement and the Proxy delivered in connection herewith shall terminate automatically and shall have no further force or effect as of the Expiration Time.
8. Company Covenants. The Company agrees to make a notation on its records and give instructions to its transfer agent(s) to not permit, prior to the Expiration Time, the transfer of any Shares or New Shares, except as permitted pursuant to Section 1(a).
9. Miscellaneous.
(a) Directors and Officers. Notwithstanding any provision of this Agreement to the contrary, Stockholder has entered into this Agreement in his or her capacity as a Stockholder of the Company, and nothing in this Agreement shall limit or restrict Stockholder from acting in the Stockholder’s capacity as a director or officer of the Company, as applicable (it being understood that this Agreement shall apply to Stockholder solely in Stockholder’s capacity as a stockholder of the Company).
(b) Waiver. No waiver by any party hereto of any condition or any breach of any term or provision set forth in this Agreement shall be effective unless in writing and signed by the other party hereto. The waiver of any breach of any term or provision of this Agreement shall not operate as or be construed to be a waiver of any other previous or subsequent breach of any term or provision of this Agreement. No delay or omission by Parent in exercising any right under this Agreement shall operate as a waiver of that right or any other right under this Agreement.
(c) Notices. All notices and other communications hereunder shall be in writing and shall be deemed given if delivered personally or by commercial delivery service, or sent via telecopy (receipt confirmed) to the parties at the following addresses or telecopy numbers (or at such other address or telecopy numbers for a party as shall be specified by like notice):
(i)if to Parent, to:
Genentech, Inc.
1 DNA Way
South San Francisco, California 94080
Attention: Corporate Secretary
Telephone No.: (650) 225-1000
Telecopy No.: (650) 467-9146
 
with a copy to:
Wilson Sonsini Goodrich & Rosati
Professional Corporation
650 Page Mill Road
Palo Alto, California 94304
Attention:  Martin W. Korman, Esq.
                              Bradley L Finkelstein, Esq.
Telephone No.: (650) 493-9300
Telecopy No.: (650) 493-6811
(ii)if to Stockholder: To the address for notice set forth on the signature page hereof.
(d) Headings. All captions and section headings used in this Agreement are for are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.
(e) Counterparts. This Agreement may be executed in one or more counterparts, all of which shall be considered the same agreement and shall become effective when one or more counterparts have been signed by each of the parties and delivered to the other party, it being understood that all parties need not sign the same counterpart.
(f) Entire Agreement; Amendment. This Agreement constitutes the entire agreement among the parties with respect to the subject matter hereof and supersedes all prior agreements and understandings, both written and oral, among the parties with respect to the subject matter hereof. This Agreement may not be changed or modified, except by an agreement in writing specifically referencing this Agreement and executed by each of the parties hereto.
(g) Severability. In the event that any provision of this Agreement, or the application thereof, becomes or is declared by a court of competent jurisdiction to be illegal, void or unenforceable, the remainder of this Agreement will continue in full force and effect and the application of such provision to other persons or circumstances will be interpreted so as reasonably to effect the intent of the parties hereto. The parties further agree to replace such void or unenforceable provision of this Agreement with a valid and enforceable provision that will achieve, to the extent possible, the economic, business and other purposes of such void or unenforceable provision.
(h) Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, regardless of the laws that might otherwise govern under applicable principles of conflicts of law thereof. The parties hereto hereby irrevocably submit to the exclusive jurisdiction of the Court of Chancery in Newcastle County in the state of Delaware (and any appellate courts therefrom), or if such jurisdiction shall be unavailable, any court in the State of Delaware and the Federal courts of the United States of America, each located within Newcastle County in the State of Delaware., solely in respect of the interpretation and enforcement of the provisions of this Agreement, and in respect of the transactions contemplated hereby and thereby, and hereby waive, and agree not to assert, as a defense in any action, suit or proceeding for the interpretation or enforcement hereof or thereof, that it is not subject thereto or that such action, suit or proceeding may not be brought or is not maintainable in said courts or that the venue thereof may not be appropriate or that this Agreement may not be enforced in or by such courts, and the parties hereto irrevocably agree that all claims with respect to such action or proceeding shall be heard and determined in the Court of Chancery in the State of Delaware or, if jurisdiction is not available in the Court of Chancery, any other Delaware state court or Federal court, each located in Newcastle, County Delaware. The parties hereby consent to and grant any such court jurisdiction over the person of such parties and over the subject matter of such dispute and agree that mailing of process or other papers in connection with any such action or proceeding in the manner provided in Section 9(c) or in such other manner as may be permitted by applicable law, shall be valid and sufficient service thereof. With respect to any particular action, suit or proceeding, venue shall lie solely in Newcastle County, Delaware.
(i) Rules of Construction. The parties hereto agree that they have been represented by counsel during the negotiation and execution of this Agreement and, therefore, waive the application of any law, regulation, holding or rule of construction providing that ambiguities in this Agreement will be construed against the party drafting such agreement or document. The words “include,” “includes” and “including” when used herein shall be deemed in each case to be followed by the words “without limitation.” All capitalized terms that are used but not defined herein shall have the meanings ascribed to them in the Merger Agreement.
(j) Remedies. The parties acknowledge that Parent will be irreparably harmed and that there will be no adequate remedy at law for a violation of any of the covenants or agreements of Stockholder set forth herein. Therefore, it is agreed that, in addition to any other remedies that may be available to Parent upon any such violation, Parent shall have the right to enforce such covenants and agreements by specific performance, injunctive relief or by any other means available to Parent at law or in equity.
(k) No Assignment. Unless otherwise provided for herein, Stockholder may not assign this Agreement. This Agreement shall inure to the benefit of Parent, Company and their respective successors and assigns.
(l) Waiver of Jury Trial. EACH OF PARENT AND STOCKHOLDER HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF PARENT OR STOCKHOLDER IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF.
 
