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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, 2008

or

 

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

Commission File Number 1-10269

Allergan, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware   95-1622442

(State or Other Jurisdiction of

Incorporation or Organization)

  (I.R.S. Employer Identification No.)

2525 Dupont Drive

Irvine, California

 

92612

(Zip Code)

(Address of Principal Executive Offices)  

(714) 246-4500

(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, $0.01 Par Value

Preferred Share Purchase Rights

  New York Stock Exchange

Securities Registered Pursuant to Section 12(g) of the Act: None

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   ¨

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   ¨     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   ¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) 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.     ¨

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

 

Large accelerated filer   þ   Accelerated filer   ¨
Non-accelerated filer   ¨  (Do not check if a smaller reporting company)   Smaller reporting company   ¨

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

As of June 30, 2008, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately $15,974 million based on the closing sale price as reported on the New York Stock Exchange.

Common stock outstanding as of February 24, 2009 — 307,511,888 shares (including 3,035,522 shares held in treasury).

DOCUMENTS INCORPORATED BY REFERENCE

Part III of this report incorporates certain information by reference from the registrant’s proxy statement for the annual meeting of stockholders to be held on April 30, 2009, which proxy statement will be filed no later than 120 days after the close of the registrant’s fiscal year ended December 31, 2008.

 

 

 


Table of Contents

TABLE OF CONTENTS

 

          Page
PART I.        1

Item 1.

   Business    1

Item 1A.

   Risk Factors    32

Item 1B.

   Unresolved Staff Comments    51

Item 2.

   Properties    52

Item 3.

   Legal Proceedings    52

Item 4.

   Submission of Matters to a Vote of Security Holders    55
PART II.        56

Item 5.

   Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities    56

Item 6.

   Selected Financial Data    57

Item 7.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations    57

Item 7A.

   Quantitative and Qualitative Disclosures About Market Risk    88

Item 8.

   Financial Statements and Supplementary Data    92

Item 9.

   Changes in and Disagreements with Accountants on Accounting and Financial Disclosure    92

Item 9A.

   Controls and Procedures    93

Item 9B.

   Other Information    93
PART III.        94

Item 10.

   Directors, Executive Officers and Corporate Governance    94

Item 11.

   Executive Compensation    94

Item 12.

   Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters    94

Item 13.

   Certain Relationships and Related Transactions, and Director Independence    94

Item 14.

   Principal Accounting Fees and Services    94
PART IV.        95

Item 15.

   Exhibits and Financial Statement Schedules    95
SIGNATURES    103

 

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Statements made by us in this report and in other reports and statements released by us that are not historical facts constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21 of the Securities Exchange Act of 1934. These forward-looking statements are necessarily estimates reflecting the best judgment of our senior management based on our current estimates, expectations, forecasts and projections and include comments that express our current opinions about trends and factors that may impact future operating results. Disclosures that use words such as we “believe,” “anticipate,” “estimate,” “intend,” “could,” “plan,” “expect,” “project” or the negative of these, as well as similar expressions, are intended to identify forward-looking statements. These statements are not guarantees of future performance and rely on a number of assumptions concerning future events, many of which are outside of our control, and involve known and unknown risks and uncertainties that could cause our actual results, performance or achievements, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. We discuss such risks, uncertainties and other factors throughout this report and specifically under the caption “Risk Factors” in Item 1A of Part I of this report below. Any such forward-looking statements, whether made in this report or elsewhere, should be considered in the context of the various disclosures made by us about our businesses including, without limitation, the risk factors discussed below. Except as required under the federal securities laws and the rules and regulations of the U.S. Securities and Exchange Commission, we do not have any intention or obligation to update publicly any forward-looking statements, whether as a result of new information, future events, changes in assumptions or otherwise.

PART I

 

Item 1. Business

General Overview of our Business

We are a multi-specialty health care company focused on developing and commercializing innovative pharmaceuticals, biologics and medical devices that enable people to see more clearly, move more freely and express themselves more fully. Our diversified approach enables us to follow our research and development into new specialty areas where unmet needs are significant.

We discover, develop and commercialize specialty pharmaceutical, medical device and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention, urological and other specialty markets in more than 100 countries around the world. We are a pioneer in specialty pharmaceutical research, targeting products and technologies related to specific disease areas such as chronic dry eye, glaucoma, retinal disease, psoriasis, acne, movement disorders, neuropathic pain and genitourinary diseases. Our diversified business model includes products for which consumers may be eligible for reimbursement and cash pay products that consumers pay for directly. Based on internal information and assumptions, we estimate that in fiscal year 2008, approximately 70% of our net product sales were derived from reimbursable products and 30% of our net product sales were derived from cash pay products.

In March 2006, we completed the acquisition of Inamed Corporation, or Inamed, a global healthcare manufacturer and marketer of breast implants, a range of dermal filler products to correct facial wrinkles, and bariatric medical devices for approximately $3.3 billion, consisting of approximately $1.4 billion in cash and 34,883,386 shares of our common stock.

In January 2007, we acquired all of the outstanding capital stock of Groupe Cornéal Laboratoires, or Cornéal, a healthcare company that develops, manufactures and markets dermal fillers, viscoelastics and a range of ophthalmic surgical device products, for an aggregate purchase price of approximately $209.2 million, net of cash acquired. The acquisition of Cornéal expanded our marketing rights to Juvéderm ® and a range of hyaluronic acid dermal fillers from the United States, Canada and Australia to all countries worldwide and provided us with control over the manufacturing process and future research and development of Juvéderm ® and other dermal fillers.

 

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In October 2007, we acquired all of the outstanding capital stock of Esprit Pharma Holding Company, Inc., or Esprit, for an aggregate purchase price of approximately $370.8 million, net of cash acquired. In addition to marketing Sanctura ® (trospium chloride), a twice-a-day anticholinergic approved for the treatment of overactive bladder, or OAB, the U.S. Food and Drug Administration, or FDA, approved Sanctura XR ® (trospium chloride extended release capsules) for the once-daily treatment of OAB in August 2007. By acquiring Esprit, we obtained an exclusive license to market Sanctura ® and Sanctura XR ® in the United States and its territories from Indevus Pharmaceuticals, Inc., or Indevus. We pay royalties to Indevus based upon our sales of Sanctura ® and Sanctura XR ® and assumed obligations of Esprit to pay certain other third-party royalties, also based upon sales of Sanctura ® and Sanctura XR ® . We also entered into a co-promotion agreement with Indevus, which we amended in January 2009, pursuant to which Indevus co-promotes Sanctura ® and Sanctura XR ® with us in the United States through the third quarter of 2009. We launched Sanctura XR ® in the United States in January 2008. In May 2008, we entered into a license agreement with Indevus and Madaus GmbH, which grants us the right to seek approval for and to commercialize Sanctura XR ® in Canada.

In July 2008, we acquired Aczone ® (dapsone) gel 5% from QLT USA, Inc., or QLT, a wholly-owned subsidiary of QLT Inc. We paid approximately $150 million for all of QLT’s assets worldwide relating to Aczone ® . Aczone ® , approved for sale in both the United States and Canada, is indicated for the treatment of acne vulgaris in patients 12 and older. Aczone ® contains the first new FDA-approved chemical entity (dapsone) for acne treatment since Tazorac ® (tazarotene) gel was approved in 1997. We launched Aczone ® in the United States in November 2008 and plan to launch Aczone ® in Canada in mid-2009.

In October 2008, we entered into a strategic collaboration arrangement with Spectrum Pharmaceuticals, Inc., or Spectrum, to develop and commercialize apaziquone, an antineoplastic agent currently being investigated for the treatment of non-muscle invasive bladder cancer by intravesical instillation. Under the collaboration, Spectrum will conduct two Phase III clinical trials to explore apaziquone’s safety and efficacy as a potential treatment for non-muscle invasive bladder cancer following surgery. Spectrum expects to complete enrollment in the trials by the end of 2009. We made an initial payment of $41.5 million to Spectrum and will make additional payments of up to $304 million based on the achievement of certain development, regulatory and commercialization milestones. Spectrum retained exclusive rights to apaziquone in Asia, including Japan and China. We received exclusive rights to apaziquone for the treatment of bladder cancer in the rest of the world, including the United States, Canada and Europe. In the United States, we will co-promote apaziquone with Spectrum and share equally in the profits and expenses. We will also pay Spectrum royalties on all of our apaziquone sales outside of the United States. Spectrum will continue to conduct the apaziquone clinical trials pursuant to a joint development plan, and we will bear the majority of these expenses.

In February 2009, in order to concentrate our resources during the current recessionary period on customer-facing activities and on building the strength of our research and development pipeline while continuing to deliver on our earnings goals, we conducted a worldwide review of our operations to improve efficiency and began implementing a restructuring plan. Pursuant to the restructuring plan, we have focused our spending on programs and businesses that produce the highest returns. The restructuring plan involved a workforce reduction of approximately 460 employees, or approximately five percent of our global headcount, primarily in the United States and Europe. The majority of the employees affected by the restructuring plan were in two areas: (1) U.S. urology sales and marketing personnel as a result of our decision to focus on the urology specialty and to seek a partner to promote Sanctura XR ® to general practitioners, and (2) marketing personnel in the United States and Europe as we adjust our back-office structures to a reduced short-term outlook for some of our businesses. We have made modest reductions in other functions as well as re-engineered our processes in order to increase productivity. Furthermore, in connection with the restructuring plan, we accelerated the vesting and removed certain stock option expiration features for all employees holding the 2008 full-round employee stock options granted in February 2008 and modified certain stock option expiration features for other stock options held by employees impacted by the restructuring plan. We anticipate substantially completing the restructuring plan by the end of the second quarter of 2009.

 

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We were founded in 1950 and incorporated in Delaware in 1977. Our principal executive offices are located at 2525 Dupont Drive, Irvine, California, 92612, and our telephone number at that location is (714) 246-4500. Our Internet website address is www.allergan.com 1 . We make our periodic and current reports, together with amendments to these reports, available on our Internet website, free of charge, as soon as reasonably practicable after such material is electronically filed with, or furnished to, the Securities and Exchange Commission. Members of the public may read and copy any materials we file with, or furnish to, the Securities and Exchange Commission, or SEC, at the SEC’s Public Reference Room at 450 Fifth Street, NW, Washington, DC 20549. To obtain information on the operation of the Public Reference Room, please call the SEC at 1-800-SEC-0330. The SEC also maintains an Internet site at www.sec.gov that contains the reports, proxy and information statements, and other information that we file electronically with the SEC.

Operating Segments

Through the first fiscal quarter of 2006, we operated our business on the basis of a single reportable segment — specialty pharmaceuticals. Due to the Inamed acquisition, beginning in the second fiscal quarter of 2006, we operated our business on the basis of two reportable segments — specialty pharmaceuticals and medical devices. The specialty pharmaceuticals segment produces a broad range of pharmaceutical products, including: ophthalmic products for chronic dry eye, glaucoma therapy, ocular inflammation, infection and allergy; Botox ® for certain therapeutic and aesthetic indications; skin care products for acne, psoriasis, other prescription and over-the-counter skin care products and, beginning in the first quarter of 2009, eyelash growth products; and, beginning in the fourth quarter of 2007, urologics products. The medical devices segment produces a broad range of medical devices, including: breast implants for augmentation, revision and reconstructive surgery; obesity intervention products, including the Lap-Band ® System and the Orbera TM Intragastric Balloon System (formerly known as the BIB ® System) and facial aesthetics products. The following table sets forth, for the periods indicated, product net sales for each of our product lines within our specialty pharmaceuticals segment and medical devices segment, domestic and international sales as a percentage of total product net sales within our specialty pharmaceuticals segment and medical devices segment, and segment operating income for our specialty pharmaceuticals segment and medical devices segment:

 

1

This website address is not intended to function as a hyperlink and the information at this website address is not incorporated by reference into this Annual Report on Form 10-K.

 

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    Year Ended December 31,  
    2008     2007     2006  
    (in millions)  

Specialty Pharmaceuticals Segment Product Net Sales by Product Line

 

Eye Care Pharmaceuticals

  $ 2,009.1     $ 1,776.5     $ 1,530.6  

Botox ® /Neuromodulator

    1,310.9       1,211.8       982.2  

Skin Care Products

    113.7       110.7       125.7  

Urologics

    68.6       6.0        
                       

Total Specialty Pharmaceuticals Segment Product Net Sales

  $ 3,502.3     $ 3,105.0     $ 2,638.5  
                       

Specialty Pharmaceuticals Segment Product Net Sales

     

Domestic

    65.2 %     65.8 %     67.9 %

International

    34.8 %     34.2 %     32.1 %

Medical Devices Segment Product Net Sales by Product Line

     

Breast Aesthetics

  $ 310.0     $ 298.4     $ 177.2  

Obesity Intervention

    296.0       270.1       142.3  

Facial Aesthetics

    231.4       202.8       52.1  
                       

Core Medical Devices

    837.4       771.3       371.6  

Other(1)

          2.7        
                       

Total Medical Devices Segment Product Net Sales

  $ 837.4     $ 774.0     $ 371.6  
                       

Medical Devices Segment Product Net Sales

     

Domestic

    62.0 %     65.1 %     64.2 %

International

    38.0 %     34.9 %     35.8 %

Specialty Pharmaceuticals Segment Operating Income(2)

  $ 1,220.1     $ 1,047.9     $ 888.8  

Medical Devices Segment Operating Income(2)

    222.0       207.1       119.9  

Consolidated Long-Lived Assets

     

Domestic

  $ 3,779.7     $ 3,702.0     $ 3,279.0  

International

    553.8       557.5       244.0  

 

 
  (1) Other medical device product sales primarily consist of sales of ophthalmic surgical devices pursuant to a manufacturing and supply agreement entered into as part of the July 2007 sale of the former Cornéal ophthalmic surgical device business, which was substantially concluded in December 2007.

 

  (2) Management evaluates business segment performance on an operating income basis exclusive of general and administrative expenses and other indirect costs, restructuring charges, in-process research and development expenses, amortization of identifiable intangible assets related to business combinations and asset acquisitions and certain other adjustments, which are not allocated to our business segments for performance assessment by our chief operating decision maker. Other adjustments excluded from our business segments for purposes of performance assessment represent income or expenses that do not reflect, according to established company-defined criteria, operating income or expenses associated with our core business activities.

We do not discretely allocate assets to our operating segments, nor does our chief operating decision maker evaluate operating segments using discrete asset information.

See Note 18, “Business Segment Information,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules,” for further information concerning our foreign and domestic operations.

 

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Specialty Pharmaceuticals Segment

Eye Care Pharmaceuticals Product Line

We develop, manufacture and market a broad range of prescription and non-prescription products designed to treat diseases and disorders of the eye, including chronic dry eye, glaucoma, inflammation, infection and allergy.

Chronic Dry Eye. Restasis ® (cyclosporine ophthalmic emulsion) 0.05%, or Restasis ® , is the first and currently the only prescription therapy for the treatment of chronic dry eye worldwide. Restasis ® is our best selling eye care product. Chronic dry eye is a painful and irritating condition involving abnormalities and deficiencies in the tear film initiated by a variety of causes. The incidence of chronic dry eye increases markedly with age, after menopause in women and in people with systemic diseases such as Sjögren’s syndrome and rheumatoid arthritis. Until the approval of Restasis ® , physicians used lubricating tears as a temporary measure to provide palliative relief of the debilitating symptoms of chronic dry eye. We launched Restasis ® in the United States in April 2003 under a license from Novartis AG, or Novartis, for the ophthalmic use of cyclosporine. Restasis ® is currently approved in 28 countries. In April 2005, we entered into a royalty buy-out agreement with Novartis related to Restasis ® and agreed to pay $110 million to Novartis in exchange for Novartis’ worldwide rights and obligations, excluding Japan, for technology, patents and products relating to the topical ophthalmic use of cyclosporine A, the active ingredient in Restasis ® . Under the royalty buy-out agreement, we no longer make royalty payments to Novartis in connection with our sales of Restasis ® . In June 2001, we entered into a licensing, development and marketing agreement with Inspire Pharmaceuticals, Inc., or Inspire, under which we obtained an exclusive license to develop and commercialize Inspire’s product candidate, Prolacria TM (diquafosol tetrasodium) 2%, or Prolacria TM , a treatment to relieve the signs of chronic dry eye by rehydrating conjunctival mucosa and increasing non-lacrimal tear component production, in exchange for our agreement to make royalty payments to Inspire on sales of both Restasis ® and, ultimately Prolacria TM , and for Inspire to promote Restasis ® in the United States. In December 2003, the FDA issued an approvable letter for Prolacria TM and also requested additional clinical data. In February 2005, Inspire announced that Prolacria TM failed to demonstrate statistically significant improvement as compared to a placebo for the primary endpoint of the incidence of corneal clearing. Inspire also announced that Prolacria TM achieved improvement compared to a placebo for a number of secondary endpoints. Inspire filed a New Drug Application, or NDA, amendment with the FDA in the second quarter of 2005. In December 2005, Inspire announced that it had received a second approvable letter from the FDA in connection with Prolacria TM . In January 2009, Inspire announced that it had reached agreement with the FDA on the design for a pivotal Phase III clinical trial for Prolacria TM . In December 2008, under an amendment to the licensing, development and marketing agreement, Inspire ceased co-promoting Restasis ® in the United States.

Artificial Tears . Our artificial tears products, including the Refresh ® and Optive TM brands, treat dry eye symptoms including irritation and dryness due to pollution, computer use, aging and other causes. Refresh ® , launched in 1986, is the best selling over-the-counter artificial tears brand in the United States and includes a wide range of preserved and non-preserved drops as well as ointments to treat dry eye symptoms. The Optive TM brand, including Optive TM Lubricant Eye Drops and Optive TM Sensitive Preservative-Free Lubricant Eye Drops, provides a dual-action formula to lubricate the surface of the eye and hydrate the eye at a cellular level to relieve dry eye symptoms. We launched Optive TM Lubricant Eye Drops in the United States in September 2006 and in certain countries in Europe in September 2007. We launched Optive TM Sensitive Preservative-Free Lubricant Eye Drops in the United States in August 2008 and in certain countries in Europe in January 2009. According to IMS Health Incorporated, an independent marketing research firm, our artificial tears products, including the Refresh ® and Optive TM brands, were again the number one selling artificial tears products worldwide for the first nine months of 2008.

 

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Glaucoma.  The largest segment of the market for ophthalmic prescription drugs is for the treatment of glaucoma, a sight-threatening disease typically characterized by elevated intraocular pressure leading to optic nerve damage. Glaucoma is currently the world’s second leading cause of blindness, and we estimate that over 60 million people worldwide have glaucoma. According to IMS Health Incorporated, our products for the treatment of glaucoma, including Lumigan ® (bimatoprost ophthalmic solution) 0.03%, or Lumigan ® , Alphagan ® (brimonidine tartrate ophthalmic solution) 0.2%, or Alphagan ® , Alphagan ® P (brimonidine tartrate ophthalmic solution) 0.15%, or Alphagan ® P 0.15% , Alphagan ® P (brimonidine tartrate ophthalmic solution) 0.1%, or Alphagan ® P 0.1%, Combigan ® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, or Combigan ® and Ganfort TM (bimatoprost/timolol maleate ophthalmic solution) captured approximately 18% of the worldwide glaucoma market for the first nine months of 2008.

Lumigan ® is a topical treatment indicated for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension. We currently sell Lumigan ® in over 75 countries worldwide and it is our second best selling eye care product. According to IMS Health Incorporated, Lumigan ® was the fourth best selling glaucoma product in the world for the first nine months of 2008. In March 2002, the European Commission approved Lumigan ® through its centralized procedure. In January 2004, the European Union’s Committee for Proprietary Medicinal Products approved Lumigan ® as a first-line therapy for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension. In June 2006, the FDA approved Lumigan ® as a first-line therapy. In May 2004, we entered into an exclusive licensing agreement with Senju Pharmaceutical Co., Ltd., or Senju, under which Senju became responsible for the development and commercialization of Lumigan ® in Japan. Senju incurs associated costs, makes clinical development and commercialization milestone payments and makes royalty-based payments on product sales. We agreed to work collaboratively with Senju on overall product strategy and management. In June 2007, Senju filed a new drug application in Japan for Lumigan ® .

In November 2003, we filed an NDA with the FDA for Ganfort TM , a Lumigan ® and timolol combination designed to treat glaucoma or ocular hypertension. In August 2004, we announced that the FDA issued an approvable letter for Ganfort TM , setting out the conditions, including additional clinical investigation, which we must meet in order to obtain final FDA approval. In May 2006, we received a license from the European Commission to market Ganfort TM in the European Union. Combined sales of Lumigan ® and Ganfort TM represented approximately 10% of our total consolidated product net sales in 2008 and 2007 and 11% of our total consolidated product net sales in 2006. The decline in the percentage of our total net sales represented by sales of Lumigan ® primarily resulted from the significant increase in our total consolidated product net sales as a result of the Inamed acquisition.

Our third best selling eye care pharmaceutical products are the ophthalmic solutions Alphagan ® , Alphagan ®   P 0.15% and Alphagan ® P 0.1%. Alphagan ® , Alphagan ® P 0.15% and Alphagan ® P 0.1% lower intraocular pressure by reducing aqueous humor production and increasing uveoscleral outflow. Alphagan ® P 0.15% and Alphagan ® P 0.1% are improved reformulations of Alphagan ® containing brimonidine, the active ingredient in Alphagan ® , preserved with Purite ® . We currently market Alphagan ® , Alphagan ® P 0.15% and Alphagan ® P 0.1% in over 70 countries worldwide.

Alphagan ® , Alphagan ® P 0.15% and Alphagan ® P 0.1% combined were the fifth best selling glaucoma products in the world for the first nine months of 2008, according to IMS Health Incorporated. Combined sales of Alphagan ® , Alphagan ® P 0.15% and Alphagan ® P 0.1% and Combigan ® represented approximately 9% of our total consolidated product net sales in 2008 and 2007 and 10% of our total consolidated product net sales in 2006. The decline in the percentage of our total net sales represented by sales of Alphagan ® , Alphagan ® P 0.15%, Alphagan ® P 0.1% and Combigan ® primarily resulted from the significant increase in our total

 

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consolidated product net sales as a result of the Inamed acquisition. In July 2002, based on the acceptance of Alphagan ® P 0.15%, we discontinued the U.S. distribution of Alphagan ® . In May 2004, we entered into an exclusive licensing agreement with Kyorin Pharmaceutical Co., Ltd., or Kyorin, under which Kyorin became responsible for the development and commercialization of Alphagan ® and Alphagan ® P 0.15% in Japan’s ophthalmic specialty area. Kyorin subsequently sublicensed its rights under the agreement to Senju. Under the licensing agreement, Senju incurs associated costs, makes clinical development and commercialization milestone payments, and makes royalty-based payments on product sales. We agreed to work collaboratively with Senju on overall product strategy and management. Alphagan ® P 0.1% was launched in the U.S. market in the first quarter of 2006. The marketing exclusivity period for Alphagan ® P 0.15% expired in the United States in September 2004 and the marketing exclusivity period for Alphagan ® P 0.1% expired in August 2008, although we have a number of patents covering the Alphagan ® P 0.15% and Alphagan ® P 0.1% technology that extend to 2021 in the United States and 2009 in Europe, with corresponding patents pending in Europe. In May 2003, the FDA approved the first generic of Alphagan ® . Additionally, a generic form of Alphagan ® is sold in a limited number of other countries, including Canada, Mexico, India, Brazil, Colombia and Argentina. See Item 3 of Part I of this report, “Legal Proceedings” and Note 14, “Legal Proceedings,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules,” for further information regarding litigation involving Alphagan ® . Falcon Pharmaceuticals, Ltd., an affiliate of Alcon Laboratories, Inc., or Alcon, attempted to obtain FDA approval for and to launch a brimonidine product to compete with our Alphagan ® P 0.15% product. However, pursuant to a March 2006 settlement with Alcon, Alcon agreed not to sell, offer for sale or distribute its brimonidine product until September 30, 2009, or earlier if specified market conditions occur. The primary market condition will have occurred if prescriptions of Alphagan ® P 0.15% have reached a specified threshold as compared to other brimonidine-containing products.

In addition to our Alphagan ® and Lumigan ® products, we developed the ophthalmic solution Combigan ® , a brimonidine and timolol combination designed to treat glaucoma and ocular hypertension in people who are not responsive to treatment with only one medication and are considered appropriate candidates for combination therapy. In November 2005, we received positive opinions for Combigan ® from 20 concerned member states included in the Combigan ® Mutual Recognition Procedure for the European Union, and we launched Combigan ® in the European Union during 2006. In October 2007, the FDA approved Combigan ® and we launched Combigan ® in the United States in November 2007. Combigan ® is now sold in over 45 countries worldwide.

Inflammation.  Our leading ophthalmic anti-inflammatory product is Acular ® (ketorolac ophthalmic solution) 0.5%, or Acular ® . Acular ® is a registered trademark of and is licensed from its developer, Syntex (U.S.A.) Inc., a business unit of Hoffmann-LaRoche Inc., the U.S. prescription drug unit of Roche Group. Acular ® is indicated for the temporary relief of itch associated with seasonal allergic conjunctivitis, the inflammation of the mucus membrane that lines the inner surface of the eyelids, and for the treatment of post-operative inflammation in patients who have undergone cataract extraction. Acular PF was the first, and currently remains the only unit-dose, preservative-free topical non-steroidal anti-inflammatory drug, or NSAID, in the United States. Acular PF is indicated for the reduction of ocular pain and photophobia following incisional refractive surgery. Acular LS ® (ketorolac ophthalmic solution) 0.4% is a version of Acular ® that has been reformulated for the reduction of ocular pain, burning and stinging following corneal refractive surgery. In addition, we have completed our Phase III clinical trials for an enhanced formula of ketorolac for an anti- inflammation indication and have filed the NDA with the FDA. The Acular ® franchise was the best selling ophthalmic NSAID in the world during the first nine months of 2008, according to IMS Health Incorporated.

Our ophthalmic anti-inflammatory product Pred Forte ® remains a leading topical steroid worldwide based on 2008 sales. Pred Forte ® has no patent protection or marketing exclusivity and faces generic competition.

Infection.  Our leading anti-infective is Zymar ® (gatifloxacin ophthalmic solution) 0.3%, or Zymar ® , which we license from Kyorin and have worldwide ophthalmic commercial rights excluding Japan, Korea, Taiwan and certain other countries in Asia. We launched Zymar ® in the United States in April 2003. Zymar ® is a fourth-generation fluoroquinolone for the treatment of bacterial conjunctivitis and is currently approved in 33 countries.

 

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Laboratory studies have shown that Zymar ® kills the most common bacteria that cause eye infections as well as specific resistant bacteria. We are also currently in Phase III development of an enhanced formula of Zymar ® for bacterial conjunctivitis. According to Verispan, an independent research firm, Zymar ® was the number two ophthalmic anti-infective prescribed by ophthalmologists in the United States in 2008. Zymar ® was the third best selling ophthalmic anti-infective product in the world for the first nine months of 2008, according to IMS Health Incorporated. Our Ocuflox ® /Oflox ® /Exocin ® ophthalmic solution is a leading product in the ophthalmic anti-infective market. Ocuflox ® has no patent protection or marketing exclusivity and faces generic competition.

Allergy.  The allergy market is, by its nature, a seasonal market, peaking during the spring months. We market Alocril ® ophthalmic solution for the treatment of itch associated with allergic conjunctivitis. We license Alocril ® from Fisons Ltd., a business unit of Sanofi-Aventis, and hold worldwide ophthalmic commercial rights excluding Japan. Alocril ® is approved in the United States, Canada and Mexico. We license Elestat ® from Boehringer Ingelheim AG, and hold worldwide ophthalmic commercial rights excluding Japan. Elestat ® is used for the prevention of itching associated with allergic conjunctivitis. We co-promote Elestat ® in the United States under an agreement with Inspire within the ophthalmic specialty area and to allergists. Under the terms of our agreement with Inspire, Inspire provided us with an up-front payment and we make payments to Inspire based on Elestat ® net sales. In addition, the agreement reduced our existing royalty payment to Inspire for Restasis ® . Inspire has primary responsibility for selling and marketing activities in the United States related to Elestat ® . We have retained all international marketing and selling rights. We launched Elestat ® in Europe under the brand names Relestat ® and Purivist ® during 2004, and Inspire launched Elestat ® in the United States during 2004. Elestat ® (together with sales under its brand names Relestat ® and Purivist ® ) is currently approved in 43 countries and was the fifth best selling ophthalmic allergy product in the world (and fourth in the United States) for the first nine months of 2008, according to IMS Health Incorporated.

Neuromodulator

Our neuromodulator product, Botox ® (botulinum toxin type A), has a long-established safety profile and has been approved by the FDA for more than 19 years to treat a variety of medical conditions, as well as for aesthetic use since 2002. With more than 3,000 publications on Botox ® in scientific and medical journals, results of dozens of clinical trials involving more than 13,000 patients and having been used in clinical practice to treat more than a million patients worldwide, Botox ® is a widely researched medicine with more than 100 potential therapeutic and aesthetic uses reported in the medical literature. Botox ® is now accepted in many global regions as the standard therapy for indications ranging from therapeutic neuromuscular disorders to facial aesthetics. The versatility of Botox ® is based on its localized treatment effect. Marketed as Botox ® , Botox ® Cosmetic, Vistabel ® or Vistabex ® , depending on the indication and country of approval, the product is currently approved in more than 75 countries for up to 21 unique indications. Sales of Botox ® represented approximately 30%, 31% and 33% of our total consolidated product net sales in 2008, 2007 and 2006 respectively. The decline in the percentage of our total net sales represented by sales of Botox ® primarily resulted from the significant increase in our total consolidated product net sales as a result of the Inamed acquisition. Botox ® is used therapeutically for the treatment of certain neuromuscular disorders which are characterized by involuntary muscle contractions or spasms. The approved therapeutic indications for Botox ® in the United States are as follows:

 

   

blepharospasm, the uncontrollable contraction of the eyelid muscles which can force the eye closed and result in functional blindness;

 

   

strabismus, or misalignment of the eyes, in people 12 years of age and over;

 

   

cervical dystonia, or sustained contractions or spasms of muscles in the shoulders or neck in adults, along with associated neck pain; and

 

   

severe primary axillary hyperhidrosis (underarm sweating) that is inadequately managed with topical agents.

 

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In many countries outside of the United States, Botox ® is also approved for treating hemifacial spasm, pediatric cerebral palsy and post-stroke focal spasticity. We are currently pursuing approvals for Botox ® in the United States and Europe for new indications, including chronic migraine, post-stroke focal spasticity, overactive bladder and benign prostate hyperplasia. In April 2005, we announced plans to conduct two Phase III clinical trials to investigate the safety and efficacy of Botox ® as a prophylactic therapy in patients with chronic migraine. On September 11, 2008, we announced completion of a top-line analysis of our Phase III clinical trials, which found that Botox ® treatment decreased the number of headache days patients with chronic migraines suffered compared to patients receiving placebo injections. In addition, Botox ® treatments were well tolerated in the trials in patients suffering from chronic migraines and patients receiving Botox ® scored statistically significantly higher improvement in quality of life compared to patients receiving placebo injections. Based on this data, we plan to file a supplemental Biologics License Application, or sBLA, with the FDA for the use of Botox ® to treat chronic migraine by mid-2009. In August 2008, we filed a sBLA with the FDA to treat post-stroke focal spasticity. In May 2005, we reached agreement with the FDA to enter Phase III clinical trials for the use of Botox ® to treat neurogenic overactive bladder and Phase II clinical trials for the use of Botox ® to treat idiopathic overactive bladder. In December 2005, we initiated Phase II clinical trials for the use of Botox ® to treat benign prostate hyperplasia.

Botox ® Cosmetic.  The FDA has approved Botox ® for the temporary improvement in the appearance of moderate to severe glabellar lines in adult men and women age 65 or younger. Referred to as Botox ® , Botox ® Cosmetic, Vistabel ® or Vistabex ® , depending on the country of approval, this product is designed to relax wrinkle-causing muscles to smooth the deep, persistent, glabellar lines between the brow that often develop during the aging process. Currently, approximately 60 countries have approved facial aesthetic indications for Botox ® , Botox ® Cosmetic, Vistabel ® or Vistabex ® . Health Canada, the Canadian national regulatory body, approved Botox ® Cosmetic for the treatment of upper facial lines in November 2005, and this indication has also been approved in Australia and New Zealand. In 2002, we launched comprehensive direct-to-consumer marketing campaigns, including television commercials, radio commercials, print advertising and interactive media aimed at dermatologists, plastic and reconstructive surgeons and other aesthetic specialty physicians, as well as consumers, in Canada and the United States and these campaigns continue. We also continue to sponsor aesthetic specialty physician training in approved countries to further expand the base of qualified physicians using Botox ® , Botox ® Cosmetic, Vistabel ® or Vistabex ® . With the integration of the former Inamed medical products into our Total Facial Rejuvenation TM portfolio, we now have a worldwide leadership position in the facial aesthetics market.

In October 2005, we entered into a long-term arrangement with GlaxoSmithKline, or GSK, under which GSK agreed to develop and promote Botox ® in Japan and China and we agreed to co-promote GSK’s products Imitrex STATdose System ® (sumatriptan succinate) and Amerge ® (naratriptan hydrochloride) in the United States. Under the terms of the arrangement, we licensed to GSK all clinical development and commercial rights to Botox ® in Japan and China, markets in which GSK has extensive commercial, regulatory and research and development resources, as well as expertise in neurology. We received an up-front payment, and we receive royalties on GSK’s Botox ® sales in Japan and China. We also manufacture Botox ® for GSK as part of a long-term supply agreement and collaboratively support GSK in its new clinical developments for Botox ® and its strategic marketing in those markets, for which we receive payments. GSK received approval of Botox ® for the treatment of glabellar lines in Japan and plans to launch Botox ® in Japan during the first quarter of 2009. In addition, we obtained the right to co-promote GSK’s products Imitrex STATdose System ® and Amerge ® in the United States to neurologists for a 5-year period, for which we receive fixed and performance payments from GSK. Imitrex STATdose System ® is approved for the treatment of acute migraine in adults and for the acute treatment of cluster headache episodes. Amerge ® is approved for the acute treatment of migraine attacks with and without an aura in adults.

 

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Skin Care Product Lines

Our skin care product lines focus on the acne, psoriasis, physician-dispensed skin care and eyelash growth markets, particularly in the United States and Canada.

Acne/Psoriasis

Aczone ® . Our product Aczone ® (dapsone) gel 5%, approved for sale in both the United States and Canada, is indicated for the treatment of acne vulgaris in patients 12 and older. Aczone ® contains the first new FDA-approved chemical entity (dapsone) for acne treatment since Tazorac ® (tazarotene) gel was approved in 1997. We launched Aczone ® in the United States in November 2008 and plan to launch Aczone ® in Canada in mid-2009.

Azelex ® .   Azelex ® cream is approved by the FDA for the topical treatment of mild to moderate inflammatory acne and is licensed from Intendis GmbH, or Intendis, a division of Bayer Schering Pharma AG. We market Azelex ® cream primarily in the United States.

Finacea ® .  We co-promoted Finacea ® (azelaic acid) gel 15%, or Finacea ® , a topical rosacea treatment, with Intendis through a collaboration with Intendis that ended by its terms in February 2008. Following the termination of the collaboration, we no longer promote Finacea ® but continue to receive certain payments for up to three years.

Tazarotene Products.   We market Tazorac ® (tazarotene) gel in the United States for the treatment of acne and plaque psoriasis, a chronic skin disease characterized by dry red patches. We also market a cream formulation of Tazorac ® in the United States for the topical treatment of acne and for the treatment of psoriasis. We have also engaged Pierre Fabre Dermatologie as our promotion partner for Zorac ® (tazarotene) in certain parts of Europe, the Middle East and Africa. We entered into a strategic collaboration agreement with Stiefel Laboratories, Inc. in September 2007 to develop and market new products involving tazarotene for dermatological use worldwide, and to co-promote Tazorac ® in the United States.

Topical Aesthetic Skin Care

Avage ® .  Our product Avage ® (tazarotene) cream is indicated for the treatment of facial fine wrinkling, mottled hypo- and hyperpigmentation (blotchy skin discoloration) and benign facial lentigines (flat patches of skin discoloration) in patients using a comprehensive skin care and sunlight avoidance program. We launched Avage ® in the United States in January 2003.

Clinique Medical.   In October 2008, we launched Clinique Medical, a new line of science-based skin care products that complement in-office aesthetic procedures affecting the skin. The Clinique Medical product line was created though a strategic collaboration with Clinique Laboratories, LLC, or Clinique, a subsidiary of the Estée Lauder Companies Inc., and is sold exclusively in physicians’ offices in the United States. As part of our collaboration with Clinique, we expanded our sales force dedicated to physician-dispensed skin care products.

M.D. Forte ® . We develop and market glycolic acid-based skin care products. We market our M.D. Forte ® line of alpha hydroxy acid products to physicians in the United States.

Prevage ® and Prevage ® MD. In January 2005, we launched Prevage ® cream, containing 1% idebenone, a clinically tested antioxidant designed to reduce the appearance of fine lines and wrinkles, as well as provide protection against environmental factors, including sun damage, air pollution and cigarette smoke. In May 2005, we entered into an exclusive license agreement with Elizabeth Arden, Inc., or Elizabeth Arden, granting Elizabeth Arden the right to globally market a new formulation of Prevage ® containing 0.5% idebenone, to leading department stores and other prestige cosmetic retailers. In September 2005, we began marketing Prevage ® MD, containing 1% idebenone, to physicians in the United States.

 

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Vivité ® . In April 2007, we launched Vivité ® , an advanced anti-aging skin care line that uses proprietary GLX Technology TM , creating a highly specialized blend of glycolic acid and natural antioxidants. We market our Vivité ® line of skin care products to physicians in the United States.

Eyelash Growth

Latisse TM (bimatoprost ophthalmic solution) 0.03%, or Latisse TM , is the first, and currently the only, FDA-approved prescription treatment of eyelash hypotrichosis, or inadequate eyelashes. The FDA approved Latisse TM in December 2008 and we launched Latisse TM in the United States in January 2009. Latisse TM is a once-daily prescription treatment applied to the base of the upper eyelashes with a sterile, single-use-per-eye disposable applicator. Patients using Latisse TM typically experience noticeable eyelash growth in eight to 16 weeks. Continued treatment with Latisse TM is required to maintain its effect.

Urologics

Sanctura ® and Sanctura XR ® . Following our October 2007 acquisition of Esprit, we began marketing Sanctura ® (trospium chloride), or Sanctura ® , a twice-a-day anticholinergic approved for the treatment of overactive bladder, or OAB. In August 2007, the FDA approved Sanctura XR ® (trospium chloride extended release capsules), or Sanctura XR ® , a once-daily anticholinergic for the treatment of OAB, and we launched Sanctura XR ® in January 2008. Sanctura XR ® is well tolerated by patients and has demonstrated improvements in certain adverse side effects common in existing OAB treatments, including dry mouth. We obtained an exclusive license to market Sanctura ® and Sanctura XR ® in the United States and its territories from Indevus Pharmaceuticals, Inc., or Indevus. We pay royalties to Indevus based upon our sales of Sanctura ® and Sanctura XR ® and assumed Esprit’s obligations to pay certain other third-party royalties, also based upon sales of Sanctura ® and Sanctura XR ® . We also entered into a co-promotion agreement with Indevus, which we amended in January 2009, pursuant to which Indevus co-promotes Sanctura ® and Sanctura XR ® with us in the United States through the third quarter of 2009. In May 2008, we entered into a license agreement with Indevus and Madaus GmbH, which grants us the right to seek approval for and to commercialize Sanctura XR ® in Canada. In 2008, we announced plans to seek a partner to promote Sanctura ® and Sanctura XR ® to general practitioners in the United States, and in February 2009, we announced a restructuring plan to focus our sales efforts on the urology specialty, which resulted in a significant reduction in our urology sales force.

Medical Devices Segment

Breast Aesthetics

For more than 25 years, our silicone gel and saline breast implants, consisting of a variety of shapes, sizes and textures, have been available to women in more than 60 countries for breast augmentation, revision and reconstructive surgery. Our breast implants consist of a silicone elastomer shell filled with either a saline solution or silicone gel with varying degrees of cohesivity. This shell can consist of either a smooth or textured surface. We market our breast implants under the trade names Natrelle ® , Inspira ® , McGhan ® and CUI ® and the trademarks BioCell ® , MicroCell ® , BioDimensional TM and Inamed ® . We currently market over 1,000 breast implant product variations worldwide to meet our customers’ preferences and needs.

Saline Breast Implants.   We sell saline breast implants in the United States and worldwide for use in breast augmentation, revision and reconstructive surgery. The U.S. market is the primary market for our saline breast implants. Following the approval of silicone gel breast implants by the FDA in November 2006, the U.S. market has been rapidly undergoing a transition from saline breast implants to silicone gel breast implants.

Silicone Gel Breast Implants.   We sell silicone gel breast implants in the United States and worldwide for use in breast augmentation, revision and reconstructive surgery. The safety of our silicone gel breast implants is supported by our extensive preclinical device testing, their use in over one million women worldwide and 18

 

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years of U.S. clinical experience involving more than 130,000 women. The FDA approved our silicone gel breast implants in November 2006 based on the FDA’s review of our 10-year core clinical study and our preclinical studies, its review of studies by independent scientific bodies and the deliberations of advisory panels of outside experts. Following approval, we are required to comply with a number of conditions, including our distribution of labeling to physicians and the distribution of our patient planner, which includes our informed consent process to help patients fully consider the risks associated with breast implant surgery. In addition and pursuant to the conditions placed on the FDA’s approval of our silicone gel breast implants, we continue to monitor patients in the 10-year core clinical study and the 5-year adjunct clinical study and, in February 2007, we initiated the Breast Implant Follow-Up Study, or the BIFS study, a 10-year post-approval clinical study. The 10-year core clinical study, which we began in 1999 and had fully enrolled in 2000 with approximately 940 augmentation, revision or reconstructive surgery patients, was designed to establish the safety and effectiveness of our silicone gel breast implants. We plan to continue to monitor patients in the 10-year core clinical study through the end of the study. In November 2006, we terminated new enrollment into our 5-year adjunct study, which was designed to further support the safety and effectiveness of silicone gel breast implants and which includes over 80,000 revision or reconstructive surgery patients. We plan to continue to monitor patients in the 5-year adjunct study through the end of the study. Finally, pursuant to the conditions placed on the FDA’s approval of our silicone gel breast implants, we initiated the BIFS study, a new 10-year post-approval study of approximately 40,000 augmentation, revision or reconstructive surgery patients with silicone gel implants and approximately 20,000 augmentation, revision or reconstructive surgery patients with saline implants acting as a control group. In November 2008, the FDA approved a modification to the BIFS study, which reduced the number of patients with saline breast implants from 20,000 to approximately 15,000. The BIFS study is designed to provide data on a number of endpoints including, for example, long-term local complications, connective tissue disease issues, neurological disease issues, offspring issues, reproductive issues, lactation issues, cancer, suicide, mammography issues and to study magnetic resonance imaging compliance and rupture results.

Tissue Expanders.   We sell a line of tissue expanders for breast reconstruction and as an alternative to skin grafting to cover burn scars and correct birth defects.

Facial Aesthetics

We develop, manufacture and market dermal filler products designed to improve facial appearance by smoothing wrinkles and folds. Our primary facial aesthetics products are the Juvéderm ® dermal filler family of products, Zyderm ® and Zyplast ® and CosmoDerm ® and CosmoPlast ® .

Juvéderm ® .  Our Juvéderm ® dermal filler family of products, including Juvéderm ® , Hydrafill TM and Surgiderm ® , are developed using our proprietary Hylacross TM technology, a technologically advanced manufacturing process that results in a smooth consistency gel formulation. This technology is based on the delivery of a homogeneous gel-based hyaluronic acid, as opposed to a particle gel-based hyaluronic acid technology, which is used in other hyaluronic acid dermal filler products. In June 2006, the FDA approved Juvéderm ® Ultra and Juvéderm ® Ultra Plus, indicated for wrinkle and fold correction, for sale in the United States. In Europe, we market various formulations of Juvéderm ® , Hydrafill TM and Surgiderm ® for wrinkle and fold augmentation. The Juvéderm ® dermal filler family of products are currently approved or registered in over 34 countries, including all major European markets.

In June 2007, the FDA approved label extensions in the United States for Juvéderm ® Ultra and Juvéderm ® Ultra Plus based on new clinical data demonstrating that the effects of both products may last for up to one year, which is a longer period of time than was reported in clinical studies that supported FDA approval of other hyaluronic acid dermal fillers. We began selling Juvéderm ® Ultra 2, 3 and 4, containing lidocaine, an anesthetic that alleviates pain during injections, in Europe in January 2008, and in Canada we began selling Juvéderm ® Ultra and Ultra Plus with lidocaine in October 2008. In 2008, we filed a premarket approval supplement with the FDA for Juvéderm ® Ultra and Ultra Plus with lidocaine.

 

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Zyderm ® and Zyplast ® .   Zyderm ® and Zyplast ® dermal fillers are injectable formulations of bovine collagen. The Zyderm ® family of dermal fillers is formulated for people with fine line wrinkles or superficial facial contour defects. Zyderm ® and Zyplast ® dermal fillers require a skin test, with a requisite 30-day period to observe the possibility of allergic reaction in the recipient. Both of these products are formulated with lidocaine. Zyderm ® and Zyplast ® are approved for marketing in the United States and Europe.

CosmoDerm ® and CosmoPlast ® . CosmoDerm ® and CosmoPlast ® dermal fillers are a line of injectable human skin-cell derived collagen products. CosmoDerm ® and CosmoPlast ® dermal fillers are formulated for people with fine line wrinkles or superficial facial contour defects. CosmoDerm ® and CosmoPlast ® implants do not require a skin test pre-treatment. Both of these products are formulated with lidocaine. CosmoDerm ® and CosmoPlast ® are approved for marketing in the United States, Canada and a number of European countries.

On January 30, 2007, our Board of Directors approved a plan to restructure and eventually sell or close the collagen manufacturing facility in Fremont, California that we acquired in the Inamed acquisition based on the anticipated reduction in market demand for human and bovine collagen products as a result of the introduction of our hyaluronic acid dermal filler products. Specifically, the plan involved a workforce reduction of approximately 59 positions, consisting principally of manufacturing positions at the facility, and lease termination and contract settlements. We began to record costs associated with the closure of the collagen manufacturing facility in the first quarter of 2007 and substantially completed all restructuring activities and closed the collagen manufacturing facility in the fourth quarter of 2008. Before closing the collagen manufacturing facility, we manufactured a sufficient quantity of collagen products to meet estimated market demand through 2010.

Obesity Intervention

We develop, manufacture and market several medical devices for the treatment of obesity. Our principal product in this area, the Lap-Band ® System, is designed to provide minimally invasive long-term treatment of severe obesity and is used as an alternative to more invasive procedures such as gastric bypass surgery or stomach stapling. The Lap-Band ® System is an adjustable silicone elastomer band that is laparoscopically placed around the upper part of the stomach through a small incision, creating a small pouch at the top of the stomach. The new pouch fills faster, making the patient feel full sooner and, because the adjustable component of the band slows the passage of food, patients retain a feeling of fullness for longer periods of time. In addition to the anatomic effect of the pouch, data also suggests that patients with a properly adjusted band are less hungry due to neurological feedback to the brain.

The Lap-Band ® System has achieved widespread acceptance in the United States and worldwide. In 2001, the FDA approved the Lap-Band ® System to treat severe obesity in adults who have failed more conservative weight reduction alternatives. The Lap-Band ® VG , a version of the Lap-Band ® System with a larger band circumference, was approved by the FDA in January 2004, and meets the needs of a wider range of patients. In June 2007, we launched the Lap-Band AP ® System, an evolution of the Lap-Band ® System. The Lap-Band AP ® System has proprietary 360-degree Omniform TM technology, which is designed to evenly distribute pressure throughout the band’s adjustment range. The Lap-Band AP ® also serves patients who are physically larger, have thicker gastric walls or have substantial abdominal fat. Over 450,000 Lap-Band ® System units have been sold worldwide since 1993. In December 2008, we completed enrollment in our pivotal adolescent study of Lap-Band ® in patients aged 14 to 17 and plan to submit data to the FDA by the end of 2009. Also in March 2008, we completed enrollment of our lower body mass index, or BMI, pivotal study for Lap-Band ® patients with a BMI of 30 to 40 and plan to review results and submit data to the FDA in 2010.

In November 2007, we entered into a co-promotion agreement with a subsidiary of Covidien Ltd., or Covidien, a leading global provider of healthcare products, under which Covidien co-promotes the Lap-Band ® System to bariatric and other surgeons in the United States. Under the multi-year agreement, which became

 

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effective in November 2007, Covidien utilizes its surgical devices sales force and other specialized staff, as an adjunct to our bariatric sales force and other specialized staff, to promote, educate and train surgeons on the Lap-Band ® System.

In February 2007, we completed the acquisition of Swiss medical technology developer EndoArt SA, or EndoArt, a pioneer in the field of telemetrically-controlled (or remote-controlled) gastric bands used to treat morbid obesity and other conditions. We paid approximately $97.1 million, net of cash acquired, for all of the outstanding EndoArt shares in an all cash transaction. The EndoArt acquisition gave us ownership of EndoArt’s proprietary technology platform, including FloWatch ® technology, which powers the EasyBand TM Remote Adjustable Gastric Band System, or EasyBand TM , a next-generation, telemetrically-adjustable gastric banding device for the treatment of morbid obesity.

The EasyBand TM , like the Lap-Band ® System, is implanted laparoscopically through a small incision. Clinical benefits of the EasyBand TM are similar to the Lap-Band ® System’s clinical benefit, except that the EasyBand TM ’s adjustments are done telemetrically rather than hydraulically, allowing for greater ease in adjustments and greater patient comfort.

We also sell the Orbera TM Intragastric Balloon System, which is a fixed-term weight loss therapy designed for use with overweight patients. Approved for sale in more than 60 countries but not in the United States, the Orbera TM System includes a silicone elastomer balloon that is filled with saline after transoral insertion into the patient’s stomach to reduce stomach capacity and create an earlier sensation of fullness. The Orbera TM System is removed endoscopically within six months of placement, and is designed to be utilized in conjunction with a comprehensive diet and exercise program.

Other Products

Contigen ® is our collagen product used for treatment of urinary incontinence due to intrinsic sphincter deficiency. C. R. Bard, Inc., or Bard, licenses from us the exclusive worldwide marketing and distribution rights to Contigen ® . We manufactured a sufficient supply of collagen to meet our contractual obligations to Bard through the expiration of our agreement with Bard in August 2011 prior to closing the Fremont manufacturing facility.

International Operations

Our international sales represented 35.4%, 34.3% and 32.6% of our total consolidated product net sales for the years ended December 31, 2008, 2007 and 2006, respectively. Our products are sold in over 100 countries. Marketing activities are coordinated on a worldwide basis, and resident management teams provide leadership and infrastructure for customer-focused, rapid introduction of new products in the local markets.

Sales and Marketing

We sell our products directly and through independent distributors in over 100 countries worldwide. We maintain a global marketing team, as well as regional sales and marketing organizations, to support the promotion and sale of our products. We also engage contract sales organizations to promote certain products. Our sales efforts and promotional activities are primarily aimed at eye care professionals, neurologists, dermatologists, plastic and reconstructive surgeons, aesthetic specialty physicians, bariatric surgeons and urologists who use, prescribe and recommend our products. We advertise in professional journals, participate in medical meetings and utilize direct mail and Internet programs to provide descriptive product literature and scientific information to specialists in the ophthalmic, dermatological, medical aesthetics, bariatric, neurology, movement disorder and urology fields. We have developed training modules and seminars to update physicians regarding evolving technology in our products. In 2008, we also utilized direct-to-consumer advertising for our Botox ® Cosmetic, Juvéderm ® , the Lap-Band ® System, Natrelle ® and Restasis ® products.

 

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Our products are sold to drug wholesalers, independent and chain drug stores, pharmacies, commercial optical chains, opticians, mass merchandisers, food stores, hospitals, group purchasing organizations, integrated direct hospital networks, ambulatory surgery centers and medical practitioners, including ophthalmologists, neurologists, dermatologists, plastic and reconstructive surgeons, aesthetic specialty physicians, bariatric surgeons, pediatricians, urologists and general practitioners. As of December 31, 2008, we employed approximately 2,800 sales representatives throughout the world. We also utilize distributors for our products in smaller international markets.

U.S. sales, including manufacturing operations, represented 64.6%, 65.7% and 67.4% of our total consolidated product net sales in 2008, 2007 and 2006, respectively. Sales to Cardinal Healthcare for the years ended December 31, 2008, 2007 and 2006 were 12.0%, 11.2% and 13.0%, respectively, of our total consolidated product net sales. Sales to McKesson Drug Company for the years ended December 31, 2008, 2007 and 2006 were 12.3%, 11.1%, and 13.0%, respectively, of our total consolidated product net sales. No other country, or single customer, generated over 10% of our total consolidated product net sales.

We supplement our marketing efforts with exhibits at medical conventions, advertisements in trade journals, sales brochures and national media. In addition, we sponsor symposia and educational programs to familiarize physicians with the leading techniques and methods for using our products.

On February 4, 2009, we announced a restructuring plan that includes a workforce reduction of approximately 460 employees, primarily from among our U.S. urology sales and marketing personnel as a result of our decision to focus on the urology specialty and to seek a partner to promote Sanctura XR ® to general practitioners, and marketing personnel in the United States and Europe as we adjust our back-office structures to a reduced short-term sales outlook for some of our businesses.

Research and Development

Our global research and development efforts currently focus on eye care, skin care, neuromodulators, medical aesthetics, obesity intervention, urology and neurology. We have a fully integrated research and development organization with in-house discovery programs, including medicinal chemistry, high throughput screening and biological sciences. We supplement our own research and development activities with our commitment to identify and obtain new technologies through in-licensing, research collaborations, joint ventures and acquisitions.

As of December 31, 2008, we had approximately 1,670 employees involved in our research and development efforts. Our research and development expenditures for 2008, 2007 and 2006 were approximately $797.9 million, $718.1 million and $1,055.5 million, respectively. Research and development expenditures in each of 2008 and 2007 were less than 2006 largely due to in-process research and development expenses of $579.3 million recorded in 2006 in connection with the Inamed acquisition compared to no in-process research and development expenses recorded in 2008 and only $72.0 million of in-process research and development expenses recorded in 2007 in connection with the EndoArt acquisition. Excluding in-process research and development expenditures related to company acquisitions, we have increased our annual investment in research and development by over $493.3 million in the past five years.

In 2004, we completed construction of a new $75 million research and development facility in Irvine, California, which provides us with approximately 175,000 square feet of additional laboratory space. In 2005, we completed construction of a new biologics facility on our Irvine, California campus at an aggregate cost of approximately $50 million. Both facilities are occupied and in use.

Our strategy includes developing innovative products to address unmet medical needs and conditions associated with aging, and otherwise assisting patients in reaching life’s potential. Our top priorities include furthering our leadership in ophthalmology, medical aesthetics and neuromodulators, identifying new potential

 

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compounds for sight-threatening diseases such as glaucoma, age-related macular degeneration and other retinal disorders and developing novel therapies for chronic dry eye, pain and genitourinary diseases as well as next generation breast implants, dermal fillers and obesity intervention devices. We plan to continue to build on our strong market positions in ophthalmic pharmaceuticals, medical aesthetics, medical dermatology, obesity intervention and neurology, and to explore new therapeutic areas that are consistent with our focus on specialty physician groups.

Our research and development efforts for the ophthalmic pharmaceuticals business focus primarily on new therapeutic products for retinal disease, glaucoma and chronic dry eye. As part of our focus on diseases of the retina, we acquired Oculex Pharmaceuticals, Inc. in 2003. With this acquisition, we obtained a novel posterior segment drug delivery system for use with compounds to treat eye diseases, including age-related macular degeneration and other retinal disorders. We concluded our Phase III studies for Posurdex ® to treat macular edema associated with retinal vein occlusion, or RVO, through our proprietary biodegradable injectable implant that slowly releases dexamethasone, a potent steroid, to the back of the eye. In December 2008, we filed the last module in our NDA application with the FDA seeking approval of Posurdex ® to treat RVO. In March 2005, we entered into an exclusive licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd., or Sanwa, to develop and commercialize Posurdex ® for the ophthalmic specialty market in Japan. Under the terms of the agreement, Sanwa is responsible for the development and commercialization of Posurdex ® in Japan and associated costs. Sanwa will pay us a royalty based on net sales of Posurdex ® in Japan, makes clinical development and commercialization milestone payments and reimburses us for certain expenses associated with our continuing Phase III studies outside of Japan. We are working collaboratively with Sanwa on the clinical development of Posurdex ® , as well as overall product strategy and management.

In June 2008, the FDA approved Trivaris TM (triamcinolone acetonide injectable suspension) 80mg/ml, a steroid with an anti-inflammatory action used for the treatment of retinal disease. Delivered via intravitreal injection, the ophthalmic indications for Trivaris TM include sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.

We continue to invest heavily in the research and development of neuromodulators, primarily Botox ® . We focus on both expanding the approved indications for Botox ® and pursuing next generation neuromodulator-based therapeutics. This includes expanding the approved uses for Botox ® to include treatment for spasticity, chronic migraine, overactive bladder and benign prostate hyperplasia. In collaboration with Syntaxin Ltd, whose technology was contributed by the United Kingdom government’s Health Protection Agency, we are focused on engineering new neuromodulators for the treatment of severe pain. We are also continuing our investment in the areas of biologic process development and manufacturing and the next generation of neuromodulator products, and we are conducting a Phase IV study of Botox ® for the treatment of palmar hyperhidrosis, as part of our conditions of approval for axillary hyperhidrosis by the FDA. In addition, GSK has received approval of Botox ® for the treatment of glabellar lines in Japan in early 2009 and plans to launch the product during the first quarter of 2009.

We have a strategic research collaboration and license agreement with ExonHit Therapeutics, or ExonHit. The goals of this collaboration are to identify new molecular targets based on ExonHit’s gene profiling DATAS TM technology and to work collaboratively to develop unique compounds and commercial products based on these targets. Our strategic alliance with ExonHit provides us with the rights to compounds developed in the fields of neurodegenerative disease, pain and ophthalmology. In 2007, we began development of a compound for a neurological indication as part of our collaboration with ExonHit. In January 2009, we extended and expanded the scope of our collaboration with ExonHit. In addition, the collaboration is currently conducting a Phase I study of a compound for pain.

In October 2008, we entered into a strategic collaboration arrangement with Spectrum Pharmaceuticals, Inc., or Spectrum, to develop and commercialize apaziquone, an antineoplastic agent currently being investigated for the treatment of non-muscle invasive bladder cancer. Under the collaboration, Spectrum will conduct two Phase III clinical trials to explore apaziquone’s safety and efficacy as a potential treatment for non-muscle invasive

 

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bladder cancer following surgery. Spectrum expects to complete enrollment in the trials by the end of 2009. Spectrum will conduct the apaziquone clinical trials pursuant to a joint development plan, and we will bear the majority of these expenses. We will also make certain additional payments to Spectrum based on the achievement of certain development, regulatory and commercialization milestones.

We also continue to invest in research and development around our Juvéderm ® family of dermal filler products, including preparation for and ongoing clinical trials. In 2008, we filed a premarket approval supplement with the FDA for Juvéderm ® Ultra and Juvéderm ® Ultra Plus with lidocaine.

In connection with our obesity intervention products, we are planning to conduct clinical trials of the EasyBand TM and have initiated a pivotal study of the Orbera TM System, with the goal of obtaining approval in the United States. In addition, in December 2008, we completed enrollment in pivotal adolescent study of Lap-Band ® patients aged 14 to 17 and plan to submit data to the FDA by the end of 2009. In March 2008, we completed enrollment of our lower BMI pivotal study for Lap-Band ® patients with a BMI of 30 to 40 and plan to review and submit data to the FDA in 2010.

The continuing introduction of new products supplied by our research and development efforts and in-licensing opportunities are critical to our success. There are intrinsic uncertainties associated with research and development efforts and the regulatory process. We cannot assure you that any of the research projects, clinical development projects, or pending drug marketing approval applications will result in new products that we can commercialize. Delays or failures in one or more significant research projects and pending drug marketing approval applications could have a material adverse affect on our future operations.

Manufacturing

We manufacture the majority of our commercial products in our own plants located at the following locations: Arklow and Westport, Ireland; San José, Costa Rica; Annecy, France; Waco, Texas; and Guarulhos, Brazil. We maintain sufficient manufacturing capacity at these facilities to support forecasted demand as well as a modest safety margin of additional capacity to meet peaks of demand and sales growth in excess of expectations. We increase our capacity as required in anticipation of future sales increases. In the event of a very large or very rapid unforeseen increase in market demand for a specific product or technology, supply of that product or technology could be negatively impacted until additional capacity is brought on line. Third parties manufacture a small number of commercial products for us, including Sanctura ® , Sanctura XR ® and Aczone ® gel. For a discussion of the risks relating to the use of third party manufacturers, see Item 1A of Part I of this report, “Risk Factors — We could experience difficulties obtaining or creating the raw materials or components needed to produce our products and interruptions in the supply of raw materials or components could disrupt our manufacturing and cause our sales and profitability to decline.”

In January 2007, we announced the closing of the collagen manufacturing facility in Fremont, California that we acquired in the Inamed acquisition, and we substantially completed all restructuring activities and closed the facility in the fourth quarter of 2008. Before closing the facility, we manufactured a sufficient quantity of our collagen products to meet estimated market demand through 2010. In January 2008, we announced that production at our Arklow, Ireland breast implant manufacturing facility, which we acquired in connection with the Inamed acquisition and which employs approximately 360 persons, will be transferred to our San José, Costa Rica manufacturing plant and we plan to phase out production at our Arklow, Ireland manufacturing facility by the end of the second quarter of 2009.

We are vertically integrated into the production of plastic parts and produce our own bottles, tips and caps for use in the manufacture of our ophthalmic solutions. Additionally, we ferment, purify and characterize the botulinum toxin used in our product Botox ® . With these two exceptions, we purchase all other significant raw materials from qualified domestic and international sources. Where practical, we maintain more than one supplier for each material, and we have an ongoing alternate program that identifies additional sources of key raw

 

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materials. In some cases, however, most notably with active pharmaceutical ingredients, we are a niche purchaser of specialty chemicals, which, in certain cases, are sole sourced. These sources are identified in filings with regulatory agencies, including the FDA, and cannot be changed without prior regulatory approval. In these cases, we maintain inventories of the raw material itself and precursor intermediates to mitigate the risk of interrupted supply. A lengthy interruption of the supply of one of these materials could adversely affect our ability to manufacture and supply commercial product. A small number of the raw materials required to manufacture certain of our products are derived from biological sources which could be subject to contamination and recall by their suppliers. We use multiple lots of these raw materials at any one time in order to mitigate such risks. However, a shortage, contamination or recall of these products could disrupt our ability to maintain an uninterrupted commercial supply of our finished goods.

Manufacturing facilities producing pharmaceutical and medical device products intended for distribution in the United States and internationally are subject to regulation and periodic review by the FDA, international regulatory authorities and European notified bodies for certain of our medical devices. All of our facilities are currently approved by the FDA, the relevant notified bodies and other regulatory authorities to manufacture pharmaceuticals and medical devices for distribution in the United States and international markets.

Competition

The pharmaceutical and medical device industries are highly competitive and require an ongoing, extensive search for technological innovation. They also require, among other things, the ability to effectively discover, develop, test and obtain regulatory approvals for products, as well as the ability to effectively commercialize, market and promote approved products, including communicating the effectiveness, safety and value of products to actual and prospective customers and medical professionals. Numerous companies are engaged in the development, manufacture and marketing of health care products competitive with those that we manufacture, develop and market. Many of our competitors have greater resources than we have. This enables them, among other things, to make greater research and development investments and spread their research and development costs, as well as their marketing and promotion costs, over a broader revenue base. Our competitors may also have more experience and expertise in obtaining marketing approvals from the FDA and other regulatory authorities. In addition to product development, testing, approval and promotion, other competitive factors in the pharmaceutical and medical device industries include industry consolidation, product quality and price, product technology, reputation, customer service and access to technical information. We believe that our products principally compete on the basis of quality, product design, an experienced sales force, physicians’ and surgeons’ familiarity with our products and brand names, regional warranty programs and our ability to identify and develop or license patented products embodying new technologies.

Specialty Pharmaceuticals Segment

Eye Care Products.   Our major eye care competitors include Alcon Laboratories, Inc., Bausch & Lomb Incorporated, Pfizer Inc., Novartis and Merck & Co., Inc. For our eye care products to be successful, we must be able to manufacture and effectively detail them to a sufficient number of eye care professionals such that they use or continue to use our current products and the new products we may introduce. Glaucoma must be treated over an extended period and doctors may be reluctant to switch a patient to a new treatment if the patient’s current treatment for glaucoma is effective and well tolerated.

We also face competition from generic drug manufacturers in the United States and internationally. For instance, Falcon Pharmaceuticals, Ltd., an affiliate of Alcon, attempted to obtain FDA approval for a brimonidine product to compete with our Alphagan ® P 0.15% product. Pursuant to our March 2006 settlement with Alcon, Alcon may sell, offer for sale or distribute its brimonidine 0.15% product after September 30, 2009, or earlier if specified market conditions occur. The primary market condition will have occurred if prescriptions of Alphagan ® P 0.15% have reached a specified threshold as compared to other brimonidine-containing products. In February 2007, we received a paragraph 4 Hatch-Waxman Act certification from Exela PharmSci, Inc., or Exela,

 

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in which it purports to have sought FDA approval to market a generic form of Alphagan ® P 0.15%. In April 2007, we received a paragraph 4 Hatch-Waxman Act certification from Apotex, Inc., or Apotex, in which it purports to have sought FDA approval to market a generic form of Alphagan ® P 0.15% and Alphagan ® P 0.1%. Furthermore, Apotex attempted to obtain FDA approval to market generic forms of Acular ® and Acular LS ® . Pursuant to certain federal court rulings, Apotex is barred from obtaining approval before our patent related to Acular ® and Acular LS ® expires in November 2009. In October 2007, we received a paragraph 4 Hatch-Waxman Act certification from Apotex Corp. in which it purports to have sought FDA approval to market a generic form of Zymar ® . In February 2009, we received a paragraph 4 Hatch-Waxman Act certification in which the applicant purports to have sought FDA approval to market a generic 0.2% brimonidine tartrate/0.5% timolol maleate ophthalmic solution. See Item 3 of Part I of this report, “Legal Proceedings” and Note 14, “Legal Proceedings,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules,” for information concerning our current litigation.

Neuromodulators.   With respect to neuromodulators, until December 2000, Botox ® was the only neuromodulator approved by the FDA. At that time, the FDA approved Myobloc ® , a neuromodulator formerly marketed by Elan Pharmaceuticals and now marketed by Solstice Neurosciences Inc. In addition, Ipsen Ltd., or Ipsen, is seeking FDA approval of its Dysport ® neuromodulator for cervical dystonia and Medicis Pharmaceutical Corporation, or Medicis, its licensee for the United States, Canada and Japan, is seeking approval of Reloxin ® for cosmetic indications. Ipsen and Medicis submitted a Biologics License Application, or BLA, to the FDA for Reloxin ® in December 2007. In December 2008, the FDA issued a Complete Response Letter to Ipsen requesting additional information, including finalization of a Risk Evaluation and Mitigation Strategy, or REMS, and of the draft labeling, as well as a Safety Update Report. In January 2009, Medicis announced that the Prescription Drug User Fee action date, or the date by which the FDA has to respond to Medicis’ BLA for Reloxin ® , was extended to April 13, 2009. Ipsen has marketed Dysport ® in Europe since 1991, prior to our European commercialization of Botox ® in 1992. In June 2006, Ipsen received marketing authorization for a cosmetic indication for Dysport ® in Germany. In 2007, Ipsen granted Galderma, a joint venture between Nestle and L’Oreal Group, an exclusive development and marketing license for Dysport ® for aesthetic indications in the European Union, Russia, Eastern Europe and the Middle East, and first rights of negotiation for other countries around the world, except the United States, Canada and Japan. In January 2008, Galderma became Ipsen’s sole distributor for Dysport ® in Brazil, Argentina and Paraguay. Ipsen has also been seeking approval for Reloxin ® for cosmetic indications across the European Union, including submitting a file to the French regulatory authority in May 2003. In January 2009, the health authorities of 15 European Union countries granted approval of the product for glabellar lines under the trade name Azzalure ® .

Mentor Corporation, or Mentor, which was acquired by Johnson & Johnson in January 2009, is conducting clinical trials for a competing neuromodulator in the United States. In addition, we are aware of competing neuromodulators currently being developed and commercialized in Asia, Europe, South America and other markets. A Chinese entity received approval to market a botulinum toxin in China in 1997, and we believe that it has launched or is planning to launch its botulinum toxin product in other lightly regulated markets in Asia, South America and Central America. These lightly regulated markets may not require adherence to the FDA’s current Good Manufacturing Practice regulations, or cGMPs, or the regulatory requirements of the European Medical Evaluation Agency or other regulatory agencies in countries that are members of the Organization for Economic Cooperation and Development. Therefore, companies operating in these markets may be able to produce products at a lower cost than we can. In addition, Merz Pharmaceuticals, or Merz, received approval for Xeomin ® in Germany and launched its product in July 2005, received approval in Mexico in 2006 and commenced sales in the United Kingdom, certain Scandinavian countries and France in 2008, and is pursuing additional approvals in the European Union and Latin America. Merz is currently in clinical trials in the United States for cervical dystonia, blepharospasm and cosmetic indications and is awaiting therapeutic licenses for Xeomin ® in many countries across the European Union. A Korean botulinum toxin product, Meditoxin ® , was approved for sale in Korea in June 2006. The company, Medy-Tox Inc., received exportation approval from Korean authorities in early 2005 to ship their product under the trade name Neuronox ® .

 

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Skin Care Product Line.   Our skin care business competes against a number of companies, including among others, Dermik, a division of Sanofi-Aventis, Galderma, Medicis Pharmaceutical Corporation, Stiefel Laboratories, Inc., Novartis, Schering-Plough Corporation, Johnson & Johnson, Obagi Medical Products, Inc., L’Oréal Group, SkinMedica, Inc. and Valeant Pharmaceuticals International, many of which have greater resources than us.

Urologics.   Our urologics business competes against a number of companies, including among others, Pfizer Inc., Watson Pharmaceuticals, Inc., Novartis, the Procter & Gamble Company, Astellas Pharma US, Inc. and GSK, many of which have greater resources than us. We also face competition from generic urologic drug manufacturers in the United States and internationally. For our urologics products to be successful, we must be able to effectively detail our products to a sufficient number of urologists, obstetrician/gynecologists, primary care physicians and other medical specialists such that they recommend our products to their patients. We will also have to demonstrate that our products are safe and reduce patients’ sense of urgency, frequency and urge urinary incontinence episodes while also having limited side effects, such as dry mouth, constipation, blurred vision, drowsiness and headaches. We also have to demonstrate the effectiveness of our urologics products to Medicare and other governmental agencies to secure an appropriate and competitive level of reimbursement.

Medical Devices Segment

Breast Aesthetics.   We compete in the U.S. breast implant market with Mentor. Mentor announced that, like us, it received FDA approval in November 2006 to sell its silicone breast implants in the United States. The conditions under which Mentor is allowed to market its silicone breast implants in the United States are similar to ours, including indications for use and the requirement to conduct post-marketing studies. If patients or physicians prefer Mentor’s breast implant products to ours or perceive that Mentor’s breast implant products are safer than ours, our sales of breast implants could materially suffer. In the United States, Sientra, Inc. is conducting clinical studies of breast implant products. Internationally, we compete with several manufacturers, including Mentor, Silimed, MediCor Ltd and its subsidiaries BioSil Ltd, Nagor and Eurosilicone, Poly Implant Prostheses, Sebbin Laboratories and certain Chinese implant manufacturers.

Obesity Intervention.   Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson, received FDA approval in September 2007 to market its gastric band product, the Realize TM Personalized Banding Solution, or the Realize TM band, in the United States. The Realize TM band began competing with our Lap-Band ® System in the United States in the fourth quarter of 2007. Outside the United States, the Lap-Band ® System competes primarily with the Realize TM band and the Heliogast ® Adjustable Gastric Ring (manufactured by Helioscopie, S.A., France, or Helioscopie). There are at least two other gastric bands on the market internationally. The Lap-Band ® System also competes with surgical obesity procedures, including gastric bypass, vertical banded gastroplasty, sleeve gastrectomy and biliopancreatic diversion. No intragastric balloons for the treatment of obesity are commercially available in the United States, and we are currently aware of only one other company outside the United States that offers an intragastric balloon. Helioscopie recently launched its intragastric balloon, the Heliosphere TM .

Facial Aesthetics.   Our facial products compete in the dermatology and plastic surgery markets with other hyaluronic acid products and animal- or cadaver-based collagen products as well as other polymer/bioceramic- based injectables, and indirectly with substantially different treatments, such as laser treatments, chemical peels, fat injections and botulinum toxin-based products. In addition, several companies are engaged in research and development activities examining the use of collagen, hyaluronic acids and other biomaterials for the correction of soft tissue defects. Internationally, we compete with products such as Restylane ® , Restylane ® Fine Lines, and Perlane TM (all manufactured by Q-Med A.B.) and many other hyaluronic acid, bioceramic, protein and other polymer-based dermal fillers. We have competed in the U.S. dermal filler market with Restylane ® since January 2004 and with Perlane TM since May 2007, both of which are distributed by Medicis. Also, in December

 

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2006, Radiesse ® , a bioceramic-based hydroxyl apatite dermal filler from BioForm Medical, Inc., received approval in the United States. In addition, Evolence ® , a collagen-based filler from OrthoNeutrogena, a division of Johnson & Johnson, received FDA approval in June 2008.

Government Regulation

Specialty Pharmaceuticals Segment

Drugs and biologics are subject to regulation by the FDA, state agencies and by foreign health agencies. Pharmaceutical products and biologics are subject to extensive pre- and post-market regulation by the FDA, including regulations that govern the testing, manufacturing, safety, efficacy, labeling, storage, record keeping, advertising and promotion of the products under the Federal Food, Drug, and Cosmetic Act, or FFDCA, regulations with respect to drugs and the Public Health Services Act and its implementing regulations with respect to biologics, and by comparable agencies in foreign countries. Failure to comply with applicable FDA or other requirements may result in civil or criminal penalties, recall or seizure of products, partial or total suspension of production or withdrawal of a product from the market.

The process required by the FDA before a new drug or biologic may be marketed in the United States is long and expensive. We must complete preclinical laboratory and animal testing, submit an Investigational New Drug Application, or IND, which must become effective before United States clinical trials may begin, and perform adequate and well controlled human clinical trials to establish the safety and efficacy of the proposed drug or biologic for its intended use. Clinical trials are typically conducted in three sequential phases, which may overlap, and must satisfy extensive Good Clinical Practice regulations and informed consent regulations. Further, an independent institutional review board, or IRB, for each medical center or medical practice proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center or practice and must monitor the study until completed. The FDA, the IRB or the study sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. In addition, the Food and Drug Administration Amendments Act of 2007, or FDAAA, imposes certain clinical trial registry obligations on study sponsors, including the posting of detailed trial design and trial results in the FDA public databases. The FDAAA also requires enhanced post marketing safety including the requirement for post marketing studies, REMS and the posting of drug safety information on the FDA’s website.

We must submit a New Drug Application, or NDA, for a new drug, or a Biologics License Application, or BLA, for a biologic, and the NDA or BLA must be reviewed and approved by the FDA before the drug or biologic may be legally marketed in the United States. To satisfy the criteria for approval, an NDA or BLA must demonstrate the safety and efficacy of the product based on results of preclinical studies and the three phases of clinical trials. Both NDAs and BLAs must also contain extensive manufacturing information, and the applicant must pass an FDA pre-approval inspection of the manufacturing facilities at which the drug or biologic is produced to assess compliance with the FDA’s current Good Manufacturing Practice regulations, or cGMPs, prior to commercialization. Satisfaction of FDA pre-market approval requirements typically takes several years and the actual time required may vary substantially based on the type, complexity and novelty of the product, and we cannot be certain that any approvals for our products will be granted on a timely basis, or at all.

Once approved, the FDA may require post-marketing clinical studies, known as Phase IV studies, and surveillance programs to monitor the effect of approved products. The FDA may limit further marketing of the product based on the results of these post-market studies and programs. Further, any modifications to the drug or biologic, including changes in indications, labeling or manufacturing processes or facilities, may require the submission of a new or supplemental NDA or BLA, which may require that we develop additional data or conduct additional preclinical studies and clinical trials.

The manufacture and distribution of drugs and biologics are subject to continuing regulation by the FDA, including recordkeeping requirements, reporting of adverse experiences associated with the drug, and cGMPs,

 

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which regulate all aspects of the manufacturing process and impose certain procedural and documentation requirements. Drug and biologic manufacturers and their subcontractors are required to register their establishments, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with regulation requirements. If the manufacturer or distributor fails to comply with the statutory and regulatory requirements, or if safety concerns arise, the FDA may take legal or regulatory action, including civil or criminal penalties, suspension, withdrawal or delay in the issuance of approvals, or seizure or recall of products, any one or more of which could have a material adverse effect upon us.

The FDA imposes a number of complex regulatory requirements on entities that advertise and promote pharmaceuticals and biologics, including, but not limited to, standards and regulations for direct-to-consumer advertising, off-label promotion, industry sponsored scientific and educational activities, and promotional activities including Internet marketing. Drugs and biologics can only be marketed for approved indications and in accordance with the labeling approved by the FDA. Failure to comply with these regulations can result in penalties, including the issuance of warning letters directing a company to correct deviations from FDA standards, a requirement that future advertising and promotional materials be pre-cleared by the FDA, and federal and state civil and criminal investigations and prosecutions. The FDA does not, however, regulate the behavior of physicians in their practice of medicine and choice of treatment. Physicians may prescribe (although manufacturers are not permitted to promote) legally available drugs and biologics for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties.

We are also subject to various laws and regulations regarding laboratory practices, the housing, care and experimental use of animals, and the use and disposal of hazardous or potentially hazardous substances in connection with our research. In each of these areas, as above, the FDA has broad regulatory and enforcement powers, including the ability to levy fines and civil penalties, suspend or delay our operations and issue approvals, seize or recall products, and withdraw approvals, any one or more of which could have a material adverse effect upon us.

Internationally, the regulation of drugs is also complex. In Europe, our products are subject to extensive regulatory requirements. As in the United States, the marketing of medicinal products has for many years been subject to the granting of marketing authorizations by medicine agencies. Particular emphasis is also being placed on more sophisticated and faster procedures for reporting adverse events to the competent authorities. The European Union procedures for the authorization of medicinal products are intended to improve the efficiency of operation of both the mutual recognition and centralized procedures to license medicines. Similar rules and regulations exist in countries around the world. Additionally, new rules have been introduced or are under discussion in several areas, including the harmonization of clinical research laws and the law relating to orphan drugs and orphan indications. Outside the United States, reimbursement pricing is typically regulated by government agencies.

The total cost of providing health care services has been and will continue to be subject to review by governmental agencies and legislative bodies in the major world markets, including the United States, which are faced with significant pressure to lower health care costs. Legislation passed in recent years has imposed certain changes to the way in which pharmaceuticals, including our products, are covered and reimbursed in the United States. For instance, recent federal legislation and regulations have created a voluntary prescription drug benefit, Medicare Part D, and have imposed significant revisions to the Medicaid Drug Rebate Program. These changes have resulted in, and may continue to result in, coverage and reimbursement restrictions and increased rebate obligations. In addition, there is growing political pressure to allow the importation of pharmaceutical and medical device products from outside the United States. These reimbursement restrictions or other price reductions or controls or imports of pharmaceutical or medical device products from outside of the United States could materially and adversely affect our revenues and financial condition. Additionally, price reductions and rebates have recently been mandated in several European countries, principally Germany, Italy, Spain and the United Kingdom. Certain products are also no longer eligible for reimbursement in France, Italy and Germany.

 

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Reference pricing is used in several markets around the world to reduce prices. Furthermore, parallel trade within the European Union, whereby products flow from relatively low-priced to high-priced markets, has been increasing.

We cannot predict the likelihood or pace of any significant regulatory or legislative action in these areas, nor can we predict whether or in what form health care legislation being formulated by various governments will be passed. Initiatives in these areas could subject Medicare and Medicaid reimbursement rates to change at any time. We cannot predict with precision what effect such governmental measures would have if they were ultimately enacted into law. However, in general, we believe that such legislative activity will likely continue.

Medical Devices Segment

Medical devices are subject to regulation by the FDA, state agencies and foreign government health agencies. FDA regulations, as well as various U.S. federal and state laws, govern the development, clinical testing, manufacturing, labeling, record keeping and marketing of medical device products. Our medical device product candidates, including our breast implants, must undergo rigorous clinical testing and an extensive government regulatory approval process prior to sale in the United States and other countries. The lengthy process of clinical development and submissions for approvals, and the continuing need for compliance with applicable laws and regulations, require the expenditure of substantial resources. Regulatory approval, when and if obtained, may be limited in scope, and may significantly limit the indicated uses for which a product may be marketed. Approved products and their manufacturers are subject to ongoing review, and discovery of previously unknown problems with products may result in restrictions on their manufacture, sale, use or their withdrawal from the market.

Our medical device products are subject to extensive regulation by the FDA in the United States. Unless an exemption applies, each medical device we market in the United States must have a 510(k) clearance or a Premarket Approval, or PMA, application in accordance with the FFDCA and its implementing regulations. The FDA classifies medical devices into one of three classes, depending on the degree of risk associated with each medical device and the extent of controls that are needed to ensure safety and effectiveness. Devices deemed to pose a lower risk are placed in either Class I or Class II, which may require the manufacturer to submit to the FDA a premarket notification under Section 510(k) of the FFDCA requesting permission for commercial distribution. Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or a device deemed to be not substantially equivalent to a previously cleared 510(k) device, are placed in Class III. In general, a Class III device cannot be marketed in the United States unless the FDA approves the device after submission of a PMA application. The majority of our medical device products, including our breast implants, are regulated as Class III medical devices.

When we are required to obtain a 510(k) clearance for a device we wish to market, we must submit a premarket notification to the FDA demonstrating that the device is “substantially equivalent” to a previously cleared 510(k) device or a device that was in commercial distribution before May 28, 1976 for which the FDA had not yet called for the submission of PMA applications. By regulation, the FDA is required to respond to a 510(k) premarket notification within 90 days after submission of the notification, although clearance can take significantly longer. If a device receives 510(k) clearance, any modification that could significantly affect its safety or efficacy, or that would constitute a major change in its intended use, design or manufacture requires a new 510(k) clearance or PMA approval. The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination that a new clearance or approval is not required for a particular modification, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or premarket approval is obtained.

A PMA application must be submitted if the device cannot be cleared through the 510(k) process. The PMA process is much more demanding than the 510(k) clearance process. A PMA application must be supported by

 

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extensive information, including data from preclinical and clinical trials, sufficient to demonstrate to the FDA’s satisfaction that the device is safe and effective for its intended use. The FDA, by statute and regulation, has 180 days to review and accept a PMA application, although the review generally occurs over a significantly longer period of time, and can take up to several years. The FDA may also convene an advisory panel of experts outside the FDA to review and evaluate the PMA application and provide recommendations to the FDA as to the approvability of the device. New PMA applications or supplemental PMA applications are required for significant modifications to the manufacturing process, labeling and design of a medical device that is approved through the PMA process. PMA supplements require information to support the changes and may include clinical data.

A clinical trial is almost always required to support a PMA application and is sometimes required for a 510(k) premarket notification. These trials generally require submission of an application for an investigational device exemption, which must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound, as well as approval by the FDA and the IRB overseeing the trial. In addition, the FDAAA imposes certain clinical trial registry obligations on study sponsors. We, the FDA or the IRB at each site at which a clinical trial is being performed may suspend a clinical trial at any time for various reasons, including a belief that the study subjects are being exposed to an unacceptable health risk. The results of clinical testing may not be sufficient to obtain approval of the product.

After a device is placed on the market, numerous regulatory requirements apply. These include:

 

   

establishing registration and device listings with the FDA;

 

   

Quality System Regulation, which requires manufacturers to follow design, testing, control documentation and other quality assurance procedures during the manufacturing process;

 

   

labeling regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;

 

   

medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; and

 

   

corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FFDCA that may present a health risk.

The FDA imposes a number of complex regulatory requirements on entities that advertise and promote medical devices, including, but not limited to, standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities, and promotional activities including Internet marketing. Medical devices can only be marketed for indications approved or cleared by the FDA. Failure to comply with these regulations can result in penalties, the issuance of warning letters directing a company to correct deviations from FDA standards, a requirement that future advertising and promotional materials be pre-cleared by the FDA, and federal and state civil and criminal investigations and prosecutions. The FDA does not, however, regulate physicians in their practice of medicine and choice of treatment. Physicians may prescribe (although manufacturers are not permitted to promote) legally available devices for uses that are not described in the product’s labeling and that differ from those tested by us and approved or cleared by the FDA. Such off-label uses are common across medical specialties.

A Class III device may have significant additional obligations imposed in its conditions of approval. Compliance with regulatory requirements is assured through periodic, unannounced facility inspections by the FDA and other regulatory authorities, and these inspections may include the manufacturing facilities of our subcontractors or other third party manufacturers. Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: warning letters or untitled letters; fines, injunctions and civil penalties; recall or seizure of our products; operating restrictions,

 

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partial suspension or total shutdown of production; refusing our request for 510(k) clearance or PMA approval of new products; withdrawing 510(k) clearance or PMAs that are already granted; and criminal prosecution.

Products that are marketed in the European Union, or EU, must comply with the requirements of the Medical Device Directive, or MDD, as implemented into the national legislation of the EU member states. The MDD, as implemented, provides for a regulatory regime with respect to the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices to ensure that medical devices marketed in the EU are safe and effective for their intended uses. Medical devices that comply with the MDD, as implemented, are entitled to bear a CE marking and may be marketed in the EU. Medical device laws and regulations similar to those described above are also in effect in many of the other countries to which we export our products. These range from comprehensive device approval requirements for some or all of our medical device products to requests for product data or certifications. Failure to comply with these domestic and international regulatory requirements could affect our ability to market and sell our products in these countries.

Other Regulations

We are subject to federal, state, local and foreign environmental laws and regulations, including the U.S. Occupational Safety and Health Act, the U.S. Toxic Substances Control Act, the U.S. Resource Conservation and Recovery Act, Superfund Amendments and Reauthorization Act, Comprehensive Environmental Response, Compensation and Liability Act and other current and potential future federal, state or local regulations. Our manufacturing and research and development activities involve the controlled use of hazardous materials, chemicals and biological materials, which require compliance with various laws and regulations regarding the use, storage and disposal of such materials. We cannot assure you, however, that environmental problems relating to properties owned or operated by us will not develop in the future, and we cannot predict whether any such problems, if they were to develop, could require significant expenditures on our part. In addition, we are unable to predict what legislation or regulations may be adopted or enacted in the future with respect to environmental protection and waste disposal. Additionally, we may be subject either directly or by contract to federal and state laws pertaining to the privacy and security of personal health information.

We are also subject to various federal and state laws pertaining to health care “fraud and abuse” and gifts to health care practitioners. For example, the federal Anti-Kickback Statute makes it illegal to solicit, offer, receive or pay any remuneration, directly or indirectly, in cash or in kind, in exchange for, or to induce, the referral of business, including the purchase or prescription of a particular product, for which payment may be made under government health care programs such as Medicare and Medicaid. The U.S. federal government has published regulations that identify “safe harbors” or exemptions for certain practices from enforcement actions under the Anti-Kickback Statute. We seek to comply with the safe harbors where possible. Due to the breadth of the statutory provisions and in 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 the Anti-Kickback Statute or similar laws. In addition, under California law, pharmaceutical companies must adopt a comprehensive compliance program that is in accordance with both the April 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers and the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals, or the PhRMA Code. The PhRMA Code seeks to promote transparency in relationships between healthcare professionals and the pharmaceutical industry and to ensure that pharmaceutical marketing activities comport with the highest ethical standards. The PhRMA Code contains strict limitations on certain interactions between healthcare professionals and the pharmaceutical industry relating to gifts, meals, entertainment and speaker programs, among others. Furthermore, the federal False Claims Act prohibits anyone from, among other things, knowingly and willingly presenting, or causing to be presented for payment to third party payors (including Medicare and Medicaid), claims for reimbursed products or services that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to health care matters. In addition, many states have adopted laws similar to the federal fraud and abuse

 

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laws discussed above, which, in some cases, apply to all payors whether governmental or private. Our activities, particularly those relating to the sale and marketing of our products, may be subject to scrutiny under these and other laws. 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).

Patents, Trademarks and Licenses

We own, or are licensed under, numerous U.S. and foreign patents relating to our products, product uses and manufacturing processes. We believe that our patents and licenses are important to all segments of our business.

With the exception of the U.S. and European patents relating to Lumigan ® , Alphagan ® , Alphagan ® P 0.15% , Alphagan ® P 0.1% , Combigan ® and the U.S. patents relating to Restasis ® , Acular ® , Zymar ® and Latisse TM , no one patent or license is materially important to our specialty pharmaceuticals segment. The U.S. patents covering Lumigan ® expire in 2012 and 2014. The European patent covering Lumigan ® expires in various countries between 2013 and 2017. The U.S. patent covering the commercial formulation of Acular ® expires in November 2009. The U.S. patents covering the commercial formulations of Alphagan ® , Alphagan ® P 0.15%, and Alphagan ® P 0.1% expire in 2012 and 2021. In addition, the marketing exclusivity period for Alphagan ® P 0.15% expired in the United States in September 2004 and the marketing exclusivity period for Alphagan ® P 0.1% expired in August 2008. Market exclusivity for Alphagan ® in the United Kingdom, France, Germany and Italy expired in March 2007. The U.S. patents covering Restasis ® expire in August 2009 and 2014. The U.S. patents covering Zymar ® expire in 2010, 2015 and 2019. The U.S. patents for Combigan ® expire in 2022 and the European patents expire in 2022 and 2023. The U.S. patents covering Latisse TM expire in 2012, 2022 and 2023 and the European patents expire in 2013 and 2021.

We have rights in well over 100 issued Botox ® related U.S. and European use and process patents covering, for example, pain associated with cervical dystonia, treatment of chronic migraine, hyperhidrosis, overactive bladder and benign prostate hyperplasia. We have granted worldwide, royalty-bearing patent licenses to Merz with regard to Xeomin ® , and to Solstice Neurosciences with regard to MyoBloc ® . In addition, in December 2007, the FDA’s grant of orphan exclusivity for Botox ® for the treatment of certain aspects of cervical dystonia expired.

With the exception of certain U.S. and European patents relating to the Lap-Band ® System and our Inspira ® and Natrelle ® Collection of breast implants, no one patent or license is materially important to our specialty medical device segment based on overall sales. The patents covering our Lap-Band ® System, some of which we license from third parties, expire in 2011, 2013 and 2014 in the United States and in 2013 in Europe. The patents covering our Inspira ® and Natrelle ® Collection of breast implants expire in 2018 in the United States and in 2017 in Europe.

Our success depends in part on our ability to obtain patents or rights to patents, protect trade secrets and other proprietary technologies and processes, operate without infringing upon the proprietary rights of others, and prevent others from infringing on our patents, trademarks, service marks and other intellectual property rights. Upon the expiration or loss of patent protection for a product, we can lose a significant portion of sales of that product in a very short period of time as other companies manufacture generic forms of our previously protected product at lower cost, without having had to incur significant research and development costs in formulating the product. In addition, the issuance of a patent is not conclusive as to its validity or as to the enforceable scope of the claims of the patent. It is impossible to anticipate the breadth or degree of protection that any such patents will afford, or that any such patents will not be successfully challenged in the future. Accordingly, our patents may not prevent other companies from developing substantially identical products. Hence, if our patent applications are not approved or, even if approved, such patents are circumvented, our ability to competitively exploit our patented products and technologies may be significantly reduced. Also, such patents may or may not provide competitive advantages for their respective products, in which case our ability to commercially exploit these products may be diminished.

 

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Third parties may challenge, invalidate or circumvent our patents and patent applications relating to our products, product candidates and technologies. Challenges may result in significant harm to our business. The cost of responding to these challenges and the inherent costs to defend the validity of our patents, including the prosecution of infringements and the related litigation, can require a substantial commitment of our management’s time, require us to incur significant legal expenses and can preclude or delay the commercialization of products. See Item 3 of Part I of this report, “Legal Proceedings” and Note 14, “Legal Proceedings,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules,” for information concerning our current intellectual property litigation.

From time to time, we may need to obtain licenses to patents and other proprietary rights held by third parties to develop, manufacture and market our products. If we are unable to timely obtain these licenses on commercially reasonable terms, our ability to commercially exploit such products may be inhibited or prevented. See Item 1A of Part I of this report, “Risk Factors.”

We market our products under various trademarks, for which we have both registered and unregistered trademark protection in the United States and certain countries outside the United States. We consider these trademarks to be valuable because of their contribution to the market identification of our products and we regularly prosecute third party infringers of our trademarks in an attempt to limit confusion in the marketplace. Any failure to adequately protect our rights in our various trademarks and service marks from infringement could result in a loss of their value to us. If the marks we use are found to infringe upon the trademark or service mark of another company, we could be forced to stop using those marks and, as a result, we could lose the value of those marks and could be liable for damages caused by infringing those marks. In addition to intellectual property protections afforded to trademarks, service marks and proprietary know-how by the various countries in which our proprietary products are sold, we seek to protect our trademarks, service marks and proprietary know-how through confidentiality agreements with third parties, including our partners, customers, employees and consultants. These agreements may be breached or become unenforceable, and we may not have adequate remedies for any such breach. It is also possible that our trade secrets will become known or independently developed by our competitors, resulting in increased competition for our products.

In addition, we are currently engaged in various collaborative ventures for the development, manufacturing and distribution of current and new products. These projects include the following:

 

 

 

We entered into an exclusive licensing agreement with Kyorin under which Kyorin became responsible for the development and commercialization of Alphagan ® and Alphagan ® P 0.15% in Japan. Kyorin subsequently sublicensed its rights under the agreement to Senju. Under the licensing agreement, Senju incurs associated costs, makes clinical development and commercialization milestone payments, and makes royalty-based payments on product sales. We are working collaboratively with Senju on overall product strategy and management.

 

 

 

We entered into an exclusive licensing agreement with Senju under which Senju became responsible for the development and commercialization of Lumigan ® in Japan’s ophthalmic specialty area. Senju incurs associated costs, makes development and commercialization milestone payments and makes royalty-based payments on product sales. We are working collaboratively with Senju on overall product strategy and management.

 

 

 

We licensed from Novartis the worldwide, excluding Japan, rights for technology, patents and products relating to the topical ophthalmic use of cyclosporine A, the active ingredient in Restasis ® . In April 2005, we entered into a royalty buy-out agreement with Novartis related to Restasis ® and agreed to pay $110 million to Novartis. As a result of the buy-out agreement, we no longer pay royalties to Novartis based on sales of Restasis ® .

 

 

 

We licensed to GSK all clinical development and commercial rights to Botox ® in Japan and China. We receive royalties on GSK’s Japan and China Botox ® sales. We also manufacture Botox ® for GSK as

 

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part of a long-term supply agreement and collaboratively support GSK in its new clinical developments for Botox ® and its strategic marketing in those markets, for which we receive payments.

 

 

 

As a result of the Esprit acquisition, we obtained an exclusive license to market Sanctura ® and Sanctura XR ® in the United States and its territories from Indevus. We pay royalties to Indevus based upon our sales of Sanctura ® and Sanctura XR ® and assumed obligations of Esprit to pay certain other third-party royalties, also based upon sales of Sanctura ® and Sanctura XR ® . We also entered into a co-promotion agreement with Indevus, which we amended in January 2009, pursuant to which Indevus co-promotes Sanctura ® and Sanctura XR ® with us in the United States through the third quarter of 2009. In May 2008, we entered into a license agreement with Indevus and Madaus GmbH, which grants us the right to seek approval for and to commercialize Sanctura XR ® in Canada.

 

   

We entered into a strategic collaboration arrangement with Spectrum to develop and commercialize apaziquone, an antineoplastic agent currently being investigated for the treatment of non-muscle invasive bladder cancer by intravesical instillation. Under the collaboration, Spectrum will conduct two Phase III clinical trials to explore apaziquone’s safety and efficacy as a potential treatment for non-muscle invasive bladder cancer following surgery. Spectrum expects to complete enrollment in the trials by the end of 2009. Spectrum retained exclusive rights to apaziquone in Asia, including Japan and China. We received exclusive rights to apaziquone for the treatment of bladder cancer in the rest of the world, including the United States, Canada and Europe. In the United States, we will co-promote apaziquone with Spectrum and equally share in the profits and expenses. We will also pay Spectrum royalties on all of our apaziquone sales outside of the United States. Spectrum will continue to conduct the apaziquone clinical trials pursuant to a joint development plan, and we will bear the majority of these expenses.

Through Inamed, in June 2004, we entered into a settlement agreement with Ethicon Endo-Surgery, Inc. pursuant to which, among other terms, we were granted a worldwide, royalty-bearing, non-exclusive license with respect to a portfolio of U.S. and international patents applicable to adjustable gastric bands.

We are also a party to license agreements allowing other companies to manufacture products using some of our technology in exchange for royalties and other compensation or benefits.

Environmental Matters

We are subject to federal, state, local and foreign environmental laws and regulations. We believe that our operations comply in all material respects with applicable environmental laws and regulations in each country where we have a business presence. We also pride ourselves on our comprehensive and successful environmental, health and safety programs and performance against internal objectives. We have been recognized many times for superior environmental health and safety performance.

Although we continue to make capital expenditures for environmental protection, we do not anticipate any expenditures in order to comply with such laws and regulations that would have a material impact on our earnings or competitive position. We are not aware of any pending litigation or significant financial obligations arising from current or past environmental practices that are likely to have a material adverse effect on our financial position. We cannot assure you, however, that environmental problems relating to properties owned or operated by us will not develop in the future, and we cannot predict whether any such problems, if they were to develop, could require significant expenditures on our part. In addition, we are unable to predict what legislation or regulations may be adopted or enacted in the future with respect to environmental protection and waste disposal.

Seasonality

Our business, both taken as a whole and by our business segments, is not materially affected by seasonal factors, although we have noticed a historical trend with respect to sales of our Botox ® product. Specifically,

 

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sales of Botox ® have tended to be lowest during the first fiscal quarter, with sales during the second and third fiscal quarters being comparable and marginally higher than sales during the first fiscal quarter. Botox ® sales during the fourth fiscal quarter have tended to be the highest due to patients obtaining their final therapeutic treatment at the end of the year, presumably to fully utilize deductibles and to receive additional aesthetic treatments prior to the holiday season.

Third Party Coverage and Reimbursement

Health care providers generally rely on third-party payors, including governmental payors such as Medicare and Medicaid, and private insurance carriers, to adequately cover and reimburse the cost of pharmaceuticals and medical devices. Such third-party payors are increasingly challenging the price of medical products and services and instituting cost containment measures to control or significantly influence the purchase of medical products and services. The market for some of our products therefore is influenced by third-party payors’ policies. This includes the placement of our pharmaceutical products on drug formularies or lists of medications.

Purchases of aesthetic products and procedures using those products generally are not covered by third-party payors, and consequently patients incur out-of-pocket costs for such products and associated procedures. This includes breast aesthetics products for augmentation and facial aesthetics products. Since 1998, however, U.S. federal law has mandated that group health plans, insurance companies and health maintenance organizations offering mastectomy coverage must also provide coverage for reconstructive surgery following a mastectomy, which includes coverage for breast implants. Outside the United States, reimbursement for breast implants used in reconstructive surgery following a mastectomy may be available, but the programs vary on a country by country basis.

Furthermore, treatments for obesity alone may not be covered by third-party payors. For example, in February 2006, Medicare began covering certain designated bariatric surgical services, including gastric bypass surgery and procedures using the Lap-Band ® System, for Medicare patients who have previously been unsuccessfully treated for obesity and who have a body mass index, or BMI, equal to or greater than 40 or a BMI of 35 and who have at least one co-morbidity. However, the policy reiterates that treatments for obesity alone are not covered, because such treatments are not considered reasonable and necessary. Without changing current coverage for morbidly obese individuals, Medicare is evaluating whether surgical procedures benefit individuals with type 2 diabetes mellitus and proposed that this indication is a co-morbid condition related to obesity under the existing policies. While Medicare policies are sometimes adopted by other third-party payors, other governmental and private insurance coverage currently varies by carrier and geographic location, and we actively work with governmental agencies and insurance carriers to obtain reimbursement coverage for procedures using our Lap-Band ® System product. For instance, the Technology Evaluation Center of the Blue Cross/Blue Shield National Association provided a positive assessment of the Lap-Band ® System, an important step in providing private payor reimbursement for the procedure.

Outside the United States, reimbursement programs vary on a country by country basis. In some countries, both the procedure and product are fully reimbursed by the government healthcare systems for all citizens who need it, and there is no limit on the number of procedures that can be performed. In other countries, there is complete reimbursement but the number of procedures that can be performed at each hospital is limited either by the hospital’s overall budget or by the national budget for the type of product.

In the United States, there have been and continue to be a number of legislative initiatives to contain health care coverage and reimbursement by governmental and other payors. For example, effective January 1, 2006, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 implemented a new Part D prescription drug benefit under which Medicare beneficiaries can purchase certain prescription drugs at discounted prices from private sector entities, or Part D plan sponsors. Currently, drug manufacturers negotiate directly with Part D plan sponsors to determine whether their drugs will be listed on a Part D formulary and the prices at which such drugs will be listed. Industry competition to be included in formularies maintained by both

 

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private payors and Part D plans can result in downward pricing pressures on pharmaceutical companies. Although certain lawmakers have suggested in the past that the federal government should be granted the authority to negotiate the prices of drugs included on Part D formularies, at this time the federal government does not have such authority. There has also been an increased emphasis in the marketplace on the delivery of more cost-effective medical devices as well as a number of federal and state proposals to limit payments by local governmental payors for medical devices and the procedures in which medical devices are used. In addition, the American Recovery and Reinvestment Act of 2009, also known as the stimulus package, includes $1.1 billion in funding to study the comparative effectiveness of health care treatments and strategies. This funding will be used, among other things, to conduct, support or synthesize research that compares and evaluates the risk and benefits, clinical outcomes, effectiveness and appropriateness of products. Congress has indicated that this funding is intended to improve the quality of health care, but it remains unclear how the research will impact coverage, reimbursement or other third-party payor policies.

Breast Implant Replacement Programs

We conduct our product development, manufacturing, marketing and service and support activities with careful regard for the consequences to patients. As with any medical device manufacturer, however, we receive communications from surgeons or patients with respect to our various breast implant products claiming the products were defective, lost volume or have resulted in injury to patients. In the event of a loss of shell integrity resulting in breast implant rupture or deflation that requires surgical intervention with respect to our breast implant products sold and implanted in the United States, in most cases our ConfidencePlus ® programs provide lifetime product replacement and some financial assistance for surgical procedures required within ten years of implantation. Breast implants sold and implanted outside of the United States are subject to a similar program. We do not warrant any level of aesthetic result and, as required by government regulation, make extensive disclosure concerning the risks of our products and implantation surgery.

Employee Relations

At December 31, 2008, we employed approximately 8,740 persons throughout the world, including approximately 4,630 in the United States. None of our U.S.-based employees are represented by unions. We believe that our relations with our employees are generally good.

Executive Officers

Our executive officers and their ages as of February 27, 2009 are as follows:

 

Name

 

Age

  

Principal Positions with Allergan

David E.I. Pyott

  55   

Chairman of the Board and Chief Executive Officer

(Principal Executive Officer)

F. Michael Ball

  53    President, Allergan

James F. Barlow

  50   

Senior Vice President, Corporate Controller

(Principal Accounting Officer)

Raymond H. Diradoorian

  51    Executive Vice President, Global Technical Operations

Dianne Dyer-Bruggeman

  59    Executive Vice President, Human Resources

Jeffrey L. Edwards

  48   

Executive Vice President, Finance and Business Development,
Chief Financial Officer

(Principal Financial Officer)

Douglas S. Ingram, Esq.

  46    Executive Vice President, Chief Administrative Officer,
General Counsel and Secretary

Scott M. Whitcup, M.D.

  49    Executive Vice President, Research & Development

Officers are appointed by and hold office at the pleasure of the Board of Directors.

 

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Mr. Pyott has been Allergan’s Chief Executive Officer since January 1998 and in 2001 became the Chairman of the Board. Mr. Pyott also served as Allergan’s President from January 1998 until February 2006. Previously, he was head of the Nutrition Division and a member of the executive committee of Novartis AG, a publicly-traded company focused on the research and development of products to protect and improve health and well-being, from 1995 until December 1997. From 1992 to 1995, Mr. Pyott was President and Chief Executive Officer of Sandoz Nutrition Corp., Minneapolis, Minnesota, a predecessor to Novartis, and General Manager of Sandoz Nutrition, Barcelona, Spain, from 1990 to 1992. Prior to that, Mr. Pyott held various positions within the Sandoz Nutrition group from 1980. Mr. Pyott is also a member of the board of directors of Avery Dennison Corporation, a publicly-traded company focused on pressure-sensitive technology and self-adhesive solutions, and Edwards Lifesciences Corporation, a publicly-traded company focused on products and technologies to treat advanced cardiovascular diseases. Mr. Pyott is a member of the Directors’ Board of The Paul Merage School of Business at the University of California, Irvine (UCI). Mr. Pyott serves on the board of directors and the Executive Committee of the California Healthcare Institute and the Board of the Biotechnology Industry Organization. Mr. Pyott also serves as a member of the board of directors of the Pan-American Ophthalmological Foundation, the International Council of Ophthalmology Foundation, and as a member of the Advisory Board for the Foundation of the American Academy of Ophthalmology.

Mr. Ball has been President, Allergan since February 2006. Mr. Ball was Executive Vice President and President, Pharmaceuticals from October 2003 until February 2006. Prior to that, Mr. Ball was Corporate Vice President and President, North America Region and Global Eye Rx Business since May 1998 and prior to that was Corporate Vice President and President, North America Region since April 1996. He joined Allergan in 1995 as Senior Vice President, U.S. Eye Care after 12 years with Syntex Corporation, a multinational pharmaceutical company, where he held a variety of positions including President, Syntex Inc. Canada and Senior Vice President, Syntex Laboratories. Mr. Ball serves on the board of directors of STEC, Inc., a publicly-traded manufacturer and marketer of computer memory and hard drive storage solutions.

Mr. Barlow has been Senior Vice President, Corporate Controller since February 2005. Mr. Barlow joined Allergan in January 2002 as Vice President, Corporate Controller. Prior to joining Allergan, Mr. Barlow served as Chief Financial Officer of Wynn Oil Company, a division of Parker Hannifin Corporation. Prior to Wynn Oil Company, Mr. Barlow was Treasurer and Controller at Wynn’s International, Inc., a supplier of automotive and industrial components and specialty chemicals, from July 1990 to September 2000. Before working for Wynn’s International, Inc., Mr. Barlow was Vice President, Controller from 1986 to 1990 for Ford Equipment Leasing Company. From 1983 to 1985 Mr. Barlow worked for the accounting firm Deloitte Haskins and Sells.

Mr. Diradoorian has served as Allergan’s Executive Vice President, Global Technical Operations since February 2006. From April 2005 to February 2006, Mr. Diradoorian served as Senior Vice President, Global Technical Operations. From February 2001 to April 2005, Mr. Diradoorian served as Vice President, Global Engineering and Technology. Mr. Diradoorian joined Allergan in July 1981. Prior to joining Allergan, Mr. Diradoorian held positions at American Hospital Supply and with the Los Angeles Dodgers baseball team.

Ms. Dyer-Bruggeman has served as Executive Vice President, Human Resources since joining Allergan in December 2008. Prior to joining Allergan, Ms. Dyer-Bruggeman served as Senior Vice President, Global Human Resources for Broadcom Corporation, a global technology company, from April 2004 through November 2008. From June 1995 to April 2004, Ms. Dyer-Bruggeman served as Vice President, Human Resources for Titan Corporation, a leading provider of information and communications products for the defense and homeland security industries.

Mr. Edwards has been Executive Vice President, Finance and Business Development, Chief Financial Officer since September 2005. Prior to that, Mr. Edwards was Corporate Vice President, Corporate Development since March 2003 and previously served as Senior Vice President, Treasury, Tax, and Investor Relations. He

 

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joined Allergan in 1993. Prior to joining Allergan, Mr. Edwards was with Banque Paribas and Security Pacific National Bank, where he held various senior level positions in the credit and business development functions.

Mr. Ingram has been Executive Vice President, Chief Administrative Officer, General Counsel and Secretary, as well as our Chief Ethics Officer, since October 2006. From October 2003 through October 2006, Mr. Ingram served as Executive Vice President, General Counsel and Secretary, as well as our Chief Ethics Officer. Prior to that, Mr. Ingram served as Corporate Vice President, General Counsel and Secretary, as well as our Chief Ethics Officer, since July 2001. Prior to that he was Senior Vice President and General Counsel since January 2001, and Assistant Secretary since November 1998. Prior to that, Mr. Ingram was Associate General Counsel from August 1998, Assistant General Counsel from January 1998 and Senior Attorney and Chief Litigation Counsel from March 1996, when he first joined Allergan. Prior to joining Allergan, Mr. Ingram was, from August 1988 to March 1996, an attorney with the law firm of Gibson, Dunn & Crutcher LLP. Mr. Ingram manages the Global Legal Affairs organization, Global Regulatory Affairs, Compliance and Internal Audit, Corporate Communications, Global Trade Compliance, and the Information Technology organization. Mr. Ingram serves as a member of the board of directors of Volcom, Inc., a publicly-traded designer and distributor of clothing and accessories.

Dr. Whitcup has been Executive Vice President, Research and Development since July 2004. Dr. Whitcup joined Allergan in January 2000 as Vice President, Development, Ophthalmology. In January 2004, Dr. Whitcup became Allergan’s Senior Vice President, Development, Ophthalmology. From 1993 until 2000, Dr. Whitcup served as the Clinical Director of the National Eye Institute at the National Institutes of Health. As Clinical Director, Dr. Whitcup’s leadership was vital in building the clinical research program and promoting new ophthalmic therapeutic discoveries. Dr. Whitcup is a faculty member at the Jules Stein Eye Institute/David Geffen School of Medicine at the University of California, Los Angeles. Dr. Whitcup serves on the board of directors of Avanir Pharmaceuticals, a publicly-traded pharmaceutical company.

 

Item 1A. Risk Factors

We operate in a rapidly changing environment that involves a number of risks. The following discussion highlights some of these risks and others are discussed elsewhere in this report. These and other risks could materially and adversely affect our business, financial condition, prospects, operating results or cash flows. The following risk factors are not an exhaustive list of the risks associated with our business. New factors may emerge or changes to these risks could occur that could materially affect our business.

We operate in a highly competitive business.

The pharmaceutical and medical device industries are highly competitive and they require an ongoing, extensive search for technological innovation. They also require, among other things, the ability to effectively discover, develop, test and obtain regulatory approvals for products, as well as the ability to effectively commercialize, market and promote approved products, including communicating the effectiveness, safety and value of products to actual and prospective customers and medical professionals.

Many of our competitors have greater resources than we have. This enables them, among other things, to make greater research and development investments and spread their research and development costs, as well as their marketing and promotion costs, over a broader revenue base. Our competitors may also have more experience and expertise in obtaining marketing approvals from the U.S. Food and Drug Administration, or FDA, and other regulatory authorities. In addition to product development, testing, approval and promotion, other competitive factors in the pharmaceutical and medical device industries include industry consolidation, product quality and price, product technology, reputation, customer service and access to technical information.

It is possible that developments by our competitors could make our products or technologies less competitive or obsolete. Our future growth depends, in part, on our ability to develop products which are more

 

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effective. For instance, for our eye care products to be successful, we must be able to manufacture and effectively market those products and effectively detail them to a sufficient number of eye care professionals such that they determine to use or continue to use our current products and the new products we may introduce. Glaucoma must be treated over an extended period and doctors may be reluctant to switch a patient to a new treatment if the patient’s current treatment for glaucoma remains effective. Sales of our existing products may decline rapidly if a new product is introduced by one of our competitors or if we announce a new product that, in either case, represents a substantial improvement over our existing products. Similarly, if we fail to make sufficient investments in research and development programs, our current and planned products could be surpassed by more effective or advanced products developed by our competitors.

Until December 2000, Botox ® was the only neuromodulator approved by the FDA. At that time, the FDA approved Myobloc ® , a neuromodulator formerly marketed by Elan Pharmaceuticals and now marketed by Solstice Neurosciences, Inc. Ipsen Ltd., or Ipsen, is seeking FDA approval of its Dysport ® neuromodulator for certain therapeutic indications, and Medicis Pharmaceutical Corporation, or Medicis, its licensee for the United States, Canada and Japan, is seeking approval of Reloxin ® for cosmetic indications. Ipsen and Medicis submitted a Biologics License Application, or BLA, to the FDA for Reloxin ® in December 2007. In January 2009, Medicis announced that the Prescription Drug User Fee action date, or the date by which the FDA has to respond to Medicis’ BLA for Reloxin ® , was extended to April 13, 2009. Ipsen has marketed Dysport ® in Europe since 1991, prior to our European commercialization of Botox ® in 1992. In June 2006, Ipsen received marketing authorization for a cosmetic indication for Dysport ® in Germany. In 2007, Ipsen granted Galderma, a joint venture between Nestle and L’Oreal Group, an exclusive development and marketing license for Dysport ® for aesthetic indications in the European Union, Russia, Eastern Europe and the Middle East, and first rights of negotiation for other countries around the world, except the United States, Canada and Japan. In January 2008, Galderma became Ipsen’s sole distributor for Dysport ® in Brazil, Argentina and Paraguay. Ipsen is also seeking approval for Reloxin ® for cosmetic indications in the European Union, having submitted a file to the French regulatory authority in May 2003. In January 2009, the health authorities of 15 European Union countries granted approval of the product for glabellar lines under the trade name Azzalure TM .

Mentor Corporation, or Mentor, which was recently acquired by Johnson & Johnson, is conducting clinical trials for a competing neuromodulator in the United States. In addition, we are aware of competing neuromodulators currently being developed and commercialized in Asia, Europe, South America and other markets. A Chinese entity received approval to market a botulinum toxin in China in 1997, and we believe that it has launched or is planning to launch its botulinum toxin product in other lightly regulated markets in Asia, South America and Central America. These lightly regulated markets may not require adherence to the FDA’s current Good Manufacturing Practice regulations, or cGMPs, or the regulatory requirements of the European Medical Evaluation Agency or other regulatory agencies in countries that are members of the Organization for Economic Cooperation and Development. Therefore, companies operating in these markets may be able to produce products at a lower cost than we can. In addition, Merz’s botulinum toxin product Xeomin ® is currently approved and for sale in certain countries in the European Union, and in Argentina and Mexico. Merz is also conducting clinical trials in the United States for cervical dystonia, blepharospasm and cosmetic indications and is awaiting therapeutic licenses for Xeomin ® in many countries in the European Union. A Korean botulinum toxin, Meditoxin ® , was approved for sale in Korea in June 2006. The company, Medy-Tox Inc., received exportation approval from Korean authorities in early 2005 to ship their product under the trade name Neuronox ® . Our sales of Botox ® could be materially and negatively impacted by this competition or competition from other companies that might obtain FDA approval or approval from other regulatory authorities to market a neuromodulator.

Mentor is our principal competitor in the United States for breast implants. Mentor announced that, like us, it received FDA approval in November 2006 to sell its silicone breast implants. The conditions under which Mentor is allowed to market its silicone breast implants in the United States are similar to ours, including indications for use and the requirement to conduct post-marketing studies. If patients or physicians prefer Mentor’s breast implant products to ours or perceive that Mentor’s breast implant products are safer than ours,

 

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our sales of breast implants could materially suffer. In addition, Sientra, Inc. is currently conducting clinical studies of breast implant products in the United States. Internationally, we compete with several manufacturers, including Mentor, Silimed, MediCor Ltd and its subsidiaries BioSil Ltd, Nagor and Eurosilicone, Poly Implant Prostheses, Sebbin Laboratories and certain Chinese implant manufacturers.

Medicis began marketing the dermal fillers Restylane ® in January 2004 and Perlane TM in May 2007. Through our purchase of Cornéal, we acquired the rights to sell the Juvéderm ® family of products worldwide. Juvéderm ® 30, Juvéderm ® Ultra and Juvéderm ® Ultra Plus were approved by the FDA for sale in the United States in June 2006, and we announced nationwide availability of Juvéderm ® Ultra and Juvéderm ® Ultra Plus in January 2007. We cannot assure you that our Juvéderm ® family of products will offer equivalent or greater facial aesthetic benefits to competitive dermal filler products, that it will be competitive in price or gain acceptance in the marketplace.

In addition, in June 2007, the FDA approved label extensions for Juvéderm ® Ultra and Juvéderm ® Ultra Plus based on new clinical data demonstrating that the effects of both products may last for up to one year, which is a longer period of time than was reported in clinical studies that supported FDA approval of other hyaluronic acid dermal fillers. In addition, in 2008, we filed a supplement to our PMA for Juvéderm ® Ultra and Juvéderm ® Ultra Plus related to a new formulation containing lidocaine, an anesthetic that alleviates pain during injections. We cannot assure you that the FDA will continue to grant our label extensions, approve the supplement to our PMA or that other dermal fillers, including hyaluronic acid dermal fillers, do not have or will not obtain labels or label extensions that demonstrate product effects that are equivalent to or better than our products. Should our competitors obtain such labels or label extensions demonstrating product effects that are equivalent to or better than our products, our sales of Juvéderm ® could be materially and negatively impacted.

In September 2007, Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson, announced FDA approval of its gastric band product, the Realize TM band, which competes with our Lap-Band ® System in the U.S. market. The Lap-Band ® System also competes with surgical obesity procedures, including gastric bypass, vertical banded gastroplasty, sleeve gastrectomy and biliopancreatic diversion.

Our products for the treatment of overactive bladder, or OAB, Sanctura ® and Sanctura XR ® , compete with several other OAB treatment products, many of which have been on the market for a longer period of time, including Pfizer Inc.’s Detrol ® and Detrol ® LA , Watson Pharmaceuticals, Inc.’s Oxytrol ® , Novartis Pharmaceuticals Corporation and the Procter & Gamble Company’s Enablex ® and Astellas Pharma US, Inc., GlaxoSmithKline’s Vesicare ® and certain generic OAB products. While we believe that Sanctura ® and Sanctura   XR ® have advantages over these competing products, we cannot assure you that Sanctura ® and Sanctura XR ® offer more effective treatment of OAB for all patients, will be competitive in price or will obtain, maintain or increase market share in the OAB treatment market.

We also face competition from generic drug manufacturers in the United States and internationally. For instance, Falcon Pharmaceuticals, Ltd., an affiliate of Alcon, attempted to obtain FDA approval for a brimonidine product to compete with our Alphagan ® P 0.15% product. Pursuant to our March 2006 settlement with Alcon, Alcon may sell, offer for sale or distribute its brimonidine 0.15% product after September 30, 2009, or earlier if specified market conditions occur. The primary market condition will have occurred if prescriptions of Alphagan ® P 0.15% have reached a specified threshold as compared to other brimonidine-containing products. In February 2007, we received a paragraph 4 Hatch-Waxman Act certification from Exela PharmSci, Inc., or Exela, in which it purports to have sought FDA approval to market a generic form of Alphagan ® P 0.15%. In April 2007, we received a paragraph 4 Hatch-Waxman Act certification from Apotex, Inc., or Apotex, in which it purports to have sought FDA approval to market a generic form of Alphagan ® P 0.15% and Alphagan ® P 0.1%. We have filed complaints against Exela and Apotex and trial is scheduled for March 9, 2009. Furthermore, Apotex attempted to obtain FDA approval for and to launch generic forms of Acular ® and Acular LS ® . Pursuant to a federal court ruling in June 2006, Apotex is barred from obtaining approval before our patent related to Acular ® and Acular LS ® expires in November 2009. In October 2007, we received a paragraph 4 Hatch-Waxman

 

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Act certification from Apotex Corp. in which it purports to have sought FDA approval to market a generic form of Zymar ® . In February 2009, we received a paragraph 4 Hatch-Waxman Act certification in which the applicant purports to have sought FDA approval to market a generic 0.2% brimonidine tartrate/0.5% timolol maleate ophthalmic solution. See Item 3 of Part I of this report, “Legal Proceedings” and Note 14, “Legal Proceedings,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules,” for information concerning our current litigation.

Adverse U.S. and international economic conditions may reduce consumer demand for our products, causing our sales and profitability to suffer.

Changing U.S. and international economic and financial market conditions, including the recent crisis in the housing and credit markets and financial services industry, may negatively affect our revenues and operating results. Many of our products, including Botox ® Cosmetic, Juvéderm ® injectable gel, Latisse TM , to a large extent the Natrelle ® line of breast implants, and to a lesser extent the Lap-Band ® System, have limited reimbursement or are not reimbursable by governmental or other health care plans and instead are partially or wholly paid for directly by the consumer. Adverse economic conditions impacting consumers, including among others, increased taxation, higher unemployment, lower consumer confidence in the economy, higher consumer debt levels, lower availability of consumer credit, higher interest rates and hardships relating to declines in the housing and stock markets, may cause consumers to reassess their spending choices and result in a decline in their purchases of our products. Any failure to attain our projected revenues and operating results as a result of reduced consumer demand due to adverse economic or market conditions could have a material adverse effect on our business, cause our sales and profitability to suffer, reduce our operating cash flow and result in a decline in the price of our common stock. Adverse economic and market conditions could also have a negative impact on our business by negatively affecting the parties with whom we do business, including among others, our business partners, creditors, third-party contractors and suppliers, causing them to fail to meet their obligations to us.

We may experience difficulties, delays or unexpected costs and not achieve or maintain anticipated cost savings from our restructuring plan.

In February 2009, in order to concentrate our resources during the current recessionary period on customer-facing activities and on building the strength of our research and development pipeline while continuing to deliver on our earnings goals, we conducted a worldwide review of our operations to improve efficiency and began implementing a restructuring plan. Pursuant to the restructuring plan, we have focused our spending on programs and businesses that produce the highest returns. The restructuring plan involved a workforce reduction of approximately 460 employees, or approximately five percent of our global headcount, primarily in the United States and Europe. The majority of the employees affected by the restructuring plan were in two areas: (1) U.S. urology sales and marketing personnel as a result of our decision to focus on the urology specialty and to seek a partner to promote Sanctura XR ® to general practitioners, and (2) marketing personnel in the United States and Europe as we adjust our back-office structures to a reduced short-term outlook for some of our businesses. We have made modest reductions in other functions as well as re-engineered our processes in order to increase productivity. We anticipate substantially completing the restructuring plan by the end of the second quarter of 2009.

Our restructuring plan also contemplates cost reductions in 2009 and beyond. Our ability to attain these cost reductions is dependent upon various future developments, some of which are beyond our control. If we are unable to attain the benefits contemplated by our cost reductions under our restructuring plan or other unforeseen events occur, our business and results of operations could be adversely affected. Further, if we experience additional adverse changes to our business, we may face further restructuring or reorganization activities in the future.

Our personnel reductions were completed through an involuntary reduction in force. In order to be successful and build our framework for future growth, we must continue to execute and deliver on our core business initiatives with fewer human resources and losses of intellectual capital. We must also attract, retain and

 

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motivate key employees including highly qualified management, scientific, manufacturing, sales and marketing personnel who are critical to our business. We may not be able to attract, retain or motivate qualified employees in the future and our inability to do so may adversely affect our business.

We could experience difficulties obtaining or creating the raw materials or components needed to produce our products and interruptions in the supply of raw materials or components could disrupt our manufacturing and cause our sales and profitability to decline.

The loss of a material supplier or the interruption of our manufacturing processes could adversely affect our ability to manufacture or sell many of our products. We obtain the specialty chemicals that are the active pharmaceutical ingredients in certain of our products from single sources, who must maintain compliance with the FDA’s cGMPs. We also obtain Aczone ® , Sanctura ® and Sanctura XR ® under manufacturing agreements with sole source suppliers. If we experience difficulties acquiring sufficient quantities of these materials or products from our existing suppliers, or if our suppliers are found to be non-compliant with the cGMPs, obtaining the required regulatory approvals, including from the FDA or the European Medical Evaluation Agency to use alternative suppliers may be a lengthy and uncertain process. A lengthy interruption of the supply of one or more of these materials could adversely affect our ability to manufacture and supply products, which could cause our sales and profitability to decline. In addition, the manufacturing process to create the raw material necessary to produce Botox ® is technically complex and requires significant lead-time. Any failure by us to forecast demand for, or to maintain an adequate supply of, the raw material and finished product could result in an interruption in the supply of Botox ® and a resulting decrease in sales of the product.

We also rely on a single supplier for silicone raw materials used in some of our products, including breast implants. Although we have an agreement with this supplier to transfer the necessary formulations to us in the event that it cannot meet our requirements, we cannot guarantee that we would be able to produce or obtain a sufficient amount of quality silicone raw materials in a timely manner. We depend on third party manufacturers for silicone molded components. These third party manufacturers must maintain compliance with the FDA’s Quality System Regulation, or QSR, which sets forth the current good manufacturing practice standard for medical devices and requires manufacturers to follow design, testing and control documentation and air quality assurance procedures during the manufacturing process. Any material reduction in our raw material supply or a failure by our third party manufacturers to maintain compliance with the QSR could result in decreased sales of our products and a decrease in our revenues. Additionally, certain of the manufacturing processes that we perform are only performed at one location worldwide. Furthermore, as a result of the credit crisis and current economic conditions, and while we analyze the financial solvency of our key suppliers, we cannot guarantee that our key suppliers will remain solvent or that we will be able to obtain sufficient supplies of key materials, particularly as we often represent a small part of the overall output of these manufacturers.

Our future success depends upon our ability to develop new products, and new indications for existing products, that achieve regulatory approval for commercialization.

For our business model to be successful, we must continually develop, test and manufacture new products or achieve new indications or label extensions for the use of our existing products. Prior to marketing, these new products and product indications must satisfy stringent regulatory standards and receive requisite approvals or clearances from regulatory authorities in the United States and abroad. The development, regulatory review and approval, and commercialization processes are time consuming, costly and subject to numerous factors that may delay or prevent the development, approval or clearance, and commercialization of new products, including legal actions brought by our competitors. To obtain approval or clearance of new indications or products in the United States, we must submit, among other information, the results of preclinical and clinical studies on the new indication or product candidate to the FDA. The number of preclinical and clinical studies that will be required for FDA approval varies depending on the new indication or product candidate, the disease or condition for which the new indication or product candidate is in development and the regulations applicable to that new indication or product candidate. Even if we believe that the data collected from clinical trials of new indications

 

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for our existing products or for our product candidates are promising, the FDA may find such data to be insufficient to support approval of the new indication or product. The FDA can delay, limit or deny approval or clearance of a new indication or product candidate for many reasons, including:

 

   

a determination that the new indication or product candidate is not safe and effective;

 

   

the FDA may interpret our preclinical and clinical data in different ways than we do;

 

   

the FDA may not approve our manufacturing processes or facilities;

 

   

the FDA may not approve our Risk Evaluation and Mitigation Strategy, or REMS, program;

 

   

the FDA may require us to perform post-marketing clinical studies; or

 

   

the FDA may change its approval policies or adopt new regulations.

Products that we are currently developing, other future product candidates or new indications or label extensions for our existing products, may or may not receive the regulatory approvals or clearances necessary for marketing or may receive such approvals or clearances only after delays or unanticipated costs. For example, the FDA may require us to implement a REMS program to manage known or potential serious risks associated with our pharmaceutical products to ensure that the benefits of our products outweigh their risks. A REMS program can include patient package inserts, medication guides, communication plans, an implementation system and other elements necessary to assure safe use of our pharmaceutical product. If the FDA determines that a REMS program is necessary, the agency will not approve our product without an approved REMS program, which could delay approval or impose additional requirements on our products. In addition, we may be subject to enforcement actions, including civil money penalties if we do not comply with REMS program requirements. Delays or unanticipated costs in any part of the process or our inability to obtain timely regulatory approval for our products, including those attributable to, among other things, our failure to maintain manufacturing facilities in compliance with all applicable regulatory requirements, including the cGMPs and QSR, could cause our operating results to suffer and our stock price to decrease. Our facilities, our suppliers’ facilities and other third parties’ facilities on which we rely must pass pre-approval reviews and plant inspections and demonstrate compliance with the cGMPs and QSR.

Further, even if we receive FDA and other regulatory approvals for a new indication or product, the product may later exhibit adverse effects that limit or prevent its widespread use or that force us to withdraw the product from the market or to revise our labeling to limit the indications for which the product may be prescribed. In addition, even if we receive the necessary regulatory approvals, we cannot assure you that new products or indications will achieve market acceptance. Our future performance will be affected by the market acceptance of products such as Acular LS ® , Aczone ® , Alphagan ® P 0.15%, Alphagan ® P 0.1%, Botox ® , Botox ® Cosmetic, Clinique Medical, Combigan ® , Elestat ® , Ganfort TM , Juvéderm ® , the Lap-Band ® System, Latisse TM , Lumigan ® , Optive TM , Refresh ® , Restasis ® , Sanctura ® , Sanctura XR ® , Tazorac ® , Vistabel ® and Zymar ® , as well as the Natrelle ® line of breast implant products, new indications for Botox ® and new products such as Posurdex ® and Trivaris TM . We cannot assure you that our currently marketed products will not be subject to further regulatory review and action. For example, on February 8, 2008, the FDA announced in an “Early Communication” that it is reviewing certain serious adverse events following the use of botulinum toxins, including the therapeutic use of Botox ® , to treat juvenile cerebral palsy and other large muscle, lower limb spasticities. In the course of its investigation, the FDA may require additional studies relating to Botox ® or Botox ® Cosmetic or additional disclosure or label restrictions around the use of Botox ® or Botox ® Cosmetic, any of which could result in substantial additional expense and may have a material adverse effect on our business and results of operations. Additionally, any negative results from such examination by the FDA could materially affect future indications for Botox ® , and the use, reimbursement and sales of Botox ® . Further, we cannot assure you that any other compounds or products that we are developing for commercialization will be approved by the FDA or foreign regulatory bodies for marketing or that we will be able to commercialize them on terms that will be profitable, or at all. If any of our products cannot be successfully or timely commercialized, our operating results could be materially adversely affected.

 

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Our product development efforts may not result in commercial products.

We intend to continue an aggressive research and development program. Successful product development in the pharmaceutical and medical device industry is highly uncertain, and very few research and development projects produce a commercial product. Product candidates that appear promising in the early phases of development, such as in early human clinical trials, may fail to reach the market for a number of reasons, such as:

 

   

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive preclinical trial results;

 

   

the product candidate was not effective in treating a specified condition or illness;

 

   

the product candidate had harmful side effects in humans or animals;

 

   

the necessary regulatory bodies, such as the FDA, did not approve the product candidate for an intended use;

 

   

the product candidate was not economical for us to manufacture and commercialize;

 

   

other companies or people have or may have proprietary rights to the product candidate, such as patent rights, and will not sell or license these rights to us on reasonable terms, or at all;

 

   

the product candidate is not cost effective in light of existing therapeutics or alternative devices; and

 

   

certain of our licensors or partners may fail to effectively conduct clinical development or clinical manufacturing activities.

Several of our product candidates have failed or been discontinued at various stages in the product development process. Of course, there may be other factors that prevent us from marketing a product. We cannot guarantee we will be able to produce commercially successful products. Further, clinical trial results are frequently susceptible to varying interpretations by scientists, medical personnel, regulatory personnel, statisticians and others, which may delay, limit or prevent further clinical development or regulatory approvals of a product candidate. Also, the length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied by product and by the intended use of a product. We expect that this will likely be the case with future product candidates and we cannot predict the length of time to complete necessary clinical trials and obtain regulatory approval.

If we are unable to obtain and maintain adequate protection for our intellectual property rights associated with the technologies incorporated into our products, our business and results of operations could suffer.

Our success depends in part on our ability to obtain patents or rights to patents, protect trade secrets and other proprietary technologies and processes, and prevent others from infringing on our patents, trademarks, service marks and other intellectual property rights. Upon the expiration or loss of patent protection for a product, we can lose a significant portion of sales of that product in a very short period of time as other companies manufacture generic forms of our previously protected product or manufacture similar products or devices at lower cost, without having had to incur significant research and development costs in formulating the product or designing the device. Therefore, our future financial success may depend in part on obtaining patent protection for technologies incorporated into our products. We cannot assure you that such patents will be issued, or that any existing or future patents will be of commercial benefit. In addition, it is impossible to anticipate the breadth or degree of protection that any such patents will afford, and we cannot assure you that any such patents will not be successfully challenged in the future. If we are unsuccessful in obtaining or preserving patent protection, or if any of our products rely on unpatented proprietary technology, we cannot assure you that others will not commercialize products substantially identical to those products. Generic drug manufacturers are currently challenging the patents covering certain of our products, and we expect that they will continue to do so in the future.

 

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Third parties may challenge, invalidate or circumvent our patents and patent applications relating to our products, product candidates and technologies. Challenges may result in potentially significant harm to our business. The cost of responding to these challenges and the inherent costs to defend the validity of our patents, including the prosecution of infringements and the related litigation, could be substantial and can preclude or delay commercialization of products. Such litigation also could require a substantial commitment of our management’s time. For certain of our product candidates, third parties may have patents or pending patents that they claim prevent us from commercializing certain product candidates in certain territories. Our success depends in part on our ability to obtain and defend patent rights and other intellectual property rights that are important to the commercialization of our products and product candidates. For additional information on our material patents, see “Patents, Trademarks and Licenses” in Item 1 of Part I of this report, “Business.”

We also believe that the protection of our trademarks and service marks is an important factor in product recognition and in our ability to maintain or increase market share. If we do not adequately protect our rights in our various trademarks and service marks from infringement, their value to us could be lost or diminished, seriously impairing our competitive position. Moreover, the laws of certain foreign countries do not protect our intellectual property rights to the same extent as the laws of the United States. In addition to intellectual property protections afforded to trademarks, service marks and proprietary know-how by the various countries in which our proprietary products are sold, we seek to protect our trademarks, service marks and proprietary know-how through confidentiality and proprietary information agreements with third parties, including our partners, customers, employees and consultants. These agreements may not provide meaningful protection or adequate remedies for violation of our rights in the event of unauthorized use or disclosure of confidential information. It is possible that these agreements will be breached or that they will not be enforceable in every instance, and that we will not have adequate remedies for any such breach. It is also possible that our trade secrets will become known or independently developed by our competitors.

We may be subject to intellectual property litigation and infringement claims, which could cause us to incur significant expenses and losses or prevent us from selling our products.

We cannot assure you that our products will not infringe patents or other intellectual property rights held by third parties. In the event we discover that we may be infringing third party patents or other intellectual property rights, we may not be able to obtain licenses from those third parties on commercially attractive terms or at all. We may have to defend, and have defended, against charges that we violated patents or the proprietary rights of third parties. Litigation is costly and time-consuming, and diverts the attention of our management and technical personnel. In addition, if we infringe the intellectual property rights of others, we could lose our right to develop, manufacture or sell products or could be required to pay monetary damages or royalties to license proprietary rights from third parties. An adverse determination in a judicial or administrative proceeding or a failure to obtain necessary licenses could prevent us from manufacturing or selling our products, which could harm our business, financial condition, prospects, results of operations and cash flows. See Item 3 of Part I of this report, “Legal Proceedings” and Note 14, “Legal Proceedings,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules,” for information concerning our current intellectual property litigation.

Importation of products from Canada and other countries into the United States may lower the prices we receive for our products.

In the United States, some of our pharmaceutical products are subject to competition from lower priced versions of those products and competing products from Canada, Mexico and other countries where government price controls or other market dynamics result in lower prices. Our products that require a prescription in the United States are often available to consumers in these other markets without a prescription, which may cause consumers to further seek out our products in these lower priced markets. The ability of patients and other customers to obtain these lower priced imports has grown significantly as a result of the Internet, an expansion of pharmacies in Canada and elsewhere targeted to American purchasers, the increase in U.S.-based businesses

 

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affiliated with Canadian pharmacies marketing to American purchasers and other factors. These foreign imports are illegal under current U.S. law, with the sole exception of limited quantities of prescription drugs imported for personal use. However, the volume of imports continues to rise due to the limited enforcement resources of the FDA and the U.S. Customs Service, and there is increased political pressure to permit the imports as a mechanism for expanding access to lower priced medicines.

In December 2003, Congress enacted the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or MMA. The MMA contains provisions that may change U.S. import laws and expand consumers’ ability to import lower priced versions of our products and competing products from Canada, where there are government price controls. These changes to U.S. import laws will not take effect unless and until the Secretary of Health and Human Services certifies that the changes will lead to substantial savings for consumers and will not create a public health safety issue. The Secretary of Health and Human Services has not made such a certification. However, it is possible that the current Secretary or a subsequent Secretary could make such a certification in the future. As directed by Congress, a task force on drug importation conducted a comprehensive study regarding the circumstances under which drug importation could be safely conducted and the consequences of importation on the health, medical costs and development of new medicines for U.S. consumers. The task force issued its report in December 2004, finding that there are significant safety and economic issues that must be addressed before importation of prescription drugs is permitted. In addition, federal legislative proposals have been made to implement the changes to the U.S. import laws without any certification, and to broaden permissible imports in other ways. Even if the changes to the U.S. import laws do not take effect, and other changes are not enacted, imports from Canada and elsewhere may continue to increase due to market and political forces, and the limited enforcement resources of the FDA, the U.S. Customs Service and other government agencies. For example, Public Law Number 110-329, which was signed into law in September 2008 and provides appropriations for the Department of Homeland Security for the 2009 fiscal year, expressly prohibits the U.S. Customs Services from using funds to prevent individuals from importing from Canada less than a 90-day supply of a prescription drug for personal use, when the drug otherwise complies with the Federal Food, Drug and Cosmetic Act. In addition, certain state and local governments have implemented importation schemes for their citizens and, in the absence of federal action to curtail such activities, other states and local governments may also launch importation efforts.

The importation of foreign products adversely affects our profitability in the United States. This impact could become more significant in the future, and the impact could be even greater if there is a further change in the law or if state or local governments take further steps to import products from abroad.

Our ownership of real property and the operation of our business will continue to expose us to risks of environmental liabilities.

Under various U.S. federal, state and local environmental laws, ordinances and regulations, a current or previous owner or operator of real property may be liable for the cost of removal or remediation of hazardous or toxic substances on, under or in such property. Such laws often impose liability whether or not the owner or operator knew of, or was responsible for, the presence of such hazardous or toxic substances. Environmental laws also may impose restrictions on the manner in which property may be used or the businesses that may be operated, and these restrictions may require expenditures. Environmental laws provide for sanctions in the event of noncompliance and may be enforced by governmental agencies or, in certain circumstances, by private parties. In connection with the acquisition and ownership of our properties, we may be potentially liable for such costs. The cost of defending against claims of liability, complying with environmental regulatory requirements or remediating any contaminated property could have a material adverse effect on our business, assets or results of operations. Any costs or expenses relating to environmental matters may not be covered by insurance.

Our product development programs and manufacturing processes involve the controlled use of hazardous materials, chemicals and toxic compounds. These programs and processes expose us to risks that an accidental contamination could lead to noncompliance with environmental laws, regulatory enforcement actions and claims

 

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for personal injury and property damage. If an accident or environmental discharge occurs, or if we discover contamination caused by prior operations, including by prior owners and operators of properties we acquire, we could be liable for cleanup obligations, damages and fines. The substantial unexpected costs we may incur could have a significant and adverse effect on our business and results of operations.

A disruption at certain of our manufacturing sites would significantly interrupt our production capabilities, which could result in significant product delays and adversely affect our results.

Certain of our products are produced at single manufacturing facilities, including Restasis ® , our obesity intervention products, and our dermal filler products. We are also in the process of transferring the manufacture of our breast implant products to a single facility. In addition, we manufacture Botox ® at two structurally separate facilities located adjacent to one another at a single site. We face risks inherent in manufacturing our products at a single facility or at a single site. These risks include the possibility that our manufacturing processes could be partially or completely disrupted by a fire, natural disaster, terrorist attack, foreign governmental action or military action. In the case of a disruption, we may need to establish alternative manufacturing sources for these products. This would likely lead to substantial production delays as we build or locate replacement facilities and seek and obtain the necessary regulatory approvals. If this occurs, and our finished goods inventories are insufficient to meet demand, we may be unable to satisfy customer orders on a timely basis, if at all. Further, our business interruption insurance may not adequately compensate us for any losses that may occur and we would have to bear the additional cost of any disruption. For these reasons, a significant disruptive event at certain of our manufacturing facilities or sites could materially and adversely affect our business and results of operations.

We may experience losses due to product liability claims, product recalls or corrections.

The design, development, manufacture and sale of our products involve an inherent risk of product liability or other claims by consumers and other third parties. We have in the past been, and continue to be, subject to various product liability claims and lawsuits. In addition, we have in the past and may in the future recall or issue field corrections related to our products due to manufacturing deficiencies, labeling errors or other safety or regulatory reasons. We cannot assure you that we will not in the future experience material losses due to product liability claims, lawsuits, product recalls or corrections.

As part of the Inamed acquisition, we assumed Inamed’s product liability risks, including any product liability for its past and present manufacturing of breast implant products. The manufacture and sale of breast implant products has been and continues to be the subject of a significant number of product liability claims due to allegations that the medical devices cause disease or result in complications and other health conditions due to rupture, deflation or other product failure. See Item 3 of Part I of this report, “Legal Proceedings” and Note 14, “Legal Proceedings,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules,” for information concerning our current product liability litigation. Historically, other breast implant manufacturers that suffered such claims in the 1990’s were forced to cease operations or even to declare bankruptcy.

Additionally, recent FDA marketing approval for our silicone breast implants requires that:

 

   

we monitor patients in our core study out to 10 years even if there has been explantation of the core device without replacement;

 

   

patients in the core study receive magnetic resonance imaging tests, or MRIs, at seven and nine years;

 

   

we conduct a large, 10-year post-approval study; and

 

   

we conduct additional smaller evaluations, including a focus group aimed at ensuring patients are adequately informed about the risks of our silicone breast implants and that the format and content of patient labeling is adequate.

 

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We are seeking marketing approval for other silicone breast implants in the United States, and if we obtain this approval, it may similarly be subject to significant restrictions and requirements, including the need for a patient registry, follow up MRIs and substantial Phase IV clinical trial commitments.

We also face a substantial risk of product liability claims from our eye care, neuromodulator, urology, skin care, obesity intervention and facial aesthetics products. Additionally, our pharmaceutical and medical device products may cause, or may appear to cause, serious adverse side effects or potentially dangerous drug interactions if misused, improperly prescribed, improperly implanted or based on faulty surgical technique. We are subject to adverse event reporting regulations that require us to report to the FDA or similar bodies in other countries if our products are associated with a death or serious injury. These adverse events, among others, could result in additional regulatory controls, such as the performance of costly post-approval clinical studies or revisions to our approved labeling, which could limit the indications or patient population for our products or could even lead to the withdrawal of a product from the market. Furthermore, any adverse publicity associated with such an event could cause consumers to seek alternatives to our products, which may cause our sales to decline, even if our products are ultimately determined not to have been the primary cause of the event.

Negative publicity concerning the safety of our products may harm our sales, force us to withdraw products and cause a decline in our stock price.

Physicians and potential and existing patients may have a number of concerns about the safety of our products, including Botox ® , breast implants, eye care pharmaceuticals, urologics products, skin care products, obesity intervention products and facial dermal fillers, whether or not such concerns have a basis in generally accepted science or peer-reviewed scientific research. These concerns may be increased by negative publicity, even if the publicity is inaccurate. For example, consumer groups and certain plaintiffs have recently alleged that certain uses of Botox ® , including off-label uses, have caused patient injuries and death and have further alleged that we failed to adequately warn patients of the risks relating to Botox ® use. Negative publicity — whether accurate or inaccurate — about the efficacy, safety or side effects of our products or product categories, whether involving us or a competitor, or new government regulations, could materially reduce market acceptance of our products, cause consumers to seek alternatives to our products, result in product withdrawals and cause our stock price to decline. Negative publicity could also result in an increased number of product liability claims, whether or not these claims have a basis in scientific fact.

Health care initiatives and other third-party payor cost-containment pressures could cause us to sell our products at lower prices, resulting in decreased revenues.

Some of our products are purchased or reimbursed by federal and state government authorities, private health insurers and other organizations, such as health maintenance organizations, or HMOs, and managed care organizations, or MCOs. Third-party payors increasingly challenge pharmaceutical and other medical device product pricing. There also continues to be a trend toward managed health care in the United States. Pricing pressures by third-party payors and the growth of organizations such as HMOs and MCOs could result in lower prices and a reduction in demand for our products.

In addition, legislative and regulatory proposals and enactments to reform health care and government insurance programs, including the MMA, the Deficit Reduction Act of 2005, or DRA, and the hospital outpatient prospective payment system, or HOPPS, could significantly influence the manner in which pharmaceutical products and medical devices are prescribed and purchased. For example, effective January 1, 2006, the MMA established a new Medicare outpatient prescription drug benefit under Part D. Though it was postponed for calendar year 2009, the MMA also established a competitive acquisition program, or CAP, in which physicians who administer drugs in their offices are offered an option to acquire drugs covered under the Medicare Part B benefit from vendors who are selected in a competitive bidding process. Further, the DRA requires the Centers for Medicare & Medicaid Services, or CMS, the federal agency that both administers the Medicare program and administers and oversees the Medicaid Drug Rebate Program, to amend certain formulas used to calculate

 

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pharmacy reimbursement and rebates under Medicaid. In July 2007, CMS issued a final rule that, among other things, clarifies and changes how drug manufacturers must calculate and report key pricing data under the Medicaid Drug Rebate Program. This data is used by CMS and state Medicaid agencies to calculate rebates owed by manufacturers under the Medicaid Drug Rebate Program and to calculate the federal upper limits on cost-sharing for certain prescription drugs. In December 2007, following a judicial challenge brought by a national association of pharmacies, a federal judge ordered an injunction that prevents CMS from implementing portions of its July rule, as they affect Medicaid payment to pharmacies and the sharing by CMS of certain drug pricing data, known as average manufacturer price, or AMP. In addition, the Medicare Improvements for Patients and Providers Act of 2008, or MIPPA, which was passed in July 2008, delays the implementation dates of these portions of the July 2007 Medicaid final rule. The MIPPA prohibits the computation of Medicaid payments based on AMP and the public availability of AMP data through September 2009. If CMS is ultimately permitted to implement its rule, changes could lead to reduced payments to pharmacies and others dispensing prescriptions for certain pharmaceutical products. These and other cost containment measures and health care reforms could adversely affect our ability to sell our products.

The DRA also requires that each state collect key pricing information related to rebates owed by us and other manufacturers of certain physician administered single source drugs as a condition of that state’s receipt of future Medicaid payments from the federal government. This change went into effect on January 1, 2006 for single source drugs and may result in an increase in the rebate amounts paid by us to each state for the period from February 2006 to the present and, in some cases, for periods prior to February 2006. These rebate amounts may be substantial and may adversely affect our revenues and profitability. Furthermore, effective January 1, 2008, CMS reduced Medicare reimbursement for most separately payable physician-administered drugs under HOPPS from an average sales price plus six percent to plus five percent. An additional reduction to average sales price plus four percent went into effect January 1, 2009 and further reductions may be imposed in the future.

In addition, individual states have also become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and to encourage importation from other countries and bulk purchasing. Legally-mandated price controls on payment amounts by third-party payors or other restrictions could negatively and materially impact our revenues and financial condition.

We expect there will continue to be federal and state laws and/or regulations, proposed and implemented, that could limit the amounts that federal and state governments will pay for health care products and services. The extent to which future legislation or regulations, if any, relating to the health care industry or third-party coverage and reimbursement may be enacted or what effect such legislation or regulation would have on our business remains uncertain. For example, the American Recovery and Reinvestment Act of 2009, also known as the stimulus package, includes $1.1 billion in funding to study the comparative effectiveness of health care treatments and strategies. This funding will be used, among other things, to conduct, support or synthesize research that compares and evaluates the risk and benefits, clinical outcomes, effectiveness and appropriateness of products. Although Congress has indicated that this funding is intended to improve the quality of health care, it remains unclear how the research will impact coverage, reimbursement or other third-party payor policies. Such measures or other health care system reforms that are adopted could have a material adverse effect on our industry generally and our ability to successfully commercialize our products or could limit or eliminate our spending on development projects and affect our ultimate profitability.

In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical and medical device products and which suppliers will be included in their prescription drug and other health care programs. This can reduce demand for our products or put pressure on our product pricing, which could negatively affect our revenues and profitability.

Our ability to sell our products to hospitals in the United States depends in part on our relationships with group purchasing organizations, or GPOs. Many existing and potential customers for our products become

 

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members of GPOs. GPOs negotiate pricing arrangements and contracts, sometimes on an exclusive basis, with medical supply manufacturers and distributors, and these negotiated prices are made available to a GPO’s affiliated hospitals and other members. If we are not one of the providers selected by a GPO, affiliated hospitals and other members may be less likely to purchase our products, and if the GPO has negotiated a strict sole source, market share compliance or bundling contract for another manufacturer’s products, we may be precluded from making sales to members of the GPO for the duration of the contractual arrangement. Our failure to renew contracts with GPOs may cause us to lose market share and could have a material adverse effect on our sales, financial condition and results of operations. We cannot assure you that we will be able to renew these contracts at the current or substantially similar terms. If we are unable to keep our relationships and develop new relationships with GPOs, our competitive position would likely suffer.

We encounter similar regulatory and legislative issues in most countries outside the United States. International operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe and other countries has and will continue to put pressure on the price and usage of our pharmaceutical and medical device products. Although we cannot predict the extent to which our business may be affected by future cost-containment measures or other potential legislative or regulatory developments, additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our current and future products, which could adversely affect our revenue and results of operations.

We are subject to risks arising from currency exchange rates, which could increase our costs and may cause our profitability to decline.

We collect and pay a substantial portion of our sales and expenditures in currencies other than the U.S. dollar. Therefore, fluctuations in foreign currency exchange rates affect our operating results. We cannot assure you that future exchange rate movements, inflation or other related factors will not have a material adverse effect on our sales or operating expenses.

Negative conditions in the financial and credit markets may impact our liquidity.

Recent dramatic changes in the global financial markets have weakened global economic conditions. These changes have not had, nor do we anticipate they will have, a significant impact on our liquidity. Given our current operating cash flow, financial assets, access to the capital markets and available lines of credit, we continue to believe that we will be able to meet our financing needs for the foreseeable future. However, there can be no assurance that global economic conditions will not worsen, which could have a corresponding negative effect on our liquidity. In addition, while we believe that we have invested our financial assets in, and executed hedging transactions with, sound financial institutions, should these institutions limit access to our assets, breach their agreements with us or fail, we may be adversely affected. Furthermore, volatile financial and credit markets may reduce our ability to raise capital or refinance our debt on favorable terms, if at all, which could materially impact our ability to meet our obligations. As market conditions change, we will continue to monitor our liquidity position.

We are subject to risks associated with doing business internationally.

Our business is subject to certain risks inherent in international business, many of which are beyond our control. These risks include, among other things:

 

   

adverse changes in tariff and trade protection measures;

 

   

reductions in the reimbursement amounts we receive for our products from foreign governments and foreign insurance providers;

 

   

unexpected changes in foreign regulatory requirements, including quality standards and other certification requirements;

 

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potentially negative consequences from changes in or interpretations of tax laws;

 

   

differing labor regulations;

 

   

changing economic conditions in countries where our products are sold or manufactured or in other countries;

 

   

differing local product preferences and product requirements;

 

   

exchange rate risks;

 

   

restrictions on the repatriation of funds;

 

   

political unrest and hostilities;

 

   

product liability, intellectual property and other claims;

 

   

new export license requirements;

 

   

differing degrees of protection for intellectual property; and

 

   

difficulties in coordinating and managing foreign operations, including ensuring that foreign operations comply with foreign laws as well as U.S. laws applicable to U.S. companies with foreign operations, such as export laws and the Foreign Corrupt Practices Act.

Any of these factors, or any other international factors, could have a material adverse effect on our business, financial condition and results of operations. We cannot assure you that we can successfully manage these risks or avoid their effects.

The consolidation of drug wholesalers and other wholesaler actions could increase competitive and pricing pressures on pharmaceutical manufacturers, including us.

We sell our pharmaceutical products primarily through wholesalers. These wholesale customers comprise a significant part of the distribution network for pharmaceutical products in the United States. This distribution network is continuing to undergo significant consolidation. As a result, a smaller number of large wholesale distributors control a significant share of the market. We expect that consolidation of drug wholesalers will increase competitive and pricing pressures on pharmaceutical manufacturers, including us. In addition, wholesalers may apply pricing pressure through fee-for-service arrangements, and their purchases may exceed customer demand, resulting in reduced wholesaler purchases in later quarters. We cannot assure you that we can manage these pressures or that wholesaler purchases will not decrease as a result of this potential excess buying.

Our failure to attract and retain key managerial, technical, scientific, selling and marketing personnel could adversely affect our business.

Our success depends upon our retention of key managerial, technical, scientific, selling and marketing personnel. The loss of the services of key personnel might significantly delay or prevent the achievement of our development and strategic objectives.

We must continue to attract, train and retain managerial, technical, scientific, selling and marketing personnel. Competition for such highly skilled employees in our industry is high, and we cannot be certain that we will be successful in recruiting or retaining such personnel. We also believe that our success depends to a significant extent on the ability of our key personnel to operate effectively, both individually and as a group. If we are unable to identify, hire and integrate new employees in a timely and cost-effective manner, our operating results may suffer.

Acquisitions of technologies, products, and businesses could disrupt our business, involve increased expenses and present risks not contemplated at the time of the transactions.

As part of our business strategy, we regularly consider and, as appropriate, make acquisitions of technologies, products and businesses that we believe are complementary to our business. Acquisitions typically

 

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entail many risks and could result in difficulties in integrating the operations, personnel, technologies and products acquired, some of which may result in significant charges to earnings. Issues that must be addressed in integrating the acquired technologies, products and businesses into our own include:

 

   

conforming standards, controls, procedures and policies, business cultures and compensation structures;

 

   

conforming information technology and accounting systems;

 

   

consolidating corporate and administrative infrastructures;

 

   

consolidating sales and marketing operations;

 

   

retaining existing customers and attracting new customers;

 

   

retaining key employees;

 

   

identifying and eliminating redundant and underperforming operations and assets;

 

   

minimizing the diversion of management’s attention from ongoing business concerns;

 

   

coordinating geographically dispersed organizations;

 

   

managing tax costs or inefficiencies associated with integrating operations; and

 

   

making any necessary modifications to operating control standards to comply with the Sarbanes-Oxley Act of 2002 and the rules and regulations promulgated thereunder.

If we are unable to successfully integrate our acquisitions with our existing business, we may not obtain the advantages that the acquisitions were intended to create, which may materially adversely affect our business, results of operations, financial condition and cash flows, our ability to develop and introduce new products and the market price of our stock. Actual costs and sales synergies, if achieved at all, may be lower than we expect and may take longer to achieve than we anticipate. In connection with acquisitions, we could experience disruption in our business or employee base, or key employees of companies that we acquire may seek employment elsewhere, including with our competitors. Furthermore, the products of companies we acquire may overlap with our products or those of our customers, creating conflicts with existing relationships or with other commitments that are detrimental to the integrated businesses.

Compliance with the extensive government regulations to which we are subject is expensive and time consuming, and may result in the delay or cancellation of product sales, introductions or modifications.

Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development and manufacturing capabilities. All companies that manufacture, market and distribute pharmaceuticals and medical devices, including us, are subject to extensive, complex, costly and evolving regulation by federal governmental authorities, principally by the FDA and the U.S. Drug Enforcement Administration, or DEA, and similar foreign and state government agencies. Failure to comply with the regulatory requirements of the FDA, DEA and other U.S. and foreign regulatory agencies may subject a company to administrative or judicially imposed sanctions, including, among others, a refusal to approve a pending application to market a new product or a new indication for an existing product. The Federal Food, Drug, and Cosmetic Act, the Controlled Substances Act and other domestic and foreign statutes and regulations govern or influence the research, testing, manufacturing, packing, labeling, storing, record keeping, safety, effectiveness, approval, advertising, promotion, sale and distribution of our products. Under certain of these regulations, we are subject to periodic inspection of our facilities, production processes and control operations and/or the testing of our products by the FDA, the DEA and other authorities, to confirm that we are in compliance with all applicable regulations, including the FDA’s cGMPs, with respect to drug and biologic products, and the FDA’s QSR, with respect to medical device products. The FDA conducts pre-approval and post-approval reviews and plant inspections of us and our direct and indirect suppliers to determine whether our record keeping, production processes and controls, personnel and quality control are in compliance with the cGMPs, the QSR and other FDA

 

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regulations. We are also required to perform extensive audits of our vendors, contract laboratories and suppliers to ensure that they are compliant with these requirements. In addition, in order to commercialize our products or new indications for an existing product, we must demonstrate that the product or new indication is safe and effective, and that our and our suppliers’ manufacturing facilities are compliant with applicable regulations, to the satisfaction of the FDA and other regulatory agencies.

The process for obtaining governmental approval to manufacture and to commercialize pharmaceutical and medical device products is rigorous, typically takes many years and is costly, and we cannot predict the extent to which we may be affected by legislative and regulatory developments. We are dependent on receiving FDA and other governmental approvals prior to manufacturing, marketing and distributing our products. We may fail to obtain approval from the FDA or other governmental authorities for our product candidates, or we may experience delays in obtaining such approvals, due to varying interpretations of data or our failure to satisfy rigorous efficacy, safety and manufacturing quality standards. Consequently, there is always a risk that the FDA or other applicable governmental authorities will not approve our products, or will take post-approval action limiting or revoking our ability to sell our products, or that the rate, timing and cost of such approvals will adversely affect our product introduction plans, results of operations and stock price. Despite the time and expense exerted, regulatory approval is never guaranteed.

Even after we obtain regulatory approval or clearance for a product candidate or new indication, we are subject to extensive regulation, including ongoing compliance with the FDA’s cGMPs and QSR, implementation of REMS programs, completion of post-marketing clinical studies mandated by the FDA, and compliance with regulations relating to labeling, advertising, marketing and promotion. In addition, we are subject to adverse event reporting regulations that require us to report to the FDA if our products are associated with a death or serious injury. If we or any third party that we involve in the testing, packaging, manufacture, labeling, marketing and distribution of our products fail to comply with any such regulations, we may be subject to, among other things, warning letters, product seizures, recalls, fines or other civil penalties, injunctions, suspension or revocation of approvals, operating restrictions and/or criminal prosecution. The FDA recently has increased its enforcement activities related to the advertising and promotion of pharmaceutical, biological and medical device products. In particular, the FDA has expressed concern regarding the pharmaceutical and medical device industry’s compliance with the agency’s regulations and guidance governing direct-to-consumer advertising, and has increased its scrutiny of such promotional materials. For example, we received a warning letter from the FDA in May 2007 stating that we submitted a false and misleading journal advertisement for Acular LS ® . The FDA may limit or, with respect to certain products, terminate our dissemination of direct-to-consumer advertisements in the future, which could cause sales of those products to decline. Physicians may prescribe pharmaceutical and biologic products, and utilize medical device products for uses that are not described in the product’s labeling or differ from those tested by us and approved or cleared by the FDA. While such off-label uses are common and the FDA does not regulate a physician’s choice of treatment, a manufacturer’s communications regarding an approved product’s off-label uses are restricted by federal statutes, FDA regulations and other governmental communications. For example, the FDA issued final guidelines on January 13, 2009 setting forth “good reprint practices” for drug and medical device manufacturers, which provide detailed recommendations for drug and device companies to follow when disseminating journal articles and referencing publications describing off-label uses of their approved products to health care professionals and entities. The standards associated with such laws and rules are complex, not well defined or articulated and are subject to conflicting interpretations. If, in the view of the FDA or other governmental agency, our promotional activities fail to comply with applicable laws, regulations, guidelines or interpretations, we may be subject to enforcement actions by the FDA or other governmental enforcement authorities.

From time to time, legislative or regulatory proposals are introduced that could alter the review and approval process relating to our products. It is possible that the FDA or other governmental authorities will issue additional regulations further restricting the sale of our present or proposed products. Any change in legislation or regulations that govern the review and approval process relating to our current and future products could make it more difficult and costly to obtain approval for new products, or to produce, market and distribute existing products.

 

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If we market products in a manner that violates health care fraud and abuse laws, we may be subject to civil or criminal penalties.

The federal health care program Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any health care item or service reimbursable under Medicare, Medicaid or other federally financed health care programs. This statute has been interpreted to apply to arrangements between pharmaceutical or medical device manufacturers, on the one hand, and prescribers, purchasers and formulary managers, on the other hand. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration could be subject to scrutiny if they do not qualify for an exemption or safe harbor.

Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid. Pharmaceutical companies have been prosecuted under these laws for a variety of alleged promotional and marketing activities, such as allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in off-label promotion that caused claims to be submitted to Medicaid for non-covered off-label uses; and submitting inflated best price information to the Medicaid Drug Rebate Program.

On March 3, 2008, we received service of a Subpoena Duces Tecum from the U.S. Attorney, U.S. Department of Justice, Northern District of Georgia, or DOJ. The subpoena requests the production of documents relating to our sales and marketing practices in connection with Botox ® . The subpoena requires us to produce a significant number of electronic and hard copy documents created over multiple years and existing in numerous electronic data bases and hard copy files. The time and expense associated with responding to the subpoena and conducting a substantive review of the documents, underlying facts and other matters involved in the DOJ’s inquiry may be extensive and we cannot predict the results of our review of the responsive documents and underlying facts or the results of the DOJ’s inquiry. The costs of responding to the DOJ’s inquiry, defending any claims raised on behalf of the government, and any resulting fines, civil damages, penalties and administrative actions could have a material impact on our reputation, business and financial condition and divert the attention of our management from operating our business. See Item 3 of Part I of this report, “Legal Proceedings” and Note 15, “Commitments and Contingencies,” in our notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules” for information concerning the DOJ’s inquiry.

The Health Insurance Portability and Accountability Act of 1996 created two new federal crimes: health care fraud and false statements relating to health care matters. The health care fraud statute prohibits knowingly and willfully executing a scheme to defraud any health care benefit program, including private payors. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services.

The majority of states also have statutes or regulations similar to these federal laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. In addition, some states have laws that require pharmaceutical companies to adopt comprehensive compliance programs. For example, under California law, pharmaceutical companies must adopt a comprehensive compliance program that is in accordance with both the April 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers and the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals, or the PhRMA Code, as updated in July 2008 and effective in January 2009. The PhRMA Code seeks to promote transparency in relationships between healthcare professionals and the pharmaceutical industry and to ensure that pharmaceutical marketing

 

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activities comport with the highest ethical standards. The most recent revisions to the PhRMA Code, effective January 2009, restrict or prohibit many activities previously permissible under the prior PhRMA Code, including: a prohibition on any entertainment or recreational events for non-employee healthcare professionals including strict limitations on meals with physicians; the elimination of non-educational business gifts; restrictions on speaker programs; and clarifications on continuing medical education funding. The updated PhRMA Code also requires that pharmaceutical companies train their representatives on all applicable laws, regulations and industry codes governing interactions with healthcare professionals. In addition, the Advanced Medical Technology Association’s Revised Code of Ethics, or the AdvaMed Code, also seeks to ensure that medical device companies and healthcare professionals have collaborative relationships that meet high ethical standards; medical decisions are based on the best interests of patients; and medical device companies and healthcare professionals comply with applicable laws, regulations and government guidance. The AdvaMed Code was updated in December 2008 and will be effective in July 2009. The revisions generally follow the 2008 changes in the PhRMA Code and include limitations on consulting arrangements, entertainment, meals and gifts, among others. We have adopted and implemented a compliance program which we believe satisfies the requirements of these laws, regulations and industry codes.

Sanctions under these federal and state laws may include civil monetary penalties, exclusion of a manufacturer’s products from reimbursement under government programs, criminal fines and imprisonment. Because of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws. For example, we and several other pharmaceutical companies are currently subject to suits by governmental entities in several jurisdictions, including Erie, Oswego and Schenectady Counties in New York and in Alabama alleging that we and these other companies, through promotional, discounting and pricing practices, reported false and inflated average wholesale prices or wholesale acquisition costs and failed to report best prices as required by federal and state rebate statutes, resulting in the plaintiffs overpaying for certain medications. If our past or present operations are found to be in violation of any of the laws described above or other similar governmental regulations to which we are subject, we may be subject to the applicable penalty associated with the violation which could adversely affect our ability to operate our business and our financial results.

We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws.

We are subject to the U.S. Foreign Corrupt Practices Act, or FCPA, which generally prohibits companies and their intermediaries from making payments to non-U.S. government officials for the purpose of obtaining or retaining business or securing any other improper advantage. We are also subject to anti-bribery laws in the jurisdictions in which we operate. Although we have policies and procedures designed to ensure that we, our employees and our agents comply with the FCPA and other anti-bribery laws, there is no assurance that such policies or procedures will protect us against liability under the FCPA or other laws for actions taken by our agents, employees and intermediaries with respect to our business or any businesses that we acquire. We do business in a number of countries in which FCPA violations have recently been enforced. Failure to comply with the FCPA, other anti-bribery laws or other laws governing the conduct of business with foreign government entities, including local laws, could disrupt our business and lead to severe criminal and civil penalties, including imprisonment, criminal and civil fines, loss of our export licenses, suspension of our ability to do business with the federal government, denial of government reimbursement for our products and exclusion from participation in government healthcare programs. Other remedial measures could include further changes or enhancements to our procedures, policies, and controls and potential personnel changes and/or disciplinary actions, any of which could have a material adverse affect on our business, financial condition, results of operations and liquidity. We could also be adversely affected by any allegation that we violated such laws.

If our collaborative partners do not perform, we will be unable to develop and market products as anticipated.

We have entered into collaborative arrangements with third parties to develop and market certain products, including our arrangement with GlaxoSmithKline to market Botox ® in Japan and China and certain other

 

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products in the United States, our arrangement with Indevus to market Sanctura XR ® in the United States, our co-promotion agreement with Covidien to promote the Lap-Band ® System in the United States, our agreement with Clinique to develop, market and distribute a new physician dispensed skin care line for sale in the United States, our agreement with Stiefel to co-promote our current Tazorac ® products to dermatologists and pediatricians and to develop and commercialize new products that include tazarotene, and our collaboration with Spectrum for the development and commercialization of apaziquone. We cannot assure you that these collaborations will be successful, lead to additional sales of our products or lead to the creation of additional products. If we fail to maintain our existing collaborative arrangements or fail to enter into additional collaborative arrangements, our licensing revenues and/or the number of products from which we could receive future revenues could decline.

Our dependence on collaborative arrangements with third parties subjects us to a number of risks. These collaborative arrangements may not be on terms favorable to us. Agreements with collaborative partners typically allow partners significant discretion in marketing our products or electing whether or not to pursue any of the planned activities. We cannot fully control the amount and timing of resources our collaborative partners may devote to products based on the collaboration, and our partners may choose to pursue alternative products to the detriment of our collaboration. In addition, our partners may not perform their obligations as expected. Business combinations, significant changes in a collaborative partner’s business strategy, or its access to financial resources may adversely affect a partner’s willingness or ability to complete its obligations. Moreover, we could become involved in disputes with our partners, which could lead to delays or termination of the collaborations and time-consuming and expensive litigation or arbitration. Even if we fulfill our obligations under a collaborative agreement, our partner can terminate the agreement under certain circumstances. If any collaborative partners were to terminate or breach our agreements with them, or otherwise fail to complete their obligations in a timely manner, we could be materially and adversely affected.

Unanticipated changes in our tax rates or exposure to additional income tax liabilities could affect our profitability.

We are subject to income taxes in both the United States and numerous foreign jurisdictions. Our effective tax rate could be adversely affected by changes in the mix of earnings in countries with different statutory tax rates, changes in the valuation of deferred tax assets and liabilities, changes in U.S. tax laws and regulations, changes in our interpretations of tax laws, including pending tax law changes, changes in our manufacturing activities and changes in our future levels of research and development spending. In addition, we are subject to the continuous examination of our income tax returns by the Internal Revenue Service and other local, state and foreign tax authorities. We regularly assess the likelihood of outcomes resulting from these examinations to determine the adequacy of our estimated income tax liabilities. There can be no assurance that the outcomes from these continuous examinations will not have an adverse effect on our provision for income taxes and estimated income tax liabilities.

Changes in applicable tax laws may adversely affect sales or the profitability of Botox ® , Botox ® Cosmetic, our dermal fillers or breast implants. Because Botox ® and Botox ® Cosmetic are pharmaceutical products and our dermal fillers and breast implants are medical devices, we generally do not collect or pay state sales or other tax on sales of Botox ® , Botox ® Cosmetic, our dermal fillers or our breast implants. We could be required to collect and pay state sales or other tax associated with prior, current or future years on sales of Botox ® or Botox ® Cosmetic, our dermal fillers or breast implants. In addition to any retroactive taxes and corresponding interest and penalties that could be assessed, if we were required to collect or pay state sales or other tax associated with current or future years on sales of Botox ® , Botox ® Cosmetic, our dermal fillers or breast implants, our sales of, or our profitability from, Botox ® , Botox ® Cosmetic, our dermal fillers or breast implants could be adversely affected due to the increased cost associated with those products.

 

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The terms of our debt agreements impose restrictions on us. Failure to comply with these restrictions could result in acceleration of our substantial debt. Were this to occur, we might not have, or be able to obtain, sufficient cash to pay our accelerated indebtedness.

Our total indebtedness as of December 31, 2008 was approximately $1,639.7 million. This indebtedness may limit our flexibility in planning for, or reacting to, changes in our business and the industry in which it operates and, consequently, place us at a competitive disadvantage to our competitors. The operating and financial restrictions and covenants in our debt agreements may adversely affect our ability to finance future operations or capital needs or to engage in new business activities. For example, our debt agreements restrict our ability to, among other things:

 

   

incur liens or engage in sale lease-back transactions; and

 

   

engage in consolidations, mergers and asset sales.

In addition, our debt agreements include financial covenants that we maintain certain financial ratios. As a result of these covenants and ratios, we have certain limitations on the manner in which we can conduct our business, and we may be restricted from engaging in favorable business activities or financing future operations or capital needs. Accordingly, these restrictions may limit our ability to successfully operate our business. Failure to comply with the financial covenants or to maintain the financial ratios contained in our debt agreements could result in an event of default that could trigger acceleration of our indebtedness. We cannot assure you that our future operating results will be sufficient to ensure compliance with the covenants in our debt agreements or to remedy any such default. In addition, in the event of any default and related acceleration of obligations, we may not have or be able to obtain sufficient funds to make any accelerated payments.

Litigation may harm our business or otherwise distract our management.

Substantial, complex or extended litigation could cause us to incur large expenditures and distract our management. For example, lawsuits by employees, stockholders, customers or competitors could be very costly and substantially disrupt our business. Disputes from time to time with such companies or individuals are not uncommon, and we cannot assure you that that we will always be able to resolve such disputes out of court or on terms favorable to us.

Our publicly-filed SEC reports are reviewed by the SEC from time to time and any significant changes required as a result of any such review may result in material liability to us and have a material adverse impact on the trading price of our common stock.

The reports of publicly-traded companies are subject to review by the Securities and Exchange Commission from time to time for the purpose of assisting companies in complying with applicable disclosure requirements and to enhance the overall effectiveness of companies’ public filings, and comprehensive reviews of such reports are now required at least every three years under the Sarbanes-Oxley Act of 2002. SEC reviews may be initiated at any time. While we believe that our previously filed SEC reports comply, and we intend that all future reports will comply in all material respects with the published rules and regulations of the SEC, we could be required to modify or reformulate information contained in prior filings as a result of an SEC review. Any modification or reformulation of information contained in such reports could be significant and could result in material liability to us and have a material adverse impact on the trading price of our common stock.

 

Item 1B. Unresolved Staff Comments

None.

 

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Item 2. Properties

Our operations are conducted in owned and leased facilities located throughout the world. We believe our present facilities are adequate for our current needs. Our headquarters and primary administrative and research facilities, which we own, are located in Irvine, California. We lease additional facilities in California to provide administrative, research and raw material support, manufacturing, warehousing and distribution. We own one facility in Texas for manufacturing and warehousing.

Outside of the United States, we own, lease and operate various facilities for manufacturing and warehousing. Those facilities are located in Brazil, France, Ireland and Costa Rica. Other material facilities include leased facilities for administration in Australia, Brazil, Canada, France, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Singapore, Spain and the United Kingdom. In January 2008, we announced that production at our Arklow, Ireland breast implant manufacturing facility, which we acquired in connection with the Inamed acquisition, will be transferred to our San José, Costa Rica manufacturing plant and we plan to phase out production at our Arklow, Ireland manufacturing facility by the second quarter of 2009.

 

Item 3. Legal Proceedings

We are involved in various lawsuits and claims arising in the ordinary course of business.

In August 2004, James Clayworth, R.Ph., doing business as Clayworth Pharmacy, filed a complaint entitled “Clayworth v. Allergan, et al.” in the Superior Court of the State of California for the County of Alameda. The complaint, as amended, named us and 12 other defendants and alleged unfair business practices, including a price fixing conspiracy relating to the reimportation of pharmaceuticals from Canada. The complaint sought damages, equitable relief, attorneys’ fees and costs. On January 8, 2007, the court entered a notice of entry of judgment of dismissal against the plaintiffs dismissing the plaintiffs’ complaint. On the same date, the plaintiffs filed a notice of appeal with the Court of Appeal of the State of California, First Appellate District. On April 14, 2007, the plaintiffs filed an opening brief with the Court of Appeal of the State of California. The defendants filed their joint opposition on July 5, 2007, and the plaintiffs filed their reply on August 24, 2007. On May 14, 2008, the court heard oral arguments and took the matter under submission. On July 25, 2008, the Court of Appeal of the State of California affirmed the Superior Court of the State of California for the County of Alameda’s ruling granting our motion for summary judgment. On August 11, 2008, the plaintiffs filed a petition for rehearing with the Court of Appeal of the State of California. On August 19, 2008, the court denied the plaintiffs’ petition for rehearing. On September 3, 2008, the plaintiffs filed a petition for review with the Supreme Court of the State of California. On November 19, 2008, the Supreme Court of the State of California granted the plaintiffs’ petition for review. On February 17, 2009, the plaintiffs filed their opening brief on the merits with the Supreme Court of the State of California.

In May 2005, after receiving a paragraph 4 invalidity and noninfringement Hatch-Waxman Act certification from Apotex, Inc., or Apotex, indicating that Apotex had filed an Abbreviated New Drug Application, or ANDA, with the FDA for a generic form of Acular LS ® , we, along with Roche Palo Alto LLC, or Roche, the holder of U.S. Patent No. 5,110,493, or the ‘493 patent, filed a complaint captioned “Roche Palo Alto LLC, formerly known as Syntex (U.S.A.) LLC and Allergan, Inc. v. Apotex, Inc., et al.” in the U.S. District Court for the Northern District of California. In the complaint, we asked the court to find that the ‘493 patent is valid, enforceable and infringed by Apotex’s proposed generic drug. Apotex filed an answer to the complaint and a counterclaim. We moved for summary judgment and, on September 11, 2007, the court granted our motion for summary judgment. On September 26, 2007, Apotex filed a notice of appeal with the U.S. Court of Appeals for the Federal Circuit. The parties filed their briefs in the appeal and the court heard oral arguments on May 7, 2008. On July 9, 2008, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the Northern District of California’s grant of our motion for summary judgment. On July 23, 2008, Apotex filed a combined petition for panel rehearing and rehearing en banc with the U.S. Court of Appeals for the Federal Circuit. On September 5, 2008, the court denied Apotex’s combined petition for panel rehearing and rehearing en

 

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banc. On December 2, 2008, Apotex filed a petition for writ of certiorari with the Supreme Court of the United States. On January 26, 2009, the Supreme Court of the United States denied Apotex’s petition.

In February 2007, we received a paragraph 4 invalidity and noninfringement Hatch-Waxman Act certification from Exela PharmSci, Inc., or Exela, indicating that Exela had filed an ANDA with the FDA for a generic form of Alphagan ® P 0.15% . In the certification, Exela contends that U.S. Patent Nos. 5,424,078, 6,562,873, 6,627,210, 6,641,834 and 6,673,337, all of which are assigned to us and are listed in the Orange Book under Alphagan ® P 0.15%, are invalid and/or not infringed by the proposed Exela product. In March 2007, we filed a complaint against Exela in the U.S. District Court for the Central District of California entitled “Allergan, Inc. v. Exela PharmSci, Inc., et al.”, or the Exela Action. In our complaint, we allege that Exela’s proposed product infringes U.S. Patent No. 6,641,834. In April 2007, we filed an amended complaint adding Paddock Laboratories, Inc. and PharmaForce, Inc. as defendants. Also in April 2007, Exela filed a complaint for declaratory judgment in the U.S. District Court for the Eastern District of Virginia, Alexandria Division, entitled “Exela PharmSci, Inc. v. Allergan, Inc.” Exela’s complaint seeks a declaration of noninfringement, unenforceability, and/or invalidity of U.S. Patent Nos. 5,424,078, 6,562,873, 6,627,210, 6,641,834 and 6,673,337. In June 2007, Exela filed a voluntary dismissal without prejudice in the Virginia action.

In April 2007, we received a paragraph 4 invalidity and noninfringement Hatch-Waxman Act certification from Apotex indicating that Apotex had filed ANDAs with the FDA for generic versions of Alphagan ® P 0.15 % and Alphagan ® P 0.1%. In the certification, Apotex contends that U.S. Patent Nos. 5,424,078, 6,562,873, 6,627,210, 6,641,834 and 6,673,337, all of which are assigned to us and are listed in the Orange Book under Alphagan ® P 0.15% and Alphagan ® P 0.1%, are invalid and/or not infringed by the proposed Apotex products. In May 2007, we filed a complaint against Apotex in the U.S. District Court for the District of Delaware entitled “Allergan, Inc. v. Apotex, Inc. and Apotex Corp.”, or the Apotex Action. In our complaint, we allege that Apotex’s proposed products infringe U.S. Patent Nos. 5,424,078, 6,562,873, 6,627,210, 6,641,834 and 6,673,337. In June 2007, Apotex filed its answer, including defenses and counterclaims. In July 2007, we filed a response to Apotex’s counterclaims.

In May 2007, we filed a motion with the multidistrict litigation panel to consolidate the Exela Action and the Apotex Action in the District of Delaware. A hearing on our motion took place on July 26, 2007. On August 20, 2007, the panel granted our motion and transferred the Exela Action to the District of Delaware for coordinated or consolidated pretrial proceedings with the Apotex Action. On March 26, 2008, the defendants in the Exela Action consented to trial in Delaware. On January 20, 2009, we and defendants Paddock Laboratories, Inc. and Pharmaforce, Inc. entered into a settlement agreement and submitted a consent judgment to the court. The court has scheduled a trial date for March 9, 2009 for the remaining defendants in the Apotex Action and the Exela Action.

In August 2007, a complaint entitled “Ocular Research of Boston, Inc. v. Allergan, Inc.” was filed in the U.S. District Court for the Eastern District of Texas, Marshall Division. The complaint alleges that our Refresh   Dry Eye Therapy ® , Refresh Endura ® and Restasis ® products infringe U.S. Patent No. 5,578,586, or the ‘586 patent entitled “Dry Eye Treatment Process and Solution” and seeks a permanent injunction against us enjoining us from making, using, selling or offering for sale in the United States any product utilizing the patented inventions or designs claimed in the ‘586 patent. The complaint also seeks treble damages for willful infringement, interest on such damages, costs and attorneys’ fees. On November 1, 2007, we filed an answer and counterclaims to the complaint, asserting the patent is invalid and not infringed by any of our products. The court has scheduled a trial date for August 2, 2010.

