Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 10-Q

 

 

 

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

For the quarterly period ended March 31, 2015

OR

 

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

For the transition period from                      to                     

 

 

 

Commission

File Number

 

Exact name of registrant as specified in its charter,

principal office and address and telephone number

 

State of incorporation

or organization

  

I.R.S. Employer

Identification No.

001-36867

 

Actavis plc

1 Grand Canal Square,

Docklands Dublin 2, Ireland

(862) 261-7000

  Ireland    98-1114402

001-36887

 

Warner Chilcott Limited

Cannon’s Court 22

  Bermuda    98-0496358
  Victoria Street     
  Hamilton HM 12     
  Bermuda     
  (441) 295-2244     

 

 

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:

 

Actavis plc   YES     x   NO     ¨
Warner Chilcott Limited   YES     x   NO     ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

 

Actavis plc   YES     x   NO     ¨
Warner Chilcott Limited   YES     x   NO     ¨

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

 

Actavis plc    Large accelerated filer    x   Accelerated filer    ¨
   Non-accelerated filer (Do not check if a smaller reporting company)    ¨   Smaller reporting company    ¨
Warner Chilcott Limited    Large accelerated filer    ¨   Accelerated filer    ¨
   Non-accelerated filer (Do not check if a smaller reporting company)    x   Smaller reporting company    ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).

 

Actavis plc   YES     ¨   NO     x
Warner Chilcott Limited   YES     ¨   NO     x

Number of shares of Actavis plc’s Ordinary Shares outstanding on May 1, 2015: 392,444,638. There is no trading market for securities of Warner Chilcott Limited, all of which are indirectly wholly owned by Actavis plc.

 

 

This Quarterly Report on Form 10-Q is a combined report being filed separately by two different registrants: Actavis plc and Warner Chilcott Limited. Warner Chilcott Limited is an indirect wholly owned subsidiary of Actavis plc. The information in this Quarterly Report on Form 10-Q is equally applicable to Actavis plc and Warner Chilcott Limited, except where otherwise indicated. Warner Chilcott Limited meets the conditions set forth in General Instruction H(1)(a) and (b) of Form 10-Q and, to the extent applicable, is therefore filing this form with a reduced disclosure format.

 

 

 


Table of Contents

TABLE OF CONTENTS

FORM 10-Q FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2015

 

         PAGE  
PART I. FINANCIAL INFORMATION   
Item 1.   Consolidated Financial Statements (unaudited)      3   
  Consolidated Balance Sheets of Actavis plc as of March 31, 2015 and December 31, 2014      3   
 

Consolidated Statements of Operations of Actavis plc for the three months ended March  31, 2015 and March 31, 2014

     4   
 

Consolidated Statements of Comprehensive (Loss) / Income of Actavis plc for the three months ended March  31, 2015 and March 31, 2014

     5   
 

Consolidated Statements of Cash Flows of Actavis plc for the three months ended March 31, 2015 and March  31, 2014

     6   
  Consolidated Balance Sheets of Warner Chilcott Limited as of March 31, 2015 and December 31, 2014      7   
 

Consolidated Statements of Operations of Warner Chilcott Limited for the three months ended March  31, 2015 and March 31, 2014

     8   
 

Consolidated Statements of Comprehensive (Loss) / Income of Warner Chilcott Limited for the three months ended March 31, 2015 and March 31, 2014

     9   
 

Consolidated Statements of Cash Flows of Warner Chilcott Limited for the three months ended March  31, 2015 and March 31, 2014

     10   
  Notes to Consolidated Financial Statements      11   
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations      80   
Item 3.   Quantitative and Qualitative Disclosures About Market Risk      98   
Item 4.   Controls and Procedures      99   
PART II. OTHER INFORMATION      99   
Item 1.   Legal Proceedings      99   
Item 1A.   Risk Factors      100   
Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds      143   
Item 6.   Exhibits      144   
  Signatures      145   

 

2


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PART I. FINANCIAL INFORMATION

 

I TEM 1. CONSOLIDATED FINANCIAL STATEMENTS

ACTAVIS PLC

CONSOLIDATED BALANCE SHEETS

(Unaudited; in millions, except par value)

 

     March 31,
2015
    December 31,
2014
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 2,114.9      $ 250.0   

Marketable securities

     16.0        1.0   

Accounts receivable, net

     3,992.8        2,372.3   

Inventories

     3,125.1        2,075.5   

Prepaid expenses and other current assets

     1,024.1        733.4   

Current assets held for sale

     143.5        949.2   

Deferred tax assets

     600.8        500.3   
  

 

 

   

 

 

 

Total current assets

  11,017.2      6,881.7   

Property, plant and equipment, net

  2,797.9      1,594.7   

Investments and other assets

  518.3      235.4   

Deferred tax assets

  99.8      107.4   

Product rights and other intangibles

  74,201.1      19,188.4   

Goodwill

  50,826.4      24,521.5   
  

 

 

   

 

 

 

Total assets

$ 139,460.7    $ 52,529.1   
  

 

 

   

 

 

 
LIABILITIES AND EQUITY

Current liabilities:

Accounts payable and accrued expenses

$ 5,820.1    $ 4,170.6   

Income taxes payable

  101.6      50.4   

Current portion of long-term debt and capital leases

  1,624.1      697.4   

Deferred revenue

  27.1      27.0   

Current liabilities held for sale

  17.4      25.9   

Deferred tax liabilities

  65.2      47.3   
  

 

 

   

 

 

 

Total current liabilities

  7,655.5      5,018.6   

Long-term debt and capital leases

  42,700.5      14,846.3   

Deferred revenue

  53.5      38.8   

Other long-term liabilities

  1,218.1      335.8   

Other taxes payable

  984.1      892.2   

Deferred tax liabilities

  15,439.5      3,061.9   
  

 

 

   

 

 

 

Total liabilities

  68,051.2      24,193.6   
  

 

 

   

 

 

 

Commitments and contingencies

Equity:

Preferred shares, $0.0001 par value per share, 5.1 million and zero shares authorized, 5.1 million and zero shares issued and outstanding, respectively

  4,929.7      —     

Ordinary shares; $0.0001 par value per share; 1,000.0 million shares authorized, 392.3 million and 265.9 million shares issued and outstanding, respectively

  —        —     

Additional paid-in capital

  67,969.3      28,994.7   

(Accumulated deficit)

  (710.9   (198.2

Accumulated other comprehensive (loss)

  (783.3   (465.4
  

 

 

   

 

 

 

Total shareholders’ equity

  71,404.8      28,331.1   

Noncontrolling interest

  4.7      4.4   
  

 

 

   

 

 

 

Total equity

  71,409.5      28,335.5   
  

 

 

   

 

 

 

Total liabilities and equity

$ 139,460.7    $ 52,529.1   
  

 

 

   

 

 

 

 

 

See accompanying Notes to Consolidated Financial Statements.

 

3


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ACTAVIS PLC

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited; in millions, except per share amounts)

 

     Three Months Ended March 31,  
     2015     2014  

Net revenues

   $ 4,234.2      $ 2,655.1   
  

 

 

   

 

 

 

Operating expenses:

Cost of sales (excludes amortization and impairment of acquired intangibles including product rights)

  1,713.4      1,293.0   

Research and development

  431.0      171.5   

Selling and marketing

  735.5      283.1   

General and administrative

  693.0      275.8   

Amortization

  925.4      424.2   

Asset sales and impairments, net

  57.8      (0.4
  

 

 

   

 

 

 

Total operating expenses

  4,556.1      2,447.2   
  

 

 

   

 

 

 

Operating (loss) / income

  (321.9   207.9   
  

 

 

   

 

 

 

Interest income

  1.8      1.0   

Interest expense

  (171.9   (72.8

Other (expense) income, net

  (198.0   5.0   
  

 

 

   

 

 

 

Total (expense), net

  (368.1   (66.8
  

 

 

   

 

 

 

(Loss) / income before income taxes and noncontrolling interest

  (690.0   141.1   

(Benefit) / provision for income taxes

  (177.7   44.4   
  

 

 

   

 

 

 

Net (loss) / income

  (512.3   96.7   

Loss / (income) attributable to noncontrolling interest

  0.3      (0.2
  

 

 

   

 

 

 

Net (loss) / income attributable to shareholders

  (512.0   96.5   
  

 

 

   

 

 

 

Dividends on preferred stock

  23.2      —     
  

 

 

   

 

 

 

Net (loss) / income attributable to ordinary shareholders

  (535.2 $ 96.5   
  

 

 

   

 

 

 

(Loss) / earnings per share attributable to ordinary shareholders:

  —     

Basic

$ (1.85 $ 0.56   
  

 

 

   

 

 

 

Diluted

$ (1.85 $ 0.55   
  

 

 

   

 

 

 

Weighted average shares outstanding:

Basic

  289.5      173.8   
  

 

 

   

 

 

 

Diluted

  289.5      174.9   
  

 

 

   

 

 

 

See accompanying Notes to Consolidated Financial Statements.

 

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ACTAVIS PLC

CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) / INCOME

(Unaudited; in millions)

 

     Three Months Ended March 31,  
     2015     2014  

Net (loss) / income

   $ (512.3   $ 96.7   

Other comprehensive (loss) / income

    

Foreign currency translation (losses)

     (313.9     (7.5

Unrealized (losses) / gains, net of tax

     (4.0     0.7   

Reclassification for gains included in net income, net of tax

     —          —     
  

 

 

   

 

 

 

Total other comprehensive (loss), net of tax

  (317.9   (6.8
  

 

 

   

 

 

 

Comprehensive (loss) / income

  (830.2   89.9   

Comprehensive loss / (income) attributable to noncontrolling interest

  0.3      (0.2
  

 

 

   

 

 

 

Comprehensive (loss) / income attributable to ordinary shareholders

$ (829.9 $ 89.7   
  

 

 

   

 

 

 

See accompanying Notes to Consolidated Financial Statements.

 

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ACTAVIS PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited; in millions)

 

     Three Months Ended March 31,  
     2015     2014  

Cash Flows From Operating Activities:

    

Net (loss) / income

   $ (512.3   $ 96.7   
  

 

 

   

 

 

 

Reconciliation to net cash provided by operating activities:

Depreciation

  57.2      55.6   

Amortization

  925.4      424.2   

Provision for inventory reserve

  30.3      38.1   

Share-based compensation

  225.5      16.7   

Deferred income tax benefit

  (304.3   (149.9

Loss / (gain) on asset sales and impairments, net

  57.8      (0.4

Amortization of inventory step up

  212.9      124.6   

Amortization of deferred financing costs

  268.3      11.1   

Accretion and contingent consideration

  28.8      (7.0

Excess tax benefit from stock-based compensation

  (36.1   (36.8

Other, net

  (6.5   (10.9

Changes in assets and liabilities (net of effects of acquisitions):

Decrease / (increase) in accounts receivable, net

  (702.1   (113.6

Decrease / (increase) in inventories

  (202.7   (108.9

Decrease / (increase) in prepaid expenses and other current assets

  58.9      21.8   

Increase / (decrease) in accounts payable and accrued expenses

  356.1      (22.6

Increase / (decrease) in income and other taxes payable

  42.4      113.1   

Increase / (decrease) in other assets and liabilities

  25.4      (12.2
  

 

 

   

 

 

 

Net cash provided by operating activities

  525.0      439.6   
  

 

 

   

 

 

 

Cash Flows From Investing Activities:

Additions to property, plant and equipment

  (136.6   (42.5

Additions to product rights and other intangibles

  (8.5   —     

Additions to investments

  (15.0   —     

Proceeds from the sale of investments and other assets

  790.5      15.0   

Proceeds from sales of property, plant and equipment

  74.9      3.4   

Acquisitions of business, net of cash acquired

  (34,646.2   —     
  

 

 

   

 

 

 

Net cash (used in) investing activities

  (33,940.9   (24.1
  

 

 

   

 

 

 

Cash Flows From Financing Activities:

Proceeds from borrowings of long-term indebtedness

  26,455.6      —     

Proceeds from borrowings on credit facility

  2,810.0      —     

Debt issuance and other financing costs

  (310.8   (20.3

Payments on debt, including capital lease obligations

  (2,660.0   (326.1

Proceeds from issuance of preferred shares

  4,929.7      —     

Proceeds from issuance of ordinary shares

  4,071.1      —     

Proceeds from stock plans

  42.6      6.4   

Payments of contingent consideration

  (24.6   (7.8

Repurchase of ordinary shares

  (64.1   (57.0

Excess tax benefit from stock-based compensation

  36.1      36.8   
  

 

 

   

 

 

 

Net cash provided / (used in) by financing activities

  35,285.6      (368.0
  

 

 

   

 

 

 

Effect of currency exchange rate changes on cash and cash equivalents

  (4.8   (1.9

Movement in cash held for sale

  —        (36.9
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

  1,864.9      8.7   

Cash and cash equivalents at beginning of period

  250.0      329.0   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

$ 2,114.9    $ 337.7   
  

 

 

   

 

 

 
Schedule of Non-Cash Investing Activities

Acquisition of Allergan net assets

$ (34,687.2   —     

Schedule of Non-Cash Financing Activities

Acquisition of Allergan net assets

$ 34,687.2      —     

See accompanying Notes to Consolidated Financial Statements.

 

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WARNER CHILCOTT LIMITED

CONSOLIDATED BALANCE SHEETS

(Unaudited; in millions)

 

     March 31,
2015
    December 31,
2014
 

ASSETS

  

Current assets:

    

Cash and cash equivalents

   $ 2,096.3      $ 244.3   

Marketable securities

     16.0        1.0   

Accounts receivable, net

     3,992.8        2,371.6   

Receivable from Parents

     342.6        269.8   

Inventories

     3,125.1        2,075.5   

Prepaid expenses and other current assets

     1,021.3        730.5   

Current assets held for sale

     143.5        949.2   

Deferred tax assets

     600.8        500.3   
  

 

 

   

 

 

 

Total current assets

  11,338.4      7,142.2   

Property, plant and equipment, net

  2,797.2      1,593.8   

Investments and other assets

  518.3      235.4   

Deferred tax assets

  99.7      107.4   

Product rights and other intangibles

  74,201.1      19,188.4   

Goodwill

  50,826.4      24,521.5   
  

 

 

   

 

 

 

Total assets

$ 139,781.1    $ 52,788.7   
  

 

 

   

 

 

 

LIABILITIES AND EQUITY

Current liabilities:

Accounts payable and accrued expenses

$ 5,785.5    $ 4,167.5   

Payables to Parents

  826.2      521.1   

Income taxes payable

  101.6      50.4   

Current portion of long-term debt and capital leases

  1,624.1      697.4   

Deferred revenue

  27.1      27.0   

Current liabilities held for sale

  17.4      25.9   

Deferred tax liabilities

  65.2      47.3   
  

 

 

   

 

 

 

Total current liabilities

  8,447.1      5,536.6   

Long-term debt and capital leases

  42,700.5      14,846.3   

Deferred revenue

  53.5      38.8   

Other long-term liabilities

  1,218.1      335.9   

Other taxes payable

  984.1      892.2   

Deferred tax liabilities

  15,439.5      3,061.9   
  

 

 

   

 

 

 

Total liabilities

  68,842.8      24,711.7   
  

 

 

   

 

 

 

Commitments and contingencies

Equity:

Member's capital

  73,143.2      29,455.9   

(Accumulated deficit)

  (1,426.3   (917.9

Accumulated other comprehensive (loss)

  (783.3   (465.4
  

 

 

   

 

 

 

Member’s equity

  70,933.6      28,072.6   

Noncontrolling interest

  4.7      4.4   
  

 

 

   

 

 

 

Total equity

  70,938.3      28,077.0   
  

 

 

   

 

 

 

Total liabilities and equity

$ 139,781.1    $ 52,788.7   
  

 

 

   

 

 

 

See accompanying Notes to Consolidated Financial Statements.

 

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Table of Contents

WARNER CHILCOTT LIMITED

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited; in millions)

 

     Three Months Ended
March 31,
 
     2015     2014  

Net revenues

   $  4,234.2      $  2,655.1   
  

 

 

   

 

 

 

Operating expenses:

Cost of sales (excludes amortization and impairment of acquired intangibles including product rights)

  1,713.4      1,293.0   

Research and development

  431.0      171.5   

Selling and marketing

  735.5      283.1   

General and administrative

  689.4      276.4   

Amortization

  925.4      424.2   

Asset sales and impairments, net

  57.8      (0.4
  

 

 

   

 

 

 

Total operating expenses

  4,552.5      2,447.8   
  

 

 

   

 

 

 

Operating (loss) / income

  (318.3   207.3   
  

 

 

   

 

 

 

Non-Operating income (expense):

Interest income

  1.8      1.0   

Interest expense

  (171.9   (72.8

Other income (expense), net

  (198.0   5.0   
  

 

 

   

 

 

 

Total other income (expense), net

  (368.1   (66.8
  

 

 

   

 

 

 

(Loss) / income before income taxes and noncontrolling interest

  (686.4   140.5   

(Benefit) / provision for income taxes

  (177.7   44.4   
  

 

 

   

 

 

 

Net (loss) / income

  (508.7   96.1   

Loss / (income) attributable to noncontrolling interest

  0.3      (0.2
  

 

 

   

 

 

 

Net (loss) / income to member

$ (508.4)    $ 95.9   
  

 

 

   

 

 

 

See accompanying Notes to Consolidated Financial Statements

 

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Table of Contents

WARNER CHILCOTT LIMITED

CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) / INCOME

(Unaudited; in millions)

 

     Three Months Ended March 31,  
     2015     2014  

Net (loss) / income

   $ (508.7   $  96.1   

Other comprehensive (loss) / income

    

Foreign currency translation (losses)

     (313.9     (7.5

Unrealized (losses) / gains, net of tax

     (4.0     0.7   

Reclassification for gains included in net income, net of tax

     —          —     
  

 

 

   

 

 

 

Total other comprehensive (loss), net of tax

  (317.9   (6.8
  

 

 

   

 

 

 

Comprehensive (loss) / income

  (826.6   89.3   

Comprehensive loss / (income) attributable to noncontrolling interest

  0.3      (0.2
  

 

 

   

 

 

 

Comprehensive (loss) / income attributable to member

$ (826.3 $ 89.1   
  

 

 

   

 

 

 

See accompanying Notes to Consolidated Financial Statements

 

9


Table of Contents

WARNER CHILCOTT LIMITED

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited; in millions)

 

     Three Months Ended
March 31,
 
     2015     2014  

Cash Flows From Operating Activities:

    

Net (loss) / income

   $ (508.7   $ 96.1   
  

 

 

   

 

 

 

Reconciliation to net cash provided by operating activities:

Depreciation

  57.2      55.6   

Amortization

  925.4      424.2   

Provision for inventory reserve

  30.3      38.1   

Share-based compensation

  225.5      16.7   

Deferred income tax benefit

  (304.3   (149.9

Loss / (gain) on asset sales and impairments, net

  57.8      —     

Amortization of inventory step up

  212.9      124.6   

Amortization of deferred financing costs

  268.3      11.1   

Accretion and contingent consideration

  28.8      (7.0

Other, net

  (6.5   (11.3

Changes in assets and liabilities (net of effects of acquisitions):

Decrease / (increase) in accounts receivable, net

  (701.4   (113.0

Decrease / (increase) in inventories

  (202.7   (108.9

Decrease / (increase) in prepaid expenses and other current assets

  59.0      20.0   

Increase / (decrease) in accounts payable and accrued expenses

  387.6      (25.6

Increase / (decrease) in income and other taxes payable

  42.4      113.1   

Increase / (decrease) in other assets and liabilities, including receivable / payable with Parents

  (44.9   (128.0
  

 

 

   

 

 

 

Net cash provided by operating activities

  526.7      355.8   
  

 

 

   

 

 

 

Cash Flows From Investing Activities:

Additions to property, plant and equipment

  (136.6   (42.5

Additions to product rights and other intangibles

  (8.5   —     

Proceeds from the sale of investments and other assets

  790.5      15.0   

Additions to investments

  (15.0   —     

Proceeds from sales of property, plant and equipment

  74.9      3.4   

Acquisitions of business, net of cash acquired

  (34,646.2   —     
  

 

 

   

 

 

 

Net cash (used in) investing activities

  (33,940.9   (24.1
  

 

 

   

 

 

 

Cash Flows From Financing Activities:

Proceeds from borrowings of long-term indebtedness

  26,455.6      —     

Proceeds from borrowings on credit facility

  2,810.0      —     

Debt issuance and other financing costs

  (310.8   (20.3

Payments on debt, including capital lease obligations

  (2,660.0   (326.1

Payments of contingent consideration

  (24.6   (7.8

Contribution from Parent

  9,000.8      —     
  

 

 

   

 

 

 

Net cash provided by / (used in) financing activities

  35,271.0      (354.2
  

 

 

   

 

 

 

Effect of currency exchange rate changes on cash and cash equivalents

  (4.8   (2.1

Movement in cash held for sale

  —        37.0   
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

  1,852.0      12.4   

Cash and cash equivalents at beginning of period

  244.3      323.5   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

$ 2,096.3    $ 335.9   
  

 

 

   

 

 

 

See accompanying Notes to Consolidated Financial Statements

 

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ACTAVIS PLC AND WARNER CHILCOTT LIMITED

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

NOTE 1 — General

Actavis plc is a global specialty pharmaceutical company engaged in the development, manufacturing, marketing, and distribution of brand name (“brand”, “branded” or “specialty brand”), medical aesthetics, generic, branded generic, biosimilar and over-the-counter (“OTC”) pharmaceutical products. The Company has operations in more than 100 countries throughout North America (United States of America (“U.S.”), Canada and Puerto Rico) and the rest of world. Warner Chilcott Limited is a wholly owned subsidiary of Actavis plc and it has the same principle business activities. As a result of the Allergan Acquisition (defined below) which closed on March 17, 2015, the Company expanded its franchises to include ophthalmology, neurosciences and medical aesthetics/dermatology/plastic surgery, which complements Actavis’ existing central nervous system, gastroenterology, women’s health and urology franchises. The combined company benefits significantly from Allergan’s global brand equity and consumer awareness of key products, including Botox ® and Restasis ® . The transaction also expands our presence and market and product reach across many international markets, with strengthened commercial positions across Canada, Europe, Southeast Asia and other high-value growth markets, including China, India, the Middle East and Latin America.

The accompanying consolidated financial statements should be read in conjunction with the Company’s annual report on Form 10-K for the year ended December 31, 2014 (“Annual Report”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States generally accepted accounting principles (“GAAP”) have been condensed or omitted from the accompanying consolidated financial statements. The accompanying year end consolidated balance sheet was derived from the audited financial statements included in the Annual Report. The accompanying interim financial statements are unaudited, and reflect all adjustments which are in the opinion of management, necessary for a fair statement of the Companies’ consolidated financial position, results of operations, comprehensive (loss) / income and cash flows for the periods presented. Unless otherwise noted, all such adjustments are of a normal, recurring nature. All intercompany transactions and balances have been eliminated in consolidation. The Companies’ results of operations, comprehensive (loss) / income and cash flows for the interim periods are not necessarily indicative of the results of operations, comprehensive (loss) / income and cash flows that it may achieve in future periods.

References throughout to “we,” “our,” “us,” the “Company” or “Actavis” refer to financial information and transactions of Actavis plc. References to “Warner Chilcott Limited” refer to Warner Chilcott Limited, the Company’s indirect wholly owned subsidiary, and, unless the context otherwise requires, its subsidiaries.

NOTE 2 – Reconciliation of Warner Chilcott Limited results to Actavis plc results

Warner Chilcott Limited is an indirect wholly-owned subsidiary of Actavis plc (Actavis plc and other Warner Chilcott Limited parents, or “Parent”), the ultimate parent of the group. The results of Warner Chilcott Limited are consolidated into the results of Actavis plc. Due to the deminimis activity between Actavis plc and Warner Chilcott Limited, references throughout this filing relate to both Actavis plc and Warner Chilcott Limited. Warner Chilcott Limited representations relate only to itself and not to any other company.

Except where otherwise indicated, and excluding certain insignificant cash and non-cash transactions at the Actavis plc level, these notes relate to the consolidated financial statements for both separate registrants, Actavis plc and Warner Chilcott Limited. In addition to certain inter-company payable and receivable amounts between the entities, the following is a reconciliation of the results of Warner Chilcott Limited to Actavis plc.

 

     March 31, 2015     December 31, 2014  
     Actavis plc     Warner Chilcott
Limited
    Difference     Actavis plc      Warner Chilcott
Limited
     Difference  

Cash and cash equivalents

   $  2,114.9      $  2,096.3      $  18.6      $ 250.0       $ 244.3       $ 5.7   

Accounts receivable, net

     3,992.8        3,992.8        —          2,372.3         2,371.6         0.7   

Prepaid expenses and other current assets

     1,024.1        1,021.3        2.8        733.4         730.5         2.9   

Property, plant and equipment, net

     2,797.9        2,797.2        0.7        1,594.7         1,593.8         0.9   

Deferred tax assets

     99.8        99.7        0.1        107.4         107.4         —     

Accounts payables and accrued liabilities

     5,820.1        5,785.5        34.6        4,170.6         4,167.5         3.1   
     Three months ended March 31, 2015     Three months ended March 31, 2014  
     Actavis plc     Warner Chilcott
Limited
    Difference     Actavis plc      Warner Chilcott
Limited
     Difference  

General and administrative expenses

   $ 693.0      $ 689.4      $ 3.6      $ 275.8       $ 276.4       $ (0.6

Operating (loss) / income

     (321.9     (318.3     (3.6     207.9         207.3         0.6   

(Loss) / income before income taxes and noncontrolling interest

     (690.0     (686.4     (3.6     141.1         140.5         0.6   

Net (loss) / income

     (512.3     (508.7     (3.6     96.7         96.1         0.6   

Dividends on preferred stock

     23.2        —          23.2        —           —           —     

 

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NOTE 3 — Summary of Significant Accounting Policies

The following are interim updates to certain of the policies described in “Note 4” of the notes to the Company’s audited consolidated financial statements for the year ended December 31, 2014 included in the Annual Report.

Revenue Recognition Including Multiple-Element Arrangements

General

Revenue from product sales is recognized when title and risk of loss to the product transfers to the customer, which is based on the transaction shipping terms. Recognition of revenue also requires reasonable assurance of collection of sales proceeds, the seller’s price to the buyer to be fixed or determinable and the completion of all performance obligations. The Company warrants products against defects and for specific quality standards, permitting the return of products under certain circumstances. Product sales are recorded net of all sales-related deductions including, but not limited to: chargebacks, trade discounts, billback adjustments, sales returns and allowances, commercial and government rebates, customer loyalty programs and fee for service arrangements with certain distributors, which we refer to in the aggregate as “SRA” allowances.

Royalty and commission revenue is recognized as a component of net revenues in accordance with the terms of their respective contractual agreements when collectability is reasonably assured and when revenue can be reasonably measured.

Multiple-Element Arrangements

The Company identifies each discrete deliverable included in a multiple-element arrangement and identifies which of those deliverables have standalone value to the customer under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 605-25 “Revenue Recognition — Multiple-Element Arrangements” (“ASC 605-25”) and Accounting Standards Update (“ASU”) 2009-13 “Revenue Recognition — Multiple-Deliverable Revenue” (“ASU No. 2009-13”). The Company allocates arrangement consideration to the deliverables based on the appropriate selling price using the hierarchy outlined in ASC 605-25, as amended by ASU No. 2009-13. The selling price used for each deliverable is based on vendor-specific objective evidence (“VSOE”) if available, third-party evidence (“TPE”) if VSOE is not available, or best estimated selling price (“BESP”) if neither VSOE nor TPE is available. BESP is determined in a manner consistent with that used to establish the price to sell the deliverable on a standalone basis. Revenue is recognized for each unit of accounting based on the relevant authoritative literature for that deliverable.

Provisions for SRAs

As is customary in the pharmaceutical industry, our gross product sales are subject to a variety of deductions in arriving at reported net product sales. When the Company recognizes gross revenue from the sale of products, an estimate of SRA is recorded, which reduces the product revenues. Accounts receivable and/or accrued liabilities are also reduced and/or increased by the SRA amount. These provisions are estimated based on historical payment experience, historical relationship of the deductions to gross product revenues, government regulations, estimated utilization or redemption rates, estimated customer inventory levels and current contract sales terms. The estimation process used to determine our SRA provision has been applied on a consistent basis and no material revenue adjustments have been necessary to increase or decrease our reserves for SRA as a result of a significant change in underlying estimates. The Company uses a variety of methods to assess the adequacy of the SRA reserves to ensure that our financial statements are fairly stated.