[Remainder of Page Intentionally Left Blank]
 
IN WITNESS WHEREOF, the undersigned have executed this Agreement on the date first above written.
 
GENENTECH, INC.
By:
 
 
Name:
 
 
Title:
 
 
STOCKHOLDER:
 
 
Signature
 
 
Print Name
Shares:
Company Common Stock: ___________________________________
Company Options: _________________________________________
Stockholder’s address for notice:
 
 
 
 
 
 
**** Signature Page to Company Voting Agreement***  
APPENDIX A
IRREVOCABLE PROXY
The undersigned stockholder (“Stockholder”) of Tanox, Inc., a Delaware corporation (the “Company”), hereby irrevocably (to the fullest extent permitted by law) appoints Stephen Julesgaard and David Ebersman of Genentech, Inc., a Delaware corporation (“Parent”), and each of them, as the sole and exclusive attorneys-in-fact and proxies of the undersigned, with full power of substitution and resubstitution, to vote and exercise all voting and related rights (to the full extent that the undersigned is entitled to do so) with respect to all Shares and New Shares (each as defined in the that certain Voting Agreement, dated of even date herewith, by and among Parent, the Company and Stockholder (the “Voting Agreement”)), in accordance with the terms of this Proxy until the Expiration Time (as defined in the Voting Agreement). The Shares beneficially owned by the undersigned stockholder of the Company as of the date of this Proxy are listed on the final page of this Proxy. Upon the undersigned’s execution of this Proxy, any and all prior proxies given by the undersigned with respect to any Shares are hereby revoked and the undersigned hereby agrees not to grant any subsequent proxies with respect to the Shares or any New Shares until after the Expiration Time (as defined in the Voting Agreement).
This Proxy is irrevocable (to the fullest extent permitted by law), is coupled with an interest, is granted pursuant to the Voting Agreement, and is granted in consideration of Parent entering into that certain Agreement and Plan of Merger, dated as of November 9, 2006, by and among Parent, the Company and certain other parties (the “Merger Agreement”). The Merger Agreement provides for the merger of a wholly-owned subsidiary of Parent with and into the Company in accordance with its terms (the “Merger”), and Stockholder is receiving a portion of the proceeds of the Merger.
The attorneys-in-fact and proxies named above are hereby authorized and empowered by the undersigned, at any time prior to the Expiration Time, to act as the undersigned’s attorney-in-fact and proxy to vote the Shares and any New Shares, and to exercise all voting, consent and similar rights of the undersigned with respect to the Shares and new Shares (including, without limitation, the power to execute and deliver written consents), at every annual, special, adjourned or postponed meeting of stockholders of the Company and in every written consent in lieu of such meeting:
(i) in favor of adoption of the Merger Agreement and in favor of any other action contemplated by the Merger Agreement or required in furtherance of the Merger and the transactions contemplated by the Merger Agreement (including one or more adjournments necessary to solicit additional proxies if there are insufficient votes to adopt the Merger Agreement and any such related proposals at the time of any meeting held for such purposes);
 
           (ii) against approval of any proposal made in opposition to, or in competition with, consummation of the Merger and the transactions contemplated by the Merger Agreement;
(iii) against any of the following actions (other than those actions contemplated by the Merger Agreement): (A) any merger, consolidation, business combination, sale of assets, reorganization or recapitalization of the Company or any subsidiary of the Company with any party, (B) any sale, lease, license or transfer of any significant part of the assets of the Company or any subsidiary of the Company, (C) any reorganization, recapitalization, dissolution, liquidation or winding up of the Company or any subsidiary of the Company, (D) any amendment to the certificate of incorporation or bylaws of the Company or any subsidiary of the Company or any material change in the capitalization of the Company or any subsidiary of the Company, or the corporate structure of the Company or any subsidiary of the Company, or (E) any other action that is intended, or could reasonably be expected to, impede, frustrate, prevent, interfere with, delay, postpone, discourage, nullify or adversely affect the Merger, the Merger Agreement or any of the other transactions contemplated by the Merger Agreement; and
(iv) in favor of waiving any notice that may have been or may be required relating to any such meeting of stockholders or written consent, the Merger, the Merger Agreement or the transactions contemplated thereby.
Any obligation of the undersigned hereunder shall be binding upon the successors and assigns of the undersigned.
This Proxy shall terminate, and be of no further force and effect, automatically as of the Expiration Time.
[Remainder of Page Intentionally Left Blank]
*****
 