In October 2007, we received a paragraph 4 invalidity and noninfringement Hatch-Waxman Act certification from Apotex indicating that Apotex had filed an ANDA with the FDA for a generic version of Zymar ® . In the certification, Apotex contends that U.S. Patent Nos. 5,880,283 and 6,333,045, both of which are licensed to us and are listed in the Orange Book under Zymar ® , are invalid and/or not infringed by the proposed Apotex product. In November 2007, we, Senju Pharmaceutical Co., Ltd., or Senju, and Kyorin Pharmaceutical Co., Ltd., or Kyorin, filed a complaint captioned “Allergan, Inc., Senju Pharmaceutical Co., Ltd. and Kyorin

 

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Pharmaceutical Co., Ltd. v. Apotex, Inc., et al.” in the U.S. District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent No. 6,333,045. On January 22, 2008, Apotex filed an answer and a counterclaim, as well as a motion to partially dismiss the plaintiffs’ complaint. On February 8, 2008, we, Senju and Kyorin filed a response of non-opposition to Apotex’s motion to partially dismiss the complaint. The court has scheduled a trial date for January 11, 2010.

In November 2007, we filed a complaint captioned “Allergan, Inc. v. Cayman Chemical Company, Jan Marini Skin Research, Inc., Athena Cosmetics, Inc., Dermaquest, Inc., Intuit Beauty, Inc., Civic Center Pharmacy and Photomedex, Inc.” in the U.S. District Court for the Central District of California. In our complaint, we allege that the defendants are infringing U.S. Patent No. 6,262,105, or the ‘105 patent, licensed to us by Murray A. Johnstone, M.D. On January 7, 2008, Photomedex, Inc., or Photomedex, filed a motion to dismiss our complaint. On January 23, 2008, we filed a motion for leave to file a second amended complaint to add Murray A. Johnstone, the holder of the ‘105 patent, as a plaintiff and to add Global MDRx and ProCyte Corporation, or ProCyte, as defendants. On March 3, 2008, the U.S. District Court for the Central District of California denied Photomedex’s motion to dismiss and granted our motion for leave to file a second amended complaint. On April 28, 2008, we filed a motion for leave to file a third amended complaint to add patent infringement claims relating to U.S. Patent No. 7,351,404 against the defendants, and to add Athena Bioscience, LLC, or Athena Bioscience, and Cosmetic Alchemy, LLC as additional defendants. On July 17, 2008, we and Jan Marini Skin Research, Inc., or Jan Marini, entered into a settlement agreement under which Jan Marini agreed to acknowledge the validity of our patents in exchange for our dismissing all claims against Jan Marini. On July 21, 2008, we and Intuit Beauty, Inc., or Intuit, entered into a settlement agreement under which Intuit agreed to acknowledge the validity of our patents in exchange for our dismissing all claims against Intuit. On July 28, 2008, the court entered a default judgment against Global MDRx for failure to defend against the summons. On August 6, 2008, the court dismissed Intuit with prejudice. On August 11, 2008, the U.S. District Court for the Central District of California dismissed Jan Marini with prejudice. On September 27, 2008, we and Cayman Chemical Company, or Cayman, entered into a settlement agreement under which Cayman agreed to cease selling certain compounds to be used in particular types of products in exchange for our dismissing all claims against Cayman. On October 16, 2008, Global MDRx filed a motion to set aside the default judgment. On October 27, 2008, the court dismissed Cayman without prejudice. On November 4, 2008, we, Photomedex and ProCyte entered into a settlement agreement under which Photomedex and ProCyte agreed to acknowledge the validity of our patents in exchange for our dismissing all claims against Photomedex and ProCyte. On November 17, 2008, the court denied Global MDRx’s motion to set aside the default judgment. On December 31, 2008, we and Athena Bioscience entered into a settlement agreement under which Athena Bioscience agreed to cease selling certain products and acknowledged the validity of the patents in exchange for our dismissing all claims against Athena Bioscience. On January 30, 2009, we, along with Dr. Johnstone, filed a motion for leave to file a fourth amended complaint adding Pharma Tech, Inc., or Pharma Tech, Dimensional Merchandising, Inc., or Dimensional Merchandising, and Cosmetic Technologies, Inc., or Cosmetic Technologies, as new defendants. Pharma Tech, Dimensional Merchandising and Cosmetic Technologies are the suppliers and manufacturers of Athena Cosmetic, Inc.’s eyelash products. On February 4, 2009, we, along with Dr. Johnstone, filed a motion for default judgment and injunction against Global MDRx. The court has scheduled a trial date for January 19, 2010 for the remaining defendants.

In March 2008, we received service of a Subpoena Duces Tecum from the DOJ. The subpoena requests the production of documents relating to our sales and marketing practices in connection with Botox ® .

In July 2008, a complaint entitled “Kramer, Bryant, Spears, Doolittle, Clark, Whidden, Powell, Moore, Hennessey, Sody, Breeding, Downey, Underwood-Boswell, Reed-Momot, Purdon & Hahn v. Allergan, Inc.” was filed in the Superior Court for the State of California for the County of Orange. The complaint makes allegations against us relating to Botox ® and Botox ® Cosmetic including failure to warn, manufacturing defects, negligence, breach of implied and express warranties, deceit by concealment and negligent misrepresentation and seeks damages, attorneys’ fees and costs. On July 17, 2008, the plaintiffs filed a first amended complaint. On September 29, 2008, we filed an answer to the first amended complaint. On February 2, 2009, the plaintiffs filed

 

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a request for dismissal without prejudice as to plaintiffs Hennessey, Hahn and Underwood-Boswell. A status conference was held on February 17, 2009. The court scheduled a further status conference for June 22, 2009.

We are involved in various other lawsuits and claims arising in the ordinary course of business. These other matters are, in the opinion of management, immaterial both individually and in the aggregate with respect to our consolidated financial position, liquidity or results of operations.

Because of the uncertainties related to the incurrence, amount and range of loss on any pending litigation, investigation, inquiry or claim, management is currently unable to predict the ultimate outcome of any litigation, investigation, inquiry or claim, determine whether a liability has been incurred or make an estimate of the reasonably possible liability that could result from an unfavorable outcome. We believe however, that the liability, if any, resulting from the aggregate amount of uninsured damages for any outstanding litigation, investigation or claim, other than the inquiry being conducted by the DOJ discussed in Note 15, “Commitments and Contingencies,” in our notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules” will not have a material adverse effect on our consolidated financial position, liquidity or results of operations. However, an adverse ruling in a patent infringement lawsuit involving us could materially affect our ability to sell one or more of our products or could result in additional competition. In view of the unpredictable nature of such matters, we cannot provide any assurances regarding the outcome of any litigation, investigation, inquiry or claim to which we are a party or the impact on us of an adverse ruling in such matters.

 

Item 4. Submission of Matters to a Vote of Security Holders

We did not submit any matter during the fourth quarter of the fiscal year covered by this report to a vote of security holders, through the solicitation of proxies or otherwise.

 

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PART II

 

Item 5. Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

The following table shows the quarterly price range of our common stock and the cash dividends declared per share of common stock during the periods listed.

 

     2008    2007(1)

Calendar Quarter

   Low    High    Div.    Low    High    Div.

First

   $ 53.51    $ 70.40    $ 0.05    $ 52.50    $ 60.61    $ 0.05

Second

     51.00      60.29      0.05      55.15      62.50      0.05

Third

     50.01      61.72      0.05      56.96      66.15      0.05

Fourth

     28.95      52.78      0.05      60.79      69.15      0.05

 

 
  (1) Historical stock prices and dividends adjusted to reflect the effect of our two-for-one stock split that was completed on June 22, 2007.

Our common stock is listed on the New York Stock Exchange and is traded under the symbol “AGN.”

The approximate number of stockholders of record of our common stock was 5,623 as of February 17, 2009.

On February 3, 2009, our Board of Directors declared a cash dividend of $0.05 per share, payable March 13, 2009 to stockholders of record on February 20, 2009.

Securities Authorized for Issuance Under Equity Compensation Plans

The information included under Item 12 of Part III of this report, “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters,” is hereby incorporated by reference into this Item 5 of Part II of this report.

Issuer Purchases of Equity Securities

The following table discloses the purchases of our equity securities during the fourth fiscal quarter of 2008.

 

Period

  Total Number
of Shares
Purchased(1)
  Average
Price Paid
per Share
  Total Number
of Shares
Purchased as
Part of Publicly

Announced Plans
or Programs
  Maximum Number
(or Approximate Dollar Value)
of Shares that
May Yet be Purchased
Under the Plans
or Programs(2)

October 1, 2008 to October 31, 2008

      0   N/A       0   14,795,450

November 1, 2008 to November 30, 2008

      0   N/A       0   14,855,802

December 1, 2008 to December 31, 2008

      0   N/A       0   14,976,008
           

Total

      0   N/A       0   N/A

 

 
  (1)

We maintain an evergreen stock repurchase program, which we first announced on September 28, 1993. Under the stock repurchase program, we may maintain up to 18.4 million repurchased shares in our treasury account at any one time. As of December 31, 2008, we held approximately 3.4 million treasury shares under this program. Effective February 6, 2009, we entered into a Rule 10b5-1 plan that authorizes our broker to purchase our common stock traded in the open market pursuant to our evergreen stock repurchase program. The terms of the plan set forth a maximum annual limit of 2.0 million shares to be repurchased, and certain quarterly maximum and minimum volume limits. The

 

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term of our Rule 10b5-1 plan ends on December 31, 2009 and is cancellable at any time in our sole discretion and in accordance with applicable insider trading laws.

 

  (2) The share numbers reflect the maximum number of shares that may be purchased under our stock repurchase program and are as of the end of each of the respective periods.

 

Item 6. Selected Financial Data

SELECTED CONSOLIDATED FINANCIAL DATA

 

    Year Ended December 31,
    2008     2007     2006     2005   2004
    (in millions, except per share data)

Summary of Operations

         

Product net sales

  $ 4,339.7     $ 3,879.0     $ 3,010.1     $ 2,319.2   $ 2,045.6

Other revenues

    63.7       59.9       53.2       23.4     13.3
                                   

Total revenues

    4,403.4       3,938.9       3,063.3       2,342.6     2,058.9

Operating costs and expenses:

         

Cost of sales (excludes amortization of acquired intangible assets)

    761.2       673.2       575.7       385.3     381.7

Selling, general and administrative

    1,856.0       1,680.1       1,333.4       936.8     791.7

Research and development

    797.9       718.1       1,055.5       388.3     342.9

Amortization of acquired intangible assets

    150.9       121.3       79.6       17.5     8.2

Restructuring charges and asset write-offs, net

    41.3       26.8       22.3       43.8     7.0
                                   

Operating income (loss)

    796.1       719.4       (3.2 )     570.9     527.4

Non-operating (expense) income

    (8.9 )     (31.7 )     (16.3 )     28.3     4.7
                                   

Earnings (loss) from continuing operations before income taxes and minority interest

    787.2       687.7       (19.5 )     599.2     532.1

Earnings (loss) from continuing operations

    578.6       501.0       (127.4 )     403.9     377.1

Loss from discontinued operations

          (1.7 )              

Net earnings (loss)

  $ 578.6     $ 499.3     $ (127.4 )   $ 403.9   $ 377.1

Basic earnings (loss) per share:

         

Continuing operations

  $ 1.90     $ 1.64     $ (0.43 )   $ 1.54   $ 1.44

Discontinued operations

                         

Diluted earnings (loss) per share:

         

Continuing operations

  $ 1.89     $ 1.62     $ (0.43 )   $ 1.51   $ 1.41

Discontinued operations

                         

Cash dividends per share

  $ 0.20     $ 0.20     $ 0.20     $ 0.20   $ 0.18

Financial Position

         

Current assets

  $ 2,270.6     $ 2,124.2     $ 2,130.3     $ 1,825.6   $ 1,376.0

Working capital

    1,573.6       1,408.5       1,472.2       781.6     916.4

Total assets

    6,791.3       6,579.3       5,767.1       2,850.5     2,257.0

Long-term debt, excluding current portion

    1,635.3       1,590.2       1,606.4       57.5     570.1

Total stockholders’ equity

    4,010.3       3,738.6       3,143.1       1,566.9     1,116.2

 

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

This financial review presents our operating results for each of the three years in the period ended December 31, 2008, and our financial condition at December 31, 2008. Except for the historical information contained herein, the following discussion contains forward-looking statements which are subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially from those

 

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expressed or implied by such forward-looking statements. We discuss such risks, uncertainties and other factors throughout this report and specifically under Item 1A of Part I of this report, “Risk Factors.” In addition, the following review should be read in connection with the information presented in our consolidated financial statements and the related notes to our consolidated financial statements.

Critical Accounting Policies, Estimates and Assumptions

The preparation and presentation of financial statements in conformity with accounting principles generally accepted in the United States, or GAAP, requires us to establish policies and to make estimates and assumptions that affect the amounts reported in our consolidated financial statements. In our judgment, the accounting policies, estimates and assumptions described below have the greatest potential impact on our consolidated financial statements. Accounting assumptions and estimates are inherently uncertain and actual results may differ materially from our estimates.

Revenue Recognition

We recognize revenue from product sales when goods are shipped and title and risk of loss transfer to our customers. A substantial portion of our revenue is generated by the sale of specialty pharmaceutical products (primarily eye care pharmaceuticals, skin care and urologics products) to wholesalers within the United States, and we have a policy to attempt to maintain average U.S. wholesaler inventory levels at an amount less than eight weeks of our net sales. A portion of our revenue is generated from consigned inventory of breast implants maintained at physician, hospital and clinic locations. These customers are contractually obligated to maintain a specific level of inventory and to notify us upon the use of consigned inventory. Revenue for consigned inventory is recognized at the time we are notified by the customer that the product has been used. Notification is usually through the replenishing of the inventory, and we periodically review consignment inventories to confirm the accuracy of customer reporting.

We generally offer cash discounts to customers for the early payment of receivables. Those discounts are recorded as a reduction of revenue and accounts receivable in the same period that the related sale is recorded. The amounts reserved for cash discounts were $3.3 million and $1.8 million at December 31, 2008 and 2007, respectively. Provisions for cash discounts deducted from consolidated sales in 2008, 2007 and 2006 were $42.1 million, $35.1 million and $30.9 million, respectively. We permit returns of product from most product lines by any class of customer if such product is returned in a timely manner, in good condition and from normal distribution channels. Return policies in certain international markets and for certain medical device products, primarily breast implants, provide for more stringent guidelines in accordance with the terms of contractual agreements with customers. Our estimates for sales returns are based upon the historical patterns of product returns matched against sales, and management’s evaluation of specific factors that may increase the risk of product returns. The amount of allowances for sales returns recognized in our consolidated balance sheets at December 31, 2008 and 2007 were $25.3 million and $29.8 million, respectively, and are recorded in “Other accrued expenses” and “Trade receivables, net” in our consolidated balance sheets. The decrease in the amount of allowances for sales returns at December 31, 2008 compared to December 31, 2007 was primarily due to a reduction in the rate of returns for medical device products and a decline in net sales of breast implant products in the fourth quarter of 2008 compared to the corresponding period in 2007. See Note 5, “Composition of Certain Financial Statement Captions” in the notes to our consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules.” Provisions for sales returns deducted from consolidated sales were $327.7 million, $297.4 million and $146.5 million in 2008, 2007 and 2006, respectively. The increase in the provision for sales returns in 2008 compared to 2007 is primarily due to the overall increase in net sales in 2008 compared to 2007. The increase in the provision for sales returns in 2007 compared to 2006 was primarily due to growth in net sales of medical device products, primarily breast implants, which generally have a significantly higher rate of return than specialty pharmaceutical products. Historical allowances for cash discounts and product returns have been within the amounts reserved or accrued.

 

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We participate in various managed care sales rebate and other incentive programs, the largest of which relates to Medicaid and Medicare. Sales rebate and other incentive programs also include contractual volume rebate programs and chargebacks, which are contractual discounts given primarily to federal government agencies, health maintenance organizations, pharmacy benefits managers and group purchasing organizations. We also offer rebate and other incentive programs for our aesthetic products, including Botox ® Cosmetic and Juvéderm ® . Sales rebates and incentive accruals reduce revenue in the same period that the related sale is recorded and are included in “Other accrued expenses” in our consolidated balance sheets. The amounts accrued for sales rebates and other incentive programs were $100.9 million and $82.0 million at December 31, 2008 and 2007, respectively. Provisions for sales rebates and other incentive programs deducted from consolidated sales were $302.4 million, $224.1 million and $175.6 million in 2008, 2007 and 2006, respectively. The increases in the amounts accrued at December 31, 2008 compared to December 31, 2007 and the provisions for sales rebates and other incentive programs in 2008 and 2007 compared to the corresponding prior year are primarily due to an increase in U.S. sales of products subject to managed care and contractual volume rebate and incentive programs, principally eye care pharmaceuticals, Botox ® and obesity intervention products, as well as an increase in sales of our aesthetic products subject to our rebate and incentive programs. In addition, an increase in our published list prices in the United States for pharmaceutical products, which occurred for several of our products in both 2008 and 2007, generally results in higher provisions for sales rebates and other incentive programs deducted from consolidated sales.

Our procedures for estimating amounts accrued for sales rebates and other incentive programs at the end of any period are based on available quantitative data and are supplemented by management’s judgment with respect to many factors, including but not limited to, current market dynamics, changes in contract terms, changes in sales trends, an evaluation of current laws and regulations and product pricing. Quantitatively, we use historical sales, product utilization and rebate data and apply forecasting techniques in order to estimate our liability amounts. Qualitatively, management’s judgment is applied to these items to modify, if appropriate, the estimated liability amounts. There are inherent risks in this process. For example, customers may not achieve assumed utilization levels; customers may misreport their utilization to us; and actual movements of the U.S. Consumer Price Index — Urban, or CPI-U, which affect our rebate programs with U.S. federal and state government agencies, may differ from those estimated. On a quarterly basis, adjustments to our estimated liabilities for sales rebates and other incentive programs related to sales made in prior periods have not been material and have generally been less than 0.5% of consolidated product net sales. An adjustment to our estimated liabilities of 0.5% of consolidated product net sales on a quarterly basis would result in an increase or decrease to net sales and earnings before income taxes of approximately $5.0 million to $6.0 million. The sensitivity of our estimates can vary by program and type of customer. Additionally, there is a significant time lag between the date we determine the estimated liability and when we actually pay the liability. Due to this time lag, we record adjustments to our estimated liabilities over several periods, which can result in a net increase to earnings or a net decrease to earnings in those periods. Material differences may result in the amount of revenue we recognize from product sales if the actual amount of rebates and incentives differ materially from the amounts estimated by management.

We recognize license fees, royalties and reimbursement income for services provided as other revenues based on the facts and circumstances of each contractual agreement. In general, we recognize income upon the signing of a contractual agreement that grants rights to products or technology to a third party if we have no further obligation to provide products or services to the third party after entering into the contract. We defer income under contractual agreements when we have further obligations that indicate that a separate earnings process has not been completed.

Pensions

We sponsor various pension plans in the United States and abroad in accordance with local laws and regulations. Our U.S. pension plans account for a large majority of our aggregate pension plans’ net periodic benefit costs and projected benefit obligations. In connection with these plans, we use certain actuarial

 

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assumptions to determine the plans’ net periodic benefit costs and projected benefit obligations, the most significant of which are the expected long-term rate of return on assets and the discount rate.

Our assumption for the weighted average expected long-term rate of return on assets in our U.S. funded pension plan for determining the net periodic benefit cost is 8.25% for 2008, which is the same rate used for 2007 and 2006. Our assumptions for the weighted average expected long-term rate of return on assets in our non-U.S. funded pension plans are 6.82%, 6.43% and 6.19% for 2008, 2007 and 2006, respectively. For our U.S. funded pension plan, we determine, based upon recommendations from our pension plan’s investment advisors, the expected rate of return using a building block approach that considers diversification and rebalancing for a long-term portfolio of invested assets. Our investment advisors study historical market returns and preserve long-term historical relationships between equities and fixed income in a manner consistent with the widely-accepted capital market principle that assets with higher volatility generate a greater return over the long run. They also evaluate market factors such as inflation and interest rates before long-term capital market assumptions are determined. For our non-U.S. funded pension plans, the expected rate of return was determined based on asset distribution and assumed long-term rates of return on fixed income instruments and equities. Market conditions and other factors can vary over time and could significantly affect our estimates of the weighted average expected long-term rate of return on plan assets. The expected rate of return is applied to the market-related value of plan assets. As a sensitivity measure, the effect of a 0.25% decline in our rate of return on assets assumptions for our U.S. and non-U.S. funded pension plans would increase our expected 2009 pre-tax pension benefit cost by approximately $1.4 million.

The weighted average discount rates used to calculate our U.S. and non-U.S. pension benefit obligations at December 31, 2008 were 6.19% and 5.71%, respectively, and at December 31, 2007 were 6.25% and 5.50%, respectively. The weighted average discount rates used to calculate our U.S. and non-U.S. net periodic benefit costs for 2008 were 6.25% and 5.50%, respectively, for 2007, 5.90% and 4.65%, respectively, and for 2006, 5.60% and 4.24%, respectively. We determine the discount rate based upon a hypothetical portfolio of high quality fixed income investments with maturities that mirror the pension benefit obligations at the plans’ measurement date. Market conditions and other factors can vary over time and could significantly affect our estimates for the discount rates used to calculate our pension benefit obligations and net periodic benefit costs for future years. As a sensitivity measure, the effect of a 0.25% decline in the discount rate assumption for our U.S and non-U.S. pension plans would increase our expected 2009 pre-tax pension benefit costs by approximately $3.6 million and increase our pension plans’ projected benefit obligations at December 31, 2008 by approximately $26.9 million.

Share-Based Compensation

We recognize compensation expense for all share-based awards made to employees and directors. The fair value of share-based awards is estimated at the grant date using the Black-Scholes option-pricing model and the portion that is ultimately expected to vest is recognized as compensation cost over the requisite service period using the straight-line single option method.

The determination of fair value using the Black-Scholes option-pricing model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables, including expected stock price volatility, risk-free interest rate, expected dividends and projected employee stock option exercise behaviors. We currently estimate stock price volatility based upon an equal weighting of the five and three-quarter year historical average and the average implied volatility of at-the-money options traded in the open market. We estimate employee stock option exercise behavior based on actual historical exercise activity and assumptions regarding future exercise activity of unexercised, outstanding options.

Share-based compensation expense is recognized only for those awards that are ultimately expected to vest, and we have applied an estimated forfeiture rate to unvested awards for the purpose of calculating compensation cost. These estimates will be revised in future periods if actual forfeitures differ from the estimates. Changes in forfeiture estimates impact compensation cost in the period in which the change in estimate occurs.

 

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Income Taxes

The provision for income taxes is determined using an estimated annual effective tax rate, which is generally less than the U.S. federal statutory rate, primarily because of lower tax rates in certain non-U.S. jurisdictions, research and development, or R&D, tax credits available in the United States and other jurisdictions, and deductions available in the United States for domestic production activities. Our effective tax rate may be subject to fluctuations during the year as new information is obtained, which may affect the assumptions we use to estimate our annual effective tax rate, including factors such as our mix of pre-tax earnings in the various tax jurisdictions in which we operate, valuation allowances against deferred tax assets, the recognition or derecognition of tax benefits related to uncertain tax positions, expected utilization of R&D tax credits and changes in or the interpretation of tax laws in jurisdictions where we conduct business. We recognize deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of our assets and liabilities along with net operating loss and tax credit carryovers. We record a valuation allowance against our deferred tax assets to reduce the net carrying value to an amount that we believe is more likely than not to be realized. When we establish or reduce the valuation allowance against our deferred tax assets, our provision for income taxes will increase or decrease, respectively, in the period such determination is made. Reductions to valuation allowances related to net operating loss carryforwards of acquired businesses have been treated as adjustments to purchased goodwill up through and until the end of our 2008 fiscal year.

Effective January 1, 2007, we adopted Financial Accounting Standards Board, or FASB, Interpretation No. 48, Accounting for Uncertainty in Income Taxes — An Interpretation of FASB Statement No. 109 , or FIN 48, which prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Historically, our policy has been to account for uncertainty in income taxes in accordance with the provisions of Statement of Financial Accounting Standards No. 5, Accounting for Contingencies , which considered whether the tax benefit from an uncertain tax position was probable of being sustained. Under FIN 48, the tax benefit from uncertain tax positions may be recognized only if it is more likely than not that the tax position will be sustained, based solely on its technical merits, with the taxing authority having full knowledge of all relevant information. We recognize deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of our assets and liabilities along with net operating loss and tax credit carryovers only for tax positions that meet the more likely than not recognition criteria. We record a liability for unrecognized tax benefits from uncertain tax positions as discrete tax adjustments in the first interim period that the more likely than not threshold is not met. Due to the inherent risks in the estimates and assumptions used in determining the sustainability of our tax positions and in the measurement of the related tax, our provision for income taxes and our effective tax rate may vary significantly from our estimates and from amounts reported in future or prior periods. We discuss this change in accounting principle and its effect on our consolidated financial statements in Note 1, “Summary of Significant Accounting Policies,” and Note 9, “Income Taxes,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules.”

Valuation allowances against our deferred tax assets were $8.4 million and $99.9 million at December 31, 2008 and December 31, 2007, respectively. Changes in the valuation allowances, when they are recognized in the provision for income taxes, are included as a component of the estimated annual effective tax rate. The decrease in the amount of valuation allowances at December 31, 2008 compared to December 31, 2007 is primarily due to an $85.1 million adjustment related to an increase in the expected utilization of net operating losses of Esprit Pharma Holding Company, Inc., or Esprit, which we acquired in October 2007, and is treated as a reduction of Esprit purchased goodwill.

We have not provided for withholding and U.S. taxes for the unremitted earnings of certain non-U.S. subsidiaries because we have currently reinvested these earnings indefinitely in these foreign operations. At December 31, 2008, we had approximately $1,630.9 million in unremitted earnings outside the United States for which withholding and U.S. taxes were not provided. Income tax expense would be incurred if these funds were remitted to the United States. It is not practicable to estimate the amount of the deferred tax

 

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liability on such unremitted earnings. Upon remittance, certain foreign countries impose withholding taxes that are then available, subject to certain limitations, for use as credits against our U.S. tax liability, if any. We annually update our estimate of unremitted earnings outside the United States after the completion of each fiscal year.

Purchase Price Allocation

The purchase price allocation for acquisitions requires extensive use of accounting estimates and judgments to allocate the purchase price to the identifiable tangible and intangible assets acquired, including in-process research and development, and liabilities assumed based on their respective fair values. Additionally, we must determine whether an acquired entity is considered to be a business or a set of net assets, because a portion of the purchase price can only be allocated to goodwill in a business combination.

On July 11, 2008, we acquired all assets relating to Aczone ® (dapsone) gel 5% for approximately $150.0 million. We accounted for the acquisition as a purchase of net assets and not as a business combination. On October 16, 2007, we acquired Esprit for an aggregate purchase price of approximately $370.8 million, net of cash acquired. On February 22, 2007, we acquired EndoArt SA, or EndoArt, for an aggregate purchase price of approximately $97.1 million, net of cash acquired. On January 2, 2007, we acquired Groupe Cornéal Laboratoires, or Cornéal, for an aggregate purchase price of approximately $209.2 million, net of cash acquired. On March 23, 2006, we acquired Inamed Corporation, or Inamed, for approximately $3.3 billion, consisting of approximately $1.4 billion in cash and 34,883,386 shares of common stock with a fair value of approximately $1.9 billion. We accounted for the acquisitions of Esprit, EndoArt, Cornéal and Inamed as business combinations. The purchase prices for the acquisitions were allocated to tangible and intangible assets acquired and liabilities assumed based on their estimated fair values at the acquisition dates. The determination of estimated fair values requires significant estimates and assumptions, including but not limited to, determining the timing and estimated costs to complete the in-process projects, projecting regulatory approvals, estimating future cash flows, and developing appropriate discount rates. We believe the estimated fair values assigned to the assets acquired and liabilities assumed are based on reasonable assumptions.

Impairment Evaluations for Goodwill and Purchased Intangible Assets

In accordance with Statement of Financial Accounting Standards No. 142, Goodwill and Other Intangible Assets , or SFAS No. 142, we evaluate goodwill for impairment on an annual basis, or more frequently if we believe indicators of impairment exist, by comparing the carrying value of each of our reporting units to their estimated fair value. We have two reporting units, specialty pharmaceuticals and medical devices, and perform our evaluation in January of each year. We primarily use the income approach and the market approach to valuation that include the discounted cash flow method, the guideline company method, as well as other generally accepted valuation methodologies to determine the fair value of our reporting units. Upon completion of the January 2008 and 2007 annual impairment assessments, we determined no impairment was indicated as the estimated fair value of each of the two reporting units exceeded its respective carrying value. As of December 31, 2008, we do not believe any significant indicators of impairment exist for our goodwill that would require additional analysis before our next annual evaluation.

In accordance with Statement of Financial Accounting Standards No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets , or SFAS No. 144, we also review purchased intangible assets for impairment when events or changes in circumstances indicate that the carrying value of our other intangible assets may not be recoverable. An impairment in the carrying value of an intangible asset is recognized whenever anticipated future undiscounted cash flows from an intangible asset are estimated to be less than its carrying value. In 2008, we recorded a pre-tax impairment charge of $5.6 million for an intangible asset related to the phase out of a collagen product.

Significant management judgment is required in the forecasts of future operating results that are used in our impairment evaluations. The estimates we have used are consistent with the plans and estimates that we use to

 

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manage our business. It is possible, however, that the plans may change and estimates used may prove to be inaccurate. If our actual results, or the plans and estimates used in future impairment analyses, are lower than the original estimates used to assess the recoverability of these assets, we could incur future impairment charges.

Discontinued Operations

On July 2, 2007, we completed the sale of the ophthalmic surgical device business that we acquired as a part of the Cornéal acquisition in January 2007, for net cash proceeds of $28.6 million. The net assets of the disposed business consisted of current assets of $24.3 million, non-current assets of $9.8 million and current liabilities of $4.2 million. We recorded a pre-tax loss of $1.3 million ($1.0 million net of tax) associated with the sale.

The following amounts related to the ophthalmic surgical device business have been segregated from continuing operations and reported as discontinued operations through the date of disposition. We did not account for our ophthalmic surgical device business as a separate legal entity. Therefore, the following selected financial data for the discontinued operations is presented for informational purposes only and does not necessarily reflect what the net sales or earnings would have been had the business operated as a stand-alone entity. The financial information for the discontinued operations includes allocations of certain expenses to the ophthalmic surgical device business. These amounts have been allocated to the discontinued operations on the basis that is considered by management to reflect most fairly or reasonably the utilization of the services provided to, or the benefit obtained by, the ophthalmic surgical device business.

The following table sets forth selected financial data of our discontinued operations for 2007.

Selected Financial Data for Discontinued Operations

 

     (in millions)  

Product net sales

   $ 20.0  

Loss from discontinued operations before income taxes

   $ (1.1 )

Loss from discontinued operations

   $ (0.7 )

Continuing Operations

Headquartered in Irvine, California, we are a multi-specialty health care company focused on discovering, developing and commercializing innovative pharmaceuticals, biologics and medical devices that enable people to see more clearly, move more freely and express themselves more fully. Our diversified approach enables us to follow our research and development into new specialty areas where unmet needs are significant.

We discover, develop and commercialize specialty pharmaceutical, medical device and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention, urological and other specialty markets in more than 100 countries around the world. We are a pioneer in specialty pharmaceutical research, targeting products and technologies related to specific disease areas such as chronic dry eye, glaucoma, retinal disease, psoriasis, acne, movement disorders, neuropathic pain and genitourinary diseases. Additionally, we are a leader in discovering, developing and marketing therapeutic and aesthetic biologic, pharmaceutical and medical device products, including saline and silicone gel breast implants, dermal fillers and obesity intervention products. At December 31, 2008, we employed approximately 8,740 persons around the world. Our principal markets are the United States, Europe, Latin America and Asia Pacific.

 

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Results of Continuing Operations

We operate our business on the basis of two reportable segments — specialty pharmaceuticals and medical devices. The specialty pharmaceuticals segment produces a broad range of pharmaceutical products, including: ophthalmic products for glaucoma therapy, ocular inflammation, infection, allergy and chronic dry eye; Botox ® for certain therapeutic and aesthetic indications; skin care products for acne, psoriasis, other prescription and over-the-counter skin care products; and urologics products. The medical devices segment produces a broad range of medical devices, including: breast implants for augmentation, revision and reconstructive surgery; obesity intervention products, including the Lap-Band ® System and the Orbera TM Intragastric Balloon System (formerly known as the BIB ® System); and facial aesthetics products. We provide global marketing strategy teams to coordinate the development and execution of a consistent marketing strategy for our products in all geographic regions that share similar distribution channels and customers.

Management evaluates our business segments and various global product portfolios on a revenue basis, which is presented below in accordance with GAAP. We also report sales performance using the non-GAAP financial measure of constant currency sales. Constant currency sales represent current period reported sales, adjusted for the translation effect of changes in average foreign exchange rates between the current period and the corresponding period in the prior year. We calculate the currency effect by comparing adjusted current period reported sales, calculated using the monthly average foreign exchange rates for the corresponding period in the prior year, to the actual current period reported sales. We routinely evaluate our net sales performance at constant currency so that sales results can be viewed without the impact of changing foreign currency exchange rates, thereby facilitating period-to-period comparisons of our sales. Generally, when the U.S. dollar either strengthens or weakens against other currencies, the growth at constant currency rates will be higher or lower, respectively, than growth reported at actual exchange rates.

The following table compares net sales by product line within each reportable segment and certain selected pharmaceutical products for the years ended December 31, 2008, 2007 and 2006:

 

    Year Ended December 31,     Change in Product Net Sales   Percent Change in Product Net Sales  
    2008     2007     Total     Performance     Currency   Total     Performance     Currency  
    (in millions)                  

Net Sales by Product Line:

               

Specialty Pharmaceuticals:

               

Eye Care Pharmaceuticals

  $ 2,009.1     $ 1,776.5     $ 232.6     $ 205.8     $ 26.8   13.1 %   11.6 %   1.5 %

Botox ® /Neuromodulator

    1,310.9       1,211.8       99.1       87.1       12.0   8.2 %   7.2 %   1.0 %

Skin Care

    113.7       110.7       3.0       3.0         2.7 %   2.7 %   %

Urologics

    68.6       6.0       62.6       62.6         1,043.3 %   1,043.3 %   %
                                           

Total Specialty Pharmaceuticals

    3,502.3       3,105.0       397.3       358.5       38.8   12.8 %   11.5 %   1.3 %
                                           

Medical Devices:

               

Breast Aesthetics

    310.0       298.4       11.6       6.2       5.4   3.9 %   2.1 %   1.8 %

Obesity Intervention

    296.0       270.1       25.9       24.4       1.5   9.6 %   9.0 %   0.6 %

Facial Aesthetics

    231.4       202.8       28.6       24.8       3.8   14.1 %   12.2 %   1.9 %
                                           

Core Medical Devices

    837.4       771.3       66.1       55.4       10.7   8.6 %   7.2 %   1.4 %

Other(a)

          2.7       (2.7 )     (2.7 )       (100.0 )%   (100.0 )%   %
                                           

Total Medical Devices

    837.4       774.0       63.4       52.7       10.7   8.2 %   6.8 %   1.4 %
                                           

Total product net sales

  $ 4,339.7     $ 3,879.0     $ 460.7     $ 411.2     $ 49.5   11.9 %   10.6 %   1.3 %
                                           

Domestic product net sales

    64.6 %     65.7 %            

International product net sales

    35.4 %     34.3 %            

Selected Product Net Sales(b):

               

Alphagan ® P, Alphagan ® and  Combigan ®

  $ 398.1     $ 341.4     $ 56.7     $ 50.1     $ 6.6   16.6 %   14.7 %   1.9 %

Lumigan ® Franchise

    426.2       391.7       34.5       27.3       7.2   8.8 %   7.0 %   1.8 %

Other Glaucoma

    14.8       15.3       (0.5 )     (1.1 )     0.6   (3.3 )%   (7.4 )%   4.1 %

Restasis ®

    444.0       344.5       99.5       99.5         28.9 %   28.9 %   %

Sanctura ® Franchise

    68.2       4.9       63.3       63.3         1,298.1 %   1,298.1 %   %

 

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    Year Ended December 31,     Change in Product Net Sales   Percent Change in Product Net Sales  
    2007     2006     Total     Performance     Currency   Total     Performance     Currency  
    (in millions)                  

Net Sales by Product Line:

               

Specialty Pharmaceuticals:

               

Eye Care Pharmaceuticals

  $ 1,776.5     $ 1,530.6     $ 245.9     $ 200.1     $ 45.8   16.1 %   13.1 %   3.0 %

Botox ® /Neuromodulator

    1,211.8       982.2       229.6       201.9       27.7   23.4 %   20.6 %   2.8 %

Skin Care

    110.7       125.7       (15.0 )     (15.1 )     0.1   (11.9 )%   (12.0 )%   0.1 %

Urologics

    6.0             6.0       6.0         %   %   %
                                           

Total Specialty Pharmaceuticals

    3,105.0       2,638.5       466.5       392.9       73.6   17.7 %   14.9 %   2.8 %
                                           

Medical Devices:

               

Breast Aesthetics

    298.4       177.2       121.2       114.1       7.1   68.4 %   64.4 %   4.0 %

Obesity Intervention

    270.1       142.3       127.8       124.0       3.8   89.8 %   87.1 %   2.7 %

Facial Aesthetics

    202.8       52.1       150.7       147.8       2.9   289.3 %   283.7 %   5.6 %
                                           

Core Medical Devices

    771.3       371.6       399.7       385.9       13.8   107.6 %   103.8 %   3.8 %

Other(a)

    2.7             2.7       2.7         %   %   %
                                           

Total Medical Devices

    774.0       371.6       402.4       388.6       13.8   108.3 %   104.5 %   3.8 %
                                           

Total product net sales

  $ 3,879.0     $ 3,010.1     $ 868.9     $ 781.5     $ 87.4   28.9 %   26.0 %   2.9 %
                                           

Domestic product net sales

    65.7 %     67.4 %            

International product net sales

    34.3 %     32.6 %            

Selected Product Net Sales(b):

               

Alphagan ® P , Alphagan ® and  Combigan ®

  $ 341.4     $ 295.9     $ 45.5     $ 35.4     $ 10.1   15.4 %   12.0 %   3.4 %

Lumigan ® Franchise

    391.7       327.5       64.2       52.1       12.1   19.6 %   15.9 %   3.7 %

Other Glaucoma

    15.3       16.3       (1.0 )     (2.1 )     1.1   (6.5 )%   (12.9 )%   6.4 %

Restasis ®

    344.5       270.2       74.3       74.1       0.2   27.5 %   27.4 %   0.1 %

Sanctura ® Franchise

    4.9             4.9       4.9         %   %   %

 

 

(a) Other medical devices sales primarily consist of sales of ophthalmic surgical devices pursuant to a manufacturing and supply agreement entered into as part of the July 2007 sale of the former Cornéal ophthalmic surgical device business, which was substantially concluded in December 2007.

 

(b) Percentage change in selected product net sales is calculated on amounts reported to the nearest whole dollar.

Product Net Sales

The $460.7 million increase in product net sales in 2008 compared to 2007 was the combined result of an increase of $397.3 million in our specialty pharmaceuticals product net sales and an increase of $63.4 million in our medical devices product net sales. The increase in specialty pharmaceuticals product net sales reflects growth across all of our specialty pharmaceutical product lines. The increase in medical devices product net sales reflects growth across all of our core medical device product lines, partially offset by a decrease in other ophthalmic surgical medical device product net sales. Net sales were also positively affected by a general strengthening of foreign currencies compared to the U.S. dollar in the foreign countries where we operated during 2008 compared to 2007.

Several of our products, including Botox ® Cosmetic, and our facial aesthetics, obesity intervention and breast implant products, are purchased based on consumer choice and have limited reimbursement or are not reimbursable by government or other health care plans and are partially or wholly paid for directly by the consumer. If the negative economic environment and related decline in consumer spending that prevailed during the second half of 2008 continues, we believe there could be a corresponding negative effect on our sales, operations and profitability in 2009.

In the second half of 2008, the U.S. dollar strengthened significantly compared to certain foreign currencies of countries where we operate. If the foreign currency exchange rates between the U.S. dollar and these currencies remain at current levels, or if the U.S. dollar continues to strengthen against these currencies, our net sales could be negatively affected in 2009 compared to 2008.

 

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Eye care pharmaceuticals sales increased in 2008 compared to 2007 primarily due to strong growth in sales of Restasis ® , our therapeutic treatment for chronic dry eye disease, an increase in sales of Combigan ® , primarily due to its launch in the United States in the fourth quarter of 2007, and increased Combigan ® sales in Canada, Europe, Latin America and Asia, an increase in sales of Ganfort™ , our Lumigan ® and timolol combination for the treatment of glaucoma, an increase in product net sales of Alphagan ®   P 0.1%, our most recent generation of Alphagan ® for the treatment of glaucoma, an increase in sales of Acular LS ® , our more recent non-steroidal anti-inflammatory, and growth in sales of artificial tears products, including the Refresh ® and Optive brands. These increases in eye care pharmaceuticals sales were partially offset by lower sales of Alphagan ®   P 0.15% due to a general decline in wholesaler demand resulting from a decrease in promotion efforts and lower sales of Elestat ® , our topical antihistamine used for the prevention of itching associated with allergic conjunctivitis. We continue to believe that generic formulations of Alphagan ® may have a negative effect on future net sales of our Alphagan ® franchise. We estimate the majority of the increase in our eye care pharmaceuticals sales was due to a shift in sales mix to a greater percentage of higher priced products, and an overall net increase in the volume of product sold. Effective January 19, 2008, we increased the published list prices for certain eye care pharmaceutical products in the United States. We increased the published U.S. list price for Restasis ® by five percent, Lumigan ® by seven percent, Alphagan ®   P 0.15% and Alphagan ® P 0.1% by eight percent, Acular LS ® by eight percent, Elestat ® by seven percent and Zymar ® by eight percent. Additionally, effective August 2, 2008, we increased the published list prices in the United States for Alphagan ®   P 0.15% and Alphagan ® P 0.1% by seven percent, Acular LS ® by six percent and Zymar ® by six percent. These price increases had a positive net effect on our U.S. sales for 2008 compared to 2007, but the actual net effect is difficult to determine due to the various managed care sales rebate and other incentive programs in which we participate. Wholesaler buying patterns and the change in dollar value of prescription product mix also affected our reported net sales dollars, although we are unable to determine the impact of these effects.

Botox ® sales increased in 2008 compared to 2007 primarily due to growth in demand in international markets and, to a lesser degree, the United States for both cosmetic and therapeutic use. We believe the rate of growth of Botox ® sales, primarily Botox ® Cosmetic, was negatively impacted by declines in consumer spending in the United States and Europe in 2008, and Botox ® therapeutic sales were negatively impacted by patients delaying certain treatments due to significant co-pays in the United States and by some national and regional governments in Europe restricting access to Botox ® due to the crisis in public finances. Effective January 1, 2008, we increased the published price for Botox ® and Botox ® Cosmetic in the United States by approximately four percent, which we believe had a positive effect on our U.S. sales growth in 2008, primarily related to sales of Botox ® Cosmetic. In the United States, the actual net effect from the increase in price for sales of Botox ® for therapeutic use is difficult to determine, primarily due to rebate programs with U.S. federal and state government agencies. International Botox ® sales benefited from strong sales growth for both cosmetic and therapeutic use in Europe, Latin America and Asia Pacific. Based on internal information and assumptions, we estimate in 2008 that Botox ® therapeutic sales accounted for approximately 50% of total consolidated Botox ® sales and grew at a rate of approximately 8% compared to 2007. In 2008, Botox ® Cosmetic sales also accounted for approximately 50% of total consolidated Botox ® sales and grew at a rate of approximately 8% compared to 2007. We believe our worldwide market share for neuromodulators, including Botox ® , is currently approximately 83%.

Skin care sales, which are presently concentrated in the United States, increased in 2008 compared to 2007 primarily due to sales of Aczone ® (dapsone) gel 5%, a topical treatment for acne vulgaris, which we launched in the fourth quarter of 2008, an increase in sales of Vivité ® , a line of physician dispensed skin care products launched in 2007 and sales of our new skin care line, Clinique Medical, which is marketed in collaboration with Clinique, a division of The Estée Lauder Companies, and was launched in the fourth quarter of 2008. These increases were partially offset by a decrease in sales of Tazorac ® , Zorac ® and Avage ® , our topical tazarotene treatments for acne and psoriasis, and lower sales of other physician dispensed creams, including M.D. Forte ® and Prevage MD. Net sales of Tazorac ® , Zorac ® and Avage ® decreased $2.7 million, or 3.4%, to $77.2 million in 2008, compared to $79.9 million in 2007. We increased the published U.S. list price for Tazorac ® , Zorac ® and Avage ® by five percent effective January 19, 2008.

 

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In connection with our Esprit acquisition in October 2007, we acquired a new product line focused on the urologics market. Beginning in the fourth quarter of 2007, we began to recognize sales of Sanctura ® , Esprit’s twice-a-day anticholinergic treatment for overactive bladder. In January 2008, we launched Sanctura XR ® , an improved once-daily anticholinergic treatment for overactive bladder. Net sales of our Sanctura ® franchise products were $68.2 million in 2008 compared to $4.9 million in 2007. In February 2009, we announced a restructuring plan to focus our sales efforts on the urology specialty market and seek a partner to promote Sanctura XR ® to general practitioners, which resulted in a significant reduction in our urology sales force.

We have a policy to attempt to maintain average U.S. wholesaler inventory levels of our specialty pharmaceutical products at an amount less than eight weeks of our net sales. At December 31, 2008, based on available external and internal information, we believe the amount of average U.S. wholesaler inventories of our specialty pharmaceutical products was near the lower end of our stated policy levels.

Breast aesthetics product net sales, which consist primarily of sales of silicone gel and saline breast implants and tissue expanders, increased in 2008 compared to 2007 primarily due to sales growth in Europe, Latin America and Asia Pacific and the rapid transition of the market in North America from lower priced saline products to higher priced silicone gel products since the U.S. Food and Drug Administration, or FDA, approval of silicone gel breast implants in November 2006. This increase in sales was partially offset by a slight decrease in breast aesthetics product net sales in North America, primarily due to a decline in the number of breast implant units sold in the United States. We believe the rate of growth in net sales of breast aesthetics products in the United States and Europe was negatively impacted in 2008 by declines in consumer spending.

Obesity intervention product net sales, which consist primarily of sales of devices used for minimally invasive long-term treatments of obesity such as our Lap-Band ® and Lap-Band AP ® Systems and Orbera TM System, increased in 2008 compared to 2007 due to strong sales growth rates in Canada, the United Kingdom, Australia and Latin America and a low rate of sales growth on a large sales base in the United States. We believe the rate of growth in net sales of obesity intervention products was negatively impacted in 2008 by the introduction of a competitive product in the United States and by declines in consumer spending in the United States.

Facial aesthetics product net sales, which consist primarily of sales of hyaluronic acid-based and collagen-based dermal fillers used to correct facial wrinkles, increased in 2008 compared to 2007 primarily due to strong sales growth in Europe and Canada, primarily due to the 2008 launch of Juvéderm ® Ultra with lidocaine in those markets, and sales growth in the United States, Latin America and Asia Pacific. The increase in net sales of facial aesthetics products was partially offset by a general decline in sales of older generation collagen-based dermal fillers. We believe the rate of growth in net sales of facial aesthetics products was negatively impacted in 2008 by declines in consumer spending in the United States and Europe.

There were no net sales of other medical devices in 2008 compared to $2.7 million of other medical devices net sales in 2007. Net sales of other medical devices in 2007 consisted of ophthalmic surgical devices sold under a manufacturing and supply agreement. The manufacturing and supply agreement was entered into as part of the July 2007 sale of the former Cornéal ophthalmic surgical device business and was substantially concluded in December 2007.

Foreign currency changes increased product net sales by $49.5 million in 2008 compared to 2007, primarily due to the strengthening of the euro and Brazilian real compared to the U.S. dollar, partially offset by the weakening of the U.K. pound compared to the U.S. dollar.

U.S. sales as a percentage of total product net sales decreased by 1.1 percentage points to 64.6% in 2008 compared to U.S. sales of 65.7% in 2007, due primarily to an increase in international product net sales as a percentage of total product net sales of our Botox ® , eye care pharmaceuticals, breast aesthetics, obesity intervention and facial aesthetics product lines, partially offset by an increase in sales of our urologics products, which are currently sold only in the United States, and an increase in U.S. sales of our skin care products.

 

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The $868.9 million increase in product net sales in 2007 compared to 2006 was the combined result of an increase of $466.5 million in our specialty pharmaceuticals product net sales and an increase of $402.4 million in our medical devices product net sales. The increase in specialty pharmaceuticals product net sales was due primarily to increases in sales of our eye care pharmaceuticals and Botox ® product lines. The increase in medical devices product net sales reflects significant growth across all product lines. The increase in medical devices product net sales in 2007 compared to 2006 was also positively impacted by the March 2006 Inamed and January 2007 Cornéal business acquisitions.

Eye care pharmaceuticals sales increased in 2007 compared to 2006 primarily because of strong growth in sales of Restasis ® , our therapeutic treatment for chronic dry eye disease, an increase in sales of our glaucoma drug Lumigan ® , including strong sales growth from Ganfort ™, our Lumigan ® and timolol combination, which we launched in 2006 in certain European markets, an increase in product net sales of Alphagan ® P 0.1%, our most recent generation of Alphagan ® for the treatment of glaucoma that we launched in the United States in the first quarter of 2006, an increase in sales of Combigan ® in Europe, Latin America, Asia, Canada and, to a lesser degree, in the United States due to the initial U.S. launch of Combigan ® late in the fourth quarter of 2007, an increase in sales of Acular LS ® , our more recent non-steroidal anti-inflammatory, and growth in sales of artificial tears products, including the Refresh ® and Optive TM brands. Optive TM was launched in the United States during 2006 and in Australia and certain countries in Europe, Latin America and Asia during 2007. In addition, net sales of eye care pharmaceuticals benefited from an increase in net sales of Elestat ® , our topical antihistamine used for the prevention of itching associated with allergic conjunctivitis, and Zymar ® , an ophthalmic anti-infective product for the treatment of bacterial conjunctivitis, in 2007 compared to 2006. These increases in eye care pharmaceuticals sales were partially offset by lower sales of Alphagan ® P 0.15% due to a general decline in U.S. wholesaler demand resulting from a decrease in promotion efforts. We estimate the majority of the increase in our eye care pharmaceuticals sales during 2007 was due to a shift in sales mix to a greater percentage of higher priced products, and an overall net increase in the volume of product sold. We increased the published list prices for certain eye care pharmaceutical products in the United States, ranging from seven percent to nine percent, effective February 3, 2007. We increased the published U.S. list price for Restasis ® by seven percent, Lumigan ® by seven percent, Alphagan ® P 0.15% and Alphagan ® P 0.1% by eight percent, Acular LS ® by nine percent, Elestat ® by seven percent and Zymar ® by seven percent. This increase in prices had a positive net effect on our U.S. sales for 2007, but the actual net effect is difficult to determine due to the various managed care sales rebate and other incentive programs in which we participate. Wholesaler buying patterns and the change in dollar value of prescription product mix also affected our reported net sales dollars, although we are unable to determine the impact of these effects. We have a policy to attempt to maintain average U.S. wholesaler inventory levels of our specialty pharmaceutical products at an amount less than eight weeks of our net sales. At December 31, 2007, based on available external and internal information, we believe the amount of average U.S. wholesaler inventories of our specialty pharmaceutical products was near the lower end of our stated policy levels.

Botox ® sales increased in 2007 compared to 2006 primarily due to strong growth in demand in the United States and in international markets for both cosmetic and therapeutic use. Effective January 1, 2007, we increased the published price for Botox ® and Botox ® Cosmetic in the United States by approximately four percent, which may have had a positive effect on our U.S. sales growth in 2007, primarily related to sales of Botox ® Cosmetic. In the United States, the actual net effect from the increase in price for sales of Botox ® for therapeutic use is difficult to determine, primarily due to rebate programs with U.S. federal and state government agencies. International Botox ® sales benefited from strong sales growth for both cosmetic and therapeutic use in Europe, Latin America and Asia Pacific. Based on internal information and assumptions, we estimate in 2007 that Botox ® therapeutic sales accounted for approximately 50% of total consolidated Botox ® sales and grew at a rate of approximately 19% compared to 2006. In 2007, Botox ® Cosmetic sales accounted for approximately 50% of total consolidated Botox ® sales and grew at a rate of approximately 29% compared to 2006.

Skin care sales decreased in 2007 compared to 2006 primarily due to lower sales of Tazorac ® , principally due to the impact of a negative change in formulary positions at key managed care plans from the end of 2006, and lower sales of other physician dispensed creams, including M.D. Forte ® and Prevage ® MD, partially offset

 

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by an increase in sales of Vivit é TM , a new line of physician dispensed skin care products. Net sales of Tazorac ® , Zorac ® and Avage ® decreased $11.3 million, or 12.4%, to $79.9 million in 2007, compared to $91.2 million in 2006. We increased the published U.S. list price for Tazorac ® , Zorac ® and Avage ® by nine percent effective February 3, 2007.

Urologics net sales in 2007 were $6.0 million and primarily relate to Sanctura ® , a twice-a-day anticholinergic for the treatment of overactive bladder that we began to recognize in October 2007 in connection with our Esprit acquisition.

Breast aesthetics product net sales increased $121.2 million, or 68.4%, to $298.4 million in 2007 compared to $177.2 million in 2006 primarily due to strong sales growth in all of our principal geographic markets and the full year impact of the Inamed acquisition in 2007 compared to only nine months of sales activity in 2006. The November 2006 FDA and Health Canada approvals of certain silicone gel breast implants for breast augmentation, revision or reconstructive surgery and the transition of the market from lower priced saline products to higher priced silicone products in North America had a positive effect on net sales in the United States and Canada in 2007 compared to 2006.

Obesity intervention product net sales increased $127.8 million, or 89.8%, to $270.1 million in 2007 compared to $142.3 million in 2006 primarily due to strong sales growth across all of our principal geographic markets and the full year impact of the Inamed acquisition in 2007 compared to only nine months of sales activity in 2006. Net sales of obesity intervention products were also positively benefited in 2007 compared to 2006 by an approximately three percent increase in the published U.S. list price for our Lap-Band ® System effective July 2, 2007 and our introduction in the United States of a premium priced, next generation Advanced Performance Lap-Band AP ® System.

Facial aesthetics product net sales increased $150.7 million, or 289.3%, to $202.8 million in 2007 compared to $52.1 million in 2006 primarily due to strong sales growth in all of our principal geographic markets and the full year impact in 2007 of the Cornéal and Inamed acquisitions. Our January 2007 launch of our FDA approved hyaluronic acid-based dermal fillers Juvéderm ® Ultra and Juvéderm ® Ultra Plus had a positive effect on net sales in the United States in 2007 compared to 2006. The 2007 launch of these products in Canada and Australia also had a positive effect on net sales growth in 2007 compared to 2006. The increase in net sales was partially offset by a general decline in sales of collagen-based dermal fillers. Our acquisition of Cornéal in January 2007 had a positive effect on our net sales of facial aesthetic products in Europe and Asia in 2007 compared to 2006.

Net sales of other medical devices were $2.7 million in 2007 and consisted of sales of ophthalmic surgical devices related to the former Cornéal ophthalmic surgical device business.

Foreign currency changes increased product net sales by $87.4 million in 2007 compared to 2006, primarily due to the strengthening of the euro, Brazilian real, U.K. pound, Australian dollar and the Canadian dollar compared to the U.S. dollar.

U.S. sales as a percentage of total product net sales decreased by 1.7 percentage points to 65.7% in 2007 compared to U.S. sales of 67.4% in 2006, due primarily to an increase in international specialty pharmaceutical product net sales as a percentage of total specialty pharmaceuticals net sales and a decrease in U.S. skin care sales, partially offset by an increase in U.S. sales of medical devices as a percentage of total medical devices net sales, primarily driven by growth in U.S. sales of Juvéderm ® dermal fillers. The increase in the international percentage of specialty pharmaceutical net sales was primarily due to growth in international product net sales of Botox ® and eye care pharmaceuticals.

Other Revenues

Other revenues increased $3.8 million to $63.7 million in 2008 compared to $59.9 million in 2007. The increase in other revenues in 2008 compared to 2007 is primarily due to an increase in royalty income from sales

 

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of Botox ® in Japan and China by GlaxoSmithKline, or GSK, under a licensing agreement and an increase in reimbursement income for services provided under a co-promotion agreement related to our Lap-Band ® obesity intervention products, partially offset by a decline in other reimbursement income.

Other revenues increased $6.7 million to $59.9 million in 2007 compared to $53.2 million in 2006. The increase in other revenues in 2007 compared to 2006 is primarily due to an increase of approximately $7.7 million in royalty income earned principally from sales of Botox ® in Japan and China by GSK under a license agreement, and other miscellaneous royalty income, partially offset by a decrease of approximately $1.0 million in reimbursement income, primarily related to services provided in connection with a contractual agreement for the development of Posurdex ® for the ophthalmic specialty pharmaceutical market in Japan.

Income and Expenses

The following table sets forth the relationship to product net sales of various items in our consolidated statements of operations:

 

     Year Ended December 31,  
     2008     2007     2006  

Product net sales

   100.0 %   100.0 %   100.0 %

Other revenues

   1.5     1.5     1.7  

Operating costs and expenses:

      

Cost of sales (excludes amortization of acquired intangible assets)

   17.5     17.4     19.1  

Selling, general and administrative

   42.8     43.3     44.3  

Research and development

   18.4     18.5     35.1  

Amortization of acquired intangible assets

   3.5     3.1     2.6  

Restructuring charges

   1.0     0.7     0.7  
                  

Operating income (loss)

   18.3     18.5     (0.1 )

Non-operating income (expense)

   (0.2 )   (0.8 )   (0.5 )
                  

Earnings (loss) from continuing operations before income taxes and minority interest

   18.1 %   17.7 %   (0.6 )%
                  

Net earnings (loss) from continuing operations

   13.3 %   12.9 %   (4.2 )%
                  

Cost of Sales

Cost of sales increased $88.0 million, or 13.1%, in 2008 to $761.2 million, or 17.5% of product net sales, compared to $673.2 million, or 17.4% of product net sales in 2007. Cost of sales in 2008 includes charges of $11.7 million for the purchase accounting fair market value inventory adjustment rollout related to the Esprit acquisition and $8.8 million for the rollout of retention termination benefits and accelerated depreciation costs capitalized in inventory related to the phased closure of our Arklow, Ireland breast implant manufacturing facility. Cost of sales in 2007 includes a charge of $3.3 million for the purchase accounting fair market value inventory adjustment rollout related to the acquisitions of Cornéal and Esprit. Excluding the effect of these charges, cost of sales increased $70.8 million, or 10.6%, in 2008 compared to 2007. This increase in cost of sales, excluding the charges described above, primarily resulted from the 11.9% increase in product net sales. Cost of sales as a percentage of product net sales, excluding the effect of the charges described above, declined to 17.1% in 2008 from 17.3% in 2007, primarily due to an increase in product net sales of our Juvéderm ® dermal filler family of products as a percentage of total facial aesthetic product net sales, an increase in the sales mix within our eye care pharmaceuticals and skin care product lines of newer products with lower cost of sales as a percentage of product net sales, and the continued transition of the breast aesthetic market in North America to higher priced silicone gel products from lower priced saline products, partially offset by the growth in urologics

 

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product net sales, which have a higher cost of sales as a percentage of product net sales than our other specialty pharmaceuticals products. In addition, cost of sales as a percentage of product net sales for our obesity intervention products increased slightly in 2008 compared to 2007.

Cost of sales increased $97.5 million, or 16.9%, in 2007 to $673.2 million, or 17.4% of product net sales, compared to $575.7 million, or 19.1% of product net sales in 2006. Cost of sales includes charges of $3.3 million in 2007 and $47.9 million in 2006 for purchase accounting fair market value inventory adjustment rollouts related to the 2007 acquisitions of Cornéal and Esprit and the 2006 acquisition of Inamed, respectively. Excluding the effect of these purchase accounting charges, cost of sales increased $142.1 million, or 26.9%, in 2007 compared to 2006. This increase in cost of sales, excluding the effect of purchase accounting charges, in 2007 compared to the 2006 primarily resulted from the 28.9% increase in product net sales. Cost of sales as a percentage of product net sales, excluding the effect of purchase accounting charges, declined to 17.3% in 2007 from 17.5% in 2006. Cost of sales as a percentage of product net sales declined during 2007 compared to 2006 primarily as a result of the January 2007 launch of Juvéderm ® Ultra and Juvéderm ® Ultra Plus and the November 2006 FDA approval of certain silicone gel breast implants in the United States. These products generally have lower cost of sales as a percentage of product net sales compared to our collagen-based dermal fillers and saline breast implants. Additionally, higher levels of production of medical device products during 2007 compared to 2006 led to improved manufacturing efficiencies. These improvements in cost of sales as a percentage of product net sales were partially offset by the impact of the overall increase in our medical device product net sales, which generally have a higher cost of sales percentage compared to our specialty pharmaceutical products.

Selling, General and Administrative

Selling, general and administrative, or SG&A, expenses increased $175.9 million, or 10.5%, to $1,856.0 million, or 42.8% of product net sales, in 2008 compared to $1,680.1 million, or 43.3% of product net sales, in 2007. The current year increase in SG&A expenses in dollars primarily relates to increases in selling, marketing and general and administrative expenses, partially offset by a decline in promotion expenses. The increase in selling and marketing expenses in 2008 compared to 2007 principally relates to the addition of our U.S. urologics sales force in the fourth quarter of 2007 related to the Esprit acquisition. In addition, the increase in selling and marketing expenses was also impacted by an increase in personnel and related incentive compensation costs driven by the expansion of our U.S. and Asia Pacific facial aesthetics sales forces, as well as launch related expenses for Sanctura XR ® , Combigan ® and Aczone ® in the United States and Juvéderm ® with lidocaine in Europe. The increase in general and administrative expenses principally relates to an increase in legal, finance and information systems costs, as well as the expansion of our management team in Asia. The decline in promotion expenses is primarily due to reduced direct-to-consumer advertising and other promotional costs for our medical device products in the United States, partially offset by launch-related promotion expenses for Sanctura XR ® , Combigan ® and Aczone ® and an increase in spending in Europe related to our Juvéderm ® product line. In 2008, SG&A expenses included $25.7 million of costs associated with the U.S. Department of Justice, or DOJ, investigation relating to sales and marketing practices in connection with Botox ® , a $13.2 million settlement related to the termination of a distribution agreement in Korea, an impairment of an intangible asset of $5.6 million related to the phase out of a collagen product, $2.1 million of integration and transition costs related to the acquisitions of Esprit and Cornéal, $0.9 million of termination benefits and asset impairments related to the phased closure of our breast implant manufacturing facility in Arklow, Ireland, $0.6 million of costs related to our acquisition of the Aczone ® assets and $0.9 million of gains on the sale of fixed assets and technology related to the phased closure of our collagen manufacturing facility in Fremont, California. In 2007, SG&A expenses also include $14.5 million of integration and transition costs related to the Esprit, Cornéal, EndoArt and Inamed acquisitions, $6.4 million of expenses associated with the settlement of a patent dispute assumed in the Inamed acquisition that related to tissue expanders and $2.3 million of expenses associated with the settlement of a pre-existing unfavorable distribution agreement between Cornéal and one of our subsidiaries. SG&A expenses as a percentage of product net sales declined in 2008 compared to 2007 due primarily to lower promotion expenses, partially offset by higher selling expenses, as a percentage of product net sales.

 

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SG&A expenses increased $346.7 million, or 26.0%, to $1,680.1 million, or 43.3% of product net sales, in 2007 compared to $1,333.4 million, or 44.3% of product net sales, in 2006. The increase in the dollar amount of SG&A expenses primarily relates to a substantial increase in promotion, selling and marketing expenses and an increase in general and administrative expenses to support the continuing growth in revenues. Promotion expenses primarily increased due to additional costs to promote our medical device product lines that we obtained in the Inamed acquisition, including an increase in direct-to-consumer advertising and other promotional costs for our Lap-Band ® System, Juvéderm ® Ultra and Juvéderm ® Ultra Plus dermal fillers, and Natrelle ® silicone breast implant products. The increase in selling and marketing expenses principally relate to personnel and related incentive compensation costs driven by the expansion of our U.S. and European facial aesthetics, neuroscience, breast implant and obesity intervention sales forces. The increase in selling and marketing expenses in 2007 compared to 2006 was also impacted by an increase in our U.S. and European ophthalmology sales forces, the addition of the Esprit sales personnel in the fourth quarter of 2007 and launch related expenses for Sanctura XR ® and Combigan ® . General and administrative expenses increased in 2007 compared to 2006 primarily due to an increase in incentive compensation, legal, finance, information systems, human resources and facilities costs. Additionally, we did not incur any significant SG&A expenses related to our medical device product lines prior to our acquisition of Inamed in March 2006. In 2006, SG&A expenses also included a $28.5 million contribution to The Allergan Foundation, $19.6 million of integration and transition costs related to the acquisition of Inamed and $5.7 million of transition and duplicate operating expenses, including a loss of $3.4 million on the sale of our Mougins, France facility, primarily related to the restructuring and streamlining of our European operations. SG&A expenses as a percentage of product net sales declined in 2007 compared to 2006 due primarily to lower general and administrative and selling expenses, partially offset by higher promotion and marketing expenses, as a percentage of product net sales.

Research and Development

Research and development, or R&D, expenses increased $79.8 million, or 11.1%, to $797.9 million in 2008, or 18.4% of product net sales, compared to $718.1 million, or 18.5% of product net sales in 2007. R&D expenses in 2008 included a charge of $41.5 million for an upfront payment for the in-licensing of apaziquone, an antineoplastic agent currently being investigated for the treatment of non-muscle invasive bladder cancer, from Spectrum Pharmaceuticals, Inc., a charge of $13.9 million for an upfront payment for the in-licensing of Sanctura XR ® product rights in Canada, where the product has not yet achieved regulatory approval, a charge of $7.0 million for an upfront payment for the in-licensing of pre-clinical drug compounds to treat diseases of the eye from Polyphor Ltd. and a charge of $6.3 million for an upfront payment for the in-licensing of preclinical drug compounds to treat diseases of the eye from Asterand plc . R&D expenses in 2007 included a charge of $72.0 million for in-process research and development assets acquired in the EndoArt acquisition. In-process research and development represents an estimate of the fair value of purchased in-process technology as of the date of acquisition that had not reached technical feasibility and had no alternative future uses in its current state. Excluding the effect of the 2008 charges related to upfront in-licensing payments for technologies that have not achieved regulatory approval and the 2007 charge for in-process research and development, R&D expenses increased by $83.1 million, or 12.9%, to $729.2 million in 2008, or 16.8% of product net sales, compared $646.1 million, or 16.7% of product net sales, in 2007. The increase in R&D expenses in dollars, excluding these charges , was primarily a result of higher rates of investment in our eye care pharmaceuticals for next generation product enhancements and line extensions as well as increased spending on Botox ® for overactive bladder and benign prostate hyperplasia programs, bimatoprost for the stimulation of eyelash growth, alpha agonists for the treatment of neuropathic pain and breast implant follow-up studies, partially offset by a reduction in expenses related to memantine and Botox ® for the treatment of chronic migraine. The increase in R&D expenses, excluding the 2008 charges related to upfront in-licensing payments for technologies that have not achieved regulatory approval and the 2007 in-process research and development charge, as a percentage of product net sales in 2008 compared to 2007 was primarily due to the 12.9% increase in R&D expenses relative to the lower percentage increase in product net sales during the same period.

 

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R&D expenses decreased $337.4 million, or 32.0%, to $718.1 million in 2007, or 18.5% of product net sales, compared to $1,055.5 million, or 35.1% of product net sales in 2006. For the year ended December 31, 2007, R&D expenses include a charge of $72.0 million for in-process research and development assets acquired in the EndoArt acquisition, and for 2006 include a charge of $579.3 million for in-process research and development assets acquired in the Inamed acquisition. Excluding the effect of the in-process research and development charges, R&D expenses increased by $169.9 million, or 35.7%, to $646.1 million in 2007, or 16.7% of product net sales, compared to $476.2 million, or 15.8% of product net sales in 2006. The increase in R&D expenses, excluding the in-process research and development charges, primarily resulted from higher rates of investment in our eye care pharmaceuticals and Botox ® product lines, increased spending for new pharmaceutical technologies and the addition of development expenses associated with our medical device products acquired in the EndoArt, Cornéal and Inamed acquisitions. R&D spending increases in 2007 compared to 2006 were primarily driven by an increase in clinical trial costs associated with Posurdex ® , Trivaris TM , certain Botox ® indications for overactive bladder and chronic migraine, and alpha agonists for the treatment of neuropathic pain, and an increase in costs related to breast implant follow-up studies and additional spending on obesity intervention technologies. R&D spending on memantine declined during 2007 compared to 2006. The increase in R&D expenses, excluding the in-process research and development charges, as a percentage of product net sales in 2007 compared to 2006 was primarily due to the 35.7% increase in R&D expenses relative to the lower percentage increase in product net sales during the same period.

Amortization of Acquired Intangible Assets

Amortization of acquired intangible assets increased $29.6 million to $150.9 million in 2008, or 3.5% of product net sales, compared to $121.3 million, or 3.1% of product net sales in 2007. The increase in amortization expense in dollars and as a percentage of product net sales is primarily due to an increase in the balance of intangible assets subject to amortization, primarily related to our October 2007 Esprit acquisition and July 2008 purchase of the Aczone ® developed technology.

Amortization of acquired intangible assets increased $41.7 million to $121.3 million in 2007, or 3.1% of product net sales, compared to $79.6 million, or 2.6% of product net sales in 2006. This increase in amortization expense in dollars and as a percentage of product net sales is primarily due to an increase in amortization of acquired intangible assets related to our 2007 acquisitions of Esprit, EndoArt and Cornéal and a full-year impact during 2007 from the Inamed acquisition that was completed on March 23, 2006.

Restructuring Charges, Integration Costs and Transition and Duplicate Operating Expenses

Restructuring charges in 2008 were $41.3 million, consisting of $27.2 million related to the restructuring and phased closure of the Arklow facility, $6.6 million related to the restructuring and integration of the Cornéal operations, $3.4 million related to the restructuring and integration of the Inamed operations, $4.0 million related to the restructuring and streamlining of our European operations and $0.1 million related to the restructuring associated with the EndoArt acquisition. Restructuring charges in 2007 were $26.8 million, consisting of $16.6 million related to the restructuring and integration of the Cornéal operations, $9.2 million related to the restructuring and integration of the Inamed operations and $1.0 million related to the restructuring and streamlining of our European operations. Restructuring charges in 2006 were $22.3 million, consisting of $13.5 million related to the restructuring and integration of the Inamed operations, $8.6 million related to the restructuring and streamlining of our European operations, $0.6 million related to the scheduled June 2005 termination of our manufacturing and supply agreement with Advanced Medical Optics and a $0.4 million restructuring charge reversal related to the streamlining of our operations in Japan.

Restructuring and Phased Closure of Arklow Facility

On January 30, 2008, we announced the phased closure of our breast implant manufacturing facility at Arklow, Ireland and the transfer of production to our manufacturing plant in Costa Rica. The Arklow facility was

 

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acquired by us in connection with our acquisition of Inamed in 2006 and employs approximately 360 people. Production at the facility is expected to be phased out by the second quarter of 2009. Based on current foreign currency exchange rates, we estimate that the total pre-tax restructuring and other transition related costs associated with the closure of the Arklow manufacturing facility will be between $60 million and $68 million, consisting primarily of employee severance and other one-time termination benefits of $31 million to $34 million, asset impairments and accelerated depreciation of $15 million to $17 million, and contract termination and other costs of $14 million to $17 million. We expect that $45 million to $51 million of the pre-tax charges will be cash expenditures. Certain employee retention termination benefits and accelerated depreciation costs related to inventory production in Arklow will be capitalized to inventory as incurred and recognized as cost of sales in the periods the related products are sold.

We began to record costs associated with the closure of the Arklow manufacturing facility in the first quarter of 2008 and expect to continue to recognize costs through the fourth quarter of 2009. We currently expect to substantially complete the phased closure of the Arklow facility by the second quarter of 2009. The restructuring charges primarily consist of employee severance, one-time termination benefits, contract termination costs and other costs related to the closure of the Arklow manufacturing facility. During 2008, we recorded pre-tax restructuring charges of $27.2 million. During 2008, we also recognized $8.8 million of cost of sales for the rollout of capitalized employee retention termination benefits and accelerated depreciation costs related to inventory production, $0.9 million of SG&A expenses and $0.3 million of R&D expenses related to one-time termination benefits and asset impairments.

At December 31, 2008, $9.5 million of capitalized employee retention termination benefits and accelerated depreciation costs are included in “Inventories” in the accompanying consolidated balance sheet.

The following table presents the restructuring activities related to the phased closure of the Arklow facility during the year ended December 31, 2008:

 

    Employee
Severance
    Contract
Termination
Costs
    Other     Total  
    (in millions)  

Net charge during 2008

  $ 20.5     $ 5.6     $ 1.1     $ 27.2  

Spending

    (7.2 )     (0.5 )     (1.0 )     (8.7 )

Foreign exchange translation effects

    (1.8 )     (0.6 )           (2.4 )
                               

Balance at December 31, 2008 (included in “Other accrued expenses”)

  $ 11.5     $ 4.5     $ 0.1     $ 16.1  
                               

Restructuring and Integration of Cornéal Operations

In connection with the January 2007 Cornéal acquisition, we initiated a restructuring and integration plan to merge the Cornéal facial aesthetics business operations with our operations. Specifically, the restructuring and integration activities involve a workforce reduction of approximately 20 positions, principally general and administrative positions, moving key Cornéal facial aesthetics business functions to our locations, integrating Cornéal’s distributor operations with our existing distribution network and integrating Cornéal’s information systems with our information systems.

We began to record costs associated with the restructuring and integration of the former Cornéal facial aesthetics business in the first quarter of 2007 and substantially completed all restructuring and integration activities in the second quarter of 2008. As of December 31, 2008, we have recorded cumulative pre-tax restructuring charges of $23.2 million and cumulative pre-tax integration and transition costs of $10.0 million. The restructuring charges primarily consist of employee severance, one-time termination benefits, employee relocation, termination of duplicative distributor agreements and other costs related to the restructuring of the

 

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Cornéal operations. During 2008 and 2007, we recorded pre-tax restructuring charges of $6.6 million and $16.6 million, respectively. The integration and transition costs primarily consist of salaries, travel, communications, recruitment and consulting costs. During 2008, we recorded pre-tax integration and transition costs of $1.5 million, consisting of $0.1 million in cost of sales and $1.4 million in SG&A expenses. During 2007, we recorded pre-tax integration and transition costs of $8.5 million, consisting of $0.1 million in cost of sales and $8.4 million in SG&A expenses.

The following table presents the cumulative restructuring activities related to the Cornéal operations through December 31, 2008:

 

    Employee
Severance
    Contract
Termination
Costs
    Total  
    (in millions)  

Net charge during 2007

  $ 3.8     $ 12.8     $ 16.6  

Spending

    (1.0 )     (4.9 )     (5.9 )
                       

Balance at December 31, 2007

    2.8       7.9       10.7  

Net charge during 2008

    0.4       6.2       6.6  

Spending

    (2.4 )     (13.5 )     (15.9 )
                       

Balance at December 31, 2008 (included in “Other accrued expenses”)

  $ 0.8     $ 0.6     $ 1.4  
                       

Restructuring and Integration of Inamed Operations

In connection with our March 2006 acquisition of Inamed, we initiated a global restructuring and integration plan to merge Inamed’s operations with our operations and to capture synergies through the centralization of certain general and administrative and commercial functions. Specifically, the restructuring and integration activities involved a workforce reduction of approximately 60 positions, principally general and administrative positions, moving key commercial Inamed business functions to our locations around the world, integrating Inamed’s distributor operations with our existing distribution network and integrating Inamed’s information systems with our information systems.

As of December 31, 2007, we substantially completed all activities related to the restructuring and operational integration of the former Inamed operations and recorded cumulative pre-tax restructuring charges of $21.0 million, cumulative pre-tax integration and transition costs of $26.0 million, and $1.6 million for income tax costs related to intercompany transfers of trade businesses and net assets related to the global restructuring and integration plan to merge Inamed’s operations with our operations. The restructuring charges primarily consisted of employee severance, one-time termination benefits, employee relocation, termination of duplicative distributor agreements and other costs related to restructuring the former Inamed operations. The integration and transition costs primarily consisted of salaries, travel, communications, recruitment and consulting costs. We did not incur any restructuring charges or integration and transition costs during 2008. During 2007 and 2006, we recorded pre-tax restructuring charges of $7.5 million and $13.5 million, respectively. During 2007, we recorded $5.3 million of pre-tax integration and transition costs associated with the global restructuring and integration of the former Inamed operations, consisting of $0.1 million in cost of sales and $5.2 million in SG&A expenses. During 2006, we recorded $20.7 million of pre-tax integration and transition costs, consisting of $0.9 million in cost of sales, $19.6 million in SG&A expenses and $0.2 million in R&D expenses. During 2006, we also recorded $1.6 million for income tax costs related to intercompany transfers of trade businesses and net assets, which we included in our provision for income taxes.

On January 30, 2007, our Board of Directors approved a plan to restructure and eventually sell or close the collagen manufacturing facility in Fremont, California that we acquired in the Inamed acquisition based on the anticipated reduction in market demand for human and bovine collagen products as a result of the introduction of our hyaluronic acid dermal filler products. Specifically, the plan involved a workforce reduction of

 

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approximately 59 positions, consisting principally of manufacturing positions at the facility, and lease termination and contract settlements. We began to record costs associated with the closure of the collagen manufacturing facility in the first quarter of 2007 and substantially completed all restructuring activities and closed the collagen manufacturing facility in the fourth quarter of 2008. Prior to the closure of the collagen manufacturing facility, we manufactured a sufficient quantity of collagen products to meet estimated market demand through 2010.

As of December 31, 2008, we recorded cumulative pre-tax restructuring charges of $5.1 million related to the restructuring of the collagen manufacturing facility. During 2008 and 2007, we recorded pre-tax restructuring charges of $3.4 million and $1.7 million, respectively.

The following table presents the cumulative restructuring activities related to the restructuring of the collagen manufacturing facility through December 31, 2008:

 

     Employee
Severance
    Contract
and Lease

Termination
Costs
     Total  
     (in millions)  

Net charge during 2007

   $ 1.7            $ 1.7  

Spending

                   
                         

Balance at December 31, 2007

     1.7              1.7  

Net charge during 2008

     0.4       3.0        3.4  

Reclassification of lease liability(a)

           1.3        1.3  

Spending

     (0.8 )     (0.5 )      (1.3 )
                         

Balance at December 31, 2008 (included in “Other accrued expenses” and “Other liabilities”)

   $ 1.3     $ 3.8      $ 5.1  
                         

 

 
  (a) Represents the reclassification of a purchase accounting liability recorded for an unfavorable lease contract for the collagen manufacturing facility in Fremont, California to an accrued liability for lease abandonment for the same facility.

Restructuring and Streamlining of European Operations

Effective January 2005, our Board of Directors approved the initiation and implementation of a restructuring of certain activities related to our European operations to optimize operations, improve resource allocation and create a scalable, lower cost and more efficient operating model for our European R&D and commercial activities. Specifically, the restructuring involved moving key European R&D and select commercial functions from our Mougins, France and other European locations to our Irvine, California, Marlow, United Kingdom and Dublin, Ireland facilities and streamlining functions in our European management services group. The workforce reduction began in the first quarter of 2005 and was substantially completed by the close of the second quarter of 2006.

As of December 31, 2006, we substantially completed all activities related to the restructuring and streamlining of our European operations and recorded cumulative pre-tax restructuring charges of $37.5 million and cumulative transition and duplicate operating expenses of $11.8 million. The restructuring charges primarily consisted of severance, relocation and one-time termination benefits, payments to public employment and training programs, contract termination costs and capital and other asset-related expenses. The transition and duplicate operating expenses primarily consisted of legal, consulting, recruiting, information system implementation costs and taxes. During 2008 and 2007, we recorded pre-tax restructuring charges of $4.0 million and $1.0 million, respectively, for adjustments to our estimated liability for an abandoned leased facility related to our European operations. During 2006, we recorded pre-tax restructuring charges of $8.6 million. We did not

 

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incur any transition and duplicate operating expenses related to the restructuring and streamlining of our European operations during 2008 and 2007. During 2006, we recorded $6.2 million of transition and duplicate operating expenses, including a $3.4 million loss related to the sale of our Mougins, France facility, consisting of $5.7 million in SG&A expenses and $0.5 million in R&D expenses. As of December 31, 2008, remaining accrued expenses of $4.8 million for restructuring charges related to the abandoned leased facility of our European operations are included in “Other liabilities.”

Other Restructuring Activities and Integration Costs

Included in 2008 is $0.1 million of restructuring charges related to the EndoArt acquisition. Included in 2006 is $0.6 million of restructuring charges related to the scheduled June 2005 termination of our manufacturing and supply agreement with Advanced Medical Optics, which we spun-off in June 2002. Also included in 2006 is a $0.4 million restructuring charge reversal related to the streamlining of our operations in Japan.

In 2008, SG&A expenses include $0.7 million of expenses related to the integration of the Esprit operations. In 2007, SG&A expenses include $0.9 million of expenses related to the integration of the Esprit and EndoArt operations.

On February 4, 2009, we announced a restructuring plan that involves a workforce reduction of approximately 460 employees, primarily in the United States and Europe. The majority of the employees affected by the restructuring plan are U.S. urology sales and marketing personnel as a result of our decision to focus on the urology specialty and to seek a partner to promote Sanctura XR ® to general practitioners, and marketing personnel in the United States and Europe as we adjust our back-office structures to a reduced short-term sales outlook for some businesses. Modest reductions are being made in other functions as we re-engineer our processes and increase productivity. Further, we have decided to accelerate the vesting and remove certain stock option expiration features for all employees holding the 2008 full-round employee stock options and to modify certain stock option expiration features for other stock options held by employees impacted by the restructuring plan.

We currently estimate that the total pre-tax charges resulting from the restructuring plan will be between $110 million and $117 million, of which $40 million to $45 million are expected to be cash expenditures. These charges will be incurred beginning in the first quarter of 2009 and are expected to continue up through and including the fourth quarter of 2009. We expect the restructuring plan to be substantially completed by the end of the second quarter of 2009.

Operating Income (Loss)

Management evaluates business segment performance on an operating income basis exclusive of general and administrative expenses and other indirect costs, restructuring charges, in-process research and development expenses, amortization of identifiable intangible assets related to business combinations and asset acquisitions and certain other adjustments, which are not allocated to our business segments for performance assessment by our chief operating decision maker. Other adjustments excluded from our business segments for purposes of performance assessment represent income or expenses that do not reflect, according to established Company-defined criteria, operating income or expenses associated with our core business activities.

General and administrative expenses, other indirect costs and other adjustments not allocated to our business segments for purposes of performance assessment consisted of the following items: for 2008, general and administrative expenses of $317.4 million, charges of $68.7 million for upfront payments for technologies that have not achieved regulatory approval, costs associated with the DOJ investigation relating to sales and marketing practices in connection with Botox ® of approximately $25.7 million, a $13.2 million charge related to the termination of a distribution agreement in Korea, a purchase accounting fair market value inventory adjustment related to the Esprit acquisition of $11.7 million, termination benefits, asset impairments and

 

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accelerated depreciation costs related to the phased closure of the Arklow facility of $10.0 million, impairment of an intangible asset of $5.6 million related to the phase out of a collagen product, integration and transition costs related to the acquisitions of Esprit and Cornéal of $2.2 million, transaction costs related to the Aczone ® asset acquisition of $0.6 million, gains on the sale of technology and fixed assets related to the phased closure of the Fremont facility of $0.9 million, and other net indirect costs of $20.9 million; for 2007, general and administrative expenses of $292.1 million, integration and transition costs related to the Esprit, EndoArt, Cornéal and Inamed acquisitions of $14.7 million, $6.4 million of expenses associated with the settlement of a patent dispute, $2.3 million of expenses associated with the settlement of a pre-existing unfavorable distribution agreement between Cornéal and one of our subsidiaries, purchase accounting fair market value inventory adjustments related to the Esprit and Cornéal acquisitions of $3.3 million and other net indirect costs of $18.1 million; and for 2006, general and administrative expenses of $244.8 million, integration and transition costs related to Inamed operations of $20.7 million, a purchase accounting fair market value inventory adjustment related to the Inamed acquisition of $47.9 million, transition and duplicate operating expenses relating to the restructuring and streamlining of our operations in Europe of $6.2 million, a contribution to The Allergan Foundation of $28.5 million, and other net indirect costs of $3.6 million.

The following table presents operating income (loss) for each reportable segment for the years ended December 31, 2008, 2007 and 2006 and a reconciliation of our segments’ operating income to consolidated operating income (loss):

 

     2008    2007    2006  
     (in millions)  

Operating income (loss):

        

Specialty pharmaceuticals

   $ 1,220.1    $ 1,047.9    $ 888.8  

Medical devices

     222.0      207.1      119.9  
                      

Total segments

     1,442.1      1,255.0      1,008.7  

General and administrative expenses, other indirect costs and other adjustments

     475.1      336.9      351.7  

In-process research and development

          72.0      579.3  

Amortization of acquired intangible assets(a)

     129.6      99.9      58.6  

Restructuring charges

     41.3      26.8      22.3  
                      

Total operating income (loss)

   $ 796.1    $ 719.4    $ (3.2 )
                      

 

 
  (a) Represents amortization of identifiable intangible assets related to business combinations and asset acquisitions and related capitalized licensing costs, as applicable.

Our consolidated operating income for the year ended December 31, 2008 was $796.1 million, or 18.3% of product net sales, compared to consolidated operating income of $719.4 million, or 18.5% of product net sales in 2007. The $76.7 million increase in consolidated operating income was due to a $460.7 million increase in product net sales and a $3.8 million increase in other revenues, partially offset by an $88.0 million increase in cost of sales, a $175.9 million increase in SG&A expenses, a $79.8 million increase in research and development, a $29.6 million increase in amortization of acquired intangible assets and a $14.5 million increase in restructuring charges.

Our specialty pharmaceuticals segment operating income in 2008 was $1,220.1 million, compared to operating income of $1,047.9 million in 2007. The $172.2 million increase in our specialty pharmaceuticals segment operating income was due primarily to an increase in product net sales of our eye care pharmaceuticals and Botox ® product lines and lower total segment promotion expenses, partially offset by an increase in selling and marketing expenses, primarily due to increased sales personnel costs and additional marketing expenses to support our expanded selling efforts and new products, including new urologics products acquired in the Esprit acquisition, and an increase in R&D expenses.

 

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Our medical devices segment operating income in 2008 was $222.0 million, compared to operating income of $207.1 million in 2007. The $14.9 million increase in our medical devices segment operating income was due primarily to an increase in product net sales across all product lines and an overall decrease in promotion expenses, partially offset by increased investments in spending for selling and marketing activities, primarily increased sales personnel costs, and an increase in R&D expenses.

Our consolidated operating income for the year ended December 31, 2007 was $719.4 million, or 18.5% of product net sales, compared to a consolidated operating loss of $3.2 million, or (0.1)% of product net sales in 2006. The $722.6 million increase in consolidated operating income was due to an $868.9 million increase in product net sales, a $6.7 million increase in other revenues and a $337.4 million decrease in R&D expenses, partially offset by a $97.5 million increase in cost of sales, a $346.7 million increase in SG&A expenses, a $41.7 million increase in amortization of acquired intangible assets and a $4.5 million increase in restructuring charges.

Our specialty pharmaceuticals segment operating income in 2007 was $1,047.9 million, compared to operating income of $888.8 million in 2006. The $159.1 million increase in our specialty pharmaceuticals segment operating income was due primarily to an increase in product net sales of our eye care pharmaceuticals and Botox ® product lines, partially offset by an increase in cost of sales, an increase in promotion, selling and marketing expenses, primarily due to increased sales personnel costs and additional promotion and marketing expenses to support our expanded selling efforts and new products, including new products acquired in the Esprit acquisition, and an increase in R&D expenses.

Our medical devices segment operating income in 2007 was $207.1 million, compared to operating income of $119.9 million in 2006. The increase in our medical devices segment operating income of $87.2 million in 2007 was due primarily to an increase in product net sales, and the combined operating results of the EndoArt, Cornéal and Inamed acquisitions in the current year compared to only nine months of operating results for the Inamed acquisition in 2006, partially offset by an increase in cost of sales, an increase in promotion, selling and marketing expenses, including an increase in direct-to-consumer advertising expenses, and an increase in R&D expenses.

Non-Operating Income and Expenses

Total net non-operating expense in 2008 was $8.9 million compared to $31.7 million in 2007. Interest income in 2008 was $33.5 million compared to interest income of $65.3 million in 2007. The decrease in interest income was primarily due to lower average cash equivalent balances earning interest of approximately $147 million and a decrease in average interest rates earned on all cash equivalent balances earning interest of approximately 2.4 percentage points in 2008 compared to 2007, partially offset by $3.5 million of statutory interest income related to income taxes recorded in 2008. Interest expense decreased $10.8 million to $60.6 million in 2008 compared to $71.4 million in 2007, primarily due to $7.9 million recognized in 2008 as the interest rate differential under our $300.0 million notional amount fixed to variable interest rate swap agreement compared to $0.3 million recognized in 2007 and a decrease in average outstanding borrowings in 2008 compared to 2007. During 2008, we recorded a net unrealized gain on derivative instruments of $14.8 million compared to a net unrealized loss of $0.4 million in 2007. Other, net income was $3.4 million in 2008, consisting primarily of $2.9 million in net realized gains from foreign currency transactions. Other, net expense was $25.2 million in 2007, consisting primarily of $25.0 million in net realized losses from foreign currency transactions.

Total net non-operating expense for the year ended December 31, 2007 was $31.7 million compared to $16.3 million in 2006. Interest income in 2007 was $65.3 million compared to interest income of $48.9 million in 2006. The increase in interest income was primarily due to higher average cash equivalent balances earning interest of approximately $143 million and an increase in average interest rates earned on all cash equivalent balances earning interest of approximately 0.27% in 2007 compared to 2006 and a $4.9 million reversal during

 

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2006 of previously recognized estimated statutory interest income related to a matter involving the recovery of previously paid state income taxes. Interest expense increased $11.2 million to $71.4 million in 2007 compared to $60.2 million in 2006, primarily due to an increase in average outstanding borrowings for 2007 compared to 2006 and a $4.9 million reversal of previously accrued statutory interest expense included in 2006 associated with the resolution of several significant uncertain income tax audit issues, partially offset by the write-off of unamortized debt origination fees of $4.4 million in 2006 due to the redemption of our Zero Coupon Convertible Senior Notes due 2022, or 2022 Notes. We incurred a substantial increase in borrowings to fund the Inamed acquisition on March 23, 2006. During 2007, we recorded a net unrealized loss on derivative instruments of $0.4 million compared to a net unrealized loss of $0.3 million in 2006. Other, net expense was $25.2 million in 2007, consisting primarily of $25.0 million in net realized losses from foreign currency transactions. Other, net expense was $4.7 million in 2006, which includes $2.7 million of costs for the settlement of a previously disclosed contingency involving non-income taxes in Brazil and net realized losses from foreign currency transactions of $3.2 million.

Income Taxes

Our effective tax rate in 2008 was 26.3% compared to the effective tax rate of 27.1% in 2007. Included in our operating income for 2008 are pre-tax charges of $68.7 million for upfront payments for technologies that have not achieved regulatory approval, an $11.7 million charge to cost of sales associated with the Esprit purchase accounting fair market value inventory adjustment rollout, a $13.2 million charge for a settlement related to the termination of a distribution agreement in Korea, a $5.6 million charge for the impairment of an intangible asset related to the phase out of a collagen product and total restructuring charges of $41.3 million. In 2008, we recorded income tax benefits of $21.6 million related to the upfront payments for technologies that have not achieved regulatory approval, $4.6 million related to the Esprit purchase accounting fair market value inventory adjustment rollout, $1.3 million related to the charge for a settlement related to the termination of a distribution agreement in Korea, $2.0 million related to the impairment of an intangible asset, $4.7 million related to the total restructuring charges and $2.4 million related to deferred tax benefits related to the legal entity integration of Esprit and Inamed. In 2008, our tax provision was also affected by a $5.5 million negative income tax impact from non-deductible losses associated with the liquidation of corporate-owned life insurance contracts previously used to fund our executive deferred compensation program. Excluding the impact of the total pre-tax charges of $140.5 million and the total net income tax benefit of $31.1 million for the items discussed above, our adjusted effective tax rate for 2008 was 25.7%. We believe that the use of an adjusted effective tax rate provides a more meaningful measure of the impact of income taxes on our results of operations because it excludes the effect of certain items that are not included as part of our core business activities. This allows investors to better determine the effective tax rate associated with our core business activities.

 

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The calculation of our adjusted effective tax rate for the year ended December 31, 2008 is summarized below:

 

    2008  
    (in millions)  

Earnings from continuing operations before income taxes and minority interest, as reported

  $ 787.2  

Upfront payments for technologies that have not achieved regulatory approval

    68.7  

Esprit fair market value inventory rollout

    11.7  

Settlement related to the termination of a distribution agreement in Korea

    13.2  

Impairment of an intangible asset

    5.6  

Total restructuring charges

    41.3  
       
  $ 927.7  
       

Provision for income taxes, as reported

  $ 207.0  

Income tax benefit (provision) for:

 

Upfront payments for technologies that have not achieved regulatory approval

    21.6  

Esprit fair market value inventory rollout

    4.6  

Settlement related to the termination of a distribution agreement in Korea

    1.3  

Impairment of an intangible asset

    2.0  

Total restructuring charges

    4.7  

Deferred tax benefit from the legal entity integration of Esprit and Inamed

    2.4  

Negative tax impact from non-deductible losses associated with the liquidation of corporate-owned life insurance contracts

    (5.5 )
       
  $ 238.1  
       

Adjusted effective tax rate

    25.7 %
       

Our effective tax rate in 2007 was 27.1% compared to the effective tax rate of 551.3% in 2006. Included in our operating income for 2007 are pre-tax charges of $72.0 million for in-process research and development acquired in the EndoArt acquisition, a $3.3 million charge to cost of sales associated with the combined Esprit and Cornéal purchase accounting fair market value inventory adjustment rollouts, $2.3 million of expenses associated with the settlement of a pre-existing unfavorable distribution agreement between Cornéal and one of our subsidiaries, total integration and transition costs of $14.7 million related to the Esprit, EndoArt, Cornéal and Inamed acquisitions, total restructuring charges of $26.8 million and a legal settlement cost of $6.4 million. In 2007, we recorded income tax benefits of $1.3 million related to the combined Esprit and Cornéal purchase accounting fair market value inventory adjustment rollouts, $3.6 million related to the total integration and transition costs, $8.0 million related to the total restructuring charges and $2.5 million related to the legal settlement cost. We did not record any income tax benefit for the in-process research and development charges or the expenses associated with the settlement of the pre-existing unfavorable distribution agreement between Cornéal and one of our subsidiaries. Also included in the provision for income taxes in 2007 is $1.6 million of tax benefit related to state income tax refunds resulting from the settlement of tax audits. Excluding the impact of the total pre-tax charges of $125.5 million and the total net income tax benefit of $17.0 million for the items discussed above, our adjusted effective tax rate for 2007 was 25.0%.

 

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The calculation of our adjusted effective tax rate for the year ended December 31, 2007 is summarized below:

 

    2007  
    (in millions)  

Earnings from continuing operations before income taxes and minority interest, as reported

  $ 687.7  

In-process research and development expense

    72.0  

Esprit and Cornéal fair market value inventory rollouts

    3.3  

Settlement of pre-existing unfavorable distribution agreement with Cornéal

    2.3  

Total integration and transition costs

    14.7  

Total restructuring charges

    26.8  

Legal settlement cost

    6.4  
       
  $ 813.2  
       

Provision for income taxes, as reported

  $ 186.2  

Income tax benefit for:

 

Esprit and Cornéal fair market value inventory rollouts

    1.3  

Total integration and transition costs

    3.6  

Total restructuring charges

    8.0  

Legal settlement cost

    2.5  

State income tax refunds

    1.6  
       
  $ 203.2  
       

Adjusted effective tax rate

    25.0 %
       

Our effective tax rate in 2006 was 551.3%. Included in our operating loss for the year ended December 31, 2006 are pre-tax charges of $579.3 million for in-process research and development acquired in the Inamed acquisition, a $47.9 million charge to cost of sales associated with the Inamed purchase accounting fair market value inventory adjustment rollout, total integration, transition and duplicate operating expenses of $26.9 million related to the Inamed acquisition and restructuring and streamlining of our European operations, a $28.5 million contribution to The Allergan Foundation and total restructuring charges of $22.3 million. In 2006, we recorded income tax benefits of $15.7 million related to the Inamed purchase accounting fair market value inventory adjustment rollout, $9.1 million related to total integration, transition and duplicate operating expenses, $11.3 million related to the contribution to The Allergan Foundation and $3.5 million related to total restructuring charges. Also included in the provision for income taxes in 2006 is a $17.2 million reduction in the provision for income taxes due to the reversal of the valuation allowance against a deferred tax asset that we have determined is realizable, a reduction of $14.5 million in estimated income taxes payable primarily due to the resolution of several significant previously uncertain income tax audit issues associated with the completion of an audit by the U.S. Internal Revenue Service for tax years 2000 to 2002, a $2.8 million reduction in income taxes payable previously estimated for the 2005 repatriation of foreign earnings that had been indefinitely re-invested outside the United States, a beneficial change of $1.2 million for the expected income tax benefit for previously paid state income taxes, which became recoverable due to a favorable state court decision concluded in 2004, an unfavorable adjustment of $3.9 million for a previously filed income tax return currently under examination and a provision for income taxes of $1.6 million related to intercompany transfers of trade businesses and net assets associated with the Inamed acquisition. Excluding the impact of the total pre-tax charges of $704.9 million and the total net income tax benefits of $69.8 million for the items discussed above, our adjusted effective tax rate for the year ended December 31, 2006 was 25.9%.

 

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The calculation of our adjusted effective tax rate for the year ended December 31, 2006 is summarized below:

 

     2006  
     (in millions)  

Loss from continuing operations before income taxes and minority interest, as reported

   $ (19.5 )

In-process research and development expense

     579.3  

Inamed fair market value inventory rollout

     47.9  

Total integration, transition and duplicate operating expenses

     26.9  

Contribution to The Allergan Foundation

     28.5  

Total restructuring charges

     22.3  
        
   $ 685.4  
        

Provision for income taxes, as reported

   $ 107.5  

Income tax benefit (provision) for:

  

Inamed fair market value inventory rollout

     15.7  

Total integration, transition and duplicate operating expenses

     9.1  

Contribution to The Allergan Foundation

     11.3  

Total restructuring charges

     3.5  

Reduction in valuation allowance associated with a deferred tax asset

     17.2  

Resolution of uncertain income tax audit issues

     14.5  

Adjustment to estimated taxes on 2005 repatriation of foreign earnings

     2.8  

Recovery of previously paid state income taxes

     1.2  

Unfavorable adjustment for previously filed tax return currently under examination

     (3.9 )

Intercompany transfers of trade businesses and net assets

     (1.6 )
        
   $ 177.3  
        

Adjusted effective tax rate

     25.9 %
        

The increase in the adjusted effective tax rate to 25.7% in 2008 compared to the adjusted effective tax rate in 2007 of 25.0% is primarily due to an increase in the mix of earnings in higher tax rate jurisdictions, partially offset by the beneficial tax rate effect of increased deductions for the amortization of acquired intangible assets associated with the Esprit acquisition and Aczone ® asset purchase and the beneficial tax rate effect of decreased interest income in the United States.

The decrease in the adjusted effective tax rate to 25.0% in 2007 compared to the adjusted effective tax rate in 2006 of 25.9% is primarily due to an increase in the mix of earnings in lower tax rate jurisdictions and the beneficial tax rate effect of increased deductions in the United States for interest expense and increased deductions for the amortization of acquired intangible assets associated with the Esprit, Cornéal and Inamed acquisitions.

Earnings (Loss) from Continuing Operations

Our earnings from continuing operations in 2008 were $578.6 million compared to earnings from continuing operations of $501.0 million in 2007. The $77.6 million increase in earnings from continuing operations was primarily the result of the increase in operating income of $76.7 million and the decrease in net non-operating expense of $22.8 million, partially offset by the increase in the provision for income taxes of $20.8 million and the increase in minority interest expense of $1.1 million.

Our earnings from continuing operations in 2007 were $501.0 million compared to a loss from continuing operations of $127.4 million in 2006. The $628.4 million increase in earnings from continuing operations was primarily the result of the increase in operating income of $722.6 million, partially offset by the increase in net

 

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non-operating expense of $15.4 million, the increase in the provision for income taxes of $78.7 million and the increase in minority interest expense of $0.1 million.

Liquidity and Capital Resources

We assess our liquidity by our ability to generate cash to fund our operations. Significant factors in the management of liquidity are: funds generated by operations; levels of accounts receivable, inventories, accounts payable and capital expenditures; the extent of our stock repurchase program; funds required for acquisitions and other transactions; adequate credit facilities; and financial flexibility to attract long-term capital on satisfactory terms.

Historically, we have generated cash from operations in excess of working capital requirements. The net cash provided by operating activities was $681.9 million in 2008 compared to $792.5 million in 2007 and $746.9 million in 2006. Cash flow from operating activities decreased in 2008 compared to 2007 primarily as a result of a net increase in cash required to fund changes in net operating assets and liabilities, principally trade receivables, inventories, accounts payable and other liabilities, partially offset by an increase in earnings from operations, including the effect of adjusting for non-cash items. We paid pension contributions of $84.5 million in 2008 compared to $23.2 million in 2007. The increase in pension contributions was primarily due to the negative impact on the value of assets in our funded pension plans due to the recent decline in the fair value of global equity securities and our desire to maintain certain minimum asset values relative to projected benefit obligations.

Cash flow from operating activities increased in 2007 compared to 2006 primarily as a result of an increase in earnings from operations, including the effect of adjusting for non-cash items, partially offset by a net increase in cash required to fund growth in net operating assets and liabilities, principally inventories and other current and non-current assets and income taxes payable, and an increase in income taxes paid. We paid pension contributions of $23.2 million in 2007 compared to $15.8 million in 2006.

Net cash used in investing activities was $459.1 million in 2008 compared to $833.1 million in 2007 and $1,484.6 million in 2006. In 2008, we paid approximately $150.1 million primarily for the acquisition of assets related to Aczone ® , and invested $190.2 million in new facilities and equipment and $56.3 million in capitalized software. In 2008, we purchased a manufacturing facility that was previously leased by us for approximately $23.0 million and an office building contiguous to our main facility in Irvine, California for approximately $15.3 million. Additionally, we capitalized $69.8 million as intangible assets including a buyout payment of contingent licensing obligations related to Sanctura ® products and milestone payments related to expected annual Restasis ® net sales and the FDA approval of Latisse TM in the United States. In 2008, we collected $3.1 million on a receivable related to the 2007 sale of the ophthalmic surgical device business that we acquired as a part of the Cornéal acquisition and $3.0 million from the sale of assets that we acquired as a part of the Esprit acquisition. We currently expect to invest between $110 million and $130 million in capital expenditures for manufacturing and administrative facilities, manufacturing equipment and other property, plant and equipment during 2009.

In 2007, we paid $683.7 million, net of cash acquired, for the acquisitions of Esprit, EndoArt and Cornéal, and invested $141.8 million in new facilities and equipment and $30.7 million in capitalized software. Additionally, we capitalized $10.0 million as intangible assets in connection with a milestone payment related to Restasis ® and an upfront licensing payment related to urologics products incurred subsequent to the Esprit acquisition. In 2007, we received $23.9 million from the sale of the ophthalmic surgical device business and $9.2 million primarily from a final installment payment related to the 2006 sale of our Mougins, France facility.

In 2006, we paid $1,328.7 million, net of cash acquired, for the cash portion of the Inamed acquisition, and invested $131.4 million in new facilities and equipment and $18.4 million in capitalized software. Additionally, we capitalized $11.5 million as intangible assets primarily related to milestone payments for regulatory approvals to commercialize the Juvéderm ® dermal filler family of products in the United States and Australia. In 2006, we received $4.8 million primarily from the sale of our Mougins, France facility.

 

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Net cash used in financing activities was $262.8 million in 2008 compared to $182.4 million in 2007 and net cash provided by financing activities of $803.0 million in 2006. In 2008, we repurchased 4.0 million shares of our common stock for $230.1 million, had net repayments of notes payable of $34.7 million and paid $60.7 million in dividends. This use of cash was partially offset by $51.6 million received from the sale of stock to employees and $11.1 million in excess tax benefits from share-based compensation. In 2007, we repurchased approximately 3.0 million shares of our common stock for $186.5 million, had net repayments of notes payable of $108.5 million and paid $60.8 million in dividends. This use of cash was partially offset by $137.4 million received from the sale of stock to employees and $36.0 million in excess tax benefits from share-based compensation. In 2006, we borrowed $825.0 million under a bridge credit facility to fund part of the cash portion of the Inamed purchase price. On April 12, 2006, we completed concurrent private placements of $750 million in aggregate principal amount of 1.50% Convertible Senior Notes due 2026, or 2026 Convertible Notes, and $800 million in aggregate principal amount of 5.75% Senior Notes due 2016, or 2016 Notes. We used part of the proceeds from these debt issuances to repay all borrowings under the bridge credit facility. Additionally, in 2006, we received $182.7 million from the sale of stock to employees, $13.0 million upon termination of an interest rate swap contract related to the 2016 Notes and $35.4 million in excess tax benefits from share-based compensation. These amounts were partially reduced by net repayments of notes payable of $67.5 million, cash payments of $20.2 million in offering fees related to the issuance of the 2026 Convertible Notes and the 2016 Notes, cash paid on the conversion of our 2022 Notes of $521.9 million, repurchase of approximately 5.8 million shares of our common stock for approximately $307.8 million and $58.4 million in dividends paid to stockholders.

Effective February 3, 2009, our Board of Directors declared a cash dividend of $0.05 per share, payable March 13, 2009 to stockholders of record on February 20, 2009.

We maintain an evergreen stock repurchase program. Our evergreen stock repurchase program authorizes us to repurchase our common stock for the primary purpose of funding our stock-based benefit plans. Under the stock repurchase program, we may maintain up to 18.4 million repurchased shares in our treasury account at any one time. As of December 31, 2008, we held approximately 3.4 million treasury shares under this program. Effective February 6, 2009, we entered into a Rule 10b5-1 plan that authorizes our broker to purchase our common stock traded in the open market pursuant to our evergreen stock repurchase program. The terms of the plan set forth a maximum annual limit of 2.0 million shares to be repurchased, and certain quarterly maximum and minimum volume limits. The term of our Rule 10b5-1 plan ends on December 31, 2009 and is cancellable at any time in our sole discretion and in accordance with applicable insider trading laws.

Our 2026 Convertible Notes pay interest semi-annually at a rate of 1.50% per annum and are convertible, at the holder’s option, at an initial conversion rate of 15.7904 shares per $1,000 principal amount of notes. In certain circumstances the 2026 Convertible Notes may be convertible into cash in an amount equal to the lesser of their principal amount or their conversion value. If the conversion value of the 2026 Convertible Notes exceeds their principal amount at the time of conversion, we will also deliver common stock or, at our election, a combination of cash and common stock for the conversion value in excess of the principal amount. We will not be permitted to redeem the 2026 Convertible Notes prior to April 5, 2009, will be permitted to redeem the 2026 Convertible Notes from and after April 5, 2009 to April 4, 2011 if the closing price of our common stock reaches a specified threshold, and will be permitted to redeem the 2026 Convertible Notes at any time on or after April 5, 2011. Holders of the 2026 Convertible Notes will also be able to require us to redeem the 2026 Convertible Notes on April 1, 2011, April 1, 2016 and April 1, 2021 or upon a change in control of us. The 2026 Convertible Notes mature on April 1, 2026, unless previously redeemed by us or earlier converted by the note holders.

Our 2016 Notes were sold at 99.717% of par value with an effective interest rate of 5.79%, pay interest semi-annually at a rate of 5.75% per annum, and are redeemable at any time at our option, subject to a make- whole provision based on the present value of remaining interest payments at the time of the redemption. The aggregate outstanding principal amount of the 2016 Notes is due and payable on April 1, 2016, unless earlier redeemed by us.

 

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At December 31, 2008, we had a committed long-term credit facility, a commercial paper program, a medium-term note program and various foreign bank facilities. In May 2007, we amended the termination date of our committed long-term credit facility to May 2012. The termination date can be further extended from time to time upon our request and acceptance by the issuer of the facility for a period of one year from the last scheduled termination date for each request accepted. The committed long-term credit facility allows for borrowings of up to $800 million. The commercial paper program also provides for up to $600 million in borrowings. Borrowings under the committed long-term credit facility and medium-term note program are subject to certain financial and operating covenants that include, among other provisions, maximum leverage ratios. Certain covenants also limit subsidiary debt. We believe we were in compliance with these covenants at December 31, 2008. As of December 31, 2008, we had no borrowings under our committed long-term credit facility, $25.0 million in borrowings outstanding under the medium-term note program, $4.4 million in borrowings outstanding under various foreign bank facilities and no borrowings under the commercial paper program. Commercial paper, when outstanding, is issued at current short-term interest rates. Additionally, any future borrowings that are outstanding under the long-term credit facility will be subject to a floating interest rate. We may from time to time seek to retire or purchase our outstanding debt. We currently expect to file in the first quarter of 2009 a new automatic shelf registration statement that will allow us to issue additional securities, including debt securities, in one or more offerings from time to time.

As of December 31, 2008, we had net pension and postretirement benefit obligations totaling $197.2 million. Future funding requirements are subject to change depending on the actual return on net assets in our funded pension plans and changes in actuarial assumptions. In 2009, we expect to pay pension contributions of between $35.0 million and $45.0 million for our U.S. and non-U.S. pension plans and between $1.0 million and $2.0 million for our other postretirement plan.

In connection with the phased closure of our breast implant manufacturing facility at Arklow, Ireland and the transfer of production to our manufacturing plant in Costa Rica, we began to record restructuring and other transition related costs beginning in the first quarter of 2008 and currently expect to incur total pre-tax costs through the fourth quarter of 2009 of between $60 million and $68 million, of which $45 million to $51 million are expected to be cash expenditures.

On February 4, 2009, we announced a restructuring plan that involves a workforce reduction of approximately 460 employees, primarily in the United States and Europe. Further, we have decided to accelerate the vesting and remove certain stock option expiration features for all employees holding the 2008 full-round employee stock options and to modify certain stock option expiration features for other stock options held by employees impacted by the restructuring plan. We currently estimate that the total pre-tax charges resulting from the restructuring plan will be between $110 million and $117 million, of which $40 million to $45 million are expected to be cash expenditures. These charges will be incurred beginning in the first quarter of 2009 and are expected to continue up through and including the fourth quarter of 2009.

A significant amount of our existing cash and equivalents are held by non-U.S. subsidiaries. We currently plan to use these funds in our operations outside the United States. Withholding and U.S. taxes have not been provided for unremitted earnings of certain non-U.S. subsidiaries because we have reinvested these earnings indefinitely in such operations. As of December 31, 2008, we had approximately $1,630.9 million in unremitted earnings outside the United States for which withholding and U.S. taxes were not provided. Tax costs would be incurred if these funds were remitted to the United States.

We believe that the net cash provided by operating activities, supplemented as necessary with borrowings available under our existing credit facilities and existing cash and equivalents, will provide us with sufficient resources to meet our current expected obligations, working capital requirements, debt service and other cash needs over the next year.

 

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Inflation

Although at reduced levels in recent years and at the end of 2008, inflation continues to apply upward pressure on the cost of goods and services that we use. The competitive and regulatory environments in many markets substantially limit our ability to fully recover these higher costs through increased selling prices. We continually seek to mitigate the adverse effects of inflation through cost containment and improved productivity and manufacturing processes.

Foreign Currency Fluctuations

Approximately 35.4% of our product net sales in 2008 were derived from operations outside the United States, and a portion of our international cost structure is denominated in currencies other than the U.S. dollar. As a result, we are subject to fluctuations in sales and earnings reported in U.S. dollars due to changing currency exchange rates. We routinely monitor our transaction exposure to currency rates and implement certain economic hedging strategies to limit such exposure, as we deem appropriate. The net impact of foreign currency fluctuations on our sales was an increase of $49.5 million, $87.4 million and $15.2 million in 2008, 2007 and 2006, respectively. The 2008 sales increase included $49.0 million related to the euro, $8.0 million related to the Brazilian real, $1.2 million related to other Latin American currencies and $0.6 million related to the Canadian dollar, partially offset by decreases of $8.7 million related to the UK pound and $0.6 million related to Asian currencies. The 2007 sales increase included $44.5 million related to the euro, $11.7 million related to the Brazilian real, $8.3 million related to the Australian dollar, $8.2 million related to the Canadian dollar, $8.2 million related to the U.K. pound and $6.5 million related to other Asian and Latin American currencies. The 2006 sales increase included $7.8 million related to the Brazilian real, $6.1 million related to the Canadian dollar, $2.0 million related to the euro and $1.0 million related to the U.K. pound, partially offset by decreases of $1.7 million primarily related to the Australian dollar and other Asian and Latin American currencies. See Note 1, “Summary of Significant Accounting Policies,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules,” for a description of our accounting policy on foreign currency translation.

Contractual Obligations and Commitments

The table below presents information about our contractual obligations and commitments at December 31, 2008:

 

    Payments Due by Period
    Less than
One Year
  1-3 Years   3-5 Years   More
than Five
Years
  Total
    (in millions)

Notes payable, convertible notes and
long-term debt obligations(a)

  $ 4.4   $ 750.0   $ 25.0   $ 798.4   $ 1,577.8

Operating lease obligations

    47.3     63.9     27.5     52.8     191.5

Purchase obligations

    308.8     142.4     164.6     70.7     686.5

Pension minimum funding(b)

    40.2     72.9     64.2         177.3

Other long-term obligations

        33.7         126.7     160.4
                             

Total

  $ 400.7   $ 1,062.9   $ 281.3   $ 1,048.6   $ 2,793.5
                             

 

 

 

  (a) Excludes the interest rate swap fair value adjustment of $61.9 million.

 

  (b)

For purposes of this table, we assume that we will be required to fund our U.S. and non-U.S. funded pension plans based on the minimum funding required by applicable regulations. In determining the minimum required funding, we utilize current actuarial assumptions and exchange rates to forecast

 

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estimates of amounts that may be payable for up to five years in the future. In management’s judgment, minimum funding estimates beyond a five year time horizon cannot be reliably estimated. Where minimum funding as determined for each individual plan would not achieve a funded status to the level of local statutory requirements, additional discretionary funding may be provided from available cash resources.

 

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

In the normal course of business, our operations are exposed to risks associated with fluctuations in interest rates and foreign currency exchange rates. We address these risks through controlled risk management that includes the use of derivative financial instruments to economically hedge or reduce these exposures. We do not enter into financial instruments for trading or speculative purposes. See Note 12, “Financial Instruments,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules,” for activities relating to interest rate and foreign currency risk management.

To ensure the adequacy and effectiveness of our interest rate and foreign exchange hedge positions, we continually monitor our interest rate swap positions and foreign exchange forward and option positions both on a stand-alone basis and in conjunction with our underlying interest rate and foreign currency exposures, from an accounting and economic perspective.

However, given the inherent limitations of forecasting and the anticipatory nature of the exposures intended to be hedged, we cannot assure you that such programs will offset more than a portion of the adverse financial impact resulting from unfavorable movements in either interest or foreign exchange rates. In addition, the timing of the accounting for recognition of gains and losses related to mark-to-market instruments for any given period may not coincide with the timing of gains and losses related to the underlying economic exposures and, therefore, may adversely affect our consolidated operating results and financial position.

Interest Rate Risk

Our interest income and expense is more sensitive to fluctuations in the general level of U.S. interest rates than to changes in rates in other markets. Changes in U.S. interest rates affect the interest earned on our cash and equivalents, interest expense on our debt as well as costs associated with foreign currency contracts.

On January 31, 2007, we entered into a nine-year, two-month interest rate swap with a $300.0 million notional amount with semi-annual settlements and quarterly interest rate reset dates. The swap receives interest at a fixed rate of 5.75% and pays interest at a variable interest rate equal to 3-month LIBOR plus 0.368%, and effectively converts $300.0 million of the $800 million aggregate principal amount of our 2016 Notes to a variable interest rate. Based on the structure of the hedging relationship, the hedge meets the criteria for using the short-cut method for a fair value hedge under the provisions of Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities , or SFAS No. 133. Under the provisions of SFAS No. 133, the investment in the derivative and the related long-term debt are recorded at fair value. At December 31, 2008 and 2007, we recognized in our consolidated balance sheets an asset reported in “Investments and other assets” and a corresponding increase in “Long-term debt” associated with the fair value of the derivative of $61.9 million and $17.1 million, respectively. The differential to be paid or received as interest rates change is accrued and recognized as an adjustment of interest expense related to the 2016 Notes. During 2008 and 2007, we recognized $7.9 million and $0.3 million, respectively, as a reduction of interest expense due to the differential to be received.

In February 2006, we entered into interest rate swap contracts based on 3-month LIBOR with an aggregate notional amount of $800 million, a swap period of 10 years and a starting swap rate of 5.198%. We entered into these swap contracts as a cash flow hedge to effectively fix the future interest rate for our 2016 Notes. In April 2006, we terminated the interest rate swap contracts and received approximately $13.0 million. The total gain is

 

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being amortized as a reduction to interest expense over a 10 year period to match the term of the 2016 Notes. As of December 31, 2008, the remaining unrecognized gain, net of tax, of $5.7 million is recorded as a component of accumulated other comprehensive loss.

At December 31, 2008, we had approximately $4.4 million of variable rate debt. If interest rates were to increase or decrease by 1% for the year, annual interest expense, including the effect of the $300.0 million notional amount of the interest rate swap entered into on January 31, 2007, would increase or decrease by approximately $3.0 million. Commercial paper, when outstanding, is issued at current short-term interest rates. Additionally, any future borrowings that are outstanding under the long-term credit facility will be subject to a floating interest rate. Therefore, higher interest costs could occur if interest rates increase in the future.

 

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The tables below present information about certain of our investment portfolio and our debt obligations at December 31, 2008 and 2007:

 

    December 31, 2008
    Maturing in     Fair
Market
Value
    2009     2010   2011     2012     2013   Thereafter     Total    
    (in millions, except interest rates)

ASSETS

               

Cash Equivalents:

               

Commercial Paper

  $ 414.1     $   —   $     $     $   —   $     $ 414.1     $ 414.1

Weighted Average Interest Rate

    3.76 %                               3.76 %  

Foreign Time Deposits

    88.2                                 88.2       88.2

Weighted Average Interest Rate

    1.65 %                               1.65 %  

Other Cash Equivalents

    506.9                                 506.9       506.9

Weighted Average Interest Rate

    1.42 %                               1.42 %  

Total Cash Equivalents

  $ 1,009.2     $   $     $     $   $     $ 1,009.2     $ 1,009.2

Weighted Average Interest Rate

    2.40 %                               2.40 %  

LIABILITIES

               

Debt Obligations:

               

Fixed Rate (US$)

  $     $   $ 750.0     $ 25.0     $   $ 798.4     $ 1,573.4     $ 1,549.0

Weighted Average Interest Rate

              1.50 %     7.47 %         5.79 %     3.77 %  

Other Variable Rate (non-US$)

    4.4                                 4.4       4.4

Weighted Average Interest Rate

    3.14 %                               3.14 %  

Total Debt Obligations(a)

  $ 4.4     $   $ 750.0     $ 25.0     $   $ 798.4     $ 1,577.8     $ 1,553.4

Weighted Average Interest Rate

    3.14 %         1.50 %     7.47 %         5.79 %     3.77 %  

INTEREST RATE DERIVATIVES

               

Interest Rate Swaps:

               

Fixed to Variable (US$)

  $     $   $     $     $   $ 300.0     $ 300.0     $ 61.9

Average Pay Rate

                              1.80 %     1.80 %  

Average Receive Rate

                              5.75 %     5.75 %  

 

 

(a) Total debt obligations in the consolidated balance sheet at December 31, 2008 include debt obligations of $1,577.8 million and the interest rate swap fair value adjustment of $61.9 million.

 

    December 31, 2007
    Maturing in     Fair
Market
Value
    2008     2009   2010   2011     2012     Thereafter     Total    
    (in millions, except interest rates)

ASSETS

               

Cash Equivalents:

               

Commercial Paper

  $ 871.0     $   —   $   —   $     $     $     $ 871.0     $ 871.0

Weighted Average Interest Rate

    4.62 %                               4.62 %  

Foreign Time Deposits

    108.1                                 108.1       108.1

Weighted Average Interest Rate

    3.55 %                               3.55 %  

Other Cash Equivalents

    96.9                                 96.9       96.9

Weighted Average Interest Rate

    5.52 %                               5.52 %  

Total Cash Equivalents

  $ 1,076.0     $   $   $     $     $     $ 1,076.0     $ 1,076.0

Weighted Average Interest Rate

    4.59 %                               4.59 %  

LIABILITIES

               

Debt Obligations:

               

Fixed Rate (US$)

  $ 34.6     $   $   $ 750.0     $ 25.0     $ 798.1     $ 1,607.7     $ 1,768.4

Weighted Average Interest Rate

    6.91 %             1.50 %     7.47 %     5.79 %     3.84 %  

Fixed Rate (non-US$)

    0.9                                 0.9       0.9

Weighted Average Interest Rate

    4.15 %                               4.15 %  

Other Variable Rate (non-US$)

    4.2                                 4.2       4.2

Weighted Average Interest Rate

    4.42 %                               4.42 %  

Total Debt Obligations(a)

  $ 39.7     $   $   $ 750.0     $ 25.0     $ 798.1     $ 1,612.8     $ 1,773.5

Weighted Average Interest Rate

    6.59 %             1.50 %     7.47 %     5.79 %     3.84 %  

INTEREST RATE DERIVATIVES

               

Interest Rate Swaps:

               

Fixed to Variable (US$)

  $     $   $   $     $     $ 300.0     $ 300.0     $ 17.1

Average Pay Rate

                              5.10 %     5.10 %  

Average Receive Rate

                              5.75 %     5.75 %  

 

 

(a) Total debt obligations in the consolidated balance sheet at December 31, 2007 include debt obligations of $1,612.8 million and the interest rate swap fair value adjustment of $17.1 million.

 

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Foreign Currency Risk

Overall, we are a net recipient of currencies other than the U.S. dollar and, as such, benefit from a weaker dollar and are adversely affected by a stronger dollar relative to major currencies worldwide. Accordingly, changes in exchange rates, and in particular a strengthening of the U.S. dollar, may negatively affect our consolidated revenues or operating costs and expenses as expressed in U.S. dollars.

From time to time, we enter into foreign currency option and forward contracts to reduce earnings and cash flow volatility associated with foreign exchange rate changes to allow our management to focus its attention on our core business issues. Accordingly, we enter into various contracts which change in value as foreign exchange rates change to economically offset the effect of changes in the value of foreign currency assets and liabilities, commitments and anticipated foreign currency denominated sales and operating expenses. We enter into foreign currency option and forward contracts in amounts between minimum and maximum anticipated foreign exchange exposures, generally for periods not to exceed one year.

We use foreign currency option contracts, which provide for the sale or purchase of foreign currencies to offset foreign currency exposures expected to arise in the normal course of our business. While these instruments are subject to fluctuations in value, such fluctuations are anticipated to offset changes in the value of the underlying exposures.

All of our outstanding foreign currency option contracts are entered into to reduce the volatility of earnings generated in currencies other than the U.S. dollar, primarily earnings denominated in the Canadian dollar, Mexican peso, Australian dollar, Brazilian real, euro, Japanese yen, Swedish krona, Swiss franc and U.K. pound. Current changes in the fair value of open foreign currency option contracts are recorded through earnings as “Unrealized gain (loss) on derivative instruments, net” while any realized gains (losses) on settled contracts are recorded through earnings as “Other, net” in the accompanying consolidated statements of operations. The premium costs of purchased foreign exchange option contracts are recorded in “Other current assets” and amortized to “Other, net” over the life of the options.

All of our outstanding foreign exchange forward contracts are entered into to protect the value of certain intercompany receivables or payables that are subject to fluctuations in foreign currency exchange rates. The realized and unrealized gains and losses from foreign currency forward contracts and the revaluation of the foreign denominated intercompany receivables or payables are recorded through “Other, net” in the accompanying consolidated statements of operations.

 

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The following table provides information about our foreign currency derivative financial instruments outstanding as of December 31, 2008 and 2007. The information is provided in U.S. dollars, as presented in our consolidated financial statements:

 

    December 31, 2008   December 31, 2007
    Notional
Amount
    Average Contract
Rate or Strike
Amount
  Notional
Amount
    Average Contract
Rate or Strike
Amount
    (in millions)         (in millions)      

Foreign currency forward contracts:

       

(Receive U.S. dollar/pay foreign currency)

       

Euro

  $ 67.9     1.36   $ 117.2     1.44

Canadian dollar

    12.9     1.24        

Japanese yen

    3.0     90.43        

Australian dollar

    17.3     0.67     9.0     0.85

New Zealand dollar

    0.5     0.55        

Swiss franc

    10.6     1.16     3.7     1.15
                   
  $ 112.2       $ 129.9    
                   

Estimated fair value

  $ (3.6 )     $ (2.0 )  
                   

Foreign currency forward contracts:

       

(Pay U.S. dollar/receive foreign currency)

       

Korean won

  $ 12.8     1411.27   $    

Euro

    50.5     1.36     58.3     1.44
                   
  $ 63.3       $ 58.3    
                   

Estimated fair value

  $ 2.7       $ 0.9    
                   

Foreign currency sold — put options:

       

Canadian dollar

  $ 48.4     1.04   $ 50.3     1.00

Mexican peso

    5.7     14.17     14.2     11.17

Australian dollar

    29.1     0.75     21.3     0.86

Brazilian real

    21.6     2.10     17.6     1.86

Euro

    99.6     1.45     151.2     1.47

Japanese yen

    12.1     90.76     10.5     107.92

Swedish krona

            10.0     6.41

Swiss franc

            4.7     1.12
                   
  $ 216.5       $ 279.8    
                   

Estimated fair value

  $ 24.3       $ 7.3    
                   

Foreign currency purchased — call options:

       

U.K. pound

  $       $ 16.0     2.05
                   

Estimated fair value

  $       $ 0.1    
                   

 

Item 8. Financial Statements and Supplementary Data

The information required by this Item is incorporated herein by reference to the financial statements set forth in Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules.”

 

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

None.

 

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Item 9A. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Principal Executive Officer and our Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. Our management, including our Principal Executive Officer and our Principal Financial Officer, does not expect that our disclosure controls or procedures will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision- making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. Also, we have investments in certain unconsolidated entities. As we do not control or manage these entities, our disclosure controls and procedures with respect to such entities are necessarily substantially more limited than those we maintain with respect to our consolidated subsidiaries.

We carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive Officer and our Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2008, the end of the annual period covered by this report. The evaluation of our disclosure controls and procedures included a review of the disclosure controls’ and procedures’ objectives, design, implementation and the effect of the controls and procedures on the information generated for use in this report. In the course of our evaluation, we sought to identify data errors, control problems or acts of fraud and to confirm the appropriate corrective actions, including process improvements, were being undertaken.

Based on the foregoing, our Principal Executive Officer and our Principal Financial Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective and were operating at the reasonable assurance level.

Further, management determined that, as of December 31, 2008, there were no changes in our internal control over financial reporting that occurred during the fourth fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Our management report on internal control over financial reporting and the report of our independent registered public accounting firm on our internal control over financial reporting are contained in Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules.”

 

Item 9B. Other Information

None.

 

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PART III

 

Item 10. Directors, Executive Officers and Corporate Governance

For information required by this Item regarding our executive officers, see Item 1 of Part I of this report, “Business.”

The information to be included in the sections entitled “Election of Directors” and “Corporate Governance” in the Proxy Statement to be filed by us with the Securities and Exchange Commission no later than 120 days after the close of our fiscal year ended December 31, 2008 (the “Proxy Statement”) is incorporated herein by reference.

The information to be included in the section entitled “Section 16(a) Beneficial Ownership Reporting Compliance” in the Proxy Statement is incorporated herein by reference.

The information to be included in the section entitled “Code of Business Conduct and Ethics” in the Proxy Statement is incorporated herein by reference.

We have filed, as exhibits to this report, the certifications of our Principal Executive Officer and Principal Financial Officer required pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

On June 5, 2008, we submitted to the New York Stock Exchange the Annual CEO Certification required pursuant to Section 303A.12(a) of the New York Stock Exchange Listed Company Manual.

 

Item 11. Executive Compensation

The information to be included in the sections entitled “Executive Compensation” and “Non-Employee Directors’ Compensation” in the Proxy Statement is incorporated herein by reference.

 

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

The information to be included in the section entitled “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” in the Proxy Statement is incorporated herein by reference.

 

Item 13. Certain Relationships and Related Transactions, and Director Independence

The information to be included in the sections entitled “Certain Relationships and Related Transactions” and “Compensation Committee Interlocks and Insider Participation” in the Proxy Statement is incorporated herein by reference.

 

Item 14. Principal Accounting Fees and Services

The information to be included in the section entitled “Independent Registered Public Accounting Firm’s Fees” in the Proxy Statement is incorporated herein by reference.

 

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PART IV

 

Item 15. Exhibits and Financial Statement Schedules

(a) 1. Consolidated Financial Statements and Supplementary Data:

The following financial statements are included herein under Item 8 of Part II of this report, “Financial Statements and Supplementary Data”:

 

     Page
Number

Management’s Report on Internal Control Over Financial Reporting

   F-1

Reports of Independent Registered Public Accounting Firm

   F-2

Consolidated Balance Sheets at December 31, 2008 and December 31, 2007

   F-4

Consolidated Statements of Operations for Each of the Years in the Three Year Period
Ended December 31, 2008

   F-5

Consolidated Statements of Stockholders’ Equity for Each of the Years in the Three Year Period
Ended December 31, 2008

   F-6

Consolidated Statements of Cash Flows for Each of the Years in the Three Year Period
Ended December 31, 2008

   F-7

Notes to Consolidated Financial Statements

   F-8

Quarterly Data

   F-55

(a) 2.  Financial Statement Schedules:

 

     Page
Number

Schedule II — Valuation and Qualifying Accounts

   F-57

All other schedules have been omitted for the reason that the required information is presented in the financial statements or notes thereto, the amounts involved are not significant or the schedules are not applicable.

 

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(a) 3.  Exhibits:

EXHIBIT INDEX

 

Exhibit
No.
  

Description

3.1    Restated Certificate of Incorporation of Allergan, Inc., as filed with the State of Delaware on May 22, 1989 (incorporated by reference to Exhibit 3.1 to Allergan, Inc.’s Registration Statement on Form S-1 No. 33-28855, filed on May 24, 1989)
3.2    Certificate of Amendment of Certificate of Incorporation of Allergan, Inc. (incorporated by reference to Exhibit 3 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended June 30, 2000)
3.3    Certificate of Amendment of Restated Certificate of Incorporation of Allergan, Inc. (incorporated by reference to Exhibit 3.1 to Allergan, Inc.’s Current Report on Form 8-K filed on September 20, 2006)
3.4    Allergan, Inc. Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to Allergan, Inc.’s Current Report on Form 8-K filed on October 7, 2008)
4.1    Certificate of Designations of Series A Junior Participating Preferred Stock, as filed with the State of Delaware on February 1, 2000 (incorporated by reference to Exhibit 4.1 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 1999)
4.2    Form of Stock Certificate for Allergan, Inc. Common Stock, par value $0.01
4.3    Rights Agreement, dated as of January 25, 2000, between Allergan, Inc. and First Chicago Trust Company of New York (incorporated by reference to Exhibit 4 to Allergan, Inc.’s Current Report on Form 8-K filed on January 28, 2000)
4.4    Amendment to Rights Agreement, dated as of January 2, 2002, among First Chicago Trust Company of New York, Allergan, Inc. and EquiServe Trust Company, N.A., as successor Rights Agent (incorporated by reference to Exhibit 4.3 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2001)
4.5    Second Amendment to Rights Agreement, dated as of January 30, 2003, among First Chicago Trust Company of New York, Allergan, Inc. and EquiServe Trust Company, N.A., as successor Rights Agent (incorporated by reference to Exhibit 1 to Allergan, Inc.’s amended Form 8-A filed on February 14, 2003)
4.6    Third Amendment to Rights Agreement, dated as of October 7, 2005, among Wells Fargo Bank, N.A. and Allergan, Inc., as successor Rights Agent (incorporated by reference to Exhibit 4.11 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 30, 2005)
4.7    Indenture, dated as of April 12, 2006, between Allergan, Inc. and Wells Fargo Bank, National Association relating to the $750,000,000 1.50% Convertible Senior Notes due 2026 (incorporated by reference to Exhibit 4.1 to Allergan, Inc.’s Current Report on Form 8-K filed on April 12, 2006)
4.8    Indenture, dated as of April 12, 2006, between Allergan, Inc. and Wells Fargo Bank, National Association relating to the $800,000,000 5.75% Senior Notes due 2016 (incorporated by reference to Exhibit 4.2 to Allergan, Inc.’s Current Report on Form 8-K filed on April 12, 2006)
4.9    Form of 1.50% Convertible Senior Note due 2026 (incorporated by reference to (and included in) the Indenture dated as of April 12, 2006 between Allergan, Inc. and Wells Fargo Bank, National Association at Exhibit 4.1 to Allergan, Inc.’s Current Report on Form 8-K filed on April 12, 2006)

 

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Exhibit
No.
  

Description

4.10    Form of 5.75% Senior Note due 2016 (incorporated by reference to (and included in) the Indenture dated as of April 12, 2006 between Allergan, Inc. and Wells Fargo Bank, National Association at Exhibit 4.2 to Allergan, Inc.’s Current Report on Form 8-K filed on April 12, 2006)
4.11    Registration Rights Agreement, dated as of April 12, 2006, among Allergan, Inc., Banc of America Securities LLC and Citigroup Global Markets Inc., as representatives of the Initial Purchasers named therein, relating to the $750,000,000 1.50% Convertible Senior Notes due 2026 (incorporated by reference to Exhibit 4.3 to Allergan, Inc.’s Current Report on Form 8-K filed on April 12, 2006)
4.12    Registration Rights Agreement, dated as of April 12, 2006, between Allergan, Inc. and Morgan Stanley & Co. Incorporated, as representative of the Initial Purchasers named therein, relating to the $800,000,000 5.75% Senior Notes due 2016 (incorporated by reference to Exhibit 4.4 to Allergan, Inc.’s Current Report on Form 8-K filed on April 12, 2006)
10.1    Form of Director and Executive Officer Indemnity Agreement† (incorporated by reference to Exhibit 10.1 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2006)
10.2    Amended and Restated Form of Allergan, Inc. Change in Control Agreement (applicable to certain employees hired on or before December 4, 2006)††
10.3    Amended and Restated Form of Allergan, Inc. Change in Control Agreement (applicable to certain employees hired on or after December 4, 2006)†††
10.4    Allergan, Inc. 2003 Nonemployee Director Equity Incentive Plan (incorporated by reference to Appendix A to Allergan, Inc.’s Proxy Statement filed on March 14, 2003)
10.5    First Amendment to Allergan, Inc. 2003 Nonemployee Director Equity Incentive Plan (incorporated by reference to Appendix A to Allergan, Inc.’s Proxy Statement filed on March 21, 2006)
10.6    Second Amendment to Allergan, Inc. 2003 Nonemployee Director Equity Incentive Plan (incorporated by reference to Exhibit 10.14 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 30, 2007)
10.7    Amended Form of Restricted Stock Award Agreement under Allergan, Inc. 2003 Nonemployee Director Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.15 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 30, 2007)
10.8    Amended Form of Non-Qualified Stock Option Award Agreement under Allergan, Inc. 2003 Nonemployee Director Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.16 to Allergan, Inc. Report on Form 10-Q for the Quarter ended March 30, 2007)
10.9    Allergan, Inc. Deferred Directors’ Fee Program, amended and restated as of July 30, 2007 (incorporated by reference to Exhibit 10.4 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 28, 2007)
10.10    Allergan, Inc. 1989 Incentive Compensation Plan (as amended and restated November 2000) (incorporated by reference to Exhibit 10.5 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2000)
10.11    First Amendment to Allergan, Inc. 1989 Incentive Compensation Plan (as amended and restated November 2000) (incorporated by reference to Exhibit 10.51 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 26, 2003)

 

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Exhibit
No.
  

Description

10.12    Second Amendment to Allergan, Inc. 1989 Incentive Compensation Plan (as amended and restated November 2000) (incorporated by reference to Exhibit 10.7 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2004)
10.13    Form of Certificate of Restricted Stock Award Terms and Conditions under Allergan, Inc. 1989 Incentive Compensation Plan (as amended and restated November 2000) (incorporated by reference to Exhibit 10.8 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2004)
10.14    Form of Restricted Stock Units Terms and Conditions under Allergan, Inc. 1989 Incentive Compensation Plan (as amended and restated November 2000) (incorporated by reference to Exhibit 10.9 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2004)
10.15    Allergan, Inc. Employee Stock Ownership Plan (Restated 2008)
10.16    Allergan, Inc. Savings and Investment Plan (Restated 2008)
10.17    First Amendment to Allergan, Inc. Savings and Investment Plan (Restated 2008)
10.18    Allergan, Inc. Pension Plan (Restated 2008)
10.19    Allergan, Inc. Supplemental Executive Benefit Plan and Supplemental Retirement Income Plan (Restated 2008)
10.20    Allergan, Inc. 2006 Executive Bonus Plan (incorporated by reference to Appendix B to Allergan, Inc.’s Proxy Statement filed on March 21, 2006)
10.21    Allergan, Inc. 2009 Executive Bonus Plan Performance Objectives
10.22    Allergan, Inc. 2009 Management Bonus Plan
10.23    Allergan, Inc. Executive Deferred Compensation Plan (2009 Restatement)
10.24    Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Appendix A to Allergan, Inc.’s Proxy Statement filed on March 20, 2008)
10.25    Sub-Plan for Restricted Stock Units for Employees in France under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.2 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.26    Sub-Plan for Stock Options for Employees in France under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.3 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.27    Form Non-Qualified Stock Option Grant Notice for Non-Employee Directors under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.4 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.28    Form Non-Qualified Stock Option Grant Notice for Employees under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.5 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)

 

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Exhibit
No.
  

Description

10.29    Addendum to Form Non-Qualified Stock Option Grant Notice for Employees in China under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.6 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.30    Addendum to Form Non-Qualified Stock Option Grant Notice for Employees in France under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.7 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.31    Addendum to Form Non-Qualified Stock Option Grant Notice for Employees in Italy under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.8 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.32    Addendum to Form Non-Qualified Stock Option Grant Notice for Employees in Thailand under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.9 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.33    Form Restricted Stock Award Grant Notice for Non-Employee Directors under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.10 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.34    Form Restricted Stock Award Grant Notice for Employees under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.11 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.35    Form Restricted Stock Award Grant Notice for Employees (Management Bonus Plan) under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.12 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.36    Form Restricted Stock Unit Award Grant Notice for Employees under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.13 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.37    Form Restricted Stock Unit Award Grant Notice for Employees (Management Bonus Plan) under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.14 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.38    Addendum to Form Restricted Stock Unit Award Grant Notice for Employees in France under the Allergan, Inc. 2008 Incentive Award Plan (incorporated by reference to Exhibit 10.15 to Allergan, Inc.’s Current Report on Form 8-K filed on May 6, 2008)
10.39    Distribution Agreement, dated as of March 4, 1994, among Allergan, Inc. and Merrill Lynch & Co. and J.P. Morgan Securities Inc. (incorporated by reference to Exhibit 10.14 to Allergan, Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 1993)
10.40    Amended and Restated Credit Agreement, dated as of March 31, 2006, among Allergan, Inc. as Borrower and Guarantor, the Banks listed therein, JPMorgan Chase Bank, as Administrative Agent, Citicorp USA Inc., as Syndication Agent and Bank of America, N.A., as Document Agent (incorporated by reference to Exhibit 10.1 to Allergan, Inc.’s Current Report on Form 8-K filed on April 4, 2006)

 

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Exhibit
No.
  

Description

10.41    First Amendment to Amended and Restated Credit Agreement, dated as of March 16, 2007, among Allergan, Inc., as Borrower and Guarantor, the Banks listed therein, JPMorgan Chase Bank, as Administrative Agent, Citicorp USA Inc., as Syndication Agent and Bank of America, N.A., as Document Agent (incorporated by reference to Exhibit 10.13 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 30, 2007)
10.42    Second Amendment to Amended and Restated Credit Agreement, dated as of May 24, 2007, among Allergan, Inc., as Borrower and Guarantor, the Banks listed therein, JPMorgan Chase Bank, as Administrative Agent, Citicorp USA Inc., as Syndication Agent and Bank of America, N.A., as Document Agent (incorporated by reference to Exhibit 10.4 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended June 29, 2007)
10.43    Purchase Agreement, dated as of April 6, 2006, among Allergan, Inc. and Banc of America Securities LLC, Citigroup Global Markets Inc. and Morgan Stanley & Co. Incorporated, as representatives of the initial purchasers named therein, relating to the $750,000,000 1.50% Convertible Senior Notes due 2026 (incorporated by reference to Exhibit 10.1 to Allergan, Inc.’s Current Report on Form 8-K filed on April 12, 2006)
10.44    Purchase Agreement, dated as of April 6, 2006, among Allergan, Inc. and Banc of America Securities LLC, Citigroup Global Markets Inc., Goldman, Sachs & Co. and Morgan Stanley & Co. Incorporated, relating to the $800,000,000 5.75% Senior Notes due 2016 (incorporated by reference to Exhibit 10.2 to Allergan, Inc.’s Current Report on Form 8-K filed on April 12, 2006)
10.45    Stock Sale and Purchase Agreement, dated as of October 31, 2006, among Allergan, Inc., Allergan Holdings France, SAS, Waldemar Kita, the European Pre-Floatation Fund II and the other minority stockholders of Groupe Cornéal Laboratoires and its subsidiaries (incorporated by reference to Exhibit 10.1 to Allergan, Inc.’s Current Report on Form 8-K filed on November 2, 2006)
10.46    First Amendment to Stock Sale and Purchase Agreement, dated as of February 19, 2007, among Allergan, Inc., Allergan Holdings France, SAS, Waldemar Kita, the European Pre-Floatation Fund II and the other minority stockholders of Groupe Cornéal Laboratoires and its subsidiaries (incorporated by reference to Exhibit 10.3 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 30, 2007)
10.47    Agreement and Plan of Merger, dated as of December 20, 2005, among Allergan, Inc., Banner Acquisition, Inc. and Inamed Corporation (incorporated by reference to Exhibit 99.2 to Allergan, Inc.’s Current Report on Form 8-K filed on December 21, 2005)
10.48    Agreement and Plan of Merger, dated as of September 18, 2007, among Allergan, Inc., Esmeralde Acquisition, Inc., Esprit Pharma Holding Company, Inc. and the Escrow Participants’ Representative (incorporated by reference to Exhibit 2.1 to Allergan, Inc.’s Current Report on Form 8-K/A filed on September 24, 2007)
10.49    Purchase Agreement, dated as of June 6, 2008, between Allergan Sales, LLC and QLT USA, Inc. (incorporated by reference to Exhibit 2.1 to Allergan, Inc.’s Current Report on Form 8-K filed on June 9, 2008)
10.50    Contribution and Distribution Agreement, dated as of June 24, 2002, between Allergan, Inc. and Advanced Medical Optics, Inc. (incorporated by reference to Exhibit 10.35 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended June 28, 2002)

 

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Exhibit
No.
  

Description

10.51    Employee Matters Agreement, dated as of June 24, 2002, between Allergan, Inc. and Advanced Medical Optics, Inc. (incorporated by reference to Exhibit 10.37 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended June 28, 2002)
10.52    Transfer Agent Services Agreement, dated as of October 7, 2005, among Allergan, Inc. and Wells Fargo Bank, National Association (incorporated by reference to Exhibit 10.57 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 30, 2005)
10.53    Botox ® — China License Agreement, dated as of September 30, 2005, among Allergan, Inc., Allergan Sales, LLC and Glaxo Group Limited (incorporated by reference to Exhibit 10.51** to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 30, 2005)
10.54    Botox ® — Japan License Agreement, dated as of September 30, 2005, among Allergan, Inc., Allergan Sales, LLC and Glaxo Group Limited (incorporated by reference to Exhibit 10.52** to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 30, 2005)
10.55    Co-Promotion Agreement, dated as of September 30, 2005, among Allergan, Inc., Allergan Sales, LLC and SmithKline Beecham Corporation d/b/a GlaxoSmithKline (incorporated by reference to Exhibit 10.53** to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 30, 2005)
10.56    Botox ® Global Strategic Support Agreement, dated as of September 30, 2005, among Allergan, Inc., Allergan Sales, LLC and Glaxo Group Limited (incorporated by reference to Exhibit 10.54** to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 30, 2005)
10.57    China Botox ® Supply Agreement, dated as of September 30, 2005, between Allergan Pharmaceuticals Ireland and Glaxo Group Limited (incorporated by reference to Exhibit 10.55** to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 30, 2005)
10.58    Japan Botox ® Supply Agreement, dated as of September 30, 2005, between Allergan Pharmaceuticals Ireland and Glaxo Group Limited (incorporated by reference to Exhibit 10.56** to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 30, 2005)
10.59    Amended and Restated License, Commercialization and Supply Agreement, dated as of September 18, 2007, between Esprit Pharma, Inc. and Indevus Pharmaceuticals, Inc. (incorporated by reference and included as Exhibit C*** to the Agreement and Plan of Merger, dated as of September 18, 2007, among Allergan, Inc., Esmeralde Acquisition, Inc., Esprit Pharma Holding Company, Inc. and the Escrow Participants’ Representative at Exhibit 2.1 to Allergan, Inc.’s Current Report on Form 8-K/A filed on September 24, 2007)
10.60    First Amendment to Amended and Restated License, Commercialization and Supply Agreement, dated as of January 9, 2009, between Allergan USA, Inc. and Indevus Pharmaceuticals, Inc.
10.61    License, Development, Supply and Distribution Agreement, dated as of October 28, 2008, among Allergan, Inc., Allergan Sales, LLC, Allergan USA, Inc. and Spectrum Pharmaceuticals, Inc.****
21    List of Subsidiaries of Allergan, Inc.
23.1    Consent of Independent Registered Public Accounting Firm
31.1    Certification of Principal Executive Officer Required Under Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended

 

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Exhibit
No.
  

Description

31.2    Certification of Principal Financial Officer Required Under Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended
32    Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350

 

** Confidential treatment was requested with respect to the omitted portions of this Exhibit, which portions have been filed separately with the Securities and Exchange Commission and which portions were granted confidential treatment on December 13, 2005

 

*** Confidential treatment was requested with respect to the omitted portions of this Exhibit, which portions have been filed separately with the Securities and Exchange Commission and which portions were granted confidential treatment on October 12, 2007

 

**** Confidential treatment has been requested with respect to the omitted portions of this Exhibit, which portions have been filed separately with the Securities and Exchange Commission

 

All current directors and executive officers of Allergan, Inc. have entered into the Indemnity Agreement with Allergan, Inc.

 

†† Certain vice president level employees, including executive officers, of Allergan, Inc., hired on or before December 4, 2006, are eligible to be party to this Amended and Restated Allergan, Inc. Change in Control Agreement

 

††† Certain vice president level employees of Allergan, Inc., hired on or after December 4, 2006, are eligible to be party to this Amended and Restated Allergan, Inc. Change in Control Agreement

(b)  Item 601 Exhibits

Reference is hereby made to the Index of Exhibits under Item 15 of Part IV of this report, “Exhibits and Financial Statement Schedules.”

 

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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.

 

A LLERGAN , I NC .
By   / S /  D AVID E.I. P YOTT
  David E.I. Pyott
 

Chairman of the Board and

Chief Executive Officer

Date: February 27, 2009

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 date indicated.

 

Date: February 27, 2009   By  

/ S /  D AVID E.I. P YOTT

    David E.I. Pyott
   

Chairman of the Board and

Chief Executive Officer

Date: February 27, 2009   By  

/ S /  J EFFREY L. E DWARDS

    Jeffrey L. Edwards
   

Executive Vice President, Finance and Business Development, Chief Financial Officer

(Principal Financial Officer)

Date: February 27, 2009   By  

/ S /  J AMES F. B ARLOW

    James F. Barlow
   

Senior Vice President, Corporate Controller

(Principal Accounting Officer)

Date: February 27, 2009   By  

/ S /  H ERBERT W. B OYER

    Herbert W. Boyer, Ph.D.,
    Vice Chairman of the Board
Date: February 27, 2009   By  

/ S /  D EBORAH D UNSIRE

    Deborah Dunsire, M.D., Director
Date: February 27, 2009   By  

/ S /  M ICHAEL R. G ALLAGHER

    Michael R. Gallagher, Director
Date: February 27, 2009   By  

/ S /  G AVIN S. H ERBERT

    Gavin S. Herbert,
    Director and Chairman Emeritus
Date: February 27, 2009   By  

/ S /  D AWN H UDSON

    Dawn Hudson, Director
Date: February 27, 2009   By  

/ S /  R OBERT A. I NGRAM

    Robert A. Ingram, Director
Date: February 27, 2009   By  

/ S /  T REVOR M. J ONES

    Trevor M. Jones, Ph.D., Director

 

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Date: February 27, 2009   By  

/ S /  L OUIS J. L AVIGNE , J R .

    Louis J. Lavigne, Jr., Director
Date: February 27, 2009   By  

/ S /  R USSELL T. R AY

    Russell T. Ray, Director
Date: February 27, 2009   By  

/ S /  S TEPHEN J. R YAN

    Stephen J. Ryan, M.D., Director
Date: February 27, 2009   By  

/ S /  L EONARD D. S CHAEFFER

    Leonard D. Schaeffer, Director

 

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MANAGEMENT’S REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING

Internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Securities Exchange Act of 1934, as amended, refers to the process designed by, or under the supervision of, our Principal Executive Officer and Principal Financial Officer, and effected by our Board of Directors, management and other personnel, 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, and 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 Allergan;

(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 Allergan are being made only in accordance with authorizations of management and directors of Allergan; and

(3) Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of Allergan’s assets that could have a material effect on the financial statements.

Allergan’s internal control over financial reporting has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their report on internal control over financial reporting as of December 31, 2008. Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk. Management is responsible for establishing and maintaining adequate internal control over financial reporting for Allergan.

Management has used the framework set forth in the report entitled “Internal Control — Integrated Framework” published by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of Allergan’s internal control over financial reporting. Management has concluded that Allergan’s internal control over financial reporting was effective as of December 31, 2008, based on those criteria.

David E.I. Pyott

Chairman of the Board and

Chief Executive Officer

(Principal Executive Officer)

Jeffrey L. Edwards

Executive Vice President, Finance and

Business Development, Chief Financial Officer

(Principal Financial Officer)

February 25, 2009

 

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Report of Independent Registered Public Accounting Firm

The Board of Directors and Stockholders of Allergan, Inc.

We have audited Allergan, Inc.’s (the “Company”) internal control over financial reporting as of December 31, 2008, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). The Company’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 included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’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, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, 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, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2008, 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 Allergan, Inc. as of December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2008 of Allergan, Inc. and our report dated February 25, 2009 expressed an unqualified opinion thereon.

/s/  E RNST  & Y OUNG LLP

Orange County, California

February 25, 2009

 

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Report of Independent Registered Public Accounting Firm

The Board of Directors and Stockholders of Allergan, Inc.

We have audited the accompanying consolidated balance sheets of Allergan, Inc. (the “Company”) as of December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2008. Our audits also included the financial statement schedule listed in the Index at Item 15(a)2. These financial statements and the financial statement schedule are the responsibility of the Company’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 consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Allergan, Inc. at December 31, 2008 and 2007, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 2008, 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 1 to the consolidated financial statements, the Company adopted the balance sheet recognition and reporting provisions of SFAS No. 158 “Employers’ Accounting for Defined Benefit Pension and Other Postretirement Plans” during the fourth fiscal quarter of 2006. In the first fiscal quarter of 2008, the Company adopted the measurement date provision of SFAS No. 158, which resulted in the Company changing its measurement date for pension and other postretirement plans from September 30 to December 31.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Allergan, Inc.’s internal control over financial reporting as of December 31, 2008, 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 25, 2009 expressed an unqualified opinion thereon.

/s/  E RNST  & Y OUNG LLP

Orange County, California

February 25, 2009

 

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ALLERGAN, INC.

CONSOLIDATED BALANCE SHEETS

 

     As of December 31,  
     2008     2007  
    

(in millions,

except share data)

 
ASSETS  

Current assets:

    

Cash and equivalents

   $ 1,110.4     $ 1,157.9  

Trade receivables, net

     538.4       463.1  

Inventories

     262.5       224.7  

Other current assets

     359.3       278.5  
                

Total current assets

     2,270.6       2,124.2  

Investments and other assets

     272.9       249.9  

Property, plant and equipment, net

     774.1       686.4  

Goodwill

     1,981.8       2,082.1  

Intangibles, net

     1,491.9       1,436.7  
                

Total assets

   $ 6,791.3     $ 6,579.3  
                
LIABILITIES AND STOCKHOLDERS’ EQUITY  

Current liabilities:

    

Notes payable

   $ 4.4     $ 39.7  

Accounts payable

     173.9       208.7  

Accrued compensation

     132.6       155.3  

Other accrued expenses

     336.7       295.7  

Income taxes

     49.4       16.3  
                

Total current liabilities

     697.0       715.7  

Long-term debt

     885.3       840.2  

Long-term convertible notes

     750.0       750.0  

Deferred tax liabilities

     44.1       220.6  

Other liabilities

     402.8       312.7  

Commitments and contingencies

    

Minority interest

     1.8       1.5  

Stockholders’ equity:

    

Preferred stock, $.01 par value; authorized 5,000,000 shares; none issued

            

Common stock, $.01 par value; authorized 500,000,000 shares; issued 307,512,000 shares as of December 31, 2008 and 2007

     3.1       3.1  

Additional paid-in capital

     2,516.2       2,450.4  

Accumulated other comprehensive loss

     (198.7 )     (34.8 )

Retained earnings

     1,882.1       1,423.5  
                
     4,202.7       3,842.2  

Less treasury stock, at cost (3,424,000 and 1,605,000 shares as of December 31, 2008 and 2007, respectively)

     (192.4 )     (103.6 )
                

Total stockholders’ equity

     4,010.3       3,738.6  
                

Total liabilities and stockholders’ equity

   $ 6,791.3     $ 6,579.3  
                

See accompanying notes to consolidated financial statements.

 

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ALLERGAN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

 

     Year Ended December 31,  
     2008     2007     2006  
    

(in millions,

except per share data)

 

Revenues:

      

Product net sales

   $ 4,339.7     $ 3,879.0     $ 3,010.1  

Other revenues

     63.7       59.9       53.2  
                        

Total revenues

     4,403.4       3,938.9       3,063.3  

Operating costs and expenses:

      

Cost of sales (excludes amortization of acquired intangible assets)

     761.2       673.2       575.7  

Selling, general and administrative

     1,856.0       1,680.1       1,333.4  

Research and development

     797.9       718.1       1,055.5  

Amortization of acquired intangible assets

     150.9       121.3       79.6  

Restructuring charges

     41.3       26.8       22.3  
                        

Operating income (loss)

     796.1       719.4       (3.2 )

Non-operating income (expense):

      

Interest income

     33.5       65.3       48.9  

Interest expense

     (60.6 )     (71.4 )     (60.2 )

Unrealized gain (loss) on derivative instruments, net

     14.8       (0.4 )     (0.3 )

Other, net

     3.4       (25.2 )     (4.7 )
                        
     (8.9 )     (31.7 )     (16.3 )
                        

Earnings (loss) from continuing operations before income taxes and
minority interest

     787.2       687.7       (19.5 )

Provision for income taxes

     207.0       186.2       107.5  

Minority interest expense

     1.6       0.5       0.4  
                        

Earnings (loss) from continuing operations

     578.6       501.0       (127.4 )

Discontinued operations:

      

Loss from discontinued operations, net of applicable income tax
benefit of $0.4 million

           (0.7 )      

Loss on sale of discontinued operations, net of applicable income tax
benefit of $0.3 million

           (1.0 )      
                        

Discontinued operations

           (1.7 )      
                        

Net earnings (loss)

   $ 578.6     $ 499.3     $ (127.4 )
                        

Basic earnings (loss) per share:

      

Continuing operations

   $ 1.90     $ 1.64     $ (0.43 )

Discontinued operations

                  
                        

Net basic earnings (loss) per share

   $ 1.90     $ 1.64     $ (0.43 )
                        

Diluted earnings (loss) per share:

      

Continuing operations

   $ 1.89     $ 1.62     $ (0.43 )

Discontinued operations

                  
                        

Net diluted earnings (loss) per share

   $ 1.89     $ 1.62     $ (0.43 )
                        

See accompanying notes to consolidated financial statements.

 

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ALLERGAN, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

 

    Common Stock   Additional
Paid-In

Capital
  Accumulated
Other
Comprehensive

Loss
    Retained
Earnings
    Treasury Stock     Total     Comprehensive
Income

(Loss)
 
    Shares   Par Value         Shares     Amount      
    (in millions, except per share data)  

Balance December 31, 2005

  268.5   $ 2.7   $ 416.3   $ (50.6 )   $ 1,305.1     (2.9 )   $ (106.6 )   $ 1,566.9    

Comprehensive income

                 

Net loss

            (127.4 )         (127.4 )   $ (127.4 )

Other comprehensive income, net of tax:

                 

Minimum pension liability adjustment

                    1.3  

Foreign currency translation adjustments

                    24.9  

Deferred holding gains, net of amortized amounts, on derivatives designated as cash flow hedges

                    7.3  

Unrealized loss on investments

                    (0.6 )
                       

Other comprehensive income

          32.9             32.9       32.9  
                       

Comprehensive loss

                  $ (94.5 )
                       

Transition adjustment upon adoption of SFAS No. 158, net of tax

          (109.7 )           (109.7 )  

Dividends ($0.20 per share)

            (58.7 )         (58.7 )  

Stock options exercised

        35.4       (58.7 )   5.3       241.3       218.0    

Activity under other stock plans

            2.2     0.2       9.6       11.8    

Issuance of common stock in connection with convertible note exchanges

  4.1                

Issuance of common stock under Inamed acquisition

  34.9     0.4     1,858.9             1,859.3    

Purchase of treasury stock

            (5.8 )     (307.8 )     (307.8 )  

Stock-based award activity

        47.4       3.2     0.2       7.2       57.8    
                                                       

Balance December 31, 2006

  307.5     3.1     2,358.0     (127.4 )     1,065.7     (3.0 )     (156.3 )     3,143.1    

Comprehensive income

                 

Net earnings

            499.3           499.3     $ 499.3  

Other comprehensive income, net of tax:

                 

Pension and postretirement benefit plan adjustments:

                 

Net gain

                    38.5  

Amortization

                    7.5  

Foreign currency translation adjustments

                    46.9  

Amortization of deferred holding gains on derivatives designated as cash flow hedges

                    (0.8 )

Unrealized gain on investments

                    0.5  
                       

Other comprehensive income

          92.6             92.6       92.6  
                       

Comprehensive income

                  $ 591.9  
                       

Dividends ($0.20 per share)

            (61.2 )         (61.2 )  

Stock options exercised

        36.0       (76.4 )   3.9       213.9       173.5    

Activity under other stock plans

            1.1     0.3       15.2       16.3    

Purchase of treasury stock

            (3.0 )     (186.5 )     (186.5 )  

Stock-based award activity

        56.4       (0.7 )   0.2       10.1       65.8    

Adjustment upon adoption of FIN 48

            (4.3 )         (4.3 )  
                                                       

Balance December 31, 2007

  307.5     3.1     2,450.4     (34.8 )     1,423.5     (1.6 )     (103.6 )     3,738.6    

Comprehensive income

                 

Net earnings

            578.6           578.6     $ 578.6  

Other comprehensive income, net of tax:

                 

Pension and postretirement benefit plan adjustments:

                 

Net losses

                    (125.8 )

Amortization

                    3.9  

Foreign currency translation adjustments

                    (39.1 )

Amortization of deferred holding gains on derivatives designated as cash flow hedges

                    (0.8 )

Unrealized loss on investments

                    (3.1 )
                       

Other comprehensive loss

          (164.9 )           (164.9 )     (164.9 )
                       

Comprehensive income

                  $ 413.7  
                       

Adjustment upon adoption of the measurement date provision of SFAS No. 158, net of tax

          1.0       (4.6 )         (3.6 )  

Dividends ($0.20 per share)

            (61.0 )         (61.0 )  

Stock options exercised

        11.1       (45.5 )   1.5       97.4       63.0    

Activity under other stock plans

            (6.1 )   0.4       26.2       20.1    

Purchase of treasury stock

            (4.0 )     (230.1 )     (230.1 )  

Stock-based award activity

        54.7       (2.8 )   0.3       17.7       69.6    
                                                       

Balance December 31, 2008

  307.5   $ 3.1   $ 2,516.2   $ (198.7 )   $ 1,882.1     (3.4 )   $ (192.4 )   $ 4,010.3    
                                                       

See accompanying notes to consolidated financial statements.

 

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ALLERGAN, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

     Year Ended December 31,  
     2008     2007     2006  
     (in millions)  

Cash flows from operating activities:

      

Net earnings (loss)

   $ 578.6     $ 499.3     $ (127.4 )

Non-cash items included in net earnings (loss)

      

In-process research and development charge

           72.0       579.3  

Depreciation and amortization

     264.3       215.4       152.4  

Settlement of a pre-existing distribution agreement in a business combination

           2.3        

Amortization of original issue discount and debt issuance costs

     3.9       4.6       10.0  

Amortization of net realized gain on interest rate swap

     (1.3 )     (1.3 )     (0.9 )

Deferred income tax benefit

     (91.5 )     (82.2 )     (47.6 )

Loss on disposal of fixed assets and investments

     3.6       4.3       4.0  

Asset impairments and write-offs

     7.9              

Loss on sale of discontinued operations

           1.3        

Unrealized (gain) loss on derivative instruments

     (14.8 )     0.4       0.3  

Expense of share-based compensation plans

     93.1       81.7       69.6  

Minority interest expense

     1.6       0.5       0.4  

Restructuring charges

     41.3       26.8       22.3  

Changes in assets and liabilities:

      

Trade receivables

     (114.5 )     (46.4 )     (57.7 )

Inventories

     (48.0 )     (22.6 )     34.1  

Other current assets

     4.6       (20.7 )     18.1  

Other non-current assets

     (2.9 )     (34.3 )     0.1  

Accounts payable

     (32.9 )     51.8       17.0  

Accrued expenses

     14.0       32.7       10.7  

Income taxes

     35.3       (18.7 )     42.5  

Other liabilities

     (60.4 )     25.6       19.7  
                        

Net cash provided by operating activities

     681.9       792.5       746.9  
                        

Cash flows from investing activities:

      

Acquisitions, net of cash acquired

     (150.1 )     (683.7 )     (1,328.7 )

Additions to property, plant and equipment

     (190.2 )     (141.8 )     (131.4 )

Additions to capitalized software

     (56.3 )     (30.7 )     (18.4 )

Additions to intangible assets

     (69.8 )     (10.0 )     (11.5 )

Proceeds from sale of business and assets

     6.1       23.9        

Proceeds from sale of property, plant and equipment

     1.2       9.2       4.8  

Proceeds from sale of investments

                 0.6  
                        

Net cash used in investing activities

     (459.1 )     (833.1 )     (1,484.6 )
                        

Cash flows from financing activities:

      

Net repayments of notes payable

     (34.7 )     (108.5 )     (67.5 )

Payments to acquire treasury stock

     (230.1 )     (186.5 )     (307.8 )

Dividends to stockholders

     (60.7 )     (60.8 )     (58.4 )

Debt issuance costs

                 (20.2 )

Repayments of convertible borrowings

                 (521.9 )

Sale of stock to employees

     51.6       137.4       182.7  

Excess tax benefits from share-based compensation

     11.1       36.0       35.4  

Proceeds from issuance of senior notes

                 797.7  

Proceeds from issuance of convertible senior notes

                 750.0  

Bridge credit facility borrowings

                 825.0  

Bridge credit facility repayments

                 (825.0 )

Net proceeds from settlement of interest rate swap

                 13.0  
                        

Net cash (used in) provided by financing activities

     (262.8 )     (182.4 )     803.0  
                        

Effect of exchange rates on cash and equivalents

     (7.5 )     11.5       7.8  
                        

Net (decrease) increase in cash and equivalents

     (47.5 )     (211.5 )     73.1  

Cash and equivalents at beginning of year

     1,157.9       1,369.4       1,296.3  
                        

Cash and equivalents at end of year

   $ 1,110.4     $ 1,157.9     $ 1,369.4  
                        

Supplemental disclosure of cash flow information

      

Cash paid during the year for:

      

Interest (net of amount capitalized)

   $ 60.7     $ 63.1     $ 34.1  
                        

Income taxes, net of refunds

   $ 261.4     $ 238.0     $ 78.4  
                        

See accompanying notes to consolidated financial statements.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

Note 1:    Summary of Significant Accounting Policies

The consolidated financial statements include the accounts of Allergan, Inc. (“Allergan” or the “Company”) and all of its subsidiaries. All significant intercompany transactions and balances among the consolidated entities have been eliminated from the consolidated financial statements.

Use of Estimates

The financial statements have been prepared in conformity with accounting principles generally accepted in the United States and, as such, include amounts based on informed estimates and judgments of management. Actual results could differ materially from those estimates.

Foreign Currency Translation

The financial position and results of operations of the Company’s foreign subsidiaries are generally determined using local currency as the functional currency. Assets and liabilities of these subsidiaries are translated at the exchange rate in effect at each year-end. Income statement accounts are translated at the average rate of exchange prevailing during the year. Adjustments arising from the use of differing exchange rates from period to period are included in accumulated other comprehensive loss in stockholders’ equity. Net gains (losses) resulting from foreign currency transactions of approximately $2.9 million, $(25.0) million and $(3.2) million for the years ended December 31, 2008, 2007 and 2006, respectively, are included in “Other, net” in the Company’s consolidated statements of operations.

Cash and Equivalents

The Company considers cash in banks, repurchase agreements, commercial paper and deposits with financial institutions with maturities of three months or less when purchased and that can be liquidated without prior notice or penalty, to be cash and equivalents.

Investments

The Company has both marketable and non-marketable equity investments in conjunction with its various collaboration arrangements. The Company classifies its marketable equity investments as available-for-sale securities with net unrealized gains or losses recorded as a component of accumulated other comprehensive loss. The non-marketable equity investments represent investments in start-up technology companies or partnerships that invest in start-up technology companies and are recorded at cost. Marketable and non-marketable equity investments are evaluated periodically for impairment. If it is determined that a decline of any investment is other than temporary, then the investment basis would be written down to fair value and the write-down would be included in earnings as a loss.

Inventories

Inventories are valued at the lower of cost or market (net realizable value). Cost is determined by the first-in, first-out method.

Long-Lived Assets

Property, plant and equipment are stated at cost. Additions, major renewals and improvements are capitalized, while maintenance and repairs are expensed. Upon disposition, the net book value of assets is relieved and resulting gains or losses are reflected in earnings. For financial reporting purposes, depreciation is

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

generally provided on the straight-line method over the useful life of the related asset. The useful lives for buildings, including building improvements, range from seven years to 40 years and, for machinery and equipment, three years to 15 years.

Leasehold improvements are amortized over the shorter of their economic lives or lease terms. Accelerated depreciation methods are generally used for income tax purposes.

All long-lived assets are reviewed for impairment in value when changes in circumstances dictate, based upon undiscounted future operating cash flows, and appropriate losses are recognized and reflected in current earnings, to the extent the carrying amount of an asset exceeds its estimated fair value determined by the use of appraisals, discounted cash flow analyses or comparable fair values of similar assets.

Goodwill and Intangible Assets

Goodwill represents the excess of acquisition cost over the fair value of the net assets of acquired businesses. Goodwill has an indefinite useful life and is not amortized, but instead tested for impairment annually. Intangible assets include developed technology, customer relationships, licensing agreements, trademarks, core technology and other rights, which are being amortized over their estimated useful lives ranging from three to 16 years, and a foreign business license with an indefinite useful life that is not amortized, but instead tested for impairment annually.

Treasury Stock

Treasury stock is accounted for by the cost method. The Company maintains an evergreen stock repurchase program. The evergreen stock repurchase program authorizes management to repurchase the Company’s common stock for the primary purpose of funding its stock-based benefit plans. Under the stock repurchase program, the Company may maintain up to 18.4 million repurchased shares in its treasury account at any one time. As of December 31, 2008 and 2007, the Company held approximately 3.4 million and 1.6 million treasury shares, respectively, under this program.

Revenue Recognition

The Company recognizes revenue from product sales when goods are shipped and title and risk of loss transfer to its customers. A portion of the Company’s revenue is generated from consigned inventory of breast implants maintained at physician, hospital and clinic locations. These customers are contractually obligated to maintain a specific level of inventory and to notify the Company upon use. Revenue for consigned inventory is recognized at the time the Company is notified by the customer that the product has been used. Notification is usually through the replenishing of the inventory, and the Company periodically reviews consignment inventories to confirm the accuracy of customer reporting.

The Company generally offers cash discounts to customers for the early payment of receivables. Those discounts are recorded as a reduction of revenue and accounts receivable in the same period that the related sale is recorded. The amounts reserved for cash discounts were $3.3 million and $1.8 million at December 31, 2008 and 2007, respectively. The Company permits returns of product from most product lines by any class of customer if such product is returned in a timely manner, in good condition and from normal distribution channels. Return policies in certain international markets and for certain medical device products, primarily breast implants, provide for more stringent guidelines in accordance with the terms of contractual agreements with customers. Estimated allowances for sales returns are based upon the Company’s historical patterns of

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

product returns matched against sales, and management’s evaluation of specific factors that may increase the risk of product returns. The amount of allowances for sales returns recognized in the Company’s consolidated balance sheets at December 31, 2008 and 2007 were $25.3 million and $29.8 million, respectively, and are recorded in “Other accrued expenses” and “Trade receivables, net” in the Company’s consolidated balance sheets. (See Note 5, “Composition of Certain Financial Statement Captions.”) Historical allowances for cash discounts and product returns have been within the amounts reserved or accrued.

The Company participates in various managed care sales rebate and other incentive programs, the largest of which relates to Medicaid and Medicare. Sales rebate and other incentive programs also include contractual volume rebate programs and chargebacks, which are contractual discounts given primarily to federal government agencies, health maintenance organizations, pharmacy benefits managers and group purchasing organizations. The Company also offers rebate and other incentive programs for its aesthetic products, including Botox ® Cosmetic and Juvéderm ® . Sales rebates and incentive accruals reduce revenue in the same period that the related sale is recorded and are included in “Other accrued expenses” in the Company’s consolidated balance sheets. (See Note 5, “Composition of Certain Financial Statement Captions.”) The amounts accrued for sales rebates and other incentive programs were $100.9 million and $82.0 million at December 31, 2008 and 2007, respectively.

The Company’s procedures for estimating amounts accrued for sales rebates and other incentive programs at the end of any period are based on available quantitative data and are supplemented by management’s judgment with respect to many factors including, but not limited to, current market dynamics, changes in contract terms, changes in sales trends, an evaluation of current laws and regulations and product pricing. Quantitatively, the Company uses historical sales, product utilization and rebate data and applies forecasting techniques in order to estimate the Company’s liability amounts. Qualitatively, management’s judgment is applied to these items to modify, if appropriate, the estimated liability amounts. Additionally, there is a significant time lag between the date the Company determines the estimated liability and when the Company actually pays the liability. Due to this time lag, the Company records adjustments to its estimated liabilities over several periods, which can result in a net increase to earnings or a net decrease to earnings in those periods.

The Company recognizes license fees, royalties and reimbursement income for services provided as other revenues based on the facts and circumstances of each contractual agreement. In general, the Company recognizes income upon the signing of a contractual agreement that grants rights to products or technology to a third party if the Company has no further obligation to provide products or services to the third party after entering into the contract. The Company defers income under contractual agreements when it has further obligations that indicate that a separate earnings process has not been completed.

Share-Based Compensation

The Company recognizes compensation expense for all share-based awards made to employees and directors. The fair value of share-based awards is estimated at the grant date using the Black-Scholes option-pricing model and the portion that is ultimately expected to vest is recognized as compensation cost over the requisite service period using the straight-line single option method.

Advertising Expenses

Advertising expenses relating to production costs are expensed as incurred and the costs of television time, radio time and space in publications are expensed when the related advertising occurs. Advertising expenses were approximately $126.0 million, $135.6 million and $99.7 million in 2008, 2007 and 2006, respectively.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Income Taxes

The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company’s assets and liabilities along with net operating loss and tax credit carryovers. The Company records a valuation allowance against its deferred tax assets to reduce the net carrying value to an amount that it believes is more likely than not to be realized. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made. Reductions to valuation allowances related to net operating loss carryforwards of acquired businesses have been treated as adjustments to purchased goodwill up through and until the end of the Company’s 2008 fiscal year.

Effective January 1, 2007, the Company adopted Financial Accounting Standards Board (FASB) Interpretation No. 48, Accounting for Uncertainty in Income Taxes — An Interpretation of FASB Statement No. 109 (FIN 48), which prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Historically, the Company’s policy has been to account for uncertainty in income taxes in accordance with the provisions of Statement of Financial Accounting Standards No. 5, Accounting for Contingencies , which considered whether the tax benefit from an uncertain tax position was probable of being sustained. Under FIN 48, the tax benefit from uncertain tax positions may be recognized only if it is more likely than not that the tax position will be sustained, based solely on its technical merits, with the taxing authority having full knowledge of all relevant information. The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of its assets and liabilities along with net operating loss and tax credit carryovers only for tax positions that meet the more likely than not recognition criteria. The Company records a liability for unrecognized tax benefits from uncertain tax positions as discrete tax adjustments in the first interim period that the more likely than not threshold is not met. The impact of the adoption of FIN 48 is discussed in Note 9, “Income Taxes” below.

Valuation allowances against the Company’s deferred tax assets were $8.4 million and $99.9 million at December 31, 2008 and December 31, 2007, respectively. Changes in the valuation allowances, when they are recognized in the provision for income taxes, are included as a component of the estimated annual effective tax rate. The decrease in the amount of valuation allowances at December 31, 2008 compared to December 31, 2007 is primarily due to an $85.1 million adjustment related to an increase in the expected utilization of net operating losses of Esprit Pharma Holding Company, Inc., which the Company acquired in October 2007, and is treated as a reduction of Esprit purchased goodwill.

The Company has not provided for withholding and U.S. taxes for the unremitted earnings of certain non-U.S. subsidiaries because it has currently reinvested these earnings indefinitely in these foreign operations. At December 31, 2008, the Company had approximately $1,630.9 million in unremitted earnings outside the United States for which withholding and U.S. taxes were not provided. Income tax expense would be incurred if these funds were remitted to the United States. It is not practicable to estimate the amount of the deferred tax liability on such unremitted earnings. Upon remittance, certain foreign countries impose withholding taxes that are then available, subject to certain limitations, for use as credits against the Company’s U.S. tax liability, if any.

Purchase Price Allocation

The purchase price allocation for acquisitions requires extensive use of accounting estimates and judgments to allocate the purchase price to the identifiable tangible and intangible assets acquired, including in-process research and development, and liabilities assumed based on their respective fair values. Additionally, the Company must determine whether an acquired entity is considered to be a business or a set of net assets, because a portion of the purchase price can only be allocated to goodwill in a business combination.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

On July 11, 2008, the Company acquired all assets relating to Aczone ® (dapsone) gel 5% for approximately $150.0 million. The Company accounted for the acquisition as a purchase of net assets and not as a business combination. On October 16, 2007, the Company acquired Esprit Pharma Holding Company, Inc. (Esprit) for an aggregate purchase price of approximately $370.8 million, net of cash acquired. On February 22, 2007, the Company acquired EndoArt SA (EndoArt) for an aggregate purchase price of approximately $97.1 million, net of cash acquired. On January 2, 2007, the Company acquired Groupe Cornéal Laboratoires (Cornéal) for an aggregate purchase price of approximately $209.2 million, net of cash acquired. On March 23, 2006, the Company acquired Inamed Corporation (Inamed) for approximately $3.3 billion, consisting of approximately $1.4 billion in cash and 34,883,386 shares of common stock with a fair value of approximately $1.9 billion. The Company accounted for the acquisitions of Esprit, EndoArt, Cornéal and Inamed as business combinations. The purchase prices for the acquisitions were allocated to tangible and intangible assets acquired and liabilities assumed based on their estimated fair values at the acquisition dates. The determination of estimated fair values requires significant estimates and assumptions, including but not limited to, determining the timing and estimated costs to complete the in-process projects, projecting regulatory approvals, estimating future cash flows, and developing appropriate discount rates. The Company believes the estimated fair values assigned to the assets acquired and liabilities assumed are based on reasonable assumptions.

Comprehensive Income (Loss)

Comprehensive income (loss) encompasses all changes in equity other than those with stockholders and consists of net earnings (losses), foreign currency translation adjustments, certain pension and other postretirement benefit plan adjustments, unrealized gains or losses on marketable equity investments and unrealized and realized gains or losses on derivative instruments, if applicable. The Company does not recognize U.S. income taxes on foreign currency translation adjustments since it does not provide for such taxes on undistributed earnings of foreign subsidiaries.

Reclassifications

Certain reclassifications of prior year amounts have been made to conform with the current year presentation.

Common Stock Split

On June 22, 2007, the Company completed a two-for-one stock split of its common stock. The stock split was structured in the form of a 100% stock dividend and was paid to stockholders of record on June 11, 2007.

All share and per share data (except par value) have been adjusted to reflect the effect of the stock split for all historical periods presented.

Recently Adopted Accounting Standards

In June 2007, the FASB ratified the consensus reached by the Emerging Issues Task Force (EITF) in EITF Issue No. 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities (EITF 07-3), which requires that nonrefundable advance payments for goods or services that will be used or rendered for future research and development (R&D) activities be deferred and amortized over the period that the goods are delivered or the related services are performed, subject to an assessment of recoverability. EITF 07-3 became effective for fiscal years beginning after December 15, 2007. The Company adopted the provisions of EITF 07-3 in the first fiscal quarter of 2008. The adoption did not have a material impact on the Company’s consolidated financial statements.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

In June 2007, the FASB ratified the consensus reached by the EITF in EITF Issue No. 06-11, Accounting for Income Tax Benefits of Dividends on Share-Based Payment Awards (EITF 06-11), which requires that the income tax benefits of dividends or dividend equivalents on unvested share-based payments be recognized as an increase in additional paid-in capital and reclassified from additional paid-in capital to the income statement when the related award is forfeited (or is no longer expected to vest). The reclassification is limited to the amount of the entity’s pool of excess tax benefits available to absorb tax deficiencies on the date of the reclassification. EITF 06-11 became effective for fiscal years beginning after December 15, 2007. The Company adopted the provisions of EITF 06-11 in the first fiscal quarter of 2008. The adoption did not have a material impact on the Company’s consolidated financial statements.