 

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Chargebacks — A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid by our wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product. The chargeback provision and related reserve varies with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventories. The provision for chargebacks also takes into account an estimate of the expected wholesaler sell-through levels to indirect customers at certain contract prices. The Company validates the chargeback accrual quarterly through a review of the inventory reports obtained from our largest wholesale customers. This customer inventory information is used to verify the estimated liability for future chargeback claims based on historical chargeback and contract rates. These large wholesalers represent the vast majority of the recipients of the Company’s chargeback payments. We continually monitor current pricing trends and wholesaler inventory levels to ensure the liability for future chargebacks is fairly stated.

Rebates — Rebates include volume related incentives to direct and indirect customers, third-party managed care and Medicare Part D rebates, Medicaid rebates and other government rebates. Rebates are accrued based on an estimate of claims to be paid for product sold into trade by the Company. Volume rebates are generally offered to customers as an incentive to use the Company’s products and to encourage greater product sales. These rebate programs include contracted rebates based on customers’ purchases made during an applicable monthly, quarterly or annual period. The provision for third-party rebates is estimated based on our customers’ contracted rebate programs and the Company’s historical experience of rebates paid. Any significant changes to our customer rebate programs are considered in establishing the provision for rebates. The provisions for government rebates are based, in part, upon historical experience of claims submitted by the various states / authorities, contractual terms and government regulations. We monitor legislative changes to determine what impact such legislation may have on our provision.

Cash Discounts  — Cash discounts are provided to customers that pay within a specific period. The provision for cash discounts is estimated based upon invoice billings and historical customer payment experience. The Company’s experience of payment history is fairly consistent and most customer payments qualify for the cash discount.

Returns and Other Allowances  — The Company’s provision for returns and other allowances include returns, pricing adjustments, promotional allowances, loyalty cards and billback adjustments.

Consistent with industry practice, the Company maintains a returns policy that allows customers to return product for a credit. In accordance with the Company’s policy, credits for customer returns of products are applied against outstanding account activity or are settled in cash. Product exchanges are not permitted. Customer returns of product are generally not resalable. The Company’s estimate of the provision for returns is based upon historical experience and current trends of actual customer returns. Additionally, we consider other factors when estimating the current period returns provision, including levels of inventory in the distribution channel, as well as significant market changes which may impact future expected returns.

Pricing adjustments, which includes shelf stock adjustments, are credits issued to reflect price decreases in selling prices charged to the Company’s direct customers. Shelf stock adjustments are based upon the amount of product our customers have in their inventory at the time of an agreed-upon price reduction. The provision for shelf stock adjustments is based upon specific terms with the Company’s customers and includes estimates of existing customer inventory levels based upon their historical purchasing patterns. We regularly monitor all price changes to evaluate the Company’s reserve balances. The adequacy of these reserves is readily determinable as pricing adjustments and shelf stock adjustments are negotiated and settled on a customer-by-customer basis.

Promotional allowances are credits that are issued in connection with a product launch or as an incentive for customers to carry our product. The Company establishes a reserve for promotional allowances based upon contractual terms.

Billback adjustments are credits that are issued to certain customers who purchase directly from us as well as indirectly through a wholesaler. These credits are issued in the event there is a difference between the customer’s direct and indirect contract price. The provision for billbacks is estimated based upon historical purchasing patterns of qualified customers who purchase product directly from us and supplement their purchases indirectly through our wholesale customers.

Loyalty cards allow the end user patients a discount per prescription and is accrued based on historical experience, contract terms and the volume of product and cards in the distribution channel.

Net revenues and accounts receivable balances in the Company’s consolidated financial statements are presented net of SRA estimates. SRA balances in accounts receivable were $1,506.3 million and $1,660.9 million at March 31, 2015 and December 31, 2014, respectively. SRA balances within accounts payable and accrued expenses were $1,843.8 million and $1,323.4 million at March 31, 2015 and December 31, 2014, respectively. The movements in the SRA reserve balances in the three months ended March 31, 2015 are as follows (in millions):

 

Balance as of December 31, 2014

$ 2,984.3   

Acquired reserves in the Allergan Acquisition (defined below)

  429.5   

Provision to reduce gross product sales to net product sales

  3,190.0   

Payments and other

  (3,253.7
  

 

 

 

Balance as of March 31, 2015

$ 3,350.1   
  

 

 

 

 

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The provisions recorded to reduce gross product sales to net product sales were as follows ($ in millions):

 

     Three Months Ended
March 31,
 
     2015     2014  

Gross product sales

   $ 7,383.5      $ 4,329.0   

Provisions to reduce gross product sales to net product sales

     (3,190.0     (1,732.1
  

 

 

   

 

 

 

Net product sales

$ 4,193.5    $ 2,596.9   
  

 

 

   

 

 

 

Percentage of provisions to gross sales

  43.2   40.0

The movement in the percentage of provisions to gross sales is a result of changes in product mix, competition and channels of distribution. In the three months ended March 31, 2015, the Company increased sales of branded products, which lowered the provision percentage. Offsetting this, was the impact of increased generic competition on some of the Company’s larger generic products which increased the rebates offered, as well as a higher portion of sales going through the wholesale channel, which has the impact of raising the rebate and chargeback percentages.

Warranties

As a result of the Allergan Acquisition, the Company began providing 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 and amounted to $7.5 million and $28.1 million, respectively, as of March 31, 2015. The U.S. programs include the ConfidencePlus ® and ConfidencePlus ® Premier warranty programs. The ConfidencePlus ® program, which is limited to saline breast implants, currently provides lifetime product replacement and contralateral implant replacement. The ConfidencePlus ® Premier program, which is standard for silicone gel implants and requires a low enrollment fee for saline breast implants, generally provides lifetime product replacement, $2,400 of financial assistance for saline breast implants and $3,500 of financial assistance for silicone gel breast implants for surgical procedures within ten years of implantation and contralateral implant replacement. The warranty programs in non-U.S. markets generally 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.

Goodwill and Intangible Assets with Indefinite-Lives

The Company tests goodwill and intangible assets with indefinite-lives for impairment annually in the second quarter by comparing the fair value of each of the Company’s reporting units to the respective carrying value of the reporting units. Additionally, the Company may perform interim tests if an event occurs or circumstances change that could potentially reduce the fair value of a reporting unit below its carrying amount. The carrying value of each reporting unit is determined by assigning the assets and liabilities, including the existing goodwill and intangible assets, to those reporting units.

Goodwill is considered impaired if the carrying amount of the net assets exceeds the fair value of the reporting unit. Impairment, if any, would be recorded in operating income and this could result in a material reduction in net (loss) / income and (loss) / earnings per share.

Acquired in-process research and development (“IPR&D”) intangible assets represent the value assigned to acquired research and development projects that, as of the date acquired, represent the right to develop, use, sell and/or offer for sale a product or other intellectual property that the Company has acquired with respect to products and/or processes that have not been completed or approved. The IPR&D intangible assets are subject to impairment testing until completion or abandonment of each project. Upon abandonment, the assets are impaired. Impairment testing requires the development of significant estimates and assumptions involving the determination of estimated net cash flows for each year for each project or product (including net revenues, cost of sales, research and development (“R&D”) costs, selling and marketing costs and other costs which may be allocated), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, the potential regulatory and commercial success risks, and competitive trends impacting the asset and each cash flow stream as well as other factors. The major risks and uncertainties associated with the timely and successful completion of the IPR&D projects include legal risk and regulatory risk. Changes in these assumptions or

 

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market conditions could result in future impairment charges. No assurances can be given that the underlying assumptions used to prepare the discounted cash flow analysis will not change or the timely completion of each project to commercial success will occur. For these and other reasons, actual results may vary significantly from estimated results.

Upon successful completion of each project and approval of the product, we will make a separate determination of the useful life of the intangible, transfer the amount to currently marketed products (“CMP”) and amortization expense will be recorded over the estimated useful life.

Litigation and Contingencies

The Company is involved in various legal proceedings in the normal course of its business, including product liability litigation, intellectual property litigation, employment litigation and other litigation. Additionally, the Company, in consultation with its counsel, assesses the need to record a liability for contingencies on a case-by-case basis in accordance with ASC Topic 450 “Contingencies” (“ASC 450”). Accruals are recorded when the Company determines that a loss related to a matter is both probable and reasonably estimable. These accruals are adjusted periodically as assessment efforts progress or as additional information becomes available. Acquired contingencies in business combinations are recorded at fair value to the extent determinable, otherwise in accordance ASC 450. Refer to “NOTE 19 — Commitments and Contingencies” for more information.

Earnings Per Share (“EPS”)

The Company accounts for EPS in accordance with ASC Topic 260, “Earnings Per Share” (“ASC 260”) and related guidance, which requires two calculations of EPS to be disclosed: basic and diluted. Basic EPS is computed by dividing net (loss) / income by the weighted average ordinary shares outstanding during a period. Diluted EPS is based on the treasury stock method and includes the effect from potential issuance of ordinary shares, such as shares issuable pursuant to the exercise of stock options and restricted stock units. Diluted EPS also includes the impact of ordinary share equivalents to be issued upon the mandatory conversion of the Company’s preferred shares. Ordinary share equivalents have been excluded where their inclusion would be anti-dilutive.

A reconciliation of the numerators and denominators of basic and diluted EPS consisted of the following (in millions, except per share amounts):

 

     Three Months
Ended
March 31,
2015
     Three Months
Ended
March 31,
2014
 

EPS — basic

     

Net (loss) / income attributable to ordinary shareholders

   $ (535.2    $ 96.5   
  

 

 

    

 

 

 

Basic weighted average ordinary shares outstanding

  289.5      173.8   
  

 

 

    

 

 

 

EPS — basic

$ (1.85 $ 0.56   
  

 

 

    

 

 

 

EPS — diluted

Net (loss) / income attributable to ordinary shareholders

$ (535.2 $ 96.5   
  

 

 

    

 

 

 

Basic weighted average ordinary shares outstanding

  289.5      173.8   

Dilutive impact of stock awards

  —        1.1  
  

 

 

    

 

 

 

Diluted weighted average ordinary shares outstanding

  289.5      174.9   
  

 

 

    

 

 

 

EPS — diluted

$ (1.85 $ 0.55   
  

 

 

    

 

 

 

Stock awards to purchase / acquire 3.5 million ordinary shares during the three months ended March 31, 2015 were outstanding, but not included in the computation of diluted EPS, because the impact of the awards were anti-dilutive. The weighted average impact of ordinary share equivalents of 5.5 million which are anticipated to result from the mandatory conversion of the Company’s preferred shares as of March 31, 2015 were not included in the calculation of diluted EPS as their impact would be anti-dilutive.

There were no anti-dilutive shares for the three months ended March 31, 2014.

 

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Table of Contents

Restructuring Costs

The Company records liabilities for costs associated with exit or disposal activities in the period in which the liability is incurred. In accordance with existing benefit arrangements, employee severance costs are accrued when the restructuring actions are probable and estimable. Costs for one-time termination benefits in which the employee is required to render service until termination in order to receive the benefits are recognized ratably over the future service period. The Company also incurs costs with contract terminations and costs of transferring products as part of restructuring activities. Refer to “NOTE 18 — Business Restructuring Charges” for more information.

Recent Accounting Pronouncements

In April 2015, the FASB issued guidance which changes the classification of debt issuance costs, from being an asset on the balance sheet to netting the costs against the carrying value of the debt. This guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2015. Management believes that the adoption of this guidance will not have a material impact on our financial statements.

NOTE 4 — Acquisitions and Other Agreements

During the three months ended March 31, 2015 and the year ended December 31, 2014, the Company acquired material assets and businesses. The pro forma results of the businesses acquired that materially impacted the reported results of the Company are as follows (unaudited; $ in millions except per share information):

 

     Three Months Ended March 31, 2015  
     As reported      Allergan
Acquisition
     Pro
Forma
 

Net Revenue

   $ 4,234.2       $ 1,523.0       $ 5,757.2   

Net (loss)/income attributable to ordinary shareholders

   $ (535.2    $ 45.7       $ (489.5

(Loss) per share

        

Basic

   $ (1.85       $ (1.25

Diluted

   $ (1.85       $ (1.25

 

     Three Months Ended March 31, 2014  
     As reported      Allergan
Acquisition
     Forest
Acquisition
     Pro Forma  

Net Revenue

   $ 2,655.1       $ 1,643.0       $ 1,150.7       $ 5,448.8   

Net (loss)/income attributable to ordinary shareholders

   $ 96.5       $ (1,020.6    $ (347.7    $ (1,271.8

(Loss) per share

           

Basic

   $ 0.56             $ (3.09

Diluted

   $ 0.55             $ (3.09

Pro forma (loss) per share includes the impact of share issuances as part of the respective acquisitions.

2015 Transactions

The following are the material transactions that were completed in the three months ended March 31, 2015.

Allergan Acquisition

On March 17, 2015, Actavis plc acquired Allergan, Inc. (“Allergan”) for approximately $77.0 billion including outstanding indebtedness assumed of $2.2 billion, cash consideration of $40.1 billion and equity consideration of $34.7 billion, which includes outstanding equity awards (the “Allergan Acquisition”). Under the terms of the agreement, Allergan shareholders received 111.2 million Actavis plc ordinary shares, 7.0 million of Actavis plc non-qualified stock options and 0.5 million Actavis plc share units. The addition of Allergan’s therapeutic franchises in ophthalmology, neurosciences and medical aesthetics/dermatology/plastic surgery will complement Actavis’ existing central nervous system, gastroenterology, women’s health and urology franchises. The combined company will also benefit significantly from Allergan’s global brand equity and consumer awareness of key products, including Botox ® and Restasis ® . The transaction also expands our presence and market and product reach across many international markets, with strengthened commercial positions across Canada, Europe, Southeast Asia and other high-value growth markets, including China, India, the Middle East and Latin America.

 

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The consolidated results of the Company include the impact of the Allergan Acquisition from March 17, 2015, including the following select operating results for the three months ended March 31, 2015 ($ in million):

 

     Three Months Ended
March 31, 2015
 

Net revenues

   $ 258.4   

Cost of sales (excludes amortization and impairment of acquired intangibles including product rights)

     117.0   

Selling and marketing

     149.7   

General and administrative

     407.9   

Operating expenses relating to the Allergan Acquisition include the financing, acquisition accounting valuation-related items, including stock-based compensation and restructuring charges associated with the acquisition.

Assets Acquired and Liabilities Assumed at Fair Value

The transaction has been accounted for using the acquisition method of accounting. This method requires that assets acquired and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date. As of March 31, 2015, certain amounts relating to the valuation of intangible assets, inventory, property, plant and equipment, SRA reserves and tax related matters have not been finalized. The finalization of these matters may result in changes to goodwill. The Company expects to finalize such matters in 2015.

The following table summarizes the preliminary fair values of the assets acquired and liabilities assumed at the acquisition date (in millions):

 

     Amounts  

Cash and cash equivalents

   $ 5,424.5   

Accounts receivable

     962.7   

Inventories

     1,223.2   

Other current assets

     318.8   

Property, plant and equipment, net

     1,202.5   

Other long-term assets

     189.3   

IPR&D intangible assets

     11,010.0   

Intangible assets

     45,050.5   

Goodwill

     26,368.5   

Current liabilities

     (1,212.2

Contingent consideration

     (379.1

Deferred tax liabilities, net

     (12,512.9

Other taxes payable

     (82.4

Other long-term liabilities

     (622.0

Outstanding indebtedness

     (2,183.5
  

 

 

 
$ 74,757.9   
  

 

 

 

Consideration

The total consideration for the Allergan Acquisition of $74.8 billion is comprised of the equity value of shares that were outstanding and vested prior to March 17, 2015 of $33.9 billion, the portion of outstanding equity awards deemed to have been earned as of March 17, 2015 of $0.8 billion and cash of $40.1 billion. The portion of outstanding equity awards deemed not to have been earned of $843.1 million as of March 17, 2015 will be expensed over the remaining future vesting period, including $268.6 million in the three months ended March 31, 2015.

Inventories

        The fair value of inventories acquired included an acquisition accounting fair market value step-up of $928.5 million. In the three months ended March 31, 2015, the Company recognized $71.0 million, as a component of cost of sales as the inventory acquired on March 17, 2015 was sold to the Company’s customers. Included in finished goods and work-in process (“WIP”) inventory as of March 31, 2015, which includes the impact of foreign currency, was $193.4 million and $679.1 million, respectively, relating to the remaining fair value step-up associated with the Allergan Acquisition.

 

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IPR&D and Intangible Assets

IPR&D intangible assets represent the value assigned to acquired R&D projects that, as of the acquisition date, had not established technological feasibility and had no alternative future use. The IPR&D intangible assets are capitalized and accounted for as indefinite-lived intangible assets and will be subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each project and launch of the product, the Company will make a separate determination of the estimated useful life of the IPR&D intangible asset and the related amortization will be recorded as an expense over the estimated useful life (“IPR&D Acquisition Accounting”).

The estimated fair value of the IPR&D and identifiable intangible assets was determined using the “income approach,” which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. Some of the more significant assumptions inherent in the development of those asset valuations include the estimated net cash flows for each year for each asset or product (including net revenues, cost of sales, R&D costs, selling and marketing costs, working capital/asset contributory asset charges and other cash flow assumptions), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, the potential regulatory and commercial success risks, competitive trends impacting the asset and each cash flow stream as well as other factors (the “IPR&D and Intangible Asset Valuation Technique”).

The fair value of the IPR&D intangible assets was determined by the IPR&D and Intangible Asset Valuation Technique. The discount rate used to arrive at the present value at the acquisition date of CMPs was 10.0% and for IPR&D intangible ranged from 10.0% to 11.0% to reflect the internal rate of return and incremental commercial uncertainty in the cash flow projections. No assurances can be given that the underlying assumptions used to prepare the discounted cash flow analysis will not change. For these and other reasons, actual results may vary significantly from estimated results.

The following table identifies the summarized amounts recognized and the weighted average useful lives using the economic benefit of intangible assets:

 

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     Amount recognized as
of the acquisition date
     Weighted average
useful lives (years)
 

Definite lived assets

     

Restasis ®

   $ 3,970.0         4.0   

Refresh ® / Optive ®

     2,720.0         7.6   

Other Eye Care Products

     6,690.0         4.2   

Botox ®

     22,570.0         8.0   

Aczone ®

     160.0         1.3   

Other Skin Products

     820.0         5.0   

Other Aesthetics

     6,370.0         6.0   
  

 

 

    

Total CMP

  43,300.0      6.7   
  

 

 

    

Trade name

  700.0      4.5   

Customer relationships

  1,050.5      3.4   
  

 

 

    

Total definite lived assets

  45,050.5      6.6   
  

 

 

    

In-process research and development

Eye Care

  6,460.0   

Botox ®

  810.0   

Aesthetics

  2,620.0   

Other

  1,120.0   
  

 

 

    
  11,010.0   
  

 

 

    
  

 

 

    

Total Intangible Assets

$ 56,060.5   
  

 

 

    

Goodwill

Among the primary reasons the Company acquired Allergan and factors that contributed to the preliminary recognition of goodwill were to expand the Company’s product portfolio, and to acquire certain benefits from the Allergan pipeline and the expectation of certain synergies. The goodwill recognized from the Allergan Acquisition, which includes the increase in the purchase price resulting from the movement in Actavis plc’s share price from the date of announcing the deal, until the date of acquisition, is not deductible for tax purposes.

Contingent Consideration

Additional consideration is conditionally due upon the achievement of certain milestones in respect to the development and commercialization of the products as well as reaching certain sales targets. The Company estimated the fair value of the contingent consideration to be $379.1 million using a probability weighting approach that considered the possible outcomes based on assumptions related to the timing and probability of the product launch date, discount rates matched to the timing of first payment, and probability of success rates and discount adjustments on the related cash flows.

Retirement Plans

The Company acquired post-retirement plans as part of the Allergan Acquisition including defined benefit pensions in the United States and Europe which had a net liability balance of $305.9 million. As of March 17, 2015, the Allergan pension plans had assets with a fair value of $1,042.0 million, which includes cash and cash equivalents of $13.6 million, equity securities of $480.1 million, and fixed income securities of $548.3 million. In addition, the Company acquired other benefit obligations which had an acquisition date fair value of assets of $117.1 million and an acquisition date fair value of liabilities of $120.0 million.

Deferred Tax Liabilities, net

Deferred tax liabilities, net, include the impact resulting from identifiable intangible assets and inventory fair value adjustments. These adjustments create excess book basis over the tax basis which is multiplied by the statutory tax rate for the jurisdiction in which the deferred taxes exist.

 

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Acquisition-Related Expenses

As a result of the acquisition, the Company incurred the following transaction and integration costs in the three months ended March 31, 2015 ($ in millions):

 

     Three Months Ended
March 31, 2015
 

Cost of sales

  

Stock-based compensation acquired for Allergan employees

   $ 6.9   

Acquisition, integration and restructuring related charges

   $ 14.5   

Research and development

  

Stock-based compensation acquired for Allergan employees

   $ 55.5   

Acquisition, integration and restructuring related charges

   $ 60.6   

Selling and marketing

  

Stock-based compensation acquired for Allergan employees

   $ 23.2   

Acquisition, integration and restructuring related charges

   $ 62.2   

General and administrative

  

Stock-based compensation acquired for Allergan employees

   $ 183.0   

Acquisition related expenditures

   $ 65.5   

Acquisition, integration and restructuring related charges

   $ 130.6   

Other (expense) income

  

Bridge loan facilities expense

   $ (263.0

Interest rate lock

   $ 31.0   
  

 

 

 

Total transaction and integration costs

$ 834.0   
  

 

 

 

Respiratory Business

As part of the Forest Acquisition (defined below), we acquired certain assets that comprised a respiratory business. During the year ended December 31, 2014, we held for sale the respiratory assets of $734.0 million, including allocated goodwill to this unit of $309.1 million. On February 5, 2015, the Company announced the sale of its respiratory business to AstraZeneca plc (“AstraZeneca”) for consideration of $600.0 million upon closing, additional funds to be received for the sale of certain of our inventory to AstraZeneca and low single-digit royalties above a certain revenue threshold. AstraZeneca also paid Actavis an additional $100.0 million, and Actavis has agreed to a number of contractual consents and approvals, including certain amendments to the ongoing collaboration agreements between AstraZeneca and Actavis (the “Respiratory Sale”). The transaction closed on March 2, 2015. As a result of the final terms of the agreement, in the quarter ended March 31, 2015, the Company recognized an incremental charge in cost of sales (including the acquisition accounting fair value mark-up of inventory) relating to inventory that will not be sold to AstraZeneca of $35.3 million. The Company also recognized a gain on the sale of the business of $33.5 million, which is included within other (expense) income.

Pharmatech

As part of the Forest Acquisition, the Company acquired certain manufacturing plants and contract manufacturing agreements within our Aptalis Pharmaceutical Technologies (“Pharmatech”) entities. In accordance with acquisition accounting, the assets were fair valued on July 1, 2014 as assets held in use, including market participant synergies anticipated under the concept of “highest and

 

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best use”. During the fourth quarter of 2014, the decision was made to hold these assets for sale as one complete unit, without integrating the unit and realizing anticipated synergies. During the year ended December 31, 2014, the Company recognized an impairment on assets held for sale of $189.9 million (the “Pharmatech Transaction”) which included a portion of goodwill allocated to this business unit. On April 1, 2015, the Company and TPG, a global private investment firm, completed the majority of the divestiture of the Pharmatech business.

Australia

During the first quarter of 2015, the Company entered into an agreement with Amneal Pharmaceuticals LLC to divest the Australian generics business for upfront consideration of $5.0 million plus future royalties, which closed on May 1, 2015 (the “Australia Transaction”). As a result of the agreement, the Company impaired intangible assets of $36.1 million, miscellaneous assets and goodwill allocated to the business of $2.5 million. The Company held for sale the remaining value of intellectual property and inventory.

Auden Mckenzie

On January 26, 2015, the Company announced that they have reached a definitive agreement, under which Actavis will acquire Auden Mckenzie Holdings Limited (“Auden”) for approximately £306.0 million in cash, plus a two-year royalty on a percentage of gross profits of one of Auden’s products. The acquisition will be accounted for as a business combination and is expected to close in the second quarter of 2015.

2014 Transactions

The following are the material transactions that were completed in the year ended December 31, 2014.

Durata Therapeutics Acquisition

On November 17, 2014, the Company completed its tender offer to purchase all of the outstanding shares of Durata Therapeutics, Inc. (“Durata”), an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses (the “Durata Acquisition”). Actavis purchased all outstanding shares of Durata, which were valued at approximately $724.5 million, including the assumption of debt. Additionally, there is one contingent value right (“CVR”) per share, entitling the holder to receive additional cash payments of up to $5.00 per CVR if certain regulatory or commercial milestones related to Durata’s lead product Dalvance™ are achieved. The CVR had an acquisition date fair value of $49.0 million.

Recognition and Measurement of Assets Acquired and Liabilities Assumed at Fair Value

The Durata Acquisition has been accounted for using the acquisition method of accounting. This method requires that assets acquired and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date. The following table summarizes the fair values of the tangible and identifiable intangible assets acquired and liabilities assumed at the acquisition date (in millions):

 

    
Final Values as
of
March 31,
2015
 

Cash and cash equivalents

   $ 17.8   

Inventory

     21.0   

IPR&D intangible assets

     249.0   

Intangible assets

     480.0   

Goodwill

     75.8   

Other assets and liabilities

     (30.2

Contingent Consideration

     (49.0

Deferred tax liabilities, net

     (39.9

Outstanding indebtedness

     (67.0
  

 

 

 

Net assets acquired

$ 657.5   
  

 

 

 

IPR&D and Intangible Assets

The fair value of the IPR&D and CMP intangible assets was determined using the IPR&D and Intangible Asset Valuation Technique. The discount rate used to arrive at the present value of CMPs was 9.5% and for IPR&D intangible assets was 10.5% to reflect the internal rate of return and incremental commercial uncertainty in the cash flow projections. No assurances can be given that the underlying assumptions used to prepare the discounted cash flow analysis will not change. For these and other reasons, actual results may vary significantly from estimated results.

Contingent Consideration

At the time of the acquisition, additional consideration was conditionally due to the seller based upon the approval of Dalvance TM in Europe, the approval of a single dose indication and the product reaching certain sales milestones. The Company estimated the acquisition accounting fair value of the contingent consideration to be $49.0 million using a probability weighted approach that considered the possible outcomes based on assumptions related to the timing and probability of the product launch date,

 

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discount rates matched to the timing of the payment, and probability of success rates and discount adjustments on the related cash flows. On March 2, 2015, the Company announced that the European Commission has granted Actavis’ subsidiary Durata Therapeutics International B.V., marketing authorization for Xydalba™ (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. The approval triggered the first CVR payment in the quarter ended March 31, 2015 of $30.9 million. The difference between the fair value of the CVR on the date of acquisition of $24.5 million and the payment made of $30.9 million, or $6.4 million, was recorded as an operating expense in the quarter ended March 31, 2015.

Furiex Acquisition

On July 2, 2014, the Company completed an agreement to acquire Furiex Pharmaceuticals, Inc. (“Furiex”) in an all-cash transaction (the “Furiex Acquisition”) valued at $1,156.2 million (including the assumption of debt) and up to approximately $360.0 million in a CVR that may be payable based on the designation of eluxadoline, Furiex’s lead product, as a controlled drug following approval (if any) which had an acquisition accounting fair value of $88.0 million on the date of acquisition (included in the value of $1,156.2 million).

Eluxadoline is a first-in-class, locally-acting mu opioid receptor agonist and delta opioid receptor antagonist for treating symptoms of diarrhea-predominant irritable bowel syndrome (IBS-d), a condition that affects approximately 28 million patients in the United States and Europe. The CVR payment is based on the status of eluxadoline, as a controlled drug following approval, if any, as follows:

 

    If eluxadoline is determined to be a schedule III (C-III) drug, there will be no additional consideration for the CVR.

 

    If eluxadoline is determined to be a schedule IV (C-IV) drug, CVR holders are entitled to $10 in cash for each CVR held.

 

    If eluxadoline is determined to be a schedule V (C-V) drug, CVR holders are entitled to $20 in cash for each CVR held.

 

    If eluxadoline is determined to not be subject to DEA scheduling, CVR holders are entitled to $30 in cash for each CVR held.

In connection with the close of the Furiex Acquisition, the Company further announced that it has closed the transaction related to the sale of Furiex’s royalties on Alogliptin and Priligy ® to Royalty Pharma for $408.6 million in cash consideration.

Contingent Consideration

Additional consideration is conditionally due to the seller based upon the status of eluxadoline as a controlled drug following approval, if any. The Company estimated the acquisition accounting fair value of the contingent consideration to be $88.0 million using a probability weighted approach that considered the possible outcomes based on assumptions related to the timing and probability of the product launch date, discount rates matched to the timing of the payment, and probability of success rates and discount adjustments on the related cash flows. The fair value as of March 31, 2015 is $88.5 million.