This Proxy shall terminate, and be of no further force and effect, automatically upon the Expiration Time (as defined in the Voting Agreement).
Dated: November 9, 2006
 
 
 
Signature
 
 
Print Name
 
 
 
 
Address
Shares:
Company Common Stock: ___________________________________
Company Options: _________________________________________
****Signature Page to Proxy****
 

EX-23.1 7 dna-ex23_1.htm CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM Consent of Independent Registered Public Accounting Firm


EXHIBIT 23.1


Consent of Independent Registered Public Accounting Firm

We consent to the incorporation by reference in the following Registration Statements:

(1)  
Registration Statement (Form S-8 No. 333-133841) pertaining to the 1991 Employee Stock Plan of Genentech, Inc.,
(2)  
Registration Statement (Form S-3 No. 333-37072) of Genentech, Inc.,
(3)  
Registration Statement (Form S-8 No. 333-115219) pertaining to the 1999 Stock Plan, 1991 Employee Stock Plan, and 2004 Equity Incentive Plan of Genentech, Inc.,
(4)  
Registration Statement (Form S-8 No. 333-87444) pertaining to the 1999 Stock Plan of Genentech, Inc.,
(5)  
Registration Statement (Form S-8 No. 333-94749) pertaining to the Tax Reduction Investment Plan of Genentech, Inc.,
(6)  
Registration Statement (Form S-8 No. 333-90669) pertaining to the 1999 Stock Plan and 1991 Employee Stock Plan of Genentech, Inc.,
(7)  
Registration Statement (Form S-8 No. 333-83989) pertaining to the 1999 Stock Plan and 1991 Employee Stock Plan of Genentech, Inc., and
(8)  
Registration Statement (Form S-8 No. 333-83157) pertaining to the 1990 Stock Option/Stock Incentive Plan, 1994 Stock Option Plan, and 1996 Stock Option/Stock Incentive Plan of Genentech, Inc.;

of our reports dated February 5, 2007, with respect to the consolidated financial statements and schedule of Genentech, Inc., Genentech, Inc. management’s assessment of the effectiveness of internal control over financial reporting, and the effectiveness of internal control over financial reporting of Genentech, Inc., included in this Annual Report (Form 10-K) for the year ended December 31, 2006.

 
/s/ ERNST & YOUNG LLP

Palo Alto, California
February 20, 2007
 
 

EX-31.1 8 dna-ex31_1.htm CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO RULES 13A-14(A) AND 15D-14(A) PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended


EXHIBIT 31.1



I, Arthur D. Levinson, certify that:

1.   I have reviewed this annual report on Form 10-K of Genentech, Inc.;

2.   Based on my knowledge, this 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 report;

3.   Based on my knowledge, the financial statements, and other financial information included in this 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 report;
 
4.   The registrant’s other certifying officer(s) 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 report is being prepared;

b)   Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)   Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)   Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5.   The registrant’s other certifying officer(s) 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:
 February 23, 2007
 
By:
/s/ ARTHUR D. LEVINSON
       
Arthur D. Levinson, Ph.D.
Chief Executive Officer


EX-31.2 9 dna-ex31_2.htm CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO RULES 13A-14(A) AND 15D-14(A) PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended


EXHIBIT 31.2



I, David A. Ebersman, certify that:

1.   I have reviewed this annual report on Form 10-K of Genentech, Inc.;

2.   Based on my knowledge, this 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 report;

3.   Based on my knowledge, the financial statements, and other financial information included in this 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 report;

4.   The registrant’s other certifying officer(s) 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 report is being prepared;

b)   Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)   Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)   Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.   The registrant’s other certifying officer(s) 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:
 February 23, 2007
 
By:
/s/ DAVID A. EBERSMAN
       
David A. Ebersman
Executive Vice President and
Chief Financial Officer


EX-32.1 10 dna-ex32_1.htm CERTIFICATIONS OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002


EXHIBIT 32.1


CERTIFICATIONS OF
CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

I, Arthur D. Levinson, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Annual Report of Genentech, Inc. on Form 10-K for the year ended December 31, 2006 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Annual Report of Genentech, Inc. on Form 10-K fairly presents in all material respects the financial condition and results of operations of Genentech, Inc.


 
By:
/s/ ARTHUR D. LEVINSON
 
 
Name:
Title:
Date:
Arthur D. Levinson, Ph.D.
Chief Executive Officer
February 23, 2007
 


I, David A. Ebersman, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Annual Report of Genentech, Inc. on Form 10-K for the year ended December 31, 2006 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Annual Report of Genentech, Inc. on Form 10-K fairly presents in all material respects the financial condition and results of operations of Genentech, Inc.


 
By:
/s/ DAVID A. EBERSMAN
 
 
Name:
Title:
 
Date:
David A. Ebersman
Executive Vice President and
   Chief Financial Officer
February 23, 2007
 


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