In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159, The Fair Value Option for Financial Assets and Financial Liabilities (SFAS No. 159), which allows an entity to voluntarily choose to measure certain financial assets and liabilities at fair value. SFAS No. 159 became effective for fiscal years beginning after November 15, 2007. The Company adopted the provisions of SFAS No. 159 in the first fiscal quarter of 2008. The adoption did not have a material impact on the Company’s consolidated financial statements.

In September 2006, the FASB issued Statement of Financial Accounting Standards No. 157, Fair Value Measurements (SFAS No. 157), which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. SFAS No. 157 became effective for fiscal years beginning after November 15, 2007. In February 2008, the FASB agreed to a one-year deferral of the effective date for nonfinancial assets and liabilities that are recognized or disclosed at fair values in the financial statements on a nonrecurring basis. The Company adopted the provisions of SFAS No. 157 in the first fiscal quarter of 2008. The adoption did not have a material impact on the Company’s consolidated financial statements. See Note 13, “Fair Value Measurements,” for information about assets and liabilities measured at fair value. The Company does not expect that the adoption of the provisions for other nonfinancial assets or liabilities will have a material impact on the Company’s consolidated financial statements.

In September 2006, the FASB issued Statement of Financial Accounting Standards No. 158, Employers’ Accounting for Defined Benefit Pension and Other Postretirement Plans (SFAS No. 158). The Company adopted the balance sheet recognition and reporting provisions of SFAS No. 158 during the fourth fiscal quarter of 2006. In the first fiscal quarter of 2008, the Company adopted the measurement date provision of SFAS No. 158, which requires the Company to change its measurement date for pension and other postretirement plans from September 30 to December 31. As a result, the Company recognized an increase of $5.2 million in its net pension liability, an increase of $1.6 million in related deferred income tax assets, a reduction of $4.6 million in its beginning retained earnings and an increase of $1.0 million in accumulated other comprehensive income.

New Accounting Standards Not Yet Adopted

In December 2008, the FASB issued Staff Position No. FAS 132(R)-1, Employers’ Disclosures about Postretirement Benefit Plan Assets (FSP FAS 132(R)-1), which amends FASB Statement No. 132 (revised 2003), Employers’ Disclosures about Pensions and Other Postretirement Benefits , and provides guidance on an employer’s disclosures about plan assets of a defined benefit pension or other postretirement plan. FSP FAS132(R)-1 requests an employer to disclose information about how investment allocation decision are made, to disclose separately for pension plans and other postretirement benefit plans the fair value of each major category of plan assets based on the nature and risks of assets as of each annual reporting date for which a statement of financial position is presented and information that enables users of financial statements to assess the inputs and valuation techniques used to develop fair value measurements of plan assets at the annual

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

reporting date. The disclosures about plan assets are to be provided for fiscal years ending after December 15, 2009, which will be the Company’s fiscal year 2009. Upon initial adoption, the provisions are not required for earlier periods that are presented for comparative purposes. The Company does not expect that the adoption of FSP FAS 132(R)-1 will have a material impact on the Company’s consolidated financial statements.

In November 2008, the FASB ratified the consensus reached by the EITF in EITF Issue No. 08-7, Accounting for Defensive Intangible Assets (EITF 08-7), which clarifies how to account for acquired intangible assets subsequent to initial measurement in situations in which an entity does not intend to actively use the assets but intends to hold the asset to prevent others from obtaining access to the asset (a defensive intangible asset), except for intangible assets that are used in research and development activities. EITF 08-7 requires that a defensive intangible asset to be accounted for as a separate unit of accounting and assigned a useful life that reflects the entity’s consumption of the expected benefits related to that asset. EITF 08-7 will be effective for intangible assets acquired on or after December 15, 2008, which will be the Company’s fiscal year 2009. The Company does not expect that the adoption of EITF 08-7 will have a material impact on the Company’s consolidated financial statements.

In May 2008, the FASB issued Staff Position No. APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (FSP APB 14-1), which clarifies the accounting for convertible debt instruments that may be settled fully or partially in cash upon conversion. FSP APB 14-1 requires entities to separately measure and account for the liability and equity components of qualifying convertible debt and amortize the value of the equity component to interest cost over the estimated life of the convertible debt instrument. By amortizing the value of the equity component, an entity will effectively recognize interest cost at its non-convertible debt borrowing rate. FSP APB 14-1 also requires re-measurement of the liability and equity components upon extinguishment of a convertible debt instrument, which may result in a gain or loss recognized in the financial statements for the extinguishment of the liability component. FSP APB 14-1 requires retrospective application for all instruments that were outstanding during any periods presented. FSP APB 14-1 is effective for fiscal years beginning after December 15, 2008, which will be the Company’s fiscal year 2009. The Company has determined that the adoption of FSP APB 14-1 will affect the accounting for its 1.50% Convertible Senior Notes due 2026 and estimates that upon adoption it will need to retrospectively increase its pre-tax interest expense by $25.1 million and $23.3 million for 2008 and 2007, respectively.

In April 2008, the FASB issued Staff Position No. FAS 142-3, Determination of the Useful Life of Intangible Assets (FSP FAS 142-3), which amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under FASB Statement No. 142, Goodwill and Other Intangible Assets . FSP FAS 142-3 allows an entity to use its own historical experience in renewing or extending similar arrangements, adjusted for specified entity-specific factors, in developing assumptions about renewal or extension used to determine the useful life of a recognized intangible asset and will be effective for fiscal years and interim periods beginning after December 15, 2008, which will be the Company’s fiscal year 2009. Additional disclosures are required to enable financial statement users to assess the extent to which the expected future cash flows associated with the asset are affected by the entity’s intent and/or ability to renew or extend the arrangement. The guidance for determining the useful life of a recognized intangible asset is to be applied prospectively to intangible assets acquired after the effective date. The disclosure requirements are to be applied prospectively to all intangible assets recognized as of, and subsequent to, the effective date. The Company does not expect that the adoption of FSP FAS 142-3 will have a material impact on the Company’s consolidated financial statements.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

In March 2008, the FASB issued Statement of Financial Accounting Standards No. 161, Disclosures about Derivative Instruments and Hedging Activities — an amendment of FASB Statement No. 133 (SFAS No. 161), which requires entities to disclose: (a) how and why an entity uses derivative instruments, (b) how derivative instruments and related hedged items are accounted for under Statement of Financial Accounting Standards No. 133 and its related interpretations, and (c) how derivative instruments and related hedged items affect an entity’s financial position, financial performance and cash flows. SFAS No. 161 will be effective for fiscal years and interim periods beginning after November 15, 2008, which will be the Company’s fiscal year 2009. The Company does not expect that the adoption of SFAS No. 161 will have a material impact on the Company’s consolidated financial statements.

In December 2007, the FASB issued Statement of Financial Accounting Standards No. 141 (revised), Business Combinations (SFAS No. 141R) and Statement of Financial Accounting Standards No. 160, Accounting and Reporting of Noncontrolling Interests in Consolidated Financial Statements, an amendment of ARB No. 51 (SFAS No. 160). These two standards will significantly change the financial accounting and reporting of business combination transactions and noncontrolling (or minority) interests in consolidated financial statements. SFAS No. 141R is required to be adopted concurrently with SFAS No. 160 and will be effective for business combination transactions occurring in fiscal years beginning after December 15, 2008, which will be the Company’s fiscal year 2009. The impact of adopting SFAS No. 141R on the Company’s consolidated financial statements will depend on the economic terms of any future business combination transactions and changes in estimated unrecognized tax benefit liabilities for pre-existing business combination transactions. The Company does not expect that the adoption of SFAS No. 160 will have a material impact on the Company’s consolidated financial statements.

In December 2007, the FASB ratified the consensus reached by the EITF in EITF Issue No. 07-1, Accounting for Collaborative Arrangements (EITF 07-1), which defines collaborative arrangements and requires that transactions with third parties that do not participate in the arrangement be reported in the appropriate income statement line items pursuant to the guidance in EITF 99-19, Reporting Revenue Gross as a Principal versus Net as an Agent . Income statement classification of payments made between participants of a collaborative arrangement are to be based on other applicable authoritative accounting literature. If the payments are not within the scope or analogy of other authoritative accounting literature, a reasonable, rational and consistent accounting policy is to be elected. EITF 07-1 will be effective for fiscal years beginning after December 15, 2008, which will be the Company’s fiscal year 2009, and applied as a change in accounting principle to all prior periods retrospectively for all collaborative arrangements existing as of the effective date. The Company does not expect that the adoption of EITF 07-1 will have a material impact on the Company’s consolidated financial statements.

Note 2:     Acquisitions

Aczone ® Asset Purchase

On July 11, 2008, the Company completed the acquisition of assets related to Aczone ® (dapsone) gel 5%, a topical treatment for acne vulgaris, from QLT USA, Inc. (QLT) for approximately $150.0 million. The acquisition was funded from cash and equivalents balances. The Company acquired QLT’s right, title and interest in and to the intellectual property, assigned contracts, registrations and inventories related to Aczone ® , which is approved for sale in both the United States and Canada for the treatment of certain dermatological conditions. The Company accounted for the acquisition as a purchase of net assets.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

The Company determined that the assets acquired consist of product rights for developed technology for Aczone ® of $145.6 million and inventories of $4.4 million. The useful life of the developed technology was determined to be approximately eight years. The Company believes the fair values assigned to the assets acquired were based on reasonable assumptions.

Esprit Acquisition

On October 16, 2007, the Company completed the acquisition of Esprit, a pharmaceutical company based in the United States with expertise in the genitourinary market, for an aggregate purchase price of approximately $370.8 million, net of cash acquired. The acquisition was funded from cash and equivalents balances. Prior to and in anticipation of the acquisition, the Company loaned Esprit $74.8 million in August 2007, the proceeds of which were used by Esprit to fund a milestone payment to a third party and to repay certain outstanding obligations to third-party lenders. The loan was secured by all of Esprit’s assets. The loan terms were at fair value. The loan and accrued interest of $0.9 million were effectively settled upon the acquisition with no resulting gain or loss. The Esprit acquisition provides the Company with a dedicated urologics product line within its specialty pharmaceuticals segment.

The following table summarizes the components of the Esprit purchase price:

 

     (in millions)

Cash consideration, net of cash acquired

   $ 288.6

Transaction costs

     6.5
      

Cash paid

     295.1

Settlement of a pre-existing loan from the Company to Esprit plus accrued interest

     75.7
      
   $ 370.8
      

Purchase Price Allocation

The Esprit purchase price was allocated to tangible and intangible assets acquired and liabilities assumed based on their estimated fair values at the acquisition date. The excess of the purchase price over the fair value of net assets acquired was allocated to goodwill. The goodwill acquired in the Esprit acquisition is not deductible for federal income tax purposes.

The Company believes the fair values assigned to the Esprit assets acquired and liabilities assumed were based on reasonable assumptions. The following table summarizes the estimated fair values of net assets acquired:

 

     (in millions)  

Current assets

   $ 40.8  

Identifiable intangible asset

     358.8  

Goodwill

     40.1  

Deferred tax assets — non-current

     85.6  

Other non-current assets

     0.1  

Accounts payable and accrued liabilities

     (24.5 )

Deferred tax liabilities — current and non-current

     (122.2 )

Other non-current liabilities

     (7.9 )
        
   $ 370.8  
        

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

In 2008, the Company adjusted the fair value assigned to the assets acquired and liabilities assumed primarily due to an increase in the expected utilization of net operating loss carryforwards of Esprit and a decrease in the amount of Esprit deferred tax liabilities attributable to state income taxes, which resulted in a net decrease of $82.5 million to goodwill from the amount reported at December 31, 2007.

EndoArt SA Acquisition

On February 22, 2007, the Company completed the acquisition of EndoArt, a provider of telemetrically-controlled (or remote-controlled) implants used in the treatment of morbid obesity and other conditions, for an aggregate purchase price of approximately $97.1 million, net of cash acquired. The acquisition consideration was all cash, funded from the Company’s cash and equivalents balances. In connection with the EndoArt acquisition, the Company acquired assets with a fair value of $98.5 million and assumed liabilities of $1.4 million.

In conjunction with the EndoArt acquisition, the Company recorded an in-process research and development expense of $72.0 million related to EndoArt’s EasyBand TM Remote Adjustable Gastric Banding System in the United States, which had not received approval by the U.S. Food and Drug Administration (FDA) as of the EndoArt acquisition date and had no alternative future use.

Cornéal Acquisition

On January 2, 2007, the Company completed the acquisition of Cornéal, a health care company that develops, manufactures and markets dermal fillers, viscoelastics and a range of ophthalmic surgical device products, for an aggregate purchase price of approximately $209.2 million, net of $2.3 million associated with the settlement of a pre-existing unfavorable distribution agreement. The Company recorded the $2.3 million charge at the acquisition date to effectively settle the pre-existing unfavorable distribution agreement between Cornéal and one of the Company’s subsidiaries, primarily related to distribution rights for Juvéderm ® in the United States. Prior to the acquisition, the Company also had a $4.4 million payable to Cornéal outstanding for products purchased under the distribution agreement, which was effectively settled upon the acquisition. In connection with the Cornéal acquisition, the Company acquired assets with a fair value of $284.8 million and assumed liabilities of $75.6 million. As a result of the acquisition, the Company obtained the technology, manufacturing process and worldwide distribution rights for Juvéderm ® , Surgiderm ® and certain other hyaluronic acid-based dermal fillers. The acquisition was funded from the Company’s cash and equivalents balances and its committed long-term credit facility.

Inamed Acquisition

On March 23, 2006, the Company completed the acquisition of Inamed, a global healthcare company that develops, manufactures and markets a diverse line of products, including breast implants, a range of facial aesthetics and obesity intervention products, for approximately $3.3 billion, consisting of approximately $1.4 billion in cash and 34,883,386 shares of the Company’s common stock with a fair value of approximately $1.9 billion. In connection with the acquisition, the Company acquired assets with a fair value of $3,813.4 million and assumed liabilities of $522.7 million.

In connection with the Inamed acquisition, the Company recorded a total charge to in-process research and development expense of $579.3 million in 2006 for acquired in-process research and development assets that the Company determined were not yet complete and had no alternative future uses in their current state. The acquired in-process research and development assets are composed of Inamed’s silicone breast implant technology for use in the United States, Inamed’s Juvéderm ® dermal filler technology for use in the United States, and Inamed’s

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

BIB ® Intragastric Balloon technology (currently known as the Orbera TM System) for use in the United States, which were valued at $405.8 million, $41.2 million and $132.3 million, respectively. All of these assets had not received approval by the FDA as of the Inamed acquisition date of March 23, 2006. Because the in-process research and development assets had no alternative future use, they were charged to expense on the Inamed acquisition date.

Pro Forma Results of Operations

The following unaudited pro forma operating results for the year ended December 31, 2007 assume the Esprit acquisition had occurred on January 1, 2007, and for the year ended December 31, 2006, assume the Esprit and Inamed acquisitions had occurred on January 1, 2006, and exclude any pro forma charges for in-process research and development, inventory fair value adjustments, share-based compensation expense and transaction costs.

 

         2007            2006    
     (in millions, except per share amounts)

Product net sales

   $ 3,911.9    $ 3,147.1

Total revenues

   $ 3,971.8    $ 3,200.3

Earnings from continuing operations

   $ 461.5    $ 411.3

Earnings per share from continuing operations — basic

   $ 1.51    $ 1.36

Earnings per share from continuing operations — diluted

   $ 1.49    $ 1.34

The pro forma information is not necessarily indicative of the actual results that would have been achieved had the Esprit and Inamed acquisitions occurred on the indicated dates, or the results that may be achieved in the future.

The Company does not consider the acquisitions of EndoArt or Cornéal to be material business combinations, either individually or in the aggregate. Accordingly, the supplemental pro forma operating results presented above do not include any adjustments related to these two acquisitions.

Note 3:    Discontinued Operations

On July 2, 2007, the Company completed the sale of the ophthalmic surgical device business that it acquired as a part of the Cornéal acquisition in January 2007, for net cash proceeds of $28.6 million. The net assets of the disposed business consisted of current assets of $24.3 million, non-current assets of $9.8 million and current liabilities of $4.2 million. The Company recorded a pre-tax loss of $1.3 million ($1.0 million net of tax) associated with the sale.

The following amounts related to the ophthalmic surgical device business have been segregated from continuing operations and reported as discontinued operations through the date of disposition. The Company did not account for its ophthalmic surgical device business as a separate legal entity. Therefore, the following selected financial data for the Company’s discontinued operations is presented for informational purposes only and does not necessarily reflect what the net sales or earnings would have been had the business operated as a stand-alone entity. The financial information for the Company’s discontinued operations includes allocations of certain expenses to the ophthalmic surgical device business. These amounts have been allocated to the Company’s discontinued operations on the basis that is considered by management to reflect most fairly or reasonably the utilization of the services provided to, or the benefit obtained by, the ophthalmic surgical device business.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

The following table sets forth selected financial data of the Company’s discontinued operations for 2007.

Selected Financial Data for Discontinued Operations

 

     (in millions)  

Product net sales

   $ 20.0  

Loss from discontinued operations before income taxes

   $ (1.1 )

Loss from discontinued operations

   $ (0.7 )

Note 4:    Restructuring Charges, Integration Costs and Transition and Duplicate Operating Expenses

Restructuring and Phased Closure of Arklow Facility

On January 30, 2008, the Company announced the phased closure of its breast implant manufacturing facility at Arklow, Ireland and the transfer of production to the Company’s manufacturing plant in Costa Rica. The Arklow facility was acquired by the Company in connection with its acquisition of Inamed in 2006 and employs approximately 360 people. Production at the facility is expected to be phased out by the second quarter of 2009. Based on current foreign currency exchange rates, the Company estimates that the total pre-tax restructuring and other transition related costs associated with the closure of the Arklow manufacturing facility will be between $60 million and $68 million, consisting primarily of employee severance and other one-time termination benefits of $31 million to $34 million, asset impairments and accelerated depreciation of $15 million to $17 million, and contract termination and other costs of $14 million to $17 million. The Company expects that $45 million to $51 million of the pre-tax charges will be cash expenditures. Certain employee retention termination benefits and accelerated depreciation costs related to inventory production in Arklow will be capitalized to inventory as incurred and recognized as cost of sales in the periods the related products are sold.

The Company began to record costs associated with the closure of the Arklow manufacturing facility in the first quarter of 2008 and expects to continue to recognize costs through the fourth quarter of 2009. The Company currently expects to substantially complete the phased closure of the Arklow facility by the second quarter of 2009. The restructuring charges primarily consist of employee severance, one-time termination benefits, contract termination costs and other costs related to the closure of the Arklow manufacturing facility. During 2008, the Company recorded pre-tax restructuring charges of $27.2 million. During 2008, the Company also recognized $8.8 million of cost of sales for the rollout of capitalized employee retention termination benefits and accelerated depreciation costs related to inventory production, $0.9 million of selling, general and administrative (SG&A) expenses and $0.3 million of R&D expenses related to one-time termination benefits and asset impairments.

At December 31, 2008, $9.5 million of capitalized employee retention termination benefits and accelerated depreciation costs are included in “Inventories” in the accompanying consolidated balance sheet.

The following table presents the restructuring activities related to the phased closure of the Arklow facility during the year ended December 31, 2008:

 

     Employee
Severance
    Contract
Termination
Costs
    Other     Total  
     (in millions)  

Net charge during 2008

   $ 20.5     $ 5.6     $ 1.1     $ 27.2  

Spending

     (7.2 )     (0.5 )     (1.0 )     (8.7 )

Foreign exchange translation effects

     (1.8 )     (0.6 )           (2.4 )
                                

Balance at December 31, 2008 (included in “Other accrued expenses”)

   $ 11.5     $ 4.5     $ 0.1     $ 16.1  
                                

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Restructuring and Integration of Cornéal Operations

In connection with the January 2007 Cornéal acquisition, the Company initiated a restructuring and integration plan to merge the Cornéal facial aesthetics business operations with the Company’s operations. Specifically, the restructuring and integration activities involve a workforce reduction of approximately 20 positions, principally general and administrative positions, moving key Cornéal facial aesthetics business functions to Company locations, integrating Cornéal’s distributor operations with the Company’s existing distribution network and integrating Cornéal’s information systems with the Company’s information systems.

The Company began to record costs associated with the restructuring and integration of the former Cornéal facial aesthetics business in the first quarter of 2007 and substantially completed all restructuring and integration activities in the second quarter of 2008. As of December 31, 2008, the Company has recorded cumulative pre-tax restructuring charges of $23.2 million and cumulative pre-tax integration and transition costs of $10.0 million. The restructuring charges primarily consist of employee severance, one-time termination benefits, employee relocation, termination of duplicative distributor agreements and other costs related to the restructuring of the Cornéal operations. During 2008 and 2007, the Company recorded pre-tax restructuring charges of $6.6 million and $16.6 million, respectively. The integration and transition costs primarily consist of salaries, travel, communications, recruitment and consulting costs. During 2008, the Company recorded pre-tax integration and transition costs of $1.5 million, consisting of $0.1 million in cost of sales and $1.4 million in SG&A expenses. During 2007, the Company recorded pre-tax integration and transition costs of $8.5 million, consisting of $0.1 million in cost of sales and $8.4 million in SG&A expenses.

The following table presents the cumulative restructuring activities related to the Cornéal operations through December 31, 2008:

 

    Employee
Severance
    Contract
Termination
Costs
    Total  
    (in millions)  

Net charge during 2007

  $ 3.8     $ 12.8     $ 16.6  

Spending

    (1.0 )     (4.9 )     (5.9 )
                       

Balance at December 31, 2007

    2.8       7.9       10.7  

Net charge during 2008

    0.4       6.2       6.6  

Spending

    (2.4 )     (13.5 )     (15.9 )
                       

Balance at December 31, 2008 (included in “Other accrued expenses”)

  $ 0.8     $ 0.6     $ 1.4  
                       

Restructuring and Integration of Inamed Operations

In connection with the Company’s March 2006 acquisition of Inamed, the Company initiated a global restructuring and integration plan to merge Inamed’s operations with the Company’s operations and to capture synergies through the centralization of certain general and administrative and commercial functions. Specifically, the restructuring and integration activities involved a workforce reduction of approximately 60 positions, principally general and administrative positions, moving key commercial Inamed business functions to the Company’s locations around the world, integrating Inamed’s distributor operations with the Company’s existing distribution network and integrating Inamed’s information systems with the Company’s information systems.

As of December 31, 2007, the Company substantially completed all activities related to the restructuring and operational integration of the former Inamed operations and recorded cumulative pre-tax restructuring charges of $21.0 million, cumulative pre-tax integration and transition costs of $26.0 million, and $1.6 million

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

for income tax costs related to intercompany transfers of trade businesses and net assets related to the global restructuring and integration plan to merge Inamed’s operations with the Company’s operations. The restructuring charges primarily consisted of employee severance, one-time termination benefits, employee relocation, termination of duplicative distributor agreements and other costs related to restructuring the former Inamed operations. The integration and transition costs primarily consisted of salaries, travel, communications, recruitment and consulting costs. The Company did not incur any restructuring charges or integration and transition costs during 2008. During 2007 and 2006, the Company recorded pre-tax restructuring charges of $7.5 million and $13.5 million, respectively. During 2007, the Company recorded $5.3 million of pre-tax integration and transition costs associated with the global restructuring and integration of the former Inamed operations, consisting of $0.1 million in cost of sales and $5.2 million in SG&A expenses. During 2006, the Company recorded $20.7 million of pre-tax integration and transition costs, consisting of $0.9 million in cost of sales, $19.6 million in SG&A expenses and $0.2 million in R&D expenses. During 2006, the Company also recorded $1.6 million for income tax costs related to intercompany transfers of trade businesses and net assets, which the Company included in its provision for income taxes.

On January 30, 2007, the Company’s Board of Directors approved a plan to restructure and eventually sell or close the collagen manufacturing facility in Fremont, California that the Company acquired in the Inamed acquisition based on the anticipated reduction in market demand for human and bovine collagen products as a result of the introduction of its hyaluronic acid dermal filler products. Specifically, the plan involved a workforce reduction of approximately 59 positions, consisting principally of manufacturing positions at the facility, and lease termination and contract settlements. The Company began to record costs associated with the closure of the collagen manufacturing facility in the first quarter of 2007 and substantially completed all restructuring activities and closed the collagen manufacturing facility in the fourth quarter of 2008. Prior to the closure of the collagen manufacturing facility, the Company manufactured a sufficient quantity of collagen products to meet estimated market demand through 2010.

As of December 31, 2008, the Company recorded cumulative pre-tax restructuring charges of $5.1 million related to the restructuring of the collagen manufacturing facility. During 2008 and 2007, the Company recorded pre-tax restructuring charges of $3.4 million and $1.7 million, respectively.

The following table presents the cumulative restructuring activities related to the restructuring of the collagen manufacturing facility through December 31, 2008:

 

     Employee
Severance
    Contract
and Lease

Termination
Costs
     Total  
     (in millions)  

Net charge during 2007

   $ 1.7            $ 1.7  

Spending

                   
                         

Balance at December 31, 2007

     1.7              1.7  

Net charge during 2008

     0.4       3.0        3.4  

Reclassification of lease liability(a)

           1.3        1.3  

Spending

     (0.8 )     (0.5 )      (1.3 )
                         

Balance at December 31, 2008 (included in “Other accrued expenses” and “Other liabilities”)

   $ 1.3     $ 3.8      $ 5.1  
                         
 
  (a) Represents the reclassification of a purchase accounting liability recorded for an unfavorable lease contract for the collagen manufacturing facility in Fremont, California to an accrued liability for lease abandonment for the same facility.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Restructuring and Streamlining of European Operations

Effective January 2005, the Company’s Board of Directors approved the initiation and implementation of a restructuring of certain activities related to the Company’s European operations to optimize operations, improve resource allocation and create a scalable, lower cost and more efficient operating model for the Company’s European R&D and commercial activities. Specifically, the restructuring involved moving key European R&D and select commercial functions from the Company’s Mougins, France and other European locations to the Company’s Irvine, California, Marlow, United Kingdom and Dublin, Ireland facilities and streamlining functions in the Company’s European management services group. The workforce reduction began in the first quarter of 2005 and was substantially completed by the close of the second quarter of 2006.

As of December 31, 2006, the Company substantially completed all activities related to the restructuring and streamlining of its European operations and recorded cumulative pre-tax restructuring charges of $37.5 million and cumulative transition and duplicate operating expenses of $11.8 million. The restructuring charges primarily consisted of severance, relocation and one-time termination benefits, payments to public employment and training programs, contract termination costs and capital and other asset-related expenses. The transition and duplicate operating expenses primarily consisted of legal, consulting, recruiting, information system implementation costs and taxes. During 2008 and 2007, the Company recorded pre-tax restructuring charges of $4.0 million and $1.0 million, respectively, for adjustments to its estimated liability for an abandoned leased facility related to its European operations. During 2006, the Company recorded pre-tax restructuring charges of $8.6 million. The Company did not incur any transition and duplicate operating expenses related to the restructuring and streamlining of the Company’s European operations during 2008 and 2007. During 2006, the Company recorded $6.2 million of transition and duplicate operating expenses, including a $3.4 million loss related to the sale of its Mougins, France facility, consisting of $5.7 million in SG&A expenses and $0.5 million in R&D expenses. As of December 31, 2008, remaining accrued expenses of $4.8 million for restructuring charges related to the abandoned leased facility of the Company’s European operations are included in “Other liabilities.”

Other Restructuring Activities and Integration Costs

Included in 2008 is $0.1 million of restructuring charges related to the EndoArt acquisition. Included in 2006 is $0.6 million of restructuring charges related to the scheduled June 2005 termination of the Company’s manufacturing and supply agreement with Advanced Medical Optics, which the Company spun-off in June 2002. Also included in 2006 is a $0.4 million restructuring charge reversal related to the streamlining of the Company’s operations in Japan.

In 2008, SG&A expenses include $0.7 million of expenses related to the integration of the Esprit operations. In 2007, SG&A expenses include $0.9 million of expenses related to the integration of the Esprit and EndoArt operations.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Note 5:     Composition of Certain Financial Statement Captions

 

     December 31,
     2008    2007
     (in millions)

Trade receivables, net

     

Trade receivables

   $ 587.6    $ 506.1

Less allowance for sales returns — medical device products

     17.8      18.7

Less allowance for rebates — medical device products

          2.9

Less allowance for doubtful accounts

     31.4      21.4
             
   $ 538.4    $ 463.1
             

Inventories

     

Finished products

   $ 174.9    $ 137.4

Work in process

     36.8      46.0

Raw materials

     50.8      41.3
             
   $ 262.5    $ 224.7
             

Other current assets

     

Prepaid expenses

   $ 80.2    $ 79.1

Deferred taxes

     238.2      158.7

Other

     40.9      40.7
             
   $ 359.3    $ 278.5
             

Investments and other assets

     

Deferred executive compensation investments

   $ 48.4    $ 61.6

Capitalized software

     85.8      54.3

Prepaid pensions

     0.9      35.8

Prepaid royalties

     20.0      20.0

Interest rate swap fair value

     61.9      17.1

Debt issuance costs

     11.7      15.1

Equity investments

     5.9      8.0

Other

     38.3      38.0
             
   $ 272.9    $ 249.9
             

Property, plant and equipment, net

     

Land

   $ 51.8    $ 37.9

Buildings

     693.5      614.2

Machinery and equipment

     529.9      456.8
             
     1,275.2      1,108.9

Less accumulated depreciation

     501.1      422.5
             
   $ 774.1    $ 686.4
             

Other accrued expenses

     

Sales rebates and other incentive programs

   $ 100.9    $ 79.1

Restructuring charges

     18.9      11.7

Royalties

     52.1      48.6

Accrued interest

     13.6      20.9

Sales returns — specialty pharmaceutical products

     7.5      11.1

Product warranties — breast implant products

     6.3      6.5

Other

     137.4      117.8
             
   $ 336.7    $ 295.7
             

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

     December 31,  
     2008     2007  
     (in millions)  

Other liabilities

    

Postretirement benefit plan

   $ 39.0     $ 35.0  

Qualified and non-qualified pension plans

     156.2       54.9  

Deferred executive compensation

     51.6       59.2  

Deferred income

     80.8       83.3  

Product warranties — breast implant products

     23.2       21.5  

Unrecognized tax benefit liabilities

     22.4       36.0  

Other

     29.6       22.8  
                
   $ 402.8     $ 312.7  
                

Accumulated other comprehensive loss

    

Foreign currency translation adjustments

   $ (15.9 )   $ 23.2  

Deferred holding gains on derivative instruments, net of taxes of $3.8 million and $4.3 million for 2008 and 2007, respectively

     5.7       6.5  

Actuarial losses not yet recognized as a component of pension and postretirement benefit plan costs, net of taxes of $98.1 million and $36.4 million for 2008 and 2007, respectively

     (187.1 )     (66.2 )

Unrealized (loss) gain on investments, net of applicable income tax benefit (expense) of $1.5 million and $(1.2) million for 2008 and 2007, respectively

     (1.4 )     1.7  
                
   $ (198.7 )   $ (34.8 )
                

At December 31, 2008 and 2007, approximately $11.2 million and $13.3 million, respectively, of the Company’s finished goods medical device inventories, primarily breast implants, were held on consignment at a large number of doctors’ offices, clinics and hospitals worldwide. The value and quantity at any one location are not significant.

Note 6:    Intangibles and Goodwill

At December 31, 2008 and 2007, the components of amortizable and unamortizable intangibles and goodwill and certain other related information were as follows:

Intangibles

 

    December 31, 2008   December 31, 2007
    Gross
Amount
  Accumulated
Amortization
    Weighted
Average
Amortization
Period
  Gross
Amount
  Accumulated
Amortization
    Weighted
Average
Amortization
Period
    (in millions)     (in years)   (in millions)     (in years)

Amortizable Intangible Assets:

           

Developed technology

  $ 1,390.8   $ (215.0 )   14.3   $ 1,247.8   $ (111.8 )   15.1

Customer relationships

    42.3     (37.8 )   3.1     42.3     (24.1 )   3.1

Licensing

    223.5     (78.9 )   10.0     159.6     (63.2 )   8.2

Trademarks

    27.3     (14.9 )   6.3     28.2     (10.9 )   6.4

Core technology

    190.4     (36.5 )   15.2     191.9     (24.0 )   15.2
                               
    1,874.3     (383.1 )   13.5     1,669.8     (234.0 )   14.0

Unamortizable Intangible Assets:

           

Business licenses

    0.7             0.9        
                               
  $ 1,875.0   $ (383.1 )     $ 1,670.7   $ (234.0 )  
                               

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Developed technology consists primarily of current product offerings, primarily saline and silicone gel breast implants, obesity intervention products, dermal fillers, skin care and urologics products acquired in connection with business combinations and asset acquisitions. Customer relationship assets consist of the estimated value of relationships with customers acquired in connection with the Inamed acquisition, primarily in the breast implant market in the United States. Licensing assets consist primarily of capitalized payments to third party licensors related to the achievement of regulatory approvals to commercialize products in specified markets and up-front payments associated with royalty obligations for products that have achieved regulatory approval for marketing. Core technology consists of proprietary technology associated with silicone gel breast implants and intragastric balloon systems acquired in connection with the Inamed acquisition, dermal filler technology acquired in connection with the Cornéal acquisition, gastric band technology acquired in connection with the EndoArt acquisition, and a drug delivery technology acquired in connection with the Company’s 2003 acquisition of Oculex Pharmaceuticals, Inc.

The increase in developed technology at December 31, 2008 compared to December 31, 2007 is primarily due to the Aczone ® asset acquisition. The increase in licensing assets is primarily due to a buyout payment of contingent licensing obligations related to Sanctura ® products and milestone payments recorded in 2008 related to expected annual Restasis ® net sales and the approval of Latisse TM in the United States.

The following table provides amortization expense by major categories of acquired amortizable intangible assets for the years ended December 31, 2008, 2007 and 2006, respectively:

 

     2008    2007    2006
     (in millions)

Developed technology

   $ 98.7    $ 71.5    $ 39.9

Customer relationships

     13.6      13.6      10.3

Licensing

     20.9      19.0      18.6

Trademarks

     4.8      4.8      3.4

Core technology

     12.9      12.4      7.4
                    
   $ 150.9    $ 121.3    $ 79.6
                    

Amortization expense related to acquired intangible assets generally benefits multiple business functions within the Company, such as the Company’s ability to sell, manufacture, research, market and distribute products, compounds and intellectual property. The amount of amortization expense excluded from cost of sales consists primarily of amounts amortized with respect to developed technology and licensing intangible assets.

Estimated amortization expense is $145.7 million for 2009, $141.7 million for 2010, $138.1 million for 2011, $132.9 million for 2012 and $119.8 million for 2013.

Goodwill

 

     December 31,
     2008    2007
     (in millions)

Specialty Pharmaceuticals

   $ 49.2    $ 132.8

Medical Devices

     1,932.6      1,949.3
             
   $ 1,981.8    $ 2,082.1
             

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

The decrease in Specialty Pharmaceuticals goodwill at December 31, 2008 compared to December 31, 2007 is primarily due to adjustments recorded in 2008 to the estimated fair values of net assets acquired related to the Esprit acquisition.

Note 7:    Notes Payable and Long-Term Debt

 

    2008
Average
Effective
Interest
Rate
    December 31,
2008
  2007
Average
Effective
Interest
Rate
    December 31,
2007
          (in millions)         (in millions)

Bank loans

  3.14 %   $ 4.4   4.37 %   $ 5.1

Medium term notes; 6.91% - 7.47%; maturing 2008 – 2012

  7.47 %     25.0   7.15 %     59.6

Senior notes due 2016

  5.79 %     798.4   5.79 %     798.1

Interest rate swap fair value adjustment

      61.9       17.1
               
      889.7       879.9

Less current maturities

      4.4       39.7
               

Total long-term debt

    $ 885.3     $ 840.2
               

At December 31, 2008, the Company had a committed long-term credit facility, a commercial paper program, a medium-term note program and various foreign bank facilities. In May 2007, the Company amended the termination date of its committed long-term credit facility to May 2012. The termination date can be further extended from time to time upon the Company’s request and acceptance by the issuer of the facility for a period of one year from the last scheduled termination date for each request accepted. The committed long-term credit facility allows for borrowings of up to $800 million. The commercial paper program also provides for up to $600 million in borrowings. Borrowings under the committed long-term credit facility and medium-term note program are subject to certain financial and operating covenants that include, among other provisions, maximum leverage ratios. Certain covenants also limit subsidiary debt. The Company was in compliance with these covenants at December 31, 2008. As of December 31, 2008, the Company had no borrowings under its committed long-term credit facility, $25.0 million in borrowings outstanding under the medium-term note program, $4.4 million in borrowings outstanding under various foreign bank facilities and no borrowings under the commercial paper program. Commercial paper, when outstanding, is issued at current short-term interest rates. Additionally, any future borrowings that are outstanding under the long-term credit facility will be subject to a floating interest rate.

On April 12, 2006, the Company completed concurrent private placements of $800 million in aggregate principal amount of 5.75% Senior Notes due 2016 (2016 Notes) and $750 million in aggregate principal amount of 1.50% Convertible Senior Notes due 2026 (2026 Convertible Notes). The 2016 Notes were sold in a private placement to qualified institutional buyers and non-U.S. persons pursuant to Rule 144A and Regulation S under the Securities Act of 1933, and the 2026 Convertible Notes were sold in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933. (See Note 8, “Convertible Notes,” for a description of the 2026 Convertible Notes.)

The 2016 Notes, which were sold at 99.717% of par value with an effective interest rate of 5.79%, are unsecured and pay interest semi-annually at a rate of 5.75% per annum, and are redeemable at any time at the Company’s option, subject to a make-whole provision based on the present value of remaining interest payments

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

at the time of the redemption. The aggregate outstanding principal amount of the 2016 Notes will be due and payable on April 1, 2016, unless earlier redeemed by the Company. The original discount of approximately $2.3 million and the deferred debt issuance costs associated with the 2016 Notes are being amortized using the effective interest method over the stated term of 10 years.

On January 31, 2007, the Company entered into a nine-year, two-month interest rate swap with a $300.0 million notional amount with semi-annual settlements and quarterly interest rate reset dates. The swap receives interest at a fixed rate of 5.75% and pays interest at a variable interest rate equal to 3-month LIBOR plus 0.368%, and effectively converts $300.0 million of the 2016 Notes to a variable interest rate. Based on the structure of the hedging relationship, the hedge meets the criteria for using the short-cut method for a fair value hedge under the provisions of Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities (SFAS No. 133). Under the provisions of SFAS No. 133, the investment in the derivative and the related long-term debt are recorded at fair value. At December 31, 2008 and 2007, the Company recognized in its consolidated balance sheets an asset reported in “Investments and other assets” and a corresponding increase in “Long-term debt” associated with the fair value of the derivative of $61.9 million and $17.1 million, respectively. The differential to be paid or received as interest rates change is accrued and recognized as an adjustment of interest expense related to the 2016 Notes. During 2008 and 2007, the Company recognized $7.9 million and $0.3 million, respectively, as a reduction of interest expense due to the differential to be received.

In February 2006, the Company entered into interest rate swap contracts based on 3-month LIBOR with an aggregate notional amount of $800 million, a swap period of 10 years and a starting swap rate of 5.198%. The Company entered into these swap contracts as a cash flow hedge to effectively fix the future interest rate for the 2016 Notes. In April 2006, the Company terminated the interest rate swap contracts and received approximately $13.0 million. The total gain was recorded to accumulated other comprehensive loss and is being amortized as a reduction to interest expense over a 10 year period to match the term of the 2016 Notes. As of December 31, 2008, the remaining unrecognized gain, net of tax, of $5.7 million is recorded as a component of accumulated other comprehensive loss.

The aggregate maturities of total long-term debt, excluding the interest rate swap fair value adjustment of $61.9 million, for each of the next five years and thereafter are as follows: $4.4 million in 2009; zero in 2010 and 2011; $25.0 million in 2012, zero in 2013 and $798.4 million thereafter. Interest incurred of $1.4 million in 2008, $1.3 million in 2007 and $0.4 million in 2006 has been capitalized and included in property, plant and equipment.

Note 8:    Convertible Notes

The 2026 Convertible Notes are unsecured and pay interest semi-annually at a rate of 1.50% per annum. The 2026 Convertible Notes will be convertible into cash and, if applicable, shares of the Company’s common stock based on an initial conversion rate of 15.7904 shares of the Company’s common stock per $1,000 principal amount of the 2026 Convertible Notes, subject to adjustment, only under the following circumstances: (i) during any fiscal quarter beginning after June 30, 2006 (and only during such fiscal quarter), if the closing price of the Company’s common stock for at least 20 trading days in the 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter is more than 120% of the applicable conversion price per share, which is $1,000 divided by the then applicable conversion rate; (ii) the Company calls the 2026 Convertible Notes for redemption; (iii) if specified distributions to holders of the Company’s common stock are made, or specified corporate transactions occur; or (iv) at any time on or after February 1, 2026 through the business day immediately preceding the maturity date. Upon conversion, a holder will receive an amount in cash

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

equal to the lesser of (i) the principal amount of the 2026 Convertible Note or (ii) the conversion value, determined in the manner set forth in the 2026 Convertible Note Indenture. If the conversion value of the 2026 Convertible Notes exceeds their principal amount at the time of conversion, the Company will also deliver at its election, cash or the Company’s common stock or a combination of cash and the Company’s common stock for the conversion value in excess of the principal amount. As of December 31, 2008, the conversion criteria had not been met. The Company will not be permitted to redeem the 2026 Convertible Notes prior to April 5, 2009, will be permitted to redeem the 2026 Convertible Notes from and after April 5, 2009 to April 4, 2011 if the closing price of its common stock reaches a specified threshold, and will be permitted to redeem the 2026 Convertible Notes at any time on or after April 5, 2011. Holders of the 2026 Convertible Notes will also be able to require the Company to redeem the 2026 Convertible Notes on April 1, 2011, April 1, 2016 and April 1, 2021 or upon a change in control of the Company. The 2026 Convertible Notes mature on April 1, 2026, unless previously redeemed by the Company or earlier converted by the note holders. The Company amortizes the deferred debt issuance costs associated with the 2026 Convertible Notes over the five year period from date of issuance in April 2006 to the first noteholder put date in April 2011.

Note 9:    Income Taxes

The components of earnings (loss) from continuing operations before income taxes and minority interest were:

 

     Year Ended December 31,  
     2008    2007    2006  
     (in millions)  

U.S.

   $ 371.2    $ 388.2    $ (232.4 )

Non-U.S.

     416.0      299.5      212.9  
                      

Total

   $ 787.2    $ 687.7    $ (19.5 )
                      

The provision for income taxes consists of the following:

 

     Year Ended December 31,  
     2008     2007     2006  
     (in millions)  

Current

  

U.S. federal

   $ 207.6     $ 186.0     $ 115.2  

U.S. state

     46.5       29.8       15.3  

Non-U.S.

     44.4       52.6       30.2  
                        

Total current

     298.5       268.4       160.7  
                        

Deferred

      

U.S. federal

     (78.4 )     (92.1 )     (34.0 )

U.S. state

     (1.9 )     9.5       (13.3 )

Non-U.S.

     (11.2 )     0.4       (5.9 )
                        

Total deferred

     (91.5 )     (82.2 )     (53.2 )
                        

Total

   $ 207.0     $ 186.2     $ 107.5  
                        

The current provision for income taxes does not reflect the tax benefit of $11.1 million, $36.0 million and $41.6 million for the years ended December 31, 2008, 2007 and 2006, respectively, related to the exercise of employee stock options recorded directly to “Additional paid-in capital” in the consolidated balance sheets.

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

The reconciliations of the U.S. federal statutory tax rate to the combined effective tax rate follow:

 

     2008     2007     2006  

Statutory rate of tax expense (benefit)

   35.0 %   35.0 %   (35.0 )%

State taxes, net of U.S. tax benefit

   4.3     4.0     44.8  

Tax differential on foreign earnings

   (14.0 )   (18.0 )   (238.9 )

U.S. tax effect of foreign earnings and dividends, net of foreign tax credits

   1.5     0.4     11.9  

Other credits (R&D)

   (3.6 )   (3.7 )   (118.9 )

In-process research and development

       10.4     1,039.8  

Intangible write-offs

           (0.6 )

Tax audit settlements/adjustments

   2.1     (0.6 )   (12.9 )

Change in valuation allowance

       (0.6 )   (130.2 )

Other

   1.0     0.2     (8.7 )
                  

Effective tax rate

   26.3 %   27.1 %   551.3 %
                  

Withholding and U.S. taxes have not been provided on approximately $1,630.9 million of unremitted earnings of certain non-U.S. subsidiaries because the Company has currently reinvested these earnings indefinitely in such operations, or the U.S. taxes on such earnings will be offset by appropriate credits for foreign income taxes paid. Such earnings would become taxable upon the sale or liquidation of these non-U.S. subsidiaries or upon the remittance of dividends. It is not practicable to estimate the amount of the deferred tax liability on such unremitted earnings. Upon remittance, certain foreign countries impose withholding taxes that are then available, subject to certain limitations, for use as credits against the Company’s U.S. tax liability, if any.

In connection with the American Jobs Creation Act of 2004 (the Act), the Company repatriated $674.0 million in extraordinary dividends, as defined by the Act, in the year ended December 31, 2005 from unremitted foreign earnings that were previously considered indefinitely reinvested by certain non-U.S. subsidiaries and recorded a corresponding tax liability of $29.9 million. The $674.0 million amount of extraordinary dividends is the qualified amount above a $53.4 million base amount determined based on the Company’s historical repatriation levels, as defined by the Act. In 2005 the Company also repatriated approximately $85.8 million in additional dividends above the base and extraordinary dividend amounts from prior and current years’ unremitted foreign earnings that were previously considered indefinitely reinvested and recorded a corresponding tax liability of $19.7 million. During 2006, the Company recorded a $2.8 million reduction in income taxes payable previously estimated for the 2005 repatriation of foreign earnings.

The Company and its domestic subsidiaries file a consolidated U.S. federal income tax return. During the first quarter of 2008, the Company completed the federal income tax audit by the U.S. Internal Revenue Service for tax years 2003 and 2004. As a result of the audit, the Company paid a total settlement amount of $21.8 million, of which $14.0 million was paid in 2007 as an advance payment and the remaining $7.8 million was paid during the first quarter of 2008. The Company and its consolidated subsidiaries are currently under examination by the U.S. Internal Revenue Service for tax years 2005 and 2006. The Company believes the additional tax liability, if any, for such years, will not have a material effect on the financial position of the Company. In April 2008, the Company formally withdrew from the U.S. Internal Revenue Service’s Compliance Assurance Program for tax year 2007. The Company’s acquired subsidiary, Inamed, is currently under examination by the U.S. Internal Revenue Service for the pre-acquisition years 2003 through 2006. Up through and until the end of the Company’s 2008 fiscal year, any estimated additional tax liability for such pre-acquisition years was treated as an adjustment to the Inamed purchased goodwill.

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

At December 31, 2008, the Company has net operating loss carryforwards in certain non-U.S. subsidiaries, with various expiration dates, of approximately $47.3 million. The Company has U.S. net operating loss carryforwards of approximately $165.7 million which are subject to limitation under section 382 of the Internal Revenue Code. If not utilized, the U.S. federal net operating loss carryforwards will begin to expire in 2026. The Company’s subsidiary, Inamed, has a U.S. federal net operating loss carryback of approximately $46.6 million generated in the pre-acquisition year 2006.

The Company has a subsidiary in Costa Rica under a tax incentive grant. The current tax incentive grant will expire at the end of 2015.

Temporary differences and carryforwards/carrybacks which give rise to a significant portion of deferred tax assets and liabilities at December 31, 2008 and 2007 are as follows:

 

     2008     2007  
     (in millions)  

Deferred tax assets

  

Net operating loss carryforwards/carrybacks

   $ 88.0     $ 107.7  

Accrued expenses

     74.0       74.7  

Manufacturing/warranty reserves

     0.7       3.5  

Capitalized expenses

     48.9       37.7  

Deferred compensation

     27.1       29.4  

Medicare, Medicaid and other accrued healthcare rebates

     28.6       24.1  

Postretirement medical benefits

     16.1       14.3  

Capitalized intangible assets

     65.3       32.0  

Deferred revenue

     15.9       16.7  

Inventory reserves and adjustments

     68.6       47.8  

Share-based compensation awards

     49.2       32.0  

Manufacturing, AMT and research credit carryforwards/carrybacks

     3.1       7.8  

Capital loss carryforwards

     0.2       11.7  

Unbilled costs

     21.0       18.7  

Pension plans

     54.3       7.4  

Transaction costs

     3.8       3.9  

State taxes

     12.9       7.5  

All other

     15.1       9.9  
                
     592.8       486.8  

Less: valuation allowance

     (8.4 )     (99.9 )
                

Total deferred tax assets

     584.4       386.9  
                

Deferred tax liabilities

    

Interest rate swap

     3.8       4.3  

Depreciation

     20.8       23.5  

Developed and core technology intangible assets

     365.8       421.0  

All other

     (0.1 )      
                

Total deferred tax liabilities

     390.3       448.8  
                

Net deferred tax assets (liabilities)

   $ 194.1     $ (61.9 )
                

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

The balances of net current deferred tax assets and net non-current deferred tax liabilities at December 31, 2008 were $238.2 million and $44.1 million, respectively. The balances of net current deferred tax assets and net non-current deferred tax liabilities at December 31, 2007 were $158.7 million and $220.6 million, respectively. Net current deferred tax assets are included in “Other current assets” in the Company’s consolidated balance sheets. The decrease in the amount of the valuation allowance at December 31, 2008 compared to December 31, 2007 is primarily due to an $85.1 million adjustment related to an increase in the expected utilization of net operating losses of Esprit, which the Company acquired in October 2007, and is treated as a reduction of Esprit purchased goodwill.

In connection with the final stage of the Inamed and Esprit legal entity integration, the Company realigned its U.S. operations during the second quarter of 2008. The state and federal deferred tax assets and deferred tax liabilities have been re-determined to reflect a true-up to the resulting tax rate. The impact of the true-up was a decrease to the provision for income taxes by $2.4 million.

Based on the Company’s historical pre-tax earnings, management believes it is more likely than not that the Company will realize the benefit of the existing total deferred tax assets at December 31, 2008. Management believes the existing net deductible temporary differences will reverse during periods in which the Company generates net taxable income; however, there can be no assurance that the Company will generate any earnings or any specific level of continuing earnings in future years. Certain tax planning or other strategies could be implemented, if necessary, to supplement income from operations to fully realize recorded tax benefits.

Adoption of FIN 48, Accounting for Uncertainties in Income Taxes — An Interpretation of FASB Statement No. 109

In the first fiscal quarter of 2007, the Company adopted FIN 48, which resulted in an increase in total income taxes payable of $2.8 million, an increase in interest payable of $0.5 million and a decrease in total deferred tax assets of $1.0 million. In addition, the Company reclassified $27.0 million of net unrecognized tax benefit liabilities from current to non-current liabilities. The Company’s total unrecognized tax benefit liabilities recorded under FIN 48 as of the date of adoption were $61.7 million, including $37.1 million that was previously recognized as income tax expense and $18.7 million of unrecognized tax benefit liabilities of acquired subsidiaries that existed at the time of acquisition. Total interest accrued on income taxes payable was $7.6 million as of the date of adoption and no income tax penalties were recorded.

FIN 48 Disclosures

The Company classifies interest expense related to uncertainty in income taxes in the consolidated statements of operations as interest expense. Income tax penalties are recorded in income tax expense, and are not material.

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

A tabular reconciliation of the total amounts of unrecognized tax benefits at the beginning and end of 2008 and 2007 is as follows:

 

     2008     2007  
     (in millions)  

Balance, beginning of year

   $ 59.6     $ 61.7  

Gross increase as a result of positions taken in a prior year

     24.0       11.7  

Gross decrease as a result of positions taken in a prior year

     (14.2 )     (20.0 )

Gross increase as a result of positions taken in current year

     1.2       7.4  

Decreases related to settlements

     (23.1 )     (1.2 )
                

Balance, end of year

   $ 47.5     $ 59.6  
                

The total amount of unrecognized tax benefits at December 31, 2008 that, if recognized, would affect the effective tax rate is $42.0 million.

In 2008, the total amount of interest expense related to uncertainty in income taxes recognized in the Company’s consolidated statement of operations is $6.3 million. The total amount of accrued interest expense related to uncertainty in income taxes included in the Company’s consolidated balance sheet is $12.8 million and $10.9 million at December 31, 2008 and 2007, respectively. The change to the accrued interest expense balance between December 31, 2008 and December 31, 2007 is primarily due to the increase for the current year interest expense, partially offset by a decrease for payments made during the year in connection with the settlement of the 2003 and 2004 U.S. Internal Revenue Service income tax audit.

The Company expects that during the next 12 months it is reasonably possible that unrecognized tax benefit liabilities related to research credits, executive compensation limitations, inventory capitalization and transfer pricing will decrease by approximately $25.4 million due to the settlement of a U.S. Internal Revenue Service income tax audit.

During the year ended December 31, 2006, the Company reduced its estimated income taxes payable for uncertain tax positions and related provision for income taxes by $14.5 million, primarily due to a change in estimate resulting from the resolution of several significant and previously uncertain income tax audit issues associated with the completion of an audit by the U.S. Internal Revenue Service for tax years 2000 to 2002. This reduction was partially offset by an increase in estimated income taxes payable of $3.9 million for a previously filed income tax return that was under examination. During 2006, the Company also increased its estimate by $1.2 million for the expected income tax benefit for previously paid state income taxes, which became recoverable due to a favorable state court decision that became final during 2004, and incurred income tax expenses of $1.6 million related to intercompany transfers of trade businesses and net assets associated with the Inamed acquisition.

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

The following tax years remain subject to examination:

 

Major Jurisdictions

   Open Years

U.S. Federal

   2005 - 2007

California

   2003 - 2007

Brazil

   2004 - 2007

Canada

   2004 - 2007

France

   2006 - 2007

Germany

   2003 - 2007

Italy

   2004 - 2007

Ireland

   2002 - 2007

Spain

   2004 - 2007

United Kingdom

   2006 - 2007

Note 10:    Employee Retirement and Other Benefit Plans

Pension and Postretirement Benefit Plans

The Company sponsors various qualified defined benefit pension plans covering a substantial portion of its employees. In addition, the Company sponsors two supplemental nonqualified plans, covering certain management employees and officers. U.S. pension benefits are based on years of service and compensation during the five highest consecutive earnings years. Foreign pension benefits are based on various formulas that consider years of service, average or highest earnings during specified periods of employment and other criteria.

The Company also has one retiree health plan that covers U.S. retirees and dependents. Retiree contributions are required depending on the year of retirement and the number of years of service at the time of retirement. Disbursements exceed retiree contributions and the plan currently has no assets. The accounting for the retiree health care plan anticipates future cost-sharing changes to the written plan that are consistent with the Company’s past practice and management’s intent to manage plan costs. The Company’s history of retiree medical plan modifications indicates a consistent approach to increasing the cost sharing provisions of the plan.

Accounting for Defined Benefit Pension and Other Postretirement Plans

In the fourth quarter of 2006, the Company adopted the balance sheet recognition and reporting provisions of SFAS No. 158, which requires the Company to recognize on its balance sheet an asset or liability equal to the over- or under-funded benefit obligation of each defined benefit pension and other postretirement plan. In the first quarter of 2008, the Company adopted the measurement date provision of SFAS No. 158, which requires the Company to change the measurement date for defined benefit pension and other postretirement plans from September 30 to December 31. As a result, the Company recognized an increase of $5.2 million in its net pension liability, an increase of $1.6 million in related deferred income tax assets, a reduction of $4.6 million in its beginning retained earnings and an increase of $1.0 million in accumulated other comprehensive income.

Actuarial 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 are recognized, net of tax, as a component of other comprehensive income. Included in accumulated other comprehensive loss as of December 31, 2008 and 2007 are unrecognized actuarial losses of $282.1 million and $100.5 million, respectively, related to the Company’s pension plans. Of the December 31, 2008 amount, the Company expects to recognize approximately $12.6 million in net periodic benefit cost during 2009. Also included in accumulated other comprehensive loss at December 31, 2008 and

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

2007 are unrecognized prior service credits of $1.9 million and $2.3 million, respectively, and unrecognized actuarial losses of $5.0 million and $4.3 million, respectively, related to the Company’s retiree health plan that have not yet been recognized in net periodic benefit cost. Of the December 31, 2008 amounts, the Company expects to recognize $0.3 million of the unrecognized prior service credits and $0.1 million of the unrecognized actuarial losses in net periodic benefit cost during 2009.

Components of net periodic benefit cost, assumptions used to determine net periodic benefit cost and projected benefit obligation, change in projected benefit obligation, change in plan assets, funded status, funding and estimated future payments are summarized below for the Company’s U.S. and major non-U.S. pension plans and retiree health plan.

Net Periodic Benefit Cost

Components of net periodic benefit cost for the years ended 2008, 2007 and 2006 were as follows:

 

     Pension Benefits     Other
Postretirement Benefits
 
     2008     2007     2006     2008     2007     2006  
     (in millions)  

Service cost

   $ 24.8     $ 24.9     $ 23.1     $ 1.5     $ 1.8     $ 1.8  

Interest cost

     34.4       30.8       27.4       2.2       2.1       2.0  

Expected return on plan assets

     (41.9 )     (36.8 )     (32.3 )                  

Gain on settlement

                 (0.8 )                  

Amortization of prior service costs (credits)

                       (0.3 )     (0.2 )     (0.2 )

Recognized net actuarial losses

     6.5       11.4       13.0       0.1       0.3       0.5  
                                                

Net periodic benefit cost

   $ 23.8     $ 30.3     $ 30.4     $ 3.5     $ 4.0     $ 4.1  
                                                

The Company terminated and settled one of its non-U.S. pension plans as part of its restructuring and streamlining of operations in Japan. As a result, the Company recognized a gain of $0.8 million upon plan settlement that was recorded as a restructuring charge reversal in the consolidated statement of operations for the year ended December 31, 2006.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Assumptions

The weighted-average assumptions used to determine net periodic benefit cost and projected benefit obligation were as follows:

 

     Pension Benefits     Other
Postretirement Benefits
 
     2008     2007     2006     2008     2007     2006  

For Determining Net Periodic Benefit Cost

            

U.S. Plans:

            

Discount rate

   6.25 %   5.90 %   5.60 %   6.25 %   5.90 %   5.60 %

Expected return on plan assets

   8.25 %   8.25 %   8.25 %            

Rate of compensation increase

   4.25 %   4.25 %   4.25 %            

Non-U.S. Pension Plans:

            

Discount rate

   5.50 %   4.65 %   4.24 %      

Expected return on plan assets

   6.82 %   6.43 %   6.19 %      

Rate of compensation increase

   4.13 %   4.24 %   4.00 %      

For Determining Projected Benefit Obligation

            

U.S. Plans:

            

Discount rate

   6.19 %   6.25 %     6.05 %   6.25 %  

Rate of compensation increase

   4.25 %   4.25 %            

Non-U.S. Pension Plans:

            

Discount rate

   5.71 %   5.50 %        

Rate of compensation increase

   4.01 %   4.13 %        

For the U.S. qualified pension plan, the expected return on plan assets was determined using a building block approach that considers diversification and rebalancing for a long-term portfolio of invested assets. Historical market returns are studied and long-term historical relationships between equities and fixed income are preserved in a manner consistent with the widely-accepted capital market principle that assets with higher volatility generate a greater return over the long run. Current market factors such as inflation and interest rates are also evaluated before long-term capital market assumptions are determined.

For non-U.S. funded pension plans, the expected rate of return was determined based on asset distribution and assumed long-term rates of returns on fixed income instruments and equities.

Assumed health care cost trend rates have a significant effect on the amounts reported as other postretirement benefits. A one-percentage-point change in assumed health care cost trend rates would have the following effects:

 

     1-Percentage-
Point Increase
   1-Percentage-
Point Decrease
 
     (in millions)  

Effect on total service and interest cost components

   $ 0.8    $ (0.6 )

Effect on postretirement benefit obligation

     7.5      (6.0 )

The assumed annual health care cost trend rate for the retiree health plan was 9% for 2008, gradually decreasing to 5% in 2016 and remaining at that level thereafter.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Benefit Obligation, Plan Assets and Funded Status

The table below presents components of the change in projected benefit obligation, change in plan assets and funded status at December 31, 2008 and 2007.

 

     Pension Benefits     Other
Postretirement
Benefits
 
     2008     2007     2008     2007  
     (in millions)  

Change in Projected Benefit Obligation

  

Projected benefit obligation, beginning of year

   $ 578.6     $ 554.3     $ 35.9     $ 36.7  

Adjustments due to adoption of SFAS No. 158 measurement date provision

     13.0             0.9        

Service cost

     24.8       24.9       1.5       1.8  

Interest cost

     34.4       30.8       2.2       2.1  

Participant contributions

     1.7       1.5              

Actuarial (gains) losses

     (2.1 )     (35.4 )     0.8       (3.5 )

Benefits paid

     (12.7 )     (10.0 )     (1.4 )     (1.2 )

Plan amendment in 2008

     1.3                    

Plan combination in 2007

           1.5              

Impact of foreign currency translation

     (19.0 )     11.0              
                                

Projected benefit obligation, end of year

     620.0       578.6       39.9       35.9  
                                

Change in Plan Assets

        

Fair value of plan assets, beginning of year

     547.5       478.5              

Adjustments due to adoption of SFAS No. 158 measurement date provision

     (2.0 )                  

Actual return on plan assets

     (141.7 )     50.3              

Company contributions

     84.5       17.0       1.4       1.2  

Participant contributions

     1.7       1.5              

Benefits paid

     (12.7 )     (10.0 )     (1.4 )     (1.2 )

Plan combination in 2007

           0.9              

Impact of foreign currency translation

     (14.6 )     9.3              
                                

Fair value of plan assets, end of year

     462.7       547.5              
                                

Funded status of plans

     (157.3 )     (31.1 )     (39.9 )     (35.9 )

Fourth quarter contributions in 2007

           10.4              
                                

Accrued benefit costs, net

   $ (157.3 )   $ (20.7 )   $ (39.9 )   $ (35.9 )
                                

Accrued benefit costs, net for pension plans and other postretirement benefits is reported in the following components of the Company’s consolidated balance sheet at December 31, 2008 and 2007:

 

     Pension Benefits     Other
Postretirement
Benefits
 
     2008     2007     2008     2007  
     (in millions)  

Investments and other assets

   $ 0.9     $ 35.8     $     $  

Accrued compensation

     (2.0 )     (1.6 )     (0.9 )     (0.9 )

Other liabilities

     (156.2 )     (54.9 )     (39.0 )     (35.0 )
                                

Accrued benefit costs, net

   $ (157.3 )   $ (20.7 )   $ (39.9 )   $ (35.9 )
                                

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

The accumulated benefit obligation for the Company’s U.S. and major non-U.S. pension plans was $543.4 million and $492.3 million at December 31, 2008 and 2007, respectively.

The projected benefit obligation, accumulated benefit obligation and fair value of plan assets for pension plans with a projected benefit obligation in excess of plan assets and pension plans with accumulated benefit obligations in excess of the fair value of plan assets at December 31, 2008 and 2007 were as follows:

 

     Projected Benefit
Obligation
Exceeds
the Fair Value of
Plan Assets
   Accumulated
Benefit
Obligation
Exceeds the Fair
Value of
Plan Assets
     2008    2007    2008    2007
     (in millions)

Projected benefit obligation

   $ 606.1    $ 57.9    $ 519.1    $ 57.9

Accumulated benefit obligation

     530.5      46.3      455.7      46.3

Fair value of plan assets

     448.0      1.0      372.6      1.0

Funding

The Company’s funding policy for its funded pension plans is based upon the greater of: (i) annual service cost, administrative expenses and a seven year amortization of any funded deficit or surplus relative to the projected pension benefit obligations or (ii) local statutory requirements. The Company’s funding policy is subject to certain statutory regulations with respect to annual minimum and maximum company contributions. Plan benefits for the nonqualified plans are paid as they come due.

The table below presents the asset allocations for the Company’s U.S. and non-U.S. funded pension plans.

 

     2009
Target

Allocation
    Percent of
Plan Assets
 
     2008     2007  

U.S. Pension Plans:

      

Equity securities

   60.0 %   47.7 %   65.0 %

Debt securities

   40.0 %   52.3 %   35.0 %
                  

Total

   100.0 %   100.0 %   100.0 %
                  

Non-U.S. Pension Plans:

      

Equity securities

   52.0 %   48.0 %   60.8 %

Debt securities

   48.0 %   52.0 %   39.2 %
                  

Total

   100.0 %   100.0 %   100.0 %
                  

The Company’s U.S. pension plan assets are managed by outside investment managers using a total return investment approach whereby a mix of equities and debt securities investments are used to maximize the long-term rate of return on plan assets. The intent of this strategy is to minimize plan expenses by outperforming plan liabilities over the long run. The Company’s overall expected long-term rate of return on assets for 2009 is 8.25% for its U.S. funded pension plan. Risk tolerance is established through careful consideration of plan liabilities, plan funded status and corporate financial condition. The investment portfolio contains a diversified blend of equity and debt securities investments. Furthermore, equity investments are diversified across geography and market capitalization through investments in U.S. large cap stocks, U.S. small cap stocks and international

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

securities. Investment risk is measured and monitored on an ongoing basis through annual liability measures, periodic asset/liability studies and quarterly investment portfolio reviews.

The Company’s non-U.S. pension plans’ assets are also managed by outside investment managers using a total return investment approach using a mix of equities and debt securities investments to maximize the long-term rate of return on the plans’ assets. The Company’s overall expected long-term rate of return on assets for 2009 is 6.03% for its non-U.S. funded pension plans.

In 2009, the Company expects to pay contributions of between $35.0 million and $45.0 million for its U.S. and non-U.S. pension plans and between $1.0 million and $2.0 million for its other postretirement plan (unaudited).

Estimated Future Benefit Payments

Estimated benefit payments over the next 10 years for the Company’s U.S. and major non-U.S. pension plans and retiree health plan are as follows:

 

     Pension
Benefits
   Other
Postretirement
Benefits
     (in millions)

2009

   $ 15.4    $ 0.9

2010

     17.2      1.1

2011

     19.0      1.2

2012

     21.2      1.3

2013

     23.7      1.5

2014 – 2018

     163.1      10.7
             
   $ 259.6    $ 16.7
             

Savings and Investment Plan

The Company has a Savings and Investment Plan, which allows all U.S. employees to become participants upon employment. In 2008, 2007 and 2006, participants’ contributions, up to 4% of compensation, generally qualified for a 100% Company match. Company contributions are generally used to purchase Allergan common stock, although such amounts may be immediately transferred by the participants to other investment fund alternatives. The Company’s cost of the plan was $16.9 million in 2008, $13.8 million in 2007 and $10.3 million in 2006. Effective February 13, 2009, the Company reduced the 100% Company match to up to 2% of compensation.

In addition, the Company has a Company sponsored retirement contribution program under the Savings and Investment Plan, which provides all U.S. employees hired after September 30, 2002 with at least six months of service and certain other employees who previously elected to participate in the Company sponsored retirement contribution program under the Savings and Investment Plan, a Company provided retirement contribution of 5% of annual pay if they are employed on the last day of each calendar year. Participating employees who receive the 5% Company retirement contribution do not accrue benefits under the Company’s defined benefit pension plan. The Company’s cost of the retirement contribution program under the Savings and Investment Plan was $17.7 million, $10.4 million and $7.1 million in 2008, 2007 and 2006, respectively.

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Note 11:    Employee Stock Plans

In 2008, the Company adopted the Allergan, Inc. 2008 Incentive Award Plan (the incentive award plan) that provides for the granting of non-qualified stock options, incentive stock options, stock appreciation rights, performance shares, restricted stock and restricted stock units to officers, key employees and non-employee directors. The incentive award plan succeeds and replaces Allergan’s 1989 Incentive Compensation Plan, 2001 Premium Priced Stock Option Plan and 2003 Non-employee Director Plan. The terms of share-based awards provided under the incentive award plan are consistent with the terms of awards under the prior plans.

Stock option grants to officers and key employees under the incentive award plan are generally granted at an exercise price equal to the fair market value at the date of grant, generally expire ten years after their original date of grant and generally become vested and exercisable at a rate of 25% per year beginning twelve months after the date of grant. Restricted share awards to officers and key employees generally become fully vested and free of restrictions four years from the date of grant, except for restricted stock grants pursuant to the Company’s management bonus plan, which generally become fully vested and free of restrictions two years from the date of grant.

Under the terms of the incentive award plan, each eligible non-employee director is granted non-qualified stock options on the date of each regular annual meeting of stockholders at which the directors are to be elected. Non-qualified stock options to non-employee directors become fully vested and exercisable one year from the date of grant. In addition, each eligible non-employee director receives a restricted share award upon election, reelection or appointment to the Board of Directors. Restricted share awards to non-employee directors generally vest and become free of restrictions at the rate of 33 1 / 3 % per year beginning twelve months after the date of grant.

At December 31, 2008, the aggregate amount of shares available for future grant under the incentive award plan for stock options and restricted share awards was approximately 22.4 million shares.

Share-Based Award Activity and Balances

The following table summarizes the Company’s stock option activity:

 

     2008    2007    2006
     Number
of

Shares
    Weighted
Average
Exercise
Price
   Number
of

Shares
    Weighted
Average
Exercise
Price
   Number
of

Shares
    Weighted
Average
Exercise
Price
     (in thousands, except option exercise price and fair value data)

Outstanding, beginning of year

   18,695     $ 44.50    20,241     $ 41.03    21,564     $ 36.43

Options granted

   4,643       63.33    4,067       59.07    4,518       55.52

Options exercised

   (1,511 )     34.35    (3,920 )     35.08    (5,324 )     34.30

Options cancelled

   (589 )     57.41    (1,693 )     59.88    (517 )     45.02
                          

Outstanding, end of year

   21,238       48.96    18,695       44.50    20,241       41.03
                          

Exercisable, end of year

   11,481       40.90    9,434       36.76    10,904       37.24
                          

Weighted average per share fair value of options granted during the year

  

$19.82

  

$17.27

  

$17.84

The aggregate intrinsic value of stock options exercised in 2008, 2007 and 2006 was $39.2 million, $106.2 million and $114.1 million, respectively.

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

As of December 31, 2008, the weighted average remaining contractual life of options outstanding and options exercisable are 6.5 years and 5.0 years, respectively, and based on the Company’s closing year-end stock price of $40.32 at December 31, 2008, the aggregate intrinsic value of options outstanding and options exercisable are $43.4 million and $40.3 million, respectively. Upon exercise of stock options, the Company generally issues shares from treasury.

The following table summarizes the Company’s restricted share activity:

 

    2008   2007   2006
    Number
of
Shares
    Weighted
Average
Grant-Date
Fair Value
  Number
of
Shares
    Weighted
Average
Grant-Date
Fair Value
  Number
of
Shares
    Weighted
Average
Grant-Date
Fair Value
    (in thousands, except fair value data)

Restricted share awards, beginning of year

  559     $ 49.56   525     $ 43.27   378     $ 37.12

Shares granted

  362       57.38   201       59.22   220       54.64

Shares vested

  (210 )     53.71   (131 )     39.25   (53 )     45.40

Shares cancelled

  (33 )     56.34   (36 )     49.19   (20 )     46.63
                       

Restricted share awards, end of year

  678       52.12   559       49.56   525       43.27
                       

The total fair value of restricted shares that vested in 2008, 2007 and 2006 was $12.7 million, $7.7 million and $2.8 million, respectively.

Valuation and Expense Recognition of Share-Based Awards

The Company accounts for the measurement and recognition of compensation expense for all share-based awards made to the Company’s employees and directors based on the estimated fair value of the awards in accordance with the provisions of Statement of Financial Accounting Standards No. 123 (revised), Share-Based Payment (SFAS No. 123R).

The following table summarizes share-based compensation expense by award type for the years ended December 31, 2008, 2007 and 2006, respectively:

 

     2008     2007     2006  
     (in millions)  

Employee and director stock options

   $ 62.2     $ 54.5     $ 48.6  

Employee and director restricted share awards

     11.0       11.3       9.2  

Stock contributed to employee benefit plans

     19.9       15.9       11.8  
                        

Pre-tax share-based compensation expense

     93.1       81.7       69.6  

Income tax benefit

     (31.8 )     (29.0 )     (25.3 )
                        

Net share-based compensation expense

   $ 61.3     $ 52.7     $ 44.3  
                        

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

The following table summarizes pre-tax share-based compensation expense by expense category for the years ended December 31, 2008, 2007 and 2006, respectively:

 

     2008    2007    2006
     (in millions)

Cost of sales

   $ 8.9    $ 7.4    $ 6.2

Selling, general and administrative

     61.4      55.0      47.5

Research and development

     22.8      19.3      15.9
                    

Pre-tax share-based compensation expense

   $ 93.1    $ 81.7    $ 69.6
                    

The Company uses the Black-Scholes option-pricing model to estimate the fair value of share-based awards on the grant date. The determination of fair value using the Black-Scholes option-pricing model is affected by the Company’s stock price as well as assumptions regarding a number of highly complex and subjective variables, including expected stock price volatility, risk-free interest rate, expected dividends and projected employee stock option exercise behaviors. Stock options granted during 2008, 2007 and 2006 were valued using the Black-Scholes option-pricing model with the following weighted-average assumptions:

 

     2008     2007     2006  

Expected volatility

   26.89 %   26.17 %   30.00 %

Risk-free interest rate

   3.49 %   4.52 %   4.48 %

Expected dividend yield

   0.40 %   0.49 %   0.50 %

Expected option life (in years)

   5.71     4.95     4.75  

The Company estimates its stock price volatility based on an equal weighting of the Company’s historical stock price volatility and the average implied volatility of at-the-money options traded in the open market. The risk-free interest rate assumption is based on observed interest rates for the appropriate term of the Company’s stock options. The Company does not target a specific dividend yield for its dividend payments but is required to assume a dividend yield as an input to the Black-Scholes option-pricing model. The dividend yield assumption is based on the Company’s history and an expectation of future dividend amounts. The expected option life assumption is estimated based on actual historical exercise activity and assumptions regarding future exercise activity of unexercised, outstanding options.

The Company recognizes shared-based compensation cost over the vesting period using the straight-line single option method. Share-based compensation expense under SFAS No. 123R is recognized only for those awards that are ultimately expected to vest. An estimated forfeiture rate has been applied to unvested awards for the purpose of calculating compensation cost. Forfeitures were estimated based on historical experience. SFAS No. 123R requires these estimates to be revised, if necessary, in future periods if actual forfeitures differ from the estimates. Changes in forfeiture estimates impact compensation cost in the period in which the change in estimate occurs.

As of December 31, 2008, total compensation cost related to non-vested stock options and restricted stock not yet recognized was approximately $140.9 million, which is expected to be recognized over the next 48 months (31 months on a weighted-average basis). The Company has not capitalized as part of inventory any share-based compensation costs because such costs were negligible as of December 31, 2008, 2007 and 2006.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Note 12:    Financial Instruments

In the normal course of business, operations of the Company are exposed to risks associated with fluctuations in interest rates and foreign currency exchange rates. The Company addresses these risks through controlled risk management that includes the use of derivative financial instruments to economically hedge or reduce these exposures. The Company does not enter into derivative financial instruments for trading or speculative purposes.

The Company has not experienced any losses on its derivative financial instruments to date due to counterparty credit risk.

Interest Rate Risk Management

The Company’s interest income and expense is more sensitive to fluctuations in the general level of U.S. interest rates than to changes in rates in other markets. Changes in U.S. interest rates affect the interest earned on cash and equivalents, interest expense on debt as well as costs associated with foreign currency contracts. For a discussion of the Company’s interest rate swap activities, see Note 7, “Notes Payable and Long-Term Debt.”

Foreign Exchange Risk Management

Overall, the Company is a net recipient of currencies other than the U.S. dollar and, as such, benefits from a weaker dollar and is adversely affected by a stronger dollar relative to major currencies worldwide. Accordingly, changes in exchange rates, and in particular a strengthening of the U.S. dollar, may negatively affect the Company’s consolidated revenues or operating costs and expenses as expressed in U.S. dollars.

From time to time, the Company enters into foreign currency option and forward contracts to reduce earnings and cash flow volatility associated with foreign exchange rate changes to allow management to focus its attention on its core business issues. Accordingly, the Company enters into various contracts which change in value as foreign exchange rates change to economically offset the effect of changes in the value of foreign currency assets and liabilities, commitments and anticipated foreign currency denominated sales and operating expenses. The Company enters into foreign currency option and forward contracts in amounts between minimum and maximum anticipated foreign exchange exposures, generally for periods not to exceed one year. The Company does not designate these derivative instruments as accounting hedges.

The Company uses foreign currency option contracts, which provide for the sale or purchase of foreign currencies to offset foreign currency exposures expected to arise in the normal course of the Company’s business. While these instruments are subject to fluctuations in value, such fluctuations are anticipated to offset changes in the value of the underlying exposures.

Probable but not firmly committed transactions are comprised of sales of products and purchases of raw material in currencies other than the U.S. dollar. A majority of these sales are made through the Company’s subsidiaries in Europe, Asia, Canada and Brazil. The Company purchases foreign exchange option contracts to economically hedge the currency exchange risks associated with these probable but not firmly committed transactions. The duration of foreign exchange hedging instruments, whether for firmly committed transactions or for probable but not firmly committed transactions, currently does not exceed one year.

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

All of the Company’s outstanding foreign currency option contracts are entered into to reduce the volatility of earnings generated in currencies other than the U.S. dollar, primarily earnings denominated in the Canadian dollar, Mexican peso, Australian dollar, Brazilian real, euro, Japanese yen, Swedish krona, Swiss franc and U.K. pound. Current changes in the fair value of open foreign currency option contracts are recorded through earnings as “Unrealized gain (loss) on derivative instruments, net” while any realized gains (losses) on settled contracts are recorded through earnings as “Other, net” in the accompanying consolidated statements of operations. The premium costs of purchased foreign exchange option contracts are recorded in “Other current assets” and amortized to “Other, net” over the life of the options.

All of the Company’s outstanding foreign exchange forward contracts are entered into to protect the value of certain intercompany receivables or payables that are subject to fluctuations in foreign currency exchange rates. The realized and unrealized gains and losses from foreign currency forward contracts and the revaluation of the foreign denominated intercompany receivables or payables are recorded through “Other, net” in the accompanying consolidated statements of operations.

At December 31, 2008 and 2007, the notional principal and fair value of the Company’s outstanding foreign currency derivative financial instruments were as follows:

 

     2008     2007  
     Notional
Principal
   Fair
Value
    Notional
Principal
   Fair
Value
 
     (in millions)  

Foreign currency forward exchange contracts
(Receive U.S. dollar/pay foreign currency)

   $ 112.2    $ (3.6 )   $ 129.9    $ (2.0 )

Foreign currency forward exchange contracts
(Pay U.S. dollar/receive foreign currency)

     63.3      2.7       58.3      0.9  

Foreign currency sold — put options

     216.5      24.3       279.8      7.3  

Foreign currency purchased — call options

                16.0      0.1  

The notional principal amounts provide one measure of the transaction volume outstanding as of year end, and do not represent the amount of the Company’s exposure to market loss. The estimates of fair value are based on applicable and commonly used pricing models using prevailing financial market information as of December 31, 2008 and 2007. The amounts ultimately realized upon settlement of these financial instruments, together with the gains and losses on the underlying exposures, will depend on actual market conditions during the remaining life of the instruments.

Other Financial Instruments

At December 31, 2008 and 2007, the Company’s other financial instruments included cash and equivalents, trade receivables, equity investments, accounts payable and borrowings. The carrying amount of cash and equivalents, trade receivables and accounts payable approximates fair value due to the short-term maturities of these instruments. The fair value of marketable equity investments, notes payable and long-term debt were estimated based on quoted market prices at year-end. The fair value of non-marketable equity investments which represent investments in start-up technology companies or partnerships that invest in start-up technology companies, are estimated based on the fair value and other information provided by these ventures.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

The carrying amount and estimated fair value of the Company’s other financial instruments at December 31, 2008 and 2007 were as follows:

 

     2008    2007
     Carrying
Amount
   Fair
Value
   Carrying
Amount
   Fair
Value
     (in millions)

Cash and equivalents

   $ 1,110.4    $ 1,110.4    $ 1,157.9    $ 1,157.9

Non-current investments:

           

Marketable equity

     0.6      0.6      6.4      6.4

Non-marketable equity

     5.3      5.3      1.6      1.6

Notes payable

     4.4      4.4      39.7      39.9

Long-term debt

     885.3      860.9      840.2      872.3

Long-term convertible notes

     750.0      750.0      750.0      878.4

Marketable equity investments include unrealized holding (losses) gains, net of tax of $(1.4) million and $1.7 million at December 31, 2008 and 2007, respectively.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to credit risk principally consist of trade receivables. Wholesale distributors, major retail chains and managed care organizations account for a substantial portion of trade receivables. This risk is limited due to the number of customers comprising the Company’s customer base, and their geographic dispersion. At December 31, 2008, no single customer represented more than 10% of trade receivables, net. Ongoing credit evaluations of customers’ financial condition are performed and, generally, no collateral is required. The Company has purchased an insurance policy intended to reduce the Company’s exposure to potential credit risks associated with certain U.S. customers. To date, no claims have been made against the insurance policy. The Company maintains reserves for potential credit losses and such losses, in the aggregate, have not exceeded management’s estimates.

Note 13:    Fair Value Measurements

Effective January 1, 2008, the Company adopted SFAS No. 159, which allows an entity to voluntarily choose to measure certain financial assets and liabilities at fair value. The Company did not elect the fair value option as allowed by SFAS No. 159 for its financial assets and liabilities that were not previously carried at fair value. Therefore, material financial assets and liabilities that are not carried at fair value, such as short-term and long-term debt obligations and trade accounts receivable and payable, are still reported at their historical carrying values.

Effective January 1, 2008, the Company adopted the methods of measuring fair value described in SFAS No. 157. As defined in SFAS No. 157, fair value is based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, SFAS No. 157 establishes a three-tier fair value hierarchy that prioritizes the inputs used to measure fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs for which little or no market data exists, therefore requiring an entity to develop its own assumptions.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Assets and Liabilities Measured at Fair Value on a Recurring Basis

As of December 31, 2008, the Company has certain assets and liabilities that are required to be measured at fair value on a recurring basis. These include commercial paper and foreign time deposits classified as cash equivalents, other cash equivalents, available-for-sale securities, foreign exchange derivatives and the interest rate swap with a $300.0 million notional amount. These assets and liabilities are classified in the table below in one of the three categories of the fair value hierarchy described above.

 

     Total    Level 1    Level 2    Level 3
     (in millions)

Assets

           

Commercial paper

   $ 414.1    $ 414.1    $    $         —

Foreign time deposits

     88.2      88.2          

Other cash equivalents

     506.9      506.9          

Available-for-sale securities

     0.6      0.6          

Foreign exchange derivative assets

     27.0           27.0     

Interest rate swap derivative asset

     61.9           61.9     
                           
   $ 1,098.7    $ 1,009.8    $      88.9    $
                           

Liabilities

           

Foreign exchange derivative liabilities

   $ 3.6    $    $ 3.6    $

Interest rate swap derivative liability

     61.9           61.9     
                           
   $ 65.5    $    $ 65.5    $
                           

Commercial paper, foreign time deposits and other cash equivalents are valued at cost, which approximates fair value due to the short-term maturities of these instruments. Available-for-sale securities are valued using quoted stock prices from the National Association of Securities Dealers Automated Quotation System at the reporting date. Foreign exchange derivative assets and liabilities are valued using quoted forward foreign exchange prices and option volatility at the reporting date. The interest rate swap derivative asset and liability are valued using LIBOR yield curves at the reporting date. The Company believes the fair values assigned to its available-for-sale securities and derivative instruments as of December 31, 2008 and 2007 are based upon reasonable estimates and assumptions.

Note 14:    Legal Proceedings

The Company is involved in various lawsuits and claims arising in the ordinary course of business.

In August 2004, James Clayworth, R.Ph., doing business as Clayworth Pharmacy, filed a complaint entitled “Clayworth v. Allergan, et al.” in the Superior Court of the State of California for the County of Alameda. The complaint, as amended, named the Company and 12 other defendants and alleged unfair business practices, including a price fixing conspiracy relating to the reimportation of pharmaceuticals from Canada. The complaint sought damages, equitable relief, attorneys’ fees and costs. On January 8, 2007, the court entered a notice of entry of judgment of dismissal against the plaintiffs dismissing the plaintiffs’ complaint. On the same date, the plaintiffs filed a notice of appeal with the Court of Appeal of the State of California, First Appellate District. On April 14, 2007, the plaintiffs filed an opening brief with the Court of Appeal of the State of California. The defendants filed their joint opposition on July 5, 2007, and the plaintiffs filed their reply on August 24, 2007. On May 14, 2008, the court heard oral arguments and took the matter under submission. On July 25, 2008, the Court of Appeal of the State of California affirmed the Superior Court of the State of California for the County of

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Alameda’s ruling granting the Company’s motion for summary judgment. On August 11, 2008, the plaintiffs filed a petition for rehearing with the Court of Appeal of the State of California. On August 19, 2008, the court denied the plaintiffs’ petition for rehearing. On September 3, 2008, the plaintiffs filed a petition for review with the Supreme Court of the State of California. On November 19, 2008, the Supreme Court of the State of California granted the plaintiffs’ petition for review. On February 17, 2009, the plaintiffs filed their opening brief on the merits with the Supreme Court of the State of California.

In March 2008, the Company received service of a Subpoena Duces Tecum from the U.S. Attorney, U.S. Department of Justice, Northern District of Georgia (“DOJ”). The subpoena requests the production of documents relating to the Company’s sales and marketing practices in connection with Botox ® .

In July 2008, a complaint entitled “Kramer, Bryant, Spears, Doolittle, Clark, Whidden, Powell, Moore, Hennessy, Sody, Breeding, Downey, Underwood-Boswell, Reed-Momot, Purdon & Hahn v. Allergan, Inc.” was filed in the Superior Court for the State of California for the County of Orange. The complaint makes allegations against the Company relating to Botox ® and Botox ® Cosmetic including failure to warn, manufacturing defects, negligence, breach of implied and express warranties, deceit by concealment and negligent misrepresentation and seeks damages, attorneys’ fees and costs. On July 17, 2008, the plaintiffs filed a first amended complaint. On September 29, 2008, the Company filed an answer to the first amended complaint. On February 2, 2009, the plaintiffs filed a request for dismissal without prejudice as to plaintiffs Hennessey, Hahn and Underwood-Boswell. A status conference was held on February 17, 2009. The court scheduled a further status conference for June 22, 2009.

The Company is involved in various other lawsuits and claims arising in the ordinary course of business. These other matters are, in the opinion of management, immaterial both individually and in the aggregate with respect to the Company’s consolidated financial position, liquidity or results of operations.

Because of the uncertainties related to the incurrence, amount and range of loss on any pending litigation, investigation, inquiry or claim, management is currently unable to predict the ultimate outcome of any litigation, investigation, inquiry or claim, determine whether a liability has been incurred or make an estimate of the reasonably possible liability that could result from an unfavorable outcome. The Company believes, however, that the liability, if any, resulting from the aggregate amount of uninsured damages for any outstanding litigation, investigation or claim, other than the inquiry being conducted by the DOJ discussed in Note 15, “Commitments and Contingencies,” will not have a material adverse effect on the Company’s consolidated financial position, liquidity or results of operations. However, an adverse ruling in a patent infringement lawsuit involving the Company could materially affect its ability to sell one or more of its products or could result in additional competition. In view of the unpredictable nature of such matters, the Company cannot provide any assurances regarding the outcome of any litigation, investigation, inquiry or claim to which the Company is a party or the impact on the Company of an adverse ruling in such matters. As additional information becomes available, the Company will assess its potential liability and revise its estimates.

Note 15:    Commitments and Contingencies

Operating Lease Obligations

The Company leases certain facilities, office equipment and automobiles and provides for payment of taxes, insurance and other charges on certain of these leases. Rental expense was $50.9 million in 2008, $41.9 million in 2007 and $30.6 million in 2006.

Future minimum rental payments under non-cancelable operating lease commitments with a term of more than one year as of December 31, 2008 are as follows: $47.3 million in 2009, $38.9 million in 2010, $25.0 million in 2011, $16.0 million in 2012, $11.5 million in 2013 and $52.8 million thereafter.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Contingencies

On March 3, 2008, the Company received service of a Subpoena Duces Tecum from the DOJ. The subpoena requests the production of documents relating to the Company’s sales and marketing practices in connection with Botox ® . During fiscal year 2008, the Company incurred approximately $25.7 million of costs associated with the DOJ’s inquiry. The Company expects to incur additional costs associated with responding to the DOJ investigation of approximately $30.0 million to $34.0 million during fiscal year 2009. Estimated costs include attorneys’ fees and costs associated with document production, imaging and information services support. Because of the uncertainties related to the incurrence, amount and range of loss, if any, that might be incurred related to this inquiry, management is currently unable to predict the ultimate outcome or determine whether a liability has been incurred or make an estimate of the reasonably possible liability that could result from an unfavorable outcome associated with this inquiry.

Note 16:    Guarantees

The Company’s Restated Certificate of Incorporation, as amended, provides that the Company will indemnify, to the fullest extent permitted by the Delaware General Corporation Law, each person that is involved in or is, or is threatened to be, made a party to any action, suit or proceeding by reason of the fact that he or she, or a person of whom he or she is the legal representative, is or was a director or officer of the Company or was serving at the request of the Company as a director, officer, employee or agent of another corporation or of a partnership, joint venture, trust or other enterprise. The Company has also entered into contractual indemnity agreements with each of its directors and executive officers pursuant to which, among other things, the Company has agreed to indemnify such directors and executive officers against any payments they are required to make as a result of a claim brought against such executive officer or director in such capacity, excluding claims (i) relating to the action or inaction of a director or executive officer that resulted in such director or executive officer gaining illegal personal profit or advantage, (ii) for an accounting of profits made from the purchase or sale of securities of the Company within the meaning of Section 16(b) of the Securities Exchange Act of 1934, as amended, or similar provisions of any state law or (iii) that are based upon or arise out of such director’s or executive officer’s knowingly fraudulent, deliberately dishonest or willful misconduct. The maximum potential amount of future payments that the Company could be required to make under these indemnification provisions is unlimited. However, the Company has purchased directors’ and officers’ liability insurance policies intended to reduce the Company’s monetary exposure and to enable the Company to recover a portion of any future amounts paid. The Company has not previously paid any material amounts to defend lawsuits or settle claims as a result of these indemnification provisions. As a result, the Company believes the estimated fair value of these indemnification arrangements is minimal.

The Company customarily agrees in the ordinary course of its business to indemnification provisions in agreements with clinical trials investigators in its drug, biologics and medical device development programs, in sponsored research agreements with academic and not-for-profit institutions, in various comparable agreements involving parties performing services for the Company in the ordinary course of business, and in its real estate leases. The Company also customarily agrees to certain indemnification provisions in its discovery and development collaboration agreements. With respect to the Company’s clinical trials and sponsored research agreements, these indemnification provisions typically apply to any claim asserted against the investigator or the investigator’s institution relating to personal injury or property damage, violations of law or certain breaches of the Company’s contractual obligations arising out of the research or clinical testing of the Company’s products, compounds or drug candidates. With respect to real estate lease agreements, the indemnification provisions typically apply to claims asserted against the landlord relating to personal injury or property damage caused by the Company, to violations of law by the Company or to certain breaches of the Company’s contractual

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

obligations. The indemnification provisions appearing in the Company’s collaboration agreements are similar, but in addition provide some limited indemnification for the collaborator in the event of third party claims alleging infringement of intellectual property rights. In each of the above cases, the terms of these indemnification provisions generally survive the termination of the agreement. The maximum potential amount of future payments that the Company could be required to make under these provisions is generally unlimited. The Company has purchased insurance policies covering personal injury, property damage and general liability intended to reduce the Company’s exposure for indemnification and to enable the Company to recover a portion of any future amounts paid. The Company has not previously paid any material amounts to defend lawsuits or settle claims as a result of these indemnification provisions. As a result, the Company believes the estimated fair value of these indemnification arrangements is minimal.

Note 17:    Product Warranties

The Company provides warranty programs for breast implant sales primarily in the United States, Europe and certain other countries. Management estimates the amount of potential future claims from these warranty programs based on actuarial analyses. Expected future obligations are determined based on the history of product shipments and claims and are discounted to a current value. The liability is included in both current and long-term liabilities in the Company’s consolidated balance sheets. The U.S. programs include the ConfidencePlus ® and ConfidencePlus ® Premier warranty programs. The ConfidencePlus ® program currently provides lifetime product replacement and $1,200 of financial assistance for surgical procedures within ten years of implantation. The ConfidencePlus ® Premier program, which generally requires a low additional enrollment fee, currently provides lifetime product replacement, $2,400 of financial assistance for surgical procedures within ten years of implantation and contralateral implant replacement. The enrollment fee is deferred and recognized as income over the ten year warranty period for financial assistance. The warranty programs in non-U.S. markets have similar terms and conditions to the U.S. programs. The Company does not warrant any level of aesthetic result and, as required by government regulation, makes extensive disclosures concerning the risks of the use of its products and breast implant surgery. Changes to actual warranty claims incurred and interest rates could have a material impact on the actuarial analysis and the Company’s estimated liabilities. A large majority of the product warranty liability arises from the U.S. warranty programs. The Company does not currently offer any similar warranty program on any other product.

The following table provides a reconciliation of the change in estimated product warranty liabilities for the years ended December 31, 2008 and 2007:

 

     2008     2007  
     (in millions)  

Balance, beginning of year

   $ 28.0     $ 24.8  

Provision for warranties issued during the year

     6.5       8.0  

Settlements made during the year

     (5.8 )     (4.8 )

Increases in warranty estimates

     0.8        
                

Balance, end of year

   $ 29.5     $ 28.0  
                

Current portion

   $ 6.3     $ 6.5  

Non-current portion

     23.2       21.5  
                

Total

   $ 29.5     $ 28.0  
                

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Note 18:    Business Segment Information

The Company operates its business on the basis of two reportable segments — specialty pharmaceuticals and medical devices. The specialty pharmaceuticals segment produces a broad range of pharmaceutical products, including: ophthalmic products for glaucoma therapy, ocular inflammation, infection, allergy and chronic dry eye; Botox ® for certain therapeutic and aesthetic indications; skin care products for acne, psoriasis and other prescription and over-the-counter dermatological products; and, beginning in the fourth quarter of 2007, urologics products. The medical devices segment produces a broad range of medical devices, including: breast implants for augmentation, revision and reconstructive surgery; obesity intervention products, including the Lap-Band ® System and the Orbera TM Intragastric Balloon System; and facial aesthetics products. The Company provides global marketing strategy teams to ensure development and execution of a consistent marketing strategy for its products in all geographic regions that share similar distribution channels and customers.

The Company evaluates segment performance on a revenue and operating income basis exclusive of general and administrative expenses and other indirect costs, restructuring charges, in-process research and development expenses, amortization of identifiable intangible assets related to business combinations and asset acquisitions and certain other adjustments, which are not allocated to the Company’s segments for performance assessment by the Company’s chief operating decision maker. Other adjustments excluded from the Company’s segments for performance assessment represent income or expenses that do not reflect, according to established Company-defined criteria, operating income or expenses associated with the Company’s core business activities. Because operating segments are generally defined by the products they design and sell, they do not make sales to each other. The Company does not discretely allocate assets to its operating segments, nor does the Company’s chief operating decision maker evaluate operating segments using discrete asset information.

Operating Segments

 

     2008    2007    2006  
     (in millions)  

Product net sales:

        

Specialty pharmaceuticals

   $ 3,502.3    $ 3,105.0    $ 2,638.5  

Medical devices

     837.4      774.0      371.6  
                      

Total product net sales

     4,339.7      3,879.0      3,010.1  

Other corporate and indirect revenues

     63.7      59.9      53.2  
                      

Total revenues

   $ 4,403.4    $ 3,938.9    $ 3,063.3  
                      

Operating income (loss):

        

Specialty pharmaceuticals

   $ 1,220.1    $ 1,047.9    $ 888.8  

Medical devices

     222.0      207.1      119.9  
                      

Total segments

     1,442.1      1,255.0      1,008.7  

General and administrative expenses, other indirect costs and other adjustments

     475.1      336.9      351.7  

In-process research and development

          72.0      579.3  

Amortization of acquired intangible assets (a)

     129.6      99.9      58.6  

Restructuring charges

     41.3      26.8      22.3  
                      

Total operating income (loss)

   $ 796.1    $ 719.4    $ (3.2 )
                      

 

 
  (a) Represents amortization of identifiable intangible assets related to business combinations and asset acquisitions and related capitalized licensing costs, as applicable.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Product net sales for the Company’s various global product portfolios are presented below. The Company’s principal markets are the United States, Europe, Latin America and Asia Pacific. The U.S. information is presented separately as it is the Company’s headquarters country. U.S. sales, including manufacturing operations, represented 64.6%, 65.7% and 67.4% of the Company’s total consolidated product net sales in 2008, 2007 and 2006, respectively.

Sales to two customers in the Company’s specialty pharmaceuticals segment each generated over 10% of the Company’s total consolidated product net sales. Sales to Cardinal Health for the years ended December 31, 2008, 2007 and 2006 were 12.0%, 11.2% and 13.0%, respectively, of the Company’s total consolidated product net sales. Sales to McKesson Drug Company for the years ended December 31, 2008, 2007 and 2006 were 12.3%, 11.1% and 13.0%, respectively, of the Company’s total consolidated product net sales. No other country or single customer generates over 10% of the Company’s total consolidated product net sales. Other medical devices product net sales consist of sales of ophthalmic surgical devices pursuant to a manufacturing and supply agreement entered into as part of the July 2007 sale of the former Cornéal ophthalmic surgical device business, which was substantially concluded in December 2007. Net sales for the Europe region also include sales to customers in Africa and the Middle East, and net sales in the Asia Pacific region include sales to customers in Australia and New Zealand.

Long-lived assets, depreciation and amortization and capital expenditures are assigned to geographic regions based upon management responsibility for such items. The Company estimates that total long-lived assets located in the United States, including manufacturing operations and general corporate assets, are approximately $3,779.7 million and $3,702.0 million as of December 31, 2008 and 2007, respectively.

Product Net Sales by Product Line

 

     2008    2007    2006
     (in millions)

Specialty Pharmaceuticals:

        

Eye Care Pharmaceuticals

   $ 2,009.1    $ 1,776.5    $ 1,530.6

Botox ® /Neuromodulators

     1,310.9      1,211.8      982.2

Skin Care

     113.7      110.7      125.7

Urologics

     68.6      6.0     
                    

Total Specialty Pharmaceuticals

     3,502.3      3,105.0      2,638.5
                    

Medical Devices:

        

Breast Aesthetics

     310.0      298.4      177.2

Obesity Intervention

     296.0      270.1      142.3

Facial Aesthetics

     231.4      202.8      52.1
                    

Core Medical Devices

     837.4      771.3      371.6

Other

          2.7     
                    

Total Medical Devices

     837.4      774.0      371.6
                    

Total product net sales

   $ 4,339.7    $ 3,879.0    $ 3,010.1
                    

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Geographic Information

 

     Product Net Sales
     2008    2007    2006
     (in millions)

United States

   $ 2,793.2    $ 2,541.3    $ 2,023.6

Europe

     881.9      762.5      548.5

Latin America

     262.5      224.2      172.5

Asia Pacific

     222.3      196.7      145.7

Other

     168.8      147.5      114.5
                    
     4,328.7      3,872.2      3,004.8

Manufacturing operations

     11.0      6.8      5.3
                    

Total product net sales

   $ 4,339.7    $ 3,879.0    $ 3,010.1
                    

 

    Long-lived Assets   Depreciation and
Amortization
  Capital Expenditures
    2008   2007   2008   2007   2006   2008   2007   2006
    (in millions)

United States

  $ 3,389.2   $ 3,379.5   $ 181.8   $ 147.8   $ 111.0   $ 72.3   $ 48.5   $ 44.8

Europe

    252.0     278.2     20.9     18.4     2.2     5.0     5.0     6.2

Latin America

    19.9     22.9     3.6     4.2     3.8     5.3     5.1     2.6

Asia Pacific

    8.1     7.1     1.7     1.3     0.9     3.3     1.2     0.3

Other

    2.5     0.1     0.1     0.1     0.1     2.5     —       —  
                                               
    3,671.7     3,687.8     208.1     171.8     118.0     88.4     59.8     53.9

Manufacturing operations

    410.9     348.7     34.8     23.8     16.9     56.5     56.6     35.7

General corporate

    250.9     223.0     21.4     19.8     17.5     45.3     25.4     41.8
                                               

Total

  $ 4,333.5   $ 4,259.5   $ 264.3   $ 215.4   $ 152.4   $ 190.2   $ 141.8   $ 131.4
                                               

The increase in long-lived assets at December 31, 2008 compared to December 31, 2007 is primarily due to the Company’s 2008 Aczone ® asset acquisition and an increase in intangible licensing assets related to Sanctura ® , Restasis ® and Latisse TM products, all of which are reflected in the United States balance above, partially offset by a decrease in goodwill related to the Esprit acquisition. Long-lived assets related to the Esprit acquisition, including goodwill and intangible assets, are reflected in the United States balance above. Long-lived assets related to the EndoArt acquisition, including goodwill and intangible assets, are reflected in the Europe balance above. Goodwill and intangible assets related to the Cornéal acquisition are reflected in the Europe balance above. All other long-lived assets related to the Cornéal acquisition are reflected in the manufacturing operations balance above.

The increase in United States depreciation and amortization for the year ended December 31, 2008 compared to the year ended December 31, 2007 primarily relates to amortization of acquired intangible assets associated with the Aczone ® asset acquisition and Esprit acquisition. The increase in United States depreciation and amortization for the year ended December 31, 2007 compared to the year ended December 31, 2006 primarily relates to amortization of acquired intangible assets associated with the Esprit and Inamed acquisitions. The increase in Europe depreciation and amortization for the year ended December 31, 2007 compared to the year ended December 31, 2006 primarily relates to amortization of acquired intangible assets associated with the EndoArt and Cornéal acquisitions.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Note 19:    Earnings Per Share

The table below presents the computation of basic and diluted earnings (loss) per share:

 

     Year Ended December 31,  
     2008    2007     2006  
    

(in millions, except

per share amounts)

 

Net earnings (loss):

       

Earnings (loss) from continuing operations

   $ 578.6    $ 501.0     $ (127.4 )

Loss from discontinued operations

          (1.7 )      
                       

Net earnings (loss)

   $ 578.6    $ 499.3     $ (127.4 )
                       

Weighted average number of shares issued

     304.1      305.1       293.8  

Net shares assumed issued using the treasury stock method for options and non-vested equity shares and share units outstanding during each period based on average market price

     2.3      3.5        

Dilutive effect of assumed conversion of convertible notes outstanding

          0.1        
                       

Diluted shares

     306.4      308.7       293.8  
                       

Basic earnings (loss) per share:

       

Continuing operations

   $ 1.90    $ 1.64     $ (0.43 )

Discontinued operations

                 
                       

Net basic earnings (loss) per share

   $ 1.90    $ 1.64     $ (0.43 )
                       

Diluted earnings (loss) per share:

       

Continuing operations

   $ 1.89    $ 1.62     $ (0.43 )

Discontinued operations

                 
                       

Net diluted earnings (loss) per share

   $ 1.89    $ 1.62     $ (0.43 )
                       

For the year ended December 31, 2008, options to purchase 11.4 million shares of common stock at exercise prices ranging from $47.32 to $65.63 per share were outstanding but were not included in the computation of diluted earnings per share because the effect from the assumed exercise of these options calculated under the treasury stock method would be anti-dilutive. There were no potentially diluted common shares related to the Company’s 2026 Convertible Notes for the year ended December 31, 2008, as the Company’s average stock price for the period was less than the conversion price of the notes.

For the year ended December 31, 2007, options to purchase 4.1 million shares of common stock at exercise prices ranging from $48.07 to $65.21 per share were outstanding but were not included in the computation of diluted earnings per share because the effect from the assumed exercise of these options calculated under the treasury stock method would be anti-dilutive.

For the year ended December 31, 2006, outstanding stock options to purchase approximately 20.2 million shares of common stock at exercise prices ranging from $6.50 to $63.76 per share were not included in the computation of diluted earnings per share because the Company incurred a loss from continuing operations and, as a result, the impact would be anti-dilutive. Additionally, for the year ended December 31, 2006, the effect of approximately 1.7 million common shares related to the Company’s Zero Coupon Convertible Senior Notes due 2022, which were fully converted or redeemed in 2006, was not included in the computation of diluted earnings per share because the Company incurred a loss from continuing operations and, as a result, the impact would be anti-dilutive. There were no potentially diluted common shares related to the Company’s 2026 Convertible Notes for the year ended December 31, 2006, as the Company’s average stock price for the period was less than the conversion price of the notes.

 

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ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

Note 20:    Comprehensive Income (Loss)

The following table summarizes the components of comprehensive income (loss) for the years ended December 31:

 

    2008     2007     2006  
    Before
Tax
Amount
    Tax
(Expense)
or
Benefit
    Net-of-
Tax
Amount
    Before
Tax
Amount
    Tax
(Expense)
or
Benefit
    Net-of-
Tax
Amount
    Before
Tax
Amount
    Tax
(Expense)
or
Benefit
    Net-of-
Tax
Amount
 
    (in millions)  

Foreign currency translation adjustments

  $ (39.1 )   $     $ (39.1 )   $ 46.9     $     $ 46.9     $ 24.9     $     $ 24.9  

Deferred holding gains on derivatives designated as cash flow hedges

                                        13.0       (5.1 )     7.9  

Amortization of deferred holding
gains on derivatives designated as
cash flow hedges

    (1.3 )     0.5       (0.8 )     (1.3 )     0.5       (0.8 )     (0.9 )     0.3       (0.6 )

Pension and postretirement benefit
plan adjustments:

                 

Net (loss) gain

    (190.3 )     64.5       (125.8 )     53.7       (15.2 )     38.5                    

Amortization

    6.5       (2.6 )     3.9       11.4       (3.9 )     7.5                    

Minimum pension liability adjustment

                                        2.3       (1.0 )     1.3  

Unrealized holding (loss) gain on available-for-sale securities

    (5.8 )     2.7       (3.1 )     0.8       (0.3 )     0.5       (0.9 )     0.3       (0.6 )
                                                                       

Other comprehensive (loss) income

  $ (230.0 )   $ 65.1       (164.9 )   $ 111.5     $ (18.9 )     92.6     $ 38.4     $ (5.5 )     32.9  
                                                     

Net earnings (loss)

        578.6           499.3           (127.4 )
                                   

Total comprehensive income (loss)

      $ 413.7         $ 591.9         $ (94.5 )
                                   

Note 21:    Subsequent Event

On February 4, 2009, the Company announced a restructuring plan that involves a workforce reduction of approximately 460 employees, primarily in the United States and Europe. The majority of the employees affected by the restructuring plan are U.S. urology sales and marketing personnel as a result of the Company’s decision to focus on the urology specialty and to seek a partner to promote Sanctura XR ® to general practitioners, and marketing personnel in the United States and Europe as the Company adjusts its back-office structures to a reduced short-term sales outlook for some businesses. Modest reductions are being made in other functions as the Company re-engineers its processes and increases productivity.

In addition, the Company has reviewed its stock option-related cost structure. The Company’s 2008 full-round employee stock option grant took place in February 2008 with a strike price of $64.47 versus a stock price of approximately $40 on the date of the announced restructuring. The Company’s Board of Directors has decided to accelerate the vesting and remove certain stock option expiration features for all employees holding the 2008 full-round employee stock options and to modify certain stock option expiration features for other stock options held by employees impacted by the restructuring plan.

 

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Table of Contents

ALLERGAN, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

 

The Company currently estimates that the total pre-tax charges resulting from the restructuring plan will be between $110 million and $117 million, of which $40 million to $45 million are expected to be cash expenditures. The remainder will be a non-cash charge associated with the acceleration of previously unrecognized share-based compensation costs and any additional estimated costs associated with the modification of stock option grants as described above and certain other non-cash asset-related charges. These charges will be incurred beginning in the first quarter of 2009 and are expected to continue up through and including the fourth quarter of 2009. The Company expects the restructuring plan to be substantially completed by the end of the second quarter of 2009.

 

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Table of Contents

ALLERGAN, INC.

QUARTERLY RESULTS (UNAUDITED)

 

     First
Quarter
    Second
Quarter
    Third
Quarter
   Fourth
Quarter
    Total
Year
 
     (in millions, except per share data)  

2008 (a)

  

Product net sales

   $ 1,061.0     $ 1,155.8     $ 1,081.9    $ 1,041.0     $ 4,339.7  

Total revenues

     1,076.6       1,172.0       1,098.2      1,056.6       4,403.4  

Operating income

     166.0       209.0       237.4      183.7       796.1  

Earnings from continuing operations before income taxes
and minority interest(c)

     155.6       196.1       239.3      196.2       787.2  

Net earnings

     111.4       147.3       169.3      150.6       578.6  

Basic earnings per share

     0.37       0.48       0.56      0.50       1.90  

Diluted earnings per share

     0.36       0.48       0.55      0.50       1.89  

2007 (b)

           

Product net sales

   $ 862.6     $ 962.6     $ 978.7    $ 1,075.1     $ 3,879.0  

Total revenues

     876.7       977.9       993.7      1,090.6       3,938.9  

Operating income

     96.9       183.6       220.5      218.4       719.4  

Earnings from continuing operations before income taxes
and minority interest(d)

     91.4       176.2       211.3      208.8       687.7  

Earnings from continuing operations

     44.8       139.0       156.0      161.2       501.0  

(Loss) earnings from discontinued operations

     (1.0 )     (1.2 )     1.4      (0.9 )     (1.7 )

Net earnings

     43.8       137.8       157.4      160.3       499.3  

Basic earnings (loss) per share:

           

Continuing operations

     0.15       0.46       0.51      0.53       1.64  

Discontinued operations

     (0.01 )     (0.01 )          (0.01 )      

Net basic earnings per share

     0.14       0.45       0.51      0.52       1.64  

Diluted earnings (loss) per share:

           

Continuing operations

     0.15       0.45       0.50      0.52       1.62  

Discontinued operations

     (0.01 )           0.01             

Net diluted earnings per share

     0.14       0.45       0.51      0.52       1.62  

 

 

(a) Fiscal quarters in 2008 ended on March 31, June 30, September 30 and December 31.

 

(b) Fiscal quarters in 2007 ended on March 30, June 29, September 28 and December 31.

 

(c) Includes 2008 pre-tax charges for the following items:

 

     Quarter     
     First    Second    Third     Fourth    Total
     (in millions)

Amortization of acquired intangible assets

   $ 34.9    $ 35.8    $ 39.3     $ 40.9    $ 150.9

Restructuring charges (reversal)

     28.4      9.4      (0.2 )     3.7      41.3

Integration and transition costs

     0.6      1.3      0.1       0.2      2.2

Termination benefits, asset impairments and accelerated
depreciation costs related to the phased closure of the
Arklow manufacturing facility

     0.7      0.3      4.8       4.2      10.0

Esprit fair market value inventory adjustment rollout

     6.7      5.0                 11.7

External costs associated with responding to the U.S.
Department of Justice subpoena

          9.0      6.7       10.0      25.7

Upfront payments for technologies that have not achieved
regulatory approval

          13.9      6.3       48.5      68.7

Settlement of a distribution agreement in Korea

                     13.2      13.2

Impairment of intangible asset

                     5.6      5.6

 

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Table of Contents

ALLERGAN, INC.

QUARTERLY RESULTS (UNAUDITED) — (Continued)

 

(d) Includes 2007 pre-tax charges for the following items:

 

     Quarter     
     First    Second    Third    Fourth    Total
     (in millions)     

In-process research and development charge

   $ 72.0    $    $    $    $ 72.0

Amortization of acquired intangible assets

     28.4      29.0      28.7      35.2      121.3

Restructuring charges

     3.2      10.1      11.0      2.5      26.8

Integration and transition costs

     5.4      3.8      2.1      3.4      14.7

Cornéal fair market value inventory adjustment rollout

               0.5           0.5

Esprit fair market value inventory adjustment rollout

                    2.8      2.8

Legal settlement of a patent dispute

          6.4                6.4

Settlement of pre-existing Cornéal distribution contract

     2.3                     2.3

 

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Table of Contents

SCHEDULE II

ALLERGAN, INC.

VALUATION AND QUALIFYING ACCOUNTS

Years Ended December 31, 2008, 2007 and 2006

 

Allowance for Doubtful Accounts

Deducted from Trade Receivables

   Balance at
Beginning
of Year
   Additions(a)    Deductions(b)     Other(c)    Balance
at End
of Year
     (in millions)

2008

   $ 21.4    $ 12.6    $ (2.6 )   $    $ 31.4

2007

     15.8      5.3      (3.4 )     3.7      21.4

2006

     4.4      7.6      (2.6 )     6.4      15.8

 

 

(a) Provision charged to earnings.

 

(b) Accounts written off, net of recoveries.

 

(c) Allowance for doubtful accounts acquired as part of the Esprit, Cornéal and Inamed acquisitions, net of amounts disposed as part of discontinued operations, as applicable.

 

F-57

Exhibit 4.2

LOGO


This certificate also evidences and entitles the holder hereof to certain rights as set forth in an Agreement between Allergan, Inc. (the “Company”) and Wells Fargo Bank, NA., as successor Rights Agent, dated as of January 25, 2000, as the same may be amended from time to time (the “Agreement”), the terms of which are hereby incorporated herein by reference and a copy of which is on file at the principal executive offices of the Company. Under certain circumstances, as set forth in the Agreement, such Rights will be evidenced by separate certificates and will no longer be evidenced by this certificate. The Company will mail to the holder of this certificate a copy of the Agreement without charge after receipt of a written request therefor. As described in the Agreement, Rights which are owned by, transferred to or have been owned by Acquiring Persons or Associates or Affiliates thereof (as defined in the Agreement) shall become null and void and will no longer be transferable.

The Corporation shall furnish without charge to each stockholder who so requests a statement of the powers, designations, preferences and relative, participating, optional, or other special rights of each class of stock of the Corporation or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights. Such requests shall be made to the Corporation’s Secretary at the principal office of the Corporation.

KEEP THIS CERTIFICATE IN A SAFE PLACE. IF IT IS LOST, STOLEN OR DESTROYED, THE CORPORATION WILL REQUIRE A BOND OF INDEMNITY AS A CONDITION TO THE ISSUANCE OF A REPLACEMENT CERTIFICATE.

The following abbreviations, when used in the inscription on the face of this certificate, shall be construed as though they were written out in full according to applicable laws or regulations:

 

TEN COM

     as tenants in common    UNIF GIFT MIN ACT —  

 

  Custodian   

 

 

TEN ENT

     as tenants by the entireties      (Cust)      (Minor)  

JT TEN

     as joint tenants with right of      under Uniform Gifts to Minors  
     survivorship and not as tenants      Act  

 

 
     in common           (State)  
           UNIF TRF MIN ACT —  

 

  Custodian (until age   

 

  )
             (Cust)       
            

 

  under Uniform Transfers
             (Minor)       
             to Minors Act  

 

                 (State)  

Additional abbreviations may also be used though not in the above list.

FOR VALUE RECEIVED,                                          hereby sell, assign and transfer unto

 

PLEASE INSERT SOCIAL SECURITY OR OTHER

IDENTIFYING NUMBER OF ASSIGNEE

 

       
         
       

 

 

(PLEASE PRINT OR TYPEWRITE NAME AND ADDRESS, INCLUDING ZIP CODE, OF ASSIGNEE)

 

 

 

 

Shares

of the common stock represented by the within Certificate, and do hereby irrevocably constitute and appoint

 

 

Attorney

to transfer the said stock on the books of the within named Corporation with full power of substitution in the premises.  

 

Dated  

 

  

 

  X  

 

  X  

 

  NOTICE:  

THE SIGNATURE(S) TO THIS ASSIGNMENT MUST CORRESPOND WITH THE NAME(S) AS WRITTEN UPON THE FACE OF THE CERTIFICATE IN EVERY PARTICULAR, WITHOUT ALTERATION OR ENLARGEMENT OR ANY CHANGE WHATEVER.

Signature(s) Guaranteed

 

By  

 

  

THE SIGNATURE(S) MUST BE GUARANTEED BY AN ELIGIBLE GUARANTOR INSTITUTION (BANKS, STOCKBROKERS, SAVINGS AND LOAN ASSOCIATIONS AND CREDIT UNIONS WITH MEMBERSHIP IN AN APPROVED SIGNATURE GUARANTEE MEDALLION PROGRAM), PURSUANT TO S.E.C. RULE 17Ad-15.

  

EXHIBIT 10.2

AMENDED AND RESTATED CHANGE IN CONTROL AGREEMENT

This Agreement (“Agreement”) dated as of                      ,                      , is entered into by and between «Emply_NameFirst» «Employee_Last_Name» (“Employee”), and Allergan, Inc., a Delaware corporation (the “Company”).

RECITALS

The Company believes that because of its position in the industry, financial resources and historical operating results there is a possibility that the Company may become the subject of a Change in Control (as defined below), either now or at some time in the future.

The Company believes that it is in the best interest of the Company and its stockholders to foster Employee’s objectivity in making decisions with respect to any pending or threatened Change in Control of the Company and to assure that the Company will have the continued dedication and availability of Employee as an employee of the Company or one of its affiliates, notwithstanding the possibility, threat or occurrence of a Change in Control. The Company believes that these goals can be accomplished by alleviating certain of the risks and uncertainties with regard to Employee’s financial and professional security that would be created by a pending or threatened Change in Control and that inevitably would distract Employee and could impair his or her ability to objectively perform his or her duties for and on behalf of the Company. Accordingly, the Company believes that it is appropriate and in the best interest of the Company and its stockholders to provide to Employee compensation arrangements upon a Change in Control that lessen Employee’s financial risks and uncertainties and that are competitive with those of other corporations.

With these and other considerations in mind, the Board of Directors of the Company, acting through its Organization and Compensation Committee, has authorized the Company to enter into this Agreement with Employee to provide the protections set forth herein for Employee’s financial security following a Change in Control.

NOW, THEREFORE, in consideration of the foregoing, it is hereby agreed as follows:

1.       Term of Agreement .     This Agreement shall be effective for the period commencing on the date first written above and ending on the second anniversary of such date. The Company may, in its sole discretion and for any reason, provide written notice of termination (effective as of the then applicable expiration date) to Employee no later than 60 days before the expiration date of this Agreement. If written notice is not so provided, this Agreement shall be automatically extended for an additional period of 12 months past the expiration date. This Agreement shall continue to be automatically extended for an additional 12 months at the end of such 12-month period and each succeeding 12-month period unless notice is given in the manner described in this Section. No termination of this Agreement shall affect Employee’s rights hereunder with respect to a Change in Control which has occurred prior to such termination.

 

1


2.     Purpose of Agreement .   The purpose of this Agreement is to provide that, in the event of a “Change in Control,” Employee may become entitled to receive certain additional benefits, as described herein, in the event of his or her termination.

3.     Change in Control .     As used in this Agreement, the phrase “Change in Control” shall mean the following and shall be deemed to occur if any of the following events occur:

(a)     Any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (a “Person”), is or becomes the “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act (a “Beneficial Owner”), directly or indirectly, of securities of the Company representing (i) 20% or more of the combined voting power of the Company’s then outstanding voting securities, which acquisition is not approved in advance of the acquisition or within 30 days after the acquisition by a majority of the Incumbent Board (as hereinafter defined) or (ii) 33% or more of the combined voting power of the Company’s then outstanding voting securities, without regard to whether such acquisition is approved by the Incumbent Board;

(b)     Individuals who, as of the date hereof, constitute the Board of Directors of the Company (the “Incumbent Board”), cease for any reason to constitute at least a majority of the Board of Directors, provided that any person becoming a director subsequent to the date hereof whose election, or nomination for election by the Company’s stockholders, is approved by a vote of at least a majority of the directors then comprising the Incumbent Board (other than an election or nomination of an individual whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of the directors of the Company, as such terms are used Rule 14a-11 of Regulation 14A promulgated under the Exchange Act) shall, for the purposes of this Agreement, be considered as though such person were a member of the Incumbent Board of the Company;

(c)     The consummation of a merger, consolidation or reorganization involving the Company, other than one which satisfies both of the following conditions:

(1)     a merger, consolidation or reorganization which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of another entity) at least 55% of the combined voting power of the voting securities of the Company or such other entity resulting from the merger, consolidation or reorganization (the “Surviving Corporation”) outstanding immediately after such merger, consolidation or reorganization and being held in substantially the same proportion as the ownership in the Company’s voting securities immediately before such merger, consolidation or reorganization, and

(2)     a merger, consolidation or reorganization in which no Person is or becomes the Beneficial Owner directly or indirectly, of securities of the

 

2


Company representing 20% or more of the combined voting power of the Company’s then outstanding voting securities; or

(d)     The stockholders of the Company approve a plan of complete liquidation of the Company or an agreement for the sale or other disposition by the Company of all or substantially all of the Company’s assets.

Notwithstanding the preceding provisions of this Section, a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this Section is (1) an underwriter or underwriting syndicate that has acquired the ownership of any of the Company’s then outstanding voting securities solely in connection with a public offering of the Company’s securities, (2) the Company or any subsidiary of the Company or (3) an employee stock ownership plan or other employee benefit plan maintained by the Company (or any of its affiliated companies) that is qualified under the provisions of the Internal Revenue Code of 1986, as amended. In addition, notwithstanding the preceding provisions of this Section, a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this Section becomes a Beneficial Owner of more than the permitted amount of outstanding securities as a result of the acquisition of voting securities by the Company which, by reducing the number of voting securities outstanding, increases the proportional number of shares beneficially owned by such Person, provided, that if a Change in Control would occur but for the operation of this sentence and such Person becomes the Beneficial Owner of any additional voting securities (other than through the exercise of options granted under any stock option plan of the Company or through a stock dividend or stock split), then a Change in Control shall occur.

4.     Effect of a Change in Control .     In the event of a Change in Control, Sections 6 through 10 of this Agreement shall become applicable to Employee. These Sections shall continue to remain applicable until the second anniversary of the date upon which the Change in Control occurs. At that point, so long as the employment of Employee has not been terminated on account of a Qualifying Termination, as defined in Section 5, this Agreement shall terminate and be of no further force. If Employee’s employment with the Company and its affiliated companies is terminated on account of a Qualifying Termination on or before such date, this Agreement shall remain in effect until Employee receives the various benefits to which he or she has become entitled under the terms of this Agreement.

5.     Qualifying Termination .     If, subsequent to a Change in Control Employee’s employment with the Company and its affiliated companies is terminated, such termination shall be considered a Qualifying Termination unless:

(a)       Employee voluntarily terminates his or her employment with the Company and its affiliated companies. Employee, however, shall not be considered to have voluntarily terminated his or her employment with the Company and its affiliated companies if, following the Change in Control, Employee’s overall compensation is reduced or adversely modified in any material respect or Employee’s duties are materially changed, and subsequent to such reduction, modification or change, Employee elects to terminate his or her employment with the Company and its affiliated companies. For such purposes, Employee’s duties shall be considered to have been “materially changed” if, without Employee’s express written consent, there is any substantial diminution or

 

3


adverse modification in Employee’s overall position, responsibilities or reporting relationship, or if, without Employee’s express written consent, Employee’s job location is transferred to a site more than 50 miles away from his or her place of employment prior to the Change in Control.

(b)     The termination is on account of Employee’s death or Disability. For such purposes, “Disability” shall mean a physical or mental incapacity as a result of which Employee becomes unable to continue the performance of his or her responsibilities for the Company and its affiliated companies and which, at least 26 weeks after its commencement, is determined to be total and permanent by a physician agreed to by the Company and Employee, or in the event of Employee’s inability to designate a physician, Employee’s legal representative. In the absence of agreement between the Company and Employee, each party shall nominate a qualified physician and the two physicians so nominated shall select a third physician who shall make the determination as to Disability.

(c)     Employee is involuntarily terminated for “cause.” For this purpose, “cause” shall be limited to only three types of events:

(1)     the willful refusal of Employee to comply with a lawful, written instruction of the Board so long as the instruction is consistent with the scope and responsibilities of Employee’s position prior to the Change in Control;

(2)     dishonesty by Employee which results in a material financial loss to the Company (or to any of its affiliated companies) or material injury to its public reputation (or to the public reputation of any of its affiliated companies); or

(3)     Employee’s conviction of any felony involving an act of moral turpitude.

In addition, notwithstanding anything contained in this Agreement to the contrary, if Employee’s employment is terminated prior to a Change in Control and it is determined that such termination (i) was at the request of a third party who has indicated an intention or taken steps reasonably calculated to effect a Change in Control and who subsequently effectuates a Change in Control (a “Third Party”) or (ii) otherwise occurred in connection with, or in anticipation of, a Change in Control which actually occurs, then, for all purposes of this Agreement, the date of a Change in Control with respect to Employee shall mean the date immediately prior to the date of such termination of Employee’s employment.

6.     Severance Payment .   If Employee’s employment is terminated as a result of a Qualifying Termination, the Company shall pay Employee within 30 days after the Qualifying Termination, or such other period as may be required by the applicable tax laws, a cash lump sum equal to «No» [«Nu»] times Employee’s “Compensation” (the “Severance Payment”).

(a)     For purposes of this Agreement, and subject to Sections 6 (c ), (d) and (e), below, Employee’s “Compensation” shall equal the sum of (i) Employee’s highest annual salary rate within the five-year period ending on the date of

 

4


Employee’s Qualifying Termination plus (ii) a “Management Bonus Increment.” The Management Bonus Increment shall equal the average of the two highest of the last five bonuses paid to Employee under the Management Bonus Plan or any successor thereto.

(b)     In lieu of a cash lump sum, Employee may elect to receive the Severance Payment provided by this Section in equal annual installments over two (2) or three (3) years at Employee’s election in accordance with the applicable tax laws. Such installments shall be paid to Employee on each anniversary of the date of Employee’s Qualifying Termination, beginning with the first such anniversary and continuing on each such anniversary thereafter until fully paid. Such election to receive the Severance Payment in installments, and the number of installments to receive, may be made and/or revoked by Employee at any time prior to the occurrence of a Change in Control by written notice to the Secretary of the Company. Upon the occurrence of a Change in Control, any such election to receive the Severance Payment in installments that has been made and not revoked prior to the Change in Control shall be irrevocable and binding on both the Company and Employee. In the event that at the time of a Change in Control there is not in effect an election by Employee to receive the Severance Payment in installments, such Severance Payment shall be paid to Employee in a single cash lump sum as provided above.

(c)     If Employee has not participated in the Management Bonus Plan (including any successor thereto) for at least two full plan years, then the missing bonus component(s) will be computed, for purposes of calculating the Management Bonus Increment under this Agreement, by reference to the guideline percentage for officers at Employee’s grade level for the most recently completed bonus period, assuming a 100% target bonus for both corporate and individual objectives.

(d)     If Employee’s normal severance payment under the Company’s applicable severance pay policies for a reduction in force would be greater than the Compensation described in Section 6(a), above, then Employee’s “Compensation” for purposes of Section 6(a) shall be such greater amount.

(e)     The Severance Payment hereunder is in lieu of any severance payment that Employee might otherwise be entitled to from the Company under the Company’s applicable severance pay policies.

7.     Incentive Compensation Grants .   Employee may have received stock option grants, grants of restricted stock or other incentive compensation awards under the Allergan, Inc. 1989 Incentive Compensation Plan or other incentive compensation plans of the Company (collectively the “Incentive Plans”). In the event of a Qualifying Termination, the Company agrees that any and all such stock options, restricted stock and other incentive compensation awards that are outstanding at the time of such termination and that have not previously become exercisable, payable or free from restrictions, as the case may be, shall immediately become exercisable, payable or free from restrictions (other than restrictions required by applicable law or any national securities exchange upon which any securities of the Company are then listed), as the case may be, in their entirety, and that the exercise period of any stock option or other incentive award granted pursuant to any of the Incentive Plans shall continue for the

 

5


length of the exercise period specified in the grant of the award determined without regard to Employee’s termination of employment.

8.     Retirement Plan .   In addition to any retirement benefits that might otherwise be due Employee under the Allergan, Inc. Savings and Investment Plan or any successor qualified defined contribution plan(s) maintained by the Company (the “SIP”) or under the Allergan, Inc. Executive Deferred Compensation Plan or any successor supplemental employee retirement plan(s) maintained by the Company (the “EDCP”), Employee shall receive additional payments from the Company calculated as set forth in this Section if Employee is terminated on account of a Qualifying Termination.

(a)     For another «No» [«Nu»] year(s) subsequent to the date of the Qualifying Termination, the Company shall pay Employee an amount equal to the Employer’s “Retirement Contributions” (not including matching contributions) to the SIP and the “Retirement Contribution Restoration Credits” to the EDCP that would have been received if Employee had continued working. For the purpose of the preceding sentence, Employee shall be deemed to have received “Compensation” under the SIP and the EDCP for the period subsequent to the Qualifying Termination at an annual rate equal to his or her Compensation, as calculated under Section 6(a) of this Agreement. The payment(s) shall be paid by the Company at the time that the retirement contributions would have been credited by the Company under the SIP and the EDCP, or such other time as may be required by the applicable tax laws.

(b)     If Employee is not a participant in the SIP and/or the EDCP because he or she is an employee of an affiliate that does not participate in the SIP and/or the EDCP, Employee will be provided with the benefits contemplated by the provisions of this Section 8 as part of the retirement plan provided by the affiliate of the Company in which Employee is employed.

9.     Additional Benefits .   In the event of a Qualifying Termination, Employee shall be entitled to continue to participate in all of the employee benefit programs available to Employee before the Qualifying Termination, including but not limited to, group medical insurance, group dental insurance, group-term life insurance, disability insurance, flat miscellaneous allowance, and tax and financial planning. In addition, Employee shall receive Executive Outplacement benefits of a type and duration generally provided to executives at Employee’s level, provided that such benefits are provided on or before the last day of the second year following the year in which the Qualifying Termination occurred, or such other time as may be permitted under Code Section 409A. These programs shall be continued at no cost to Employee, except to the extent that tax rules require the inclusion of the value of such benefits in Employee’s income. The programs shall be continued in the same way and at the same level as immediately prior to the Qualifying Termination. If Employee is employed by an affiliate of the Company that does not provide the additional benefits enumerated, Employee shall be entitled to continue to participate in the employee benefit programs in which Employee had been participating prior to the Qualifying Termination. The programs shall continue for «No» [«Nu»] year(s).

10.     Indemnification for Excise Tax .   In the event that Employee becomes entitled to receive a Severance Payment in accordance with the provisions of Section 6 above, and such Severance Payment or any other benefits or payments (including transfers of

 

6


Property) that Employee receives, or is to receive, pursuant to this Agreement or any other agreement, plan or arrangement with the Company in connection with a Change in Control of the Company (“Other Benefits”) shall be subject to the tax imposed pursuant to Section 4999 of the Internal Revenue Code of 1986, as amended (the “Code”) (or any successor thereto) or any comparable provision of state law (an “Excise Tax”), the following rules shall apply:

(a)     The Company shall pay to Employee, within 30 days after Employee’s Qualifying Termination, or such other period as may be required by the applicable tax laws, an additional amount (the “Gross-Up Payment”) such that the net amount retained by Employee, after deduction of any Excise Tax with respect to the Severance Payments or the Other Benefits and any federal, state and local income tax, employment tax and Excise Tax upon such Gross-Up Payment, is equal to the amount that would have been retained by Employee if such Excise Tax were not applicable, as determined by the accounting firm (the “Auditors”) serving as the Company’s independent registered public accounting firm immediately prior to the Change in Control. It is intended that Employee shall not suffer any loss or expense resulting from the assessment of any Excise Tax or the Company’s reimbursement of Employee for payment of any such Excise Tax.

(b)     For purposes of determining whether any of the Severance Payments or Other Benefits will be subject to an Excise Tax and the amount of such Excise Tax, (i) any other payment or benefits received or to be received by Employee in connection with a Change in Control of the Company or Employee’s termination of employment (whether pursuant to the terms of this Agreement or any other plan, arrangement or agreement with the Company, any person whose actions result in a Change in Control or any person affiliated with the Company or such person) shall be treated as “parachute payments” within the meaning of Section 280G(b)(2) of the Code (or any successor thereto), and all “excess parachute payments” within the meaning of Section 280G(b)(1) of the Code (or any successor thereto) shall be treated as subject to the Excise Tax, unless in the opinion of tax counsel selected by the Auditors and acceptable to Employee such other payments or benefits (in whole or in part) do not constitute parachute payments, or such excess parachute payments (in whole or in part) represent reasonable compensation for services actually rendered within the meaning of Section 280G(b)(4) of the Code (or any successor thereto), (ii) the amount of the Severance Payments and Other Benefits which shall be treated as subject to the Excise Tax shall be equal to the lesser of (A) the total amount of the Severance Payments or Other Benefits or (B) the amount of excess parachute payments within the meaning of Sections 280G(b)(1) and (4) of the Code (or any successor or successors thereto), after applying clause (i), above, and (iii) the value of any non-cash benefits or any deferred payment or benefit shall be determined by the Auditors in accordance with the principles of Sections 280G(d)(3) and (4) of the Code (or any successor or successors thereto).

(c)     For purposes of determining the amount of the Gross-Up Payment, Employee shall be deemed to pay federal income taxes at the highest marginal rate of federal income taxation in the calendar year in which the Gross-Up Payment is to be made and state and local income taxes at the highest marginal rates of taxation in the state and locality of Employee’s residence on the date of Employee’s Qualifying Termination, net of the maximum reduction in federal

 

7


income taxes which could be obtained from deduction of such state and local taxes.

(d)     In the event that the Excise Tax is subsequently determined to be less than the amount taken into account hereunder at the time of Employee’s Qualifying Termination, Employee shall repay to the Company, at the time that the amount of such reduction in Excise Tax is finally determined, the portion of the Gross-Up Payment attributable to such reduction plus interest on the amount of such repayment at the rate provided in Section 1274(b)(2)(B) of the Code (or any successor thereto) (the “Applicable Rate”). In the event that the Excise Tax is determined to exceed the amount taken into account hereunder at the time of such Qualifying Termination (including by reason of any payment the existence or amount of which cannot be determined at the time of the Gross-Up Payment), the Company shall make an additional Gross-Up Payment in respect of such excess (plus interest, determined at the Applicable Rate, payable with respect to such excess) at the time that the amount of such excess is finally determined.

11.     Rights and Obligations Prior to a Change in Control .   Except as otherwise provided in the last paragraph of Section 5, prior to a Change in Control, the rights and obligations of Employee with respect to his or her employment by the Company shall be determined in accordance with the policies and procedures adopted from time to time by the Company and the provisions of any written employment contract in effect between the Company and Employee from time to time. Except as otherwise provided in the last paragraph of Section 5, this Agreement deals only with certain rights and obligations of Employee subsequent to a Change in Control, and the existence of this Agreement shall not be treated as raising any inference with respect to what rights and obligations exist prior to a Change in Control. Unless otherwise expressly set forth in a separate employment agreement between Employee and the Company, the employment of Employee is at-will, and Employee or the Company may terminate Employee’s employment with the Company at any time and for any reason, with or without cause, provided that if such termination occurs within two years after a Change in Control and constitutes a Qualifying Termination (as defined in Section 5 above) the provisions of this Agreement shall govern the payment of the Severance Payment and certain other benefits as provided herein.

12.     Non-Exclusivity of Rights .   Subject to Section 6(d) above, nothing in this Agreement shall prevent or limit Employee’s continuing or future participation in any benefit, bonus, incentive or other plan or program provided by the Company or any of its affiliated companies and for which Employee may qualify, nor shall anything herein limit or otherwise affect (except as provided in Section 7 above) such rights as Employee may have under any stock option or other agreements with the Company or any of its affiliated companies. Except as otherwise provided in Section 6(d) above, amounts which are vested benefits or which Employee is otherwise entitled to receive under any plan or program of the Company or any of its affiliated companies at or subsequent to the date of any Qualified Termination shall be payable in accordance with such plan or program.

13.     Confidentiality Covenant .   Employee hereby agrees that Employee shall not, directly or indirectly, disclose or make available to any person, firm, corporation, association or other entity for any reason or purpose whatsoever, any Confidential Information (as hereinafter defined). Employee agrees that, upon termination of

 

8


Employee’s employment with the Company, all Confidential Information in Employee’s possession that is in written or other tangible form (together with all copies or duplicates thereof, including computer files) shall be returned to the Company and shall not be retained by Employee or furnished to any third party, in any form except as provided herein; provided , however , that Employee shall not be obligated to treat as confidential, or return to the Company copies of any Confidential Information that (i) was publicly known at the time of disclosure to Employee, (ii) becomes publicly known or available thereafter other than by any means in violation of this Agreement or any other duty owed to the Company by any person or entity, or (iii) is lawfully disclosed to Employee by a third party. As used in this Agreement, the term “Confidential Information” means: information disclosed to Employee or known by Employee as a consequence of or through Employee’s relationship with the Company, about the products, research and development efforts, regulatory efforts, manufacturing processes, customers, employees, business methods, public relations methods, organization, procedures or finances, including, without limitation, information of or relating to customer lists, of the Company and its affiliates.

14.     Non-Solicitation Covenant .     Employee hereby agrees that during Employee’s employment by the Company and for the period commencing on the date of termination of Employee’s employment with the Company and ending on the first anniversary thereof, Employee shall not, either on Employee’s own account or jointly with or as a manager, agent, officer, employee, consultant, partner, joint venturer, owner or shareholder or otherwise on behalf of any other person, firm or corporation, directly or indirectly solicit or attempt to solicit away from the Company any of its officers or employees or offer employment to any person who, on or during the six (6) months immediately preceding the date of such solicitation or offer, is or was an officer or employee of the Company; provided, however, that a general advertisement to which an employee of the Company responds shall in no event be deemed to result in a breach of this Section 14.

15.     Full Settlement .   The Company’s obligation to make the payments provided for in this Agreement and otherwise to perform its obligations hereunder shall not be affected by any set-off, counter-claim, recoupment, defense or other claim, right or action which the Company may have against Employee or others. In no event shall Employee be obligated to seek other employment or to take any other action by way of mitigation of the amounts payable to Employee under any of the provisions of this Agreement. The Company agrees to pay, to the full extent permitted by law, all legal fees and expenses which Employee may reasonably incur as a result of any contest (regardless of the outcome thereof) by the Company or others of the validity or enforceability of, or liability under, any provision of this Agreement or any guarantee of performance thereof (including as a result of any contest by Employee about the amount of any payment pursuant to Section 10 of this Agreement), plus in each case interest at the Applicable Rate (as defined in Section 10 above), unless the referee or the court, as the case may be, determines that the Employee’s material claims in such contest were frivolous or were asserted in bad faith, provided, however, that any payments made under this sentence shall, unless otherwise permitted by Treas. Reg. § 1.409A-1(b)(11), be limited to expenses incurred on or before December 31 of the second calendar year following the calendar year in which Employee’s termination of employment occurs and any payments be paid no later than December 31 of the third calendar year.

 

9


16.   Successors .

(a)     This Agreement is personal to Employee, and without the prior written consent of the Company shall not be assignable by Employee other than by will or the laws of descent and distribution. This Agreement shall inure to the benefit of and be enforceable by Employee’s legal representatives.

(b)     The rights and obligations of the Company under this Agreement shall inure to the benefit of and shall be binding upon the successors and assigns of the Company.

17.     Governing Law .     This Agreement is made and entered into in the State of California, and the laws of California shall govern its validity and interpretation in the performance by the parties hereto of their respective duties and obligations hereunder.

18.     Entire Agreement .     This Agreement constitutes the entire agreement between the parties respecting the benefits due Employee in the event of a Change in Control followed by a Qualifying Termination, and there are no representations, warranties or commitments, other than those set forth herein, which relate to such benefits. This Agreement supersedes any and all prior agreements between the parties respecting the benefits due Employee in the event of a Change in Control followed by a Qualifying Termination. This Agreement may be amended or modified only by an instrument in writing executed by all of the parties hereto.

19.     Dispute Resolution .

(a)     Any controversy or dispute between the parties involving the construction, interpretation, application or performance of the terms, covenants, or conditions of this Agreement or in any way arising under this Agreement (a “Covered Dispute”) shall, on demand by either of the parties by written notice served on the other party in the manner prescribed in Section 20 hereof, be referenced pursuant to the procedures described in California Code of Civil Procedure (“CCP”) Sections 638, et seq ., as they may be amended from time to time (the “Reference Procedures”), to a retired Judge from the Superior Court for the County of Los Angeles or the County of Orange for a decision.

(b)     The Reference Procedures shall be commenced by either party by the filing in the Superior Court of the State of California for the County of Orange of a petition pursuant to CCP Section 638(1) (a “Petition”).

Said Petition shall designate as a referee a Judge from the list of retired Los Angeles County and Orange County Superior Court Judges who have made themselves available for trial or settlement of civil litigation under said Reference Procedures. If the parties hereto are unable to agree on the designation of a particular retired Los Angeles County or Orange County Superior Court Judge or the designated Judge is unavailable or unable to serve in such capacity, request shall be made in said Petition that the Presiding or Assistant Presiding Judge of the Orange County Superior Court appoint as referee a retired Los Angeles County or Orange County Superior Court Judge from the aforementioned list.

 

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(c)     Except as hereafter agreed by the parties, the referee shall apply the law of California in deciding the issues submitted hereunder. Unless formal pleadings are waived by agreement among the parties and the referee, the moving party shall file and serve its complaint within 15 days from the date a referee is designated as provided herein, and the other party shall have 15 days thereafter in which to plead to said complaint. Each of the parties reserves its respective rights to allege and assert in such pleadings all claims, causes of action, contentions and defenses which it may have arising out of or relating to the general subject matter of the Covered Dispute that is being determined pursuant to the Reference Procedures. Reasonable notice of any motions before the referee shall be given, and all matters shall be set at the convenience of the referee. Discovery shall be conducted as the parties agree or as allowed by the referee. Unless waived by each of the parties, a reporter shall be present at all proceedings before the referee.

(d)     It is the parties’ intention by this Section 19 that all issues of fact and law and all matters of a legal and equitable nature related to any Covered Dispute will be submitted for determination by a referee designated as provided herein. Accordingly, the parties hereby stipulate that a referee designated as provided herein shall have all powers of a Judge of the Superior Court including, without limitation, the power to grant equitable and interlocutory and permanent injunctive relief.

(e)     Each of the parties specifically (i) consents to the exercise of jurisdiction over his or her person by a referee designated as provided herein with respect to any and all Covered Disputes; and (ii) consents to the personal jurisdiction of the California courts with respect to any appeal or review of the decision of any such referee.

(f)     Each of the parties acknowledges that the decision by a referee designated as provided herein shall be a basis for a judgment as provided in CCP Section 644 and shall be subject to exception and review as provided in CCP Section 645.

20.     Notices .   Any notice or communications required or permitted to be given to the parties hereto shall be delivered personally, sent via facsimile or via an overnight courier service or be sent by United States registered or certified mail, postage prepaid and return receipt requested, and addressed or delivered as follows, or as such other addresses the party addressed may have substituted by notice pursuant to this Section:

 

(a)

  

  If to the Company:

  

            Allergan, Inc.

     

            2525 Dupont Drive

     

            Irvine, California 92612

     

            Attn: General Counsel

(b)

  

  If to Employee:

  

            «Home_Address»

            «Home_Address»

            «City», «State» «Zipcode»

21.     Captions .   The captions of this Agreement are inserted for convenience and do not constitute a part hereof.

 

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22.     Severability .   In case any one or more of the provisions contained in this Agreement shall for any reason be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision of this Agreement, but this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein and there shall be deemed substituted for such invalid, illegal or unenforceable provision such other provision as will most nearly accomplish the intent of the parties to the extent permitted by the applicable law. In case this Agreement, or any one or more of the provisions hereof, shall be held to be invalid, illegal or unenforceable within any governmental jurisdiction or subdivision thereof, this Agreement or any such provision thereof shall not as a consequence thereof be deemed to be invalid, illegal or unenforceable in any other governmental jurisdiction or subdivision thereof.

23.     Counterparts .   This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which shall together constitute one in the same Agreement.

24.     Key Employee 6-Month Payment Delay .   Notwithstanding any contrary provision of this Agreement, if and to the extent any portion of any payment, compensation or other benefit provided to the Employee in connection with the termination of his or her employment is determined to constitute “nonqualified deferred compensation” within the meaning of Section 409A and he or she is a specified employee as defined in Code Section 409A(a)(2)(B)(i), as determined by the Company (or any successor) in accordance with its procedures, by which determination Employee hereby agrees that he or she is bound, such portion of the payment, compensation or other benefit shall not be paid before the earlier of (i) the day that is six (6) months plus one (1) day after his or her separation from service as determined under Section 409A, or (ii) fifteen (15) days after Employee’s death (the “New Payment Date”). The aggregate of any payments that otherwise would have been paid to him or her during the period between the separation from service and the New Payment Date shall be paid to him or her in a lump sum on such New Payment Date. Thereafter, any payments that remain outstanding as of the day immediately following the New Payment Date shall be paid without delay over the time period originally scheduled, in accordance with the terms of this Agreement. In any event, the Company makes no representations or warranties and shall have no liability to Employee or any other person if any provisions of or payments under this Agreement are determined to constitute deferred compensation subject to Code Section 409A but not to satisfy the conditions of that section.

 

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IN WITNESS HEREOF, the parties hereto have caused this Agreement to be duly executed and delivered as of the day and year first written above.

 

   

ALLERGAN, INC.

 
 

By:  

 

 

 
   

David E.I. Pyott

 
   

Chairman of the Board and

 
   

Chief Executive Officer

 
   

 

 
   

«Employee_Last_Name»

 
   

Employee

 

 

13

EXHIBIT 10.3

AMENDED AND RESTATED CHANGE IN CONTROL AGREEMENT

This Agreement (“Agreement”) dated as of                      ,                      , is entered into by and between «Emply_NameFirst» «Employee_Last_Name» (“Employee”), and Allergan, Inc., a Delaware corporation (the “Company”).

RECITALS

The Company believes that because of its position in the industry, financial resources and historical operating results there is a possibility that the Company may become the subject of a Change in Control (as defined below), either now or at some time in the future.

The Company believes that it is in the best interest of the Company and its stockholders to foster Employee’s objectivity in making decisions with respect to any pending or threatened Change in Control of the Company and to assure that the Company will have the continued dedication and availability of Employee as an employee of the Company or one of its affiliates, notwithstanding the possibility, threat or occurrence of a Change in Control. The Company believes that these goals can be accomplished by alleviating certain of the risks and uncertainties with regard to Employee’s financial and professional security that would be created by a pending or threatened Change in Control and that inevitably would distract Employee and could impair his or her ability to objectively perform his or her duties for and on behalf of the Company. Accordingly, the Company believes that it is appropriate and in the best interest of the Company and its stockholders to provide to Employee compensation arrangements upon a Change in Control that lessen Employee’s financial risks and uncertainties and that are competitive with those of other corporations.

With these and other considerations in mind, the Board of Directors of the Company, acting through its Organization and Compensation Committee, has authorized the Company to enter into this Agreement with Employee to provide the protections set forth herein for Employee’s financial security following a Change in Control.

NOW, THEREFORE, in consideration of the foregoing, it is hereby agreed as follows:

1.       Term of Agreement .     This Agreement shall be effective for the period commencing on the date first written above and ending on the second anniversary of such date. The Company may, in its sole discretion and for any reason, provide written notice of termination (effective as of the then applicable expiration date) to Employee no later than 60 days before the expiration date of this Agreement. If written notice is not so provided, this Agreement shall be automatically extended for an additional period of 12 months past the expiration date. This Agreement shall continue to be automatically extended for an additional 12 months at the end of such 12-month period and each succeeding 12-month period unless notice is given in the manner described in this

 

1


Section. No termination of this Agreement shall affect Employee’s rights hereunder with respect to a Change in Control which has occurred prior to such termination.

2.     Purpose of Agreement .     The purpose of this Agreement is to provide that, in the event of a “Change in Control,” Employee may become entitled to receive certain additional benefits, as described herein, in the event of his or her termination.

3.     Change in Control .     As used in this Agreement, the phrase “Change in Control” shall mean the following and shall be deemed to occur if any of the following events occur:

(a)   Any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (a “Person”), is or becomes the “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act (a “Beneficial Owner”), directly or indirectly, of securities of the Company representing (i) 20% or more of the combined voting power of the Company’s then outstanding voting securities, which acquisition is not approved in advance of the acquisition or within 30 days after the acquisition by a majority of the Incumbent Board (as hereinafter defined) or (ii) 33% or more of the combined voting power of the Company’s then outstanding voting securities, without regard to whether such acquisition is approved by the Incumbent Board;

(b)   Individuals who, as of the date hereof, constitute the Board of Directors of the Company (the “Incumbent Board”), cease for any reason to constitute at least a majority of the Board of Directors, provided that any person becoming a director subsequent to the date hereof whose election, or nomination for election by the Company’s stockholders, is approved by a vote of at least a majority of the directors then comprising the Incumbent Board (other than an election or nomination of an individual whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of the directors of the Company, as such terms are used Rule 14a-11 of Regulation 14A promulgated under the Exchange Act) shall, for the purposes of this Agreement, be considered as though such person were a member of the Incumbent Board of the Company;

(c)   The consummation of a merger, consolidation or reorganization involving the Company, other than one which satisfies both of the following conditions:

(1)   a merger, consolidation or reorganization which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of another entity) at least 55% of the combined voting power of the voting securities of the Company or such other entity resulting from the merger, consolidation or reorganization (the “Surviving Corporation”) outstanding immediately after such merger, consolidation or reorganization and being held in substantially the same proportion as the ownership in the Company’s voting securities immediately before such merger, consolidation or reorganization, and

 

2


(2)   a merger, consolidation or reorganization in which no Person is or becomes the Beneficial Owner directly or indirectly, of securities of the Company representing 20% or more of the combined voting power of the Company’s then outstanding voting securities; or

(d)     The stockholders of the Company approve a plan of complete liquidation of the Company or an agreement for the sale or other disposition by the Company of all or substantially all of the Company’s assets.

Notwithstanding the preceding provisions of this Section, a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this Section is (1) an underwriter or underwriting syndicate that has acquired the ownership of any of the Company’s then outstanding voting securities solely in connection with a public offering of the Company’s securities, (2) the Company or any subsidiary of the Company or (3) an employee stock ownership plan or other employee benefit plan maintained by the Company (or any of its affiliated companies) that is qualified under the provisions of the Internal Revenue Code of 1986, as amended. In addition, notwithstanding the preceding provisions of this Section, a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this Section becomes a Beneficial Owner of more than the permitted amount of outstanding securities as a result of the acquisition of voting securities by the Company which, by reducing the number of voting securities outstanding, increases the proportional number of shares beneficially owned by such Person, provided, that if a Change in Control would occur but for the operation of this sentence and such Person becomes the Beneficial Owner of any additional voting securities (other than through the exercise of options granted under any stock option plan of the Company or through a stock dividend or stock split), then a Change in Control shall occur.

4.   Effect of a Change in Control .   In the event of a Change in Control, Sections 6 through 10 of this Agreement shall become applicable to Employee. These Sections shall continue to remain applicable until the second anniversary of the date upon which the Change in Control occurs. At that point, so long as the employment of Employee has not been terminated on account of a Qualifying Termination, as defined in Section 5, this Agreement shall terminate and be of no further force. If Employee’s employment with the Company and its affiliated companies is terminated on account of a Qualifying Termination on or before such date, this Agreement shall remain in effect until Employee receives the various benefits to which he or she has become entitled under the terms of this Agreement.

5.   Qualifying Termination .   If, subsequent to a Change in Control Employee’s employment with the Company and its affiliated companies is terminated, such termination shall be considered a Qualifying Termination unless:

(a)         Employee voluntarily terminates his or her employment with the Company and its affiliated companies. Employee, however, shall not be considered to have voluntarily terminated his or her employment with the Company and its affiliated companies if, following the Change in Control, Employee’s overall compensation is reduced or adversely modified in any material respect or Employee’s duties are materially changed, and subsequent to such reduction, modification or change, Employee elects to terminate his or her employment with the Company and its affiliated companies. For such purposes,

 

3


Employee’s duties shall be considered to have been “materially changed” if, without Employee’s express written consent, there is any substantial diminution or adverse modification in Employee’s overall position, responsibilities or reporting relationship, or if, without Employee’s express written consent, Employee’s job location is transferred to a site more than 50 miles away from his or her place of employment prior to the Change in Control.

(b)   The termination is on account of Employee’s death or Disability. For such purposes, “Disability” shall mean a physical or mental incapacity as a result of which Employee becomes unable to continue the performance of his or her responsibilities for the Company and its affiliated companies and which, at least 26 weeks after its commencement, is determined to be total and permanent by a physician agreed to by the Company and Employee, or in the event of Employee’s inability to designate a physician, Employee’s legal representative. In the absence of agreement between the Company and Employee, each party shall nominate a qualified physician and the two physicians so nominated shall select a third physician who shall make the determination as to Disability.

(c)   Employee is involuntarily terminated for “cause.” For this purpose, “cause” shall be limited to only three types of events:

(1)   the willful refusal of Employee to comply with a lawful, written instruction of the Board so long as the instruction is consistent with the scope and responsibilities of Employee’s position prior to the Change in Control;

(2)   dishonesty by Employee which results in a material financial loss to the Company (or to any of its affiliated companies) or material injury to its public reputation (or to the public reputation of any of its affiliated companies); or

(3)   Employee’s conviction of any felony involving an act of moral turpitude.

In addition, notwithstanding anything contained in this Agreement to the contrary, if Employee’s employment is terminated prior to a Change in Control and it is determined that such termination (i) was at the request of a third party who has indicated an intention or taken steps reasonably calculated to effect a Change in Control and who subsequently effectuates a Change in Control (a “Third Party”) or (ii) otherwise occurred in connection with, or in anticipation of, a Change in Control which actually occurs, then, for all purposes of this Agreement, the date of a Change in Control with respect to Employee shall mean the date immediately prior to the date of such termination of Employee’s employment.

6.   Severance Payment .   If Employee’s employment is terminated as a result of a Qualifying Termination, the Company shall pay Employee within 30 days after the Qualifying Termination, or such other period as may be required by the applicable tax laws, a cash lump sum equal to «No» [«Nu»] times Employee’s “Compensation” (the “Severance Payment”).

 

4


(a)   For purposes of this Agreement, and subject to Sections 6 (c ), (d) and (e), below, Employee’s “Compensation” shall equal the sum of (i) Employee’s highest annual salary rate within the five-year period ending on the date of Employee’s Qualifying Termination plus (ii) a “Management Bonus Increment.” The Management Bonus Increment shall equal the average of the two highest of the last five bonuses paid to Employee under the Management Bonus Plan or any successor thereto.

(b)   In lieu of a cash lump sum, Employee may elect to receive the Severance Payment provided by this Section in equal annual installments over two (2) or three (3) years at Employee’s election in accordance with the applicable tax laws. Such installments shall be paid to Employee on each anniversary of the date of Employee’s Qualifying Termination, beginning with the first such anniversary and continuing on each such anniversary thereafter until fully paid. Such election to receive the Severance Payment in installments, and the number of installments to receive, may be made and/or revoked by Employee at any time prior to the occurrence of a Change in Control by written notice to the Secretary of the Company. Upon the occurrence of a Change in Control, any such election to receive the Severance Payment in installments that has been made and not revoked prior to the Change in Control shall be irrevocable and binding on both the Company and Employee. In the event that at the time of a Change in Control there is not in effect an election by Employee to receive the Severance Payment in installments, such Severance Payment shall be paid to Employee in a single cash lump sum as provided above.

(c)   If Employee has not participated in the Management Bonus Plan (including any successor thereto) for at least two full plan years, then the missing bonus component(s) will be computed, for purposes of calculating the Management Bonus Increment under this Agreement, by reference to the guideline percentage for officers at Employee’s grade level for the most recently completed bonus period, assuming a 100% target bonus for both corporate and individual objectives.

(d)   If Employee’s normal severance payment under the Company’s applicable severance pay policies for a reduction in force would be greater than the Compensation described in Section 6(a), above, then Employee’s “Compensation” for purposes of Section 6(a) shall be such greater amount.

(e)   The Severance Payment hereunder is in lieu of any severance payment that Employee might otherwise be entitled to from the Company under the Company’s applicable severance pay policies.

7.   Incentive Compensation Grants .   Employee may have received stock option grants, grants of restricted stock or other incentive compensation awards under the Allergan, Inc. 1989 Incentive Compensation Plan or other incentive compensation plans of the Company (collectively the “Incentive Plans”). In the event of a Qualifying Termination, the Company agrees that any and all such stock options, restricted stock and other incentive compensation awards that are outstanding at the time of such termination and that have not previously become exercisable, payable or free from restrictions, as the case may be, shall immediately become exercisable, payable or free from restrictions (other than restrictions required by applicable law or any national

 

5


securities exchange upon which any securities of the Company are then listed), as the case may be, in their entirety, and that the exercise period of any stock option or other incentive award granted pursuant to any of the Incentive Plans shall continue for the length of the exercise period specified in the grant of the award determined without regard to Employee’s termination of employment.

8.   Retirement Plan .   In addition to any retirement benefits that might otherwise be due Employee under the Allergan, Inc. Savings and Investment Plan or any successor qualified defined contribution plan(s) maintained by the Company (the “SIP”) or under the Allergan, Inc. Executive Deferred Compensation Plan or any successor supplemental employee retirement plan(s) maintained by the Company (the “EDCP”), Employee shall receive additional payments from the Company calculated as set forth in this Section if Employee is terminated on account of a Qualifying Termination.

(a)     For another «No» [«Nu»] year(s) subsequent to the date of the Qualifying Termination, the Company shall pay Employee an amount equal to the Employer’s “Retirement Contributions” (not including matching contributions) to the SIP and the “Retirement Contribution Restoration Credits” to the EDCP that would have been received if Employee had continued working. For the purpose of the preceding sentence, Employee shall be deemed to have received “Compensation” under the SIP and the EDCP for the period subsequent to the Qualifying Termination at an annual rate equal to his or her Compensation, as calculated under Section 6(a) of this Agreement. The payment(s) shall be paid by the Company at the time that the retirement contributions would have been credited by the Company under the SIP and the EDCP, or such other time as may be required by the applicable tax laws.

(b)     If Employee is not a participant in the SIP and/or the EDCP because he or she is an employee of an affiliate that does not participate in the SIP and/or the EDCP, Employee will be provided with the benefits contemplated by the provisions of this Section 8 as part of the retirement plan provided by the affiliate of the Company in which Employee is employed.

9.   Additional Benefits .   In the event of a Qualifying Termination, Employee shall be entitled to continue to participate in all of the employee benefit programs available to Employee before the Qualifying Termination, including but not limited to, group medical insurance, group dental insurance, group-term life insurance, disability insurance, flat miscellaneous allowance, and tax and financial planning. In addition, Employee shall receive Executive Outplacement benefits of a type and duration generally provided to executives at Employee’s level, provided that such benefits are provided on or before the last day of the second year following the year in which the Qualifying Termination occurred, or such other time as may be permitted under Code Section 409A. These programs shall be continued at no cost to Employee, except to the extent that tax rules require the inclusion of the value of such benefits in Employee’s income. The programs shall be continued in the same way and at the same level as immediately prior to the Qualifying Termination. If Employee is employed by an affiliate of the Company that does not provide the additional benefits enumerated, Employee shall be entitled to continue to participate in the employee benefit programs in which Employee had been participating prior to the Qualifying Termination. The programs shall continue for «No» [«Nu»] year(s).

 

6


10.   Parachute Payment Matters .   In the event that Employee becomes entitled to receive a Severance Payment in accordance with the provisions of Section 6 above, and such Severance Payment or any other benefits or payments (including transfers of Property) that Employee receives, or is to receive, pursuant to this Agreement or any other agreement, plan or arrangement with the Company in connection with a Change in Control of the Company (“Other Benefits”) would not be deductible by the Company by reason of Section 280G of the Internal Revenue Code of 1986, as amended (the “Code”) (or any successor thereto) or any comparable provision of state law, the following rules shall apply:

(a)   The Severance Payment shall be reduced (to zero if necessary) and, if the Severance Payment is reduced to zero, Other Benefits shall be reduced (to zero if necessary) until no portion of the Severance Payment and Other Benefits is not deductible by the Company by reason of Section 280G of the Code, provided , however, that (i) no such reduction shall be made unless the net after-tax benefit received by Employee after such reduction would exceed the net after-tax benefit received by Employee if no such reduction was made and (ii) if Other Benefits are required to be reduced, Employee shall be given the opportunity to select which Other Benefits shall be reduced.

(b)   All determinations under this Section 10 shall be made by the accounting firm (the “Auditors”) that is serving as the Company’s independent registered public accounting firm immediately prior to the Change in Control. For purposes of determining whether any of the Severance Payments or Other Benefits would not be deductible by the Company by reason of Section 280G and whether any of such payments shall be reduced pursuant to Section 10(a), (i) any other payment or benefits received or to be received by Employee in connection with a Change in Control of the Company or Employee’s termination of employment (whether pursuant to the terms of this Agreement or any other plan, arrangement or agreement with the Company, any person whose actions result in a Change in Control or any person affiliated with the Company or such person) shall be treated as “parachute payments” within the meaning of Section 280G(b)(2) of the Code (or any successor thereto), and all “excess parachute payments” within the meaning of Section 280G(b)(1) of the Code (or any successor thereto) shall be treated as being nondeductible by the Company by reason of Section 280G, unless in the opinion of tax counsel selected by the Auditors and acceptable to Employee such other payments or benefits (in whole or in part) do not constitute parachute payments, or such excess parachute payments (in whole or in part) represent reasonable compensation for services actually rendered within the meaning of Section 280G(b)(4) of the Code (or any successor thereto), (ii) the amount of the Severance Payments and Other Benefits which shall be treated as nondeductible by reason of Section 280G shall be equal to the lesser of (A) the total amount of the Severance Payments or Other Benefits or (B) the amount of excess parachute payments within the meaning of Sections 280G(b)(1) and (4) of the Code (or any successor or successors thereto), after applying clause (i), above, and (iii) the value of any non-cash benefits or any deferred payment or benefit shall be determined by the Auditors in accordance with the principles of Sections 280G(d)(3) and (4) of the Code (or any successor or successors thereto).

 

7


(c)   For purposes of determining Employee’s net after-tax benefits under Section 10(a), Employee shall be deemed to pay federal income taxes at the highest marginal rate of federal income taxation in the calendar year in which the “parachute payments” are to be made and state and local income taxes at the highest marginal rates of taxation in the state and locality of Employee’s residence on the date of Employee’s Qualifying Termination, net of the maximum reduction in federal income taxes which could be obtained from deduction of such state and local taxes.

(d)   For purposes of making the determinations and calculations required herein, the Auditors and any tax counsel selected by the Auditors may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999 of the Code, provided that the Auditors’ determinations must be made on the basis of “substantial authority” (within the meaning of Section 6662 of the Code). All fees and expenses of the Auditors shall be borne solely by the Company.

11.   Rights and Obligations Prior to a Change in Control .   Except as otherwise provided in the last paragraph of Section 5, prior to a Change in Control, the rights and obligations of Employee with respect to his or her employment by the Company shall be determined in accordance with the policies and procedures adopted from time to time by the Company and the provisions of any written employment contract in effect between the Company and Employee from time to time. Except as otherwise provided in the last paragraph of Section 5, this Agreement deals only with certain rights and obligations of Employee subsequent to a Change in Control, and the existence of this Agreement shall not be treated as raising any inference with respect to what rights and obligations exist prior to a Change in Control. Unless otherwise expressly set forth in a separate employment agreement between Employee and the Company, the employment of Employee is at-will, and Employee or the Company may terminate Employee’s employment with the Company at any time and for any reason, with or without cause, provided that if such termination occurs within two years after a Change in Control and constitutes a Qualifying Termination (as defined in Section 5 above) the provisions of this Agreement shall govern the payment of the Severance Payment and certain other benefits as provided herein.

12.   Non-Exclusivity of Rights .   Subject to Section 6(d) above, nothing in this Agreement shall prevent or limit Employee’s continuing or future participation in any benefit, bonus, incentive or other plan or program provided by the Company or any of its affiliated companies and for which Employee may qualify, nor shall anything herein limit or otherwise affect (except as provided in Section 7 above) such rights as Employee may have under any stock option or other agreements with the Company or any of its affiliated companies. Except as otherwise provided in Section 6(d) above, amounts which are vested benefits or which Employee is otherwise entitled to receive under any plan or program of the Company or any of its affiliated companies at or subsequent to the date of any Qualified Termination shall be payable in accordance with such plan or program.

13.   Confidentiality Covenant .   Employee hereby agrees that Employee shall not, directly or indirectly, disclose or make available to any person, firm, corporation,

 

8


association or other entity for any reason or purpose whatsoever, any Confidential Information (as hereinafter defined). Employee agrees that, upon termination of Employee’s employment with the Company, all Confidential Information in Employee’s possession that is in written or other tangible form (together with all copies or duplicates thereof, including computer files) shall be returned to the Company and shall not be retained by Employee or furnished to any third party, in any form except as provided herein; provided , however , that Employee shall not be obligated to treat as confidential, or return to the Company copies of any Confidential Information that (i) was publicly known at the time of disclosure to Employee, (ii) becomes publicly known or available thereafter other than by any means in violation of this Agreement or any other duty owed to the Company by any person or entity, or (iii) is lawfully disclosed to Employee by a third party. As used in this Agreement, the term “Confidential Information” means: information disclosed to Employee or known by Employee as a consequence of or through Employee’s relationship with the Company, about the products, research and development efforts, regulatory efforts, manufacturing processes, customers, employees, business methods, public relations methods, organization, procedures or finances, including, without limitation, information of or relating to customer lists, of the Company and its affiliates.

14.   Non-Solicitation Covenant .   Employee hereby agrees that during Employee’s employment by the Company and for the period commencing on the date of termination of Employee’s employment with the Company and ending on the first anniversary thereof, Employee shall not, either on Employee’s own account or jointly with or as a manager, agent, officer, employee, consultant, partner, joint venturer, owner or shareholder or otherwise on behalf of any other person, firm or corporation, directly or indirectly solicit or attempt to solicit away from the Company any of its officers or employees or offer employment to any person who, on or during the six (6) months immediately preceding the date of such solicitation or offer, is or was an officer or employee of the Company; provided, however, that a general advertisement to which an employee of the Company responds shall in no event be deemed to result in a breach of this Section 14.

15.   Full Settlement .   The Company’s obligation to make the payments provided for in this Agreement and otherwise to perform its obligations hereunder shall not be affected by any set-off, counter-claim, recoupment, defense or other claim, right or action which the Company may have against Employee or others. In no event shall Employee be obligated to seek other employment or to take any other action by way of mitigation of the amounts payable to Employee under any of the provisions of this Agreement. The Company agrees to pay, to the full extent permitted by law, all legal fees and expenses which Employee may reasonably incur as a result of any contest (regardless of the outcome thereof) by the Company or others of the validity or enforceability of, or liability under, any provision of this Agreement or any guarantee of performance thereof (including as a result of any contest by Employee about the amount of any payment pursuant to Section 10 of this Agreement), plus in each case interest at the Applicable Rate (as defined in Section 10 above), unless the referee or the court, as the case may be, determines that the Employee’s material claims in such contest were frivolous or were asserted in bad faith, provided, however, that any payments made under this sentence shall, unless otherwise permitted by Treas. Reg. § 1.409A-1(b)(11), be limited to expenses incurred on or before December 31 of the second calendar year following the calendar year in which Employee’s termination of employment occurs and any payments be paid no later than December 31 of the third calendar year.

 

9


16.   Successors .

(a)   This Agreement is personal to Employee, and without the prior written consent of the Company shall not be assignable by Employee other than by will or the laws of descent and distribution. This Agreement shall inure to the benefit of and be enforceable by Employee’s legal representatives.

(b)   The rights and obligations of the Company under this Agreement shall inure to the benefit of and shall be binding upon the successors and assigns of the Company.

17.   Governing Law .   This Agreement is made and entered into in the State of California, and the laws of California shall govern its validity and interpretation in the performance by the parties hereto of their respective duties and obligations hereunder.

18.   Entire Agreement .   This Agreement constitutes the entire agreement between the parties respecting the benefits due Employee in the event of a Change in Control followed by a Qualifying Termination, and there are no representations, warranties or commitments, other than those set forth herein, which relate to such benefits. This Agreement supersedes any and all prior agreements between the parties respecting the benefits due Employee in the event of a Change in Control followed by a Qualifying Termination. This Agreement may be amended or modified only by an instrument in writing executed by all of the parties hereto.

19.   Dispute Resolution .

(a)   Any controversy or dispute between the parties involving the construction, interpretation, application or performance of the terms, covenants, or conditions of this Agreement or in any way arising under this Agreement (a “Covered Dispute”) shall, on demand by either of the parties by written notice served on the other party in the manner prescribed in Section 20 hereof, be referenced pursuant to the procedures described in California Code of Civil Procedure (“CCP”) Sections 638, et seq ., as they may be amended from time to time (the “Reference Procedures”), to a retired Judge from the Superior Court for the County of Los Angeles or the County of Orange for a decision.

(b)   The Reference Procedures shall be commenced by either party by the filing in the Superior Court of the State of California for the County of Orange of a petition pursuant to CCP Section 638(1) (a “Petition”).

Said Petition shall designate as a referee a Judge from the list of retired Los Angeles County and Orange County Superior Court Judges who have made themselves available for trial or settlement of civil litigation under said Reference Procedures. If the parties hereto are unable to agree on the designation of a particular retired Los Angeles County or Orange County Superior Court Judge or the designated Judge is unavailable or unable to serve in such capacity, request shall be made in said Petition that the Presiding or Assistant Presiding Judge of the Orange County Superior Court appoint as referee a retired Los Angeles County or Orange County Superior Court Judge from the aforementioned list.

 

10


(c)   Except as hereafter agreed by the parties, the referee shall apply the law of California in deciding the issues submitted hereunder. Unless formal pleadings are waived by agreement among the parties and the referee, the moving party shall file and serve its complaint within 15 days from the date a referee is designated as provided herein, and the other party shall have 15 days thereafter in which to plead to said complaint. Each of the parties reserves its respective rights to allege and assert in such pleadings all claims, causes of action, contentions and defenses which it may have arising out of or relating to the general subject matter of the Covered Dispute that is being determined pursuant to the Reference Procedures. Reasonable notice of any motions before the referee shall be given, and all matters shall be set at the convenience of the referee. Discovery shall be conducted as the parties agree or as allowed by the referee. Unless waived by each of the parties, a reporter shall be present at all proceedings before the referee.

(d)   It is the parties’ intention by this Section 19 that all issues of fact and law and all matters of a legal and equitable nature related to any Covered Dispute will be submitted for determination by a referee designated as provided herein. Accordingly, the parties hereby stipulate that a referee designated as provided herein shall have all powers of a Judge of the Superior Court including, without limitation, the power to grant equitable and interlocutory and permanent injunctive relief.

(e)   Each of the parties specifically (i) consents to the exercise of jurisdiction over his or her person by a referee designated as provided herein with respect to any and all Covered Disputes; and (ii) consents to the personal jurisdiction of the California courts with respect to any appeal or review of the decision of any such referee.

(f)   Each of the parties acknowledges that the decision by a referee designated as provided herein shall be a basis for a judgment as provided in CCP Section 644 and shall be subject to exception and review as provided in CCP Section 645.

20.   Notices .   Any notice or communications required or permitted to be given to the parties hereto shall be delivered personally, sent via facsimile or via an overnight courier service or be sent by United States registered or certified mail, postage prepaid and return receipt requested, and addressed or delivered as follows, or as such other addresses the party addressed may have substituted by notice pursuant to this Section:

 

(a)

  

  If to the Company:

  

            Allergan, Inc.

     

            2525 Dupont Drive

     

            Irvine, California 92612

     

            Attn: General Counsel

(b)

  

  If to Employee:

  

            «Home_Address»

            «Home_Address»

            «City», «State» «Zipcode»

 

11


21.   Captions .   The captions of this Agreement are inserted for convenience and do not constitute a part hereof.

22.   Severability .   In case any one or more of the provisions contained in this Agreement shall for any reason be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision of this Agreement, but this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein and there shall be deemed substituted for such invalid, illegal or unenforceable provision such other provision as will most nearly accomplish the intent of the parties to the extent permitted by the applicable law. In case this Agreement, or any one or more of the provisions hereof, shall be held to be invalid, illegal or unenforceable within any governmental jurisdiction or subdivision thereof, this Agreement or any such provision thereof shall not as a consequence thereof be deemed to be invalid, illegal or unenforceable in any other governmental jurisdiction or subdivision thereof.

23.   Counterparts .   This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which shall together constitute one in the same Agreement.

24.   Key Employee 6-Month Payment Delay .   Notwithstanding any contrary provision of this Agreement, if and to the extent any portion of any payment, compensation or other benefit provided to the Employee in connection with the termination of his or her employment is determined to constitute “nonqualified deferred compensation” within the meaning of Section 409A and he or she is a specified employee as defined in Code Section 409A(a)(2)(B)(i), as determined by the Company (or any successor) in accordance with its procedures, by which determination Employee hereby agrees that he or she is bound, such portion of the payment, compensation or other benefit shall not be paid before the earlier of (i) the day that is six (6) months plus one (1) day after his or her separation from service as determined under Section 409A, or (ii) fifteen (15) days after Employee’s death (the “New Payment Date”). The aggregate of any payments that otherwise would have been paid to him or her during the period between the separation from service and the New Payment Date shall be paid to him or her in a lump sum on such New Payment Date. Thereafter, any payments that remain outstanding as of the day immediately following the New Payment Date shall be paid without delay over the time period originally scheduled, in accordance with the terms of this Agreement. In any event, the Company makes no representations or warranties and shall have no liability to Employee or any other person if any provisions of or payments under this Agreement are determined to constitute deferred compensation subject to Code Section 409A but not to satisfy the conditions of that section.

 

12


IN WITNESS HEREOF, the parties hereto have caused this Agreement to be duly executed and delivered as of the day and year first written above.

 

   

ALLERGAN, INC.

 
 

By:

 

 

 
   

David E.I. Pyott

 
   

Chairman of the Board and

 
   

Chief Executive Officer

 
   

 

 
   

«Employee_Last_Name»

 
   

Employee

 

 

13

EXHIBIT 10.15

 

 

 

ALLERGAN, INC.

EMPLOYEE STOCK OWNERSHIP PLAN

 

 

 

 

 

RESTATED

2008


TABLE OF CONTENTS

 

     PAGE

ARTICLE I

  

INTRODUCTION

   1

1.1

  

Plan Name

   1

1.2

  

Plan Purpose

   1

1.3

  

Effective Date of 2008 Restated Plan

   1

1.4

  

Amendments to Plan

   1

1.5

  

Plan Qualification

   2

ARTICLE II

  

DEFINITIONS

   3

2.1

  

Affiliated Company

   3

2.2

  

Beneficiary

   3

2.3

  

Board of Directors

   3

2.4

  

Break in Service

   3

2.5

  

Code

   3

2.6

  

Committee

   3

2.7

  

Company

   3

2.8

  

Company Stock

   3

2.9

  

Compensation

   3

2.10

  

Credited Service

   5

2.11

  

Disability

   6

2.12

  

Effective Date

   6

2.13

  

Eligible Employee

   7

2.14

  

Eligible Retirement Plan

   7

2.15

  

Eligible Rollover Distribution

   7

2.16

  

Employee

   7

2.17

  

Employment Commencement Date

   8

2.18

  

ERISA

   8

2.19

  

ESOP Account

   8

2.20

  

Exempt Loan

   8

2.21

  

Exempt Loan Suspense Subfund

   9

2.22

  

415 Suspense Account

   9

2.23

  

Highly Compensated Employee

   9

2.24

  

Hour of Service

   10

2.25

  

Investment Manager

   10

2.26

  

Leased Employee

   10

2.27

  

Leave of Absence

   10

2.28

  

Normal Retirement Age

   11

2.29

  

Participant

   11

2.30

  

Period of Severance

   12

2.31

  

Plan

   12

2.32

  

Plan Administrator

   12


TABLE OF CONTENTS

 

     PAGE

2.33

  

Plan Year

   12

2.34

  

Reemployment Commencement Date

   12

2.35

  

Severance

   12

2.36

  

Severance Date

   13

2.37

  

Sponsor

   13

2.38

  

Trust

   13

2.39

  

Trust Agreement

   13

2.40

  

Trustee

   13

2.41

  

Valuation Date

   13

ARTICLE III

  

ELIGIBILITY AND PARTICIPATION

   14

3.1

  

Participation

   14

3.2

  

Duration of Participation

   14

3.3

  

Participation after Reemployment

   14

3.4

  

Participation After Normal Retirement Age

   14

ARTICLE IV

  

CONTRIBUTIONS AND ALLOCATION TO ACCOUNTS

   15

4.1

  

Contributions to the Trust Fund

   15

4.2

  

Allocation of Contributions to Trust Fund

   15

4.3

  

Forfeitures

   17

4.4

  

Employee Contributions and Rollovers

   17

ARTICLE V

  

VESTING AND DISTRIBUTIONS

   18

5.1

  

No Vested Rights Except as Herein Specified

   18

5.2

  

Vesting

   18

5.3

  

Severance When Less Than Fully Vested

   18

5.4

  

Distribution upon Severance

   19

5.5

  

Distribution upon Death

   19

5.6

  

Distribution upon Disability

   20

5.7

  

Withdrawal upon Age 59-1/2

   20

5.8

  

Designation of Beneficiary

   20

5.9

  

Form of Distribution

   21

5.10

  

Distribution Rules

   22

5.11

  

Put Option for Company Stock Allocated to ESOP Accounts

   24

5.12

  

Diversification Rule

   28

5.13

  

Lapsed Benefits

   30

 

ii


TABLE OF CONTENTS

 

     PAGE

ARTICLE VI

  

TRUST FUND AND INVESTMENTS

   32

6.1

  

General

   32

6.2

  

Single Trust

   32

6.3

  

Investment of the Trust

   32

6.4

  

Certain Offers for Company Stock

   34

6.5

  

Securities Law Limitation

   39

6.6

  

Accounting and Valuations

   39

6.7

  

Dividends

   40

6.8

  

Non-Diversion of Trust Fund

   42

6.9

  

Company, Committee and Trustee Not Responsible for Adequacy of Trust Fund

   42

6.10

  

Distributions

   43

6.11

  

Taxes

   43

6.12

  

Trustee Records to be Maintained

   43

6.13

  

Annual Report of Trustee

   43

6.14

  

Appointment of Investment Manager

   44

ARTICLE VII

  

OPERATION AND ADMINISTRATION

   45

7.1

  

Appointment of Committee

   45

7.2

  

Appointment of Investment Subcommittee

   45

7.3

  

Transaction of Business

   45

7.4

  

Voting

   46

7.5

  

Responsibility of Committees

   46

7.6

  

Committee Powers

   47

7.7

  

Additional Powers of Committee

   48

7.8

  

Investment Subcommittee Powers

   48

7.9

  

Periodic Review of Funding Policy

   49

7.10

  

Claims Procedures

   49

7.11

  

Appeals Procedures

   50

7.12

  

Limitation on Liability

   51

7.13

  

Indemnification and Insurance

   51

7.14

  

Compensation of Committees and Plan Expenses

   51

7.15

  

Resignation

   52

7.16

  

Voting of Company Stock

   52

7.17

  

Reliance Upon Documents and Opinions

   54

ARTICLE VIII

  

AMENDMENT AND ADOPTION OF PLAN

   55

8.1

  

Right to Amend Plan

   55

8.2

  

Adoption of Plan by Affiliated Companies

   55

 

iii


TABLE OF CONTENTS

 

     PAGE

ARTICLE IX

  

DISCONTINUANCE OF CONTRIBUTIONS

   56

ARTICLE X

  

TERMINATION AND MERGER

   57

10.1

  

Right to Terminate Plan

   57

10.2

  

Effect on Trustee and Committee

   57

10.3

  

Merger Restriction

   57

10.4

  

Effect of Reorganization, Transfer of Assets or Change in Control

   57

ARTICLE XI

  

LIMITATION ON ALLOCATIONS

   61

11.1

  

General Rule

   61

11.2

  

Annual Additions

   61

11.3

  

Other Defined Contribution Plans

   62

11.4

  

Adjustments for Excess Annual Additions

   62

11.5

  

Compensation

   63

11.6

  

Treatment of 415 Suspense Account Upon Termination

   63

ARTICLE XII

  

TOP-HEAVY RULES

   65

12.1

  

Applicability

   65

12.2

  

Definitions

   65

12.3

  

Top-Heavy Status

   66

12.4

  

Minimum Contributions

   67

12.5

  

Minimum Vesting Rules

   68

12.6

  

Non-Eligible Employees

   68

ARTICLE XIII

  

RESTRICTION ON ASSIGNMENT OR OTHER ALIENATION OF PLAN BENEFITS

   69

13.1

  

General Restrictions Against Alienation

   69

13.2

  

Qualified Domestic Relations Orders

   69

ARTICLE XIV

  

MISCELLANEOUS PROVISIONS

   73

14.1

  

No Right of Employment Hereunder

   73

14.2

  

Limitation on Company Liability

   73

14.3

  

Effect of Article Headings

   73

14.4

  

Gender

   73

 

iv


TABLE OF CONTENTS

 

     PAGE

14.5

  

Interpretation

   73

14.6

  

Withholding For Taxes

   73

14.7

  

California Law Controlling

   73

14.8

  

Plan and Trust as One Instrument

   73

14.9

  

Invalid Provisions

   73

14.10

  

Counterparts

   74

 

v


ALLERGAN, INC.