Forest Laboratories

On July 1, 2014, the Company acquired Forest Laboratories, Inc. (“Forest”) for $30.9 billion including outstanding indebtedness assumed of $3.3 billion, equity consideration of $20.6 billion, which includes outstanding equity awards, and cash consideration of $7.1 billion (the “Forest Acquisition”). Under the terms of the transaction, Forest shareholders received 89.8 million Actavis plc ordinary shares, 6.1 million Actavis plc non-qualified stock options and 1.1 million Actavis plc share units. Forest was a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. Forest marketed a portfolio of branded drug products and developed new medicines to treat patients suffering from diseases principally in the following therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, anti-infective, and cystic fibrosis.

Assets Acquired and Liabilities Assumed at Fair Value

The transaction has been accounted for using the acquisition method of accounting. This method requires that assets acquired and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date. The following table summarizes the fair values of the assets acquired and liabilities assumed at the acquisition date (in millions):

 

     Final
Values as of
March
31, 2015
 

Cash and cash equivalents

   $ 3,424.2   

Accounts receivable

     496.2   

Inventories

     1,455.8   

Other current assets

     261.2   

Current assets held for sale

     87.1   

Property, plant and equipment, net

     221.1   

Other long-term assets

     84.1   

IPR&D intangible assets

     1,362.0   

 

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Table of Contents
     Final
Values as of
March 31, 2015
 

Intangible assets

     11,515.5   

Goodwill

     16,372.4   

Current liabilities

     (1,322.1

Deferred tax liabilities, net

     (2,296.1

Other taxes payable

     (618.4

Other long-term liabilities

     (120.0

Outstanding indebtedness

     (3,261.9
  

 

 

 
$ 27,661.1   
  

 

 

 

Consideration

The total consideration for the Forest Acquisition of $27.7 billion is comprised of the equity value of shares that were outstanding and vested prior to July 1, 2014 of $20.0 billion, the portion of outstanding equity awards deemed to have been earned as of July 1, 2014 of $568.1 million and cash of $7.1 billion. The portion of outstanding equity awards deemed not to have been earned of $570.4 million as of July 1, 2014 will be expensed over the remaining future vesting period, including $57.9 million in the three months ended March 31, 2015.

Inventories

The fair value of inventories acquired included an acquisition accounting fair market value step-up of $1,036.3 million. In the three months ended March 31, 2015, the Company recognized $136.8 million, as a component of cost of sales as the inventory acquired on July 1, 2014 was sold to the Company’s customers in addition to a write-off associated with the Respiratory Sale. Included in inventory as of March 31, 2015 was $107.8 million, relating to the remaining fair value step-up associated with the Forest Acquisition.

Acquisition-Related Expenses

As a result of the Forest Acquisition, the Company incurred the following transaction and integration costs in the three months ended March 31, 2015 ($ in millions):

 

     Three Months Ended
March 31, 2015
 

Cost of sales

  

Stock-based compensation acquired for Forest employees

   $ 1.2   

Severance related charges

     1.0   

Research and development

  

Stock-based compensation acquired for Forest employees

     16.0   

Severance related charges

     8.8   

Selling and marketing

  

Stock-based compensation acquired for Forest employees

     19.6   

Severance related charges

     16.8   

General and administrative

  

Stock-based compensation acquired for Forest employees

     21.1   

Other integration charges

     1.6   

Severance related charges

     11.4   
  

 

 

 

Total transaction and integration costs

$ 97.5   
  

 

 

 

Western European Divestiture

During the year ended December 31, 2013, we held for sale our then current commercial infrastructure in France, Italy, Spain, Portugal, Belgium, Germany and the Netherlands, including products, marketing authorizations and dossier license rights. On January 17, 2014, we announced our intention to enter into an agreement with Aurobindo Pharma Limited (“Aurobindo”) to sell these businesses. On April 1, 2014, the Company completed the sale of the assets in Western Europe.

2013 Transactions

The following are the material transactions that were completed in the year ended December 31, 2013.

Acquisition of Warner Chilcott

On October 1, 2013, the Company completed the acquisition of Warner Chilcott plc (“Warner Chilcott”) in a stock for stock transaction for a value, including the assumption of debt, of $9.2 billion (the “Warner Chilcott Acquisition”). Warner Chilcott was a leading specialty pharmaceutical company focused on the women’s healthcare, gastroenterology, urology and dermatology segments of the branded pharmaceuticals market, primarily in North America.

 

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Inventories

In the quarters ended March 31, 2015 and 2014, the Company recognized $1.9 million and $124.6 million as a component of cost of sales, respectively, as the inventory acquired on October 1, 2013 was sold to the Company’s customers.

Acquisition-Related Expenses

Included in general and administrative expenses for the quarter ended March 31, 2014 are integration and restructuring charges of $12.4 million, including stock-based compensation of $5.0 million incurred in connection with the Warner Chilcott Acquisition.

NOTE 5 – Assets Held For Sale

The following represents the net assets held for sale ($ in millions):

 

     March 31, 2015      December 31, 2014  

Accounts receivable, net

   $ 15.2       $ 17.7   

Inventories

     42.7         161.5   

Prepaid expenses and other current assets

     70.2         197.5   

Intangible assets

     15.4         453.0   

Goodwill

     —           309.1   

Impairment on the assets held for sale

     —           (189.6
  

 

 

    

 

 

 

Total assets held for sale

$ 143.5    $ 949.2   
  

 

 

    

 

 

 

Accounts payable and accrued expenses

$ 17.4    $ 25.9   
  

 

 

    

 

 

 

Total liabilities held for sale

$ 17.4    $ 25.9   
  

 

 

    

 

 

 

Net assets held for sale

$ 126.1    $ 923.3   
  

 

 

    

 

 

 

As of March 31, 2015, the Company had the followings assets held for sale:

 

    Assets in connection with the Pharmatech Transaction. The assets held for sale are $76.0 million and liabilities held for sale are $17.4 million. The movement from December 31, 2014 is due to revised fair values and currency movements.

 

    Assets in connection with the Australia Transaction, which increased assets held for sale of $30.4 million.

 

    Properties acquired in the Forest Acquisition including the following remaining assets from those held for sale at December 31, 2014:

 

    Commack, Long Island - $12.3 million

 

    St. Louis, Missouri - $3.6 million

 

    Hauppauge, NY - $12.9 million

 

    Facilities in Corona, California of $2.8 million.

 

    A facility in Ontario, Canada of $5.5 million.

As of December 31, 2014, the Company had the followings assets held for sale:

 

    Certain intangible assets and related inventory for products sold under the respiratory therapeutic unit. The book value of the respiratory assets held for sale was $734.0 million as of December 31, 2014, including allocated goodwill to this unit included within North American Brands of $309.1 million. The transaction closed on March 2, 2015.

 

    Assets in connection with the Pharmatech Transaction, which included assets held for sale of $97.2 million and liabilities held for sale of $25.9 million. The majority of this transaction closed on April 1, 2015.

 

    Properties acquired in the Forest Acquisition including:

 

    Commack, Long Island - $46.4 million

 

    St. Louis, Missouri - $20.4 million

 

    Hauppauge, NY - $14.8 million

 

    Facilities in Corona, California of $36.2 million.

 

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Table of Contents

NOTE 6 — Share-Based Compensation

The Company recognizes compensation expense for all share-based compensation awards made to employees and directors based on the fair value of the awards on the date of grant. A summary of the Company’s share-based compensation plans is presented below.

Equity Award Plans

The Company has adopted several equity award plans which authorize the granting of options, restricted shares, restricted stock units and other forms of equity awards of the Company’s ordinary shares, subject to certain conditions.

The Company grants awards with the following features:

 

    Time based vesting restricted stock awards;

 

    Performance based restricted stock awards measured to the EBITDA, as defined, of the Company or other performance based targets defined by the Company;

 

    Performance based restricted stock awards measured to the Total Stockholders Return, compared to pre-defined metrics;

 

    Non-qualified options to purchase outstanding shares; and

 

    Cash settled awards recorded as a liability. These cash settled awards are based on pre-established earnings per share, total shareholder returns, cost savings targets and the value of the Company’s stock.

Option award plans require options to be granted at the fair value of the shares underlying the options at the date of the grant and generally become exercisable over periods ranging from three to five years. Each option granted expires ten years from the date of grant. Restricted stock awards are grants that entitle the holder to ordinary shares, subject to certain terms. Restricted stock unit awards are grants that entitle the holder the right to receive an ordinary share, subject to certain terms. Restricted stock and restricted stock unit awards (both time-based vesting and performance-based vesting) generally have restrictions eliminated over a one to four year vesting period. Restrictions generally lapse for non-employee directors after one year. Certain restricted stock units are performance-based awards issued at a target number with the actual number of restricted shares issued ranging based on achievement of the performance criteria. The Company’s equity award plans include 2015 Acquired Awards from the Allergan Acquisition and 2014 Acquired Awards from the Forest Acquisition.

Fair Value Assumptions

All restricted stock and restricted stock units (whether time-based vesting or performance-based vesting), are granted and expensed, using the fair value per share on the applicable grant date, over the applicable vesting period. Non-qualified options to purchase ordinary shares are granted to employees at exercise prices per share equal to the closing market price per share on the date of grant. The fair value of non-qualified options is determined on the applicable grant dates using the Black-Scholes method of valuation and that amount is recognized as an expense over the vesting period. Using the Black-Scholes valuation model, the fair value of options is based on the following assumptions:

 

     2015
Grants
     2015 Acquired
Awards
     2014
Grants
     2014 Acquired
Awards
 

Dividend yield

     0%         0%         0%         0%   

Expected volatility

     26.0 - 29.0%         26.0%         29.0%         28.0%   

Risk-free interest rate

     1.9%         0.1 – 1.9%         1.9 – 2.2%         0 - 2.1%   

Expected term (years)

     7.0 – 7.5         up to 6.9         7.5         up to 6.4   

 

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Share-Based Compensation Expense

Share-based compensation expense recognized in the Company’s results of operations for the quarters ended March 31, 2015 and 2014 were as follows ($ in millions):

 

     Three Months
Ended

March 31,
2015
     Three Months
Ended

March 31,
2014
 

Equity based compensation awards

   $ 225.5       $ 16.7   

Cash-settled equity awards in connection with the Allergan Acquisition

     127.1         —     

Non equity-settled awards other

     —           —     
  

 

 

    

 

 

 

Total stock-based compensation expense

$ 352.6    $ 16.7   
  

 

 

    

 

 

 

Included in the equity based compensation awards for the three months ended March 31, 2015 is the impact of accelerations and step-ups relating to the acquisition accounting treatment of outstanding awards acquired in the Allergan and Forest acquisitions of $119.7 million and $44.9 million, respectively.

Unrecognized future stock-based compensation expense was $1,019.1 million as of March 31, 2015, including $574.5 million from the Allergan Acquisition and $202.8 million from the Forest Acquisition. This amount will be recognized as an expense over a remaining weighted average period of 2.1 years. Stock-based compensation is being amortized and charged to operations over the same period as the restrictions are eliminated for the participants, which is generally on a straight-line basis.

Share Activity

The following is a summary of equity award activity for unvested restricted stock and stock units in the period from December 31, 2014 through March 31, 2015:

 

(in millions, except per share data)    Shares      Weighted
Average
Grant Date
Fair Value
     Weighted
Average
Remaining
Contractual
Term (Years)
     Aggregate
Grant Date
Fair Value
 

Restricted shares / units outstanding at December 31, 2014

     2.1       $ 148.79         1.3       $ 312.5   

Granted

     0.4         325.74            130.3   

Vested

     (0.5      (116.03         (58.0

Assumed as part of the Allergan Acquisition **

     0.5         218.47            102.8   

Forfeited

     —           (115.18         (4.4
  

 

 

    

 

 

    

 

 

    

 

 

 

Restricted shares / units outstanding at March 31, 2015

  2.5    $ 193.36      2.6    $ 483.2   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

** Assumed as part of the Allergan Acquisition for the pro rata portion representing future compensation as of March 17, 2015.

The following is a summary of equity award activity for non-qualified options to purchase ordinary shares in the period from December 31, 2014 through March 31, 2015:

 

(in millions, except per share data)    Options      Weighted
Average
Exercise
Price
     Weighted
Average
Remaining
Contractual
Term (Years)
     Aggregate
Intrinsic
Value
 

Outstanding, December 31, 2014

     5.4       $ 93.96         7.3       $ 858.9   

Granted

     0.2         300.79         

Exercised

     (0.5      (81.82      

Assumed as part of the Allergan Acquisition**

     7.0         103.63         

Cancelled

     (0.3      (108.82      
  

 

 

    

 

 

    

 

 

    

 

 

 

Outstanding, March 31, 2015

  11.8    $ 106.23      7.2    $ 2,257.8   
  

 

 

    

 

 

    

 

 

    

 

 

 

Vested and expected to vest at March 31, 2015

  11.3    $ 105.86      7.2    $ 2,170.8   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

** Assumed as part of the Allergan Acquisition for the pro rata portion representing future compensation as of March 17, 2015.

 

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In addition to the awards discussed above, the Company also grants deminimis awards to be settled in cash due to local statutory requirements.

NOTE 7 — Reportable Segments

As of and for the three months ended March 31, 2015, the Company organized its business into three operating segments: North American Brands, North American Generics and International and Anda Distribution. The North American Brands segment includes patent-protected and off-patent products that the Company sells and markets as brand pharmaceutical products within North America. The North American Generics and International segment includes certain trademarked off-patent products that the Company sells and markets as off-patent pharmaceutical products that are therapeutically equivalent to proprietary products and over-the counter products within North America. Also included in this segment are international revenues which include patent-protected and off-patent products that the Company sells and markets as brand pharmaceutical products, certain trademarked off-patent products that the Company sells and markets as off-patent pharmaceutical products that are therapeutically equivalent to proprietary products, over the counter products and revenues from our third-party Medis business. The Anda Distribution segment distributes generic and brand pharmaceutical products manufactured by third parties, as well as by the Company, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians’ offices. The Anda Distribution segment operating results exclude sales of products developed, acquired, or licensed by the North American Brands and North American Generics and International segments.

In addition to the segments above, in connection with the Allergan Acquisition, the Company managed the acquired Allergan business as a separate segment from March 17, 2015 through March 31, 2015. The Company is considering revising its segment structure in future periods.

The Company evaluates segment performance based on segment contribution. Segment contribution represents segment net revenues less cost of sales (excluding amortization and impairment of acquired intangibles including product rights), selling and marketing expenses and general and administrative expenses. The Company does not evaluate total assets, capital expenditures, R&D expenses, amortization and asset sales and impairments, net by segment as not all such information has been accounted for at the segment level, or such information has not been used by all segments.

Segment net revenues, segment operating expenses and segment contribution information for the Company’s segments consisted of the following for the three months ended March 31, 2015 and 2014 ($ in millions):

 

    Three Months Ended March 31, 2015     Three Months Ended March 31, 2014  
    North America     North America Generics     Anda                 North America     North America Generics     Anda        
    Brands     and International     Distribution     Allergan     Total     Brands     and International     Distribution     Total  

Product sales

  $ 1,720.3      $ 1,756.4      $ 461.6      $ 255.2      $ 4,193.5      $ 572.0      $ 1,634.7      $ 390.2      $ 2,596.9   

Other revenue

    15.7        21.8        —          3.2        40.7        22.0        36.2        —          58.2   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net revenues

    1,736.0        1,778.2        461.6        258.4        4,234.2        594.0        1,670.9        390.2        2,655.1   

Operating expenses:

                 

Cost of sales (1)

    372.0        826.8        404.0        110.6        1,713.4        185.5        776.3        331.2        1,293.0   

Selling and marketing

    411.1        174.5        31.4        118.5        735.5        87.6        170.0        25.5        283.1   

General and administrative

    281.8        118.1        9.1        284.0        693.0        71.5        195.0        9.3        275.8   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Contribution

  $ 671.1      $ 658.8      $ 17.1      $ (254.7   $ 1,092.3      $ 249.4      $ 529.6      $ 24.2      $ 803.2   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Contribution margin

    38.7     37.0     3.7     (98.6 )%      25.8     42.0     31.7     6.2     30.3
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Research and development

            431.0              171.5   

Amortization

            925.4              424.2   

Asset sales and impairments, net

            57.8              (0.4
         

 

 

         

 

 

 

Operating (loss) income

          $ (321.9         $ 207.9   
         

 

 

         

 

 

 

Operating margin

            (7.6 )%            7.8

 

(1) Excludes amortization and impairment of acquired intangibles including product rights.

 

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The following table presents net revenues for the reporting units in the North American Brands segment for the three months ended March 31, 2015 and 2014 (in millions):

 

     Three Months Ended
March 31
 
     2015      2014  

North American Brands

     

CNS

     

Namenda ® IR

   $ 245.4       $ —     

Namenda XR ®

     150.6         —     

Viibyrd ® / Fetzima ®

     79.6         —     

Saphris ®

     42.0         —     

Other CNS

     24.0         —     
  

 

 

    

 

 

 

Total CNS

  541.6      —     

Gastroenterology

Delzicol ® /Asacol ® HD

  136.2      140.8   

Linzess ® /Constella ™

  96.2      —     

Carafate ® / Sulcrate ®

  54.3      —     

Canasa ® / Salofalk ®

  37.3      —     

Zenpep ® , Ultrase ® & Viokace ®

  40.2      —     

Other Gastroenterology

  12.4      —     
  

 

 

    

 

 

 

Total Gastroenterology

  376.6      140.8   

Women’s Health

Lo Loestrin ® Fe

  83.3      62.4   

Minastrin ® 24 Fe

  65.4      47.9   

Estrace ® Cream

  71.9      53.3   

Other Women’s Health

  46.9      49.0   
  

 

 

    

 

 

 

Total Women’s Health

  267.5      212.6   

Cardiovascular, Respiratory & Acute Care

Bystolic ®

  164.1      —     

Daliresp ® (1)

  23.6      —     

Tudorza ® (1)

  28.2      —     
  

 

 

    

 

 

 

Total Cardiovascular, Respiratory & Acute Care

  215.9      —     

Urology

  68.3      72.1   

Infectious Disease

  37.8      —     

Dermatology/Established Brands

  228.3      168.5   
  

 

 

    

 

 

 

Total North American Brands

$ 1,736.0    $ 594.0   
  

 

 

    

 

 

 

 

(1)   Products were divested March 2, 2015 as part of the Respiratory Sale.

North American Brands revenues are classified based on the current mix of promoted products within the respective categories. Movement of products between categories may occur from time to time based on changes in promotional activities.

Net revenues in our North American Generics and International segment consisted of the following for the three months ended March 31, 2015 and 2014 (in millions):

 

     Three Months Ended
March 31,
 
     2015      2014  

North American Generics

   $ 1,220.2       $ 1,024.2   

International

     558.0         646.7   
  

 

 

    

 

 

 

Net revenues

$ 1,778.2    $ 1,670.9   
  

 

 

    

 

 

 

 

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NOTE 8 — Inventories

Inventories consist of finished goods held for sale and distribution, raw materials and work-in-process. Inventories are stated at the lower of cost (first-in, first-out method) or market (net realizable value). The Company writes down inventories to net realizable value based on forecasted demand, market conditions or other factors, which may differ from actual results.

Inventories consisted of the following (in millions):

 

     March 31,
2015
     December 31,
2014
 

Raw materials

   $ 688.5       $ 625.3   

Work-in-process

     442.4         205.3   

Finished goods

     2,187.2         1,421.6   
  

 

 

    

 

 

 
  3,318.1      2,252.2   

Less: inventory reserves

  193.0      176.7   
  

 

 

    

 

 

 

Inventories

$ 3,125.1    $ 2,075.5   
  

 

 

    

 

 

 

Included in inventory as of March 31, 2015 was the following amounts related to the fair-value step-up of acquired inventory ($ in millions):

 

     Allergan
Acquisition
     Forest
Acquisition
     Durata
Acquisition
     Total  

Work-in-process

   $ 193.4       $ —         $ —         $     193.4   

Finished goods

     679.1         107.8         13.4         800.3   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

$ 872.5    $ 107.8    $ 13.4    $ 993.7   
  

 

 

    

 

 

    

 

 

    

 

 

 

Included in inventory as of December 31, 2014 was the following amounts related to the fair-value step-up of acquired inventory ($ in millions):

 

     Forest
Acquisition
     Durata
Acquisition
     Warner
Chilcott
Acquisition
     Total  

Work-in-process

   $  —         $  —         $  —         $  —     

Finished goods

     285.3        16.3        1.9        303.5  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

$ 285.3    $ 16.3    $ 1.9    $     303.5   
  

 

 

    

 

 

    

 

 

    

 

 

 

NOTE 9 — Investments and Other Assets

Investments in marketable securities, other investments and other assets consisted of the following (in millions):

 

     March 31,
2015
     December 31,
2014
 

Marketable securities:

     

U.S. Treasury and agency securities — maturing within one year

   $ 16.0       $ 1.0   
  

 

 

    

 

 

 

Total marketable securities

$ 16.0    $ 1.0   
  

 

 

    

 

 

 

Investments and other assets:

Equity method investments

$ 24.5    $ 9.8   

Cost method and other long-term investments

  101.2      54.8   

Deferred executive compensation investments

  117.1      —     

 

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Table of Contents
     March 31,
2015
     December 31,
2014
 

Taxes receivable

     21.1         57.7   

Deferred loan costs

     188.0         58.9   

Other assets

     66.4         54.2   
  

 

 

    

 

 

 

Total investments and other assets

$ 518.3    $ 235.4   
  

 

 

    

 

 

 

The Company’s marketable securities and other long-term investments are classified as available-for-sale and are recorded at fair value based on quoted market prices using the specific identification method. These investments are classified as either current or non-current, as appropriate, in the Company’s consolidated balance sheets.

NOTE 10 — Accounts payable and accrued expenses

Accounts payable and accrued expenses consisted of the following (in millions):

 

     March 31,
2015
     December 31,
2014
 

Accrued expenses:

     

Accrued third-party rebates

   $ 1,659.0       $ 1,200.8   

Accrued payroll and related benefits

     488.1         387.2   

Litigation-related reserves and legal fees

     401.4         415.3   

Accrued severance, retention and other shutdown costs

     366.7         125.1   

Current portion of contingent consideration obligations

     317.8         237.8   

Royalties and sales agent payables

     274.4         212.4   

Accrued pharmaceutical fees

     203.8         132.7   

Interest payable

     202.3         82.7   

Accrued indirect returns

     184.9         122.6   

Accrued non-provision taxes

     169.8         19.4   

Accrued R&D expenditures

     155.0         179.4   

Accrued selling and marketing expenditures

     112.9         24.2   

Accrued professional fees

     39.3         44.1   

Manufacturing related

     31.5         11.2   

Dividends payable

     23.4         —     

Accrued warranties

     7.5         —     

Accrued co-promotion liabilities

     5.7         7.5   

Other accrued expenses

     406.3         323.6   
  

 

 

    

 

 

 

Total accrued expenses

$ 5,049.8    $ 3,526.0   
  

 

 

    

 

 

 

Total accounts payable

  770.3      644.6   
  

 

 

    

 

 

 

Total accounts payable and accrued expenses

$ 5,820.1    $ 4,170.6   
  

 

 

    

 

 

 

 

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Table of Contents

NOTE 11 — Goodwill, Product Rights and Other Intangible Assets

Goodwill for the Company’s reporting segments consisted of the following (in millions):

 

     North American
Brands
    North American
Generics and
International
    Anda Distribution      Allergan      Total  

Balance at December 31, 2014

   $ 20,717.9      $ 3,717.3      $ 86.3       $ —         $ 24,521.5   

Additions through acquisitions

     —          —          —          26,368.5         26,368.5   

Measurement period adjustments and other

     (8.7     —          —           —           (8.7

Impairments

     —          (2.5     —           —           (2.5

Foreign exchange and other adjustments

     9.1        (61.5     —           —           (52.4
  

 

 

   

 

 

   

 

 

    

 

 

    

 

 

 

Balance at March 31, 2015

$ 20,718.3    $ 3,653.3    $ 86.3    $ 26,368.5    $ 50,826.4   
  

 

 

   

 

 

   

 

 

    

 

 

    

 

 

 

As of March 31, 2015 and December 31, 2014, the gross balance of goodwill was $51,493.7 million and $25,186.3 million, respectively.

During the three months ended March 31, 2015, there was an increase in goodwill of $26,368.5 million resulting from the Allergan Acquisition, a measurement period adjustment increasing goodwill of $4.2 million resulting from the Durata Acquisition, offset by a measurement period adjustment decreasing goodwill by $(12.9) million resulting from the Forest Acquisition.

Product rights and other intangible assets consisted of the following ($ in millions):

 

Cost basis

   Balance as of
December 31,
2014
    Acquisitions     Impairments     Held for Sale /
Disposals/
Other
    Foreign
Currency
Translation
    Balance as
of
March 31,
2015
 

Intangibles with definite lives:

            

Product rights and other related intangibles

   $ 20,034.9      $ 44,359.0      $  —        $ 538.9      $ (81.0   $ 64,851.8   

Trade Name

     411.2        700.0        —         (4.2     (40.2     1,066.8   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total definite-lived intangible assets

$ 20,446.1    $ 45,059.0    $  —      $ 534.7    $ (121.2 $ 65,918.6   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Intangibles with indefinite lives:

IPR&D

$ 4,300.5    $ 11,010.0    $ (3.7 ) $ (1,041.9 $ (26.8 $ 14,238.1   

Trade Name

  76.2      —        —        —        —        76.2   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total indefinite-lived intangible assets

$ 4,376.7    $ 11,010.0    $ (3.7 $ (1,041.9 $ (26.8 $ 14,314.3   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total product rights and related intangibles

$ 24,822.8    $ 56,069.0    $ (3.7 $ (507.2 $ (148.0 $ 80,232.9   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Accumulated Amortization

   Balance as of
December 31,
2014
    Amortization     Impairments     Disposals/
Other
    CTA     Balance as
of
March 31,
2015
 

Intangibles with definite lives:

            

Product rights and other related intangibles

   $ (5,595.9   $ (917.9   $ (33.4   $ 448.8      $ 110.5      $ (5,987.9

Trade Name

     (38.5     (7.5     (2.7     4.2        0.6        (43.9
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total definite-lived intangible assets

$ (5,634.4 $ (925.4 $ (36.1 $ 453.0    $ 111.1    $ (6,031.8
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total product rights and related intangibles

$ (5,634.4 $ (925.4 $ (36.1 $ 453.0    $ 111.1    $ (6,031.8
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net Product Rights and Other Intangibles

$ 19,188.4    $ 74,201.1   
  

 

 

           

 

 

 

The following items had a significant impact on net product rights and other intangibles in the three months ended March 31, 2015:

 

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    On March 17, 2015, the Company acquired intangibles assets in connection with the Allergan Acquisition of $56,060.5 million.

 

    In the quarter ended March 31, 2015, the Company divested Doryx resulting in a reduction of intangible assets of approximately $46.6 million.

 

    In the quarter ended March 31, 2015, the Company evaluated its product portfolio as part of the integration of Allergan. As a result of this review, the Company is no longer promoting certain products in Australia, resulting in an impairment charge of $36.1 million in the quarter ended March 31, 2015. Additionally, the Company held for sale the remaining assets of $15.4 million related to the Australian business.

Assuming no additions, disposals or adjustments are made to the carrying values and/or useful lives of the intangible assets, annual amortization expense on product rights and other related intangibles as of March 31, 2015 over the remainder of 2015 and each of the next five years is estimated to be as follows ($ in millions):

 

     Amount  

2015 remaining

   $ 4,921.6   

2016

   $ 6,421.9   

2017

   $ 6,369.0   

2018

   $ 5,829.8   

2019

   $ 5,690.1   

2020

   $ 5,324.9   

The above amortization expense is an estimate. Actual amounts may change from such estimated amounts due to fluctuations in foreign currency exchange rates, additional intangible asset acquisitions, finalization of preliminary fair value estimates, potential impairments, accelerated amortization or other events.

 

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Table of Contents

NOTE 12 —   Long-Term Debt and Capital Leases

Total debt and capital leases consisted of the following ($ in millions):

 

     Balance As of     Fair Market Value As of  
     March 31,
2015
    December 31,
2014
    March 31,
2015
     December 31,
2014
 

Senior Notes:

         

Floating Rate Notes

         

$500.0 million floating rate notes due September 1, 2016

   $ 500.0      $ —        $ 501.0       $ —     

$500.0 million floating rate notes due March 12, 2018

     500.0        —          503.9         —     

$500.0 million floating rate notes due March 12, 2020

     500.0        —          508.2         —     
  

 

 

   

 

 

   

 

 

    

 

 

 
     1,500.0        —          1,513.1         —     
  

 

 

   

 

 

   

 

 

    

 

 

 

Fixed Rate Notes

         

$800.0 million 5.750% notes due April 1, 2016

     800.0        —          836.9         —     

$1,000.0 million 1.850% notes due March 1, 2017

     1,000.0        —          1,007.7         —     

$500.0 million 1.300% notes due June 15, 2017

     500.0        500.0        497.0         489.0   

$1,200.0 million 1.875% notes due October 1, 2017

     1,200.0        1,200.0        1,201.0         1,187.3   

$3,000.0 million 2.350% notes due March 12, 2018

     3,000.0        —          3,039.9         —     

$250.0 million 1.350%% notes due March 15, 2018

     250.0        —          247.3         —     

$1,050.0 million 4.375% notes due February 1, 2019

     1,050.0        1,050.0        1,125.3         1,111.4   

$500.0 million 2.450% notes due June 15, 2019

     500.0        500.0        499.8         498.2   

$400.0 million 6.125% notes due August 15, 2019

     400.0        400.0        459.6         457.9   

$3,500.0 million 3.000% notes due March 12, 2020

     3,500.0        —          3,584.4         —     

$650.0 million 3.375% notes due September 15, 2020

     650.0        —          674.1         —     

$750.0 million 4.875% notes due February 15, 2021

     750.0        750.0        824.6         808.9   

$1,200.0 million 5.000% notes due December 15, 2021

     1,200.0        1,200.0        1,328.6         1,301.0   

$3,000.0 million 3.450% notes due March 15, 2022

     3,000.0        —          3,069.3         —     

$1,700.0 million 3.250% notes due October 1, 2022

     1,700.0        1,700.0        1,704.6         1,647.5   

$350.0 million 2.800% notes due March 15, 2023

     350.0        —          332.2         —     

$1,200.0 million 3.850% notes due June 15, 2024

     1,200.0        1,200.0        1,238.9         1,215.5   

$4,000.0 million 3.800% notes due March 15, 2025

     4,000.0        —          4,122.0         —     

$2,500.0 million 4.550% notes due March 15, 2035

     2,500.0        —          2,613.0         —     

$1,000.0 million 4.625% notes due October 1, 2042

     1,000.0        1,000.0        1,028.6         980.1   

$1,500.0 million 4.850% notes due June 15, 2044

     1,500.0        1,500.0        1,608.3         1,539.9   

$2,500.0 million 4.750% notes due March 15, 2045

     2,500.0        —          2,646.5         —     
  

 

 

   

 

 

   

 

 

    

 

 

 
     32,550.0        11,000.0        33,689.6         11,236.7   
  

 

 

   

 

 

   

 

 

    

 

 

 

Total Senior Notes Gross

     34,050.0        11,000.0        35,202.7         11,236.7   
  

 

 

   

 

 

   

 

 

    

 

 

 

Unamortized premium

     286.6        239.9        —           —     

Unamortized discount

     (116.0     (52.1     —           —     
  

 

 

   

 

 

   

 

 

    

 

 

 

Total Senior Notes Net

     34,220.6        11,187.8        35,202.7         11,236.7   
  

 

 

   

 

 

   

 

 

    

 

 

 

Term Loan Indebtedness:

         

WC Term Loan

         

WC Three Year Tranche variable rate debt maturing October 1, 2016

     306.9        506.9        

WC Five Year Trance variable rate debt maturing October 1, 2018**

     622.1        744.7        
  

 

 

   

 

 

      
     929.0        1,251.6        
  

 

 

   

 

 

      

ACT Term Loan

         

2017 Term Loan variable rate debt maturing October 31, 2017**

     903.4        932.6        

2019 Term Loan variable rate debt maturing July 1, 2019**

     1,850.0        1,900.0        
  

 

 

   

 

 

      
     2,753.4        2,832.6        
  

 

 

   

 

 

      

AGN Term Loan

         

AGN Three Year Tranche variable rate debt maturing March 17, 2018

     2,750.0        —          

AGN Five Year Tranche variable rate debt maturing March 17, 2020**

     2,750.0        —          
  

 

 

   

 

 

      
     5,500.0        —          
  

 

 

   

 

 

      

Total Term Loan Indebtedness

     9,182.4        4,084.2        
  

 

 

   

 

 

      

Other Indebtedness

         

Bridge Loan Facility

     810.0        —          

Revolver borrowings

     —          255.0        

Other

     98.4        —          
  

 

 

   

 

 

      

Total Other Borrowings

     908.4        255.0        
  

 

 

   

 

 

      

Capital Leases

     13.2        16.7        
  

 

 

   

 

 

      

Total Indebtedness

   $ 44,324.6      $ 15,543.7        
  

 

 

   

 

 

      

 

** The indebtedness requires a quarterly repayment of 2.5%.

 

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Table of Contents

Fair market value in the table above is determined in accordance with ASC Topic 820 “Fair Value Measurement” (“ASC 820”) under Level 2 based upon quoted prices for similar items in active markets. The book value of the outstanding term loan indebtedness approximates fair value as the debt is at variable interest rates and re-prices frequently.

Unless otherwise indicated, the remaining loan balances after the quarterly required payments are due upon maturity.

Floating Rate Notes

On March 4, 2015, Actavis Funding SCS, a limited partnership (société en commandite simple) organized under the laws of the Grand Duchy of Luxembourg and an indirect wholly-owned subsidiary of Actavis plc, issued floating rate notes due 2016 (the “2016 Floating Rate Notes”), floating rate notes due 2018 (the “2018 Floating Rate Notes”), floating rate notes due 2020 (the “2020 Floating Rate Notes”), 1.850% notes due 2017 (the “1.850% 2017 Notes”), 2.350% notes due 2018 (the “2.350% 2018 Notes”), 3.000% notes due 2020 (the “3.000% 2020 Notes”), 3.450% notes due 2022 (the “3.450% 2022 Notes”), 3.800% notes due 2025 (the “3.800% 2025 Notes”), 4.550% notes due 2035 (the “4.550% 2035 Notes”) and 4.750% notes due 2045 (the “4.750% 2045 Notes”). The notes will be fully and unconditionally guaranteed by Actavis Funding SCS’s indirect parents, Warner Chilcott Limited and Actavis Capital S.a.r.l. (“Actavis Capital”), and by Actavis, Inc., a subsidiary of Actavis Capital, on an unsecured and unsubordinated basis. Actavis plc has not guaranteed the notes.

The 2016 Floating Rate Notes, the 2018 Floating Rate Notes and the 2020 Floating Rate Notes will bear interest at a floating rate equal to three-month LIBOR plus 0.875%, 1.080% and 1.255% per annum, respectively. Interest on the 2016 Floating Rate Notes will be payable quarterly on March 1, June 1, September 1 and December 1 of each year, beginning on June 1, 2015. Interest on the 2018 Floating Rate Notes and the 2020 Floating Rate Notes will be payable quarterly on March 12, June 12, September 12 and December 12 of each year, beginning on June 12, 2015.

Fixed Rate Notes

The Company has issued fixed rate notes over multiple issuances for various business needs. Interest on the various notes is generally payable semi-annually with various payment dates.

The following represents the activity to the fixed rate notes during the three months ended March 31, 2015:

 

    Actavis Funding SCS issued the 1.850% 2017 Notes, the 2.350% 2018 Notes, the 3.000% 2020 Notes, the 3.450% 2022 Notes, the 3.800% 2025 Notes, the 4.550% 2035 Notes and the 4.750% 2045 Notes; and

 

    On May 7, 2015, Actavis Funding SCS and Wells Fargo entered into a second supplemental indenture amending the indenture dated as of March 12, 2015 between Actavis Funding SCS and Warner Chilcott Limited, Actavis Capital S.à r.l., and Actavis, Inc., as guarantors (collectively, the “Guarantors”), and Wells Fargo as supplemented and amended by the first supplemental indenture dated as of March 12, 2015 between Actavis Funding SCS, the Guarantors and Wells Fargo (the “Indenture”). The second supplemental indenture amends certain inconsistencies in the terms of the notes offered under the Indenture.

 

    On March 17, 2015 in connection with the Allergan Acquisition, the Company acquired, and subsequently guaranteed, along with Warner Chilcott Limited, the indebtedness of Allergan comprised of the $350.0 million 2.800% senior notes due 2023, the $650.0 million 3.375% senior notes due 2020, the $250.0 million 1.350% senior notes due 2018 and the $800.0 million 5.750% senior notes due 2016. Interest payments are due on the $350.0 million senior notes semi-annually on the principal amount of the notes at a rate of 2.80% 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 at the time of the redemption, if the redemption occurs prior to December 15, 2022 (three months prior to the maturity of the 2023 senior notes). If the redemption occurs on or after December 15, 2022, then such redemption is not subject to the make-whole provision. Interest payments are due on the $650.0 million senior notes semi-annually on the principal amount of the notes at a rate of 3.375% 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 at the time of the redemption. Interest payments are due on the $250.0 million senior notes semi-annually on the principal amount of the notes at a rate of 1.350% 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 at the time of the redemption. Interest payments are due on the $800.0 million senior notes semi-annually on the principal amount of the notes at a rate of 5.750% 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 at the time of the redemption. The fair value of the acquired senior notes was determined to be $2,087.5 million as of March 17, 2015. As such, as part of acquisition accounting, the company recorded a premium of $37.5 million to be amortized as contra interest over the life of the notes.

Term Loan Indebtedness

WC Term Loan

On December 17, 2014, Actavis plc and certain of its subsidiaries entered into a second amendment agreement (the “WC Term Loan Amendment”) among Actavis plc, Warner Chilcott Limited, Warner Chilcott Finance, LLC, Actavis WC 2 S.à r.l. (“Actavis WC 2”), Warner Chilcott Company, LLC (“WCCL”), Warner Chilcott Corporation (“WC Corporation” and together with Actavis WC 2 and WCCL, the “WC Borrowers”), Bank of America, N.A. (“BofA”), as administrative agent, and the lenders party thereto. The WC Term Loan Amendment amends and restates Actavis plc’s existing amended and restated WC term loan credit and guaranty

 

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agreement, dated as of June 9, 2014 (such agreement, prior to its amendment and restatement pursuant to the WC Term Loan Amendment, the “2014 WC Term Loan”), among the WC Borrowers, Actavis plc, Warner Chilcott Limited, Warner Chilcott Finance, LLC, the lenders from time to time party thereto and BofA, as administrative agent, which amended and restated Actavis plc’s existing WC term loan credit and guaranty agreement, dated as of August 1, 2013 (such agreement, prior to its amendment and restatement pursuant to the 2014 WC Term Loan Amendment, the “Existing WC Term Loan”) among the WC Borrowers, Warner Chilcott Finance, LLC, Actavis Limited, BofA, as administrative agent and a syndicate of banks participating as lenders.

Pursuant to the Existing WC Term Loan, on October 1, 2013 (the “WC Closing Date”), the lenders party thereto provided term loans in a total aggregate principal amount of $2.0 billion, comprised of (i) a $1.0 billion tranche that will mature on October 1, 2016 (the “WC Three Year Tranche”) and (ii) a $1.0 billion tranche that will mature on October 1, 2018 (the “WC Five Year Tranche”). The proceeds of borrowings under the Existing WC Term Loan Agreement, together with $41.0 million of cash on hand, were used to finance the repayment in full of all amounts outstanding under Warner Chilcott’s then-existing Credit Agreement, dated as of March 17, 2011, as amended by Amendment No. 1 on August 20, 2012, among the WC Borrowers, Warner Chilcott Holdings Company III, Limited, BofA, as administrative agent and a syndicate of banks participating as lenders.

Borrowings under the WC Term Loan Agreement bear interest at the applicable borrower’s choice of a per annum rate equal to either (a) a base rate plus an applicable margin per annum varying from (x) 0.00% per annum to 0.75% per annum under the WC Three Year Tranche and (y) 0.125% per annum to 0.875% per annum under the WC Five Year Tranche, depending on the publicly announced debt ratings for non-credit-enhanced, senior unsecured long-term indebtedness of Actavis plc (such applicable debt rating the “Debt Rating”) or (b) a Eurodollar rate, plus an applicable margin varying from (x) 1.00% per annum to 1.75% per annum under the WC Three Year Tranche and (y) 1.125% per annum to 1.875% per annum under the WC Five Year Tranche, depending on the Debt Rating.

The Company is subject to, and, at March 31, 2015, was in compliance with, all financial and operational covenants under the terms of the WC Term Loan.

ACT Term Loan

On December 17, 2014, Actavis plc and certain of its subsidiaries entered into a third amendment agreement (the “ACT Term Loan Amendment”) among Actavis plc, Warner Chilcott Limited, Actavis Capital, Actavis, Inc., Actavis Funding SCS, BofA, as administrative agent, and the lenders party thereto. The ACT Term Loan Amendment amends and restates Actavis plc’s existing second amended and restated Actavis term loan credit and guaranty agreement, dated as of March 31, 2014 (such agreement, prior to its amendment and restatement pursuant to the ACT Term Loan Amendment, the “2014 ACT Term Loan Agreement” and together with the Existing ACT Term Loan Agreement (defined below), the “ACT Term Loan”) among Actavis Capital, Actavis plc, Warner Chilcott Limited, Actavis, Inc., Actavis Funding SCS, BofA, as administrative agent, and the lenders from time to time party thereto, which amended and restated Actavis plc’s existing amended and restated Actavis term loan credit and guaranty agreement, dated as of October 1, 2013 (such agreement, prior to its amendment and restatement pursuant to the ACT Term Loan Amendment, the “Existing ACT Term Loan Agreement”) among Actavis Capital, Actavis plc, Actavis, Inc., BofA, as administrative agent, and the lenders from time to time party thereto.

The Existing ACT Term Loan Agreement amended and restated Actavis, Inc.’s $1,800.0 million senior unsecured term loan credit facility, dated as of June 22, 2012. At the closing of the Existing ACT Term Loan Agreement, an aggregate principal amount of $1,572.5 million was outstanding (the “2017 Term Loan”). The 2017 Term Loan matures on October 31, 2017.

On March 31, 2014, Actavis plc, Actavis Capital, Actavis, Inc., BofA, as Administrative Agent, and a syndicate of banks participating as lenders entered into the 2014 ACT Term Loan Agreement to amend and restate the Existing ACT Term Loan Agreement. On July 1, 2014, in connection with the Forest Acquisition, the Company borrowed $2.0 billion of term loan indebtedness under tranche A-2 of the 2014 ACT Term Loan Agreement, which is due July 1, 2019 (the “2019 Term Loan”).

The ACT Term Loan provides that loans thereunder will bear interest, at the Company’s choice, of a per annum rate equal to either (a) a base rate, plus an applicable margin per annum varying from (x) 0.00% per annum to 1.00% per annum with respect to the 2017 term-loan and (y) 0.125% per annum to 0.875% per annum with respect to the 2019 term-loan, depending on the Debt Rating or (b) a Eurodollar rate, plus an applicable margin varying from (x) 1.00% per annum to 2.00% per annum with respect to the 2017 term-loan and (y) 1.125% per annum to 1.875% per annum with respect to the 2019 term-loan, depending on the Debt Rating.

The Company is subject to, and at March 31, 2015 was in compliance with, all financial and operational covenants under the terms of the ACT Term Loan.

AGN Term Loan

On December 17, 2014, Actavis and certain of its subsidiaries entered into a senior unsecured term loan credit agreement (the “AGN Term Loan”), among Actavis Capital, as borrower, Actavis plc, Warner Chilcott Limited, Actavis, Inc., Actavis Funding SCS, the lenders from time to time party thereto (the “Term Lenders”), JPMorgan Chase Bank, N.A. (“JPMCB”), as administrative agent and the other financial institutions party thereto. Under the AGN Term Loan, the Term Lenders provided (i) a $2.75 billion tranche maturing on March 17, 2018 (the “AGN Three Year Tranche”) and (ii) a $2.75 billion tranche and maturing on March 17, 2020 (the “AGN Five Year Tranche”). The proceeds of borrowings under the AGN Term Loan were to be used to finance, in part, the cash component of the Allergan Acquisition consideration and certain fees and expenses incurred in connection with the Allergan Acquisition.

 

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Borrowings under the AGN Term Loan bear interest at our choice of a per annum rate equal to either (a) a base rate plus an applicable margin per annum varying from (x) 0.00% per annum to 1.00% per annum under the AGN Three Year Tranche and (y) 0.125% per annum to 1.250%% per annum under the AGN Five Year Tranche, depending on the Debt Rating or (b) a Eurodollar rate, plus an applicable margin varying from (x) 1.00% per annum to 2.00% per annum under the AGN Three Year Tranche and (y) 1.125% per annum to 2.250% per annum under the AGN Five Year Tranche, depending on the Debt Rating. The outstanding principal amount of loans under the AGN Three Year Tranche is not subject to quarterly amortization and shall be payable in full on the maturity date. The outstanding principal amount of loans under the AGN Five Year Tranche is payable in equal quarterly amounts of 2.50% per quarter prior to March 17, 2020, with the remaining balance payable on March 17, 2020.

The obligations of Actavis Capital under the Term Loan Credit Agreement are guaranteed by Warner Chilcott Limited, Actavis, Inc. and Actavis Funding SCS and will be guaranteed by any subsidiary of Actavis plc (other than Actavis Capital or a direct subsidiary of Actavis plc) that becomes a guarantor of third party indebtedness in an aggregate principal amount exceeding $350.0 million (unless, in the case of a foreign subsidiary, such guarantee would give rise to adverse tax consequences as reasonably determined by Actavis plc).

Bridge Loan Facility

On December 17, 2014, Actavis and certain of its subsidiaries entered into a 364-day senior unsecured bridge credit agreement (the “Bridge Loan Facility”), among Actavis Capital, as borrower, Actavis plc, Warner Chilcott Limited, Actavis, Inc., Actavis Funding SCS, the lenders from time to time party thereto (the “Bridge Lenders”), JPMCB, as administrative agent and the other financial institutions party thereto. Under the Bridge Loan Facility, the Bridge Lenders committed to provide, subject to certain conditions, unsecured bridge financing, of which $2.8 billion was drawn to finance the Allergan Acquisition on March 17, 2015. As of March 31, 2015, $810.0 million of the Bridge Loan Facility was outstanding. The outstanding balance of the Bridge Loan Facility was repaid on April 9, 2015.

Borrowings under the Bridge Loan Facility bore interest at our choice of a per annum rate equal to either (a) a base rate plus an applicable margin per annum varying from 0.00% per annum to 2.50% per annum, depending on the Debt Rating and the number of days for which the loans remain outstanding from the date of funding thereunder or (b) a Eurodollar rate, plus an applicable margin varying from 1.00% per annum to 3.50% per annum, depending on the Debt Rating and the number of days for which the loans remain outstanding from the date of funding thereunder.

Revolving Credit Facility

On December 17, 2014, Actavis plc and certain of its subsidiaries entered into a revolving credit loan and guaranty agreement (the “Revolver Agreement”) among Actavis Capital, as borrower, Actavis plc, Warner Chilcott Limited, Actavis, Inc., Actavis Funding SCS, the lenders from time to time party thereto (the “Revolving Lenders”), JPMCB as administrative agent, J.P. Morgan Europe Limited, as London agent, and the other financial institutions party thereto. Under the Revolver Agreement, the Revolving Lenders have committed to provide an unsecured revolving credit facility in an aggregate principal amount of up to $1.0 billion.

The Revolver Agreement provides that loans thereunder will bear interest, at our choice, of a per annum rate equal to either (a) a base rate, plus an applicable margin per annum varying from 0.00% per annum to 1.00% per annum depending on the Debt Rating or (b) a Eurodollar rate, plus an applicable margin varying from 0.875% per annum to 2.00% per annum depending on the Debt Rating. Additionally, to maintain availability of funds, the Company pays an unused commitment fee, which according to the pricing grid is set at 0.075% to 0.250% per annum, depending on the Debt Rating, of the unused portion of the revolver. The Revolving Credit Agreement will mature on December 17, 2019.

The obligations under the Revolver Agreement are guaranteed by Actavis plc, Warner Chilcott Limited, Actavis, Inc. and Actavis Funding SCS and will be guaranteed by any subsidiary of Actavis (other than Actavis Capital) that becomes a guarantor of third party indebtedness in an aggregate principal amount exceeding $350.0 million (unless, in the case of a foreign subsidiary, such guarantee would give rise to adverse tax consequences as reasonably determined by Actavis plc).

The Company is subject to, and as of March 31, 2015 was in compliance with, all financial and operational covenants under the terms of the Revolving Credit Facility. At March 31, 2015, there was no outstanding borrowings under the Revolving Credit Facility and letters of credit outstanding were $29.2 million. The net availability under the Revolving Credit Facility was $970.8 million.

 

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Annual Debt Maturities

As of March 31, 2015, annual debt maturities were as follows (in millions):

 

     Total Payments  

2015 remaining

   $ 498.6   

2016

     2,347.5   

2017

     4,217.6   

2018

     7,145.8   

2019

     3,325.0   

2020

     6,093.8   

2021 and after

     19,604.1   
  

 

 

 
  43,232.4   
  

 

 

 

Capital Leases

  13.2   

Bridge Loan Facility

  810.0   

Other short-term borrowings

  98.4   

Unamortized Premium

  286.6   

Unamortized Discount

  (116.0
  

 

 

 

Total Indebtedness

$ 44,324.6   
  

 

 

 

Amounts represent total anticipated cash payments assuming scheduled repayments.

NOTE 13 — Other Long-Term Liabilities

Other long-term liabilities consisted of the following (in millions):

 

     March 31,
2015
     December 31,
2014
 

Long-term pension and post retirement liability

   $ 470.3       $ 103.1   

Acquisition related contingent consideration liabilities

     453.0         159.0   

Deferred executive compensation

     117.3         —     

Long-term severance and restructuring liabilities

     40.5         4.3   

Long-term contractual obligations

     28.9         29.7   

Product warranties

     28.1         —     

Litigation-related reserves

     —           4.9   

Other long-term liabilities

     80.0         34.8   
  

 

 

    

 

 

 

Total other long-term liabilities

$ 1,218.1    $ 335.8   
  

 

 

    

 

 

 

 

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NOTE 14 — Income Taxes

The Company’s effective tax rate for the three months ended March 31, 2015 was (25.8)% compared to 31.5% for the three months ended March 31, 2014. The effective tax rate for the three months ended March 31, 2015 was impacted by income earned in low tax jurisdictions, losses in certain jurisdictions for which no tax benefit is provided and the amortization of intangibles and the step-up in inventory benefited at rates other than the Irish statutory rate. The effective tax rate for the quarter ended March 31, 2014 was impacted by income earned in low tax jurisdictions, losses in certain jurisdictions for which no tax benefit is provided and the amortization of intangibles and the step-up in inventory benefited at rates other than the Irish statutory rate. Additionally, the tax provision for the quarter ended March 31, 2014 included a benefit of $9.7 million related to certain changes to the Company’s uncertain tax positions.

ASC 740-270-25 generally requires the tax (or benefit) for an interim period to be computed based on an estimated annual effective tax rate. Our estimated annual effective tax rate for 2015 is subject to wide variability due to the overall level of forecasted pre-tax book income, the mix of earnings between jurisdictions and significant acquisition related expenses. As a result, we have computed the income tax benefit for the quarter ended March 31, 2015 based on year to date results.

The Company conducts business globally and, as a result, it files federal, state and foreign tax returns. The Company strives to resolve open matters with each tax authority at the examination level and could reach agreement with a tax authority at any time. While the Company has accrued for amounts it believes are the probable outcomes, the final outcome with a tax authority may result in a tax liability that is more or less than that reflected in the condensed consolidated financial statements. Furthermore, the Company may later decide to challenge any assessments, if made, and may exercise its right to appeal. The uncertain tax positions are reviewed quarterly and adjusted as events occur that affect potential liabilities for additional taxes, such as lapsing of applicable statutes of limitations, proposed assessments by tax authorities, negotiations between tax authorities, identification of new issues and issuance of new legislation, regulations or case law. Management believes that adequate amounts of tax and related penalty and interest have been provided for any adjustments that may result from these uncertain tax positions.

With the exception of the Forest group, the Company is generally no longer subject to U.S. federal, state and local, or non-U.S. income tax examinations for years before 2008. For the Watson group’s 2008 and 2009 tax years, the Company and the IRS have agreed on all issues except the timing of the deductibility of certain litigation costs. Due to our numerous acquisitions we have several concurrent IRS tax audits for pre-acquisition periods. The table set forth below lists the acquired U.S. entities and taxable years that are currently under audit by the IRS:

 

IRS Audits

   Tax Years

Watson Pharmaceuticals, Inc.

   2010 and 2009

Actavis Inc.

   2009, 2010, 2011 and 2012

Warner Chilcott Corporation

   2010, 2011 and 2012

Forest Laboratories, Inc.

   2007, 2008 and 2009

Aptalis Holdings, Inc.

   2013

Durata Therapeutics Inc.

   2012

Allergan Inc.

   2009 and 2010

While it is often difficult to predict the final outcome or the timing of resolution of any particular uncertain tax position, the Company has accrued for amounts it believes are the likely outcomes at this time.

As part of acquisition accounting, the Company accrued income taxes, including withholding taxes, of approximately $1,221.5 million for certain pre-acquisition earnings primarily related to the Allergan acquisition. The Company expects that future subsidiary earnings will be indefinitely reinvested. In addition, as part of acquisition accounting, the Company accrued $69.9 million of uncertain tax positions related to the Allergan pre-acquisition tax years. This amount, if recognized, world favorably impact the Company’s effective tax rate.

NOTE 15 — Shareholders’ Equity

A summary of the changes in shareholders’ equity for the quarter ended March 31, 2015 consisted of the following (in millions):

 

     Actavis plc  

Shareholders’ equity as of December 31, 2014

   $ 28,331.1   

Additional paid-in-capital issued on March 17, 2015 for the Allergan Transaction

     34,685.9   

Increase in additional paid in capital for share based compensation plans

     225.5   

Net (loss) attributable to ordinary shareholders

     (535.2)   

Proceeds from stock plans

     42.6   

Proceeds from the issuance of Mandatorily Convertible Preferred Shares

     4,929.7   

Proceeds from the March 2, 2015 issuance of Ordinary Shares

     4,071.1   

Excess tax benefit from employee stock plans

     36.1   

Repurchase of ordinary shares

     (64.1

Other comprehensive (loss)

     (317.9
  

 

 

 

Shareholders’ equity as of March 31, 2015

$ 71,404.8   
  

 

 

 

 

     Warner Chilcott Limited  

Member’s equity as of December 31, 2014

   $ 28,072.6   

Contribution from Parent

     43,687.3   

Net (loss)

     (508.4

Other comprehensive (loss)

     (317.9
  

 

 

 

Member’s equity as of March 31, 2015

$ 70,933.6   
  

 

 

 

Preferred Shares

On February 24, 2015, the Company completed an offering of 5,060,000 of our 5.500% mandatory convertible preferred shares, Series A, par value $0.0001 per share (the “Mandatory Convertible Preferred Shares”). Dividends on the Mandatory Convertible Preferred Shares will be payable on a cumulative basis when, as and if declared by our board of directors, or an authorized committee thereof, at an annual rate of 5.500% on the liquidation preference of $1,000.00 per Mandatory Convertible Preferred Share. The Company may pay declared dividends in cash, by delivery of our ordinary shares or by delivery of any combination of cash and our ordinary shares, as determined by us in our sole discretion, subject to certain limitations, on March 1, June 1, September 1 and December 1 of each year commencing June 1, 2015, to and including March 1, 2018. The net proceeds from the Mandatory Convertible Preferred Share issuance of $4,929.7 million were used to fund the Allergan Acquisition.

Each Mandatory Convertible Preferred Share will automatically convert on March 1, 2018, into between 2.8345 and 3.4722 ordinary shares, subject to anti-dilution adjustments. The number of our ordinary shares issuable on conversion of the Mandatory Convertible Preferred Shares will be determined based on the average volume weighted average price per ordinary share over the 20 consecutive trading day period beginning on and including the 22nd scheduled trading day immediately preceding March 1, 2018, the mandatory conversion date. At any time prior to March 1, 2018, other than during a fundamental change conversion period as defined, holders of the Mandatory Convertible Preferred Shares may elect to convert each Mandatory Convertible Preferred Share into our ordinary shares at the minimum conversion rate of 2.8345 ordinary shares per Mandatory Convertible Preferred Share, subject to anti-dilution adjustments. In addition, holders may elect to convert any Mandatory Convertible Preferred Shares during a specified period beginning on the fundamental change effective date, in which case such Mandatory Convertible Preferred Shares will be converted into our ordinary shares at the fundamental change conversion rate and converting holders will also be entitled to receive a fundamental change dividend make-whole amount and accumulated dividend amount.