EMPLOYEE STOCK OWNERSHIP PLAN

ARTICLE I

INTRODUCTION

1.1         Plan Name .    This document, made and entered into by Allergan, Inc., a Delaware corporation (“Allergan”), amends and restates in its entirety the Allergan, Inc. Employee Stock Ownership Plan (Restated 2005) and shall be known hereafter as the “Allergan, Inc. Employee Stock Ownership Plan (Restated 2008).”

1.2         Plan Purpose .    The purpose of the Allergan, Inc. Employee Stock Ownership Plan (Restated 2008), hereinafter referred to as the “Plan,” is to offer Participants a systematic program for accumulation of beneficial ownership interests in Company Stock and to encourage and develop employee interest and involvement in the Company. Through the beneficial ownership of Company Stock, enhanced by means of possible debt financed acquisition of Company Stock, Allergan intends to provide Participants with a meaningful voice in matters affecting both it and Participants as shareholders. In order to accomplish these objectives, the Plan is expressly authorized and directed to acquire and hold Company Stock as its primary investment. All assets acquired under the Plan shall be administered, distributed, forfeited and otherwise governed by the provisions of the Plan, which is to be administered by the Committee for the exclusive benefit of Participants in the Plan and their Beneficiaries.

1.3         Effective Date of 2008 Restated Plan .    The Effective Date of this amended and restated Plan shall be January 1, 2008 unless otherwise specified in the Plan. The provisions of this Plan document apply generally only to Employees who have completed at least one (1) Hour of Service for Allergan or any Affiliated Companies on or after January 1, 2008 and the rights and benefits, if any, of Employees or Participants whose employment with Allergan or any Affiliated Companies terminated prior to January 1, 2008 shall be determined in accordance with the provisions of the Plan then in effect unless otherwise provided herein and subject to any modification provided herein that may affect the holding or distribution of Participants’ Accounts.

1.4         Amendments to Plan .    The Plan has been amended from time to time since its Original Effective Date of July 26, 1989 to reflect changes in the Plan’s operations and applicable law including, but not limited to, the following:

(a)        This Plan document that amends the Plan:  (i) to comply with all changes made by the Economic Growth and Tax Relief Reconciliation Act of 2001 (with technical corrections made by the Job Creation and Worker Assistance Act of 2002), the Pension Funding Equity Act of 2004, the American Jobs Creation Act of 2004, and the Gulf Opportunity Zone Act of 2005 as well as the changes to the qualification requirements listed on the “2006 Cumulative List of Changes in Plan Qualification Requirements” as set forth in Notice 2007-3 and (ii) to comply with a change made by the Pension


Protection Act of 2006 by permitting non-spouse beneficiaries to elect direct rollovers of lump sum distributions.

(b)        The Plan document for the Allergan, Inc. Employee Stock Ownership Plan (Restated 2005) that incorporated the provisions of the amendments made under the First, Second, and Third Amendments to the Allergan, Inc. Employee Stock Ownership Plan (Restated 2003) and amended the Plan, effective March 28, 2005, so that the Plan’s mandatory distribution rule applies only to Accounts, the vested portions of which, do not exceed $1,000.

(c)        Amendments to the Plan that (i) limited participation in the Plan to those Employees who were Participants in the Plan as of December 31, 2002 and (ii) in connection with the distribution of the stock of Advanced Medical Optics, Inc. (“AMO”) by Allergan to its stockholders on June 29, 2002, provided for the transfer of the assets and liabilities attributable to the ESOP Accounts of “AMO Employees” (as defined in Section 2.16) from the Plan to the Advanced Medical Optics, Inc. 401(k) Plan, a qualified profit sharing plan with a qualified cash or deferred arrangement, in accordance with Code Section 414(l), Regulation Section 1.414(1)-1, and Section 208 of ERISA, and the allocation of AMO stock to Participants’ ESOP Accounts and the Exempt Loan Suspense Subfund and the treatment of AMO stock not yet allocated to Participants’ ESOP Accounts.

1.5         Plan Qualification .    The Plan is an employee benefit plan that is intended to qualify under Code Section 401(a) as a qualified stock bonus plan and under Code Section 4975(e)(7) as an employee stock ownership plan. The Plan’s last determination letter was issued by the Internal Revenue Service on March 7, 2003 with respect to the Allergan, Inc. Employee Stock Ownership Plan (Restated 2003). This Plan document is intended to reflect all law changes made by the Economic Growth and Tax Relief Reconciliation Act of 2001 (with technical corrections made by the Job Creation and Worker Assistance Act of 2002), the Pension Funding Equity Act of 2004, the American Jobs Creation Act of 2004, and the Gulf Opportunity Zone Act of 2005 as well as the changes to the qualification requirements listed on the “2006 Cumulative List of Changes in Plan Qualification Requirements” as set forth in Notice 2007-3.

 

2


ARTICLE II

DEFINITIONS

2.1.         Affiliated Company .    “Affiliated Company” shall mean (i) any corporation, other than the Sponsor, which is included in a controlled group of corporations (within the meaning of Code Section 414(b)) of which the Sponsor is a member, (ii) any trade or business, other than the Sponsor, which is under common control (within the meaning of Code Section 414(c)) with the Sponsor, (iii) any entity or organization, other than the Sponsor, which is a member of an affiliated service group (within the meaning of Code Section 414(m)) of which the Sponsor is a member, and (iv) any entity or organization, other than the Sponsor, which is affiliated with the Sponsor under Code Section 414(o). An entity shall be an Affiliated Company pursuant to this Section only during the period of time in which such entity has the required relationship with the Sponsor under clauses (i), (ii), (iii) or (iv) of this Section after the Original Effective Date of the Plan.

2.2.         Beneficiary .    “Beneficiary” or “Beneficiaries” shall mean the person or persons last designated by a Participant as set forth in Section 5.8 or, if there is no designated Beneficiary or surviving Beneficiary, the person or persons designated pursuant to Section 5.8 to receive the interest of a deceased Participant in such event.

2.3.         Board of Directors .    “Board of Directors” shall mean the Board of Directors of the Sponsor (or its delegate) as it may from time to time be constituted.

2.4.         Break in Service .    “Break in Service” shall mean, with respect to an Employee, each period of 12 consecutive months during a Period of Severance that commences on the Employee’s Severance Date or on any anniversary of such Severance Date.

2.5.         Code .    “Code” shall mean the Internal Revenue Code of 1986 and the regulations thereunder. Reference to a specific Code Section shall be deemed also to refer to any applicable regulations under that Section, and shall also include any comparable provisions of future legislation that amend, supplement or supersede that specific Section.

2.6.         Committee .    “Committee” shall mean the committee appointed under the provisions of Section 7.1.

2.7.         Company .    “Company” shall mean collectively the Sponsor and each Affiliated Company that adopts the Plan in accordance with Section 8.2.

2.8.         Company Stock .    “Company Stock” shall mean any class of stock of the Sponsor which both constitutes “qualifying employer securities” as defined in Section 407(d)(5) of ERISA and “employer securities” as defined in Code Section 409(1).

2.9.         Compensation .    “Compensation” shall mean the following:

 

3


(a)        Compensation shall include amounts paid during a Plan Year to a Participant by the Company for services rendered, including base earnings, commissions and similar incentive compensation, cost of living allowances earned within the United States of America, holiday pay, overtime earnings, pay received for election board duty, pay received for jury and witness duty, pay received for military service (annual training), pay received for being available for work, if required (call-in premium), shift differential and premium, sickness/accident related pay, vacation pay (other than as excluded in paragraph (c) below), vacation shift premium, and bonus amounts paid under the (i) Sales Bonus Program, (ii) Management Bonus Plan or Executive Bonus Plan, either in cash or in restricted stock, and (iii) group performance sharing payments, such as the “Partners for Success.”

(b)        Compensation shall include amounts of salary reduction elected by a Participant under a Code Section 401(k) cash or deferred arrangement or a Code Section 125 cafeteria plan.

(c)        Compensation shall not include business expense reimbursements; Company gifts or the value of Company gifts; Company stock related options and payments; employee referral awards; flexible compensation credits paid in cash; special overseas payments, allowances and adjustments including, but not limited to, pay for cost of living adjustments and differentials paid for service outside of the United States, expatriate reimbursement payments, and tax equalization payments; forms of imputed income; long-term disability pay; payment for loss of Company car; Company car allowance; payments for patents or for writing articles; relocation and moving expenses; retention and employment incentive payments; severance pay; long-term incentive awards, bonuses or payments; “Impact Award” payments; “Employee of the Year” payments; “Awards for Excellence” payments; “Hidden Gem Award” payments; special group incentive payments and individual recognition payments which are nonrecurring in nature; tuition reimbursement; lump sum amounts paid to Employees under the Company’s vacation buy-back policy on or after October 1, 2004; and contributions by the Company under the Plan or distributions hereunder, any contributions or distributions pursuant to any other plan sponsored by the Company and qualified under Code Section 401(a) (other than contributions constituting salary reduction amounts elected by the Participant under a Code Section 401(k) cash or deferred arrangement), any payments under a health or welfare plan sponsored by the Company, or premiums paid by the Company under any insurance plan for the benefit of Employees.

(d)        Compensation for any Plan Year shall not include amounts in excess of $210,000, as adjusted for cost-of-living increases in accordance with Code Section 401(a)(17)(B) for purposes of determining all benefits provided under the Plan for any Plan Year. Any cost-of-living adjustments in effect for a calendar year shall apply to the Plan Year beginning with or within such calendar year.

 

4


(e)        Notwithstanding the foregoing, for purposes of applying the provisions of Articles XI and XII, a Participant’s Compensation shall be determined pursuant to the definition of “Compensation” as set forth in Section 11.5 or 12.2(i), as the case may be.

2.10.       Credited Service .    “Credited Service” shall mean, with respect to each Employee, his or her years and months of Credited Service determined in accordance with the following rules:

(a)        In the case of any Employee who was employed by the Company on the Original Effective Date, for the period prior to such Effective Date such Employee shall be credited with Credited Service under the Plan equal to the period (if any) of uninterrupted employment of such Employee with the Company up to and including the day before the Original Effective Date. For purposes of this paragraph (a), such a period of pre-Effective Date employment shall not be deemed to have been interrupted by reason of (i) any break in or interruption of employment which continued for less than one year, or (ii) any Leave of Absence granted to such Employee under applicable Company policies regarding Leaves of Absence.

(b)        On and after the Effective Date, an Employee shall receive Credited Service credit for the elapsed period of time between each Employment Commencement Date (or Reemployment Commencement Date) of the Employee and the Severance Date which immediately follows that Employment Commencement Date (or Reemployment Commencement Date). Solely for the purpose of determining an Employee’s Credited Service under this paragraph (b), in the case of an Employee who is employed on the Effective Date, that date shall be deemed to be an Employment Commencement Date of the Employee (with service credit for periods prior to the Effective Date to be determined under paragraph (a) above). An Employee who is absent from work on an authorized Leave of Absence shall be deemed to have incurred a Severance (if any) in accordance with the rules of Section 2.35.

(c)        An Employee shall receive Credited Service credit for periods between a Severance and his or her subsequent Reemployment Commencement Date in accordance with the following rules:

(i)      If an Employee incurs a Severance by reason of a quit, discharge or retirement (other than such a Severance occurring during an approved Leave of Absence, which situation is covered under the provisions of subparagraph (ii) below), and the Employee is later reemployed by the Company prior to his or her incurring a Break in Service, he or she shall receive Credited Service for the period commencing with his or her Severance Date and ending with his or her subsequent Reemployment Commencement Date.

(ii)     If an Employee is on an approved Leave of Absence and then incurs a Severance by reason of a quit, discharge or retirement during the Leave of Absence, or a failure to return to work as scheduled following such Leave, and

 

5


such Employee is later reemployed by the Company within 12 months of the date on which he or she discontinued active employment and commenced such Leave, he or she shall receive Credited Service for the period commencing with his or her Severance Date and ending with his or her subsequent Reemployment Commencement Date. For such purposes an Employee shall be deemed to have incurred a Severance (if any) in accordance with the rules of Section 2.35.

(iii)    Other than as expressly set forth above in this paragraph (c), an Employee shall receive no Credited Service with respect to periods between a Severance and a subsequent Reemployment Commencement Date.

(d)        For all purposes of the Plan, an Employee’s total Credited Service shall be determined by aggregating any separate periods of Credited Service separated by any Breaks in Service.

(e)        An Employee shall be credited with Credited Service with respect to a period of employment with an Affiliated Company, but only to the extent that such period of employment would be so credited under the foregoing rules set forth in this Section had such Employee been employed during such period by the Company.

(f)        Notwithstanding the foregoing, unless the Sponsor shall so provide by resolution of its Board of Directors, or unless otherwise expressly stated in the Plan, an Employee shall not receive such Credited Service credit for any period of employment with an Affiliated Company prior to such entity becoming an Affiliated Company, except that Employees of Allergan Optical, Inc., Allergan Humphrey, and Allergan Medical Optics shall receive Credited Service credit for any period of employment with such companies prior to the time such companies became Affiliated Companies.

(g)        Notwithstanding any provision of the Plan to the contrary, contributions, benefits and service credit with respect to qualified military service shall be provided in accordance with Code Section 414(u).

2.11.       Disability .    “Disability” shall mean any mental or physical condition which, in the judgment of the Committee, based on such competent medical evidence as the Committee may require, renders an individual unable to engage in any substantial gainful activity for the Company for which he or she is reasonably fitted by education, training, or experience and which condition can be expected to result in death or which has lasted or can be expected to last for a continuous period of at least 12 months. The determination by the Committee, upon opinion of a physician selected by the Committee, as to whether a Participant has incurred a Disability shall be final and binding on all persons.

2.12.       Effective Date .    “Effective Date” of this restated Plan shall mean January 1, 2008 unless otherwise specified in the Plan. The “Original Effective Date” of the Plan shall mean July 26, 1989.

 

6


2.13.       Eligible Employee .    “Eligible Employee” shall mean any Employee who was a Participant in the Plan on December 31, 2002 and who has not incurred a Severance on or after January 1, 2003.

2.14.       Eligible Retirement Plan .    “Eligible Retirement Plan” shall mean (i) an individual retirement account or annuity described in Code Section 408(a) or 408(b), (ii) a qualified retirement plan described in Code Section 401(a) or 403(a) that accepts Eligible Rollover Distributions, (iii) an annuity contract described in Code Section 403(b) that accepts Eligible Rollover Distributions, and (iv) an eligible plan described in Code Section 457(b) which is maintained by a state, political subdivision of a state, or any agency or instrumentality of a state or political subdivision of a state and which agrees to separately account for amounts transferred into such plan from this Plan. Notwithstanding the foregoing, “Eligible Retirement Plan” shall mean an individual retirement account or annuity described in Code Section 408(a) or 408(b) with respect to a non-spouse Beneficiary.

2.15.       Eligible Rollover Distribution .    “Eligible Rollover Distribution” shall mean any distribution of all or any portion of the balance to the credit of the Distributee, except that an Eligible Rollover Distribution does not include:

(a)        any distribution that is one of a series of substantially equal periodic payments (not less frequently than annually) made for the life (or life expectancy) of the Distributee or the joint lives (or joint life expectancies) of the Distributee and the Distributee’s designated beneficiary, or for a specified period of ten years or more;

(b)        any distribution to the extent such distribution is required under Code Section 401(a)(9); and

(c)        the portion of any distribution that is not includible in gross income (determined without regard to the exclusion for net unrealized appreciation with respect to employer securities).

(d)        any other distribution that is reasonably expected to total less than $200 during the year.

For purposes of this Section, “Distributee” shall mean any Employee or former Employee receiving a distribution from the Plan. A Distributee also includes the Employee or former Employee’s surviving spouse and the Employee or former Employee’s spouse or former spouse who is the Alternate Payee under a Qualified Domestic Relations Order (as defined in Article XIII) with regard to the interest of the spouse or former spouse and, on or after, January 1, 2007, the Employee or former Employee’s Beneficiary.

2.16.       Employee .    “Employee” shall mean, for purposes of the Plan, any individual who is employed by the Sponsor or an Affiliated Company in any capacity, any portion of whose income is subject to withholding of income tax and/or for whom Social Security contributions

 

7


are made by the Sponsor or an Affiliated Company; provided, however, that such term shall not include:

(a)        Any individual who performs services for the Sponsor or an Affiliated Company and who is classified or paid as an independent contractor as determined by the payroll records of the Sponsor or an Affiliated Company even if a court or administrative agency determines that such individual is a common-law employee and not an independent contractor;

(b)        Any individual who performs services for the Sponsor or an Affiliated Company pursuant to an agreement between the Sponsor or an Affiliated Company and any other person including a leasing organization except to the extent such individual is a Leased Employee; and

(c)        Any individual whose employment is transferred from the Sponsor or an Affiliated Company to Advanced Medical Optics, Inc. (“AMO”) in connection with the distribution of the stock of AMO by the Sponsor to its stockholders, effective as of the day following such transfer, hereinafter referred to as an “AMO Employee.” An individual is an AMO Employee if classified or identified as such in the payroll records of the Sponsor or an Affiliated Company or in the Employee Matters Agreement entered into between the Sponsor and AMO.

2.17.       Employment Commencement Date .    “Employment Commencement Date” shall mean the date on which an Employee is first credited with an Hour of Service for the Sponsor or an Affiliated Company. An Employee shall not, for the purpose of determining his or her Employment Commencement Date, be deemed to have commenced employment with an Affiliated Company prior to the effective date on which the entity became an Affiliated Company unless the Sponsor expressly determines otherwise, and except as is expressly provided otherwise in the Plan or in resolutions of the Board of Directors.

2.18.       ERISA .    “ERISA” shall mean the Employee Retirement Income Security Act of 1974 and the regulations thereunder. Reference to a specific ERISA Section shall be deemed also to refer to any applicable regulations under that Section, and shall also include any comparable provisions of future legislation that amend, supplement or supersede that specific Section.

2.19.       ESOP Account .    “ESOP Account” shall mean, with respect to each Participant, the account established and maintained for purposes of holding and accounting for the Participant’s allocated share of assets of the Plan, including any subaccounts established thereunder from time to time (including his or her Stock Subaccount and Non-Stock Subaccount established pursuant to Section 6.6).

2.20.       Exempt Loan .    “Exempt Loan” shall mean any loan to the Plan or Trust, the proceeds of which are used to finance the acquisition of Company Stock or to refinance such a prior Exempt Loan, which is not prohibited by Code Section 4975(c) and meets the requirements

 

8


set forth in Code Section 4975(d)(3) and Treasury Regulation § 54.4975-7(b)(5), including the requirements that (i) any collateral for such loan shall be limited to Company Stock purchased with the proceeds of the loan or the proceeds from any prior Exempt Loan, (ii) no person entitled to payment under the loan shall have any right to Plan assets other than collateral given for such loan, contributions (other than contributions of Company Stock) made to repay such loan, and earnings attributable to such collateral and the investment of such contributions, and (iii) any payments made with respect to such loan by the Plan during a Plan Year must not exceed an amount equal to the sum of contributions and earnings received during or prior to such Plan Year less such payments in prior Plan Year.

2.21.       Exempt Loan Suspense Subfund .    “Exempt Loan Suspense Subfund” shall mean the subfund established under Section 4.1 hereof as part of the Trust Fund to hold Company Stock purchased with the proceeds of an Exempt Loan pending the allocation of such Company Stock to individual ESOP Accounts.

2.22.       415 Suspense Account .    “415 Suspense Account” shall mean the account (if any) established and maintained in accordance with the provisions of Article XI for the purpose of holding and accounting for allocations of excess Annual Additions (as defined in Article XI).

2.23.       Highly Compensated Employee .    “Highly Compensated Employee” shall mean:

(a)        An Employee who performed services for the Employer during the Plan Year or preceding Plan Year and is a member of one or more of the following groups:

(i)      Employees who at any time during the Plan Year or preceding Plan Year were Five Percent Owners (as defined in Section 12.2).

(ii)     Employees who received Compensation during the preceding Plan Year from the Employer in excess of $80,000 (as adjusted in such manner as permitted under Code Section 414(q)(1)).

(b)        For the purpose of this Section , the term “Compensation” means compensation as defined in Code Section 415(c)(3), as set forth in Section 11.5.

(c)        The term “Highly Compensated Employee” includes a Former Highly Compensated Employee. A Former Highly Compensated Employee is any Employee who was (i) a Highly Compensated Employee when he or she terminated employment with the Employer or (ii) a Highly Compensated Employee at any time after attaining age 55. Notwithstanding the foregoing, an Employee who separated from service prior to 1987 shall be treated as a Former Highly Compensated Former Employee only if during the separation year (or year preceding the separation year) or any year after the Employee attains age 55 (or the last year ending before the Employee’s 55th birthday), the Employee either received Compensation in excess of $50,000 or was a Five Percent Owner.

 

9


(d)        For the purpose of this Section, the term “Employer” shall mean the Sponsor and any Affiliated Company.

(e)        The determination of who is a Highly Compensated Employee, including the determination of the Compensation that is considered, shall be made in accordance with Code Section 414(q) and the regulations thereunder.

2.24.       Hour of Service .    “Hour of Service” shall mean an hour for which an Employee is paid or entitled to payment for the performance of duties for the Sponsor and any Affiliated Company.

2.25.       Investment Manager .    “Investment Manager” shall mean the one or more investment managers, if any, appointed pursuant to Section 6.14 and who constitute investment managers under Section 3(38) of ERISA.

2.26.       Leased Employee .    “Leased Employee” shall mean any person (other than an Employee of the recipient) who pursuant to an agreement between the recipient and any other person (“leasing organization”) has performed services for the recipient (or for the recipient and related persons determined in accordance with Code Section 414(n)(6)) on a substantially full time basis for a period of at least one (1) year, and such services are performed under the primary direction or control by recipient employer. Contributions or benefits provided to a Leased Employee by a leasing organization which are attributable to services performed for the recipient employer shall be treated as provided by the recipient employer. A Leased Employee shall not be considered an Employee of the recipient if Leased Employees do not constitute more than 20 percent of the recipient’s nonhighly compensated workforce and such Leased Employee is covered by a money purchase pension plan providing (i) a nonintegrated employer contribution rate of at least ten (10) percent of compensation as defined under Code Section 415(c)(3); (ii) immediate participation; and (iii) full and immediate vesting.

2.27.       Leave of Absence .

(a)        “Leave of Absence”    shall mean any personal leave from active employment (whether with or without pay) duly authorized by the Company under the Company’s standard personnel practices. All persons under similar circumstances shall be treated alike in the granting of such Leaves of Absence. Leaves of Absence may be granted by the Company for reasons of health (including temporary sickness or short term disability) or public service or for any other reason determined by the Company to be in its best interests.

(b)        In addition to Leaves of Absence as defined in paragraph (a) above, the term Leave of Absence shall also mean a Maternity or Paternity Leave, as defined herein, but only to the extent and for the purposes required under paragraph (c) below. As used herein, “Maternity or Paternity Leave” shall mean an absence from work for any period (i) by reason of the pregnancy of the Employee, (ii) by reason of the birth of a child of the Employee, (iii) by reason of the placement of a child with the Employee in

 

10


connection with the adoption of the child by the Employee, or (iv) for purposes of caring for the child for a period beginning immediately following the birth or placement referred to in clauses (ii) or (iii) above.

(c)        Subject to the provisions of paragraph (d) below, a Maternity or Paternity Leave described in paragraph (b) above shall be deemed to constitute an authorized Leave of Absence for purposes of the Plan only to the extent consistent with the following rules:

(i)      For purposes of determining whether a Break in Service has occurred, the Severance Date of a Participant who is absent by reason of a Maternity or Paternity Leave shall not be deemed to occur any earlier than the second anniversary of the date upon which such Maternity or Paternity Leave commences.

(ii)     The Maternity or Paternity Leave shall be treated as a Leave of Absence solely for purposes of determining whether or not an Employee has incurred a Break in Service. Accordingly, such a Maternity or Paternity Leave shall not result in an accrual of Credited Service for purposes of the vesting provisions of the Plan or for purposes of determining eligibility to participate in the Plan (except only in determining whether a Break in Service has occurred).

(iii)    A Maternity or Paternity Leave shall not be treated as a Leave of Absence unless the Employee provides such timely information as the Committee may reasonably require to establish that the absence is for the reasons listed in paragraph (b) above and to determine the number of days for which there was such an absence.

(d)        Notwithstanding the limitations provided in paragraph (c) above, a Maternity or Paternity Leave described in paragraph (b) above shall be treated as an authorized Leave of Absence, as described in paragraph (a), for all purposes of the Plan to the extent the period of absence is one authorized as a Leave of Absence under the Company’s standard personnel practices and thus is covered by the provisions of paragraph (a) above without reference to the provisions of paragraph (b) above, provided, however, that the special rule provided under this paragraph (d) shall not apply if it would result in a Participant who is absent on a Maternity or Paternity Leave being deemed to have incurred a Break in Service sooner than under the rules set forth in paragraph (c).

2.28.       Normal Retirement Age .    “Normal Retirement Age” shall mean a Participant’s sixty-fifth (65th) birthday.

2.29.       Participant .    “Participant” shall mean any Eligible Employee or former Eligible Employee who has commenced participation in the Plan pursuant to Section 3.1 and who retains rights under the Plan.

 

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2.30.       Period of Severance .    “Period of Severance” shall mean the period of time commencing on an Employee’s Severance Date and ending on the Employee’s subsequent Reemployment Commencement Date, if any.

2.31.       Plan .    “Plan” shall mean the Allergan, Inc. Employee Stock Ownership Plan described herein and as amended from time to time.

2.32.       Plan Administrator .    “Plan Administrator” shall mean the administrator of the Plan within the meaning of Section 3(16)(A) of ERISA. The Plan Administrator shall be the Allergan Executive Committee whose members are appointed by the Board of Directors pursuant to the provisions of Section 7.1 to administer the Plan.

2.33.       Plan Year .    “Plan Year” shall mean the calendar year.

2.34.       Reemployment Commencement Date .    “Reemployment Commencement Date” shall mean, in the case of an Employee who incurs a Severance and who is subsequently reemployed by the Sponsor or an Affiliated Company, the first day following the Severance on which the Employee is credited with an Hour of Service for the Sponsor or an Affiliated Company with respect to which he or she is compensated or entitled to compensation by the Sponsor or an Affiliated Company. An Employee shall not, for the purpose of determining his or her Reemployment Commencement Date, be deemed to have commenced employment with an Affiliated Company prior to the effective date on which such entity becomes an Affiliated Company unless the Sponsor shall expressly determine otherwise, and except as is expressly provided otherwise in the Plan or in resolutions of the Board of Directors.

2.35.       Severance .    “Severance” shall mean the termination of an Employee’s employment with the Sponsor or an Affiliated Company by reason of such Employee’s quit, discharge, Disability, death, retirement, or otherwise. For purposes of determining whether an Employee has incurred a Severance, the following rules shall apply:

(a)        An Employee shall not be deemed to have incurred a Severance (i) because of his or her absence from employment with the Sponsor or an Affiliated Company by reason of any paid vacation or holiday period, or (ii) by reason of any Leave of Absence, subject to the provisions of paragraph (b) below.

(b)        For purposes of the Plan, an Employee shall be deemed to have incurred a Severance on the earlier of (i) the date on which he or she dies, resigns, is discharged, or otherwise terminates his or her employment with the Sponsor or an Affiliated Company; or (ii) the date on which he or she is scheduled to return to work after the expiration of an approved Leave of Absence, if he or she does not in fact return to work on the scheduled expiration date of such Leave; or (iii) in the case of a Leave of Absence for longer than one year, the first anniversary of the commencement of such Leave, provided such Employee does not actually return to work on or before said first anniversary date. In no event shall an Employee’s Severance be deemed to have occurred before the last day on which such Employee performs any services for the Sponsor or an Affiliated Company in

 

12


the capacity of an Employee with respect to which he or she is compensated or entitled to compensation by the Sponsor or an Affiliated Company.

(c)        Notwithstanding the foregoing, in the case of a Participant who is absent by reason of a Maternity or Paternity Leave, the provisions of Section 2.27(c)-(d) shall apply for purposes of determining whether such a Participant has incurred a Break in Service by reason of such Leave.

2.36.       Severance Date .    “Severance Date” shall mean, in the case of any Employee who incurs a Severance, the day on which such Employee is deemed to have incurred said Severance as determined in accordance with the provisions of Section 2.35, provided, however, that the special rule set forth under Section 2.27(c)-(d) shall apply with respect to determining whether a Participant on a Maternity or Paternity Leave has incurred a Break in Service. In the case of any Employee who incurs a Severance as provided under Section 2.35 and who is entitled to a subsequent payment of compensation for reasons other than future services (e.g., as back pay for past services rendered or as payments in the nature of severance pay), the Severance Date of such Employee shall be as of the effective date of the Severance event (e.g., the date of his or her death, effective date of a resignation or discharge, etc.), and the subsequent payment of the aforementioned type of post-Severance compensation shall not operate to postpone the timing of the Severance Date for purposes of the Plan.

2.37.       Sponsor .    “Sponsor” shall mean Allergan, Inc., a Delaware corporation, and any successor corporation or entity.

2.38.       Trust .    “Trust” or “Trust Fund” shall mean the trust maintained pursuant to the Trust Agreement and as described in Section 6.1 hereof, which shall hold all cash and securities and all other assets of whatsoever nature deposited with or acquired by the Trustee in its capacity as Trustee hereunder, together with accumulated net earnings.

2.39.       Trust Agreement .    “Trust Agreement” shall mean the agreement between the Trustee and the Sponsor pursuant to which the Trust is maintained.

2.40.       Trustee .    “Trustee” shall mean the one or more trustees of the Trust established pursuant to Section 6.1 hereof.

2.41.       Valuation Date .    “Valuation Date” shall mean the last day of each Plan Year and any other date which the Committee may designate from time to time.

 

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ARTICLE III

ELIGIBILITY AND PARTICIPATION

3.1.         Participation .    Each Employee or former Employee who was a Participant in the Plan as of December 31, 2002 shall continue as a Participant. Any other Employee shall not be eligible to participate in the Plan.

3.2.         Duration of Participation .    A Participant shall remain an active Participant until he or she incurs a Severance, at which time he or she shall become an inactive Participant until he or she receives a distribution of the entire vested portion of his or her ESOP Account. Once such a distribution is made, such Participant shall no longer be considered a Participant in the Plan. Any Participant who (i) transfers out of employment with the Company but who remains an Employee of an Affiliated Company that has not adopted the Plan pursuant to Section 8.2, or (ii) remains an Employee of the Company but is no longer an Eligible Employee, shall become an inactive Participant.

3.3.         Participation after Reemployment .    A Participant who incurs a Severance after he or she is fully vested in his or her ESOP Account and who is subsequently reemployed prior to receiving a distribution of his or her entire ESOP Account shall continue as an inactive Participant (but shall not be reinstated as an Eligible Participant as defined in Section 4.2(d)). A Participant who incurs a Severance before he or she is fully vested in his or her ESOP Account and who is subsequently reemployed shall be reinstated as an inactive Participant (but shall not be reinstated as an Eligible Participant as defined in Section 4.2(d)) as of his or her Reemployment Commencement Date; provided, that such Participant has a right to reinstatement of his or her forfeited ESOP Account upon his or her Reemployment Commencement Date pursuant to Section 5.3. Any other Participant who incurs a Severance and who is subsequently reemployed, including a Participant who incurs a Severance after he or she is fully vested in his or her ESOP Account and who receives a distribution of his or her entire ESOP Account, shall not be eligible to participate in the Plan.

3.4.         Participation After Normal Retirement Age .    An Eligible Employee may continue as a Participant after reaching his or her Normal Retirement Age in the same manner as an Eligible Employee who has not reached his or her Normal Retirement Age.

 

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ARTICLE IV

CONTRIBUTIONS AND ALLOCATION TO ACCOUNTS

4.1.         Contributions to the Trust Fund .    The Company may contribute to the Trust Fund for each Plan Year an amount to be determined by the Board of Directors solely in its discretion. Such amount shall be contributed in cash or Company Stock and paid over to the Trustee for allocation to the Trust Fund not later than the date prescribed for filing the Sponsor’s federal income tax return (including all extensions thereto) for its fiscal year corresponding to such Plan Year. Contributions shall first be applied, if necessary, to reinstate the ESOP Accounts of applicable reemployed Participants who had previously forfeited their ESOP Accounts pursuant to Section 5.3 of the Plan, but only after all forfeitures for the Plan Year have been so applied pursuant to Section 4.3. Some or all of the remaining contributions under this Section 4.1 may be applied to repay any principal and/or interest outstanding on any Exempt Loan or to pay Plan expenses as provided in Section 7.14. The determination of the extent to which such contributions shall be used to repay such Exempt Loans or pay Plan expenses shall be made at the sole discretion of the Committee. Company Stock acquired by the Trust Fund through an Exempt Loan shall be added to and maintained in the Exempt Loan Suspense Subfund and shall thereafter be released from the Exempt Loan Suspense Subfund and allocated to Participants’ ESOP Accounts as provided in Section 4.2. Contributions in excess of amounts used for other purposes described in this Section 4.1 shall be allocated to the ESOP Accounts of Participants as provided in Section 4.2.

4.2.         Allocation of Contributions to Trust Fund .

(a)        As of a date not later than the last day of each Plan Year, an allocation shall be made to the ESOP Account of the allocable share of each “Eligible Participant” as defined in paragraph (d) below for such Plan Year of (i) Company contributions of Company Stock contributed in kind to the Trust Fund and (ii) Company contributions in other than Company Stock, which are not used for other purposes described in Section 4.1. Such allocations shall be made in the same proportion that the Compensation for the Plan Year for such Eligible Participant bears to the total Compensation of all Eligible Participants for such Plan Year.

(b)        Company Stock acquired for the Trust Fund through an Exempt Loan shall be released from the Exempt Loan Suspense Subfund as the Exempt Loan is repaid, in accordance with the provisions of this Section 4.2(b).

(i)      For each Plan Year until the Exempt Loan is fully repaid, the number of shares of Company Stock released from the Exempt Loan Suspense Subfund shall equal the number of unreleased shares immediately before such release for the current Plan Year multiplied by the “Release Fraction.” As used herein, the Release Fraction shall be a fraction, the numerator of which is the amount of principal and interest paid on the Exempt Loan for such current Plan Year, and the denominator of which is the sum of the numerator plus the principal and interest to be paid on such Exempt Loan for all future years during the

 

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duration of the term of such Loan (determined without reference to any possible extensions or renewals thereof). Notwithstanding the foregoing, in the event such Loan shall be repaid with the proceeds of a subsequent Exempt Loan (the “Substitute Loan”), such repayment shall not operate to release all such Company Stock in the Exempt Loan Suspense Subfund, but, rather, such release shall be effected pursuant to the foregoing provisions of this Section 4.2(b) on the basis of payments of principal and interest on such Substitute Loan.

(ii)     If the Committee so determines in its discretion, then in lieu of applying the provisions of Section 4.2(b)(i) hereof with respect to such Exempt Loan or Substitute Loan, shares shall be released from the Exempt Loan Suspense Subfund as the principal amount of an Exempt Loan is repaid (and without regard to interest payments), provided the following three conditions are satisfied:

(A)        The Exempt Loan must provide for annual payments of principal and interest at a cumulative rate that is not less rapid at any time than level annual payments of such amounts for ten years.

(B)        The interest portion of any payment is disregarded only to the extent it would be treated as interest under standard loan amortization tables.

(C)        If the Exempt Loan is renewed, extended or refinanced, the sum of the expired duration of the Exempt Loan and the renewal, extension or new Exempt Loan period must not exceed ten years.

(iii)    It is intended that the provisions of this Section 4.2(b) shall be applied and construed in a manner consistent with the requirements and provisions of Treasury Regulation § 54.4975-7(b)(8), and any successor regulation thereto. All Company Stock released from the Exempt Loan Suspense Subfund during any Plan Year shall be allocated among Participants as prescribed by Section 4.2(c) hereof, except to the extent provided in Section 6.7.

(c)        Shares of Company Stock released from the Exempt Loan Suspense Subfund for a Plan Year in accordance with Section 4.2(b) hereof and Section 6.7(b)(i) shall be held in the Trust Fund on an unallocated basis until allocated by the Committee as of not later than the last day of that Plan Year. The allocation of such shares shall be made among the ESOP Accounts of Eligible Participants (as that term is defined in paragraph (d) below). The number of shares allocable to each such Eligible Participant’s ESOP Account shall be the number of shares which bears the same ratio to the total shares released for such Plan Year as the Compensation for the Plan Year for such Eligible Participant bears to the total Compensation of all Eligible Participants for such Plan Year.

 

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(d)        For purposes of Section 4.2, an “Eligible Participant” shall mean any Participant who is an Eligible Employee on the last business day of such Plan Year or who ceased to be an Eligible Employee during such Plan Year due to death, Disability, or retirement at or after age 55 (as such retirement is determined under the Allergan, Inc. Pension Plan). Any Eligible Participant who, on or after January 1, 2003, (i) incurs a Severance and is subsequently reemployed or (ii) transfers out of employment with the Company to employment with an Affiliated Company that has not adopted the Plan pursuant to Section 8.2 and is subsequently transferred back to employment with Company, shall not be an Eligible Participant following his or her Reemployment Commencement Date or transfer date.

4.3.         Forfeitures .    Any amount which is forfeited pursuant to Section 5.3 or 5.13 during a Plan Year shall be segregated from other amounts held under the Plan and shall first be used to reinstate the ESOP Accounts of reemployed Participants (or Beneficiaries, if applicable) who had previously forfeited such ESOP Accounts and who have a right to reinstatement of their forfeited ESOP Accounts pursuant to Section 5.3 or 5.13. Should any forfeitures then remain, they may next be used to pay Plan expenses as provided under Section 7.14. Should any forfeitures then remain, they shall be allocated as of the last day of the Plan Year to the ESOP Accounts of Eligible Participants (as that term is defined in Section 4.2(d)) based on Compensation in the same manner as allocations under Section 4.2(a) and (c).

4.4.         Employee Contributions and Rollovers .    No Employee contributions are permitted under the Plan. No rollover contributions to the Plan are permitted whether or not any such contributions would satisfy the applicable requirements of Code Sections 402, 403, 408 or 409.

 

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ARTICLE V

VESTING AND DISTRIBUTIONS

5.1.         No Vested Rights Except as Herein Specified .    No Employee shall have any vested right or interest in any assets of the Trust, except as provided in this Article V. Neither the making of any allocations nor the credit to any ESOP Account of a Participant in the Trust shall vest in any Participant any right, title, or interest in or to any assets of the Trust except as provided in this Article V.

5.2.         Vesting .

(a)        The interest of a Participant in amounts allocated to his or her ESOP Account, including cash dividends on shares of Company Stock allocated to such Participant’s ESOP Account, shall vest in accordance with the following schedule:

 

Year of Credited Service

   Vested Percentage

Less than 1

       0%

1 but less than 2

     20%

2 but less then 3

     40%

3 but less than 4

     60%

4 but less than 5

     80%

5 or more

   100%

(b)        Notwithstanding the above, a Participant shall become fully vested in his or her ESOP Account upon the occurrence of the death, Disability, or attainment of age 62 of such Participant while an Employee, or upon the occurrence of a Change in Control pursuant to Section 10.4(b).

5.3.         Severance When Less Than Fully Vested .    Subject to Section 5.10(b), a Participant who incurs a Severance and who is not or does not become 100% vested pursuant to Section 5.2, may elect to receive a distribution of the vested portion of his or her ESOP Account in a single lump sum payment in the form prescribed by Section 5.9 hereof, as soon as practicable following the Participant’s Severance Date. The non-vested portion of such Participant’s ESOP Account shall be forfeited in accordance with the following rules:

(a)        In the event a distribution of the entire vested portion of such Participant’s ESOP Account is made pursuant to this Section 5.3, the non-vested portion shall be forfeited as of such Participant’s distribution date. A Participant who incurs a Severance when no portion of his or her ESOP Account is vested shall be deemed to have received a distribution pursuant to this paragraph (a) as of his or her Severance Date and his or her ESOP Account shall be forfeited as of the Participant’s Severance Date. If the Participant is rehired by the Company prior to the date such Participant incurs five consecutive Breaks in Service, the amount forfeited under this paragraph (a) shall be reinstated to the

 

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Participant’s ESOP Account as of the Participant’s Reemployment Commencement Date (without regard to any interest or investment earnings on such amount).

(b)        In the event a distribution of the entire vested portion of such Participant’s ESOP Account is not made pursuant to this Section 5.3, the non-vested portion shall be forfeited as of such Participant’s Severance Date. If the Participant is rehired by the Company prior to the date such Participant incurs five consecutive Breaks in Service, the amount so forfeited plus an amount equal to the rate of return that the amount forfeited would have received but for forfeiture pursuant to this paragraph (b) shall be reinstated to the Participant’s ESOP Account as of the Participant’s Reemployment Commencement Date. The Company shall be obligated to contribute to the Trust Fund any amounts necessary after application of Section 4.3 to reinstate a Participant’s ESOP Account if reinstatement is required under the provisions of this paragraph.

(c)        At any relevant time after Severance pursuant to paragraphs (a) and (b) above, the Participant’s vested portion of his or her ESOP Account shall be equal to an amount (“X”) determined by the following formula:

X = P*(AB + D) - D

For the purposes of applying the formula:

P = the vested percentage at any relevant time determined pursuant to Section 5.2

AB = the ESOP Account balance at the relevant time

D = the total amount of any distributions from the ESOP Account since such Severance

5.4.         Distribution upon Severance .    Subject to Section 5.10(b), a Participant who incurs a Severance on or after becoming 100% vested pursuant to Section 5.2, may elect to receive a distribution of his or her ESOP Account, in a single lump-sum payment in the form prescribed by Section 5.9 hereof, as soon as practicable following the Participant’s Severance Date. Notwithstanding anything to the contrary, upon receipt of a Qualified Domestic Relations Order on or after a Participant is 100% vested pursuant to Section 5.2, the amount payable to an Alternate Payee (as such terms are described in Section 13.2) shall be distributed to the Alternate Payee as soon as administratively feasible regardless of whether the Participant incurs a Severance.

5.5.         Distribution upon Death .

(a)        Upon the death of a Participant while still an Employee, the Committee shall give such directions as may be necessary to cause a distribution of his or her ESOP Account to be made in a single lump-sum payment to the Beneficiary designated by the deceased Participant in the form prescribed in Section 5.9 hereof, as soon as practicable

 

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following the Participant’s death, but in no event later than the last day of the Plan Year following the Plan Year in which the Participant died.

(b)        Upon the death of a Participant after he or she ceases to be an Employee but before he or she receives his or her entire vested interest in the Trust, the Committee shall give such directions as may be necessary to cause a distribution, in the manner and time provided in Section 5.5(a) hereof, of any vested balance remaining in the Participant’s ESOP Account to the Beneficiary designated by the Participant.

(c)        The Committee may require the execution and delivery of such documents, papers and receipts as the Committee may determine necessary or appropriate in order to establish the fact of death of the deceased Participant and of the right and identity of any Beneficiary or other person or persons claiming any benefits under this Section 5.5.

5.6.         Distribution upon Disability .    Subject to Section 5.10(b), in the event the Committee shall determine that a Participant has suffered a Disability while an Employee, the Committee shall proceed to cause a distribution to be made of such Participant’s ESOP Account in a single lump-sum payment in the form prescribed in Section 5.9 hereof as soon as practicable following the Committee’s determination that the Participant has incurred a Disability.

5.7.         Withdrawal upon Age 59-1/2 .    After attaining age 59-1/2, a Participant who is still an Employee may, following such reasonable advance notice as may be required by the Committee, withdraw the entire vested amount credited to his or her ESOP Account. Such a withdrawal shall be in the same form and using the same valuation methods as provided for distributions pursuant to Section 5.9.

5.8.         Designation of Beneficiary .

(a)        At any time, and from time to time, each Participant shall have the unrestricted right to designate the Beneficiary to receive the portion of his or her death benefit and to revoke any such designation. Each such designation shall be evidenced by a written instrument signed by the Participant and filed with the Committee.

(b)        If the Participant is married and designates a Beneficiary other than his or her spouse, said designation shall not be honored by the Committee unless accompanied by the written consent of said spouse to said designation. Such consent (i) must designate a Beneficiary which may not be changed without the consent of the spouse (or the consent of the spouse expressly permits designation by the Participant without any further consent by the spouse), (ii) must acknowledge the effect of the designation, and (iii) must be witnessed by a Plan representative or a notary public. No consent of such spouse shall be necessary if it is established to the satisfaction of a Plan representative that the consent required under this paragraph (b) cannot or need not be obtained because (i) there is no spouse, (ii) the spouse cannot be located, or (iii) there exist such other circumstances which, pursuant to regulations under Code Section 417, permit a distribution to another

 

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Beneficiary. Any consent of a spouse obtained pursuant to this paragraph (b) or any determination that the consent of the spouse cannot (or need not) be obtained, shall be effective only with respect to that spouse. If a Participant becomes married following his or her designation of a Beneficiary other than his or her spouse, such designation shall be ineffective unless the spousal consent requirements of this paragraph are satisfied with respect to such spouse (subject, however, to the provisions of Article XIII regarding Qualified Domestic Relations Orders).

(c)        If the Participant is married and does not designate a Beneficiary, the Participant’s spouse shall be his or her Beneficiary for purposes of this Section. If the deceased Participant is not married and shall have failed to designate a Beneficiary, or if the Committee shall be unable to locate the designated Beneficiary after reasonable efforts have been made, or if such Beneficiary shall be deceased, distribution of the Participant’s death benefit shall be made by payment of the deceased Participant’s entire interest in the Trust to his or her personal representative in a single lump-sum payment. In the event the deceased Participant is not a resident of California at the date of his or her death, the Committee, in its discretion, may require the establishment of ancillary administration in California. If the Committee cannot locate a qualified personal representative of the deceased Participant, or if administration of the deceased Participant’s estate is not otherwise required, the Committee, in its discretion, may pay the deceased Participant’s interest in the Trust to his or her heirs at law (determined in accordance with the laws of the State of California as they existed at the date of the Participant’s death).

5.9.         Form of Distribution .

(a)        All shares of Company Stock or Advanced Medical Optics, Inc. allocated to a Participant’s ESOP Account shall be distributed in the form of cash, unless the Participant elects under paragraph (b) below to receive the distribution in the form of Company Stock or Advanced Medical Optics, Inc. stock, with cash in lieu of fractional shares. To the extent that Company Stock or Advanced Medical Optics, Inc. stock must be valued to effect such a distribution, such valuation shall be equal to the fair market value of such stock determined as of the last Valuation Date prior to the date of distribution.

(b)        A Participant may elect that all shares of Company Stock or Advanced Medical Optics, Inc. allocated to his or her ESOP Account be distributed in the form of Company Stock or in the form of Advanced Medical Optics, Inc. stock, with cash in lieu of fractional shares. Notwithstanding the foregoing, if applicable corporate charter or bylaw provisions restrict ownership of substantially all outstanding Company Stock to Employees or to a plan or trust described in Code Section 401(a), then any distribution of a Participant’s ESOP Account shall only be in cash.

 

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(c)        Notwithstanding the foregoing, in the case of an Eligible Rollover Distribution, a Participant may elect that an Eligible Rollover Distribution be paid directly by the Trustee to the trustee of an Eligible Retirement Plan.

5.10.       Distribution Rules .    Notwithstanding the provisions of Sections 5.3, 5.4, 5.5, 5.6, 5.7, and 5.9 of the Plan regarding distributions of Participants’ ESOP Accounts, the following additional rules shall apply to all such distributions.

(a)        In no event shall any benefits under the Plan, including benefits upon retirement, termination of employment, or Disability, be paid to a Participant prior to the “Consent Date” (as defined herein) unless the Participant consents in writing to the payment of such benefits prior to said Consent Date. As used herein, the term “Consent Date” shall mean the later of (i) the Participant’s 62nd birthday, or (ii) the Participant’s Normal Retirement Age. Notwithstanding the foregoing, the provisions of this paragraph shall not apply (i) following the Participant’s death, or (ii) to the extent paragraph (b) below applies.

(b)        Notwithstanding anything to the contrary in the Plan, if the total amount of the vested portion of a Participant’s ESOP Account does not exceed $1,000 ($5,000, prior to March 28, 2005), the vested portion of such Participant’s ESOP Account shall be distributed, in a single lump-sum payment in the form prescribed by Section 5.9 hereof, as soon as practicable following the Participant’s Severance Date.

(c)        Unless the Participant elects otherwise pursuant to paragraph (a) above, distributions of the vested portion of a Participant’s ESOP Accounts shall commence no later than the 60th day after the close of the Plan Year in which the latest of the following events occurs: (i) the Participant’s Normal Retirement Age; (ii) the tenth anniversary of the year in which the Participant commenced participation in the Plan; or (iii) the Participant’s Severance.

(d)        Minimum Required Distributions during Participant’s Lifetime. Notwithstanding anything to the contrary in the Plan, unless the entire vested portion of a Participant’s Accounts is distributed in a single sum on or before the Required Beginning Date, distributions shall be made in accordance with this paragraph (d) as of the first Distribution Calendar Year and the entire vested portion of a Participant’s Accounts shall be distributed, or begin to be distributed, to the Participant no later than the Participant’s Required Beginning Date as set forth below:

(i)      Amount of Minimum Required Distribution for each Distribution Calendar Year. During the Participant’s lifetime, the minimum amount that shall be distributed for each Distribution Calendar Year is the lesser of:

(A)        the quotient obtained by dividing the Participant’s Account Balance by the distribution period in the Uniform Lifetime Table set forth in Regulation Section 1.401(a)(9)-9, using the

 

22


Participant’s age as of the Participant’s birthday in the Distribution Calendar Year; or

(B)        if the Participant’s sole Designated Beneficiary for the Distribution Calendar Year is the Participant’s spouse, the quotient obtained by dividing the Participant’s Account Balance by the number in the Joint and Last Survivor Table set forth in Regulation Section 1.401(a)(9)-9, using the Participant’s and spouse’s attained ages as of the Participant’s and spouse’s birthdays in the Distribution Calendar Year.

(ii)     Lifetime Minimum Required Distributions continue through Year of Participant’s Death. Minimum required distributions shall be determined under this paragraph (d) beginning with the first Distribution Calendar Year and up to and including the Distribution Calendar Year that includes the Participant’s date of death.

(iii)    For purposes of this paragraph, the following definitions shall apply:

(A)        “Account Balance” shall mean the account balance of a Participant’s Account as of the last valuation date in the calendar year immediately preceding the Distribution Calendar Year (valuation calendar year) increased by the amount of any contributions made and allocated or forfeitures allocated to a Participant’s Accounts as of dates in the valuation calendar year after the valuation date and decreased by distributions made in the valuation calendar year after the valuation date. The Account Balance for the valuation calendar year includes any amounts rolled over or transferred to the plan either in the valuation calendar year or in the Distribution Calendar Year if distributed or transferred in the valuation calendar year.

(B)        “Designated Beneficiary” shall mean the individual who is designated as the Beneficiary under Section 5.8 and is the Designated Beneficiary under Code Section 401(a)(9) and Regulation Section 1.401(a)(9)-1, Q&A-4.

(C)        “Distribution Calendar Year” shall mean a calendar year for which a minimum distribution is required. For distributions beginning before the Participant’s death, the first Distribution Calendar Year is the calendar year immediately preceding the calendar year which contains the Participant’s Required Beginning Date. The minimum required distribution for the Participant’s first Distribution Calendar Year shall be made on or before the Participant’s Required Beginning Date. The minimum required distribution for other

 

23


Distribution Calendar Years, including the minimum required distribution for the Distribution Calendar Year in which the Participant’s Required Beginning Date occurs, shall be made on or before December 31 of that Distribution Calendar Year.

(D)        “Life expectancy” shall mean as computed by use of the Single Life Table in Regulation Section 1.401(a)(9)-9.

(E)        “Required Beginning Date” shall mean April 1 of the calendar year immediately following the later of the calendar year in which the Participant attains age 70-1/2 or incurs a Severance; provided, however, if such Participant is a Five Percent Owner (as defined in Code Section 416(i) and applicable regulations) with respect to the Plan Year ending in the calendar year in which such Participant attains age 70-1/2, the Required Beginning Date shall be April 1 of the calendar year immediately following the year in which such Participant attains age 70-1/2.

(iv)     Treasury Regulations Incorporated by Reference. All distributions required under this subsection shall be determined and made in accordance with the Treasury Regulations under Code Section 401(a)(9).

(e)        Minimum Required Distributions following Participant’s Death. If a Participant dies before the entire vested portion of his or her ESOP Account is distributed, the entire vested portion of the Participant’s ESOP Account shall be distributed as provided in Section 5.5.

(f)        If it is not administratively practical to calculate and commence payments by the latest date specified in the rules of paragraphs (b), (c), (d) and (e) above because the amount of the Participant’s benefit cannot be calculated, or because the Committee is unable to locate the Participant after making reasonable efforts to do so, the payment shall be made as soon as is administratively possible (but not more than 60 days) after the Participant can be located and the amount of the distributable benefit can be ascertained.

(g)        If any payee under the Plan is a minor or if the Committee reasonably believes that any payee is legally incapable of giving a valid receipt and discharge for any payment due him, the Committee may have such payment, or any part thereof, made to the person (or persons or institution) whom it reasonably believes is caring for or supporting such payee, or, if applicable, to any duly appointed guardian or committee or other authorized representative of such payee. Any such payment shall be a payment for the account of such payee and shall, to the extent thereof, be a complete discharge of any liability under the Plan to such payee.

5.11.       Put Option for Company Stock Allocated to ESOP Accounts .

 

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(a)        Solely in the event that a Participant receives a distribution consisting in whole or in part of Company Stock that at the time of distribution thereof is not readily tradable stock within the meaning of Code Section 409(h) then such distributed Company Stock shall be made subject to a put option in the hands of a Qualified Holder (as defined herein below), with such put option to be subject to the following provisions:

(i)      As used herein, the term “Qualified Holder” shall mean the Participant or Beneficiary receiving the distribution of such Company Stock, any other party to whom such stock is transferred by gift or by reason of death, and also any trustee of an Individual Retirement Account (as defined under Code Section 408) to which all or any portion of such distributed Company Stock is transferred pursuant to a tax-free “rollover” transaction satisfying the requirements of Code Section 402.

(ii)     During the sixty (60) day period following any distribution of such Company Stock, a Qualified Holder shall have the right to require the Company to purchase all or any portion of said distributed Company Stock held by said Qualified Holder. A Qualified Holder shall exercise such right by giving written notice to the Company within the aforesaid sixty (60) day period of the number of shares of distributed Company Stock that such Qualified Holder intends to sell to the Company. The purchase price to be paid for any such Company Stock shall be its fair market value determined as of the Valuation Date coincident with or immediately preceding the date of the distribution.

(iii)    If a Qualified Holder shall fail to exercise his or her put option right under subparagraph (ii) above, such option right shall temporarily lapse upon the expiration of the sixty (60) day period thereof. As soon as is reasonably practicable following the last day of the Plan Year in which said sixty (60) day option period expires, the Company shall notify each such non-electing Qualified Holder who is then a shareholder of record of the valuation of such Company Stock as of the most recent Valuation Date. During the sixty (60) day period following receipt of such valuation notice, any such Qualified Holder shall have the right to require the Company to purchase all or any portion of such distributed Company Stock. The purchase price to be paid therefor shall be based on the valuation of such Company Stock as of the Valuation Date coinciding with or next preceding the exercise of the option under this Section 5.11(c). If a Qualified Holder fails to exercise his or her option right under this subparagraph (iii) with respect to any portion of such distributed Company Stock, no further options shall be applicable under the Plan and the Company shall have no further purchase obligations hereunder.

(iv)     In the event that a Qualified Holder shall exercise a put option under this Section, then the Company shall have the option of paying the purchase price of the Company Stock which is subject to such put option (hereafter the “Option Stock”) under either of the following methods:

 

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(A)        A lump sum payment of the purchase price within ninety (90) days after the date upon which such put option is exercised (the “Exercise Date”) or

(B)        A series of six equal installment payments, with the first such payment to be made within thirty (30) days after the Exercise Date and the five remaining payments to be made on the five anniversary dates of the Exercise Date, so that the full amount shall be paid as of the fifth anniversary of such Exercise Date. If the Company elects to pay the purchase price of the Option Stock under the installment method provided in this clause (2), then the Company shall, within thirty (30) days after the Exercise Date, give the Qualified Holder who is exercising the put option the Company’s promissory note for the full unpaid balance of the option price. Such note shall, at a minimum, provide adequate security (if required under applicable regulations), state a rate of interest reasonable under the circumstances (but at least equal to the imputed compound rate in effect as of the Exercise Date pursuant to the regulations promulgated under Code Sections 483 or 1274, whichever shall be applicable) and provide that the full amount of such note shall accelerate and become due immediately in the event that the Company defaults in the payment of a scheduled installment payment.

(v)      The put options under subparagraphs (ii)and (iii) above shall be effective solely against the Company and shall not obligate the Plan in any manner; provided, however, with the Company’s consent, the Plan may elect to purchase any Company Stock that otherwise must be purchased by the Company pursuant to a Qualified Holder’s exercise of any such option.

(vi)     If at the time of any distribution of said Company Stock it is known that any applicable Federal or State law would be violated by the Company’s honoring of such a put option as provided under this Section, the Company shall designate another entity that will honor such put option. Such other entity shall be one having a substantial net worth at the time such loan is made and whose net worth is reasonably expected to remain substantial.

(vii)    In the event that a Qualified Holder is unable to exercise the put option provided hereunder because the Company (or other entity bound by such put option) is prohibited from honoring it by reason of any applicable Federal or State law, then the sixty (60) day option periods during which such put option is exercisable under subparagraphs (ii) and (iii) shall not include any such time during which said put option may not be exercised due to such reason.

(viii)   Except as is expressly provided herein above with respect to any distributed Company Stock that is readily tradeable stock within the meaning of

 

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Code Section 409(h), no Participant shall have any put option rights with respect to Company Stock distributed under the Plan, and neither the Company nor the Plan shall have any obligation whatsoever to purchase any such distributed Company Stock from any Participant or other Qualified Holder.

(ix)     At the time of distribution of Company Stock that is not readily tradable stock within the meaning of Code Section 409(h), to a Participant or Beneficiary, the Company shall furnish to such Participant or Beneficiary the most recent annual certificate of value prepared by the Company with respect to such Stock. In addition, the Company shall furnish to such Participant or Beneficiary a copy of each subsequent annual certificate of value until the put options provided for in this Section with respect to such distributed Company Stock shall expire.

(b)        Notwithstanding any other provisions of the Plan regarding a Participant’s right to exercise a put option, the put option described in paragraph (a) above shall be subject to the following additional provisions:

(i)      If the distribution constitutes a Total Distribution (as defined below), in the event that a Qualified Holder exercises a put option under this Section, then the Company shall have the right to pay the purchase price of the Option Stock under either of the following methods:

(A)        A lump sum payment of the purchase price within thirty (30) days after the Exercise Date; or

(B)        A series of five substantially equal annual payments with the first such payment to be made within thirty (30) days after the Exercise Date. If the Company elects to pay the purchase price of the Option Stock under the installment method provided in this clause (2), then the Company shall, within 30 days after the Exercise Date, give the Qualified Holder who is exercising the put option the Company’s promissory note for the full unpaid balance of the option price. Such note shall, at a minimum, provide adequate security, state a rate of interest reasonable under the circumstances (but at least equal to the imputed compound rate in effect as of the Exercise Date pursuant to the regulations promulgated under Code Sections 483 or 1274, whichever shall be applicable) and provide that the full amount of such note shall accelerate and become due immediately in the event that the Company defaults in the payment of a scheduled installment payment.

(ii)     If the distribution does not constitute a Total Distribution (as defined below), in the event that a Qualified Holder exercises a put option under this Section, then the Company shall pay the purchase price of the Option Stock in a lump sum within thirty (30) days after the Exercise Date.

 

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For purposes of this Section, “Total Distribution” shall mean a distribution to a Participant (or his or her Beneficiary, if applicable) within one taxable year of such recipient of the entire balance to the credit of the Participant.

(c)        This Section shall be applied to any securities of the Company held by the Plan to the extent required under Code Section 401(a)(23) and the regulations issued thereunder and its provisions shall be interpreted and applied in accordance with all applicable requirements of Code Section 409(h) and the regulations issued thereunder.

5.12.       Diversification Rule .

(a)        For the purpose of Section 5.12 only, the following definitions shall apply:

(i)      “Qualified Participant” shall mean a Participant who is fully vested in his or her ESOP Account as determined under Section 5.2.

(ii)     “Insider” shall mean any Participant who is directly or indirectly the beneficial owner of more than 10% of any class of any equity security (other than an exempted security) of the Sponsor (or the Company) which is registered pursuant to Section 12 of the Securities Exchange Act of 1934, or who is a “director” or an “officer” of the sponsor or the Company as those terms are interpreted under the Securities Exchange Act of 1934 for the purpose of determining persons subject to Section 16 of such Act.

(b)        Effective as of September 1, 2002 or as soon as administratively practicable thereafter, a Participant may elect to diversify his or her ESOP Account as follows:

(i)      Any Participant who is a Qualified Participant may elect to diversify up to 50% of the Company Stock allocated to his or her ESOP Account.

(ii)     The number of shares of Company Stock that may be diversified shall be determined by applying the diversification percentage of 50% to the total number of shares allocated to a Participant’s ESOP Account and reducing such number by the number of shares of Company Stock previously diversified under this Section.

(c)        Notwithstanding the foregoing, effective as of January 1, 2002 and ending on the effective date of the diversification rules set forth in subsection (b) above, a Participant may elect to diversify his or her ESOP Account as follows:

(i)      Any Participant who is a Qualified Participant as of December 31, 2001 may elect to diversify up to 50% of the Company Stock allocated to his or her ESOP Account in accordance with the following schedule that increases the Diversification Percentage over the following three Plan Years:

 

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       Plan Year    Diversification Percentage

2002

   up to 25%

2003

   up to 40%

2004 and thereafter

   up to 50%

(ii)     Any Participant who becomes a Qualified Participant on or after January 1, 2002 may elect to diversify up to 50% of the Company Stock allocated to his or her ESOP Account in accordance with the following schedule that increases the Diversification Percentage over the following three Plan Years:

 

       Plan Year    Diversification Percentage

Plan Year after becoming a Qualified Participant

   up to 25%

Next succeeding Plan Year

   up to 40%

Next succeeding Plan Year and thereafter

   up to 50%

(iii)    The number of shares of Company Stock that may be diversified in any given Plan Year shall be determined by applying the Diversification Percentage in the above schedules to the total number of shares allocated to a Participant’s ESOP Account as of the beginning of the Plan Year and reducing such number by the number of shares of Company Stock previously diversified under this Section.

(d)        For Plan Years prior to the 2002 Plan Year, each Qualified Participant shall be permitted to direct the Plan as to the diversification of 25 percent of the value of the vested portion of the Participant’s ESOP Account within 90 days after the last day of each Plan Year during the Participant’s Qualified Election Period. For the purpose of this paragraph (d), the term “Qualified Participant” means a Participant who has attained age 55 and who has completed at least 10 years of participation in the Plan and the term “Qualified Election Period” shall mean the six Plan Year period beginning with the Plan Year in which the Participant first becomes a Qualified Participant. Within 90 days after the close of the last Plan Year in the Participant’s Qualified Election Period, a Qualified Participant may direct the Plan as to the diversification of 50 percent of the value of the vested portion of such ESOP Account. Upon such direction by a Qualified Participant, the Plan shall transfer to the Allergan, Inc. Savings and Investment Plan (the “SIP”) that portion of the Participant’s ESOP Account that is covered by the election within 90 days after the last day of the period during which the election can be made which shall be allocated to a rollover account maintained on behalf of the Qualified Participant. Under the SIP, the Qualified Participant may invest the amount so transferred under any of the investment options available under the SIP or may direct that the amount so transferred be distributed to him or her.

 

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(e)        A Qualified Participant who elects to diversify his or her ESOP Account as provided under this Section shall do so by transferring diversified amounts to any of the investment funds currently offered and currently available to Participants as determined by the Committee pursuant to Section 6.3(c); provided, however, that any allocations among the investment funds shall be made in 1% increments. Any election to diversify shall be effective as soon as administratively feasible and subject to paragraph (f) below. A Qualified Participant shall effect a diversification election under procedures established by the Committee for this purpose.

(f)        For purposes of this Section and consistent with the requirements of Code Section 401(a)(28) if applicable, a Qualified Participant who is an Insider may only elect to diversify his or her ESOP Account if within six (6) months before the Participant’s election, he or she has not made an election under the Allergan, Inc. Savings and Investment Plan or the provision of any company plan covered by Rule 16b-3 (promulgated pursuant to the Securities Exchange Act of 1934) then in existence that would result in the transfer into a Company equity securities fund.

5.13.       Lapsed Benefits .

(a)        In the event that a Participant’s ESOP Account is payable under the Plan and after reasonable efforts the Participant cannot be located for the purpose of paying his or her ESOP Account during a period of three consecutive years, the Participant shall be presumed dead and his or her ESOP Account shall, upon the expiration of that three year period, be paid to the Participant’s Beneficiary. If the Participant’s Beneficiary cannot be located for the purpose of paying the Participant’s ESOP Account for the following two years, then the Participant’s ESOP Account shall, upon expiration of such two-year period, be forfeited and reallocated to the ESOP Accounts of other Participants as provided in Section 4.3.

(b)        If a Participant dies prior to receiving a distribution of the entire vested portion of his or her ESOP Account (other than a Participant presumed to have died as provided above) and if after reasonable efforts the Beneficiary of the Participant cannot be located for the purpose of paying the Participant’s ESOP Account during a period of five consecutive years, the benefit shall, upon expiration of such five-year period, be forfeited and reallocated to the ESOP Accounts of the other Participants as provided in Section 4.3.

(c)        For purposes of this Section, the term “Beneficiary” shall include any person entitled under Section 5.8 to receive the vested interest of a deceased Participant or deceased designated Beneficiary. It is the intention of this Section that during the relevant waiting period (two years or five years) the vested portion of a Participant’s ESOP Account shall be distributed to a Beneficiary in a lower priority category under Section 5.8 if no Beneficiary in a higher priority category can be located by the Committee after reasonable efforts have been made.

 

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(d)        Notwithstanding the foregoing rules, if after such a forfeiture the Participant or a Beneficiary claims the forfeited ESOP Account, the amount forfeited shall be reinstated (without regard to any interest or investment earnings on such amount) and paid to the Participant or Beneficiary as soon as practical following the production of reasonable proof of the identity of the Participant or Beneficiary and his or her entitlement to the amounts forfeited (determined pursuant to the Plan’s normal claim procedures under Section 7.10).

(e)        The Committee shall direct the Trustee with respect to the procedures to be followed concerning a missing Participant (or Beneficiary), and the Company shall be obligated to contribute to the Trust Fund any amounts necessary after the application of Section 4.3 to pay any reinstated benefit after it has been forfeited pursuant to the provisions of this Section.

 

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ARTICLE VI

TRUST FUND AND INVESTMENTS

6.1.         General .    All contributions made under the Plan and investments made and property of any kind or character acquired with any such funds or otherwise contributed, and all income, profits, and proceeds derived therefrom, shall be held in Trust and shall be held and administered by the Trustee in accordance with the provisions of the Plan and Trust Agreement.

6.2.         Single Trust .    Assets of the Trust shall be held in a separate fund which shall consist of the Trust Fund. Individual Participant interests in the Trust Fund shall be reflected in the ESOP Accounts maintained for the Participants. Notwithstanding the foregoing, the Trust Fund shall be treated as a single trust for purposes of investment and administration, and nothing contained herein shall require a physical segregation of assets for any fund or for any Account maintained under the Plan.

6.3.         Investment of the Trust .

(a)        Subject to paragraph (c) below and Sections 6.4 and 5.12 hereof, the Trust Fund shall be invested primarily in Company Stock and neither the Company nor the Committee nor the Trustee shall have any responsibility or duty to time any transaction involving Company Stock, in order to anticipate market conditions or changes in stock value, nor shall any such person have any responsibility or duty to sell Company Stock held in the Trust Fund (or otherwise to provide investment management for Company Stock held in the Trust Fund) in order to maximize return or minimize loss. The Committee may direct the Trustee to have the Plan enter into one or more Exempt Loans to finance the acquisition of Company Stock for the Trust Fund. Company contributions in cash, and other cash received or held by the Trustee, may be used to acquire shares of Company Stock from the Company, Company shareholders, from the ESOP Accounts of Participants about to receive distributions under the Plan, or on the open market.

(b)        Notwithstanding anything contained herein to the contrary, proceeds of an Exempt Loan shall be used, within a reasonable time after receipt by the Trust, only for the following purposes:

(i)      to acquire Company Stock;

(ii)     to repay the same Exempt Loan; or

(iii)    to repay any previous Exempt Loan.

An Exempt Loan shall be repaid only from amounts loaned to the Trust and the proceeds of such loans, from Company contributions in cash and earnings attributable thereto, from any collateral given for the loan (including, in the case where the Exempt Loan is a refinancing of a prior Exempt Loan, unallocated Company Stock acquired with

 

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the proceeds of the prior Exempt Loan), and from dividends paid on Company Stock acquired with proceeds of the Exempt Loan. Except as provided in Section 5.11 or as otherwise required by applicable law, no Company Stock acquired with the proceeds of an Exempt Loan may be subject to a put, call, or other option or buy-sell or similar arrangement while held by and when distributed from the Plan.

(c)        Notwithstanding paragraph (a) above, the Committee may establish separate investment funds under the Plan, with each fund representing an investment alternative available to Participants for the investment of their ESOP Accounts as provided in paragraph (d) below and Section 5.12. Each Participant shall have a subaccount under the Plan corresponding to the Participant’s interest which is allocated to each investment fund. Each such subaccount may be valued separately. The manner in which assets of the Trust shall be invested in such investment funds, including the establishment of alternative investment funds, the elimination of any previously established funds, or the placement of limitations on the availability of an investment fund to Participants, shall be chosen by the Committee at its discretion. Amounts invested in any one of the investment funds shall not share in gains and losses experienced by any other fund. Notwithstanding the establishment of separate investment funds within the Trust, the Trust shall at all times constitute a single trust.

(d)        A Participant may elect at any time to transfer any cash or other property, including shares of Advanced Medical Optics, Inc. (“non-Company Stock assets”) or amounts previously diversified under Section 5.12, accumulated in his or her ESOP Account among any of the investment funds currently offered and currently available to Participants as determined by the Committee pursuant to paragraph (c) above; provided, however, the total amount transferred shall be made in 1% increments of the amount accumulated in such funds. Any transfer among investment funds shall be effective as soon as administratively feasible. A Participant shall effect a transfer election under procedures established by the Committee for this purpose.

(e)        Notwithstanding anything in the Plan to the contrary, the following additional transfer restrictions shall apply to all Participants who are Insiders as defined in Section 5.12.

(i)      Any Insider who transfers amounts invested in Company Stock and into another fund or withdraws cash in a transaction that results in the liquidation of Company Stock (pursuant to Sections 5.7 or to the extent applicable under Section 5.12), may not for a period of six months following the Participant’s election to so transfer funds or withdraw cash, as the case may be, make an election to transfer amounts from another fund and invest in Company Stock.

(ii)     Any Insider who transfers amounts invested in a non-Company Stock fund to invest in Company Stock, may not for a period of six months following the Participant’s election to so transfer funds make an election to (1) sell Company Stock and transfer the proceeds to another fund, (2) withdraw

 

33


cash that results in the liquidation of Company Stock or (3) make a diversification election under Section 5.12 subject to the requirements of Code Section 401(a)(28), if applicable or (4) utilize the Allergan Inc. Savings and Investment Plan or the provision of any Company plan covered by Rule 16b-3 (promulgated pursuant to the Exchange Act) then in existence that would result in the transfer out of a Company equity securities fund.

(f)        It is intended that to the extent a Participant may diversify or direct the investment of his or her ESOP Account under the Plan that the Plan constitute a plan described in Section 404(c) of ERISA and the regulations thereunder, and neither the Company, Committee, nor any fiduciary with respect to the Plan who is employed by the Company shall be liable for investment losses sustained by any Participant or Beneficiary as a direct and necessary result of the investment instructions given by such Participant or Beneficiary. Such fiduciaries set forth in the preceding sentence shall be under no duty to question the investment direction of the Participant or Beneficiary or to advise a Participant or Beneficiary as to the manner in which his or her ESOP Account is to be invested. The fact that an investment option is offered shall not be construed to be a recommendation of investment.

(g)        On June 29, 2002, Allergan spun-off AMO and distributed the stock of AMO (referred to in the Plan as “AMO Stock”) to its shareholders. The following provisions of the Plan shall apply to AMO Stock as if the term “AMO Stock” was substituted for the term “Company Stock”: Section 6.4 (Certain Offers for Company Stock); Section 6.5 (Securities Law Limitation); Section 6.7 (Dividends); Section 6.14 (Appointment of Investment Manager); Section 7.1 (Appointment of Committee); Section 7.2 (Appointment of Investment Subcommittee); Section 7.7 (Additional Powers of Committee); Section 7.8 (Investment Subcommittee Powers); Section 7.14 (Compensation of Committees and Plan Expenses); and Section 7.16 (Voting of Company Stock), as applicable.

6.4.         Certain Offers for Company Stock .    Notwithstanding any other provision of the Plan to the contrary, in the event an offer shall be received by the Trustee (including but not limited to a tender offer or exchange offer within the meaning of the Securities Exchange Act of 1934, as from time to time amended and in effect) to acquire any or all shares of Company Stock held by the Trust (an “Offer”), whether or not such Company Stock is allocated to Participants’ ESOP Accounts, the discretion or authority to sell, exchange or transfer any of such shares of Company Stock shall be determined in accordance with the following rules:

(a)        The Trustee shall have no discretion or authority to sell, exchange or transfer any Company Stock pursuant to an Offer except to the extent, and only to the extent that the Trustee is timely directed to do so in writing (i) with respect to any Company Stock held by the Trustee subject to such Offer and allocated to any Participant’s ESOP Account, by each Participant to whose ESOP Account any of such Company Stock is allocated and (ii) with respect to any Company Stock held by the Trustee subject to such Offer and not allocated to any Participant’s ESOP Account, by

 

34


each Participant who is an Eligible Employee with respect to a number of shares (including fractional shares) of such unallocated Company Stock equal to the total number of shares of such unallocated Company Stock multiplied by a fraction the numerator of which is the annualized Compensation of such Participant for the calendar year in which such Offer is made and the denominator of which is the total annualized Compensation for the calendar year in which such Offer is made of all such Participants who are Eligible Employees.

(b)        To the extent there remains any residual fiduciary responsibility with respect to Company Stock pursuant to an Offer after application of paragraph (a) above, the Trustee shall sell, exchange or transfer such Company Stock as directed by the Committee or as directed by an independent fiduciary if duly appointed by the Sponsor. To the extent the Committee or an independent fiduciary is required to exercise any residual fiduciary responsibility with respect to an Offer, the Committee or independent fiduciary shall take into account in exercising its fiduciary judgment, unless it is clearly imprudent to do so, directions timely received from Participants, as such directions are most indicative of what action is in the best interests of Participants. Further, the Committee or independent fiduciary, in addition to taking into consideration any relevant financial factors bearing on any such decision, shall take into consideration any relevant non-financial factors, including, but not limited to, the continuing job security of Participants as employees of the Sponsor or any Affiliated Company, conditions of employment, employment opportunities and other similar matters, and the prospect of the Participants and prospective Participants for future benefits under the Plan (including any subsequent release and allocation of Company Stock held in the Exempt Loan Suspense Subfund).

(c)        Upon timely receipt of such instructions, the Trustee shall, subject to the provisions of paragraphs (e) and (o) of this Section, sell, exchange or transfer pursuant to such Offer, only such shares as to which such instructions were given. The Committee shall use its best efforts to communicate or cause to be communicated to each Participant the consequences of any failure to provide timely instructions to the Trustee.

(d)        In the event, under the terms of an Offer or otherwise, any shares of Company Stock tendered for sale, exchange or transfer pursuant to such Offer may be withdrawn from such Offer, the Trustee shall follow such instructions respecting the withdrawal of such shares from such Offer in the same manner and the same proportion as shall be timely received by the Trustee from the Participants entitled under this Section to give instructions as to the sale, exchange or transfer of shares pursuant to such Offer.

(e)        In the event that an Offer for fewer than all of the shares of Company Stock held by the Trustee in the Trust shall be received by the Trustee, each Participant shall be entitled to direct the Trustee as to the acceptance or rejection of such Offer (as set forth herein) with respect to the largest portion of such Company Stock as may be possible given the total number or amount of shares of Company Stock the Plan may sell, exchange or transfer pursuant to the Offer based upon the instructions received by the

 

35


Trustee from all other Participants who shall timely instruct the Trustee pursuant to this paragraph to sell, exchange or transfer such shares pursuant to such Offer, each on a pro rata basis in accordance with the maximum number of shares each such Participant would have been permitted to direct under paragraph (a) had the Offer been for all shares of Company Stock held in the Trust.

(f)        In the event an Offer is received by the Trustee and instructions have been solicited from Participants regarding such Offer, and prior to termination of such Offer, another Offer is received by the Trustee for the Company Stock subject to the first Offer, the Trustee shall inform the Committee of such other Offer and the Committee shall use its best efforts under the circumstances to solicit instructions from the Participants (i) with respect to securities tendered for sale, exchange or transfer pursuant to the first Offer, whether to withdraw such tender, if possible, and, if withdrawn, whether to tender any Company Stock so withdrawn for sale, exchange or transfer pursuant to the second Offer and (ii) with respect to Company Stock not tendered for sale, exchange or transfer pursuant to the first Offer, whether to tender or not to tender such Company Stock for sale, exchange or transfer pursuant to the second Offer. The Trustee shall follow all such instructions received in a timely manner from Participants in the same manner and in the same proportion as provided in paragraph (a) of this Section. With respect to any further Offer for any Company Stock received by the Trustee and subject to any earlier Offer (including successive Offers from one or more existing offers), the Trustee shall act in the same manner as described above.

(g)        With respect to any Offer received by the Trustee, the Trustee shall inform the Sponsor of such Offer and the Sponsor shall distribute, at its expense, copies of all relevant material including but not limited to material filed with the Securities and Exchange Commission with such Offer or regarding such Offer, which shall seek confidential written instructions from each Participant who is entitled to respond to such Offer pursuant to paragraph (a). The identities of Participants, the amount of Company Stock allocated to their ESOP Accounts, and the Compensation of each Participant shall be determined from the list of Participants delivered to the Sponsor by the Committee which shall take all reasonable steps necessary to provide the Sponsor with the latest possible information.

(h)        The Sponsor shall distribute and/or make available to each Participant who is entitled to respond to an Offer pursuant to paragraphs (a), an instruction form to be used by each such Participant who wishes to instruct the Trustee. The instruction form shall state that (i) if the Participant fails to return an instruction form to the Trustee by the indicated deadline, the Company Stock with respect to which he or she is entitled to give instructions shall not be sold, exchanged or transferred pursuant to such Offer unless the Trustee is directed otherwise as provided in paragraph (b) above, (ii) the Participant shall be a named fiduciary (as described in paragraph (m) below) with respect to all shares of Company Stock for which he or she is entitled to give instructions, and (iii) the Company acknowledges and agrees to honor the confidentiality of the Participant’s instructions to the Trustee.

 

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(i)        Each Participant may choose to instruct the Trustee in one of the following two ways: (i) not to sell, exchange or transfer any shares of Company Stock for which he or she is entitled to give instructions, or (ii) to sell, exchange or transfer all Company Stock for which he or she is entitled to give instructions. The Sponsor shall follow up with additional mailings and postings of bulletins, as reasonable under the time constraints then prevailing, to obtain instructions from Participants not otherwise responding to such requests for instructions. Subject to paragraph (e), the Trustee shall then sell, exchange or transfer shares according to instructions from Participants, except that shares for which no instructions are received shall not be sold, exchanged or transferred unless directed otherwise as provided in paragraph (b) above.

(j)        The Sponsor shall furnish former Participants who have received distributions of Company Stock so recently as to not be shareholders of record with the information given to Participants pursuant to paragraphs (g), (h) and (i) of this Section. The Trustee shall then sell, exchange or transfer shares according to instructions from such former Participants, except that shares for which no instructions are received shall not be sold, exchanged or transferred.

(k)        Neither the Company, the Committee nor the Trustee shall express any opinion or give any advice or recommendation to any Participant concerning the Offer, nor shall they have any authority or responsibility to do so.

(l)        The Trustee shall not reveal or release a Participant’s instructions to the Company, its officers, directors, employees, or representatives. If some but not all Company Stock held by the Trust is sold, exchanged, or transferred pursuant to an Offer, the Company, with the Trustee’s cooperation, shall take such action as is necessary to maintain the confidentiality of Participant’s records including, without limitation, establishment of a security system and procedures which restrict access to Participant records and retention of an independent agent to maintain such records. If an independent record keeping agent is retained, such agent must agree, as a condition of its retention by the Sponsor, not to disclose the composition of any Participant ESOP Accounts to the Company, its officers, directors, employees, or representatives. The Company acknowledges and agrees to honor the confidentiality of Participants’ instructions to the Trustee.

(m)        Each Participant shall be a named fiduciary (as that term is defined in Section 402(a)(2) of ERISA) with respect to Company Stock allocated to his or her ESOP Account under the Plan and with respect to his or her pro-rata portion of the unallocated Company Stock for which he or she is entitled to issue instructions in accordance with paragraph (a) of this Section solely for purposes of exercising the rights of a shareholder with respect to an Offer pursuant to this Section 6.4 and voting rights pursuant to Section 7.16.

 

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(n)        To the extent that an Offer results in the sale of Company Stock in the Trust and allocated to the ESOP Accounts of Participants, the Committee shall instruct the Trustee as to the investment of the proceeds of such sale. To the extent that an Offer results in the sale of Company Stock in the Trust and not allocated to the ESOP Accounts of any Participant, the proceeds from such sale shall first be applied to repay the fullest extent possible, all Exempt Loans then outstanding. To effect such repayment, the Trustee shall seek such consents and approvals from lenders under any Exempt Loans as may be necessary or convenient to permit the tender of shares of Company Stock held in the Exempt Loan Suspense Subfund. To the extent that proceeds from the sale of shares held in the Exempt Loan Suspense Subfund exceed the outstanding principal and interest of all Exempt Loans, such excess proceeds shall be allocated to each Eligible Participant’s (as defined in Section 4.2(d)) Non-Stock Subaccount in the same manner as allocations under Section 4.2(a); provided, however, that only an Eligible Participant who is employed on the date of the closing of the sale pursuant to the Offer shall be deemed an Eligible Participant entitled to an allocation of excess sale proceeds for purposes of this Section 6.4(n) only. To the extent that less than all of the shares of Company Stock held in the Exempt Loan Suspense Subfund are tendered in an Offer and repayment of an Exempt Loan results in a release of shares of Company Stock from the Exempt Loan Suspense Subfund in excess of those tendered in such Offer, the excess released shares of Company Stock shall be allocated to each Eligible Participant’s ESOP Account in the same manner as allocations under Section 4.2(c); provided, however, that only an Eligible Participant who is employed on the date of the closing of the sale pursuant to the Offer shall be deemed an Eligible Participant entitled to an allocation of Company Stock for purposes of this Section 6.4(n) only. To the extent that allocations to Eligible Participants under this Section 6.4(n) constitute Annual Additions, all such allocations shall be subject to the limitations set forth in Article XI hereof. Any allocations to which Eligible Participants would be entitled under this Section 6.4(n) but for the limitations of Article XI, shall be held in the 415 Suspense Account and allocated to Eligible Participants in accordance with Article XI.

(o)        In the event a court of competent jurisdiction shall issue to the Plan, the Committee, the Sponsor or the Trustee an opinion or order, which shall, in the opinion of counsel to the Committee, the Sponsor or the Trustee, invalidate, in all circumstances or in any particular circumstances, any provision or provisions of this Section regarding the determination to be made as to whether or not Company Stock held by the Trustee shall be sold, exchanged or transferred pursuant to an Offer or cause any such provision or provisions to conflict with securities laws, then, upon notice thereof to the Committee, the Sponsor or the Trustee, as the case may be, such invalid or conflicting provisions of this Section shall be given no further force or effect. In such circumstances, the Trustee shall continue to follow instructions received from Participants, to the extent such instructions have not been invalidated by such order or opinion. To the extent the Trustee is required by such opinion or order to exercise any residual fiduciary responsibility with respect to such Offer, the Sponsor shall appoint an independent fiduciary who shall exercise such residual fiduciary responsibility as provided in paragraph (b) above and

 

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shall direct the Trustee as to whether or not Company Stock held by the Trustee shall be sold, exchanged or transferred pursuant to such Offer.

6.5.         Securities Law Limitation .    Neither the Committee nor the Trustee shall be required to engage in any transaction, including without limitation, directing the purchase or sale of Company Stock, which either determines in its sole discretion might tend to subject itself, its members, the Plan, the Company, or any Participant or Beneficiary to a liability under federal or state securities laws.

6.6.         Accounting and Valuations .

(a)        The following special accounting rules shall apply to the Trust Fund.

(i)      Each Participant’s ESOP Account shall consist of (1) a portion comprised of cash and all other assets except for Company Stock and AMO Stock (the “Non-Stock Subaccount”); (2) a portion comprised solely of AMO Stock (the “AMO Subaccount”); and (3) a portion comprised solely of Company Stock (the “Stock Subaccount”).

(ii)     Gains or losses on Non-Stock Subaccounts shall be credited in accordance with this Section as if the Non-Stock Subaccounts collectively constituted a separate pooled investment fund.

(iii)    Stock Subaccounts shall be credited with a specific number of shares of Company Stock rather than an individual interest in a pool of Company Stock.

(iv)     AMO Subaccounts shall be credited with a specific number of shares of AMO Stock rather than an individual interest in a pool of AMO Stock.

(b)        Non-Stock Subaccounts may be invested in Company Stock from time to time, and Company Stock so acquired shall be allocated among Stock Subaccounts in proportion to the amount debited to the corresponding Non-Stock Subaccounts.

(c)        As of each Valuation Date each Participant’s Non-Stock Subaccount shall be credited (debited) with the “allocable share” of the net income (loss) of the non-Company Stock portion of the Trust Fund valued as of such Valuation Date in proportion to Non-Stock Subaccount balances. For this purpose, except as provided in Section 6.7, the net income (loss) of the Trust Fund shall not include any income with respect to securities in the Exempt Loan Suspense Subfund acquired with the proceeds of an Exempt Loan.

(d)        In making valuations required by the Plan, the Trustee shall value all assets of the Trust at fair market value. Such fair market value shall be determined from facts reasonably available to the Trustee. In making said determination, the Trustee may,

 

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but need not, select and rely upon the advice and opinions of appraisers, brokers, investment counsel, or any other persons believed by the Trustee to be competent. Any determination of value so made shall, for all purposes of the Plan, conclusively establish such value.

(e)        If Company Stock is readily tradeable stock (as that term is used under Code Section 409(h)), valuation of each Participant’s Stock Subaccount shall, at any relevant times, be worth the fair market value on that date of the shares of Company Stock credited to it. Valuations of any Company Stock held by the Trust which is not readily tradable stock shall be performed by an independent appraiser or valuation consultant.

(f)        The Committee shall establish accounting procedures for the purpose of making the allocations, valuations and adjustments to Participants’ ESOP Accounts provided for in Article VI hereof. Such accounting procedures shall include adequate records of the cost basis of Company Stock allocated to ESOP Accounts and the identity of shares acquired with the proceeds of an Exempt Loan. From time to time, the Committee may modify its accounting procedures for the purpose of achieving equitable and nondiscriminatory allocations among the ESOP Accounts of Participants in accordance with the provisions of the Plan.

(g)        In the event any rights, warrants, or options are issued with respect to Company Stock held in Stock Subaccounts, the Committee shall direct the Trustee as to whether such rights, warrants, or options shall be exercised for such Subaccounts using cash as may be available in corresponding Non-Stock Subaccounts. Company Stock so acquired shall be credited to corresponding Stock Subaccounts in proportion to the amount of cash withdrawn from the corresponding Non-Stock Subaccounts. A Participant shall have no right to request, direct, or demand that the Trust exercise on his or her behalf rights to purchase Company Stock.

(h)        The Participants and their Beneficiaries shall assume all risks in connection with any decrease in the value of any assets invested in the Trust Fund which are allocated to their ESOP Accounts.

(i)        Paragraphs (e) and (g) of this Section 6.6 shall apply to AMO Stock as if the term “AMO Stock” was substituted for the term “Company Stock” and the term “AMO Subaccount” was substituted for the term “Stock Subaccount,” as applicable.

6.7.         Dividends .

(a)        As determined by the Committee, dividends on shares of Company Stock allocated to ESOP Accounts shall be either (i) applied to repay an Exempt Loan then outstanding; (ii) paid directly to Participants or Beneficiaries; or (iii) retained in the Trust and treated as net income of the Trust. Any resulting allocation shall be made according to the following rules:

 

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(i)      If cash dividends are used to repay an Exempt Loan, the appropriate number of shares of Company Stock shall be released from the Exempt Loan Suspense Subfund pursuant to Section 4.2(b). Notwithstanding the foregoing, if the fair market value of the shares released pursuant to Section 4.2(b) from the application of cash dividends to repay an Exempt Loan under this Section 6.7(a)(i) is less than such cash dividends, additional shares shall be released from the Exempt Loan Suspense Subfund until the fair market value of such released shares equals the amount of such cash dividends. Such Company Stock shall be allocated to Participants’ Stock Subaccounts in proportion to the number of shares of Company Stock allocated to Participants’ Stock Subaccounts for which such cash dividend was paid.

(ii)     If cash dividends are retained in the Trust and are not used to pay expenses of the Plan, such dividends shall be allocated as of the date specified by the Committee to Non-Stock Subaccounts in proportion to the shares of Company Stock held in corresponding Stock Subaccounts for which such dividends were distributed to the Trust.

(iii)    If stock dividends are retained in the Trust and are not used to pay expenses of the Plan, such dividends shall be credited on the date specified by the Committee to Stock Subaccounts in proportion to the shares of Company Stock held in such Subaccounts for which such dividends were distributed to the Trust.

(iv)     If the Committee determines that cash or stock dividends shall be distributed directly to Participants or Beneficiaries, such dividends shall be distributed on the date specified by the Committee in proportion to the shares of Company Stock held in such Participant’s or Beneficiary’s Stock Subaccount for which such dividends were distributed.

(v)     If cash dividends are received by the Trust on or after January 1, 2002, such dividends to the extent received on shares of Company Stock allocable to a Participant’s ESOP Account shall be reinvested in Company Stock and held in such Participant’s or Beneficiary’s Stock Subaccounts, or to the extent such dividends are vested, shall be distributed to the Participant or Beneficiary not later than 90 days after the close of the Plan Year in which such dividends are paid if so elected by the Participant or Beneficiary.

(b)        As determined by the Committee, dividends on shares of Company Stock held in the Exempt Loan Suspense Subfund or on shares of Company Stock contributed to the Trust Fund but not yet allocated to Participant’s ESOP Accounts shall be either (i) applied to repay an Exempt Loan then outstanding or (ii) retained in the Trust. Any resulting allocation shall be made according to the following rules:

 

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(i)      If cash or stock dividends are used to repay an Exempt Loan, the appropriate number of shares of Company Stock shall be released from the Exempt Loan Suspense Subfund pursuant to Section 4.2(b). Such Company Stock shall be allocated to Participants Stock Subaccounts pursuant to Section 4.2(c).

(ii)     If cash dividends are not used to repay an Exempt Loan, they shall be considered income of the Trust and, if not used to pay expenses of the Plan, shall be allocated to Participants’ ESOP Accounts in proportion to their respective ESOP Account balances.

(iii)    If stock dividends are not used to repay an Exempt Loan or used to pay expenses of the Plan, they shall be retained in the Exempt Loan Suspense Subfund until released from such Subfund pursuant to Section 4.2(b) and allocated to Participants Stock Subaccounts pursuant to Section 4.2(c).

6.8.         Non-Diversion of Trust Fund .    Except as hereinafter provided, all assets of the Trust shall be held by the Trustee for the exclusive benefit of Plan Participants and Beneficiaries. At no time shall any part of the Trust be used for or diverted to purposes other than for the exclusive benefit of the Participants and Beneficiaries under the Plan except as follows:

(a)        In the case of a contribution which is made by a mistake of fact, that contribution at the Sponsor’s written request, shall be returned to the Company as directed by the Sponsor within one (1) year after it is made.

(b)        All contributions to the Trust are hereby conditioned upon the Plan satisfying all of the requirements of Code Section 401(a), as evidenced by the issuance by the Internal Revenue Service of a favorable determination letter with respect to the Plan. If the Plan does not qualify, the Plan may be revoked at the Sponsor’s written election, and any or all such contributions with respect to the portion revoked may be returned to the Company within one year after the date of the Internal Revenue Service’s denial of the qualification of the Plan or a portion thereof. Upon such a revocation the affairs of the Plan and Trust shall be terminated and wound up as the Sponsor shall direct.

(c)        Contributions to the Trust Fund are conditioned on deductibility under Code Section 404. To the extent a deduction is disallowed and at the Sponsor’s written request, such contributions shall be returned to the Company as directed by the Sponsor within one year after the disallowance.

(d)        The residue of the 415 Suspense Account that cannot be allocated to Participants upon a Plan termination shall revert to the Company as directed by the Sponsor in accordance with the provisions of Section 11.6.

6.9.         Company, Committee and Trustee Not Responsible for Adequacy of Trust Fund .    Neither any member of the Committee, any Trustee nor the Company shall be liable or

 

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responsible for the adequacy of the Trust to meet and discharge any or all payments and liabilities hereunder. All Plan benefits will be paid only from the Trust assets, and neither any member of the Committee, any Trustee, nor the Company shall have any duty or liability to furnish the Trust with any funds, securities or other assets except as expressly provided in the Plan. Except as required under the Plan or Trust or under Part 4 of Subtitle B, Title I of ERISA, the Company shall not be responsible for any decision, act, or omission of a Trustee or a member of the Committee or any Investment Manager (if applicable), or responsible for the application of any moneys, securities, investments, or other property paid or delivered to the Trustee.

6.10.       Distributions .    Money and property of the Trust shall be paid out, disbursed, or applied by the Trustee for the benefit of Participants and Beneficiaries under the Plan in accordance with directions received by the Trustee from the Committee. Upon direction of the Committee, the Trustee may pay money or deliver property from the Trust for any purpose authorized under the Plan. The Trustee shall be fully protected in paying out money or delivering property from the Trust from time to time upon written order of the Committee and shall not be liable for the application of such money or property by the Committee.

The Trustee shall not be required to determine or to make any investigation to determine the identity or mailing address of any person entitled to benefits hereunder and shall have discharged its obligation in that respect when it shall have sent checks or other property by first-class mail to such persons at their respective addresses as may be certified to it by the Committee.

6.11.       Taxes .    If the whole or any part of the Trust, or the proceeds thereof, shall become liable for the payment of any estate, inheritance, income or other tax, charge, or assessment which the Trustee shall be required to pay, the Trustee shall have full power and authority to pay such tax, charge, or assessment out of any moneys or other property in its hands for the account of the person whose interests hereunder are so liable, but at least ten (10) days prior to making any such payment, the Trustee shall mail notice to the Committee of its intention to make such payment. Prior to making any transfers or distributions of any of the Trust, the Trustee may require such releases or other documents from any lawful taxing authority as it shall deem necessary.

6.12.       Trustee Records to be Maintained .     The Trustee shall keep accurate and detailed accounts of all investments, receipts, disbursements, and other transactions hereunder, and all accounts, books, and records relating thereto shall be open to inspection and audit at all reasonable times by any person designated by the Company (subject to the provisions of Sections 6.4(1) and 7.13(c)).

6.13.       Annual Report of Trustee .    Promptly following the close of each Plan Year (or such other period as may be agreed upon between the Trustee and Committee), or promptly after receipt of a written request from the Company, the Trustee shall prepare for the Company a written account which will enable the Company to satisfy the annual financial reporting requirements of ERISA, and which will set forth among other things all investments, receipts, disbursements, and other transactions effected by the Trustee during such Plan Year or during the

 

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period from the close of the last Plan Year to the date of such request. Such account shall also describe all securities and other investments purchased and sold during the period to which it refers, the cost of acquisition or net proceeds of sale, the securities and investments held as of the date of such account, and the cost of each item thereof as carried on the books of the Trustee. All accounts so filed shall be open to inspection during business hours by the Company, the Committee, and by Participants and Beneficiaries of the Plan (subject to the provisions of Sections 6.4(1) and 7.13(c)).

6.14.       Appointment of Investment Manager .    From time to time the Committee, in accordance with Section 7.7 hereof, may appoint one or more Investment Managers who shall have investment management and control over assets of the Trust not invested or to be invested in Company Stock. The Committee shall notify the Trustee of such assets of the appointment of the Investment Manager. In the event more than one Investment Manager is appointed, the Committee shall determine which assets shall be subject to management and control by each Investment Manager and shall also determine the proportion in which funds withdrawn or disbursed shall be charged against the assets subject to each Investment Manager’s management and control. As shall be provided in any contract between an Investment Manager and the Committee, such Investment Manager shall hold a revocable proxy with respect to all securities which are held under the management of such Investment Manager pursuant to such contract (except for Company Stock), and such Investment Manager shall report the voting of all securities subject to such proxy on an annual basis to the Committee.

 

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ARTICLE VII

OPERATION AND ADMINISTRATION

7.1.         Appointment of Committee .    There is hereby created a committee (the “Committee”) which shall exercise such powers and have such duties in administering the Plan as are hereinafter set forth. The Board of Directors shall determine the number of members of such Committee. The members of the Committee shall be appointed by the Board of Directors and such Board shall from time to time fill all vacancies occurring in said Committee. The members of the Committee shall constitute the Named Fiduciaries of the Plan within the meaning of Section 402(a)(2) of ERISA; provided that solely for purposes of Section 6.4 hereof, Participants shall be Named Fiduciaries with respect to shares of Company Stock for which they have the right to sell, transfer, or exchange pursuant to Section 6.4 and solely for purposes of Section 7.16, Participants shall be Named Fiduciaries with respect to shares of Company Stock on matters as to which they are entitled to provide voting directions pursuant to Section 7.16.

7.2.         Appointment of Investment Subcommittee .    There is hereby created an investment subcommittee of the Committee (hereinafter referred to as the “Investment Subcommittee” for purposes of this Article VII) which shall exercise management and control over the assets of the Trust. The Board of Directors, acting through its Organization and Compensation Committee, shall determine the number of members of the Investment Subcommittee. The members of the Investment Subcommittee shall be appointed by the Board of Directors, acting through its Organization and Compensation Committee, and shall from time to time appoint such members to or fill any vacancies in the Investment Subcommittee. The members of the Investment Subcommittee shall constitute the Named Fiduciaries of the Plan within the meaning of Section 402(a)(2) of ERISA with respect to the management and control of the assets of the Trust; provided that solely for purposes of Section 6.4 hereof, Participants shall be Named Fiduciaries with respect to shares of Company Stock for which they have the right to sell, transfer, or exchange pursuant to Section 6.4 and solely for purposes of Section 7.16, Participants shall be Named Fiduciaries with respect to shares of Company Stock on matters as to which they are entitled to provide voting directions pursuant to Section 7.16.

7.3.         Transaction of Business .    The Committee and Investment Subcommittee shall transact business as provided in paragraphs (a) and (b), respectively:

(a)        A majority of the Committee shall constitute a quorum for the transaction of business. Actions of the Committee may be taken either by vote at a meeting or in writing without a meeting. All action taken by the Committee at any meeting shall be by a vote of the majority of those present at such meeting. All action taken in writing without a meeting shall be by a vote of the majority of those responding in writing. All notices, advices, directions and instructions to be transmitted by the Committee shall be in writing and signed by or in the name of the Committee. In all its communications with the Trustee, the Committee may, by either of the majority actions specified above, authorize any one or more of its members to execute any document or documents on behalf of the Committee, in which event it shall notify the Trustee in writing of such

 

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action and the name or names of its members so designated and the Trustee shall thereafter accept and rely upon any documents executed by such member or members as representing action by the Committee until the Committee shall file with the Trustee a written revocation of such designation.

(b)        A majority of the Investment Subcommittee shall constitute a quorum for the transaction of business. Actions of the Investment Subcommittee may be taken either by vote at a meeting or in writing without a meeting. All action taken by the Investment Subcommittee at any meeting shall be by a vote of the majority of those present at such meeting. All action taken in writing without a meeting shall be by a vote of the majority of those responding in writing. All notices, advices, directions and instructions to be transmitted by the Investment Subcommittee shall be in writing and signed by or in the name of the Investment Subcommittee. In all its communications with the Trustee, the Investment Subcommittee may, by action specified above, authorize any one or more of its members to execute any document or documents on behalf of the Investment Subcommittee, in which event it shall notify the Trustee in writing of such action and the name or names of its members so designated and the Trustee shall thereafter accept and rely upon any documents executed by such member or members as representing action by the Investment Subcommittee until the Investment Subcommittee shall file with the Trustee a written revocation of such designation.

7.4.         Voting .    Any member of the Committee who is also a Participant hereunder shall not be qualified to act or vote on any matter relating solely to himself or herself, and upon such matter his or her presence at a meeting shall not be counted for the purpose of determining a quorum. If, at any time a member of the Committee is not so qualified to act or vote and the qualified members of the Committee shall be reduced below two (2), the Board of Directors shall promptly appoint one or more special members to the Committee so that there shall be at least one qualified member to act upon the matter in question. Such special Committee members shall have power to act only upon the matter for which they were especially appointed and their tenure shall cease as soon as they have acted upon the matter for which they were especially appointed.

7.5.         Responsibility of Committees .    The responsibilities of the Committee and Investment Subcommittee shall be as provided in paragraphs (a) and (b), respectively:

(a)        The authority to manage and control the operation and administration of the Plan, the general administration of the Plan, the responsibility for carrying out the Plan, and to the extent provided in Section 7.7(f), the authority and responsibility to manage and control the assets of the Trust are hereby delegated by the Board of Directors to and vested in the Committee except to the extent reserved to the Board of Directors, the Sponsor, or the Company. Subject to the limitations of the Plan, the Committee shall, from time to time, establish rules for the performance of its functions and the administration of the Plan. In the performance of its functions, the Committee shall not discriminate in favor of Highly Compensated Employees.

 

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(b)        The authority and responsibility to manage and control the assets of the Trust are hereby delegated by the Board of Directors, acting through its Organization and Compensation Committee, to and vested in the Investment Subcommittee except to the extent reserved to the Board of Directors or the Board of Directors, acting through its Organization and Compensation Committee, or the Sponsor. Subject to the limitations of the Plan, the Investment Subcommittee shall, from time to time, establish rules for the performance of its functions.

7.6.         Committee Powers .    The Committee shall have all discretionary powers necessary to supervise the administration of the Plan and control its operations. In addition to any discretionary powers and authority conferred on the Committee elsewhere in the Plan or by law, the Committee shall have, but not by way of limitation, the following discretionary powers and authority:

(a)        To designate agents to carry out responsibilities relating to the Plan, other than fiduciary responsibilities as provided in Section 7.7.

(b)        To employ such legal, actuarial, medical, accounting, clerical, and other assistance as it may deem appropriate in carrying out the provisions of the Plan, including one or more persons to render advice with regard to any responsibility any Named Fiduciary or any other fiduciary may have under the Plan.

(c)        To establish rules and regulations from time to time for the conduct of the Committee’s business and the administration and effectuation of the Plan.

(d)        To administer, interpret, construe, and apply the Plan and to decide all questions which may arise or which may be raised under the Plan by any Employee, Participant, former Participant, Beneficiary or other person whatsoever, including but not limited to all questions relating to eligibility to participate in the Plan, the amount of Credited Service of any Participant, and the amount of benefits to which any Participant or his or her Beneficiary may be entitled.

(e)        To determine the manner in which the assets of the Plan, or any part thereof, shall be disbursed.

(f)        Subject to provisions (a) through (d) of Section 8.1, to make administrative amendments to the Plan that do not cause a substantial increase or decrease in benefit accruals to Participants and that do not cause a substantial increase in the cost of administering the Plan.

(g)        To perform or cause to be performed such further acts as it may deem to be necessary, appropriate or convenient in the efficient administration of the Plan.

Any action taken in good faith by the Committee in the exercise of discretionary power conferred upon it by the Plan shall be conclusive and binding upon the Participants and their

 

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Beneficiaries. All discretionary powers conferred upon the Committee shall be absolute; provided, however, that all such discretionary power shall be exercised in a uniform and nondiscriminatory manner.

7.7.         Additional Powers of Committee .    In addition to any discretionary powers or authority conferred on the Committee elsewhere in the Plan or by law, such Committee shall have the following discretionary powers and authority:

(a)        To appoint one or more Investment Managers to manage and control any or all of the assets of the Trust not invested or to be invested in Company Stock.

(b)        To designate persons (other than the members of the Committee) to carry out fiduciary responsibilities, other than any responsibility to manage or control the assets of the Trust;

(c)        To allocate fiduciary responsibilities among the members of the Committee, other than any responsibility to manage or control the assets of the Trust;

(d)        To cancel any such designation or allocation at any time for any reason;

(e)        To direct the voting of any Company Stock or any other security held by the Trust subject to Section 7.16 hereof; and

(f)        To exercise management and control over the assets of the Trust to the extent provided in paragraph (a) above and in Section 7.9 (relating to review by the Committee of the long-run and short-run financial needs of the Plan and the determination of the funding policy for the Plan).

Any action under this Section 7.7 shall be taken in writing, and no designation or allocation under Subsection (a), (b) or (c) shall be effective until accepted in writing by the indicated responsible person.

7.8.         Investment Subcommittee Powers .    The Investment Subcommittee shall have all discretionary powers necessary to manage and control the assets of the Trust, including but not limited to, the following:

(a)        To exercise management and control over the assets of the Trust except to the extent the Committee appoints an Investment Manager pursuant to Section 7.7(a) and subject to the requirement that all action taken by the Investment Subcommittee shall be in accordance and consistent with the funding policy established by the Committee and shall be communicated to the Committee at periodic intervals.

(b)        To employ consulting, actuarial, and other assistance as it may deem appropriate in carrying out its responsibilities under the Plan, including one or more

 

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persons to render advice with regard to any fiduciary responsibility the Investment Subcommittee may have under the Plan.

(c)        To establish rules and regulations from time to time for the conduct of the Investment Subcommittee’s business.

(d)        To direct the Trustee, in writing, from time to time, to invest and reinvest the Trust Fund, or any part thereof, or to purchase, exchange, or lease any property, real or personal, which the Investment Subcommittee may designate. This shall include the right to direct the investment of all or any part of the Trust in any one security or any one type of securities permitted hereunder.

(e)        To direct the purchase and sale of Company Stock (and any other securities that are “qualifying employer securities” as defined in Code Section 4975(e)) for the Trust.

Any action taken in good faith by the Investment Subcommittee in the exercise of discretionary powers conferred upon it by the Plan shall be conclusive and binding upon the Participants and their Beneficiaries.

7.9.         Periodic Review of Funding Policy .    Notwithstanding the delegation of authority and responsibility to manage and control the assets of the Trust to the Investment Subcommittee, the Committee, at periodic intervals, shall review the long-run and short-run financial needs of the Plan and shall determine a funding policy for the Plan consistent with the objectives of the Plan and the minimum funding standards of ERISA, if applicable. In determining such funding policy the Committee shall take into account, at a minimum, not only the long-term investment objectives of the Trust Fund consistent with the prudent management of the assets thereof, but also the short-run needs of the Plan to pay benefits. All actions taken by the Committee with respect to the funding policy of the Plan, including the reasons therefor, shall be fully reflected in the minutes of the Committee.

7.10.       Claims Procedures .    If a Participant or his or her Beneficiary believes that he or she is being denied any rights or benefits under the Plan, the Participant, Beneficiary, or in either case, his or her authorized representative (the “Claimant”) shall follow the administrative procedures for filing a claim for benefits as set forth in this Section. A claim for benefits shall be in writing and shall be reviewed by the Committee or a claims official designated by the Committee. The Committee or claims official shall review a claim for benefits in accordance with the procedures established by the Committee subject to the following administrative procedures set forth in this Section.

(a)        The Committee shall furnish the Claimant with written or electronic notice of the decision rendered with respect to a claim for benefits within 90 days following receipt by the Committee (or its delegate) of the claim unless the Committee determines that special circumstances require an extension of time for processing the claim. In the event an extension is necessary, written or electronic notice of the extension shall be

 

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furnished to the Claimant prior to the expiration of the initial 90 day period. The notice shall indicate the special circumstances requiring an extension of time and the date by which a final decision is expected to be rendered. In no event shall the period of the extension exceed 90 days from the end of the initial 90 day period.

(b)        In the case of a denial of the Claimant’s claim, the written or electronic notice of such denial shall set forth (i) the specific reasons for the denial, (ii) references to the Plan provisions upon which the denial is based, (iii) a description of any additional information or material necessary for perfection of the claim (together with an explanation why such material or information is necessary), (iv) an explanation of the Plan’s appeals procedures, and (v) a statement of the Claimant’s right to bring a civil action under Section 502(a) of ERISA if his or her claim is denied upon appeal.

(c)        In the case of a denial of a claim, a Claimant who wishes to appeal the decision shall follow the administrative procedures for an appeal as set forth in Section 7.11 below.

7.11.       Appeals Procedures .    A Claimant who wishes to appeal the denial of his or her claim for benefits shall follow the administrative procedures for an appeal as set forth in this Section and shall exhaust such administrative procedures prior to seeking any other form of relief. Appeals shall be reviewed in accordance with the procedures established by the Committee subject to the following administrative procedures set forth in this Section.

(a)    In order to appeal a decision rendered with respect to his or her claim for benefits, a Claimant must file an appeal with the Committee in writing within 60 days following his or her receipt of the notice of denial with respect to the claim.

(b)    The Claimant’s appeal may include written comments, documents, records and other information relating to his or her claim. The Claimant may review all pertinent documents and, upon request, shall have reasonable access to or be provided free of charge, copies of all documents, records, and other information relevant to his or her claim.

(c)    The Committee shall provide a full and fair review of the appeal and shall take into account all claim related comments, documents, records, and other information submitted by the Claimant without regard to whether such information was submitted or considered under the initial determination or review of the initial determination. Where appropriate, the Committee will overturn a notice of denial if it determines that an error was made in the interpretation of the controlling plan documents or if the Committee determines that an existing interpretation of the controlling plan documents should be changed on a prospective basis. In the event the Claimant is a subordinate, as determined by the Committee, to an individual conducting the review, such individual shall recuse himself or herself from the review of the appeal.

 

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(d)        The Committee shall furnish the Claimant with written or electronic notice of the decision rendered with respect to an appeal within 60 days following receipt by the Committee of the appeal unless the Committee determines that special circumstances require an extension of time for processing the appeal. In the event an extension is necessary, written or electronic notice of the extension shall be furnished to the Claimant prior to the expiration of the initial 60 day period. The notice shall indicate the special circumstances requiring an extension of time and the date by which a final decision is expected to be rendered. In no event shall the period of the extension exceed 60 days from the end of the initial 60 day period.

(e)        In the case of a denial of an appeal, the written or electronic notice of such denial shall set forth (i) the specific reasons for the denial, (ii) references to the Plan provisions upon which the denial is based, (iii) a statement that the Claimant is entitled to receive, upon request and free of charge, reasonable access to, and copies of, all documents, records, and other information relating to his or her claim for benefits, and (iv) a statement of the Claimant’s right to bring a civil action under Section 502(a) of ERISA.

7.12.       Limitation on Liability .    Each of the fiduciaries under the Plan shall be solely responsible for its own acts and omissions and no fiduciary shall be liable for any breach of fiduciary responsibility resulting from the act or omission of any other fiduciary or person to whom fiduciary responsibilities have been allocated or delegated pursuant to Section 7.2 or 7.7, except as provided in Sections 405(a) and 405(c)(2)(A) or (B) of ERISA. Neither the Committee nor the Investment Subcommittee shall have responsibility over assets as to which management and control has been delegated to an Investment Manager appointed pursuant to Section 6.14 hereof or as to which management and control has been retained by the Trustee.

7.13.       Indemnification and Insurance .    To the extent permitted by law, the Company shall indemnify and hold harmless the Committee, the Investment Subcommittee and each member thereof, the Board of Directors and each member thereof, and such other persons as the Board of Directors may specify, from the effects and consequences of his or her acts, omissions, and conduct in his or her official capacity in connection with the Plan and Trust. To the extent permitted by law, the Company may also purchase liability insurance for such persons.

7.14.       Compensation of Committees and Plan Expenses .    Members of the Committee and the Investment Subcommittee shall serve as such without compensation unless the Board of Directors shall otherwise determine, but in no event shall any member of the Committee or Investment Subcommittee who is an Employee receive compensation from the Plan for his or her services as a member of the Committee or the Investment Subcommittee. All members shall be reimbursed for any necessary expenditures incurred in the discharge of duties as members of the Committee or the Investment Subcommittee. The compensation or fees, as the case may be, of all officers, agents, counsel, the Trustee or other persons retained or employed by the Committee or the Investment Subcommittee shall be fixed by the Committee, subject to approval by the Board of Directors. The expenses incurred in the administration and operation of the Plan, including but not limited to the expenses incurred by the members of the Committee or the

 

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Investment Subcommittee in exercising their duties, shall be paid by the Plan from the Trust Fund, unless paid by the Company, provided, however, that the Plan and not the Company shall bear the cost of interest and normal brokerage charges which are included in the cost of securities purchased by the Trust Fund (or charged to proceeds in the case of sales). If such expenses are to be paid by the Plan from the Trust Fund, the Investment Subcommittee may direct the Trustee to use forfeitures and dividends (and to sell the shares of Company Stock that represent such forfeitures or dividends) to pay such expenses.

7.15.       Resignation .    Any member of the Committee or Investment Subcommittee may resign by giving fifteen (15) days notice to the Board of Directors, and any member shall resign forthwith upon receipt of the written request of the Board of Directors, whether or not said member is at that time the only member of the Committee or the Investment Subcommittee.

7.16.       Voting of Company Stock .    Notwithstanding any other provision of the Plan to the contrary, the Trustee shall have no discretion or authority to vote Company Stock held in the Trust on any matter presented for a vote by the stockholders of the Company except in accordance with timely directions received by the Trustee either from the Committee or from Participants, depending on who has the right to direct the voting of such Company Stock as provided in the following provisions of this Section 7.16.

(a)        All Company Stock held in the Trust Fund shall be voted by the Trustee as the Committee directs in its absolute discretion, except as provided in this Section 7.16(a).

(i)      If the Sponsor has a registration-type class of securities (as defined in Code Section 409(e)(4)), then with respect to all corporate matters, (1) each Participant shall be entitled to direct the Trustee as to the voting of all Company Stock allocated and credited to his or her ESOP Account and (2) each Participant who is an Eligible Employee shall be entitled to direct the Trustee as to the voting of a portion of all Company Stock not allocated to the ESOP Accounts of Participants, with such portion equal to the total number of shares of such unallocated stock multiplied by a fraction the numerator of which is the number of shares of Company Stock allocated and credited to his or her ESOP account and the denominator of which is the total number of shares of Company Stock allocated and credited to all ESOP Accounts of Participants.

(ii)     If the Sponsor does not have a registration-type class of securities, then only with respect to such matters as the approval or disapproval of any corporate merger or consolidation, recapitalization, reclassification, liquidation, dissolution, sale of substantially all assets of trade or business, or such similar transactions as may be prescribed in Code Section 409(e)(4) and the regulations thereunder, (1) each Participant shall be entitled to direct the Trustee as to the voting of all Company Stock allocated and credited to his or her ESOP Account and (2) each Participant who is an Eligible Employee shall be entitled to direct the Trustee as to the voting of a portion of all Company Stock not allocated to the

 

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ESOP Accounts of Participants, with such portion determined in the same manner as under paragraph (a)(i) above.

(b)        To the extent there remains any residual fiduciary responsibility with respect to the voting of Company Stock after application of paragraph (a) above, the Trustee shall vote such Company Stock as directed by the Committee or as directed by an independent fiduciary if duly appointed by the Sponsor. To the extent the Committee or an independent fiduciary is required to exercise any residual fiduciary responsibility with respect to the voting of Company Stock, the Committee or independent fiduciary shall take into account in exercising its fiduciary judgment, unless it is clearly imprudent to do so, directions timely received from Participants, as such directions are most indicative of what action is in the best interests of Participants. Further, the Committee or independent fiduciary, in addition to taking into consideration any relevant financial factors bearing on any such decision, shall take into consideration any relevant non-financial factors, including, but not limited to, the continuing job security of Participants as employees of the Sponsor or any Affiliated Company, conditions of employment, employment opportunities and other similar matters, and the prospect of the Participants and prospective Participants for future benefits under the Plan.

(c)        All Participants entitled to direct such voting shall be notified by the Sponsor, pursuant to its normal communications with shareholders, of each occasion for the exercise of such voting rights within a reasonable time before such rights are to be exercised. Such notification shall include all information distributed to shareholders either by the Sponsor or any other party regarding the exercise of such rights. Such Participants shall be so entitled to direct the voting of fractional shares (or fractional interests in shares); provided, however, that the Trustee may, to the extent possible, vote the combined fractional shares (or fractional interests in shares) so as to reflect the aggregate direction of all Participants giving directions with respect to fractional shares (or fractional interests in shares). To the extent that a Participant shall fail to direct the Trustee as to the exercise of voting rights arising under Company Stock credited to his or her ESOP Account, such Company Stock shall not be voted unless the Trustee is directed otherwise as provided in paragraph (b) above. The Trustee shall maintain confidentiality with respect to the voting directions of all Participants.

(d)        Each Participant shall be a named fiduciary (as that term is defined in Section 402(a)(2) of ERISA) with respect to Company Stock for which he or she has the right to direct the voting under the Plan but solely for the purpose of exercising voting rights pursuant to this Section 7.16 or certain Offers pursuant to Section 6.4.

(e)        In the event a court of competent jurisdiction shall issue an opinion or order to the Plan, the Committee, the Sponsor or the Trustee, which shall, in the opinion of counsel to the Committee, the Sponsor or the Trustee, invalidate under ERISA, in all circumstances or in any particular circumstances, any provision or provisions of this paragraph regarding the manner in which Company Stock held in the Trust shall be voted or cause any such provision or provisions to conflict with ERISA, then, upon notice

 

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thereof to the Committee, the Sponsor or the Trustee, as the case may be, such invalid or conflicting provisions of this Section shall be given no further force or effect. In such circumstances the Trustee shall continue to follow instructions received from Participants, to the extent such instructions have not been invalidated by such order or opinion. To the extent the Trustee is required by such opinion or order to exercise any residual fiduciary responsibility with respect to voting, the Sponsor shall appoint an independent fiduciary who shall exercise such residual fiduciary responsibility as provided in paragraph (b) above and shall direct the Trustee as to the manner in which Company Stock held by the Trustee shall be voted.

7.17.       Reliance Upon Documents and Opinions .    The members of the Committee, the Investment Subcommittee, the Board of Directors, the Company and any person delegated to carry out any fiduciary responsibilities under the Plan (hereinafter a “delegated fiduciary”), shall be entitled to rely upon any tables, valuations, computations, estimates, certificates and reports furnished by any consultant, or firm or corporation which employs one or more consultants, upon any opinions furnished by legal counsel, and upon any reports furnished by the Trustee or any Investment Manager. The members of the Committee, the Investment Subcommittee, the Board of Directors, the Company and any delegated fiduciary shall be fully protected and shall not be liable in any manner whatsoever for anything done or action taken or suffered in reliance upon any such consultant, or firm or corporation which employs one or more consultants, Trustee, Investment Manager, or counsel. Any and all such things done or such action taken or suffered by the Committee, the Investment Subcommittee, the Board of Directors, the Company and any delegated fiduciary shall be conclusive and binding on all Employees, Participants, Beneficiaries, and any other persons whomsoever, except as otherwise provided by law. The Committee, the Investment Subcommittee, and any delegated fiduciary may, but are not required to, rely upon all records of the Company with respect to any matter or thing whatsoever, and may likewise treat such records as conclusive with respect to all Employees, Participants, Beneficiaries, and any other persons whomsoever, except as otherwise provided by law.

 

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ARTICLE VIII

AMENDMENT AND ADOPTION OF PLAN

8.1.         Right to Amend Plan .    The Sponsor, by resolution of the Board of Directors, shall have the right to amend the Plan and Trust Agreement at any time and from time to time and in such manner and to such extent as it may deem advisable, including retroactively, subject to the following provisions:

(a)        No amendment shall have the effect of reducing any Participant’s vested interest in the Plan or eliminating an optional form of distribution.

(b)        No amendment shall have the effect of diverting any part of the assets of the Plan to persons or purposes other than the exclusive benefit of the Participants or their Beneficiaries.

(c)        No amendment shall have the effect of increasing the duties or responsibilities of a Trustee without its written consent.

(d)        No amendment shall result in discrimination in favor of officers, shareholders, or other highly compensated or key employees.

The Committee shall have the right to amend the Plan, subject to paragraphs (a) through (d), in accordance with the provisions of Section 7.6(f).

8.2.         Adoption of Plan by Affiliated Companies .    Subject to approval by the Board of Directors and consistent with the provisions of ERISA, an Affiliated Company may adopt the Plan for all or any specified group of its Eligible Employees by entering into an adoption agreement in the form and substance prescribed by the Committee. The adoption agreement may include such modification of the Plan provisions with respect to such Eligible Employees as the Committee approves after having determined that no prohibited discrimination or other threat to the qualification of the Plan is likely to result. The Board of Directors may prospectively revoke or modify an Affiliated Company’s participation in the Plan at any time and for any or no reason, without regard to the terms of the adoption agreement, or terminate the Plan with respect to such Affiliated Company’s Eligible Employees and Participants. By execution of an adoption agreement (each of which by this reference shall become part of the Plan), the Affiliated Company agrees to be bound by all the terms and conditions of the Plan.

 

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ARTICLE IX

DISCONTINUANCE OF CONTRIBUTIONS

In the event the Company decides it is impossible or inadvisable for business reasons to continue to make contributions under the Plan, it may, by resolution of the Board of Directors, discontinue contributions to the Plan. Upon the permanent discontinuance of contributions to the Plan and notwithstanding any other provisions of the Plan, the rights of Participants shall become fully vested and nonforfeitable unless replaced by a comparable plan. The permanent discontinuance of contributions on the part of the Company shall not terminate the Plan as to the funds and assets then held in the Trust, or operate to accelerate any payments of distributions to or for the benefit of Participants or Beneficiaries, and the Trust shall continue to be administered in accordance with the provisions hereof until the obligations hereunder shall have been discharged and satisfied. If, at the time of discontinuance, there is any amount outstanding on an Exempt Loan, any amount remaining in the Exempt Loan Suspense Subfund shall be disposed of as provided in any applicable loan agreement.

 

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ARTICLE X

TERMINATION AND MERGER

10.1.       Right to Terminate Plan .    In the event the Board of Directors decides it is impossible or inadvisable for business reasons to continue the Plan, then it may, by resolution, terminate the Plan. Upon and after the effective date of such termination, the Company shall not make any further contributions under the Plan. Upon the termination or partial termination of the Plan for any reason, the interest in the Trust of each affected Participant shall automatically become fully vested unless the Plan is continued after its termination by conversion of the Plan into a comparable Plan through Plan amendment or through merger. If, at the time of termination, there is any amount outstanding in an Exempt Loan, any amount remaining in the Exempt Loan Suspense Subfund shall be disposed of in a manner that provides for the repayment of amounts outstanding in any such Exempt Loan. After the satisfaction of all outstanding liabilities of the Plan to persons other than Participants and Beneficiaries, all unallocated assets shall be allocated to the ESOP Accounts of Eligible Participants as defined in Section 4.2(d) to the maximum extent permitted by law. The Trust Fund may not be fully or finally liquidated until all assets are allocated to ESOP Accounts; alternatively any unallocated assets may be transferred to another defined contribution plan maintained by the Sponsor or an Affiliated Company qualified under Code Section 401 where such assets shall be allocated among the accounts of Participants herein who are participants in such transferee plan. In no event, however, shall any part of the Plan revert to or be recoverable by the Company, or be used for or diverted to purposes other than for the exclusive benefit of the Participants or their Beneficiaries. Notwithstanding the foregoing, amounts held in the 415 Suspense Account may revert to the Company in accordance with Section 11.6.

10.2.       Effect on Trustee and Committee .    The Trustee and the Committee shall continue to function as such for such period of time as may be necessary for the winding up of the Plan and for the making of distributions in the manner prescribed by the Board of Directors at the time of termination of the Plan.

10.3.       Merger Restriction .    Notwithstanding any other provision in the Plan, the Plan shall not in whole or in part merge or consolidate with, or transfer its assets or liabilities to, any other plan unless each affected Participant in the Plan would (if such other plan then terminated) receive a benefit immediately after the merger, consolidation, or transfer which is equal to or greater than the benefit he or she would have been entitled to receive immediately before the merger, consolidation, or transfer (if the Plan had then terminated).

10.4.       Effect of Reorganization, Transfer of Assets or Change in Control .

(a)        In the event of a consolidation or merger of the Company, or in the event of a sale and/or any other transfer of the operating assets of the Company, any ultimate successor or successors to the business of the Company may continue the Plan in full force and effect by adopting the same by resolution of its board of directors and by executing a proper supplemental or transfer agreement with the Trustee.

 

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(b)        In the event of a Change in Control (as herein defined), all Participants who were Participants on the date of such Change in Control shall become 100% vested in any amounts allocated to their ESOP Accounts on the date of such Change in Control and in any amounts allocated to their ESOP Accounts subsequent to the date of the Change in Control. Notwithstanding the foregoing, the Board of Directors may, at its discretion, amend or delete this paragraph (b) in its entirety prior to the occurrence of any such Change in Control. For the purpose of this paragraph (b) and prior to January 1, 2000, a “Change in Control” shall be as defined in the Plan prior to this restatement. On or after January 1, 2000, a “Change in Control” shall mean the following and shall be deemed to occur if any of the following events occur:

(i)      Any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (a “Person”), is or becomes the “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act (a “Beneficial Owner”), directly or indirectly, of securities of the Sponsor representing (1) 20% or more of the combined voting power of the Sponsor’s then outstanding voting securities, which acquisition is not approved in advance of the acquisition or within 30 days after the acquisition by a majority of the Incumbent Board (as hereinafter defined) or (2) 33% or more of the combined voting power of the Sponsor’s then outstanding voting securities, without regard to whether such acquisition is approved by the Incumbent Board;

(ii)     Individuals who, as of the date hereof, constitute the Board of Directors (the “Incumbent Board”), cease for any reason to constitute at least a majority of the Board of Directors, provided that any person becoming a director subsequent to the date hereof whose election, or nomination for election by the Sponsor’s stockholders, is approved by a vote of at least a majority of the directors then comprising the Incumbent Board (other than an election or nomination of an individual whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of the directors of the Sponsor, as such terms are used in Rule 14a-11 of Regulation 14A promulgated under the Exchange Act) shall, for the purposes of this Plan, be considered as though such person were a member of the Incumbent Board of the Sponsor;

(iii)    The consummation of a merger, consolidation or reorganization involving the Sponsor, other than one which satisfies both of the following conditions:

(A)        a merger, consolidation or reorganization which would result in the voting securities of the Sponsor outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities

 

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of another entity) at least 55% of the combined voting power of the voting securities of the Sponsor or such other entity resulting from the merger, consolidation or reorganization (the “Surviving Corporation”) outstanding immediately after such merger, consolidation or reorganization and being held in substantially the same proportion as the ownership in the Sponsor’s voting securities immediately before such merger, consolidation or reorganization, and

(B)        a merger, consolidation or reorganization in which no Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Sponsor representing 20% or more of the combined voting power of the Sponsor’s then outstanding voting securities; or

(iv)     The stockholders of the Sponsor approve a plan of complete liquidation of the Sponsor or an agreement for the sale or other disposition by the Sponsor of all or substantially all of the Sponsor’s assets.

Notwithstanding the preceding provisions of this paragraph (b), a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this paragraph (b) is (i) an underwriter or underwriting syndicate that has acquired any of the Sponsor’s then outstanding voting securities solely in connection with a public offering of the Sponsor’s securities, (ii) the Sponsor or any subsidiary of the Sponsor or (iii) an employee stock ownership plan or other employee benefit plan maintained by the Company or an Affiliated Company that is qualified under the provisions of the Code. In addition, notwithstanding the preceding provisions of this paragraph (b), a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this paragraph (b) becomes a Beneficial Owner of more than the permitted amount of outstanding securities as a result of the acquisition of voting securities by the Company or an Affiliated Company which, by reducing the number of voting securities outstanding, increases the proportional number of shares beneficially owned by such Person, provided, that if a Change in Control would occur but for the operation of this sentence and such Person becomes the Beneficial Owner of any additional voting securities (other than through the exercise of options granted under any stock option plan of the Sponsor or through a stock dividend or stock split), then a Change in Control shall occur.

(c)        In the event of a Change in Control (as defined in Section 10.4(b) above), the Company shall be required to repay in full, solely from its own funds and within thirty (30) days following the date of such Change in Control, all Exempt Loans and Substitute Loans outstanding on the date of the Change in Control. Notwithstanding any other provision of the Plan to the contrary, all assets (including Company Stock) and funds that released from the Exempt Loan Suspense Subfund on account of repayment by

 

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the Company under this Section 10.4(c) shall be allocated, for the Plan Year in which the Change in Control occurs, in accordance with the formula set forth herein (consistent with the requirements imposed under Article XI and other requirements of the Code). Under the formula for allocation set forth herein, assets and funds that are released shall be allocated to Employees who are Eligible Participants (as defined in Section 4.2(d)) as of the date of the Change in Control (or who would have been Eligible Participants but for their death, Disability or retirement at or after age 55 during the Plan Year) in the same ratio that each such Participant’s Compensation for the Plan Year through the last pay period ending on or before the date of such Change in Control bears to the total Compensation of all such Participants for the Plan Year through their last pay periods ending on or before the date of such Change in Control.

(d)        For purposes of this Section 10.4, a Change of Control shall not be deemed to have occurred upon the distribution of the stock of Advanced Medical Optics, Inc. on June 29, 2002 by the Sponsor to its stockholders.

 

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ARTICLE XI

LIMITATION ON ALLOCATIONS

11.1.       General Rule .

(a)        The total Annual Additions under the Plan to a Participant’s ESOP Account shall not exceed the lesser of:

(i)      Forty Thousand Dollars ($40,000), as adjusted for increases in the cost-of-living under Code Section 415(d); or

(ii)     One Hundred Percent (100%) of the Participant’s Compensation (as defined in Section 11.5), from the Company for the Limitation Year.

Notwithstanding the foregoing sentence, the compensation limit set forth in subparagraph (ii) shall not apply to any contribution for medical benefits after separation from service (within the meaning of Code Section 401(h) or Code Section 419A(f)(2)) which is otherwise treated as an Annual Addition.

(b)        For the purpose of this Article XI, the term “Company” shall mean the Sponsor and any Affiliated Company (determined by reference to Code Section 415(h)) whether or not such Affiliated Company has adopted the Plan pursuant to Section 8.2 and the term “Limitation Year” shall mean the Plan Year.

11.2.       Annual Additions .    For purposes of Section 11.1, the term “Annual Additions” shall mean with respect to a Participant, for any Limitation Year with respect to the Plan, the sum of the amounts described below:

(a)        All amounts contributed or deemed contributed by the Company, except that the Annual Addition shall exclude the portion of the Company contribution representing interest on an Exempt Loan, provided that no more than one-third of the Company’s contributions to the Trust Fund deductible under Code Section 404(a)(9) for a Limitation Year are allocated to Highly Compensated Employees.

(b)        All amounts contributed by the Participant.

(c)        Forfeitures allocated to such Participant. For purposes of this Section 11.2, forfeitures shall not include forfeitures of Company Stock acquired through the Trust Fund with the proceeds of an Exempt Loan, provided that no more than one-third of the Company’s contributions to the Trust Fund deductible under Code Section 404(a)(9) for a Limitation Year are allocated to Highly Compensated Employees.

 

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(d)        Any amounts allocated, after March 31, 1984, to an individual medical account as defined in Code Section 415(l)(2) established under a pension or annuity plan maintained by the Company.

(e)        Any amounts allocated for such Plan Year which amounts are derived from contributions paid or accrued after December 31, 1985, in taxable years ending after such date, which are attributable to postretirement medical benefits allocated to the separate account of a key employee (as defined in Code Section 419A(d)(3)) under a welfare benefit fund (as defined in Code Section 419(e)) maintained by the Company.

11.3.       Other Defined Contribution Plans .    If the Company maintains any other defined contribution plan, then each Participant’s Annual Additions under such defined contribution plan shall be aggregated with the Participant’s Annual Additions under the Plan for the purposes of applying the limitations of Section 11.1.

11.4.       Adjustment for Excess Annual Additions .    If as a result of the allocation of forfeitures, a reasonable error in estimating a Participant’s Compensation, or under other limited facts and circumstances that the Commissioner of Internal Revenue finds justify the availability of the rules set forth in Regulation Section 1.415-6(b)(6), the Annual Additions on behalf of any Participant in a Limitation Year to the Plan and all other defined contribution plans maintained by the Company exceed the limitations set forth in Section 11.1, then excess Annual Additions shall be eliminated in accordance with the following rules and in the following order:

(a)        Excess Annual Additions shall be eliminated by reducing the allocation to the Participant’s ESOP Account by the amount of the excess and treating such amount as a forfeiture under Section 5.3 hereof and reallocating such amount proportionately to the ESOP Accounts of other Participants receiving allocations for the Limitation Year up to the limits set forth in Section 11.1.

(b)        After each Participant’s ESOP Account has been credited under paragraph (a) with an amount bringing his or her ESOP Account up to his or her maximum Annual Addition (determined under the provisions of this Article XI), any remaining excess Annual Addition shall be transferred and credited to a 415 Suspense Account established for the purpose of this Section 11.4. This paragraph shall only apply on or after January 1, 2008, if the establishment of a 415 Suspense Account is permitted under Revenue Procedure 2006-27 (or its successor).

(c)        Any amounts held in the 415 Suspense Account shall be treated as Company contributions and allocated to the ESOP Accounts of Eligible Participants (as defined in Section 4.2(d)) as of the last day of the next succeeding Plan Year in accordance with the allocation formula applicable to Company contributions provided in Section 4.2. The 415 Suspense Account shall be exhausted before any Company contributions shall be allocated to the ESOP Accounts of Participants subsequent to the date upon which any residue excess Annual Addition as described in paragraph (c) is credited to the 415 Suspense Account.

 

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11.5.       Compensation .    For the purpose of this Article XI, Compensation shall mean a Participant’s earned income, wages, salaries, fees for professional services, and other amounts received (without regard to whether or not an amount is paid in cash) for personal services actually rendered in the course of employment with the Company maintaining the Plan and shall be determined as described below:

(a)        Compensation shall include to the extent that the amounts are includible in gross income (including, but not limited to, commissions paid salespeople, compensation for services on the basis of a percentage of profits, commissions on insurance premiums, tips, bonuses, fringe benefits, and reimbursements or other expense allowances under a nonaccountable plan as described in Regulation 1.62-2(c)).

(b)        Compensation shall include any elective deferral as defined in Code Section 402(g)(3), any amount which is contributed or deferred by the Company at the election of the Employee that is excludable from an Employee’s gross income under Code Sections 125 or 457 and, for Plan Years beginning on or after January 1, 1998, any elective amount that is excludable from an Employee’s gross income under Code Section 132(f)(4).

(d)        Compensation shall not include (i) any employer contributions to a plan of deferred compensation which are not included in the Employee’s gross income for the taxable year in which contributed, (ii) any distributions from a plan of deferred compensation, (iii) any amounts realized from the exercise of a non-qualified stock option or when restricted stock or property held by the Employee becomes either freely transferable or is no longer subject to a substantial risk of forfeiture under Code Section 83 if such option, stock, or property was granted to the Employee by the Company, (iv) any amounts realized from the sale, exchange, or other disposition of stock acquired under a qualified stock option, (v) any contribution for medical benefits (within the meaning of Code Section 419(f)(2) after termination of employment which is otherwise treated as an Annual Addition, and (vi) any amount otherwise treated as an Annual Addition under Code Section 415(l)(1).

(d)        Notwithstanding anything in the Plan to the contrary, Compensation shall be determined in accordance with Code Section 415(c)(3) as in effect for Plan Years beginning prior to January 1, 1998 where required by applicable law.

11.6.       Treatment of 415 Suspense Account Upon Termination .    In the event the Plan shall terminate at a time when all amounts in the 415 Suspense Account have not been allocated to the ESOP Accounts of the Participants, the 415 Suspense Account amounts shall be applied as follows:

(a)        The amount in the 415 Suspense Account shall first be allocated, as of the Plan termination date, to Participants in accordance with the allocation formula applicable to Company contributions provided under Section 4.2(a).

 

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(b)        If, after those allocations have been made, any further residue funds remain in the 415 Suspense Account, the residue may revert to the Company in accordance with applicable provisions of the Code, ERISA, and the regulations thereunder.

(c)        Notwithstanding paragraphs (a) and (b) above, in the event that termination of the plan occurs after a Change in Control, all amounts in the 415 Suspense Account shall be allocated to Participants only in accordance with Section 10.4 hereof, and no part of the 415 Suspense Account shall revert to or be recoverable by the Company, or be used for or diverted to purposes other than for the exclusive benefit of the Participants or their Beneficiaries.

 

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ARTICLE XII

TOP-HEAVY RULES

12.1.     Applicability .    Notwithstanding any provision in the Plan to the contrary, and subject to the limitations set forth in Section 12.6, the requirements of Sections 12.4 and 12.5 shall apply under the Plan in the case of any Plan Year in which the Plan is determined to be a Top-Heavy Plan under the rules of Section 12.3. For the purpose of this Article XII, the term “Company” shall mean the Sponsor and any Affiliated Company whether or not such Affiliated Company has adopted the Plan.

12.2.     Definitions .    For purposes of this Article XII, the following special definitions and rules shall apply:

(a)        The term “Key Employee” means any Employee or former Employee (including any deceased Employee) who, at any time during the Plan Year that includes the Determination Date, was an officer of the Company having annual Compensation greater than $130,000 (as adjusted under Code Section 416(i)(1) for Plan Years beginning after December 31, 2002), a Five Percent Owner of the Company, or an One Percent Owner of the Company having annual Compensation of more than $150,000.

(b)        The term “Five Percent Owner” means any person who owns (or is considered as owning within the meaning of Code Section 318) more than 5% of the outstanding stock of the Company or stock possessing more than 5% of the total combined voting power of all stock of the Company.

(c)        The term “One Percent Owner” means any person who would be described in paragraph (b) if “1%” were substituted for “5%” each place where it appears therein.

(d)        The term “Non-Key Employee” means any Employee who is not a Key Employee.

(e)        The term “Determination Date” means, with respect to any plan year, the last day of the preceding plan year. In the case of the first plan year of any plan, the term “Determination Date” shall mean the last day of that plan year.

(f)        The term “Aggregation Group” means (i) each qualified plan of the Company in which at least one Key Employee participates or participated at any time during the determination period (regardless of whether the plan has terminated), and (ii) any other qualified plan of the Company which enables a plan described in clause (i) to meet the requirements of Code Sections 401(a)(4) or 410. Any plan not required to be included in an Aggregation Group under the preceding rules may be treated as being part of such group if the group would continue to meet the requirements of Code Sections 401(a)(4) and 410 with the plan being taken into account.

 

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(g)        For purposes of determining ownership under paragraphs (a), (b) and (c) above, the following special rules shall apply: (i) Code Section 318(a)(2)(C) shall be applied by substituting “5%” for “50%”, and (ii) the aggregation rules of Code Sections 414(b), (c) and (m) shall not apply, with the result that the ownership tests of this Section 12.2 shall apply separately with respect to each Affiliated Company.

(h)        The terms “Key Employee” and “Non-Key Employee” shall include their Beneficiaries, and the definitions provided under this Section 12.2 shall be interpreted and applied in a manner consistent with the provisions of Code Section 416(i) and the regulations thereunder.

(i)        For purposes of this Article XII, an Employee’s Compensation shall be determined in accordance with the rules of Section 11.5.

12.3.       Top-Heavy Status

(a)        The term “Top-Heavy Plan” means, with respect to any Plan Year:

(i)      Any defined benefit plan if, as of the Determination Date, the present value of the cumulative accrued benefits under the plan for Key Employees exceeds 60% of the present value of the

(ii)     cumulative accrued benefits under the plan for all Employees; and

(iii)    Any defined contribution plan if, as of the Determination Date, the aggregate of the account balances of Key Employees under the plan exceeds 60% of the aggregate of the account balances of all Employees under the plan.

In applying the foregoing provisions of this paragraph (a), the valuation date to be used in valuing Plan assets shall be (i) in the case of a defined benefit plan, the same date which is used for computing costs for minimum funding purposes, and (ii) in the case of a defined contribution plan, the most recent valuation date within a 12-month period ending on the applicable Determination Date.

(b)        Each plan maintained by the Company required to be included in an Aggregation Group shall be treated as a Top-Heavy Plan if the Aggregation Group is a Top-Heavy Group.

(c)        The term “Top-Heavy Group” means any Aggregation Group if the sum (as of the Determination Date) of (i) the present value of the cumulative accrued benefits for Key Employees under all defined benefit plans included in the group, and (ii) the aggregate of the account balances of Key Employees under all defined contribution plans included in the group exceeds 60% of a similar sum determined for all Employees. For purposes of determining the present value of the cumulative accrued benefit of any Employee, or the amount of the account balance of any Employee, such present value or

 

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amount shall be increased by the aggregate distributions made with respect to the Employee under the plan (including a terminated plan which, had it not been terminated, would have been aggregated with the plan under Code Section 416(g)(2)(A)(i))during the one year period ending on the Determination Date. In the case of distributions made for a reason other than separation from service, death, or disability, the preceding sentence shall be applied by substituting “5-year period” for “l -year period.” Any rollover contribution or similar transfer initiated by the Employee and made after December 31, 1983, to a plan shall not be taken into account with respect to the transferee plan for purposes of determining whether such plan is a Top-Heavy Plan (or whether any Aggregation Group which includes such plan is a Top-Heavy Group).

(d)        If any individual is a Non-Key Employee with respect to any plan for any plan year, but the individual was a Key Employee with respect to the plan for any prior plan year, any accrued benefit for the individual (and the account balance of the individual) shall not be taken into account for purposes of this Section 12.3.

(e)        If any individual has not performed services for the Company at any time during the one year period ending on the Determination Date, any accrued benefit for such individual (and the account balance of the individual) shall not be taken into account for purposes of this Section 12.3.

(f)        In applying the foregoing provisions of this Section, the accrued benefit of a Non-Key Employee shall be determined (i) under the method, if any, which is used for accrual purposes under all plans of the Company and any Affiliated Companies, or (ii) if there is no such uniform method, as if such benefit accrued not more rapidly than the slowest accrual rate permitted under Code Section 411(b)(1)(C).

(g)        For all purposes of this Article XII, the definitions provided under this Section 12.3 shall be applied and interpreted in a manner consistent with the provisions of Code Section 416(g) and the regulations thereunder.

12.4.       Minimum Contributions .    For any Plan Year in which the Plan is determined to be a Top-Heavy Plan, the minimum Company Contributions for that year shall be determined in accordance with the rules of this Section 12.4.

(a)        Except as provided below, the minimum contribution for each Non-Key Employee shall be not less than 3% of his or her compensation.

(b)        Subject to the following rules of this paragraph (b), the percentage set forth in paragraph (a) above shall not be required to exceed the percentage at which contributions are made (or are required to be made) under the Plan for the year for the Key Employee for whom the percentage is the highest for the year. This determination shall be made by dividing the contributions for each Key Employee by so much of his or her total compensation for the Plan Year as does not exceed the applicable Compensation limit. For purposes of this paragraph (b), all defined contribution plans required to be

 

67


included in an Aggregation Group shall be treated as one plan. Notwithstanding the foregoing, the exceptions to paragraph (a) as provided under this paragraph (b) shall not apply to any plan required to be included in an Aggregation Group if the plan enables a defined benefit plan to meet the requirements of Code Sections 401(a)(4) or 410.

(c)        The Participant’s minimum contribution determined under this Section 12.4 shall be calculated without regard to any Social Security benefits payable to the Participant.

(d)        In the event a Participant is covered by both a defined contribution and a defined benefit plan maintained by the Company, both of which are determined to be Top-Heavy Plans, the Company shall satisfy the minimum benefit requirements of Code Section 416 by providing (in lieu of the minimum contribution described in paragraph (a) above) a minimum benefit under the defined benefit plan so as to prevent the duplication of required minimum benefits hereunder.

12.5.       Minimum Vesting Rules .    For any Plan Year in which it is determined that the Plan is a Top-Heavy Plan, the vesting schedule shall be the vesting schedule set forth in Section 5.2.

12.6.       Non-Eligible Employees .    The rules of this Article XII shall not apply to any Employee included in a unit of employees covered by a collective bargaining agreement between employee representatives and one or more employers if retirement benefits were the subject of good faith bargaining between such employee representatives and the employer or employers.

 

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ARTICLE XIII

RESTRICTION ON ASSIGNMENT OR OTHER

ALIENATION OF PLAN BENEFITS

13.1.       General Restrictions Against Alienation .

(a)        The interest of any Participant or his or her Beneficiary in the income, benefits, payments, claims or rights hereunder, or in the Trust Fund, shall not in any event be subject to sale, assignment, hypothecation, or transfer. Each Participant and Beneficiary is prohibited from anticipating, encumbering, assigning, or in any manner alienating his or her interest under the Trust Fund, and is without power to do so, except as may be permitted in connection with providing security for a loan from the Plan to the Participant pursuant to the provisions of the Plan as it may be amended from time to time. The interest of any Participant or Beneficiary shall not be liable or subject to his or her debts, liabilities, or obligations, now contracted, or which may hereafter be contracted, and such interest shall be free from all claims, liabilities, or other legal process now or hereafter incurred or arising. Neither the interest of a Participant or Beneficiary, nor any part thereof, shall be subject to any judgment rendered against any such Participant or Beneficiary. Notwithstanding the foregoing, a Participant’s or Beneficiary’s interest in the Plan may be subject to the enforcement of a Federal tax levy made pursuant to Code Section 6331 or the collection by the United States on a judgment resulting from an unpaid tax assessment.

(b)        In the event any person attempts to take any action contrary to this Article XIII, such action shall be null and void and of no effect, and the Company, the Committee, the Trustee and all Participants and their Beneficiaries, may disregard such action and are not in any manner bound thereby, and they, and each of them, shall suffer no liability for any such disregard thereof, and shall be reimbursed on demand out of the Trust Fund for the amount of any loss, cost or expense incurred as a result of disregarding or of acting in disregard of such action.

(c)        The foregoing provisions of this Section shall be interpreted and applied by the Committee in accordance with the requirements of Code Section 401(a)(13) and Section 206(d) of ERISA as construed and interpreted by authoritative judicial and administrative rulings and regulations.

13.2.       Qualified Domestic Relations Orders .    The rules set forth in Section 13.1 above shall not apply with respect to a “Qualified Domestic Relations Order” as described below.

(a)        A “Qualified Domestic Relations Order” is a judgment, decree, or order (including approval of a property settlement agreement) that:

 

69


(i)      Creates or recognizes the existence of an Alternate Payee’s right to, or assigns to an Alternate Payee the right to, receive all or a portion of the benefits payable under the Plan with respect to a Participant,

(ii)     Relates to the provision of child support, alimony payments, or marital property rights to a spouse, former spouse, child or other dependent of a Participant,

(iii)    Is made pursuant to a State domestic relations law (including a community property law), and

(iv)     Clearly specifies: (1) the name and last known mailing address (if any) of the Participant and the name and mailing address of each Alternate Payee covered by the order (if the Committee does not have reason to know that address independently of the order); (2) the amount or percentage of the Participant’s benefits to be paid to each Alternate Payee, or the manner in which the amount or percentage is to be determined; (3) the number of payments or period to which the order applies; and (4) each plan to which the order applies.

For purposes of this Section 13.2, “Alternate Payee” means any spouse, former spouse, child or other dependent of a Participant who is recognized by a domestic relations order as having a right to receive all, or a portion of, the benefits payable with respect to the Participant.

(b)        A domestic relations order is not a Qualified Domestic Relations Order if it requires:

(i)      The Plan to provide any type or form of benefit, or any option, not otherwise provided under the Plan;

(ii)     The Plan to provide increased benefits; or

(iii)    The payment of benefits to an Alternate Payee that are required to be paid to another Alternate Payee under a previous Qualified Domestic Relations Order.

(c)        A domestic relations order shall not be considered to fail to satisfy the requirements of paragraph (b)(i) above with respect to any payment made before a Participant has separated from service solely because the order requires that payment of benefits be made to an Alternate Payee:

(i)      On or after the date on which the Participant attains (or would have first attained) his or her earliest retirement age (as defined in Code Section 414(p)(4)(B));

 

70


(ii)     As if the Participant had retired on the date on which such payment is to begin under such order (but taking into account only the present value of accrued benefits and not taking into account the present value of any subsidy for early retirement benefits); and

(iii)    In any form in which such benefits may be paid under the Plan to the Participant (other than in the form of a joint and survivor annuity with respect to the Alternate Payee and his or her subsequent spouse).

Notwithstanding the foregoing, if the Participant dies before his or her earliest retirement age (as defined in Section 414(p)(4)(B)), the Alternate Payee is entitled to benefits only if the Qualified Domestic Relations Order requires survivor benefits to be paid to the Alternate Payee.

(d)        To the extent provided in any Qualified Domestic Relations Order, the former spouse of a Participant shall be treated as a surviving Spouse of the Participant for purposes of applying the rules (relating to minimum survivor annuity requirements) of Code Sections 401(a)(11) and 417, and any current spouse of the Participant shall not be treated as a spouse of the Participant for such purposes.

(e)        In the case of any domestic relations order received by the Plan, the Committee shall promptly notify the Participant and any Alternate Payee named in the order that an order has been received and shall provide a copy of the Plan’s procedures for determining the qualified status of domestic relations orders. An Alternate Payee may designate a representative for receipt of copies of notices and plan information that are sent to the Alternate Payee with respect to domestic relations order. Within a reasonable period after the receipt of the order, the Committee shall determine whether the order is a Qualified Domestic Relations Order and shall notify the Participant and each Alternate Payee of such determination.

(f)        The Committee shall establish reasonable procedures to determine the qualified status of domestic relations orders and to administer distributions under Qualified Domestic Relations Orders. During any period in which the issue of whether a domestic relations order is a Qualified Domestic Relations Order is being determined (by the Committee, by a court of competent jurisdiction, or otherwise), the Committee shall direct the Trustee to segregate in a separate account in the Plan (or in an escrow account) the amounts which would have been payable to the Alternate Payee during the period if the order had been determined to be a Qualified Domestic Relations Order. If within the 18 Month Period (as defined below), the order (or modification thereof) is determined to be a Qualified Domestic Relations Order, the Committee shall direct the Trustee to pay the segregated amounts (plus any interest thereon) to the person or persons entitled thereto. However, if within the 18 Month Period (i) it is determined that the order is not a Qualified Domestic Relations Order, or (ii) the issue as to whether the order is a Qualified Domestic Relations Order is not resolved, then the Committee shall direct the Trustee to pay the segregated amounts (plus any interest thereon) to the person or persons who

 

71


would have been entitled to the amounts if there had been no order (assuming such benefits were otherwise payable). Any determination that an order is a Qualified Domestic Relations Order that is made after the close of the 18 Month Period shall be applied prospectively only. For purposes of this Section 13.2, the “18 Month Period” shall mean the 18 month period beginning with the date on which the first payment would be required to be made under the domestic relations order.

 

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ARTICLE XIV

MISCELLANEOUS PROVISIONS

14.1.       No Right of Employment Hereunder .    The adoption and maintenance of the Plan and Trust shall not be deemed to constitute a contract of employment or otherwise between the Company and any Employee or Participant, or to be a consideration for, or an inducement or condition of, any employment. Nothing contained herein shall be deemed to give any Employee the right to be retained in the service of the Company or to interfere with the right of the Company to discharge, with or without cause, any Employee or Participant at any time, which right is hereby expressly reserved.

14.2.       Limitation on Company Liability .    Any benefits payable under the Plan shall be paid or provided for solely from the Plan and the Company assumes no liability or responsibility therefor.

14.3.       Effect of Article Headings .    Article headings are for convenient reference only and shall not be deemed to be a part of the substance of this instrument or in any way to enlarge or limit the contents of any Article.

14.4.       Gender .    Masculine gender shall include the feminine and the singular shall include the plural unless the context clearly indicates otherwise.

14.5.       Interpretation .    The provisions of the Plan shall in all cases be interpreted in a manner that is consistent with the Plan satisfying (a) the requirements of Code Section 401(a) and related statutes for qualification as a stock bonus plan and (b) the requirements of Code Section 4975(e)(7) and related statutes for qualification as an employee stock ownership plan and eligibility for the prohibited transaction exemption provided under Code Section 4975(d)(3) and its related statutes under ERISA.

14.6.       Withholding For Taxes .    Any payments from the Trust Fund may be subject to withholding for taxes as may be required by any applicable federal or state law.

14.7.       California Law Controlling .    All legal questions pertaining to the Plan which are not controlled by ERISA shall be determined in accordance with the laws of the State of California and all contributions made hereunder shall be deemed to have been made in that State.

14.8.       Plan and Trust as One Instrument .    The Plan and the Trust Agreement shall be construed together as one instrument. In the event that any conflict arises between the terms and/or conditions of the Trust Agreement and the Plan, the provisions of the Plan shall control, except that with respect to the duties and responsibilities of the Trustee, the Trust Agreement shall control.

14.9.       Invalid Provisions .    If any paragraph, section, sentence, clause or phrase contained in the Plan shall become illegal, null or void or against public policy, for any reason, or shall be

 

73


held by any court of competent jurisdiction to be incapable of being construed or limited in a manner to make it enforceable, or is otherwise held by such court to be illegal, null or void or against public policy, the remaining paragraphs, sections, sentences, clauses or phrases contained in the Plan shall not be affected thereby.

14.10.       Counterparts .    This instrument may be executed in one or more counterparts each of which shall be legally binding and enforceable.

 

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IN WITNESS WHEREOF, Allergan, Inc. hereby executes this instrument, evidencing the terms of the Allergan, Inc. Employee Stock Ownership Plan as restated this 29th day of January, 2008.

 

ALLERGAN, INC.
By:   /s/ Douglas S. Ingram
  Douglas S. Ingram
 

Executive Vice President, Chief Administrative Officer, General Counsel

and Secretary

 

75

EXHIBIT 10.16

ALLERGAN, INC.

SAVINGS AND INVESTMENT PLAN

 

RESTATED

2008


TABLE OF CONTENTS

 

      PAGE
ARTICLE I   
INTRODUCTION      1
1.1    Plan Name      1
1.2    Plan Purpose      1
1.3    Effective Date of 2008 Restated Plan      1
1.4    Amendments to Plan      1
1.5    Plan Qualification      2
ARTICLE II   
DEFINITIONS      4
2.1    Accounts      4
2.2    Affiliated Company      4
2.3    After Tax Deposits      4
2.4    After Tax Deposits Account      4
2.5    Anniversary Date      4
2.6    Before Tax Deposits      4
2.7    Before Tax Deposits Account      4
2.8    Beneficiary      4
2.9    Board of Directors      5
2.10    Break in Service      5
2.11    Code      5
2.12    Committee      5
2.13    Company      5
2.14    Company Contributions      5
2.15    Company Contributions Accounts      5
2.16    Company Stock      5
2.17    Compensation      5
2.18    Credited Service      7
2.19    Disability      8
2.20    Effective Date      9
2.21    Eligible Employee      9
2.22    Eligible Retirement Plan      9
2.23    Eligible Rollover Distribution      9
2.24    Employee    10
2.25    Employment Commencement Date    11
2.26    ERISA    11
2.27    Forfeitures    11
2.28    415 Suspense Account    11
2.29    Highly Compensated Employee    11
2.30    Hour of Service    12
2.31    Investment Manager    12
2.32    Leased Employee    12


TABLE OF CONTENTS

 

      PAGE
2.33    Leave of Absence    12
2.34    Matched Deposits    14
2.35    Matching Contributions    14
2.36    Matching Contributions Account    14
2.37    Normal Retirement Age    14
2.38    Participant    14
2.39    Participant Deposits    14
2.40    Period of Severance    14
2.41    Plan    14
2.42    Plan Administrator    15
2.43    Plan Year    15
2.44    Reemployment Commencement Date    15
2.45    Retirement Account Participant    15
2.46    Retirement Contributions    15
2.47    Retirement Contributions Account    15
2.48    Rollover Contributions    15
2.49    Rollover Contributions Account    15
2.50    Severance    15
2.51    Severance Date    16
2.52    Sponsor    16
2.53    Trust    16
2.54    Trust Agreement    16
2.55    Trustee    16
2.56    Valuation Date    17
ARTICLE III   
ELIGIBILITY AND PARTICIPATION    18
3.1    General Eligibility and Participation    18
3.2    Eligibility for Retirement Contributions    18
3.3    Duration of Participation    19
3.4    Eligibility and Participation After Normal Retirement Age    19
ARTICLE IV   
PARTICIPANT DEPOSITS    20
4.1    Election    20
4.2    Amount Subject to Election    21
4.3    Limitation on Compensation Deferrals    22
4.4    Provisions for Return of Excess Before Tax Deposits    25
4.5   

Provision for Recharacterization or Return of Excess Deferrals

by Highly Compensated Participants

   27
4.6   

Termination, Change in Rate, or Resumption of

Before Tax Deposits or After Tax Deposits

   29

 

ii


TABLE OF CONTENTS

 

      PAGE
4.7    Character of Deposits    29
4.8    Rollover Contributions    29
ARTICLE V   
TRUST FUND AND COMPANY CONTRIBUTIONS    32
5.1    General    32
5.2    Single Trust    32
5.3    Matching Contributions    32
5.4    Retirement Contributions    33
5.5    Form of Company Contributions    33
5.6    Investment of Trust Assets    33
5.7    Irrevocability    36
5.8    Company, Committee and Trustee Not Responsible for Adequacy of Trust Fund    37
5.9    Certain Offers for Company Stock    37
5.10    Voting of Company Stock    41
5.11    Securities Law Limitation    42
5.12    Distributions    43
5.13    Taxes    43
5.14    Trustee Records to be Maintained    43
5.15    Annual Report of Trustee    43
5.16    Appointment of Investment Manager    43
ARTICLE VI   
ACCOUNTS AND ALLOCATIONS    45
6.1    Participants’ Accounts    45
6.2    Allocation of Participant Deposits    45
6.3    Allocation of Company Contributions and Forfeitures    45
6.4    Valuation of Participants’ Accounts    46
6.5    Valuation of Company Stock    46
6.6    Dividends, Splits, Recapitalizations, Etc.    46
6.7    Stock Rights, Warrants or Options    46
6.8    Treatment of Accounts Upon Severance    47
6.9    Cash Dividends    47
6.10    Miscellaneous Allocation Rules    47
6.11    Limitations on After Tax Deposits and Matching Contributions    48
6.12   

Provision for Disposition of Excess After Tax Deposits or Matching Contributions

on Behalf of Highly Compensated Participants

   52

 

iii


TABLE OF CONTENTS

 

      PAGE
ARTICLE VII   
VESTING IN PLAN ACCOUNTS    55
7.1    No Vested Rights Except as Herein Provided    55
7.2    Vesting of Participant Deposits    55
7.3    Vesting of Company Contributions    55
ARTICLE VIII   
PAYMENT OF PLAN BENEFITS    57
8.1    Withdrawals During Employment    57
8.2    Distributions Upon Termination of Employment or Disability    58
8.3    Distribution Upon Death of Participant    59
8.4    Designation of Beneficiary    59
8.5    Hardship Withdrawal Rules    60
8.6    Distribution Rules    61
8.7    Forfeitures    67
8.8    Valuation of Accounts Upon Distribution    68
8.9    Lapsed Benefits    68
8.10    Persons Under Legal Disability    69
8.11    Additional Documents    70
8.12    Trustee-to-Trustee Transfers    70
8.13    Loans to Participants    70
ARTICLE IX   
OPERATION AND ADMINISTRATION    73
9.1    Appointment of Committee    73
9.2    Appointment of Investment Subcommittee    73
9.3    Transaction of Business    73
9.4    Voting    74
9.5    Responsibility of Committees    74
9.6    Committee Powers    75
9.7    Additional Powers of Committee    76
9.8    Investment Subcommittee Powers    76
9.9    Periodic Review of Funding Policy    77
9.10    Claims Procedures    77
9.11    Appeals Procedures    78
9.12    Limitation on Liability    79
9.13    Indemnification and Insurance    79
9.14    Compensation of Committees and Plan Expenses    79
9.15    Resignation    80
9.16    Reliance Upon Documents and Opinions    80

 

iv


TABLE OF CONTENTS

 

      PAGE
ARTICLE X   
AMENDMENT AND ADOPTION OF PLAN    81
10.1    Right to Amend Plan    81
10.2    Adoption of Plan by Affiliated Companies    81
ARTICLE XI   
DISCONTINUANCE OF CONTRIBUTIONS    82
ARTICLE XII   
TERMINATION AND MERGER    83
12.1    Right to Terminate Plan    83
12.2    Merger Restriction    83
12.3    Effect on Trustee and Committee    83
12.4    Effect of Reorganization, Transfer of Assets or Change in Control    83
ARTICLE XIII   
LIMITATION ON ALLOCATIONS    86
13.1    General Rule    86
13.2    Annual Additions    86
13.3    Other Defined Contribution Plans    87
13.4    Adjustments for Excess Annual Additions    87
13.5    Compensation    87
13.6    Treatment of 415 Suspense Account Upon Termination    88
ARTICLE XIV   
TOP-HEAVY RULES    89
14.1    Applicability    89
14.2    Definitions    89
14.3    Top-Heavy Status    90
14.4    Minimum Contributions    91
14.5    Minimum Vesting Rules    92
14.6    Noneligible Employees    92
ARTICLE XV   
RESTRICTION ON ASSIGNMENT OR OTHER ALIENATION OF PLAN BENEFITS    93
15.1    General Restrictions Against Alienation    93
15.2    Qualified Domestic Relations Orders    93

 

v


TABLE OF CONTENTS

 

      PAGE
ARTICLE XVI   
MISCELLANEOUS PROVISIONS    97
16.1    No Right of Employment Hereunder    97
16.2    Effect of Article Headings    97
16.3    Limitation on Company Liability    97
16.4    Gender    97
16.5    Interpretation    97
16.6    Withholding For Taxes    97
16.7    California Law Controlling    97
16.8    Plan and Trust as One Instrument    97
16.9    Invalid Provisions    97
16.10    Counterparts    98
APPENDIX A   

 

vi


ALLERGAN, INC.

SAVINGS AND INVESTMENT PLAN

ARTICLE I

INTRODUCTION

1.1           Plan Name .  This document, made and entered into by Allergan, Inc., a Delaware corporation (“Allergan”), amends and restates in its entirety the “Allergan, Inc. Savings and Investment Plan (Restated 2005)” and shall be known hereafter as the “Allergan, Inc. Savings and Investment Plan (Restated 2008).”

1.2           Plan Purpose .  The purpose of the Allergan, Inc. Savings and Investment Plan (Restated 2008), hereinafter referred to as the “Plan,” is to enable Eligible Employees of Allergan, and any Affiliated Companies that are authorized by the Board of Directors to participate in the Plan, to share in the growth and prosperity of the Company and to provide Participants with an opportunity to accumulate capital for their future economic security. All assets acquired under the Plan as a result of Participant Deposits and Company Contributions, income, and other additions to the Fund under the Plan shall be administered, distributed, forfeited and otherwise governed by the provisions of the Plan, which is to be administered by the Committee for the exclusive benefit of Participants in the Plan and their Beneficiaries.

1.3           Effective Date of 2008 Restated Plan .  The Effective Date of this amended and restated Plan shall be January 1, 2008 unless otherwise specified in the Plan. The provisions of this Plan document apply generally to Employees who have completed at least one (1) Hour of Service for Allergan or any Affiliated Companies on or after January 1, 2008 and the rights and benefits, if any, of Employees or Participants whose employment with Allergan or any Affiliated Companies terminated prior to January 1, 2008 shall be determined in accordance with the provisions of the Plan then in effect unless otherwise provided herein and subject to any modification provided herein that may affect the holding or distribution of Participants’ Accounts.

1.4           Amendments to Plan .  The Plan has been amended from time to time since its Original Effective Date of July 26, 1989 to reflect changes in the Plan’s operations and applicable law including, but not limited to, the following:

(a)        This Plan document that restates the Plan by incorporating the provisions of the First, Second, and Third Amendments to the Allergan, Inc. Savings and Investment Plan (Restated 2005) and amends the Plan: (i) to comply with all changes made by the Economic Growth and Tax Relief Reconciliation Act of 2001 (with technical corrections made by the Job Creation and Worker Assistance Act of 2002), the Pension Funding Equity Act of 2004, the American Jobs Creation Act of 2004, and the Gulf Opportunity Zone Act of 2005 as well as the changes to the qualification requirements listed on the “2006 Cumulative List of Changes in Plan Qualification Requirements” as set forth in Notice 2007-3, and (ii) to comply with certain changes made by the Pension Protection Act of 2006 by (1) by treating a Participant’s Beneficiary the same as the Participant’s spouse or dependent for purposes of the Plan’s hardship withdrawals, (2) expanding the


Plan’s rollover distribution provisions to permit the direct rollover of after-tax contributions to and from an annuity contract described in Code Section 403(b), and (3) permitting non-spouse beneficiaries to elect direct rollovers of lump sum distributions.

(b)        The Plan document for the Allergan, Inc. Savings and Investment Plan (Restated 2005) that incorporated the provisions of the First, Second, and Third Amendments to the Allergan, Inc. Savings and Investment Plan (Restated 2003) and amended the Plan, effective March 28, 2005, so that the Plan’s mandatory distribution rule applies only to Accounts, the vested portions of which, do not exceed $1,000.

(c)        The Plan document for the Allergan, Inc. Savings and Investment Plan (Restated 2003) that incorporated the provisions of the First Amendment to the Allergan, Inc. Savings and Investment Plan (Restated 2001) and amended the Plan to enhance Company Contributions made to the Plan by (i) increasing the Company’s Matching Contributions from an average 50% match on certain Participant Deposits not to exceed 5% of Compensation to a 100% match on certain Participant Deposits not to exceed 4% of Compensation and (ii) adding a Retirement Contribution feature for certain Eligible Employees hired on or after October 1, 2002 and other Eligible Employees who made a one-time irrevocable election to cease active participation in the Allergan, Inc. Pension Plan.

(d)        Amendments to the Plan that in accordance with Code Section 414(l), Regulation Section 1.414(1)-1, and Section 208 of ERISA, (i) provided for the merger of the Inamed Corporation Retirement Savings Plan was with and into the Plan effective as of December 31, 2006 and provided further that all account balances transferred to the Plan as a result of the merger are to be administered, distributed, forfeited and otherwise governed by the provisions of the Plan, (ii) in connection with the distribution of the stock of Advanced Medical Optics, Inc. (“AMO”) by the Plan Sponsor to its stockholders on June 29, 2002, provided for the transfer of assets and liabilities attributable to the Accounts of AMO Employees (as defined in Section 2.24) from the Plan to the Advanced Medical Optics, Inc. 401(k) Plan, a qualified profit sharing plan with a qualified cash or deferred arrangement, and the allocation of AMO stock to Participants’ Accounts, and (iii) provided for the merger of the Allergan, Inc. Puerto Rico Savings and Investment Plan with and into the Plan effective as of January 1, 1999 and provided further that all account balances transferred to the Plan as a result of the merger are to be administered, distributed, forfeited and otherwise governed by the provisions of the Plan and Appendix A, which is attached hereto and made a part hereof.

1.5           Plan Qualification .  The Plan is an employee benefit plan that is intended to qualify under Code Section 401(a) as a qualified profit sharing plan and under Code Section 401(k) as a qualified cash or deferred arrangement. The Plan’s last determination letter was issued by the Internal Revenue Service on July 22, 2002 with respect to the Allergan, Inc. Savings and Investment Plan (Restated 2001). This Plan document is intended to reflect all law changes made by the Economic Growth and Tax Relief Reconciliation Act of 2001 (with technical corrections made by the Job Creation and Worker Assistance Act of 2002), the Pension

 

2


Funding Equity Act of 2004, the American Jobs Creation Act of 2004, and the Gulf Opportunity Zone Act of 2005 as well as the changes to the qualification requirements listed on the “2006 Cumulative List of Changes in Plan Qualification Requirements” as set forth in Notice 2007-3.

 

3


ARTICLE II

DEFINITIONS

2.1.           Accounts .  “Accounts” or “Participant’s Accounts” shall mean the After Tax Deposits Accounts, Before Tax Deposits Accounts, Matching Contributions Accounts, Retirement Contributions Accounts, and Rollover Contributions Accounts maintained for the various Participants.

2.2.           Affiliated Company .  “Affiliated Company” shall mean (i) any corporation, other than the Sponsor, which is included in a controlled group of corporations (within the meaning of Code Section 414(b)) of which the Sponsor is a member, (ii) any trade or business, other than the Sponsor, which is under common control (within the meaning of Code Section 414(c)) with the Sponsor, (iii) any entity or organization, other than the Sponsor, which is a member of an affiliated service group (within the meaning of Code Section 414(m)) of which the Sponsor is a member, and (iv) any entity or organization, other than the Sponsor, which is affiliated with the Sponsor under Code Section 414(o). An entity shall be an Affiliated Company pursuant to this Section only during the period of time in which such entity has the required relationship with the Sponsor under clauses (i), (ii), (iii) or (iv) of this Section after the Original Effective Date of the Plan.

2.3.           After Tax Deposits .  “After Tax Deposits” shall mean those contributions made by a Participant which represent after-tax contributions.

2.4.           After Tax Deposits Account .    “After Tax Deposits Account” shall mean a Participant’s individual account in the Trust Fund in which are held his or her After Tax Deposits and the earnings thereon.

2.5.           Anniversary Date .  “Anniversary Date” shall mean the last day of each Plan Year.

2.6.           Before Tax Deposits .    “Before Tax Deposits” shall mean those contributions made by a Participant which represent pre-tax contributions.

2.7.           Before Tax Deposits Account .    “Before Tax Deposits Account” shall mean a Participant’s individual account in the Trust Fund in which are held his or her Before Tax Deposits, any pre-tax contributions (elective deferrals as defined in Code Section 402(g)(3)) transferred from the Participant’s account in the Inamed Corporation Retirement Savings Plan, and the earnings thereon. Any pre-tax contributions transferred from a Participant’s account in the Inamed Corporation Retirement Savings Plan shall be fully vested

2.8.           Beneficiary .  “Beneficiary” or “Beneficiaries” shall mean the person or persons last designated by a Participant as set forth in Section 8.4 or, if there is no designated Beneficiary or surviving Beneficiary, the person or persons designated pursuant to Section 8.4 to receive the interest of a deceased Participant in such event.

 

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2.9.           Board of Directors .  “Board of Directors” shall mean the Board of Directors of the Sponsor (or its delegate) as it may from time to time be constituted.

2.10.         Break in Service .  “Break in Service” shall mean, with respect to an Employee, each period of 12 consecutive months during a Period of Severance that commences on the Employee’s Severance Date or on any anniversary of such Severance Date.

2.11.         Code .  “Code” shall mean the Internal Revenue Code of 1986 and the regulations thereunder. Reference to a specific Code Section shall be deemed also to refer to any applicable regulations under that Section, and shall also include any comparable provisions of future legislation that amend, supplement or supersede that specific Section.

2.12.         Committee .  “Committee” shall mean the committee to be appointed under the provisions of Section 9.1 to administer the Plan.

2.13.         Company .  “Company” shall mean collectively the Sponsor and each Affiliated Company that adopts the Plan in accordance with Section 10.2.

2.14.         Company Contributions .    “Company Contributions” shall mean Matching Contributions and Retirement Contributions (whether in cash or other property, including Company Stock), paid by the Company pursuant to Sections 5.3 and 5.4 into the Trust Fund established and maintained under the provisions of the Plan for the purpose of providing benefits for Participants and their Beneficiaries. Unless expressly stated otherwise in the Plan, Company Contributions shall not include Before Tax Deposits, After Tax Deposits, or Rollover Contributions.

2.15.         Company Contributions Accounts .    “Company Contributions Accounts” shall mean a Participant’s Matching Contributions Account and Retirement Contributions Account.

2.16.         Company Stock .  “Company Stock” shall mean any class of stock of the Sponsor which both constitutes “qualifying employer securities” as defined in Section 407(d)(5) of ERISA and “employer securities” as defined in Code Section 409(l).

2.17.         Compensation .  “Compensation” shall mean the following:

(a)        Compensation shall include amounts paid during a Plan Year to a Participant by the Company for services rendered, including base earnings, commissions and similar incentive compensation, cost of living allowances earned within the United States of America, holiday pay, overtime earnings, pay received for election board duty, pay received for jury and witness duty, pay received for military service (annual training), pay received for being available for work, if required (call-in premium), shift differential and premium, sickness/accident related pay, vacation pay (other than as excluded in paragraph (c) below), vacation shift premium, and bonus amounts paid under the (i) Sales Bonus Program, (ii) Management Bonus Plan or Executive Bonus Plan, either in cash or in restricted stock, and (iii) group performance sharing payments, such as the “Partners for Success.”

 

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(b)        Compensation shall include amounts of salary reduction elected by a Participant under a Code Section 401(k) cash or deferred arrangement, a Code Section 125 cafeteria plan and, solely for purposes of determining Retirement Contributions under Section 5.4, amounts deferred under the Executive Deferred Compensation Plan.

(c)        Compensation shall not include business expense reimbursements; Company gifts or the value of Company gifts; Company stock related options and payments; employee referral awards; flexible compensation credits paid in cash; special overseas payments, allowances and adjustments including, but not limited to, pay for cost of living adjustments and differentials paid for service outside of the United States, expatriate reimbursement payments, and tax equalization payments; forms of imputed income; long-term disability pay; payment for loss of Company car; Company car allowance; payments for patents or for writing articles; relocation and moving expenses; retention and employment incentive payments; severance pay; long-term incentive awards, bonuses or payments; “Impact Award” payments; “Employee of the Year” payments; “Awards for Excellence” payments; “Hidden Gem Award” payments; special group incentive payments and individual recognition payments which are nonrecurring in nature; tuition reimbursement; lump sum amounts paid to Employees under the Company’s vacation buy-back policy; and contributions by the Company under the Plan or distributions hereunder, any contributions or distributions pursuant to any other plan sponsored by the Company and qualified under Code Section 401(a) (other than contributions constituting salary reduction amounts elected by the Participant under a Code Section 401(k) cash or deferred arrangement), any payments under a health or welfare plan sponsored by the Company, or premiums paid by the Company under any insurance plan for the benefit of Employees.

(d)        Solely for purposes of determining Retirement Contributions under Section 5.4, Compensation shall include compensation paid by Oculex Pharmaceuticals, Inc. to an Eligible Employee prior to Oculex Pharmaceuticals, Inc. becoming an Affiliated Company but only to the extent provided in paragraphs (a), (b), and (c) above and only to the extent of compensation paid by Oculex Pharmaceuticals, Inc. in 2003.

(e)        Compensation for any Plan Year shall not include amounts in excess of $210,000, as adjusted for cost-of-living increases in accordance with Code Section 401(a)(17)(B) for purposes of determining all benefits provided under the Plan for any Plan Year. Any cost-of-living adjustments in effect for a calendar year shall apply to the Plan Year beginning with or within such calendar year.

(f)        Notwithstanding the foregoing, for purposes of applying the provisions of Articles XIII and XIV, a Participant’s Compensation shall be determined pursuant to the definition of “Compensation” as set forth in Section 13.5 or 14.2(i), as the case may be.

 

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2.18.       Credited Service .  “Credited Service” shall mean, with respect to each Employee, his or her years and months of Credited Service determined in accordance with the following rules:

(a)        In the case of any Employee who was employed by the Company at any time prior to the Original Effective Date, for the period prior to January 1, 1989 such Employee shall be credited with Credited Service under the Plan equal to the period (if any) of service credited to such Employee under the SmithKline Beckman Savings and Investment Plan.

(b)        In the case of any Employee who is employed by the Company on or after the Original Effective Date, an Employee shall receive Credited Service for the elapsed period of time between each Employment Commencement Date (or Reemployment Commencement Date) of the Employee and the Severance Date which immediately follows that Employment Commencement Date (or Reemployment Commencement Date). Solely for the purpose of determining an Employee’s Credited Service under this paragraph (b), in the case of an Employee who is employed on January 1, 1989, that date shall be deemed to be an Employment Commencement Date of the Employee (with service credit for periods prior to January 1, 1989 to be determined under paragraph (a) above). An Employee who is absent from work on an authorized Leave of Absence shall be deemed to have incurred a Severance (if any) in accordance with the rules of Section 2.50.

(c)        An Employee shall receive Credited Service credit for periods between a Severance and his or her subsequent Reemployment Commencement Date in accordance with the following rules:

(i)        If an Employee incurs a Severance by reason of a quit, discharge, Disability, or retirement whether or not such a Severance occurs during an approved Leave of Absence and the Employee is later reemployed by the Company prior to his or her incurring a Break in Service, he or she shall receive Credited Service for the period commencing with his or her Severance Date and ending with his or her subsequent Reemployment Commencement Date.

(ii)       Other than as expressly set forth above in this paragraph (c), an Employee shall receive no Credited Service with respect to periods between a Severance and a subsequent Reemployment Commencement Date.

(d)        For all purposes of the Plan, an Employee’s total Credited Service shall be determined by aggregating any separate periods of Credited Service separated by any Breaks in Service.