 

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2015 Ordinary Shares Offering

On March 2, 2015, in connection with the Allergan Acquisition, the Company issued 14,513,889 of its ordinary shares for an actual public offering price of $288.00 per share. The net proceeds of $4,071.1 million were used, in part, to finance the Allergan Acquisition.

Accumulated Other Comprehensive (Loss)

For most of the Company’s international operations, the local currency has been determined to be the functional currency. The results of its non-U.S. dollar based operations are translated to U.S. dollars at the average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the date of the equity transaction. Translation adjustments are reflected in shareholders’ equity and are included as a component of other comprehensive (loss) / income. The effects of converting non-functional currency assets and liabilities into the functional currency are recorded as general and administrative expenses in the consolidated statements of operations.

The movements in accumulated other comprehensive (loss) for the three months ended March 31, 2015 were as follows (in millions):

 

     Foreign
Currency
Translation
Items
     Unrealized
(losses) net
of tax
     Total
Accumulated
Other
Comprehensive
(Loss)
 

Balance as of December 31, 2014

   $ (434.4    $ (31.0    $ (465.4

Other comprehensive (loss) before reclassifications into general and administrative

     (313.9      (4.0      (317.9
  

 

 

    

 

 

    

 

 

 

Total other comprehensive (loss)

  (313.9   (4.0   (317.9
  

 

 

    

 

 

    

 

 

 

Balance as of March 31, 2015

$ (748.3 $ (35.0 $ (783.3
  

 

 

    

 

 

    

 

 

 

The movements in accumulated other comprehensive income / (loss) for the three months ended March 31, 2014 were as follows (in millions):

 

     Foreign
Currency
Translation
Items
     Unrealized
gains net
of tax
     Total
Accumulated
Other
Comprehensive
Income / (Loss)
 

Balance as of December 31, 2013

   $ 85.1       $ 5.4       $ 90.5   

Other comprehensive (loss)/income before reclassifications into general and administrative

     (7.5      0.7         (6.8
  

 

 

    

 

 

    

 

 

 

Total other comprehensive (loss)/income

  (7.5   0.7      (6.8
  

 

 

    

 

 

    

 

 

 

Balance as of March 31, 2014

$ 77.6    $ 6.1    $ 83.7   
  

 

 

    

 

 

    

 

 

 

NOTE 16 — Derivative Instruments and Hedging Activities

The Company’s revenue, earnings, cash flows and fair value of its assets and liabilities can be impacted by fluctuations in foreign exchange risks and interest rates, as applicable. The Company manages the impact of foreign exchange risk and interest rate movements through operational means and through the use of various financial instruments, including derivative instruments such as foreign currency derivatives.

 

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Foreign Currency Derivatives

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 and favorably impact operating expenses in U.S. dollars.

Primarily as a result of the Allergan Acquisition and from time to time, the Company enters into foreign currency derivatives 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 derivatives in amounts between minimum and maximum anticipated foreign exchange exposures. The Company does not designate these derivative instruments as accounting hedges.

The Company uses foreign currency derivatives, which provide for the sale or purchase of foreign currencies to economically hedge the currency exchange risks associated with probable but not firmly committed transactions that arise in the normal course of the Company’s business. Probable but not firmly committed transactions are comprised primarily of sales of products and purchases of raw material in currencies other than the U.S. dollar. The foreign currency derivatives are entered into to reduce the volatility of earnings generated in currencies other than the U.S. dollar. While these instruments are subject to fluctuations in value, such fluctuations are anticipated to offset changes in the value of the underlying exposures.

During the three months ended March 31, 2015 and 2014, the Company recognized losses on such contracts of $12.8 million and zero, respectively.

The fair value of outstanding foreign currency derivatives are recorded in “Prepaid expenses and other current assets” or “Accounts payable and accrued expenses.” At March 31, 2015 and December 31, 2014, foreign currency derivative assets associated with the foreign exchange option contracts of $129.1 million and $2.3 million, respectively, were included in “Prepaid expenses and other current assets.” At March 31, 2015 and December 31, 2014, net foreign currency derivative liabilities associated with the foreign exchange forward contracts of $3.4 million and zero were included in “Accounts payable and accrued expenses.”

NOTE 17 — Fair Value Measurement

Fair value is the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants. Fair values determined based on Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined based on Level 2 inputs utilize observable quoted prices for similar assets and liabilities in active markets and observable quoted prices for identical or similar assets in markets that are not very active. Fair values determined based on Level 3 inputs utilize unobservable inputs and include valuations of assets or liabilities for which there is little, if any, market activity. A financial asset or liability’s classification within the above hierarchy is determined based on the lowest level input that is significant to the fair value measurement.

Assets and liabilities measured at fair value or disclosed at fair value on a recurring basis as of March 31, 2015 and December 31, 2014 consisted of the following (in millions):

 

     Fair Value Measurements as of March 31,
2015 Using:
 
     Total      Level 1      Level 2      Level 3  

Assets:

           

Marketable securities

   $ 16.0       $ 16.0       $ —         $ —     

Deferred executive compensation investments

     117.1         93.7         23.4         —     

Foreign currency derivatives

     129.1         —           129.1         —     

Marketable equity securities

     44.0         44.0         —           —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

$ 306.2    $ 153.7    $ 152.5    $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Liabilities:

Foreign currency derivatives

  3.4      —        3.4      —     

Deferred executive compensation liabilities

  111.1      87.7      23.4      —     

Contingent consideration obligations

  770.8      —        —        770.8   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities

$  885.3    $ 87.7    $ 26.8    $  770.8   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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     Fair Value Measurements as of
December 31, 2014 Using:
 
     Total      Level 1      Level 2      Level 3  

Assets:

           

Marketable securities

   $ 1.0       $ 1.0       $ —         $ —     

Foreign currency derivatives

     2.3         —           2.3         —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

$ 3.3    $ 1.0    $ 2.3    $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Liabilities:

Contingent consideration

  396.8      —        —        396.8   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities

$ 396.8    $ —      $ —      $ 396.8   
  

 

 

    

 

 

    

 

 

    

 

 

 

Marketable securities and investments consist of available-for-sale investments in U.S. treasury and agency securities and publicly traded equity securities for which market prices are readily available. Unrealized gains or losses on marketable securities and investments are recorded in accumulated other comprehensive (loss).

Foreign Currency Contracts

At March 31, 2015 and December 31, 2014, the notional principal and fair value of the Company’s outstanding foreign currency derivative financial instruments were as follows:

 

     March 31, 2015      December 31, 2014  
     Notional
Principal
     Fair
Value
     Notional
Principal
     Fair
Value
 
(in millions)       

Foreign currency forward exchange contracts

   $ 89.2       $ (3.4    $ 10.3       $ 2.3   

Foreign currency sold — put options

     849.4         129.1         —           —     

The notional principal amounts provide one measure of the transaction volume outstanding as of March 31, 2015 and December 31, 2014, 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 March 31, 2015 and December 31, 2014. 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.

Contingent Consideration Obligations

The fair value measurement of the contingent consideration obligations is determined using Level 3 inputs and is based on a probability-weighted income approach. The measurement is based upon unobservable inputs supported by little or no market activity based on our own assumptions. Changes in the fair value of the contingent consideration obligations, including accretion, are recorded in our consolidated statements of operations as follows ($ in millions):

 

     Three Months Ended  

Expense / (income)

   March 31, 2015      March 31, 2014  

Cost of sales

   $ 28.0       $ 0.3   

General and administrative

     0.3         —     

Research and development

     0.5         (7.3
  

 

 

    

 

 

 
$ 28.8    $ (7.0
  

 

 

    

 

 

 

The table below provides a summary of the changes in fair value, including net transfers in and/or out, of all financial assets and liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the three months ended March 31, 2015 and 2014 (in millions):

 

     Balance at
December 31,
2014
     Net
transfers
in to
(out of)
Level 3
     Purchases
and
settlements,
net
     Net
accretion
and fair
value
adjustments
    Foreign
currency
translation
    Balance
at
March 31,
2015
 

Liabilities:

               

Contingent consideration obligations

   $ 396.8       $ —        $ 347.7       $ 28.8      $ (2.5   $ 770.8   
     Balance at
December 31,
2013
     Net
transfers
in to
(out of)
Level 3
     Purchases
and
settlements,
net
     Net
accretion
and fair
value
adjustments
    Foreign
currency
translation
    Balance
at
March 31,
2014
 

Liabilities:

               

Contingent consideration obligations

   $ 207.8       $ —        $ 49.2       $ (7.0   $ (0.8   $ 249.2   

 

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During the quarter ended March 31, 2015, the following activity in contingent consideration obligations by acquisition was incurred ($ in million):

 

     December 31, 2014      Acquisitions      Fair Value
Adjustments and Accretion
    Payments and Other     March 31, 2015  

Medicines 360 Acquisition

   $ 126.6       $ —         $ 50.8      $ —        $ 177.4   

Furiex Acquisition

     88.4         —           0.1        —          88.5   

Forest Acquisition

     52.4         —           (29.6     —          22.8   

Durata Acquisition

     49.0         —           6.4        (30.9     24.5   

Metrogel Acquisition

     31.2         —           0.4        —          31.6   

May 2014 Acquisition

     19.1         —           0.4        (2.1     17.4   

Uteron Acquisition

     10.4         —           0.1        —          10.5   

Allergan Acquisition

     —           379.1         —          0.2        379.3   

Other

     19.7         —           0.2        (1.1     18.8   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Total

$ 396.8    $ 379.1    $ 28.8    $ (33.9 $ 770.8   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

NOTE 18 — Business Restructuring Charges

During 2014 and the quarter ended March 31, 2015 activity related to our business restructuring and facility rationalization activities primarily related to the cost optimization initiatives in conjunction with the Allergan, Forest, Warner Chilcott and Actavis acquisitions as well as optimization of our operating cost structure through our global supply chain initiative. Restructuring activities for the quarter ended March 31, 2015 as follows (in millions):

 

     Severance and
Retention
    Share-Based
Compensation
    Accelerated
Depreciation
    Other     Total  

Accrual Balance at December 31, 2014

   $ 129.4      $ —        $ —        $ —        $ 129.4   

Acquired Liability

     27.9        —          —          29.2        57.1   

Charged to expense

          

Cost of sales

     23.7        6.6        0.9        8.2        39.4   

Research and development

     67.2        59.9        —          —          127.1   

Selling and marketing

     72.0        23.6        —          —          95.6   

General and administrative

     125.0        190.0        —          7.6        322.6   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total expense

  287.9      280.1      0.9      15.8      584.7   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash payments

  (70.2   (127.1   —        (9.5   (206.8

Non-cash adjustments

  (2.7   (153.0   (0.9   (0.6   (157.2
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Accrual Balance at March 31, 2015

$ 372.3    $ —      $ —      $ 34.9    $ 407.2   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

During the quarters ended March 31, 2015 and 2014, the Company recognized restructuring charges of $584.7 million and $24.8 million, respectively.

 

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NOTE 19 — Commitments and Contingencies

Legal Matters

The Company and its affiliates are involved in various disputes, governmental and/or regulatory inspections, inquires, investigations and proceedings, and litigation matters that arise from time to time in the ordinary course of business. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect the Company, its results of operations, financial condition and cash flows. The Company’s general practice is to expense legal fees as services are rendered in connection with legal matters, and to accrue for liabilities when losses are probable and reasonably estimable.

The Company evaluates, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that is accrued. As of March 31, 2015, the Company’s consolidated balance sheet includes accrued loss contingencies of approximately $375.0 million.

The Company’s legal proceedings range from cases brought by a single plaintiff to mass tort actions and class actions with thousands of putative class members. These legal proceedings, as well as other matters, involve various aspects of our business and a variety of claims (including, but not limited to, qui tam actions, antitrust, product liability, breach of contract, securities, patent infringement and trade practices), some of which present novel factual allegations and/or unique legal theories. In addition, a number of the matters pending against us are at very early stages of the legal process (which in complex proceedings of the sort faced by us often extend for several years). As a result, some matters have not yet progressed sufficiently through discovery and/or development of important factual information and legal issues to enable us to estimate a range of possible loss. In those proceedings in which plaintiffs do request publicly quantified amounts of relief, the Company does not believe that the quantified amounts are meaningful because they are merely stated jurisdictional limits, exaggerated and/or unsupported by the evidence or applicable burdens of proof.

 

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Antitrust Litigation

Actos ® Litigation . On December 31, 2013 two putative class actions were filed in the federal court for the Southern District of New York against Actavis plc and certain of its affiliates alleging that Watson Pharmaceuticals, Inc.’s (“Watson” now known as Actavis, Inc.) 2010 patent lawsuit settlement with Takeda Pharmaceutical, Co. Ltd. related to Actos ® (pioglitazone hydrochloride and metformin “Actos ® ”) is unlawful. Several additional complaints have also been filed. Plaintiffs then filed a consolidated, amended complaint on May 20, 2014. The amended complaint, asserted on behalf of a putative class of indirect purchaser plaintiffs, generally alleges an overall scheme that included Watson improperly delaying the launch of its generic version of Actos ® in exchange for substantial payments from Takeda in violation of federal and state antitrust and consumer protection laws. The complaint seeks declaratory and injunctive relief and unspecified damages. Defendants have moved to dismiss the amended complaint.

The Company believes that it has substantial meritorious defenses to the claims alleged. However, these actions, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

AndroGel ® Litigation.  On January 29, 2009, the U.S. Federal Trade Commission and the State of California filed a lawsuit in federal district court in California alleging that the September 2006 patent lawsuit settlement between Watson and Solvay Pharmaceuticals, Inc. (“Solvay”), related to AndroGel ® 1% (testosterone gel) CIII is unlawful. The complaint generally alleged that Watson improperly delayed its launch of a generic version of AndroGel ® in exchange for Solvay’s agreement to permit Watson to co-promote AndroGel ® for consideration in excess of the fair value of the services provided by Watson, in violation of federal and state antitrust and consumer protection laws. The complaint sought equitable relief and civil penalties. On February 2 and 3, 2009, three separate lawsuits alleging similar claims were filed in federal district court in California by various private plaintiffs purporting to represent certain classes of similarly situated claimants. On April 8, 2009, the Court transferred the government and private cases to the United States District Court for the Northern District of Georgia. The FTC and the private plaintiffs filed amended complaints on May 28, 2009. The private plaintiffs amended their complaints to include allegations concerning conduct before the U.S. Patent and Trademark Office (the “USPTO”), conduct in connection with the listing of Solvay’s patent in the FDA “Orange Book,” and sham litigation. Additional actions alleging similar claims have been filed in various courts by other private plaintiffs purporting to represent certain classes of similarly situated direct or indirect purchasers of AndroGel ® . The Judicial Panel on Multidistrict Litigation (“JPML”) transferred all federal court actions then pending outside of Georgia to that district. The district court then granted the Company’s motion to dismiss all claims except the private plaintiffs’ sham litigation claims. After the dismissal was upheld by the Eleventh Circuit Court of Appeals, the FTC petitioned the United States Supreme Court to hear the case. On June 17, 2013, the Supreme Court issued a decision, holding that the settlements between brand and generic drug companies which include a payment from the brand company to the generic competitor must be evaluated under a “rule of reason” standard of review and ordered the case remanded (the “Supreme Court AndroGel Decision”). The case in now back in the district court in Georgia August 5, 2014 the indirect purchaser plaintiffs filed an amended complaint which the Company answered on September 15, 2014.

The Company believes it has substantial meritorious defenses and intends to defend itself vigorously. However, these actions, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

 

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Botox ® Litigation . On February 24, 2015, a class action complaint was filed in federal court in California. The complaint alleges unlawful market allocation in violation of Section 1 of the Sherman Act, 15 U.S.C. §1, agreement in restraint of trade in violation of 15 U.S.C. §1 of the Sherman Act, unlawful maintenance of monopoly market power in violation of Section 2 of the Sherman Act, 15 U.S.C. §2 of the Sherman Act, violations of California’s Cartwright Act, Section 16700 et seq. of Calif. Bus. and Prof. Code., and violations of California’s unfair competition law, Section 17200 et seq. of Calif. Bus. and Prof. Code. The Company believes it has substantial meritorious defenses and intends to defend itself vigorously. However, these actions, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Cipro ® Litigation . Beginning in July 2000, a number of suits were filed against Watson and certain Company affiliates including The Rugby Group, Inc. (“Rugby”) in various state and federal courts alleging claims under various federal and state competition and consumer protection laws. The actions generally allege that the defendants engaged in unlawful, anticompetitive conduct in connection with alleged agreements, entered into prior to Watson’s acquisition of Rugby from Sanofi Aventis (“Sanofi”), related to the development, manufacture and sale of the drug substance ciprofloxacin hydrochloride, the generic version of Bayer’s brand drug, Cipro ® . The actions generally seek declaratory judgment, damages, injunctive relief, restitution and other relief on behalf of certain purported classes of individuals and other entities. While many of these actions have been dismissed, actions remain pending in various state courts, including California, Kansas, Tennessee, and Florida. There has been activity in Tennessee and Florida since 2003. In the action pending in Kansas, plaintiffs’ motion for class certification has been fully briefed. In the action pending in the California state court, following the decision from the United States Supreme Court in the Federal Trade Commission v. Actavis matter involving AndroGel ® , described above, Plaintiffs and Bayer announced that they reached an agreement to settle the claims pending against Bayer and Bayer has now been dismissed from the action. Plaintiffs are continuing to pursue claims against the generic defendants, including Watson and Rugby. The remaining parties submitted letter briefs to the court regarding the impact of the Supreme Court AndroGel Decision and on May 7, 2015, the California Supreme Court issued a ruling, consistent with the Supreme Court AndroGel Decision discussed above, that the settlements between brand and generic drug companies which include a payment from the brand company to the generic competitor must be evaluated under a “rule of reason” standard of review.

In addition to the pending actions, the Company understands that various state and federal agencies are investigating the allegations made in these actions. Sanofi has agreed to defend and indemnify Watson and its affiliates in connection with the claims and investigations arising from the conduct and agreements allegedly undertaken by Rugby and its affiliates prior to Watson’s acquisition of Rugby, and is currently controlling the defense of these actions.

Doryx ® Litigation . In July 2012, Mylan Pharmaceuticals Inc. (“Mylan”) filed a complaint against Warner Chilcott and Mayne Pharma International Pty. Ltd. (“Mayne”) in federal court in Pennsylvania alleging that Warner Chilcott and Mayne prevented or delayed Mylan’s generic competition to Warner Chilcott’s Doryx ® products in violation of U.S. federal antitrust laws and tortiously interfered with Mylan’s prospective economic relationships under Pennsylvania state law. In the complaint, Mylan seeks unspecified treble and punitive damages and attorneys’ fees. Following the filing of Mylan’s complaint, three putative class actions were filed against Warner Chilcott and Mayne by purported direct purchasers, and one putative class action was filed against by purported indirect purchasers. In addition, four retailers filed in the same court a civil antitrust complaint in their individual capacities against Warner Chilcott and Mayne regarding Doryx ® . In each of the class and individual cases the plaintiffs allege that they paid higher prices for Warner Chilcott’s Doryx ® products as a result of Warner Chilcott’s and Mayne’s alleged actions preventing or delaying generic competition in violation of U.S. federal antitrust laws and/or state laws. Plaintiffs seek unspecified injunctive relief, treble damages and/or attorneys’ fees. All of the actions were consolidated in the federal district court.

 

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Warner Chilcott and Mayne’s motion to dismiss was denied without prejudice by the court in June 2013. Thereafter, Warner Chilcott and Mayne reached agreements to settle the claims of the Direct Purchaser Plaintiff class representatives, the Indirect Purchaser Plaintiff class representatives and each of the individual retailer plaintiffs. Warner Chilcott and Mylan filed motions for summary judgment on March 10, 2014. On April 16, 2015, the court issued an order granting Warner Chilcott and Mayne’s motion for summary judgment, denying Mylan’s summary judgment motion and entering judgment in favor of Warner Chilcott and Mayne on all counts. Mylan has not yet indicated whether they will be appealing the court’s ruling.

The Company intends to vigorously defend its rights in the litigations. However, it is impossible to predict with certainty the outcome of any litigation and whether any additional similar suits will be filed. The Company can offer no assurance as to whether Mylan will appeal the district court’s ruling and, if it does, whether the Company will be successful on the appeal.

Lidoderm ® Litigation . On November 8, 2013, a putative class action was filed in the federal district court against Actavis, Inc. and certain of its affiliates alleging that Watson’s 2012 patent lawsuit settlement with Endo Pharmaceuticals, Inc. related to Lidoderm ® (lidocaine transdermal patches, “Lidoderm ® ”) is unlawful. The complaint, asserted on behalf of putative classes of direct purchaser plaintiffs, generally alleges that Watson improperly delayed launching generic versions of Lidoderm ® in exchange for substantial payments from Endo in violation of federal and state antitrust and consumer protection laws. The complaint seeks declaratory and injunctive relief and damages. Additional lawsuits containing similar allegations have followed on behalf of other classes of putative direct purchasers and suits have been filed on behalf of putative classes of end-payer plaintiffs. The Company anticipates additional claims or lawsuits based on the same or similar allegations may be filed. On April 3, 2014 the JPML consolidated the cases in federal district court in California. Defendants filed motions to dismiss each of the plaintiff classes’ claims. On November 17, 2014, the court issued an order granting the motion in part but denying it with respect to the claims under Section 1 of the Sherman Act. Plaintiffs then filed an amended, consolidated complaint on December 19, 2014. Defendants have responded to the amended consolidated complaint. On March 5, 2015, a group of five retailers filed a civil antitrust complaint in their individual capacities regarding Lidoderm ® in the same court where it was consolidated with the direct and indirect purchaser class complaints. The retailer complaint recites similar facts and asserts similar legal claims for relief to those asserted in the related cases described above.

The Company believes it has substantial meritorious defenses and intends to defend itself vigorously. However, these actions, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Loestrin ® 24 Litigation.  On April 5, 2013, two putative class actions were filed in the federal district court against Actavis, Inc. and certain affiliates alleging that Watson’s 2009 patent lawsuit settlement with Warner Chilcott related to Loestrin ® 24 Fe (norethindrone acetate/ethinyl estradiol tablets and ferrous fumarate tablets, “Loestrin ® 24”) is unlawful. The complaints, both asserted on behalf of putative classes of end-payors, generally allege that Watson and another generic manufacturer improperly delayed launching generic versions of Loestrin ® 24 in exchange for substantial payments from Warner Chilcott, which at the time was an unrelated company, in violation of federal and state antitrust and consumer protection laws. The complaints each seek declaratory and injunctive relief and damages. Additional complaints have been filed by different plaintiffs seeking to represent the same putative class of end-payors. In addition to the end-payor suits, two lawsuits have been filed on behalf of a class of

 

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direct payors. The Company anticipates additional claims or lawsuits based on the same or similar allegations. After a hearing on September 26, 2013, the JPML issued an order transferring all related Loestrin ® 24 cases to the federal court for the District of Rhode Island. On September 4, 2014, the court granted the defendants’ motion to dismiss the complaint. The plaintiffs are appealing the district court’s decision to the First Circuit Court of Appeals.

The Company believes it has substantial meritorious defenses and intends to defend itself vigorously including in the appeal of the district court’s decision granting the Company’s motion to dismiss. However, these actions, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Namenda ® Litigation . On September 15, 2014, the State of New York, through the Office of the Attorney General of the State of New York, filed a lawsuit in the United States District Court for the Southern District of New York alleging that Forest is acting to prevent or delay generic competition to Forest’s immediate-release product Namenda ® in violation of federal and New York antitrust laws and committed other fraudulent acts in connection with its commercial plans for Namenda ® XR. In the complaint, the state seeks unspecified monetary damages and injunctive relief. On September 24, 2014, the state filed a motion for a preliminary injunction prohibiting Forest from discontinuing or otherwise limiting the availability of immediate-release Namenda ® until the conclusion of the litigation. A hearing was held in November 2014 on the state’s preliminary injunction motion. On December 11, 2014, the district court issued a ruling granting the state’s injunction motion and issued an injunction on December 15, 2014. Forest appealed the preliminary injunction order to the Court of Appeals for the Second Circuit, which heard oral argument on April 13, 2015. Forest’s appeal remains pending.

The Company believes it has substantial meritorious defenses and intends to defend both its brand and generic defendant entities vigorously. However, these actions, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Opana Litigation . On December 19, 2014, a putative class action was filed in California state court against Actavis, Inc. and Actavis South Atlantic LLC alleging, among other things, that Actavis’ 2009 patent lawsuit settlement with Endo Pharmaceuticals, Inc. related to Opana ER ® (extended release oxymorphone hydrochloride tablets) is unlawful. The complaint, asserted on behalf of a putative class of end payer plaintiffs, generally alleges that Actavis and Impax improperly delayed launching generic versions of Opana ER ® in exchange for substantial consideration from Endo in violation of CA state antitrust, unfair competition and consumer protection laws. The complaint seeks damages and other equitable relief. On March 4, 2015, plaintiffs in this action agreed to voluntarily dismiss the Actavis defendants from the action without prejudice. The Company anticipates additional claims or lawsuits based on the same or similar allegations may be filed. However, this action and any others like it, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Zymar ® /Zymaxid ® Litigation . On February 16, 2012, Apotex Inc. and Apotex Corp. filed a complaint in the federal district court in Delaware Senju Pharmaceuticals Co., Ltd. (“Senju”), Kyorin Pharmaceutical Co., Ltd. (“Kyorin”), and Allergan, Inc. (“Allergan”) alleging monopolization in violation of Section 2 of the Sherman Act, conspiracy to monopolize, and unreasonable restraint of trade in the market for gatifloxacin ophthalmic formulations, which includes Allergan’s ZYMAR ® gatifloxacin ophthalmic solution 0.3% and ZYMAXID ® gatifloxacin ophthalmic solution 0.5% products. On May 24, 2012, Allergan filed a motion to dismiss the complaint to the extent it seeks to impose liability for alleged injuries occurring prior to August 19, 2011, which is the date Apotex obtained final approval of its proposed generic product. Allergan and the other defendants also moved to dismiss. Defendants also

 

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filed a motion to stay the action pending resolution of related patent actions in the federal court in Delaware and in the U.S. Court of Appeals for the Federal Circuit. On February 7, 2013, the court granted defendants’ motion to stay the proceedings pending resolution of the appeal in the patent dispute and denied the motion to dismiss without prejudice to renew. On September 18, 2014, defendants filed a new motion to dismiss the Apotex plaintiffs’ complaint. On June 6, 2014, a separate antitrust class action complaint was filed in the federal district court in Delaware against the same defendants as in the Apotex case. The complaint alleges that defendants unlawfully excluded or delayed generic competition in the gatifloxacin ophthalmic formulations market (generic versions of ZYMAR ® and ZYMAXID ® ). On September 18, 2014, Allergan filed a motion to dismiss for lack of subject matter jurisdiction and joined in co-defendants’ motion to dismiss for failure to state a claim.

The Company believes it has substantial meritorious defenses and intends to defend itself vigorously. However, these actions, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Commercial Litigation

Botox ® Royalty Dispute . On June 3, 2014, the Regents for the University of the Colorado filed a complaint against Allergan, Inc. and Allergan Botox Limited (together, the “Allergan Parties”) in federal district court in Colorado. The complaint alleges various breaches of a license agreement. On July 24, 2014, plaintiffs filed an amended complaint alleging that the Allergan Parties breached the license agreement with the University of Colorado as follows: (1) failing to use a mutually agreed-upon survey provider for calculation of net BOTOX ® sales covered by the license agreement, (2) failing to provide books and records to the University, (3) failing to pay for the PwC inspection of the Allergan Parties’ books and records, (4) underpaying royalties owed, and (5) failing to prosecute the European patent application number 10169366.1 (the “’366 application”). The Company believes it has substantial meritorious defenses and intends to defend itself vigorously. However, these actions, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Celexa ® /Lexapro ® Class Actions . Forest and certain of its affiliates are defendants in three federal court actions filed on behalf of individuals who purchased Celexa ® and/or Lexapro ® for pediatric use, all of which have been consolidated for pretrial purposes in an MDL proceeding in the federal district court Massachusetts (the “Celexa ® /Lexapro ® MDL”). These actions, two of which were originally filed as putative nationwide class actions, and one of which is a putative California-wide class action, allege that Forest marketed Celexa ® and/or Lexapro ® for off-label pediatric use and paid illegal kickbacks to physicians to induce prescriptions of Celexa ® and Lexapro ® . The complaints assert various similar claims, including claims under the state consumer protection statutes and state common laws. Plaintiffs in the various actions sought to have certified California, Missouri, Illinois and New York state-wide classes. However, only the Missouri state class was certified. Forest subsequently reached an agreement with the MDL plaintiffs to settle the Missouri class claims, including claims by both individuals and third party payors that purchased Celexa ® or Lexapro ® for use by a minor from 1998 to December 31, 2013, for $7.65 million with a potential to increase the amount to $10.35 million if settling plaintiffs meet certain thresholds. On September 8, 2014 the court granted final approval for the settlement.

Additional actions relating to the promotion of Celexa ® and/or Lexapro ® have been filed all of which have been consolidated in the Celexa ® /Lexapro ® MDL. On May 3, 2013, an action was filed in federal court in California on behalf of individuals who purchased Lexapro ® for adolescent use, seeking to certify a state-wide class action in California and alleging that our promotion of Lexapro ® for adolescent depression has been deceptive. On March 5, 2014 the court granted Forest’s motion to dismiss this complaint. Plaintiff then appealed the district court’s decision to the Court of Appeals for the First Circuit and on February 20, 2015, the First Circuit affirmed the dismissal of the complaint, ruling that Plaintiffs’ California state law claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA). On November 13, 2013, an action was filed in federal court in Minnesota seeking to certify a nationwide class of third-party payor entities that purchased Celexa ® and Lexapro ® for pediatric use. The

 

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complaint asserts claims under the federal Racketeer Influenced and Corrupt Organizations Act, alleging that Forest engaged in an off-label marketing scheme and paid illegal kickbacks to physicians to induce prescriptions of Celexa ® and Lexapro ® . Forest moved to dismiss the complaint and on December 12, 2014, the court issued a ruling dismissing plaintiff’s claims under Minnesota’s Deceptive Trade Practices Act, but denying the remaining portions of the motion. On March 13, 2014, an action was filed in the federal court in Massachusetts by two third-party payors seeking to certify a nationwide class of persons and entities that purchased Celexa ® and Lexapro ® for use by pediatric use. The complaint asserts claims under the federal Racketeer Influenced and Corrupt Organizations Act, state consumer protection statutes, and state common laws, alleging that Forest engaged in an off-label marketing scheme and paid illegal kickbacks to physicians to induce prescriptions of Celexa ® and Lexapro ® . The court granted Forest’s motion to dismiss this complaint in its December 12, 2014 ruling. On August 28, 2014, an action was filed in the federal district court in Washington seeking to certify a nationwide class of consumers and subclasses of Washington and Massachusetts consumers that purchased Celexa ® and Lexapro ® for pediatric use. The complaint asserts claims under the federal Racketeer Influenced and Corrupt Organizations Act, alleging that Forest engaged in off-label marketing scheme and paid illegal kickbacks to physicians to induce prescriptions of Celexa ® and Lexapro ® . Forest’s response to the complaint was filed on December 19, 2014.

Forest and certain of its affiliates are also named as defendants in two actions filed on behalf of entities or individuals who purchased or reimbursed certain purchases of Celexa ® and Lexapro ® for pediatric use pending in the Missouri state court. These claims arise from similar allegations as those contained in the federal actions described in the preceding paragraphs. One action, filed on November 6, 2009, was brought by two entities that purchased or reimbursed certain purchases of Celexa ® and/or Lexapro ® . The complaint asserts claims under the Missouri consumer protection statute and Missouri common law, and seeks unspecified damages and attorneys’ fees. The other action, filed on July 22, 2009, was filed as a putative class action on behalf of a class of Missouri citizens who purchased Celexa ® for pediatric use. The complaint asserts claims under the Missouri consumer protection statute and Missouri common law, and seeks unspecified damages and attorneys’ fees. In October 2010, the court certified a class of Missouri domiciliary citizens who purchased Celexa ® for pediatric use at any time prior to the date of the class certification order, but who do not have a claim for personal injury. The Company reached agreements with both sets of plaintiffs in the Missouri actions to resolve each matter for payments that are not material to our financial condition or results of operations.

The Company intends to continue to vigorously defend against these actions. At this time, the Company does not believe losses, if any, would have a material effect on the results of operations or financial position taken as a whole.

Columbia Laboratories, Inc. Securities Litigation . On June 8, 2012, Watson and certain of its officers were named as defendants in a consolidated amended class action complaint filed in the federal district court in New Jersey by a putative class of Columbia Laboratories’ stock purchasers. The amended complaint generally alleges that between December 6, 2010 and January 20, 2012, Watson and certain of its officers, as well as Columbia Laboratories and certain of its officers, made false and misleading statements regarding the likelihood of Columbia Laboratories obtaining FDA approval of Prochieve ® progesterone gel, Columbia Laboratories’ developmental drug for prevention of preterm birth. Watson licensed the rights to Prochieve ® from Columbia Laboratories in July 2010. The amended complaint further alleges that the defendants failed to disclose material information concerning the statistical analysis of the clinical studies performed by Columbia Laboratories in connection with its pursuit of FDA approval of Prochieve ® . The complaint seeks unspecified damages. On October 21, 2013, the court granted the defendants’ motion to dismiss the second amended complaint. Plaintiffs appealed this decision. On March 10, 2015, the Third Circuit Court of Appeals court issued its ruling affirming the district court’s dismissal of the plaintiffs’ amended complaint. Plaintiffs did not file a petition for certiorari with the United States Supreme Court.

 

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Forest Laboratories Securities Litigation.  In February and March 2014, several putative stockholder class actions were brought against Forest, Forest’s directors, Actavis plc, and certain of Actavis’s affiliates. Four actions were filed in the Delaware Court of Chancery and in New York State Supreme Court. The amended complaints in these actions seek, among other remedies, to enjoin Actavis’s proposed acquisition of Forest or damages in the event the transaction closes. The complaints generally allege, among other things, that the members of the Forest Board of Directors breached their fiduciary duties by agreeing to sell Forest for inadequate consideration and pursuant to an inadequate process, and that the disclosure document fails to disclose allegedly material information about the transaction. The complaints also allege that Actavis, and certain of its affiliates, aided and abetted these alleged breaches. On May 28, 2014, the defendants reached an agreement in principle with plaintiffs to settle both actions. The parties entered into a definitive stipulation of settlement on February 6, 2015 that remains subject to customary conditions, including court approval. A fairness hearing has not yet been scheduled. If the settlement is finally approved by the court, it will resolve and release all claims in all actions that were or could have been brought challenging any aspect of the proposed transaction, the merger agreement, and any disclosure made in connection therewith, including in the Definitive Joint Proxy Statement/Prospectus. There can be no assurance that the court will approve the proposed settlement. If the proposed settlement is not approved, the proposed settlement may be terminated. At this time, the Company does not believe losses, if any, would have a material effect on the results of operations or financial position taken as a whole.

Furiex Securities Litigation . In May 2014, four putative stockholder class actions were brought against Forest, Furiex Pharmaceuticals, Inc. (“Furiex”), and Furiex’s board of directors in the Delaware Court of Chancery and in North Carolina state court. These actions alleged, among other things, that the members of the Furiex Board of Directors breached their fiduciary duties by agreeing to sell Furiex for inadequate consideration and pursuant to an inadequate process. These actions also alleged that Forest aided and abetted these alleged breaches. These actions sought class certification, to enjoin the proposed acquisition of Furiex, and an award of unspecified damages, attorneys’ fees, experts’ fees, and other costs. Two of the actions also sought rescission of the acquisition and unspecified rescissory damages if the acquisition was completed. On June 23, 2014, the defendants reached an agreement in principle with plaintiffs regarding a settlement of all actions, and on January 15, 2015, the parties entered into a stipulation of settlement which is subject to court approval. A fairness hearing has not yet been scheduled. If the settlement is finally approved by the court, it will resolve and release all claims in all four actions that were or could have been brought challenging any aspect of the proposed transaction and any disclosure made in connection therewith. There can be no assurance that the court will approve the settlement. In such event, the proposed settlement may be terminated. At this time, the Company does not believe losses, if any, would have a material effect on the results of operations or financial position taken as a whole.

Mezzion Declaratory Judgment Action . On April 8, 2014, Warner Chilcott Company, LLC filed a declaratory judgment action against Mezzion Pharma Co. Ltd. (“Mezzion”), a Korean pharmaceutical company formerly known as Dong-A PharmaTech Co. Ltd. The suit was filed to protect Warner Chilcott Company, LLC’s rights and interests under an exclusive license and distribution agreement, involving Mezzion’s product udenafil that is used to treat erectile dysfunction and benign prostate hyperplasia. On January 22, 2015, the Company and Mezzion reached an agreement to settle the litigation.

Telephone Consumer Protection Act Litigation. A putative class action complaint against Anda, Inc. (“Anda”), a subsidiary of the Company, in Missouri state court alleging conversion and alleged violations of the Telephone Consumer Protection Act (“TCPA”) and Missouri Consumer Fraud and

 

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Deceptive Business Practices Act. An amended complaint alleges that by sending unsolicited facsimile advertisements, Anda misappropriated the class members’ paper, toner, ink and employee time when they received the alleged unsolicited faxes, and that the alleged unsolicited facsimile advertisements were sent to the plaintiff in violation of the TCPA and Missouri Consumer Fraud and Deceptive Business Practices Act. The complaint seeks to assert class action claims on behalf of the plaintiff and other similarly situated third parties. On May 19, 2011, the plaintiff’s filed a motion seeking certification of a class of entities with Missouri telephone numbers who were sent Anda faxes for the period January 2004 through January 2008 but the court vacated the class certification hearing until the FCC Petition, described in more detail below, was addressed. On May 1, 2012, a separate action was filed in federal court in Florida, purportedly on behalf of the “end users of the fax numbers in the United States but outside Missouri to which faxes advertising pharmaceutical products for sale by Anda were sent.” On July 10, 2012, Anda filed its answer and affirmative defenses. The parties filed a joint motion to stay the action pending the resolution of the FCC Petition which the court granted. In addition, in October 2012, Forest and certain of its affiliates were named as defendants, in a putative class action in federal court in Missouri. This suit alleges that Forest and another defendant violated the TCPA and was filed on behalf of a proposed class that includes all persons who, from four years prior to the filing of the action, were sent telephone facsimile messages of material advertising the commercial availability of any property, goods, or services by or on behalf of defendants, which did not display an opt-out notice compliant with a certain regulation promulgated by the FCC. On July 17, 2013, the district court granted Forest’s motion to stay the action pending the administrative proceeding initiated by the pending FCC Petition and a separate petition Forest filed.

In a related matter, in November 2010 Anda filed a petition with the FCC, asking the FCC to clarify the statutory basis for its regulation requiring “opt-out” language on faxes sent with express permission of the recipient (the “FCC Petition”). On May 2, 2012, the Consumer & Governmental Affairs Bureau of the FCC dismissed the FCC Petition. On May 14, 2012, Anda filed an application for review of the Bureau’s dismissal by the full Commission, requesting the FCC to vacate the dismissal and grant the relief sought in the FCC Petition. The FCC did not rule on the application for review. On June 27, 2013, Forest filed a Petition for Declaratory Ruling with the FCC requesting that the FCC find that (1) the faxes at issue in the action complied, or substantially complied with the FCC regulation, and thus did not violate it, or (2) the FCC regulation was not properly promulgated under the TCPA. On January 31, 2014, the FCC issued a Public Notice seeking comment on several other recently-filed petitions, all similar to the one Anda filed in 2010. On October 30, 2014, the FCC issued a final order on the FCC Petition granting Anda, Forest and several other petitioners a retroactive waiver of the opt-out notice requirement for all faxes sent with express consent. The litigation plaintiffs, who had filed comments on the January 2014 Public Notice, have appealed the final order to the Court of Appeals for the District of Columbia. Anda, Forest and other petitioners have moved to intervene in the appeal seeking review of that portion of the FCC final order addressing the statutory basis for the opt out/express consent portion of the regulation.

Anda and Forest believe they have substantial meritorious defenses to the putative class actions brought under the TCPA, and intend to defend the actions vigorously. However, these actions, if successful, could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Prescription Drug Abuse Litigation . On May 21, 2014, the California counties Santa Clara and Orange filed a lawsuit in California state court on behalf of the State of California against several pharmaceutical manufacturers. Plaintiffs named Actavis plc in the suit. The California plaintiffs filed an amended complaint on June 9, 2014. On June 2, 2014, the City of Chicago also filed a complaint in Illinois state court against the same set of defendants, including Actavis plc, that were sued in the California Action. Co-defendants in the action removed the matter to the federal court in Illinois. Both the California and Chicago complaints allege that the manufacturer defendants engaged in a deceptive

 

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campaign to promote their products in violation of state and local laws. Each of the complaints seeks unspecified monetary damages, penalties and injunctive relief. Defendants have moved to dismiss the complaints in each action. The Company anticipates that additional suits will be filed. The Company believes it has several meritorious defenses to the claims alleged. However, an adverse determination in these actions could have an adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Testosterone Replacement Therapy Class Action . On November 24, 2014, the Company was served with a putative class action complaint filed on behalf a class of third party payers in federal court in Illinois. The suit alleges that the Company and other named pharmaceutical defendants violated various laws including the federal Racketeer Influenced and Corrupt Organizations Act and state consumer protection laws in connection with the sale and marketing of certain testosterone replacement therapy pharmaceutical products (“TRT Products”), including the Company’s Androderm ® product. This matter was filed in the TRT Products Liability MDL, described in more detail below, notwithstanding that it is not a product liability matter. Plaintiff alleges that it reimbursed third parties for dispensing TRT Products to beneficiaries of its insurance policies. Plaintiff seeks to obtain certain equitable relief, including injunctive relief and an order requiring restitution and/or disgorgement, and to recover damages and multiple damages in an unspecified amount. Defendants filed a joint motion to dismiss the complaint. The Company believes it has substantial meritorious defenses to the claims alleged and intends to vigorously defend the action. However, an adverse determination in the case could have an adverse effect on the Company’s business, results of operations, financial condition and cash flows.

TNS Products Litigation . On March 19, 2014, a complaint was filed in the federal district court in California. The complaint alleges violations of the California Unfair Competition Law, the Consumers Legal Remedies Act, and the False Advertising Law, and deceit. On June 2, 2014, Plaintiff filed a first amended complaint. On June 23, 2014, Allergan filed a motion to dismiss the first amended complaint. On September 5, 2014, the court granted-in-part and denied-in-part Allergan’s motion to dismiss. On September 8, 2014, the court set trial for September 1, 2015. On November 4, 2014, Allergan and SkinMedica filed a motion to dismiss. On January 7, 2015, Allergan and SkinMedica’s motion to dismiss was denied. The Company believes it has substantial meritorious defenses and intends to defend itself vigorously. However, these actions, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

West Virginia Prescription Drug Abuse Litigation . On June 26, 2012, the State of West Virginia filed a lawsuit against multiple distributors of prescription drugs, including Anda. The complaint generally alleges that the defendants distributed prescription drugs in West Virginia in violation of state statutes, regulation and common law. The complaint seeks injunctive relief and unspecified damages and penalties. On January 3, 2014, plaintiff filed an amended complaint which the defendants moved to dismiss. On December 16, 2014, the court issued an order denying the defendants’ motion to dismiss. The case is in its preliminary stages and the Company believes it has substantial meritorious defenses to the claims alleged. However, an adverse determination in the case could have an adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Employment Litigation

In July 2012, Forest and certain of its affiliates were named as defendants in an action brought by certain former company sales representatives and specialty sales representatives in the federal district court in New York. The action is a putative class and collective action, and alleges class claims under Title VII for gender discrimination with respect to pay and promotions, as well as discrimination on the basis of pregnancy, and a collective action claim under the Equal Pay Act. The proposed Title VII gender

 

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class includes all current and former female sales representatives employed by the Company throughout the U.S. from 2008 to the date of judgment, and the proposed Title VII pregnancy sub-class includes all current and former female sales representatives who have been, are, or will become pregnant while employed by the Company throughout the U.S. from 2008 to the date of judgment. The proposed Equal Pay Act collective action class includes current, former, and future female sales representatives who were not compensated equally to similarly-situated male employees during the applicable liability period. The Second Amended Complaint also includes non-class claims on behalf of certain of the named Plaintiffs for sexual harassment and retaliation under Title VII, and for violations of the Family and Medical Leave Act. On August 14, 2014, the court issued a decision on the Company’s motion to dismiss, granting it in part and denying it in part, striking the plaintiffs’ proposed class definition and instead limiting the proposed class to a smaller set of potential class members and dismissing certain of the individual plaintiffs’ claims. Plaintiffs have until May 15, 2015 to file a motion for conditional certification of the Equal Pay Act class. The litigation is still in its early stages and the parties are beginning to work on discovery matters. The Company intends to continue to vigorously defend against this action. At this time, the Company does not believe losses, if any, would have a material effect on the results of operations or financial position taken as a whole.

FDA Litigation

In May 2002, Company subsidiary Watson Laboratories, Inc. reached an agreement with the FDA on the terms of a consent decree with respect to its Corona, California manufacturing facility. The court approved the consent decree on May 13, 2002 ( United States of America v. Watson Laboratories, Inc., et. al ., United States District Court for the Central District of California, EDCV-02-412-VAP). The consent decree applies only to the Company’s Corona, California facility and not other manufacturing sites. The decree requires that the Corona, California facility complies with the FDA’s current Good Manufacturing Practices (“cGMP”) regulations.

Pursuant to the agreement, the Company hired an independent expert to conduct inspections of the Corona facility at least once each year. In February 2014 the independent expert concluded its most recent inspection of the Corona facility. At the conclusion of the inspection, the independent expert reported its opinion to the FDA that, based on the findings of the audit of the facility, the FDA’s applicable cGMP requirements, applicable FDA regulatory guidance, and the collective knowledge, education, qualifications and experience of the expert’s auditors and reviewers, the systems at the Corona facility audited and evaluated by the expert are in compliance with the FDA’s cGMP regulations. However, the FDA is not required to accept or agree with the independent expert’s opinion. The FDA has conducted periodic inspections of the Corona facility since the entry of the consent decree, and concluded its most recent general cGMP inspection in April 2014. At the conclusion of the inspection, the FDA inspectors issued a Form 483 to the facility identifying certain observations concerning the instances where the facility failed to follow cGMP regulations. The facility recently responded to the Form 483 observations. If in the future, the FDA determines that, with respect to its Corona facility, the Company has failed to comply with the consent decree or FDA regulations, including cGMPs, or has failed to adequately address the FDA’s inspectional observations, the consent decree allows the FDA to order a variety of actions to remedy the deficiencies. These actions could include ceasing manufacturing and related operations at the Corona facility, and recalling affected products. Such actions, if taken by the FDA, could have a material adverse effect on the Company, its results of operations, financial position and cash flows.

Patent Litigation

Patent Enforcement Matters

Amrix ® . In August 2014, Aptalis Pharmatech, Inc. (“Aptalis”) and Ivax International GmbH (“Ivax”), Aptalis’s licensee for Amrix, brought an action for infringement of U.S. Patent No. 7,790,199

 

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(the “‘199 patent”), and 7,829,121 (the “‘121 patent”) in the U.S. District Court for the District of Delaware against Apotex Inc. and Apotex Corp. (collectively “Apotex”). Apotex has notified Aptalis that it has filed an ANDA with the FDA seeking to obtain approval to market a generic version of Amrix before these patents expire. (The ‘199 and ‘121 patents expire in November 2023.) This lawsuit triggered an automatic stay of approval of Apotex’s ANDA until no earlier than December 27, 2016 (unless a court issues a decision adverse to Forest sooner, and subject to any other exclusivities, such as a first filer 180 day market exclusivity). Trial is scheduled to begin on November 16, 2015. The Company believes it has meritorious claims to prevent the generic applicant from launching a generic version of Amrix. However, there can be no assurance a generic version will not be launched.

Atelvia ® . In August and October 2011 and March 2012, Warner Chilcott received Paragraph IV certification notice letters from Watson Laboratories, Inc. – Florida (together with Actavis, Inc. (formerly Watson Pharmaceuticals, Inc.) and its subsidiaries, “Actavis”), Teva and Ranbaxy Laboratories Ltd. (together with its affiliates, “Ranbaxy”) indicating that each had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of Atelvia ® 35 mg tablets (“Atelvia ® ”). The notice letters contend that Warner Chilcott’s U.S. Patent Nos. 7,645,459 (the “‘459 Patent”) and 7,645,460 (the “‘460 Patent”), two formulation and method patents expiring in January 2028, are invalid, unenforceable and/or not infringed. Warner Chilcott filed a lawsuit against Actavis in October 2011, against Teva in November 2011 and against Ranbaxy in April 2012 in the U.S. District Court for the District of New Jersey charging each with infringement of the ‘459 Patent and ‘460 Patent. On August 21, 2012, the United States Patent and Trademark Office issued to the Company U.S. Patent No. 8,246,989 (the “‘989 Patent”), a formulation patent expiring in January 2026. The Company listed the ‘989 Patent in the FDA’s Orange Book, each of Actavis, Teva and Ranbaxy amended its Paragraph IV certification notice letter to contend that the ‘989 Patent is invalid and/or not infringed, and Warner Chilcott amended its complaints against Actavis, Teva and Ranbaxy to assert the ‘989 Patent. On October 2, 2013, Actavis divested its ANDA to Amneal Pharmaceuticals. In September 2013, Warner Chilcott received a Paragraph IV certification notice letter from Impax Laboratories, Inc. indicating that it had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of Atelvia ® . Warner Chilcott filed a lawsuit against Impax on October 23, 2013, asserting infringement of the ‘459, ‘460, and ‘989 patents. On June 13, June 30, and July 15, 2014, the Company entered into settlement agreements with Ranbaxy, Amneal and Impax, respectively. Each agreement permits Ranbaxy, Amneal and Impax to launch generic versions of Atelvia ® on July 9, 2025, or earlier in certain circumstances. Trial against Teva began on July 14, 2014 and concluded on July 18, 2014. On March 4, 2015, the District Court ruled that the claims at issue in the litigation are invalid for obviousness. The Company intends to appeal this ruling. On March 5, 2015, the Company filed a motion for entry of an injunction or stay pending appeal seeking to enjoin Teva from launching a generic version of Atelvia pending such appeal. On March 30, 2015, the District Court denied the Company’s motion for entry of an injunction or stay during the pendency of an appeal, but temporarily enjoined Teva from launching its generic product for 10 business days following entry of the order so that the Company could move before the Federal Circuit for an injunction pending appeal. On April 27, 2015, the Federal Circuit temporarily enjoined Teva from launching its generic product pending resolution of the Company’s motion for an injunction pending appeal.

While the Company intends to vigorously defend the ‘459 Patent, the ‘460 Patent, and the ‘989 Patent and pursue its legal rights, the Company can offer no assurance as to when the lawsuit will be decided, whether such lawsuit will be successful or that a generic equivalent of Atelvia ® will not be approved and enter the market prior to the July 9, 2025 settlement dates above.

Canasa ® . In July 2013, Aptalis Pharma US, Inc. and Aptalis Pharma Canada Inc. brought actions for infringement of U.S. Patent Nos. 8,217,083 (the “‘083 patent”) and 8,436,051 (the “‘051 patent”) in the U.S. District Court for the District of New Jersey against Mylan and Sandoz. These companies have notified Aptalis that they have filed ANDAs with the FDA seeking to obtain approval to market generic versions of Canasa ® before these patents expire. Amended complaints were filed against these companies

 

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in November 2013 adding claims for infringement of U.S. Patent No. 7,854,384 (the “‘384 patent”). The ‘083, ‘051, and ‘384 patents expire in June 2028. No trial date has been set. The Company believes it has meritorious claims to prevent the generic applicants from launching a generic version of Canasa ® . However, there can be no assurance a generic version will not be launched.

Combigan ® I . After Sandoz, Inc. (“Sandoz”), Alcon Research, Ltd. and its affiliates (“Alcon”), Hi-Tech, Apotex, Watson Pharma, Inc. and Watson Pharmaceuticals, Inc. (“Watson,” and collectively, the “Combigan Defendants”) each filed an ANDA seeking approval of generic forms of Combigan®, a brimonidine tartrate 0.2%, timolol 0.5% ophthalmic solution, Allergan, Inc. (“Allergan”) received Paragraph IV invalidity and noninfringement certifications from the Combigan Defendants contending that U.S. Patent Numbers 7,030,149, 7,320,976, 7,323,463 and 7,642,258 (the “Combigan Patents”) are invalid or not infringed by the proposed generic products. Allergan filed a complaint against the Combigan Defendants in the U.S. District Court for the Eastern District of Texas, Marshall Division, alleging infringement of the Combigan Patents. Before trial, Allergan settled with Hi-Tech. In 2011, the U.S. District Court held a bench trial and issued its opinion holding that the Combigan Patents are not invalid and are infringed by defendants’ proposed products, and entered a final judgment and injunction in Allergan’s favor. In May 2013, the U.S. Court of Appeals for the Federal Circuit affirmed the ruling of the U.S. District Court finding that U.S. Patent Number 7,030,149 is not invalid, affirmed the District Court’s claim construction ruling and reversed the District Court’s ruling finding that the asserted claims of U.S. Patent Number 7,323,463 are not invalid; the Court of Appeals declined to address the claims regarding U.S. Patent Numbers 7,320,976 and 7,642,258. In January 2014, Sandoz and Alcon filed a Petition for Writ of Certiorari to the U.S. Supreme Court appealing this Court of Appeals ruling. In September and October 2013, Sandoz, Alcon, and Apotex filed a motion seeking to modify the permanent injunction issued by the U.S. District Court for the Eastern District of Texas. In December 2013, the U.S. District Court for the Eastern District of Texas denied Sandoz, Alcon, and Apotex’s motion to modify the permanent injunction. In February 2014, Sandoz, Alcon and Apotex filed a Notice of Appeal to the U.S. Court of Appeals for the Federal Circuit appealing this District Court ruling. In March 2014, the U.S. Supreme Court denied Sandoz, Inc., Alcon Research, Ltd. and Falcon Pharmaceuticals, Ltd.’s Petition for Writ of Certiorari. In December 2014, the U.S. Court of Appeals for the Federal Circuit heard oral argument and affirmed the decision of the U.S. District Court for the Eastern District of Texas denying Sandoz, Alcon, and Apotex’s amended motion to modify the injunction. In February 2015, Sandoz and Alcon filed a petition for panel rehearing and rehearing en banc. In April 2015, the U.S. Court of Appeals for the Federal Circuit denied Sandoz and Alcon’s Petition for rehearing and rehearing en banc. In April 2015, Allergan filed a stipulated voluntary dismissal of the Apotex defendants with respect to the rehearing petition appeal. On April 28, 2015, the District Court for the Eastern District of Texas entered the Mandate of the U.S. Court of Appeals for the Federal Circuit.

Combigan ® II . In 2012, Allergan filed a complaint against Sandoz, Alcon, Apotex and Watson in the U.S. District Court for the Eastern District of Texas, Marshall Division, alleging that their proposed products infringe U.S. Patent Number 8,133,890 (“‘890 Patent”), and subsequently amended their complaint to assert infringement of U.S. Patent Number 8,354,409. In March 2013, Allergan received a Paragraph IV invalidity and noninfringement certification from Sandoz, contending that the ‘890 Patent is invalid and not infringed by the proposed generic product. In October 2013, Allergan filed a motion to stay and administratively close the Combigan II matter, which was granted. In April 2015, Allergan filed a stipulation of dismissal and the U.S. District Court granted the Order with respect to the Watson defendants.

Combigan ® III . On January 26, 2015, Allergan received a Paragraph IV letter from Sandoz contending that U.S. Patent Numbers 7,030,149, 7,320,976, 7,642,258, and 8,748,425 are invalid and not infringed by the proposed generic product. In March 2015, Allergan filed a complaint against Sandoz in the U.S. District Court for the Eastern District of Texas, Marshall Division, alleging that their proposed products infringe U.S. Patent Numbers 7,030,149, 7,320,976, 7,642,258, and 8,748,425 (the “Combigan Patents”).

 

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Combigan ® IPR . On March 10, 2015, Allergan received a notification letter that an Inter Partes Review of the USPTO (“IPR”) petition was filed by Ferrum Ferro Capital, LLC (“FFC”) regarding U.S. Patent No. 7,030,149, expiring in April 2022 (the “’149 Patent”). FFC filed the IPR petition on March 9, 2015.

Enablex ® . On December 18, 2013, Warner Chilcott Company LLC and Warner Chilcott (US) LLC sued Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. (together “Torrent”) in the United States District Court for the District of Delaware, alleging that sales of Torrent’s darifenacin tablets, a generic version of Warner Chilcott’s Enablex ® , would infringe U.S. Patent No. 6,106,864 (the ‘864 patent). The complaint seeks injunctive relief. Pursuant to the provisions of the Hatch-Waxman Act, the FDA is precluded from granting final approval to Torrent until the earlier of thirty months after the generic applicant provided Warner Chilcott with notice of its ANDA filing or the generic applicant prevails in the pending litigation, subject to any other exclusivities, such as a first filer 180 day market exclusivity.