(e)        An Employee shall be credited with Credited Service with respect to a period of employment with an Affiliated Company, but only to the extent that such period of employment would be so credited under the foregoing rules set forth in this Section had such Employee been employed during such period by the Company.

 

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(f)        Notwithstanding the foregoing, unless the Sponsor shall so provide by resolution of its Board of Directors, or unless otherwise expressly stated in the Plan, an Employee shall not receive such Credited Service credit for any period of employment with an Affiliated Company prior to such entity becoming an Affiliated Company.

(g)        In accordance with paragraph (f) above, an Eligible Employee shall receive Credited Service for any period of employment with Allergan Medical Optics - Lenoir facility, Oculex Pharmaceuticals, Inc., or Inamed Corporation and any subsidiary of Inamed Corporation prior to each becoming an Affiliated Company but only to the extent provided in paragraph (e) above. Notwithstanding anything in this Section to the contrary and for purposes of this Plan only, the Employment Commencement Date (or Reemployment Commencement Date) of an Eligible Employee described in this paragraph (g) shall mean, for purposes of paragraph (b), the date (or, in the case of a Reemployment Commencement Date, the date following a Severance) on which the Eligible Employee was first credited with an Hour of Service with Allergan Medical Optics - Lenoir facility, Oculex Pharmaceuticals, Inc., or Inamed Corporation and any subsidiary of Inamed Corporation including any date prior to Allergan Medical Optics - Lenoir facility, Oculex Pharmaceuticals, Inc., or Inamed Corporation and any subsidiary of Inamed Corporation becoming an Affiliated Company.

(h)        In accordance with paragraph (f) above, an Eligible Employee who was employed by Esprit Pharma, Inc. on October 16, 2007 and who is classified or identified as such in the payroll records of the Company or in the Stock Purchase Agreement by and between Allergan, Inc. and Esprit Pharma, Inc. shall, for purposes of the vesting and in-service withdrawal provisions of the Plan only, receive Credited Service for any period of employment with Esprit Pharma, Inc. prior to it becoming an Affiliated Company but only to the extent provided in paragraph (e) above. Notwithstanding anything in this Section to the contrary and for purposes of determining Credited Service under this paragraph, the Employment Commencement Date (or Reemployment Commencement Date) of an Eligible Employee described in this paragraph (i) shall mean, for purposes of paragraph (b), the date (or, in the case of a Reemployment Commencement Date, the date following a Severance) on which the Eligible Employee was first credited with an Hour of Service with Esprit Pharma, Inc. including any date prior to Esprit Pharma, Inc. becoming an Affiliated Company.

(i)        Notwithstanding any provision of the Plan to the contrary, contributions, benefits and service credit with respect to qualified military service shall be provided in accordance with Code Section 414(u).

2.19.       Disability .  “Disability” shall mean any mental or physical condition which, in the judgment of the Committee, based on such competent medical evidence as the Committee may require, renders an individual unable to engage in any substantial gainful activity for the Company for which he or she is reasonably fitted by education, training, or experience and which condition can be expected to result in death or which has lasted or can be expected to last for a continuous period of at least 12 months. The determination by the Committee, upon

 

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opinion of a physician selected by the Committee, as to whether a Participant has incurred a Disability shall be final and binding on all persons.

2.20.       Effective Date .  “Effective Date” of this restated Plan shall mean January 1, 2008 unless otherwise specified in the Plan. The “Original Effective Date” of the Plan shall mean July 26, 1989.

2.21.       Eligible Employee .  “Eligible Employee” shall mean any United States-based payroll Employee and any Puerto Rico-based payroll Employee of the Company and any expatriate Employee of the Company who is a United States citizen or permanent resident, but excluding:

(a)        any non-resident alien of the United States and Puerto Rico, non-regular manufacturing site transition Employee, Leased Employee, or Employee covered by a collective bargaining agreement; and

(b)        prior to January 1, 2007, any Employee who is employed by (i) Inamed Corporation and any of its subsidiaries (or any Affiliated Company that is designated by the Sponsor as a successor thereto) on or after the “Effective Time” as defined in the Agreement and Plan of Merger dated as of December 20, 2005 by and among Allergan, Inc., Banner Acquisition, Inc., and Inamed Corporation or (ii) the Company as of the date he or she becomes classified as “Inamed-benefited” in the payroll records of the Company.

2.22.       Eligible Retirement Plan .  “Eligible Retirement Plan” shall mean (i) an individual retirement account or annuity described in Code Section 408(a) or 408(b), (ii) a qualified retirement plan described in Code Section 401(a) or 403(a) that accepts Eligible Rollover Distributions, (iii) an annuity contract described in Code Section 403(b) that accepts Eligible Rollover Distributions, and (iv) an eligible plan described in Code Section 457(b) which is maintained by a state, political subdivision of a state, or any agency or instrumentality of a state or political subdivision of a state that accepts Eligible Rollover Distributions and agrees to separately account for amounts transferred into such plan from this Plan. Notwithstanding the foregoing, “Eligible Retirement Plan” shall mean an individual retirement account or annuity described in Code Section 408(a) or 408(b) with respect to a non-spouse Beneficiary.

2.23.       Eligible Rollover Distribution .  “Eligible Rollover Distribution” shall mean any distribution of all or any portion of the balance to the credit of the Distributee, except that an Eligible Rollover Distribution shall not include:

(a)        any distribution that is one of a series of substantially equal periodic payments (not less frequently than annually) made for the life (or life expectancy) of the Distributee of the joint lives (or joint life expectancies) of the Distributee and the Distributee’s designated beneficiary, or for a specified period of ten years or more;

(b)        any distribution to the extent such distribution is required under Code Section 401(a)(9);

 

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(c)        the portion of any distribution that is not includable in gross income (determined without regard to the exclusion for net unrealized appreciation with respect to employer securities);

(d)        any hardship withdrawal made pursuant to Section 8.1(e); and

(e)        any other distribution that is reasonably expected to total less than $200 during the year.

A portion of a distribution shall not fail to be an Eligible Rollover Distribution merely because the portion consists of After Tax Deposits or the portion consists of rollover after tax employee contributions made pursuant to Section 4.8. which are not includible in gross income. However, such portion(s) may be transferred only to an individual retirement account or annuity described in Code Section 408(a) or 408(b), to a qualified defined contribution plan described in Code Section 401(a) or 403(a) or, on or after January 1, 2007, to an annuity contract described in Code Section 403(b) that agrees to separately account for amounts so transferred, including separately accounting for the portion of such distribution which is includible in gross income and the portion of such distribution which is not so includible. For purposes of this Section, “Distributee” shall mean any Employee or former Employee receiving a distribution from the Plan. A Distributee also includes the Employee or former Employee’s surviving spouse and the Employee or former Employee’s spouse or former spouse who is the Alternate Payee under a Qualified Domestic Relations Order (as defined in Article XV) with regard to the interest of the spouse or former spouse and, on or after, January 1, 2007, the Employee or former Employee’s Beneficiary.

2.24.       Employee .  “Employee” shall mean, for purposes of the Plan, any individual who is employed by the Sponsor or an Affiliated Company in any capacity, any portion of whose income is subject to withholding of income tax and/or for whom Social Security contributions are made by the Sponsor or an Affiliated Company, including any Puerto Rico-based payroll Employee of the Sponsor or an Affiliated Company; provided, however, that such term shall not include:

(a)        Any individual who performs services for the Sponsor or an Affiliated Company and who is classified or paid as an independent contractor as determined by the payroll records of the Sponsor or an Affiliated Company even if a court or administrative agency determines that such individual is a common-law employee and not an independent contractor;

(b)        Any individual who performs services for the Sponsor or an Affiliated Company pursuant to an agreement between the Sponsor or an Affiliated Company and any other person including a leasing organization except to the extent such individual is a Leased Employee; and

(c)        Any individual whose employment is transferred from the Sponsor or an Affiliated Company to Advanced Medical Optics, Inc. (“AMO”) in connection with the

 

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distribution of the stock of AMO by the Sponsor to its stockholders, effective as of the day following such transfer, hereinafter referred to as an “AMO Employee.” An individual is an AMO Employee if classified or identified as such in the payroll records of the Sponsor or an Affiliated Company or in the Employee Matters Agreement entered into between the Sponsor and AMO.

2.25.       Employment Commencement Date .    “Employment Commencement Date” shall mean the date on which an Employee is first credited with an Hour of Service for the Sponsor or an Affiliated Company. An Employee shall not, for the purpose of determining his or her Employment Commencement Date, be deemed to have commenced employment with an Affiliated Company prior to the effective date on which the entity became an Affiliated Company unless the Sponsor expressly determines otherwise, and except as is expressly provided otherwise in the Plan or in resolutions of the Board of Directors.

2.26.       ERISA .    “ERISA” shall mean the Employee Retirement Income Security Act of 1974 and the regulations thereunder. Reference to a specific ERISA Section shall be deemed also to refer to any applicable regulations under that Section, and shall also include any comparable provisions of future legislation that amend, supplement or supersede that specific Section.

2.27.       Forfeitures .    “Forfeitures” shall mean the nonvested portion of a Participant’s Matching Contributions Account or Retirement Contributions Account, whichever the case may be, that is forfeited in accordance with the provisions of Article VIII.

2.28.       415 Suspense Account .    “415 Suspense Account” shall mean the account (if any) established and maintained in accordance with the provisions of Article XIII for the purpose of holding and accounting for allocations of excess Annual Additions (as defined in Article XIII).

2.29.       Highly Compensated Employee .    “Highly Compensated Employee” shall mean:

 (a)        An Employee who performed services for the Employer during the Plan Year or preceding Plan Year and is a member of one or more of the following groups:

(i)        Employees who at any time during the Plan Year or preceding Plan Year were Five Percent Owners (as defined in Section 14.2).

(ii)       Employees who received Compensation during the preceding Plan Year from the Employer in excess of $80,000 (as adjusted in such manner as permitted under Code Section 414(q)(1)).

 (b)        For the purpose of this Section , the term “Compensation” means compensation as defined in Code Section 415(c)(3), as set forth in Section 13.5.

 (c)        The term “Highly Compensated Employee” includes a Former Highly Compensated Employee. A Former Highly Compensated Employee is any Employee who was (i) a Highly Compensated Employee when he or she terminated employment

 

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with the Employer or (ii) a Highly Compensated Employee at any time after attaining age 55. Notwithstanding the foregoing, an Employee who separated from service prior to 1987 shall be treated as a Former Highly Compensated Former Employee only if during the separation year (or year preceding the separation year) or any year after the Employee attains age 55 (or the last year ending before the Employee’s 55th birthday), the Employee either received Compensation in excess of $50,000 or was a Five Percent Owner.

 (d)        For the purpose of this Section, the term “Employer” shall mean the Sponsor and any Affiliated Company.

 (e)        The determination of who is a Highly Compensated Employee, including the determination of the Compensation that is considered, shall be made in accordance with Code Section 414(q) and applicable regulations to the extent permitted thereunder. The Committee, for administrative convenience, may establish rules and procedures for purposes of identifying Highly Compensated Employees, which rules and procedures may result in an Eligible Employee being deemed to be a Highly Compensated Employee for purposes of the limitations of Article IV and Article VI, whether or not such Eligible Employee is a Highly Compensated Employee described in Code Section 414(q).

2.30.       Hour of Service .    “Hour of Service” shall mean an hour for which an Employee is paid or entitled to payment for the performance of duties for the Sponsor and any Affiliated Company.

2.31.       Investment Manager .    “Investment Manager” shall mean the one or more Investment Managers, if any, that are appointed pursuant to Section 5.16 and who constitute investment managers under Section 3(38) of ERISA.

2.32.       Leased Employee .    “Leased Employee” shall mean any person (other than an Employee of the recipient) who pursuant to an agreement between the recipient and any other person (“leasing organization”) has performed services for the recipient (or for the recipient and related persons determined in accordance with Code Section 414(n)(6)) on a substantially full time basis for a period of at least one (1) year, and such services are performed under the primary direction or control by recipient employer. Contributions or benefits provided to a Leased Employee by a leasing organization which are attributable to services performed for the recipient employer shall be treated as provided by the recipient employer. A Leased Employee shall not be considered an Employee of the recipient if Leased Employees do not constitute more than 20 percent of the recipient’s nonhighly compensated workforce and such Leased Employee is covered by a money purchase pension plan providing (i) a nonintegrated employer contribution rate of at least ten (10) percent of compensation as defined under Code Section 415(c)(3); (ii) immediate participation; and (iii) full and immediate vesting.

2.33.       Leave of Absence .

 (a)        “Leave of Absence” shall mean any personal leave from active employment (whether with or without pay) duly authorized by the Company under the

 

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Company’s standard personnel practices. All persons under similar circumstances shall be treated alike in the granting of such Leaves of Absence. Leaves of Absence may be granted by the Company for reasons of health (including temporary sickness or short term disability) or public service or for any other reason determined by the Company to be in its best interests.

 (b)        In addition to Leaves of Absence as defined in paragraph (a) above, the term Leave of Absence shall also mean a Maternity or Paternity Leave, as defined herein, but only to the extent and for the purposes required under paragraph (c) below. As used herein, “Maternity or Paternity Leave” shall mean an absence from work for any period (i) by reason of the pregnancy of the Employee, (ii) by reason of the birth of a child of the Employee, (iii) by reason of the placement of a child with the Employee in connection with the adoption of the child by the Employee, or (iv) for purposes of caring for the child for a period beginning immediately following the birth or placement referred to in clauses (ii) or (iii) above.

 (c)        Subject to the provisions of paragraph (d) below, a Maternity or Paternity Leave described in paragraph (b) above shall be deemed to constitute an authorized Leave of Absence for purposes of the Plan only to the extent consistent with the following rules:

(i)        For purposes of determining whether a Break in Service has occurred, the Severance Date of a Participant who is absent by reason of a Maternity or Paternity Leave shall not be deemed to occur any earlier than the second anniversary of the date upon which such Maternity or Paternity Leave commences.

(ii)       The Maternity or Paternity Leave shall be treated as a Leave of Absence solely for purposes of determining whether or not an Employee has incurred a Break in Service. Accordingly, such a Maternity or Paternity Leave shall not result in an accrual of Credited Service for purposes of the vesting provisions of the Plan or for purposes of the eligibility and participation provisions of Article III (except only in determining whether a Break in Service has occurred).

(iii)      A Maternity or Paternity Leave shall not be treated as a Leave of Absence unless the Employee provides such timely information as the Committee may reasonably require to establish that the absence is for the reasons listed in paragraph (b) above and to determine the number of days for which there was such an absence.

 (d)        Notwithstanding the limitations provided in paragraph (c) above, a Maternity or Paternity Leave described in paragraph (b) above shall be treated as an authorized Leave of Absence, as described in paragraph (a), for all purposes of the Plan to the extent the period of absence is one authorized as a Leave of Absence under the Company’s standard personnel practices and thus is covered by the provisions of

 

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paragraph (a) above without reference to the provisions of paragraph (b) above, provided, however, that the special rule provided under this paragraph (d) shall not apply if it would result in a Participant who is absent on a Maternity or Paternity Leave being deemed to have incurred a Break in Service sooner than under the rules set forth in paragraph (c).

2.34.       Matched Deposits .    “Matched Deposits” of a Participant shall mean his or her Participant Deposits (whether Before Tax, including “catch up” Before Tax Deposits described in Section 4.2(e) or After Tax but excluding Rollover Contributions) not in excess of four percent (4%) of Compensation. Matched Deposits shall participate in allocations of Matching Contributions and Matching Contribution Forfeitures.

2.35.       Matching Contributions .    “Matching Contributions” shall mean all amounts (whether in cash or other property, including Company Stock) paid by the Company pursuant to Sections 5.3(a) and 5.3(b) into the Trust Fund established and maintained under the provisions of the Plan for the purpose of providing benefits for Participants and their Beneficiaries.

2.36.       Matching Contributions Account .    “Matching Contributions Account” shall mean a Participant’s individual account in the Trust Fund in which are held Matching Contributions, any amounts transferred from the Participant’s account in the SmithKline Beckman Savings and Investment Plan to the Plan, any matching contributions transferred from the Participant’s account in the Inamed Corporation Retirement Savings Plan, and the earnings thereon. Any amounts transferred from the Participant’s account in the SmithKline Beckman Savings and Investment Plan shall be fully vested. Any matching contributions transferred from a Participant’s account in the Inamed Corporation Retirement Savings Plan shall be fully vested including the matching contributions of a Participant who terminated prior to December 31, 2006 so long as his or her Participant’s account in the Inamed Corporation Retirement Savings Plan was greater than zero on December 31, 2006.

2.37.       Normal Retirement Age .    “Normal Retirement Age” shall mean a Participant’s sixty-fifth (65th) birthday.

2.38.       Participant .      “Participant” shall mean any Eligible Employee or former Eligible Employee who has commenced participation in the Plan pursuant to Section 3.1 and who retains rights under the Plan.

2.39.       Participant Deposits .    “Participant Deposits” shall mean all of a Participant’s deposits to the Plan, including After Tax Deposits, Before Tax Deposits, and Rollover Contributions.

2.40.       Period of Severance .    “Period of Severance” shall mean the period of time commencing on an Employee’s Severance Date and ending on the Employee’s subsequent Reemployment Commencement Date, if any.

2.41.       Plan .    “Plan” shall mean the Allergan, Inc. Savings and Investment Plan described herein and as amended from time to time.

 

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2.42.       Plan Administrator .    “Plan Administrator” shall mean the administrator of the Plan within the meaning of Section 3(16)(A) of ERISA. The Plan Administrator shall be the Allergan Executive Committee whose members are appointed by the Board of Directors pursuant to the provisions of Section 9.1 to administer the Plan.

2.43.       Plan Year .    “Plan Year” shall mean the calendar year.

2.44.       Reemployment Commencement Date .    “Reemployment Commencement Date” shall mean, in the case of an Employee who incurs a Severance and who is subsequently reemployed by the Sponsor or an Affiliated Company, the first day following the Severance on which the Employee is credited with an Hour of Service for the Sponsor or an Affiliated Company with respect to which he or she is compensated or entitled to compensation by the Sponsor or an Affiliated Company. An Employee shall not, for the purpose of determining his or her Reemployment Commencement Date, be deemed to have commenced employment with an Affiliated Company prior to the effective date on which such entity becomes an Affiliated Company unless the Sponsor shall expressly determine otherwise, and except as is expressly provided otherwise in the Plan or in resolutions of the Board of Directors.

2.45.       Retirement Account Participant .    “Retirement Account Participant” shall mean any Eligible Employee who has met the eligibility requirements of Section 3.2 but excluding any Eligible Employee who is an “Active Participant” in the Allergan, Inc. Pension Plan as such term is defined therein.

2.46.       Retirement Contributions .    “Retirement Contributions” shall mean all amounts (whether in cash or other property, including Company Stock) paid by the Company pursuant to Section 5.4 into the Trust Fund established and maintained under the provisions of the Plan for the purpose of providing benefits for Participants and their Beneficiaries.

2.47.       Retirement Contributions Account .    “Retirement Contributions Account” shall mean a Participant’s individual account in the Trust Fund in which are held Retirement Contributions and the earnings thereon.

2.48.       Rollover Contributions .    “Rollover Contributions” shall mean those contributions made by a Participant pursuant to Section 4.8.

2.49.       Rollover Contributions Account .    “Rollover Contributions Account” shall mean a Participant’s individual account in the Trust Fund in which are held Rollover Contributions made pursuant to Section 4.8.

2.50.       Severance .    “Severance” shall mean the termination of an Employee’s employment with the Sponsor or an Affiliated Company by reason of such Employee’s quit, discharge, Disability, death, retirement, or otherwise. For purposes of determining whether an Employee has incurred a Severance, the following rules shall apply:

(a)        An Employee shall not be deemed to have incurred a Severance (i) because of his or her absence from employment with the Sponsor or an Affiliated

 

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Company by reason of any paid vacation or holiday period, or (ii) by reason of any Leave of Absence, subject to the provisions of paragraph (b) below.

 (b)        For purposes of the Plan, an Employee shall be deemed to have incurred a Severance on the earlier of (i) the date on which he or she dies, resigns, is discharged, or otherwise terminates his or her employment with the Sponsor or an Affiliated Company; or (ii) the date on which he or she is scheduled to return to work after the expiration of an approved Leave of Absence, if he or she does not in fact return to work on the scheduled expiration date of such Leave. In no event shall an Employee’s Severance be deemed to have occurred before the last day on which such Employee performs any services for the Sponsor or an Affiliated Company in the capacity of an Employee with respect to which he or she is compensated or entitled to compensation by the Sponsor or an Affiliated Company.

 (c)        Notwithstanding the foregoing, in the case of a Participant who is absent by reason of a Maternity or Paternity Leave, the provisions of Section 2.33(c)-(d) shall apply for purposes of determining whether such a Participant has incurred a Break in Service by reason of such Leave.

2.51.       Severance Date .    “Severance Date” shall mean, in the case of any Employee who incurs a Severance, the day on which such Employee is deemed to have incurred said Severance as determined in accordance with the provisions of Section 2.50, provided, however, that the special rules set forth under Section 2.33(c)-(d) shall apply with respect to determining whether a Participant on a Maternity or Paternity Leave has incurred a Break in Service. In the case of any Employee who incurs a Severance as provided under Section 2.50 and who is entitled to a subsequent payment of compensation for reasons other than future services (e.g., as back pay for past services rendered or as payments in the nature of severance pay), the Severance Date of such Employee shall be as of the effective date of the Severance event (e.g., the date of his or her death, effective date of a resignation or discharge, etc.), and the subsequent payment of the aforementioned type of post-Severance compensation shall not operate to postpone the timing of the Severance Date for purposes of the Plan.

2.52.       Sponsor .    “Sponsor” shall mean Allergan, Inc., a Delaware corporation, and any successor corporation or entity.

2.53.       Trust .    “Trust” or “Trust Fund” shall mean the trust maintained pursuant to the Trust Agreement and as described in Section 5.1 hereof, which shall hold all cash and securities and all other assets of whatsoever nature deposited with or acquired by the Trustee in its capacity as Trustee hereunder, together with accumulated net earnings.

2.54.       Trust Agreement .    “Trust Agreement” shall mean the agreement between the Trustee and the Sponsor pursuant to which the Trust is maintained.

2.55.       Trustee .    “Trustee” shall mean the individual or entity acting as a trustee of the Trust Fund.

 

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2.56.       Valuation Date .    “Valuation Date” shall mean the date as of which the Trustee shall determine the value of the assets in the Trust Fund for purposes of determining the value of each Account, which shall be each business day in accordance with rules applied in a consistent and uniform basis.

 

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ARTICLE III

ELIGIBILITY AND PARTICIPATION

3.1         General Eligibility and Participation .    An Eligible Employee shall participate in the Plan on the later of: (i) his or her Employment Commencement Date or (ii) the date he or she becomes an Eligible Employee. A Participant who incurs a Severance shall participate in the Plan immediately upon his or her Reemployment Commencement Date so long as he or she is reemployed as an Eligible Employee.

3.2         Eligibility for Retirement Contributions .    An Eligible Employee shall be eligible to receive allocations of Retirement Contributions as provided in Section 5.4 only if he or she is a Retirement Account Participant as described below:

 (a)        An Eligible Employee shall become a Retirement Account Participant on the date that immediately follows the later of:

(i)        The date such Eligible Employee performs an Hour of Service as an Eligible Employee;

(ii)       The date such Eligible Employee completes six (6) months of Credited Service with the Sponsor or an Affiliated Company as an Employee; or

(iii)      The date such Eligible Employee ceases to be an “Active Participant” in the Allergan, Inc. Pension Plan as such term is defined therein.

 (b)        A Participant who becomes a Retirement Account Participant shall remain an active Retirement Account Participant until he or she: (i) incurs a Severance, (ii) transfers employment to an Affiliated Company that has not adopted the Plan pursuant to Section 10.2, or (iii) is no longer an Eligible Employee even though he or she remains an Employee of the Company, at which time such Retirement Account Participant shall become an inactive Retirement Account Participant and shall no longer be eligible to receive allocations of Retirement Contributions as provided in Section 5.4.

 (c)        A Retirement Account Participant or an Employee who is not a Retirement Account Participant but who has completed the service requirement specified in paragraph (a)(i) above shall, if he or she incurs a Severance and is subsequently reemployed as an Eligible Employee, become a Retirement Account Participant immediately upon his or her Reemployment Commencement Date. A Retirement Account Participant who becomes an inactive Retirement Account Participant shall become a Retirement Account Participant upon the date he or she resumes Eligible Employee status. An Employee who has not completed the service requirement specified in paragraph (a)(i) above shall, if he or she incurs a Severance and is subsequently reemployed, become a Retirement Account Participant on the date determined under paragraph (a) above.

 

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3.3         Duration of Participation .    An Eligible Employee who becomes a Participant shall remain an active Participant until he or she incurs a Severance, at which time he or she shall become an inactive Participant until he or she receives a distribution of the entire vested portion of his or her Accounts. Once such a distribution is made, such Participant shall no longer be considered a Participant in the Plan. A Participant who (i) transfers out of employment with the Company but who remains an Employee of an Affiliated Company that has not adopted the Plan pursuant to Section 10.2, or (ii) remains an Employee of the Company but is no longer an Eligible Employee, shall become an inactive Participant.

3.4         Eligibility and Participation After Normal Retirement Age .    An Eligible Employee may become, or continue as, a Participant or a Retirement Account Participant after reaching his or her Normal Retirement Age in the same manner as an Eligible Employee who has not reached his or her Normal Retirement Age.

 

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ARTICLE IV

PARTICIPANT DEPOSITS

4.1         Election .

 (a)        Each Eligible Employee may elect to defer the receipt of a portion of his or her Compensation and to have the deferred amount contributed directly by the Company to the Plan as Before Tax Deposits. Before Tax Deposits may be made only by means of payroll deduction.

 (b)        Each Eligible Employee may elect to contribute to the Plan a portion of his or her Compensation as After Tax Deposits. After Tax Deposits may be made only by means of payroll deduction.

 (c)        The Committee shall prescribe procedures to implement automatic enrollment elections, pursuant to which an Eligible Employee or, if limited to newly hired Eligible Employees as determined by the Committee, shall be deemed to have elected to defer the receipt of three percent (3%) of his or her Compensation and to have such deferred amount contributed directly by the Company to the Plan as Before Tax Deposits if such Eligible Employee fails to change or terminate the automatic election for any Plan Year within the time period prescribed by the Committee (or, in the case of newly hired Eligible Employee, he or she fails to change or terminate the automatic election within 30 days of his or her hire date). Such procedures shall require that an Eligible Employee receive a written notice of explanation of the automatic election informing the Eligible Employee of the effective date of the automatic election, the automatic deferral percentage and his or her right to terminate the automatic election or to change the amount of his or her Before Tax Deposits made to the Plan as well as the procedures for exercising such rights and the timing for implementing a different election. An automatic election under this paragraph (c) shall be effective as of the first pay period of the Plan Year (or, in the case of newly hired Eligible Employee, the first pay period following the 30-day period beginning on his or her date of hire) and shall remain in effect until superseded by a subsequent election by the Eligible Employee. Amounts contributed directly by the Company to the Plan under this paragraph (c) shall be invested in the Balanced Fund described in Section 5.6(b) until superseded by a subsequent election by the Eligible Employee.

 (d)        Notwithstanding anything in this Section to the contrary, a Participant who makes a withdrawal of After Tax Deposits (whether Matched Deposits or non-Matched Deposits) pursuant to Section 8.1(a) or a hardship withdrawal pursuant to Section 8.1(e) shall not be permitted to make Before Tax Deposits or After Tax Deposits to the Plan during the 6-month period beginning as soon as administratively feasible following the date of the hardship withdrawal. The foregoing sentence shall not apply to a withdrawal of After Tax Deposits if the After Tax Deposits can also be withdrawn under Section 8.1(d) or the withdrawal is comprised solely of After Tax Deposits which are not Matched Deposits and which were contributed prior to July 1, 2000.

 

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 (e)        The Committee shall prescribe such procedures, either in writing or in practice, and provide such forms as are necessary or appropriate for each Participant and each Eligible Employee who will become a Participant to make Deposits pursuant to this Article IV subject, however to the requirement that an election by a Participant shall not be adopted retroactively.

4.2         Amount Subject to Election .

 (a)        Each Participant may elect to contribute a whole percentage of his or her Compensation to the Plan as Before Tax Deposits not to exceed the lesser of one hundred percent (100%) when aggregated with the After Tax Deposits contributed by such Participant pursuant to paragraph (b) below. Notwithstanding the foregoing except to the extent permitted under the catch-up provisions of paragraph (e) below and Code Section 414(v), no Participant shall be permitted to make Before Tax Deposits to the Plan during any taxable year in excess of: (i) $12,000 (or such larger amount as may be determined by the Secretary of the Treasury pursuant to Code Section 402(g), hereinafter referred to as the “Before Tax Deposit Limit”, (ii) the Actual Deferral Percentage test limitation set forth in Section 4.3, or (iii) the Annual Addition limitation set forth in Section 13.1. For purposes of the Before Tax Deposit Limit described in preceding clause (i), the Before Tax Deposits of a Participant for any taxable year is the sum of all Before Tax Deposits under the Plan and all salary reduction amounts under any other qualified cash or deferred arrangement (as defined in Code Section 401(k)), a simplified employee pension (as defined in Code Section 408(k) and Code Section 402(h)(1)(B)), a deferred compensation plan under Code Section 457, a trust described in Code Section 501(c)(18) and any salary reduction amount used to purchase an annuity contract under Code Section 403(b) whether or not sponsored by the Company but shall not include any amounts properly distributed as excess annual additions.

 (b)        Each Participant may elect to contribute a whole percentage of his or her Compensation to the Plan as After Tax Deposits not to exceed one hundred percent (100%) when aggregated with the Before Tax Deposits contributed by such Participant pursuant to paragraph (a) above. Notwithstanding the foregoing, no Participant shall be permitted to make After Tax Deposits to the Plan during any Plan Year in excess of the Actual Contribution Percentage test limitation set forth in Section 6.11 or the Annual Addition limitation set forth in Section 13.1 and the Committee may, in its discretion, establish an “After Tax Deposit Limit” for a Plan Year.

 (c)        Notwithstanding paragraphs (a) and (b), a Participant’s combined Before Tax Deposits and After Tax Deposits shall not exceed a Participant’s Compensation net of his or her salary deductions or reductions (including but not limited to, federal withholding taxes and “FICA” taxes deducted pursuant Code Sections 3102 and 3402, respectively, withholding of state taxes, and amounts contributed by the Company pursuant to a salary reduction agreement which are excludable from an Employee’s gross income under Code Sections 125, 132(f)(4), 402(e)(3), 402(h)(1)(B) and 403(b)) as determined by the payroll records of the Sponsor or an Affiliated Company.

 

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(d)        Notwithstanding paragraphs (a) and (b), a Participant who makes a hardship withdrawal pursuant to Section 8.1(e) or a withdrawal of After Tax Deposits (whether Matched Deposits or non-Matched Deposits) pursuant to Section 8.1(a) shall not be permitted to make Before Tax Deposits or After Tax Deposits to the Plan during the 6-month period beginning as soon as administratively feasible following the date of the withdrawal. The preceding sentence shall not apply to a withdrawal of After Tax Deposits if such Deposits can also be withdrawn under Section 8.1(d) or the withdrawal is comprised solely of After Tax Deposits which are not Matched Deposits and which were contributed prior to July 1, 2000.

(e)        Each Participant who has attained age 50 before the close of the Plan Year may elect to contribute a percentage of his or her Compensation to the Plan as “catch-up” Before Tax Deposits in accordance with, and subject to the limitations of, Code Section 414(v). Such catch-up Before Tax Deposits shall not be taken into account under paragraph (a) above or Section 13.1 or any other provision of the Plan implementing the contribution limitations of Code Sections 402(g) and 415. Moreover, the Plan shall not be treated as failing to satisfy the provisions of the plan implementing the requirements of Code Section 401(k)(3), 401(k)(11), 401(k)(12), 410(b), or 416, as applicable, by reason of a Participant electing to contribute catch-up Before Tax Deposits to the Plan pursuant to this paragraph.

(f)        The Committee shall prescribe such procedures, either in writing or in practice, as it deems necessary or appropriate regarding the maximum amount that a Participant may elect to defer and the timing of such an election. These procedures shall apply to all individuals eligible to make an election described in Section 4.1. The Committee may, at any time during a Plan Year, require the suspension, reduction, or recharacterization of Before Tax Deposits or the suspension or reduction of After Tax Deposits of any Highly Compensated Employee such that the limitations of Section 4.2(a) and (b) are satisfied.

4.3         Limitation on Compensation Deferrals . With respect to each Plan Year, Compensation Deferral Contributions by a Participant for the Plan Year shall not exceed the limitation on contributions by or on behalf of Highly Compensated Participants under Code Section 401(k), as provided in this Section. In the event that Compensation Deferral Contributions under the Plan by or on behalf of Highly Compensated Participants exceed the limitations of this Section for any reason, either such excess contributions shall be recharacterized as After Tax Deposits or such excess contributions, adjusted for any income or loss allocable thereto, shall be returned to the Participant, as provided in Section 4.5.

(a)        The Compensation Deferral Contributions by Participants for a Plan Year shall satisfy the Actual Deferral Percentage Test set forth in (i) below, or, to the extent not precluded by applicable regulations, the alternative Actual Deferral Percentage test set forth in (ii) below:

 

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(i)      The average Actual Deferral Percentage of Highly Compensated Participants for the Plan Year shall not be more than the prior Plan Year’s average Actual Deferral Percentage of Participants who were not Highly Compensated Employees for the prior Plan Year multiplied by 1.25, or

(ii)     The average Actual Deferral Percentage of Highly Compensated Participants for the Plan Year shall not be more than the prior Plan Year’s Actual Deferral Percentage of Participants who were not Highly Compensated Employees for the prior Plan Year multiplied by 2.0, provided that the average Actual Deferral Percentage of Highly Compensated Participants does not exceed the average Actual Deferral Percentage of Participants who were not Highly Compensated Employees for the prior Plan Year by more than two (2) percentage points.

(b)        Notwithstanding any other provisions of the Plan, for the purposes of the limitations of this Section 4.3 and Section 4.5 only, the following definitions shall apply:

(i)      “Actual Deferral Percentage” shall mean, with respect to the group of Highly Compensated Participants and the group of all other Participants for a Plan Year, the ratios calculated separately and to the nearest one-hundredth of one percent for each Participant in such group, as follows:

(A)        For a Highly Compensated Participant, the ratio of such Participant’s Compensation Deferral Contributions for the current Plan Year to such Participant’s Compensation for the current Plan Year; provided, however, that the Actual Deferral Percentage of a Highly Compensated Participant with no Compensation Deferral Contributions made on his or her behalf shall be zero.

(B)        For any other Participant, the ratio of such Participant’s Compensation Deferral Contributions for the preceding Plan Year to such Participant’s Compensation for the preceding Plan Year; provided, however, that the Actual Deferral Percentage of a Participant with no Compensation Deferral Contributions made on his or her behalf shall be zero.

To the extent determined by the Committee and in accordance with regulations issued by the Secretary of the Treasury, qualified nonelective contributions on behalf of a Participant that satisfy the requirements of Code Section 401(k)(3)(c)(ii) may also be taken into account for the purpose of determining the Actual Deferral Percentage of a Participant.

(ii)     “Highly Compensated Participant” shall mean for any Plan Year any Participant who is a Highly Compensated Employee. A Participant is a Highly Compensated Employee for a particular Plan Year if he or she meets the definition of a Highly Compensated Employee in effect for that Plan Year.

 

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Similarly, a Participant is not a Highly Compensated Employee for a particular Plan Year if he or she does not meet the definition of a Highly Compensated Employee in effect for that Plan Year.

(iii)    “Participant” shall mean any Eligible Employee who satisfied the requirements of Section 3.1 during the Plan Year, whether or not such Eligible Employee has elected to contribute to the Plan for such Plan Year.

(iv)     “Compensation Deferral Contributions” shall mean amounts contributed to the Plan by a Participant as Before Tax Deposits pursuant to Section 4.2(a), including excess Before Tax Deposits (as defined in Section 4.4(a)) of Highly Compensated Participants but excluding (1) excess Before Tax Deposits of all other Participants that arise solely from Before Tax Deposits made under the Plan or plans of the Company, (2) Before Tax Deposits that are taken into account in the Actual Contribution Percentage test (as defined in Section 6.11) provided that the Actual Deferral Percentage test is satisfied both with and without exclusions of these Before Tax Deposits, and (3) any deferrals properly distributed as excess Annual Additions. Compensation Deferral Contributions may include, at the election of the Company, any Company Contributions that meet the requirements for such inclusion under Code Section 401(k)(3)(C).

(v)      “Compensation” shall mean compensation as described below:

(A)        Compensation means compensation determined by the Company in accordance with the requirements of Code Section 414(s) and the regulations thereunder.

(B)        For purposes of this Section 4.3, Compensation may, at the Company’s election, exclude amounts which are excludable from a Participant’s gross income under Code Section 125 (pertaining to cafeteria plans) and Code Section 402(e)(3) (pertaining to 401(k) salary reductions). The Company may change its election provided such change does not discriminate in favor of Highly Compensated Employees.

(C)        Compensation taken into account for any Plan Year shall not exceed $210,000, as adjusted for cost-of-living increases in accordance with Code Section 401(a)(17)(B). Any cost-of-living adjustments in effect for a calendar year shall apply to the Plan Year beginning with or within such calendar year.

(c)        In the event the Plan satisfies the requirements of Code Sections 401(k), 401(a)(4) or 410(b) only if aggregated with one or more other plans which include arrangements under Code Section 401(k), then this Section 4.3 shall be applied by determining the Actual Deferral Percentages of Participants as if all such plans were a single plan, in accordance with regulations prescribed by the Secretary of the

 

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Treasury under Code Section 401(k). Any adjustments to the Actual Deferral Percentage of Participants who are not Highly Compensated Employees for the prior year shall be made in accordance with Notice 98-1 and any superseding guidance. Plans may be aggregated in order to satisfy Code Sections 401(k) only if they have the same Plan Year and use the same Actual Deferral Percentage testing method.

(d)        For the purposes of this Section 4.3, the “Actual Deferral Percentage” for any Highly Compensated Participant who is a Participant under two or more Code Section 401(k) arrangements of the Company shall be determined by taking into account the Highly Compensated Participant’s compensation under each such arrangement and contributions under each such arrangement which qualify for treatment under Code Section 401(k), in accordance with regulations prescribed by the Secretary of the Treasury under Code Section 401(k). If the arrangements have different Plan Years, this paragraph shall be applied by treating all such arrangements ending with or within the same calendar year as a single arrangement. Notwithstanding the foregoing, certain plans shall be treated as separate plans if mandatorily disaggregated pursuant to regulations under Code Section 401(k).

(e)        For purposes of the Actual Deferral Percentage test, Compensation Deferral Contributions must be made before the last day of the twelve-month period immediately following the Plan Year to which such contributions relate.

(f)        The determination and treatment of Compensation Deferral Contributions and the Actual Deferral Percentage of any Participant shall satisfy such other requirements as may be prescribed by the Secretary of the Treasury.

(g)        The Committee shall keep or cause to have kept such records as are necessary to demonstrate that the Plan satisfies the requirements of Code Section 401(k) and (m) and the regulations thereunder, in accordance with regulations prescribed by the Secretary of the Treasury.

4.4         Provisions for Return of Excess Before Tax Deposits .

(a)        In the event that due to error or otherwise, an amount of a Participant’s Compensation in excess of the Before Tax Deposit Limit (after application of any necessary adjustment) described in Section 4.2(a) is deferred under the Plan in any calendar year pursuant to such Participant’s Compensation deferral agreement (but without regard to amounts deferred under any other plan) the excess Before Tax Deposits, if any, together with income allocable to such amount shall be returned to the Participant (after withholding applicable federal, state and local taxes due on such amounts) on or before the first April 15 following the close of the calendar year in which such excess contribution is made; provided, however, if there is a loss allocable to the excess Before Tax Deposits, the amount distributed shall be the amount of the excess as adjusted to reflect such loss. Any Matching Contributions allocated to the Participant’s Matched Deposits pursuant to Section 6.3(b) which are attributable to any excess Before Tax Deposits by a Participant, and any income or loss allocable to such Matching

 

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Contributions, shall either be returned to the Company or applied to reduce any future Matching Contributions by the Company.

(b)        The amount of income or loss attributable to any excess Before Tax Deposits described in paragraph (a) above shall be equal to the sum of the following:

(i)      The income or loss allocable to the Participant’s Before Tax Deposits Account for the Plan Year multiplied by a fraction, the numerator of which is the excess Before Tax Deposits as determined under paragraph (a) above, and the denominator of which is the balance of the Participant’s Before Tax Deposits Account as of the last day of the Plan Year, without regard to any income or loss allocable to such Account during the Plan Year; and

(ii)     The amount of allocable income or loss for the Gap Period using the “safe harbor” method set forth in regulations prescribed by the Secretary of the Treasury under Code Section 402(g). Under the “safe harbor” method, such allocable income or loss is equal to 10% of the amount calculated under Section 4.4(b)(i) above, multiplied by the number of calendar months from the last day of the Plan Year until the date of distribution of the Participant’s excess Before Tax Deposits. A distribution on or before the 15th of the month is treated as made on the last day of the preceding month, a distribution after the 15th of the month is treated as made on the first day of the next month.

(c)        For the purpose of this Section 4.4, “Gap Period” shall mean the period between the last day of the Plan Year and the date of distribution of any excess Before Tax Deposits.

(d)        In accordance with procedures as may be established, either in writing or in practice, by the Committee, not later than March 1 of a calendar year a Participant may submit a claim to the Committee in which he or she certifies in writing the specific amount of his or her Before Tax Deposits for the preceding calendar year which, when added to amounts deferred for such calendar year under other plans or arrangements described in Code Sections 401(k), 408(k) or 403(b), shall cause the Participant to exceed the Before Tax Deposit Limit (after application of any necessary adjustment) described in Section 4.2(a) for such preceding calendar year. Notwithstanding the amount of the Participant’s Before Tax Deposits under the Plan for such preceding calendar year, the Committee shall treat the amount specified by the Participant in his or her claim as a Before Tax Deposit in excess of the Before Tax Deposit Limit (after application of any necessary adjustment) for such calendar year and return it to the Participant in accordance with Section 4.4(a) above. A Participant is deemed to notify the Committee of any excess Before Tax Deposits that arise by taking into account only those Before Tax Deposits made to the Plan and other plans of the Company.

(e)        Any Before Tax Deposits in excess of the Before Tax Deposit Limit (after application of any necessary adjustment) described in Section 4.2(a) which are distributed to a Participant in accordance with this Section, shall to the extent required by regulations

 

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issued by the Secretary of the Treasury be treated as Annual Additions under Article XIII for the Plan Year for which the excess Before Tax Deposits were made, unless such amounts are distributed no later than the first April 15th following the close of the Participant’s taxable year.

(f)        The Committee shall not be liable to any Participant (or his or her Beneficiary, if applicable) for any losses caused by a mistake in calculating the amount of any Participant’s excess Before Tax Deposits or the income or losses attributable thereto.

4.5          Provision for Recharacterization or Return of Excess Deferrals by Highly Compensated Participants . The provisions of this Section 4.5 shall be applied after implementation of the provisions of Section 4.4.

(a)        The Committee shall determine in accordance with the procedures set forth in Section 4.3, as soon as is reasonably possible following the close of each Plan Year, the extent (if any) to which deferral treatment under Code Section 401(k) may not be available for Compensation Deferral Contributions on behalf of any Highly Compensated Participants. If, pursuant to these determinations by the Committee, a Highly Compensated Participant’s Compensation Deferral Contributions are not eligible for tax-deferral treatment then, as determined by the Committee, either (i) any excess Compensation Deferral Contributions shall be recharacterized as After Tax Deposits in accordance with regulations issued under Code Section 401(k), or (ii) any excess Compensation Deferral Contributions together with any income or loss allocable thereto shall be returned to the Highly Compensated Participant (after withholding applicable federal, state, and local taxes due on such amounts). Such return or recharacterization shall be made within the first two and one-half (2-1/2) months following the close of the Plan Year for which such excess deferrals were made, provided however, that if any excess deferrals and income or loss allocable thereto are, due to error or otherwise, not returned by such date, such amounts as are required to be returned shall be returned not later than the end of the first Plan Year following the Plan Year for which such excess deferrals were made.

(b)        For purposes of satisfying the Actual Deferral Percentage test of Section 4.3(a), the amount of any excess Compensation Deferral Contributions by a Highly Compensated Participant shall be determined by the Committee by application of a leveling method under which the Compensation Deferral Contributions of the Highly Compensated Participant who has the highest dollar amount of Compensation Deferral Contributions for such Plan Year is reduced to the extent required to cause such Highly Compensated Participant’s Compensation Deferral Contributions to equal the Compensation Deferral Contributions of the Highly Compensated Participant with the next highest Compensation Deferral Contributions; provided, however, if a lesser amount, when added to the total dollar amount already returned under this paragraph (b), equals the total excess Compensation Deferral Contributions that are required to be returned to enable the Plan to satisfy the Actual Deferral Percentage test, the lesser amount shall be returned. This process shall be repeated until the Plan satisfies the Actual Deferral Percentage test.

 

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(c)        The amount of income or loss attributable to any excess Compensation Deferral Contributions by a Highly Compensated Participant for a Plan Year shall be equal to the sum of the following:

(i)      The income or loss allocable to the Highly Compensated Participant’s Compensation Deferral Contribution Accounts for the Plan Year multiplied by a fraction, the numerator of which is the excess Compensation Deferral Contribution as determined under Section 4.3, and the denominator of which is the balance of the Highly Compensated Participant’s Compensation Deferral Contribution Accounts as of the last day of the Plan Year without regard to any income or loss allocable to such Accounts during the Plan Year; and

(ii)     The amount of allocable income or loss for the Gap Period using the “safe harbor” method set forth in the regulations prescribed by the Secretary of the Treasury under Code Section 401(k). Under the “safe harbor” method, such allocable income or loss is equal to 10% of the amount calculated under Section 4.5(c)(i) above, multiplied by the number of calendar months from the last day of the Plan Year until the date of distribution of the Participant’s excess Compensation Deferral Contribution. A distribution on or before the 15th of the month is treated as made on the last day of the preceding month, a distribution after the 15th of the month is treated as made on the first day of the next month.

(d)        For the purpose of this Section 4.5 the following shall apply:

(i)      “Compensation Deferral Contribution Accounts” shall mean the Participant’s Before Tax Deposits Account and shall mean any other accounts of the Participant to which Company Contributions has been allocated where such Company Contributions has been included as Compensation Deferral Contributions pursuant to Section 4.3(b)(iv).

(ii)     “Gap Period” shall mean the period beginning with the last day of the Plan Year and the date of distribution of any excess Compensation Deferral Contributions.

(e)        For purposes of this Section, the amount of Compensation Deferral Contributions by a Participant who is not a Highly Compensated Participant for a Plan Year shall be reduced by any Before Tax Deposits which have been distributed to the Participant under Section 4.4, in accordance with regulations prescribed by the Secretary of the Treasury under Code Section 401(k).

(f)        In the event that the Committee determines that an amount to be deferred pursuant to the Compensation deferral agreement provided in Section 4.1 would cause Company Contributions under this and any other tax-qualified retirement plan maintained by the Company to exceed the applicable deduction limitations contained in Code Section 404, or to exceed the maximum Annual Addition determined in accordance with

 

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Article XIII, the Committee may treat such amount in accordance with the rules set forth above in Section 4.5(a).

(g)        The Committee shall not be liable to any Participant (or his or her Beneficiary, if applicable) for any losses caused by a mistake in calculating the amount of any Participant’s excess Compensation Deferral Contribution or the income or losses attributable thereto.

(h)        To the extent required by regulations under Code Sections 401(k) or 415, any excess Compensation Deferral Contributions with respect to a Highly Compensated Participant shall be treated as Annual Additions under Article XIII for the Plan Year for which the excess Compensation Deferral Contributions were made, notwithstanding the distribution of such excess in accordance with the provisions of this Section.

4.6         Termination, Change in Rate, or Resumption of Before Tax Deposits or After Tax Deposits .

(a)        A Participant may, at any time, terminate, change the rate, or resume Before Tax Deposits or After Tax Deposits in 1% increments.

(b)        The right of a Participant to make Before Tax Deposits or After Tax Deposits shall cease during any Period of Severance.

(c)        Any termination, change in rate or resumption of Before Tax Deposits or After Tax Deposits made by a Participant pursuant to paragraph (a) above shall be effective as of the following pay period or, if later, as soon as administratively feasible.

4.7         Character of Deposits . Before Tax Deposits shall be treated as Company Contributions for purposes of Code Sections 401(k) and 414(h). After Tax Deposits shall not constitute “qualified voluntary employee contributions” under Code Section 219 (relating to the deductibility of those amounts).

4.8         Rollover Contributions .

(a)        Pursuant to procedures as the Committee may prescribe (either in writing or practice), an Eligible Employee may make a Direct Rollover Contribution, a Participant Rollover Contribution, or an IRA Rollover Contribution to the Plan.

(b)        A “Direct Rollover Contribution” shall mean a contribution by an Eligible Employee which is a direct rollover of an Eligible Rollover Distribution from:

(i)      A qualified plan described in Code Section 401(a) or 403(a) including any portion attributable to after-tax employee contributions; provided, that such portion can be accounted for separately, including separately accounting for the portion which is includible in gross income and the portion of which is not so includible;

 

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(ii)     An annuity contract described in Code Section 403(b) including, on or after January 1, 2007, any portion attributable to after-tax employee contributions; provided, that such portion can be accounted for separately, including separately accounting for the portion which is includible in gross income and the portion of which is not so includible; or

(iii)    An eligible plan under Code Section 457(b) which is maintained by a state, political subdivision of a state, or any agency or instrumentality of a state or political subdivision of a state; provided, that such Direct Rollover Contribution can be accounted for separately.

(c)        A “Participant Rollover Contribution” shall mean a contribution by an Eligible Employee which is an Eligible Rollover Distribution (excluding any portion attributable to after-tax employee contributions) received by the Trustee not later than 60 days after such distribution was received by the Eligible Employee; provided, such Eligible Rollover Distribution is from:

(i)      A qualified plan described in Code Section 401(a) or 403(a);

(ii)     An annuity contract described in Code Section 403(b); or

(iii)    An eligible plan under Code Section 457(b) which is maintained by a state, political subdivision of a state, or any agency or instrumentality of a state or political subdivision of a state.

The 60-day rollover requirement shall not apply if the Participant substantiates that the 60-day rollover requirement has been waived by the Secretary of the Treasury.

(d)        An “IRA Rollover Contribution” shall mean a contribution by an Eligible Employee which is a distribution (excluding any portion attributable to after-tax employee contributions) from an individual retirement account or annuity described in Code Section 408(a) or 408(b) received by the Trustee not later than 60 days after such distribution was received by the Eligible Employee or received by the Plan through a direct trustee-to-trustee transfer from such individual retirement arrangement or annuity. The 60-day rollover requirement shall not apply if the Participant substantiates that the 60-day rollover requirement has been waived by the Secretary of the Treasury.

(e)        Pursuant to procedures as the Committee may prescribe (either in writing or practice), a former Eligible Employee who commenced participation in the Plan pursuant to Section 3.1 may make Rollover Contributions to the Plan from his or her account in the Allergan, Inc. Employee Stock Ownership Plan so long as he or she retains rights under the Plan.

(f)        An Eligible Employee’s Rollover Contributions made pursuant the rules of this Section 4.8 shall be held in a separate Rollover Contributions Account for the

 

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Eligible Employee. A Rollover Contributions Account shall not share in any allocations of Company Contributions or Forfeitures under Section 6.3.

 

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ARTICLE V

TRUST FUND AND COMPANY CONTRIBUTIONS

5.1           General .    All contributions made under the Plan and investments made and property of any kind or character acquired with any such funds or otherwise contributed, and all income, profits, and proceeds derived therefrom, shall be held in Trust and shall be held and administered by the Trustee in accordance with the provisions of the Plan and Trust Agreement.

5.2           Single Trust .     Assets of the Trust shall be held in a separate fund which shall consist of the Trust Fund. Individual Participant interests in the Trust Fund shall be reflected in the Accounts maintained for the Participants. Notwithstanding the foregoing, the Trust Fund shall be treated as a single trust for purposes of investment and administration, and nothing contained herein shall require a physical segregation of assets for any fund or for any Account maintained under the Plan.

5.3           Matching Contributions .  Subject to the limitations of Article XIII, the suspension provisions of Section 8.1 and to the extent that the Company has current or accumulated profits, the Company shall make Matching Contributions to the Plan on behalf of Participants in accordance with the following rules:

(a)        The Company shall contribute and allocate Matching Contributions on a pay period basis which, when added to Matching Contribution Forfeitures available after application of Section 6.3, is equal to 100% of each Participant’s Matched Deposits for the pay period. The Board of Directors, acting upon the advice and direction of the Committee, may authorize and direct that Matching Contributions (expressed as a percentage of Participants’ Matched Deposits as set forth above) be changed from time to time from a minimum of 0% to a maximum of 100%.

(b)        For each Plan Year, the Company shall contribute on behalf of each Eligible Participant, additional Matching Contributions which, when added to Matching Contribution Forfeitures available after application of Section 6.3, is equal to the difference, if any, between the amount of each Eligible Participant’s Matching Contributions determined under paragraph (a) and the amount of such Eligible Participant’s Matching Contributions if paragraph (a) was applied on a Plan Year basis instead of a pay period basis. For the purpose of this paragraph (b), the term “Eligible Participant” shall include only those Participants who are Eligible Employees on the first and last business day of the Plan Year and who did not incur a Severance during the Plan Year. The additional Matching Contributions contributed on behalf of Eligible Participants shall be allocated to the Matching Contributions Account of such Eligible Participants as of the last day of each Plan Year and shall be paid to the Trust at such times as determined by the Sponsor.

(c)        The Company shall contribute amounts sufficient to satisfy the Matching Contributions reinstatement requirements of Section 8.7 to the extent Matching

 

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Contribution Forfeitures are insufficient to satisfy the reinstatement requirement of Section 8.7 if so directed and at such times as may be determined by the Committee.

5.4           Retirement Contributions .  Subject to the limitations of Article XIII and to the extent that the Company has current or accumulated profits, the Company shall make Retirement Contributions to the Plan on behalf of Retirement Account Participants in accordance with the following rules:

(a)        The Company shall contribute and allocate Retirement Contributions on a Plan Year basis for each Retirement Account Participant who is employed by the Company or an Affiliated Company on the last day of such Plan Year or who incurred a Severance during the Plan Year by reason of Disability, death, or retirement on or after age 55; the amount of which, when added to Retirement Contribution Forfeitures available after the application of Section 6.3, shall be equal to five percent (5%) of the Retirement Account Participant’s Compensation (as adjusted pursuant to paragraph (c) below) for such Plan Year. A Retirement Account Participant’s Compensation received while such Retirement Account Participant is an inactive Participant as defined in Section 3.2(b) or an “Active Participant” in the Allergan, Inc. Pension Plan as such term is defined therein or while he or she is not an Eligible Employee shall not be taken into account in determining such Participant’s Retirement Contributions.

(b)        Retirement Contributions contributed on behalf of Retirement Account Participants shall be allocated to the Retirement Contributions Account of such Retirement Account Participants as of the last day of each Plan Year and shall be paid to the Trust at such times as determined by the Sponsor.

(c)        Solely for the purpose of determining Retirement Contributions pursuant to this Section 5.4, a Retirement Account Participant’s Compensation shall include his or her “Annual Deferrals” (as defined in the Allergan, Inc. Executive Deferred Compensation Plan) for the Plan Year.

(d)        The Company shall contribute amounts sufficient to satisfy the Retirement Contributions reinstatement requirements of Section 8.7 to the extent Retirement Contribution Forfeitures are insufficient to satisfy the reinstatement requirement of Section 8.7 if so directed and at such times as may be determined by the Committee.

5.5           Form of Company Contributions .  Company Contributions to the Trust Fund shall be paid in cash, property, or Company Stock as the Sponsor may from time to time determine.

5.6           Investment of Trust Assets .

(a)        The manner in which assets of the Trust will be invested shall be chosen by the Committee at its discretion, although the Committee may delegate the management to one or more Investment Managers appointed pursuant to Section 5.16. Notwithstanding the foregoing, Matching Contributions shall be invested in Company Stock except to the extent invested pursuant to Section 5.6(e).

 

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(b)        The Committee may establish separate investment funds under the Plan, with each fund representing an investment alternative available to Participants for the investment of their Accounts as provided in Section 5.6(c) and (d) below. Each Participant shall have a subaccount under the Plan corresponding to the Participant’s interest which is allocated to each investment fund. Each such subaccount may be valued separately. The Committee may, at its discretion, establish alternative investment funds or eliminate any previously established funds, including but not limited to the following types of investment funds:

(i)          The Interest Income Fund investing in group annuity contracts with major insurance companies.

(ii)         The Balanced Fund investing in common stocks, bonds, government securities and similar types of investments.

(iii)        The Equity Fund investing in a mutual fund which may invest in equity securities, bonds, preferred stocks, and interest-bearing cash investments.

(iv)        The Company Stock Fund consisting exclusively of Company Stock.

(v)         The AMO Stock Fund consisting exclusively of AMO Stock.

Notwithstanding the establishment of separate investment funds, up to one hundred percent (100%) of the assets of the Plan may be invested in Company Stock.

(c)        A Participant may elect the investment fund to which his or her Participant Deposits or Retirement Contributions are invested under the Plan or may change such elections at any time; provided, however, that any allocations among the investment funds shall be made in 1% increments. Any change in investment funds shall be effective as soon as administratively feasible. Any investment elections shall be limited to the investment funds currently offered and currently available to Participants as determined by the Committee pursuant to paragraphs (a) and (b) above. A Participant shall effect an investment election by properly completing and submitting the form authorized by the Committee for this purpose.

(d)        A Participant may elect at any time to transfer amounts accumulated in his or her Accounts among any of the investment funds currently offered and currently available to Participants as determined by the Committee pursuant to paragraphs (a) and (b) above; provided, however, the total amount transferred shall be made in 1% increments of the amount accumulated in the investment fund. Any transfer among investment funds shall be effective as soon as administratively feasible. A Participant shall effect a transfer election by properly completing and submitting the form authorized by the Committee for this purpose.

 

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(e)        Notwithstanding the requirement of paragraph (a) above that Matching Contributions be invested in the Company Stock Fund, (i) any Participant may elect that amounts accumulated in his or her Matching Contributions Account which are held in the Company Stock Fund be reinvested and (ii) any Participant on or after the date he or she attains age 55 may elect that any future Matching Contributions be invested, in any of the investment funds currently offered and currently available to Participants as determined by the Committee pursuant to paragraphs (a) and (b) above. An election made under this paragraph (e) shall be effective as soon as administratively feasible. A Participant shall make any election, and may change any election, at such times and in accordance with the requirements imposed by paragraphs (c) and (d) above.

(f)        Amounts invested in any one of the investment funds shall not share in gains and losses experienced by any other fund.

(g)        Notwithstanding the establishment of separate investment funds within the Trust, the Trust shall at all times constitute a single trust.

(h)        Notwithstanding anything to the contrary in this Section 5.6 or Section 4.1 or Section 8.1, the following additional transfer and withdrawal restrictions shall apply to all Participants who are Insiders. For the purpose of this Section 5.6, the term “Insider” shall mean any Participant who is directly or indirectly the beneficial owner of more than 10% of any class of any equity security (other than an exempted security) of the Sponsor (or the Company) which is registered pursuant to Section 12 of the Securities Exchange Act of 1934 (the “Exchange Act”) or who is a “director” or an “officer” of the Sponsor or the Company as those terms are interpreted for the purpose of determining persons subject to Section 16 of the Exchange Act.

(i)          Any Insider who transfers amounts invested in the Company Stock Fund out of such fund and into another fund or withdraws cash in a transaction that results in the liquidation of amounts in the Company Stock Fund (pursuant to Sections 8.1 or 8.13), may not for a period of six months following the Participant’s election to so transfer funds, withdraw cash or take a loan, as the case may be, make an election to transfer amounts from another fund into the Company Stock Fund.

(ii)         Any Insider who transfers amounts invested in a fund other than the Company Stock Fund into the Company Stock Fund, may not for a period of six months following the Participant’s election to so transfer funds make an election to (1) transfer amounts from the Company Stock Fund into another fund, (2) withdraw cash or take a loan in a transaction that results in the liquidation of amounts in the Company Stock Fund or (3) utilize the diversification rule of Section 5.12 of the Allergan Inc. Employee Stock Ownership Plan or the provision of any Company plan covered by Rule 16b-3 (promulgated pursuant to the Exchange Act) then in existence that would result in the transfer out of a Company equity securities fund.

 

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(i)        It is intended that to the extent a Participant may direct the investment of his or her Accounts under the Plan that the Plan constitute a plan described in Section 404(c) of ERISA and the regulations thereunder, and neither the Company, Committee, nor any fiduciary with respect to the Plan who is employed by the Company shall be liable for investment losses sustained by any Participant or Beneficiary as a direct and necessary result of the investment instructions given by such Participant or Beneficiary. Such fiduciaries set forth in the preceding sentence shall be under no duty to question the investment direction of the Participant or Beneficiary or to advise a Participant or Beneficiary as to the manner in which his or her Accounts is to be invested. The fact that an investment option is offered shall not be construed to be a recommendation of investment.

(j)        The Committee, in its sole discretion, may select a default investment fund that meets the requirements of a “qualified default investment alternative” or “QDIA” as described in Section 2550.404c-5 of the Department of Labor Regulations as amended from time to time. In such case: (i) a Participant on whose behalf an investment in a QDIA may be made shall be notified at least 30 days in advance of the first such investment and shall be notified at least 30 days in advance of each subsequent Plan Year and (2) any material relating to the Participant’s investment in the QDIA (e.g., account statements, prospectuses) shall be provided to such Participant. If a QDIA is selected by the Committee, it is intended that to the extent provided under Section 2550.404c-5 of the Department of Labor Regulations, as amended from time to time, neither the Company nor the Committee shall be liable for investment losses sustained by any Participant or Beneficiary that is the direct and necessary result of (i) investing all or a part of a Participant’s or Beneficiary’s Account in a QDIA and (ii) investment decisions made in connection with the management of the QDIA.

(k)        On June 29, 2002, Allergan spun-off AMO and distributed the stock of AMO (referred to in the Plan as “AMO Stock”) to its shareholders. The following provisions of the Plan shall apply to AMO Stock as if the term “AMO Stock” was substituted for the term “Company Stock”: Section 5.9 (Certain Offers for Company Stock); Section 5.10 (Voting of Company Stock); Section 5.11 (Securities Law Limitation); Section 5.16 (Appointment of Investment Manager); Section 6.4 (Valuation of Participants’ Accounts); Section 6.5 (Valuation of Company Stock); Section 6.6 (Dividends, Splits, Recapitalizations, Etc.); Section 6.7 (Stock Rights, Warrants or Options); Section 6.9 (Cash Dividends); Section 6.10 (Miscellaneous Allocation Rules); Section 9.1 (Appointment of Committee); Section 9.2 (Appointment of Investment Subcommittee); Section 9.7 (Additional Powers of Committee); and Section 9.14 (Compensation of Committees and Plan Expenses), as applicable.

5.7         Irrevocability .  The Company shall have no right or title to, nor interest in, the contributions made to the Trust Fund, and no part of the Trust Fund shall revert to the Company except that on or after the Original Effective Date funds may be returned to the Company as follows:

 

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(a)        In the case of Company Contributions which are made by a mistake of fact and at the Sponsor’s written request, such contributions shall be returned to the Company as directed by the Sponsor within one (1) year after it is made.

(b)        All Company Contributions contributed to the Trust are hereby conditioned upon the Plan satisfying all of the requirements of Code Section 401(a). If the Plan does not qualify, the Plan may be revoked at the Sponsor’s written election and all such contributions shall be returned to the Company as directed by the Sponsor within one year after the date of Internal Revenue Service denial of the qualification of the Plan. Upon such a revocation the affairs of the Plan and Trust shall be terminated and wound up as the Sponsor shall direct.

(c)        All Company Contributions to the Plan are conditioned upon the deductibility of those contributions under Code Section 404. To the extent a deduction is disallowed and at the Sponsor’s written request, such contributions shall be returned to the Company as directed by the Sponsor within one year after the disallowance.

(d)        In the event that the Plan is terminated when there are amounts remaining in the Suspense Account, the excess funds shall revert to the Company as directed by the Sponsor to the extent provided in Section 13.6.

5.8         Company, Committee and Trustee Not Responsible for Adequacy of Trust Fund .

(a)        The Company, Committee, and the Trustee shall not be liable or responsible for the adequacy of the Trust Fund to meet and discharge any or all payments and liabilities hereunder. All Plan benefits will be paid only from the Trust assets, and neither the Company, the Committee nor the Trustee shall have any duty or liability to furnish the Trust with any funds, securities or other assets except as expressly provided in the Plan.

(b)        Except as required under the Plan or Trust or under Part 4 of Subtitle B of Title I of ERISA, the Company shall not be responsible for any decision, act or omission of the Trustee, the Committee, or the Investment Manager (if applicable), and shall not be responsible for the application of any moneys, securities, investments or other property paid or delivered to the Trustee.

5.9         Certain Offers for Company Stock .  Notwithstanding any other provision of the Plan to the contrary, in the event an offer shall be received by the Trustee (including but not limited to a tender offer or exchange offer within the meaning of the Securities Exchange Act of 1934, as from time to time amended and in effect) to acquire any or all shares of Company Stock held by the Trust (an “Offer”), the discretion or authority to sell, exchange or transfer any of such shares of Company Stock shall be determined in accordance with the following rules:

(a)        The Trustee shall have no discretion or authority to sell, exchange or transfer any Company Stock pursuant to an Offer except to the extent, and only to the

 

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extent, that the Trustee is timely directed to do so in writing by each Participant with respect to shares of Company Stock that are allocated to such Participant’s Accounts.

(b)        To the extent there remains any residual fiduciary responsibility with respect to Company Stock pursuant to an Offer after application of paragraph (a) above, the Trustee shall sell, exchange or transfer such Company Stock as directed by the Committee or as directed by an independent fiduciary if duly appointed by the Sponsor. To the extent the Committee or an independent fiduciary is required to exercise any residual fiduciary responsibility with respect to an Offer, the Committee or independent fiduciary shall take into account in exercising its fiduciary judgment, unless it is clearly imprudent to do so, directions timely received from Participants, as such directions are most indicative of what action is in the best interests of Participants. Further, the Committee or independent fiduciary, in addition to taking into consideration any relevant financial factors bearing on any such decision, shall take into consideration any relevant non-financial factors, including, but not limited to, the continuing job security of Participants as employees of the Sponsor or any Affiliated Company, conditions of employment, employment opportunities and other similar matters, and the prospect of the Participants and prospective Participants for future benefits under the Plan.

(c)        Upon timely receipt of such instructions, the Trustee shall, subject to the provisions of paragraphs (e) and (o) of this Section, sell, exchange or transfer pursuant to such Offer, only such shares as to which such instructions were given. The Committee shall use its best efforts to communicate or cause to be communicated to each Participant the consequences of any failure to provide timely instructions to the Trustee.

(d)        In the event, under the terms of an Offer or otherwise, any shares of Company Stock tendered for sale, exchange or transfer pursuant to such Offer may be withdrawn from such Offer, the Trustee shall follow such instructions respecting the withdrawal of such shares from such Offer in the same manner and the same proportion as shall be timely received by the Trustee from the Participants entitled under this paragraph (a) to give instructions as to the sale, exchange or transfer of shares pursuant to such Offer.

(e)        In the event that an Offer for fewer than all of the shares of Company Stock held by the Trustee in the Trust shall be received by the Trustee, each Participant shall be entitled to direct the Trustee as to the acceptance or rejection of such Offer (as set forth herein) with respect to the largest portion of such Company Stock as may be possible given the total number or amount of shares of Company Stock the Plan may sell, exchange or transfer pursuant to the Offer based upon the instructions received by the Trustee from all other Participants who shall timely instruct the Trustee pursuant to this paragraph to sell, exchange or transfer such shares pursuant to such Offer, each on a pro rata basis in accordance with the maximum number of shares each such Participant would have been permitted to direct under paragraph (a) had the Offer been for all shares of Company Stock held in the Trust.

 

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(f)        In the event an Offer is received by the Trustee and instructions have been solicited from Participants regarding such Offer, and prior to termination of such Offer, another Offer is received by the Trustee for the Company Stock subject to the first Offer, the Trustee shall inform the Committee of such other Offer and the Committee shall use its best efforts under the circumstances to solicit instructions from the Participants (i) with respect to securities tendered for sale, exchange or transfer pursuant to the first Offer, whether to withdraw such tender, if possible, and, if withdrawn, whether to tender any Company Stock so withdrawn for sale, exchange or transfer pursuant to the second Offer and (ii) with respect to Company Stock not tendered for sale, exchange or transfer pursuant to the first Offer, whether to tender or not to tender such Company Stock for sale, exchange or transfer pursuant to the second Offer. The Trustee shall follow all such instructions received in a timely manner from Participants in the same manner and in the same proportion as provided in paragraph (a) of this Section. With respect to any further Offer for any Company Stock received by the Trustee and subject to any earlier Offer (including successive Offers from one or more existing offers), the Trustee shall act in the same manner as described above.

(g)        With respect to any Offer received by the Trustee, the Trustee shall inform the Sponsor of such Offer and the Sponsor shall distribute, at its expense, copies of all relevant material including but not limited to material filed with the Securities and Exchange Commission with such Offer or regarding such Offer, which shall seek confidential written instructions from each Participant who is entitled to respond to such Offer pursuant to paragraph (a). The identities of Participants, the amount of Company Stock allocated to their Accounts, and the Compensation of each Participant shall be determined from the list of Participants delivered to the Sponsor by the Committee which shall take all reasonable steps necessary to provide the Sponsor with the latest possible information.

(h)        The Sponsor shall distribute and/or make available to each Participant who is entitled to respond to an Offer pursuant to paragraph (a), an instruction form to be used by each such Participant who wishes to instruct the Trustee. The instruction form shall state that (i) if the Participant fails to return an instruction form to the Trustee by the indicated deadline, the Company Stock with respect to which he or she is entitled to give instructions shall not be sold, exchanged or transferred pursuant to such Offer, (ii) the Participant shall be a named fiduciary (as described in paragraph (m) below) with respect to all shares of Company Stock for which he or she is entitled to give instructions, and (iii) the Company acknowledges and agrees to honor the confidentiality of the Participant’s instructions to the Trustee.

(i)        Each Participant may choose to instruct the Trustee in one of the following two ways: (i) not to sell, exchange or transfer any shares of Company Stock for which he or she is entitled to give instructions, or (ii) to sell, exchange or transfer all Company Stock for which he or she is entitled to give instructions. The Sponsor shall follow up with additional mailings and postings of bulletins, as reasonable under the time constraints then prevailing, to obtain instructions from Participants not otherwise responding to such requests for instructions. Subject to paragraph (e), the Trustee shall

 

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then sell, exchange or transfer shares according to instructions from Participants, except that shares for which no instructions are received shall not be sold, exchanged or transferred unless directed otherwise as provided in paragraph (b) above.

(j)        The Sponsor shall furnish former Participants who have received distributions of Company Stock so recently as to not be shareholders of record with the information given to Participants pursuant to paragraphs (g), (h) and (i) of this Section. The Trustee shall then sell, exchange or transfer shares according to instructions from such former Participants, except that shares for which no instructions are received shall not be sold, exchanged or transferred.

(k)        Neither the Company, the Committee nor the Trustee shall express any opinion or give any advice or recommendation to any Participant concerning the Offer, nor shall they have any authority or responsibility to do so.

(l)        The Trustee shall not reveal or release a Participant’s instructions to the Company, its officers, directors, employees, or representatives. If some but not all Company Stock held by the Trust is sold, exchanged, or transferred pursuant to an Offer, the Company, with the Trustee’s cooperation, shall take such action as is necessary to maintain the confidentiality of Participant’s records including, without limitation, establishment of a security system and procedures which restrict access to Participant records and retention of an independent agent to maintain such records. If an independent record keeping agent is retained, such agent must agree, as a condition of its retention by the Sponsor, not to disclose the composition of any Participant Accounts to the Company, its officers, directors, employees, or representatives. The Company acknowledges and agrees to honor the confidentiality of Participants’ instructions to the Trustee.

(m)        Each Participant shall be a named fiduciary (as that term is defined in Section 402(a)(2) of ERISA) with respect to Company Stock allocated to his or her Accounts under the Plan solely for purposes of exercising the rights of a shareholder with respect to an Offer pursuant to this Section 5.9 and voting rights pursuant to Section 5.10.

(n)        To the extent that an Offer results in the sale of Company Stock in the Trust, the Committee or the Participants, if so permitted under the terms of the Plan, shall instruct the Trustee as to the investment of the proceeds of such sale.

(o)        In the event a court of competent jurisdiction shall issue to the Plan, the Committee, the Sponsor or the Trustee an opinion or order, which shall, in the opinion of counsel to the Committee, the Sponsor or the Trustee, invalidate, in all circumstances or in any particular circumstances, any provision or provisions of this Section regarding the determination to be made as to whether or not Company Stock held by the Trustee shall be sold, exchanged or transferred pursuant to an Offer or cause any such provision or provisions to conflict with securities laws, then, upon notice thereof to the Committee, the Sponsor or the Trustee, as the case may be, such invalid or conflicting provisions of this Section shall be given no further force or effect. In such circumstances, the Trustee

 

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shall continue to follow instructions received from Participants, to the extent such instructions have not been invalidated by such order or opinion. To the extent the Trustee is required by such opinion or order to exercise any residual fiduciary responsibility with respect to such Offer, the Sponsor shall appoint an independent fiduciary who shall exercise such residual fiduciary responsibility as provided in paragraph (b) above and shall direct the Trustee as to whether or not Company Stock held by the Trustee shall be sold, exchanged or transferred pursuant to such Offer.

5.10       Voting of Company Stock .  Notwithstanding any other provision of the Plan to the contrary, the Trustee shall have no discretion or authority to vote Company Stock held in the Trust on any matter presented for a vote by the stockholders of the Company except in accordance with timely directions received by the Trustee from either the Committee or Participants, depending on who has the right to direct the voting of such Company Stock as provided in the following provisions of this Section 5.10.

 (a)        All Company Stock held in the Trust Fund shall be voted by the Trustee as the Committee directs in its absolute discretion, except as provided in this Section 5.10(a).

(i)        If the Sponsor has a registration-type class of securities (as defined in Code Section 409(e)(4)), then with respect to all corporate matters, each Participant shall be entitled to direct the Trustee as to the voting of all Company Stock allocated and credited to his or her Accounts.

(ii)       If the Sponsor does not have a registration-type class of securities, then only with respect to such matters as the approval or disapproval of any corporate merger or consolidation, recapitalization, reclassification, liquidation, dissolution, sale of substantially all assets of trade or business, or such similar transactions as may be prescribed in Code Section 409(e)(4) and the regulations thereunder, each Participant shall be entitled to direct the Trustee as to the voting of all Company Stock allocated and credited to his or her Accounts.

 (b)        To the extent there remains any residual fiduciary responsibility with respect to the voting of Company Stock after application of paragraph (a) above, the Trustee shall vote such Company Stock as directed by the Committee or as directed by an independent fiduciary if duly appointed by the Sponsor. To the extent the Committee or an independent fiduciary is required to exercise any residual fiduciary responsibility with respect to the voting of Company Stock, the Committee or independent fiduciary shall take into account in exercising its fiduciary judgment, unless it is clearly imprudent to do so, directions timely received from Participants, as such directions are most indicative of what action is in the best interests of Participants. Further, the Committee or independent fiduciary, in addition to taking into consideration any relevant financial factors bearing on any such decision, shall take into consideration any relevant non-financial factors, including, but not limited to, the continuing job security of Participants as employees of the Sponsor or any Affiliated Company, conditions of employment, employment

 

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opportunities and other similar matters, and the prospect of the Participants and prospective Participants for future benefits under the Plan.

 (c)        All Participants entitled to direct such voting shall be notified by the Sponsor, pursuant to its normal communications with shareholders, of each occasion for the exercise of such voting rights within a reasonable time before such rights are to be exercised. Such notification shall include all information distributed to shareholders either by the Sponsor or any other party regarding the exercise of such rights. Such Participants shall be so entitled to direct the voting of fractional shares (or fractional interests in shares), provided, however, that the Trustee may, to the extent possible, vote the combined fractional shares (or fractional interests in shares) so as to reflect the aggregate direction of all Participants giving directions with respect to fractional shares (or fractional interests in shares). To the extent that a Participant shall fail to direct the Trustee as to the exercise of voting rights arising under any Company Stock credited to his or her Accounts, such Company Stock shall not be voted unless the Trustee is directed otherwise as provided in paragraph (b) above. The Trustee shall maintain confidentiality with respect to the voting directions of all Participants.

 (d)        Each Participant shall be a named fiduciary (as that term is defined in Section 402(a)(2) of ERISA) with respect to Company Stock for which he or she has the right to direct the voting under the Plan but solely for the purpose of exercising voting rights pursuant to this Section 5.10 or certain Offers pursuant to Section 5.9.

 (e)        In the event a court of competent jurisdiction shall issue an opinion or order to the Plan, the Committee, the Sponsor or the Trustee, which shall, in the opinion of counsel to the Committee, the Sponsor or the Trustee, invalidate under ERISA, in all circumstances or in any particular circumstances, any provision or provisions of this Section regarding the manner in which Company Stock held in the Trust shall be voted or cause any such provision or provisions to conflict with ERISA, then, upon notice thereof to the Committee, the Sponsor or the Trustee, as the case may be, such invalid or conflicting provisions of this Section shall be given no further force or effect. In such circumstances the Trustee shall continue to follow instructions received from Participants, to the extent such instructions have not been invalidated by such order or opinion. To the extent the Trustee is required by such opinion or order to exercise any residual fiduciary responsibility with respect to voting, the Sponsor shall appoint an independent fiduciary who shall exercise such residual fiduciary responsibility as provided in paragraph (b) above and shall direct the Trustee as to the manner in which Company Stock held by the Trustee shall be voted.

5.11       Securities Law Limitation .    Neither the Committee nor the Trustee shall be required to engage in any transaction, including without limitation, directing the purchase or sale of Company Stock, which either determines in its sole discretion might tend to subject itself, its members, the Plan, the Company, or any Participant or Beneficiary to a liability under federal or state securities laws.

 

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5.12       Distributions .  Money and property of the Trust shall be paid out, disbursed, or applied by the Trustee for the benefit of Participants and Beneficiaries under the Plan in accordance with directions received by the Trustee from the Committee. Upon direction of the Committee, the Trustee may pay money or deliver property from the Trust for any purpose authorized under the Plan. The Trustee shall be fully protected in paying out money or delivering property from the Trust from time to time upon written order of the Committee and shall not be liable for the application of such money or property by the Committee. The Trustee shall not be required to determine or to make any investigation to determine the identity or mailing address of any person entitled to benefits hereunder and shall have discharged its obligation in that respect when it shall have sent checks or other property by first-class mail to such persons at their respective addresses as may be certified to it by the Committee.

5.13       Taxes .  If the whole or any part of the Trust, or the proceeds thereof, shall become liable for the payment of any estate, inheritance, income or other tax, charge, or assessment which the Trustee shall be required to pay, the Trustee shall have full power and authority to pay such tax, charge, or assessment out of any moneys or other property in its hands for the account of the person whose interests hereunder are so liable, but at least ten (10) days prior to making any such payment, the Trustee shall mail notice to the Committee of its intention to make such payment. Prior to making any transfers or distributions of any of the Trust, the Trustee may require such releases or other documents from any lawful taxing authority as it shall deem necessary.

5.14       Trustee Records to be Maintained .  The Trustee shall keep accurate and detailed accounts of all investments, receipts, disbursements, and other transactions hereunder, and all accounts, books, and records relating thereto shall be open to inspection and audit at all reasonable times by any person designated by the Company (subject to the provisions of Sections 5.9(l) and 5.10(c)).

5.15       Annual Report of Trustee .  Promptly following the close of each Plan Year (or such other period as may be agreed upon between the Trustee and Committee), or promptly after receipt of a written request from the Company, the Trustee shall prepare for the Company a written account which will enable the Company to satisfy the annual financial reporting requirements of ERISA, and which will set forth among other things all investments, receipts, disbursements, and other transactions effected by the Trustee during such Plan Year or during the period from the close of the last Plan Year to the date of such request. Such account shall also describe all securities and other investments purchased and sold during the period to which it refers, the cost of acquisition or net proceeds of sale, the securities and investments held as of the date of such account, and the cost of each item thereof as carried on the books of the Trustee. All accounts so filed shall be open to inspection during business hours by the Company, the Committee, and by Participants and Beneficiaries of the Plan (subject to the provisions of Sections 5.9(l) and 5.10(c)).

5.16       Appointment of Investment Manager .    From time to time the Committee, in accordance with Section 9.7 hereof, may appoint one or more Investment Managers who shall have investment management and control over assets of the Trust not invested or to be invested in Company Stock. The Committee shall notify the Trustee of such assets of the appointment of

 

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the Investment Manager. In the event more than one Investment Manager is appointed, the Committee shall determine which assets shall be subject to management and control by each Investment Manager and shall also determine the proportion in which funds withdrawn or disbursed shall be charged against the assets subject to each Investment Manager’s management and control. As shall be provided in any contract between an Investment Manager and the Committee, such Investment Manager shall hold a revocable proxy with respect to all securities which are held under the management of such Investment Manager pursuant to such contract (except for Company Stock), and such Investment Manager shall report the voting of all securities subject to such proxy on an annual basis to the Committee.

 

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ARTICLE VI

ACCOUNTS AND ALLOCATIONS

6.1         Participants’ Accounts .    In order to account for the allocated interest of each Participant in the Trust Fund, there shall be established and maintained for each Participant (making such form of contribution) a Before Tax Deposits Account, an After Tax Deposits Account, a Matching Contributions Account, a Retirement Contributions Account, and a Rollover Contributions Account.

6.2         Allocation of Participant Deposits .  All Participant Deposits shall be allocated to the separate Accounts established and maintained for that Participant. Participant Deposits shall be paid by the Company to the Trustee as soon as the amount can reasonably be identified and separated from the Company’s other assets, but in any event no later than the 15th business day of the month following the month in which such amounts would otherwise be payable to the Participant, or such other time provided in applicable regulations under the Code or ERISA.

6.3         Allocation of Company Contributions and Forfeitures .  Company Contributions and Forfeitures shall be allocated as follows:

(a)        Matching Contributions shall be allocated to the Matching Contributions Accounts of all Participants who made Matched Deposits in such amounts and at such times as provided in Sections 5.3(a) and 5.3(b).

(b)        Retirement Contributions shall be allocated to the Retirement Contributions Accounts of all Retirement Account Participants in such amounts and at such times as provided in Sections 5.4(a) and 5.4(b).

(c)        Matching Contribution Forfeitures and Retirement Contribution Forfeitures shall first be used to restore the Matching Contributions Accounts of rehired Participants and the Retirement Contributions Accounts of rehired Retirement Account Participants, respectively, if so required under Section 8.7 and shall then be allocated to the Matching Contributions Accounts of Participants and Retirement Contributions Accounts of Retirement Account Participants, respectively, to the extent necessary to correct insufficient allocations made to such Accounts in prior months discovered during the Plan Year to which such Forfeitures are attributable.

(d)        After application of paragraph (c) above, any remaining Matching Contribution Forfeitures and Retirement Contribution Forfeitures shall be used to reduce Matching Contributions and Retirement Contributions, respectively, made by the Company pursuant to Sections 5.3 and 5.4 unless applied towards plan expenses consistent with the allocation described under Section 9.14.

(e)        Any other Company Contributions shall be used to restore the Accounts of rehired Participants if so required under Section 8.7 and to the extent Forfeitures are

 

45


unavailable. Any amounts remaining may be used to pay Plan expenses to the extent described in Section 9.14.

The allocations of Company Contributions under this Section 6.3 shall be made only after any allocations required by Sections 6.10 and 13.4 have been made.

6.4         Valuation of Participants’ Accounts .  Within sixty (60) days after each Valuation Date the Trustee shall value the assets of the Trust on the basis of fair market values. Company Stock held by the Trust shall be valued in accordance with Section 6.5. If separate investment funds are maintained under the Trust pursuant to Section 5.6(b) then each such fund shall be valued separately so that gains or losses of the various funds shall not be commingled. Upon receipt of these valuations from the Trustee, the Committee shall revalue the Accounts and subaccounts (as established pursuant to Section 5.6(b)), if any, of each Participant as of the applicable Valuation Date so as to reflect, among other things, a proportionate share in any increase or decrease in the fair market value of the assets in the Trust Fund, determined by the Trustee as of that date as compared with the value of the assets in the Trust Fund as of the immediately preceding Valuation Date.

6.5         Valuation of Company Stock .  Company Stock held by the Trust shall be valued according to the following rules:

(a)        In the case of Company Stock that is publicly traded on a national securities exchange, such stock shall be valued by reference to the closing price of such stock on such exchange on the last trading day of the month for which such stock is being valued.

(b)        In the case of Company Stock that is not publicly traded on a national securities exchange, such stock shall be valued as of the first day of each Plan Year, or such other time as established by the Committee, by determining the fair market value of such stock through the use of an independent appraiser. Such fair market valuation shall be used to determine the valuation of each Participant’s Company Stock Account on each Valuation Date in such Plan Year pursuant to Section 6.4.

6.6         Dividends, Splits, Recapitalizations, Etc .  Any Company Stock received by the Trustee as a stock split, dividend, or as a result of a reorganization or other recapitalization of the Company shall be allocated in the same manner as the Company Stock to which it is attributable is then allocated.

6.7         Stock Rights, Warrants or Options .

(a)        In the event any rights, warrants, or options are issued on Company Stock held in the Trust Fund, the Trustee shall exercise them for the acquisition of additional Company Stock as directed by the Committee to the extent that cash is then available in the Trust Fund.

 

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(b)        Any Company Stock acquired in this fashion shall be treated as Company Stock purchased by the Trustee for the net price paid and shall be allocated in the same manner as the funds used to purchase the Company Stock were or would be allocated under the provisions of the Plan. Thus, if the funds used to purchase the stock consisted of unallocated Company Contributions, the stock would be allocated under the terms of Section 6.3; if the funds used consisted of the unallocated net income of the Trust, the stock would be allocated as provided in Section 6.4; and if the funds used consisted of funds previously allocated to the Accounts, the stock would be allocated in the manner in which the Accounts or subaccounts are debited and credited.

(c)        Any rights, warrants, or options on Company Stock which cannot be exercised for lack of cash may, as directed by the Committee, be sold by the Trustee and the proceeds allocated in accordance with the source of the Company Stock with respect to which the rights, warrants, or options were issued in accordance with rules of paragraph (b) above.

6.8         Treatment of Accounts Upon Severance .    Upon a Participant’s Severance, pending distribution of the Participant’s benefit pursuant to the provisions of Article VIII, the Participant’s Accounts shall continue to be maintained and accounted for in accordance with all applicable provisions of the Plan, including but not limited to the allocation of Company Contributions and net income or loss to which the Accounts are entitled under the applicable provisions of Sections 6.3 and 6.4 as of any Valuation Date or other date preceding the distribution of the Participant’s entire benefit under the Plan.

6.9         Cash Dividends .

(a)        All cash dividends paid to the Trustee with respect to Company Stock that has been allocated to a Participant’s Account as of the quarterly date on which the dividend is received by the Trustee shall be allocated to the Participant’s Account.

(b)        If a Participant (or Beneficiary) has a current right to a distribution in Company Stock pursuant to Article VIII and such stock has not yet been re-registered in the name of the Participant (or Beneficiary) as of the record date of any dividend on such stock, such dividend shall be distributed to the Participant (or Beneficiary).

(c)        Notwithstanding the provisions of paragraphs (a) and (b) above, the Committee may determine, in its discretion, that cash dividends on such shares may be used to purchase additional shares of Company Stock, or in whatever other manner it deems appropriate.

6.10       Miscellaneous Allocation Rules .

(a)        In the event that there is more than one class of Company Stock to be allocated to Participants’ Accounts, there shall be allocated to the Account of each Participant (entitled to share in allocations of Company Stock as of any applicable date) the portion of each class of Company Stock (to be allocated as of that date) which the

 

47


amount to be allocated to the Account of the Participant bears to the total amount to be allocated to the Accounts of all Participants entitled to share in such allocation.

(b)        Allocations of all assets other than Company Stock shall be made on the basis of, and expressed in terms of dollar value. Allocations of Company Stock shall be on the basis of the number of shares of Company Stock (including fractional shares) and valuations, as of each Valuation Date, shall be expressed in terms of number of shares and dollar value.

(c)        The Committee and the Trustee shall establish such additional accounting procedures as may be necessary for the purpose of making the allocations, valuations, withdrawals, and adjustments to Participants’ Accounts provided for in this Article VI. From time to time the Committee and Trustee may modify such additional accounting procedures for the purpose of achieving equitable, nondiscriminatory, and administratively feasible allocations among the Accounts of Participants in accordance with the general concepts of the Plan and the provisions of this Article VI.

(d)        The Company, the Committee and Trustee do not in any manner or to any extent whatsoever warrant, guarantee or represent that the value of a Participant’s Account shall at any time equal or exceed the amount previously contributed thereto.

6.11       Limitations on After Tax Deposits and Matching Contributions .  With respect to each Plan Year, After Tax Deposits and Matching Contributions under the Plan for the Plan Year shall not exceed the limitations by or on behalf of Highly Compensated Participants under Code Section 401(m), as provided in this Section. In the event that After Tax Deposits and Matching Contributions under the Plan by or on behalf of Highly Compensated Participants for any Plan Year exceed the limitations of this Section for any reason, such excess After Tax Deposits and Matching Contributions and any income or loss allocable thereto shall be disposed of in accordance with Section 6.12.

(a)        The After Tax Deposits by Participants and Matching Contributions on behalf of Participants for a Plan Year shall satisfy the Actual Contribution Percentage test set forth in (i) below, or, to the extent not precluded by applicable regulations, the alternative Actual Contribution Percentage test set forth in (ii) below:

(i)        The Actual Contribution Percentage of Highly Compensated Participants for the Plan Year shall not be more than the prior Plan Year’s Actual Contribution Percentage of Participants who were not Highly Compensated Employees for the prior Plan Year multiplied by 1.25, or

(ii)       The Actual Contribution Percentage of Highly Compensated Participants for the Plan Year shall not be more than the prior Plan Year’s Actual Contribution Percentage of Participants who were not Highly Compensated Employees for the prior Plan Year multiplied by 2.0, provided that the Actual Contribution Percentage of Highly Compensated Participants does not exceed the Actual Contribution Percentage of Participants who were not Highly

 

48


Compensated Employees for the prior Plan Year by more than two (2) percentage points.

(iii)      If one or more Highly Compensated Employees participate in both a cash or deferred arrangement and a plan subject to the Actual Contribution Percentage test maintained by the Sponsor or an Affiliated Company and the sum of the Actual Deferral Percentage and Contribution Percentage of those Highly Compensated Employees subject to either or both test exceeds the Aggregate Limit, then the Contribution Percentages of those Highly Compensated Employees who also participate in the cash or deferred arrangement shall be reduced (beginning with such Highly Compensated Employee whose Actual Contribution Percentage is the highest) so that the limit is not exceeded. The amount by which each Highly Compensated Employee’s Contribution Percentage is reduced shall be treated as an Excess Aggregate Contribution. The Actual Deferral Percentage and Contribution Percentage of the Highly Compensated Employee are determined after any corrections required to meet the Actual Deferral Percentage and Actual Contribution Percentage tests and are deemed to be the maximum permitted under such tests for the Plan Year.

(b)       For purposes of this Section 6.11 and Section 6.12 the following definitions shall apply:

(i)        “Actual Contribution Percentage” shall mean the average of the Contribution Percentages, with respect to the group of Highly Compensated Participants and the group of all other Participants for a Plan Year. The “Contribution Percentage” for any Participant shall mean the ratio, calculated separately and to the nearest one-hundredth of one percent for each Participant in such group, determined as follows:

(A)        For a Highly Compensated Participant, the ratio of such Participant’s After Tax Deposits and Matching Contributions for the current Plan Year to such Participant’s Compensation for the current Plan Year; provided, however, that the Contribution Percentage of a Highly Compensated Participant with no After Tax Deposits and Matching Contributions made on his or her behalf shall be zero.

(B)        For any other Participant, the ratio of such Participant’s After Tax Deposits and Matching Contributions for the preceding Plan Year to such Participant’s Compensation for the preceding Plan Year; provided, however, that the Contribution Percentage of a Participant with no After Tax Deposits and Matching Contributions made on his or her behalf shall be zero.

The Contribution Percentage, in each case, however, shall not include Matching Contributions that are forfeited either to correct Excess Aggregate Contributions or because the contribution to which they relate are excess Before Tax Deposits, excess After Tax Deposits, or Excess Aggregate Contributions. To the extent determined by the Committee and in accordance with regulations issued by the Secretary of the Treasury under Code Section 401(m)(3), Before

 

49


Tax Deposits and any qualified nonelective contributions, within the meaning of Code Section 401(m)(4)(C) on behalf of a Participant may also be taken into account for purposes of calculating the Contribution Percentage of a Participant. However, if any Before Tax Deposits are taken into account for purposes of determining Actual Deferral Percentages under Section 4.3 then such Before Tax Deposits shall not be taken into account under this Section 6.11.

(ii)       “Highly Compensated Participant” shall mean for any Plan Year any Participant who is a Highly Compensated Employee. A Participant is a Highly Compensated Employee for a particular Plan Year if he or she meets the definition of a Highly Compensated Employee in effect for that Plan Year. Similarly, a Participant is not a Highly Compensated Employee for a particular Plan Year if he or she does not meet the definition of a Highly Compensated Employee in effect for that Plan Year.

(iii)      “Participant” shall mean any Eligible Employee who satisfied the requirements of Section 3.1 during the Plan Year whether or not such Eligible Employee has elected to contribute to the Plan for such Plan Year.

(iv)      “Compensation” shall mean compensation as described below:

(A)        Compensation means compensation determined by the Company in accordance with the requirements of Code Section 414(s) and the regulations thereunder.

(B)        For purposes of this Section 6.11, Compensation may, at the Company’s election, exclude amounts which are excludable from a Participant’s gross income under Code Section 125 (pertaining to cafeteria plans) and Code Section 402(e)(3) (pertaining to 401(k) salary reductions). The Company may change its election provided such change does not discriminate in favor of Highly Compensated Employees.

(C)        Compensation taken into account for any Plan Year shall not exceed $210,000, as adjusted for cost-of-living increases in accordance with Code Section 401(a)(17)(B). Any cost-of-living adjustments in effect for a calendar year shall apply to the Plan Year beginning with or within such calendar year.

(v)       “Aggregate Limit” shall mean the sum of (1) 125 percent of the greater of the average Actual Deferral Percentage of all Non-Highly Compensated Participants for the Plan Year or the Actual Contribution Percentage of Non-Highly Compensated Participants under the Plan subject to Code Section 401(m) for the Plan Year beginning with or within the Plan Year of the cash or deferred

 

50


arrangement and (2) the lesser of 200% or two plus the lesser of such average Actual Deferral Percentage or Actual Contribution Percentage. “Lesser” is substituted for “greater” in (1) above, and “greater” is substituted for “lesser” after “two plus the” in (2) above if it would result in a larger Aggregate Limit.

(vi)        “Excess Aggregate Contributions” shall mean, with respect to any Plan Year, the excess of:

(A)        The aggregate After Tax Deposits and Matching Contributions taken into account in computing the numerator of the Contribution Percentage actually made on behalf of Highly Compensated Employees for such Plan year, over

(B)        The maximum After Tax Deposits and Matching Contributions permitted under the Actual Contribution Percentage test as determined by reducing such Matching Contributions made on behalf of Highly Compensated Employees in order of their Contribution Percentages, beginning with the highest of such percentages.

Such determination shall be made after first determining excess Before Tax Deposits pursuant to Sections 4.2(a) and 4.3.

(c)        In the event the Plan satisfies the requirements of Code Sections 401(m), 401(a)(4) or 410(b) only if aggregated with one or more other plans which include arrangements under Code Section 401(k), then this Section 6.11 shall be applied by determining the Contribution Percentages of Participants as if all such plans were a single plan. Any adjustments to the Contribution Percentages of Participants who are not Highly Compensated Employees for the prior year shall be made in accordance with Notice 98-1 and any superseding guidance. Plans may be aggregated in order to satisfy Code Section 401(m) only if they have the same Plan Year and use the same Actual Contribution Percentage testing method.

(d)        For purposes of this Section 6.11, the Contribution Percentage for any Highly Compensated Participants who is eligible to have After Tax Deposits or Matching Contributions allocated to his or her account under two or more plans maintained by the Sponsor or an Affiliated Company shall be determined as if the total of such After Tax Deposits or Matching Contributions was made under each plan. If a Highly Compensated Employee participates in two or more cash or deferred arrangements that have different plan years, all cash or deferred arrangements that have different plan years, all cash or deferred arrangements ending with or within the same calendar year shall be treated as a single arrangement. Notwithstanding the foregoing, certain plans shall be treated as separate plans if mandatorily disaggregated pursuant to regulations under Code Section 401(m).

(e)        For purposes of the Actual Contribution Percentage test, After Tax Deposits shall be considered to have been made in the Plan Year in which contributed to

 

51


the Trust. Matching Contributions shall be considered made for a Plan Year if made no later than the end of the twelve-month period beginning on the day after the close of the Plan Year.

(f)        The determination and treatment of the Contribution Percentage of any Participant shall satisfy such other requirements as may be prescribed by the Secretary of the Treasury.

(g)        The Committee shall keep or cause to have kept such records as are necessary to demonstrate that the Plan satisfies the requirements of Code Section 401(m) and the regulations thereunder, in accordance with regulations prescribed by the Secretary of the Treasury.

6.12       Provision for Disposition of Excess After Tax Deposits or Matching Contributions on Behalf of Highly Compensated Participants .  After application of the provisions of Section 4.4 and 4.5, the following provisions shall be implemented:

(a)        The Committee shall determine, as soon as is reasonably possible following the close of each Plan Year, the extent (if any) to which contributions by or on behalf of Highly Compensated Participants may cause the Plan to exceed the limitations of Section 6.11 for such Plan Year. If, pursuant to the determination by the Committee and as required by the leveling method described in paragraph (b) below, contributions by or on behalf of a Highly Compensated Participant may cause the Plan to exceed such limitations, then the Committee shall take the following steps:

(i)        First, any excess After Tax Deposits that were not matched by Matching Contributions, together with income or loss allocable to such amount (determined in accordance with paragraph (c) below) shall be returned to the Highly Compensated Participant.

(ii)       Second, if any excess remains after the provisions of (i) above are applied, to the extent necessary to eliminate the excess, Matching Contributions with respect to the Highly Compensated Participant, any corresponding matched After Tax Deposits, and any income or loss allocable thereto, shall either be distributed (if non-forfeitable) to the Highly Compensated Participant or forfeited (to the extent forfeitable under the Plan) on a pro-rata basis. Amounts of excess Matching Contributions forfeited by Highly Compensated Participants under this Section 6.12, including any income or loss allocable thereto, shall be applied to reduce Matching Contributions by the Company or the Affiliated Company that made the Matching Contribution on behalf of the Highly Compensated Participant for the Plan Year for which the excess contribution was made.

(iii)      If administratively feasible, any amounts distributed pursuant to subparagraphs (i) or (ii) above shall be returned within two and one-half (2-1/2) months following the close of the Plan Year for which such excess After Tax Deposits or Matching Contributions were made, but in any event no later than the

 

52


end of the first Plan Year following the Plan Year for which the excess After Tax Deposits or Matching Contributions were made. After Tax Deposits and Matching Contributions for any Plan Year shall be made on the basis of the respective portions of such excess After Tax Deposits and Matching Contributions attributable to each Highly Compensated Participant.

(b)        For purposes of satisfying the Actual Contribution Percentage test, the amount of any excess After Tax Deposits or Matching Contributions by or on behalf of Highly Compensated Participants for a Plan Year under Section 6.11 shall be determined by application of a leveling method under which the After Tax Deposits or Matching Contributions of the Highly Compensated Participant who has the highest dollar amount of After Tax Deposits or Matching Contributions for such Plan Year is reduced to the extent required to cause such Highly Compensated Participant’s After Tax Deposits and Matching Contributions to equal the After Tax Deposits and Matching Contributions of the Highly Compensated Participant with the next highest After Tax Deposits and Matching Contributions; provided, however, if a lesser amount, when added to the total dollar amount already distributed under this paragraph (b), equals the total excess After Tax Deposits and Matching Contributions that are required to be distributed to enable the Plan to satisfy the Actual Contribution Percentage test, the lesser amount shall be distributed. This process shall be repeated until the Plan satisfies the Actual Contribution Percentage test.

(c)        The amount of income or loss attributable to any excess After Tax Deposits or Matching Contributions, as determined under this Section 6.12 (the “Excess Aggregate Contribution”) by a Highly Compensated Participant for a Plan Year shall be equal to the sum of the following:

(i)        The income or loss allocable to the Highly Compensated Participant’s Excess Aggregate Contribution Accounts for the Plan Year multiplied by a fraction, the numerator of which is the Excess Aggregate Contribution and the denominator of which is the sum of the balance of the Highly Compensated Participant’s Excess Aggregate Contribution Accounts without regard to any income or loss allocable to such Accounts during the Plan Year; and

(ii)       The amount of allocable income or loss for the Gap Period using the “safe harbor” method set forth in regulations prescribed by the Secretary of the Treasury under Code Section 401(m). Under the “safe harbor” method, such allocable income or loss is equal to 10% of the amount calculated under Section 6.12(c)(i) above, multiplied by the number of calendar months from the last day of the Plan Year until the date of distribution of the Participant’s excess After Tax Deposits or Matching Contributions. A distribution on or before the 15th of the month is treated as made on the last day of the preceding month, a distribution after the 15th of the month is treated as made on the first day of the next month.

 

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(d)        For the purpose of this Section 6.12, the following shall apply:

(i)        “Excess Aggregate Contribution Accounts” shall mean the Participant’s After Tax Deposits Account and Matching Contributions Account.

(ii)       “Gap Period” shall mean the period between last day of the Plan Year and the date of distribution of any Excess Aggregate Contributions.

(e)        Any excess After Tax Deposits and/or Matching Contributions distributed to a Highly Compensated Participant or forfeited by a Highly Compensated Participant in accordance with this Section 6.12, shall be treated as Annual Additions under Article XIII for the Plan Year for which the excess contribution was made.

(f)        Neither the Committee nor the Company shall be liable to any Participant (or his or her Beneficiary, if applicable) for any losses caused by a mistake in calculating the amount of any Excess Aggregate Contributions by or on behalf of a Highly Compensated Participant and the income or loss allocable thereto.

 

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ARTICLE VII

VESTING IN PLAN ACCOUNTS

7.1         No Vested Rights Except as Herein Provided .    No Participant shall have any vested right or interest to, or any right of payment of, any assets of the Trust Fund, except as expressly provided in the Plan. Neither the making of any allocations nor the credit to any Account of a Participant shall vest in any Participant any right, title, or interest in or to any assets of the Trust Fund.

7.2         Vesting of Participant Deposits .  A Participant shall be fully vested at all times in the amounts allocated to his or her Before Tax Deposits Account, After Tax Deposits Account, and Rollover Contributions Account.

7.3         Vesting of Company Contributions .

(a)        A Participant’s interest in his or her Matching Contributions Account shall vest in accordance with the following schedule:

 

Years of Credited Service

   Vested Percentage
Less than 3        0%
3 or more    100%

(b)        A Participant’s interest in his or her Retirement Contributions Account shall vest in accordance with the following schedule:

 

Years of Credited Service

   Vested Percentage
Less than 1        0%
1 but less than 2      20%
2 but less than 3      40%
3 but less than 4      60%
4 but less than 5      80%
5 or more    100%

(c)        A Participant shall at all times be 100% vested in all amounts transferred from the SmithKline Beckman Corporation Savings and Investment Plan and all amounts transferred from the Inamed Corporation Retirement Savings Plan to the Plan.

(d)        Notwithstanding paragraphs (a) and (b) above, a Participant shall become fully vested in his or her Matching Contributions Account and Retirement Contributions Account upon the occurrence of any of the following events, if such Participant is then still an Employee:

(i)        Attainment of age sixty-two (62);

 

55


(ii)        Death;

(iii)       Severance due to a Disability; or

(iv)       Occurrence of a Change in Control pursuant to Section 12.4.

 

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ARTICLE VIII

PAYMENT OF PLAN BENEFITS

8.1         Withdrawals During Employment .    A Participant may withdraw, once in any calendar quarter, amounts of at least $500 from his or her Accounts while an Employee in accordance with the following rules:

(a)        A Participant may, for any reason, withdraw any portion of the amount allocated to his or her After Tax Deposits Account (excluding any After Tax Deposits recharacterized as such under Section 4.5). A Participant who makes a withdrawal of After Tax Deposits (whether Matched Deposits or non-Matched Deposits) shall not be permitted to make any After Tax or and Before Tax Deposits during the six (6) month period beginning as soon as administratively feasible following the date of the withdrawal unless the After Tax Deposits can also be withdrawn under paragraph (d) below or the withdrawal is comprised solely of After Tax Deposits which are not Matched Deposits and which were contributed prior to July 1, 2000.

(b)        A Participant may, for any reason, withdraw any portion of the amount allocated to his or her Rollover Contributions Account.

(c)        After withdrawing all After Tax Deposits pursuant to paragraph (a) and all amounts allocated to his or her Rollover Contributions Account under paragraph (b) above, a Participant with 3 or more years of Credited Service may, for any reason, withdraw any portion of the amount allocated to his or her Matching Contributions Account that was so allocated 2 or more years prior to the date of such a withdrawal.

(d)        On or after the attainment of age 59-1/2, a Participant may withdraw any vested portion of the amounts allocated to any of his or her Accounts.

(e)        After withdrawing all amounts permitted pursuant to paragraphs (a), (b) (c), and (d) above, a Participant may withdraw amounts from his or her Before Tax Deposits Account (excluding any earnings attributable to such Account after December 31, 1988), the vested portion of his or her Matching Contributions Account, and any remaining amount in his or her After Tax Deposits (amounts which were recharacterized as After Tax Deposits under Section 4.5 but excluding any earnings attributable to recharacterized After Tax Deposits after December 31, 1988) but excluding amounts from his or her Retirement Contributions Account upon incurring a hardship as defined in Section 8.5.

(f)        Except as provided in paragraphs (a) through (e) above, Participants may not receive a distribution of their benefits under the Plan prior to termination of employment.

(g)        Except as provided in Section 8.5(c), all withdrawals shall be made in cash, except to the extent any of the vested portion of a Participant’s Account to be

 

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withdrawn is invested in the Company Stock Fund or in the stock of Advanced Medical Optics, Inc., then such withdrawal may be made in Company Stock or in the stock of Advanced Medical Optics, Inc. at the election of the Participant to the extent so invested.

(h)        Except as provided in Section 8.5(c), all withdrawals shall be made to Participants as soon as reasonably practicable following the Valuation Date in the month for which a properly completed withdrawal request is deemed perfected. All withdrawals shall be based on the Account balances of a Participant as of such Valuation Date. If a properly completed withdrawal request is received by the Company during any month and on or before the fifteenth day of such month, the withdrawal request shall be deemed perfected in such month, otherwise such withdrawal request shall be deemed perfected in the immediately following month.

(i)        Notwithstanding anything to the contrary in this Section 8.1 or Section 4.1, the additional withdrawal restrictions stated in Section 5.6(h) shall apply to all Participants who are Insiders, as that term is defined Section 5.6(h).

8.2         Distributions Upon Termination of Employment or Disability .

(a)        Subject to the provisions of Section 8.6, if a Participant incurs a Severance for any reason (including Disability) other than death, all or a portion of such Participant’s entire vested portion of his or her Accounts under the Plan shall be (i) distributed directly to such Participant or (ii) at the election of the Participant, distributed as an Eligible Rollover Distribution and paid directly by the Trustee to the trustee of an Eligible Retirement Plan.

(b)        Any distribution made pursuant to paragraph (a) shall be paid no more than once in any calendar quarter in amounts of at least $500 (or the Participant’s entire vested portion of his or her Accounts under the Plan if lesser) and shall be made in cash except to the extent any of the vested portion of such Participant’s Accounts is invested in the Company Stock Fund or in the stock of Advanced Medical Optics, Inc. then, to the extent so invested, such distribution may be made in Company Stock or in the stock of Advanced Medical Optics, Inc. at the election of the Participant.

(c)        Notwithstanding the provisions contained in the foregoing paragraphs of this Section 8.2 or Section 8.1, any provision which restricts or would deny a Participant through the withholding of consent or the exercise of discretion by some person or persons other than the Participant (and where relevant, other than the Participant’s spouse) of an alternative form of benefit, in violation of Code Section 411(d)(6) and the regulation promulgated thereunder, is hereby amended by the deletion of the consent and/or discretion requirement.

(d)        Notwithstanding the provisions contained in the foregoing paragraphs of this Section 8.2 or Section 8.1, upon receipt of a Qualified Domestic Relations Order, the amount payable to an Alternate Payee (as such terms are described in Section 15.2) may be distributed to the Alternate Payee as soon as administratively feasible.

 

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8.3         Distribution Upon Death of Participant .  Subject to the provisions of Section 8.6, in the event of the death of a Participant, the entire vested portion of the Participant’s Accounts shall be distributed to the surviving spouse as Beneficiary (if still alive) unless the Participant designated another Beneficiary pursuant to Section 8.4. The Participant’s Beneficiary (or prior to January 1, 2007, a Beneficiary who is the surviving spouse of the Participant), may elect to have an Eligible Rollover Distribution paid directly by the Trustee to the trustee of an Eligible Retirement Plan. Distributions to the Beneficiary pursuant to this Section 8.3 shall be in the same form as specified in Section 8.2(b) above, as elected by the Beneficiary. All such distributions shall be made as soon as practicable after the death of the Participant. A Beneficiary may not elect to defer such a distribution.

8.4         Designation of Beneficiary .  At any time, and from time to time, each Participant shall have the unrestricted right to designate the Beneficiary or Beneficiaries to receive the entire vested portion of his or her Accounts upon his or her death and to revoke any such designation subject to paragraphs (a) and (b) below. Each such designation shall be evidenced by a written instrument signed by the Participant and filed with the Committee.

(a)        If the Participant is married and designates a Beneficiary other than his or her spouse, said designation shall not be honored by the Committee unless accompanied by the written consent of said spouse to said designation. Such consent (i) must designate a Beneficiary which may not be changed without the consent of the spouse (or the consent of the spouse expressly permits designation by the Participant without any further consent by the spouse), (ii) must acknowledge the effect of the designation, and (iii) must be witnessed by a Plan representative or a notary public. No consent of such spouse shall be necessary if it is established to the satisfaction of a Plan representative that the consent required under this paragraph (a) cannot or need not be obtained because (i) there is no spouse, (ii) the spouse cannot be located, or (iii) there exist such other circumstances which, pursuant to regulations under Code Section 417, permit a distribution to another Beneficiary. Any consent of a spouse obtained pursuant to this paragraph (a) or any determination that the consent of the spouse cannot (or need not) be obtained, shall be effective only with respect to that spouse. If a Participant becomes married following his or her designation of a Beneficiary other than his or her spouse, such designation shall be ineffective unless the spousal consent requirements of this paragraph are satisfied with respect to such spouse (subject, however, to the provisions of Article XV regarding Qualified Domestic Relations Orders).

(b)        If the Participant is married and does not designate a Beneficiary, the Participant’s spouse shall be his or her Beneficiary for purposes of this Section. If the deceased Participant is not married and shall have failed to designate a Beneficiary, or if the Committee shall be unable to locate the designated Beneficiary after reasonable efforts have been made, or if such Beneficiary shall be deceased, distribution of the Participant’s death benefit shall be made by payment of the deceased Participant’s entire interest in the Trust to his or her personal representative in a single lump-sum payment. In the event the deceased Participant is not a resident of California at the date of his or her death, the Committee, in its discretion, may require the establishment of ancillary

 

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administration in California. If the Committee cannot locate a qualified personal representative of the deceased Participant, or if administration of the deceased Participant’s estate is not otherwise required, the Committee, in its discretion, may pay the deceased Participant’s interest in the Trust to his or her heirs at law (determined in accordance with the laws of the State of California as they existed at the date of the Participant’s death).

8.5         Hardship Withdrawal Rules .    A hardship withdrawal shall be made to a Participant only if the Committee (or its representative) determines that the Participant has an immediate and heavy financial need and that a withdrawal from the Plan is necessary to satisfy such need as set forth in paragraphs (a) and (b) below.

(a)        A hardship withdrawal shall be authorized by the Committee only if the Committee, based upon the Participant’s representation and such other facts as are known to the Committee, determines that the requested withdrawal is on the account of:

(i)        Medical expenses described in Code Section 213(d) incurred by the Participant or the Participant’s spouse, Beneficiary or any dependents of the Participant (as defined in Code Section 152, without regard to Code Section 152(b)(1), (b)(2), and (d)(1)(B));

(ii)       The purchase (excluding mortgage payments) of a principal residence for the Participant only;

(iii)      The payment of tuition and related educational fees for the next twelve (12) months of post-secondary education for the Participant or the Participant’s spouse, Beneficiary, children, or dependents (as defined in subparagraph (i) above);

(iv)      The need to prevent the eviction of the Participant from his or her principal residence or foreclosure on the mortgage of the Participant’s principal residence;

(v)       The payment of burial or funeral expenses for the Participant’s parents, spouse, Beneficiary, children, or dependents (as defined in subparagraph (i) above);

(vi)      The payment of expenses to repair damage of the Participant’s principal residence that would qualify as a casualty loss under Code Section 165; or

(vii)      Any other situation deemed as immediate and heavy financial needs by the Internal Revenue Service through the publication of revenue rulings, notices, and other documents of general applicability.

 

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(b)        A hardship withdrawal shall be authorized by the Committee only if the Committee, based upon the Participant’s representation and such other facts as are known to the Committee, determines that all of the following conditions are or will be satisfied:

(i)              The amount of the withdrawal is not in excess of the amount required to relieve the financial need (including amounts necessary to pay any federal, state, or local income taxes or penalties reasonably anticipated to result from the withdrawal).

(ii)             The Participant has obtained all distributions (including distributions of ESOP dividends or Code Section 404(k)), other than hardship withdrawals, and all nontaxable (at the time of the loan) loans from the Plan or any other plan maintained by the Company.

(iii)            The Participant shall not be permitted to make Before Tax Deposits or After Tax Deposits during the 6-month period beginning as soon as administratively feasible following the date of the hardship withdrawal from the Plan or any other plan maintained by the Company.

(c)        Notwithstanding the provisions of Section 8.1(g), all hardship withdrawals shall be made in cash regardless of the fund from which such withdrawal is made. The Committee may, at its discretion, establish written procedures whereby Participants may receive an estimated prepayment of a hardship withdrawal based on the last available valuation of such Participant’s Accounts with a reconciling adjustment made to such Participant’s Accounts after current valuation data is available.

8.6         Distribution Rules .  Notwithstanding any other provisions of this Article VIII of the Plan regarding distributions of Participant’s Accounts, the following additional rules shall apply to all such distributions.

(a)        In no event shall any benefits under the Plan, including benefits upon retirement, Severance, or Disability, be paid (or commence to be paid) to a Participant prior to the “Consent Date” (as defined herein) unless the Participant consents in writing to the payment (or commencement of payment) of such benefits prior to said Consent Date. As used herein, the term “Consent Date” shall mean the later of (i) the Participant’s 62nd birthday, or (ii) the Participant’s Normal Retirement Age. Notwithstanding the foregoing, the provisions of this paragraph shall not apply (i) following the Participant’s death, or (ii) to the extent paragraph (b) below applies.

(b)        Notwithstanding anything to the contrary in the Plan, if the total amount of the vested portion of a Participant’s Accounts does not exceed $1,000 ($5,000, prior to March 28, 2005), the vested portion of such Participant’s Accounts shall be distributed, in a single lump-sum payment, as soon as practicable following the Participant’s Severance Date. For purposes of this paragraph (b), Rollover Contributions and the earnings thereon, shall be included in determining the value of the vested portion of a Participant’s

 

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Accounts for distributions made after December 31, 2001 with respect to Participants who incur a Severance after December 31, 2001.

(c)        Unless a Participant elects otherwise pursuant to paragraph (a) above, distributions of the vested portion of a Participant’s Accounts shall commence no later than the 60th day after the close of the Plan Year in which the latest of the following events occurs: (i) the Participant’s Normal Retirement Age; (ii) the tenth anniversary of the year in which the Participant commenced participation in the Plan; or (iii) the termination of the Participant’s employment with the Company.

(d)        Minimum Required Distributions during Participant’s Lifetime. Notwithstanding anything to the contrary in the Plan unless the entire vested portion of a Participant’s Accounts is distributed in a single sum on or before the Required Beginning Date, distributions shall be made in accordance with this paragraph (d) as of the first Distribution Calendar Year and the entire vested portion of a Participant’s Accounts shall be distributed, or begin to be distributed, to the Participant no later than the Participant’s Required Beginning Date as set forth below:

(i)          Amount of Minimum Required Distribution for each Distribution Calendar Year. During the Participant’s lifetime, the minimum amount that shall be distributed for each Distribution Calendar Year is the lesser of:

    (A)        the quotient obtained by dividing the Participant’s Account Balance by the distribution period in the Uniform Lifetime Table set forth in Regulation Section 1.401(a)(9)-9, using the Participant’s age as of the Participant’s birthday in the Distribution Calendar Year; or

    (B)        if the Participant’s sole Designated Beneficiary for the Distribution Calendar Year is the Participant’s spouse, the quotient obtained by dividing the Participant’s Account Balance by the number in the Joint and Last Survivor Table set forth in Regulation Section 1.401(a)(9)-9, using the Participant’s and spouse’s attained ages as of the Participant’s and spouse’s birthdays in the Distribution Calendar Year.

(ii)         Lifetime Minimum Required Distributions continue through Year of Participant’s Death. Minimum required distributions shall be determined under this paragraph (d) beginning with the first Distribution Calendar Year and up to and including the Distribution Calendar Year that includes the Participant’s date of death.

(iii)        Minimum Required Distributions for the 2002 Distribution Calendar Year. Notwithstanding the foregoing, with respect to distributions made for the 2002 Distribution Calendar Year, the Plan will apply the minimum distribution requirements of Code Section 401(a)(9) in accordance with the

 

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regulations under Code Section 401(a)(9) that were proposed on January 17, 2001, notwithstanding any provision of the Plan to the contrary.

  (iv)        Treasury Regulations Incorporated by Reference. All distributions required under this paragraph shall be determined and made in accordance with the Treasury Regulations under Code Section 401(a)(9).

(e)        Minimum Required Distributions following Participant’s Death. Notwithstanding anything to the contrary in the Plan if a Participant dies before the entire vested portion of his or her Accounts is distributed, the following rules shall apply:

(i)        Required Distribution Dates. If a Participant dies before the entire vested portion of his or her Accounts is distributed, distributions shall be made, or begin to be made, no later than as follows:

(A)    If the Participant’s surviving spouse is the Participant’s sole Designated Beneficiary, then, except as provided in subparagraph (iv) below, distributions to the surviving spouse shall begin by December 31 of the calendar year immediately following the calendar year in which the Participant died, or by December 31 of the calendar year in which the Participant would have attained age 70-1/2, if later.

(B)    If the Participant’s surviving spouse is not the Participant’s sole Designated Beneficiary, then, except as provided in subparagraph (iv) below, distributions to the Designated Beneficiary shall begin by December 31 of the calendar year immediately following the calendar year in which the Participant died.

(C)    If there is no Designated Beneficiary as of September 30 of the year following the year of the Participant’s death, the Participant’s entire interest shall be distributed by December 31 of the calendar year containing the fifth anniversary of the Participant’s death.

(D)    If the Participant’s surviving spouse is the Participant’s sole Designated Beneficiary and the surviving spouse dies after the Participant but before distributions to the surviving spouse begin, this subparagraph (i), other than clause (A), shall apply as if the surviving spouse were the Participant.

    For purposes of this subparagraph (i) and subparagraphs (ii) and (iii) below, unless clause (D) above applies, distributions are considered to begin on the Participant’s Required Beginning Date. If clause (D) applies, distributions are considered to begin on the date distributions are required to begin to the surviving spouse under clause (A).

 

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    (ii)        Forms of Distribution if Participant Dies On or After Distributions Begin. Unless the entire vested portion of a Participant’s Accounts is distributed in a single sum on or before the dates set forth in subparagraph (i) above, the entire vested portion of a Participant’s Accounts shall be distributed, or begin to be distributed, as set forth below:

(A)    Participant Survived by Designated Beneficiary. If the Participant dies on or after the date distributions begin and there is a Designated Beneficiary, the minimum amount that shall be distributed for each Distribution Calendar Year after the year of the Participant’s death is the quotient obtained by dividing the Participant’s Account Balance by the longer of the remaining life expectancy of the Participant or the remaining life expectancy of the Participant’s Designated Beneficiary, determined as follows:

(1)        The Participant’s remaining life expectancy is calculated using the age of the Participant in the year of death, reduced by one for each subsequent year.

(2)        If the Participant’s surviving spouse is the Participant’s sole Designated Beneficiary, the remaining life expectancy of the surviving spouse is calculated for each Distribution Calendar Year after the year of the Participant’s death using the surviving spouse’s age as of the spouse’s birthday in that year. For Distribution Calendar Years after the year of the surviving spouse’s death, the remaining life expectancy of the surviving spouse is calculated using the age of the surviving spouse as of the spouse’s birthday in the calendar year of the spouse’s death, reduced by one for each subsequent calendar year.

(3)        If the Participant’s surviving spouse is not the Participant’s sole Designated Beneficiary, the Designated Beneficiary’s remaining life expectancy is calculated using the age of the beneficiary in the year following the year of the Participant’s death, reduced by one for each subsequent year.

(B)    No Designated Beneficiary. If the Participant dies on or after the date distributions begin and there is no Designated Beneficiary as of September 30 of the year after the year of the Participant’s death, the minimum amount that shall be distributed for each Distribution Calendar Year after the year of the Participant’s death is the quotient obtained by dividing the Participant’s Account Balance by the Participant’s remaining life expectancy calculated

 

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using the age of the Participant in the year of death, reduced by one for each subsequent year.

    (iii)        Forms of Distribution if Participant Dies Before Distributions Begin. Unless the entire vested portion of a Participant’s Accounts is distributed in a single sum on or before the dates set forth in subparagraph (i) above, the entire vested portion of a Participant’s Accounts shall be distributed, or begin to be distributed, as set forth below:

(A)        Participant Survived by Designated Beneficiary. Except as provided in subparagraph (iv) below, if the Participant dies before the date distributions begin and there is a Designated Beneficiary, the minimum amount that shall be distributed for each Distribution Calendar Year after the year of the Participant’s death is the quotient obtained by dividing the Participant’s Account Balance by the remaining life expectancy of the Participant’s Designated Beneficiary, determined as provided in subparagraph (ii)(A) above.

(B)        No Designated Beneficiary. If the Participant dies before the date distributions begin and there is no Designated Beneficiary as of September 30 of the year following the year of the Participant’s death, distribution of the Participant’s entire interest shall be completed by December 31 of the calendar year containing the fifth anniversary of the Participant’s death.

(C)        Death of Surviving Spouse Before Distributions to Surviving Spouse Are Required to Begin. If the Participant dies before the date distributions begin, the Participant’s surviving spouse is the Participant’s sole Designated Beneficiary, and the surviving spouse dies before distributions are required to begin to the surviving spouse under subparagraph (i)(A) above, this subparagraph (iii) shall apply as if the surviving spouse were the Participant.

    (iv)        Election to Apply 5-Year Rule to Distributions to Designated Beneficiaries. If the Participant dies before the entire vested portion of his or her Accounts is distributed and there is a Designated Beneficiary, distribution to the Designated Beneficiary is not required to begin by the date specified in subparagraph (i) if the Participant or Designated Beneficiary elects that the entire vested portion of the Participant’s Accounts be distributed to the Designated Beneficiary by December 31 of the calendar year containing the fifth anniversary of the Participant’s death. If the Participant’s surviving spouse is the Participant’s sole Designated Beneficiary and the surviving spouse dies after the Participant but before distributions to either the Participant or the surviving spouse begin, an election under this subparagraph shall apply as if the surviving spouse were the Participant. The election must be made no later than the earlier of September 30 of the calendar year in which distribution would be required to begin under

 

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subparagraph (i), or by September 30 of the calendar year which contains the fifth anniversary of the Participant’s (or, if applicable, surviving spouse’s) death. If neither the Participant nor Designated Beneficiary makes an election under this subparagraph, distributions shall be made in accordance with subparagraphs (i) and (iii).

(v)        Election to Allow Designated Beneficiary Receiving Distributions under 5-Year Rule to Elect Life Expectancy Distributions. A Designated Beneficiary who is receiving payments under the 5-year rule described in subparagraph (iv) above, may make a new election to receive payments under the life expectancy rule until December 31, 2003, provided that all amounts that would have been required to be distributed under the life expectancy rule for all Distribution Calendar Years before 2004 are distributed by the earlier of December 31, 2003 or the end of the 5-year period.

(vi)       Minimum Required Distributions for the 2002 Distribution Calendar Year. Notwithstanding the foregoing, with respect to distributions made for the 2002 Distribution Calendar Year, the Plan shall apply the minimum distribution requirements of Code Section 401(a)(9) in accordance with the regulations under Code Section 401(a)(9) that were proposed on January 17, 2001, notwithstanding any provision of the Plan to the contrary.

(vii)      Treasury Regulations Incorporated by Reference. All distributions required under this paragraph shall be determined and made in accordance with the Treasury Regulations under Code Section 401(a)(9).

(f)        Definitions for Minimum Required Distribution Rules. For purposes of paragraphs (d) and (e) above, the following definitions shall apply:

(i)        “Account Balance” shall mean the account balance of a Participant’s Account as of the last valuation date in the calendar year immediately preceding the Distribution Calendar Year (valuation calendar year) increased by the amount of any contributions made and allocated or forfeitures allocated to a Participant’s Accounts as of dates in the valuation calendar year after the valuation date and decreased by distributions made in the valuation calendar year after the valuation date. The Account Balance for the valuation calendar year includes any amounts rolled over or transferred to the plan either in the valuation calendar year or in the Distribution Calendar Year if distributed or transferred in the valuation calendar year.

(ii)       “Designated Beneficiary” shall mean the individual who is designated as the Beneficiary under Section 8.4 and is the Designated Beneficiary under Code Section 401(a)(9) and Regulation Section 1.401(a)(9)-1, Q&A-4.

(iii)      “Distribution Calendar Year” shall mean a calendar year for which a minimum distribution is required. For distributions beginning before the

 

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Participant’s death, the first Distribution Calendar Year is the calendar year immediately preceding the calendar year which contains the Participant’s Required Beginning Date. For distributions beginning after the Participant’s death, the first Distribution Calendar Year is the calendar year in which distributions are required to begin under paragraph (e). The minimum required distribution for the Participant’s first Distribution Calendar Year shall be made on or before the Participant’s Required Beginning Date. The minimum required distribution for other Distribution Calendar Years, including the minimum required distribution for the Distribution Calendar Year in which the Participant’s Required Beginning Date occurs, shall be made on or before December 31 of that Distribution Calendar Year.

(iv)        “Life expectancy” shall mean as computed by use of the Single Life Table in Regulation Section 1.401(a)(9)-9.

(v)         “Required Beginning Date” shall mean the April 1 of the calendar year immediately following the later of the calendar year in which the Participant attains age 70-1/2 or incurs a Severance; provided, however, if such Participant is a Five Percent Owner (as defined in Code Section 416(i) and applicable regulations) with respect to the Plan Year ending in the calendar year in which such Participant attains age 70-1/2, the Required Beginning Date shall be April 1 of the calendar year immediately following the year in which such Participant attains age 70-1/2.

(g)        If it is not administratively practical to calculate and commence payments by the latest date specified in the rules of paragraphs (b), (c), (d) and (e) above because the amount of the Participant’s benefit cannot be calculated, or because the Committee is unable to locate the Participant (or eligible Beneficiary) after making reasonable efforts to do so, the payment shall be made as soon as is administratively possible (but not more than 60 days) after the amount of the benefit can be ascertained or the Participant (or Beneficiary) can be located.

8.7         Forfeitures .  The non-vested portion of a Participant’s Accounts shall be forfeited in accordance with the following rules:

(a)        In the event a Participant who incurs a Severance receives a distribution of the entire vested portion of his or her Accounts when he or she is not fully vested in such Accounts, the non-vested portion of the Participant’s Accounts shall be forfeited as of the Participant’s distribution date. A Participant who incurs a Severance when no portion of his or her Accounts are vested shall be deemed to have received a distribution pursuant to this paragraph (a) as of his or her Severance Date and his or her Accounts shall be forfeited as of the Participant’s Severance Date. If the Participant is rehired by the Company prior to the date he or she incurs five consecutive Breaks in Service, the amounts forfeited shall be reinstated to the Participant’s Accounts as of the Participant’s Reemployment Commencement Date (without regard to any interest or investment earnings on such amount).

 

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(b)        In the event a Participant who incurs a Severance does not receive a distribution of the entire vested portion of his or her Accounts when he or she is not fully vested in such Accounts, the Participant’s Accounts shall be held by the Trustee as provided in Section 6.8 for 90 days at which time, the nonvested portion of the Participant’s Accounts shall be forfeited as of the last day of the month in which the 90-day period ends. If the Participant is rehired by the Company prior to the date he or she incurs five consecutive Breaks in Service, the amount so forfeited plus an amount equal to the rate of return that the amount forfeited would have received but for forfeiture pursuant to this paragraph (b) shall be reinstated to the Participant’s Accounts as of the Participant’s Reemployment Commencement Date. The Company shall be obligated to contribute to the Trust Fund any amounts necessary after application of Section 6.3 to reinstate a Participant’s Accounts if reinstatement is required under the provisions of this paragraph.

(c)        At any relevant time after application of paragraphs (a) and (b) above, a Participant’s vested portion of his or her Accounts shall be equal to an amount (“X”) determined by the following formula:

X = P*(AB + D) - D

For the purposes of applying the formula:

P = the vested percentage at any relevant time determined pursuant to Section 7.2

AB = the Account balance at the relevant time

D = the total amount of any distributions from the Accounts since such Severance

(d)        Forfeitures shall be allocated in the manner provided in Section 6.3 at such times as determined by the Committee and to the extent available shall be used to reduce contributions made by the Company pursuant to Sections 5.3 and 5.4.

8.8         Valuation of Accounts Upon Distribution .  For the purpose of any distribution of Accounts under this Article VIII, the amount of such distribution shall be based on the value of a Participant’s Accounts as of the Valuation Date in the month in which the application for such distribution is deemed perfected. If a properly completed distribution application is received by the Committee during any month and on or before the fifteenth day of such month, the distribution application shall be deemed perfected in such month, otherwise such distribution application shall be deemed perfected in the immediately following month.

8.9         Lapsed Benefits .

(a)        In the event that a Participant’s Accounts is payable under the Plan and after reasonable efforts the Participant cannot be located for the purpose of paying his or her Accounts during a period of three consecutive years, the Participant shall be

 

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presumed dead and his or her Accounts shall, upon the expiration of that three year period, be paid to the Participant’s Beneficiary. If the Participant’s Beneficiary cannot be located for the purpose of paying the Participant’s Accounts for the following two years, then the Participant’s Accounts shall, upon expiration of such two-year period, be forfeited and reallocated to the Accounts of other Participants in accordance with Section 6.3.

(b)        If a Participant dies prior to receiving a distribution of the entire vested portion of his or her Accounts (other than a Participant presumed to have died as provided above) and if after reasonable efforts the Beneficiary of the Participant cannot be located for the purpose of paying the Participant’s Accounts during a period of five consecutive years, the benefit shall, upon expiration of such five-year period, be forfeited and reallocated to the Accounts of the other Participants in accordance with Section 6.3.

(c)        For purposes of this Section, the term “Beneficiary” shall include any person entitled under Section 8.4 to receive the vested interest of a deceased Participant or deceased designated Beneficiary. It is the intention of this Section that during the relevant waiting period (two years or five years) the vested portion of a Participant’s Accounts shall be distributed to a Beneficiary in a lower priority category under Section 8.4 if no Beneficiary in a higher priority category can be located by the Committee after reasonable efforts have been made.

(d)        Notwithstanding the foregoing rules, if after such a forfeiture the Participant or a Beneficiary claims the forfeited Accounts, the amount forfeited shall be reinstated (without regard to any interest or investment earnings on such amount) and paid to the Participant or Beneficiary as soon as practical following the production of reasonable proof of the identity of the Participant or Beneficiary and his or her entitlement to the amounts forfeited (determined pursuant to the Plan’s normal claim procedures under Section 9.10).

(e)        The Committee shall direct the Trustee with respect to the procedures to be followed concerning a missing Participant (or Beneficiary), and the Company shall be obligated to contribute to the Trust Fund any amounts necessary after the application of Section 6.3 to pay any reinstated benefit after it has been forfeited pursuant to the provisions of this Section.

8.10       Persons Under Legal Disability .

(a)        If any payee under the Plan is a minor or if the Committee reasonably believes that any payee is legally incapable of giving a valid receipt and discharge for any payment due him/her, the Committee may have the payment, or any part thereof, made to the person (or persons or institution) whom it reasonably believes is caring for or supporting the payee, unless it has received due notice of claim therefor from a duly appointed guardian or committee of the payee.

 

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(b)        Any such payment shall be a payment from the Accounts of the payee and shall, to the extent thereof, be a complete discharge of any liability under the Plan to the payee.

8.11       Additional Documents .

(a)        The Committee or the Company may require satisfactory proof of any matter under the Plan from or with respect to any Employee, Participant, or Beneficiary, and no person shall be entitled to receive any benefits under the Plan until the required proof shall be furnished.

(b)        The Committee or Trustee, or both, may require the execution and delivery of such documents, papers and receipts as the Committee or Trustee may determine necessary or appropriate in order to establish the fact of death of the deceased Participant and of the right and identity of any Beneficiary or other person or persons claiming any benefits under this Article VIII.

(c)        The Committee or the Trustee, or both, may, as a condition precedent to the payment of death benefits hereunder, require an inheritance tax release and/or such security as the Committee or Trustee, or both, may deem appropriate as protection against possible liability for State or Federal death taxes attributable to any death benefits.

8.12       Trustee-to-Trustee Transfers .  In the case of any Participant or Participants who have terminated employment with the Company and all Affiliated Companies and subsequently become employed by an unrelated successor employer, the Committee, shall at the request of such Participant or Participants, direct the Trustee to transfer the assets in the Accounts of such Participant or Participants directly to the trustee of any retirement plan maintained by such successor employer or employers in lieu of any distribution described in the preceding provisions of this Article VIII but only if (i) the retirement plan maintained by such successor employer is determined to the satisfaction of the Committee to be qualified under Code Section 401, (ii) the sponsor and trustee of such plan consent to the transfer, and (iii) such transfer satisfies the conditions of Section 12.2 hereof.

8.13       Loans to Participants .  A Participant may borrow from his or her Accounts except from his or her Retirement Contributions Account while an Employee in accordance with the following rules:

(a)        Subject to minimum and maximum loan requirements, a Participant may borrow up to 50% of his or her After Tax Deposits Account, Before Tax Deposits Account, Rollover Contributions Account, and the vested portion of his or her Matching Contributions Account. Only one loan may be outstanding to a Participant any time. The minimum loan amount shall be $1,000 and the maximum loan amount shall be $50,000. The $50,000 maximum loan amount shall be reduced by the excess, if any, of the highest outstanding balance of loans from the Plan to the Participant during the one-year period

 

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ending on the day before the loan is made over the outstanding balance of loans on the date the loan is made.

(b)        A loan to a Participant shall be made solely from his or her Account(s) and shall be considered an investment directed by the Participant. Loan amounts shall be funded from the Participant’s Accounts as determined under procedures established by the Committee; provided, however, that principal repayments shall be credited to the Participant’s Accounts in the inverse of the order used to fund the loan and interest payments shall be credited to the Participant’s Accounts in direct proportion to the principal repayments.

(c)        A loan to a Participant shall bear an interest rate equal to the prime rate reported in the Wall Street Journal on first business day of the month in which the loan is granted (the last business day of the previous month for loans made prior to July 1, 2000) plus one percent (1%) and shall remain fixed throughout the term of the loan. Notwithstanding the preceding sentence, if the Committee determines that such rate is not reasonable or otherwise not in accordance with applicable requirements under the Code or ERISA, the Committee shall set an alternate interest rate at the time that the loan is taken.

(d)        A loan to a Participant shall have a definite maturity date. Loans, other than loans made for the purpose of acquiring the principal residence of the Participant, shall be made for a period not to exceed five (5) years. Loans made for the purpose of acquiring the principal residence of the Participant shall be made for a period not to exceed fifteen (15) years.

(e)        A loan to a Participant shall have a definite repayment schedule and shall be amortized on a substantially level basis with repayments occurring not less frequently than quarterly. Notwithstanding the foregoing, the loan repayments shall be suspended during an unpaid Leave of Absence not to exceed one year at which time loan repayments shall resume in accordance with Regulation Section 1.72(p)-1. In the case of a Leave of Absence due to uniformed service, loan repayments shall be suspended as permitted under Code Section 414(u)(4) and in accordance with Regulation Section 1.72(p)-1.

(f)        A loan to a Participant shall be secured by the vested portion of the Participant’s Account(s). No more than 50% of the Participant’s vested Account(s) as determined on the date the loan is issued shall be considered by the Plan as security for a loan. A Participant who borrows from the Plan hereby agrees that, unless expressly provided otherwise in loan documents, any such loan is automatically secured by 50% of his or her vested Account(s).

(g)        A loan to a Participant shall be evidenced by a promissory note and/or such other documentation as required by the Committee.

 

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(h)        A loan to a Participant shall be treated as a distribution unless the entire principal amount and any interest accrued thereon is repaid within ninety (90) days after the occurrence of a Participant’s Severance. Absent repayment by the Participant, the Committee shall instruct the Trustee to distribute the note to the Participant as part of his or her distribution and the Participant’s vested Account(s) shall be reduced to the extent of such distribution and treatment shall be in accordance with Regulation Section 1.72(p)-1.

(i)        The Committee shall establish the participant loan program and have the duty to manage and administer the participant loan program in accordance with the terms and provisions of this Section. The Committee shall have, but not by way of limitation, the following discretionary powers and authority:

(i)        To determine the manner in which loan repayments shall occur whether it be through automatic payroll deductions or otherwise.

(ii)       To determine the amount of loan repayments following suspension due to an unpaid Leave of Absence subject to the requirement that the loan must be repaid by the latest date permitted under paragraph (d).

(iii)      To establish any fees, including but not limited to application fees and maintenance fees, and the manner in which such fees are collected from the Participant.

(iv)      To consider only those factors which would be considered in a normal commercial setting by persons in the business of making similar types of loans in establishing the participant loan program. Such factors may include the applicant’s credit worthiness and financial need, but may not include any factor which would discriminate against Participants who are not Highly Compensated Employees. Loans shall be made available to all Participants without regard to a Participant’s race, color, religion, sex, age or national origin and shall not be made available to Participants who are Highly Compensated Employees in an amount greater than the amount made available to Participants who are not Highly Compensated Employees.

 

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ARTICLE IX

OPERATION AND ADMINISTRATION

9.1         Appointment of Committee .  There is hereby created a committee (the “Committee”) which shall exercise such powers and have such duties in administering the Plan as are hereinafter set forth. The Board of Directors shall determine the number of members of such Committee. The members of the Committee shall be appointed by the Board of Directors and such Board shall from time to time fill all vacancies occurring in said Committee. The members of the Committee shall constitute the Named Fiduciaries of the Plan within the meaning of Section 402(a)(2) of ERISA; provided that solely for purposes of Section 5.9 hereof, Participants shall be Named Fiduciaries with respect to shares of Company Stock allocated to their respective Accounts and solely for purposes of Section 5.10, Participants shall be Named Fiduciaries with respect to shares of Company Stock allocated to their respective Accounts on matters as to which they are entitled to provide voting directions.

9.2         Appointment of Investment Subcommittee .  There is hereby created an investment subcommittee of the Committee (hereinafter referred to as the “Investment Subcommittee” for purposes of this Article IX) which shall exercise management and control over the assets of the Trust. The Board of Directors, acting through its Organization and Compensation Committee, shall determine the number of members of the Investment Subcommittee. The members of the Investment Subcommittee shall be appointed by the Board of Directors, acting through its Organization and Compensation Committee, and shall from time to time appoint such members to or fill any vacancies in the Investment Subcommittee. The members of the Investment Subcommittee shall constitute the Named Fiduciaries of the Plan within the meaning of Section 402(a)(2) of ERISA with respect to the management and control of the assets of the Trust; provided that solely for purposes of Section 5.9 hereof, Participants shall be Named Fiduciaries with respect to shares of Company Stock allocated to their respective Accounts and solely for purposes of Section 5.10, Participants shall be Named Fiduciaries with respect to shares of Company Stock allocated to their respective Accounts on matters as to which they are entitled to provide voting directions.

9.3         Transaction of Business .  The Committee and Investment Subcommittee shall transact business as provided in paragraphs (a) and (b), respectively:

(a)        A majority of the Committee shall constitute a quorum for the transaction of business. Actions of the Committee may be taken either by vote at a meeting or in writing without a meeting. All action taken by the Committee at any meeting shall be by a vote of the majority of those present at such meeting. All action taken in writing without a meeting shall be by a vote of the majority of those responding in writing. All notices, advices, directions and instructions to be transmitted by the Committee shall be in writing and signed by or in the name of the Committee. In all its communications with the Trustee, the Committee may, by either of the majority actions specified above, authorize any one or more of its members to execute any document or documents on behalf of the Committee, in which event it shall notify the Trustee in writing of such action and the name or names of its members so designated and the Trustee shall

 

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thereafter accept and rely upon any documents executed by such member or members as representing action by the Committee until the Committee shall file with the Trustee a written revocation of such designation.

(b)        A majority of the Investment Subcommittee shall constitute a quorum for the transaction of business. Actions of the Investment Subcommittee may be taken either by vote at a meeting or in writing without a meeting. All action taken by the Investment Subcommittee at any meeting shall be by a vote of the majority of those present at such meeting. All action taken in writing without a meeting shall be by a vote of the majority of those responding in writing. All notices, advices, directions and instructions to be transmitted by the Investment Subcommittee shall be in writing and signed by or in the name of the Investment Subcommittee. In all its communications with the Trustee, the Investment Subcommittee may, by action specified above, authorize any one or more of its members to execute any document or documents on behalf of the Investment Subcommittee, in which event it shall notify the Trustee in writing of such action and the name or names of its members so designated and the Trustee shall thereafter accept and rely upon any documents executed by such member or members as representing action by the Investment Subcommittee until the Investment Subcommittee shall file with the Trustee a written revocation of such designation.

9.4         Voting .  Any member of the Committee who is also a Participant hereunder shall not be qualified to act or vote on any matter relating solely to himself or herself, and upon such matter his or her presence at a meeting shall not be counted for the purpose of determining a quorum. If, at any time a member of the Committee is not so qualified to act or vote, the qualified members of the Committee shall be reduced below two (2) and the Board of Directors shall promptly appoint one or more special members to the Committee so that there shall be at least one qualified member to act upon the matter in question. Such special Committee members shall have power to act only upon the matter for which they were especially appointed and their tenure shall cease as soon as they have acted upon the matter for which they were especially appointed.

9.5         Responsibility of Committees .  The responsibilities of the Committee and Investment Subcommittee shall be as provided in paragraphs (a) and (b), respectively:

(a)        The authority to manage and control the operation and administration of the Plan, the general administration of the Plan, the responsibility for carrying out the Plan, and to the extent provided in Section 9.7(f), the authority and responsibility to manage and control the assets of the Trust are hereby delegated by the Board of Directors to and vested in the Committee except to the extent reserved to the Board of Directors, the Sponsor, or the Company. Subject to the limitations of the Plan, the Committee shall, from time to time, establish rules for the performance of its functions and the administration of the Plan. In the performance of its functions, the Committee shall not discriminate in favor of Highly Compensated Employees.

(b)        The authority and responsibility to manage and control the assets of the Trust are hereby delegated by the Board of Directors, acting through its Organization and

 

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Compensation Committee, to and vested in the Investment Subcommittee except to the extent reserved to the Board of Directors or the Board of Directors, acting through its Organization and Compensation Committee, or the Sponsor. Subject to the limitations of the Plan, the Investment Subcommittee shall, from time to time, establish rules for the performance of its functions.

9.6         Committee Powers .  The Committee shall have all discretionary powers necessary to supervise the administration of the Plan and control its operations. In addition to any discretionary powers and authority conferred on the Committee elsewhere in the Plan or by law, the Committee shall have, but not by way of limitation, the following discretionary powers and authority:

(a)        To designate agents to carry out responsibilities relating to the Plan, other than fiduciary responsibilities as provided in Section 9.7.

(b)        To employ such legal, actuarial, medical, accounting, clerical, and other assistance as it may deem appropriate in carrying out the provisions of the Plan, including one or more persons to render advice with regard to any responsibility any Named Fiduciary or any other fiduciary may have under the Plan.

(c)        To establish rules and regulations from time to time for the conduct of the Committee’s business and the administration and effectuation of the Plan.

(d)        To administer, interpret, construe, and apply the Plan and to decide all questions which may arise or which may be raised under the Plan by any Employee, Participant, former Participant, Beneficiary or other person whatsoever, including but not limited to all questions relating to eligibility to participate in the Plan, the amount of Credited Service of any Participant, and the amount of benefits to which any Participant or his or her Beneficiary may be entitled.

(e)        To determine the manner in which the assets of the Plan, or any part thereof, shall be disbursed.

(f)        Subject to provisions (a) through (d) of Section 10.1, to make administrative amendments to the Plan that do not cause a substantial increase or decrease in benefit accruals to Participants and that do not cause a substantial increase in the cost of administering the Plan.

(g)        To perform or cause to be performed such further acts as it may deem to be necessary, appropriate or convenient in the efficient administration of the Plan.

Any action taken in good faith by the Committee in the exercise of discretionary powers conferred upon it by the Plan shall be conclusive and binding upon the Participants and their Beneficiaries. All discretionary powers conferred upon the Committee shall be absolute; provided, however, that all such discretionary power shall be exercised in a uniform and nondiscriminatory manner.

 

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9.7         Additional Powers of Committee .    In addition to any discretionary powers or authority conferred on the Committee elsewhere in the Plan or by law, such Committee shall have the following discretionary powers and authority:

(a)        To appoint one or more Investment Managers pursuant to Section 5.16 to manage and control any or all of the assets of the Trust not invested or to be invested in Company Stock.

(b)        To designate persons (other than the members of the Committee) to carry out fiduciary responsibilities, other than any responsibility to manage or control the assets of the Trust;

(c)        To allocate fiduciary responsibilities among the members of the Committee, other than any responsibility to manage or control the assets of the Trust;

(d)        To cancel any such designation or allocation at any time for any reason;

(e)        To direct the voting of any Company Stock or any other security held by the Trust subject to Sections 5.10 and 9.16 hereof; and

(f)        To exercise management and control over the assets of the Trust to the extent provided in paragraph (a) above and in Section 9.9 (relating to review by the Committee of the long-run and short-run financial needs of the Plan and the determination of the funding policy for the Plan).

Any action under this Section 9.7 shall be taken in writing, and no designation or allocation under paragraphs (a), (b) or (c) shall be effective until accepted in writing by the indicated responsible person.

9.8         Investment Subcommittee Powers .    The Investment Subcommittee shall have all discretionary powers necessary to manage and control the assets of the Trust, including but not limited to, the following:

(a)        To exercise management and control over the assets of the Trust except to the extent the Committee appoints an Investment Manager pursuant to Section 9.7(a) and subject to the requirement that all action taken by the Investment Subcommittee shall be in accordance and consistent with the funding policy established by the Committee and shall be communicated to the Committee at periodic intervals.

(b)        To employ consulting, actuarial, and other assistance as it may deem appropriate in carrying out its responsibilities under the Plan, including one or more persons to render advice with regard to any fiduciary responsibility the Investment Subcommittee may have under the Plan.

 

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(c)        To establish rules and regulations from time to time for the conduct of the Investment Subcommittee’s business.

(d)        To direct the Trustee, in writing, from time to time, to invest and reinvest the Trust Fund, or any part thereof, or to purchase, exchange, or lease any property, real or personal, which the Investment Subcommittee may designate. This shall include the right to direct the investment of all or any part of the Trust in any one security or any one type of securities permitted hereunder.

(e)        To direct the purchase and sale of Company Stock (and any other securities that are “qualifying employer securities” as defined in Code Section 4975(e)) for the Trust.

Any action taken in good faith by the Investment Subcommittee in the exercise of discretionary powers conferred upon it by the Plan shall be conclusive and binding upon the Participants and their Beneficiaries.

9.9         Periodic Review of Funding Policy .  Notwithstanding the delegation of authority and responsibility to manage and control the assets of the Trust to the Investment Subcommittee, the Committee, at periodic intervals, shall review the long-run and short-run financial needs of the Plan and shall determine a funding policy for the Plan consistent with the objectives of the Plan and the minimum funding standards of ERISA, if applicable. In determining such funding policy the Committee shall take into account, at a minimum, not only the long-term investment objectives of the Trust Fund consistent with the prudent management of the assets thereof, but also the short-run needs of the Plan to pay benefits. All actions taken by the Committee with respect to the funding policy of the Plan, including the reasons therefor, shall be fully reflected in the minutes of the Committee.

9.10       Claims Procedures .  If a Participant or his or her Beneficiary believes that he or she is being denied any rights or benefits under the Plan, the Participant, Beneficiary, or in either case, his or her authorized representative (the “Claimant”) shall follow the administrative procedures for filing a claim for benefits as set forth in this Section. A claim for benefits shall be in writing and shall be reviewed by the Committee or a claims official designated by the Committee. The Committee or claims official shall review a claim for benefits in accordance with the procedures established by the Committee subject to the following administrative procedures set forth in this Section.

(a)        The Committee shall furnish the Claimant with written or electronic notice of the decision rendered with respect to a claim for benefits within 90 days following receipt by the Committee (or its delegate) of the claim unless the Committee determines that special circumstances require an extension of time for processing the claim. In the event an extension is necessary, written or electronic notice of the extension shall be furnished to the Claimant prior to the expiration of the initial 90 day period. The notice shall indicate the special circumstances requiring an extension of time and the date by which a final decision is expected to be rendered. In no event shall the period of the extension exceed 90 days from the end of the initial 90 day period.

 

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(b)        In the case of a denial of the Claimant’s claim, the written or electronic notice of such denial shall set forth (i) the specific reasons for the denial, (ii) references to the Plan provisions upon which the denial is based, (iii) a description of any additional information or material necessary for perfection of the claim (together with an explanation why such material or information is necessary), (iv) an explanation of the Plan’s appeals procedures, and (v) a statement of the Claimant’s right to bring a civil action under Section 502(a) of ERISA if his or her claim is denied upon appeal.

(c)        In the case of a denial of a claim, a Claimant who wishes to appeal the decision shall follow the administrative procedures for an appeal as set forth in Section 9.11 below.

9.11       Appeals Procedures .  A Claimant who wishes to appeal the denial of his or her claim for benefits shall follow the administrative procedures for an appeal as set forth in this Section and shall exhaust such administrative procedures prior to seeking any other form of relief. Appeals shall be reviewed in accordance with the procedures established by the Committee subject to the following administrative procedures set forth in this Section.

(a)        In order to appeal a decision rendered with respect to his or her claim for benefits, a Claimant must file an appeal with the Committee in writing within 60 days following his or her receipt of the notice of denial with respect to the claim.

(b)        The Claimant’s appeal may include written comments, documents, records and other information relating to his or her claim. The Claimant may review all pertinent documents and, upon request, shall have reasonable access to or be provided free of charge, copies of all documents, records, and other information relevant to his or her claim.

(c)        The Committee shall provide a full and fair review of the appeal and shall take into account all claim related comments, documents, records, and other information submitted by the Claimant without regard to whether such information was submitted or considered under the initial determination or review of the initial determination. Where appropriate, the Committee will overturn a notice of denial if it determines that an error was made in the interpretation of the controlling plan documents or if the Committee determines that an existing interpretation of the controlling plan documents should be changed on a prospective basis. In the event the Claimant is a subordinate, as determined by the Committee, to an individual conducting the review, such individual shall recuse himself or herself from the review of the appeal.

(d)        The Committee shall furnish the Claimant with written or electronic notice of the decision rendered with respect to an appeal within 60 days following receipt by the Committee of the appeal unless the Committee determines that special circumstances require an extension of time for processing the appeal. In the event an extension is necessary, written or electronic notice of the extension shall be furnished to the Claimant prior to the expiration of the initial 60 day period. The notice shall indicate the special circumstances requiring an extension of time and the date by which a final decision is

 

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expected to be rendered. In no event shall the period of the extension exceed 60 days from the end of the initial 60 day period.

(e)        In the case of a denial of an appeal, the written or electronic notice of such denial shall set forth (i) the specific reasons for the denial, (ii) references to the Plan provisions upon which the denial is based, (iii) a statement that the Claimant is entitled to receive, upon request and free of charge, reasonable access to, and copies of, all documents, records, and other information relating to his or her claim for benefits, and (iv) a statement of the Claimant’s right to bring a civil action under Section 502(a) of ERISA.

9.12       Limitation on Liability   Each of the fiduciaries under the Plan shall be solely responsible for its own acts and omissions and no fiduciary shall be liable for any breach of fiduciary responsibility resulting from the act or omission of any other fiduciary or person to whom fiduciary responsibilities have been allocated or delegated pursuant to Section 9.2 or 9.7, except as provided in Sections 405(a) and 405(c)(2)(A) or (B) of ERISA. Neither the Committee nor the Investment Subcommittee shall have responsibility over assets as to which management and control has been delegated to an Investment Manager appointed pursuant to Section 5.16 hereof or as to which management and control has been retained by the Trustee.

9.13       Indemnification and Insurance .  To the extent permitted by law, the Company shall indemnify and hold harmless the Committee, the Investment Subcommittee and each member thereof, the Board of Directors and each member thereof, and such other persons as the Board of Directors may specify, from the effects and consequences of his or her acts, omissions, and conduct in his or her official capacity in connection with the Plan and Trust. To the extent permitted by law, the Company may also purchase liability insurance for such persons.

9.14       Compensation of Committees and Plan Expenses .  Members of the Committee and the Investment Subcommittee shall serve as such without compensation unless the Board of Directors shall otherwise determine, but in no event shall any member of the Committee or Investment Subcommittee who is an Employee receive compensation from the Plan for his or her services as a member of the Committee or the Investment Subcommittee. All members shall be reimbursed for any necessary expenditures incurred in the discharge of duties as members of the Committee or the Investment Subcommittee. The compensation or fees, as the case may be, of all officers, agents, counsel, the Trustee or other persons retained or employed by the Committee or the Investment Subcommittee shall be fixed by the Committee, subject to approval by the Board of Directors. The expenses incurred in the administration and operation of the Plan, including but not limited to the expenses incurred by the members of the Committee or the Investment Subcommittee in exercising their duties, shall be paid by the Plan from the Trust Fund, unless paid by the Company, provided, however, that the Plan and not the Company shall bear the cost of interest and normal brokerage charges which are included in the cost of securities purchased by the Trust Fund (or charged to proceeds in the case of sales). With respect to the expenses that are paid by the Plan from the Trust Fund, such expenses shall be allocated among Participants’ Accounts in a manner determined by the Committee. Any Forfeitures remaining after application of Section 6.3(c) shall share in such allocation to the extent required under applicable law. The Investment Subcommittee shall direct the Trustee to use Plan assets (and, if

 

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necessary, to sell the shares of Company Stock that represent such Plan assets) to pay such expenses.

9.15       Resignation .  Any member of the Committee or Investment Subcommittee may resign by giving fifteen (15) days notice to the Board of Directors, and any member shall resign forthwith upon receipt of the written request of the Board of Directors, whether or not said member is at that time the only member of the Committee or the Investment Subcommittee.

9.16       Reliance Upon Documents and Opinions .  The members of the Committee, the Investment Subcommittee, the Board of Directors, the Company and any person delegated to carry out any fiduciary responsibilities under the Plan (hereinafter a “delegated fiduciary”), shall be entitled to rely upon any tables, valuations, computations, estimates, certificates and reports furnished by any consultant, or firm or corporation which employs one or more consultants, upon any opinions furnished by legal counsel, and upon any reports furnished by the Trustee or any Investment Manager. The members of the Committee, the Investment Subcommittee, the Board of Directors, the Company and any delegated fiduciary shall be fully protected and shall not be liable in any manner whatsoever for anything done or action taken or suffered in reliance upon any such consultant, or firm or corporation which employs one or more consultants, Trustee, Investment Manager, or counsel. Any and all such things done or such action taken or suffered by the Committee, the Investment Subcommittee, the Board of Directors, the Company and any delegated fiduciary shall be conclusive and binding on all Employees, Participants, Beneficiaries, and any other persons whomsoever, except as otherwise provided by law. The Committee, the Investment Subcommittee, and any delegated fiduciary may, but are not required to, rely upon all records of the Company with respect to any matter or thing whatsoever, and may likewise treat such records as conclusive with respect to all Employees, Participants, Beneficiaries, and any other persons whomsoever, except as otherwise provided by law.

 

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ARTICLE X

AMENDMENT AND ADOPTION OF PLAN

10.1       Right to Amend Plan .   The Sponsor, by resolution of the Board of Directors, shall have the right to amend the Plan and Trust Agreement at any time and from time to time and in such manner and to such extent as it may deem advisable, including retroactively, subject to the following provisions:

(a)        No amendment shall have the effect of reducing any Participant’s vested interest in the Plan or eliminating an optional form of distribution.

(b)        No amendment shall have the effect of diverting any part of the assets of the Plan to persons or purposes other than the exclusive benefit of the Participants or their Beneficiaries.

(c)        No amendment shall have the effect of increasing the duties or responsibilities of a Trustee without its written consent.

(d)        No amendment shall result in discrimination in favor of officers, shareholders, or other highly compensated or key employees.

The Committee shall have the right to amend the Plan, subject to paragraphs (a) through (d), in accordance with the provisions of Section 9.6(f).

10.2       Adoption of Plan by Affiliated Companies .  Subject to approval by the Board of Directors and consistent with the provisions of ERISA, an Affiliated Company may adopt the Plan for all or any specified group of its Eligible Employees by entering into an adoption agreement in the form and substance prescribed by the Committee. The adoption agreement may include such modification of the Plan provisions with respect to such Eligible Employees as the Committee approves after having determined that no prohibited discrimination or other threat to the qualification of the Plan is likely to result. The Board of Directors may prospectively revoke or modify an Affiliated Company’s participation in the Plan at any time and for any or no reason, without regard to the terms of the adoption agreement, or terminate the Plan with respect to such Affiliated Company’s Eligible Employees and Participants. By execution of an adoption agreement (each of which by this reference shall become part of the Plan), the Affiliated Company agrees to be bound by all the terms and conditions of the Plan.

 

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ARTICLE XI

DISCONTINUANCE OF CONTRIBUTIONS

In the event the Company decides it is impossible or inadvisable for business reasons to continue to make contributions under the Plan, it may, by resolution of the Board of Directors, discontinue contributions to the Plan. Upon the permanent discontinuance of contributions to the Plan and notwithstanding any other provisions of the Plan, the rights of Participants shall become fully vested and nonforfeitable unless replaced by a comparable plan. The permanent discontinuance of contributions on the part of the Company shall not terminate the Plan as to the funds and assets then held in the Trust, or operate to accelerate any payments of distributions to or for the benefit of Participants or Beneficiaries, and the Trust shall continue to be administered in accordance with the provisions hereof until the obligations hereunder shall have been discharged and satisfied.

 

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ARTICLE XII

TERMINATION AND MERGER

12.1       Right to Terminate Plan .    In the event the Board of Directors decides it is impossible or inadvisable for business reasons to continue the Plan, then it may, by resolution, terminate the Plan. Upon and after the effective date of such termination, the Company shall not make any further contributions under the Plan. Upon the termination or partial termination of the Plan for any reason, the interest in the Trust of each affected Participant shall automatically become fully vested unless the Plan is continued after its termination by conversion of the Plan into a comparable Plan through Plan amendment or through merger. After the satisfaction of all outstanding liabilities of the Plan to persons other than Participants and Beneficiaries, all unallocated assets shall be allocated to the Accounts of Participants to the maximum extent permitted by law. The Trust Fund may not be fully or finally liquidated until all assets are allocated to Accounts; alternatively any unallocated assets may be transferred to another defined contribution plan maintained by the Sponsor or an Affiliated Company qualified under Code Section 401 where such assets shall be allocated among the accounts of Participants herein who are participants in such transferee plan. In no event, however, shall any part of the Plan revert to or be recoverable by the Company, or be used for or diverted to purposes other than for the exclusive benefit of the Participants or their Beneficiaries. Notwithstanding the foregoing, amounts held in the 415 Suspense Account may revert to the Company in accordance with Section 13.6.

12.2       Merger Restriction .    Notwithstanding any other provision in the Plan, the Plan shall not in whole or in part merge or consolidate with, or transfer its assets or liabilities to, any other plan unless each affected Participant in the Plan would (if such other plan then terminated) receive a benefit immediately after the merger, consolidation, or transfer which is equal to or greater than the benefit he or she would have been entitled to receive immediately before the merger, consolidation, or transfer (if the Plan had then terminated).

12.3       Effect on Trustee and Committee .  The Trustee and the Committee shall continue to function as such for such period of time as may be necessary for the winding up of the Plan and for the making of distributions in the manner prescribed by the Board of Directors at the time of termination of the Plan.

12.4       Effect of Reorganization, Transfer of Assets or Change in Control .

(a)        In the event of a consolidation or merger of the Company, or in the event of a sale and/or any other transfer of the operating assets of the Company, any ultimate successor or successors to the business of the Company may continue the Plan in full force and effect by adopting the same by resolution of its board of directors and by executing a proper supplemental or transfer agreement with the Trustee.

(b)        In the event of a Change in Control (as herein defined), all Participants who were Participants on the date of such Change in Control shall become 100% vested in any amounts allocated to their Company Contributions

 

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Accounts on the date of such Change in Control and in any amounts allocated to their Company Contributions Accounts subsequent to the date of the Change in Control. Notwithstanding the foregoing, the Board of Directors may, at its discretion, amend or delete this paragraph (b) in its entirety prior to the occurrence of any such Change in Control. For the purpose of this paragraph (b), “Change in Control” shall mean the following and shall be deemed to occur if any of the following events occur:

(i)        Any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (a “Person”), is or becomes the “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act (a “Beneficial Owner”), directly or indirectly, of securities of the Sponsor representing (1) 20% or more of the combined voting power of the Sponsor’s then outstanding voting securities, which acquisition is not approved in advance of the acquisition or within 30 days after the acquisition by a majority of the Incumbent Board (as hereinafter defined) or (2) 33% or more of the combined voting power of the Sponsor’s then outstanding voting securities, without regard to whether such acquisition is approved by the Incumbent Board;

(ii)       Individuals who, as of the date hereof, constitute the Board of Directors (the “Incumbent Board”), cease for any reason to constitute at least a majority of the Board of Directors, provided that any person becoming a director subsequent to the date hereof whose election, or nomination for election by the Sponsor’s stockholders, is approved by a vote of at least a majority of the directors then comprising the Incumbent Board (other than an election or nomination of an individual whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of the directors of the Sponsor, as such terms are used in Rule 14a-11 of Regulation 14A promulgated under the Exchange Act) shall, for the purposes of the Plan, be considered as though such person were a member of the Incumbent Board of the Sponsor;

(iii)      The consummation of a merger, consolidation or reorganization involving the Sponsor, other than one which satisfies both of the following conditions:

 (A)        a merger, consolidation or reorganization which would result in the voting securities of the Sponsor outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of another entity) at least 55% of the combined voting power of the voting securities of the Sponsor or such other entity resulting from the merger, consolidation or reorganization (the “Surviving Corporation”) outstanding immediately after such merger, consolidation or reorganization and being held in substantially the same proportion as the ownership in the Sponsor’s voting

 

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securities immediately before such merger, consolidation or reorganization, and

 (B)        a merger, consolidation or reorganization in which no Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Sponsor representing 20% or more of the combined voting power of the Sponsor’s then outstanding voting securities; or

(iv)      The stockholders of the Sponsor approve a plan of complete liquidation of the Sponsor or an agreement for the sale or other disposition by the Sponsor of all or substantially all of the Sponsor’s assets.

Notwithstanding the preceding provisions of this paragraph (b), a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this paragraph (b) is (i) an underwriter or underwriting syndicate that has acquired any of the Sponsor’s then outstanding voting securities solely in connection with a public offering of the Sponsor’s securities, (ii) the Sponsor or any subsidiary of the Sponsor or (iii) an employee stock ownership plan or other employee benefit plan maintained by the Sponsor or an Affiliated Company that is qualified under the provisions of the Code. In addition, notwithstanding the preceding provisions of this paragraph (b), a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this paragraph (b) becomes a Beneficial Owner of more than the permitted amount of outstanding securities as a result of the acquisition of voting securities by the Sponsor or an Affiliated Company which, by reducing the number of voting securities outstanding, increases the proportional number of shares beneficially owned by such Person, provided, that if a Change in Control would occur but for the operation of this sentence and such Person becomes the Beneficial Owner of any additional voting securities (other than through the exercise of options granted under any stock option plan of the Sponsor or through a stock dividend or stock split), then a Change in Control shall occur.

(c)        For purposes of this Section 12.4, a Change of Control shall not be deemed to have occurred upon the distribution of the stock of Advanced Medical Optics, Inc. on June 29, 2002 by the Sponsor to its stockholders.

 

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ARTICLE XIII

LIMITATION ON ALLOCATIONS

13.1       General Rule .

(a)        The total Annual Additions under the Plan to a Participant’s Accounts shall not exceed the lesser of:

(i)        Forty Thousand Dollars ($40,000) as adjusted for increases in the cost-of-living under Code Section 415(d); or

(ii)       One Hundred Percent (100%) of the Participant’s Compensation (as defined in Section 13.5), from the Company for the Limitation Year,

except to the extent “catch-up” contributions are permitted under Section 4.2(e) and Code Section 414(v). Notwithstanding the foregoing sentence, the compensation limit set forth in subparagraph (ii) shall not apply to any contribution for medical benefits after separation from service (within the meaning of Code Section 401(h) or Code Section 419A(f)(2)) which is otherwise treated as an Annual Addition.

(b)        For the purpose of this Article XIII, the term “Company” shall mean the Sponsor and any Affiliated Company (determined by reference to Code Section 415(h)) whether or not such Affiliated Company has adopted the Plan pursuant to Section 10.2 and the term “Limitation Year” shall mean the Plan Year.

13.2       Annual Additions .  For purposes of Section 13.1, the term “Annual Additions” shall mean with respect to a Participant, for any Limitation Year with respect to the Plan, the sum of the amounts described below:

(a)        All amounts contributed or deemed contributed by the Company.

(b)        All amounts contributed by the Participant.

(c)        Forfeitures allocated to such Participant.

(d)        Any amounts allocated, after March 31, 1984, to an individual medical account as defined in Code Section 415(l)(2) established under a pension or annuity plan maintained by the Company.

(e)        Any amounts allocated for such Plan Year which amounts are derived from contributions paid or accrued after December 31, 1985, in taxable years ending after such date, which are attributable to postretirement medical benefits allocated to the separate account of a key employee (as defined in Code Section 419A(d)(3)) under a welfare benefit fund (as defined in Code Section 419(e)) maintained by the Company.

 

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(f)        Excess deferral amounts determined pursuant to Sections 4.5 and 6.12.

(g)       Excess deferral amounts determined pursuant to Section 4.4 to the extent such amounts are distributed after the first April 15th following the close of the Participant’s taxable year.

Notwithstanding the foregoing, a Participant’s Rollover Contributions shall not be considered an Annual Addition.

13.3       Other Defined Contribution Plans .  If the Company maintains any other defined contribution plan, then each Participant’s Annual Additions under such defined contribution plan shall be aggregated with the Participant’s Annual Additions under the Plan for the purposes of applying the limitations of Section 13.1.

13.4       Adjustments for Excess Annual Additions .    If as a result of the allocation of forfeitures, a reasonable error in estimating a Participant’s Compensation, or under other limited facts and circumstances that the Commissioner of Internal Revenue finds justify the availability of the rules set forth in Regulation Section 1.415-6(b)(6), the Annual Additions on behalf of any Participant in a Limitation Year to the Plan and all other defined contribution plans maintained by the Company exceed the limitation set forth in Section 13.1, such Participant’s Annual Additions for the Plan shall be reduced in the following order: (i) After Tax Deposits that are not Matched Deposits, (ii) After Tax Deposits that are Matched Deposits, (iii) Before Tax Deposits that are not Matched Deposits, (iv) Before Tax Deposits that are Matched Deposits, (v) Matching Contributions, and (vi) Retirement Contributions. The portion of the reduction attributable to After Tax Deposits and Before Tax Deposits shall be refunded to the Participants and the balance attributable to Matching Contributions, if any, shall be held unallocated in a 415 Suspense Account established for the purpose of this Section 13.4 and shall be used to reduce Company Contributions for the next limitation year (and succeeding limitation year, as necessary) for all Participants in the Plan. The 415 Suspense Account shall be exhausted before any Company contributions shall be allocated to the Accounts of Participants.

13.5       Compensation .  For the purpose of this Article XIII, Compensation shall mean a Participant’s earned income, wages, salaries, fees for professional services, and other amounts received (without regard to whether or not an amount is paid in cash) for personal services actually rendered in the course of employment with the Company maintaining the Plan and shall be determined as described below:

(a)        Compensation shall include to the extent that the amounts are includible in gross income (including, but not limited to, commissions paid salespeople, compensation for services on the basis of a percentage of profits, commissions on insurance premiums, tips, bonuses, fringe benefits, and reimbursements or other expense allowances under a nonaccountable plan as described in Regulation 1.62-2(c)).

(b)        Compensation shall include any elective deferral as defined in Code Section 402(g)(3), any amount which is contributed or deferred by the Company at the election of the Employee that is excludable from an Employee’s gross income under

 

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Code Sections 125 or 457 and, for Plan Years beginning on or after January 1, 1998, any elective amount that is excludable from an Employee’s gross income under Code Section 132(f)(4).

(c)        Compensation shall not include (i) any employer contributions to a plan of deferred compensation which are not included in the Employee’s gross income for the taxable year in which contributed, (ii) any distributions from a plan of deferred compensation, (iii) any amounts realized from the exercise of a non-qualified stock option or when restricted stock or property held by the Employee becomes either freely transferable or is no longer subject to a substantial risk of forfeiture under Code Section 83 if such option, stock, or property was granted to the Employee by the Company, (iv) any amounts realized from the sale, exchange, or other disposition of stock acquired under a qualified stock option, (v) any contribution for medical benefits (within the meaning of Code Section 419(f)(2) after termination of employment which is otherwise treated as an Annual Addition, and (vi) any amount otherwise treated as an Annual Addition under Code Section 415(l)(1).

13.6       Treatment of 415 Suspense Account Upon Termination .  In the event the Plan shall terminate at a time when all amounts in the 415 Suspense Account have not been allocated to the Accounts of the Participants, the 415 Suspense Account amounts shall be applied as follows:

(a)        The amount in the 415 Suspense Account shall first be allocated, as of the Plan termination date, to Participants in accordance with the allocation formula applicable to Company Contributions provided under Section 6.3.

(b)        If, after those allocations have been made, any further residue funds remain in the 415 Suspense Account, the residue may revert to the Company in accordance with applicable provisions of the Code, ERISA, and the regulations thereunder.

 

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ARTICLE XIV

TOP-HEAVY RULES

14.1       Applicability .  Notwithstanding any provision in the Plan to the contrary, and subject to the limitations set forth in Section 14.6, the requirements of Sections 14.4 and 14.5 shall apply under the Plan in the case of any Plan Year in which the Plan is determined to be a Top-Heavy Plan under the rules of Section 14.3. For the purpose of this Article XIV, the term “Company” shall mean the Sponsor and any Affiliated Company whether or not such Affiliated Company has adopted the Plan.

14.2       Definitions .  For purposes of this Article XIV, the following special definitions and rules shall apply:

(a)        The term “Key Employee” means any Employee or former Employee (including any deceased Employee) who, at any time during the Plan Year that includes the Determination Date, was an officer of the Company having annual Compensation greater than $130,000 (as adjusted under Code Section 416(i)(1) for Plan Years beginning after December 31, 2002), a Five Percent Owner of the Company, or an One Percent Owner of the Company having annual Compensation of more than $150,000.

(b)        The term “Five Percent Owner” means any person who owns (or is considered as owning within the meaning of Code Section 318) more than 5% of the outstanding stock of the Company or stock possessing more than 5% of the total combined voting power of all stock of the Company.

(c)        The term “One Percent Owner” means any person who would be described in paragraph (b) if “1%” were substituted for “5%” each place where it appears therein.

(d)        The term “Non-Key Employee” means any Employee who is not a Key Employee.

(e)        The term “Determination Date” means, with respect to any plan year, the last day of the preceding plan year. In the case of the first plan year of any plan, the term “Determination Date” shall mean the last day of that plan year.

(f)        The term “Aggregation Group” means (i) each qualified plan of the Company in which at least one Key Employee participates or participated at any time during the determination period (regardless of whether the plan has terminated), and (ii) any other qualified plan of the Company which enables a plan described in clause (i) to meet the requirements of Code Sections 401(a)(4) or 410. Any plan not required to be included in an Aggregation Group under the preceding rules may be treated as being part of such group if the group would continue to meet the requirements of Code Sections 401(a)(4) and 410 with the plan being taken into account.

 

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(g)        For purposes of determining ownership under paragraphs (a), (b) and (c) above, the following special rules shall apply: (i) Code Section 318(a)(2)(C) shall be applied by substituting “5%” for “50%”, and (ii) the aggregation rules of Code Sections 414(b), (c) and (m) shall not apply, with the result that the ownership tests of this Section 14.2 shall apply separately with respect to each Affiliated Company.

(h)        The terms “Key Employee” and “Non-Key Employee” shall include their Beneficiaries, and the definitions provided under this Section 14.2 shall be interpreted and applied in a manner consistent with the provisions of Code Section 416(i) and the regulations thereunder.

(i)        For purposes of this Article XIV, an Employee’s Compensation shall be determined in accordance with the rules of Section 13.5.

14.3       Top-Heavy Status .

(a)        The term “Top-Heavy Plan” means, with respect to any Plan Year:

(i)        Any defined benefit plan if, as of the Determination Date, the present value of the cumulative accrued benefits under the plan for Key Employees exceeds 60% of the present value of the cumulative accrued benefits under the plan for all Employees; and

(ii)       Any defined contribution plan if, as of the Determination Date, the aggregate of the account balances of Key Employees under the plan exceeds 60% of the aggregate of the account balances of all Employees under the plan.

In applying the foregoing provisions of this paragraph (a), the valuation date to be used in valuing Plan assets shall be (i) in the case of a defined benefit plan, the same date which is used for computing costs for minimum funding purposes, and (ii) in the case of a defined contribution plan, the most recent valuation date within a 12-month period ending on the applicable Determination Date.

(b)        Each plan maintained by the Company required to be included in an Aggregation Group shall be treated as a Top-Heavy Plan if the Aggregation Group is a Top-Heavy Group.

(c)        The term “Top-Heavy Group” means any Aggregation Group if the sum (as of the Determination Date) of (i) the present value of the cumulative accrued benefits for Key Employees under all defined benefit plans included in the group, and (ii) the aggregate of the account balances of Key Employees under all defined contribution plans included in the group exceeds 60% of a similar sum determined for all Employees. For purposes of determining the present value of the cumulative accrued benefit of any Employee, or the amount of the account balance of any Employee, such present value or amount shall be increased by the aggregate distributions made with respect to the Employee under the plan (including a terminated plan which, had it not been terminated,

 

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would have been aggregated with the plan under Code Section 416(g)(2)(A)(i)) during the one year period ending on the Determination Date. In the case of distributions made for a reason other than separation from service, death, or disability, the preceding sentence shall be applied by substituting “five year period” for “one year period.” Any rollover contribution or similar transfer initiated by the Employee and made after December 31, 1983, to a plan shall not be taken into account with respect to the transferee plan for purposes of determining whether such plan is a Top-Heavy Plan (or whether any Aggregation Group which includes such plan is a Top-Heavy Group).

(d)        If any individual is a Non-Key Employee with respect to any plan for any plan year, but the individual was a Key Employee with respect to the plan for any prior plan year, any accrued benefit for the individual (and the account balance of the individual) shall not be taken into account for purposes of this Section 14.3.

(e)        If any individual has not performed services for the Company at any time during the one year period ending on the Determination Date, any accrued benefit for such individual (and the account balance of the individual) shall not be taken into account for purposes of this Section 14.3.

(f)        In applying the foregoing provisions of this Section, the accrued benefit of a Non-Key Employee shall be determined (i) under the method, if any, which is used for accrual purposes under all plans of the Company and any Affiliated Companies, or (ii) if there is no such uniform method, as if such benefit accrued not more rapidly than the slowest accrual rate permitted under Code Section 411(b)(1)(C).

(g)        For all purposes of this Article XIV, the definitions provided under this Section 14.3 shall be applied and interpreted in a manner consistent with the provisions of Code Section 416(g) and the regulations thereunder.

14.4       Minimum Contributions .  For any Plan Year in which the Plan is determined to be a Top-Heavy Plan, the minimum employer contributions for that year shall be determined in accordance with the rules of this Section 14.4.

(a)        Except as provided below, the minimum contribution for each Non-Key Employee shall be not less than 3% of his or her compensation. Before Tax Deposits shall not be taken into account but Matching Contributions as defined in Section 6.11 shall be taken into account for purposes of satisfying the minimum contribution requirement. Matching Contributions that are used to satisfy the minimum contribution requirement shall be treated as matching contributions for purposes of the actual contribution percentage test and other requirements of Code Section 401(m).

(b)        Subject to the following rules of this paragraph (b), the percentage set forth in paragraph (a) above shall not be required to exceed the percentage at which contributions (including amounts deferred under a cash or deferred arrangement under Code Section 401(k)) are made (or are required to be made) under the Plan for the year for the Key Employee for whom the percentage is the highest for the year. This

 

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determination shall be made by dividing the contributions for each Key Employee by so much of his or her total compensation for the Plan Year as does not exceed the applicable Compensation limit. For purposes of this paragraph (b), all defined contribution plans required to be included in an Aggregation Group shall be treated as one plan. Notwithstanding the foregoing, the exceptions to paragraph (a) as provided under this paragraph (b) shall not apply to any plan required to be included in an Aggregation Group if the plan enables a defined benefit plan to meet the requirements of Code Sections 401(a)(4) or 410.

(c)        The Participant’s minimum contribution determined under this Section 14.4 shall be calculated without regard to any Social Security benefits payable to the Participant.

(d)        In the event a Participant is covered by both a defined contribution and a defined benefit plan maintained by the Company, both of which are determined to be Top-Heavy Plans, the Company shall satisfy the minimum benefit requirements of Code Section 416 by providing (in lieu of the minimum contribution described in paragraph (a) above) a minimum benefit under the defined benefit plan so as to prevent the duplication of required minimum benefits hereunder.

14.5       Minimum Vesting Rules .  For any Plan Year in which it is determined that the Plan is a Top-Heavy Plan, the vesting schedule for Matching Contributions shall be the vesting schedule set forth in Section 7.2(a) and the vesting schedule for Retirement Contributions shall be the vesting schedule set forth in Section 7.2(b).