On June 6, 2014, Warner Chilcott Company LLC and Warner Chilcott (US) LLC sued Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC (together “Amneal”) in the United States District Court for the District of Delaware, alleging that sales of Amneal’s darifenacin tablets, a generic version of Warner Chilcott’s Enablex ® , would infringe the ‘864 patent. The complaint seeks injunctive relief. Pursuant to the provisions of the Hatch-Waxman Act, the FDA is precluded from granting final approval to Amneal until the earlier of thirty months after the generic applicant provided Warner Chilcott with notice of its ANDA filing or the generic applicant prevails in the pending litigation, subject to any other exclusivities, such as a first filer 180 day market exclusivity. On July 7, 2014, the Company settled with Torrent. The Company also settled with Amneal on September 24, 2014. The Company has also received a Notice Letter dated June 19, 2014 from Apotex Corp et al. and an analogous complaint was filed.

Under the settlement agreements entered into in the third quarter of 2010 to resolve outstanding patent litigation, each of Teva, Anchen Pharmaceuticals, Inc. and Watson agreed not to launch a generic version of Enablex ® until the earlier of March 15, 2016 (or June 15, 2016, if a 6-month pediatric extension of regulatory exclusivity is granted) or, among other circumstances, (i) the effective date of any license granted to a third party for a generic Enablex product or (ii) in the event a third party launches a generic Enablex ® product “at risk” and injunctive relief is not sought or granted.

The Company believes it has meritorious claims to prevent Apotex from launching a generic version of Enablex. However, if Apotex prevails in the pending litigation or if Amneal or another ANDA filer launches a generic version of Enablex ® before the pending or any subsequent litigation is finally resolved, it could have an adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Generess ® Fe . On November 22, 2011, Warner Chilcott Company sued Mylan Inc., Mylan Pharmaceuticals Inc. and Famy Care Ltd. in the United States District Court for the District of New Jersey, alleging that sales of norethindrone and ethinyl estradiol and ferrous fumarate tablets, a generic version of Warner Chilcott’s Generess ® Fe tablets (which is exclusively licensed by Warner Chilcott), would infringe U.S. Patent No. 6,667,050 (the ‘050 patent). The complaint seeks injunctive relief. On December 12, 2011 Warner Chilcott sued Lupin Ltd. and Lupin Pharmaceuticals, Inc. in the United States District Court for the District of New Jersey, alleging that sales of Lupin’s generic version of Generess ® Fe would infringe the ‘050 patent. The trial concluded on February 21, 2014. On April 14, 2014 Warner Chilcott reached an agreement with Mylan and the counterparties to settle their case. Under the terms of the settlement, Mylan may launch its ANDA product on April 1, 2015, or Mylan can launch an authorized

 

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generic version of Generess on October 1, 2015. The litigation against Lupin is still pending. On April 29, 2014, the district court ruled that the ‘050 patent is invalid. Warner Chilcott has appealed the decision and the appeal is currently pending. The Company believes Warner Chilcott has meritorious claims on appeal. Lupin and the Company have entered into a settlement agreement and have moved the District Court for an indicative ruling that it would vacate the prior decision if the pending appeal is remanded. On April 8, 2015, the District Court granted the parties’ motion. However, the appeal is not remanded and if Lupin prevails in the pending litigation or launches a generic version of Generess ® Fe it could have an adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Juvéderm ® XC . In September 2013, Allergan filed a complaint against Medicis Aesthetics, Inc., Medicis Pharmaceutical Corp., Valeant Pharmaceuticals North America LLC, Valeant Pharmaceuticals International, and Valeant Pharmaceuticals International, Inc. (collectively, “Medicis”) in the U.S. District Court for the Central District of California alleging that defendants’ products, Perlane L and Restylane L, infringe U.S. Patent No. 8,450,475, expiring in December 2030 (the “’475 patent”). In December 2013, Allergan filed an amended complaint alleging that defendants’ products infringe the ‘475 patent and U.S. Patent No. 8,357,795, expiring in October 2030 (the “’795 patent”).

In February 2014, the court scheduled a jury trial for August 4, 2015. In November 2014, Allergan filed a second amended complaint adding as a defendant Galderma Laboratories LP.

In March 2015, Allergan filed a motion for partial summary judgment that the patents in suit are not invalid for prior use. On March 26, 2015, Allergan filed a motion to strike defendants’ untimely evidence regarding alleged prior use and the court set oral argument regarding the motion for partial summary judgment and the motion to strike for June 1, 2015.

Juvéderm XC IPR . On September 2, 2014, Allergan received notification letters that an IPR of the USPTO was filed by Galderma S.A. & Q-Med AB (collectively, “Galderma”) regarding U.S. Patent Nos. 8,450,475 (the “’475 patent”) and 8,357,795 (the “’795 patent”). Galderma filed the IPR petition on August 29, 2014. In March 2015, the USPTO denied Galderma’s petition. In April 2015, Galderma filed a petition for rehearing with the USPTO.

Latisse ® . After Apotex, Sandoz, Hi-Tech and Watson each filed an ANDA seeking approval of a generic form of Latisse® 0.03% bimatoprost ophthalmic solution, Allergan received Paragraph IV invalidity and noninfringement certifications from Apotex, Sandoz, Hi-Tech and Watson contending that U.S. Patent Numbers 7,351,404 (“‘404 Patent”), 7,388,029 (“‘029 Patent”), 8,038,988 (“‘988 Patent”) and 8,101,161 (“‘161 Patent”) are invalid or not infringed by the proposed generic products. Allergan, with Duke University (“Duke”), filed complaints against Sandoz, Alcon, Apotex and Watson in the U.S. District Court for the Middle District of North Carolina alleging that their proposed products infringe the ‘404, ‘029, ‘988 and ‘161 Patents.

 

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In 2012, the U.S. District Court commenced a bench trial on the ‘404 and ‘029 Patents in the Apotex, Sandoz, and Hi-Tech actions. In January 2013, the U.S. District Court issued its opinion holding that the ‘404 and ‘029 Patents are not invalid and are infringed by Apotex, Sandoz, and Hi-Tech’s proposed products and entered a final judgment in Allergan’s favor and against these defendants. In February 2013, the U.S. District Court issued judgment for Allergan and Duke against Watson, finding that the ‘404 and ‘029 Patents are not invalid and are infringed by Watson’s proposed product. In February 2013, Allergan and Duke filed motions for permanent injunction as to Apotex, Sandoz, Hi-Tech and Watson. In February 2013, Apotex, Sandoz and Hi-Tech filed a Notice of Appeal. The U.S. District Court has not yet set a trial date for the actions on the ‘988 and ‘161 Patents.

In January 2013, Allergan filed a complaint against Apotex, Sandoz, Hi-Tech and Watson in the U.S. District Court for the Middle District of North Carolina alleging that the defendants’ proposed products infringe U.S. Patent Number 8,263,054 (“054 Patent”). No trial date has been set. In April 2013, the U.S. District Court granted Allergan and Duke’s motions for permanent injunction as to Apotex, Sandoz, Hi-Tech, and Watson. In April 2013, the U.S. District Court for the Middle District of North Carolina entered a permanent injunction against Apotex, Sandoz, Hi-Tech, and Watson. In May 2013, the U.S. Court of Appeals for the Federal Circuit denied Allergan’s motion to dismiss Apotex, Sandoz, and Hi-Tech’s appeal, but granted it with respect to Watson. In May 2013, Watson filed an amended notice of appeal and its appeal was consolidated with that of Apotex, Sandoz, and Hi-Tech. In February 2014, the U.S. Court of Appeals for the Federal Circuit heard oral argument on Apotex, Sandoz, Hi-Tech, and Watson’s appeal regarding the ‘404 and ‘029 Patents and took the matter under submission. In June 2014, the U.S. Court of Appeals for the Federal Circuit reversed the finding of the U.S. District Court for the Middle District of North Carolina and held that U.S. Patent Numbers 7,351,404 and 7,388,029 are invalid.

In June 2014, Apotex filed an ANDA seeking approval of a generic form of Latisse® 0.03% bimatoprost ophthalmic solution. Allergan subsequently received a Paragraph IV invalidity and noninfringement certification from Apotex contending that U.S. Patent Numbers 8,632,760 (“‘760 Patent”) and 8,541,466 (“‘466 Patent”) are invalid or not infringed by Apotex’s proposed generic product.

In June 2014, Sandoz filed an ANDA seeking approval of a generic form of Latisse ® 0.03% bimatoprost ophthalmic solution. Allergan subsequently received a Paragraph IV invalidity and noninfringement certification from Sandoz contending that U.S. Patent Numbers 8,038,988 (“‘988 Patent”); 8,101,161 (“‘161 Patent”); 8,263,054 (“‘054 Patent”); ‘760 Patent, and ‘466 Patent are invalid or not infringed by Sandoz’s proposed generic product.

In August 2014, Allergan received Paragraph IV invalidity and noninfringement certifications from Apotex contending that U.S. Patent Number 8,758,733 (the “’733 Patent”) is invalid or not infringed by Apotex’s proposed generic product.

In August 2014, Allergan and Duke filed a petition for panel rehearing or rehearing en banc in the U.S. Court of Appeals for the Federal Circuit, which was denied in September 2014. In September 2014, the U.S. Court of Appeal for the Federal Circuit issued a mandate. In October 2014, Allergan filed a Petition for Writ of Certiorari to the U.S. Supreme Court appealing the Court of Appeals’ ruling. In January 2015, the U.S. Supreme Court denied Allergan’s Petition for Writ of Certiorari.

Latisse ® III . In December 2014, Allergan and Duke filed a complaint for declaratory judgment of infringement of U.S. Patent Nos. 8,906,962 (“‘962 Patent”) against Apotex. In January 2015, Allergan and Duke subsequently filed an amended complaint against Apotex to assert infringement of U.S. Patent Number 8,926,953 (“‘953 Patent”). In March 2015, Allergan and Duke filed a second amended complaint asserting only the ‘953 Patent. Apotex filed a motion to dismiss for failure to state a claim with respect to the ‘953 Patent.

 

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In December 2014, Allergan and Duke filed a complaint for infringement of U.S. Patent No. 8,906,962 (“‘962 Patent”) against Sandoz, Inc. (“Sandoz”), Akorn, Inc. (“Akorn”), Hi-Tech Parmacal Co., Inc. (“Hi-Tech”), and Actavis, Inc., Watson Laboratories, Inc., and Actavis Pharma, Inc. (collectively, “Actavis”). In January 2015, Allergan and Duke subsequently filed an amended complaint against Sandoz, Akorn, Hi-Tech, and Actavis to assert infringement of U.S. Patent Number 8,926,953 (“‘953 Patent”). In March 2015, Allergan filed a notice of voluntary dismissal as to the Actavis defendants. In March 2015, Allergan and Duke filed a second amended complaint asserting only the ‘953 Patent.

Lo Loestrin ® Fe . In July 2011 and April 2012, Warner Chilcott received Paragraph IV certification notice letters from Lupin and Actavis indicating that each had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of Warner Chilcott’s oral contraceptive, Lo Loestrin ® Fe. The notice letters contend that the ‘394 Patent and Warner Chilcott’s U.S. Patent No. 7,704,984 (the “‘984 Patent”), which cover Lo Loestrin ® Fe and expire in 2014 and 2029, respectively, are invalid and/or not infringed. Warner Chilcott filed a lawsuit against Lupin in September 2011 and against Actavis in May 2012 in the U.S. District Court for the District of New Jersey charging each with infringement of the ‘394 Patent and the ‘984 Patent. On October 2, 2013, Actavis divested its ANDA to Amneal Pharmaceuticals. On January 17, 2014, the district court issued its decision that the ‘984 Patent is valid and infringed by Lupin’s and Amneal’s respective ANDAs and the United States Court of Appeals for the Federal Circuit issued its decision affirming the District Court and upholding the validity of the ‘984 patent on October 22, 2014.

In September 2013, Warner Chilcott received Paragraph IV certification notice letter from Mylan and Famy Care indicating that they had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of Warner Chilcott’s oral contraceptive, Lo Loestrin ® Fe. The notice letter contends that Warner Chilcott’s ‘984 Patent, which covers Lo Loestrin ® Fe and expires in 2029, is invalid and/or not infringed. Warner Chilcott filed a lawsuit against Mylan in October 2013 in the U.S. District Court for the District of New Jersey charging Mylan and Famy Care with infringement of the ‘984 Patent. The complaint seeks injunctive relief. The lawsuit results in a stay of FDA approval of Mylan and Famy Care’s ANDA for 30 months from the date of Warner Chilcott’s receipt of the notice letter, subject to the prior resolution of the matter before the court. The Mylan/Famy Care case is not consolidated with the Lupin case and is currently pending in the district court. On February 3, 2015, Mylan filed an Inter Partes Review before the Patent Trial and Appeal Board, U.S. Patent and Trademark Office, (No. 2015-00682), with respect to the ‘984 patent.

While the Company intends to vigorously defend the ‘984 Patent and pursue its legal rights, it can offer no assurance as to when the lawsuits will be decided, whether such lawsuits will be successful or that a generic equivalent of Lo Loestrin ® Fe will not be approved and enter the market prior to the expiration of the ‘984 Patent in 2029.

Lumigan ® 0.01% . After Sandoz, Lupin, Hi-Tech and Watson (the “Lumigan Defendants”) each filed an ANDA seeking approval of a generic form of Lumigan® 0.01% bimatoprost ophthalmic solution, Allergan received Paragraph IV invalidity and noninfringement certifications contending that U.S. Patent Numbers 7,851,504 and 5,688,819 (“Lumigan Patents”) are invalid or not infringed by the proposed generic products. Allergan filed complaints against the Lumigan Defendants in the U.S. District Court for the Eastern District of Texas alleging that their proposed products infringe the Lumigan Patents. In January 2013, Allergan filed an amended complaint against the Lumigan Defendants alleging that, in addition to the Lumigan Patents, the defendants’ proposed generic products infringe U.S. Patent Numbers 8,278,353, 8,299,118, 8,309,605, and 8,338,479 (“Additional Lumigan Patents”). In July 2013, a bench trial was held and the U.S. District Court for the Eastern District of Texas took the matter under submission. In 2013, after Lupin and Watson separately filed an ANDA with the FDA seeking approval

 

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to market a generic version of Lumigan® 0.01%, Allergan received Paragraph IV invalidity and noninfringement certifications from Lupin and Watson, contending that the Additional Lumigan Patents are invalid and not infringed by the proposed generic product. In January 2014, the U.S. District Court issued its opinion holding that the Lumigan Patents and Additional Lumigan Patents (excluding U.S. Patent Number 5,688,819, which claim was previously dismissed by Allergan) are not invalid and are infringed by the Lumigan Defendants’ proposed products and entered a final judgment and injunction in Allergan’s favor and against the Lumigan Defendants. In February 2014, the Lumigan Defendants filed a Notice of Appeal to the U.S. Court of Appeals for the Federal Circuit. In March 2015, the U.S. Court of Appeals for the Federal Circuit set oral argument for May 7, 2015.

Minastrin ® 24 Fe. On June 6, 2014, Warner Chilcott sued Lupin Atlantis Holdings SA, Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”) in the United States District Court for the District of Maryland, alleging that sales of Lupin’s norethindrone and ethinyl estradiol chewable tablets, a generic version of Warner Chilcott’s Minastrin ® 24 Fe, would infringe U.S. Patent 6,667,050 (the “‘050 patent”). The Complaint seeks an injunction. Pursuant to the provisions of the Hatch-Waxman Act, the FDA is precluded from granting final approval to the generic applicants until the earlier of thirty months after the generic applicant provided Warner Chilcott with notice of its abbreviated new drug application filing or the generic applicant prevails in the pending litigation. Warner Chilcott further notes that FDA will not approve any ANDA product before May 8, 2016 due to Minastrin ® 24 Fe’s new dosage form exclusivity, which expires on that date. The litigation against Lupin is pending. Warner Chilcott notes that on April 29, 2014, several of the claims of the ‘050 patent were declared invalid in the Generess litigation discussed above. Warner Chilcott has appealed the Generess decision and the appeal is currently pending. Lupin and the Company have entered into a settlement agreement and have moved the District Court in the Generess matter for an indicative ruling that it would vacate the decision in Generess if the pending appeal in that case is remanded. On April 8, 2015, the District Court granted the parties’ motion. The Company believes Warner Chilcott has meritorious claims on appeal. However, if the Generess decision is not vacated and if Lupin ultimately prevails in the Generess appeal, or in the instant litigation, it could have an adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Namenda XR ® . Between January and October 2014, Forest Laboratories, Inc., Forest Laboratories Holdings, Ltd. (collectively, “Forest”) and Merz Pharma and Adamas Pharmaceuticals, Forest’s licensors for Namenda XR (all collectively, “Plaintiffs”), brought actions for infringement of some or all of U.S. Patent Nos. 5,061,703 (the “‘703 patent”), 8,039,009 (the “’009 patent”), 8,168,209 (the “‘209 patent”), 8,173,708 (the “‘708 patent”), 8,283,379 (the “‘379 patent”), 8,329,752 (the “‘752 patent”), 8,362,085 (the “‘085 patent”), and 8,598,233 (the “‘233 patent”) in the U.S. District Court for the District of Delaware against Wockhardt, Teva, Sun, Apotex, Anchen, Zydus, Watson, Par, Mylan, Amneal, Ranbaxy, , and Amerigen, and related subsidiaries and affiliates thereof. These companies have notified Plaintiffs that they have filed ANDAs with the FDA seeking to obtain approval to market generic versions of Namenda XR before these certain patents expire. Including a 6-month pediatric extension of regulatory exclusivity, the ‘703 patent expires in October 2015, the ‘009 patent expires in September 2029, and the ‘209, ‘708, ‘379, ‘752, ‘085, and ‘233 patents expire in May 2026. These lawsuits triggered an automatic stay of approval of the applicable ANDAs that expires no earlier than June 2016 (unless a court issues a decision adverse to Plaintiffs sooner). On June 11, 2014, Mylan filed a motion to dismiss for lack of personal jurisdiction, which the district court denied on March 30, 2015. On December 18, 2014, Ranbaxy filed an Inter Partes Review before the Patent Trial and Appeal Board, U.S. Patent and Trademark Office, with respect to the ‘085 patent. Adamas filed a preliminary response on April 14, 2015. On October 17, 2014, Forest and Actavis Laboratories FL, Inc. (f/k/a Watson Laboratories, Inc. — Florida) filed a stipulation dismissing their respective claims without prejudice. On November 3, 2014, Plaintiffs entered into a settlement agreement with Wockhardt. Under the terms of the settlement agreement, and subject to review of the settlement terms by the U.S. Federal Trade Commission,

 

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Plaintiffs will provide a license to Wockhardt that will permit it to launch its generic version of Namenda XR as of the date that is the later of (a) two (2) calendar months prior to the expiration date of the last to expire of the ‘703 patent, the ‘209 patent, the ‘708 patent, the ‘379 patent, the ‘752 patent, the ‘085 patent, and the ‘233 patent, including any extensions and/or pediatric exclusivities; or (b) the date that Wockhardt obtains final FDA approval of its ANDA, or earlier in certain circumstances. On January 13, 2015, Plaintiffs entered into settlement agreements with Anchen and Par. Under the terms of the settlement agreements, and subject to review of the settlement terms by the U.S. Federal Trade Commission, Plaintiffs will provide licenses to Anchen and Par that will permit them to launch their generic versions of Namenda XR as of the date that is the later of (a) two (2) calendar months prior to the expiration date of the last to expire of the ‘209 patent, the ‘708 patent, the ‘379 patent, the ‘752 patent, the ‘085 patent, and the ‘233 patent, as well as the ‘009 patent for Par only, including any extensions and/or pediatric exclusivities; or (b) the dates that Anchen and Par obtain final FDA approval of their respective ANDAs, or earlier in certain circumstances. On May 1, 2015, Forest entered into a settlement agreement with Ranbaxy. Trial is scheduled to begin in February 2016. The Company believes it has meritorious claims to prevent the generic applicants from launching a generic version of Namenda XR. However, there can be no assurance a generic version will not be launched.

Rapaflo ® . On June 17, 2013, Actavis, Inc., Watson Laboratories, Inc., and Kissei Pharmaceutical Co., Ltd. sued Hetero USA Inc., Hetero Labs Limited, and Hetero Labs Limited, Unit 3 (collectively, “Hetero”) in the United States District Court for the District of Delaware, alleging that sales of silodosin tablets, a generic version of Actavis’ Rapaflo ® tablets, would infringe U.S. Patent No. 5,387,603 (the ‘603 patent). On June 17, 2013 Actavis, Inc., Watson Laboratories, Inc., and Kissei Pharmaceutical Co., Ltd. sued Sandoz Inc. in the United States District Court for the District of Delaware, alleging that sales of Sandoz’s generic version of Rapaflo ® would infringe the ‘603 patent. The complaints seeks injunctive relief. On December 22, the Parties completed a settlement agreement with Hetero. Actavis and Kissei’s lawsuit against Sandoz have been consolidated and remain pending. Pursuant to the provisions of the Hatch-Waxman Act, the FDA is precluded from granting final approval to the generic applicants prior to April 8, 2016. The Company believes it has meritorious claims to prevent the generic applicants from launching a generic version of Rapaflo. However, if a generic applicant prevails in the pending litigation or launches a generic version of Rapaflo before the pending litigation is finally resolved, it could have an adverse effect on the Company’s business, results of operations, financial condition and cash flows.

 

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Saphris ® . Between September 2014 and February 2015, Forest Laboratories, LLC, and Forest Laboratories Holdings, Ltd. (collectively, “Forest”) brought actions for infringement of some or all of U.S. Patent Nos. 5,763,476 (the “‘476 patent”), 7,741,358 (the “‘358 patent”) and 8,022,228 (the “‘228 patent”) in the U.S. District Court for the District of Delaware against Sigmapharm Laboratories, LLC , Hikma Pharmaceuticals, LLC , Breckenridge Pharmaceutical, Inc. and Alembic Pharmaceuticals, Ltd., and related subsidiaries and affiliates thereof. Including a 6-month pediatric extension of regulatory exclusivity, the ‘476 patent expires in December 2020, and the ‘358 and ‘228 patents expire in October 2026. These lawsuits triggered an automatic stay of approval of the applicable ANDAs that expires no earlier than February 13, 2017 (unless a court issues a decision adverse to Forest sooner). On February 3, 2015, the district court consolidated the pending actions for all purposes and issued a scheduling order setting a trial date in August 2016. The Company believes it has meritorious claims to prevent the generic applicants from launching a generic version of Saphris. However, there can be no assurance a generic version will not be launched.

Savella ® . Between September 2013 and February 2014, Forest Laboratories, Inc., Forest Laboratories Holdings, Ltd. (collectively, “Forest”) and Royalty Pharma Collection Trust (“Royalty”), Forest’s licensor for Savella, brought actions for infringement of U.S. Patent Nos. 6,602,911 (the “‘911 patent”), 7,888,342 (the “‘342 patent”), and 7,994,220 (the “‘220 patent”) in the U.S. District Court for the District of Delaware against Amneal, Apotex, First Time US Generics, Glenmark, Hetero, Lupin, Mylan, Par, Ranbaxy, and Sandoz, and related subsidiaries and affiliates thereof. These companies have notified Forest and Royalty that they have filed ANDAs with the FDA seeking to obtain approval to market generic versions of Savella before these patents expire. (The ‘342 patent expires in November 2021, the ‘911 patent expires in January 2023, and the ‘220 patent expires in September 2029.) These lawsuits triggered an automatic stay of approval of the applicable ANDAs until July 14, 2016 (unless a court issues a decision adverse to Forest and Royalty Pharma sooner). On March 7, 2014, Forest and Royalty voluntarily dismissed, without prejudice, all claims against Sandoz. On March 20, 2014, the district court consolidated all of the remaining pending actions for all purposes and issued a scheduling order setting a trial date in January 2016. On May 12, 2014, Forest and Royalty entered into a settlement agreement with First Time US Generics. Under the terms of the settlement agreement, and subject to review of the settlement terms by the U.S. Federal Trade Commission, Forest will provide a license to First Time that will permit it to launch its generic version of Savella as of the date that is the later of (a) six (6) calendar months prior to the expiration date of the last to expire of the ‘911 patent, the ‘342 patent, and the ‘220 patent, including any extensions and/or pediatric exclusivities; or (b) the date that First Time obtains final FDA approval of its ANDA, or earlier in certain circumstances. On December 15, 2014, Forest and Royalty entered into a settlement agreement with Ranbaxy. On April 8, 2015, Defendants filed a motion to dismiss for lack of standing. On or about April 29, 2015, Forest entered into a settlement agreement with Par that will permit Par to launch its generic version of Savella as of the date that is the later of (a) six (6) calendar months prior to the expiration date of the last to expire of the ‘911 patent, the ‘342 patent, and the ‘220 patent, including any extensions and/or pediatric exclusivities; or (b) the date that Par obtains final FDA approval of its ANDA, or earlier in certain circumstances. The Company believes it has meritorious claims to prevent the remaining generic applicants from launching a generic version of Savella. However, there can be no assurance a generic version will not be launched.

 

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Teflaro ® . In January 2015, Forest Laboratories, LLC, Forest Laboratories Holdings, Ltd., and Cerexa, Inc. (collectively, “Forest”) and Takeda Pharmaceutical Company Limited (“Takeda”), Forest’s licensor for Teflaro, brought an action for infringement of some or all of U.S. Patent Nos. 6,417,175 (the “‘175 patent”), 6,906,055 (the “‘055 patent”), 7,419,973 (the “‘973 patent”) and 8,247,000 (the “‘400 patent”) in the U.S. District Court for the District of Delaware against Apotex and Sandoz, and related subsidiaries and affiliates thereof. These companies have notified Forest and Takeda that they have filed ANDAs with the FDA seeking to obtain approval to market generic versions of Teflaro before some or all of the ‘175, ‘055, ‘973 and ‘400 patents expire. (The ‘175 patent expires in April 2022 (including a patent term extension), the ‘055 and ‘973 patents expire in December 2021, and the ‘400 patent expires in February 2031.) These lawsuits triggered an automatic stay of approval of the applicable ANDAs until April 29, 2018 (unless a court issues a decision adverse to Forest and Takeda sooner). No trial date has been set.

Viibryd ® . In March 2015, Forest Laboratories, LLC, Forest Laboratories Holdings, Ltd., (collectively, “Forest”) and Merck KGaA and Merck Patent Gesellschaft Mit Beschränkter Haftung (collectively, “Merck”), Forest’s licensor for Viibryd, brought actions for infringement of U.S. Patent Nos. 7,834,020 (the “‘020 patent”), 8,193,195 (the “‘195 patent”), 8,236,804 (the “‘804 patent”) and 8,673,921 (the “‘921 patent”) in the U.S. District Court for the District of Delaware against Accord Healthcare Inc. , Alembic Pharmaceuticals, Ltd. , Apotex, Inc. , InvaGen Pharmaceuticals, Inc. , and Teva Pharmaceuticals USA, Inc. , and related subsidiaries and affiliates thereof. These companies have notified Forest and/or Merck that they have filed ANDAs with the FDA seeking to obtain approval to market generic versions of Viibryd before the ‘020, ‘195, ‘804 and ‘921 patents expire in June 2022. These lawsuits triggered an automatic stay of approval of the applicable ANDAs until July 21, 2018 (unless a court issues a decision adverse to Forest and Merck sooner). No trial date has been set.

Patent Defense Matters

Bayer Patent Litigation . In August 2012, Bayer Pharma AG (together with its affiliates, “Bayer”) filed a complaint against Warner Chilcott in the U.S. District Court for the District of Delaware alleging that Warner Chilcott’s manufacture, use, offer for sale, and/or sale of its Lo Loestrin ® Fe oral contraceptive product infringes Bayer’s U.S. Patent No. 5,980,940. In the complaint, Bayer seeks injunctive relief and unspecified monetary damages for the alleged infringement. In December 2012, Bayer amended the complaint to add a patent interference claim seeking to invalidate the Company’s ‘984 Patent, which covers the Lo Loestrin ® Fe product. On December 15, 2014, Warner Chilcott filed a Summary Judgment motion seeking dismissal of the case. On April 21, 2015, the District Court granted Warner Chilcott’s motion and held the ‘940 patent invalid for indefiniteness. The Company does not know whether Bayer intends to appeal this decision.

Although it is impossible to predict with certainty the outcome of any litigation, the Company believes that it has a number of strong defenses to the allegations in the complaints and intends to vigorously defend the litigations. These cases are in the early stages of litigation, and an estimate of the potential loss, or range of loss, if any, to the Company relating to these proceedings is not possible at this time.