14.6       Noneligible Employees .    The rules of this Article XIV shall not apply to any Employee included in a unit of employees covered by a collective bargaining agreement between employee representatives and one or more employers if retirement benefits were the subject of good faith bargaining between such employee representatives and the employer or employers.

 

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ARTICLE XV

RESTRICTION ON ASSIGNMENT OR

OTHER ALIENATION OF PLAN BENEFITS

15.1       General Restrictions Against Alienation .

(a)        The interest of any Participant or his or her Beneficiary in the income, benefits, payments, claims or rights hereunder, or in the Trust Fund, shall not in any event be subject to sale, assignment, hypothecation, or transfer. Each Participant and Beneficiary is prohibited from anticipating, encumbering, assigning, or in any manner alienating his or her interest under the Trust Fund, and is without power to do so, except as may be permitted in connection with providing security for a loan from the Plan to the Participant pursuant to the provisions of the Plan as it may be amended from time to time. The interest of any Participant or Beneficiary shall not be liable or subject to his or her debts, liabilities, or obligations, now contracted, or which may hereafter be contracted, and such interest shall be free from all claims, liabilities, or other legal process now or hereafter incurred or arising. Neither the interest of a Participant or Beneficiary, nor any part thereof, shall be subject to any judgment rendered against any such Participant or Beneficiary. Notwithstanding the foregoing, a Participant’s or Beneficiary’s interest in the Plan may be subject to the enforcement of a Federal tax levy made pursuant to Code Section 6331 or the collection by the United States on a judgment resulting from an unpaid tax assessment.

(b)        In the event any person attempts to take any action contrary to this Article XV, such action shall be null and void and of no effect, and the Company, the Committee, the Trustee and all Participants and their Beneficiaries, may disregard such action and are not in any manner bound thereby, and they, and each of them, shall suffer no liability for any such disregard thereof, and shall be reimbursed on demand out of the Trust Fund for the amount of any loss, cost or expense incurred as a result of disregarding or of acting in disregard of such action.

(c)        The foregoing provisions of this Section shall be interpreted and applied by the Committee in accordance with the requirements of Code Section 401(a)(13) and Section 206(d) of ERISA as construed and interpreted by authoritative judicial and administrative rulings and regulations.

15.2       Qualified Domestic Relations Orders .  The rules set forth in Section 15.1 above shall not apply with respect to a “Qualified Domestic Relations Order” as described below.

(a)        A “Qualified Domestic Relations Order” is a judgment, decree, or order (including approval of a property settlement agreement) that:

(i)        Creates or recognizes the existence of an Alternate Payee’s right to, or assigns to an Alternate Payee the right to, receive all or a portion of the benefits payable under the Plan with respect to a Participant,

 

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(ii)        Relates to the provision of child support, alimony payments, or marital property rights to a spouse, former spouse, child or other dependent of a Participant,

(iii)       Is made pursuant to a State domestic relations law (including a community property law), and

(iv)      Clearly specifies: (A) the name and last known mailing address (if any) of the Participant and the name and mailing address of each Alternate Payee covered by the order (if the Committee does not have reason to know that address independently of the order); (B) the amount or percentage of the Participant’s benefits to be paid to each Alternate Payee, or the manner in which the amount or percentage is to be determined; (C) the number of payments or period to which the order applies; and (D) each plan to which the order applies.

For purposes of this Section 15.2, “Alternate Payee” means any spouse, former spouse, child or other dependent of a Participant who is recognized by a domestic relations order as having a right to receive all, or a portion of, the benefits payable with respect to the Participant.

(b)        A domestic relations order is not a Qualified Domestic Relations Order if it requires:

(i)        The Plan to provide any type or form of benefit, or any option, not otherwise provided under the Plan;

(ii)       The Plan to provide increased benefits; or

(iii)      The payment of benefits to an Alternate Payee that are required to be paid to another Alternate Payee under a previous Qualified Domestic Relations Order.

(c)        A domestic relations order shall not be considered to fail to satisfy the requirements of paragraph (b)(i) above with respect to any payment made before a Participant has separated from service solely because the order requires that payment of benefits be made to an Alternate Payee:

(i)        On or after the date on which the Participant attains (or would have first attained) his or her earliest retirement age (as defined in Code Section 414(p)(4)(B));

 

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(ii)        As if the Participant had retired on the date on which such payment is to begin under such order (but taking into account only the present value of accrued benefits and not taking into account the present value of any subsidy for early retirement benefits); and

(iii)       In any form in which such benefits may be paid under the Plan to the Participant (other than in the form of a joint and survivor annuity with respect to the Alternate Payee and his or her subsequent spouse).

Notwithstanding the foregoing, if the Participant dies before his or her earliest retirement age (as defined in Code Section 414(p)(4)(B)), the Alternate Payee is entitled to benefits only if the Qualified Domestic Relations Order requires survivor benefits to be paid to the Alternate Payee.

(d)        To the extent provided in any Qualified Domestic Relations Order, the former spouse of a Participant shall be treated as a surviving Spouse of the Participant for purposes of applying the rules (relating to minimum survivor annuity requirements) of Code Sections 401(a)(11) and 417, and any current spouse of the Participant shall not be treated as a spouse of the Participant for such purposes.

(e)        In the case of any domestic relations order received by the Plan, the Committee shall promptly notify the Participant and any Alternate Payee named in the order that an order has been received and shall provide a copy of the Plan’s procedures for determining the qualified status of domestic relations orders. An Alternate Payee may designate a representative for receipt of copies of notices and plan information that are sent to the Alternate Payee with respect to domestic relations order. Within a reasonable period after the receipt of the order, the Committee shall determine whether the order is a Qualified Domestic Relations Order and shall notify the Participant and each Alternate Payee of such determination.

(f)        The Committee shall establish reasonable procedures to determine the qualified status of domestic relations orders and to administer distributions under Qualified Domestic Relations Orders. During any period in which the issue of whether a domestic relations order is a Qualified Domestic Relations Order is being determined (by the Committee, by a court of competent jurisdiction, or otherwise), the Committee shall direct the Trustee to segregate in a separate account in the Plan (or in an escrow account) the amounts which would have been payable to the Alternate Payee during the period if the order had been determined to be a Qualified Domestic Relations Order. If within the 18 Month Period (as defined below), the order (or modification thereof) is determined to be a Qualified Domestic Relations Order, the Committee shall direct the Trustee to pay the segregated amounts (plus any interest thereon) to the person or persons entitled thereto. However, if within the 18 Month Period (i) it is determined that the order is not a Qualified Domestic Relations Order, or (ii) the issue as to whether the order is a Qualified Domestic Relations Order is not resolved, then the Committee shall direct the Trustee to pay the segregated amounts (plus any interest thereon) to the person or persons who would have been entitled to the amounts if there had been no order (assuming such

 

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benefits were otherwise payable).   Any determination that an order is a Qualified Domestic Relations Order that is made after the close of the 18 Month Period shall be applied prospectively only. For purposes of this Section 15.2, the “18 Month Period” shall mean the 18 month period beginning with the date on which the first payment would be required to be made under the domestic relations order.

 

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ARTICLE XVI

MISCELLANEOUS PROVISIONS

16.1       No Right of Employment Hereunder .  The adoption and maintenance of the Plan and Trust shall not be deemed to constitute a contract of employment or otherwise between the Company and any Employee or Participant, or to be a consideration for, or an inducement or condition of, any employment. Nothing contained herein shall be deemed to give any Employee the right to be retained in the service of the Company or to interfere with the right of the Company to discharge, with or without cause, any Employee or Participant at any time, which right is hereby expressly reserved.

16.2       Effect of Article Headings .  Article headings are for convenient reference only and shall not be deemed to be a part of the substance of this instrument or in any way to enlarge or limit the contents of any Article.

16.3       Limitation on Company Liability .  Any benefits payable under the Plan shall be paid or provided for solely from the Plan and the Company assumes no liability or responsibility therefor.

16.4       Gender .  Masculine gender shall include the feminine and the singular shall include the plural unless the context clearly indicates otherwise.

16.5       Interpretation .  The provisions of the Plan shall in all cases be interpreted in a manner that is consistent with the Plan satisfying (i) the requirements of Code Section 401(a) and related statutes for qualification as a defined contribution plan and (ii) the requirements of Code Section 401(k) and related statutes for qualification as a cash or deferred arrangement.

16.6       Withholding For Taxes .  Any payments from the Trust Fund may be subject to withholding for taxes as may be required by any applicable federal or state law.

16.7       California Law Controlling .  All legal questions pertaining to the Plan which are not controlled by ERISA shall be determined in accordance with the laws of the State of California and all contributions made hereunder shall be deemed to have been made in that State.

16.8       Plan and Trust as One Instrument .  The Plan and the Trust Agreement shall be construed together as one instrument. In the event that any conflict arises between the terms and/or conditions of the Trust Agreement and the Plan, the provisions of the Plan shall control, except that with respect to the duties and responsibilities of the Trustee, the Trust Agreement shall control.

16.9       Invalid Provisions .  If any paragraph, section, sentence, clause or phrase contained in the Plan shall become illegal, null or void or against public policy, for any reason, or shall be held by any court of competent jurisdiction to be incapable of being construed or limited in a manner to make it enforceable, or is otherwise held by such court to be illegal, null

 

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or void or against public policy, the remaining paragraphs, sections, sentences, clauses or phrases contained in the Plan shall not be affected thereby.

16.10       Counterparts .  This instrument may be executed in one or more counterparts each of which shall be legally binding and enforceable.

 

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IN WITNESS WHEREOF, Allergan, Inc. hereby executes this instrument, evidencing the terms of the Allergan, Inc. Savings and Investment Plan as restated this 29th day of January, 2008.

 

ALLERGAN, INC.
By:   /s/ Douglas S. Ingram        
  Douglas S. Ingram
 

Executive Vice President, Chief Administrative Officer, General Counsel

and Secretary

 

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APPENDIX A

SPECIAL PROVISIONS FOR PUERTO RICO-BASED PAYROLL EMPLOYEES

PART I

INTRODUCTION

1.1           Effective Date .  The effective date of this Appendix A is January 1, 2008.

1.2           Purpose of Appendix A .  The provisions of the Plan shall apply to all Puerto Rico-based payroll Employees except as specifically provided in this Appendix A.

1.3           Plan Qualification .  The Plan is an employee benefit plan that is intended to qualify under PR-Code Section 1165(a) as a qualified profit sharing plan and under PR-Code Section 1165(e) as a qualified cash or deferred arrangement.

PART II

DEFINITIONS

The Definitions of Article II of the Plan shall apply to all Puerto Rico-based Employees and shall have the same meaning for the purpose of this Appendix A except as set forth below:

2.1           Plan Section 2.17 .  “Compensation” shall have the same meaning as set forth in Plan Section 2.17 except that in the case of a Puerto Rico-based Employee, Compensation shall also include cost of living allowances earned within Puerto Rico, amounts paid under the Christmas bonus program, and amounts of salary reduction elected by a Puerto Rico-based Participant under a PR-Code Section 1165(e) cash or deferred arrangement, but shall exclude contributions or distributions pursuant to any other plan sponsored by the Company and qualified under PR-Code Section 1165(a).

2.2           Plan Section 2.18 .  “Credited Service” shall have the same meaning as set forth in Plan Section 2.18 except that in the case of a Puerto Rico-based Employee who was employed by the Company at any time prior to the Original Effective Date, for the period prior to January 1, 1989, Credited Service shall include service, if any, credited to such Employee under the Savings and Investment Plan for Employees of Subsidiaries of SmithKline Beckman Corporation Whose Principal Office is Located in Puerto Rico.

2.3           Plan Section 2.21 .  For the purpose of this Appendix A only, the definition of “Eligible Employee” as defined in Plan Section 2.21 shall not apply and “Eligible Employee” or “Eligible Puerto Rico-based Employee” shall mean any Puerto Rico-based Employee but shall exclude any non-regular manufacturing site transition employee, any non-resident alien of Puerto Rico and the United States, any Leased Employee, and any Employee covered by a collective bargaining agreement.


2.4           Plan Section 2.24 .  For the purpose of this Appendix A only, the definition of “Employee” as defined in Plan Section 2.24 shall not apply and “Employee” or “Puerto Rico-based Employee” shall mean any person who is employed in any capacity by the Sponsor or any Affiliated Company at its Puerto Rico locations, any portion of whose income is subject to withholding of income tax and/or for whom Social Security contribution are made by the Sponsor or an Affiliated Company except that such term shall not include (i) any individual who performs services for the Sponsor or an Affiliated Company and who is classified or paid as an independent contractor as determined by the payroll records of the Sponsor or an Affiliated Company even if a court or administrative agency determines that such individual is a common-law employee and not an independent contractor, (ii) any individual who performs services for the Sponsor or an Affiliated Company pursuant to an agreement between the Sponsor or an Affiliated Company and any other person including a leasing organization except to the extent such individual is a Leased Employee, and (iii) any individual whose employment is transferred from the Sponsor or an Affiliated Company to Advanced Medical Optics, Inc. (“AMO”) in connection with the distribution of the stock of AMO by the Sponsor to its stockholders, effective as of the day following such transfer, hereinafter referred to as an “AMO Employee.” An individual is an AMO Employee if classified or identified as such in the payroll records of the Sponsor or an Affiliated Company or in the Employee Matters Agreement entered into between the Sponsor and AMO.

2.5           Plan Section 2.38 .  For the purpose of this Appendix A only, “Participant” as defined in Plan Section 2.38 shall not apply and “Participant” or “Puerto Rico-based Participant” shall mean a Puerto Rico-based Employee or former Puerto Rico-based Employee who has commenced participation in the Plan pursuant to Section 3.1 and who retains rights under the Plan.

2.6           Additional Terms .  Additional terms shall have the following meaning:

  (a)        “PR-Code” shall mean the Puerto Rico Internal Revenue Code of 1994, as amended. Where the context so requires a reference to a particular PR-Code Section shall also refer to any successor provision of the PR-Code to such PR-Code Section.

  (b)        “Top One-Third Highly Compensated Employee” shall mean any Eligible Puerto Rico-based Employee who has Compensation for a Plan Year that is greater than the Compensation for such Plan Year of two-thirds (2/3) of all Eligible Puerto Rico-based Employees.

PART III

ELIGIBILITY AND PARTICIPATION

The provisions of Article III of the Plan shall apply to all Puerto Rico-based Employees.

 

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PART IV

PARTICIPANT DEPOSITS

The provisions of Article IV of the Plan shall apply to all Puerto Rico-based Employees except as set forth below:

4.1         Plan Section 4.1 .    The provisions of Plan Section 4.1(d) shall apply to all Puerto Rico-based Participants except that Puerto Rico-based Participants who make hardship withdrawals pursuant to Plan Section 8.1(e) shall not be permitted to make Before Tax Deposits or After Tax Deposits to the Plan during the 12-month period beginning as soon as administratively feasible following the date of the hardship withdrawal. Also, to the extent permissible by ERISA and the Code, each contribution made by the Company to the Plan under Plan Section 4.1 with respect to the Before Tax Deposits of a Puerto Rico-based Participant shall be made only to the extent that the Company has current or accumulated earnings and profits, as determined under the PR-Code, and is expressly conditioned on the deductibility of such contribution under Section 1023(n) of the PR-Code for the taxable year for which contributed. If the Puerto Rico Secretary of the Treasury disallows the deduction, or if the contribution was made by a mistake of fact, such contribution shall be returned to the Company within one (1) year after the disallowance of the deduction (to the extent disallowed), or after the payment of such contribution, respectively. Such contributions to the Plan by the Company shall be paid to the Trustee not later than the date for filing the Company’s Puerto Rico income tax return for the taxable year in which such payroll period falls, including any extensions thereof.

4.2         Plan Section 4.2 .    The provisions of Plan Section 4.2 shall apply to all Puerto Rico-based Employees except as set forth below:

(a)        Notwithstanding the provisions of paragraph (a) of Plan Section 4.2, a Puerto Rico-based Participant may elect to contribute a whole percentage of his or her Compensation to the Plan as Before Tax Deposits; provided, however, that no Puerto Rico-based Participant shall be permitted to make Before Tax Deposits to the Plan during any taxable year in excess of: (i) ten percent (10%) of Compensation up to a maximum of $8,000, or such larger amount as may be determined by the Puerto Rico Secretary of the Treasury pursuant to the PR-Code; provided that, if a Puerto Rico-based Participant contributes to a Puerto Rico individual retirement account as described in PR-Code Section 1169, the maximum amount of his or her Before Tax Deposits may not exceed the difference, if any, between the amount available as a contribution up to the limit of $8,000 and the contribution made to a Puerto Rico individual retirement account, or as otherwise provided by the PR-Code, (ii) the Actual Deferral Percentage test limitation set forth in Plan Section 4.3 and Section 4.3 of this Appendix, and (iii) the Annual Addition limitation set forth in Plan Section 13.1.

(b)        Notwithstanding the provisions of paragraph (e) of Plan Section 4.2, a Puerto Rico-based Participant who has attained age 50 before the close of the Plan Year may elect to contribute a percentage of his or her Compensation to the Plan as “catch-up” Before Tax Deposits in accordance with, and subject to the limitations of, the PR-Code. Such catch-up Before Tax Deposits shall not be taken into account under paragraph (a) above, Section 4.3 of this Appendix to the extent permitted under the PR-Code, Plan Section 4.3, Plan Section 13.1 or

 

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any other provision of the Plan implementing the contribution limitations of Code Sections 402(g) and 415.

4.3         Additional Contribution Deferral Limitation .    In addition to the limitations on Compensation Deferral Contributions set forth in Plan Section 4.3, Compensation Deferral Contributions by a Puerto Rico-based Participant shall not exceed the limitation on contributions by or on behalf of the Top One-Third Highly Compensation Employees under PR-Code Section 1165(e), as provided in this Section 4.3 with respect to each Plan Year. In the event that Compensation Deferrals Contributions under the Plan by or on behalf of the Top One-Third Highly Compensated Employees exceed the limitations of this Section for any reason, such excess contributions shall be recharacterized as After Tax Deposits or such excess contributions, adjusted for any income or loss allocable thereto, shall be returned to such Participant, as provided in Plan Section 4.5.

(a)      The Compensation Deferral Contributions by Participants for a Plan Year shall satisfy the Actual Deferral Percentage test under the PR-Code as set forth in subparagraph (i) below, or to the extent not precluded by applicable regulations, the alternate Actual Deferral Percentage test as set forth in (ii) below:

(i)        The average “Actual Deferral Percentage” for the Top One-Third Highly Compensated Employees shall not be more than the average Actual Deferral Percentage of all non-Top One-Third Highly Compensated Employees multiplied by 1.25, or

(ii)        The excess of the average Actual Deferral Percentage for the Top One-Third Highly Compensated Employees over the average Actual Deferral Percentage for all non-Top One-Third Highly Compensated Employees shall not be more than two (2) percentage points and the average Actual Deferral Percentage for the Top One-Third Highly Compensated Employee shall not be more than the average Actual Deferral Percentage of all non-Top One-Third Highly Compensated Employees multiplied by 2.0.

  (b)      For the purpose of this Section 4.3 only, the following definitions shall apply:

(i)        “Actual Deferral Percentage” shall mean, with respect to the group of all Top One-Third Highly Compensated Employees and the group of all non-Top One-Third Highly Compensated Employees for a Plan Year, the ratio, calculated separately for each Participant in such group, of the amount of the Participant’s Compensation Deferral Contribution for such Plan Year, to such Participant’s Compensation for such Plan Year, in accordance with regulations prescribed by the Puerto Rico Secretary of the Treasury under PR-Code Section 1165(e). For purposes of computing the Actual Deferral Percentage, an Eligible Employee who would be a Participant but for the failure to make Before Tax Deposits shall be treated as a Participant on whose behalf no Before Tax Deposits are made.

 

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(ii)         “Participant” shall mean any Eligible Puerto Rico-based Employee who satisfied the requirements under Plan Article III during the Plan Year, whether or not such Eligible Employee elected to contribute to the Plan for such Plan Year.

(iii)        “Compensation Deferral Contributions” shall mean amounts contributed to the Plan by a Participant as Before Tax Deposits pursuant to Section 4.1(a) of this Appendix, including any other amounts prescribed under PR-Code Section 1165(e) and applicable regulations. To the extent determined by the Committee and in accordance with regulations issued by the Puerto Rico Secretary of the Treasury, matching contributions and qualified nonelective contributions on behalf of a Participant that satisfy the requirements of PR-Code Section 1165(e)(3)(D)(ii) may also be taken into account for the purpose of determining the Actual Deferral Percentage of such Participant.

(iv)        “Compensation” shall mean compensation as defined in PR-Code Section 1165(e) and applicable regulations.

  (c)      In the event that as of the first day of Plan Year, the Plan satisfies the requirements of PR-Code Section 1165(a) only if aggregated with one or more other plans which include arrangements under PR-Code Section 1165(e), then this Section 4.3 shall be applied by determining the Actual Deferral Percentages of Participants as if all such plans were a single plan, in accordance with regulations prescribed by the Secretary of the Treasury under PR-Code Section 1165(e). Plans may be considered one plan for purposes of satisfying PR-Code Section 1165(e) only if they have the same Plan Year.

  (d)      For the purpose of this Section 4.3, the “Actual Deferral Percentage” for any Top One-Third Highly Compensated Employee who is a Participant under two or more PR-Code Section 1165(e) arrangements of the Company shall be determined by taking into account the Top One-Third Highly Compensated Employee’s Compensation under each such arrangement and contributions under each such arrangement which qualify for treatment under PR-Code Section 1165(e) in accordance with regulations prescribed by the Puerto Rico Secretary of the Treasury under PR-Code Section 1165(e). If the arrangements have different Plan Years, this paragraph shall be applied by treating all such arrangements ending with or within the same calendar year as a single arrangement. Notwithstanding the foregoing, certain plans shall be treated as separate plans if mandatorily disaggregated pursuant to regulations under Code Section 401(k).

  (e)      For purposes of the Actual Deferral Percentage test under the PR-Code, Compensation Deferral Contributions must be made before the last day of the twelve-month period immediately following the Plan Year to which such contributions relate.

  (f)      The determination and treatment of Compensation Deferral Contributions and the Actual Deferral Percentage of any Participant under this Section 4.3 shall satisfy such other requirements as may be prescribed by the Puerto Rico Secretary of the Treasury.

 

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(g)        The Committee shall keep or cause to have kept such records as are necessary to demonstrate that the Plan satisfies the requirements of PR-Code Section 1165(e) and the regulations thereunder, in accordance with regulations prescribed by the Puerto Rico Secretary of the Treasury.

(h)        Notwithstanding any provision of this Appendix A to the contrary, to the extent permitted by the PR-Code and its regulations, all Employees employed by the Sponsor and any Affiliated Company that participates in the Plan may be aggregated for purposes of determining compliance by the Plan with the Actual Deferral Percentage test under the PR-Code and the determination of Top One-Third Highly Compensated Employees.

4.4         Plan Section 4.4 .    The provisions of Plan Section 4.4 entitled “Provisions for Return of Excess Before Tax Deposits” shall be applied by substituting the dollar limitation contained in Section 4.2 of this Appendix for the “Before Tax Deposit Limit” in each place it appears.

4.5         Plan Section 4.5 .    The provisions of Plan Section 4.5 entitled “Provision for Recharacterization or Return of Excess Deferrals by Highly Compensated Participants” shall be applied as follows:

(a)        “Highly Compensated Participant and Top One-Third Highly Compensated Employee” shall be substituted for “Highly Compensated Participant” in each place it appears.

(b)        For purposes of satisfying the Actual Deferral Percentage test under the PR-Code, the amount of any excess Compensation Deferral Contributions by a Top One-Third Highly Compensated Employee shall be determined by the Committee taking into account the leveling method applied under the PR-Code and its regulations that provide that the leveling method shall begin with the Top One-Third Highly Compensated Employee who has the highest deferral percentage.

(c)        Any reference to Code Sections shall include reference to the corresponding PR-Code Section unless the context clearly indicates otherwise. For example, references to “Code Section 401(k)” and “Code Section 404” shall include references to PR-Code Section 1165(e) and PR-Code Section 1023(n), respectively.

4.6         Reserved for Future Modification .

4.7         Plan Section 4.7 .    In addition to the provisions of Plan Section 4.7 entitled “Character of Deposits,” Before Tax Deposits shall be treated as employer contributions for purposes of PR-Code Section 1165(e).

4.8         Plan Section 4.8 .    For purposes of Plan Section 4.8, a “Direct Rollover Contribution” or a “Participant Rollover Contribution” from a retirement plan qualified under PR-Code Section 1165(a) (unless such plan is also qualified under Code Section 401(a)) or an “IRA Rollover Contribution” from a Puerto-Rico individual retirement account or annuity shall not be permitted under the Plan.

 

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PART V

TRUST FUND AND MATCHING CONTRIBUTIONS

The provisions of Article V shall apply to all Puerto Rico-based Employees except as set forth below:

5.1         Plan Section 5.6 .    The provisions of Plan Section 5.6 entitled “Irrevocability” shall be applied by including a corresponding reference to “PR-Code Section 1165(a)” and “PR-Code Section 1023(n)” in each place “Code Section 401(a)” and “Code Section 404” appears, respectively.

PART VI

ACCOUNTS AND ALLOCATIONS

The provisions of Article VI of the Plan shall apply to all Puerto Rico-based Employees.

PART VII

VESTING IN PLAN ACCOUNTS

The provisions of Article VII of the Plan shall apply to all Puerto Rico-based Employees.

PART VIII

PAYMENT OF PLAN BENEFITS

The provisions of Article VIII of the Plan shall apply to all Puerto Rico-based Employees except as set forth below:

8.1         Plan Section 8.2(a) .  For purposes of Plan Section 8.2(a), a Puerto Rico-based Participant may elect, at the time and in the manner prescribed by the Committee, to have the entire portion of a lump-sum distribution from the Plan paid directly to a qualified trust described in PR-Code Section 1165(a) that accepts the Puerto Rico-based Participant’s distribution or an individual retirement account or annuity described in PR-Code Sections 1169(a) and (b), respectively.

8.2         Plan Section 8.4 .    In addition to the provisions of Plan Section 8.4 entitled “Designation of Beneficiary,” the following rules shall apply to a Participant, as defined in Section 2.6 of this Appendix:

    (a)        In the event a deceased Participant is not a resident of Puerto Rico at the date of his or her death, the Committee, in its discretion, may require the establishment of ancillary administration in Puerto Rico.

 

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(b)        If the Committee cannot locate a qualified personal representative of the deceased Participant, or if administration of the deceased Participant’s estate is not otherwise required, the Committee, in its discretion, may pay the deceased Participant’s interest in the Trust Fund to his or her heirs at law (determined in accordance with the laws of the Commonwealth of Puerto Rico) as they existed at the date of the Participant’s death.

8.3         Plan Section 8.5 .  Notwithstanding the provisions of Plan Section 8.5, a hardship withdrawal shall be made to a Puerto Rico-based Participant only if the Committee (or its representative), based upon the Participant’s representation and such other facts as are known to the Committee, determines that the requested withdrawal is on the account of:

(a)        A deductible medical expense (within the meaning of PR-Code Section 1023(aa)(2)(p)) incurred by the Participant, his or her spouse, children or dependents;

(b)        The purchase (excluding mortgage payments) of a principal residence for the Participant;

(c)        The payment of tuition for the next twelve (12) months of post-secondary education for the Participant, the Participant’s spouse, children, or dependents;

(d)        The need to prevent the eviction of the Participant from his or her principal residence or foreclosure on the mortgage of the Participant’s principal residence; and

(e)        Such other events as the PR-Code, regulations or the Puerto Rico Secretary of the Treasury may allow.

Notwithstanding anything in the Plan to the contrary, Puerto Rico-based Participants who make hardship withdrawals pursuant to Plan Section 8.1(e) shall not be permitted to make Before Tax Deposits or After Tax Deposits to the Plan during the 12-month period beginning as soon as administratively feasible following the date of the hardship withdrawal.

8.4         Plan Section 8.6(a) .    Notwithstanding the provisions of Plan Section 8.6(a) entitled “Distribution Rules,” in the case of a Puerto Rico-based Participant in no event shall any benefits under the Plan, including benefits upon retirement, Severance, or Disability, be paid (or commence to be paid) to a participant prior to the “Consent Date” (as defined herein) unless the Participant consents in writing to the payment (or commencement of payment) of such benefits prior to said Consent Date. As used herein, the term “Consent Date” shall mean the later of (i) the Participant’s 62nd birthday, or (ii) the Participant’s Normal Retirement Age. Notwithstanding the foregoing, the provisions of this Paragraph shall not apply (i) following the Participant’s death, or (ii) with respect to a lump sum distribution of the vested portion of a Participant’s Account if the total amount of such vested portion does not exceed $1,000 ($5,000 for lump sum distributions made prior to March 28, 2005).

 

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8.5         Plan Section 8.11(c) .  The provisions of Plan Section 8.11(c) entitled “Additional Documents” shall be applied by including reference to “Puerto Rico” in each place “State or Federal” appears.

8.6         Plan Section 8.12 .  The provisions of Plan Section 8.12 entitled “Trustee-Trustee Transfers” shall be applied by including a corresponding reference to “PR-Code Section 1165” in each place “Code Section 401” appears.

PART IX

PLAN ARTICLES IX THROUGH XI

The provisions of Articles IX through XI of the Plan shall apply to all Puerto Rico-based Employees.

PART X

TERMINATION AND MERGER

The provisions of Articles XII of the Plan shall apply to all Puerto Rico-based Employees except as follows:

10.1         Plan Section 12.1 .    In addition to the provisions of Plan Section 12.1, the Committee may determine that no distributions shall be made to a Puerto Rico-based Participant in the event the Plan is terminated, until such time as the Puerto Rico Department of the Treasury shall have determined in writing that such termination will not adversely affected the prior qualification of the Plan under the PR-Code.

10.2         Plan Section 12.2 .  In addition to the provisions of Plan Section 12.2, any merger or consolidation of the Plan with, or transfer in whole or in part of the assets and liabilities of the Trust to, another trust fund as applied to a Puerto Rico-based Participant will be limited to the extent such other plan and trust are qualified under PR-Code Section 1165(a).

PART XI

PLAN ARTICLES XIII THROUGH XV

The provisions of Articles XIII through XV of the Plan shall apply to all Puerto Rico-based Employees.

PART XII

MISCELLANEOUS PROVISIONS

 

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The provisions of Article XVI of the Plan shall apply to all Puerto Rico-based Employees except as follows:

12.1         Plan Section 16.5 .    In addition to the provisions of Plan Section 16.5 entitled “Interpretation,” the provisions of the Plan shall be interpreted in a manner consistent with the Plan satisfying (i) the requirements of PR-Code Section 1165(a) and related statutes for qualification as a defined contribution plan and (ii) the requirements of PR-Code Section 1165(e) and related statutes for qualification as a cash or deferred arrangement to the extent such interpretation would not violate (i) the requirements of Code Section 401(a) and related statutes for qualification as a defined contribution plan and (ii) the requirements of Code Section 401(k) and related statutes for qualification as a cash or deferred arrangement.

12.2         Plan Section 16.6 .    In addition to the provisions of Plan Section 16.6 entitled “Withholding for Taxes,” any payments from the Trust Fund may be subject to withholding for taxes as may be required by any applicable Puerto Rico law.

12.3         Plan Section 16.7 .    In addition to the provisions of Plan Section 16.7 entitled “California Law Controlling,” the Committee shall determine whether all legal questions pertaining to the Plan which are not controlled by ERISA shall be determined in accordance with the laws of the Commonwealth of Puerto Rico or the laws of the State of California in the case of a Puerto Rico-based Employee or Participant.

 

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Exhibit 10.17

FIRST AMENDMENT

TO

ALLERGAN, INC.

SAVINGS AND INVESTMENT PLAN

(RESTATED 2008)

The ALLERGAN, INC. SAVINGS AND INVESTMENT PLAN (the “Plan”) is hereby amended as follows:

 

1. Section 2.34 of the Plan is hereby amended as follows:

2.34     Matched Deposits .    “Matched Deposits” of a Participant shall mean his or her Participant Deposits (whether Before Tax, including “catch up” Before Tax Deposits described in Section 4.2(e) or After Tax but excluding Rollover Contributions) not in excess of two percent (2%) of Compensation. Matched Deposits shall participate in allocations of Matching Contributions and Matching Contribution Forfeitures. The Matched Deposits of Participants (expressed as a percentage of Participant’s Compensation as set forth above) may be changed at any time and from time to time by action of the delegate of the Board of Directors, provided that such change is within the scope of authority of the delegate. In the event that the Matched Deposits are increased retroactively for a Plan Year, additional Matching Contributions shall be allocated to “Eligible Participants” as defined in Section 5.3(b) and in accordance with the terms of that Section.

 

2. Section 5.3(a) of the Plan is hereby amended as follows:

(a)    The Company shall contribute and allocate Matching Contributions on a pay period basis which, when added to Matching Contribution Forfeitures available after application of Section 6.3, is equal to one hundred percent (100%) of each Participant’s Matched Deposits for the pay period. The Board of Directors (or its delegate, provided that such change is within the scope of authority of the delegate) may authorize and direct that Matching Contributions (expressed as a percentage of Participant’s Matched Deposits as set forth above) be changed from time to time from a minimum of zero percent (0%) to such maximum percentage that when expressed as a percentage of Participants’ Compensation, does not exceed four percent (4%) of Participants’ Compensation, in aggregate, for any Plan Year.

 

3. This First Amendment shall be effective as of the pay period beginning January 31, 2009.


IN WITNESS WHEREOF, Allergan, Inc. hereby executes this First Amendment to the Allergan, Inc. Savings and Investment Plan (Restated 2008) on this 27 day of January, 2009.

 

By   /s/ Dianne Dyer-Bruggeman
 

Dianne Dyer-Bruggeman

Executive Vice President, Human Resources

EXHIBIT 10.18

 

 

 

 

 

ALLERGAN, INC.

PENSION PLAN

 

 

 

 

 

RESTATED

2008


TABLE OF CONTENTS

 

          PAGE
ARTICLE I   
INTRODUCTION      1
1.1    Plan Name      1
1.2    Plan Purpose      1
1.3    Effective Date of 2008 Restated Plan      1
1.4    Amendments to Plan      1
1.5    Plan Qualification      3
ARTICLE II   
DEFINITIONS      4
2.1    Accrued Benefit      4
2.2    Active Participant      4
2.3    Actuarial Equivalent      4
2.4    Affiliated Company      4
2.5    Age      4
2.6    Annuity Starting Date      4
2.7    Average Earnings      4
2.8    Beneficiary      5
2.9    Benefit Year      5
2.10    Board of Directors      5
2.11    Code      5
2.12    Committee      5
2.13    Company      5
2.14    Earnings      5
2.15    Effective Date      7
2.16    Eligibility Computation Period      7
2.17    Eligible Employee      7
2.18    Eligible Retirement Plan      8
2.19    Eligible Rollover Distribution      8
2.20    Employee      9
2.21    Employment Commencement Date      9
2.22    ERISA      9
2.23    Fund      9
2.24    Highly Compensated Employee    10
2.25    Hour of Service    10
2.26    Investment Manager    10
2.27    Leased Employee    10
2.28    Normal Retirement Date    11
2.29    Participant    11
2.30    Period of Severance    11


TABLE OF CONTENTS

 

          PAGE
2.31    Plan    11
2.32    Plan Administrator    11
2.33    Plan Year    11
2.34    Primary Social Security Benefit    11
2.35    Qualified Joint and Survivor Annuity    12
2.36    Reemployment Commencement Date    12
2.37    Severance    12
2.38    Severance Date    13
2.39    Single Life Annuity    13
2.40    SKB Plan    13
2.41    Special Retirement Eligibility Date    13
2.42    Spin-Off Date    13
2.43    Sponsor    13
2.44    Trust    13
2.45    Trustee    13
2.46    Vesting Year    14
ARTICLE III   
PARTICIPATION    15
3.1    Participation for the 2003 Plan Year and thereafter    15
3.2    Participation for the 2002 Plan Year    15
3.3    Participation prior to the 2002 Plan Year    15
ARTICLE IV   
ACCRUAL OF BENEFITS    16
4.1    Accrued Benefit Formula    16
4.2    Minimum Accrued Benefit    16
4.3    Accrued Benefit for Participants with Earnings in excess of $150,000   
   prior to January 1, 1994    16
4.4    Accrued Benefit for Participants   
   participating in the Voluntary Early Retirement Incentive Program    17
4.5    Temporary Supplemental Monthly Benefit for Participants   
   participating in the Voluntary Early Retirement Incentive Program    17
ARTICLE V   
BENEFITS    19
5.1    Normal Retirement    19
5.2    Postponed Retirement    19
5.3    Early Retirement    19
5.4    Termination of Employment    21

 

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TABLE OF CONTENTS

 

          PAGE
5.5    Consent to Pension Payments    22
5.6    Maximum Pension    23
5.7    Defined Benefit Fraction and Defined Contribution Fraction    25
5.8    Mandatory Commencement of Benefits    27
5.9    Reemployment    27
5.10    Other Disabled Participants    28
5.11    Nonforfeitable Interest    29
5.12    Compensation for Maximum Pension    29
ARTICLE VI   
FORM OF PENSIONS    30
6.1    Unmarried Participants    30
6.2    Married Participants    30
6.3    Election of Optional Form of Benefit    30
6.4    Optional Forms of Benefit    31
6.5    Cash-Outs    32
6.6    Retroactive Annuity Starting Dates    32
ARTICLE VII   
PRE-RETIREMENT DEATH BENEFITS    35
7.1    Eligibility    35
7.2    Spousal Benefit    35
7.3    Alternative Death Benefit    36
7.4    Children’s Survivor Benefit    36
7.5    Waiver of Spousal Benefit    37
ARTICLE VIII   
CONTRIBUTIONS    38
8.1    Company Contributions    38
8.2    Source of Benefits    38
8.3    Irrevocability    38
ARTICLE IX   
ADMINISTRATION    40
9.1    Appointment of Committee    40
9.2    Appointment of Investment Subcommittee    40
9.3    Transaction of Business    40
9.4    Voting    41
9.5    Responsibility of Committees    41

 

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TABLE OF CONTENTS

 

          PAGE
9.6    Committee Powers    42
9.7    Additional Powers of Committee    42
9.8    Investment Subcommittee Powers    43
9.9    Periodic Review of Funding Policy    44
9.10    Claims Procedures    44
9.11    Appeals Procedures    45
9.12    Limitation on Liability    46
9.13    Indemnification and Insurance    46
9.14    Compensation of Committee and Plan Expenses    46
9.15    Resignation    46
9.16    Reliance Upon Documents and Opinions    46
9.17    Appointment of Investment Manager    47
ARTICLE X   
AMENDMENT AND ADOPTION OF PLAN    48
10.1    Right to Amend Plan    48
10.2    Adoption of Plan by Affiliated Companies    48
ARTICLE XI   
TERMINATION AND MERGER    49
11.1    Right to Terminate Plan    49
11.2    Merger Restriction    49
11.3    Effect on Trustee and Committee    49
11.4    Effect of Reorganization, Transfer of Assets or Change in Control    49
11.5    Termination Restrictions    51
ARTICLE XII   
TOP-HEAVY RULES    53
12.1    Applicability    53
12.2    Definitions    53
12.3    Top-Heavy Status    54
12.4    Minimum Benefit    55
12.5    Maximum Benefit    56
12.6    Minimum Vesting Rules    57
12.7    Noneligible Employees    57

 

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TABLE OF CONTENTS

 

          PAGE
ARTICLE XIII   
RESTRICTION ON ASSIGNMENT OR OTHER ALIENATION OF PLAN BENEFITS    58
13.1    General Restrictions Against Alienation    58
13.2    Qualified Domestic Relations Orders    58
ARTICLE XIV   
MISCELLANEOUS    61
14.1    No Right of Employment Hereunder    61
14.2    Effect of Article Headings    61
14.3    Limitation on Company Liability    61
14.4    Interpretation    61
14.5    Withholding For Taxes    61
14.6    California Law Controlling    61
14.7    Plan and Trust as One Instrument    61
14.8    Invalid Provisions    61
14.9    Counterparts    61
14.10    Forfeitures    62
14.11    Facility of Payment    62
14.12    Lapsed Benefits    62
APPENDIX A   
APPENDIX B   
APPENDIX C   

 

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ALLERGAN, INC.

PENSION PLAN

ARTICLE I

INTRODUCTION

1.1         Plan Name .    This document, made and entered into by Allergan, Inc., a Delaware corporation (“Allergan”) amends and restates in its entirety the “Allergan, Inc. Pension Plan (Restated 2005)” and shall be known hereafter as the “Allergan, Inc. Pension Plan (Restated 2008).”

1.2         Plan Purpose .    The purpose of the Allergan, Inc. Pension Plan (Restated 2008), hereinafter referred to as the “Plan,” is to provide additional retirement income to Eligible Employees of Allergan, and any Affiliated Companies that are authorized by the Board of Directors of Allergan to participate in the Plan for their future economic security. The Plan is fully funded through Company contributions and the assets of the Plan shall be administered, distributed, forfeited and otherwise governed by the provisions of the Plan, which is to be administered by the Committee for the exclusive benefit of Participants in the Plan and their Beneficiaries.

1.3         Effective Date of 2008 Restated Plan .    The Effective Date of this amended and restated Plan shall be January 1, 2008 unless otherwise specified in the Plan. The provisions of this Plan document apply generally to Employees who have completed at least one (1) Hour of Service for Allergan or any Affiliated Companies on or after January 1, 2008 and the rights and benefits, if any, of Employees or Participants whose employment with Allergan or any Affiliated Companies terminated prior to January 1, 2008 shall be determined in accordance with the provisions of the Plan then in effect unless otherwise provided herein and subject to any modification provided herein that may affect the payment of benefits under the Plan.

1.4         Amendments to Plan .    The Plan has been amended from time to time since its Original Effective Date of July 26, 1989 to reflect changes in the Plan’s operations and applicable law including, but not limited to, the following:

(a)        This Plan document that restates the Plan by incorporating the provisions of the First and Second Amendments to the Allergan, Inc. Pension Plan (Restated 2005) and amends the Plan: (i) to comply with all changes made by the Economic Growth and Tax Relief Reconciliation Act of 2001 (with technical corrections made by the Job Creation and Worker Assistance Act of 2002), the Pension Funding Equity Act of 2004, the American Jobs Creation Act of 2004, and the Gulf Opportunity Zone Act of 2005 as well as the changes to the qualification requirements listed on the “2006 Cumulative List of Changes in Plan Qualification Requirements” as set forth in Notice 2007-3, (ii) to comply with certain changes made by the Pension Protection Act of 2006 by (1) adding a 75% contingent beneficiary payment option, (2) extending the distribution election period from 90 days to up to 180 days and providing that distribution elections will include an explanation of a Participant’s right to defer and the effect of deferring benefit payment,


and (3) permitting non-spouse beneficiaries to elect direct rollovers of lump sum distributions, and (iii) to clarify certain operational provisions regarding, including but not limited to, the pension amount paid for benefit commencement dates after age 65.

(b)        The Plan document for the Allergan, Inc. Pension Plan (Restated 2005) that incorporated the provisions of the amendments made under the First and Second Amendments to the Allergan, Inc. Pension Plan (Restated 2003) and amended the Plan to eliminate the mandatory cash-out of Accrued Benefits that do not exceed $5,000 effective March 28, 2005.

(c)        Amendments to the Plan that (i) limited participation in the Plan to those Employees who were Eligible Employees (as defined in Section 2.17(b)) on September 30, 2002 who made a one-time irrevocable election to continue active participation in the Plan for Plan Years beginning on and after January 1, 2003 until their participation is terminated under the terms of the Plan in lieu of ceasing active participation in the Plan and participating in the Retirement Contribution feature of the Allergan, Inc. Savings and Investment Plan as provided under and subject to the terms of that plan and (ii) provided further that those Employees who elected to cease active participation in the Plan: (1) shall not be credited with Benefit Years after December 31, 2002 but shall continue to be credited with Vesting Years as provided under the terms of the Plan and (2) shall be entitled to a monthly pension upon completing five (5) Vesting Years or upon reaching the Special Retirement Eligibility Date and completing one (1) Vesting Year, the amount of which shall be equal to their Accrued Benefit determined as of December 31, 2002, at such times and in such forms as permitted under the Plan.

(d)        Amendments to the Plan that in connection with the distribution of the stock of Advanced Medical Optics, Inc. (“AMO”) by Allergan to its stockholders on June 29, 2002, provided that (i) AMO Employees (as defined in Section 2.20) shall cease to be eligible to participate in the Plan and shall cease to be credited with Benefit Years and Vesting Years under the Plan, (ii) AMO Employees shall have a nonforfeitable interest in their Accrued Benefits notwithstanding Section 5.11, and (iii) the assets attributable to, and the liabilities relating to, arising out of, or resulting from the Accrued Benefits of AMO Employees shall remain with the Pension Plan and shall be payable from the Plan to AMO Employees at such times and in such forms as permitted under the Plan.

(e)        Amendments to the Plan that in connection with the closure of the Allergan, Inc. Medical Plastics facility in Santa Ana, California (“Medical Plastics”), provided that (i) Participants whose employment is terminated as a result of the closure of Medical Plastics, as determined by the payroll records of the Sponsor or any Affiliated Company shall have a nonforfeitable interest in their Accrued Benefits notwithstanding Section 5.11 effective as of their termination dates, and (ii) the Accrued Benefits of such Participants shall be payable from the Plan to such Participants at such times and in such forms as permitted under the Plan.

 

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1.5         Plan Qualification .    The Plan is an employee benefit plan that is intended to qualify under Code Section 401(a) as a qualified pension plan so as to assure that the trust created under the Plan is tax exempt pursuant to Code Section 501(a). The Plan’s last determination letter was issued by the Internal Revenue Service on March 7, 2003 with respect to the Allergan, Inc. Pension Plan (Restated 2003). This Plan document is intended to reflect all law changes made by the Economic Growth and Tax Relief Reconciliation Act of 2001 (with technical corrections made by the Job Creation and Worker Assistance Act of 2002), the Pension Funding Equity Act of 2004, the American Jobs Creation Act of 2004, and the Gulf Opportunity Zone Act of 2005 as well as the changes to the qualification requirements listed on the “2006 Cumulative List of Changes in Plan Qualification Requirements” as set forth in Notice 2007-3.

 

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ARTICLE II

DEFINITIONS

2.1         Accrued Benefit .    “Accrued Benefit” shall mean, for each Participant, the amount of pension accrued by him or her under Article IV as of the date of reference. An Accrued Benefit shall only be payable in accordance with Articles V and VII.

2.2         Active Participant .    “Active Participant” shall mean a Participant who is an Eligible Employee.

2.3         Actuarial Equivalent .    “Actuarial Equivalent” shall mean a benefit of equal actuarial value under the assumptions set forth in Appendix A.

2.4         Affiliated Company .    “Affiliated Company” shall mean (i) any corporation, other than the Sponsor, which is included in a controlled group of corporations (within the meaning of Code Section 414(b)) of which the Sponsor is a member, (ii) any trade or business, other than the Sponsor, which is under common control (within the meaning of Code Section 414(c)) with the Sponsor, (iii) any entity or organization, other than the Sponsor, which is a member of an affiliated service group (within the meaning of Code Section 414(m)) of which the Sponsor is a member, and (iv) any entity or organization, other than the Sponsor, which is affiliated with the Sponsor under Code Section 414(o). An entity shall be an Affiliated Company pursuant to this Section only during the period of time in which such entity has the required relationship with the Sponsor under clauses (i), (ii), (iii) or (iv) of this Section after the Original Effective Date of the Plan.

2.5         Age .    “Age” shall mean a Participant’s age at his or her most recent birthday.

2.6         Annuity Starting Date .    “Annuity Starting Date” shall mean the first day of the first period for which a Participant’s pension is paid as an annuity or as any other optional form of benefit.

2.7         Average Earnings .    “Average Earnings” shall mean, for each Participant, 12 times the monthly average of his or her Earnings for the 60 consecutive months that yield the highest average. For purposes of this Section, (i) nonconsecutive months interrupted only by months in which a Participant has no Earnings shall be treated as consecutive and (ii) unless the Sponsor expressly determines otherwise, and except as is expressly provided otherwise in the Plan or in resolutions of the Board of Directors, amounts paid to a Participant by a domestic Affiliated Company prior to the effective date on which it became an Affiliated Company (that would have been Earnings if paid by the Company) before he or she became a Participant shall be treated as Earnings but only to the extent such Earnings when added to the Earnings actually paid by the Company do not result in more than 60 consecutive months of Earnings. If a Participant does not have Earnings for 60 consecutive months, his or her Average Earnings shall be 12 times the monthly average of his or her Earnings. For periods beginning on or after April 1, 2000, a partial month of employment shall be taken into account only if doing so yields a higher monthly average.

 

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2.8         Beneficiary .    “Beneficiary” or “Beneficiaries” shall mean the person or persons last designated by the Participant to receive the interest of a deceased Participant.

2.9         Benefit Year .    “Benefit Year” shall mean a credit used to measure a Participant’s service in calculating his or her Accrued Benefit. Each Participant shall be credited with a number of Benefit Years equal to 1/365th of (i) the aggregate number of days between his or her Employment Commencement Date (or Reemployment Commencement Date) of the Employee and the Severance Date which immediately follows that Employment Commencement Date (or Reemployment Commencement Date) and (ii) the aggregate number of days during a Period of Severance of less than 30 days, but in each case, disregarding any day such Participant is not an Active Participant and, for periods beginning on or after January 1, 2003, any day such Participant is on an “Extended Leave of Absence” as such term is defined in the Allergan, Inc. Welfare Benefits Plan.

2.10       Board of Directors .    “Board of Directors” shall mean the Board of Directors of the Sponsor (or its delegate) as it may from time to time be constituted.

2.11       Code .    “Code” shall mean the United States Internal Revenue Code of 1986 and the regulations thereunder. “Puerto Rico Code” shall mean the Puerto Rico Internal Revenue Code of 1994 and the regulations thereunder. Reference to a specific United States Internal Revenue Code Section or Puerto Rico Internal Revenue Code Section shall be deemed also to refer to any applicable regulations under that Section, and shall also include any comparable provisions of future legislation that amend, supplement or supersede that specific Section.

2.12       Committee .    “Committee” shall mean the committee to be appointed under the provisions of Section 9.1 to administer the Plan.

2.13       Company .    “Company” shall mean collectively the Sponsor and each Affiliated Company that adopts the Plan in accordance with Section 10.2.

2.14       Earnings .    “Earnings” shall mean the following:

(a)        Earnings shall include amounts paid during a Plan Year to an Employee by the Company for services rendered, including base earnings, commissions and similar incentive compensation, cost of living allowances earned within the United States of America, holiday pay, overtime earnings, pay received for election board duty, pay received for jury and witness duty, pay received for military service (annual training), pay received for being available for work, if required (call-in premium), shift differential and premium, sickness/accident related pay, vacation pay, vacation shift premium, and bonus amounts paid under the (i) Sales Bonus Program, (ii) Management Bonus Plan or Executive Bonus Plan, either in cash or in restricted stock, and (iii) group performance sharing payments, such as the “Partners for Success.”

 

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(b)        Earnings shall include amounts of salary reduction elected by the Employee under a Code Section 401(k) cash or deferred arrangement or a Code Section 125 cafeteria plan or a Puerto Rico Code Section 1165(e) cash or deferred arrangement, amounts deferred under the Executive Deferred Compensation Plan, and amounts paid to an Employee pursuant to a “split pay arrangement” between the Company and an Affiliated Company.

(c)        Earnings shall not include business expense reimbursements; Company gifts or the value of Company gifts; Company stock related options and payments; employee referral awards; flexible compensation credits paid in cash; special overseas payments, allowances and adjustments including, but not limited to, pay for cost of living adjustments and differentials paid for service outside of the United States (including Puerto Rico), expatriate reimbursement payments, and tax equalization payments; forms of imputed income; long-term disability pay; payment for loss of Company car; Company car allowance; payments for patents or for writing articles; relocation and moving expenses; retention and employment incentive payments; severance pay; long-term incentive awards, bonuses or payments; “Impact Award” payments; “Employee of the Year” payments; “Awards for Excellence” payments; special group incentive payments and individual recognition payments which are nonrecurring in nature; tuition reimbursement; and contributions by the Company under the Plan or distributions hereunder, any contributions or distributions pursuant to any other plan sponsored by the Company and qualified under Code Section 401(a) and/or Puerto Rico Code Section 1165 (other than contributions constituting salary reduction amounts elected by the Employee under a Code Section 401(k) cash or deferred arrangement or a Puerto Rico Code Section 1165(e) cash or deferred arrangement), any payments under a health or welfare plan sponsored by the Company, or premiums paid by the Company under any insurance plan for the benefit of Employees.

(d)        For purposes of this Section and notwithstanding paragraph (a) above, (i) for periods on or after January 1, 2005, Earnings shall not include lump sum amounts paid to Employees under the Company’s vacation buy-back policy, (ii) for periods beginning on or after January 1, 2003, if a Participant is not an Active Participant at any time during the month, he or she shall be deemed to have no Earnings for that month, (iii) for the period beginning on April 1, 2001 and ending on December 31, 2002, if a Participant is an Employee at any time during a month, Earnings for that month shall be the Earnings actually paid to the Participant during such month, and (iv) for periods prior to April 1, 2001, if a Participant is not an Employee for the entire month, he or she shall be deemed to have no Earnings for that month.

(e)        Earnings shall not exceed $200,000, as adjusted for cost-of-living increases in accordance with Code Section 401(a)(17)(B), for purposes of determining all benefits provided under the Plan. Any cost-of-living adjustments in effect for a calendar year shall apply to the Plan Year beginning with or within such calendar year. For purposes of determining benefits provided under the Plan in a Plan Year beginning on or after January 1, 2002, Earnings for any prior Plan Year shall not exceed $200,000.

 

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2.15       Effective Date .    “Effective Date” of this restated Plan shall mean January 1, 2005 except as provided herein or as otherwise required for the Plan to continue to maintain its qualified status under Code Section 401(a). The “Original Effective Date” of the Plan shall mean July 26, 1989.

2.16       Eligibility Computation Period .    “Eligibility Computation Period” shall mean a 365 day period used for determining whether an Employee is eligible to participate in the Plan. Each Employee shall be credited with (i) the aggregate number of days between each Employment Commencement Date (or Reemployment Commencement Date) of the Employee and the Severance Date which immediately follows that Employment Commencement Date (or Reemployment Commencement Date) and (ii) the aggregate number of days during a Period of Severance of less than twelve months.

2.17       Eligible Employee .    “Eligible Employee” shall mean:

(a)        For Plan Years beginning on or after January 1, 2003 and subject to paragraph (d) below, an Eligible Employee is any “Election Eligible Employee” who makes a one-time irrevocable election under procedures established by the Sponsor to continue as an Active Participant for Plan Years beginning on or after January 1, 2003 and who did not incur a Severance on or after October 1, 2002. An “Election Eligible Employee” is any Employee who is an Eligible Employee (as defined in paragraph (b) below) on September 30, 2002. The classification of an Employee as an Eligible Employee for Plan Years beginning on or after January 1, 2003 shall be determined solely from the records obtained during the election period established by the Sponsor.

(b)        For the 2002 Plan Year only and subject to paragraph (d) below, an Eligible Employee is any Employee who is employed by the Company but not by a joint venture in which the Company is a joint venturer and whose Employment Commencement Date or most recent Reemployment Commencement Date is prior to October 1, 2002; provided, however, if a former Employee is rehired on or after October 1, 2002 but prior to January 1, 2003 and would be an Eligible Employee but for his or her Reemployment Commencement Date, he or she shall be an Eligible Employee commencing on his or her Reemployment Commencement Date but shall cease to be an Eligible Employee as of January 1, 2003. Notwithstanding the foregoing, a Leased Employee or an Employee of the Company who, as of October 1, 2002, is neither a United States citizen nor a United States resident shall not be an Eligible Employee.

(c)        For Plan Years beginning prior to January 1, 2002 and subject to paragraph (d) below, an Eligible Employee is any Employee who is employed by the Company but not by a joint venture in which the Company is a joint venturer; provided, however, a Leased Employee or an Employee of the Company who is neither a United States citizen nor a United States resident shall not be an Eligible Employee.

 

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(d)        Notwithstanding paragraphs (a), (b), and (c) above, (i) an Employee with respect to whom retirement benefits have been the subject of good faith collective bargaining shall be an Eligible Employee to the extent a collective bargaining agreement relating to him or her so provides and (ii) a temporary employee classified as such by the Sponsor or an Affiliated Company shall not be an Eligible Employee for Plan Years beginning prior to January 1, 1996.

2.18       Eligible Retirement Plan .    “Eligible Retirement Plan” shall mean (i) an individual retirement account or annuity described in Code Section 408(a) or 408(b), (ii) a qualified retirement plan described in Code Section 401(a) or 403(a) that accepts Eligible Rollover Distributions, (iii) an annuity contract described in Code Section 403(b) that accepts Eligible Rollover Distributions, and (iv) an eligible plan described in Code Section 457(b) which is maintained by a state, political subdivision of a state, or any agency or instrumentality of a state or political subdivision of a state and which agrees to separately account for amounts transferred into such plan from this Plan. Notwithstanding the foregoing, “Eligible Retirement Plan” shall mean (i) with respect to a Participant or Beneficiary who is a resident of Puerto Rico, a qualified retirement plan described in Code Section 401(a) or 403(a) that accepts Eligible Rollover Distributions and that is also a qualified plan under Puerto Rico Code Section 1165 and (ii) with respect to a non-spouse Beneficiary, an individual retirement account or annuity described in Code Section 408(a) or 408(b).

2.19       Eligible Rollover Distribution .    “Eligible Rollover Distribution” shall mean any distribution of all or any portion of the balance to the credit of the Distributee, except that an Eligible Rollover Distribution shall not include:

(a)        any distribution that is one of a series of substantially equal periodic payments (not less frequently than annually) made for the life (or life expectancy) of the Distributee or the joint lives (or joint life expectancies) of the Distributee and the Distributee’s designated beneficiary, or for a specified period of ten years or more;

(b)        any distribution to the extent such distribution is required under Code Section 401(a)(9);

(c)        the portion of any distribution that is not includible in gross income (determined without regard to the exclusion for net unrealized appreciation with respect to employer securities); and

(d)        any other distribution that is reasonably expected to total less than $200 during the year.

For purposes of this Section, ‘Distributee’ shall mean any Employee or former Employee receiving a distribution from the Plan. A Distributee also includes the Employee or former Employee’s Beneficiary and the Employee or former Employee’s spouse or former spouse who is the Alternate Payee under a Qualified Domestic Relations Order (as defined in Article XIII) with regard to the interest of the spouse or former spouse. For purposes of the Puerto Rico Code, any

 

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distribution to a Distributee who is a resident of Puerto Rico shall be an Eligible Rollover Distribution.

2.20       Employee .    “Employee” shall mean, for purposes of the Plan, any individual who is employed by the Sponsor or an Affiliated Company, any portion of whose income is subject to withholding of income tax and/or for whom Social Security contributions are made by the Sponsor or an Affiliated Company; provided, however, that such term shall not include:

(a)        Any individual who performs services for the Sponsor or an Affiliated Company and who is classified or paid as an independent contractor as determined by the payroll records of the Sponsor or an Affiliated Company even if a court or administrative agency determines that such individual is a common-law employee and not an independent contractor;

(b)        Any individual who performs services for the Sponsor or an Affiliated Company pursuant to an agreement between the Sponsor or an Affiliated Company and any other person including a leasing organization except to the extent such individual is a Leased Employee; and

(c)        Any individual whose employment is transferred from the Sponsor or an Affiliated Company to Advanced Medical Optics, Inc. (“AMO”) in connection with the distribution of the stock of AMO by the Sponsor to its stockholders, effective as of the day following such transfer, hereinafter referred to as an “AMO Employee.” An individual is an AMO Employee if classified or identified as such in the payroll records of the Sponsor or an Affiliated Company or in the Employee Matters Agreement entered into between the Sponsor and AMO.

2.21       Employment Commencement Date .    “Employment Commencement Date” shall mean the date on which an Employee is first credited with an Hour of Service for the Sponsor or an Affiliated Company. An Employee shall not, for the purpose of determining his or her Employment Commencement Date, be deemed to have commenced employment with an Affiliated Company prior to the effective date on which the entity became an Affiliated Company unless the Sponsor expressly determines otherwise, and except as is expressly provided otherwise in the Plan, in Appendix C to the Plan, or in resolutions of the Board of Directors.

2.22       ERISA .    “ERISA” shall mean the Employee Retirement Income Security Act of 1974 and the regulations thereunder. Reference to a specific ERISA Section shall be deemed also to refer to any applicable regulations under that Section, and shall also include any comparable provisions of future legislation that amend, supplement or supersede that specific Section.

2.23       Fund .    “Fund” shall mean the assets accumulated for purposes of the Plan.

 

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2.24       Highly Compensated Employee .    “Highly Compensated Employee” shall mean:

(a)        An Employee who performed services for the Company during the Plan Year or preceding Plan Year and is a member of one or more of the following groups:

(i)      Employees who at any time during the Plan Year or preceding Plan Year are or were Five Percent Owners (as defined in Section 12.2).

(ii)     Employees who received Compensation during the preceding Plan Year from the Company in excess of $80,000 (as adjusted in such manner as permitted under Code Section 414(q)(1)).

(b)        The term “Highly Compensated Employee” includes a Former Highly Compensated Employee. A Former Highly Compensated Employee is any Employee who was (i) a Highly Compensated Employee when he or she terminated employment with the Company or (ii) a Highly Compensated Employee at any time after attaining age 55. Notwithstanding the foregoing, an Employee who separated from service prior to 1987 shall be treated as a Former Highly Compensated Former Employee only if during the separation year (or year preceding the separation year) or any year after the Employee attains age 55 (or the last year ending before the Employee’s 55th birthday), the Employee either received Compensation in excess of $50,000 or was a Five Percent Owner (as defined in Section 12.2).

(c)        For the purpose of this Section , the term “Compensation” means compensation as defined in Code Section 415(c)(3), as set forth in Section 5.12.

(d)        For the purpose of this Section, the term “Company” shall mean the Sponsor and any Affiliated Company.

The determination of who is a Highly Compensated Employee, including the determination of the Compensation that is considered, shall be made in accordance with Code Section 414(q) and applicable regulations to the extent permitted thereunder.

2.25       Hour of Service .    “Hour of Service” shall mean an hour for which an Employee is paid or entitled to payment for the performance of duties for the Sponsor and any Affiliated Company.

2.26       Investment Manager .    “Investment Manager” shall mean the one or more Investment Managers, if any, that are appointed pursuant to the provisions of Section 9.15 and who constitute investment managers under Section 3(38) of ERISA.

2.27       Leased Employee .    “Leased Employee” shall mean any person (other than an Employee of the recipient) who pursuant to an agreement between the recipient and any other person (“leasing organization”) has performed services for the recipient (or for the recipient and related persons determined in accordance with Code Section 414(n)(6)) on a substantially full

 

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time basis for a period of at least one (1) year, and such services are performed under the primary direction or control by recipient employer. Contributions or benefits provided to a Leased Employee by a leasing organization which are attributable to services performed for the recipient employer shall be treated as provided by the recipient employer. A Leased Employee shall not be considered an Employee of the recipient if Leased Employees do not constitute more than 20 percent of the recipient’s nonhighly compensated workforce and such Leased Employee is covered by a money purchase pension plan providing (i) a nonintegrated employer contribution rate of at least ten (10) percent of compensation as defined under Code Section 415(c)(3); (ii) immediate participation; and (iii) full and immediate vesting.

2.28       Normal Retirement Date .    “Normal Retirement Date” shall mean the date a Participant attains age 65.

2.29       Participant .    “Participant” shall mean: (i) an Active Participant, or (ii) a former Active Participant who is eligible for an immediate or deferred benefit under Article V.

2.30       Period of Severance .    “Period of Severance” shall mean the period of time commencing on an Employee’s Severance Date and ending on the Employee’s subsequent Reemployment Commencement Date, if any.

2.31       Plan .    “Plan” shall mean the Allergan, Inc. Pension Plan described herein and as amended from time to time.

2.32       Plan Administrator .    “Plan Administrator” shall mean the administrator of the Plan within the meaning of Section 3(16)(A) of ERISA. The Plan Administrator shall be the Allergan Executive Committee whose members are appointed by the Board of Directors pursuant to the provisions of Section 9.1 to administer the Plan.

2.33       Plan Year .    “Plan Year” shall mean the calendar year. The Plan Year shall be the limitation year for purposes of computing limitations on contributions, benefits and allocations.

2.34       Primary Social Security Benefit .    “Primary Social Security Benefit” shall mean for purposes of determining a Participant’s Accrued Benefit:

(a)        for an Employee whose Severance occurs on or after the date he or she attains Age 62, the immediate benefit that is or would have been payable to him or her at Age 65 or his or her actual retirement, if earlier, under the Social Security Act (or foreign equivalent) as then in effect; or

(b)        for an Employee whose Severance occurs prior to Age 62, the benefit that would be payable to him or her at Age 62 under the Social Security Act (or foreign equivalent) as in effect when he or she incurs a Severance, without adjustments for cost of living, projected on the assumption that for each month before Age 60, he or she continues to receive wages for Social Security purposes equal to one-twelfth of his or her Earnings for the calendar year preceding the year in which his or her Severance occurs,

 

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and that he or she shall receive no further wages for Social Security purposes after the later of Age 60 or his or her actual Severance.

2.35       Qualified Joint and Survivor Annuity .    “Qualified Joint and Survivor Annuity” shall mean the form of pension benefit described in this Section. Under a Qualified Joint and Survivor Annuity, monthly payments to the Participant shall begin on the date provided in Article V and continue until the last day of the month in which the Participant’s death occurs. On the first day of the following month, monthly payments in an amount equal to 50% of the monthly payment to the Participant which is attributable to his or her Accrued Benefit shall begin to his or her surviving spouse but only if the spouse was married to the Participant on the date as of which payments to the Participant began. Payments to a surviving spouse under a Qualified Joint and Survivor Annuity shall end on the last day of the month in which the spouse’s death occurs. The anticipated payments under a Qualified Joint and Survivor Annuity shall be the actuarial equivalent of a pension in the form of a Single Life Annuity in the amount set forth in Article V.

2.36       Reemployment Commencement Date .    “Reemployment Commencement Date” shall mean, in the case of an Employee who incurs a Severance and who is subsequently reemployed by the Sponsor or an Affiliated Company, the first day following the Severance on which the Employee is credited with an Hour of Service for the Sponsor or an Affiliated Company with respect to which he or she is compensated or entitled to compensation by the Sponsor or an Affiliated Company. An Employee shall not, for the purpose of determining his or her Reemployment Commencement Date, be deemed to have commenced employment with an Affiliated Company prior to the effective date on which the entity became an Affiliated Company unless the Sponsor shall expressly determine otherwise, and except as is expressly provided otherwise in the Plan or in resolutions of the Board of Directors.

2.37       Severance .    “Severance” shall mean the termination of an Employee’s employment with the Sponsor or an Affiliated Company by reason of such Employee’s death, retirement, resignation or discharge, or otherwise. For purposes of determining a Participant’s Vesting Years and Benefit Years, such Participant shall not incur a Severance by reason of the following:

(a)        absence due to service in the Armed Forces of the United States, if the Employee makes application to the Company for resumption of work with the Company, following discharge, within the time specified by then applicable law or absence due to qualified military service if so required by Code Section 414(u);

(b)        absence resulting from temporary disability on account of illness or accident;

(c)        absence while covered by a long term disability plan maintained by the Company that is prior to the earlier of (i) a Participant’s Normal Retirement Date (or, if later, such date the Participant is no longer classified as an Eligible Employee as determined by the payroll records of the Sponsor or Affiliated Company or (ii) the date

 

12


his or her pension under the Plan commences, provided that the Participant has at least five (5) Vesting Years as of the first date of such absence; or

(d)        such other types of absence as the Company may determine by uniform policy.

2.38       Severance Date .    “Severance Date” shall mean, in the case of any Employee who incurs a Severance, the day on which such Employee is deemed to have incurred such Severance as determined in accordance with the provisions of Section 2.37. In the case of any Employee who incurs a Severance as provided under Section 2.37 and who is entitled to a subsequent payment of compensation for reasons other than future services (e.g., as back pay for past services rendered or as payments in the nature of severance pay), the Severance Date of such Employee shall be as of the effective date of the Severance event (e.g., the date of his or her death, effective date of a resignation or discharge, etc.), and the subsequent payment of the aforementioned type of post-Severance compensation shall not operate to postpone the timing of the Severance Date for purposes of the Plan except as provided in Section 2.37.

2.39       Single Life Annuity .    “Single Life Annuity” shall mean the form of pension benefit described in this Section. Under a Single Life Annuity, monthly payments to the Participant shall begin on the date provided in Article V and continue until the last day of the month in which the Participant’s death occurs.

2.40       SKB Plan .    “SKB Plan” shall mean the Retirement Plan for Employees of SmithKline Beckman Corporation.

2.41       Special Retirement Eligibility Date .    “Special Retirement Eligibility Date” shall mean the date a Participant attains age 62.

2.42       Spin-Off Date .    “Spin-Off Date” shall mean on or about July 26, 1989, SmithKline Beckman Corporation distributed the stock of the Sponsor to its shareholders, rendering Eligible Employees of the Company ineligible to participate in the SKB Plan. The liability for the accrued benefits of Eligible Employees under the SKB Plan and assets sufficient to satisfy applicable legal requirements were transferred to the Plan in November of 1989. The benefits which were previously provided by the SKB Plan for former employees of Company who terminated prior to the Spin-Off Date shall be paid under the Plan.

2.43       Sponsor .    “Sponsor” shall mean Allergan, Inc., a Delaware corporation, and any successor corporation or entity.

2.44       Trust .    “Trust” or” Trust Fund” shall mean the one or more trusts created for funding purposes under the Plan.

2.45       Trustee .    “Trustee” shall mean the individual or entity acting as a trustee of the Trust Fund.

 

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2.46       Vesting Year .    “Vesting Year” shall mean a credit awarded as follows:

(a)        In the case of any Employee who was employed by the Sponsor or an Affiliated Company at any time prior to the Original Effective Date, for the period prior to the Original Effective Date, such Employee shall be credited with that number of Vesting Years under this Plan equal to the number of Vesting Years (as that term is defined in the SKB Plan) credited to such Employee under the SKB Plan as of the Original Effective Date.

(b)        In the case of any Employee who is employed by the Sponsor or an Affiliated Company on or after the Original Effective Date, an Employee shall be credited with a number of Vesting Years equal to 1/365th of (i) the aggregate number of days between each Employment Commencement Date (or Reemployment Commencement Date) of the Employee and the Severance Date which immediately follows that Employment Commencement Date (or Reemployment Commencement Date) and (ii) the aggregate number of days for any Period of Severance of less than twelve months. Solely for the purpose of determining an Employee’s Vesting Years under this paragraph (b), in the case of an Employee who is employed by the Sponsor or an Affiliated Company on the Original Effective Date, that date shall be deemed to be an Employment Commencement Date of the Employee (with Vesting Years for the period prior to the Original Effective Date determined under paragraph (a) above).

(c)        In the case of any Employee who is employed under Departments 120 through 130 at the Allergan Medical Optics - Lenoir facility, such Employee shall be credited with a number of Vesting Years equal to 1/365th of (i) the aggregate number of days between each Employment Commencement Date (or Reemployment Commencement Date) of the Employee and the Severance Date which immediately follows that Employment Commencement Date (or Reemployment Commencement Date) and (ii) the aggregate number of days for any Period of Severance of less than twelve months. Solely for the purpose of determining an Employee’s Vesting Years under this paragraph (c), an Employee’s Employment Commencement Date or Reemployment Commencement Date shall include dates prior to Allergan Medical Optics - Lenoir facility becoming an Affiliated Company.

 

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ARTICLE III

PARTICIPATION

3.1         Participation for the 2003 Plan Year and thereafter .    For Plan Years beginning on or after January 1, 2003, participation in the Plan shall be determined as follows:

(a)        Each Employee or former Employee who is a Participant in the Plan as of December 31, 2002 shall continue as a Participant and each Participant who is an Active Participant in the Plan as of December 31, 2002 shall continue as an Active Participant so long as he or she is an Eligible Employee (as defined in Section 2.17(a)). Any other Employee shall not be eligible to become a Participant in the Plan and any Participant who is not an Active Participant on January 1, 2003 shall not be eligible to become an Active Participant in the Plan.

(b)        If an Active Participant incurs a Severance after January 1, 2003 and is subsequently reemployed, he or she shall not be reinstated as an Active Participant but shall continue to be credited with Vesting Service in accordance with Section 2.46 and shall be entitled to a monthly pension upon completing five (5) Vesting Years or reaching the Special Retirement Eligibility Date and completing one (1) Vesting Year, the amount of which shall be equal to his or her Accrued Benefit determined as of his or her first Severance Date following January 1, 2003, at such times and in such forms as permitted under Article V.

3.2         Participation for the 2002 Plan Year .    For the 2002 Plan Year, each Employee or former Employee who is a Participant in the Plan as of December 31, 2001 shall continue as a Participant and each Participant who is an Active Participant in the Plan as of December 31, 2001 shall continue as an Active Participant so long as he or she is an Eligible Employee (as defined in Section 2.17(b)). Any other Eligible Employee (as defined in Section 2.17(b)) shall become a Participant in the Plan on the later of: (i) the date the Eligible Employee completes his or her Eligibility Computation Period, or December 31, 2002, if earlier, or (ii) the date the Employee becomes an Eligible Employee, and shall continue as an Active Participant so long as he or she is an Eligible Employee.

3.3         Participation prior to the 2002 Plan Year .    For Plan Years prior to January 1, 2002, each Eligible Employee (as defined in Section 2.17(c)) became a Participant in the Plan on the later of: (i) the date the Employee completed his or her Eligibility Computation Period or (ii) the date the Employee became an Eligible Employee, and continued as an Active Participant so long as he or she was an Eligible Employee.

 

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ARTICLE IV

ACCRUAL OF BENEFITS

4.1         Accrued Benefit Formula .    Each Participant shall have an Accrued Benefit equal to one-twelfth (1/12) of the sum of:

(a)        1.23% of his or her Average Earnings not in excess of Covered Compensation multiplied by the number of his or her Benefit Years to a maximum of 35 Benefit Years; plus

(b)        1.73% of his or her Average Earnings in excess of Covered Compensation multiplied by the number of his or her Benefit Years to a maximum of 35 Benefit Years; plus

(c)        .50% of his or her Average Earnings multiplied by the number of his or her Benefit Years in excess of 35 Benefit Years.

For purposes of this Section, “Covered Compensation” is the average (without indexing) of the social security wage bases in effect for each calendar year during the 35-year period ending with the calendar year in which the Participant attains (or will attain) the social security retirement age as defined in Code Section 415(b)(8). In determining a Participant’s Covered Compensation for a Plan Year, it is assumed that the social security wage base in effect at the beginning of the Plan Year will remain the same for all future calendar years.”

4.2         Minimum Accrued Benefit .    Notwithstanding any other provision of the Plan, under no circumstances shall any Participant’s Accrued Benefit under the Plan be less than the amount of his or her accrued benefit under the SKB Plan as of the Spin-Off Date under the terms of the SKB Plan in effect as of that date, including any amendments made to the SKB Plan which are effective on the Spin-Off Date, notwithstanding the fact that they may have been adopted after such date.

4.3         Accrued Benefit for Participants with Earnings in excess of $150,000 prior to January 1, 1994 .    The Accrued Benefit of a “Section 401(a)(17) Employee” shall be the greater of:

(a)        The Section 401(a)(17) Employee’s Accrued Benefit determined under the benefit formula in effect on or after January 1, 1994 taking into account all Benefit Years of the Section 401(a)(17) Employee; or

(b)        the sum of:

(i)      the Section 401(a)(17) Employee’s Accrued Benefit determined as of December 31, 1993 frozen in accordance with Section 1.401(a)(4)-13 of the Treasury Regulations; and

 

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(ii)     the Section 401(a)(17) Employee’s Accrued Benefit determined under the benefit formula applicable for Plan Years beginning on or after January 1, 1994 taking into account only those Benefit Years of the Section 401(a)(17) Employee credited on or after January 1, 1994; or

(c)        the sum of:

(i)      the Employee’s Accrued Benefit determined as of December 31, 1988 under the SKB Plan and frozen in accordance with Section 1.401(a)(4)-13 of the Treasury Regulations; and

(ii)     the Section 401(a)(17) Employee’s Accrued Benefit determined under the benefit formula applicable for Plan Years beginning on or after January 1, 1989 taking into account only those Benefit Years of the Section 401(a)(17) Employee credited on or after January 1, 1989 and before January 1, 1994; and

(iii)    the Section 401(a)(17) Employee’s Accrued Benefit determined under the benefit formula applicable for Plan Years beginning on or after January 1, 1994 taking into account only those Benefit Years of the Section 401(a)(17) Employee credited on or after January 1, 1994.

For purposes of this Section, a “Section 401(a)(17) Employee” means a Participant whose current Accrued Benefit as of January 1, 1994 is based on Earnings in excess of $150,000.

4.4         Accrued Benefit for Participants participating in the Voluntary Early Retirement Incentive Program (“VERI”) .    The Accrued Benefit of a “VERI Employee” shall be determined as follows:

(a)        For the purpose of calculating the Accrued Benefit of a VERI Employee under Section 4.1, a VERI Employee shall be credited with five (5) Benefit Years in addition to the number of Benefit Years credited under Section 2.9.

(b)        The early retirement reduction factors of Sections 5.3(a) and 5.3(b) shall not apply to reduce the monthly pension derived from the Accrued Benefit of a VERI Employee.

For purposes of this Section 4.4 and Section 4.5 below, a “VERI Employee” means a Participant who has elected by August 31, 1998 (or such later date as approved by the Sponsor but in no event later than September 30, 1998) to participate in the Voluntary Early Retirement Incentive program offered by the Sponsor.

4.5         Temporary Supplemental Monthly Benefit for Participants participating in the Voluntary Early Retirement Incentive Program .    In addition to his or her Accrued Benefit, a VERI Employee shall receive a temporary supplemental monthly pension determined as follows:

 

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(a)        A VERI Employee who is unmarried when his or her monthly pension payments begin shall receive a temporary supplemental monthly pension following the month in which his or her retirement occurs and continuing until the earlier of (i) the month in which the VERI Employee attains age 62 or (ii) the month in which the VERI Employee dies. The amount of the temporary supplemental monthly pension shall be determined in accordance with the following Table:

 

Age at

December 31, 1998

  

Amount of

Supplemental Monthly Pension

60-61

   $500.00 

55-59

   $400.00 

50-54

   $300.00 

(b)        A VERI Employee who is married when his or her monthly pension payments begin shall receive a temporary supplemental monthly pension following the month in which his or her retirement occurs and continuing until the earlier of (i) the month in which the VERI Employee attain age 62 or (ii) the month in which the VERI Employee dies unless the VERI Employee elects to receive his or her monthly pension in the form of (i) a contingent beneficiary option, (ii) a guaranteed payment option, or (iii) a level income option as described in Section 6.4. In such case, if the married VERI Employee dies before reaching age 62, his or her temporary supplemental monthly pension shall be paid to his or her spouse, if living, and shall continue until the month in which the VERI Employee would have attained age 62. The amount of the temporary supplemental monthly pension shall be determined in accordance with the Table set forth in subsection (a) above.

 

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ARTICLE V

BENEFITS

5.1         Normal Retirement .    If a Participant incurs a Severance on account of retirement on or between the Special Retirement Eligibility Date and the Normal Retirement Date, he or she shall be entitled to a monthly pension that begins as of the first day of the month coincident with or next following his or her Severance Date which is equal to his or her Accrued Benefit.

5.2         Postponed Retirement .    If a Participant incurs a Severance on account of retirement after attaining the Normal Retirement Date, he or she shall be entitled to a monthly pension that begins as of the first day of the month coincident with or next following his or her Severance Date which is equal to his or her Accrued Benefit determined as of the Normal Retirement Date increased by the greater of (i) any additional benefit accruals provided under Article IV after the Normal Retirement Date, or (ii) an actuarial adjustment to take into account a delay in the payment of the Participant’s Accrued Benefit using the actuarial assumptions set forth in Appendix A for determining actuarial equivalence. The foregoing provisions of this Section 5.2 shall be interpreted and applied in accordance with the provisions of Proposed Treasury Regulation Section 1.411(b)-2(b)(4)(iii) or the corresponding provision of any subsequently adopted final regulations.

5.3         Early Retirement .    A Participant shall be eligible for Early Retirement as set forth below:

(a)        If a Participant who has at least five (5) Vesting Years and whose age is at least 55 incurs a Severance on account of retirement, he or she shall be eligible for Early Retirement as set forth in this paragraph (a):

(i)      Such Participant shall be entitled to a monthly pension that begins as of the first day of the month coincident with or next following his or her Severance Date or, at his or her election, a monthly pension that begins as of the first day of any subsequent month not later than the Normal Retirement Date.

(ii)     Such Participant’s monthly pension shall be equal to his or her Accrued Benefit but reduced in accordance with the following Table, with the percentage for a fractional part of a year of age being prorated on the basis of a number of full months.

 

Age When

Payments

Begin

  

% of Normal Pension

Computed Under

Article IV

  

Age When

Payments

Begin

  

% of Normal Pension

Computed Under

Article IV

61

   94    57    70

60

   88    56    64

59

   82    55    58

58

   76      

 

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(iii)    A Participant who is an AMO Employee (as defined in Section 2.20) shall be treated as having not less than five (5) Vesting Years as of the day following his or her transfer to Advanced Medical Optics, Inc. for purposes of this paragraph (a).

(b)        If a Participant who was a Participant on June 26, 1990, and who has at least five (5) Vesting Years, and whose age plus Benefit Years sum to at least 55 incurs a Severance on account of retirement, he or she shall be eligible for Early Retirement as set forth in this paragraph (b):

(i)      Such Participant shall be entitled to a monthly pension that begins as of the first day of the month coincident with or next following his or her Severance Date or, at his or her election, a monthly pension that begins as of the first day of any subsequent month not later than the Normal Retirement Date.

(ii)     Such Participant’s monthly pension shall be equal to his or her Accrued Benefit determined as of June 26, 1990, as set forth under the formula contained in Appendix B, but reduced in accordance with the following Table, with the percentage for a fractional part of a year of age being prorated on the basis of a number of full months.

 

Age When

Payments

Begin

  

% of Normal Pension

Computed Under

Article IV

  

Age When

Payments

Begin

  

% of Normal Pension

Computed Under

Article IV

61

   94    48    36

60

   88    47    34

59

   82    46    32

58

   76    45    30

57

   70    44    28

56

   64    43    27

55

   58    42    26

54

   52    41    25

53

   46    40    24

52

   44    39    23

51

   42    38    22

50

   40    37    21

49

   38      

Provided, that the above percentages shall be increased by 1% to a maximum of 10% for each of the Participant’s Benefit Years in excess of 20, with the percentage for a fractional part of a Benefit Year being prorated on the basis of the number of full months. In no event, however, shall a percentage be increased above 100%.

 

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(iii)    Notwithstanding subparagraph (ii) above, (1) if the Participant is age 55 or older when payments begin, the Participant shall receive a total monthly pension which is the greater of the amount determined under paragraph (a)(ii) or paragraph (b)(ii) above, and (2) if the Participant is less than age 55 when benefit payments begin, the Participant shall receive a monthly pension which is determined under paragraph (b)(ii) plus an additional monthly pension commencing at age 55 which is actuarially equivalent to the excess, if any, of the actuarial equivalent value of the monthly pension under paragraph (a)(ii) determined at age 55 over the actuarial equivalent value of the monthly pension under paragraph (b)(ii) determined at age 55.

(c)        A Participant who has elected by August 31, 1998 (or such later date as approved by the Sponsor but in no event later than September 30, 1998) to participate in the Voluntary Early Retirement Incentive program offered by the Sponsor shall be entitled to a monthly pension that begins as of the first day of the month coincident with or next following his or her Severance Date or, at his or her election, a monthly pension that begins as of the first day of any subsequent month not later than the Normal Retirement Date.

(d)        If a Participant incurs a Severance and retires under this Section, and his or her monthly pension begins after the first day of the month coincident with or next following the Special Retirement Eligibility Date, such Participant shall be entitled to the monthly pension payments he or she would have received had his or her pension began as of the first day of the month following the Special Retirement Eligibility Date.

5.4         Termination of Employment .

(a)        If a Participant who has at least five (5) Vesting Years incurs a Severance for any reason other than death and is not eligible to retire under Section 5.3, he or she shall be entitled to a monthly pension that begins on the first day of the month coincident with or next following the date he or she attains age 55, or at his or her election, a monthly pension that begins as of the first day of any subsequent month not later than the Normal Retirement Date. In the event a Participant elects that his or her monthly pension begin prior to the Special Retirement Eligibility Date, the amount of his or her monthly pension shall be determined as provided in Section 5.3(a).

(b)        If a Participant who has at least five (5) Vesting Years incurs a Severance for any reason other than death and is not eligible to retire under Section 5.3 but was a Participant on June 26, 1990, he or she shall be entitled to a monthly pension that begins on the first day of the month coincident with or next following the date his or her Age and Benefit Years total 55 years, or at his or her election, a monthly pension that begins as of the first day of any subsequent month not later than the Normal Retirement Date. In the event a Participant elects that his or her monthly pension begin prior to the Special

 

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Retirement Eligibility Date, the amount of his or her monthly pension shall be determined as provided in Section 5.3(b).

(c)        If a Participant incurs a Severance and is entitled to a monthly pension under this Section, and his or her monthly pension begins after the first day of the month coincident with or next following the Special Retirement Eligibility Date, such Participant shall be entitled to the monthly pension payments he or she would have received had his or her pension began as of the first day of the month following the Special Retirement Eligibility Date. If a Participant incurs a Severance and is entitled to a monthly pension under this Section, and his or her monthly pension begins after the first day of the month coincident with or next following the Normal Retirement Date, such Participant shall be entitled to the monthly pension payments he or she would have received had his or her pension began as of the first day of the month following the Special Retirement Eligibility Date (or, if later, his or Severance Date) or, in lieu thereof, a monthly pension which is equal to his or her Accrued Benefit determined as of the Special Retirement Eligibility increased by an actuarial adjustment to take into account a delay in the payment of the Participant’s Accrued Benefit using the actuarial assumptions set forth in Appendix A for determining actuarial equivalence.

5.5         Consent to Pension Payments .    The Participant and, if applicable, the Participant’s spouse must consent to the payment or commencement of the Participant’s pension prior to the Normal Retirement Date in accordance with the following rules:

(a)        The consent of the Participant shall be obtained in writing within the election period established by the Committee which shall commence no more than 180 days prior to the Participant’s Annuity Starting Date. No such consent shall be effective with respect to a married Participant unless the Participant’s spouse consents thereto in writing. Spousal consent shall not be required if a married Participant elects a joint and survivor option providing for payment of at least 50% of his or her annuity to his or her surviving spouse or the Sponsor determines there is no spouse or the spouse cannot be located. Neither the consent of the Participant nor the Participant’s spouse shall be required to the extent the payment or commencement of the Participant’s pension is required to begin under Section 5.8.

(b)        Each Participant shall receive in written nontechnical language, a notice which shall include a general description of the material features, and an explanation of the relative values of, the available optional forms of benefit. Such notice shall be furnished to the Participant no less than 30 days and no more than 180 days prior to the Participant’s Annuity Starting Date; provided, however, the Participant’s pension may be paid or commence less than 30 days after such notice is furnished if the notice clearly informs the Participant that he or she has at least 30 days after receiving the notice to consider the decision of whether or not to elect the commencement of his or her pension (and, if applicable, an optional form of benefit), and the Participant, after receiving the notice, affirmatively elects to commence his or her pension.

 

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5.6         Maximum Pension .    The largest aggregate annual pension that may be paid to any Participant in any Plan Year under the Plan shall be determined as follows:

(a)        Subject to paragraphs (b) through (d), the largest aggregate annual pension that may be paid to any Participant in any Plan Year, when added to the pension under any other qualified defined benefit plan maintained by the Sponsor or any Affiliated Company, shall not exceed the lesser of:

(i)      The Defined Benefit Dollar Limitation of $160,000 ($90,000 for Plan Years prior to the 2002 Limitation Year), multiplied by a fraction the numerator of which is the number of the Participant’s years of participation (or a part thereof) in the Plan or, up to the Spin-Off Date in the SKB Plan or in the Beckman Instruments, Inc. Pension Plan, not in excess of ten, and the denominator of which is ten; or

(ii)     The Defined Benefit Compensation Limitation of 100% of the Participant’s average annual total cash remuneration from the Company in the thirty-six consecutive months which yield the highest average, multiplied by a fraction the numerator of which is the number of the Participant’s Vesting Years (or a part thereof) not in excess of ten and the denominator of which is ten.

Benefit increases resulting from the increase in the Defined Benefit Dollar Limitation and the Defined Benefit Compensation Limitation under the Economic Growth and Tax Relief Reconciliation Act of 2001 shall apply to all Employees participating in the Plan who have one (1) Hour of Service on or after January 1, 2002.

(b)        The limitations set forth in this Section 5.6 shall be determined as provided below:

(i)      The Defined Benefit Dollar Limitation shall automatically be adjusted annually for increases in the cost of living as provided in Code Section 415(d). The adjusted limitation shall be effective as of January 1st of each calendar year and shall be applicable to Limitation Years ending with or within that calendar year. Such new limitation is incorporated herein by this reference and shall be substituted for the Defined Benefit Dollar Limitation set forth in paragraph (a) above.

(ii)     “Cash remuneration” shall mean “compensation” as defined in Section 5.12.

(iii)    For purposes of this Section, a Participant’s pension shall be measured as a Single Life Annuity or Qualified Joint and Survivor Annuity. A pension benefit shall be treated as a Qualified Joint and Survivor Annuity if it meets all of the requirements as defined in Section 2.35 except that the periodic payments to the spouse may be equal to or greater than 50%, but not more than 100%, of those to the Participant.

 

23


(iv)     A benefit payable in a form other than a Single Life Annuity or Qualified Joint and Survivor Annuity described in subparagraph (iii) above shall be adjusted to the Actuarial Equivalent of a Straight Life Annuity before applying the limitations of this Section. Effective for Limitation Years commencing on or after January 1, 1995, Actuarial Equivalent for the form of benefit shall be determined using (1) the interest rate and mortality table specified in Appendix A or (2) 5% interest (or for lump sums or other benefits subject to Code Section 417(e)(3), the applicable interest rate under Code Section 415(b)(2)(E)(ii) as determined as provided in Appendix A) and the applicable mortality table under Code Section 415(b)(2)(E)(v), whichever produces the greater Actuarial Equivalent value.

(v)      In addition to other limitations set forth in the Plan and notwithstanding any other provisions of the Plan, the accrued benefit, including the right to any optional benefits provided in the Plan (and all other defined benefit plans required to be aggregated with this Plan under the provisions of Code Section 415) shall not increase to an amount in excess of the amount permitted under Code Section 415 at any time.

(c)        For Limitation Years beginning on or after January 1, 2002, the Defined Benefit Dollar Limitation for any Participant shall be adjusted as follows:

(i)      If a Participant’s pension begins prior to age 62, the Defined Benefit Dollar Limitation applicable to the Participant at such earlier age is an annual benefit payable in the form of a straight life annuity beginning at the earlier age that is the actuarial equivalent of the Defined Benefit Dollar Limitation applicable to the Participant at age 62 (as adjusted under paragraph (a) above, if required). The Defined Benefit Dollar Limitation applicable at an age prior to age 62 is determined as the lesser of (1) the Actuarial Equivalent (at such age) of the Defined Benefit Dollar Limitation computed using the factors specified in Section 5.3 or (2) the actuarial equivalent (at such age) of the Defined Benefit Dollar Limitation computed using a 5 percent interest rate and the applicable mortality table specified in Appendix A to the Plan. Any decrease in the Defined Benefit Dollar Limitation determined in accordance with this paragraph (c) shall not reflect a mortality decrement if benefits are not forfeited upon the death of the Participant. If any benefits are forfeited upon death, the full mortality decrement is taken into account.

(ii)     If a Participant’s pension begins after age 65, the Defined Benefit Dollar Limitation applicable to the Participant at such later age is the annual benefit payable in the form of a straight life annuity beginning at the later age that is actuarially equivalent to the defined benefit dollar limitation applicable to the Participant at age 65 (as adjusted under paragraph (a) above, if required). The Defined Benefit Dollar Limitation applicable at an age after age 65 is determined as the lesser of (1) the Actuarial Equivalent (at such age) of the Defined Benefit Dollar Limitation computed using the interest rate and mortality table specified in Appendix A to the Plan or (2) the actuarial equivalent (at such age) of the Defined Benefit Dollar Limitation computed using a 5 percent interest rate assumption and

 

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the applicable mortality table specified in Appendix A to the Plan. For these purposes, mortality between age 65 and the age at which benefits commence shall be ignored.

(d)        For Limitation Years beginning prior to January 1, 2002, the Defined Benefit Dollar Limitation for any Participant shall be adjusted if a Participant’s pension begins before or after he or she attains his or her Social Security Retirement Age. In such case, the Defined Benefit Dollar Limitation shall be adjusted to its Actuarial Equivalent beginning at the Participant’s Social Security Retirement Age; except that if his or her pension begins before he or she attains his or her Social Security Retirement Age, but after he or she attains age 62, the Defined Benefit Dollar Limitation shall be reduced by 5/9 of 1% for each of the first 36 months and 5/12 of 1% for each additional month by which the Participant’s benefit commencement date precedes his or her Social Security Retirement Age. The Defined Benefit Dollar Limitation applicable at an age prior to age 62 is determined as the lesser of (1) the Actuarial Equivalent (at such age) of the Defined Benefit Dollar Limitation computed using the factors specified in Section 5.3 or (2) the actuarial equivalent (at such age) of the Defined Benefit Dollar Limitation computed using a 5 percent interest rate and the applicable mortality table specified in Appendix A to the Plan. The interest rate used to determine the Actuarial Equivalent shall be the rate stated in the Plan, but shall be 5% if the pension begins after the Social Security Retirement Age. For purposes of this Section and Section 5.7, “Social Security Retirement Age” means (i) for any Participant born before January 1, 1938, Age 65, (ii) for any Participant born after December 31, 1937 but before January 1, 1955, Age 66, or (iii) for any other Participant, Age 67. A Participant’s pension shall be measured as a Single Life Annuity beginning at his or her Social Security Retirement Age.

5.7         Defined Benefit Fraction and Defined Contribution Fraction .    For Plan Years beginning prior to the 2000 Plan Year, the largest aggregate annual pension that may be paid to any Participant in any Plan Year under the Plan shall not, when added to the pension under any other qualified defined benefit plan maintained by the Sponsor or any Affiliated Company, exceed the lesser of the dollar limitation described in Section 5.6 or the amount that would cause the sum of a Participant’s Defined Benefit Fraction and Defined Contribution Fraction for the Plan Year in which the Participant’s Severance occurs to equal 1.0. To the extent the sum of a Participant’s Defined Benefit Fraction and Defined Contribution Fraction exceeds 1.0, adjustments shall be made first by reducing the Participant’s benefit under any defined benefit plan maintained by the Sponsor or an Affiliated Company.

(a)        A Participant’s Defined Benefit Fraction for a given Plan Year is a fraction, the numerator of which is his or her projected annual benefit for the Plan Year and the denominator of which is the lesser of (i) 1.25 multiplied by $90,000, adjusted to reflect commencement before or after Social Security Retirement Age, or (ii) 1.4 multiplied by 100% of his or her average annual total cash remuneration from the Sponsor or any Affiliated Company in the thirty-six consecutive months which yield the highest average.

(b)        A Participant’s Defined Contribution Fraction for a given Plan Year is a fraction, the numerator of which is the sum of his or her annual additions for all calendar

 

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years and the denominator of which is the sum of his or her maximum aggregate amounts for all calendar years in which he or she is an Employee. A Participant’s maximum aggregate amounts for any Plan Year shall equal the lesser of 1.25 multiplied by the dollar limitation for such Plan Year or 1.4 multiplied by the percentage limitation for such Plan Year.

(c)        The annual addition to a Participant’s account for any year is the sum, determined with respect to all defined contribution plans maintained by the Sponsor or an Affiliated Company (including any voluntary contributions feature of any defined benefit plan thereof), of:

(i)      Company contributions and forfeitures allocated to the Participant’s account;

(ii)     For Plan Years beginning after December 31, 1986, the amount of the Participant’s contributions; for Plan Years beginning before January 1, 1987, the lesser of:

(A)        50% of his or her contributions; or

(B)        For each calendar year after 1975 the amount by which the Participant’s contributions exceed 6% of his or her cash remuneration; for each calendar year before 1976 during which he or she was a Participant, the excess of the aggregate amount of his or her contributions for all such years over 10% of his or her aggregate cash remuneration from the Sponsor or an Affiliated Company for all such years, multiplied by a fraction the numerator of which is one and the denominator of which is the number of such years.

(iii)    Amounts allocated after March 31, 1984 to an individual medical account (as defined in Code Section 415(l)(2)) that is part of a pension or annuity plan maintained by the Sponsor or an Affiliated Company;

(iv)     Amounts derived from contributions paid or accrued after December 31, 1985, in taxable years ending after such date, that are attributable to post-retirement medical benefits allocated to the separate account of a key employee (as defined in Code Section 419A(d)(3)) under a welfare benefit fund (as defined in Code Section 419(e)) maintained by the Sponsor or an Affiliated Company; and

(v)      allocations under a simplified employee pension.

 

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5.8         Mandatory Commencement of Benefits .

(a)        A Participant’s pension shall begin no later than sixty days after the close of the Plan Year in which falls the later of his or her attainment of the Normal Retirement Date or the date he or she incurs a Severance.

(b)        In the case of a Participant, payment shall begin no later than a Participant’s required beginning date determined under the rules of subparagraphs (i) or (ii) below:

(i)      Active Participants attaining age 70-1/2 prior to 1999: The required beginning date of an Active Participant who attains age 70-1/2 prior to 1999 shall be April 1 of the calendar year immediately following the year in which the Active Participant attains age 70-1/2; provided, however, that an Active Participant, other than an Active Participant who is a Five Percent Owner (as defined in Section 12.2), who attains age 70-1/2 in 1996, 1997, or 1998 may elect to defer the required beginning date until the first day of the month coincident with or next following his or her Severance Date.

(ii)     Participants attaining age 70-1/2 after 1998: The required beginning date of a Participant who attains age 70-1/2 after 1998 shall be the first day of the month coincident with or next following his or her Severance Date; provided, however, if such Participant is a Five Percent Owner (as defined in Section 12.2) with respect to the Plan Year ending in the calendar year in which such Participant attains age 70-1/2, the required beginning date shall be April 1 of the calendar year immediately following the year in which such Participant attains age 70-1/2.

5.9         Reemployment .    If a Participant who is receiving benefits again becomes an Employee, his or her pension shall be subject to the following rules:

(a)        A Participant’s pension shall not be suspended if he or she is subsequently reemployed on or after October 1, 2002.

(b)        A Participant’s pension shall be suspended if he or she was subsequently reemployed as an Eligible Employee prior to October 1, 2002 as follows:

(i)      The Participant’s pension shall be suspended and recomputed upon his or her Severance Date if he or she has not reached the Normal Retirement Date.

(ii)     The Participant’s pension shall be suspended for each calendar month or for each four or five week payroll period ending in a calendar month during which the Participant either completes 40 or more Hours of Service (counting each day of employment in a position designated by the Company as

 

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full time as five (5) Hours of Service), or receives payment for any such Hours of Service performed on each of eight or more days or separate work shifts in such month or payroll period if the Participant has reached the Normal Retirement Date. No adjustment to the Participant’s pension shall be made on account of such non-payment. No payment shall be withheld pursuant to this subparagraph (ii) until the Participant is notified by personal delivery or first class mail during the first calendar month or payroll period in which payments are suspended that his benefits are suspended. Such notification shall contain a description of the specific reasons why benefit payments are being suspended, a general description of the Plan provisions relating to the suspension of payments, a copy of such provisions, and a statement to the effect that applicable Department of Labor regulations may be found in § 2530.203-3 of the Code of Federal Regulations. In addition, the suspension notification shall inform the Participant of the Plan’s procedures for affording a review of the suspension of benefits.

(iii)    A Participant described in subparagraphs (i) or (ii) above, shall be eligible to receive credit for additional Benefit Years for any period of reemployment (as an Eligible Employee). The pension of such Participant shall be reduced by the Actuarial Equivalent of any payment received by the Participant under the Plan prior to his or her attainment of the Special Retirement Eligibility Date, or, if earlier, the first day on which he or she would have been entitled to 100% of his or her Accrued Benefit under Section 5.3(b) (if on his or her prior Severance Date he or she had deferred his or her benefit until that date).

5.10       Other Disabled Participants .    A former Active Participant who is covered under a long term disability plan maintained by the Company, who has at least five (5) Vesting Years, and who becomes eligible for benefits under such plan, shall be eligible to accrue Benefit Years pursuant to this Section for the duration of his or her disability until the earlier of (i) the later of his or her Normal Retirement Date or Severance Date or (ii) the date he or she commences to receive a pension under the Plan. The following rules shall apply to benefit accruals under this Section:

(a)        The Employee’s Average Earnings during his or her disability shall be deemed to be his or her Average Earnings calculated at the time his or her disability commenced.

(b)        The Employee’s Primary Social Security Benefit shall be as defined in Article II and the Employee’s Covered Compensation as defined in Section 4.1 shall be determined as of the year for which he or she is credited with his or her final Benefit Year.

(c)        In addition, a former Active Participant described in this Section shall be treated as an Employee for purposes of the survivor income benefits described in Section 7.1 while he or she is eligible to accrue Benefit Years pursuant to this Section.

 

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5.11       Nonforfeitable Interest .    Notwithstanding any other provision in the Plan to the contrary, a Participant shall have a nonforfeitable interest in his or her Accrued Benefit upon reaching the Normal Retirement Date, or if earlier, upon being credited with five (5) or more Vesting Years. In addition, a Participant shall have a nonforfeitable interest in his or her Accrued Benefit upon reaching the Special Retirement Eligibility Date or if later, upon being credited with one (1) Vesting Year.

5.12       Compensation for Maximum Pension .    For purposes of Sections 5.6 and 5.7, Compensation shall mean a Participant’s earned income, wages, salaries, fees for professional services, and other amounts received (without regard to whether or not an amount is paid in cash) for personal services actually rendered in the course of employment with the Company maintaining the Plan and shall be determined as described below:

(a)        Compensation shall include to the extent that the amounts are includible in gross income (including, but not limited to, commissions paid salespeople, compensation for services on the basis of a percentage of profits, commissions on insurance premiums, tips, bonuses, fringe benefits, and reimbursements or other expense allowances under a nonaccountable plan as described in Regulation 1.62-2(c)).

(b)        Compensation shall include any elective deferral as defined in Code Section 402(g)(3) or Puerto Rico Code Section 1165(e), any amount which is contributed or deferred by the Company at the election of the Employee that is excludable from an Employee’s gross income under Code Sections 125 or 457 and, for Plan Years beginning on or after January 1, 1998, any elective amount that is excludable from an Employee’s gross income under Code Section 132(f)(4).

(c)        Compensation shall not include (i) any employer contributions to a plan of deferred compensation which are not included in the Employee’s gross income for the taxable year in which contributed, (ii) any distributions from a plan of deferred compensation, (iii) any amounts realized from the exercise of a non-qualified stock option or when restricted stock or property held by the Employee becomes either freely transferable or is no longer subject to a substantial risk of forfeiture under Code Section 83 if such option, stock, or property was granted to the Employee by the Company, (iv) any amounts realized from the sale, exchange, or other disposition of stock acquired under a qualified stock option, (v) any contribution for medical benefits (within the meaning of Code Section 419(f)(2)) after termination of employment which is otherwise treated as an annual addition, and (vi) any amount otherwise treated as an annual addition under Code Section 415(l)(1).

(d)        Notwithstanding anything in the Plan to the contrary, Compensation shall be determined in accordance with Code Section 415(c)(3) as in effect for Plan Years beginning prior to January 1, 1998 where required by applicable law.

 

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ARTICLE VI

FORM OF PENSIONS

6.1         Unmarried Participants .    The pension of a Participant who is unmarried when payments begin shall be paid as a Single Life Annuity unless he or she elects an optional form of benefit under Section 6.3 or receives a lump sum distribution under Section 6.5.

6.2         Married Participants .    The pension of a Participant who is married when payments begin shall be paid as a Qualified Joint and Survivor Annuity, unless he or she elects an optional form of benefit under Section 6.3 or receives a lump sum distribution under Section 6.5.

6.3         Election of Optional Form of Benefit .    A Participant may waive the Single Life Annuity or, in the case of a married Participant, the Qualified Joint and Survivor Annuity and elect any optional form of benefit described in Section 6.4 in accordance with the following rules:

(a)        The election shall be made in writing in a manner prescribed by the Committee on a form that clearly states that the Participant is electing to receive his or her pension other than as a Single Life Annuity or, in the case of a married Participant, his or her pension other than as a Qualified Joint and Survivor Annuity. No such election shall be effective with respect to a married Participant unless: (i) the Participant’s spouse consents in writing to the election; (ii) such election designates the form of benefit and a specific beneficiary; (iii) the consent acknowledges the effect of the election; and (iv) the consent is witnessed by a notary public or by a Plan representative. Notwithstanding the foregoing, an election without spousal consent shall be effective if a married Participant elects a joint and survivor option providing for payment of at least 50% of his or her annuity to his or her surviving spouse, the Sponsor determines there is no spouse, or the spouse cannot be located.

(b)        The election may be made or revoked at any time during an election period established by the Committee. Such election period shall begin when the information described in paragraph (d) is furnished to the Participant and, subject to paragraphs (c) through (e), shall end, with no opportunity for a further election, on the Participant’s Annuity Starting Date. For purposes of Article VII (pertaining to pre-retirement death benefits), if an optional form of benefit is elected in accordance with this Section 6.3 within the 90 day period ending on the Participant’s date of death, the Participant’s pension shall be deemed to have commenced even if the Participant dies prior to the Annuity Starting Date.

(c)        Subject to paragraphs (d) and (e), in the case of a Participant who retires after attaining age 55, the election period described in paragraph (b) shall end on the date of the Participant’s Severance, or on such later date as the Committee shall fix, but an election made during the election period may be revoked at any time before the later of the end of the election period or the Participant’s Annuity Starting Date.

 

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(d)        Each Participant shall receive a written explanation of a Single Life Annuity or, in the case of a married Participant, a Qualified Joint and Survivor Annuity which shall include: (i) the terms and conditions of such annuity form of benefit; (ii) the Participant’s right to make and the effect of waiving such annuity form of benefit; (iii) the rights of a spouse; (iv) the right to make, and the effect of, a revocation of a previous election to waive such annuity form of benefit; (v) the relative values of the optional forms of benefit available under the Plan; and (vi) on or after December 31, 2006 and if applicable, the Participant’s right to defer and the effect of deferring the payment of his or her benefit. Such explanation shall be furnished to the Participant no less than 30 days and no more than 180 days prior to the Participant’s Annuity Starting Date except as provided in paragraph (e).

(e)        The written explanation described in paragraph (d) may be furnished to the Participant less than 30 days prior to the Participant’s Annuity Starting Date; provided, that, the written explanation: (i) clearly indicates that the Participant has at least 30 days to consider whether to waive the Single Life Annuity or, in the case of a married Participant, the Qualified Joint and Survivor Annuity and to elect with spousal consent, if applicable, an optional form of benefit; (ii) the Participant is permitted to revoke any affirmative distribution election at least until the Annuity Starting Date or, if later, at any time prior to the expiration of the 7-day period that begins the day after the written explanation is provided to the Participant; and (iii) the Annuity Starting Date is a date after the date that the written explanation was provided to the Participant. Notwithstanding the foregoing, the Annuity Starting Date may be a date prior to the date the written explanation is provided to the Participant; provided, that, the Participant’s pension is not paid or does not commence until at least 30 days after such written explanation is furnished, subject to the waiver of the 30-day period as provided in the foregoing sentence.

6.4         Optional Forms of Benefit .    Subject to the provisions of Sections 6.3 and 6.5, a Participant may elect to receive the Actuarial Equivalent of his or her pension in another form. The specific options shall be (i) a Single Life Annuity which pays a monthly benefit for the Participant’s lifetime; (ii) a contingent beneficiary option which pays a reduced monthly benefit for the Participant’s lifetime, then continues 100%, 75%, 66-2/3%, or 50% of the reduced monthly benefit for the lifetime of one designated beneficiary; (iii) a guaranteed payment option which pays a reduced monthly benefit for the longer of the Participant’s lifetime or a specified number of months (60, 120, 180, or 240) with any remaining guaranteed payments on the Participant’s death to a designated beneficiary or beneficiaries (as more fully described in Appendix B); or (iv) a level income option (as more fully described in Appendix B) which pays an increased monthly benefit to a Participant (if payments begin between the ages of 55 and 62) until age 62, and a reduced monthly benefit beginning at age 62. Under each such option the Actuarial Equivalent of the anticipated payments to the Participant shall be greater than that of those to his or her beneficiary, except that if the beneficiary is the Participant’s spouse, the option may provide for a joint and survivor annuity under which the periodic payments to the spouse are no greater than those to the Participant and each option shall otherwise comply with Code Section 401(a)(9) and the final and temporary Treasury Regulations thereunder.

 

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6.5         Cash-Outs .

(a)        Notwithstanding anything in this Article to the contrary, if the lump sum Actuarial Equivalent of a Participant’s nonforfeitable Accrued Benefit does not exceed or has never exceeded $5,000, the Participant, or the Participant’s beneficiary in the event of the Participant’s death, may only elect (i) to be paid the lump sum Actuarial Equivalent, or (ii) to have the lump sum Actuarial Equivalent paid directly by the Trustee to the trustee of an Eligible Retirement Plan.

(b)        If the lump sum Actuarial Equivalent of a Participant’s nonforfeitable Accrued Benefit exceeds $5,000 but does not exceed $10,000, the Participant, or the Participant’s beneficiary in the event of the Participant’s death, may elect (i) to be paid the lump sum Actuarial Equivalent, or (ii) to have the lump sum Actuarial Equivalent paid directly by the Trustee to the trustee of an Eligible Retirement Plan. No distribution may be elected under this paragraph (b) unless the Participant has attained at least age 55 with five (5) or more Vesting Years. For purposes of this paragraph (b), a Participant who is an AMO Employee (as defined in Section 2.20) shall be treated as having not less than five (5) Vesting Years as of the day following his or her transfer to Advanced Medical Optics, Inc. In addition, the election may not be made after pension payments start, except that a Participant or a Participant’s beneficiary whose payments started prior to September 1, 1993, and whose lump sum Actuarial Equivalent did not exceed $10,000 at the date payments started, may elect to be paid the remaining lump sum Actuarial Equivalent. A married Participant who elects a lump sum under this paragraph (b) must comply with the applicable requirements for spousal consent.

(c)        A Participant who has no nonforfeitable Accrued Benefit in the Plan at the time of his or her Severance shall be deemed to have been cashed out with a zero cash benefit upon such Severance Date.

6.6         Retroactive Annuity Starting Dates .    Notwithstanding anything in the Plan to the contrary, in the case of pensions paid to a Participant and spousal benefits (as described in Section 7.2) paid to a Participant’s surviving spouse, a Participant or a surviving spouse may elect a Retroactive Annuity Starting Date under this Section; provided, that the requirements of this Section are met.

(a)        A Retroactive Annuity Starting Date shall be permitted under this Section only if the following requirements are met:

(i)      The Retroactive Annuity Starting Date may not be earlier than the date on which benefit payments otherwise could have commenced under the terms of the Plan in effect as of the Retroactive Annuity Starting Date.

 

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(ii)     Any future periodic payments shall be the same as the future periodic payments (if any) that would have been paid had payment actually begun on the Retroactive Annuity Starting Date.

(iii)    A make-up payment shall be made in an amount equal to any missed payment or payments for the period from the Retroactive Annuity Starting Date to the date of the actual make-up payment (with an appropriate interest adjustment for that period).

(iv)     In determining whether any Retroactive Annuity Starting Date pension (including the required interest adjustment for the make-up payment described above) satisfies Code Section 415, the date that distribution commences shall be treated as the Annuity Starting Date for all purposes, including the determination of the applicable interest rate and the applicable mortality table; provided, that this requirement shall not apply to any form of payment if:

(A)        The form of payment would not have been subject to the present value requirements under Regulation Section 1.417(e)-1(d)(6) had payment commenced on the Retroactive Annuity Starting Date; and

(B)        The date payment commences in that form begins no more than twelve (12) months after the Retroactive Annuity Starting Date.

(b)        The election of a Retroactive Annuity Starting Date shall be made in writing in a manner prescribed by the Committee on a form that clearly states that the Participant is electing a Retroactive Annuity Starting Date. No such election shall be effective with respect to a married Participant unless his or her spouse consents to such election as provided in Section 6.3(a); provided that, this requirement shall not apply if the amount of the spouse’s survivor annuity payments under the Retroactive Annuity Starting Date election is no less than the survivor benefit amount the spouse would have been entitled to receive under the Qualified Joint and Survivor Annuity with an Annuity Starting Date after the date that the required written explanation was provided to the Participant.

(c)        For any form of benefit that would have been subject to Code Section 417(e)(3) had distribution commenced as of the Retroactive Annuity Starting Date, the amount of the distribution must be no less than what the amount would have been as of the date the distribution actually begins, using the (i) applicable interest rate and the applicable mortality table in effect under the Plan on that date and (ii) same annuity form in determining present value.

(d)        If a Participant or a surviving spouse elects a Retroactive Annuity Starting Date, the date that benefit payments actually begin shall be treated as the Annuity Starting Date for purposes of satisfying the notice and other requirements for commencing benefit payments to the Participant or surviving spouse under this Article VI and Article VII.

 

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(e)        For purposes of this Section, a Retroactive Annuity Starting Date means an annuity starting date affirmatively elected by a Participant or surviving spouse that (i) is on or before the date that the written explanation required under Section 6.3 is provided and (ii) otherwise meets the requirements of this Section and Treasury Regulations under Code Section 417.

 

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ARTICLE VII

PRE-RETIREMENT DEATH BENEFITS

7.1         Eligibility .    A death benefit shall be payable under Section 7.2 with respect to a Participant if, on the date of his or her death:

(a)        he or she is an Employee who has met the requirements for normal or early retirement under Sections 5.1 or 5.3;

(b)        he or she is an Employee not described in paragraph (a), above, who has a nonforfeitable interest in his or her Accrued Benefit; or

(c)        he or she is a former Employee who has a nonforfeitable interest in his or her Accrued Benefit and whose pension has not yet commenced to be paid.

7.2         Spousal Benefit .    Upon the death of a Participant described in Section 7.1, the Participant’s surviving spouse, if living on the date set forth in this Section, shall receive a lump sum distribution if applicable under Section 6.5 or a pension in accordance with the following rules:

(a)        If the Participant is an Employee who has met the requirements for normal or early retirement under Sections 5.1 or 5.3, the pension to the surviving spouse shall begin as of the first day of the month following the Participant’s date of death, shall end on the last day of the month in which the spouse’s death occurs, and shall be in a monthly amount equal to the amount the spouse would have received if the Participant had retired on the date of his or her death and had elected an immediate pension in the form of a Qualified Joint and Survivor Annuity beginning on the first day of the month following the day of his or her death with the spouse as joint annuitant.

(b)        If the Participant is an Employee who has not met the requirements for normal or early retirement under Sections 5.1 or 5.3 but at the time of death has a nonforfeitable interest in his or her Accrued Benefit, the pension to the surviving spouse shall begin on the first day of the month following the month in which the Participant would have first met the requirements for early retirement, shall end on the last day of the month in which the spouse’s death occurs, and shall be in a monthly amount equal to the amount the spouse would have received if (i) the Participant’s Severance had occurred on the date of his or her death, (ii) the Participant had survived to meet the requirements for early retirement, (iii) the Participant had elected an immediate pension in the form of a Qualified Joint and Survivor Annuity beginning on the first day of the month coincident with or next following his or her attainment of the earliest retirement age with the spouse as joint annuitant, and (iv) the Participant had died the day after the date his or her pension commenced.

(c)        If the Participant is a former Employee who retired under Section 5.1, the pension to the surviving spouse shall begin as of the first day of the month coincident

 

35


with or next following the Participant’s date of death, shall end on the last day of the month in which the spouse’s death occurs, and shall be in a monthly amount equal to the amount the spouse would have received if the Participant had elected an immediate pension in the form of a Qualified Joint and Survivor Annuity beginning on the first day of the month coincident with or next following the date of his or her death with the spouse as joint annuitant.

(d)        If the Participant is a former Employee who retired under Section 5.3, the pension to the surviving spouse shall begin as of the first day of the month coincident with or next following the Participant’s date of death, shall end on the last day of the month in which the spouse’s death occurs, and shall be in a monthly amount equal to the amount the spouse would have received if the Participant had elected an immediate pension in the form of a Qualified Joint and Survivor Annuity beginning on the first day of the month coincident with or next following the date of his or her death with the spouse as joint annuitant.

(e)        If the Participant is a former Employee who did not meet the requirements for normal or early retirement under Sections 5.1 or 5.3 but has a nonforfeitable interest in his or her Accrued Benefit, the pension to the surviving spouse shall begin on the first day of the month coincident with or next following the date the Participant would have first met the requirements for early retirement if he or she had not died but had lived, shall end on the last day of the month in which the spouse’s death occurs, and shall be in a monthly amount equal to the amount the spouse would have received if (i) the Participant had survived to meet the requirements for early retirement, (ii) the Participant had elected an immediate pension in the form of a Qualified Joint and Survivor Annuity beginning on the first day of the month coincident with or next following his or her attainment of the earliest retirement age with the spouse as joint annuitant, and (iii) the Participant had died the day after the date his or her pension commenced.

7.3         Alternate Death Benefit .    In lieu of the benefit provided in Section 7.2, a Participant described in Section 7.1(a) may, at any time before his or her pension commences, select a beneficiary or beneficiaries other than his or her spouse for a survivor income benefit subject to Section 7.5. The monthly payment to the beneficiary shall equal the payment the beneficiary would have received and which would have been attributable to the Participant’s Accrued Benefit, if the Participant had retired on the day of his or her death with a pension in the form of a 50% joint and survivor annuity beginning as of the first day of the month following the day of his or her death with the beneficiary as joint annuitant.

7.4         Children’s Survivor Benefit .    In lieu of the benefit provided in Section 7.2, a Participant described in Section 7.1(a) may, at any time before his or her pension commences, select his or her child or children as beneficiary or beneficiaries for the survivor income benefit subject to Section 7.5. The aggregate monthly payment to the child or children shall equal the monthly payment a surviving spouse of an age equal to that of the Participant would have received and which would have been attributable to the Participant’s Accrued Benefit, if the Participant had been covered by Section 7.2 and had left such a surviving spouse. Payments to

 

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each child shall continue during such child’s life or until the end of the month in which the child attains age 19, whichever is earlier except that if the child is enrolled as a full-time student in an academic institution, payments shall continue until the earlier of the end of the month in which the child attains age 23 or the termination of the child’s education.

7.5         Waiver of Spousal Benefit .    An election under Section 7.3 or 7.4 shall be effective with respect to a married Participant only if he or she waives the benefit provided in Section 7.2 in accordance with the following rules:

(a)        A waiver shall be made in writing in a manner prescribed by the Committee on a form that clearly states that the Participant is waiving the benefit provided in Section 7.2. No such waiver shall be effective unless: (i) the Participant’s spouse consents in writing to the waiver; (ii) the waiver election designates the form of benefit and a specific beneficiary; (iii) the spouse’s consent to the waiver acknowledges the effect of the waiver; and (iv) the spouse’s consent is witnessed by a notary public or by a Plan representative. A waiver without spousal consent shall be effective if the Sponsor determines there is no spouse or the spouse cannot be located.

(b)        Each Participant and his or her spouse shall receive a written explanation of the benefit provided in Section 7.2 which shall include: (i) the terms and conditions of the benefit; (ii) the Participant’s right to make and the effect of waiving the benefit; (iii) the rights of a spouse; and (iv) the right to make, and the effect of, a revocation of a previous election to waive the benefit. Such explanation shall be furnished to the Participant within the applicable period. The term “applicable period” means, with respect to a Participant, whichever of the following periods ends earliest: (i) the period beginning with the first day of the Plan Year in which the Participant becomes a Participant described in Section 7.1(a) and ending on the date of the Participant’s death or (ii) the period beginning with the first day of the Plan Year in which the Participant becomes a Participant described in Section 7.1(a) and ending on the date his or her pension commences.

 

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ARTICLE VIII

CONTRIBUTIONS

8.1         Company Contributions .    The Company shall contribute each year an amount actuarially determined to be sufficient to provide the benefits under the Plan. Notwithstanding the foregoing, Company contributions for any Plan Year shall be conditioned upon the deductibility of such contributions by the Company under Code Section 404. The Company reserves the right, however, to reduce, suspend or discontinue its contributions under the Plan for any reason at any time. Except as provided in Section 8.3, it shall be impossible for any part of the Company’s contributions to revert to the Company, or to be used for, or diverted to, any purpose other than for the exclusive benefit of Participants and their Beneficiaries.

8.2         Source of Benefits .    All benefits under the Plan shall be paid exclusively from the Fund, and the Company shall have no duty to contribute thereto except as provided in this Article.

8.3         Irrevocability .    The Company shall have no right or title to, nor interest in, the Company contributions made to the Fund, and no part of the Fund shall revert to the Company, except that on and after the Effective Date funds may be returned to the Company as follows:

(a)        In the case of a contribution which is made by a mistake of fact, such contribution may be returned to the Company within one year after it is made.

(b)        In the case of a contribution conditioned on the initial qualification of the Plan under Code Section 401 (or any successor statute thereto), and the Plan does not initially qualify upon the filing of a timely determination letter request, such contribution may be returned to the Company within one year after the date of denial of the initial qualification of the Plan.

(c)        In the case of a contribution conditioned on the deductibility thereof under Code Section 404 (or any successor statute thereto), such contribution shall, to the extent such deduction is disallowed, be returned to the Company within one year after such disallowance.

(d)        In the case of a contribution conditioned on the initial qualification of the Plan under Puerto Rico Code Section 1165 (or any successor statute thereto), and the Plan does not initially qualify upon the filing of a timely determination letter request, such contribution may be returned to the Company within one year after the date of denial of the initial qualification of the Plan, provided, such return of such contribution does not cause the Plan to be disqualified under the Code.

(e)        In the case of a contribution conditioned on the deductibility thereof under Puerto Rico Code Section 1023(n) (or any successor statute thereto), such contribution shall, to the extent such deduction is disallowed, be returned to the Company within one

 

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year after such disallowance, provided, such return of such contribution does not cause the Plan to be disqualified under the Code.

 

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ARTICLE IX

ADMINISTRATION

9.1         Appointment of Committee .    There is hereby created a committee (the “Committee”) which shall exercise such powers and have such duties in administering the Plan as are hereinafter set forth. The Board of Directors shall determine the number of members of such Committee. The members of the Committee shall be appointed by the Board of Directors and such Board shall from time to time fill all vacancies occurring in said Committee. The members of the Committee shall constitute the Named Fiduciaries of the Plan within the meaning of Section 402(a)(2) of ERISA.

9.2         Appointment of Investment Subcommittee .    There is hereby created an investment subcommittee of the Committee (hereinafter referred to as the “Investment Subcommittee” for purposes of this Article IX) which shall exercise management and control over the assets of the Trust. The Board of Directors, acting through its Organization and Compensation Committee, shall determine the number of members of the Investment Subcommittee. The members of the Investment Subcommittee shall be appointed by the Board of Directors, acting through its Organization and Compensation Committee, and shall from time to time appoint such members to or fill any vacancies in the Investment Subcommittee. The members of the Investment Subcommittee shall constitute the Named Fiduciaries of the Plan within the meaning of Section 402(a)(2) of ERISA with respect to the management and control of the assets of the Trust.

9.3         Transaction of Business .    The Committee and Investment Subcommittee shall transact business as provided in paragraphs (a) and (b), respectively:

(a)        A majority of the Committee shall constitute a quorum for the transaction of business. Actions of the Committee may be taken either by vote at a meeting or in writing without a meeting. All action taken by the Committee at any meeting shall be by a vote of the majority of those present at such meeting. All action taken in writing without a meeting shall be by a vote of the majority of those responding in writing. All notices, advices, directions and instructions to be transmitted by the Committee shall be in writing and signed by or in the name of the Committee. In all its communications with the Trustee, the Committee may, by either of the majority actions specified above, authorize any one or more of its members to execute any document or documents on behalf of the Committee, in which event it shall notify the Trustee in writing of such action and the name or names of its members so designated and the Trustee shall thereafter accept and rely upon any documents executed by such member or members as representing action by the Committee until the Committee shall file with the Trustee a written revocation of such designation.

(b)        A majority of the Investment Subcommittee shall constitute a quorum for the transaction of business. Actions of the Investment Subcommittee may be taken either by vote at a meeting or in writing without a meeting. All action taken by the Investment Subcommittee at any meeting shall be by a vote of the majority of those present at such

 

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meeting. All action taken in writing without a meeting shall be by a vote of the majority of those responding in writing. All notices, advices, directions and instructions to be transmitted by the Investment Subcommittee shall be in writing and signed by or in the name of the Investment Subcommittee. In all its communications with the Trustee, the Investment Subcommittee may, by action specified above, authorize any one or more of its members to execute any document or documents on behalf of the Investment Subcommittee, in which event it shall notify the Trustee in writing of such action and the name or names of its members so designated and the Trustee shall thereafter accept and rely upon any documents executed by such member or members as representing action by the Investment Subcommittee until the Investment Subcommittee shall file with the Trustee a written revocation of such designation.

9.4         Voting .    Any member of the Committee who is also a Participant hereunder shall not be qualified to act or vote on any matter relating solely to himself or herself, and upon such matter his or her presence at a meeting shall not be counted for the purpose of determining a quorum. If, at any time a member of the Committee is not so qualified to act or vote, the qualified members of the Committee shall be reduced below two (2) and the Board of Directors shall promptly appoint one or more special members to the Committee so that there shall be at least one qualified member to act upon the matter in question. Such special Committee members shall have power to act only upon the matter for which they were especially appointed and their tenure shall cease as soon as they have acted upon the matter for which they were especially appointed.

9.5         Responsibility of Committees .    The responsibilities of the Committee and Investment Subcommittee shall be as provided in paragraphs (a) and (b), respectively:

(a)        The authority to manage and control the operation and administration of the Plan, the general administration of the Plan, the responsibility for carrying out the Plan, and to the extent provided in Section 9.7(e), the authority and responsibility to manage and control the assets of the Trust are hereby delegated by the Board of Directors to and vested in the Committee except to the extent reserved to the Board of Directors, the Sponsor, or the Company. Subject to the limitations of the Plan, the Committee shall, from time to time, establish rules for the performance of its functions and the administration of the Plan. In the performance of its functions, the Committee shall not discriminate in favor of Highly Compensated Employees.

(b)        The authority and responsibility to manage and control the assets of the Trust are hereby delegated by the Board of Directors, acting through its Organization and Compensation Committee, to and vested in the Investment Subcommittee except to the extent reserved to the Board of Directors or the Board of Directors, acting through its Organization and Compensation Committee, or the Sponsor. Subject to the limitations of the Plan, the Investment Subcommittee shall, from time to time, establish rules for the performance of its functions.

 

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9.6         Committee Powers .    The Committee shall have all discretionary powers necessary to supervise the administration of the Plan and control its operations. In addition to any discretionary powers and authority conferred on the Committee elsewhere in the Plan or by law, the Committee shall have, but not by way of limitation, the following discretionary powers and authority:

(a)        To designate agents to carry out responsibilities relating to the Plan, other than fiduciary responsibilities as provided in Section 9.7.

(b)        To employ such legal, actuarial, medical, accounting, clerical, and other assistance as it may deem appropriate in carrying out the provisions of the Plan, including one or more persons to render advice with regard to any responsibility any Named Fiduciary or any other fiduciary may have under the Plan.

(c)        To establish rules and regulations from time to time for the conduct of the Committee’s business and the administration and effectuation of the Plan.

(d)        To administer, interpret, construe, and apply the Plan and to decide all questions which may arise or which may be raised under the Plan by any Employee, Participant, former Participant, Beneficiary or other person whatsoever, including but not limited to all questions relating to eligibility to participate in the Plan, the amount of Benefit Years or Vesting Years of any Participant, and the amount of benefits to which any Participant or his or her Beneficiary may be entitled.

(e)        To determine the manner in which the assets of the Plan, or any part thereof, shall be disbursed.

(f)        Subject to provisions (a) through (d) of Section 10.1, to make administrative amendments to the Plan that do not cause a substantial increase or decrease in benefit accruals to Participants and that do not cause a substantial increase in the cost of administering the Plan.

(g)        To perform or cause to be performed such further acts as it may deem to be necessary, appropriate or convenient in the efficient administration of the Plan.

Any action taken in good faith by the Committee in the exercise of discretionary powers conferred upon it by the Plan shall be conclusive and binding upon the Participants and their Beneficiaries. All discretionary powers conferred upon the Committee shall be absolute; provided, however, that all such discretionary power shall be exercised in a uniform and nondiscriminatory manner.

9.7         Additional Powers of Committee .    In addition to any discretionary powers or authority conferred on the Committee elsewhere in the Plan or by law, such Committee shall have the following discretionary powers and authority:

 

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(a)        To appoint one or more Investment Managers pursuant to Section 9.17 to manage and control any or all of the assets of the Trust.

(b)        To designate persons (other than the members of the Committee) to carry out fiduciary responsibilities, other than any responsibility to manage or control the assets of the Trust;

(c)        To allocate fiduciary responsibilities among the members of the Committee, other than any responsibility to manage or control the assets of the Trust;

(d)        To cancel any such designation or allocation at any time for any reason;

(e)        To exercise management and control over the assets of the Trust to the extent provided in paragraph (a) above and in Section 9.9 (relating to review by the Committee of the long-run and short-run financial needs of the Plan and the determination of the funding policy for the Plan).

Any action under this Section 9.7 shall be taken in writing, and no designation or allocation under paragraphs (a), (b) or (c) shall be effective until accepted in writing by the indicated responsible person.

9.8         Investment Subcommittee Powers .    The Investment Subcommittee shall have all discretionary powers necessary to manage and control the assets of the Trust, including but not limited to, the following:

(a)        To exercise management and control over the assets of the Trust except to the extent the Committee appoints an Investment Manager pursuant to Section 9.7(a) and subject to the requirement that all action taken by the Investment Subcommittee shall be in accordance and consistent with the funding policy established by the Committee and shall be communicated to the Committee at periodic intervals.

(b)        To employ consulting, actuarial, and other assistance as it may deem appropriate in carrying out its responsibilities under the Plan, including one or more persons to render advice with regard to any fiduciary responsibility the Investment Subcommittee may have under the Plan.

(c)        To establish rules and regulations from time to time for the conduct of the Investment Subcommittee’s business.

(d)        To direct the Trustee, in writing, from time to time, to invest and reinvest the Trust Fund, or any part thereof, or to purchase, exchange, or lease any property, real or personal, which the Investment Subcommittee may designate. This shall include the right to direct the investment of all or any part of the Trust in any one security or any one type of securities permitted hereunder. Among the securities which the Investment

 

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Subcommittee may direct the Trustee to purchase are “qualifying employer securities” as defined in ERISA Section 407(d)(5).

Any action taken in good faith by the Investment Subcommittee in the exercise of discretionary powers conferred upon it by the Plan shall be conclusive and binding upon the Participants and their Beneficiaries.

9.9         Periodic Review of Funding Policy .    Notwithstanding the delegation of authority and responsibility to manage and control the assets of the Trust to the Investment Subcommittee, the Committee, at periodic intervals, shall review the long-run and short-run financial needs of the Plan and shall determine a funding policy for the Plan consistent with the objectives of the Plan and the minimum funding standards of ERISA, if applicable. In determining such funding policy the Committee shall take into account, at a minimum, not only the long-term investment objectives of the Trust Fund consistent with the prudent management of the assets thereof, but also the short-run needs of the Plan to pay benefits. All actions taken by the Committee with respect to the funding policy of the Plan, including the reasons therefor, shall be fully reflected in the minutes of the Committee.

9.10       Claims Procedures .    If a Participant or his or her Beneficiary believes that he or she is being denied any rights or benefits under the Plan, the Participant, Beneficiary, or in either case, his or her authorized representative (the “Claimant”) shall follow the administrative procedures for filing a claim for benefits as set forth in this Section. A claim for benefits shall be in writing and shall be reviewed by the Committee or a claims official designated by the Committee. The Committee or claims official shall review a claim for benefits in accordance with the procedures established by the Committee subject to the following administrative procedures set forth in this Section.

(a)        The Committee shall furnish the Claimant with written or electronic notice of the decision rendered with respect to a claim for benefits within 90 days following receipt by the Committee (or its delegate) of the claim unless the Committee determines that special circumstances require an extension of time for processing the claim. In the event an extension is necessary, written or electronic notice of the extension shall be furnished to the Claimant prior to the expiration of the initial 90 day period. The notice shall indicate the special circumstances requiring an extension of time and the date by which a final decision is expected to be rendered. In no event shall the period of the extension exceed 90 days from the end of the initial 90 day period.

(b)        In the case of a denial of the Claimant’s claim, the written or electronic notice of such denial shall set forth (i) the specific reasons for the denial, (ii) references to the Plan provisions upon which the denial is based, (iii) a description of any additional information or material necessary for perfection of the claim (together with an explanation why such material or information is necessary), (iv) an explanation of the Plan’s appeals procedures, and (v) a statement of the Claimant’s right to bring a civil action under Section 502(a) of ERISA if his or her claim is denied upon appeal.

 

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(c)        In the case of a denial of a claim, a Claimant who wishes to appeal the decision shall follow the administrative procedures for an appeal as set forth in Section 9.11 below.

9.11       Appeals Procedures .    A Claimant who wishes to appeal the denial of his or her claim for benefits shall follow the administrative procedures for an appeal as set forth in this Section and shall exhaust such administrative procedures prior to seeking any other form of relief. Appeals shall be reviewed in accordance with the procedures established by the Committee subject to the following administrative procedures set forth in this Section.

(a)        In order to appeal a decision rendered with respect to his or her claim for benefits, a Claimant must file an appeal with the Committee in writing within 60 days following his or her receipt of the notice of denial with respect to the claim.

(b)        The Claimant’s appeal may include written comments, documents, records and other information relating to his or her claim. The Claimant may review all pertinent documents and, upon request, shall have reasonable access to or be provided free of charge, copies of all documents, records, and other information relevant to his or her claim.

(c)        The Committee shall provide a full and fair review of the appeal and shall take into account all claim related comments, documents, records, and other information submitted by the Claimant without regard to whether such information was submitted or considered under the initial determination or review of the initial determination. Where appropriate, the Committee will overturn a notice of denial if it determines that an error was made in the interpretation of the controlling plan documents or if the Committee determines that an existing interpretation of the controlling plan documents should be changed on a prospective basis. In the event the Claimant is a subordinate, as determined by the Committee, to an individual conducting the review, such individual shall recuse himself or herself from the review of the appeal.

(d)        The Committee shall furnish the Claimant with written or electronic notice of the decision rendered with respect to an appeal within 60 days following receipt by the Committee of the appeal unless the Committee determines that special circumstances require an extension of time for processing the appeal. In the event an extension is necessary, written or electronic notice of the extension shall be furnished to the Claimant prior to the expiration of the initial 60 day period. The notice shall indicate the special circumstances requiring an extension of time and the date by which a final decision is expected to be rendered. In no event shall the period of the extension exceed 60 days from the end of the initial 60 day period.

(e)        In the case of a denial of an appeal, the written or electronic notice of such denial shall set forth (i) the specific reasons for the denial, (ii) references to the Plan provisions upon which the denial is based, (iii) a statement that the Claimant is entitled to receive, upon request and free of charge, reasonable access to, and copies of, all

 

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documents, records, and other information relating to his or her claim for benefits, and (iv) a statement of the Claimant’s right to bring a civil action under Section 502(a) of ERISA.

9.12       Limitation on Liability .     Each of the fiduciaries under the Plan shall be solely responsible for its own acts and omissions and no fiduciary shall be liable for any breach of fiduciary responsibility resulting from the act or omission of any other fiduciary or person to whom fiduciary responsibilities have been allocated or delegated pursuant to Section 9.2 or 9.7, except as provided in Sections 405(a) and 405(c)(2)(A) or (B) of ERISA. Neither the Committee nor the Investment Subcommittee shall have responsibility over assets as to which management and control has been delegated to an Investment Manager appointed pursuant to Section 9.17 hereof or as to which management and control has been retained by the Trustee.

9.13       Indemnification and Insurance .    To the extent permitted by law, the Company shall indemnify and hold harmless the Committee, the Investment Subcommittee and each member thereof, the Board of Directors and each member thereof, and such other persons as the Board of Directors may specify, from the effects and consequences of his or her acts, omissions, and conduct in his or her official capacity in connection with the Plan and Trust. To the extent permitted by law, the Company may also purchase liability insurance for such persons.

9.14       Compensation of Committee and Plan Expenses .    Members of the Committee and the Investment Subcommittee shall serve as such without compensation unless the Board of Directors shall otherwise determine, but in no event shall any member of the Committee or Investment Subcommittee who is an Employee receive compensation from the Plan for his or her services as a member of the Committee or the Investment Subcommittee. All members shall be reimbursed for any necessary expenditures incurred in the discharge of duties as members of the Committee or the Investment Subcommittee. The compensation or fees, as the case may be, of all officers, agents, counsel, the Trustee or other persons retained or employed by the Committee or the Investment Subcommittee shall be fixed by the Committee, subject to approval by the Board of Directors. The expenses incurred in the administration and operation of the Plan, including but not limited to the expenses incurred by the members of the Committee or the Investment Subcommittee in exercising their duties, shall be paid by the Plan from the Trust Fund, unless paid by the Company, provided, however, that the Plan and not the Company shall bear the cost of interest and normal brokerage charges which are included in the cost of securities purchased by the Trust Fund (or charged to proceeds in the case of sales).

9.15       Resignation .    Any member of the Committee or Investment Subcommittee may resign by giving fifteen (15) days notice to the Board of Directors, and any member shall resign forthwith upon receipt of the written request of the Board of Directors, whether or not said member is at that time the only member of the Committee or the Investment Subcommittee.

9.16       Reliance Upon Documents and Opinions .    The members of the Committee, the Investment Subcommittee, the Board of Directors, the Company and any person delegated to carry out any fiduciary responsibilities under the Plan (hereinafter a “delegated fiduciary”), shall be entitled to rely upon any tables, valuations, computations, estimates, certificates and reports

 

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furnished by any consultant, or firm or corporation which employs one or more consultants, upon any opinions furnished by legal counsel, and upon any reports furnished by the Trustee or any Investment Manager. The members of the Committee, the Investment Subcommittee, the Board of Directors, the Company and any delegated fiduciary shall be fully protected and shall not be liable in any manner whatsoever for anything done or action taken or suffered in reliance upon any such consultant, or firm or corporation which employs one or more consultants, Trustee, Investment Manager, or counsel. Any and all such things done or such action taken or suffered by the Committee, the Investment Subcommittee, the Board of Directors, the Company and any delegated fiduciary shall be conclusive and binding on all Employees, Participants, Beneficiaries, and any other persons whomsoever, except as otherwise provided by law. The Committee, the Investment Subcommittee, and any delegated fiduciary may, but are not required to, rely upon all records of the Company with respect to any matter or thing whatsoever, and may likewise treat such records as conclusive with respect to all Employees, Participants, Beneficiaries, and any other persons whomsoever, except as otherwise provided by law.

9.17       Appointment of Investment Manager .    From time to time the Committee, in accordance with Section 9.7 hereof, may appoint one or more Investment Managers who shall have investment management and control over assets of the Trust. The Committee shall notify the Trustee of such assets of the appointment of the Investment Manager. In the event more than one Investment Manager is appointed, the Committee shall determine which assets shall be subject to management and control by each Investment Manager and shall also determine the proportion in which funds withdrawn or disbursed shall be charged against the assets subject to each Investment Manager’s management and control. As shall be provided in any contract between an Investment Manager and the Committee, such Investment Manager shall hold a revocable proxy with respect to all securities which are held under the management of such Investment Manager pursuant to such contract, and such Investment Manager shall report the voting of all securities subject to such proxy on an annual basis to the Committee.

 

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ARTICLE X

AMENDMENT AND ADOPTION OF PLAN

10.1       Right to Amend Plan .    The Sponsor, by resolution of the Board of Directors, shall have the right to amend the Plan and any trust agreement with the Trustee at any time and from time to time and in such manner and to such extent as it may deem advisable, including retroactively, subject to the following provisions:

(a)        No amendment shall have the effect of reducing any Participant’s vested interest in the Plan or eliminating an optional form of distribution.

(b)        No amendment shall have the effect of diverting any part of the assets of the Plan to persons or purposes other than the exclusive benefit of the Participants or their Beneficiaries.

(c)        No amendment shall have the effect of increasing the duties or responsibilities of a Trustee without its written consent.

(d)        No amendment shall result in discrimination in favor of officers, shareholders, or other highly compensated or key employees.

The Committee shall have the right to amend the Plan, subject to paragraphs (a) through (d) above, in accordance with the provisions of Section 9.5(g).

10.2       Adoption of Plan by Affiliated Companies .    Subject to approval by the Board of Directors and consistent with the provisions of ERISA, an Affiliated Company may adopt the Plan for all or any specified group of its Eligible Employees by entering into an adoption agreement in the form and substance prescribed by the Committee. The adoption agreement may include such modification of the Plan provisions with respect to such Eligible Employees as the Committee approves after having determined that no prohibited discrimination or other threat to the qualification of the Plan is likely to result. The Board of Directors may prospectively revoke or modify an Affiliated Company’s participation in the Plan at any time and for any or no reason, without regard to the terms of the adoption agreement, or terminate the Plan with respect to such Affiliated Company’s Eligible Employees and Participants. By execution of an adoption agreement (each of which by this reference shall become part of the Plan), the Affiliated Company agrees to be bound by all the terms and conditions of the Plan.

 

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ARTICLE XI

TERMINATION AND MERGER

11.1       Right to Terminate Plan .    The Sponsor, by resolution of the Board of Directors, may terminate or partially terminate the Plan. If the Plan is terminated or partially terminated, the assets of the Plan shall be allocated, subject to Section 11.3, as provided in Section 4044 of the Employee Retirement Income Security Act of 1974 (as it may be from time to time amended or construed by any appropriate governmental agency or corporation), without subclasses. Effective as of the first day of the sixth calendar year following the adoption date of this amended and restated Plan, in the event of a termination of the Plan (other than a partial termination), any amount remaining after all fixed and contingent liabilities of the Plan have been satisfied shall revert to the Company notwithstanding any provision in the Plan to the contrary. In the event of a termination of the Plan (other than a partial termination) prior to the first day of the sixth calendar year following the adoption date of this amended and restated Plan, any amount remaining after all fixed and contingent liabilities of the Plan have been satisfied shall be allocated to each Participant in proportion to the present value of a benefit commencing at Normal Retirement Date equal to such Participant’s Average Earnings times Benefit Years. Any allocations under this Section to Participants with respect to whom the Plan is terminating shall be nonforfeitable. Except as otherwise required by law, the time and manner of distribution of the assets or the time and manner of any reversion of assets to the Company shall be determined by the Sponsor by amendment to the Plan.

11.2       Merger Restriction .    No merger or consolidation with, or transfer of any of the Plan’s assets or liabilities to, any other plan shall occur at any time unless each Participant would (if the Plan had then terminated) receive a benefit immediately after the merger, consolidation, or transfer which is equal to or greater than the benefit he or she would have been entitled to receive immediately before the merger, consolidation, or transfer (if the Plan had then terminated).

11.3       Effect on Trustee and Committee .    The Trustee and the Committee shall continue to function as such for such period of time as may be necessary for the winding up of the Plan and for the making of distributions in the manner prescribed by the Board of Directors at the time of termination of the Plan.

11.4       Effect of Reorganization, Transfer of Assets or Change in Control .

(a)        In the event of a consolidation or merger of the Company, or in the event of a sale and/or any other transfer of the operating assets of the Company, any ultimate successor or successors to the business of the Company may continue the Plan in full force and effect by adopting the same by resolution of its board of directors and by executing a proper supplemental or transfer agreement with the Trustee.

(b)        In the event of a Change in Control (as herein defined), all Participants who were Participants on the date of such Change in Control shall become 100% vested in their Accrued Benefit on the date of such Change in Control and in any benefit accruals subsequent to the date of the Change in Control. Notwithstanding the foregoing, the

 

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Board of Directors may, at its discretion, amend or delete this paragraph (b) in its entirety prior to the occurrence of any such Change in Control. For the purpose of this paragraph (b), “Change in Control” shall mean the following and shall be deemed to occur if any of the following events occur:

(i)      Any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (a “Person”), is or becomes the “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act (a “Beneficial Owner”), directly or indirectly, of securities of the Sponsor representing (1) 20% or more of the combined voting power of the Sponsor’s then outstanding voting securities, which acquisition is not approved in advance of the acquisition or within 30 days after the acquisition by a majority of the Incumbent Board (as hereinafter defined) or (2) 33% or more of the combined voting power of the Sponsor’s then outstanding voting securities, without regard to whether such acquisition is approved by the Incumbent Board;

(ii)     Individuals who, as of the date hereof, constitute the Board of Directors (the “Incumbent Board”), cease for any reason to constitute at least a majority of the Board of Directors, provided that any person becoming a director subsequent to the date hereof whose election, or nomination for election by the Sponsor’s stockholders, is approved by a vote of at least a majority of the directors then comprising the Incumbent Board (other than an election or nomination of an individual whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of the directors of the Sponsor, as such terms are used in Rule 14a-11 of Regulation 14A promulgated under the Exchange Act) shall, for the purposes of the Plan, be considered as though such person were a member of the Incumbent Board of the Sponsor;

(iii)    The consummation of a merger, consolidation or reorganization involving the Sponsor, other than one which satisfies both of the following conditions:

(A)        a merger, consolidation or reorganization which would result in the voting securities of the Sponsor outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of another entity) at least 55% of the combined voting power of the voting securities of the Sponsor or such other entity resulting from the merger, consolidation or reorganization (the “Surviving Corporation”) outstanding immediately after such merger, consolidation or reorganization and being held in substantially the same proportion as the ownership in the Sponsor’s voting securities immediately before such merger, consolidation or reorganization, and

 

50


(B)        a merger, consolidation or reorganization in which no Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Sponsor representing 20% or more of the combined voting power of the Sponsor’s then outstanding voting securities; or

(iv)     The stockholders of the Sponsor approve a plan of complete liquidation of the Sponsor or an agreement for the sale or other disposition by the Sponsor of all or substantially all of the Sponsor’s assets.

Notwithstanding the preceding provisions of this paragraph (b), a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this paragraph (b) is (i) an underwriter or underwriting syndicate that has acquired any of the Sponsor’s then outstanding voting securities solely in connection with a public offering of the Sponsor’s securities, (ii) the Sponsor or any subsidiary of the Sponsor or (iii) an employee stock ownership plan or other employee benefit plan maintained by the Sponsor or an Affiliated Company that is qualified under the provisions of the Code. In addition, notwithstanding the preceding provisions of this paragraph (b), a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this paragraph (b) becomes a Beneficial Owner of more than the permitted amount of outstanding securities as a result of the acquisition of voting securities by the Sponsor or an Affiliated Company which, by reducing the number of voting securities outstanding, increases the proportional number of shares beneficially owned by such Person, provided, that if a Change in Control would occur but for the operation of this sentence and such Person becomes the Beneficial Owner of any additional voting securities (other than through the exercise of options granted under any stock option plan of the Sponsor or through a stock dividend or stock split), then a Change in Control shall occur.

(c)        For purposes of this Section 11.4, a Change of Control shall not be deemed to have occurred upon the distribution of the stock of Advanced Medical Optics, Inc. on June 29, 2002 by the Sponsor to its stockholders.

11.5       Termination Restrictions .    The following termination restrictions shall apply:

(a)        In the event the Plan is terminated, the Accrued Benefit of any Highly Compensated Employee (active or former) shall be limited to an Accrued Benefit that is nondiscriminatory under Code Section 401(a)(4).

(b)        The Accrued Benefit distributed to any of the 25 most Highest Compensated Employees (active or former) with the greatest Earnings in the current or any prior year shall be restricted so that the annual payments to such Highest Compensated Employee are no greater than an amount equal to the payment that would be made on behalf of the Highly Compensated Employee under a straight life annuity that is the actuarial equivalent of the sum of the Highly Compensated Employee’s Accrued Benefit, other benefits under the Plan (other than social security supplement, within the

 

51


meaning of Section 1.411(a)-7(c)(4)(ii) of the Income Tax Regulations), and the amount that he or she is entitled to receive under a social security supplement.

(c)        Paragraph (b) shall not apply if:

(i)        After payment of the Accrued Benefit to an Employee described in paragraph (a), the value of Plan assets equals or exceeds 110% of the value of current liabilities, as defined in Code Section 412(1)(7),

(ii)       The value of the Accrued Benefit for an Employee described in paragraph (a) is less than 1% of the value of current liabilities before distribution, or

(iii)      The value of the Accrued Benefit payable under the Plan to an Employee described in paragraph (b) does not exceed $3,500.

For purposes of this paragraph (c), the Accrued Benefit includes loans in excess of the amount set forth in Code Section 72(p)(2)(A), any periodic income, any withdrawal values payable to a living Employee, and any death benefits not provided for by insurance on the Employee’s life.

 

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ARTICLE XII

TOP-HEAVY RULES

12.1       Applicability .    Notwithstanding any provision in the Plan to the contrary, and subject to the limitations set forth in Section 12.7, the requirements of Sections 12.4, 12.5, and 12.6 shall apply under the Plan in the case of any Plan Year in which the Plan is determined to be a Top-Heavy Plan under the rules of Section 12.3. For the purpose of this Article XII, the term “Company” shall mean the Sponsor and any Affiliated Company whether or not such Affiliated Company has adopted the Plan.

12.2       Definitions .    For purposes of this Article XII, the following special definitions and rules shall apply:

(a)        The term “Key Employee” means any Employee or former Employee (including any deceased Employee) who, at any time during the Plan Year that includes the Determination Date, was an officer of the Company having annual Compensation greater than $130,000 (as adjusted under Code Section 416(i)(1) for Plan Years beginning after December 31, 2002), a Five Percent Owner of the Company, or an One Percent Owner of the Company having annual Compensation of more than $150,000.

(b)        The term “Five Percent Owner” means any person who owns (or is considered as owning within the meaning of Code Section 318) more than 5% of the outstanding stock of the Company or stock possessing more than 5% of the total combined voting power of all stock of the Company.

(c)        The term “One Percent Owner” means any person who would be described in paragraph (b) if “1%” were substituted for “5%” each place where it appears therein.

(d)        The term “Non-Key Employee” means any Employee who is not a Key Employee.

(e)        The term “Determination Date” means, with respect to any plan year, the last day of the preceding plan year. In the case of the first plan year of any plan, the term “Determination Date” shall mean the last day of that plan year.

(f)        The term “Aggregation Group” means (i) each qualified plan of the Company in which at least one Key Employee participates or participated at any time during the determination period (regardless of whether the plan has terminated), and (ii) any other qualified plan of the Company which enables a plan described in clause (i) to meet the requirements of Code Sections 401(a)(4) or 410. Any plan not required to be included in an Aggregation Group under the preceding rules may be treated as being part of such group if the group would continue to meet the requirements of Code Sections 401(a)(4) and 410 with the plan being taken into account.

 

53


(g)        For purposes of determining ownership under paragraphs (a), (b) and (c) above, the following special rules shall apply: (i) Code Section 318(a)(2)(C) shall be applied by substituting “5%” for “50%”, and (ii) the aggregation rules of Code Sections 414(b), (c) and (m) shall not apply, with the result that the ownership tests of this Section 12.2 shall apply separately with respect to each Affiliated Company.

(h)        The terms “Key Employee” and “Non-Key Employee” shall include their Beneficiaries, and the definitions provided under this Section 12.2 shall be interpreted and applied in a manner consistent with the provisions of Code Section 416(i) and the regulations thereunder.

(i)        For purposes of this Article XII, an Employee’s Compensation shall be determined in accordance with the rules of Code Section 415 and the regulations thereunder.

12.3       Top-Heavy Status .

(a)        The term “Top-Heavy Plan” means, with respect to any Plan Year:

(i)      Any defined benefit plan if, as of the Determination Date, the present value of the cumulative accrued benefits under the plan for Key Employees exceeds 60% of the present value of the cumulative accrued benefits under the plan for all Employees; and

(ii)     Any defined contribution plan if, as of the Determination Date, the aggregate of the account balances of Key Employees under the plan exceeds 60% of the aggregate of the account balances of all Employees under the plan.

In applying the foregoing provisions of this paragraph (a), the valuation date to be used in valuing Plan assets shall be (i) in the case of a defined benefit plan, the same date which is used for computing costs for minimum funding purposes, and (ii) in the case of a defined contribution plan, the most recent valuation date within a 12-month period ending on the applicable Determination Date.

(b)        Each plan maintained by the Company required to be included in an Aggregation Group shall be treated as a Top-Heavy Plan if the Aggregation Group is a Top-Heavy Group.

(c)        The term “Top-Heavy Group” means any Aggregation Group if the sum (as of the Determination Date) of (i) the present value of the cumulative accrued benefits for Key Employees under all defined benefit plans included in the group, and (ii) the aggregate of the account balances of Key Employees under all defined contribution plans included in the group exceeds 60% of a similar sum determined for all Employees. For purposes of determining the present value of the cumulative accrued benefit of any Employee, or the amount of the account balance of any Employee, such present value or

 

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amount shall be increased by the aggregate distributions made with respect to the Employee under the plan (including a terminated plan which, had it not been terminated, would have been aggregated with the plan under Code Section 416(g)(2)(A)(i))during the one year period ending on the Determination Date. In the case of distributions made for a reason other than separation from service, death, or disability, the preceding sentence shall be applied by substituting “5-year period” for “l -year period.” Any rollover contribution or similar transfer initiated by the Employee and made after December 31, 1983, to a plan shall not be taken into account with respect to the transferee plan for purposes of determining whether such plan is a Top-Heavy Plan (or whether any Aggregation Group which includes such plan is a Top-Heavy Group).

(d)        If any individual is a Non-Key Employee with respect to any plan for any plan year, but the individual was a Key Employee with respect to the plan for any prior plan year, any accrued benefit for the individual (and the account balance of the individual) shall not be taken into account for purposes of this Section 12.3.

(e)        If any individual has not performed services for the Company at any time during the one year period ending on the Determination Date, any accrued benefit for such individual (and the account balance of the individual) shall not be taken into account for purposes of this Section 12.3.

(f)        In applying the foregoing provisions of this Section, the accrued benefit of a Non-Key Employee shall be determined (i) under the method, if any, which is used for accrual purposes under all plans of the Company and any Affiliate, or (ii) if there is no such uniform method, as if such benefit accrued not more rapidly than the slowest accrual rate permitted under Code Section 411(b)(1)(C).

(g)        For all purposes of this Article XII, the definitions provided under this Section 12.3 shall be applied and interpreted in a manner consistent with the provisions of Code Section 416(g) and the Regulations thereunder.

12.4       Minimum Benefit .

(a)        The Plan shall provide a minimum benefit for each Participant who is not classified as a “Key Employee.” This minimum benefit, when expressed as an annual retirement benefit payable in the form of a single life annuity beginning when the Participant attains Age 65, shall not be less than the Participant’s average annual compensation during the period of consecutive years (not exceeding five (5)) during which the Participant had the greatest aggregate compensation from the Company multiplied by the lesser of:

(i)      Two percent (2%) multiplied by the number of his or her Vesting Years; or

(ii)     Twenty percent (20%).

 

55


(b)        For purposes of this Section 12.4, Vesting Years shall be determined under Code Sections 411(a)(4), (5), and (6), but excluding:

(i)      Any Vesting Year if the Plan was not a Top-Heavy Plan for the Plan Year ending during such Vesting Year;

(ii)     Any Vesting Year which was completed in a Plan Year beginning before January 1, 1984; and

(iii)    Any Vesting Year which was completed in a Plan Year beginning on or after January 1, 2002 during which the Plan benefits (within the meaning of Code Section 410(b)) no Key Employee or former Key Employee.

(c)        The Participant’s minimum benefit determined under this Section 12.4 shall be calculated without regard to any Social Security benefits payable to the Participant.

(d)        In the event a Participant is covered by both a defined contribution and a defined benefit plan maintained by the Company, both of which are determined to be Top-Heavy Plans, the Company shall satisfy the minimum benefit requirements of Code Section 416 by providing (in lieu of the minimum contribution described under the defined contribution plan) a minimum benefit under the Plan so as to prevent the duplication of required minimum benefits hereunder.

12.5       Maximum Benefit .

(a)        Except as set forth below, in the case of any Top-Heavy Plan the rules of Sections 5.7(a)(i) and 5.7(b) shall be applied by substituting “1.0” for “1.25.”

(b)        The rule set forth in paragraph (a) above shall not apply if the requirements of both subparagraphs (i) and (ii) are satisfied.

(i)      The requirements of this subparagraph (i) are satisfied if the rules of Section 12.4(a) above would be satisfied after substituting “three percent (3%)” for “two percent (2%)” where it appears therein and by increasing (but not by more than ten (10) percentage points) twenty percent (20%) by one (1) percentage point for each year for which the Plan is a Top Heavy Plan.

(ii)     The requirements of this subparagraph (ii) are satisfied if the Plan would not be a Top-Heavy Plan if “ninety percent (90%)” were substituted for “sixty percent (60%)” each place it appears in Sections 12.3(a) and 12.3(c).

(c)    The rules of paragraph (a) shall not apply with respect to any Employee as long as there are no --

 

56


(i)      Company contributions, forfeitures, or voluntary nondeductible contributions allocated to the Employee under a defined contribution plan maintained by the Company, or

(ii)     Accruals by the Employee under a defined benefit plan maintained by the Company.

(d)        In the case where the Plan is subject to the rules of paragraph (a) above, the transition fraction rules of Code Section 415(e)(6) shall be applied by substituting “$41,500” for “$51,875.”

12.6       Minimum Vesting Rules .

(a)        For any Plan Year in which it is determined that the Plan is a Top-Heavy Plan, the vesting schedule of the Plan shall be changed to that set forth below (unless the Plan’s vesting schedule otherwise provides for vesting at a rate at least as rapid as that set forth below):

 

Number of Vesting Years

   Nonforfeitable Percentage

Less than 3 years

       0%

3 or more

   100%

(b)        If the Plan ceases to be a Top-Heavy Plan, the vesting schedule of the Plan shall (for such Plan Years as the Plan is not a Top-Heavy Plan) revert to that provided in Section 5.11 (the “Regular Vesting Schedule”). If such reversion to the Regular Vesting Schedule is deemed to constitute a vesting schedule change that is attributable to a Plan amendment (within the meaning of Code Section 411(a)(10)), then such reversion to said Regular Vesting Schedule shall be subject to the requirements of Code Section 411(a)(10). For such purposes, the date of the adoption of such deemed amendment shall be the Determination Date as of which it is determined that the Plan has ceased to be a Top-Heavy Plan.

12.7         Noneligible Employees .    The rules of this Article XII shall not apply to any Employee included in a unit of employees covered by a collective bargaining agreement between employee representatives and one or more employers if retirement benefits were the subject of good faith bargaining between such employee representatives and the employer or employers.

 

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ARTICLE XIII

RESTRICTION ON ASSIGNMENT OR

OTHER ALIENATION OF PLAN BENEFITS

13.1       General Restrictions Against Alienation .

(a)        The interest of any Participant or his or her Beneficiary in the income, benefits, payments, claims or rights hereunder, or in the Trust Fund, shall not in any event be subject to sale, assignment, hypothecation, or transfer. Each Participant and Beneficiary is prohibited from anticipating, encumbering, assigning, or in any manner alienating his or her interest under the Trust Fund, and is without power to do so. The interest of any Participant or Beneficiary shall not be liable or subject to his or her debts, liabilities, or obligations, now contracted, or which may hereafter be contracted, and such interest shall be free from all claims, liabilities, or other legal process now or hereafter incurred or arising. Neither the interest of a Participant or Beneficiary, nor any part thereof, shall be subject to any judgment rendered against any such Participant or Beneficiary. Notwithstanding the foregoing, a Participant’s or Beneficiary’s interest in the Plan may be subject to the enforcement of a Federal tax levy made pursuant to Code Section 6331 or the collection by the United States on a judgment resulting from an unpaid tax assessment.

(b)        In the event any person attempts to take any action contrary to this Article XIII, such action shall be null and void and of no effect, and the Company, the Committee, the Trustee and all Participants and their Beneficiaries, may disregard such action and are not in any manner bound thereby, and they, and each of them, shall suffer no liability for any such disregard thereof, and shall be reimbursed on demand out of the Trust Fund for the amount of any loss, cost or expense incurred as a result of disregarding or of acting in disregard of such action.

(c)        The foregoing provisions of this Section shall be interpreted and applied by the Committee in accordance with the requirements of Code Section 401(a)(13) and Section 206(d) of ERISA as construed and interpreted by authoritative judicial and administrative rulings and regulations.

13.2         Qualified Domestic Relations Orders .    The rule set forth in Section 13.1 above shall not apply with respect to a “Qualified Domestic Relations Order” as described below.

(a)        A “Qualified Domestic Relations Order” is a judgment, decree, or order (including approval of a property settlement agreement) that:

(i)      Creates or recognizes the existence of an Alternate Payee’s right to, or assigns to an Alternate Payee the right to, receive all or a portion of the benefits payable under this Plan with respect to a Participant,

 

58


(ii)     Relates to the provision of child support, alimony payments, or marital property rights to a spouse, former spouse, child or other dependent of a Participant,

(iii)    Is made pursuant to a State domestic relations law (including a community property law), and

(iv)     Clearly specifies: (1) the name and last known mailing address (if any) of the Participant and the name and mailing address of each Alternate Payee covered by the order (if the Committee does not have reason to know that address independently of the order); (2) the amount or percentage of the Participant’s benefits to be paid to each Alternate Payee, or the manner in which the amount or percentage is to be determined; (3) the number of payments or period to which the order applies; and (4) each plan to which the order applies.

For purposes of this Section 13.2, “Alternate Payee” means any spouse, former spouse, child or other dependent of a Participant who is recognized by a domestic relations order as having a right to receive all, or a portion of, the benefits payable with respect to the Participant.

(b)        A domestic relations order is not a Qualified Domestic Relations Order if it requires:

(i)      The Plan to provide any type or form of benefit, or any option, not otherwise provided under the Plan;

(ii)     The Plan to provide increased benefits; or

(iii)    The payment of benefits to an Alternate Payee that are required to be paid to another Alternate Payee under a previous Qualified Domestic Relations Order.

(c)        A domestic relations order shall not be considered to fail to satisfy the requirements of paragraph (b)(i) above with respect to any payment made before a Participant has separated from service solely because the order requires that payment of benefits be made to an Alternate Payee:

(i)      On or after the date on which the Participant attains (or would have first attained) his earliest retirement age (as defined in Code Section 414(p)(4)(B));

(ii)     As if the Participant had retired on the date on which such payment is to begin under such order (but taking into account only the present value of accrued benefits and not taking into account the present value of any subsidy for early retirement benefits); and

 

59


(iii)    In any form in which such benefits may be paid under the Plan to the Participant (other than in the form of a joint and survivor annuity with respect to the Alternate Payee and his or her subsequent spouse).

Notwithstanding the foregoing, if the Participant dies before his or her earliest retirement age (as defined in Code Section 414(p)(4)(B)), the Alternate Payee is entitled to benefits only if the Qualified Domestic Relations Order requires survivor benefits to be paid to the Alternate Payee.

(d)        To the extent provided in any Qualified Domestic Relations Order, the former spouse of a Participant shall be treated as a surviving spouse of the Participant for purposes of applying the rules (relating to minimum survivor annuity requirements) of Code Sections 401(a)(11) and 417, and any current spouse of the Participant shall not be treated as a spouse of the Participant for such purposes.

(e)        In the case of any domestic relations order received by the Plan, the Committee shall promptly notify the Participant and any Alternate Payee of the receipt of the order and the Plan’s procedures for determining the qualified status of domestic relations orders. Within a reasonable period after the receipt of the order, the Committee shall determine whether the order is a Qualified Domestic Relations Order and shall notify the Participant and each Alternate Payee of such determination.

(f)        The Committee shall establish reasonable procedures to determine the qualified status of domestic relations orders and to administer distributions under Qualified Domestic Relations Orders. During any period in which the issue of whether a domestic relations order is a Qualified Domestic Relations Order is being determined (by the Committee, by a court of competent jurisdiction, or otherwise), the Committee shall segregate in a separate account in the Plan (or in an escrow account) the amounts which would have been payable to the Alternate Payee during the period if the order had been determined to be a Qualified Domestic Relations Order. If within the 18 Month Period (as defined below), the order (or modification thereof) is determined to be a Qualified Domestic Relations Order, the Committee shall pay the segregated amounts (plus any interest thereon) to the person or persons entitled thereto. However, if within the 18 Month Period (i) it is determined that the order to not a Qualified Domestic Relations Order, or (ii) the issue as to whether the order is a Qualified Domestic Relations Order is not resolved, then the Committee shall pay the segregated amounts (plus any interest thereon) to the person or persons who would have been entitled to the amounts if there had been no order (assuming such benefits were otherwise payable). Any determination that an order is a Qualified Domestic Relations Order that is made after the close of the 18 Month Period shall be applied prospectively only. For purposes of this Section 13.2, the “18 Month Period” shall mean the 18 month period beginning with the date on which the first payment would be required to be made under the domestic relations order.

 

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ARTICLE XIV

MISCELLANEOUS

14.1         No Right of Employment Hereunder .    The adoption and maintenance of the Plan and Trust shall not be deemed to constitute a contract of employment or otherwise between the Company and any Employee or Participant, or to be a consideration for, or an inducement or condition of, any employment. Nothing contained herein shall be deemed to give any Employee the right to be retained in the service of the Company or to interfere with the right of the Company to discharge, with or without cause, any Employee or Participant at any time, which right is hereby expressly reserved.

14.2         Effect of Article Headings .    Article headings are for convenient reference only and shall not be deemed to be a part of the substance of this instrument or in any way to enlarge or limit the contents of any Article.

14.3         Limitation on Company Liability .    Any benefits payable under the Plan shall be paid or provided for solely from the Plan and the Company assumes no liability or responsibility therefor.

14.4         Interpretation .    The provisions of the Plan shall in all cases be interpreted in a manner that is consistent with the Plan satisfying the requirements of Code Section 401(a) and related statutes for qualification as a defined benefit plan.

14.5         Withholding For Taxes .    Any payments from the Trust Fund may be subject to withholding for taxes as may be required by any applicable federal or state law.

14.6         California Law Controlling .    All legal questions pertaining to the Plan which are not controlled by ERISA shall be determined in accordance with the laws of the State of California and all contributions made hereunder shall be deemed to have been made in that State.

14.7         Plan and Trust as One Instrument .    The Plan and any trust agreement adopted hereunder shall be construed together as one instrument. In the event that any conflict arises between the terms and/or conditions of any trust agreement with the Trustee and the Plan, the provisions of the Plan shall control, except that with respect to the duties and responsibilities of the Trustee, the trust agreement shall control.

14.8         Invalid Provisions .     If any paragraph, section, sentence, clause or phrase contained in the Plan shall become illegal, null or void or against public policy, for any reason, or shall be held by any court of competent jurisdiction to be incapable of being construed or limited in a manner to make it enforceable, or is otherwise held by such court to be illegal, null or void or against public policy, the remaining paragraphs, sections, sentences, clauses or phrases contained in the Plan shall not be affected thereby.

14.9         Counterparts .    This instrument may be executed in one or more counterparts each of which shall be legally binding and enforceable.

 

61


14.10     Forfeitures .    All forfeitures arising under the Plan shall be used as soon as possible to reduce the Company’s contributions and shall not be applied to increase the benefits any person would otherwise receive under the Plan.

14.11     Facility of Payment .    If the Committee deems any person incapable of receiving benefits to which he is entitled by reason of minority, illness, infirmity, or other incapacity, it may direct that payment be made directly for the benefit of such person or to any person selected by the Committee to disburse it, whose receipt shall be a complete acquittance therefor. Such payments shall, to the extent thereof, discharge all liability of the Company and the party making the payment.

14.12     Lapsed Benefits .

(a)        In the event that a benefit is payable under the Plan to a Participant and after reasonable efforts the Participant cannot be located for the purpose of paying the benefit during a period of three consecutive years, the Participant shall be presumed dead and the benefit (if any) shall, upon the termination of that three year period, be paid to the Participant’s Beneficiary.

(b)        If any eligible Beneficiary cannot be located for the purpose of paying the benefit for the following two years, then the benefit shall be forfeited and applied in accordance with the provisions of Section 14.10.

(c)        Notwithstanding the foregoing rules, if after such a forfeiture the Participant or an eligible Beneficiary shall claim the forfeited benefit, the amount forfeited shall be reinstated and paid to the claimant as soon as practical following the claimant’s production of reasonable proof of his or her identity and entitlement to the benefit (determined pursuant to the Plan’s normal claim review procedures under Sections 9.8 and 9.9).

(d)        The Committee shall direct the Trustee with respect to the procedures to be followed concerning a missing Participant (or Beneficiary), and the Company shall be obligated to contribute to the Trust Fund any amounts necessary after the application of Section 14.10 to pay any reinstated benefit after it has been forfeited pursuant to the provisions of this Section.

 

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IN WITNESS WHEREOF, Allergan, Inc. hereby executes this instrument, evidencing the terms of the Allergan, Inc. Pension Plan as restated this 29 th day of January, 2008.

 

ALLERGAN, INC.

 

By:   /s/ Douglas S. Ingram        
  Douglas S. Ingram
 

Executive Vice President, Chief Administrative Officer, General Counsel

and Secretary

 

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APPENDIX A

A.1      The Actuarial Equivalent of a benefit other than a lump sum shall be determined as follows:

(a)        For Annuity Starting Dates on or after July 1, 2002, the Actuarial Equivalent of a benefit other than a lump sum shall be determined by applying a 7% interest rate and the 1994 Group Annuity Reserving Table; provided, however, the Actuarial Equivalent of a contingent benefit option which provides a benefit following a Participant’s death to the Participant’s surviving spouse shall be determined by the factors set forth in Table I under this Appendix A if greater.

(b)        For Annuity Starting Dates commencing as of the Plan’s Original Effective Date and ending June 30, 2002, the Actuarial Equivalent of a benefit other than a lump sum shall be determined by applying a 7% interest rate and the 1971 GAM Mortality Table — Males (age set-back 2 years); provided, however, the Actuarial Equivalent of a contingent benefit option which provides a benefit following a Participant’s death to the Participant’s surviving spouse shall be determined by the factors set forth in Table II under this Appendix A.

A.2      The Actuarial Equivalent of a lump sum benefit shall, for purposes of Section 6.5, be determined as follows:

(a)        The Actuarial Equivalent of a lump sum benefit with an Annuity Starting Date on or after July 1, 2002, shall mean an amount of equal actuarial value based on the Applicable Mortality Table and the Applicable Interest Rate where:

(i)      “Applicable Mortality Table” means the 1994 Group Annuity Reserving Table; and

(ii)     “Applicable Interest Rate” means the annual interest rate on 30-year Treasury securities as specified by the Commissioner of Internal Revenue for the first full calendar month preceding the Plan Year that contains the annuity starting date.

(b)        The Actuarial Equivalent of a lump sum benefit with an Annuity Starting Date on or after January 1, 1995 and prior to July 1, 2002, shall mean an amount of equal actuarial value based on the Applicable Mortality Table and the Applicable Interest Rate where:

(i)      “Applicable Mortality Table” means the 1983 Group Annuity Mortality Table; and

 

A-1


(ii)     “Applicable Interest Rate” means the annual interest rate on 30-year Treasury securities as specified by the Commissioner of Internal Revenue for the first full calendar month preceding the Plan Year that contains the annuity starting date.

(c)        The Actuarial Equivalent of a lump sum benefit with an Annuity Starting Date prior to January 1, 1995, shall mean an amount of equal actuarial value based on the interest rate(s) which would be used (as of the first day of the Plan Year in which falls the annuity starting date) by the Pension Benefit Guaranty Corporation (PBGC) for a trusteed single-employer plan to value a benefit upon termination of an insufficient trusteed single-employer plan and the 1971 GAM Mortality Table — Males (age set-back 2 years).

 

A-2


ATTACHMENT TO APPENDIX A

TABLE I

OPTIONAL BENEFIT FORM FACTORS

(TO BE APPLIED TO STRAIGHT LIFE ANNUITY)

7%/1994 Group Annuity Reserving Table

 

Retiree   50%   66-2/3%   75%   100%     5 Yr   10 Yr   15 Yr   20 Yr
  Age   J&S     J&S   J&S     J&S   C&C   C&C   C&C   C&C
35   0.984   0.979   0.977   0.969   1.000   0.998   0.997   0.994
36   0.984   0.978   0.976   0.968   1.000   0.998   0.996   0.994
37   0.983   0.977   0.974   0.966   1.000   0.998   0.996   0.994
38   0.982   0.976   0.973   0.964   1.000   0.998   0.996   0.993
39   0.981   0.974   0.971   0.962   0.999   0.998   0.995   0.992
40   0.980   0.973   0.970   0.960   0.999   0.998   0.995   0.992
41   0.979   0.972   0.968   0.958   0.999   0.998   0.995   0.991
42   0.977   0.970   0.967   0.956   0.999   0.997   0.994   0.990
43   0.976   0.968   0.965   0.953   0.999   0.997   0.994   0.989
44   0.975   0.967   0.963   0.951   0.999   0.997   0.993   0.987
45   0.973   0.965   0.961   0.948   0.999   0.996   0.992   0.986
46   0.972   0.963   0.959   0.946   0.999   0.996   0.991   0.984
47   0.970   0.961   0.956   0.943   0.999   0.996   0.990   0.982
48   0.969   0.959   0.954   0.939   0.999   0.995   0.989   0.980
49   0.967   0.957   0.951   0.936   0.999   0.995   0.988   0.977
50   0.965   0.954   0.949   0.933   0.998   0.994   0.986   0.974
51   0.963   0.952   0.946   0.929   0.998   0.993   0.984   0.971
52   0.961   0.949   0.943   0.925   0.998   0.992   0.982   0.967
53   0.959   0.946   0.940   0.921   0.998   0.991   0.979   0.963
54   0.957   0.943   0.937   0.917   0.997   0.990   0.976   0.958
55   0.954   0.940   0.933   0.913   0.997   0.988   0.973   0.953
56   0.952   0.937   0.930   0.908   0.997   0.986   0.969   0.947
57   0.949   0.934   0.926   0.904   0.996   0.984   0.965   0.941
58   0.947   0.930   0.922   0.899   0.995   0.982   0.960   0.934
59   0.944   0.927   0.918   0.894   0.995   0.979   0.955   0.926
60   0.941   0.923   0.915   0.889   0.994   0.976   0.949   0.918
61   0.939   0.920   0.911   0.884   0.993   0.973   0.943   0.909
62   0.936   0.916   0.906   0.879   0.992   0.969   0.937   0.899
63   0.933   0.912   0.902   0.874   0.991   0.965   0.929   0.888
64   0.930   0.909   0.898   0.869   0.989   0.961   0.921   0.877
65   0.927   0.905   0.894   0.864   0.988   0.956   0.913   0.865

 

A-3


ATTACHMENT TO APPENDIX A

TABLE I

OPTIONAL BENEFIT FORM FACTORS

(TO BE APPLIED TO STRAIGHT LIFE ANNUITY)

7%/1994 Group Annuity Reserving Table

 

Retiree   50%   66-2/3%   75%   100%     5 Yr   10 Yr   15 Yr   20 Yr
  Age   J&S     J&S   J&S     J&S   C&C   C&C   C&C   C&C
66   0.924   0.901   0.890   0.859   0.986   0.951   0.904   0.852
67   0.921   0.898   0.887   0.854   0.985   0.946   0.894   0.838
68   0.919   0.894   0.883   0.850   0.983   0.940   0.883   0.824
69   0.916   0.891   0.879   0.845   0.981   0.933   0.871   0.808
70   0.913   0.887   0.875   0.840   0.979   0.926   0.858   0.791
71   0.910   0.883   0.871   0.835   0.976   0.917   0.844   0.773
72   0.907   0.879   0.866   0.829   0.973   0.907   0.828   0.754
73   0.904   0.875   0.862   0.824   0.970   0.896   0.811   0.734
74   0.900   0.871   0.857   0.819   0.966   0.884   0.792   0.712
75   0.897   0.867   0.853   0.813   0.961   0.870   0.772   0.690
76   0.893   0.863   0.848   0.807   0.955   0.854   0.750   0.667
77   0.890   0.858   0.843   0.801   0.948   0.837   0.727   0.643
78   0.886   0.854   0.838   0.795   0.941   0.819   0.703   0.619
79   0.883   0.849   0.834   0.790   0.932   0.798   0.678   0.595
80   0.879   0.845   0.829   0.784   0.923   0.777   0.653   0.570

 

A-4


ATTACHMENT TO APPENDIX A

TABLE II

OPTIONAL BENEFIT FORM FACTORS

(TO BE APPLIED TO STRAIGHT LIFE ANNUITY)

7%/1971 GAM Mortality Table -- Males (age set-back 2 years)

 

Retiree
  Age
  50% J&S   66 2/3% J&S   100% J&S   5 Yr C&C   10 Yr C&C   15 Yr C&C   20 Yr C&C
40   .975   .960   .945   .999   .996   .990   .983
41   .973   .958   .942   .999   .995   .989   .981
42   .971   .956   .939   .999   .995   .988   .979
43   .969   .954   .936   .999   .994   .986   .976
44   .967   .952   .933   .998   .993   .984   .973
45   .965   .950   .930   .998   .992   .982   .970
46   .963   .948   .926   .998   .991   .980   .967
47   .961   .946   .922   .997   .990   .978   .963
48   .959   .944   .918   .997   .988   .975   .959
49   .957   .942   .914   .997   .987   .972   .954
50   .955   .940   .910   .996   .985   .969   .950
51   .953   .937   .906   .996   .984   .966   .945
52   .951   .934   .902   .995   .982   .962   .939
53   .949   .931   .898   .995   .980   .959   .933
54   .947   .928   .894   .994   .978   .954   .926
55   .945   .925   .890   .993   .975   .950   .919
56   .942   .921   .885   .993   .973   .945   .911
57   .939   .917   .880   .992   .970   .939   .902
58   .936   .913   .875   .991   .967   .933   .893
59   .933   .909   .870   .990   .963   .926   .883
60   .930   .905   .865   .989   .959   .918   .872
61   .927   .901   .860   .987   .954   .909   .860
62   .924   .897   .855   .986   .949   .899   .847
63   .921   .893   .850   .984   .943   .889   .833
64   .918   .889   .845   .982   .937   .877   .818
65   .915   .885   .840   .980   .929   .865   .802
66   .911   .881   .834   .977   .921   .851   .785
67   .907   .877   .828   .974   .911   .836   .768
68   .903   .873   .822   .971   .901   .821   .749
69   .899   .869   .816   .967   .890   .804   .730

 

A-5


ATTACHMENT TO APPENDIX A

TABLE II

OPTIONAL BENEFIT FORM FACTORS

(TO BE APPLIED TO STRAIGHT LIFE ANNUITY)

7%/1971 GAM Mortality Table -- Males (age set-back 2 years)

 

Retiree

  Age

  50% J&S   66 2/3% J&S   100% J&S   5 Yr C&C   10 Yr C&C   15 Yr C&C   20 Yr C&C
70   .895   .865   .810   .962   .878   .787   .711
71   .892   .862   .805   .957   .865   .769   .691
72   .889   .859   .800   .952   .851   .750   .671
73   .886   .856   .795   .946   .837   .731   .651
74   .883   .853   .790   .940   .822   .711   .631
75   .880   .850   .785   .934   .806   .691   .610
76   .877   .846   .781   .927   .789   .671   .590
77   .874   .842   .777   Left intentionally blank
78   .871   .838   .773   Left intentionally blank
79   .868   .834   .769   Left intentionally blank
80   .865   .830   .765   Left intentionally blank

 

A-6


APPENDIX B

B.1      For purposes of Section 4.3(b) of the Plan, the Accrued Benefit of a Participant shall be equal to one-twelfth (1/12) of the difference between:

(a)        the sum of:

(i)      1.7% of his or her Average Earnings multiplied by the number of his or her Benefit Years to a maximum of 35 Benefit Years; plus

(ii)     0.5% of his or her Average Earnings for each Benefit Year in excess of 35 Benefit Years; and

(b)        1.43% of the Participant’s Primary Social Security Benefit multiplied by the number of his or her Benefit Years to a maximum of 35 Benefit Years.

Notwithstanding the foregoing, the Accrued Benefit of a Participant who is considered a highly compensated employee in 1989 within the meaning of Code Section 414(q)(1)(A) or (B) is limited to the Participant’s Accrued Benefit under the SKB Plan as of the Spin-Off Date. The Accrued Benefit of a Participant who is considered a highly compensated employee in 1990 within the meaning of Code Section 414(q)(1)(A) or (B), and is not considered a highly compensated employee in 1989 within the meaning of Code Section 414(q)(1)(A) or (B) is limited to the Participant’s Accrued Benefit as of December 31, 1989.

B.2      The level income option offered as an optional form of benefit under Section 6.4(b) of the Plan, provides a monthly pension payable as a Single Life Annuity or under a contingent beneficiary option. For purposes of this paragraph, the Single Life Annuity or, if a contingent beneficiary option is elected, the monthly amount payable to a Participant as reduced for the contingent beneficiary option shall be referred to as the Participant’s Life Pension. In order to recognize the increased benefits payable until age 62 (the “Temporary Pension”), the Participant’s Life Pension is reduced. The Temporary Pension shall end on the earlier of the Participant’s death or his or her attainment of age 62. If a contingent beneficiary option is elected and the Participant dies, then 100%, 75%, 66 2/3% or 50% (as previously elected by the Participant) of the Participant’s Life Pension as determined prior to the adjustment for the Temporary Pension shall be payable for the lifetime of his or her designated beneficiary.

B.3      The guaranteed payment option offered as an optional form of benefit under Section 6.4(b) of the Plan, provides a reduced benefit for the longer of the Participant’s lifetime or a specified number of months (60, 120, 180, or 240) with payments made to the Participant and any remaining guaranteed payments on the Participant’s death to a designated beneficiary or beneficiaries (hereinafter referred to as the “designated beneficiary”). For purposes of the guaranteed payment option, the following rules shall apply to beneficiary designations:

(a)        A Participant may change his or her designated beneficiary at any time and may designate a secondary beneficiary or beneficiaries to receive any remaining

 

B-1


guaranteed payments on the Participant’s death in the event his or her designated beneficiary predeceases the Participant or dies during the guaranteed payment period.

(b)        If the Participant fails to designate a secondary beneficiary and the Participant’s designated beneficiary predeceases the Participant, any guaranteed payments on the Participant’s death shall be paid in a lump sum to either the Participant’s personal representative or heirs at law as determined under paragraph (d) below.

(c)        If the Participant fails to designate a secondary beneficiary and the Participant’s designated beneficiary dies while receiving payments during the guaranteed payment period, the designated beneficiary’s interest in the remaining guaranteed payments shall be paid in a lump sum to either the designated beneficiary’s personal representative or heirs at law as determined under paragraph (d) below.

(d)        In the event the deceased Participant or deceased designated beneficiary under paragraphs (b) and (c) above, respectively, is not a resident of California at the date of his or her death, the Committee, in its discretion, may require the establishment of ancillary administration in California. If the Committee cannot locate a qualified personal representative of the deceased Participant or deceased designated beneficiary, or if administration of the deceased Participant’s or deceased designated beneficiary’s estate is not otherwise required, the Committee, in its discretion, may pay the remaining guaranteed payments (or interest therein) to the deceased Participant’s or deceased designated beneficiary’s heirs at law (determined in accordance with the laws of the State of California as they existed at the date of the Participant’s or designated beneficiary’s death).

B.4      Notwithstanding anything in the Plan to the contrary, the reductions applied to the Accrued Benefits of Participants whose last Severance Date was prior to July 27, 1989 to reflect the value of coverage for pre-retirement death benefits shall no longer apply to benefits with Annuity Starting Dates on or after July 1, 2002.

 

B-2


APPENDIX C

Benefit Years and Vesting Years include service with the following Affiliated Companies (or their predecessors) effective on the dates shown:

 

   

Vesting

Service

Effective

   Date   

     

Benefit

Service

Effective

   Date

Allergan America

  At hire     04/11/80

Allergan Corporate

  At hire     At hire*

Allergan Humphrey

  02/07/80     01/01/87

Allergan International

  At hire     At hire*

Allergan Medical Optics

  At hire     04/30/86

Allergan Medical Optics-Ioptex

  At hire     09/08/94

Allergan Medical Optics-Lenoir

  At hire     03/01/92

  (Departments 120-130)

     

Allergan Medical Optics-Puerto Rico

  At hire     04/30/86

Allergan Optical Inc.

  At hire     11/13/87

  (formerly International Hydron Corporation)

     

Allergan Optical Puerto Rico, Inc.

  At hire     11/13/87

Allergan Optical

  At hire     At hire*

Allergan Pharmaceuticals

  At hire     At hire*

Allergan Phoenix

  At hire     12/01/95

Allergan Puerto Rico, Inc.

  At hire     04/11/80

(formerly Allergan Caribbean)

     

Allergan Surgical

  At hire     At hire*

(formerly Innovative Surgical Products)

     

Herbert Labs

  At hire     At hire*

Herald Pharmacal

  At hire     08/03/95

Oculinum, Inc.

  At hire     06/28/91

Optical Micro Systems, Inc.

  At hire     01/27/95

 

 

*        If employment terminated between April 11, 1980 and January 1, 1986, Benefit Years shall be credited from April 11, 1980 or date of hire, whichever is later.

 

C-1

EXHIBIT 10.19

ALLERGAN, INC.

SUPPLEMENTAL EXECUTIVE BENEFIT PLAN

and

SUPPLEMENTAL RETIREMENT INCOME PLAN

Effective as of January 1, 2005

 

 

RESTATED 2008


ARTICLE I

INTRODUCTION

1.1.       Plans .  Allergan, Inc., a Delaware corporation (the “Sponsor”) currently sponsors the Allergan, Inc. Supplemental Retirement Income Plan (“SRIP”) and the Allergan, Inc. Supplemental Executive Benefit Plan (“SEBP”) (collectively, the “Plans”). Unless otherwise specified, a reference to the “Plan” shall refer to both Plans.

1.2.       Amendment and Restatement of the Plan .  This document, made and entered into by the Sponsor, evidences the terms of both the SRIP and the SEBP, effective as of January 1, 2005, unless otherwise stated in the Plan.

1.3.       Applicability of Code Section 409A .  With respect to benefits accruing or vesting under the Plan after December 31, 2004 (the “Section 409A Benefits”), it is intended that the provisions of the Plan be construed in accordance with Code Section 409A, the Treasury regulations, and other guidance issued thereunder. With respect to benefits accrued and vested under the Plan on or before December 31, 2004 (the “Grandfathered Benefits”), it is intended that the general terms of the Plan in effect on October 3, 2004 shall govern such benefits, provided that such terms may be amended by this document to the extent that such amendment does not constitute a material modification under Code Section 409A. Unless otherwise specified, all provisions of the Plan shall apply to both Section 409A Benefits and Grandfathered Benefits.

1.4.       Purpose of Plan .  The purpose of the Plan is to provide certain supplemental retirement benefits to a select group of officers, management, and other highly compensated employees of the Sponsor and its Affiliated Companies as more fully provided herein.

1.5.       Effective Date and Term .  The Plan was established by the Board of Directors of the Sponsor effective as of July 27, 1989 and shall continue in effect until terminated by the Board of Directors.

1.6.       Participation .  Participation in the Plan shall be open to all Eligible Employees.

(a)       For purposes of the SRIP, “Eligible Employees” means employees of the Sponsor or any Affiliated Company whose benefits under the Pension Plan are limited by reason of Code Section 415 and who (i) are not classified or paid as independent contractors (regardless of their classification for federal tax or other legal purposes) by the Sponsor or an Affiliated Company, and (ii) do not perform services for the Sponsor or an Affiliated Company pursuant to an agreement between the Sponsor or an Affiliated Company and any other person including a leasing organization.

(b)       For purposes of the SEBP, “Eligible Employees” means employees of the Sponsor or any Affiliated Company whose benefits under the Pension Plan are limited by reason of the includible compensation limitation of Code Section 401(a)(17) and who (i) are not classified or paid as independent contractors (regardless of their classification for federal tax or other legal purposes) by the Sponsor or an Affiliated Company, and (ii)

 

- 1 -


do not perform services for the Sponsor or an Affiliated Company pursuant to an agreement between the Sponsor or an Affiliated Company and any other person including a leasing organization.

1.7.       Applicability of ERISA .

(a)       The SRIP is intended to be an unfunded “excess benefit plan” within the meaning of Section 4(b)(5) of ERISA.

(b)       The SEBP is intended to be a “top-hat” plan -- that is, an unfunded plan maintained primarily for the purpose of providing deferred compensation to a select group of management or highly compensated employees within the meaning of ERISA.

1.8.       Spin-Off of Advanced Medical Optics, Inc.   In connection with the distribution of the stock of Advanced Medical Optics, Inc. (“AMO”) by Allergan to its stockholders (the “AMO Spin-Off”) and, effective as of the AMO Spin-Off Date: (i) AMO Employees shall cease to be eligible to participate in the Plan and shall cease to accrue benefits under the Plan, and (ii) the assets attributable to, and the liabilities relating to, arising out of, or resulting from the benefits of AMO Employees shall remain with the Plan and shall be payable from the Plan to AMO Employees at such times and in such forms as permitted under the Plan. The “AMO Spin-Off Date” shall be June 29, 2002 and “AMO Employees” shall be those individuals whose employment is transferred from Allergan to AMO in connection with the AMO Spin-Off, as reflected in the payroll records of Allergan or in the Employee Matters Agreement entered into between Allergan and AMO.

ARTICLE II

DEFINITIONS

2.1.       Affiliated Company .  “Affiliated Company” means any affiliate of the Sponsor which has adopted the Pension Plan as provided therein.

2.2.       Board; Board of Directors .  “Board” and “Board of Directors” each mean the board of directors of the Sponsor.

2.3.       Code .  “Code” means the Internal Revenue Code of 1986, as amended.

2.4.       Committee .  “Committee” means the committee authorized to administer the Plan as set forth in Section 3.1 hereof.

2.5.       Effective Date .  “Effective Date” means July 27, 1989.

2.6.       ERISA .  “ERISA” means the Employee Retirement Income Security Act of 1974, as amended.

2.7.       Grandfathered Benefits .  “Grandfathered Benefits” means those benefits accrued and vested under the Plan on or before December 31, 2004, as provided in Section 1.3 hereof.

 

- 2 -


2.8.       Key Employee .  “Key Employee” means any Participant who is an officer or a Grade 11E Vice President of Sponsor or any Affiliated Company.

2.9.       Participant .  “Participant” means any Eligible Employee of the Sponsor or any Affiliated Company as defined under Section 1.6 hereof.

2.10.     Pension Plan .  “Pension Plan” means the Allergan, Inc. Pension Plan as it may be amended from time to time.

2.11.     Plan .  “Plan” means both the Allergan, Inc. Supplemental Retirement Income Plan and the Allergan, Inc. Supplemental Executive Benefit Plan as each is amended and restated herein and as each may be amended from time to time, unless otherwise specified herein to mean only one or the other.

2.12.     Section 409A Benefits .  “Section 409A Benefits” means those benefits accruing and/or vesting under the Plan after December 31, 2004, as provided in Section 1.3 hereof, and thus subject to Code Section 409A.

2.13.     Sponsor .  “Sponsor” means Allergan, Inc., a Delaware corporation.

2.14.     Termination .  “Termination” means the termination of a Participant’s employment with the Sponsor and any Affiliated Company for any reason whatsoever, whether voluntary or involuntary.

2.15.     Termination Date .  “Termination Date” means, with respect to any Participant, the effective date of such Participant’s Termination.

ARTICLE III

ADMINISTRATION OF THE PLAN

3.1.       Administration By Committee .  The Plan shall be administered by the same committee (the “Committee”) which is appointed to administer the Pension Plan. A member of the Committee may be a Participant in the Plan, provided, however, that any action to be taken by the Committee, solely with respect to the particular interest in the Plan of a Committee member who is also a Participant in the Plan shall be taken by the remaining members of the Committee.

3.2.       Committee Authority, Rules and Regulations .  The Committee shall have discretionary authority to (i) make, amend, interpret and enforce all appropriate rules and regulations for the administration of the Plan, (ii) decide or resolve any and all questions, including interpretations of the Plan, as may arise in connection with the Plan, and (iii) take or approve all such other actions relating to the Plan (other than amending the Plan, except as provided in Section 6.6, or terminating the Plan); provided, however, that the Board may, by written notice to the Committee, withdraw all or any part of the Committee’s authority at any time, in which case such withdrawn authority shall immediately revest in the Board. The decision or action of the Committee in respect of any question arising out of or in connection with the administration, interpretation and application of the Plan and the rules and regulations

 

- 3 -


promulgated hereunder shall be final, conclusive and binding upon all persons having any interest in the Plan.

3.3.       Appointment of Agents .  In the administration of the Plan, the Board and/or the Committee may from time to time employ agents (which may include officers and/or employees of the Sponsor or any Affiliated Company) and delegate to them such administrative duties as it sees fit and may from time to time consult with counsel who may be counsel to the Sponsor or any Affiliated Company.

3.4.       Application For Benefits .  The Committee may require any person claiming benefits under the Plan to submit an application therefor, together with such documents and information as the Committee may require. In the case of any person suffering from a disability which prevents such person from making personal application for benefits, the Committee may, in its discretion, permit application to be made by another person acting on his or her behalf. Notwithstanding the foregoing, if the Committee shall have all information necessary to determine the amount and form of Plan benefits payable to a Participant or Beneficiary who is entitled to benefit payments under the Plan (including, to the extent applicable and without limiting the generality of the foregoing, the name, age, sex and proper mailing address of all parties entitled to benefit payments), then the failure of a Participant or Beneficiary to file an application for benefits shall not cause the Committee to defer the commencement of benefit payments beyond the benefit commencement date required under the Plan.

3.5.       Claims Procedures .  If a person is required by the Committee to submit an application for benefits under Section 3.4 or if a Participant or her Beneficiary believes that he or she is being denied any rights or benefits under the Plan, the Participant, Beneficiary, or in either case, his or her authorized representative (the “Claimant”) shall follow the administrative procedures for filing a claim for benefits as set forth in this Section. An application for benefits or a claim for benefits shall be in writing and shall be reviewed by the Committee or a claims official designated by the Committee. The Committee or claims official shall review a claim for benefits in accordance with the procedures established by the Committee subject to the following administrative procedures set forth in this Section.

(a)       The Committee shall furnish the Claimant with written or electronic notice of the decision rendered with respect to a claim for benefits within 90 days following receipt by the Committee (or its delegate) of the claim unless the Committee determines that special circumstances require an extension of time for processing the claim. In the event an extension is necessary, written or electronic notice of the extension shall be furnished to the Claimant prior to the expiration of the initial 90 day period. The notice shall indicate the special circumstances requiring an extension of time and the date by which a final decision is expected to be rendered. In no event shall the period of the extension exceed 90 days from the end of the initial 90 day period.

(b)       In the case of a denial of the Claimant’s claim, the written or electronic notice of such denial shall set forth (i) the specific reasons for the denial, (ii) references to the Plan provisions upon which the denial is based, (iii) a description of any additional information or material necessary for perfection of the claim (together with an

 

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explanation why such material or information is necessary), (iv) an explanation of the Plan’s appeals procedures and, if applicable, (v) a statement of the Claimant’s right to bring a civil action under Section 502(a) of ERISA if his or her claim is denied upon appeal.

(c)       In the case of a denial of a claim, a Claimant who wishes to appeal the decision shall follow the administrative procedures for an appeal as set forth in Section 3.6 hereof.

3.6.       Appeals Procedures .  A Claimant who wishes to appeal the denial of his or her claim for benefits shall follow the administrative procedures for an appeal as set forth in this Section and shall exhaust such administrative procedures prior to seeking any other form of relief. Appeals shall be reviewed in accordance with the procedures established by the Committee subject to the following administrative procedures set forth in this Section.

(a)       In order to appeal a decision rendered with respect to his or her claim for benefits, a Claimant must file an appeal with the Committee in writing within 60 days following his or her receipt of the notice of denial with respect to the claim.

(b)       The Claimant’s appeal may include written comments, documents, records and other information relating to his or her claim. The Claimant may review all pertinent documents and, upon request, shall have reasonable access to or be provided free of charge, copies of all documents, records, and other information relevant to his or her claim.

(c)       The Committee shall provide a full and fair review of the appeal and shall take into account all claim related comments, documents, records, and other information submitted by the Claimant without regard to whether such information was submitted or considered under the initial determination or review of the initial determination. Where appropriate, the Committee will overturn a notice of denial if it determines that an error was made in the interpretation of the controlling plan documents or if the Committee determines that an existing interpretation of the controlling plan documents should be changed on a prospective basis. In the event the Claimant is a member of the Committee or, as determined by the Committee, the Claimant is a subordinate to a member of the Committee, such individual shall recuse himself or herself from the review of the appeal.

(d)       The Committee shall furnish the Claimant with written or electronic notice of the decision rendered with respect to an appeal within 60 days following receipt by the Committee of the appeal unless the Committee determines that special circumstances require an extension of time for processing the appeal. In the event an extension is necessary, written or electronic notice of the extension shall be furnished to the Claimant prior to the expiration of the initial 60 day period. The notice shall indicate the special circumstances requiring an extension of time and the date by which a final decision is expected to be rendered. In no event shall the period of the extension exceed 60 days from the end of the initial 60 day period.

 

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(e)       In the case of a denial of an appeal, the written or electronic notice of such denial shall set forth (i) the specific reasons for the denial, (ii) references to the Plan provisions upon which the denial is based, (iii) a statement that the Claimant is entitled to receive, upon request and free of charge, reasonable access to, and copies of, all documents, records, and other information relating to his or her claim for benefits and, if applicable, (iv) a statement of the Claimant’s right to bring a civil action under Section 502(a) of ERISA.

ARTICLE IV

BENEFITS

4.1.       Determination of Benefits .

(a)       For the SRIP, except as provided in Article V hereof, the supplemental retirement benefit payable to any Participant under the Plan shall be determined as of such Participant’s Termination Date and shall be an amount equal to the excess (if any) of (i) the retirement benefit to which such Participant would be entitled under the Pension Plan if his or her retirement benefit under the Pension Plan were determined without regard to the limits imposed by Code Section 415 over (ii) the retirement benefit to which such Participant is actually entitled under the Pension Plan.

(b)       For the SEBP, except as provided in Article V hereof, the supplemental retirement benefit payable to any Participant under the Plan shall be determined as of such Participant’s Termination Date and shall be an amount equal to the excess (if any) of (i) the retirement benefit to which such Participant would be entitled under the Pension Plan if his or her retirement benefit under the Pension Plan were determined without regard to the limits imposed by Code Sections 401(a)(17) and/or 415, over (ii) the retirement benefit to which such Participant would be entitled under the Pension Plan if his or her benefit under the Pension Plan were determined without regard to the limits imposed by Code Section 415.

Benefits under the Plan shall be calculated by including any additional service credit a Participant may be awarded in a separate written agreement between the Participant and the Sponsor.

4.2.       Time and Form of Benefit Payments for Grandfathered Benefits .  Except as provided in Article V hereof or as provided in Section 4.5 hereof, a Participant’s Grandfathered Benefits under this Plan as determined pursuant to Section 4.1 hereof shall be paid to the Participant in the same form and at the same time, and shall be calculated under the same actuarial assumptions, as the Participant’s benefits under the Pension Plan. For example, if a Participant were entitled to monthly benefit payments under the Pension Plan, the Participant’s benefit under this Plan would also be paid on a monthly basis at the same time as the monthly benefit payments under the Pension Plan, and in the amount as determined under Section 4.1. Notwithstanding the foregoing, if the level income payment option is elected for an annuity under the Pension Plan, a Participant’s Grandfathered Benefits will be payable in the form of annuity selected under the Pension Plan, but disregarding the level income payment option.

 

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4.3.       Time of Benefit Payments for Section 409A Benefits .  Except as provided in Article V hereof or as provided in Sections 4.5, 4.6, 4.7, and 4.8 hereof, a Participant’s Section 409A Benefits under the Plan as determined pursuant to Section 4.1 hereof shall commence as of the later of: (i) the first day of the month coincident with or next following the Participant’s attainment of age 55; or (ii) the first day of the month coincident with or next following the Participant’s Termination Date. Payments that are scheduled to be made on the first day of the month may be delayed (but not more than sixty (60) days) in order to process payment.

4.4.       Form of Benefit Payments for Section 409A Benefits .  Except as provided in Article V hereof or as provided in Sections 4.5, 4.6, or 4.7 hereof, a Participant’s Section 409A Benefits under the Plan shall be paid as a 50% Joint and Survivor Annuity. Prior to the start of benefit payment, a Participant may elect an alternative form of life annuity permitted by the Sponsor, provided that such alternative form is actuarially equivalent to the 50% Joint and Survivor Annuity applying reasonable actuarial methods and assumptions. A single election shall be made solely for purposes of the SRIP and the SEBP, and shall govern payment of Section 409A Benefits payments made under each Plan (i.e., the SRIP and the SEBP shall have the same form of life annuity). To the extent that payment of Section 409A Benefits under the SRIP and the SEBP and payment under the Pension Plan commence at the same time, the election of a form of life annuity (but not an election of the level income payment option) under the Pension Plan shall apply for payment of Section 409A Benefits under the Plans.

4.5.       Small Benefit Payments .  Effective January 1, 2009, notwithstanding any other provision of the Plan, if the lump sum Actuarial Equivalent (as defined in the Pension Plan) of a Participant’s combined benefit under both the SRIP and SEBP at the start of payment does not exceed the applicable dollar limit under Code Section 402(g)(1)(B) for the calendar year of payment (for 2008, $15,500), the Participant’s entire combined benefit under both plans shall be paid in a single lump sum payment as soon as administratively practicable to such Participant following his or her Termination Date (and no later than two and a half months after the calendar year of the Termination Date) or to the Participant’s spouse or Beneficiary (as defined in Section 6.1) as soon as administratively practicable following the Participant’s death (and no later than two and a half months after the calendar year of the death).

4.6.       Transition Elections for Section 409A Benefits .

(a)       Notwithstanding the provisions of Sections 4.3 and 4.4 hereof, for Section 409A Benefits commenced on or prior to December 31, 2008, time and form of a Participant’s benefit payment under the Plan shall continue to follow the Participant’s payment election made prior to December 31, 2008 under the Pension Plan.

(b)       Notwithstanding the provisions of Sections 4.3, 4.4, or 4.6(a) hereof, to the extent permitted by the Sponsor, a Participant may elect on or before December 31, 2008 the time of payment of Section 409A Benefits in accordance with procedures set by the Sponsor, provided that such election applies only to amounts that would not otherwise be payable in the year of the election and does not cause an amount to be paid in the year of the election that would not otherwise be payable in such year.

 

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4.7.       Second Elections for Time of Section 409A Benefits .  Effective January 1, 2009, notwithstanding the provisions of Sections 4.3, 4.4, or 4.6 hereof, to the extent permitted and in accordance with procedures established by the Sponsor, a Participant may elect to change the time that payment of Section 409A Benefits under the Plan shall commence, subject to the following requirements:

(a)       the new election may not take effect until at least 12 months after the date on which the new election is made;

(b)       the new election must defer payments for at least 5 years from the date of attaining age 55 and/or from the date of termination (i.e., a Participant may elect to change to either (i) the later of age 60 (or later) or termination of employment, (ii) the later of age 55 or 5 years (or later) after termination of employment, or (iii) the later of age 60 (or later) or 5 years (or later) after termination of employment);

(c)       if the new election defers payment from the date of attaining age 55, the new election must be made at least 12 months prior to Participant attaining age 55 (however a new election to defer payment to 5 years after termination may be made even after 12 months prior to age 55); and

(d)       a Participant may make a second election only once.

For purposes of this Section 4.7, entitlement to an annuity is treated as entitlement to a single payment.

4.8.       Delay for Key Employees for Section 409A Benefits .  Notwithstanding any other provision of this Article IV, in the case of a Participant who is a “Key Employee,” payment of Section 409A Benefits upon termination of employment shall (i) commence no earlier than (i) the first business day after six (6) months following the Participant’s Termination Date, or (ii) the death of the Participant, whichever occurs first, and (ii) any payments to which the Participant would have been entitled to during the six-month delay shall be paid on the first business day of the seventh month.

ARTICLE V

CHANGE IN CONTROL

5.1.        Effect of a Change in Control .  Notwithstanding the provisions of Article IV hereof and subject to Section 5.5 hereof, in the event that a Change In Control (as defined in Section 5.4 hereof) occurs on or after the Effective Date hereof, each Participant shall receive a “Lump Sum Benefit” in lieu of any benefits under the Plan to which such Participant is or would otherwise become entitled and which have not already been paid as of the date such Change In Control occurs (the “Change In Control Date”), with such Lump Sum Benefit to be paid as provided in Section 5.2 hereof in the amount calculated as provided in Section 5.3 hereof.

5.2.        Payment of Lump Sum Benefit .  Subject to Section 5.5 hereof, the Lump Sum Benefit payable to any Participant under Section 5.1 hereof shall be paid to such Participant within 30 days following such Participant’s Determination Date. As used herein, a Participant’s

 

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“Determination Date” shall be the later of the Change In Control Date or such Participant’s Termination Date.

5.3.       Amount of Lump Sum Benefit .  Subject to Section 5.5 hereof, the amount of the Lump Sum Benefit payable to any Participant pursuant to Section 5.1 hereof shall be the amount equal to the lump sum actuarial equivalent, determined as of such Participant’s Determination Date, of the unpaid Plan benefits to which such Participant is entitled under Article IV hereof, provided, however, that in determining the lump sum actuarial equivalent of such Participant’s unpaid Plan benefits, the following special rules shall apply:

(a)       The interest/discount rate assumed shall be 3.6 percent (3.6%);

(b)       The mortality table used shall be the same as the mortality table used for purposes of determining the Sponsor’s minimum funding obligation under ERISA with respect to the Pension Plan for the plan year preceding the plan year in which the Participant’s Determination Date falls; and

(c)       In the case of a Participant who has not commenced receiving Plan benefits, it shall be assumed that the Participant would commence receiving benefit payments under the Pension Plan and under Article IV of the Plan as of the date which is the later of (i) such Participant’s Termination Date or (ii) the earliest date such Participant would be eligible to commence receiving Plan benefits.

5.4.       Change in Control .  As used in the Plan, “Change in Control” shall mean the following and shall be deemed to occur if any of the following events occur:

(a)       Any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (a “Person”), is or becomes the “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act (a “Beneficial Owner”), directly or indirectly, of securities of the Sponsor representing (i) 20% or more of the combined voting power of the Sponsor’s then outstanding voting securities, which acquisition is not approved in advance of the acquisition or within 30 days after the acquisition by a majority of the Incumbent Board (as hereinafter defined) or (ii) 33% or more of the combined voting power of the Sponsor’s then outstanding voting securities, without regard to whether such acquisition is approved by the Incumbent Board;

(b)       Individuals who, as of the date hereof, constitute the Board of Directors (the “Incumbent Board”), cease for any reason to constitute at least a majority of the Board of Directors, provided that any person becoming a director subsequent to the date hereof whose election, or nomination for election by the Sponsor’s stockholders, is approved by a vote of at least a majority of the directors then comprising the Incumbent Board (other than an election or nomination of an individual whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of the directors of the Sponsor, as such terms are used in Rule 14a-11 of Regulation 14A promulgated under the Exchange Act) shall, for the purposes of the Plan, be considered as though such person were a member of the Incumbent Board of the Sponsor;

 

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(c)       The consummation of a merger, consolidation or reorganization involving the Sponsor, other than one which satisfies both of the following conditions:

  (i)        a merger, consolidation or reorganization which would result in the voting securities of the Sponsor outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of another entity) at least 55% of the combined voting power of the voting securities of the Sponsor or such other entity resulting from the merger, consolidation or reorganization (the “Surviving Corporation”) outstanding immediately after such merger, consolidation or reorganization and being held in substantially the same proportion as the ownership in the Sponsor’s voting securities immediately before such merger, consolidation or reorganization, and

  (ii)        a merger, consolidation or reorganization in which no Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Sponsor representing 20% or more of the combined voting power of the Sponsor’s then outstanding voting securities; or

(d)       The stockholders of the Sponsor approve a plan of complete liquidation of the Sponsor or an agreement for the sale or other disposition by the Sponsor of all or substantially all of the Sponsor’s assets.

Notwithstanding the preceding provisions of this Section 5.4, a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this Section 5.4 is (i) an underwriter or underwriting syndicate that has acquired any of the Sponsor’s then outstanding voting securities solely in connection with a public offering of the Sponsor’s securities, (ii) the Sponsor or any subsidiary of the Sponsor or (iii) an employee stock ownership plan or other employee benefit plan maintained by the Sponsor (or any of its subsidiaries) that is qualified under the provisions of the Code. In addition, notwithstanding the preceding provisions of this Section 5.4, a Change in Control shall not be deemed to have occurred, (i) if the Person described in the preceding provisions of this Section 5.4 becomes a Beneficial Owner of more than the permitted amount of outstanding securities as a result of the acquisition of voting securities by the Sponsor which, by reducing the number of voting securities outstanding, increases the proportional number of shares beneficially owned by such Person, provided, that if a Change in Control would occur but for the operation of this sentence and such Person becomes the Beneficial Owner of any additional voting securities (other than through the exercise of options granted under any stock option plan of the Sponsor or through a stock dividend or stock split), then a Change in Control shall occur, and (ii) upon the distribution of the stock of Advanced Medical Optics, Inc. on June 29, 2002 by the Sponsor to its stockholders.

5.5.       Limitation to Section 409A Change in Control .  Upon a Change in Control, to the extent that the Change in Control does not also qualify as a Section 409A Change in Control, as defined in Section 5.6 below, Sections 5.1 thru 5.3 shall not apply to any Section 409A Benefits (but shall apply to Grandfathered Benefits), and the provisions of Article IV shall continue to govern the payment of such Section 409A Benefits. If the Change in Control qualifies as a Section 409A Change in Control, Section 409A Benefits shall be paid as provided

 

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in Sections 5.1 thru 5.3, provided that, in the case of a Participant who is still employed when the Change in Control occurs, the Participant’s Termination Date is within two years after the Change in Control, and provided that any amount attributable to Section 409A Benefits that are otherwise to be paid upon Key Employee’s Termination Date (as opposed to upon the Change in Control for Participants who have already terminated prior to the Change in Control) shall be delayed pursuant to Section 4.8.

5.6.       Section 409A Change in Control Defined .  As used in this Plan, “ Section 409A Change in Control” shall mean the following and shall be deemed to occur if any of the following events occur:

(a)       Any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (a “Person”) or “Group” (within the meaning of Rule 13d-5 of the Exchange Act and Treas. Reg. § 1.409A-3(i)(5)(B)), is or becomes the “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act (a “Beneficial Owner”), directly or indirectly, of securities of the Sponsor representing 30% or more of the combined voting power of the Sponsor’s then outstanding voting securities, by acquisition or through merger, consolidation, or reorganization;

(b)       Individuals who, at the beginning of any 12 month period, constitute the Board of Directors (the “Incumbent Board”), cease for any reason to constitute at least a majority of the Board of Directors, provided that any person becoming a director subsequent to the date hereof whose election, or nomination for election by the Sponsor’s stockholders, is approved by a vote of at least a majority of the directors shall, for the purposes of this Plan, be considered as though such person were a member of the Incumbent Board of the Sponsor (provided that this paragraph (b) does not apply if a majority shareholder of the Sponsor is another corporation); or

(c)       The consummation of sale or other disposition by the Sponsor of all or substantially all of the Sponsor’s assets based on the total gross fair market value of the Sponsor’s assets (and assuming that “substantially all” means in excess of 80%) to a Person or Group (each as defined in paragraph (a)) within a 12 month period ending on the then most recent acquisition of assets. For this purpose, “gross fair market value” means the value of the assets of the Sponsor, or the value of the assets being disposed of, determined without regard to any liabilities associated with such assets. There is no Change in Control event under this paragraph (c) when there is a transfer to (i) a shareholder of the Sponsor (immediately before the asset transfer) in exchange for or with respect to such shareholder’s stock; (ii) an entity, 50% or more of the total value or voting power of which is owned, directly or indirectly, by the Sponsor; (iii) a person, or more than one person acting as a Group, that owns, directly or indirectly, 50% or more of the total value or voting power of all the outstanding stock of the Sponsor; or (iv) an entity, at least 50% of the total value or voting power of which is owned, directly or indirectly, by a person described in clause (iii).

Notwithstanding the preceding provisions of this Section 5.6, a Section 409A Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions

 

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of this Section 5.6 is (1) an underwriter or underwriting syndicate that has acquired the ownership of any of the Sponsor’s then outstanding voting securities solely in connection with a public offering of the Sponsor’s securities, (2) the Sponsor or any subsidiary of the Sponsor or (3) to the extent permitted by Code Section 409A, an employee stock ownership plan or other employee benefit plan maintained by the Sponsor (or any of its subsidiaries) that is qualified under the provisions of the Code. In addition, no Section 409A Change in Control shall have occurred unless the transaction or series of transactions results in a Section 409A Change in Control within the meaning of Code Section 409A and the regulations thereunder. This Section 409A Change in Control definition shall be interpreted in a manner that is consistent with Code Section 409A and the regulations thereunder, including with respect to any applicable limitations on the kinds of events that would constitute a Section 409A Change in Control.

ARTICLE V

MISCELLANEOUS PROVISIONS

6.1.       Designated Beneficiary .  A Participant shall be entitled to designate one or more individuals or entities, in any combination, as his “Beneficiary” or “Beneficiaries” to receive any Plan payments to which such Participant is entitled as of, or by reason of, his death. Any such designation may be made or changed at any time prior to the Participant’s death by written notice filed with the Committee, with such written notice to be in such form and contain such information as the Committee may from time to time determine. In the event that either (a) a Beneficiary designation is not on file at the date of a Participant’s death, (b) no Beneficiary survives the Participant or (c) no Beneficiary is living at the time any payment becomes payable under the Plan, then, for purposes of making any further payment of any unpaid benefits under the Plan, such Participant’s Beneficiary or Beneficiaries shall be deemed to be the person or persons entitled to receive the Participant’s survivor and death benefits under the Pension Plan.

6.2.       Payments During Incapacity .  In the event a Participant (or Beneficiary) is under mental or physical incapacity at the time of any payment to be made to such Participant (or Beneficiary) pursuant to the Plan, any such payment may be made to the conservator or other legally appointed personal representative having authority over and responsibility for the person or estate of such Participant (or Beneficiary), as the case may be, and for purposes of such payment references in the Plan to the Participant (or Beneficiary) shall mean and refer to such conservator or other personal representative, whichever is applicable. In the absence of any lawfully appointed conservator or other personal representative of the person or estate of the Participant (or Beneficiary), any such payment may be made to any person or institution that has apparent responsibility for the person and/or estate of the Participant (or Beneficiary) as determined by the Committee. Any payment made in accordance with the provisions of this Section 6.2 to a person or institution other than the Participant (or Beneficiary) shall be deemed for all purposes of the Plan as the equivalent of a payment to such Participant (or Beneficiary), and neither the Sponsor nor any Affiliated Company shall have any further obligation or responsibility with respect to such payment.

6.3.       Domestic Relations Orders .  Notwithstanding any provision in the Plan to the contrary and subject to the approval of the Committee, in the event all or portion of a Participant’s benefit is awarded to an individual (hereinafter referred to as the “alternate payee”)

 

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pursuant to a domestic relations order entered by a court in settlement of marital property rights (hereinafter referred to as a “DRO”), the awarded benefit shall be treated as a Grandfathered Benefit and shall be distributed in accordance with the alternate payee’s distribution election under the Pension Plan. It is intended that a DRO shall be approved by the Committee only if it meets the applicable requirements of a “qualified domestic relations order” as defined in Code Section 414(p).

6.4.       Prohibition Against Assignment .  Except as otherwise expressly provided in Section 6.1 and Section 6.2 hereof, the rights, interests and benefits of a Participant under the Plan (i) may not be sold, assigned, transferred, pledged, hypothecated, gifted, bequeathed or otherwise disposed of to any other party by such Participant or any Beneficiary, executor, administrator, heir, distributee or other person claiming under such Participant, and (ii) shall not be subject to execution, attachment or similar process. Any attempted sale, assignment, transfer, pledge, hypothecation, gift, bequest or other disposition of such rights, interests or benefits contrary to the foregoing provisions of this Section 6.3 shall be null and void and without effect.

6.5.       Binding Effect .  The provisions of the Plan shall be binding upon the Sponsor, each Affiliated Companies, the Participants and any successor-in-interest to the Sponsor, any Affiliated Company or any Participant.

6.6.       No Transfer of Interest .  Benefits under the Plan shall be payable solely from the general assets of the Sponsor and no person shall be entitled to look to any source for payment of such benefits other than the general assets of the Sponsor. The Sponsor shall have and possess all title to, and beneficial interest in, any and all funds or reserves maintained or held by the Sponsor on account of any obligation to pay benefits as required under the Plan, whether or not earmarked by the Sponsor as a fund or reserve for such purpose; any such funds, other property or reserves shall be subject to the claims of the creditors of the Sponsor, and the provisions of the Plan are not intended to create, and shall not be interpreted as vesting, in any Participant, Beneficiary or other person, any right to or beneficial interest in any such funds, other property or reserves. Nothing in this Section 6.5 shall be construed or interpreted as prohibiting or restricting the establishment of a grantor trust within the meaning of Code Section 671 which is unfunded for purposes of Sections 4(b)(5), 201(2), 301(a)(3) and 401(a)(1) of ERISA, from which benefits under the Plan may be payable.

6.7.       Amendment or Termination of the Plan .  The Sponsor, by action of its Board of Directors, may amend the Plan from time to time in any respect that it deems appropriate or desirable, and may terminate the Plan at any time, subject to the following provisions:

(a)       Any such Plan amendment or Plan termination shall not, without a Participant’s written consent, be given effect with respect to such Participant to the extent such Plan amendment or Plan termination operates to reduce or eliminate, in any material respect, such Participant’s accrued Plan benefit. For purposes of the preceding sentence, the determination as to whether any Plan amendment or Plan termination operates to reduce or eliminate, in any material respect, a Participant’s accrued Plan benefit shall be made at the time of, and not until, such Participant’s Termination.

 

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(b)       An amendment or termination of the Plan shall be treated as reducing or eliminating a Participant’s accrued Plan benefit only if, and to the extent that, (i) the benefit (expressed as a single life annuity payable monthly) to which such Participant is actually entitled under the Pension Plan upon his or her Termination, is less than (ii) such Participant’s “accrued benefit” under the Pension Plan as of the effective date of such Plan amendment or Plan termination (expressed as a single life annuity payable monthly), with such “accrued benefit” to be determined (A) as if such Participant incurred a Termination on the effective date of such Plan amendment or Plan termination and (B) without regard to the limits imposed by Code Sections 415 or 401(a)(17).

The Committee shall have the right to amend the Plan, subject to paragraphs (a) and (b) hereof, to make administrative amendments to the Plan that do not cause a substantial increase or decrease in benefits to Participants and that do not cause a substantial increase in the cost of administering the Plan.

6.8.       No Right to Employment .  The Plan is voluntary on the part of the Sponsor and each Affiliated Company, and the Plan shall not be deemed to constitute an employment contract between the Sponsor or any Affiliated Company and any Participant, nor shall the adoption or existence of the Plan or any provision contained in the Plan be deemed to be a required condition of the employment of any Participant. Nothing contained in the Plan shall be deemed to give any Participant the right to continued employment with the Sponsor or any Affiliated Company, and the Sponsor and each Affiliated Company may terminate any Participant who is in its employ at any time, in which case the Participant’s rights arising under the Plan shall be only those expressly provided under the terms of the Plan.

6.9.       Notices .  All notices, requests, or other communications (hereinafter collectively referred to as “Notices”) required or permitted to be given hereunder or which are given with respect to the Plan shall be in writing and may be personally delivered, or may be deposited in the United States mail, postage prepaid and addressed as follows:

 

To the Sponsor    Allergan, Inc.
or the Committee at:        Attention:        Global Investments & Benefits Subcommittee
          (Supplemental Executive Retirement Plan)
   2525 Dupont Drive
   Irvine, CA 92612
   cc: General Counsel
To Participant at:    The Participant’s residential mailing address as reflected in the Sponsor’s or Affiliated Company’s employment records

A Notice which is delivered personally shall be deemed given as of the date of personal delivery, and a Notice mailed as provided herein shall be deemed given on the second business day following the date so mailed. Any Participant may change his or her address for purposes of Notices hereunder pursuant to a Notice to the Committee, given as provided herein, advising the Committee of such change. The Sponsor, the Committee and/or any Affiliated Company may at

 

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any time change its address for purposes of Notices hereunder pursuant to a Notice to all affected Participants, given as provided herein, advising the affected Participants of such change.

6.10.       Governing Law .  The Plan shall be governed by, interpreted under, and construed and enforced in accordance with the internal laws, and not the laws pertaining to conflicts or choice of laws, of the State of California applicable to agreements made and to be performed wholly within the State of California.

6.11.       Titles and Headings: Gender of Term .  Article and Section headings herein are for reference purposes only and shall not be deemed to be part of the substance of the Plan or in any way to enlarge or limit the meaning or interpretation of any provision in the Plan. Use in the Plan of the masculine, feminine or neuter gender shall be deemed to include each of the omitted genders if the context so requires.

6.12.       Severability .  In the event that any provision of the Plan is found to be invalid or otherwise unenforceable by a court or other tribunal of competent jurisdiction, such invalidity or unenforceability shall not be construed as rendering any other provision contained herein invalid or unenforceable, and all such other provisions shall be given full force and effect to the same extent as though the invalid and unenforceable provision was not contained herein.

6.13.       Tax Effect of Plan .  Neither the Sponsor nor any Affiliated Company warrants any tax benefit nor any financial benefit under the Plan. Without limiting the foregoing, the Sponsor, all Affiliated Companies and their directors, officers, employees and agents shall be held harmless by the Participant from, and shall not be subject to any liability on account of, any Federal or State tax consequences or any consequences under ERISA of any determination as to the amount of Plan benefits to be paid, the method by which Plan benefits are paid, the persons to whom Plan benefits are paid, or the commencement or termination of the payment of Plan benefits.

IN WITNESS WHEREOF, the Sponsor hereby executes this instrument, evidencing the terms of the Plan as amended and restated this 19 th day of December , 2008.

 

ALLERGAN, INC.
By:     /s/ Douglas S. Ingram  
  Douglas S. Ingram
  Executive Vice President, Chief Administrative Officer, General Counsel and Secretary

 

- 15 -

EXHIBIT 10.21

2009 PERFORMANCE OBJECTIVES – CEO AND PRESIDENT

 

 

TARGET BONUS AS A PERCENTAGE OF BASE SALARY

The 2009 target bonus for the Chief Executive Officer (“ CEO ”) of Allergan, Inc. (the “ Company ”) will be an amount equal to 120% of the CEO’s annual base salary as of the last day of the 2009 fiscal year. The 2009 target bonus for the President of the Company (“ President ”) will be an amount equal to 70% of the President’s annual base salary as of the last day of the 2009 fiscal year. The 2009 target bonus amounts for the CEO and the President are referred to herein individually as a “ Target Bonus Amount ” and collectively as the “ Target Bonus Amounts .”

 

 

2009 PERFORMANCE OBJECTIVES AND BONUS AMOUNT DETERMINATION

If the Company’s 2009 Adjusted EPS is greater than the Threshold EPS, the CEO and President will be eligible to receive a bonus based on the following three criteria: (i) 2009 Adjusted EPS, (ii) 2009 Revenue Growth and (iii) 2009 R&D Reinvestment Rate. The bonus (if any) payable will be an amount determined by multiplying (i) the Target Bonus Amount by (ii) the Target Bonus Multiplier. In no event, however, will the CEO or President be eligible to receive all or any portion of such bonus if the Company’s 2009 Adjusted EPS does not exceed the Threshold EPS. For sake of clarity, if the Company’s performance exceeds any of the targets for 2009 Revenue Growth and/or 2009 R&D Reinvestment Rate, but actual 2009 Adjusted EPS does not exceed the Threshold EPS, no bonus will be payable. Payment of the CEO’s and President’s 2009 performance bonus (if any) will be made in accordance with, and subject to, the terms of the Allergan, Inc. 2006 Executive Bonus Plan, as in effect on the date hereof (the “ Plan ”), including, without limitation, the provisions of Sections 2.4, 3.3 and 6.3 of the Plan.

For purposes of determining the CEO’s and President’s 2009 performance bonus, the following terms will have the following meanings:

2009 Adjusted EPS ” means the Company’s 2009 Adjusted Net Earnings divided by the weighted average number of common shares outstanding on a diluted basis during 2009, rounded to the fourth decimal place.

2009 Adjusted Net Earnings ” means the Company’s net earnings from continuing operations for the 2009 fiscal year, adjusted to:

 

   

remove the effects of extraordinary, unusual or non-recurring items;

 

   

remove the effects of items that are outside the scope of the Company’s core, on-going business activities;

 

   

remove the effects of accounting changes required by United States generally accepted accounting principles;

 

   

remove the effects of financing activities;

 

   

remove the effects of expenses for restructuring or productivity initiatives;

 

   

remove the effects of non-operating items;

 

   

remove the effects of spending for acquisitions;

 

   

remove the effects of divestitures; and

 

   

remove the effects of amortization of acquired intangible assets.

 

 

 

1


2009 PERFORMANCE OBJECTIVES

ALLERGAN, INC.

 

 

2009 Revenue Growth ” means the percentage increase (if any) in net product sales for the 2009 fiscal year relative to net product sales for the 2008 fiscal year, adjusted for the translation effect of changes in foreign exchange rates between each fiscal year, rounded to the nearest one-hundredth of one percent.

2009 R&D Reinvestment Rate ” means total research and development expenses for the 2009 fiscal year as a percentage of the Company’s total net sales, for the 2009 fiscal year, rounded to the nearest one-hundredth of one percent.

EPS Target ” means an amount per share specified by the Organization and Compensation Committee at the time of adoption of these performance objectives.

Target Bonus Multiplier ” means the sum of the “% of Target Bonus Amount” corresponding to: (a) the Company’s 2009 Adjusted EPS, (b) the Company’s 2009 Revenue Growth, and (c) the Company’s 2009 R&D Reinvestment Rate, in each case as determined in accordance with the tables set forth on Exhibit A .

Threshold EPS ” means the EPS Target, less $0.15.

 

 

2009 METHOD OF BONUS PAYMENT

Bonuses will be paid in cash up to a maximum bonus pool equal to 100% of Plan participants’ bonus targets. Bonuses will be paid in restricted stock or restricted stock units to the extent the bonus pool exceeds 100% of Plan participants’ bonus targets. Such restricted stock or restricted stock units will provide for cliff vesting two years from the award effective date. Any payment in the form of restricted stock or restricted stock units will be issued under the Company’s 2008 Incentive Award Plan. Upon a recipient’s death or Total Disability (as defined below), or upon a recipient’s Normal Retirement Eligibility Date (as defined below), all of the restrictions imposed on the recipient’s restricted stock or restricted stock units shall lapse. Total Disability shall be defined as the inability of a recipient, by reason of mental or physical illness or accident, to perform any and every duty of the occupation at which such recipient was employed when such disability commenced, which disability is expected to continue for a period of at least 12 months. A recipient’s Normal Retirement Eligibility Date shall be defined as the date on which the recipient has (i) attained age 55 and (ii) been employed by the Company for a minimum of 5 years.

 

 

 

2


2009 PERFORMANCE OBJECTIVES

ALLERGAN, INC.

 

 

EXHIBIT A

TO

2009 PERFORMANCE OBJECTIVES – CEO AND PRESIDENT

2009 ADJUSTED EPS, 2009 REVENUE GROWTH AND

2009 R&D REINVESTMENT RATE PERFORMANCE

 

2009 EPS
Range %

  

2009 Adjusted
EPS Range $

   % of Target
Bonus
Amount
  2009
Revenue
Growth
  % of
Target
Bonus
Amount
  2009 R&D
Reinvestment
Rate
  % of Target
Bonus

Amount

-5.5%

   EPS Target - $0.150    0.0%        

-2.9%

   EPS Target - $0.080    50.0%   -0.2%   0.0%   15.55%   0.0%

-2.5%

   EPS Target - $0.070    62.5%   0.8%   2.0%   15.80%   2.0%

-1.6%

   EPS Target - $0.045    75.0%   1.8%   4.0%   16.05%   4.0%

-1.3%

   EPS Target - $0.035    80.0%   2.8%   6.0%   16.30%   6.0%

-0.7%

   EPS Target - $0.020    85.0%   3.8%   8.0%   16.55%   8.0%

EPS Target

   EPS Target    90.0%   4.8%   10.0%   16.80%   10.0%

1.1%

   EPS Target + $0.030    95.0%   5.8%   13.8%   17.05%   13.8%

2.2%

   EPS Target + $0.060    100.0%   6.8%   17.5%   17.30%   17.5%

2.9%

   EPS Target + $0.080    105.0%   7.8%   21.3%   17.55%   21.3%

3.6%

   EPS Target + $0.100    110.0%   8.8%   25.0%   17.80%   25.0%

If the Company’s performance exceeds the highest performance level shown above for one or more of the specified performance measures ( i.e. , 2009 Adjusted EPS, 2009 Revenue Growth, and 2009 R&D Reinvestment Rate), the “% of Target Bonus Amount” achieved with respect to that performance measure will be the maximum “% of Target Bonus Amount” specified for that performance measure. For example, if 2009 Adjusted EPS equals EPS Target + $0.11, the “% of Target Bonus Amount” will nonetheless be 110% for that performance measure.

 

 

 

3


2009 PERFORMANCE OBJECTIVES

ALLERGAN, INC.

 

 

If actual results for any one or more of the performance measures falls between the performance levels shown above, the bonus will be prorated accordingly.

Each component of the Target Bonus Multiplier will be determined independently of each other component of the Target Bonus Multiplier; provided that no bonus will be payable in the event the Company’s 2009 Adjusted EPS does not exceed the Threshold EPS.

 

 

4

EXHIBIT 10.22

 

ALLERGAN

2009

MANAGEMENT BONUS PLAN


 

PURPOSE OF THE PLAN

The Allergan, Inc. 2009 Management Bonus Plan (the “Plan”) is designed to reward eligible management-level employees for their contributions to providing Allergan’s stockholders increased value for their investment through the successful accomplishment of specific financial objectives and individual performance objectives.

 

 

PLAN YEAR

The Plan year runs from January 1, 2009 through December 31, 2009.

 

 

ELIGIBILITY

All regular full-time and part-time employees of Allergan, Inc. and its subsidiaries (the “Company”) scheduled to work 20 or more hours per week in salary grades 7E and above who are not covered by any other bonus or sales incentive plan, unless otherwise provided in a written agreement between the Company and a Plan participant, are eligible to participate in the Plan. Notwithstanding anything in this Plan to the contrary, any individual who (a) performs services for the Company and is classified or paid as an independent contractor (regardless of his or her classification for federal tax or other legal purposes) by the Company or (b) performs services for the Company pursuant to an agreement between the Company and any other person (e.g. a leasing organization) shall not be eligible to participate in the Plan. In addition, in order to be eligible to receive a bonus, participants must be employed by the Company on or before June 30, 2009 and must be actively employed by the Company on the date bonuses are paid. Participants who resign or are terminated for reasons other than those noted below will receive no bonus.

Bonuses, if any, for participants who become eligible after the beginning of the plan year, retire (“normal retirement” is defined as termination of employment after the Plan participant has attained age 55, provided that such participant has been employed by the Company for a minimum of 5 years), become disabled, die or transfer into a position covered by another incentive plan will be prorated, except in cases of normal retirement and termination (a) by mutual agreement, (b) during counseling review, (c) after counseling review or (d) for serious misconduct. In such cases, participants will receive no bonus. Bonuses, if any, for participants who are laid-off will be prorated provided the participant was eligible for at least six months of the Plan year. All proration will be based on the number of months of participation in the Plan during the Plan year.

 

 

PERFORMANCE OBJECTIVES

Bonuses for Plan participants are based on both corporate performance and individual performance in relation to pre-established objectives, as follows:

CORPORATE OBJECTIVES

 

  ¿  

Earnings Per Share (“EPS”) —EPS is defined as adjusted net earnings from continuing operations as measured by Wall Street divided by the weighted average number of common and common equivalent shares on a diluted basis.

 

  ¿  

Revenue Growth in Local Currency —Net sales stated in constant local currency compared to the prior year. Specifically defined as the percentage change in annual net sales in constant local currency from the previous fiscal year end to the current fiscal year end (“Revenue Growth”). The purpose of net sales stated in constant local currency is to remove any impact on net sales growth from changes in currency exchange rates from year to year.

 

 

 

09 MBP Page -1-


  ¿  

Research and Development (“R&D”) Reinvestment Rate —R&D expense as a percentage of revenue. Specifically defined as the total annual R&D expense as a percentage of annual net sales as of the current fiscal year end.

 

  ¿  

Operating Income —Operating Income compared to budget may be considered for allocation of bonus pools by Business Unit/Function. Operating Income is defined as Net Sales minus Cost of Goods minus Selling and General Administrative expenses minus Research & Development minus allocated corporate interest where applicable.

INDIVIDUAL OBJECTIVES

Management Bonus Objectives (“MBOs”) are prepared by each participant and his or her supervisor at the beginning of the Plan year and may be modified throughout the year as necessary. Objectives should reflect major results and accomplishments to be achieved in order to meet short and long-term business goals that contribute to increased stockholder value. MBOs are expressed as specific, quantifiable measures of performance in relation to key operating decisions for the participant’s business unit, such as managing inventory levels, receivables, expenses, payables, increasing sales, eliminating unnecessary capital expenditures, etc.

At the end of the Plan year, the supervisor evaluates the participant’s performance in relation to his or her objectives in order to determine the size of the bonus award, if any. A more detailed description of how the award is calculated is provided under “Individual Bonus Award Calculation.”

 

 

BONUS POOL CALCULATION

The components of this calculation for bonus pool funding are: (1) EPS, (2) Revenue Growth and (3) R&D Reinvestment Rate.

Bonus pool funding –Bonuses are funded when the Company achieves a threshold level of target EPS performance. The level of bonus funding is determined by EPS performance, Revenue Growth and R&D Reinvestment Rate as outlined in the table below.

 

  ¿  

Earnings Per Share, Revenue Growth and R&D Reinvestment Rate

 

2009 EPS
RANGE %
  2009 EPS
RANGE
  BONUS %
OF TARGET
  REVENUE
GROWTH
  BONUS %
OF TARGET
  R&D
REINVEST.
RATE
  BONUS %
OF TARGET
 

TOTAL

BONUS % OF
TARGET

-5.5%

  -$0.150       0.0%               0.0%

-2.9%

  -$0.080     50.0%   -0.2%     0.0%   15.55%     0.0%     50.0%

-2.5%

  -$0.070     62.5%   0.8%     2.0%   15.80%     2.0%     66.5%

-1.6%

  -$0.045     75.0%   1.8%     4.0%   16.05%     4.0%     83.0%

-1.3%

  -$0.035     80.0%   2.8%     6.0%   16.30%     6.0%     92.0%

-0.7%

  -$0.020     85.0%   3.8%     8.0%   16.55%     8.0%   101.0%
  Target     90.0%   4.8%   10.0%   16.80%   10.0%   110.0%

1.1%

  $0.030     95.0%   5.8%   13.8%   17.05%   13.8%   122.5%

2.2%

  $0.060   100.0%   6.8%   17.5%   17.30%   17.5%   135.0%

2.9%

  $0.080   105.0%   7.8%   21.3%   17.55%   21.3%   147.5%

3.6%

  $0.100   110.0%   8.8%   25.0%   17.80%   25.0%   160.0%

 

 

 

09 MBP Page -2-


Revenue Growth and R&D Reinvestment Rate bonus funding may not exceed target unless EPS performance is equal to or greater than target. If actual results fall between the performance levels shown above, bonuses will be prorated accordingly. For sake of clarity, if the Company’s performance exceeds any of the targets for Revenue Growth and/or R&D Reinvestment Rate, but EPS does not exceed the threshold level of target EPS performance, no bonus will be payable.

BONUS POOL DIFFERENTIATION BY BUSINESS UNIT/FUNCTION

 

  ¿  

Operating Income —The target bonus pool determined by EPS, Revenue Growth and R&D Reinvestment Rate performance may be modified for each business unit/function based on Operating Income results vs. budget. That is, a business unit that exceeds budget may receive a greater share of the total Company pool than a business unit that is below budget.

At the end of the year, the Company’s Chief Executive Officer may recommend adjustments to the bonus funding levels to the Organization and Compensation Committee (the “Committee”) after consideration of key operating results. When calculating corporate performance for purposes of this Plan, the Committee has the discretion to include or exclude any or all of the following items:

 

   

extraordinary, unusual or non-recurring items;

 

   

effects of accounting changes;

 

   

effects of financing activities;

 

   

expenses for restructuring or productivity initiatives;

 

   

other non-operating items;

 

   

spending for acquisitions;

 

   

effects of divestitures; and

 

   

amortization of acquired intangible assets.

 

 

INDIVIDUAL BONUS AWARD CALCULATION

Target bonus awards are expressed as a percentage of the participant’s year-end annualized base salary. The target percentages vary by salary grade (see Attachment No. 1).

A participant’s actual bonus award may vary above or below the targeted level based on the supervisor’s evaluation of his or her performance in relation to the predetermined MBOs. Except as may otherwise be approved by the Committee, each participant’s actual bonus award may be modified down to 0% or up to 150% of his or her target bonus amount. However, the total of all bonus awards given within each business unit must total no more than 100% of the total bonus pool dollars allocated to that business unit.

 

 

METHOD OF PAYMENT

Except as may otherwise be approved by the Committee, for grade 8 Directors and above, bonuses are paid in cash up to a maximum bonus pool equal to 100% of participants’ bonus targets and performance over such pool is paid in restricted stock or restricted stock units with cliff vesting two years from the award effective date. Any payment in the form of stock will be issued under the 2008 Incentive Award Plan. Upon a recipient’s normal retirement eligibility date (defined as the date on which the recipient has (i) attained age 55 and (ii) been employed by the

 

 

 

09 MBP Page -3-


Company for a minimum of 5 years) all of the restrictions imposed on the recipient’s restricted stock shall lapse. For grade 7 participants, all bonuses are paid in cash. Bonus awards are paid following the close of the Plan year after the review and authorization of bonuses by the Committee. Bonuses will be paid within 30 days following management communication of the award, through the participant’s normal payroll channel. In the event of a Change in Control (as defined in Attachment No. 2), bonuses will be paid within 30 days of the effective date of the Change in Control.

 

 

CHANGE IN CONTROL

If a Change in Control occurs after the close of the Plan year and Company performance supports bonus pool funding, participants will be paid a bonus based on performance in relation to the EPS, Revenue Growth and R&D Reinvestment Rate targets.

If the Change in Control occurs during the Plan year, participants will be paid a bonus prorated to the effective date of the Change in Control and EPS, Revenue Growth and R&D Reinvestment Rate performance will be deemed to be the greater of:

 

   

100% of the EPS, Revenue Growth and R&D Reinvestment Rate targets; or

 

   

the prorated actual year-to-date performance.

In either case, a participant’s actual bonus may vary above or below the targeted level according to the provisions outlined in “Individual Bonus Award Calculation” above. Participants must be employed by the Company or its successor on the effective date of the Change in Control in order to receive the prorated payment, unless their employment is terminated for retirement, death, disability, or otherwise without cause. For purposes of this plan, “cause” shall be limited to only three types of events: the willful refusal to comply with a lawful, written instruction of the Board so long as the instruction is consistent with the scope and responsibilities of the participant’s position prior to the Change in Control; dishonesty which results in a material financial loss to the Company (or to any of its affiliated companies) or material injury to its public reputation (or to the public reputation of any of its affiliated companies); or conviction of any felony involving an act of moral turpitude.

 

 

GENERAL

Management reserves the right to define corporate performance and individual performance and to review, alter, amend, or terminate the Plan at any time subject to approval of the Committee. This Plan does not constitute a contract of employment and cannot be relied upon as such. Any questions regarding this Plan should be directed to the Human Resources department or the Vice President, Global Compensation and Benefits. This Management Bonus Plan document supersedes any previous document you may have received.

 

 

 

09 MBP Page -4-


ATTACHMENT NO. 1

ALLERGAN

2009 MANAGEMENT BONUS PLAN

TARGET AWARDS

 

Salary Grade    US
Target Bonus
  Intl
Target Bonus

7E

   12%   15%

8E

   17%   20%

9E

   23%   25%

10E

   25%   30%

11E

   35%   35%

12E

   35%   40%

13E

   40%   45%

14E

   50%  

15E

   65%  

 

 

 

09 MBP Page -5-


ATTACHMENT NO. 2

CHANGE IN CONTROL DEFINITION

“Change in Control” shall mean the following and shall be deemed to occur if any of the following events occur:

(a) Any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (a “Person”), who becomes the “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act or any successor rule (a “Beneficial Owner”), directly or indirectly, of securities of Allergan, Inc., a Delaware corporation (“Allergan”) representing (i) 20% or more of the combined voting power of Allergan’s then outstanding voting securities, which acquisition is not approved in advance of the acquisition or within 30 days after the acquisition by a majority of the Incumbent Board (as hereinafter defined) or (ii) 33% or more of the combined voting power of Allergan’s then outstanding voting securities, without regard to whether such acquisition is approved by the Incumbent Board; or

(b) Individuals who, as of the date hereof, constitute the Board of Directors of Allergan (the “Incumbent Board”), cease for any reason to constitute at least a majority of the Board of Directors, provided that any person becoming a director subsequent to the date hereof whose election, or nomination for election by Allergan’s stockholders, is approved by a vote of at least a majority of the directors then comprising the Incumbent Board (other than an election or nomination of an individual whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of the directors of Allergan) shall be considered as though such person were a member of the Incumbent Board of Allergan; or

(c) The consummation of a merger, consolidation or reorganization involving Allergan, other than one which satisfies both of the following conditions:

(1) a merger, consolidation or reorganization which would result in the voting securities of Allergan outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of another entity) at least 55% of the combined voting power of the voting securities of Allergan or such other entity resulting from the merger, consolidation or reorganization (the “Surviving Corporation”) outstanding immediately after such merger, consolidation or reorganization and being held in substantially the same proportion as the ownership in Allergan’s voting securities immediately before such merger, consolidation or reorganization, and

(2) a merger, consolidation or reorganization in which no Person is or becomes the Beneficial Owner directly or indirectly, of securities of Allergan representing 20% or more of the combined voting power of Allergan’s then outstanding voting securities; or

(d) The stockholders of Allergan approve a plan of complete liquidation of Allergan or an agreement for the sale or other disposition by Allergan of all or substantially all of Allergan’s assets.

Notwithstanding the preceding provisions, a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions is (1) an underwriter or underwriting syndicate that has acquired the ownership of any of Allergan’s then outstanding voting securities solely in connection with a public offering of Allergan’s securities, (2) Allergan or any subsidiary of Allergan or (3) an employee stock ownership plan or other employee benefit plan maintained by Allergan (or any of its affiliated companies) that is qualified under the provisions of the Internal Revenue Code of 1986, as amended. In addition, notwithstanding the preceding provisions, a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions becomes a Beneficial Owner of more than the permitted amount of outstanding securities as a result of the acquisition of voting securities by Allergan which, by reducing the number of voting securities outstanding, increases the proportional number of shares beneficially owned by such Person, provided, that if a Change in Control would occur but for the operation of this sentence and such Person becomes the Beneficial Owner of any additional voting securities (other than through the grant or issuance of securities pursuant to an award (e.g., stock option grant, restricted stock award, restricted stock unit award) granted by the Company, or through a stock dividend or stock split), then a Change in Control shall occur.

 

 

 

09 MBP Page -6-

EXHIBIT 10.23

ALLERGAN, INC.

EXECUTIVE DEFERRED COMPENSATION PLAN

(2009 RESTATEMENT)

Effective as of January 1, 2009


ALLERGAN, INC.

EXECUTIVE DEFERRED COMPENSATION PLAN

(2009 RESTATEMENT)

Effective as of January 1, 2009

ARTICLE I

INTRODUCTION

1.1        Purpose .  The Allergan, Inc. Executive Deferred Compensation Plan was previously established by the Board of Directors of Allergan, Inc., a Delaware corporation (“Allergan”), to provide deferred compensation benefits to selected executive and management employees of the Company as more fully provided herein. The benefits provided under this Plan are intended to be in addition to other employee benefit programs offered by the Company, including but not limited to tax-qualified employee benefit plans.

1.2        Effective Date and Term .  This Plan was adopted effective as of January 1, 1995, and is hereby amended and restated effective as of January 1, 2009 (the “2009 Restatement”), and shall continue in effect until terminated by the Board of Directors.

1.3        Applicability of Code Section 409A .  All benefits under the Plan shall be subject to Code Section 409A. Under the terms of the Plan prior to this 2009 Restatement, all current Participants of the Plan were permitted to make an election prior to January 1, 2009 under the Code Section 409A transition election rule to conform their distribution elections for their outstanding Deferral Accounts to the permitted distribution options of this 2009 Restatement.

1.4        Applicability of ERISA .  This Plan is intended to be a “top-hat” plan -- that is, an unfunded plan maintained primarily for the purpose of providing deferred compensation to a select group of management or highly compensated employees within the meaning of ERISA.

ARTICLE II

DEFINITIONS

As used herein, the following definitions shall apply unless context clearly indicates to the contrary.

2.1        Annual Deferral .  “Annual Deferral” means the amount of Base Salary and/or Bonuses which the Participant elects to defer for each Plan Year pursuant to Section 3.1.

2.2        Base Salary .  “Base Salary” means the Participant’s annual basic rate of pay from the Company (excluding Bonuses, commissions, and other non-regular forms of compensation) before reductions for deferrals under this Plan, the Savings and Investment Plan, or “cafeteria plan” under Code Section 125.


2.3        Beneficiary .  “Beneficiary” means the person or persons or entity designated as such in accordance with Section 13.1.

2.4        Board; Board of Directors .  “Board” and “Board of Directors” each mean the Board of Directors of Allergan. The Organization and Compensation Committee of the Board, or any successor thereto or any designee, shall exercise any and all rights, duties and obligations that are retained by or assigned to the Board under the Plan.

2.5        Bonuses .  “Bonuses” means non-salary amounts earned by the Participant that are designated as bonuses or commissions. Bonuses shall relate to the Plan Year for which the services were performed even though they may be paid in the subsequent Plan Year in accordance with Company policies or practice.

2.6        Code .  “Code” means the Internal Revenue Code of 1986, as amended.

2.7        Committee .  “Committee” means the committee authorized to administer this Plan as set forth in Section 10.1 hereof.

2.8        Company .  “Company” means Allergan, Inc., a Delaware corporation, and each Affiliated Company (as defined in the Savings and Investment Plan) designated by the Board of Directors.

2.9        Company Rate .  “Company Rate” means one hundred twenty percent (120%) of the ten-year Treasury Note one hundred twenty (120) month rolling average to be determined on October 1 of each Plan Year and made applicable for the next following Plan Year. The Company Rate shall only be used to measure investment earnings for certain grandfathered amounts as described in Section 5.3.

2.10      Deferral Accounts .  “Deferral Accounts” means the separate accounts maintained solely for record keeping purposes on behalf of each Participant to which a Participant’s Annual Deferrals and Restoration Credits are credited pursuant to Section 5.1. A Participant will have one Termination Benefit Account and, at any given time, up to two Scheduled In-Service Withdrawal Accounts.

2.11      Deferral Election .  “Deferral Election” means the election made by the Participant pursuant to the terms of Section 4.1.

2.12      Disability .  “Disability” means, for purposes of Section 4.3 only, any medically determinable physical or mental impairment which can be expected to result in death or can be expected to last for a continuous period of not less than six (6) months and as a result the Participant is unable to perform the duties of his or her position or any substantially similar position. For all other purposes, “Disability” means any medically determinable physical or mental impairment which can be expected to result in death or can be expected to last for a continuous period of not less than 12 months and as a result of (i) the Participant is unable to engage in any substantial gainful activity or (ii) the Participant is, receiving income replacement benefits for a period of not less than three months under the Company’s long term disability insurance program. Notwithstanding the foregoing, a Participant shall be deemed to have incurred a Disability if determined to be (i) totally disabled by the Social Security Administration

 

- 2 -


or (ii) disabled under the Company’s long term disability insurance program; provided, that benefits are only payable as a result of a disability that complies with this Section.

2.13      Effective Date .  “Effective Date” means January 1, 2009 for this 2009 Restatement.

2.14      Eligible Employee .  “Eligible Employee” means an employee of the Company who is a U.S. local or U.S. based expatriate that is either grade 8E/8S and above or is employed in another executive or management position as approved by the Committee.

An employee shall not be an Eligible Employee if (i) he or she is classified or paid as an independent contractor (regardless of his or her classification for federal tax or other legal purposes) by the Company, or (ii) he or she performs services for the Company pursuant to an agreement between the Company and any other person including a leasing organization.

2.15      Enrollment Forms .  “Enrollment Forms” mean, collectively, the form or forms prescribed by the Committee for enrollment in the Plan including (i) a “Deferral Election Form” pursuant to which a Participant agrees to defer Base Salary and/or Bonuses for a Plan Year, (ii) a “Distribution Election Form” pursuant to which a Participant allocates the amounts of the Deferral Election for each Plan Year among each of his or her Deferral Accounts and elects or changes the form and time of payment for such Deferral Accounts, and (iii) an “Investment Election Form” pursuant to which a Participant allocates his or her Annual Deferrals or transfers amounts in his or her Deferral Accounts among the Fund Media or from the Company Rate.

2.16      ERISA .  “ERISA” means the Employee Retirement Income Security Act of 1974, as amended.

2.17      Fund Rate .  “Fund Rate” means, with respect to any portion of a Participant’s Deferral Account(s) for which the Fund Rate is applicable, the rate of return based on the income, gains, losses and expenses of the investment vehicles (collectively called “Fund Media”) selected by the Participant in accordance with Section 5.4.

2.18      Key Employee .  “Key Employee” means all corporate officers of the Company plus employees who are grade 11E and above, unless otherwise timely designated by the Committee in accordance with Code Section 409A.

2.19      Open Enrollment Period .  “Open Enrollment Period” means the enrollment period during which an Eligible Employee may enroll in the Plan for a Plan Year or the remainder of the Plan Year. Open Enrollment Periods shall be established as determined by the Company subject to any limitations or requirements set forth under the terms of the Plan.

2.20      Participant .  “Participant” means any Eligible Employee who enrolls or commences participation in this Plan as provided under Article III hereof.

2.21      Plan .  “Plan” means this Allergan, Inc. Executive Deferred Compensation Plan adopted as of the Effective Date hereof and as it may be amended from time to time.

 

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2.22      Plan Entry Date .  “Plan Entry Date” means the first day of the calendar quarter following the day an employee satisfies the requirements of Section 2.14.

2.23      Plan Year .  “Plan Year” means the calendar year.

2.24      Restoration Credits .  “Restoration Credits” means the amounts, if any, credited to a Participant’s Deferral Account(s) pursuant to Section 5.1(b), (c), or (d).

2.25      Savings and Investment Plan .  “Savings and Investment Plan” means the Allergan, Inc. Savings and Investment Plan, as amended.

2.26      Scheduled In-Service Withdrawal .  “Scheduled In-Service Withdrawal” means a withdrawal elected by the Participant pursuant to Article VII that is payable or commences prior to Termination of Employment.

2.27      Termination Benefit .  “Termination Benefit” means a distribution elected by the Participant pursuant to Article VI that is payable upon Termination of Employment.

2.28      Termination; Termination of Employment .  “Termination” or “Termination of Employment” means the termination of a Participant’s employment with the Company for any reason whatsoever, whether voluntary or involuntary.

ARTICLE III

ELIGIBILITY AND PARTICIPATION

3.1        Open Enrollment .  For each Plan Year, an Eligible Employee may elect to enroll in the Plan by completing Enrollment Forms during the Open Enrollment Period preceding such Plan Year. If an Eligible Employee fails to complete Enrollment Forms during an Open Enrollment Period, he or she shall not be eligible to make Annual Deferrals for such Plan Year but shall remain eligible to do so for a subsequent Plan Year; provided, that he or she continues his or her status as an Eligible Employee and completes Enrollment Forms during a subsequent Open Enrollment Period.

3.2        First Year of Eligibility .  An employee who becomes an Eligible Employee on or after the first day of a Plan Year, may for his or her first year of initial eligibility, complete Enrollment Forms during the Open Enrollment Period that shall end no later than 30 days after the Eligible Employee’s Plan Entry Date. In the event an Eligible Employee completes Enrollment Forms during the Open Enrollment Period following his or her Plan Entry Date, such elections made thereunder shall only apply to compensation paid for services performed following receipt of such Enrollment Forms by the Company. In the event an Eligible Employee fails to complete Enrollment Forms during such Open Enrollment Period, he or she shall not be eligible to make Annual Deferrals under the Plan for the remainder of the Plan Year but shall remain eligible to do so for a subsequent Plan Year; provided, that he or she continues his or her status as an Eligible Employee and completes Enrollment Forms during a subsequent Open Enrollment Period. This Section 3.2 shall not apply to any Eligible Employee who was a former Eligible Employee at any time during the 24-month period ending on such Eligible Employee’s

 

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subsequent return to Eligible Employee status unless the balance of all Deferral Accounts was paid to the Eligible Employee prior to his or her subsequent Plan Entry Date.

3.3        Automatic Enrollment for Restoration Credits .  An Eligible Employee who fails to enroll in the Plan for a Plan Year during an Open Enrollment Period shall automatically be enrolled in the Plan for any Plan Year for which he or she receives “Restoration Credits” as described in Section 5.1.

ARTICLE IV

DEFERRAL ELECTIONS

4.1        Deferral Election .  For each Plan Year, an Eligible Employee may make a Deferral Election on a voluntary basis by properly completing and submitting Enrollment Forms during the applicable Open Enrollment Period for the Plan Year subject to the following:

(a)      A Deferral Election shall be irrevocable for the Plan Year or, if applicable, the remainder of the Plan Year unless terminated under Section 4.3.

(b)      If an Eligible Employee ceases to be an Eligible Employee during a Plan Year, any Deferral Election shall continue in effect for the remainder of the Plan Year unless terminated under Section 4.3.

(c)      A Deferral Election may only apply to amounts paid for an Eligible Employee’s services performed after the date he or she properly completes and submits his or her Deferral Election Form.

(d)      A Deferral Election shall be subject to the requirements set forth in Sections 4.2 below.

(e)      An employee who becomes an Eligible Employee after the first day of a Plan Year under Section 3.2 may only defer Base Salary earned after the date he or she properly completes and submits his or her Deferral Election Form and may not defer any Bonus earned during that first Plan Year.

4.2        Maximum Deferral Amount .  Subject to the restrictions provided in Section 4.1, and in accordance with procedures established by the Company, an Eligible Employee may elect to defer up to one hundred percent (100%) of Base Salary and/or up to one hundred percent (100%) of any Bonus earned during the Plan Year, stated as a percentage. The Committee, in its sole discretion, may change the maximum deferral percentage for a Plan Year or may replace or provide other Deferral Election options. To the extent permitted by Code Section 409A, a Deferral Election shall be automatically reduced or adjusted if the Committee determines that such action is necessary or appropriate to meet Federal, State or other applicable tax withholding obligations or to pay for benefits or other obligations arising from the Participant’s relationship with the Company.

 

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4.3        Termination of Deferral Election .  An Eligible Employee’s Deferral Election for a Plan Year shall be immediately terminated upon his or her Termination of Employment, or a hardship withdrawal under the Savings and Investment Plan. An Eligible Employee may request that his or her Deferral Election for a Plan Year be terminated upon Disability; provided, that, in the case of Disability, the Deferral Election is terminated by the 15 th day of the third month following the date the Eligible Employee incurs the Disability. If an Eligible Employee’s Deferral Election is terminated under this Section, any Deferral Election for a subsequent Plan Year shall be made in accordance with Article III.

4.4        Time and Form of Payment .  During the applicable Open Enrollment Period, an Eligible Employee shall elect the time and/or form of payment of amounts deferred during the Plan Year by allocating such amounts (in whole percentages) among the Participant’s three Deferral Accounts using a Distribution Election Form. If an Eligible Employee fails to submit a properly completed Distribution Election Form during an Open Enrollment Period or is automatically enrolled in the Plan for a Plan Year pursuant to Section 3.3, the amounts deferred for such Plan Year shall be put in the Participant’s Termination Benefit Account. Once an amount is placed in a Deferral Account, it may not be moved into a different Deferral Account, except as provided in Section 5.5(c) (for Scheduled In-Service Distribution Accounts to be distributed which have not yet fully vested). The time and form of payment of each of the Deferral Accounts shall be determined under Articles VI through VIII.

ARTICLE V

DEFERRAL ACCOUNTS

5.1        Deferral Accounts .    Solely for record keeping purposes, up to three Deferral Accounts (one Termination Benefit Account and up to two Scheduled In-Service Withdrawal Accounts) shall be established and maintained for each Participant. Pursuant to a Participant’s Distribution Election Form, the Deferral Accounts shall be credited with the following:

(a)       Annual Deferrals .  Annual Deferrals, if any, shall be credited at the time such amounts would otherwise have been paid to the Participant for the Plan Year.

(b)       Matching Contribution Restoration Credit .  If a Participant has contributed the maximum “Before Tax Deposits” (as defined in the Savings and Investment Plan) permitted under Section 4.2 of the Savings and Investment Plan (but without regard to the catch-up provisions of Section 4.2(e) of the Savings and Investment Plan and Code Section 414(v)) for the Plan Year, then such Participant’s Deferral Account(s) for such Plan Year shall be credited with a “Matching Contribution Restoration Credit” equal to the excess of the dollar amount or value of (i) the Participant’s “Matching Contributions” (as defined in the Savings and Investment Plan), without regard to trust income or earnings, based on such Participant’s “Matched Deposits” (as defined in the Savings and Investment Plan), and such Participant’s “Compensation” (as defined in the Savings and Investment Plan) as increased by any Annual Deferrals made under this Plan up to the limitation imposed by Code Section 401(a)(17), over (ii) the Participant’s actual “Matching Contributions” for the

 

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Plan Year under the Savings and Investment Plan. The Matching Contribution Restoration Credit (if any) shall be credited to a Participant’s Deferral Account for such Plan Year after the end of the Plan Year to which such credit relates and after the Participant’s “Matching Contributions” for such Plan Year under the Savings and Investment Plan are determined, but not later than the end of the Plan Year following the Plan Year to which such credit relates.

(c)       Retirement Contribution Restoration Credit .  If a Participant is a “Retirement Account Participant” (as defined in the Savings and Investment Plan) and is eligible to receive a Retirement Contribution allocation pursuant to Section 5.4 of the Savings and Investment Plan for a Plan Year, e.g. , employed by the Company on the last day of the Plan Year, then such Participant’s Deferral Account(s) for such Plan Year shall be credited with a “Retirement Contribution Restoration Credit,” the amount of which is equal to the excess of the dollar amount of (i) such Participant’s “Retirement Contribution” (as defined in the Savings and Investment Plan), without regard to trust income or earnings, based on the Participant’s “Compensation” (as defined in the Savings and Investment Plan) as increased by any Annual Deferrals made under this Plan and without regard to the limitations imposed by Code Sections 401(a)(4), 401(a)(17) and 415, over (ii) such Participant’s actual “Retirement Contribution” for such Plan Year under the Savings and Investment Plan. The Retirement Contribution Restoration Credit (if any) shall be credited to a Participant’s Deferral Account(s) for such Plan Year after the end of the Plan Year to which such credit relates and after the Participant’s “Retirement Contribution” for such Plan Year under the Savings and Investment Plan is determined, but not later than the end of the Plan Year following the Plan Year to which such credit relates.

(d)       ESOP Restoration Credit .  A Participant’s Deferral Account(s) may also contain an ESOP Restoration Credit, for Plan Years beginning prior to January 1, 2003.

The amounts (if any) to be credited to a Participant’s Deferral Accounts pursuant to paragraphs (b) and (c) above shall be credited after the end of the Plan Year to which such credits relate and after such Participant’s actual “Retirement Contribution” and actual “Matching Contributions” (each as defined in the Savings and Investment Plan) for such Plan Year under the Savings and Investment Plan are determined, but not later than the end of the Plan Year following the Plan Year to which such credits relate.

A Participant’s Restoration Credits shall be credited to the Participant’s Termination Benefit Account under Article VI and shall not be eligible for distribution as a Scheduled In-Service Withdrawal under Article VII.

5.2        Investment Earnings on Deferral Accounts .  The Deferral Accounts of a Participant shall be credited with investment earnings at the Fund Rate or interest at the Company Rate, if applicable, as provided in Section 5.3. For any portion of a Deferral Account to which the Company Rate is applicable, such portion of the Deferral Account shall be credited each month with interest which shall be compounded on an annual basis under rules determined by the Committee in its sole discretion.

 

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5.3        Participant Investment Elections .

(a)       Deferrals and Restoration Credits .  Any Annual Deferrals made by a Participant and any Restoration Credits credited to a Participant’s Deferral Account with respect to a Deferral Period shall be credited with investment earnings at the Fund Rate and shall not be eligible to be credited with interest at the Company Rate. The investment allocation of a Participant’s Restoration Credits to Fund Media shall be the allocation selected by the Participant in his or her most recent Investment Election Form. If a Participant does not submit an Investment Election Form or otherwise select the Fund Media for his or her Restoration Credits, then such Restoration Credits shall be credited to Dodge & Cox Balanced Fund listed on Appendix A (or, if the Dodge & Cox Balanced Fund is unavailable for any reason, then such Fund Media as the Committee shall determine in its sole discretion), until superseded by a subsequent Investment Election Form properly completed and submitted by such Participant.

(b)       Amounts eligible for the Company Rate .  Certain grandfathered amounts that as of January 1, 2009 are invested at the Company Rate will continue to be eligible to accrue investment earnings at the Company Rate unless transferred to the Fund Rate under subsection (c) below. No other amounts are eligible for the Company Rate.

(c)       Transfers from Company Rate to Fund Rate .  Each Participant may request to change the investment of all or any portion of his or her Deferral Account from the Company Rate to the Fund Rate subject to the following conditions:

(i)      An Investment Election Form, which includes the allocation among Fund Media, must be submitted by such time as may be established by the Committee from time to time.

(ii)     An investment transfer from the Company Rate to the Fund Rate shall be irrevocable.

(d)       Allocation to Fund Media .  With respect to any portion of the Deferral Account to which the Fund Rate applies, the Participant may prospectively change the investment allocation to Fund Media on a periodic basis as set by the Company, but not less frequently than monthly , in whole or part by submitting an Investment Election Form or by using such electronic means and under such procedures as the Committee may permit.

5.4        Fund Media .  The initial Fund Media under the Plan shall be as set forth on Appendix A , attached hereto. The Committee may add or delete Fund Media in its sole discretion from time to time. In the event of a deletion of a Fund Media, the Committee is not required to provide a new Fund Media option with similar investment objectives as those of the deleted Fund Media. For any amounts for which a deleted Fund Media had been selected, the Committee, in its sole discretion, may select an alternative Fund Media, either a fixed income Fund Media or an existing Fund Media that has similar investment objectives as the deleted Fund Media, to which to assign those amounts until the Participant selects otherwise. The Committee shall have no liability or responsibility with respect to the absolute or relative return of such

 

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alternative Fund Media to which it assigns such amounts. Participants must make an investment allocation to Fund Media in whole percentages equal to one hundred percent (100%), in the aggregate, of the amount invested in Deferral Accounts to which the Fund Rate applies.

5.5        Vesting of Deferral Account .

(a)      A Participant shall be fully vested in his or her Annual Deferrals, Matching Contribution Restoration Credits, and ESOP Restoration Credits.

(b)      A Participant shall vest in his or her Retirement Contribution Restoration Credits and any investment earnings thereon in accordance with the following schedule:

 

Years of Service    Vested Percentage
Less than 1        0%
1 but less than 2      20%
2 but less than 3      40%
3 but less than 4      60%
4 but less than 5      80%
5 or more    100%

For purposes of this Section 5.5, a Participant’s Years of Service under the Plan shall be equal to the Participant’s “Credited Service” (as defined in the Savings and Investment Plan) credited to such Participant under the Savings and Investment Plan.

Upon a Participant’s Termination of Employment, any unvested amounts and applicable investment earnings thereon shall be forfeited after 90 days from the Termination of Employment, as of the last day of the month in which the 90-day period ends, and his or her Deferral Accounts will be adjusted accordingly. Any forfeited amounts shall be used to offset Restoration Credits to be made by the Company for the following Plan Year.

(c)      Notwithstanding paragraph (b) above, a Participant shall become fully vested in his or her Retirement Contribution Restoration Credits and any investment earnings thereon, if while employed by the Company, (i) he or she attains age 62, (ii) he or she dies, (iii) he or she incurs a “Severance” due to a “Disability” (as each term is defined in the Savings and Investment Plan), or (iv) a Change in Control occurs as defined in Section 11.2.

5.6        Statement of Accounts .  The Committee shall provide to each Participant periodic statements setting forth the balance of the Deferral Accounts maintained for such Participant. Notwithstanding anything contained in such statements, the provisions of the Plan shall govern exclusively the actual rate of investment earnings to be credited and paid.

 

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ARTICLE VI

TERMINATION BENEFIT ACCOUNT

6.1        Payment Upon Termination of Employment .  Upon a Participant’s Termination of Employment, the Company shall pay to the Participant his or her Termination Benefit Account, as well as his or her outstanding Scheduled In-Service Withdrawal Accounts (even if such Deferral Accounts are in pay status) as a Termination Benefit at such time and in such form as provided in Sections 6.2 and 6.3 or as permitted in Section 6.4.

6.2        Time of Commencement .  A Termination Benefit shall commence payment on the first business day of January of the next following calendar year after Termination of Employment, subject to the following rules:

(a)       Six-Month Delay .  In the case of a Participant who is a Key Employee, the payment of a Participant’s Termination Benefit shall (i) commence or shall be made no earlier than (1) the first business day after six (6) months following the Participant’s Termination of Employment or (2) the death of the Participant, whichever occurs first and (ii) any payments to which such Participant would have been entitled to during the six-month delay shall be paid on the first day of the seventh month.

(b)       Administrative Delay of Payment .  For purposes of this Section 6.2, the payment of a Termination Benefit shall be treated as made upon the date specified herein, if, in the sole discretion of the Company, payment commences or is made by (i) the last day of the calendar year which contains the scheduled payment date, (ii) the last day of the calendar year in which a six-month delay (as described in subsection (a)) expires, or (iii) the 15th day of the third calendar month following the scheduled payment date or delayed payment date, whichever is the latest to occur.

6.3        Form of Termination Benefit .  Upon Termination of Employment, a Participant’s Deferral Accounts shall be paid in twenty (20) quarterly installments (the “default payment”), subject to the following:

(a)       Participant Election .  A Participant may elect that the Termination Benefit shall be paid in the form of either forty (40) or sixty (60) quarterly installments, if such election is made either (i) prior to January 1, 2009 in accordance with the Code Section 409A transition election rule described in Section 1.3, or (ii) during the Participant’s first Open Enrollment Period, i.e., prior to the time any amounts have ever been deferred by the Participant under the Plan.

(b)       Predetermined Cash-Out of $50,000 .  If the total sum of a Participant’s Deferral Accounts on the date of his or her Termination of Employment (as adjusted for amounts accrued as of that date but not yet credited) is more than the limited cash-out amount described in subsection (a) but $50,000 or less, his or her Termination Benefit shall be paid in a single lump sum.

6.4        Change in Payout Timing .  A Participant may elect to change the time and/or form of the Termination Benefit, provided that such form of payment is permitted under Section 6.3, and provided that:

 

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(a)      No more than two (2) elections shall be permitted;

(b)      The election shall not take effect until 12 months after the date on which the election is made; and

(c)      The payment date installment payments are to begin shall be postponed by the election for at least five (5) years later than the prior payment date.

ARTICLE VII

SCHEDULED IN-SERVICE WITHDRAWALS

7.1        Entitlement to Scheduled In-Service Withdrawal .  A Participant may elect to place Annual Deferral amounts (but not Restoration Credits) in up to two (at any given time) Scheduled In-Service Withdrawal Accounts for distribution of benefits as separate Scheduled In-Service Withdrawals prior to Termination of Employment at such times and in such forms as permitted in Sections 7.3 and 7.4 below. Notwithstanding placement of amounts in Scheduled In-Service Withdrawal Accounts, if the Participant has a Termination of Employment prior to full payment of a Scheduled In-Service Withdrawal Account, the Scheduled In-Service Withdrawal shall be superseded and any unpaid amounts shall be paid as a Termination Benefit under Article VI.

7.2        Number of Outstanding Scheduled In-Service Withdrawal Accounts .  A Participant may have no more than two (2) outstanding Scheduled In-Service Withdrawal Accounts at a time, however, once a Scheduled In-Service Withdrawal Account has been completely paid out, a new Scheduled In-Service Withdrawal Account may be elected.

For example, for 2009, a Participant elects for half of his Annual Deferrals to go into a Scheduled In-Service Withdrawal Account to be paid as a single-lump sum in 2012, and the other half to go into a second Scheduled In-Service Withdrawal Account to be paid as a single lump sum in 2015. After the first Scheduled In-Service Withdrawal Account has been distributed in 2012, the Participant may elect for amount being deferred in 2013 to go into a new Scheduled In-Service Withdrawal Account to be paid as a single lump sum in 2016.

7.3        Time of Commencement .  The payment of a Scheduled In-Service Withdrawal shall commence or shall be made in January of such year as elected by the Participant but in no event earlier than the third calendar year following the Plan Year for which the amounts are being deferred.

For example, under the same facts as the example in Section 7.2, although a Participant could elect for his Annual Deferrals for 2013 to go into the new Scheduled In-Service Withdrawal Account to be paid as a single lump sum in 2016, the Participant could not elect for amounts being deferred in 2013 to go into the other Scheduled In-Service Withdrawal Account, which is to be paid as a single lump sum in 2015, because the payment date is earlier than the third calendar year following the 2013 Plan Year.

 

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7.4        Form of Scheduled In-Service Withdrawal .  A Scheduled In-Service Withdrawal shall be paid in the form of a single lump sum, unless a Participant elects for payment in quarterly installments over two (2), three (3), or four (4) years.

7.5        Change in Time and/or Form of Payment .  A Participant may change the time and/or form of a Scheduled In-Service Withdrawal, provided that such form of payment is permitted under Sections 7.5, and provided that:

(a)      No more than two (2) elections shall be permitted for a given Scheduled In-Service Withdrawal;

(b)      The election shall not take effect until 12 months after the date on which the election is made;

(c)      The payment date or first scheduled installment payment date shall be postponed by the election for at least five (5) years later than the prior payment date or first scheduled installment payment date; and

(d)      An election shall not be permitted unless the election is made at least 12 months prior to payment date or first scheduled installment payment date.

ARTICLE VIII

ACCELERATION UPON DEATH OR DISABILITY

Notwithstanding the distribution provisions of Articles VI and VII, in the event that a Participant incurs a Disability or dies, the Company shall pay to the Participant, or the Participant’s Beneficiary in the event of Participant’s death, all of his or her outstanding Deferral Accounts (including unpaid Deferral Accounts already in pay status) in a single lump sum within ninety (90) days of the occurrence of the Disability or death. For example, if a Participant dies on April 1 st while still employed, all of the Participant’s outstanding Deferral Accounts shall be paid to the Participant’s Beneficiary by June 30 th , regardless of any election of the Participant.

ARTICLE IX

ADDITIONAL BENEFIT PAYMENT RULES

9.1        Constructive Receipt .  To the extent permitted under Code Section 409A, the Committee may change any election or option available under the Plan, or the form or timing of any benefit payment, if the Committee determines, based on the advice of counsel or other consultants to the Company, that such a change is necessary or advisable in order to avoid or limit the risk of adverse tax consequences to Participants or Beneficiaries under Code Section 409A or based on application of the doctrine of “constructive receipt” or a similar Federal or State tax principle.

 

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9.2        Postponement of Payment .  To the extent permitted under Code Section 409A, if a distribution of all or part of a Participant’s Deferral Accounts would not be deductible to the Company because of the restrictions imposed by Code Section 162(m) (or any successor provision), such distribution shall be postponed (to the extent necessary) to the first business day of the first Plan Year in which the limitation on deductibility would not apply. Any postponed distribution under this Section shall be credited with investment earnings at the rate otherwise applicable to the Deferral Accounts at the time when the distribution was originally scheduled for payment.

9.3        Installment Payments .  Investment earnings shall be credited to the date that the Committee selects in its sole discretion for valuation for distribution purposes and the Committee shall make appropriate adjustments to an installment amount to reflect investment gains or losses by dividing the remaining amount of a Participant’s Deferral Account(s) by the remaining number of installments. For purposes of Code Section 409A, the entitlement to a series of installment payments shall be treated as the entitlement to a single payment.

ARTICLE X

ADMINISTRATION OF THE PLAN

10.1      Administration by Committee .  This Plan shall be administered by a committee (the “Committee”) which shall exercise such powers and have such duties in administering the Plan as are hereinafter set forth. The Board of Directors shall determine the number of members of such Committee. The members of the Committee shall be appointed by the Board and the Board shall from time to time fill all vacancies occurring in said Committee. A member of the Committee may be a Participant in this Plan; provided, however, that any action to be taken by the Committee solely with respect to the particular interest in this Plan of a Committee member shall be taken by the remaining members of the Committee.

10.2      Committee Authority; Rules and Regulations .  The Committee shall have discretionary authority to (i) make, amend, interpret and enforce all appropriate rules and regulations for the administration of the Plan, (ii) decide or resolve any and all questions, including interpretations of the Plan, as may arise in connection with the Plan, and (iii) take or approve all such other actions relating to the Plan (other than amending or terminating the Plan); provided, however, that the Board may, by written notice to the Committee, withdraw all or any part of the Committee’s authority at any time, in which case such withdrawn authority shall immediately revest in the Board. The decision or action of the Committee in respect of any question arising out of or in connection with the administration, interpretation and application of this Plan and the rules and regulations promulgated hereunder shall be final, conclusive and binding upon all persons having any interest in the Plan.

10.3      Appointment of Agents .  In the administration of the Plan, the Board and the Committee may from time to time employ agents (which may include officers and employees or the Company) and delegate to them such administrative duties as it sees fit and may from time to time consult with counsel who may be counsel to the Company.

 

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10.4      Application of Benefits .  The Committee may require any person claiming benefits under the Plan to submit an application therefor, together with such documents and information as the Committee may require. In the case of any person suffering from a disability or other condition which prevents such person from making personal application for benefits, the Committee may, in its discretion, permit application to be made by another person acting on his or her behalf. Notwithstanding the foregoing, if the Committee shall have all information necessary to determine the amount and form of Plan benefits payable to a Participant or Beneficiary who is entitled to benefit payments under this Plan (including, to the extent applicable and without limiting the generality of the foregoing, the name, age, sex and proper mailing address of all parties entitled to benefit payments), then the failure of a Participant or Beneficiary to file an application for benefits shall not cause the Committee to defer the commencement of benefit payments beyond the benefit commencement date required under this Plan.

10.5      Claims Procedures .  If a Participant or his or her Beneficiary believes that he or she is being denied any rights or benefits under the Plan, the Participant, Beneficiary, or in either case, his or her authorized representative (the “Claimant”) shall follow the administrative procedures for filing a claim for benefits as set forth in this Section. A claim for benefits shall be in writing and shall be reviewed by the Committee or a claims official designated by the Committee. The Committee or claims official shall review a claim for benefits in accordance with the procedures established by the Committee subject to the following administrative procedures set forth in this Section.

(a)      The Committee shall furnish the Claimant with written or electronic notice of the decision rendered with respect to a claim for benefits within 90 days following receipt by the Committee (or its delegate) of the claim unless the Committee determines that special circumstances require an extension of time for processing the claim. In the event an extension is necessary, written or electronic notice of the extension shall be furnished to the Claimant prior to the expiration of the initial 90 day period. The notice shall indicate the special circumstances requiring an extension of time and the date by which a final decision is expected to be rendered. In no event shall the period of the extension exceed 90 days from the end of the initial 90 day period.

(b)      In the case of a denial of the Claimant’s claim in whole or in part, the written or electronic notice of such denial shall set forth (i) the specific reasons for the denial, (ii) references to the Plan provisions upon which the denial is based, (iii) a description of any additional information or material necessary for perfection of the claim (together with an explanation why such material or information is necessary), (iv) an explanation of the Plan’s appeals procedures, and, if applicable, (v) a statement of the Claimant’s right to bring a civil action under Section 502(a) of ERISA if his or her claim is denied upon appeal.

(c)      In the case of a denial of a claim, a Claimant who wishes to appeal the decision shall follow the administrative procedures for an appeal as set forth in Section 10.6 below.

 

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10.6      Appeals Procedures .  A Claimant who wishes to appeal the denial of his or her claim for benefits shall follow the administrative procedures for an appeal as set forth in this Section and shall exhaust such administrative procedures prior to seeking any other form of relief. Appeals shall be reviewed in accordance with the procedures established by the Committee subject to the following administrative procedures set forth in this Section.

(a)      In order to appeal a decision rendered with respect to his or her claim for benefits, a Claimant must file an appeal with the Committee in writing within 60 days following his or her receipt of the notice of denial with respect to the claim.

(b)      The Claimant’s appeal may include written comments, documents, records and other information relating to his or her claim. The Claimant may review all pertinent documents and, upon request, shall have reasonable access to or be provided free of charge, copies of all documents, records, and other information relevant to his or her claim.

(c)      The Committee shall provide a full and fair review of the appeal and shall take into account all claim related comments, documents, records, and other information submitted by the Claimant without regard to whether such information was submitted or considered under the initial determination or review of the initial determination. Where appropriate, the Committee will overturn a notice of denial if it determines that an error was made in the interpretation of the controlling plan documents or if the Committee determines that an existing interpretation of the controlling plan documents should be changed on a prospective basis. In the event the Claimant is a subordinate, as determined by the Committee, to an individual conducting the review, such individual shall recuse himself or herself from the review of the appeal.

(d)      The Committee shall furnish the Claimant with written or electronic notice of the decision rendered with respect to an appeal within 60 days following receipt by the Committee of the appeal unless the Committee determines that special circumstances require an extension of time for processing the appeal. In the event an extension is necessary, written or electronic notice of the extension shall be furnished to the Claimant prior to the expiration of the initial 60 day period. The notice shall indicate the special circumstances requiring an extension of time and the date by which a final decision is expected to be rendered. In no event shall the period of the extension exceed 60 days from the end of the initial 60 day period.

(e)      In the case of a denial of an appeal, the written or electronic notice of such denial shall set forth (i) the specific reasons for the denial, (ii) references to the Plan provisions upon which the denial is based, (iii) a statement that the Claimant is entitled to receive, upon request and free of charge, reasonable access to, and copies of, all documents, records, and other information relating to his or her claim for benefits, and, if applicable, (iv) a statement of the Claimant’s right to bring a civil action under Section 502(a) of ERISA.

 

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ARTICLE XI

CHANGE IN CONTROL

11.1      Effect of a Change in Control .  Notwithstanding any other provision of the Plan, in the event that a Change in Control (as defined in Section 11.2) occurs on or after the Effective Date hereof, the Company may not amend or terminate the Plan in any manner in order to (i) change downward the method of determining the Fund Rate of any Fund Media or the Company Rate, if applicable, to be credited to the Deferral Accounts of Participants thereafter without the written consent of such Participants, or (ii) modify or eliminate any distribution method, selection of Fund Media, option or election (including all such methods, options and elections set forth in Articles V through VIII) available to Participants with respect to Deferral Accounts and Deferral Elections that exist on the date such Change in Control occurs.

11.2      Change in Control Defined .  As used in this Plan, “Change in Control” shall mean the following and shall be deemed to occur if any of the following events occur:

(a)      Any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (a “Person”), is or becomes the “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act (a “Beneficial Owner”), directly or indirectly, of securities of Allergan representing (i) 20% or more of the combined voting power of Allergan’s then outstanding voting securities, which acquisition is not approved in advance of the acquisition or within 30 days after the acquisition by a majority of the Incumbent Board (as hereinafter defined) or (ii) 33% or more of the combined voting power of Allergan’s then outstanding voting securities, without regard to whether such acquisition is approved by the Incumbent Board;

(b)      Individuals who, as of the Effective Date hereof, constitute the Board of Directors (the “Incumbent Board”) cease for any reason to constitute at least a majority of the Board of Directors, provided that any person becoming a director subsequent to the Effective Date hereof whose election, or nomination for election by Allergan’s stockholders, is approved by a vote of at least a majority of the directors then comprising the Incumbent Board (other than an election or nomination of an individual whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of the directors of Allergan, as such terms are used in Rule 14a-11 of Regulation 14A promulgated under the Exchange Act) shall, for the purposes of this Plan, be considered as though such person were a member of the Incumbent Board of Allergan;

(c)      The consummation of a merger, consolidation or reorganization involving Allergan, other than one which satisfies both of the following conditions:

(i)      a merger, consolidation or reorganization which would result in the voting securities of Allergan outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of another entity) at least 55% of the combined voting power of the voting securities of Allergan or such other entity resulting from the merger, consolidation or reorganization (the “Surviving Corporation”) outstanding

 

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immediately after such merger, consolidation or reorganization and being held in substantially the same proportion as the ownership in Allergan’s voting securities immediately before such merger, consolidation or reorganization, and

(ii)     a merger, consolidation or reorganization in which no Person is or becomes the Beneficial Owner, directly or indirectly, of securities of Allergan representing 20% or more of the combined voting power of Allergan’s then outstanding voting securities; or

(d)      The stockholders of Allergan approve a plan of complete liquidation of Allergan or an agreement for the sale or other disposition by Allergan of all or substantially all of Allergan’s assets.

Notwithstanding the preceding provisions of this Section 11.2, a Change in Control shall not be deemed to have occurred if the Person described in the preceding provisions of this Section 13.2 is (i) an underwriter or underwriting syndicate that has acquired the ownership of any of Allergan’s then outstanding voting securities solely in connection with a public offering of Allergan’s securities, (ii) Allergan or any subsidiary of Allergan or (iii) an employee stock ownership plan or other employee benefit plan maintained by Allergan (or any of its affiliated companies) that is qualified under the provisions of the Code. In addition, notwithstanding the preceding provisions of this Section 13.2, a Change in Control shall not be deemed to have occurred, (i) if the Person described in the preceding provisions of this Section 13.2 becomes a Beneficial Owner of more than the permitted amount of outstanding securities as a result of the acquisition of voting securities by Allergan which, by reducing the number of voting securities outstanding, increases the proportional number of shares beneficially owned by such Person, provided, that if a Change in Control would occur but for the operation of this sentence and such Person becomes the Beneficial Owner of any additional voting securities (other than through the exercise of options granted under any stock option plan of the Company or through a stock dividend or stock split), then a Change in Control shall occur, and (ii) upon the distribution of the stock of Advanced Medical Optics, Inc. on June 29, 2002 by Allergan to its stockholders.

ARTICLE XII

ESTABLISHMENT OF TRUST

12.1      Establishment of Trust .  Contemporaneous with the adoption of this Plan, the Company established the Trust Agreement for Allergan, Inc. Executive Deferred Compensation Plan (the “Trust” or “Trust Agreement”). The Trust created thereunder is a grantor trust within the meaning of subpart E, part I, subchapter J, chapter 1, subtitle A of the Code. JPMorgan Chase Bank, N.A. has been named as Trustee under such Trust Agreement. The provisions of the Trust Agreement are incorporated herein by reference.

12.2      Funding of Trust .  All amounts of Base Salary or Bonuses that are subject to Deferral Elections by Participants under this Plan shall be contributed by the Company to the Trust (or directly to other investment vehicles to be held by the Trustee as part of the Trust’s

 

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assets) at or about the same time as such amounts are credited to the Deferral Accounts of Participants.

12.3      Investment in Fund Media .  With respect to assets of the Trust attributable to Deferral Elections where the Fund Rate applies, the Committee may provide, in its sole discretion, methods by electronic means or otherwise for Participants (or the Committee where the Plan so provides) to make or change investment decisions consistent with the terms of the Plan.

ARTICLE XIII

MISCELLANEOUS PROVISIONS

13.1      Designation of Beneficiary .  A Participant shall be entitled to designate one or more individuals or entities, in any combination, as his or her “Beneficiary” or “Beneficiaries” to receive any Plan payments to which such Participant is entitled as of, or by reason of, his or her death. Any such designation may be made or changed at any time prior to the Participant’s death by written notice filed with the Committee, with such written notice to be in such form and contain such information as the Committee may from time to time determine. In the event that either (i) a Beneficiary designation is not on file at the date of a Participant’s death, (ii) no Beneficiary survives the Participant, or (iii) no Beneficiary is living at the time any payment becomes payable under this Plan, then, for purposes of making any further payment of any unpaid benefits under this Plan, such Participant’s Beneficiary or Beneficiaries shall be deemed to be the estate of the Participant.

13.2      Payments During Incapacity .  In the event a Participant (or Beneficiary) is under mental or physical incapacity at the time of any payment to be made to such Participant (or Beneficiary) pursuant to this Plan, any such payment may be made to the conservator or other legally appointed personal representative having authority over and responsibility for the person or estate of such Participant (or Beneficiary), as the case may be, and for purposes of such payment references in this Plan to the Participant (or Beneficiary) shall mean and refer to such conservator or other personal representative, whichever is applicable. In the absence or any lawfully appointed conservator or other personal representative of the person or estate of the Participant (or Beneficiary), any such payment may be made to any person or institution that has apparent responsibility for the person and/or estate or the Participant (or Beneficiary) as determined by the Committee. Any payment made in accordance with the provisions of this Section 13.2 to a person or institution other than the Participant (or Beneficiary) shall be deemed for all purposes of this Plan as the equivalent of a payment to such Participant (or Beneficiary), and the Company shall have no further obligation or responsibility with respect to such payment.

13.3      Domestic Relations Orders .  Notwithstanding any provision in the Plan to the contrary and subject to the approval of the Committee, in the event all or portion of a Participant’s vested benefit under the Plan is awarded to an individual (hereinafter referred to as the “alternate payee”) pursuant to a domestic relations order entered by a court in settlement of marital property rights (hereinafter referred to as a “DRO”), the awarded benefit shall be distributed to the alternate payee in a single lump sum as soon as administratively feasible

 

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following receipt of the DRO by the Company. If the alternate payee is awarded an interest in both the vested and non-vested portions of a Participant’s benefit under the Plan, the awarded benefit shall be distributed to the alternate payee in a single lump sum as soon as administratively feasible following the date the Participant is fully vested in his or her benefit or, if earlier, the date on which the Participant’s entire vested benefit under the Plan can be determined. It is intended that a DRO shall be approved by the Committee only if it meets the applicable requirements of a “qualified domestic relations order” as defined in Code Section 414(p) and only to the extent the distribution provisions of this Section are permitted under Code Section 409A.

13.4      Prohibition Against Assignment .  Except as otherwise expressly provided in Sections 13.1, 13.2, and 13.3 hereof, the rights, interests and benefits of a Participant under this Plan (i) may not be sold, assigned, transferred, pledged, hypothecated, gifted, bequeathed or otherwise disposed of to any other party by such Participant or any Beneficiary, executor, administrator, heir, distributee or other person claiming under such Participant, and (ii) shall not be subject to execution, attachment or similar process. Any attempted sale, assignment, transfer, pledge, hypothecation, gift, bequest or other disposition of such rights, interests or benefits contrary to the foregoing provisions of this Section 13.4 shall be null and void and without effect.

13.5      Binding Effect .  The provisions of this Plan shall be binding upon the Company, the Participants and any successor-in-interest to the Company or to any Participant.

13.6      No Transfer of Interest .  Other than as provided in Article XII and in the Trust Agreement, benefits under this Plan shall be payable solely from the general assets of the Company and no person shall be entitled to look to any source for payment of such benefits other than the general assets of the Company. The Company shall have and possess all title to, and beneficial interest in, any and all funds or reserves maintained or held by the Company on account of any obligation to pay benefits as required under this Plan, whether or not earmarked by the Company as a fund or reserve for such purpose; any such funds or reserves shall be subject to the claims of the creditors of the Company, and the provisions of this Plan are not intended to create, and shall not be interpreted as vesting, in any Participant, Beneficiary or other person, any right to or beneficial interest in any such funds or reserves.

13.7      Amendment or Termination of the Plan .  The Company, by action of its Board of Directors, may amend this Plan from time to time in any respect that it deems appropriate or desirable, and may terminate this Plan at any time; provided , however , that any such Plan amendment or Plan termination shall not, without a Participant’s written consent, be given effect with respect to such Participant to the extent such Plan amendment or Plan termination operates to reduce or eliminate (except to the extent that amounts are distributed under the Plan) such Participant’s Deferral Accounts as of the date of such amendment or termination. In addition, if the Board amends the Plan so as to make a change in the formula for determining the Fund Rate of any Fund Media or the Company Rate, if applicable, to be credited under the Plan, such amendment shall not become effective until thirty (30) days advance written notice is given to Participants.

 

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13.8      No Right to Employment .  This Plan is voluntary on the part of the Company, and the Plan shall not be deemed to constitute an employment contract between the Company and any Participant, nor shall the adoption or existence of the Plan or any provision contained in the Plan be deemed to be a required condition of the employment of any Participant. Nothing contained in this Plan shall be deemed to give any Participant the right to continued employment with the Company, and the Company may terminate any Participant at any time, in which case the Participant’s rights arising under this Plan shall be only those expressly provided under the terms of this Plan.

13.9      Notices .  All notices, requests, or other communications (hereinafter collectively referred to as “Notices”) required or permitted to be given hereunder or which are given with respect to this Plan shall be in writing and may be personally delivered, or may be deposited in the United States mail, postage prepaid and addressed as follows:

 

To the Company    Allergan, Inc.   
or the Committee at:    Attention:    Global Investments & Benefits Subcommittee
      (Executive Deferred Compensation Plan)
   2525 Dupont Drive
   Irvine, CA 92612
   cc: General Counsel
To Participant at:    The Participant’s residential mailing address as reflected in the Company’s employment records

A Notice which is delivered personally shall be deemed given as of the date or personal delivery, and a Notice mailed as provided herein shall be deemed given on the second business day following the date so mailed. Any Participant may change his or her address for purposes of Notices hereunder pursuant to a Notice to the Committee, given as provided herein, advising the Committee of such change. The Company and/or the Committee may at any time change its address for purposes of Notices hereunder pursuant to a Notice to all Participants, given as provided herein, advising the Participants of such change.

13.10     Governing Law .  This Plan shall be governed by, interpreted under, and construed and enforced in accordance with ERISA and, to the extent applicable, the internal laws (and not the laws pertaining to conflicts or choice of laws), of the State of California applicable to agreements made and to be performed wholly within the State of California.

13.11     Titles and Headings; Gender of Terms .  Article and Section headings herein are for reference purposes only and shall not be deemed to be part of the substance of this Plan or in any way to enlarge or limit the meaning or interpretation of any provision in this Plan. Use in this Plan of the masculine, feminine or neuter gender shall be deemed to include each of the omitted genders if the context so requires.

13.12     Severability .  In the event that any provision of this Plan is found to be invalid or otherwise unenforceable by a court or other tribunal of competent jurisdiction, such invalidity or

 

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unenforceability shall not be construed as rendering any other provision contained herein invalid or unenforceable, and all such other provisions shall be given full force and effect to the same extent as though the invalid and unenforceable provision was not contained herein.

13.13     Tax Effect of Plan .  The Company does not warrant any tax benefit nor any financial benefit under the Plan. Without limiting the foregoing, directors, officers, and employees of the Company (other than in their capacity as Participants) shall be held harmless by the Company from, and shall not be subject to any liability on account of, any Federal or State tax consequences or any consequences under ERISA of any determination as to the amount of Plan benefits to be paid, the method by which Plan benefits are paid, the persons to whom Plan benefits are paid, or the commencement or termination of the payment of Plan benefits.

IN WITNESS WHEREOF, Allergan, Inc. hereby executes this instrument, evidencing the terms of the Allergan, Inc. Executive Deferred Compensation Plan as restated this 19 th day of December , 2008.

 

ALLERGAN, INC.
By   /s/ Douglas S. Ingram   
  Douglas S. Ingram   
  Executive Vice President, Chief Administrative Officer, General Counsel and Secretary

 

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APPENDIX A

Fund Media

The following are designated as the Fund Media as of the adoption date of this 2009 Restatement subject to addition or deletion as set forth in Section 5.4:

Vanguard Prime Money Market Fund

Western Asset Core Plus Bond Portfolio - Inst

Dodge & Cox Balanced Fund

Dodge & Cox Stock Fund

American Century Income and Growth Fund - Inst

Barclays Global Inv S&P 500 Equity Index Fund - I

Janus Adviser INTECH Risk-Managed Growth-I

Columbia Marsico Equities - Z

TIAA-CREF Inst’l Small Cap Blend Index - Inst

Evergreen Special Values - I

TimesSquare Small Cap Growth Fund

American Funds New Perspective Fund – R5

American Funds EuroPacific Growth Fund – R5

This Appendix A shall be changed automatically to reflect the current Fund Media when the Committee adds or deletes Fund Media in accordance with Section 5.4.

EXHIBIT 10.60

FIRST AMENDMENT TO AMENDED AND RESTATED LICENSE,

COMMERCIALIZATION AND SUPPLY AGREEMENT

THIS FIRST AMENDMENT TO AMENDED AND RESTATED LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENT (this “ Amendment ”), dated as of January 9, 2009 (the “ Amendment Effective Date ”), is entered into by and among Indevus Pharmaceuticals, Inc., a corporation organized and existing under the laws of the State of Delaware and having its principal office at 33 Hayden Avenue, Lexington, MA 02421 (“ Indevus ”), and Allergan USA, Inc., a corporation organized and existing under the laws of the State of Delaware and having its principal office at 2525 Dupont Drive, Irvine, CA 92612 (f/k/a Esprit Pharma, Inc.) (“ Allergan ”). Indevus and Allergan are collectively referred to herein as the “ Parties ”.

W I T N E S S E TH:

WHEREAS , the Parties entered into that certain Amended and Restated License, Commercialization and Supply Agreement, dated as of September 18, 2007 (as in effect as of the Amendment Effective Date, the “ Agreement ”); and

WHEREAS , the Parties mutually desire to extend the Copromotion Period and to otherwise amend the Agreement to set forth certain terms and conditions applicable to the extension of the Copromotion Period.

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

1.         Definitions and References .  Except as set forth herein, capitalized terms not otherwise defined or amended in this Amendment shall have the meaning ascribed to them in the Agreement. References to Articles or Sections are to the same with all their subparts as they appear in the Agreement. References to Paragraphs are to the numbered paragraphs with all their subparts as they appear in this Amendment.

2.         Amendments to the Agreement .  Effective as of the Amendment Effective Date, the Agreement shall be amended as set forth in this Paragraph 2:

(a)         Section 1.20 shall be amended and restated in its entirety to read as follows:

“1.20         Copromotion Period ” means the period commencing on the Effective Date and expiring on (a) September 30, 2009, or (b) the last day of any applicable Cure Period in which Indevus completes its Detail Obligations in accordance with Section 5.5(b)(ii) after September 30, 2009.”

(b)         Section 5.5 (b) shall be amended to add the following subsection (iii) after subsection (ii) thereof:

“(iii) The number of Quarterly Indevus Details, all of which shall be Secondary Position Details, to be delivered to the Indevus Target Prescribers during the Calendar Quarters


ending June 30, 2009 and September 30, 2009 shall be twenty-three thousand four hundred thirty-seven (23,437) per Calendar Quarter.”

(c)         Section 6.3 shall be amended to (i) change the current subsection (c) thereof to subsection (d); and (ii) insert the following new subsection (c) thereof:

  “(c)        Allergan shall pay to Indevus, as a sales force reimbursement for the Indevus Sales Force, an amount equal to (i) US$1,150,000 (one million one hundred fifty thousand dollars) for each Calendar Quarter from April 1, 2009 through September 30, 2009.

The sales force reimbursement amounts set forth in (a), (b) and (c), above (the “ Sales Force Reimbursement ”) shall be payable in accordance with Section 6.4(a).”

3.         Other .

(a)        Effect of Amendment.   From and after the Amendment Effective Date, all references to the Agreement shall mean the Agreement as amended by this Amendment. Except as expressly amended by this Amendment, all of the provisions of the Agreement shall remain in full force and effect.

(b)        Counterparts.   This Amendment may be executed in two or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Signatures to this Amendment transmitted by fax, by email in “portable document format” (“.pdf”) or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Amendment shall have the same effect as physical delivery of the paper document bearing original signature.

(c)        Severability.   In the event that any of the provisions contained in this Amendment are held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provisions(s) adversely affects the substantive rights of the Parties. In such event, the Parties covenant and agree to renegotiate any such term, covenant or application thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant or condition of this Amendment or the application thereof that is invalid or unenforceable, it being the intent of the Parties that the basic purposes of this Amendment are to be effectuated.

(d)        Specific Performance.   Each of the Parties acknowledges and agrees that the other Party would be damaged irreparably in the event any of the provisions of this Amendment are not performed in all material respects or otherwise are breached. Accordingly, and notwithstanding anything herein to the contrary, each of the Parties agree that the other party shall be entitled to injunctive relief to prevent breaches of the provisions of this Agreement, and/or to enforce specifically this Amendment and the terms and provisions hereof, in any action instituted in any court or tribunal having jurisdiction over the Parties and the matter, without posting any bond or other security, and that such injunctive relief shall be in addition to any other remedies to which such Party may be entitled, at law or in equity.

(e)        Waiver.   The waiver by a Party hereto of any right hereunder or the failure to perform or of a breach by another Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said Party whether of a similar nature or otherwise.

 

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(f)        Applicable Law and Venue.   This Amendment shall be governed by the laws of the State of New York. All actions and proceedings arising out of or relating to this Amendment shall be heard and determined in any New York State or federal court sitting in the City of New York, County of Manhattan, and the Parties hereto hereby irrevocably submit to the exclusive jurisdiction of such courts in any such action or proceeding and irrevocably waive any defense of an inconvenient forum to the maintenance of any such action or proceeding. The United Nations Convention on Contracts for the International Sale of Goods shall not apply in any action, suit or proceeding arising out of or relating to this Amendment.

(g)        Entire Amendment.   This Amendment contains the entire understanding of the Parties with respect to the subject matter of this Amendment. All express or implied agreements and understandings, either oral or written, made on or before the Amendment Effective Date, including any offering letters or term sheets, are expressly superseded by this Amendment. This Amendment may be amended, or any term hereof modified, only by a written instrument duly executed by all Parties.

(h)        Notices.   All notices, requests and other communications hereunder shall be in writing and shall be personally delivered or sent by facsimile transmission (and promptly confirmed by personal delivery, registered or certified mail or overnight courier) or by registered or certified mail, return receipt requested, postage prepaid, or sent by internationally-recognized overnight courier, in each case to the respective address specified below, or such other address as may be specified in writing to the other party hereto:

if to Indevus to:

Indevus Pharmaceuticals, Inc.

33 Hayden Avenue

Lexington, MA 02421

Attention: General Counsel

Fax No.: 781-861-0253

if to Allergan to:

Allergan, Inc.

2525 Dupont Drive

Irvine, CA 92612

Attention: General Counsel

Fax No.: 714-246-4774

 

 

[Remainder of page intentionally left blank]

 

- 3 -


IN WITNESS WHEREOF , the Parties have executed this Amendment as of the Amendment Effective Date.

 

Indevus Pharmaceuticals, Inc.
By:   /s/ Mark S. Butler
Name:   Mark S. Butler
Title:   Executive Vice President, Chief Administrative Officer and General Counsel

 

 

 

Allergan USA, Inc.

By:   /s/ David Lawrence        
Name:   David Lawrence
Title:   Vice President

 

- 4 -

Exhibit 10.61

EXECUTION COPY

 

LICENSE, DEVELOPMENT, SUPPLY AND DISTRIBUTION AGREEMENT

by and among

 

ALLERGAN SALES, LLC,

ALLERGAN USA, INC.,

ALLERGAN, INC.

and

SPECTRUM PHARMACEUTICALS, INC.

 

dated October 28, 2008

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Table of Contents

 

ARTICLE 1 DEFINITIONS; INTERPRETATION    1

1.1

     Definitions    1

1.2

     Interpretation    2
ARTICLE 2 LICENSES; DELIVERY    2

2.1

     License to Allergan    2

2.2

     Degree of Exclusivity    3

2.3

     Allergan Sublicense Right    3

2.4

     Spectrum’s Retained Rights    3

2.5

     Spectrum Additional Limitations    4

2.6

     Additional Restrictions    6

2.7

     Diversion    8

2.8

     Delivery Obligations of Spectrum    9

2.9

     Delivery Obligations of Allergan    9
ARTICLE 3 DEVELOPMENT; SUPPLY; MARKETING    9

3.1

     Development Obligations    9

3.2

     Joint Development Plans    10

3.3

     Manufacturing Obligations    14

3.4

     Commercialization Rights and Obligations    18
ARTICLE 4 COMMITTEES    20

4.1

     Generally    20

4.2

     Governance of Each Committee    21

4.3

     Joint Development Committee    21

4.4

     Joint Supply Committee    22

4.5

     Joint Marketing Committee    23

4.6

     Escalation Procedure    23
ARTICLE 5 REGULATORY MATTERS    25

5.1

     Obligations of the Parties Relating to Regulatory Submissions    25

5.2

     Information Sharing    27

5.3

     Remedial Actions    27

5.4

     Costs Of Remedial Action    27

5.5

     Pharmacovigilance or Adverse Event Reporting    28

5.6

     Notification of Complaints    28

5.7

     Notification of Threatened Action    29

5.8

     Regulatory Inspections    29

5.9

     Audits    29

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


ARTICLE 6 PAYMENTS AND ROYALTIES    29

6.1

     Upfront Payment    29

6.2

     Development Milestone Payments    30

6.3

     Sales Milestone Payments    31

6.4

     Running Royalties    32

6.5

     Royalty Payment Schedule    35

6.6

     Development Costs    35

6.7

     Currency of Payments    36

6.8

     Budget    36

6.9

     Books; Records    36

6.10

     Audits    36

6.11

     Offset    37

6.12

     Stacking    37

6.13

     Withholding Taxes    37

6.14

     Spectrum’s Obligations    38

6.15

     Late Payment    38
ARTICLE 7 TRADEMARK ASSIGNMENT    38

7.1

     Assignment    38

7.2

     No Use by Spectrum    38
ARTICLE 8 INTELLECTUAL PROPERTY    39

8.1

     Ownership    39

8.2

     Prosecution    39

8.3

     Enforcement    40
ARTICLE 9 CONFIDENTIAL INFORMATION    42

9.1

     Confidentiality Obligations    42

9.2

     Disclosure Required by Law    43

9.3

     Equitable Relief    44

9.4

     Independent Development; Residuals    44
ARTICLE 10 CERTAIN REMEDIES; NOTICE RIGHT    44

10.1

     Development Trigger    44

10.2

     Change in Control Trigger    45

10.3

     Co-Promotion Trigger    45

10.4

     Clarification    46

10.5

     Notice    46
ARTICLE 11 REPRESENTATIONS, WARRANTIES AND COVENANTS    46

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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11.1

     Both Parties    46

11.2

     Licensed Intellectual Property: Ownership/Right to License; Non-Infringement; Validity    47

11.3

     All Rights Granted    48

11.4

     No Law Suits    48

11.5

     Trademarks    48

11.6

     Confidentiality    49

11.7

     Regulatory Approvals    49

11.8

     Professional Standards    50

11.9

     No Conflict    50

11.10

     Additional Warranties    51

11.11

     Licensed Product Warranties    51

11.12

     Inaccuracies    52

11.13

     DISCLAIMER OF ALL OTHER WARRANTIES    52
ARTICLE 12 INDEMNIFICATION; LIMITATIONS ON LIABILITY; INSURANCE REQUIREMENTS    52

12.1

     Indemnification By Spectrum    52

12.2

     Indemnification By Allergan    53

12.3

     Procedure    53

12.4

     Allocation of Product Liability Risks    54

12.5

     Infringement Remedies    56

12.6

     LIMITATIONS ON LIABILITY    56

12.7

     Insurance    56
ARTICLE 13 TERM AND TERMINATION    57

13.1

     Term    57

13.2

     Termination at Will    57

13.3

     Material Breach    59

13.4

     365(n)    59

13.5

     Effect of Termination    59
ARTICLE 14 MISCELLANEOUS    60

14.1

     Relationship of Parties    60

14.2

     Force Majeure Event    61

14.3

     Entire Agreement    61

14.4

     No Waiver; Amendment    61

14.5

     Partial Invalidity    61

14.6

     Assignment    62

14.7

     Governing Law    62

14.8

     Remedies    62

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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14.9

     Further Assurances    62

14.10

     Counterparts; Facsimile    62

14.11

     Notices    62

14.12

     Press Releases and Announcements    64

14.13

     Use of Subcontractors    64

List of Schedules

Schedule 1.1 – Definitions

Exhibit A to Schedule 1.1 – Apaziquone

Exhibit B to Schedule 1.1 –  Example of Closed System Packaging

Exhibit C to Schedule 1.1 – TPP

Schedule 3.1(a) - Joint Development Plan

Schedule 3.1(c) - Key Development Personnel

Schedule 3.2 (f)(i) - List of Subcontractors

Schedule 3.2(f)(ii) - Hospitals and Institutions that are clinical trial sites

Schedule 3.3(b) - Spectrum Manufacturing Agreements

Schedule 3.3(d) - Specifications

Schedule 3.4(a) - Co-Promotion Agreement

Section 3.4(b)(i) - Initial Joint Marketing Plan

Schedule 6.4(a) - Example of Royalties

Schedule 7.1 - Trademark Assignment Agreement, including Exhibit A

Schedule 11.2(e) - Disclosures

Schedule 11.5(c) - Trademark and Domain Name Applications and Registrations for the Acquired Trademarks

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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LICENSE, DEVELOPMENT, SUPPLY AND DISTRIBUTION AGREEMENT

This LICENSE, DEVELOPMENT, SUPPLY AND DISTRIBUTION AGREEMENT (this “ Agreement ”), entered into as of October 28, 2008 (the “ Effective Date ”), is made by and among Allergan Sales, LLC, a Delaware corporation with its principal place of business at 2525 Dupont Drive, Irvine, California 92612 (“ Allergan Sales ”), Allergan USA, Inc., a Delaware corporation with its principal place of business at 2525 Dupont Drive, Irvine, California 92612 (“ Allergan USA ”), Allergan, Inc., a Delaware corporation with its principal place of business at 2525 Dupont Drive, Irvine, California 92612 (“ Allergan, Inc. ” and, collectively with Allergan Sales and Allergan USA, “ Allergan ”) and Spectrum Pharmaceuticals, Inc. (“ Spectrum ”), a Delaware corporation with its principal place of business at 157 Technology Drive, Irvine, CA 92618. Allergan and Spectrum are collectively referred to herein as the “ Parties ” and individually as a “ Party ”.

RECITALS

WHEREAS, Spectrum has developed certain intellectual property relating to the use of Apaziquone for urological treatments and is conducting Phase 3 trials using the immediate intravesical instillation of Apaziquone for the treatment of bladder cancer;

WHEREAS, Allergan has substantial expertise in the research, development, manufacture, distribution, sales and marketing of urologic products, but does not currently market or manufacture a bladder cancer treatment;

WHEREAS, the Parties desire to collaborate in conducting development and related activities, marketing in certain territories, and selling of product(s) containing Apaziquone for certain indications in those territories all on the terms and conditions set forth herein, but it is not the intention of the Parties to undertake an employment, joint venture, partnership or other fiduciary relationship; and

WHEREAS, Allergan USA will be responsible for the Allergan sales and distribution of the products described herein and Allergan Sales will be responsible for the Allergan development and manufacturing obligations described herein.

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual representations, warranties, covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

ARTICLE 1

DEFINITIONS; INTERPRETATION

1.1      Definitions . For the purposes of this Agreement, the capitalized terms used in this Agreement, and not otherwise defined when used, shall have the meanings specified in Schedule 1.1.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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1.2      Interpretation . This Agreement shall be governed by the following rules of construction, unless otherwise specified by the Agreement: (a) words of one gender shall be deemed to include words of other genders; (b) any reference to an Article, Section, Exhibit, clause, subclause, paragraph, subparagraph, Schedule or Recital is a reference to an Article, Section, Exhibit, clause, subclause, paragraph, subparagraph, Schedule or Recital of this Agreement; (c) any reference to any statute shall be construed as including all statutory provisions consolidating, amending or replacing such statute; (d) the terms “hereof,” “hereby,” “hereto,” “hereunder” and similar terms shall refer to this Agreement as a whole; (e) the word “including” and words of similar import mean “including, without limitation” and “including, but not limited to”; (f) the headings contained herein are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement; (g) this Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the Party drafting or causing any instrument to be drafted; (h) all references to “dollars” or “$” refer to United States dollars; and (i) all references to “days” mean calendar days. In the event of any inconsistency between the terms of the Schedules and the terms of the main body of this Agreement, the terms of the main body of this Agreement shall prevail, except that in the event of any inconsistency between the terms of Schedule 1.1 and the terms of the main body of this Agreement, the terms of Schedule 1.1 shall prevail.

ARTICLE 2

LICENSES; DELIVERY

2.1      License to Allergan . Subject to the terms and conditions of this Agreement, Spectrum hereby grants to Allergan and its Affiliates the following rights and licenses:

(a)     an exclusive (even as to Spectrum, but subject to Section 2.2), irrevocable, right and license, under the Licensed Intellectual Property, with the right to grant sublicenses (subject to Section 2.3), to make, have made, use, conduct clinical trials for, sell, offer for sale, have sold, import, export, or otherwise exploit the Licensed Product in the Allergan Territory; provided , however , that Allergan shall not make, have made, use, conduct clinical trials for, sell, offer for sale, have sold, import, export, or otherwise exploit the Licensed Product, under the Licensed Intellectual Property, outside the Field of Use in the Allergan Territory without Spectrum’s consent;

(b)     a non-exclusive, irrevocable, royalty-free right and license, under the Licensed Intellectual Property, with the right to grant sublicenses, to manufacture and have manufactured the Licensed Product in the Spectrum Territory solely for use or sale of such Licensed Product pursuant to Section 2.1(a); and

(c)     a non-exclusive, irrevocable, royalty-free right and license, with the right to grant sublicenses, to use, perform, modify, create derivative works of, copy, display, reproduce and distribute any and all Documents on or relating to the Licensed Product for the purpose of

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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exercising the rights granted in Section 2.1(a).

2.2      Degree of Exclusivity . The license granted in Section 2.1(a) is exclusive. As used herein, “exclusive” shall mean that Spectrum may not:

(a)     grant any other license to any other licensee of the Licensed Intellectual Property within the scope of the license granted to Allergan under Section 2.1(a), in whole or in part;

(b)     itself make, have made, use, conduct clinical trials for, sell, offer for sale, have sold, import, export, or otherwise exploit under the Licensed Intellectual Property within the scope of the license granted to Allergan under Section 2.1(a); and

(c)     assign, transfer or otherwise dispose of the Licensed Intellectual Property except as part of an assignment of the entire Agreement pursuant to Section 14.6.

Notwithstanding the foregoing, Spectrum shall:

(i)     have the right to perform its obligations set forth in this Agreement and the Co-Promotion Agreement;

(ii)    have the rights set forth in Section 2.5(b); and

(iii)   shall have the right, under the Licensed Intellectual Property, to manufacture and have manufactured any formulation including Apaziquone in the Allergan Territory solely for use or sale of such formulation including Apaziquone within the scope of Spectrum’s retained rights under Sections 2.4(a) and (b).

2.3      Allergan Sublicense Right . Allergan shall have the unrestricted right to grant sublicenses under the license in Section 2.1(a) in the Field of Use to its Affiliates without the prior written consent of Spectrum, and in the Field of Use to any other Third Parties: (a) with the prior written consent of Spectrum in the Co-Promotion Region during the term of the Co-Promotion Agreement; and (b) without the prior written consent of Spectrum in any other country or territory in the Allergan Territory. Allergan shall have the unrestricted right to subcontract any of its obligations hereunder which do not require the sublicenses described in Section 2.3(a) above.

2.4      Spectrum’s Retained Rights .

(a)     Spectrum retains the right under the Licensed Intellectual Property to develop and commercialize any formulation including Apaziquone in the Spectrum Territory. Provided that Spectrum is not in material breach of the terms of this Agreement, on written request by Spectrum, Allergan agrees to negotiate in good faith for a reasonable period the terms of a commercially reasonable royalty-bearing license under the Allergan Solely Developed Know How and Allergan’s rights under the Joint Intellectual Property for Spectrum to develop and commercialize any formulation including Apaziquone in the Spectrum Territory.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(b)     Spectrum retains the right under the Licensed Intellectual Property to develop and commercialize any formulation including Apaziquone that is not a Licensed Product in the Allergan Territory. Provided that Spectrum is not in material breach of the terms of this Agreement, on written request by Spectrum, Allergan agrees to negotiate in good faith for a reasonable period the terms of a commercially reasonable royalty-bearing license under the Allergan Solely Developed Know How and Allergan’s rights under the Joint Intellectual Property for Spectrum to develop and commercialize any formulation including Apaziquone that is not a Licensed Product in the Allergan Territory.

(c)     If the Parties cannot agree on the royalty rate and scope of the license grant terms of such commercially reasonable royalty-bearing licenses (in Section 2.4 (a) or (b), or in Section 2.5(b)(iii)(A) or Section 13.2(c)(i)) within a reasonable period of time, either Party may initiate, and the Parties shall jointly submit to, binding arbitration in California, and the sole issues to be submitted to arbitration shall be the royalty rate and scope of the license grant. Upon conclusion of such arbitration, the Parties agree to effect the arbitrator’s order which shall be binding.

2.5      Spectrum Additional Limitations .

(a)     Spectrum will not conduct clinical trials in the Field of Use with any formulation including Apaziquone in the Allergan Territory, other than for the Licensed Product in the Field of Use under this Agreement.

(b)     If Spectrum desires to develop or commercialize any Licensed Product for use outside the Field of Use in the Allergan Territory the following shall apply:

(i)     prior to Spectrum initiating any clinical trial using a Licensed Product for use outside the Field of Use in the Allergan Territory (such as ****), Spectrum will notify Allergan in writing (the “ Option Notice ”) detailing such proposed use and will provide Allergan with any data (including Spectrum’s then current development plan and budget) then possessed by Spectrum on such Licensed Product for such use in such indication (such Licensed Product for such use in such indication is the “ Option Product ”);

(ii)    Allergan may, at its option, choose to co-develop and co-promote such Option Product with Spectrum by delivering to Spectrum written notice within ninety (90) days after receipt of the Option Notice. If Allergan elects to co-develop and/or co-promote such Option Product with Spectrum, the Parties shall negotiate in good faith a written agreement (the “ Option Product Agreement ”) covering the following:

(A)     the terms for development and/or commercialization of such Option Product;

(B)     a committee structure for the oversight of the development, marketing and commercialization of the Option Product, with similar decision-making rules as those in effect under this Agreement; and

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(C)     cross licenses under the Allergan Solely Developed Know How, Licensed Intellectual Property and Allergan’s rights in the Joint Intellectual Property to develop and commercialize such Option Product under similar terms to those set forth in this Agreement.

(iii)    If Allergan chooses not to co-develop and co-promote such Option Product with Spectrum (as indicated by Allergan’s delivery of written notice to Spectrum rejecting such rights, or failure to make an affirmative election within ninety (90) days after receipt of the Option Notice), or the Parties fail to enter into an Option Product Agreement, then Spectrum will have the right to pursue the development and commercialization of such Option Product for the scope described to Allergan in the Option Notice on its own and at its own expense (by itself or with a Third Party, subject to Section 2.5(b)(iv)), and the following will apply:

(A)     Allergan agrees to negotiate in good faith for a reasonable period the terms of a commercially reasonable royalty-bearing license under the Allergan Solely Developed Know How and Allergan’s rights under the Joint Intellectual Property for Spectrum to develop and commercialize the Option Product for use outside the Field of Use in the Allergan Territory (any disagreement shall be subject to binding arbitration pursuant to the terms of Section 2.4(c));

(B)     Spectrum shall not use any Trademark that is the same as, or similar to (so as to cause confusion in consumers), the Acquired Trademarks or any other Trademark used by Allergan or its Affiliates in Spectrum’s development or commercialization of the Option Product;

(C)     Spectrum will package the Option Product in a manner that will not be confused with the Licensed Product in the Field of Use, and will label such Option Product as “not for bladder cancer treatment”; and

(D)     Spectrum will not promote, market, sell or distribute such Option Product for use in the Field of Use in the Allergan Territory, and will use diligent efforts to prevent and curb any use of such Option Product in the Field of Use in the Allergan Territory, including meeting the requirements set forth in Sections 2.7(a) and (d).

(iv)     If Allergan opts out of developing and/or commercializing an Option Product under subsection (iii) or the Parties fail to enter into an Option Product Agreement, and Spectrum or any of its Affiliates desires to commence development or commercialization of such Option Product with a Third Party (excluding any Affiliate of Spectrum) (“ Proposed Transaction ”), then the following shall apply:

(A)     the terms of the Proposed Transaction under which Spectrum (or its Affiliate) contracts with such Third Party may not be more favorable to such

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Third Party, taken as a whole, than the terms applicable to Allergan last offered to Spectrum by Allergan; and

(B)     if Spectrum (or its Affiliate) does not execute a definitive agreement for the Proposed Transaction with a Third Party within nine (9) months following the date that Allergan opts out under subsection (iii) or the Parties’ terminated negotiation of an Option Product Agreement, then Spectrum (or its Affiliate) shall be obligated to comply with this Section 2.5(b) again prior to entering into a Proposed Transaction with a Third Party (i.e., Spectrum (or its Affiliate) shall deliver a new Option Notice under Section 2.5(b)(i) and update its data delivery, and recommence the option process with Allergan).

For clarity, if Allergan opts out of developing and/or commercializing an Option Product under subsection (iii) or fails to make an affirmative election within ninety (90) days after the receipt of an Option Notice, or the Parties fail to enter into an Option Product Agreement, then Spectrum may then commence a clinical trial of the Option Product for use outside the Field of Use. Spectrum acknowledges and agrees that neither it nor its Affiliates will use this process to circumvent the intent of this Section 2.5(b).

2.6      Additional Restrictions .

(a)     For the period commencing on the Effective Date and ending **** after the First Commercial Sale of a Licensed Product in the Field of Use in the Allergan Territory, Allergan will not develop or commercialize any formulation including Apaziquone, except as a Licensed Product in the Field of Use, without Spectrum’s written consent. It shall not be a breach of this subsection to the extent that: (A) there is a Change in Control of Allergan and the acquirer of Allergan’s stock or other securities or all or substantially all of the assets or any integral part of any Allergan, at the time of acquisition, is developing or commercializing itself or through its Affiliates any formulation that includes Apaziquone outside the Field of Use; or (B) Allergan directly or indirectly, including through an Affiliate, acquires or purchases the stock or other securities or all or substantially all of the assets or any integral part of any Third Party which at the time of acquisition is developing or commercializing itself or through its Affiliates any formulation that includes Apaziquone outside the Field of Use.

(b)     Except for Spectrum’s performance obligations hereunder, for the period commencing on the Effective Date and ending on the earlier of (i) an Allergan Trigger Date (hereinafter defined), or (ii) **** after the First Commercial Sale of a Licensed Product in the Field of Use in the Allergan Territory, Spectrum and its Affiliates shall not, by license or otherwise, research, develop, make, use, market, sell, distribute or otherwise commercialize any Antineoplastic (hereinafter defined) in the Field of Use in the Allergan Territory. It shall not be a breach of this subsection to the extent that: (A) there is a Change in Control of Spectrum and the acquirer of Spectrum’s stock or other securities or all or substantially all of the assets or any integral part of Spectrum, at the time of acquisition, is developing or commercializing itself or through its Affiliates an Antineoplastic in the Field of Use in the Allergan Territory; or (B)

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Spectrum directly or indirectly, including through an Affiliate, acquires or purchases the stock or other securities or all or substantially all of the assets or any integral part of any Third Party which at the time of acquisition is developing or commercializing itself or through its Affiliates any Antineoplastic in the Field of Use in the Allergan Territory.

(c)     Except for the Licensed Product, for the period commencing on the Effective Date and ending on the earlier of (i) a Spectrum Trigger Date (hereinafter defined), or (ii) **** after the First Commercial Sale of a Licensed Product in the Field of Use in the Allergan Territory, Allergan and its Affiliates shall not, by license or otherwise, research, develop, make, use, market, sell, distribute or otherwise commercialize any Antineoplastic in the Field of Use in the Allergan Territory. It shall not be a breach of this subsection to the extent that: (A) there is a Change in Control of Allergan and the acquirer of Allergan’s stock or other securities or all or substantially all of the assets or any integral part of Allergan, at the time of acquisition is developing or commercializing itself or through its Affiliates an Antineoplastic in the Field of Use in the Allergan Territory; or (B) Allergan directly or indirectly, including through an Affiliate, acquires or purchases the stock or other securities or all or substantially all of the assets or any integral part of any Third Party which at the time of acquisition is developing or commercializing itself or through its Affiliates any Antineoplastic in the Field of Use in the Allergan Territory.

(d)     If the foregoing restrictions in subsections (b) and (c) are held by a court of competent jurisdiction to be unenforceable, the restriction shall be automatically converted into a covenant under which the applicable Party shall have the right of first negotiation to license the rights covered by the restrictions in subsection (b) and (c) prior to their use or disposal of such rights by the Party that would otherwise be in breach of subsection (b) or (c), upon commercially reasonable terms.

(e)     The following terms have the meanings set forth next to them when used in this Section 2.6:

(i)     “ Allergan Trigger Date ” means the date on which (A) there is a Change in Control of Allergan and the acquirer of Allergan’s stock or other securities or all or substantially all of the assets or any integral part of any Allergan, at the time of acquisition is developing or commercializing itself or through its Affiliates an Antineoplastic (except for a Licensed Product) in the Field of Use in the Allergan Territory, or (B) Allergan directly or indirectly, including through an Affiliate, acquires or purchases the stock or other securities or all or substantially all of the assets or any integral part of any Third Party which at the time of acquisition is developing or commercializing itself or through its Affiliates any Antineoplastic (except for a Licensed Product) in the Field of Use in the Allergan Territory.

(ii)    “ Antineoplastic ” means a chemotherapeutic agent that causes cell death via redox cycle or alkylation of DNA.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(iii)    “ Spectrum Trigger Date ” means the date on which (A) there is a Change in Control of Spectrum and the acquirer of Spectrum’s stock or other securities or all or substantially all of the assets or any integral part of Spectrum, at the time of acquisition, is developing or commercializing itself or through its Affiliates an Antineoplastic in the Field of Use in the Allergan Territory, or (B) Spectrum directly or indirectly, including through an Affiliate, acquires or purchases the stock or other securities or all or substantially all of the assets or any integral part of any Third Party which at the time of acquisition is developing or commercializing itself or through its Affiliates any Antineoplastic in the Field of Use in the Allergan Territory.

2.7      Diversion .

(a)     Except pursuant to Section 2.5(b), Spectrum shall not sell the Licensed Product, including via the Internet or mail order, to any Third Party, address or Internet Protocol (“ IP ”) address in the Allergan Territory. If any of Spectrum’s product is diverted for use in the Field of Use in the Allergan Territory, the following shall apply: (i) if such product were diverted by an identifiable customer, distributor, employee, consultant or agent of Spectrum then, upon the request of Allergan, Spectrum shall not sell such category of product to, or allow the sale of such category of product by, any such customer, distributor, employee, consultant or agent for the remaining Term and shall use commercially reasonable efforts to buy back all such product from such customer, distributor, employee, consultant or agent within ten (10) business days of such request from Allergan; or (ii) Spectrum shall use commercially reasonable efforts to investigate the location of such diverted product and buy it back; but, if and to the extent that, Spectrum elects not to, or is unable to, buy back the applicable diverted product, then Allergan may, in its sole discretion, buy back the applicable diverted product and Spectrum shall reimburse Allergan for all reasonable costs incurred by Allergan in connection with the buy-back of any such diverted product.

(b)     Allergan shall not sell Licensed Product, including via the Internet or mail order, to any Third Party, address or IP address in the Spectrum Territory. If any of Allergan’s Licensed Product is diverted for sale in the Spectrum Territory, the following shall apply: (i) if such Licensed Product were diverted by an identifiable customer, distributor, employee, consultant or agent of Allergan then, upon the request of Spectrum, Allergan shall not sell Licensed Product to, or allow the sale of Licensed Product by, any such customer, distributor, employee, consultant or agent for the remaining Term and shall use commercially reasonable efforts to buy back all such Licensed Product from such customer, distributor, employee, consultant or agent within ten (10) business days of such request from Spectrum; or (ii) Allergan shall use commercially reasonable efforts to investigate the location of such diverted Licensed Product and buy it back; but, if and to the extent that, Allergan elects not to, or is unable to, buy back the applicable diverted Licensed Product, then Spectrum may, in its sole discretion, buy back the applicable diverted Licensed Product and Allergan shall reimburse Spectrum for all reasonable costs incurred by Spectrum in connection with the buy-back of any such diverted Licensed Product.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(c)     The Parties acknowledge that, during the term of the Co-Promotion Agreement, the Parties have different financial arrangements in the Co-Promotion Region than in the Royalty Territory. During the term of the Co-Promotion Agreement, Allergan shall use substantially similar efforts to the efforts Allergan uses with other Allergan prescription products to monitor the sales of the Licensed Product in the Field of Use in the Royalty Territory in order to minimize the quantity of Licensed Product in the Field of Use that is sold in the Royalty Territory with a view to diversion for final sale in the Co-Promotion Region. The failure to stop such diversion shall not be deemed a material breach of this Agreement. During the term of the Co-Promotion Agreement, if there is any change in government policies in the Allergan Territory that materially affects the ability to move Licensed Product in the Field of Use from the Royalty Territory into the Co-Promotion Region, the Parties will meet to discuss in good faith the effect of such changes on diversion.

(d)     If any formulation containing Apaziquone sold by Spectrum, its Affiliates or sublicensees (the “ Spectrum Product ”) is used in the Field of Use in the Allergan Territory, Spectrum shall pay to Allergan royalties on the actual sales of such Spectrum Product resulting in such use at the rate of ****; provided , however , that, if, in any country in the Allergan Territory, the use of such Spectrum Product in the Field of Use accounts for **** or more of the use of any of Allergan’s Licensed Product in the Field of Use in such country, then Spectrum will pay to Allergan royalties on Spectrum’s Royalty-Bearing Net Sales of all such Spectrum Product sold in such country (regardless of the indication in which it is used) at the rate of ****.

2.8      Delivery Obligations of Spectrum . Spectrum shall promptly disclose, in writing, to Allergan all material Licensed Intellectual Property relevant to the license grants set forth herein that is developed, conceived or reduced to practice during the Term of this Agreement by Spectrum and its Affiliates, whether solely or jointly with Allergan, and shall make available to Allergan all Spectrum employees involved in the development of such Licensed Intellectual Property, during normal business hours, as may be reasonably requested by Allergan to assist Allergan in understanding such deliveries.

2.9      Delivery Obligations of Allergan . Upon agreement to the royalty-bearing licenses described in Sections 2.4, 2.5 and/or Section 13.2(c)(i), Allergan shall promptly disclose, in writing, to Spectrum all applicable material Allergan Solely Developed Know How and material Joint Intellectual Property licensed to Spectrum, and shall make available to Spectrum all Allergan employees involved in the development of such material Allergan Solely Developed Know How and material Joint Intellectual Property, during normal business hours, as may be reasonably requested by Spectrum to assist Spectrum in understanding such deliveries.

ARTICLE 3

DEVELOPMENT; SUPPLY; MARKETING

3.1      Development Obligations .

(a)     The Parties shall jointly develop the Licensed Product (which in final form will be

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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in Closed-System Packaging) for use in the Field of Use in accordance with Articles 3, 4 and 5. The Parties shall develop the Licensed Product (which in final form will be in Closed-System Packaging) for use in the Field of Use in the Co-Promotion Region and EU (and elsewhere in the Allergan Territory where the Parties mutually agree to co-fund the development) pursuant to the joint development plan that is attached as Schedule 3.1(a) (which is comprised of two documents, the work plan and budget) (the “ JDP ”) as may be modified by the Parties from time to time as set forth herein.

(b)     Obtaining the US Marketing Clearance and EU Marketing Clearance for the Licensed Product (which in final form will be in Closed-System Packaging) for use in the Field of Use is of the essence of this Agreement, and Spectrum shall develop the Licensed Product (which in final form will be in Closed System Packaging) for use in the Field of Use and seek US Marketing Clearance and EU Marketing Clearance for such Licensed Product pursuant to the terms of the JDP; provided , however , that Allergan shall cooperate with Spectrum and perform its obligations pursuant to the terms of the JDP.

(c)     Without limiting Allergan’s rights and remedies hereunder, Spectrum shall devote the resources necessary to conduct and complete the 611 Study, 612 Study, BCG Refractory Study and, as applicable, all other clinical trials described in Sections 3.2(b) and (c) using diligent efforts to meet the timetables set forth in the JDP. Without limiting the foregoing obligation, Spectrum agrees that, for as long as it has the responsibility to carry out the 611 Study, 612 Study and/or the BCG Refractory Study under the JDP: (i) it will use commercially reasonable efforts to retain each of the individuals specified in Schedule 3.1(c) to continue to perform services for Spectrum for the applicable term set forth in Schedule 3.1(c) , as either an employee or independent contractor (collectively the “ Key Development Personnel ”); and (ii) it will use commercially reasonable efforts to replace any Key Development Personnel who leave Spectrum during the applicable term set forth in Schedule 3.1(c) for any reason, with a person or persons of comparable skill and experience in the industry for such term. For purposes of clarity, Spectrum shall be able to cure any material breach of (i) above by complying with (ii) above. All Key Development Personnel shall allocate their time to performing development services under this Agreement in accordance with the JDP until the US Marketing Clearance and EU Marketing Clearance for Licensed Product in the Field of Use is received.

(d)     Spectrum shall, at its sole cost and expense (except as otherwise specified in Section 6.6), reasonably expand its development and clinical trial staff for performance of the services set forth in this Article 3 as set forth in the JDP.

3.2      Joint Development Plans .

(a)          Currently Contemplated Clinical Trials .

(i)     As of the Effective Date, the Parties have agreed upon the activities to be performed by each Party to carry out the 611 Study and 612 Study, and a budget for Development Costs relating thereto, as set forth in the JDP. The portions of the JDP

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(including the work plan and budget) relating to the 611 Study and 612 Study are final and are hereinafter referred to as the “ 611 Study and 612 Study JDP ”. Spectrum shall perform the services necessary to continue to successfully conduct and complete the 611 Study and the 612 Study in compliance with the terms and conditions set forth in the 611 Study and 612 Study JDP using diligent efforts to meet the timetables set forth in the JDP. Spectrum shall continue to be named as the sponsor of the 611 Study and 612 Study.

(ii)    As of the Effective Date, the Parties have reached preliminary agreement upon the activities to be performed by each Party to carry out the BCG Refractory Study, and a budget for Development Costs relating thereto, as set forth in the JDP. The portions of the JDP relating to the BCG Refractory Study (including the work plan and budget) are in draft form and are hereinafter the “ BCG Refractory Study JDP ”. Such BCG Refractory Study JDP is subject to finalization pursuant to this Section. The Parties agree that the draft BCG Refractory Study JDP is subject to regulatory feedback from both the FDA and EMEA and feedback from Key Opinion Leaders selected by mutual agreement of the Parties. “ Key Opinion Leaders ” are specialists in the field recognized as leaders by their peers. The JDC shall consider the feedback from Key Opinion Leaders when determining whether the protocol for the BCG Refractory Study JDP requires modification. The Members (hereinafter defined) of the JDC for both Allergan and Spectrum will participate in all meetings with the Key Opinion Leaders relating to the BCG Refractory Study. The Parties may invite additional observers to such meetings, as set forth in Section 4.2(d). Spectrum shall promptly modify the study protocol (as agreed to by the Parties) for the BCG Refractory Study based on regulatory feedback from the FDA and EMEA and shall design and finalize a final protocol and study parameters for the BCG Refractory Study which meet the needs of the FDA and EMEA and are designed to achieve the TPP for the Licensed Product in the Field of Use. The Parties acknowledge that they may need to modify the TPP for the Licensed Product in the Field of Use as is reasonably required to meet FDA and EMEA approvals. Spectrum shall perform the services necessary to successfully conduct and complete the BCG Refractory Study in compliance with the terms and conditions set forth in the BCG Refractory Study JDP using diligent efforts to meet the timetables set forth in the JDP. Spectrum shall be named as the sponsor of the BCG Refractory Study.

(b)          Additional Clinical Trials for BCG Refractory Indication . If the EMEA requires additional clinical trials for the Licensed Product for the BCG Refractory Indication (other than modifications to the protocol for the BCG Refractory Study as described above), the Party who receives notice from the EMEA shall promptly provide such notice to the other Party. The Parties acknowledge that the conducting and completion of any such clinical trial(s) is of the essence of this Agreement. The Parties shall coordinate the clinical trial(s) pursuant to one of the following subsections:

(i)     if the Parties agree to work on such clinical trial together, the following shall apply: (A) within thirty (30) days of receipt of such notice, Spectrum shall submit to

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Allergan a proposed development plan (including protocol, timeline and budget); (B) Allergan and Spectrum shall work together in good faith in a timely manner to modify the development plan to reflect the Parties’ agreement on the clinical trial (including protocol, timeline and budget) consistent with the feedback from the EMEA; (C) once approved by the Parties, the JDP shall be modified to include such development plan, whereupon Spectrum shall be responsible for conducting the clinical trial, subject to Allergan’s right, in its sole discretion, to take control of and to conduct the clinical trial by providing written notice to Spectrum, and each Party shall perform their respective obligations for the clinical trial under the JDP; (D) Spectrum shall be the sponsor of the clinical trial unless Allergan exerts its right to take control of and conduct such clinical trial; and (E) the Development Costs incurred in such clinical trial shall be paid as set forth in Section 6.6, or, at Spectrum’s request, Allergan shall pay all of the Development Costs for such performance and shall receive a credit for such payments for Spectrum’s share (of 35%) of such costs from royalties and milestone payments due hereunder; or

(ii)    if the Parties cannot agree on the development plan as set forth in Section 3.2(b)(i)(B) above, then: (A) Allergan may unilaterally create the development plan for the clinical trial (including protocol, timeline and budget), consistent with the feedback from the EMEA; (B) on completion, the JDP shall be modified to include such development plan, whereupon Spectrum shall be responsible for conducting the clinical trial, subject to Allergan’s right, in its sole discretion, to take over the control of and to conduct the clinical trial by providing written notice to Spectrum, and each Party shall perform their respective obligations for the clinical trial under such JDP; (C) Allergan shall be the sponsor of the clinical trial; and (D) the Development Costs incurred in such clinical trial shall be paid as set forth in Section 6.6, or, at Spectrum’s request, Allergan shall pay all of the Development Costs for such performance and shall receive a credit for such payments for Spectrum’s share (of 35%) of such costs from royalties and milestone payments due hereunder.

(c)      Other Clinical Trials . As long as the Co-Promotion Agreement has not been terminated, any additional clinical trial for the Licensed Product in the Field of Use in the Co-Promotion Region (including Phase 3b trials and Phase 4 trials that the JMC (defined below) desires to conduct), other than those set forth above, shall, upon the mutual agreement by the Parties, be documented in a joint development plan (including protocol, timeline and budget) as a modification to the JDP, and shall be conducted by the Parties in accordance with the JDP. If Spectrum elects not to conduct such clinical trials or not to fund such clinical trials upfront, Allergan may still conduct such clinical trials, and the Development Costs incurred in such clinical trials shall be split evenly. At Spectrum’s request, Allergan shall pay all of the Development Costs for such performance and shall receive a credit for such payments for Spectrum’s share of such costs from royalties and milestone payments due hereunder. Allergan shall be the sponsor of all such clinical trials that Spectrum elects not to conduct. Any additional clinical trials outside the Co-Promotion Region shall be conducted and paid for by Allergan.

(d)      Additional Development Activities . Except for the 611 Study, 612 Study and

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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BCG Refractory Study, nothing in this Agreement shall prevent Allergan from developing and performing any clinical trials with respect to the Licensed Product in the Field of Use in the Allergan Territory unilaterally and at its own expense. If Allergan requests that Spectrum assist in such trials, and Spectrum agrees to do so and agrees to assist in funding such trials, the Parties shall amend the JDP to govern such trials and the Development Costs incurred in such clinical trials shall be paid as set forth in Section 6.6. Spectrum shall not conduct any development activities with respect to the Licensed Product in the Allergan Territory other than pursuant to this Article 3 or as permitted in Section 2.5(b).

(e)      Modifications to the JDP . The JDC (defined below) shall have the right to amend the JDP, except that the following modifications to the JDP must be agreed upon mutually by the Parties (any modified JDP shall be deemed incorporated herein by reference):

(i)     any change in the JDP that would result in an increase of the total development budget set forth in the JDP by more than ten percent (10%) as compared to the total development budget set forth in the JDP as of the Effective Date; provided , however , that if another BCG Refractory clinical trial is required under Section 3.2(b) or other clinical trials under Section 3.2(c), then the expenditure in connection therewith shall not be subject to the limitation of this Section 3.2(e) or applied against the ten percent (10%) allowance under this Section 3.2(e)(i);

(ii)    except for the clinical trials set forth in Section 3.2(a), (b) and (c), any new clinical trials for the Licensed Product in the Field of Use in the Allergan Territory for which Allergan wants Spectrum to conduct the clinical trials;

(iii)   any adjustment of the clinical trials specified above that have an adverse impact on the TPP relating to the Indications;

(iv)   any adjustment of the TPP (except in response to the FDA or EMEA) that would have a material impact on the clinical trials set forth above. Except as set forth in the preceding sentence, Spectrum acknowledges that Allergan has final approval rights on the TPP for the Licensed Product in the Field of Use, including over changes made in response to the FDA and EMEA;

(v)    any material changes to the percentage of Key Development Personnel time spent on development hereunder; and

(vi)   any changes to completion dates specified in the JDP.

(f)      Spectrum Subcontract Rights . Except for Clinical Trial Institutions (as defined below), Spectrum shall not subcontract any of its obligations under Sections 3.1 and 3.2 without the prior written consent of Allergan, such consent not to be unreasonably withheld, delayed or conditioned. In negotiating such subcontractor agreements, Spectrum will obtain the right to assign such subcontractor agreements to Allergan in the event Allergan assumes the responsibility for the development of the Licensed Product, and such agreements will provide

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Allergan with the same audit and inspection rights as those provided in Section 5.9. The Parties acknowledge that, as of the Effective Date, Spectrum has engaged for development purposes the subcontractors listed on Schedule 3.2(f)(i) , and Allergan hereby consents to Spectrum’s right to continue to use such subcontractors. If not already provided in the agreements with such subcontractors, Spectrum will use commercially reasonable efforts to amend such agreements so that Spectrum will have the right to assign such agreements to Allergan in the event Allergan assumes the responsibility for the development of the Licensed Product, and to provide Allergan with the same audit and inspection rights as those provided in Section 5.9. The subcontractors and their contracts as of the Effective Date are identified on Schedule 3.2(f)(i) , except for the hospitals or similar institutions operating as a site for clinical trials if they are not providing broader services such as collecting or managing data from other sites (the “ Clinical Trial Institutions ”). All Clinical Trial Institutions, as of the Effective Date, are identified on Schedule 3.2(f)(ii) . Spectrum shall update Schedules 3.2(f)(i) and 3.2(f)(ii) each Fiscal Quarter with the then-current development subcontractors.

3.3      Manufacturing Obligations .

(a)      Obligations . The Parties shall perform their respective obligations pertaining to manufacturing and supply set forth in the joint supply plan (“ JSP ”); provided , however , that Allergan shall have the right to take over Spectrum’s role under the JSP at any time with written notice to Spectrum. The initial JSP (for clinical trials supply and validation batches) forms part of the JDP attached as Schedule 3.1(a) . The Parties acknowledge that all modifications to the JSP must be agreed upon by the Parties, and that neither Party may unilaterally modify the JSP. Any modified JSP shall be deemed incorporated herein by reference. Subject to the terms and conditions of this Agreement, including the JSP, Spectrum agrees to have manufactured and supplied to Allergan all of Allergan’s requirements for the Licensed Product for clinical development under the terms of this Agreement. Spectrum agrees to have manufactured and supplied to Allergan all of Allergan’s requirements for the Licensed Product for commercial use pursuant to an amended JSP reflecting commercial supply and a mutually agreed upon supply agreement as contemplated by Section 3.3(d).

(b)      Subcontracting . Spectrum may meet its obligations to supply the Licensed Product to Allergan hereunder through subcontracts with Third Parties, subject to the following requirements:

(i)     Spectrum may not subcontract the performance of any services or sublicense any rights set forth in this Section 3.3 to any sublicensee/subcontractor without Allergan’s prior written permission. Allergan may, in its sole discretion, disapprove of any sublicensee/subcontractor; provided , however , that, Allergan hereby gives its written consent to the use of the following manufacturers as subcontractors pursuant to the terms of the contracts set forth on Schedule 3.3(b) (such contracts, the “ Spectrum Manufacturing Agreements ”). Within a reasonable time after the Effective Date, Spectrum will use commercially reasonable efforts to amend the Spectrum Manufacturing Agreements so that such agreements are assignable to Allergan (without

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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further consent of a Third Party), provide Allergan with the same audit and inspection rights as those set forth herein, ensure that the quality standards of such agreements are no less stringent than those determined by the JSC pursuant to Section 3.3(d) below, and ensure that such sublicensee/subcontractor complies with all applicable regulatory obligations and applicable Law;

(ii)    Spectrum will supervise each sublicensee/subcontractor’s performance of the services and compliance with the terms of this Agreement;

(iii)   All fees, costs, and other expenses relating to each sublicensee/subcontractor shall be deemed Development Costs as set forth in the JDP prior to the First Commercial Sale of the Licensed Product in the Field of Use, and after the First Commercial Sale of the Licensed Product in the Field of Use shall be set forth in the supply agreement, and both shall be calculated without any surcharge for any sublicensee/subcontractor fees;

(iv)   Spectrum must enter into a written agreement with each sublicensee/subcontractor engaged by Spectrum after the Effective Date obligating such sublicensee/subcontractor to comply with Spectrum’s obligations under the applicable terms of this Agreement, including the quality standards determined by the JSC pursuant to Section 3.3(d), and that the sublicensee/subcontractor will comply with all applicable regulatory obligations. Each such agreement shall be at least as protective of Allergan’s rights as the terms and conditions of this Agreement, and subordinate thereto. Spectrum shall require that Allergan be a third party beneficiary to each such agreement, and that all such agreements be assignable to Allergan. Spectrum shall provide Allergan with a copy of each executed agreement with each sublicensee/subcontractor permitted hereunder;

(v)    Spectrum will not retain (even if approved by Allergan) any sublicensee/subcontractor in any country where doing so would violate any applicable Laws, including due to embargoes or other restrictions;

(vi)   Spectrum acknowledges and agrees that, except and to the extent that Allergan assumes Spectrum’s manufacture obligations under Section 3.3(f), Allergan has no obligations under this Agreement to any such sublicensee/subcontractor and no sublicensee/subcontractor has any rights or remedies against Allergan hereunder (except where such agreements are assigned to Allergan hereunder); and

(vii)  Allergan has the right but not the obligation to directly pay the sublicensee/subcontractor for any manufacturing and supply services it performs on Spectrum’s behalf and to include the amount of such payment in the calculation of Development Costs under this Agreement prior to the First Commercial Sale of the Licensed Product in the Field of Use or as covered in the supply agreement after the First Commercial Sale of the Licensed Product in the Field of Use.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(c)      Allergan Cooperation. Allergan acknowledges that Spectrum does not possess manufacturing facilities and that Spectrum’s ability to perform its obligations under this Section 3.3 depends on the timely engagement of manufacturing subcontractors which Spectrum is obligated to engage hereunder. Allergan agrees to cooperate with Spectrum in the establishment of a commercial supply chain for the Licensed Product in the Field of Use in the Allergan Territory and agrees not to unreasonably withhold, condition or delay its consent to the selection of subcontractors or the approval of contracts.

(d)      Specifications; Additional Terms . The current specifications for the drug substance, drug product and diluent of the Licensed Product (“ Specifications ”) are attached hereto as Schedule 3.3(d) . Subject to Section 4.6(b), Schedule 3.3(d) can only be amended by written agreement of the Parties. The Parties acknowledge that the Specifications will be updated and finalized by the Parties as part of the Regulatory Approval in the Co-Promotion Region and the EU. If and to the extent that Spectrum ships any Licensed Product to Allergan, each shipment shall be in accordance with Allergan’s written instructions and applicable Laws governing the shipment, labeling and packaging of such Licensed Product. Prior to the production of Licensed Product under this Agreement, the Joint Supply Committee shall determine the quality standards applicable to the manufacture of the Licensed Product. At least two (2) years prior to the Anticipated Approval Date, the Parties shall negotiate in good faith, and enter into, a separate written supply agreement which will provide for the manufacture and supply of the Licensed Product in the Field of Use on terms mutually acceptable to the Parties. The supply agreement between the Parties shall contain:

(i)     terms consistent with provisions customarily found in agreements for the manufacture and supply of commercial quantities of products of a similar nature, including provisions relating to timing and size of production orders, shipping, certificates on delivery, risk of loss, inspection and acceptance, timing of invoices and payments, failure to supply, remedies for breach of representations and warranties;

(ii)    the transfer price for all such Licensed Product, which shall be the actual cost of manufacturing, which shall include the actual charges from Third Parties for testing, packaging, freight, insurance and exporting the Licensed Product, but excluding any of Spectrum’s overhead or general and administrative costs;

(iii)   the representations and warranties set forth in Section 11.11 for the commercial supply of Licensed Product in the Field of Use (unless the Parties mutually agree to modify such provisions); and

(iv)   the indemnification and disclaimers and limitations on liability as set forth in Article 12 for the commercial supply of Licensed Product in the Field of Use (unless the Parties mutually agree to modify such provisions).

(e)      Supply Agreement Mediation. The Parties acknowledge that timely negotiation of a mutually-agreeable supply agreement will be critical to the ability to launch the Licensed

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Product. If at any time more than ninety (90) days after the commencement of negotiation of such agreement, either Party believes such negotiations have reached an impasse, such Party may by written notice to the other Party cause a meeting of the Vice President of Global Technical Operations of Allergan and the Chief Executive Officer of Spectrum to seek to resolve such impasse. Such meeting shall be held within twenty (20) days following such written notice. If, following such meeting of senior executives, either Party believes an impasse still exists, then such Party may by written notice cause the Parties to engage in a non-binding mediation of their differences over the proposed agreement. Unless the Parties otherwise agree at the time, such mediation, including the selection of the mediator, shall be conducted in accordance with the rules of the American Arbitration Association. The fees and costs of the mediator shall be borne equally by the Parties, regardless of the outcome of the mediation. If the Parties cannot agree through mediation to the terms of the supply agreement, then Spectrum will enable Allergan by assigning the Spectrum Manufacturing Agreements to Allergan in addition to transferring to Allergan the validated process for manufacturing and the other items set forth in subsection (f) below.

(f)      Right to Terminate . Allergan may terminate Spectrum’s responsibility to have manufactured and supplied Licensed Product to Allergan for sale in the Allergan Territory under this Agreement at any time with prior written notice. Such termination shall be effective thirty (30) days after delivery of the notice, or such later date, at Allergan’s sole discretion, as necessary to complete transition to another manufacturer or to Allergan. Termination of Spectrum’s manufacture and supply obligation shall not relieve the Parties of any amounts owing between them. On termination of Spectrum’s manufacture and supply obligation, Spectrum shall provide to Allergan a copy of all of the then-current Know How Controlled by Spectrum necessary or useful for the manufacture of the Licensed Product in the Field of Use, shall make its manufacturing personnel available for reasonable consultation with Allergan regarding the processes for Licensed Product manufacture, and shall provide all other technical transfers of all parts of the validated process for the Licensed Product in the Field of Use, including Documents and other regulatory items. Subject to the terms of the Spectrum Manufacturing Agreements, Spectrum shall assign to Allergan, and Allergan shall assume responsibility under, all of Spectrum’s supply subcontracts for the Licensed Product applicable to the Field of Use. The Parties shall negotiate in good faith the transition of Spectrum’s sourcing of Licensed Product from such Third Party (for example, bifurcating the supply agreement). After termination of Spectrum’s manufacturing and supply obligations as set forth herein, Allergan shall be responsible for all supply and manufacture of Licensed Product in the Field of Use in the Allergan Territory, including fulfilling such subcontract agreements from the applicable date of assignment. After Allergan terminates Spectrum’s manufacturing rights and responsibilities under this Section 3.3(f), to the extent that such rights and responsibilities are transferred to Allergan, Spectrum shall have no further performance obligation under this Section 3.3, and Allergan shall thereafter be responsible for compliance with the product quality representations set forth in Section 11.11 for Licensed Product manufactured for sale in the Co-Promotion Region, with any costs of non-compliance with such representations to be borne by Allergan and not included within allowable expenses.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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3.4      Commercialization Rights and Obligations .

(a)      Rights . Allergan shall have the sole right to commercialize the Licensed Product in the Field of Use in the Allergan Territory, except as set forth herein and in the co-promotion agreement (“ Co-Promotion Agreement ”) identical to the form attached as Schedule 3.4(a) and entered into by the Parties on the Effective Date. During the term of the Co-Promotion Agreement, the commercialization of the Licensed Product in the Field of Use in the Co-Promotion Region shall be the Parties’ joint right and responsibility and shall be subject to the oversight of the Joint Marketing Committee (“ JMC ”) and pursuant to the JMP as described in Section 3.4(b) below.

(b)      Co-Promotion Region; Joint Marketing Plan . The strategy for the commercialization of the Licensed Product in the Field of Use in the Co-Promotion Region during the term of the Co-Promotion Agreement shall be described in a comprehensive plan that describes the pre-launch, launch and subsequent commercialization activities (including advertising, education, planning, marketing, sales force training and allocation) (the “ Joint Marketing Plan ” or “ JMP ”), as follows:

(i)     An initial JMP setting forth the Parties’ agreement on the pre-launch commercial planning activities and the budgeting relating thereto for the Licensed Product in the Field of Use in the Co-Promotion Region, is attached to this Agreement as Schedule 3.4(b)(i) . At least twelve (12) months prior to the Anticipated Approval Date, the Parties shall finalize the portion of the initial JMP setting forth the launch activities for the Licensed Product in the Field of Use in the Co-Promotion Region and the budget relating thereto, and develop and finalize a follow-on JMP that governs the post-launch activities for the Licensed Product in the Field of Use in the Co-Promotion Region, as well as the budget relating thereto, and such JMP shall be subject to the approval of the JMC.

(ii)    Following the launch of the Licensed Product, on or before November 1 of each Fiscal Year during the Term of this Agreement, the Parties shall create an updated JMP detailing activities for the following Fiscal Year. The initial JMP and follow-on JMPs shall generally conform to the level of detail utilized by Allergan in preparation of its own product commercialization plans, with the overall objectives of maximizing the economic value of the Licensed Product in the Field of Use in the Co-Promotion Region and of providing Spectrum a meaningful role in the commercialization of the Licensed Product in the Field of Use in the Co-Promotion Region. The JMP shall be deemed Confidential Information of both Parties, and each Party shall use the JMP for the sole purpose of performing or monitoring commercialization activities for the Licensed Product in the Field of Use in the Co-Promotion Region. From time to time as reasonably necessary during the term of commercialization of the Licensed Product in the Field of Use in the Co-Promotion Region, the JMC may update the JMP.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(iii)   During the term of the Co-Promotion Agreement, except as set forth in Section 6.14, all costs and expenses incurred by the Parties and specifically set forth in the JMP shall be deemed allowable expenses and included in the calculation of product profits and losses under the Co-Promotion Agreement.

(iv)   Notwithstanding anything to the contrary in this Agreement, or any provision granting final decision making authority to any Party on a particular matter under this Agreement, during the pre-launch phase any change in the initial JMP that would result in an increase of the total pre-launch budget for the Licensed Product in the Field of Use in the Co-Promotion Region by more than ten percent (10%) as compared to the total pre-launch budget for the Licensed Product in the Field of Use in the Co-Promotion Region set forth in the JMP as of the Effective Date, shall in each case be subject to the Parties’ mutual written agreement.

(c)      Performance Obligation .

(i)     Allergan shall file for Regulatory Approval for the Licensed Product for the Initial Indication in the Field of Use in the EU within **** of the date on which filings for Regulatory Approval for the Licensed Product for the Initial Indication in the Field of Use have been made in the Co-Promotion Region, provided , however , that the applicable clinical data is timely delivered to Allergan by Spectrum. No such failure is a material breach of this Agreement. If Allergan fails to do so, then, upon Spectrum’s written request, Allergan and Spectrum shall meet to discuss future activities relating to the Licensed Product for the Initial Indication in the Field of Use in the EU.

(ii)    Allergan shall use efforts consistent with the efforts used by Allergan to launch other Allergan prescription products to launch the Licensed Product in the Field of Use (A) in the Co-Promotion Region within **** after the date on which Regulatory Approval for the Licensed Product in the Field of Use has been obtained in the Co-Promotion Region; and (B) in the EU (an EU launch being defined as a launch in at least two (2) of the major countries which are members of the EU) within **** after the date on which Regulatory Approval for the Licensed Product in the Field of Use has been obtained in such countries, provided , however , that such **** periods of time shall be tolled by any periods of time in which the Regulatory Approval in the respective territory has been revoked or such launches are delayed for reasons beyond the reasonable control of Allergan.

(iii)   If Allergan materially breaches Section 3.4(c)(ii), Spectrum may terminate Allergan’s license to Licensed Product in the affected territory (either the Co-Promotion Region and/or the EU, as the case may be) with written notice to Allergan within thirty (30) days of the applicable failure, and in such cases Allergan shall cooperate in the transfer to Spectrum of the Licensed Product rights in such territory(ies). Such transfer of product rights shall be effected by means of removing the U.S. and/or the EU (as the case may be) from the Allergan Territory and adding it to the Spectrum Territory, and

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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otherwise proceeding with respect to such transferred territory as if there had been a termination by will by Allergan under Section 13.2.

(d)      Additional Performance Obligations .

(i)     Each Party shall conduct its activities under the JMP and this Agreement in compliance in all material respects with all applicable Laws (including the Foreign Corrupt Practices Act of 1977, as amended, and laws applicable to the sale and promotion of pharmaceutical products) and in accordance with the following provisions:

(A)     as between the Parties, Allergan shall be responsible for receiving and filling orders, controlling invoicing, collecting payments, returns, charge-backs and rebates on sales of the Licensed Product in the Field of Use in the Allergan Territory, and shall have sole control over distribution of the Licensed Product in the Field of Use in the Allergan Territory, in each case including the Licensed Product under co-promotion by the Parties in the Field of Use in the Co-Promotion Region. If Spectrum receives any order for the Licensed Product for the Field of Use in the Allergan Territory, it shall promptly refer such orders to Allergan. If Allergan receives any order for the Licensed Product for sale in the Spectrum Territory, it shall promptly refer such orders to Spectrum; and

(B)     each Party shall regularly update the JMC regarding the progress and results of all commercialization activities for the Licensed Product in the Field of Use. Once each Fiscal Year, during the term of the Co-Promotion Agreement, the Parties shall meet by phone or in person to discuss the commercialization plans and strategies of both Parties relating to the Licensed Product in the Field of Use in the Allergan Territory; provided , however , that the Parties shall not share competitively sensitive information (such as pricing or business plans) for their own products that are not the Licensed Product in the Field of Use.

ARTICLE 4

COMMITTEES

4.1      Generally . The Parties shall form three (3) committees, as described in this Article 4, to assist in the overseeing of, and making recommendations and decisions for, the development, regulatory approvals, supply, marketing and commercialization of the Licensed Product in the Field of Use in the Allergan Territory. The committees may exist simultaneously, and may be dissolved over time, as their functions are completed. None of the committees shall have any power to amend this Agreement or bind or incur liability on behalf of either Party without both Parties’ express prior written authorization. Each Party shall comply with the decisions of the applicable committee, to the extent such decisions fall within the applicable committee’s role and their delineated powers and responsibilities, except in areas where such Party has sole responsibility for performance as set forth herein.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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4.2      Governance of Each Committee . Each committee described in this Article 4 shall be comprised of four (4) voting members (each a “ Member ”). Each Party shall have the right to appoint two (2) Members to each committee (each a “ Member Designee ”). The following shall apply to each committee and their Members:

(a)     each Party may remove any of its Member Designees for any reason at any time upon written notice to the other Party, and a replacement may be appointed by such Party to fill such vacancy;

(b)     each committee shall meet at least once each Fiscal Quarter and as otherwise agreed upon by the Parties;

(c)     the presence of at least one (1) Spectrum Member Designee and one (1) Allergan Member Designee for that committee shall be required to constitute a quorum at any meeting of such committee. No business shall be transacted at any meeting of a committee unless a quorum of such committee’s Members is present at the time when the meeting proceeds to business;

(d)     in addition to Member Designees, each Party shall have the right to invite observers to each meeting by providing the other Party with advance written notice of such observer(s); provided , however , that such observer(s) may not attend such meeting if the other Party reasonably objects to the requesting Party’s observer(s) prior to such meeting. Such observers shall not have any voting rights and shall be bound by written obligations of confidentiality and non-use, either by virtue of his/her employment by such Party or by a separate written agreement;

(e)     meetings of each committee shall alternate between the offices of Spectrum and Allergan in Irvine, California. At their election, the Parties may conduct any meeting of the committees by telephone;

(f)      action items and resolutions of the committee meetings shall be kept, reviewed and approved by the applicable committee Member Designees;

(g)     decisions of each committee shall be made by unanimous agreement of the applicable committee’s Members, with each Party’s Member Designees having collectively one (1) vote, subject to Section 4.6; and

(h)     each committee shall continue to exist until the first to occur of: (i) the Parties mutually agreeing to disband the committee; or (ii) a Party providing to the other Party written notice of its intention to disband and no longer participate in such committee. Once a Party has provided the other Party written notice as referred to in subsection (ii) above, such committee shall have no further obligations under this Agreement and the receiving Party shall have the right to solely decide, without consultation, any matters previously before such committee, without affecting either Party’s obligations hereunder.

4.3      Joint Development Committee . Within ten (10) days of the Effective Date, the

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Parties shall establish a Joint Development Committee (“ JDC ”). The JDC’s sole role shall be to assist in the overseeing of and in the making decisions for the development of, clinical trials for, and preparation and submission of regulatory documentation for obtaining Regulatory Approval for the Licensed Product in the Field of Use for the Co-Promotion Region, EU and any other country in the Allergan Territory where each Party contributes to the funding of development/regulatory matters (“ JDC Role ”). In performing the JDC Role, the powers and responsibilities of the JDC are limited to the matters set forth in this Section 4.3. The JDC shall coordinate with the respective Party to meet its responsibilities hereunder. The JDC shall be responsible for overseeing and making decisions regarding:

(a)        clinical activities and clinical and registration strategy including clinical trial designs and registration plans to support the TPP for the Licensed Product in the Field of Use;

(b)        clinical data go/no-go decisions through the development and registration process;

(c)        pre-clinical and clinical development of Licensed Product in the Field of Use; and

(d)        other development of the Licensed Product in the Field of Use.

4.4         Joint Supply Committee .  Within ten (10) days of the Effective Date, the Parties shall establish a Joint Supply Committee (“ JSC ”). The JSC’s sole role shall be to assist in the overseeing of and in the making decisions for the manufacture and supply of Licensed Product in the Field of Use, and monitoring continuing compliance with all regulatory requirements for the manufacturing of the Licensed Product after receipt of the Regulatory Approval for the Licensed Product in the EU and Co-Promotion Region (“ JSC Role ”). In performing the JSC Role, the powers and responsibilities of the JSC are limited to the matters set forth in this Section 4.4. The JSC shall coordinate with the respective Party to meet its responsibilities hereunder. The JSC shall be responsible for overseeing and making decisions regarding:

(a)        the Chemistry, Manufacturing, and Control (“ CMC ”) processes required in developing the Licensed Product in the Field of Use;

(b)        the clinical drug supply to meet requirements of the JDP;

(c)        developing a robust and validated supply process for both drug substance and Licensed Product in the Field of Use;

(d)        ensuring final drug substance and Licensed Product in the Field of Use meet FDA and EMEA standards;

(e)        ensuring the required reports, data, and other CMC information included in the US Marketing Clearances filings and EU Marketing Clearances filings meet standards expected for final regulatory approval and the timelines set forth in the JSP and the JDP;

(f)        ensuring a validated process for drug substance and drug manufacturing with

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Allergan or Spectrum’s Third Party commercial supplier(s) and the supply forecast meets the anticipated demand. The JMP sets forth the pre-launch and pre-market marketing activities, as may be amended pursuant to the Co-Promotion Agreement; and

(g)        ensuring the final packaging configurations for Licensed Product in the Field of Use for commercial launch in the Co-Promotion Region and the EU is the Closed-System Packaging configuration.

4.5         Joint Marketing Committee .  Within ten (10) days of the Effective Date, the Parties shall form a JMC to assist in recommendations and decision-making for the pre-marketing and commercialization planning of the Licensed Product in the Field of Use in the Co-Promotion Region. The JMC’s sole role shall be to assist in the overseeing of and in the making decisions for the marketing, promotion, calling and detailing of Licensed Product in the Field of Use within the Co-Promotion Region (“ JMC Role ”). In performing the JMC Role, the powers and responsibilities of the JMC are limited to the matters set forth in this Section 4.5. The JMC shall coordinate with the respective Party to meet its responsibilities hereunder. The JMC shall be dissolved automatically on termination of the Co-Promotion Agreement. The JMC shall be responsible for overseeing and making decisions regarding:

(a)        assisting the JDC in the prioritization of Phase IV trials of the Licensed Product in the Field of Use;

(b)        overseeing marketing activities for the Licensed Product in the Field of Use in the Co-Promotion Region and making decisions regarding the promotion plan for pre-launch, launch and post-launch activities in the Co-Promotion Region;

(c)        developing a calling plan, including an allocation of sales force efforts by Spectrum and Allergan in the Co-Promotion Region and also including the development of primary detail equivalent targets for each Party;

(d)        reviewing the overall performance and effectiveness of the marketing groups and sales force and the actual results of the promotion of the Licensed Product in the Field of Use in the Co-Promotion Region;

(e)        reviewing and making other decisions related to pre-launch, launch and post-launch marketing activities of the Licensed Product in the Field of Use in the Co-Promotion Region as they may arise; and

(f)        updating the JMP on a quarterly basis, including updating the JMP with the timeline and forecast for the Licensed Product in the Field of Use when the primary market information for the Co-Promotion Region is complete and upon filing for the Initial Indication.

4.6         Escalation Procedure .  In the event that a committee cannot agree on matters falling within the scope of its JDC Role, JSC Role, or JMC Role, as applicable, and its powers and responsibilities as set forth in Sections 4.3, 4.4 and 4.5, respectively, (whether due to failure

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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to agree or failure to have a quorum present at a designated meeting time), then the Chief Executive Officer of Spectrum (or a designee thereof) shall meet with the Executive Vice President, Research & Development of Allergan (or a designee thereof for research and development matters) or the Corporate Vice President for Global Strategic Marketing (or a designee thereof for commercial matters) at an agreed location or by telephone to resolve the disagreement within twenty (20) days of the meeting at which such disagreement occurred. If such officers of the Parties (or their designees) are unable to resolve the disagreement within an additional thirty (30) day period then:

(a)        in the case of a dispute of the JDC, Spectrum shall have final approval rights over the matter at dispute and shall promptly provide written notice to Allergan of its reasonable final position regarding the matter at issue; provided , however , that Allergan shall have final approval rights over the clinical trials, and the portions of the JDP related thereto, covered by Sections 3.2(b), (c) and (d), and the regulatory filings and negotiations as described in Sections 5.1(a)(iii) and (v), and the Parties shall mutually agree on the JDP amendments described in Section 3.2(e). The Parties shall comply with the position taken by the Party with final approval rights on such issue. Notwithstanding the foregoing, if (i) ****, (ii) the Co-Promotion Agreement is terminated (other than by Spectrum opting out of it as permitted therein), or (iii) the Co-Promotion Agreement terminates by reason of Spectrum’s decision to opt out under such agreement and the 611 Study, 612 Study and BCG Refractory Study have been concluded, then the Parties shall comply with the position taken by Allergan on such issue (including over the items in Section 3.2(e)(iii),(iv), and (vi));

(b)        In the case of a dispute of the JSC, Spectrum shall have final approval rights over the matter at dispute and shall promptly provide written notice to Allergan of its reasonable final position regarding the matter at issue. The Parties shall comply with the position taken by Spectrum on such issue. Notwithstanding the foregoing, if ****, or if Allergan terminates its supply agreement with Spectrum pursuant to Section 3.3(f), the Parties shall comply with the position taken by Allergan on such issue (including over the items in Section 3.2(e) (iii), (iv), and (vi)). Notwithstanding Allergan’s final approval rights set forth in the preceding sentence, Spectrum shall have the final decision making authority as to the manufacturing process for the Final Licensed Product, the CMC section for the Final Licensed Product, the formulation of the Final Licensed Product, and the design of the Closed-System Packaging (as long as all such items are in compliance with the JSP, Specifications, Closed-System Packaging and the TPP for the Licensed Product in the Field of Use as of the Effective Date);

(c)        in the case of a dispute of the JMC, Allergan shall have final approval rights over the matter at dispute and shall promptly provide written notice to Spectrum of its reasonable final position regarding the matter at issue. The Parties shall comply with the position taken by Allergan on such issue; and

(d)        in the event the provisions of this Article 4 do not provide, and the Parties cannot agree on, which of the JDC, JSC and JMC has control over an item for resolution, Allergan shall have final approval over which committee controls or whether such item falls within the scope of

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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any committee; provided , however , such authorization does not alter the approval rights set forth in subsections (a), (b) and (c) or allow Allergan to modify the responsibilities of each committee as set forth in Sections 4.3, 4.4 and 4.5.

ARTICLE 5

REGULATORY MATTERS

5.1      Obligations of the Parties Relating to Regulatory Submissions .

(a)      Co-Promotion Region .  The following terms shall apply for the period commencing on the Effective Date and ending on the earlier of (i) the occurrence of a Development Trigger or Change in Control Trigger that results in Allergan delivering notice under Section 10.1(c) or 10.2(a), and (ii) termination of this Agreement:

(i)     Spectrum shall own all regulatory filings relating to the Licensed Product in the Field of Use in the Co-Promotion Region;

(ii)    Spectrum hereby appoints Allergan as its exclusive (even as to Spectrum) authorized agent for all regulatory activities relating to the Licensed Product in the Field of Use in the Co-Promotion Region, including filing, obtaining and maintaining Regulatory Approvals and authorizations, except for Spectrum’s role in preparing regulatory submissions expressly set forth in this Section 5.1(a). In order to perfect the foregoing appointment, Spectrum irrevocably appoints Allergan as Spectrum’s attorney in fact for the purpose of acting as authorized agent, including executing documents. Allergan shall be the sole point of contact with regulatory agencies in the Co-Promotion Region in all matters relating to the Licensed Product in the Field of Use both before and after any Licensed Product in the Field of Use receives Regulatory Approval for sales;

(iii)   Spectrum shall prepare all regulatory submissions relating to the Licensed Product in the Field of Use in the Co-Promotion Region in the eCTD format. Spectrum shall provide Allergan with draft copies of all submissions to regulatory agencies for Allergan’s feedback, including a draft copy of each module of the eCTD form as each module is being created and the completed modules. In addition, Spectrum shall provide to Allergan copies of all final submissions to regulatory agencies which relate to the Licensed Product in the Field of Use in the Co-Promotion Region reasonably in advance of the applicable filing deadline. If Allergan has not filed such filings with the applicable regulatory agencies by the applicable filing deadline, then Spectrum may send such final submissions to the relevant regulatory agency with prior written notice to Allergan;

(iv)   Each Party shall provide the other Party with copies of any correspondence received from regulatory agencies relating to the Licensed Product in the Field of Use in the Co-Promotion Region within ten (10) days of receipt, and shall provide the other Party with written notice of any other contact by regulatory agencies

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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relating to the Licensed Product in the Field of Use in the Co-Promotion Region within ten (10) days of such contact;

(v)   Allergan shall conduct all negotiations with regulatory agencies in the Co-Promotion Region relating to the Licensed Product in the Field of Use, and shall determine and have final decision making on all regulatory negotiations in the Co-Promotion Region relating to the Licensed Product in the Field of Use, provided that Allergan shall use commercially reasonable efforts to schedule such negotiations or any other meetings or teleconferences with regulatory agencies to allow Spectrum to participate. Allergan shall provide copies of all materials relating thereto to Spectrum and shall advise Spectrum of, and Spectrum may provide input relating to, all planned regulatory activities and exchanges with regulatory authorities for Licensed Product in the Field of Use within the Co-Promotion Region. Both Parties shall participate in all planned meetings and conference calls with regulatory agencies relating to the Licensed Product in the Field of Use in the Co-Promotion Region. If either Party is unable to participate in such a meeting or conference call, then the other Party shall provide a written summary of the discussion within thirty (30) days;

(vi)   The regulatory filing fees in the Co-Promotion Region shall be deemed Development Costs and shared by the Parties pursuant to Section 6.6; and

(vii)  Allergan shall not be responsible or liable for any Spectrum taxes assessed by a Government Authority as a result of Allergan’s appointment and actions under Section 5.1.

(b)      Royalty Territory .

(i)     Allergan shall own all regulatory filings relating to the Licensed Product in the Field of Use in the Royalty Territory;

(ii)    Except to the extent set forth in Section 3.4(c), Allergan shall have the responsibility but not the obligation, at its sole expense and with the reasonable assistance of Spectrum, for all regulatory activities relating to the Licensed Product in the Field of Use within the Royalty Territory, including preparing, obtaining and maintaining Regulatory Approvals and authorizations. Allergan shall determine, in its sole discretion, the content of all such submissions and of all correspondence with regulatory agencies relating to such Licensed Product in the Field of Use; and

(iii)   The regulatory filing fees for the Licensed Product in the Field of Use for the Royalty Territory shall be borne solely by Allergan.

(c)      NCE Exclusivity . Each Party shall deliver written notice to the other Party of any ANDA or other foreign equivalent filings it receives for generic equivalents or competitors to the Licensed Product in the Field of Use in the Allergan Territory within ten (10) days of receipt or notice of such filings. The Parties shall have the rights to respond to each such ANDA or other

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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foreign equivalent filings pursuant to the procedures set forth in Section 8.3(c).

5.2      Information Sharing .  This Section 5.2 shall not apply to any pharmacovigilance data (which is addressed in Section 5.5). Each Party shall provide the other Party with copies of all final submissions and correspondence to and from all regulatory agencies relating to the Licensed Product in the Field of Use within ten (10) days of submission or receipt, as applicable. Each Party shall permit the other Party to access, and shall provide the other Party with rights to reference and use in association with the Licensed Product in the Field of Use, all of its, its Affiliates’, and its or their sublicensees’ regulatory, preclinical and clinical data documentation, regulatory filings, and Regulatory Approvals with respect to the Licensed Product in the Field of Use. A Party shall be entitled to provide such data to its Affiliates and sublicensees pursuant to Section 9.1.

5.3      Remedial Actions .  Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product in the Field of Use may be subject to a Remedial Action. A “ Remedial Action ” is any recall, corrective action or other regulatory action taken by virtue of applicable Law. The Parties will assist each other in gathering and evaluating such information as is required to determine the necessity of conducting a Remedial Action with respect to a Licensed Product in the Field of Use; provided, however, that Allergan shall have sole responsibility for collecting information from its customers in the Allergan Territory, including customer complaints. Each Party will maintain adequate records to permit the Parties to trace the manufacture of the Licensed Product in the Field of Use and the distribution and use of the Licensed Product in the Field of Use. In the event Allergan determines that any Remedial Action with respect to the Licensed Product in the Field of Use in the Allergan Territory should be commenced or Remedial Action is required by any Governmental Authority having jurisdiction over the matter, Allergan will control and coordinate all efforts necessary to conduct such Remedial Action. In the event that (a) Spectrum determines that any Remedial Action with respect to the Licensed Product outside the Field of Use in the Allergan Territory or Licensed Product in the Spectrum Territory should be commenced, or (b) Remedial Action is required by any Governmental Authority having jurisdiction over the matter, Spectrum will control and coordinate all efforts necessary to conduct such Remedial Action.

5.4      Costs Of Remedial Action .  The cost and expense of a Remedial Action (including the Parties’ reasonable costs and expenses in conducting such Remedial Action, but excluding Third Party Claims, which are addressed in Article 12) shall be allocated as follows:

(a)     if and to the extent that such Remedial Action is due to (i) Allergan’s gross negligence or willful misconduct, (ii) Allergan’s material breach of this Agreement, or (iii) Allergan’s material breach of or substantial noncompliance with any Law, but only to the extent such Remedial Action is due to the foregoing (i) – (iii), such costs and expenses shall be borne and paid by Allergan;

(b)     if and to the extent that such Remedial Action is due to (i) Spectrum’s gross

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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negligence or willful misconduct, (ii) Spectrum’s material breach of this Agreement, or (iii) Spectrum’s material breach of or substantial noncompliance with any Law, but only to the extent such Remedial Action is due to the foregoing (i) – (iii), such costs and expenses shall be borne and paid by Spectrum; and

(c)         if and to the extent that such Remedial Action is due to reasons other than as set forth in Sections 5.4(a) and (b), then:

    (i)        during any period when Spectrum is responsible for the manufacture and supply of the Licensed Product in the Field of Use for Allergan and for all lots of Licensed Products manufactured by Spectrum or its subcontractors for sale by Allergan in the Field of Use in the Allergan Territory, the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to the Licensed Product in the Field of Use in the Allergan Territory shall be borne and paid as follows: Allergan shall pay **** of such costs and expenses, and Spectrum shall pay **** of such costs and expenses; and

    (ii)        except for all lots of Licensed Products manufactured by Spectrum or its subcontractors, commencing on the date on which Allergan assumes the responsibility for the manufacture and supply of the Licensed Product for sale in the Field of Use in the Allergan Territory: (A) during the term of the Co-Promotion Agreement in the Co-Promotion Region, the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to Licensed Products in the Field of Use shall be borne and paid as follows: Allergan shall pay **** of such costs and expenses, and Spectrum shall pay **** of such costs and expenses; and (B) in the Royalty Territory, and the Co-Promotion Region after termination of the Co-Promotion Agreement, the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to the Licensed Product in the Field of Use shall be borne and paid as follows: Allergan shall pay **** of such costs and expenses, and Spectrum shall pay **** of such costs and expenses.

5.5         Pharmacovigilance or Adverse Event Reporting . Within sixty (60) days of the Effective Date, the Parties shall enter into a pharmacovigilance or adverse event reporting agreement.

5.6         Notification of Complaints . Each Party shall (a) notify the other Party immediately of any information concerning any complaint involving the possible failure of Licensed Product in the Field of Use to meet any requirement of applicable Law, and any serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidents associated with the distribution of the Licensed Product in the Field of Use, whether or not determined to be attributable to the Licensed Product in the Field of Use, and (b) with respect to adverse events, comply with the provisions of Section 5.5 and the applicable agreements described therein.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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5.7         Notification of Threatened Action . Each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Party, including, without limitation, a Governmental Authority which may affect the safety or efficacy claims of the Licensed Product in the Field of Use or the continued marketing of the Licensed Product relating to the Field of Use. Upon receipt of such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action. The Parties shall allocate all costs and expenses associated with taking such action as is described with regard to Remedial Actions in Section 5.4.

5.8         Regulatory Inspections . Each Party shall use good faith efforts to obtain and reveal to the other Party, all inspection reports for itself, its Affiliates, or for any of its vendors, suppliers or other Third Parties by any Government Authority arising from an inspection of the facilities where a Licensed Product for the Field of Use is manufactured, packaged or stored (a “ Facility Inspection ”), and the progress and outcome of any Facility Inspection as it may relate to the Licensed Product in the Field of Use. Upon receipt of notice of any Facility Inspection, the receiving Party will promptly notify the other Party thereof and the receiving Party will provide the other Party with the inspection report and any other relevant information available about the progress and outcome of such inspection available to the receiving Party.

5.9         Audits . Each Party and its duly authorized representatives shall have the right to inspect all facilities utilized by the other Party or its subcontractors (including to the extent provided in, and subject to, the Spectrum Manufacturing Agreements) in connection with the development, manufacture, sale, storage or distribution of the Licensed Product for the Field of Use, upon reasonable prior written notice during normal business hours to ensure compliance with the terms and conditions of this Agreement, and compliance by both Parties, as applicable, with industry standards and applicable Law with respect to Licensed Product for the Field of Use it manufactures for itself. In the event of a disagreement between the Parties as to (a) whether a material adverse defect exists with respect to a Licensed Product or (b) the outcome of a particular audit, an independent, mutually agreed upon arbiter shall be selected by the Parties to resolve the dispute. The cost of such arbiter shall be shared equally by the Parties. All audits shall be conducted without any undue disruption to the business and operations of the audited Party. Any Third Parties conducting such audits shall enter into confidentiality agreements with the audited Party in a form reasonably suitable to the audited Party. Both Parties shall correct, or cause the correction of, any deficiencies which are discovered by any such audit.

ARTICLE 6

PAYMENTS AND ROYALTIES

6.1         Upfront Payment . Allergan shall pay to Spectrum the sum of Forty-One Million Five Hundred Thousand Dollars ($41,500,000) within ten (10) days after the Effective Date (the “ Upfront Payment ”), and such payment shall be non-refundable, non-creditable and non-returnable under any circumstances; provided that the foregoing statement shall not be construed as a limitation to any remedies available to Allergan for the breach by Spectrum of this

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Agreement or the Co-Promotion Agreement.

6.2         Development Milestone Payments .

(a)        Subject to Section 6.2(b), Allergan shall pay to Spectrum additional amounts within thirty (30) calendar days of the completion of certain development milestones, as set forth below:

    (i)       a one time payment of **** upon Allergan’s receipt of written notice from Spectrum of the completion of enrollment for the 611 Study and 612 Study, but only if such enrollment is completed on or before ****;

    (ii)      a one time payment of **** upon Allergan’s receipt of written notice from Spectrum of the completion of enrollment for the BCG Refractory Study, but only if such enrollment is completed on or before ****;

    (iii)     a one time payment of **** upon Allergan’s receipt of written notice of acceptance by the FDA of the first filing of an NDA in the Co-Promotion Region for Licensed Product for use for the Initial Indication;

    (iv)     a one time payment of **** upon Allergan’s receipt of written notice of acceptance by the EMEA of the first filing of an MAA in the EU for Licensed Product for use for the Initial Indication;

    (v)      a one time payment of **** upon Allergan’s receipt of written notice of the first approval by the FDA of an NDA in the Co-Promotion Region for Licensed Product for use for the Initial Indication;

    (vi)     a one time payment of **** upon Allergan’s receipt of written notice of the first approval by the FDA of an sNDA in the Co-Promotion Region for Licensed Product for use for the BCG Refractory Indication;

    (vii)    a one time payment of **** upon Allergan’s receipt of written notice of the first approval by the EMEA of an MAA for Licensed Product for use for the Initial Indication; and

    (viii)   a one time payment of **** upon Allergan’s receipt of written notice of first approval by the EMEA of an MAA or an equivalent of an sNDA for Licensed Product for use for the BCG Refractory Indication.

(b)        In the event of a Development Trigger after which Allergan delivers notice to Spectrum under Section 10.1, the development milestone payments not yet due at the date of delivery of Allergan’s notice, shall be reduced by ****, provided , however that if such notice is delivered under Sections 10.1(b) and (c), the development milestone payments not yet due at the date of delivery of Allergan’s notice, shall instead be reduced by **** (each a “ Standard

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Development Trigger Reduction ”). Further, in the case of a Development Trigger that also constitutes an uncured material breach hereunder, Allergan shall have the right to seek all available rights and remedies to it, under law or equity (including injunctive relief against such breach or to enforce the right granted to Allergan hereunder, except the Standard Development Trigger Reduction), for such material breach by Spectrum that is not cured as set forth in Section 13.3(a) hereof and the amount of milestone payments not yet paid to Spectrum as of such time under Section 6.2(a) shall be reduced by **** (the “ Material Breach Development Trigger Reduction ”). The Material Breach Development Trigger Reduction shall be a remedy in lieu of, but not in addition to, the Standard Development Trigger Reduction remedy to Allergan. For clarity, the occurrence of a Development Trigger alone shall not automatically invoke the Material Breach Development Trigger Reduction, unless the event giving rise to such Development Trigger itself constitutes an uncured material breach of Spectrum’s obligation hereunder that is not cured as set forth in Section 13.3(a) hereof. In addition, the express options set forth in this Agreement available to Allergan in the event of a Development Trigger shall not be construed to limit Allergan’s other rights and remedies in the event such occurrence of a Development Trigger also constitutes an uncured material breach under this Agreement by Spectrum.

6.3         Sales Milestone Payments .

(a)         Milestones . Subject to Sections 6.3(c) and 6.4(e), Allergan shall pay to Spectrum sales milestone payments within sixty (60) days of the end of the Fiscal Quarter in which the following milestones have been met:

    (i)        a one time payment of **** for the first time in which Royalty-Bearing Net Sales of all Royalty-Bearing Product sold in the Royalty Territory exceed **** in a given Fiscal Year;

    (ii)        a one time payment of **** for the first time in which Royalty-Bearing Net Sales of all Royalty-Bearing Product sold in the Royalty Territory exceed **** in a given Fiscal Year;

    (iii)       a one time payment of **** for the first time in which Royalty-Bearing Net Sales of all Royalty-Bearing Product sold in the Royalty Territory exceed **** in a given Fiscal Year; and

    (iv)       a one time payment of **** for the first time in which Royalty-Bearing Net Sales of all Royalty-Bearing Product sold in the Royalty Territory exceed **** in a given Fiscal Year.

(b)         Co-Promotion Region . Subject to Sections 6.3(c), 6.4(e) and 10.2(c), if the Co-Promotion Agreement is terminated, then for sales of Royalty-Bearing Product sold in the Co-Promotion Region following such termination of the Co-Promotion Agreement, Allergan shall pay to Spectrum additional sales milestone payments within sixty (60) days of the end of the

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Fiscal Quarter in which the following milestones have been met:

    (i)        a one time payment of **** for the first time in which Royalty-Bearing Net Sales of all Royalty-Bearing Product sold in the Co-Promotion Region exceed **** in a given Fiscal Year;

    (ii)        a one time payment of **** for the first time in which Royalty-Bearing Net Sales of all Royalty-Bearing Product sold in the Co-Promotion Region exceed **** in a given Fiscal Year;

    (iii)       a one time payment of **** for the first time in which Royalty-Bearing Net Sales of all Royalty-Bearing Product sold in the Co-Promotion Region exceed **** in a given Fiscal Year; and

    (iv)       a one time payment of **** for the first time in which Royalty-Bearing Net Sales of all Royalty-Bearing Product sold in the Co-Promotion Region exceed **** in a given Fiscal Year.

(c)         Calculation . More than one sales milestone can be earned in any given Fiscal Year, but each sales milestone can only be earned once.

6.4         Running Royalties .

(a)         Base Rate for the Royalty Territory . During the Royalty Term, Allergan shall also pay to Spectrum as earned royalties on sales of Royalty-Bearing Product in the Royalty Territory the following royalty payments:

    (i)        for the first **** of Royalty-Bearing Net Sales earned for Royalty-Bearing Product sold in the Royalty Territory in a Fiscal Year, Allergan shall pay Spectrum a royalty at the rate of **** of such Royalty-Bearing Net Sales;

    (ii)        for the next **** of Royalty-Bearing Net Sales earned for Royalty-Bearing Product sold in the Royalty Territory in the same Fiscal Year, Allergan shall pay Spectrum a royalty at the rate of **** of such Royalty-Bearing Net Sales;

    (iii)       for the next **** of Royalty-Bearing Net Sales earned for Royalty-Bearing Product sold in the Royalty Territory in the same Fiscal Year, Allergan shall pay Spectrum a royalty at the rate of **** of such Royalty-Bearing Net Sales; and

    (iv)       for any additional Royalty-Bearing Net Sales earned for Royalty-Bearing Product sold in the Royalty Territory in the same Fiscal Year, Allergan shall pay Spectrum a royalty at the rate of **** of such Royalty-Bearing Net Sales.

By way of example only, Schedule 6.4(a) provides an example of how the royalties will be calculated.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(b)         Base Rate for the Co-Promotion Region . If the Co-Promotion Agreement is terminated (subject to Section 10.2(c)), then for sales of Royalty-Bearing Product sold in the Co-Promotion Region following such termination of the Co-Promotion Agreement, during the Royalty Term, Allergan shall also pay to Spectrum as earned royalties on sales of Royalty-Bearing Product in the Co-Promotion Region at the following royalty payments:

    (i)        for the first **** of Royalty-Bearing Net Sales earned for the Royalty-Bearing Product sold in the Co-Promotion Region in a Fiscal Year, Allergan shall pay Spectrum a royalty at the rate of **** of such Royalty-Bearing Net Sales;

    (ii)        for the next **** of Royalty-Bearing Net Sales earned for the Royalty-Bearing Product sold in the Co-Promotion Region in the same Fiscal Year, Allergan shall pay Spectrum a royalty at the rate of **** of such Royalty-Bearing Net Sales;

    (iii)       for the next **** of Royalty-Bearing Net Sales earned for the Royalty-Bearing Product sold in the Co-Promotion Region in the same Fiscal Year, Allergan shall pay Spectrum a royalty at the rate of **** of such Royalty-Bearing Net Sales; and

    (iv)       for any additional Royalty-Bearing Net Sales earned for Royalty-Bearing Product sold in the Co-Promotion Region in the same Fiscal Year, Allergan shall pay Spectrum a royalty at the rate of **** of such Royalty-Bearing Net Sales.

(c)         Calculations . Notwithstanding the terms of subsections (a) and (b) above:

    (i)        no royalty payments shall be due for Royalty-Bearing Product which are sold and returned as defective, unusable, rejected by a purchaser or for which neither Allergan nor any of its Affiliates or its or their Sublicensees receives payment, and to the extent royalties have already been paid prior to such circumstances being made apparent, Allergan may credit such amounts previously paid against future royalties due;

    (ii)        there shall only be a single payment of royalties at the amounts set forth in this Section 6.4 to Spectrum payable on any sale of Royalty-Bearing Product, regardless of the number of patent applications or patents which are involved; and

    (iii)       no royalty payments shall be due for Royalty-Bearing Product which are used or provided to others by Allergan, its Affiliates or its or their Sublicensees solely for promotion (without consideration), research, conducting clinical trials, demonstration, evaluation, testing or training purposes.

(d)         No Patent Protection . If any Royalty-Bearing Product is sold in a country in the Allergan Territory in which (i) there is no Patent Protection, (ii) there is no Regulatory Exclusivity, and (iii) a Generic Product exists, then the royalty rates set forth in Sections 6.4(a) and (b) for such Royalty-Bearing Product shall be ****. “ Generic Product ” means, with respect to a Royalty-Bearing Product in the Field of Use in a particular country in the Allergan Territory, another pharmaceutical product that: (x) contains as an active ingredient Apaziquone;

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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and (y) is approved for use in such country (pursuant to 21 U.S.C. 355(b)(2), an ANDA, a separate NDA, compendia listing, other drug approval application or otherwise, including foreign equivalents of the foregoing, as applicable). “ Patent Protection ” means, in the country of sale in the Allergan Territory, that at least one of the claims of an issued and unexpired patent included within the Licensed Intellectual Property which would be infringed by the sale of the Royalty-Bearing Product in that country is in effect, and has not been revoked or held unenforceable or invalid by a final decision of a court or other governmental agency of competent jurisdiction having authority over said patent and that final decision is not appealed or unappealable (all claims are considered valid until so adjudicated and during prosecution of a patent application containing such claims) and is sufficient to prevent a Generic Product from being sold in such country. “ Regulatory Exclusivity ” means market exclusivity granted by a Governmental Authority designed to prevent the entry of Generic Product(s) onto the market in the Field of Use, including new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity and 180-day generic product exclusivity. The foregoing shall not apply for sales in the Co-Promotion Region as long as the Co-Promotion Agreement is in effect.

(e)         Royalty Term . Allergan’s royalty obligations under Sections 6.4(a) and (b) shall commence on the First Commercial Sale of a Royalty-Bearing Product and expire, on a country-by-country basis, on the date which falls on the later of the following conditions (the “ Royalty Term ”):

    (i)        the expiration or earlier invalidation of all of the: (A) patents in the Licensed Intellectual Property issued as of the Effective Date claiming the composition of matter of, the formulation of, or the method of making or using, Royalty-Bearing Product in the Field of Use in such country; and (B) other patents in the Licensed Intellectual Property issued after the Effective Date but prior to the **** anniversary of the First Commercial Sale of a Royalty-Bearing Product in the Field of Use in the Co-Promotion Region which are: (I) issued prior to entry of a Generic Product in the country; (II) of sufficient breadth to block the entry of Generic Products in the country; and (III) claim the composition of matter of, the formulation of, or the method of making or using, Licensed Product in the Field of Use in such country (except for the Original Patent Rights, such patents covered by this subsection are “ Extension Patents ”);

    (ii)        the **** anniversary of the First Commercial Sale of such Royalty-Bearing Product in the Field of Use in the Co-Promotion Region; or

    (iii)       the expiration of all Regulatory Exclusivity covering such Royalty-Bearing Product in the Field of Use in such country.

After the expiration of the Royalty Term in a particular country, but only if Allergan has fulfilled its payment obligations under this Article 6 in such country: (x) the licenses set forth in Section 2.1 in such country shall be deemed fully-paid up, perpetual and royalty-free; (y) Allergan may use such licenses in such country perpetually without additional royalties and

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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milestone payments due; and (z) such licenses in such country shall survive expiration or termination of this Agreement regardless of cause.

6.5         Royalty Payment Schedule . Within five (5) business days after the end of each Fiscal Quarter during which a Royalty-Bearing Product in the Field of Use is sold by Allergan, its Affiliates or its or their Sublicensees in the Royalty Territory, Allergan shall provide to Spectrum the estimated royalty payment calculation for Spectrum to complete its quarterly accounting close. Within forty-five (45) days after the end of each Fiscal Quarter during which a Royalty-Bearing Product in the Field of Use is sold by Allergan, its Affiliates or its or their Sublicensees in the Royalty Territory, Allergan shall deliver to Spectrum a detailed report, which shall include at least: (a) the net quantity sold, total sales, total to net deducts, and Royalty-Bearing Net Sales of Royalty-Bearing Product in the Field of Use for which royalties are due hereunder that it has sold in the prior Fiscal Quarter; (b) the calculation in U.S. dollars of royalty payments due hereunder with respect to such sales; and (c) the total due hereunder for such Fiscal Quarter, including deduction for any offsets. Simultaneously with the delivery of each such report, Allergan shall pay to Spectrum the amount specified in Section 6.5(c). Notwithstanding the foregoing, to the extent that Royalty-Bearing Net Sales also include Sublicensee Net Sales of Royalty-Bearing Product (including under Sections 6.3 and 6.4), Allergan shall have additional time as reasonably necessary to provide Spectrum with the information relating to such Sublicensee Net Sales of Royalty-Bearing Product in the foregoing report and payment or to determine whether the sales milestones have been met and subsequently make payments therefor.

6.6         Development Costs . Except as set forth in the Co-Promotion Agreement, commencing with the Fiscal Quarter beginning January 1, 2009, and occurring each Fiscal Quarter thereafter, the Parties agree to pay the Development Costs for the development and Regulatory Approval of the Licensed Product in the Field of Use as follows: Allergan shall be responsible for sixty-five percent (65%) of Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder, and Spectrum is responsible for thirty-five percent (35%) of the Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder. Within the first five (5) business days of each Fiscal Quarter commencing on January 1, 2009, Allergan shall pay Spectrum quarterly in advance Allergan’s share of the estimated Development Costs which Spectrum is estimated to incur for such Fiscal Quarter (as set forth in the JDP). On a monthly basis the Parties agree to discuss the Development Costs incurred in the previous month and review tracking of actual Development Costs to estimated Development Costs. The Parties shall reconcile their respective applicable Development Costs, and will deliver to the other Party, by the third business day after the new Fiscal Quarter, the backup requested by such other Party to complete such other Party’s quarterly accounting close. The estimate provided by each Party on the third business day shall be materially correct as regards actual Development Costs incurred. Within thirty (30) days after the end of each Fiscal Quarter, Allergan will provide Spectrum with an invoice representing thirty-five percent (35%) of the Development Costs incurred by Allegan during the previous Fiscal Quarter and Spectrum will process a payment to Allergan within thirty (30) days following receipt of this invoice. Within thirty (30) days after the end of each Fiscal Quarter, Spectrum shall perform a true-up to determine its

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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actual Development Costs incurred during the previous Fiscal Quarter. If the true-up reflects actual Development Costs incurred in excess of advances previously made by Allergan, Spectrum will provide Allergan with an invoice representing the excess and Allergan will process a payment to Spectrum within thirty (30) days following receipt of this invoice. If the true-up reflects actual Development Costs incurred less than advances previously made by Allergan, Spectrum will reduce their next quarterly advance from Allergan by the amount of the shortfall. Spectrum shall bear all Development Costs for development of the Licensed Product incurred prior to January 1, 2009. In the event of a Development Trigger after which Allergan delivers notice to Spectrum under Section 10.1 for Allergan to take over development, all of the Development Costs incurred by Allergan in performing the development and Regulatory Approval services itself shall also be borne by the Parties in the ratio(s) set forth in this Section 6.6.

6.7         Currency of Payments . All payments under this Agreement will be made in U.S. dollars by electronic funds transfer to such bank accounts as each Party may designate from time to time, or by check. When Royalty-Bearing Product is sold for monies other than U.S. dollars, the exchange rate shall be determined based on the average daily exchange rate calculated by averaging the closing daily rate between the country in which the Royalty-Bearing Product was sold and the U.S., as obtained from Bloomberg or equivalent successor (absent manifest error therein), on a monthly basis during the Fiscal Quarter that Allergan records the sale for accounting purposes.

6.8         Budget . Each Party shall spend the amount specified as required to be budgeted by such Party for performance of their obligations hereunder, as set forth in the applicable JDP, JSP and JMP. Each Party shall account for FTEs assigned to such Party under the JDP, pre-launch JMP or JSP at the FTE Rate.

6.9         Books; Records . During the Term and for three (3) years thereafter, the Parties shall keep and maintain at their respective regular places of business complete and accurate books, records and accounts in accordance with the U.S. Generally Accepted Accounting Principles, or other accounting standards mandated by the U.S. Securities and Exchange Commission, in sufficient detail to reflect all amounts required to be paid under this Agreement, as well as any other books, records or accounts required to be maintained in connection with the Licensed Product under any applicable Law. Prior to destroying any books, records or accounts which are material to the Parties’ rights and obligations under this Agreement, a Party must seek prior written consent from the other Party, which consent may not be unreasonably withheld.

6.10         Audits . During the Term and for three (3) years thereafter, each Party (including a firm of certified public accountants engaged for such purpose) shall have access to and the right to examine such relevant records and accounts that the other Party is required to maintain pursuant to Section 6.9 at such other Party’s premises for the sole purpose of verifying the payments owing such Party hereunder; provided, however, that any such examination: (a) shall be at the auditing Party’s expense; (b) shall be during normal business hours upon reasonable prior written notice which shall in no event be less than five (5) business days; and (c) shall not

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

36


unreasonably interfere with such other Party’s operations and activities. Neither Party may re-audit the other Party’s records once audited. All information reviewed during any such examination shall be treated as Confidential Information of the other Party. The audited Party shall promptly pay the auditing Party any underpayment discovered in the course of such audit, together with interest at the rate specified in Section 6.15 accrued from the date due until paid. Notwithstanding subsection (a) above, if the audit uncovers an underpayment that is more than five percent (5%) of the amount payable for the period subject to such audit, the audited Party shall reimburse the auditing Party for its out-of-pocket expense of such audit.

6.11         Offset . Either Party shall be entitled to offset from any payment due to the other Party under this Agreement any amounts due from the other Party and/or its Affiliates which such other Party fails to pay, including Indemnifiable Amounts (defined in Section 6.14 below). In the event of any offset under this Section, the Party making such offset shall provide receipts of payment of any withheld amounts or other Documents reasonably available to it in support of such offset.

6.12         Stacking .

(a)           If, in order to make or have made, use, conduct clinical trials for, sell, offer for sale, have sold, import, export, or otherwise exploit a Final Licensed Product in the Allergan Territory, it is necessary for Allergan to take a royalty-bearing license under Intellectual Property Rights owned by a Third Party (excluding an Affiliate of Allergan), Allergan may deduct such amounts from amounts due hereunder; provided , however , that Spectrum shall have the first right to negotiate such Third Party license, provided that, if Spectrum does not obtain such license on a timely basis in view of the timeline and circumstance of the development and/or commercialization of the Licensed Product at such time, then Allergan shall have the right, upon ten (10) business days prior written notice to Spectrum, to obtain such license itself under reasonable terms.

(b)           To the extent that subsection (a) does not apply, if the Parties obtain and/or maintain a license under Intellectual Property Rights owned by a Third Party (excluding an Affiliate of Allergan) in order to make, have made, use, conduct clinical trials for, sell, offer for sale, have sold, import, export, or otherwise exploit the Licensed Product in the Field of Use in the Allergan Territory, then, except as provided in Section 6.14, payments made to such Third Party in exchange for the practice of such license by Allergan in the Allergan Territory shall be borne by Allergan, provided , however , that Allergan may deduct **** of the royalty payments to such Third Party from its payments due to Spectrum hereunder, including under the Co-Promotion Agreement, provided that such payments shall not reduce the royalties due to Spectrum under Section 6.4 by more than ****.

6.13         Withholding Taxes . Notwithstanding anything to the contrary herein, in the event that withholding taxes apply with respect to any amounts due by Allergan hereunder, Allergan shall be entitled to withhold from any payment due to Spectrum under this Agreement any taxes that Allergan is required to pay and such withholding shall decrease by an equivalent amount the

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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payment due to Spectrum. Allergan shall provide Spectrum with notification of any anticipated withholding requirements with as much advance notice as practicable and shall cooperate in good faith with Spectrum to legally minimize such withholding taxes. Allergan will timely pay to the proper governmental authority the amount of any taxes withheld and will provide Spectrum with an official tax certificate or other evidence of tax obligation, together with proof of payment from the relevant governmental authority sufficient to enable Spectrum to claim such payment of taxes.

6.14       Spectrum’s Obligations . Spectrum shall be solely responsible for, and shall pay, any royalties or other payments due under the ****, the **** or any other license to the Licensed Intellectual Property existing as of the Effective Date. No royalties and other payments borne exclusively by Spectrum under this Section 6.14 shall be considered as a cost or expense under any JDP, JSP or JMP budget. Further, no Indemnifiable Amounts due under this Agreement shall be considered as a cost or expense, as part of any JDP, JSP or JMP budget. “ Indemnifiable Amounts ” as it is used herein means any amount payable to the other Party by way of an indemnification clause under this Agreement or other indemnification.

6.15       Late Payment . If a Party does not receive payment of any sum due to it on or before the due date, simple interest shall thereafter accrue on the sum due to such Party from the due date until the date of payment at a rate equal to LIBOR, as reported in the Wall Street Journal, plus one percent (1%) or the maximum rate allowable by applicable law, whichever is less.

ARTICLE 7

TRADEMARK ASSIGNMENT

7.1         Assignment . Spectrum hereby assigns all right, title, and interest in and to the Acquired Trademarks, including the accompanying goodwill, pursuant to that certain trademark assignment agreement between the Parties dated as of the Effective Date identical to the form attached hereto as Schedule 7.1 (the “ Trademark Assignment Agreement ”). Allergan may, at its sole discretion, rebrand and rename the Licensed Product in connection with Allergan’s marketing, distribution and sale of the Licensed Product. Allergan shall be the sole and exclusive owner of any such brand or name and all Trademarks therein.

7.2         No Use by Spectrum . Except as provided in the Co-Promotion Agreement, Spectrum shall make no use of the Acquired Trademarks, or any Trademark that includes any of the Acquired Trademarks or is confusingly similar thereto, or any of Allergan’s or its Affiliates’ Trademarks, on or in connection with any product or service anywhere in the world. Without limiting the generality of the foregoing, Spectrum shall not use any Trademark that is the same as, or similar to (so as to cause confusion in consumers), the Acquired Trademarks or any other Trademark used by Allergan or its Affiliates to market the Licensed Product. The foregoing shall not be construed as restricting Spectrum from making factual references to the Acquired Trademarks in its regulatory filings or to satisfy its legal and regulatory obligations. Unless otherwise agreed to by the Parties, within one hundred twenty (120) days after the Effective

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Date, Spectrum shall cease using the Acquired Trademarks and, thereafter, the JMC will shall have the authority to determine how the Licensed Product shall be referenced.

ARTICLE 8

INTELLECTUAL PROPERTY

8.1         Ownership . The Parties agree as follows:

(a)        subject to the licenses granted herein during the Term of this Agreement, Spectrum retains ownership of all Spectrum Intellectual Property;

(b)        Allergan retains ownership of all Allergan Solely Developed Know How (subject to any licenses agreed upon pursuant to Sections 2.4, 2.5 and/or 13.2(c)(i)); and

(c)        subject to the licenses granted herein during the Term of this Agreement, the Joint Intellectual Property shall be owned jointly by the Parties in accordance with joint ownership interests of co-inventors under United States patent and copyright laws, with each Party owning an undivided half interest in such Joint Intellectual Property, with the right to exploit and license such intellectual property without the duty of accounting to the other Party or seeking consent from the other Party. For the purpose of determining inventorship under this Section 8.1(c), inventorship shall be determined in accordance with United States patent and copyright laws.

8.2         Prosecution .

(a)         Notice . Spectrum shall promptly notify Allergan in writing of the issuance of any patent in the Licensed Intellectual Property.

(b)         Prosecution . Spectrum at its expense shall diligently prosecute and maintain the patents and patent applications in the Licensed Intellectual Property (including in the Joint Intellectual Property) using counsel of its choice, which counsel shall also be subject to the reasonable approval of Allergan. Allergan and Spectrum shall consult in good faith with each other prior to any filings or other actions before the U.S. Patent and Trademark Office and other offices with respect to the patents and patent applications in the Licensed Intellectual Property (including the Joint Intellectual Property), including any continuations, and the Parties shall jointly make all decisions pertaining thereto. Allergan may request Spectrum to obtain patent protection for Licensed Intellectual Property (including the Joint Intellectual Property) and, if so requested, Spectrum shall cooperate and diligently file, prosecute and maintain such rights. Upon request, Spectrum shall promptly provide Allergan and its counsel with copies of all relevant documentation so that Allergan may be informed and apprised of the continuing prosecution of the patents and patent applications in the Licensed Intellectual Property (including the Joint Intellectual Property). In the event that Spectrum decides not to prosecute, or otherwise to abandon, a patent or application therefor relating to the Licensed Intellectual Property (including the Joint Intellectual Property) in a country in which it is required to do so, Spectrum shall send Allergan written notice of said decision at least ninety (90) days in advance of the action or payment due date. Allergan shall thereupon have the option to take over the patent or

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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application, and Spectrum shall assign to Allergan all rights in such patent or application in such jurisdiction. In the event that Allergan takes over the prosecution and maintenance of the applicable patents and patent applications in the Licensed Intellectual Property (including the Joint Intellectual Property), Allergan may deduct Spectrum’s share of the Patent Expenses (defined below) from any amounts due hereunder, provided, however, that if Spectrum assigns such patent or application in such jurisdiction to Allergan, then Allergan shall bear the Patent Expenses for such patent or application at its sole expense.

(c)         Patent Expenses . “ Patent Expenses ” means the reasonable fees and expenses of outside counsel and payments to Third Parties incurred after the Effective Date in connection with the preparation, filing, prosecution and maintenance of patent applications and patents included in the Licensed Intellectual Property (including the Joint Intellectual Property) that cover the Licensed Product in the Field of Use in the Allergan Territory or its manufacture or use (including the costs of patent interference and opposition proceedings). Except as set forth in subsection (b), all Patent Expenses incurred for the protection of market exclusivity in the Allergan Territory shall be ****. Spectrum shall deliver to Allergan within sixty (60) days of the end of the Fiscal Quarter in which such Patent Expenses were incurred by Spectrum an accounting of all such Patent Expenses. Allergan shall reimburse Spectrum for its undisputed share within thirty (30) days of receipt thereof.

(d)         License Recordals . Should local counsel in a given country recommend that Allergan be appointed as a licensee of Spectrum for the patents and patent applications in the Licensed Intellectual Property (including the Joint Intellectual Property) and that such license be recorded with the appropriate patent office, then Spectrum at its expense (subject to Section 8.2(c) above) shall prepare and file the necessary documents subject to Allergan’s approval, which shall not be unreasonably withheld or delayed.

8.3         Enforcement .

(a)         Notice of Infringement . If either Party learns of the actual, suspected, threatened or likely infringement or misappropriation of any of the Licensed Intellectual Property (including the Joint Intellectual Property), then that Party shall give written notice thereof to the other Party and shall provide the other Party with any evidence of such infringement or misappropriation in its possession.

(b)         Pre-Issuance . Where the suspected or actual infringement or other suspected or actual unauthorized use relates to the claims in a patent application in the Licensed Intellectual Property (including the Joint Intellectual Property) in the Allergan Territory for which no patent has yet been issued, Spectrum shall promptly give notice to the Third Party infringer of the publication of the patent application.

(c)         Infringement by Third Parties in the Allergan Territory .

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(i)        Allergan may, but shall be under no obligation to, unilaterally take, at its expense, any court or administrative action to enforce any suspected or actual infringement or other unauthorized use of the Licensed Intellectual Property (including the Joint Intellectual Property and including responding to Paragraph IV patent certifications) in the Allergan Territory. If Allergan takes such enforcement action, Spectrum may elect to join as a party in that action at Spectrum’s expense, provided that if Allergan does not have standing without Spectrum joining the action, Spectrum shall join the action at Allergan’s expense and hereby consents to the exercise of personal jurisdiction by the relevant courts.

(ii)       If Allergan fails to commence enforcement of a court or administrative action within ninety (90) days following the earlier of: (A) Allergan becoming aware of such matter at the level of direct reports to the Chief Executive Officer of Allergan; or (B) written request by Spectrum for Allergan to do so, then Spectrum may, but shall be under no obligation to, in its own name, and at its own expense, commence any court or administrative enforcement action Spectrum deems necessary. Notwithstanding the foregoing sentence, if there is a deadline to take that court or administrative action, then, at least one (1) week prior to such filing deadline, Allergan shall either commence such enforcement action or give written notice to Spectrum that it has declined to do so. If Spectrum commences such enforcement action and Spectrum requests Allergan to join as a party to that action, Allergan shall join as a party to that action at Spectrum’s expense and hereby consents to the exercise of personal jurisdiction by the relevant courts.

(iii)      If Allergan commences any such enforcement action, Allergan shall have the exclusive right to employ counsel of its own selection and to direct and control the litigation or any settlement thereof; provided , however , that Allergan shall not, without obtaining Spectrum’s prior written consent, settle any such actions in any way that would limit Spectrum’s rights in the Licensed Intellectual Property (including the Joint Intellectual Property). Allergan may reimburse itself for **** of the reasonable costs and expenses it incurs in enforcing any such action that relates to Licensed Product in the Allergan Territory by deducting such amounts from the royalties and milestone payments due to Spectrum hereunder. To the extent Allergan is paid any settlement amount or awarded damages, costs or expenses, Allergan may first apply such settlement or award to reimburse itself for all remaining reasonable costs and expenses it incurred in enforcing the action and Spectrum for all costs and expenses paid or deducted as set forth above (each Party shall receive such amounts on a pro rated basis). Any amount remaining after this reimbursement shall result in a payment to ****, calculated by applying the ****. However, if the Co-Promotion Agreement has not been terminated, for infringement in the Co-Promotion Region, the Parties shall ****.

(iv)      If Spectrum commences any such enforcement action, Spectrum shall have the exclusive right to employ counsel of its own selection and to direct and control the litigation or any settlement thereof; provided , however , that Spectrum shall not, without obtaining Allergan’s prior written consent, settle any such actions in any way that

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

41


would limit Allergan’s rights hereunder. Spectrum may reimburse itself for **** of the reasonable costs and expenses it incurs in enforcing any such action that relates to Licensed Product in the Field of Use in the Allergan Territory by deducting such amounts from any payment due to Allergan, by including such amount in its calculation of PSMM to be reimbursed by Allergan, or, after the profit share arrangement has been terminated, by providing Allergan with an invoice therefor, which Allergan shall pay within thirty (30) days of its receipt. To the extent Spectrum is paid any settlement amount or awarded damages, costs or expenses, Spectrum may first apply such settlement or award to reimburse itself for all remaining reasonable costs and expenses it incurred in enforcing the action and Allergan for all costs and expenses paid or deducted as set forth above (each Party shall receive such amounts on a pro rated basis). Any amount remaining after this reimbursement shall result in a payment to ****, calculated by applying the ****, with the remainder paid to ****. However, if the Co-Promotion Agreement has not been terminated, for infringement in the Co-Promotion Region, the Parties shall ****.

    (v)        In any suit or dispute involving any Third Party infringer, the Parties shall cooperate fully, and upon the request of the enforcing Party, the non-enforcing Party shall make available to the enforcing Party all relevant records, papers, information, samples, specimens, and the like which may be relevant and in its possession.

ARTICLE 9

CONFIDENTIAL INFORMATION

9.1         Confidentiality Obligations .

(a)        Both Spectrum and Allergan acknowledge that, in furtherance of this Agreement, including the Co-Promotion Agreement, they have and will receive from the other Party certain Confidential Information.

(b)        All proprietary or confidential materials and information, whether oral or in writing, exchanged by the Parties or their Affiliates in furtherance of this Agreement (including the Co-Promotion Agreement) shall be considered confidential information of the disclosing Party or its Affiliates, including testing protocols, research, formulations, business methods and practices, information about the expertise of employees or consultants, other technical, business, financial, customer and product development plans, training materials and methods of training the sales force, identity and location of customers, supplier information, forecasts, strategies and similar information, prospective customers and suppliers, financial information, inventions, processes, Know How, methods, products, patent applications, specifications, drawings, sketches, models, samples, designs, ideas, technical information, and all other confidential business information and trade secrets (“ Confidential Information ”). This Agreement shall supersede the Mutual Confidentiality Agreement between Spectrum and Allergan, effective December 14, 2007, and all confidential information disclosed by a Party to the other Party thereunder shall be deemed Confidential Information of the disclosing Party under this

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Agreement.

(c)        Notwithstanding the foregoing, “Confidential Information” shall not include any information which was: (i) in the public domain at the time of disclosure; (ii) in the possession of the receiving Party at the time of disclosure to it whether prior to or during the Term of this Agreement, including the Co-Promotion Agreement, and not as a result of disclosure by or on behalf of the other Party, as evidenced by written records; (iii) received by the receiving Party from a Third Party who had a lawful right to disclose such information to it; or (iv) independently developed by the receiving Party without reference to Confidential Information of the other Party or its Affiliates, as evidenced by the receiving Party.

(d)        Each Party for itself and its Affiliates hereby acknowledges and agrees that all Confidential Information is proprietary to the disclosing Party or its disclosing Affiliates.

(e)        Each Party for itself and its Affiliates agrees: (i) to use Confidential Information disclosed by the disclosing Party or its Affiliates only for the purposes described herein, including the Co-Promotion Agreement; and (ii) to hold in confidence and protect such Confidential Information from dissemination to, and use by, any Third Party (except for Affiliates of such Party), except as may be permitted in this Agreement.

(f)        Neither Party shall, and each Party shall cause its Affiliates not to, without the prior written consent of the disclosing Party, in any manner whatsoever, disclose or communicate any Confidential Information received from the disclosing Party or its Affiliates to any employee, officer or director, subcontractor, agents, advisor, and/or consultants of the receiving Party or its Affiliates or to any other Third Party, except for those who need to know such information solely for the purpose of this Agreement (including the Co-Promotion Agreement) and who have been advised of and have agreed to treat such information in accordance with the terms of this Agreement (including the Co-Promotion Agreement). Each Party is responsible for any breach of this Article 9 by those to whom such Party or its Affiliates disclose the other Party’s or its Affiliates’ Confidential Information.

9.2         Disclosure Required by Law . Nothing in this Agreement shall be construed as preventing or in any way inhibiting either Party or its Affiliates from disclosing Confidential Information of the other Party or its Affiliates or taking any other actions necessary to comply with applicable Laws (subject to the terms of Section 14.12 for press releases and public announcements). In the event a Party or its Affiliates shall deem it reasonably necessary to disclose Confidential Information belonging to the disclosing Party or its Affiliates under this Section 9.2, such Party or its Affiliates (a) shall to the extent possible give reasonable advance notice of such disclosure to the disclosing Party or its Affiliates in order that the disclosing Party or its Affiliates may seek an appropriate protective order, and barring such protective order, that a copy of such legally compelled disclosure or announcement is delivered to the disclosing Party or its Affiliates prior to dissemination, and (b) shall consider in good faith the disclosing Party’s or its Affiliates’ objections to such disclosure, including suggestions to redact Confidential Information, and take reasonable measures to seek confidential treatment of such information.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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9.3         Equitable Relief . Each Party and its Affiliates acknowledges that a breach of this Article 9 cannot reasonably or adequately be compensated in damages in an action at law and that such a breach shall cause the other Party irreparable injury and damage. By reason thereof, each Party and its Affiliates agree that the other Party shall be entitled, in addition to any other remedies it may have under this Agreement or otherwise, to preliminary and permanent injunctive and other equitable relief to prevent or curtail any breach of the obligations relating to Confidential Information set forth herein by the other Party. Each Party and its Affiliates agree that the existence of any claim, demand, or cause of action of it against the other Party, whether predicated upon this Agreement, or otherwise, shall not constitute a defense to the enforcement by the other Party, or its successors or assigns, of the obligations relating to Confidential Information set forth herein.

9.4         Independent Development; Residuals . Each Party acknowledges that the other Party may currently or in the future be developing information internally, or receiving information from Third Parties, that is similar to the Confidential Information. Accordingly, except as set forth in Section 2.6, nothing in this Agreement will be construed as a representation or agreement that the Parties will not develop or have developed for it products, concepts, systems or techniques that are similar to or compete with the Licensed Product, concepts, systems or techniques contemplated by or embodied in the Confidential Information, provided that the Parties do not violate any of their obligations under this Agreement in connection with such development. Additionally, each Party shall be free to use the Residuals resulting from access to or work with the other Party’s Confidential Information for any purpose. The term “ Residuals ” means information in intangible form, retained in the unaided memory (without the assistance of notes or other memory aids and without any conscious attempt to memorize or refresh recollections) of Persons employed or retained by a Party who have had access to or worked with the Confidential Information, including ideas, concepts, know-how or techniques contained therein. The Parties shall not have any obligation to limit or restrict the assignment of such Persons or to pay royalties for any work resulting from the use of Residuals.

ARTICLE 10

CERTAIN REMEDIES; NOTICE RIGHT

10.1       Development Trigger . In the event of a Development Trigger, in addition to all other remedies available to Allergan under this Agreement, at law, or in equity, if any, Allergan at its option, and with written notice to Spectrum (effective upon receipt), may select any or all of the following options; provided, however, that Allergan may only select the option provided in Section 10.1(c) if it also selects the option provided in Section 10.1(b):

(a)        take over control of all development activities;

(b)        **** or ****Spectrum’s **** or****associated with the ****and ****Allergan ****the ****and ****;

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(c)        require Spectrum to **** Allergan ****all ****and ****is not ****Spectrum ****Allergan **** relating to the Licensed Product in the Field of Use in the Allergan Territory;

(d)        take over the **** relating to the Licensed Product in the Field of Use in the Allergan Territory under this Agreement. In such event, Allergan shall be ****; and

(e)        ****, rather than ****, shall have ****and ****as set forth in****Allergan’s ****shall be****Allergan’s ****shall be **** In addition****shall be ****to allow ****set forth ****as compared to the ****as of the ****Also, Allergan ****of the ****which ****and ****Spectrum’s ****.

10.2       Change in Control Trigger . In the event of a Change in Control Trigger, Allergan at its option, and with written notice to Spectrum (effective upon receipt), may select any or all of the following options:

(a)        require Spectrum to **** Allergan **** all **** and **** is not **** Spectrum **** Allergan **** relating to the Licensed Product in the Field of Use in the Allergan Territory;

(b)        take over the **** relating to the Licensed Product in the Field of Use in the Allergan Territory under this Agreement. In such event, Allergan shall be ****;

(c)        **** with written notice to Spectrum**** written notification to Spectrum) within thirty (30) days of being notified by Spectrum of such Change in Control pursuant to Section 10.5. In the event Allergan **** as set forth above, ****In the event **** in lieu of the terms set forth in ****, the Parties ****, pursuant to the ****; and

(d)        ****, rather than ****, shall have **** and **** as set forth in **** Allergan’s **** shall be **** Allergan’s **** shall be **** In addition**** shall be **** to allow **** set forth **** as compared to the **** as of the **** Also, Allergan **** of the **** which **** and **** Spectrum’s ****.

10.3       Co-Promotion Trigger . In the event that the Co-Promotion Agreement terminates, the following shall apply:

(a)        if the Co-Promotion Agreement terminates because Spectrum opts out of the Co-Promotion Agreement (pursuant to the terms thereof), then ****, Allergan may, upon written notice to Spectrum, require Spectrum to assign to Allergan the ownership of all NDAs, sNDAs, MMAs and other Regulatory Approvals relating to the Licensed Product in the Field of Use in the Co-Promotion Region; or

(b)        if the Co-Promotion Agreement terminates for any reason other than as set forth in subsection (a), then within three (3) months after the date of termination, Allergan may, upon written notice to Spectrum, require Spectrum to assign to Allergan the ownership of all NDAs, sNDAs, MMAs and other Regulatory Approvals relating to the Licensed Product in the Field of

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Use in the Co-Promotion Region.

10.4       Clarification . Notwithstanding Allergan taking over control of development under Section 10.1 or 10.2, Spectrum shall still remain on the JDC and shall still be responsible for its payment obligations hereunder. However, to the extent that Allergan assumes development responsibilities pursuant to Section 10.1 or 10.2 of this Agreement, Spectrum or Spectrum’s successor in interest, as applicable, shall no longer be obligated to perform the services associated with such responsibilities.

10.5       Notice . Spectrum shall provide Allergan with written notice of any bona fide discussions it has with a Third Party to acquire Spectrum through the consummation of a Change in Control; provided, however, that Spectrum shall not be obligated to disclose the identity of such Third Party or terms of the discussions. Spectrum shall provide written notice to Allergan thirty (30) days in advance of a closing of a transaction that will result in a Change in Control Trigger.

ARTICLE 11

REPRESENTATIONS, WARRANTIES AND COVENANTS

11.1       Both Parties . Each of the Parties provides the following representations, warranties and covenants during the Term of this Agreement for this Agreement, including the Co-Promotion Agreement (collectively, “ the Agreement ” for the purposes of this Section 11.1):

(a)        Each Party hereby represents, warrants and covenants to the other Party that: (i) it has all requisite right, power and authority to enter into the Agreement on behalf of itself and its Affiliates and to perform its respective obligations hereunder and to cause its Affiliates to perform their respective obligations hereunder; (ii) the execution, delivery and performance by such Party of the Agreement has been duly authorized and approved by all necessary action by such Party; and (iii) assuming due authorization, execution and delivery by the other Party, the Agreement constitutes the legal, valid and binding obligations of such Party, enforceable against such Party in accordance with its respective terms.

(b)        Each Party represents, warrants and covenants to the other Party that the execution and delivery of the Agreement and the performance of such Party’s and its Affiliates’ obligations hereunder: (i) do not conflict with or violate any requirement of applicable Law as of the Effective Date; (ii) do not, and will not, conflict with or otherwise interfere with in such a manner as to result in a violation, breach, or default under or require any consent that has not been obtained under any Contract between such Party or any of its Affiliates and any Third Party; and (iii) there are no, and shall be no, liens, conveyances, mortgages, assignments, encumbrances, or other Contracts that would prevent or impair such Party’s or any of its Affiliates’ full and complete exercise of the terms and conditions of the Agreement.

(c)        Each Party hereby represents, warrants and covenants to the other Party that it and its Affiliates shall at all times comply with all applicable Laws relating or pertaining to their

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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obligations under the Agreement.

11.2       Licensed Intellectual Property: Ownership/Right to License; Non-Infringement; Validity . Spectrum represents, warrants and covenants that:

(a)        except to the extent that it would not cause a material adverse consequence, (i) as of the Effective Date, it is the sole and exclusive owner of all right, title and interest, in, to and under the Licensed Intellectual Property; (ii) other than Allergan’s interest in Joint Intellectual Property, it is the sole and exclusive owner of or has the sole and exclusive license to all right, title and interest, in, to and under the Licensed Intellectual Property incorporated in or used in manufacturing the Final Licensed Product, and (iii) other than Allergan’s interest in Joint Intellectual Property, it is the sole and exclusive owner of or has the sole and exclusive license to all right, title and interest, in, to and under the Extension Patents, in each case free and clear of any security interests, claims, encumbrances or charges of any kind;

(b)        it has sufficient rights to grant the licenses and rights granted herein, free and clear of any security interests, claims, encumbrances or charges of any kind;

(c)        it has not assigned and/or granted licenses, nor shall it assign and/or grant licenses, to the Licensed Intellectual Property to any Third Party that would restrict or impair the rights granted hereunder, and it has not granted to anyone any rights that cover the Licensed Product in the Field of Use in the Allergan Territory that remain in effect as of the Effective Date;

(d)        the making or having made, use, marketing, sale, offering for sale, import, export and other exploitation of Final Licensed Product in the Field of Use in the Allergan Territory does not, and shall not, infringe upon, misappropriate or otherwise violate any Intellectual Property Rights of any Third Party;

(e)        ****, as of the Effective Date: (i) the patents in the Original Patent Rights are valid and enforceable; (ii) to its actual knowledge, there is no reason why the claims that may issue from the patent applications in the Original Patent Rights would not be valid and enforceable; (iii) no Third Party has asserted that any Licensed Intellectual Property is invalid or not enforceable; and (iv) Spectrum has obtained assignment of the Original Patent Rights from the inventors named therein, and all such assignments of inventorship rights are valid and enforceable. As of the Effective Date, all applications, registrations, maintenance and renewal fees in respect of the Original Patent Rights have been paid and all documents and certificates required to be filed with the relevant agencies for the purpose of maintaining the Original Patent Rights have been filed. ****, all inventors who should have been listed in the Original Patent Rights as inventors have been listed in the Original Patent Rights as inventors. As of the Effective Date, none of the Licensed Intellectual Property was developed with federal or state funding from any Governmental Authority such that any Governmental Authority has any march in rights or other rights to use the Licensed Intellectual Property;

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(f)        to its actual knowledge, no Third Party has infringed the Licensed Intellectual Property; and

(g)        it has provided to Allergan the patent searches, and ****.

11.3      All Rights Granted .  Spectrum represents, warrants and covenants that: (a) it shall not invoke any dominant patent or patent application owned or controlled by, or licensed to, Spectrum or its Affiliates to in any way restrict the rights and/or licenses granted to Allergan and its Affiliates under this Agreement (including the Co-Promotion Agreement); (b) the Licensed Intellectual Property licensed under Section 2.1(a) constitutes all of the Intellectual Property Rights that are necessary to make, have made, use, market, sell, offer for sale, have sold, import, export and otherwise exploit the Final Licensed Product in the Field of Use in the Allergan Territory; and (c) as of the Effective Date, Spectrum has delivered to Allergan copies of all material Documents relating to the development, manufacture and sale of Licensed Product in the Field of Use and other material Licensed Intellectual Property, and has made all applicable Spectrum employees involved in the development of material Licensed Intellectual Property available to Allergan to assist Allergan in understanding the data delivered to Allergan.

11.4       No Law Suits .  Spectrum represents, warrants and covenants that, as of the Effective Date, there is no legal, administrative, arbitration, or other proceeding, suit, claim or action of any nature, judgment, decree, decision, injunction, writ or order pending or, to the knowledge of Spectrum’s senior management, threatened by, against or involving Spectrum, the Licensed Intellectual Property, or this Agreement, including the Co-Promotion Agreement, whether at law or in equity, before or by any Person. Spectrum shall provide notice of any of the foregoing to the extent they involve the Licensed Product, the Licensed Intellectual Property, or this Agreement, including the Co-Promotion Agreement. Allergan represents, warrants and covenants that, as of the Effective Date, there is no legal, administrative, arbitration, or other proceeding, suit, claim or action of any nature, judgment, decree, decision, injunction, writ or order pending or, to the knowledge of Allergan’s senior management, threatened by, against or involving this Agreement, including the Co-Promotion Agreement, whether at law or in equity, before or by any Person. Allergan shall provide notice of any of the foregoing to the extent they involve this Agreement, including the Co-Promotion Agreement.

11.5       Trademarks .  Spectrum represents, warrants and covenants that as of Effective Date:

(a)         it is the sole and exclusive owner of all right, title and interest in the Acquired Trademarks, free and clear of any security interests, claims, encumbrances or charges of any kind;

(b)         it has not assigned and/or granted licenses to the Acquired Trademarks to any Third Party that would restrict or impair the rights granted hereunder;

(c)          Schedule 11.5(c) constitutes a complete and accurate list of all of trademark and

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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domain name applications and registrations for the Acquired Trademarks, both active and inactive;

(d)        **** no Third Party has asserted that the Acquired Trademarks are invalid or not enforceable;

(e)        **** all Acquired Trademarks that are registered trademarks or are the subject of pending trademark applications are in full force and effect, and all actions required to keep such registrations or application pending or in effect or to provide full available protection, including payment of filing and maintenance fees and filing of renewals, statements of use or affidavits of incontestability, have been taken, and no such applications or registrations are the subject of any opposition, cancellation, or other proceeding placing in question the validity or scope of such rights; and

(f)        **** Spectrum has received no notice that the use, presentation or display of the Acquired Trademarks on or in connection with the Licensed Product infringes or otherwise violates any Trademark or Intellectual Property Rights of any Third Parties. Spectrum is not aware of any circumstances likely to give rise to any claim of infringement or other violation of any Third Party’s Trademark by use of the Acquired Trademarks.

11.6       Confidentiality .  Except to the extent that it would not cause a material adverse consequence, Spectrum represents, warrants and covenants as of the Effective Date that all Know How known to Spectrum and relating to the Licensed Product in the Field of Use and all other Licensed Intellectual Property which has not been patented has been kept confidential, except for public disclosures customarily made in the industry, and all employees, consultants, agents and contractors of Spectrum and its Affiliates, or other Third Parties, to whom Spectrum has disclosed such Know How or other Licensed Intellectual Property have executed, and are subject to, confidential and proprietary information agreements that protect and limit the use and disclosure of the Licensed Intellectual Property in a manner comparable to the confidentiality and non-use provisions contained in Article 9.

11.7       Regulatory Approvals .  Spectrum represents, warrants and covenants as of subsections (a)-(d) below and Allergan represents, warrants and covenants as of subsection (e) below that:

(a)        as of the Effective Date, Spectrum has provided Allergan with all applicable details on the regulatory status of all Licensed Product in the Field of Use in the Allergan Territory, and Spectrum has provided copies of all clearances and applications therefor;

(b)        Spectrum is the owner of record of the Investigational New Drug Application (filed with the FDA) for the 611 Study and 612 Study, except to the extent that Allergan takes ownership pursuant to its rights under this Agreement;

(c)        with respect to all regulatory filings to obtain Regulatory Approvals for the Licensed Product in the Field of Use: (i) the data and information in the Spectrum Group’s

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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submissions were, are and shall be free from fraud or material falsity; (ii) the Regulatory Approvals have not been and will not be obtained either through bribery or the payment of illegal gratuities by the Spectrum Group; (iii) the data and information in the Spectrum Group’s submissions are, were and shall be accurate and reliable for purposes of supporting approval of the submissions; and (iv) the Regulatory Approvals shall be obtained without illegal or unethical behavior of any kind by the Spectrum Group; provided that Spectrum shall not be deemed to be in breach of this Section 11.7(c) if the violation of this Section 11.7(c) results from the action or omission of Allergan, its Affiliates or sublicensees;

(d)        as of the Effective Date, neither Apaziquone nor any of its corresponding active moieties (following enzymatic activation), nor any of the salts, esters, isomers, mixtures of isomers, complexes or derivatives of Apaziquone have been (i) previously approved as an active ingredient under section 505(b) of the FD&C Act, or (ii) authorized by the EMEA or other regulatory authorities in the EU; and

(e)        except for information provided by Spectrum, its Affiliates or sublicensees or others in the Spectrum Group, with respect to all regulatory filings to obtain Regulatory Approvals for the Licensed Product in the Field of Use: (i) the data and information in the Allergan Group’s submissions and modifications thereof shall be free from fraud or material falsity; (ii) the Regulatory Approvals will not be obtained either through bribery or the payment of illegal gratuities by the Allergan Group; (iii) the data and information in the Allergan Group’s submissions and modifications thereof shall be accurate and reliable for purposes of supporting approval of the submissions; and (iv) the Regulatory Approvals shall be obtained without illegal or unethical behavior of any kind by the Allergan Group; provided that Allergan shall not be deemed to be in breach of this Section 11.7(e) if the violation of this Section 11.7(e) results from the action or omission of Spectrum, its Affiliates or sublicensees.

11.8       Professional Standards .  Each Party represents, warrants and covenants that, with respect to the services provided hereunder to the other Party, it, its Affiliates and their respective employees, contractors and agents who perform services have the experience, capability and resources to efficiently and skillfully perform the services, and shall perform, where applicable, all such services in a professional and workmanlike manner and in accordance with the generally accepted then-current standards, forms, procedures and techniques established from time to time by the industry (including eCTD where applicable).

11.9       No Conflict .  Spectrum represents, warrants and covenants that: (a) no Contracts that it or its Affiliates may have with any Third Party provide such Third Party with any rights of first offer, rights of first refusal, or any other rights to make, have made, use, conduct clinical trials for, sell, offer for sale, have sold, import, export, or otherwise exploit the Licensed Product in the Field of Use in the Allergan Territory or the use of the Licensed Intellectual Property in connection with the making, developing or commercializing of the Licensed Product in the Field of Use in the Allergan Territory; and (b) it has received no notice from a Third Party of any suit, action, proceeding or arbitration pending or threatened against it that the proposed terms and conditions of this Agreement, including the Co-Promotion Agreement, and the Parties’

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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performance in accordance therewith, do or shall conflict or interfere with in a manner resulting in a breach or default under, or other violation of, any Contracts that Spectrum or its Affiliates may have with any Third Party.

11.10    Additional Warranties .  Spectrum represents, warrants and covenants that:

(a)        Apaziquone is a member of the series of compounds known as Indoloquinones licensed to Spectrum under the ****;

(b)        Spectrum dissolved its subsidiary known as NeoOncoRx, Inc. on January 23, 2003, and as a result, Spectrum was the sole licensee under the **** and no other Third Party has any claims as a licensee under the ****;

(c)        prior to the Effective Date, Allergan has been supplied with a true and correct copy of the **** and ****, together with all amendments, waivers or other changes thereto;

(d)        Spectrum has performed all obligations required to be performed by it in connection with the **** and ****, Spectrum is not in breach of the **** or **** as of the Effective Date, and Spectrum is not in receipt of any claim of default, cure notice or show cause notice under the **** or ****;

(e)        Spectrum has no present expectation or intention of not fully performing any material obligation pursuant to the **** or ****, and, to the knowledge of Spectrum, there is no current breach or anticipated breach by any other party to the **** or **** and Spectrum shall fully perform all material obligations pursuant to the **** and ****;

(f)        the **** and the **** are valid and enforceable in accordance with their terms, are in full force and effect, and there are no approvals or consents required to make the **** and the **** effective; and

(g)       as of the Effective Date: (i) Spectrum has provided complete and accurate factual responses to all material requests for information that were made by the Allergan Group prior to the Effective Date, and Spectrum has not omitted to supply Allergan with any material information in its possession concerning the Licensed Intellectual Property or Licensed Product in the Field of Use in the Allergan Territory or the transactions contemplated by this Agreement that would be material to Allergan’s decision to enter into this Agreement and undertake the commitments and obligations set forth in this Agreement; and (ii) the Data (as hereinafter defined) provided in writing to Allergan or its Affiliates by Spectrum relating to the Licensed Product has been accurate in all material respects and Spectrum has made no material misrepresentation or material omission in connection with such Data. “Data” means any and all research data, pharmacology data, preclinical data, clinical data and/or all other Documents, with respect to the Licensed Product that have been submitted, or are required to be submitted, to the FDA or EMEA in association with a Regulatory Approval.

11.11   Licensed Product Warranties .  For Licensed Product supplied to Allergan by

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Spectrum or its subcontractor’s prior to agreement on the supply agreement pursuant to Section 3.3(d), Spectrum represents, warrants and covenants that: (i) all Licensed Product are provided free of defects in materials and workmanship and manufacturing; (ii) all Licensed Product shall be manufactured in compliance with the applicable Specifications and shall be free and clear of all liens, security interests and encumbrances; (iii) Spectrum’s and it subcontractor’s manufacturing facilities will be in compliance, as applicable, with all GMP/QSR Regulations and ISO 13485:1996, EN 46001 requirements; and (iv) if applicable, no Licensed Product, at the time of delivery to Allergan, shall be adulterated or misbranded or an article which may not be introduced into interstate commerce within the meaning of the FD&C Act. Allergan represents, warrants and covenants that after such Licensed Product has been delivered to Allergan by or on behalf of Spectrum, Allergan shall (either by itself or through its subcontractor), prior to sale of the Licensed Product, store, handle and transport such Licensed Product under appropriate conditions in compliance with all applicable Laws.

11.12     Inaccuracies .  Without limiting either Party’s rights and remedies at law, in equity or under this Agreement, if, at any point in time (not just at the times when the warranties are deemed granted), either Party becomes aware of any inaccuracies in the foregoing warranties and representations, such Party shall promptly notify the other Party of such inaccuracies, with a detailed written explanation.

11.13     DISCLAIMER OF ALL OTHER WARRANTIES .  THE WARRANTIES SET FORTH IN THIS AGREEMENT AND THE CO-PROMOTION AGREEMENT ARE THE PARTIES’ ONLY WARRANTIES WITH RESPECT HERETO AND ARE MADE EXPRESSLY IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WHICH ARE HEREBY DISCLAIMED, INCLUDING ANY IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, OR OTHERWISE.

ARTICLE 12

INDEMNIFICATION; LIMITATIONS ON LIABILITY; INSURANCE

REQUIREMENTS

12.1      Indemnification By Spectrum .  Except to the extent of any Losses covered by Section 12.2, Spectrum agrees to defend, indemnify and hold harmless Allergan, its Affiliates, and their respective directors, officers, employees, and agents (“ Allergan Indemnitees ”) from and against any and all Losses arising out of a Claim by a Third Party (other than an Affiliate of Allergan arising out of, resulting from or relating to: (a) any breach or alleged breach of a representation or warranty made by Spectrum in this Agreement, including the Co-Promotion Agreement; (b) any breach or alleged breach of any covenant of, or obligation required to be performed by, Spectrum contained in this Agreement, including the Co-Promotion Agreement; (c) any allegation regarding the negligent or willful act or misconduct of anyone in the Spectrum Group in connection with this Agreement, including the Co-Promotion Agreement; (d) when Spectrum has the right to conduct a Remedial Action under this Agreement, any allegation regarding Spectrum’s handling of such Remedial Action or Spectrum electing not to commence such Remedial Action; (e) any allegation regarding a Remedial Action relating to Spectrum’s

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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products including those which contain Apaziquone; (f) any allegation that the development, manufacture, marketing, promotion, use, sale, import, export, distribution or any other exploitation of the Final Licensed Product in the Field of Use in the Allergan Territory, or the use of Licensed Intellectual Property existing as of the Effective Date in connection therewith, violates, infringes upon or misappropriates the Intellectual Property Rights of any Third Party; (g) any allegation that the use of the Licensed Intellectual Property (other than Allergan’s contributions to Joint Intellectual Property) as permitted herein misappropriates the Intellectual Property Rights of any Third Party; (h) any allegation that personal injury or death, or any damage to any property, was caused or allegedly caused by a manufacturing defect in any Licensed Product manufactured by Spectrum or for Spectrum by Third Parties; (i) any design defect in the Closed-System Packaging System that forms part of the Final Licensed Product (but expressly excluding the formulation of the Licensed Product); or (j) any violation by Spectrum of any Regulatory Approval involving the Licensed Product.

12.2    Indemnification By Allergan . Except to the extent of any Losses covered by Section 12.1, Allergan agrees to defend, indemnify and hold harmless Spectrum, its Affiliates, and their respective directors, officers, employees, and agents from and against any and all Losses arising out of a Claim by a Third Party (other than an Affiliate of Spectrum) arising out of, resulting from or relating to: (a) any breach or alleged breach of a warranty made by Allergan in this Agreement, including the Co-Promotion Agreement; (b) breach or alleged breach of any covenant or obligation required to be performed by Allergan contained in this Agreement, including the Co-Promotion Agreement; (c) the negligent or willful act or misconduct of any of the Allergan Group in connection with this Agreement, including the Co-Promotion Agreement; (d) when Allergan has the right to conduct a Remedial Action under this Agreement, any allegation regarding Allergan’s handling of such Remedial Action or Allergan electing not to commence such Remedial Action; (e) any allegation that personal injury or death, or any damage to any property, was caused or allegedly caused by a manufacturing defect in any Licensed Product manufactured by Allergan or directly for Allergan by Third Parties (after Allergan assumes manufacturing responsibility under this Agreement; or (f) the violation by Allergan of any Regulatory Approval involving the Licensed Product.

12.3    Procedure . A Party entitled to be indemnified under Sections 12.1 or 12.2 (the “ Indemnified Party ”) shall promptly notify the other Party liable for such indemnification (the “ Indemnifying Party ”) in writing of any Claim which the Indemnified Party has determined has given or could give rise to a right of indemnification under this Agreement, including the Co-Promotion Agreement. Failure to promptly notify the Indemnifying Party of any such claim shall not relieve the Indemnifying Party of any such duty to so indemnify except to the extent that the Indemnifying Party can demonstrate actual loss and prejudice as a result of such failure. The Indemnifying Party shall have the right, but not the obligation, to control the defense of the Indemnified Party against any such Third Party Claim, utilizing counsel chosen in the Indemnifying Party’s sole discretion; provided, however, that the Indemnified Party may participate in any such defense, at its own expense, by separate counsel of its choice; provided further, that any such participation shall not limit the Indemnifying Party’s right to control such defense. Notwithstanding the foregoing, the Indemnifying Party: (a) shall not be entitled to have

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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sole control over any Third Party Claim that seeks an order, injunction or other equitable relief against any Indemnified Party; and (b) shall obtain the prior written approval of the Indemnified Party before ceasing to defend against any Third Party indemnification Claim or entering into any settlement, adjustment or compromise of such Claim involving injunctive or similar equitable relief being asserted against any Indemnified Party or any of its Affiliates. The Indemnified Party shall cooperate with the Indemnifying Party in the provision of any such defense by providing to the Indemnifying Party all such information, assistance and authority as may reasonably be requested by the Indemnifying Party.

12.4    Allocation of Product Liability Risks . The Parties hereby agree that all Losses arising out of a Claim(s) by a Third Party (other than an Affiliate of either Party) asserted against a Party, its Affiliates, or their respective directors, officers, employees, and agents that result from, arise out of or relate to an allegation that personal injury or death, or any damage to any property, was caused or allegedly caused by any Licensed Product in the Field of Use in the Allergan Territory used or sold by or on behalf of either Party or their respective Affiliates or sublicensees, except to the extent such Claim is attributable to a matter covered under Section 12.1 or 12.2, shall be allocated between the Parties as follows: (a) within the Co-Promotion Region so long as the Parties continue to share product profit, **** (Spectrum: Allergan) and (b) in all other cases in the Allergan Territory, **** (Spectrum: Allergan). The Parties shall indemnify each other so as to allocate the Losses according to the preceding ratios. Each Party shall promptly notify the other Party in writing of any Claim which could give rise to the rights set forth in this Section 12.4. Failure to promptly notify the other Party of any such claim shall not relieve the other Party of any such duty to so indemnify except to the extent that the other Party can demonstrate actual loss and prejudice as a result of such failure.

(a)     Allergan shall have the first right, but not the obligation, to control the defense of any such Third Party Claim, utilizing counsel chosen in Allergan’s sole discretion (with the costs and expenses incurred by Allergan included in the calculation of the Losses subject to the ratio above); provided , however , that Spectrum may participate in any such defense, at its own expense (outside the ratios set forth above), by separate counsel of its choice; provided further, that any such participation shall not limit Allergan’s right to control such defense. Notwithstanding the foregoing, Allergan shall obtain the prior written approval of Spectrum before: (i) ceasing to defend against any such Third Party Claim (if Allergan elects to defend an action and, then, after commencement of the defense decides to no longer defend); and (ii) entering into any settlement, adjustment or compromise of such claim or demand involving injunctive or similar equitable relief being asserted against Spectrum or its Affiliates or an admission of liability by Spectrum or its Affiliates. Spectrum shall cooperate with Allergan in the provision of any such defense by providing to Allergan all such information, assistance and authority as may reasonably be requested by Allergan.

(b)     If Allergan does not initiate the defense of such Third Party Claim within sixty (60) days receiving such Claim, then Spectrum shall have the right to control such defense utilizing counsel chosen in Spectrum’s sole discretion (with the costs and expenses incurred by Spectrum included in the calculation of the Losses subject to the ratio above). In such event,

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Allergan may participate in any such defense, at its own expense (outside the ratios set forth above), by separate counsel of its choice; provided further, that any such participation shall not limit Spectrum’s right to control such defense. Notwithstanding the foregoing, Spectrum shall obtain the prior written approval of Allergan before: (i) ceasing to defend against any such Third Party Claim (if Spectrum elects to defend an action and, then, after commencement of the defense decides to no longer defend); and (ii) entering into any settlement, adjustment or compromise of such claim or demand involving injunctive or similar equitable relief being asserted against Allergan or its Affiliates or an admission of liability by Allergan or its Affiliates. Allergan shall cooperate with Spectrum in the provision of any such defense by providing to Spectrum all such information, assistance and authority as may reasonably be requested by Spectrum.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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12.5    Infringement Remedies . Without limiting Spectrum’s other obligations set forth herein, in the event that the development, manufacturing, marketing, use, sale, import, export, distribution or any other exploitation of the Final Licensed Product in the Field of Use in the Allergan Territory, or the use of Licensed Intellectual Property in connection therewith, is alleged to violate, infringe upon or misappropriate the Intellectual Property Rights of any Third Party, Spectrum shall, at its expense, obtain a license from such Third Party and shall have the first right to negotiate with such Third Party for such license, provided, however, that, if Spectrum does not obtain such license on a timely basis given the timeline and circumstance of the development and/or commercialization of the Final Licensed Product at such time, then Allergan shall have the right to, upon written notice to Spectrum, obtain such license itself under reasonable terms, and, if Allergan and Spectrum cannot obtain a license, Spectrum shall indemnify Allergan for any Losses arising in relation thereto.

12.6    LIMITATIONS ON LIABILITY . EXCEPT FOR BREACH BY EITHER PARTY OF SECTIONS 2.6(a), (b) OR (c), OR ARTICLE 9, OR SPECTRUM’S REVOCATION OF ALLERGAN’S EXCLUSIVE AGENT STATUS UNDER SECTION 5.1(a)(ii), IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR TO ANY THIRD PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY, OR CONSEQUENTIAL DAMAGES ARISING FROM OR RELATING TO THIS AGREEMENT, INCLUDING THE CO-PROMOTION AGREEMENT, OR FOR ANY AMOUNTS REPRESENTING LOSS OF PROFITS OR LOSS OF BUSINESS, WHETHER THE BASIS OF THE LIABILITY IS BREACH OF CONTRACT, TORT, STATUTES, OR ANY OTHER LEGAL THEORY, AND WHETHER SUCH FIRST PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR NOT. THE FOREGOING EXCLUSIONS OF DAMAGES ARE NOT INTENDED TO LIMIT THE INDEMNIFICATION OBLIGATIONS HEREUNDER TO THE EXTENT THAT THE THIRD PARTY (OTHER THAN ANY AFFILIATE OF THE INDEMNIFIED PARTY) CLAIMS COVERED BY SUCH OBLIGATIONS INCLUDE THE TYPE OF DAMAGES THAT ARE EXCLUDED HEREUNDER.

12.7    Insurance .

(a)     At all times during the Term and for **** thereafter, Spectrum shall: (i) except as provided in subsection (ii), maintain Commercial General Liability (comparable to standard ISO general liability form) insurance (including bodily injury and property damage coverage and all of Spectrum’s indemnification obligations hereunder)) including coverages of: (A) products and completed operations; (B) premises –operations; and (C) broad form contractual liability at limits not less than **** during the pre-commercialization period, and **** during the commercialization period (collectively the “ Spectrum Insurance Policies ”); (ii) obtain and maintain the maximum available Extended Discovery Period insurance, if Spectrum terminates the Spectrum Insurance Policies during the Term; (iii) include Allergan as “Additional Insured” under the Spectrum Insurance Policies; (iv) provide, within thirty (30) days of Allergan’s request, Certificates of Insurance verifying insurance limits agreed upon as well as a thirty (30) day notice of cancellation, non-renewal, or material change; (v) maintain all risk Property

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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insurance at limits not less than ****; (vi) maintain Automobile Liability insurance with minimum limits of ****, combined single limits for bodily injury and property damage with coverage extending to all owned, hired and non-owned vehicles; and (vii) maintain adequate coverage as respects any clinical trial activity. Spectrum shall obtain all the insurance policies described in clauses (i) through (vii) from insurers having A.M. Best’s Ratings of A - VII or higher.

(b)     At all times during the Term and for **** thereafter, Allergan shall: (i) except as provided in subsection (ii), maintain Commercial General Liability insurance (including bodily injury and property damage coverage) including coverages of: (A) products and completed operations; (B) premises –operations; and (C) broad form contractual liability at limits not less than **** (collectively the “ Allergan Insurance Policies ”); (ii) obtain and maintain the maximum available Extended Discovery Period insurance if Allergan terminates the Allergan Insurance Policies during the Term; (iii) include Spectrum as “Additional Insured” under the Allergan Insurance Policies; (iv) provide, within thirty (30) days of Spectrum’s request, Certificates of Insurance verifying insurance limits agreed upon as well as a thirty (30) day notice of cancellation, non-renewal or material change; (v) maintain all risk Property insurance at limits not less than ****; and (vi) maintain Automobile Liability insurance with minimum limits of ****, combined single limits for bodily injury and property damage with coverage extending to all owned, hired and non-owned vehicles. Allergan shall obtain all the insurance policies described in clauses (i) through (vi) from insurers having A.M. Best’s Ratings of A - VII or equivalent.

ARTICLE 13

TERM AND TERMINATION

13.1    Term . This Agreement shall continue until terminated as set forth herein (“ Term ”). If the Co-Promotion Agreement has been terminated (regardless of the cause) then, upon expiration of the Royalty Term in the last country of the Royalty Territory the following provisions shall be null and void and without further effect on either Party or its Affiliates: Articles 3, 4, 10 and 11 and Sections 2.5, 2.6, 2.7, 2.8, 2.9, 5.1(a)(i), (iii), (iv), (v), and (vi), 5.1(b)(ii) and (iii), 5.1(c), 5.2, 5.3, 5.4, 5.8, 5.9, 6.1 through 6.8 (inclusive), 6.12, 6.14, 6.15, 8.2 (except as it relates to Joint Intellectual Property), 8.3 (except as it relates to Joint Intellectual Property), 12.1 through 12.5 (inclusive, but only to the extent that the facts underlying the Claim arose after such expiration) and all the Schedules except for Schedule 1.1 and Schedule 7.1 .

13.2    Termination at Will . Allergan may terminate this Agreement at will by providing Spectrum with six (6) month’s prior written notice. Upon such termination, in addition to those provisions that survive the termination as set forth in Section 13.5 below, the following shall also apply:

(a)     the licenses granted to Allergan under Article 2 shall terminate after Allergan has completed the Inventory Sell-Off (as hereinafter defined);

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(b)     the Co-Promotion Agreement shall terminate in its entirety; and

(c)     Allergan shall negotiate in good faith with Spectrum the terms of a commercially reasonable agreement (which may be royalty bearing or one time payment as negotiated by the Parties) reflecting Allergan’s economic contribution to the manufacturing, development and commercialization of the Licensed Product in the Field of Use up to the date of such termination (considering all Allergan contributions (including both positive as well as negative factors) including obligations, commitments and payments made hereunder or as a result hereof such as upfront or milestone payments, whether the trademarks are included for marketed products) with respect to the Licensed Product in the Field of Use which negotiation shall include, but not be limited to the following:

(i)     a license under the Allergan Solely Developed Know How and Allergan’s rights under the Joint Intellectual Property, in each case only if such Intellectual Property Rights have been incorporated in the Licensed Product in the Field of Use, or the making or using thereof, as of the effective date of such termination, for Spectrum to develop and commercialize the Licensed Product in the Field in the Allergan Territory to the extent mutually agreeable to the Parties;

(ii)    Spectrum’s continued right to use the data and results generated under this Agreement for its manufacture, development and/or commercialization of the Licensed Product in the Field of Use anywhere in the world;

(iii)   assignment of regulatory filings and Regulatory Approvals relating to the Licensed Product in the Field of Use in the Allergan Territory that are in the name of Allergan, its Affiliates and sublicensees;

(iv)   assignment to Spectrum (to the extent mutually agreed between the Parties) to contracts entered into by Allergan in connection with the development, manufacturing and/or commercialization of the Licensed Product in the Field of Use in the Allergan Territory;

(v)    if, at time of such termination, Allergan has terminated Spectrum’s right and has itself assumed the responsibility to manufacture the Licensed Product pursuant to Section 3.3(f), and Spectrum has assumed all contracts entered into by Allergan in connection with the development, manufacturing and/or commercialization of the Licensed Product in the Field of Use in the Allergan Territory, then transfer of manufacturing responsibility to Spectrum, which shall include providing Spectrum with a copy of all of the then-current Know-How Controlled by Allergan necessary or useful for the manufacture of the Licensed Product and assignment to Spectrum of all supply contracts for the Licensed Product or otherwise to enable Spectrum to procure supply of the Licensed Product in the Field of Use in the Allergan Territory; and

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(vi)   Spectrum’s purchase from Allergan all of the inventory of the Licensed Product held by Allergan as of the date of termination at a price equal to one hundred percent (100%) of Allergan’s actual costs in procuring such Licensed Product, but only to the extent such costs have not been already paid or reimbursed by Spectrum.

13.3    Material Breach .

(a)     In the event that Spectrum materially breaches this Agreement, and fails to cure such breach within sixty (60) days of receipt of written notice thereof specifying the breach in detail from Allergan, unless such breach cannot be cured within the sixty (60) day period, in which case Spectrum shall have undertaken good faith efforts to cure such breach within such sixty (60) day period and diligently prosecuted such cure to prompt completion, then Allergan shall have the right to seek all available remedies under this Agreement, at law or in equity. Notwithstanding the foregoing, termination shall only be available as a remedy for such uncured material breaches by Spectrum if the uncured material breach results in a material adverse impact on Allergan or its Affiliates such that termination is the only reasonable remedy. This Section 13.3(a) shall not limit Allergan’s right to terminate under Section 13.2.

(b)     In the event that Allergan materially breaches this Agreement, and fails to cure such breach within sixty (60) days of receipt of written notice thereof specifying the breach in detail from Spectrum, unless such breach cannot be cured within the sixty (60) day period, in which case Allergan shall have undertaken good faith efforts to cure such breach within such sixty (60) day period and diligently prosecuted such cure to prompt completion, then Spectrum shall have the right to seek all available remedies under this Agreement, at law or in equity except that Spectrum may not under any circumstance (whether for breach, uncured breach, material breach or uncured material breach) (i) terminate this Agreement; and/or (ii) seek or enforce injunctive relief which interferes with the scope or use of the license granted in Section 2.1(a).

13.4    365(n) . THE PARTIES INTEND FOR THIS AGREEMENT AND THE LICENSES GRANTED HEREIN TO COME WITHIN SECTION 365(n) OF THE U.S. BANKRUPTCY CODE AND, NOTWITHSTANDING THE BANKRUPTCY OR INSOLVENCY OF SPECTRUM, THIS AGREEMENT AND THE LICENSES GRANTED HEREIN SHALL REMAIN IN FULL FORCE AND EFFECT SO LONG AS ALLERGAN IS IN MATERIAL COMPLIANCE WITH THE TERMS AND CONDITIONS HEREOF.

13.5    Effect of Termination . Upon any termination of this Agreement under Section 13.2 or 13.3(a):

(a)     the following provisions shall survive: Articles 1, 9, 12 (to the extent any Loss arises prior to the effective date of such expiration or termination) and 14, Sections 2.4, 5.1(a)(ii) (except that if Allergan terminates this Agreement at will, the appointment of Allergan as Spectrum’s agent shall be deemed terminated on the effective date of termination), 5.5, 5.6, 5.7, 6.9, 6.10, 6.11, 6.13, 6.15, 8.1, 8.2 (as it relates to Joint Intellectual Property only), 8.3 (as it

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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relates to Joint Intellectual Property only), 13.1, 13.2, 13.3 and 13.5 and Schedule 1.1 . In addition, if Allergan terminates this Agreement under Section 13.3(a), or if the licenses become fully paid up, then Sections 2.1, 2.2, 2.3, 2.5, 2.8 and 2.9 (on a fully paid up basis) shall also survive any termination of this Agreement;

(b)     unless otherwise agreed in writing by the Parties, Spectrum shall promptly deliver to Allergan or destroy (at Allergan’s sole discretion) all Confidential Information of Allergan, subject to Spectrum retaining a copy of such Confidential Information for legal archival purposes only and/or as may be required by Law;

(c)     if Allergan terminates this Agreement at will under Section 13.2, unless otherwise agreed in writing by the Parties, Allergan shall promptly deliver to Spectrum or destroy (at Spectrum’s sole discretion) all Confidential Information of Spectrum, subject to Allergan retaining a copy of such Confidential Information solely as may be reasonably necessary for Allergan to perform under subsection (e) below and for legal archival purposes and/or as may be required by Law;

(d)     the Co-Promotion Agreement shall automatically terminate upon termination of this Agreement;

(e)     termination of this Agreement shall not release either Party from the obligation to make payment of all amounts then due and payable; and

(f)     if Allergan terminates this Agreement at will under Section 13.2, Allergan shall be permitted to sell any inventory of the Licensed Product (to the extent not purchased by Spectrum under Section 13.2(c)(vi)) in the Field of Use in its (or its Affiliates’ or licensees’) possession or in production at the time of termination (the “ Inventory Sell-Off ”) and the licenses shall continue on a non-exclusive basis until all such units have been sold, provided Allergan continues to pay the applicable royalty, Spectrum’s share of product profits, and, if applicable, sales milestones, on resulting applicable Royalty-Bearing Net Sales of Royalty-Bearing Product in the Royalty-Bearing Territory (and Co-Promotion Region, if applicable under Section 6.4(b)).

ARTICLE 14

MISCELLANEOUS

14.1    Relationship of Parties . The relationship of the Parties established by this Agreement is solely that of independent contractors, and nothing shall be deemed to create or imply any employer/employee, principal/agent, partner/partner or co-venturer relationship, or that the Parties are participants in a common undertaking. Except as permitted in Section 5.1(a) regarding Allergan’s role as authorized agent, neither Party shall have the right to direct or control the activities of the other Party or incur, assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other Party or bind such other Party to any obligation for any purpose whatsoever.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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14.2    Force Majeure Event .

(a)     Neither Allergan nor Spectrum shall be considered in default in performance of their obligations hereunder to the extent that performance is delayed, hindered or prevented by a Force Majeure Event, but only to the extent and only for the period that its performance of such obligations is prevented by the Force Majeure Event. “ Force Majeure Event ” means any event or condition, not existing as of the date of this Agreement, not reasonably foreseeable as of such date and not reasonably within the control of the affected Party, which prevents in whole or in material part the performance by the affected Party of its obligations hereunder or which renders the performance of such obligations so difficult or costly as to make such performance commercially unreasonable, including without limitation riots, civil or military disturbances, war, strikes, lockouts, labor slowdowns or stoppages, prolonged shortage of energy supplies, epidemics, fire, flood, hurricane, typhoon, earthquake, lightning, and explosion. The Party claiming relief under this Section 14.2 shall promptly notify the other Party in writing, but in no event later than ten (10) calendar days of the occurrence, should any such cause arise and shall promptly take steps to remedy any delay or failure in performance upon removal of the circumstances causing such delay or failure. In no event shall any Party be required to prevent or settle any labor disturbance or dispute. For clarity, the Development Trigger shall not be extended by reason of this Section 14.2.

(b)     During the period that the performance by one of the Parties of its obligations under this Agreement has been suspended by reason of a Force Majeure Event, the other Party may likewise suspend the performance of all or part of its obligations hereunder to the extent that such suspension is commercially reasonable.

14.3    Entire Agreement . This Agreement, including the Schedules (including the Co-Promotion Agreement) attached hereto and incorporated as an integral part of this Agreement, constitutes the entire agreement of the Parties with respect to the subject matter hereof, and supersedes all prior and contemporaneous agreements and understandings, whether written or oral, relating to such subject matter in any way.

14.4    No Waiver; Amendment . No waiver of any term or condition of this Agreement shall be valid or binding on any Party unless agreed to in writing by the Party to be charged. No course of dealing between or among any Persons having any interest in this Agreement shall be deemed effective to modify, amend or discharge any part of this Agreement or any rights or obligations of any Person under or by reason of this Agreement. The failure of either Party to enforce at any time any of the provisions of this Agreement, or the failure to require at any time performance by the other Party of any of the provisions of this Agreement, shall in no way be construed to be a present or future waiver of such provisions, nor in any way affect the validity of either Party to enforce each and every such provision thereafter. This Agreement may not be amended or modified except by the written agreement of the Parties.

14.5    Partial Invalidity . Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable Law, but if any provision

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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of this Agreement is held to be invalid by a court of competent jurisdiction, then the remaining provisions shall remain, nevertheless, in full force and effect. The Parties agree to renegotiate in good faith, or request the court to rewrite, any term held invalid and to be bound by the mutually agreed substitute provision in order to give the most approximate effect intended by the Parties.

14.6    Assignment . This Agreement shall be binding upon and shall inure to the benefit of, the Parties and their Affiliates and their respective successors and permitted assigns. Except as expressly provided in this Agreement, Spectrum and its Affiliates may not assign any rights or delegate any duties under this Agreement to any Third Party without the prior written consent of Allergan, which consent shall not be unreasonably withheld, delayed or conditioned; provided, however, that Spectrum may freely assign all of its rights and obligations hereunder to an Affiliate of Spectrum if Spectrum guarantees the performance of such Affiliate. Spectrum may also freely assign all of its rights and obligations hereunder as part of a merger, consolidation or sale of all or substantially all of the stock or assets of Spectrum, or sale of the business of Spectrum or the business relating to activities under this Agreement, without Allergan’s consent. Allergan may freely assign its rights hereunder to an Affiliate of Allergan; provided, however, that Allergan guarantees the performance of such Affiliate. Allergan may also freely assign all of its rights and obligations hereunder as part of a merger, consolidation or sale of all or substantially all of the stock or assets of Allergan, or sale of the business of Allergan or the business relating to activities under this Agreement, without Spectrum’s consent. All other assignments of this Agreement by Allergan shall be subject to Spectrum’s prior written consent, not to be unreasonably withheld, delayed or conditioned. Any attempted assignment without such consent shall be null and void.

14.7    Governing Law . This Agreement shall be governed by, and interpreted and construed in accordance with the laws of the State of New York, without reference to rules of conflicts or choice of laws, except that the federal law of the United States of America shall apply to question regarding the validity, infringement or enforceability of United States federal patent, copyright and trademark rights relating in any way to this Agreement. The Parties agree to submit to the jurisdiction of the state or federal courts (as applicable) in New York.

14.8    Remedies . The exercise of any remedies hereunder shall be cumulative and in addition to and not in limitation of any other remedies available to such Party at law or in equity.

14.9    Further Assurances . Each Party agrees to cooperate fully with the other and execute such instruments, documents and agreements and take such further actions to carry out the intents and purposes of this Agreement.

14.10 Counterparts; Facsimile . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and all of which, taken together, shall constitute one instrument. For purposes hereof, a facsimile copy of this Agreement, including the signature pages hereto, shall be deemed to be an original.

14.11 Notices . All notices required to be given under this Agreement shall be in writing

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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and shall be deemed to have been given: (a) when personally delivered or sent by confirmed telecopy (with hard copy to follow); (b) one (1) business day after sent by reputable overnight express courier (charges prepaid); or (c) five (5) business days following mailing by certified or registered mail, postage prepaid and return receipt requested. Unless another address is specified in writing, such notices to Spectrum and Allergan shall be sent to the addresses indicated below:

 

If to Allergan:     

Allergan Sales, LLC

2525 Dupont Drive

Irvine, CA 92612

Attn: General Counsel

Facsimile No.: (714) 246 6987

 

Allergan USA, Inc.

2525 Dupont Drive

Irvine, CA 92612

Attn: General Counsel

Facsimile No.: (714) 246 6987

 

Allergan, Inc.

2525 Dupont Drive

Irvine, CA 92612

Attn: General Counsel

Facsimile No.: (714) 246 6987

 

and

 

Dorsey & Whitney, LLP

38 Technology Drive

Irvine, CA 92618

Attn: David Hayes, Esq.

Facsimile No.: (949) 932-3601

 

If to Spectrum:     

Spectrum Pharmaceuticals, Inc.

157 Technology Drive

Irvine, CA 92618

Attn: Legal Counsel

Facsimile No.: (949) 788-6706

 

with a copy to:

 

Cooley Godward Kronish LLP

5 Palo Alto Square

3000 El Camino Real

Palo Alto, CA 94306

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Attn: Robert L. Jones, Esq.

Facsimile No.: (650) 849-7400

14.12 Press Releases and Announcements . The Parties shall jointly issue a press release concerning the transactions contemplated by this Agreement, with the prior written consent of each Party, upon execution of this Agreement. Except as set forth in the preceding sentence, neither Party may issue any press release or make any public announcement concerning the transactions contemplated by this Agreement without the prior written consent of the other Party (except for filings made to the U.S. Securities and Exchange Commission or similar requirements under applicable Law in which case the Party proposing to make such release or announcement will allow the other Party a reasonable opportunity to review and comment on such release or announcement in advance of such issuance and will redact any copies of this Agreement (including the Co-Promotion Agreement) to the extent reasonably permitted by applicable Law). Notwithstanding the foregoing, any such release noted in the preceding sentence will be limited in its disclosure, based on advice of legal counsel, only to information that is required for such disclosing Party to be in compliance with applicable Law. Neither Party may disclose any information regarding the prospective or expected or potential sales of Licensed Product without the prior written consent of the other Party, at its sole discretion. Spectrum may not issue any publications concerning the Licensed Product in the Field of Use, and, except as provided by Law or in the Co-Promotion Agreement, Spectrum shall make no use of Allergan’s name or the Allergan Trademarks (as that term is defined in the Co-Promotion Agreement).

14.13 Use of Subcontractors . Each Party will remain obligated for the performance of its obligations under this Agreement notwithstanding its use of subcontractors as permitted herein, and, as between the Parties, Allergan shall be responsible for its subcontractors and Spectrum shall be responsible for its subcontractors to the same extent as each Party is responsible hereunder.

[Signature page to follow]

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

64


IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed on the Effective Date.

 

ALLERGAN SALES, LLC
By:  

/s/ JEFFREY L. EDWARDS

 

Name:  

Jeffrey L. Edwards

Title:  

Vice President and

 

Chief Financial Officer

 

ALLERGAN USA, INC.
By:  

/s/ JEFFREY L. EDWARDS

 

Name:  

Jeffrey L. Edwards

Title:  

Vice President and

 

Chief Financial Officer

 

 

ALLERGAN, INC.
By:  

/s/ JEFFREY L. EDWARDS

 

Name:  

Jeffrey L. Edwards

Title:  

Executive Vice President,

 

Finance and Business Development,

 

Chief Financial Officer

 

 

SPECTRUM PHARMACEUTICALS, INC.
By:  

/s/ RAJESH C. SHROTRIYA

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

65


Name:  

Rajesh C. Shrotriya

Title:  

Chief Executive Officer and

 

President

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

66


Schedule 1.1

Definitions

(a)     “ 611 Study ” means the Phase III study as detailed within the current study protocol filed with the FDA under ****.

(b)     “ 612 Study ” means the Phase III study as detailed within the current study protocol filed with the FDA under ****.

(c)     “ Acquired Trademarks ” means the Trademarks listed on Schedule 7.1 , Exhibit A .

(d)     “ Affiliate ” means, with respect to a party, any Person (other than an individual) that currently or in the future is directly or indirectly controlled by, under common control with, or that controls such party. For the avoidance of doubt, any such Person shall cease to be an “Affiliate” of such party under this Agreement when such Person is no longer directly or indirectly controlled by, under common control with, or controlling such party. For purposes of this definition, “ controls ,” “ control ” and “ controlling ” mean the direct or indirect ownership or control (whether through contract or otherwise) of shares entitled to more than fifty percent (50%) of the vote for the election of directors in the case of corporate entities and in the case of non-corporate entities, more than fifty percent (50%) of the equity interest with the power to direct management policies, or the direct or indirect power to direct or cause the direction of the management or policies of the party.

(e)     “ Allergan Group ” means Allergan, its Affiliates and/or their respective employees, agents and Third Party independent contractors.

(f)     “ Allergan Solely Developed Know How ” means all Know How (and all Intellectual Property Rights therein) conceived or developed during the Term of this Agreement solely by the Allergan Group (without the participation of the Spectrum Group or funding by Spectrum or its Affiliates) in the course of Allergan’s performance of its obligations under the Agreement which relate to, or are necessary or useful to manufacture, have manufactured, use, sell, offer for sale, have sold, import, export or otherwise exploit the Licensed Product or manufacture Apaziquone (including submitting for Regulatory Approval).

(g)     “ Allergan Territory ” means, collectively, the Royalty Territory and the Co-Promotion Region.

(h)     “ ANDA ” means Abbreviated New Drug Application, as defined in the FD&C Act.

(i)     “ Anticipated Approval Date ” means the then-current date of expected first Regulatory Approval (as well as any pricing and reimbursement approval, if necessary) for the Licensed Product in the Field of Use in the Co-Promotion Region as determined by the JMC.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S1.1-1


(j)     “ Apaziquone ” means the compound having the structure set forth on Exhibit A to this Schedule 1.1 .

(k)    “ Asia ” means Bangladesh, Bhutan, Brunei, Burma (Myanmar), Cambodia, China, Hong Kong, India, Indonesia, Japan, North Korea, Laos, Macao, Malaysia, Maldives, Mongolia, Nepal, Pakistan, Philippines, Qatar, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam, as their boundaries are defined as of the Effective Date, and including any successors of the foregoing countries to the extent within the boundaries of the countries set forth above as of the Effective Date.

(l)     “ BCG Refractory ” means a case of bladder cancer that ****.

(m)   “ BCG Refractory Indication ” means the intravesical use of the Licensed Product for the treatment of BCG Refractory.

(n)    “ BCG Refractory Study ” means pre-clinical studies and clinical trials designed specifically to support the application for Regulatory Approval of the Licensed Product for use in the BCG Refractory Indication.

(o)    “****” means ****.

(p)    “ Change in Control ” means, with respect to a Party, (i) any sale, assignment or other transfer of such Party’s voting securities by an equity holder resulting in any Third Party owning, directly or indirectly, securities which comprise more than fifty percent (50%) of such Party’s outstanding voting securities, (ii) the sale, assignment or other transfer of all or substantially all of such Party’s assets (determined on a consolidated basis) to any Third Party, (iii) the issuance or sale of voting securities, or any merger, consolidation, combination, reorganization, recapitalization or other transaction or series of related transactions that results in the ownership by any Third Party prior thereto owning, directly or indirectly, securities which comprise more than fifty percent (50%) of such Party’s outstanding voting securities, or (iv) acquisition by a Third Party of the direct or indirect power to cause the direction of the management or policies of such Party.

(q)    “ Change in Control Trigger ” means a Change in Control with respect to Spectrum.

(r)     “ Claim ” means any claim, action, demand, inquiry or investigation.

(s)     “ Closed-System Packaging ” ****, an example of which is illustrated in Exhibit B to Schedule 1.1 .

(t)     “ Confidential Information ” has the meaning set forth in Section 9.1.

(u)    “ Contract ” means any contract, agreement, license, commitment, guarantee, undertaking, memorandum of understanding, memorandum of agreement and any other

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S1.1-2


understanding or arrangement, whether written or oral.

(v)      “ Control ” or “ Controlled ” means, with respect to any Know How or Intellectual Property Rights, that a Party owns or has a license to.

(w)     “ Co-Promotion Agreement ” has the meaning set forth in Section 3.4(a).

(x)      “ Co-Promotion Region ” means the United States of America and its territories and possessions, including Puerto Rico, Guam and the Virgin Islands.

(y)      “ Development Costs ” means the costs that are included in the JDP (including regulatory filing fees in the Co-Promotion Region) that are actually incurred by a Party or for its account and that are specifically attributable to the development of the Licensed Product in the Field of Use pursuant to such Party’s obligations under the applicable JDP in the Co-Promotion Region, provided that such costs are less than or equal to the amount specified therefor in the budget associated with such JDP. Development Costs shall include out-of-pocket costs actually incurred by each Party, and all internal costs (including FTE expenses calculated using the then-current FTE Rate) incurred by a Party in connection with the development of the Licensed Product in the Field of Use, which are specified in the JDP.

(z)      “ Development Trigger ” means any or all of the following: (i) Spectrum materially breaches any of its development obligations (and fails to cure after **** written notice thereof from Allergan); (ii) the screen failure rate for the 611 Study or 612 Study is equal to or greater than ****; (iii) Spectrum fails to achieve the last patient enrolled by at least **** after the final specified Last Patient Enrollment (“ LPE ”) date for the 611 Study or 612 Study as set forth in the 611 Study and 612 Study JDP attached to this Agreement as of the Effective Date; (iv) Spectrum fails to achieve the last patient enrolled by at least **** after the final specified LPE date for the BCG Refractory Study as set forth in the BCG Refractory Study JDP attached to this Agreement as of the Effective Date; (v) Spectrum materially breaches Section 3.1(c); or (vi) a Force Majeure Event has occurred materially affecting Spectrum’s performance obligations pertaining to development for a period of **** or longer.

(aa)    “ Documents ” means the original and all non-identical copies or reproductions of any written, printed, typed or recorded matter, including letters, correspondence, facsimile, emails, memoranda, instructions, reports, studies, surveys, minutes, pamphlets, notes, records, charts, writings, drawings, tabulations, and accounting records, as well as all licenses, permits and certificates from federal, state, local and foreign authorities.

(bb)    “ **** ” means ****.

(cc)    “ eCTD ” means the electronic common technical document, as specified by the applicable Governmental Authority.

(dd)    “ EMEA ” means the European Medicines Agency.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S1.1-3


(ee)    “ EU ” means the European Union.

(ff)     “ EU Marketing Clearance ” means Regulatory Approval of a Licensed Product (which in final form is in Closed-System Packaging) in the Field of Use in the EU, including MAAs.

(gg)    “ Extension Patents ” has the meaning set forth in Section 6.4(e).

(hh)    “ FDA ” means the United States Food and Drug Administration, or any of its successor agencies.

(ii)      “ FD&C Act ” means the United States Federal Food, Drug and Cosmetics Act, as amended from time to time, and the regulations promulgated thereunder.

(jj)      “ Field of Use ” means use for the treatment of bladder cancer, or pre-bladder cancer, conditions.

(kk)    “ Final Licensed Product ” means the then-current Licensed Product (in Closed-System Packaging) in any stages of development during the Term up to and including the Licensed Product first sold in commercial quantities to the public as an approved product by Allergan in the Field of Use in the Co-Promotion Region and the EU.

(ll)      “ First Commercial Sale ” means sale of a Licensed Product in the Field of Use, after product launch, for value.

(mm)  “ Fiscal Quarter ” means each calendar quarter within each Fiscal Year.

(nn)    “ Fiscal Year ” means January 1st through December 31st of any year.

(oo)    “ FTE ” means the equivalent of one person working full time for one twelve (12)-month period in a research, development, commercialization, regulatory or other relevant capacity, approximating **** hours per year. For clarity, a single individual who works more than **** hours in a single year shall be treated as one FTE regardless of the number of hours worked.

(pp)    “ FTE Rate ” means an initial annual rate of **** per FTE. The FTE Rate for each FTE shall include compensation and ****; but shall not include any costs described above specifically and forming a part of the independent line items of the JDP budget and reimbursed as such. The FTE Rate shall be adjusted annually to reflect ****.

(qq)    “ Generic Product ” has the meaning set forth in Section 6.4(d).

(rr)     “ GMP/QSR Regulations ” shall mean the Good Manufacturing Practices/Quality System Regulations set forth in 21 C.F.R. Section 820.

(ss)     “ Governmental Authority ” means any legislative, executive, judicial, regulatory

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S1.1-4


or administrative unit of any governmental entity (multinational, foreign, federal, state or local) or any department, commission, board, agency, bureau, ministry, official, arbitrator (public) or other similar body exercising executive, legislative, regulatory, administrative or judicial authority or functions of or pertaining to government, including any authority or other quasi-governmental entity established by any of the foregoing to perform any such functions.

(tt)       “ Indications ” means the Initial Indication and the BCG Refractory Indication.

(uu)     “ Initial Indication ” means the intravesical instillation of a Licensed Product into the bladder for the treatment of non-muscle invasive bladder cancer, administered immediately ****after transurethral resection.

(vv)     “ Intellectual Property Rights ” means any and all intellectual property and industrial design rights, whether protected, created or arising under the Laws of the United States or any other foreign jurisdiction, including the following: (i) patents, patent applications (along with all patents issuing thereon), statutory invention registrations, divisions, continuations, continuations-in-part, substitute applications of the foregoing and any extensions, reissues, restorations and reexaminations thereof, and all rights therein provided by international treaties or conventions; (ii) copyrights, mask work rights, database rights and design rights, whether or not registered, published or unpublished, and registrations and applications for registration thereof, and all rights therein whether provided by international treaties or conventions or otherwise; (iii) trade secrets; and (iv) all other applications and registrations related to any of the rights set forth in the foregoing clauses (i) – (iii) above. As used in this Agreement, the term “Intellectual Property Rights” expressly excludes Trademarks.

(ww)    “ JDP ” is defined in Section 3.1(a).

(xx)      “ Joint Intellectual Property ” means all Know How, and all Intellectual Property Rights therein, that is: (i) not Allergan Solely Developed Know How or Spectrum Intellectual Property but that is conceived or developed jointly by one or more of the Allergan Group and one or more of the Spectrum Group under or in performance of this Agreement, including the Co-Promotion Agreement, and during the Term of this Agreement; or (ii) conceived or developed solely by or on behalf of either Party (without the participation of the other Party, or their Affiliates, or their respective employees, agents and Third Party independent contractors) but funded, at least in part, by the other Party under or in performance of this Agreement, including the Co-Promotion Agreement, and during the Term of this Agreement.

(yy)      “ Know How ” means, individually and collectively, the data, information, discoveries, conceptions, ideas, inventions, innovations, improvements, enhancements, modifications, technological developments, processes, procedures, methods, techniques, systems, designs, protocols, formulae, formulations, molecules, compounds, compositions, specifications, trade secrets, know how, show how, test results, studies, analyses, raw material sources, samples, production technology, results of research and development, programs and information and works of authorship, and all recordings, graphs, drawings, reports, analyses, and other

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S1.1-5


Documents and other information in any form whether or not specifically listed herein and whether or not patentable, copyrightable, or susceptible to any other form of legal protection.

(zz)       “ Law ” means any domestic or foreign federal, state, provincial or local statute, law (including common law), ordinance, regulation, rule, code or governmental order, or any other requirement or rule of law.

(aaa)     “ Licensed Intellectual Property ” means the Spectrum Intellectual Property and all of Spectrum’s and its Affiliates’ rights in the Joint Intellectual Property.

(bbb)    “ Licensed Product ” means any formulation that includes Apaziquone that is suitable for use in treating cancer or precancerous conditions via instillation in any body cavity, but expressly excluding formulations for intravenous use, oral tablets or capsules for systemic use, topical dermatological application or direct local administration to the brain.

(ccc)     “ Losses ” means all losses, expenses, damages, liabilities, fines, penalties, assessments, judgments, settlements, costs and expenses (including reasonable external and internal attorneys’ fees and court costs).

(ddd)    “ MAA ” means a Marketing Authorization Application, which is issued by the EMEA.

(eee)     “ NDA ” means a New Drug Application, as defined in the FD&C Act.

(fff)      “ Net Sales ” means, with respect to a given period of time, gross amounts invoiced by a Party or its Affiliates in such period, less the following deductions from such gross amounts which are actually incurred, allowed, paid, accrued or specifically allocated:

(i)     credits or allowances actually granted for damaged products, returns or rejections of product, price adjustments and billing errors;

(ii)    governmental and other rebates (or equivalents thereof) granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), federal, state/provincial, local and other governments, their agencies and purchasers and reimbursers or to trade customers;

(iii)   normal and customary trade, cash and quantity discounts, allowances and credits actually allowed or paid;

(iv)   distribution services agreement fees allowed or paid to Third Party distributors;

(v)    transportation costs, including insurance, for outbound freight related to delivery of the product to the extent included in the gross amount invoiced;

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S1.1-6


(vi)     sales taxes, VAT taxes and other taxes directly linked to the sales of the Licensed Product to the extent included in the gross amount invoiced; and

(vii)    any other items that reduce gross sales amounts as required by United States Generally Accepted Accounting Principles applied on a consistent basis.

Sales between or among a Party or its Affiliates shall be excluded from the computation of Net Sales, but the subsequent final sales to Third Parties by such Affiliates shall be included in the computation of Net Sales.

(ggg)   “ Original Patent Rights ” means the patent rights to any of the subject matter described in, claimed in or covered by any of the following patents or patent applications: **** and any continuing applications of the foregoing including divisions, substitutions and continuation-in-part applications, any patents issuing on said applications or continuing applications including reissues, re-examinations and extensions, and any corresponding foreign applications or patents.

(hhh)   “ Patent Rights ” means: (i) the Original Patent Rights; and (ii) any and all other patent rights (including covenants not to sue) Controlled solely (as between the Parties) by Spectrum or its Affiliates whether now or during the Term of this Agreement which relate to, or are necessary or useful to manufacture, have manufactured, use, sell, offer for sale, have sold, import, export or otherwise exploit the Licensed Product (including submitting for Regulatory Approval), and any continuing applications thereof including divisions, substitutions and continuation-in-part applications, any patents issuing on said applications or continuing applications including reissues, re-examinations and extensions, and any corresponding foreign applications or patents.

(iii)      “ Person ” means an individual, partnership, corporation, joint stock company, estate, trust (including a business trust), limited liability company, unincorporated association, joint venture or other entity or a Governmental Authority.

(jjj)      “ PSMM ” is defined in the Co-Promotion Agreement.

(kkk)   “ Regulatory Approval ” means all registrations, approvals (including labeling, pricing, or reimbursement approvals), licenses (including product and/or establishment licenses) and authorizations required for the marketing, importation, exportation, transport, storage, manufacture, commercial use and sale of a product in a country or jurisdiction.

(lll)       Royalty-Bearing Net Sales ” means (a) a Party’s and its Affiliates’ Net Sales; less (b) Net Sales invoiced by such Party or any of its Affiliate(s) for sales to its or their Sublicensee(s); and plus (c) Sublicensee Net Sales reported by any and all of the Sublicensees of such Party or any of its Affiliate(s) (after such Party makes its adjustments set forth in the definition of “Net Sales” in subsections (fff) (i) – (vii) inclusive above, if any).

(mmm)“ Royalty-Bearing Product ” means a Licensed Product in the Field of Use that is

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S1.1-7


developed under this Agreement.

(nnn)     “ Royalty Term ” has the meaning set forth in Section 6.4(e).

(ooo)     “ Royalty Territory ” means all countries and territories of the world, except for Asia and the Co-Promotion Region.

(ppp)     “ sNDA ” means a Supplemental New Drug Application, as defined in the FD&C Act.

(qqq)     “ Spectrum Group ” means Spectrum, its Affiliates and/or their respective employees, agents and Third Party independent contractors.

(rrr)       “ Spectrum Intellectual Property ” means all of the: (i) Patent Rights; (ii) Know How (and all Intellectual Property Rights therein) Controlled solely (as between the Parties) by Spectrum or its Affiliates whether now or during the Term of this Agreement which relate to, or are necessary or useful to manufacture, have manufactured, use, sell, offer for sale, have sold, import, export or otherwise exploit the Licensed Product (including submitting for Regulatory Approval); and (iii) Spectrum Solely Developed Know How (to the extent not already covered in subsections (i) and (ii)).

(sss)       “ Spectrum Solely Developed Know How ” means all Know How (and all Intellectual Property Rights therein) conceived or developed during the Term of this Agreement solely by the Spectrum Group (without the participation of the Allergan Group or funding by Allergan or its Affiliates) in the course of Spectrum’s performance of its obligations under the Agreement which relate to, or are necessary or useful to manufacture, have manufactured, use, sell, offer for sale, have sold, import, export or otherwise exploit the Licensed Product (including submitting for Regulatory Approval).

(ttt)        “ Spectrum Territory ” means all countries and territories in Asia.

(uuu)     “ Sublicensee ” means a Third Party to whom a Party (or its Affiliate(s)) (i) will have granted a license or sublicense under its rights under this Agreement (which for Allergan is a sublicense under the Licensed Intellectual Property, and for Spectrum is a license under Spectrum’s retained rights) to sell, offer for sale, or import Royalty-Bearing Product in one or more countries, and (ii) will have granted the right to distribute Royalty-Bearing Product wherein such Third Party pays to such Party (or its Affiliate(s)) granting such license (or sublicense) a royalty based upon the revenues received by the such Third Party for the sale of Royalty-Bearing Product; provided, however, “Sublicensee” will not include (A) any Third Party who receives a license to use a unit of Royalty-Bearing Product arising by operation of law or otherwise, or as a consequence of the purchase of said unit of Royalty-Bearing Product, or (B) any Third Party where such Party (or its Affiliate(s)) granting the license (or sublicense) sells Royalty-Bearing Product under a Trademark license or under a fixed price to such distributor for resale by such distributor and in each case such Party (or its Affiliate(s)) is not compensated based on the resale price of such Royalty-Bearing Product by such distributor.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S1.1-8


(vvv)    “ Sublicensee Net Sales ” means, with respect to a given period of time, gross amounts invoiced by a Sublicensee of a Party or any of its Affiliates in such period, less the following deductions from such gross amounts which are actually incurred, allowed, paid, accrued or specifically allocated:

(i)        credits or allowances actually granted for damaged products, returns or rejections of product, price adjustments and billing errors;

(ii)      governmental and other rebates (or equivalents thereof) granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), federal, state/provincial, local and other governments, their agencies and purchasers and reimbursers or to trade customers;

(iii)     normal and customary trade, cash and quantity discounts, allowances and credits actually allowed or paid;

(iv)     distribution services agreement fees allowed or paid to Third Party distributors;

(v)      transportation costs, including insurance, for outbound freight related to delivery of the product to the extent included in the gross amount invoiced;

(vi)     sales taxes, VAT taxes and other taxes directly linked to the sales of the Licensed Product to the extent included in the gross amount invoiced; and

(vii)    any other items that reduce gross sales amounts as required by United States Generally Accepted Accounting Principles applied on a consistent basis.

(www) “ Term ” has the meaning set forth in Section 13.1.

(xxx)    “ Third Party ” means any Person other than Allergan or Spectrum.

(yyy)    “ TPP ” means targeted product profile, the initial draft of which is attached as Exhibit C to this Schedule 1.1 .

(zzz)     “ Trademark Assignment Agreement ” has the meaning set forth in Section 7.1.

(aaaa)   “ Trademarks ” means rights in trademarks, trade names, service marks, service names, design marks, logos, slogans, trade dress, or similar rights with respect to indicators of origin, whether registered or unregistered, as well as rights in internet domain names, uniform resource locators and e-mail addresses.

(bbbb)  “ Upfront Payment ” has the meaning set forth in Section 6.1.

(cccc)   “ US Marketing Clearance ” means Regulatory Approval of a Licensed Product (which in final form is in Closed System Packaging) in the Field of Use in the Co-Promotion

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S1.1-9


Region, including NDAs and sNDAs.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S1.1-10


Exhibit A to Schedule 1.1

Apaziquone

 

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

A-1


Exhibit A to Schedule 1.1 Apaziquone Chemical Structure

LOGO

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Exhibit B to Schedule 1.1

Example of Closed System Packaging

 

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

B-1


Exhibit B to Schedule 1.1 Closed System

Illustration of Closed-System Packaging

****

 

 

 

 

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Exhibit C to Schedule 1.1

TPP

 

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

C-1


Exhibit C to Schedule 1.1 TPP

EOquin ® Target Product Profile Document

****

 

 

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Minimum VS. Expected TPP’s

****

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Schedule 3.1(a)

Joint Development Plan

****

 

 

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S3.1(a)-1


Schedule 3.1(c)

Key Development Personnel

 

Key Employee Name   

Term

1. ****or his replacement under Section 3.1(c)    Latter of ****
2. ****or her replacement     under Section 3.1(c)    Latter of ****
3. ****or his replacement under Section 3.1(c)    Latter of ****
4. ****or his replacement under Section 3.1(c)    Latter of ****
5. ****or his replacement under Section 3.1(c)    ****
6. ****or his replacement under Section 3.1(c)    ****
7. ****or his replacement under Section 3.1(c)    ****
8. ****or his replacement under Section 3.1(c)    ****

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S3.1(c)-1


Schedule 3.2 (f)(i)

List of Subcontractors

****

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S3.2(f)(i)-1


Schedule 3.2(f)(ii)

Hospitals and Institutions that are clinical trial sites

****

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S3.2(f)(ii)-1


Schedule 3.3(b)

Spectrum Manufacturing Agreements

****

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S3.3(b)-1


Schedule 3.3(d)

Specifications

****

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S3.3(d)-1


Schedule 3.4(a)

Co-Promotion Agreement

 

 

 

 

 

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S3.4(a)-1


EXECUTION COPY

CO-PROMOTION AGREEMENT

This Co-Promotion Agreement (this “ Agreement ”) is made and entered into effective as of October 28, 2008 (the “ Effective Date ”) by and among Allergan Sales, LLC, a Delaware corporation with its principal place of business at 2525 Dupont Drive, Irvine, California 92612 (“ Allergan Sales ”), Allergan USA, Inc., a Delaware corporation with its principal place of business at 2525 Dupont Drive, Irvine, California 92612 (“ Allergan USA ”, and, collectively with Allergan Sales, “ Allergan ”), and Spectrum Pharmaceuticals, Inc. (“ Spectrum ”), a Delaware corporation with its principal place of business at 157 Technology Drive, Irvine, CA 92618. Allergan and Spectrum are collectively referred to herein as the “ Parties ” and individually as a “ Party ”.

RECITALS

WHEREAS, Allergan, Allergan, Inc. and Spectrum have entered into a License, Development, Supply and Distribution Agreement dated October 28, 2008 (the “ License Agreement ”) which includes agreement to a pre-launch JMP;

WHEREAS, the License Agreement grants Allergan certain exclusive rights to make, use and sell the Licensed Product; and

WHEREAS, the Parties desire for Spectrum and Allergan (via Allergan USA) to co-promote the Licensed Product in the Field of Use in the Co-Promotion Region pursuant to the terms and conditions of this Agreement and the License Agreement.

NOW THEREFORE, in consideration of the foregoing promises and the mutual representations, warranties, covenants and agreements contained herein and in the License Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

1.1      Definitions . All capitalized terms not otherwise defined herein shall have the meaning given to them in the License Agreement; provided, however, that when used in this Agreement, “ Licensed Product ” means Royalty-Bearing Product. The following terms shall have the meanings set forth next to them when used in this Agreement:

(a)  “ Call ” or “ Calling ” means an interactive, face-to-face visit by a member of a Party’s Sales Force to a member of the Target Audience to discuss the patient and physician benefits and features associated with the Licensed Product’s FDA-approved indicated uses in the Field of Use, safety, effectiveness, contraindications, side effects, warnings and other relevant characteristics of the Licensed Product in a fair and balanced manner consistent with the requirements of the FD&C Act, the PDMA and all other applicable Laws, codes and policies, using the Labeling and Promotional Materials.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


(b)  “ Costs of Goods Sold ” means fully-burdened standard costs of supplying Licensed Product in the Field of Use for the Co-Promotion Region calculated in accordance with Allergan’s accounting methods consistently applied, which methodology will be calculated in compliance with local generally accepted accounting principles or International Financial Reporting Standards. Standard costs include raw materials, active pharmaceutical ingredient, components, labor and overhead attributed to the production, processing, quality control, labeling, packaging, shipping and warehousing of the Licensed Product.

(c)  “ DDMAC ” means the Division of Drug Marketing, Advertising and Communication.

(d)  “ Deficiency ” means, for any Deficient Quarter, with respect to the applicable Party, the percentage calculated using the following formula: ((A-B)/A), where A is the number of PDEs (as defined below) assigned to such Party under the then-current JMP for such Fiscal Quarter, and B is the number of PDEs actually delivered by the Sales Force of such Party during such Fiscal Quarter.

(e)  “ Deficient Quarter ” means, with respect to a Party, the Fiscal Quarter during which the Sales Force of such Party delivered fewer PDEs than the number of PDEs assigned to such Party for such Fiscal Quarter under the then-current JMP.

(f)  “ Gross Margin ” means Royalty-Bearing Net Sales of Licensed Product in the Co-Promotion Region less Costs of Goods Sold.

(g)  “ Labeling ” means (i) the FDA full prescribing information for the Licensed Product in the Field of Use, including any required patient information, and (ii) all labels and other written, printed or graphic matter upon any container, wrapper or any package insert or outsert utilized with or for the Licensed Product in the Field of Use.

(h)  “ PDMA ” means the Prescription Drug Marketing Act of 1987, as amended from time to time, and the regulations promulgated thereunder.

(i)  “ Promotional Material(s) ” means all training materials and all written, printed, graphic, electronic, audio or video matter, including journal advertisements, sales visual aids, leave items, formulary binders, reprints, direct mail, direct-to-consumer advertising, Internet postings, broadcast advertisements, and sales reminder aids (for example, scratch pads, pens and other such items), in each case created by Allergan or on its behalf, reviewed by the JMC and used or intended for use by the Sales Forces in connection with any promotion of the Licensed Product hereunder, but excluding the Labeling.

(j)  “ Promotional, Sales, Marketing, and Medical Affairs Expenses ” or “ PSMM ” means those costs which are incurred by a Party or for its account which are specifically identifiable to the promotion, marketing, distribution and customer support, medical affairs support, Calling and detailing of the Licensed Product in the Field of Use in the Co-Promotion

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Region during the Term and related professional promotion and education expenses (to the extent not performed by the Sales Forces), including television and electronic advertisements, advertorials and infomercials, print advertisements, direct mail, exhibitions at seminars and conferences, promotional samples, sales and promotional literature or other materials and market research, and Promotional Materials, in each case consistent with the JMP and otherwise with the terms of this Agreement.

(k)  “ Sales Force ” means each Party’s respective sales personnel Calling on the Target Audience with regard to the Licensed Product in the Field of Use in the Co-Promotion Region that are qualified to do so pursuant to the terms and conditions of this Agreement.

(l)  “ Target Audience ” means the Persons identified as such in the then-current JMP.

1.2       Interpretation . This Agreement shall be governed by the following rules of construction, unless otherwise specified by this Agreement: (a) words of one gender shall be deemed to include words of other genders; (b) any reference to an Article, Section, Exhibit, clause, subclause, paragraph, subparagraph, Schedule or Recital is a reference to an Article, Section, Exhibit, clause, subclause, paragraph, subparagraph, Schedule or Recital of this Agreement; (c) any reference to any statute shall be construed as including all statutory provisions consolidating, amending or replacing such statute; (d) the terms “hereof,” “hereby,” “hereto,” “hereunder” and similar terms shall refer to this Agreement as a whole; (e) the word “including” and words of similar import means “including, without limitation” and “including, but not limited to”; (f) the headings contained herein are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement; (g) this Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the Party drafting or causing any instrument to be drafted; (h) all references to “dollars” or “$” refer to United States dollars; and (i) all references to “days” refer to calendar days.

ARTICLE 2

OBLIGATIONS

2.1       Performance . Allergan shall have the sole right and responsibility for fielding personnel and taking actions related to the development of Promotional Materials, medical affairs, managed care contracting and all other promotional and marketing matters and distribution of the Licensed Product in the Field of Use in the Co-Promotion Region during the Term, except as set forth below:

(a)     each Party shall perform their respective obligations under the JMP;

(b)     each Party shall build and deploy a Sales Force that can adequately deliver the specified number of primary detail equivalents (“ PDE ”) as set forth in the then-current JMP. Each Party shall, throughout the Term, deliver **** of the overall PDEs as set forth in the then-current JMP; provided , however , that after the annual call plan is established prior to the beginning of a Fiscal Year, any adjustments in the quarterly PDE goals during such Fiscal Year

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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cannot be increased by more than **** of the amounts set forth in the annual call plan without the written consent of both Parties;

(c)     Spectrum may, in its sole discretion, use its own medical affairs field based personnel to assist its medical affairs support efforts for the Licensed Product in the Field of Use in the Co-Promotion Region during the Term for on label medical information support only subject to the conditions in this Section 2.1(c):

i.        Spectrum shall inform Allergan at least two (2) Fiscal Quarters prior to exercising its right to field its own medical affairs function. The final number of Spectrum field based personnel and their pro rata allocations per Section 2.1(c)(iii) must be approved by Allergan, with reasonable consent not being withheld; and

ii.       Spectrum’s field based medical affairs activities must always conform to the requirements herein, including compliance with Sections 2.2(c), (d), and (e), and to the standards set by Allergan’s regulatory affairs department; and

iii.      the costs and expenses incurred by Spectrum in connection with such function after the First Commercial Sale of the Licensed Product in the Field of Use in the Co-Promotion Region (on a pro rata basis to the extent allocated to the support of the Licensed Product in the Field of Use in the Co-Promotion Region) shall be included in the PSMM. Prior to the First Commercial Sale of the Licensed Product in the Field of Use in the Co-Promotion Region, compensation for such function shall be at Spectrum’s sole expense; and

(d)     Spectrum may, in its sole discretion, maintain a small marketing alliance management function, equivalent to one (1) FTE, to support its marketing efforts for the Licensed Product in the Field of Use in the Co-Promotion Region during the Term. Compensation for this function shall be included in the calculation of the PSMM after the First Commercial Sale of the Licensed Product in the Field of Use in the Co-Promotion Region. Prior to the First Commercial Sale of the Licensed Product in the Field of Use in the Co-Promotion Region, compensation for this function shall be at Spectrum’s sole expense. Spectrum shall not allocate any additional FTEs to such function without prior approval by the JMC.

2.2      Promotion of the Licensed Product .

(a)     The Parties acknowledge that their Sales Forces must be trained, qualified and ready to launch the marketing, promotion, Calling and detailing of the Licensed Product in the Field of Use in the Co-Promotion Region on the date of launch as specified in the then-current JMP. During the Term, after US Marketing Clearance has been received for the Initial Indication for the Licensed Product, and subject to the terms and conditions of this Agreement, the Parties shall deploy their respective Sales Forces to market, promote, Call and detail the Licensed Product in the Field of Use in the Co-Promotion Region in accordance with the then-current JMP.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(b)     Allergan shall be solely responsible for preparing all training materials with regard to the Licensed Product in the Field of Use in the Co-Promotion Region, such training to include a reasonable proficiency examination, with oversight by the JMC. Both Parties agree to only utilize sales training materials that have been reviewed by the JMC and approved by Allergan’s regulatory department. Training shall include a home study period and an initial classroom-setting training program, which shall include medical and technical information about use of the Licensed Product in the Field of Use. The JMC shall direct which personnel shall receive training on the use of the Licensed Product in the Field of Use and which Party shall perform the training. Only personnel who have passed the proficiency examination with a minimum 85% proficiency are qualified to promote, market, Call or detail the Licensed Product in the Field of Use in the Co-Promotion Region.

(c)     The Parties shall in all material respects conform their practices and procedures relating to the marketing, detailing, Calling and promotion of the Licensed Product in the Field of Use in the Co-Promotion Region to Allergan’s policies and procedures, as amended by Allergan from time to time (the “ Allergan Policies ”), but in no event less than the requirements of all applicable Laws and guidelines, including the FD&C Act, the PDMA, the requirements of DDMAC, the Federal Health Care Programs Anti-Kickback Law, 42 U.S.C. 1320a-7b(b), the Pharmaceutical Research and Manufacturers of America (“ PhRMA ”) Code of Pharmaceutical Marketing Practices (the “ PhRMA Code ”) and the American Medical Association (“ AMA ”) Guidelines on Gifts to Physicians from Industry (the “ AMA Guidelines ”), as the same may be amended from time to time. Each Party shall promptly notify the other Party of and provide the other Party with a copy of any correspondence or other reports with respect to the marketing, detailing, Calling and/or promotion of the Licensed Product in the Field of Use in the Co-Promotion Region submitted to or received from the U.S. Department of Health and Human Services or its components (including the FDA and the Office of the Inspector General), PhRMA or the AMA relating to such Laws and guidelines.

(d)     The Parties shall in all material respects conform their practices and procedures relating to educating the medical community in the Co-Promotion Region with respect to the Licensed Product in the Field of Use to the Allergan Policies, the Accreditation Council for Continuing Medical Education (“ ACCME ”) Standards for Commercial Support of Continuing Medical Education (the “ ACCME Standards ”) and any applicable FDA regulations or guidelines, as the same may be amended from time to time. Each Party shall promptly notify the other Party of and provide the other Party with a copy of any correspondence or other reports submitted to or received from the ACCME with respect to the Licensed Product in the Field of Use in the Co-Promotion Region relating to the ACCME Standards or such FDA regulations or guidelines.

(e)     Allergan shall provide Spectrum, and Spectrum shall provide each member of its Sales Force (prior to performance of services hereunder), with a copy of the then-current Allergan code of ethics (such copy to be included along with Spectrum’s standard employee manual). Spectrum shall ensure that each member of its Sales Force acknowledges receipt of

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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and agrees to comply with the then-current Allergan code of ethics in performing services under this Agreement.

(f)     Allergan and Spectrum shall each provide an electronic call reporting system to each member of their respective Sales Force. The deployed system shall be in compliance with Allergan’s Policies and all PDMA regulations and other applicable regulations. The applicable member of each Sales Force shall produce detailed electronic notes following each Call. Each member of the Sales Force shall be responsible for Call planning and Call routing, using sales data to plan, monitor and measure territory performance, as well as reporting to the JMC useful marketing information obtained in the Co-Promotion Region regarding the Licensed Product in the Field of Use, competitors and product trends. Within thirty (30) days after the end of each calendar month, each Party will deliver a report to the other Party summarizing its Sales Force’s activity collected from their respective electronic call reporting system in the prior calendar month. Specific reportable information shall be determined by the JMC but shall, at minimum, include: (i) total number of PDEs reported for each Sales Force personnel, by month, by Fiscal Quarter and Year-To-Date; (ii) aggregate PDEs by month, by Fiscal Quarter and Year-To-Date to each unique member of the Target Audience; and (iii) roll-up of each Party’s monthly, Fiscal Quarter and Year-To-Date aggregate PDEs versus the monthly, by Fiscal Quarter and Year-To-Date goal as specified in the JMP. Such information shall be reported in a Microsoft Excel format or such other format as reasonably requested by Allergan.

(g)     For any Deficient Quarter in which Spectrum’s Sales Force delivers fewer than one hundred percent (100%) of the PDEs assigned to Spectrum under the then-current JMP for such Fiscal Quarter:

i.       if the Deficiency is less than **** for such Deficient Quarter, the Spectrum Sales Force shall cure the Deficiency by delivering the deficient number of PDEs during the Fiscal Quarter immediately following the Deficient Quarter in addition to its required PDEs for such Fiscal Quarter as set forth in the then-current JMP;

ii.      if the Deficiency is equal to or more than **** but less than **** for such Deficient Quarter, then: (A) the Spectrum Sales Force shall cure the Deficiency by delivering the deficient number of PDEs during the Fiscal Quarter immediately following the Deficient Quarter in addition to its required PDEs for such Fiscal Quarter as set forth in the then-current JMP; and (B) after calculation of the profit or loss for such Deficient Quarter, as set forth in Section 3.4 and Exhibit A , the Parties will share profit or loss for such Deficient Quarter as follows: if there is a profit, **** of the profit to Spectrum and **** to Allergan; if there is a loss, **** of the loss to Allergan and **** to Spectrum; and

iii.     if the Deficiency is equal to or more than **** for such Deficient Quarter, then: (A) the Spectrum Sales Force shall cure the Deficiency by delivering the deficient number of PDEs during the Fiscal Quarter immediately following the Deficient Quarter

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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in addition to its required PDEs for such Fiscal Quarter as set forth in the then-current JMP; and (B) after calculation of the profit or loss for such Deficient Quarter, as set forth in Section 3.4 and Exhibit A , the Parties will share profit or loss for such Deficient Quarter as follows: if there is a profit, **** of the profit to Spectrum and **** to Allergan; if there is a loss, **** of the loss to Allergan and **** to Spectrum.

(h)     For any Deficient Quarter in which Allergan’s Sales Force delivers fewer than one hundred percent (100%) of the PDEs assigned to Allergan under the then-current JMP for such Fiscal Quarter:

i.       if the Deficiency is less than **** for such Deficient Quarter, the Allergan Sales Force shall cure the Deficiency by delivering the deficient number of PDEs during the Fiscal Quarter immediately following the Deficient Quarter in addition to its required PDEs for such Fiscal Quarter as set forth in the then-current JMP;

ii.      if the Deficiency is equal to or more than **** but less than **** for such Deficient Quarter, then: (A) the Allergan Sales Force shall cure the Deficiency by delivering the deficient number of PDEs during the Fiscal Quarter immediately following the Deficient Quarter in addition to its required PDEs for such Fiscal Quarter as set forth in the then-current JMP; and (B) after calculation of the profit or loss for such Deficient Quarter, as set forth in Section 3.4 and Exhibit A , the Parties will share profit or loss for such Deficient Quarter as follows: if there is a profit, **** of the profit to Allergan and **** to Spectrum; if there is a loss, **** of the loss to Spectrum and **** to Allergan; and

iii.     if the Deficiency is equal to or more than **** for such Deficient Quarter, then: (A) the Allergan Sales Force shall cure the Deficiency by delivering the deficient number of PDEs during the Fiscal Quarter immediately following the Deficient Quarter in addition to its required PDEs for such Fiscal Quarter as set forth in the then-current JMP; and (B) after calculation of the profit or loss for such Deficient Quarter, as set forth in Section 3.4 and Exhibit A , the Parties will share profit or loss for such Deficient Quarter as follows: if there is a profit, **** of the profit to Allergan and **** to Spectrum; if there is a loss, **** of the loss to Spectrum and **** to Allergan.

(i)     For a Deficient Quarter in which both Parties’ Sales Forces deliver fewer than one hundred percent (100%) of the PDEs assigned to such Party under the then-current JMP for such Fiscal Quarter: (A) each Party’s Sales Force shall cure its Deficiency by delivering the deficient number of PDEs during the Fiscal Quarter immediately following the Deficient Quarter in addition to its required PDEs for such Fiscal Quarter as set forth in the then-current JMP; and (B) the Party having the smaller actual Deficiency shall be deemed to have delivered **** of the PDEs assigned to it under the then-current JMP (for sole purposes of this Section 2.2(i)(B)), and its Deficiency for the purpose of determining the consequence under Section 2.2(g) or (h) above shall be reduced to ****, and the Party having the larger actual Deficiency shall, for the purpose

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

7


of determining the consequence under Section 2.2(g) or (h) above, have its Deficiency reduced by ****, and shall be subject to the applicable terms of Section 2.2(g) or (h). For example, for a Deficient Quarter in which Spectrum’s Deficiency is **** and Allergan’s Deficiency is ****: (i) Spectrum shall be deemed to not have any Deficiency (for sole purposes of this Section 2.2(i)(B)) in which event none of the provisions under Section 2.2(g) shall apply to such Deficiency; and (ii) Allergan shall be deemed to have a Deficiency of ****, in which event Section 2.2(h)(i) (instead of Section 2.2(h)(ii)) shall apply to such Deficiency.

(j)       Deficiencies that are carried forward to the next Fiscal Quarter under Sections 2.2(g), (h) or (i) shall be included in the calculation of the PDEs assigned in the successive Fiscal Quarters, until satisfied in full.

(k)      Each Party shall be entitled to audit the records of the other Party (as well as the records of the other Party’s subcontractors) to verify such other Party’s delivery of PDEs under this Agreement pursuant to the audit provisions of the License Agreement.

(l)       At each meeting of the JMC, the Parties shall furnish to each other a summary of information coming to their attention in the Co-Promotion Region concerning introductions and promotional activities of products competitive with the Licensed Product in the Field of Use, and of any serious complaints regarding the Licensed Product, it being understood that there is no obligation on the Parties to solicit such information.

(m)     At Allergan’s reasonable request, Spectrum shall provide Allergan with copies of any written communications disseminated by Spectrum generally to its Sales Force promoting the Licensed Product or relating to any marketing strategy for the Licensed Product.

(n)      In connection with the marketing, promotion, Calling and detailing of the Licensed Product hereunder, neither Party nor any member(s) of their respective Sales Forces shall make any statement, representation or warranty, oral or written, to Third Parties, concerning the Licensed Product that is inconsistent with, or contrary to, the Labeling or Promotional Materials or that is disparaging to the Licensed Product, the other Party, or any of other Party’s Affiliates, officers, directors or employees.

2.3      Promotional Materials .

(a)       During the Term, the JMC shall determine which Promotional Materials, including positioning and key messages, are necessary or appropriate to be distributed in the Co-Promotion Region under the JMP. Allergan shall create and develop such Promotional Materials, and such Promotional Materials shall be subject to review by the JMC. The Parties shall establish a tracking system or utilize Allergan’s tracking system (if appropriate and mutually agreed) for Promotional Materials to ensure that all such Promotional Materials are accurately tracked and submitted to the FDA. Allergan will file all Promotional Materials with the FDA if, and as required, by FDA regulations.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(b)     Spectrum shall not create, develop or distribute any sales, promotional content or other similar materials (including Labeling) relating to the Licensed Product in the Co-Promotion Region except as set forth in this Section. All oral communications that Spectrum or its Sales Force has with Third Parties relating to the Licensed Product shall conform to the pre-approved talking points (which shall be the same for the Sales Force of both Parties) as agreed to within the JMC and provided by Allergan in writing. Spectrum shall not be required to distribute any Promotional Materials prepared after the Effective Date which: (i) do not mention the Licensed Product; (ii) are inaccurate or misleading; or (iii) were not approved by the JMC and Allergan. Spectrum shall distribute Promotional Materials of the type identified in this subsection in accordance with the JMP and with the terms of this Agreement. Print marketing materials produced by Allergan for use for the Target Audience shall include Spectrum’s name, and shall display the names and logos of Allergan and Spectrum in equal prominence. Except as specifically permitted by this Section or under the License Agreement, neither Party shall distribute or have distributed any materials bearing the name or any Trademarks of the other Party without the prior written approval of the other.

(c)     Allergan shall own all right, title and interest in and to the Promotional Materials, including all Intellectual Property Rights and all Trademarks appurtenant thereto but excluding any rights in or to the Spectrum name (the “ Allergan Trademarks ”). Allergan hereby grants to Spectrum the right, during the Term, to use Promotional Materials generated pursuant to the JMP in connection with its promotion of the Licensed Product and in accordance with this Agreement. Spectrum shall only be able to use the Allergan Trademarks in connection with the Licensed Product as required by law. In addition, Spectrum shall be able to use the Allergan Trademarks that are used in connection with the Licensed Product on its website and in press releases with the prior written consent of Allergan. All rights of Allergan in and to the Allergan Trademarks not expressly granted under this Article 2 are reserved by Allergan.

(d)     Spectrum shall promptly notify Allergan of any apparent infringement by a Third Party of any of the Allergan Trademarks.

(e)     Spectrum acknowledges and agrees that Allergan is the owner of all rights in the Allergan Trademarks, that all use of the Allergan Trademarks shall inure to the benefit of Allergan, that Spectrum will not take any action which is inconsistent with Allergan’s ownership of the Allergan Trademarks, and that upon termination or expiration of this Agreement, all rights in the Allergan Trademarks shall remain the property of Allergan.

2.4      Subcontracting . Spectrum may not subcontract its rights hereunder to Third Parties without the prior written consent of Allergan. Allergan may freely subcontract is rights hereunder except to the extent restricted under Section 2.3(a) of the License Agreement.

ARTICLE 3

SALES AND EXPENSES

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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3.1      Sales and Distribution . Notwithstanding the JMP or any other provision herein and in the License Agreement to the contrary, Allergan shall have the sole right and responsibility for establishing and modifying the terms and conditions with respect to the sale of Licensed Product in the Field of Use in the Co-Promotion Region, including, without limitation, the price at which the Licensed Product will be sold, reimbursement, and any discounts attributable to payments on receivables and the distribution of the Licensed Product. Allergan shall make the actual sale of all Licensed Product to each customer, and shall book each sale.

3.2      Budget . Without limiting the obligations set forth in Section 2.1, each Party shall spend the amounts set forth in the JMP as their spending obligations thereunder.

3.3      Promotional, Sales, Marketing, and Medical Affairs Expenses . Spectrum and Allergan shall each be responsible for the expenses it incurs, and the Parties shall share equally in the PSMM within the Co-Marketing Region on a fifty-fifty basis as part of the profit sharing discussed in Section 3.4 below and illustrated in Exhibit A . Each Party warrants and represents that it will maintain accurate and complete records of the PSMM incurred by it hereunder, including the nature of each such expense. Pursuant to Section 3.2, each Party represents and warrants that it will only incur and submit to the other Party expenses that are consistent with its commercial rights in the Co-Promotion Region and as set forth in the then-current JMP. For each Fiscal Year during the Term, each Party shall issue a report to the other Party at each meeting of the JMC, setting forth the PSMM incurred by such Party since the immediately preceding meeting of the JMC. Each Party shall be entitled to audit the source data and documents used to compile the PSMM reports of the other Party pursuant to the audit provisions of the License Agreement.

3.4      Profit and Loss . The Parties shall account for the profits and loss arising from the sale of Licensed Product in the Field of Use in the Co-Promotion Region pursuant to the terms of Exhibit A . Profit and loss will be shared equally by the Parties on a fifty-fifty basis as illustrated in Exhibit A subject to adjustments pursuant to Sections 2.2(g), (h), and (i).

ARTICLE 4

OPERATING PROCEDURES

4.1      Exchange of Information .

(a)     Each Party shall provide the other Party with such information as the other Party may reasonably request during the Term in order to support the requesting Party’s Sales Force’s promotion, marketing, Calling and detailing of the Licensed Product in the Field of Use in the Co-Promotion Region.

(b)     During the Term and subject to the provisions of this Agreement, each Party will provide the other with all information relevant to the marketing, detailing, Calling and promotion of the Licensed Product in the Field of Use within the Co-Promotion Region within a

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

10


reasonable time after such information becomes known to the Party; provided , however , that such information is not received from an independent Third Party under a secrecy obligation.

(c)     Each Party shall promptly communicate to the other Party all comments, statements, requests and inquiries of the medical profession or any other Third Parties relating to the Licensed Product in the Field of Use in the Co-Promotion Region that are out of the ordinary, or not covered by the Labeling, of which such Party becomes aware. All responses to the medical profession or such other Third Parties within the Co-Promotion Region shall be handled solely by Allergan (except to the extent permitted under Section 2.1(c)). Spectrum shall refer all medical inquiries concerning the Licensed Product in the Field of Use and all quality complaints within the Co-Promotion Region to the following address/number:

Director, Scientific Information Medical Compliance

Allergan Sales, LLC

2525 Dupont Drive

PO Box 19534

Irvine, CA 92713-4285

714-246-4285

(d)     Spectrum shall assist Allergan with respect to customer communications (as reasonably requested by Allergan) within the Co-Promotion Region and shall keep Allergan advised of market, economic, regulatory and other developments of which Spectrum may become aware which may affect the sale of the Licensed Product in the Field of Use in the Co-Promotion Region.

(e)     Both Parties shall utilize an electronic sales force automation system for data collection and data management consistent with industry standard practices to produce reports and analyses of their respective Sales Force’s activities and the Licensed Product’s performance in the Field of Use in the Co-Promotion Region. Allergan reserves the right to review and approve the Spectrum sales force automation system utilized in the Co-Promotion Region.

(f)     Spectrum and Allergan shall report to each other all information necessary to permit Allergan to make timely reports as required by any governmental regulatory agency in the Co-Promotion Region regarding the Licensed Product in the Field of Use.

ARTICLE 5

REPRESENTATIONS, WARRANTIES AND COVENANTS

5.1      Spectrum Representations, Warranties, and Covenants . Spectrum represents, warrants and covenants that:

(a)     Spectrum has the requisite personnel, facilities, equipment, expertise, experience and skill to perform its obligations hereunder and to render the services contemplated hereby;

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

11


(b)     Spectrum and its Sales Force shall perform the services in a professional, timely, competent and efficient manner, and it and its Sales Force shall abide by all Laws that apply to its and their performance; and

(c)     any negligent or wrongful act or omission on the part of Spectrum’s Sales Force (both individually and as a group) shall be deemed to be negligent or wrongful acts or omissions of Spectrum. Spectrum shall notify Allergan in writing as promptly as practicable of any alleged negligent or wrongful acts or omissions on the part of Spectrum’s Sales Force, and of any allegations of negligent or wrongful acts or omissions made against Allergan’s Sales Force.

5.2      Allergan Warranties and Covenants . Allergan warrants and covenants that:

(a)     Allergan has the requisite personnel, facilities, equipment, expertise, experience and skill to perform its obligations hereunder and to render the services contemplated hereby;

(b)     Allergan and its Sales Force shall perform such services in a professional, timely, competent and efficient manner, and it and its Sales Force shall abide by all Laws that apply to its and their performance; and

(c)     any negligent or wrongful act or omission on the part of Allergan’s Sales Force (both individually and as a group) shall be deemed to be negligent or wrongful acts or omissions of Allergan. Allergan shall notify Spectrum in writing as promptly as practicable of any alleged negligent or wrongful acts or omissions on the part of Allergan’s Sales Force, and of any allegations of negligent or wrongful acts or omissions made against Spectrum’s Sales Force.

5.3      Performance by Affiliates . Spectrum recognizes that Allergan may perform some or all of its obligations under this Agreement through its Affiliates.

5.4      DISCLAIMER OF ALL OTHER WARRANTIES . THE WARRANTIES SET FORTH IN THIS AGREEMENT AND THE LICENSE AGREEMENT ARE THE PARTIES’ ONLY WARRANTIES WITH RESPECT HERETO AND ARE MADE EXPRESSLY IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WHICH ARE HEREBY DISCLAIMED, INCLUDING ANY IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, OR OTHERWISE.

ARTICLE 6

TERM AND TERMINATION

6.1      Term . The term of this Agreement shall commence on the Effective Date and continue until the earlier of (a) termination of the License Agreement or (b) the date on which

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

12


this Agreement is terminated pursuant to the provisions herein (the “ Term ”).

6.2      Termination .

(a)     Spectrum may, in its sole discretion, opt out of performing under this Agreement only by providing written notice of its intent to opt-out of (and terminate) this Agreement delivered on the first day of any Fiscal Quarter during 2011, or on the first day of the first Fiscal Quarter of 2012. Such termination shall be effective (the “ Opt-Out Effective Date ”) on the last day of the Fiscal Quarter in which such notice is delivered. During the period between delivery of notification and the Opt-Out Effective Date, Spectrum shall continue to be responsible for its thirty-five percent (35%) share of Development Costs incurred during such period pursuant to the terms of the License Agreement, and for its fifty-percent (50%) share of pre-market planning expenses and any other costs related to the planned commercialization of the Licensed Product pursuant to the terms of the JMP and Exhibit A . On the Opt-Out Effective Date:

i.       Spectrum’s obligation to pay future Development Costs under Section 6.6 of the License Agreement shall automatically be reduced to **** and Allergan’s obligation to pay future Development Costs under Section 6.6 of the License Agreement shall be automatically increased to ****; and

ii.      provided that Spectrum is in compliance with the terms and conditions of this Agreement as of the Opt-Out Effective Date, Allergan will reimburse Spectrum retroactively, in the form of a one time payment, an amount equal to **** of the aggregate Development Costs and pre-launch costs pursuant to the JMP incurred by Spectrum under the License Agreement and this Agreement (and not, for clarity, Development Costs incurred or paid by Spectrum prior to January 1, 2009); and

iii.     this Agreement shall be deemed automatically terminated and the sales milestones and royalties set forth in the License Agreement shall apply as provided therein.

(b)     Without limiting the rights set forth in subsection (c) below, either Party may terminate this Agreement by giving notice in writing to the other Party in the event the other Party is in material breach of this Agreement and shall have failed to cure such breach within sixty (60) days of receipt of written notice thereof specifying the breach in detail from the non-breaching Party. In addition, each Party shall have the right to seek all available rights and remedies to it, under law or equity (including injunctive relief) for such uncured material breach by such other Party.

(c)     In addition to the rights set forth in subsection (b) above, Allergan may:

i.       terminate Spectrum’s rights under this Agreement with written notice to Spectrum in the event of: (A) **** consecutive Deficient Quarters by Spectrum in which

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

13


the Deficiency is greater than **** for each such quarter and Allergan’s Sales Force delivers a higher percentage of its assigned PDEs in each such quarter than Spectrum delivers for its assigned PDEs; (B) **** Deficient Quarters by Spectrum in a **** Fiscal Quarter period and Allergan’s Sales Force delivers a higher percentage of its assigned PDEs in each such Deficient Quarter than Spectrum delivers for its assigned PDEs; or (C) a material breach of such a nature, duration or frequency (I) that there occurs a material failure of consideration under such section that cannot be adequately remedied by money damages, or (II) that demonstrates that Spectrum is an unreliable co-promotion partner, such as material repetitive violations (even if cured);

ii.     immediately terminate this Agreement with written notice to Spectrum (with no right to cure) in the event of a material breach by Spectrum of Sections 2.1(c)(ii), 2.2(c), (d), or (n), or 2.3(b) which has an adverse effect on Allergan or the Licensed Product.

6.3      Effect of Termination or Expiration . Termination or expiration of this Agreement in whole or in part shall not relieve the Parties of any amounts owing between them at the date termination or expiration. Upon termination or expiration of this Agreement, Spectrum shall, at its sole expense and within thirty (30) days of such termination or expiration, return to Allergan all Promotional Materials and any samples of the Licensed Product then in the possession of Spectrum and any of its Sales Force. The following provisions shall survive any termination or expiration of this Agreement: Articles 1 and 7 and Sections 2.3(c) and (e), 5.4, 6.2(a)(i), (ii) and (iii) and 6.3.

ARTICLE 7

GENERAL PROVISIONS

7.1      Incorporation of Terms from the License Agreement . This Agreement forms an integral part of the License Agreement, and is incorporated into the License Agreement. As a part of the License Agreement, this Agreement is subject to all terms and conditions of the License Agreement. Without limiting the generality of the foregoing, Article 14 (Miscellaneous) of the License Agreement applies to this Agreement as if stated herein. In the event of any contradictions or inconsistencies between the terms of this Agreement and those of the License Agreement, the terms of the License Agreement shall govern.

[Signature page to follow]

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

14


EXECUTION COPY

IN WITNESS WHEREOF, the Parties, intending to be bound hereby, have executed this Agreement as of the date first written above.

 

ALLERGAN SALES, LLC

By:

 

/s/ Jeffrey L. Edwards

Name:

 

Jeffrey L. Edwards

Title:

 

Vice President and

 

Chief Financial Officer

ALLERGAN USA, INC.

By:

 

/s/ Jeffrey L. Edwards

Name:

 

Jeffrey L. Edwards

Title:

 

Vice President and

 

Chief Financial Officer

SPECTRUM PHARMACEUTICALS,

INC.

By:

 

/s/ Rajesh C. Shrotriya

Name:

 

Rajesh C. Shrotriya

Title:

 

Chief Executive Officer and

 

President

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Exhibit A

Profit Split and PSMM Share Process

Prior to the launch of the Licensed Product in the Field of Use in the Co-Promotion Region, each Party will share equally in the PSMM incurred by the Parties. During this time, each Party will be responsible for their share of the PSMM and by the third day of each Fiscal Quarter, each Party will deliver to the other Party a report itemizing the total PSMM incurred by such Party in the prior Fiscal Quarter. Each Party shall then deliver a check, within thirty (30) days, to the other Party reimbursing the other Party for 50% of the PSMM incurred by the other Party in the prior Fiscal Quarter.

After the launch of the Licensed Product in the Field of Use in the Co-Promotion Region, Spectrum will deliver to Allergan an invoice by the third day of each Fiscal Quarter itemizing its aggregate PSMM for the Licensed Product for the prior Fiscal Quarter. Allergan shall then deliver a check, within thirty (30) days, to Spectrum reimbursing Spectrum for the PSMM incurred by Spectrum in the prior Fiscal Quarter. Allergan shall aggregate the amounts specified on Spectrum’s invoice with Allergan’s aggregate PSMM for the Licensed Product for the prior Fiscal Quarter, and will deduct the total from the Licensed Product’s Gross Margin from the prior Fiscal Quarter to yield a product profit or loss. Each Party will share equally in this profit or loss, when there is a profit Allergan will pay Spectrum 50% of the profit and when there is a loss Spectrum will reimburse Allergan 50% of the loss (except as set forth in Sections 2.2(g), (h), and (i)). Allergan will complete and distribute the analysis within thirty (30) days after the end of the prior Fiscal Quarter. The Party responsible to make payment based on such analysis will do so within thirty (30) days of issuance of such analysis.

Examples (the following table is for illustration purposes only and makes no representation to the accuracy of the assumptions):

 

(1)    (2)
Assumptions:    Assumptions:
Total Sales - $50M    Total Sales - $8M
COGS - $7M    COGS - $1M
Total-to-Net Deductions - $8M    Total-to-Net Deductions - $1M
PSMM - $10M    PSMM - $8M
      Allergan - $8M          Allergan - $6M
      Spectrum Invoice - $2M          Spectrum Invoice - $2M
   
Example P&L:    Example P&L:
Total Sales -                      $50M    Total Sales -                      $8M
Deductions -                       $8M    Deductions -                       $1M

Royalty-Bearing Net Sales -

$42M

  

Royalty-Bearing Net Sales -                                            $7M

COGS -                             $ 1M

  Manufacturing Margin-  $6M

PSMM -                                $8M

  Operating Margin -         ($2M)

COGS -                               $7M   
  Manufacturing Margin -   $35   
PSMM -                                  $10   
  Operating Margin -          $25   

 

Licensed Product Profit/(Loss) -    $25M

  

Licensed Product Profit/(Loss) -    ($2M)

 

 

$12.5M will be paid by Allergan to Spectrum in the form of the profit and loss split.

  

$1M will be paid to Allergan by Spectrum in the form of the profit and loss split reimbursement.

 

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Schedule 3.4(b)(i)

Initial Joint Marketing Plan

****

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S3.4(b)(i)-1


Schedule 6.4(a)

Example of Royalties

If, in Fiscal Year One, Allergan earns **** in Royalty-Bearing Net Sales from Royalty-Bearing Product sales in the Royalty Territory, Spectrum would be due royalties as follows:

(i) **** x **** = ****.

So, the total royalties due Spectrum for Fiscal Year One would be ****.

If, in Fiscal Year Two, Allergan earns **** in Royalty-Bearing Net Sales from Royalty-Bearing Product sales in the Royalty Territory, Spectrum would be due royalties as follows:

(i) on the first **** of the ****, Spectrum would be due **** x **** = ****; and

(ii) on the next **** of the ****, Spectrum would be due **** x **** = ****.

So, the total royalties due Spectrum for Fiscal Year Two would be **** + **** = ****.

If, in Fiscal Year Three, Allergan earns **** in Royalty-Bearing Net Sales from Royalty-Bearing Product sales in the Royalty Territory, Spectrum would be due royalties as follows:

(i) on the first **** of the ****, Spectrum would be due **** x **** = ****;

(ii) on the next **** of the ****, Spectrum would be due **** x **** = ****; and

(iii) on the next **** of the ****, Spectrum would be due **** x **** = ****.

So, the total royalties due Spectrum for Fiscal Year Three would be **** + **** + **** = ****.

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S6.4(a)-1


Schedule 7.1

Trademark Assignment Agreement

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S7.1-1


TRADEMARK AND DOMAIN NAME ASSIGNMENT

This TRADEMARK AND DOMAIN NAME ASSIGNMENT (this “Assignment”) is made and entered into effective as of October 28, 2008 (the “Effective Date”) by and between Allergan, Inc. (“Allergan”), a Delaware corporation with its principal place of business at 2525 Dupont Drive, Irvine, California 92612, and Spectrum Pharmaceuticals, Inc. (“Spectrum”), a Delaware corporation with its principal place of business at 157 Technology Drive, Irvine, CA 92618.

Allergan and Spectrum are two of the parties to a License, Development, Supply and Distribution Agreement entered into on the date hereof (the “License Agreement”). Pursuant to Section 7.1 of the License Agreement, the parties wish to document the transfer of certain trademarks and domain names covered by the License Agreement.

1.     Assignment. In partial consideration of the fees paid by Allergan under the License Agreement, receipt of which is hereby acknowledged, Spectrum does hereby sell, convey, assign and transfer to Allergan, absolutely and not as security, all of Spectrum’s worldwide right, title and interest in and to the following:

1.1.      All of the trademarks identified on Exhibit A (“Acquired Trademarks”) and all of the domain names identified on Exhibit B (“Acquired Domain Names”);

1.2.      All goodwill of Spectrum’s business symbolized by the Acquired Trademarks and Acquired Domain Names; and

1.3.      All claims by Spectrum against any Third Party for past, present or future infringement of the Acquired Trademarks or Acquired Domain Names and all rights to payment with respect to any cause of action affecting or relating to such Acquired Trademarks or Acquired Domain Names.

2.     Further Assurances for Acquired Trademarks. Spectrum will deliver to Allergan reasonably promptly after the Effective Date, appropriate trademark assignments for recordation by Allergan with the appropriate Patent and Trademark Offices duly executed by Spectrum. Spectrum agrees that, upon reasonable request from time to time, it shall execute and deliver all such additional documents as may be required, and do all other acts which may be reasonably necessary or appropriate, in the reasonable opinion of Allergan’s counsel to perfect or record the right or title of Allergan to the Acquired Trademarks transferred hereby.

3.     Further Assurances for Acquired Domain Names. The parties acknowledge that in order to effect the sale, transfer, assignment and transfer of registration of the Acquired Domain Names from Spectrum to Allergan, the parties must follow certain procedures stipulated by the registrar of each such Acquired Domain Name (the “Domain Transfer

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

- 1 -


Procedures”). The parties agree to fully cooperate with each other and to promptly take all necessary actions in order to comply with the Domain Transfer Procedures so as to effect the transactions contemplated in this Agreement within fifteen days from the Effective Date, including Spectrum directing the registrar(s) to release and unlock the Acquired Domain Names and, upon notice from Registrar that such Acquired Domain Names have been unlocked, immediately requesting that the Acquired Domain Names be transferred to Allergan.

[ Remainder of page intentionally left blank. ]

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

- 2 -


IN WITNESS WHEREOF, the parties herein have executed this Assignment as of the Effective Date.

 

ALLERGAN, INC.
By:  

/s/ Jeffrey L. Edwards

Name:   Jeffrey L. Edwards
Title:   Executive Vice President,
  Finance and Business Development,
  Chief Financial Officer
SPECTRUM PHARMACEUTICALS, INC.
By:  

/s/ Rajesh C. Shrotriya

Name:   Rajesh C. Shrotriya
Title:   Chief Executive Officer and President

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

- 3 -


EXHIBIT A TO TRADEMARK AND DOMAIN NAME ASSIGNMENT

Acquired Trademarks

EOQUIN either (a) as a stand-alone mark or (b) as the mark has been used in combination with any other words, stylizations, logos, or designs so as to create a unitary trademark

Applications

 

Country   Mark   Application No.   Filing Date   Status
****   ****   ****   ****   ****

Registrations

 

Country   Mark   Registration No.  

Registration

Date

  Status
****   ****   ****   ****   ****

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

- 4 -


EXHIBIT B TO TRADEMARK AND DOMAIN NAME ASSIGNMENT

 

Acquired Domain Names

 

Domain Name   Registrar   Registration Date   Expiration Date
****   ****   ****   ****

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

- 5 -


Schedule 11.2(e)

Disclosures

****

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

S11.2(e)-1


Schedule 11.5(c)

Trademark and Domain Name Applications and Registrations for the Acquired

Trademarks

See Schedule 7.1 Exhibit A and Exhibit B

 

**** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

EXHIBIT 21

ENTITIES OF ALLERGAN, INC.

 

TAB

 

NAME OF SUBSIDIARY

    

PLACE OF
INCORPORATION
OR ORGANIZATION

1.   Allergan Productos Farmaceuticos S.A.      Argentina
2.   Allergan Australia Pty Limited      Australia
3.   Inamed Pty Ltd.      Australia
4.   Collagen Vertrieb Biomedizinischer Produkte Gesellschaft m.b.H.      Austria
5.   Allergan N.V.      Belgium
6.   Collagen Aesthetics Benelux S.A.      Belgium
7.   Allergan Holdings B Ltd.      Bermuda
8.   Allergan Produtos Farmacêuticos Ltda.      Brazil
9.   Inamed do Brazil Ltda      Brazil
10.   McGhan Do Brazil      Brazil
11.   Allergan Inc.      Canada
12.   Allergan Pharmaceuticals Ireland      Cayman Islands
13.   Allergan Holdings C, Ltd.      Cayman Islands
14.   Allergan Laboratorios Limitada      Chile
15.   Allergan de Colombia S.A.      Colombia
16.   Allergan Costa Rica, S.R.L.      Costa Rica
17.   Allergan A/S      Denmark
18.   Allergan France S.A.S.      France
19.   Allergan Holdings France SAS      France
20.   Collagen Aesthetics France SARL      France
21.   Allergan Industrie S.A.S.      France
22.   S.C.I. Focus      France
23.   S.C.I. Val Promery      France
24.   Pharm-Allergan GmbH      Germany
25.   Allergan Asia Limited      Hong Kong
26.   Allergan Asia (Taiwan) Ltd.      Hong Kong
27.   Allergan Hong Kong Limited      Hong Kong
28.   Allergan Healthcare India Private Limited      India
29.   Allergan India Private Limited*      India
30.   Allergan Pharmaceutical Development Center India Private Limited      India
31.   Allergan Botox Limited      Ireland
32.   Allergan Sales, Limited      Ireland
33.   Allergan Services International, Limited      Ireland
34.   Allergan Pharmaceuticals Holdings (Ireland) Limited      Ireland
35.   McGhan Limited      Ireland
36.   McGhan Ireland Holdings Ltd.      Ireland
37.   Medisyn Technologies Limited      Ireland
38.   BioEnterics Limited      Ireland
39.   Chamfield Limited      Ireland
40.   Collagen Aesthetics International Limited      Ireland
41.   The Seabreeze Holdings LLC Inamed International Corporation Limited Partnership      Ireland
42.   Seabreeze Silicone Limited      Ireland
43.   Allergan S.p.A.      Italy
44.   Allergan K.K.      Japan
45.   Allergan International YK      Japan
46.   Allergan NK      Japan
47.   Collagen KK      Japan
48.   McGhan Medical Group      Japan
49.   McGhan Medical Asia Pacific      Japan
50.   Allergan Korea Limited      Korea


TAB

 

NAME OF SUBSIDIARY

    

PLACE OF
INCORPORATION
OR ORGANIZATION

51.   Collagen Luxemburg S.A.      Luxemburg
52.   Allergan Malaysia Sdn. Bhd.      Malaysia
53.   Allergan, S.A. de C.V.      Mexico
54.   Allergan Servicios Profesionales, S. de R.L. de C.V.      Mexico
55.   BioEnterics Latin America S.A. de C.V.      Mexico
56.   McGhan Medical Mexico S.A. de C.V.      Mexico
57.   Allergan B.V.      Netherlands
58.   Allergan Services B.V.      Netherlands
59.   McGhan Medical B.V.      Netherlands
60.   Allergan Holdings B.V.      Netherlands Antilles
61.   Allergan New Zealand Limited      New Zealand
62.   Allergan AS      Norway
63.   Allergan C.I.S. SARL      Russia
64.   Allergan Singapore Pte. Ltd.      Singapore
65.   Endoart Singapore Pte. Ltd.      Singapore
66.   Allergan Pharmaceuticals (Proprietary) Limited      South Africa
67.   Allergan, S.A.U.      Spain
68.   Allergan Norden AB      Sweden
69.   Allergan AG      Switzerland
70.   Allergan Medical SA      Switzerland
71.   Allergan (Thailand) Ltd.      Thailand
72.   Allergan Holdings Limited      United Kingdom
73.   Allergan Limited      United Kingdom
74.   Collagen Aesthetics (UK) Limited      United Kingdom
75.   Inamed Aesthetics Limited      United Kingdom
76.   McGhan Medical UK Limited      United Kingdom
77.   Allergan Optical Irvine, Inc.      United States/CA
78.   Allergan Sales Puerto Rico, Inc.      United States/CA
79.   CUI Corporation      United States/CA
80.   Herbert Laboratories      United States/CA
81.   Inamed Development Company      United States/CA
82.   Oculex Pharmaceuticals, Inc.      United States/CA
83.   Silicone Engineering, Inc.      United States/CA
84.   Allergan USA, Inc.      United States/DE
85.   Allergan America, LLC      United States/DE
86.   Allergan Holdings, Inc.      United States/DE
87.   Allergan Puerto Rico Holdings, Inc.      United States/DE
88.   Allergan Sales, LLC      United States/DE
89.   Allergan Specialty Therapeutics, Inc.      United States/DE
90.   Inamed, LLC      United States/DE
91.   Inamed Corporation      United States/DE
92.   Inamed International Corp.      United States/DE
93.   Pacific Pharma, Inc.      United States/DE
94.   Seabreeze LP Holdings, LLC      United States/DE
95.   Flowmatrix Corporation      United States/NV
96.   TotalSkinCare.com Corporation      United States/NV
97.   Allergan de Venezuela, S.A.      Venezuela

 

*

  Except for Allergan India Private Limited, all of the above-named subsidiaries are 100% owned by the Registrant. Allergan India Private Limited is 51% owned by the Registrant.

EXHIBIT 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the incorporation by reference in the Registration Statements (Form S-3 Nos. 333-136188, 333-102425, 333-99219, 333-50524, 33-55061; Form S-4 Nos. 333-136189, 333-129871; and Form S-8 Nos. 333-133817, 333-117939, 333-117937, 333-117936, 333-117935, 333-65176, 333-43584, 333-43580, 333-94157, 333-94155, 333-70407, 333-64559, 333-25891, 333-04859, 333-09091, 33-66874, 33-48908, 33-44770, 33-29528, 33-29527) of Allergan, Inc. and in the related Prospectuses of our reports dated February 25, 2009, with respect to: (1) the consolidated financial statements and schedule of Allergan, Inc., and (2) the effectiveness of internal control over financial reporting of Allergan, Inc., included in this Annual Report (Form 10-K) for the year ended December 31, 2008.

 

/s/ Ernst & Young LLP

Orange County, California

February 25, 2009

EXHIBIT 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

I, David E.I. Pyott, certify that:

1. I have reviewed this annual report on Form 10-K of Allergan, 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 the 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.

 

/s/ DAVID E.I. PYOTT
David E.I. Pyott

Chairman of the Board and

Chief Executive Officer

(Principal Executive Officer)

Date: February 25 , 2009

EXHIBIT 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

I, Jeffrey L. Edwards, certify that:

1. I have reviewed this annual report on Form 10-K of Allergan, 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 the 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.

 

/s/ JEFFREY L. EDWARDS

Jeffrey L. Edwards

Executive Vice President, Finance

and Business Development, Chief Financial Officer

(Principal Financial Officer)

Date: February 25 , 2009

EXHIBIT 32

The following certifications are being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350 and in accordance with SEC Release No. 33-8238. These certifications shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall they be incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Certification of Principal Executive Officer

Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Allergan, Inc., a Delaware corporation (the “Company”), hereby certifies, to his knowledge, that:

 

  (i) the accompanying Annual Report on Form 10-K of the Company for the period ended December 31, 2008 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

  (ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ DAVID E.I. PYOTT
David E.I. Pyott

Chairman of the Board and

Chief Executive Officer

(Principal Executive Officer)

Dated: February 25 , 2009

A signed original of this written statement required by Section 906 has been provided to Allergan, Inc. and will be retained by Allergan, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

Certification of Principal Financial Officer

Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Allergan, Inc., a Delaware corporation (the “Company”), hereby certifies, to his knowledge, that:

 

  (i) the accompanying Annual Report on Form 10-K of the Company for the period ended December 31, 2008 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

  (ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ JEFFREY L. EDWARDS
Jeffrey L. Edwards

Executive Vice President, Finance

and Business Development, Chief Financial Officer

(Principal Financial Officer)

Dated: February 25 , 2009

A signed original of this written statement required by Section 906 has been provided to Allergan, Inc. and will be retained by Allergan, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.