Oxymorphone Extended-Release Tablets (Generic version of Opana ® ER) . On December 11, 2012, Endo Pharmaceuticals Inc. (“Endo”) sued Actavis and certain of its affiliates in the United States District Court for the Southern District of New York, alleging that sales of the Company’s 7.5 mg and 15 mg oxymorphone extended-release tablets, generic versions of Endo’s Opana ® ER, infringe U.S. Patent Nos. 7,851,482; 8,309,122; and 8,329,216. Thereafter, FDA approved Actavis’ 5 mg, 10 mg, 20 mg, 30 mg, and 40 mg oxymorphone extended-release tablets and Endo filed a motion for a preliminary injunction

 

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seeking to prevent Actavis from selling the new strengths. On September 12, 2013, the district court denied Endo’s motion for a preliminary injunction and Actavis immediately launched the new strengths. On March 31, 2014, the Federal Circuit reversed the district court’s denial of Endo’s motion for a preliminary injunction and remanded the matter to the district court for further consideration. On January 13, 2015, Endo dismissed its claims against Actavis concerning the ‘482 patent. Trial with respect to the ‘122 and ‘216 patents began on March 23, 2015 and concluded on April 24, 2015. The court has not issued its decision. On November 7, 2014, Endo and Mallinckrodt LLC sued Actavis and certain of its affiliates in the United States District Court for the District of Delaware, alleging that sales of the Company’s generic versions of Opana ® ER, 5mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg, generic versions of Endo’s Opana ® ER, infringe U.S. Patent Nos. 7,808,737 and 8,871,779, which Endo licensed from Mallinckrodt and the USPTO recently issued to or Endo, respectively The case is currently pending. The Company believes it has substantial meritorious defenses to the case. However, Actavis has sold and is continuing to sell its generic versions of Opana ® ER. Therefore, an adverse final determination that one of the patents in suit is valid and infringed could have an adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Budesonide Inhalation Suspension (Generic version of Pulmicort Respules ® ) . On March 19, 2008, AstraZeneca LP and AstraZeneca AB (“Astra”) sued Breath Limited in the United States District Court for the District of New Jersey, alleging that Breath’s filing of an ANDA for Budesonide Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL, a generic version of Astra’s Pulmicort Respules product, infringe U.S. Patent Nos. 6,598,603 (“the ‘603 patent”); 6,899,099 (“the ‘099 patent”); and 7,524,834 (“the ‘834 patent”). On December 2, 2009, Watson Pharmaceuticals, Inc. (now known as Actavis, Inc.), acquired Breath Limited as part of its acquisition of the Arrow Group. On November 1, 2010, in connection with a preliminary injunction against Apotex, the Federal Circuit affirmed a district court decision that the asserted claims of the ‘099 patent are invalid. On April 1, 2013, the United States District Court for the District of New Jersey found the asserted claims of the ‘603 patent invalid and that Breath/Watson’s ANDA did not infringe the asserted claims of the ‘834 patent. On April 3, 2013, the district court entered an injunction preventing the launch of any generic product to allow Astra to file an appeal with the Federal Circuit. The Federal Circuit continued that injunction pending the appeal. On October 30, 2013, the Federal Circuit affirmed the district court’s finding that the asserted claims of the ‘603 patent are invalid, but reversed the district court’s non-infringement finding with respect to the ‘834 patent and remanded the case back to the district court for reconsideration and a new trial under a new claim construction for the term “micronized powder composition”. The second trial concluded on October 29, 2014, and the court heard closing arguments on January 29, 2015. On February 13, 2015, the district court found that the asserted claims of the ‘834 patent are invalid and denied Astra’s request for a permanent injunction. That same day, Astra filed a motion for an injunction pending appeal. The court denied Astra’s motion for an injunction that same day. On February 13, 2015, Actavis commercially launched the Breath/Watson approved product. On February 16, 2015, Astra filed a notice of appeal and filed with the Federal Circuit an emergency motion for an injunction pending appeal. On March 12, 2015, the Federal Circuit issued an order granting Astra’s motion for an injunction pending the appeal. On May 7, 2015, the Federal Circuit issued its decision affirming the district court’s decision that the asserted claims of the ‘834 patent are invalid and dissolving the March 12, 2015 injunction pending appeal. That same day, Actavis re-launched the Breath/Watson approved product. The Company believes it has substantial meritorious defenses to the case. However, Actavis has sold its generic versions of the 0.25 mg/2 mL and 0.5 mg/2 mL strengths of Pulmicort Respules. Therefore, an adverse final determination that ‘834 patent is valid and infringed could have an adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Teva Namenda XR Patent Litigation . In December 2013, Forest Laboratories, Inc. (“Forest”) was named as a defendant in an action brought by Teva Pharmaceuticals USA, Inc. and Mayne Pharma International Pty Ltd. in the U.S. District Court for the District of Delaware. The complaint alleges that Forest infringes U.S. Patent No. 6,194,000 by making, using, selling, offering to sell, and importing Namenda XR. The relief requested includes preliminary and permanent injunctive relief, and damages.

 

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The district court has scheduled a trial to begin in July 2016. The Company intends to continue to vigorously defend against this action. At this time, the Company does not believe losses, if any, would have a material effect on the results of operations or financial position taken as a whole.

Product Liability Litigation

Actonel ® Litigation . Warner Chilcott is a defendant in approximately 200 cases and a potential defendant with respect to approximately 415 unfiled claims involving a total of approximately 627 plaintiffs and potential plaintiffs relating to Warner Chilcott’s bisphosphonate prescription drug Actonel ® . The claimants allege, among other things, that Actonel ® caused them to suffer osteonecrosis of the jaw (“ONJ”), a rare but serious condition that involves severe loss or destruction of the jawbone, and/or atypical fractures of the femur (“AFF”). All of the cases have been filed in either federal or state courts in the United States. Warner Chilcott is in the initial stages of discovery in these litigations. In addition, Warner Chilcott is aware of four purported product liability class actions that were brought against Warner Chilcott in provincial courts in Canada alleging, among other things, that Actonel ® caused the plaintiffs and the proposed class members who ingested Actonel ® to suffer atypical fractures or other side effects. It is expected that these plaintiffs will seek class certification. Plaintiffs have typically asked for unspecified monetary and injunctive relief, as well as attorneys’ fees. Warner Chilcott is indemnified by Sanofi for certain Actonel claims pursuant to a collaboration agreement relating to the two parties’ co-promotion of the product in the United States and other countries. In addition, Warner Chilcott is also partially indemnified by the Proctor & Gamble Company (“P&G”) for ONJ claims that were pending at the time Warner Chilcott acquired P&G’s global pharmaceutical business in October 2009. In May and September 2013, Warner Chilcott entered into two settlement agreements which will resolve a majority of the then-existing ONJ-related claims which are subject to the acceptance by the individual respective claimants.

The Company believes it has substantial meritorious defenses to these cases and intends to defend these claims vigorously. Warner Chilcott maintains product liability insurance against such cases. However, litigation is inherently uncertain and the Company cannot predict the outcome of this litigation. These actions, if successful, or if insurance does not provide sufficient coverage against such claims, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Alendronate Litigation . Beginning in 2010, approximately 130 product liability suits on behalf of approximately 175 plaintiffs have been filed against the Company and certain of its affiliates, including Cobalt Laboratories, as well as other manufacturers and distributors of alendronate for personal injuries including AFF and ONJ allegedly arising out of the use of alendronate. The actions are pending in various state and federal courts. Several of the cases were consolidated in an MDL proceeding in federal court in New Jersey. In 2012, the MDL court granted the Company’s motion to dismiss all of the cases then pending against the Company in the New Jersey MDL. The Third Circuit affirmed the dismissal. Any new cases against the Company filed in the MDL are subject to dismissal unless plaintiffs can establish that their claims should be exempted from the 2012 dismissal order. Other cases were consolidated in an MDL in federal court in New York, where the Company filed a similar motion to dismiss. The Court granted, in part, the motion to dismiss which has resulted in the dismissal of several other cases. The Company has also been served with nine cases that are part of a consolidated litigation in the California state court. In 2012, the California court partially granted a motion filed on behalf of all generic defendants seeking dismissal. Appeals in the California cases have been exhausted and the Company has not yet been able to determine how that will affect the cases filed against it. All cases pending in state courts in Kentucky and Missouri have been discontinued against the Company. The remaining active cases are part of a mass tort coordinated proceeding in New Jersey state court. In the New Jersey proceeding, the Court granted, in part, a motion to dismiss. The Company believes that it has substantial

 

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meritorious defenses to these cases and maintains product liability insurance against such cases. However, litigation is inherently uncertain and the Company cannot predict the outcome of this litigation. These actions, if successful, or if our indemnification arrangements or insurance do not provide sufficient coverage against such claims, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Benicar ® Litigation. The Company is named in approximately ninety actions involving allegations that Benicar ® , a treatment for hypertension that Forest co-promoted with Daiichi Sankyo between 2002 and 2008, caused certain gastrointestinal injuries. Under Forest’s Co-Promotion Agreement, Daiichi Sankyo is defending us in these lawsuits.

Celexa ® /Lexapro ® Litigation . Forest and its affiliates are defendants in approximately ten actions pending in various federal district courts involving allegations that Celexa ® or Lexapro ® caused or contributed to individuals committing or attempting suicide, or caused a violent event. The Company was granted summary judgment in three cases, all of which are being appealed. Two other matters have been stayed pending a decision by the Fourth Circuit Court of Appeals. At present, two trials are scheduled in 2015 with the possibility that additional cases could be set for trial in 2015 or 2016.

Approximately 180 actions are pending against Forest and its affiliates involving allegations that Celexa ® or Lexapro ® caused various birth defects. Several of the cases involve multiple minor-plaintiffs. The majority of these actions have been consolidated in state court in Missouri where one case is set for trial in November 2015. In addition, several matters are pending in federal district court in Missouri and three of those matters are set for trial in August 2016. Multiple additional actions were filed in New Jersey state court. None of the New Jersey cases are set for trial. There are birth defect cases pending in other jurisdictions but none currently are set for trial.

The Company believes it has substantial meritorious defenses to the Celexa ® /Lexapro ® cases and maintains product liability insurance against such cases. However, litigation is inherently uncertain and the Company cannot predict the outcome of this litigation. These actions, if successful, or if insurance does not provide sufficient coverage against such claims, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Metoclopramide Litigation. Beginning in 2009, a number of product liability suits were filed against certain Company affiliates, including legacy Actavis and Watson companies, as well as other manufacturers and distributors of metoclopramide, for personal injuries allegedly arising out of the use of metoclopramide. Approximately 1,500 cases remain pending against Actavis, Watson and/or its affiliates in state and federal courts, representing claims by multiple plaintiffs. Discovery in these cases is in the preliminary stages as the Company is actively moving to dismiss the suits and either initiating or defending appeals on such motions. The Company believes that, with respect to the majority of the cases against the legacy Watson companies, it will be defended in and indemnified by Pliva, Inc., an affiliate of Teva, from whom the Company purchased its metoclopramide product line in late 2008. With respect to the cases pending against the legacy Actavis companies, the Company is actively defending them. The Company believes that it has substantial meritorious defenses to these cases and maintains product liability insurance against such cases. However, litigation is inherently uncertain and the Company cannot predict the outcome of this litigation. These actions, if successful, or if our indemnification arrangements or insurance do not provide sufficient coverage against such claims, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Propoxyphene Litigation. Beginning in 2011, a number of product liability suits were filed against Watson and certain of its affiliates, as well as other manufacturers and distributors of propoxyphene, for

 

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personal injuries including adverse cardiovascular events or deaths allegedly arising out of the use of propoxyphene. Cases are pending against Watson and/or its affiliates in various state and federal courts, representing claims by approximately 1,400 plaintiffs. A number of the cases were consolidated in an MDL in federal district court in Kentucky. On June 22, 2012, the MDL court granted the generic defendants’ joint motion to dismiss the remaining MDL cases. On June 27, 2014, the Sixth Circuit affirmed the district court’s dismissal. Plaintiffs did not file a petition for a writ of certiorari with the United States Supreme Court. In addition, approximately 35 cases were filed in California state court. These cases were removed to federal district courts and, after disputes over whether the cases should be remanded to state court, the Ninth Circuit Court of Appeals determined that the removals to federal court were proper. Once the procedural matters are resolved, the defendants will file demurrers and motions to dismiss the remaining suits. In November 2014, one additional action was filed in Oklahoma state court. The Company believes that it has substantial meritorious defenses to these cases and maintains product liability insurance against such cases. However, litigation is inherently uncertain and the Company cannot predict the outcome of this litigation. These actions, if successful, or if insurance does not provide sufficient coverage against such claims, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Testosterone Litigation . Beginning in 2014, a number of product liability suits were filed against the Company and certain of its affiliates, as well as other manufacturers and distributors of testosterone products, for personal injuries including but not limited to cardiovascular events allegedly arising out of the use of Androderm ® testosterone cypionate, AndroGel and/or testosterone enanthate. Actavis, Inc. and/or one or more of its subsidiaries have been served in approximately 130 currently pending actions, all of which are pending in federal court. These actions have been consolidated in an MDL in federal court in Illinois. The defendants have responded to the plaintiffs’ master complaint. These cases are in the initial stages and discovery is in the early stages. The Company anticipates that additional suits will be filed. The Company believes that it has substantial meritorious defenses to these cases and maintains product liability insurance against such cases. However, litigation is inherently uncertain and the Company cannot predict the outcome of this litigation. These actions, if successful, or if insurance does not provide sufficient coverage against such claims, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Government Investigations, Government Litigation and Qui Tam Litigation

Warner Chilcott. Beginning in February 2012, Warner Chilcott, along with several of its current and former employees in its sales organization and certain third parties, received subpoenas from the United States Attorney for the District of Massachusetts. The subpoena received by Warner Chilcott seeks information and documentation relating to a wide range of matters, including sales and marketing activities, payments to people who are in a position to recommend drugs, medical education, consultancies, prior authorization processes, clinical trials, off-label use and employee training (including with respect to laws and regulations concerning off-label information and physician remuneration), in each case relating to a number of our current products. The Company is cooperating in responding to the subpoena. The Company has recorded a contingent liability for the quarter ended March 31, 2015 under ACS 450, Contingencies, based on its analysis of this matter, however, there can be no assurance that the Company’s estimate will not differ materially from the recorded contingent liability. The Company is also aware of three qui tam complaints filed by former Warner Chilcott sales representatives and unsealed in February and March 2013 and March 2014. Two unsealed federal qui tam complaints were filed in the federal court in Massachusetts and allege that Warner Chilcott violated Federal and state false claims acts through the promotion of all of Warner Chilcott’s current key products by, among other things, making improper claims concerning the products, providing kickbacks to physicians and engaging in improper conduct concerning prior authorizations. Since then, one of the two

 

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complaints was voluntarily dismissed. The remaining complaint seeks, among other things, treble damages, civil penalties of up to eleven thousand dollars for each alleged false claim and attorneys’ fees and costs. Other similar complaints may exist under seal. The United States of America has elected not to intervene at this time in the unsealed actions though it may choose to at a later time. The government has successfully moved the court in the federal actions litigation to stay that proceeding through March 1, 2015. The company has met with the government to discuss the status, and a potential resolution of, its investigation. The third complaint was filed in California state court and contains similar allegations as the other qui tam complaints and asserts additional causes of action under California state law. The State of California declined to intervene in this action. Warner Chilcott filed a motion to dismiss this complaint. Warner Chilcott intends to vigorously defend itself in the litigations. However, these cases are in the early stages of litigation, it is impossible to predict with certainty the outcome of any litigation, and the Company can offer no assurance as to when the lawsuits will be decided, whether Warner Chilcott will be successful in its defense and whether any additional similar suits will be filed. If these claims are successful, such claims could adversely affect the Company and could have a material adverse effect on the Company’s business, financial condition, results of operation and cash flows.

Forest . Forest received a subpoena dated August 5, 2013 from the U.S. Department of Health and Human Services, Office of Inspector General. The subpoena requests documents relating to the marketing and promotion of Bystolic ® , Savella ® , and Namenda ® , including with respect to speaker programs for these products. In February 2014, the U.S. District Court for the Eastern District of Wisconsin unsealed a qui tam complaint. The complaint asserts claims under the False Claims Act and contains allegations regarding off-label promotion of Bystolic ® and Savella ® and “kickbacks” provided to physicians to induce prescriptions of Bystolic ® , Savella ® , and Viibryd ® . Forest has responded to the complaint. The U.S. Attorney’s Office declined to intervene in this action but has reserved the right to do so at a later date. The Company continues to cooperate with this investigation and to discuss these issues with the government.

In April 2014, the federal district court in Massachusetts unsealed a qui tam complaint which asserts claims under the False Claims Act and contains allegations regarding off-label promotion of Namenda ® . The Company filed a motion to dismiss the relator’s Second Amended Complaint and the court granted in part and denied in part Forest’s motion, dismissing the False Claims Act conspiracy claim only. The U.S. Attorney’s Office declined to intervene in this action but has reserved the right to do so at a later date.

The Company intends to vigorously defend itself in the ligitations. However, these cases are in the early stages of litigation, it is impossible to predict with certain the outcome of any litigation, and the Company can offer no assurance as to when the lawsuits will be decided, whether the Company will be successful in its defense and whether any additional similar suits will be filed. If these claims are successful, such claims could adversely affect the Company and could have a material adverse effect on the Company’s business, financial condition, results of operation and cash flows.

Allergan . In December 2011, the federal district court in Pennsylvania issued an order partially unsealing the second amended qui tam complaint, filed by relators Herbert J. Nevyas, M.D. and Anita Nevyas-Wallace, M.D., to be informally provided to Allergan, Inc. The complaint asserts claims under Federal and State False Claims Acts and Federal and State Anti Kickback Acts. On December 16, 2013, the court entered an order to unseal this qui tam action. On April 1, 2014, Allergan filed a motion to dismiss.

Patent Settlement Investigations . The Company and various of its affiliates have received letters and investigatory subpoenas from the U.S. Federal Trade Commission (“FTC”) indicating that the FTC is conducting a nonpublic investigations into certain agreements the Company have made to settle patent disputes with other brand and generic pharmaceutical companies. The Company is cooperating in responding to the investigations.

 

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Governmental Reimbursement and Drug Pricing Investigations and Litigation . The Company has also received investigatory subpoenas from the U.S. Attorney’s Office and various state agencies requesting information and documents relating to certain categories of drug pricing including, but not limited to, Average Wholesale Price (“AWP”), Wholesale Acquisition Cost (“WAC”), Average Manufacturer Price (“AMP”) and Best Price (“BP”). The company intends to cooperate with this subpoena.

Beginning in 1999, the Company was informed by the U.S. Department of Justice that it, along with numerous other pharmaceutical companies, is a defendant in a qui tam action brought in 1995 under the U.S. False Claims Act. Since that time, the Company also received and responded to notices or subpoenas from the U.S. House Committee on Energy and Commerce as well as from Attorneys General of various states, including Florida, Nevada, New York, California and Texas, relating to pharmaceutical pricing issues and whether allegedly improper actions by pharmaceutical manufacturers led to excessive payments by Medicare and/or Medicaid. Other state and federal inquiries regarding pricing and reimbursement issues are anticipated.

The Company and certain of its subsidiaries have also been named as defendants in various lawsuits filed by numerous states and qui tam relators, including Wisconsin, Kentucky, Illinois, Mississippi, Missouri, South Carolina, Utah, Kansas and Louisiana. These actions allege generally that the plaintiffs (all governmental entities) were overcharged for their share of Medicaid drug reimbursement costs as a result of reporting by manufacturers of AWP that did not correspond to actual provider costs of prescription drugs. In 2011, Watson settled certain claims made against it by a relator in a qui tam action brought against the Company on behalf of the United States. The settlement of that qui tam action resolved all claims on behalf of the United States asserted in that action except for claims relating to the federal share of Medicaid payments made by the States of Alabama, Alaska, Kentucky, Idaho, Illinois, South Carolina and Wisconsin. The Company subsequently settled all claims, including the claims on behalf of the United States, brought by Alabama. In addition, the Company has reached settlements with the states of the Louisiana, Missouri, Kansas and South Carolina. In addition, the Company has begun having discussions with the plaintiffs in the Illinois and Wisconsin actions about a possible resolution of those matters. Based on developments in these two actions, the Company recently increased its contingent loss accrual by approximately $23 million. The court in the Utah case recently dismissed that state’s claims against the Company. The case against Watson on behalf of Kentucky was tried in November 2011. The jury reached a verdict in Watson’s favor on each of Kentucky’s claims against Watson. An agreed form of judgment has been entered and the case now has been dismissed with prejudice. The case against Watson on behalf of Mississippi was tried from November 2012 through April 2013. On August 28, 2013, the court issued a ruling in favor of the state and awarded the state $12.4 million in compensatory damages and civil penalties, and on March 20, 2014 issued its ruling imposing an additional $17.9 million in punitive damages. Post-trial motions were filed and denied by the court. The Company is appealing both the original and punitive damage awards.

In addition, Forest and certain of its affiliates are defendants in four state court actions pending in Illinois, Mississippi, Utah and Wisconsin that contain similar actions as those raised in the actions against Watson. Discovery is ongoing in these actions. A trial in the Mississippi action is scheduled in August 2015. Forest and the other defendants filed a motion to dismiss Utah’s amended complaint. This motion to dismiss was denied in part, and discovery is proceeding. On February 17, 2014, the Wisconsin state court granted defendants’ motion to dismiss plaintiff’s Second Amended Complaint. However, the relator filed a separate action making the same basic allegations as in its amended complaint in the original action. The Company intends to continue to vigorously defend against these actions. At this time, the Company does not believe losses, if any, would have a material effect on the results of operations or financial position taken as a whole.

 

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With regard to the remaining drug pricing actions, the Company believes that it has meritorious defenses and intends to vigorously defend itself in those actions. The Company continually monitors the status of these actions and may settle or otherwise resolve some or all of these matters on terms that the Company deems to be in its best interests. However, the Company can give no assurance that it will be able to settle the remaining actions on terms it deems reasonable, or that such settlements or adverse judgments in the remaining actions, if entered, will not exceed the amounts of the liability reserves. Additional actions by other states, cities and/or counties are anticipated. These actions and/or the actions described above, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

DESI Drug Reimbursement Litigation.  In December 2009, the Company learned that numerous pharmaceutical companies, including certain subsidiaries of the Company, were named as defendants in a qui tam action pending in federal court in Massachusetts. The tenth amended complaint, which was served on certain of the Company’s subsidiaries, alleges that the defendants falsely reported to the United States that certain pharmaceutical products, including those subject to the Food and Drug Administration’s Drug Efficacy Study Implementation (“DESI”) review program, were eligible for Medicaid reimbursement and thereby allegedly caused false claims for payment to be made through the Medicaid program. The Company’s subsidiaries named in the action together with all other named defendants filed a Joint Motion to Dismiss the Tenth Amended Complaint on December 9, 2011. On February 25, 2013, the court granted the motion to dismiss as to all defendants. The plaintiff may appeal. On September 11, 2013, a similar action was filed against certain Company subsidiaries as well as Warner Chilcott and numerous other pharmaceutical company defendants by the State of Louisiana based on the same core set of allegations as asserted in the federal court action in Massachusetts. Defendants filed exceptions to plaintiffs’ complaint. Additional actions alleging similar claims could be asserted. The Company believes that it has meritorious defenses to the claims and intends to vigorously defend itself against such allegations. However, these actions or similar actions, if successful, could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Medicaid Price Adjustments.  The Company has notified the Centers for Medicare and Medicaid Services (“CMS”) that certain of the legacy Actavis group’s Medicaid price submissions require adjustment for the period 2007 through 2012. The Company is in the process of completing the resubmissions. Based on prevailing CMS practices the Company does not expect to incur penalties in connection with the resubmissions. With respect to periods prior to 2007, the Company has advised CMS that its records are insufficient to support a reliable recalculation of its price submissions, and has proposed not to recalculate the price submissions for such periods. Because there are insufficient records to support a reliable recalculation of its price submissions prior to 2007, at this time the amount of any potential liability related to the price submissions prior to 2007 is not estimable and the Company has not concluded that any liability for periods prior to 2007 is probable. The Company believes it has substantial meritorious positions and defenses with respect to these pricing resubmission matters. However, if CMS were to successfully pursue claims against the Company for the periods in question, such claims could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

Paroxetine Investigation . On April 19, 2013, the UK Office of Fair Trading (which closed in April, 2014 in connection with a government restructuring and transferred responsibility for this matter to the U.K. Competition and Markets Authority) issued a Statement of Objections against GlaxoSmithKline (“GSK”) and various generic drug companies, including Actavis UK Limited, formerly known as Alpharma Limited, now a subsidiary of the Company, alleging that GSK’s settlements with such generic drug companies improperly delayed generic entry of paroxetine, in violation of the United Kingdom’s competition laws. The Company has responded to the Statement of Objections, and believes it has substantial meritorious defenses to the allegations. However, an adverse determination in the matter could have an adverse effect on the Company’s business, results of operations, financial condition and cash flows.

 

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The Company and its affiliates are involved in various other disputes, governmental and/or regulatory inspections, inquires, investigations and proceedings that could result in litigation, and other litigation matters that arise from time to time. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect the Company, its results of operations, financial condition and cash flows.

 

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NOTE 20 – Warner Chilcott Limited (“WCL”) Guarantor and Non-Guarantor Condensed Consolidating Financial Information

The following financial information is presented to segregate the financial results of WCL, Actavis Funding SCS (the issuers of the long-term notes), the guarantor subsidiaries for the long-term notes and the non-guarantor subsidiaries. The guarantors jointly and severally, and fully and unconditionally, guarantee the Company’s obligation under the long-term notes.

The information includes elimination entries necessary to consolidate the guarantor and the non-guarantor subsidiaries. Investments in subsidiaries are accounted for using the equity method of accounting. The principal elimination entries eliminate investments in subsidiaries, equity and intercompany balances and transactions.

WCL, Actavis Capital S.a.r.l. and Actavis, Inc. are guarantors of the long-term notes.

Warner Chilcott Limited has revised its consolidating balance sheet as previously presented in Footnote 25 of the 2014 Annual Report on Form 10-K due to an incorrect presentation of intercompany activity relating to certain subsidiaries inappropriately included in the Actavis, Inc. and non-guarantor columns of such disclosure. The Company overstated the line item “Investment in Subsidiaries” for the non-guarantor column with an offsetting amount in total equity with a corresponding offset to the elimination column. Also, the Company understated in the footnote disclosure for the guarantor labeled Actavis, Inc. the net income with a corresponding offset to the elimination column. Specifically, the balance sheet caption “Investment in Subsidiaries” has been revised from the previously reported amount of $3,747.2 million as of December 31, 2014 to $4,761.1 million with an offset to total equity. Further, the line item disclosure related to the earnings in equity subsidiaries in the consolidating statement of operations footnote will be revised from a loss of $(127.7) million for the year end December 31, 2014 to income of $886.2 when next presented. The amounts presented in the Quarterly Report on Form 10-Q for the period ended September 30, 2014 will also be revised when presented next. No other periods were impacted. There is no impact to the consolidated financial statements of Actavis plc or Warner Chilcott Limited as previously filed in the 2014 Annual Report on Form 10-K or Quarterly Reports on Form 10-Q.

The following financial information presents the consolidating balance sheets as of March 31, 2015 and December 31, 2014, the related statement of operations for the three months ended March 31, 2015 and 2014 and the statement of cash flows for the three months ended March 31, 2015 and 2014.

 

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Warner Chilcott Limited

Consolidating Balance Sheets

As of March 31, 2015

(Unaudited; in millions)

 

    Warner Chilcott
Limited

(Parent
Guarantor)
    Actavis Capital
S.a.r.l.
(Guarantor)
    Actavis
Funding SCS
(Issuer)
    Actavis
Inc.
(Issuer and
Guarantor)
    Non-
guarantors
    Eliminations     Consolidated
Warner Chilcott
Limited
 

Current assets:

             

Cash and cash equivalents

  $ —        $ 0.3      $ —        $ 2.3      $ 2,093.7      $ —        $ 2,096.3   

Marketable securities

    —          —          —          —          16.0        —          16.0   

Accounts receivable, net

    —          —          —          —          3,992.8        —          3,992.8   

Receivable from Parents

    —          —          —          —          342.6        —          342.6   

Inventories, net

    —          —          —          —          3,125.1        —          3,125.1   

Intercompany receivables

    —          93,750.6        24,569.9        13,270.0        112,288.5        (243,879.0     —     

Prepaid expenses and other current assets

    —          14.5        24.5        6.2        976.1        —          1,021.3   

Current assets held for sale

    —          —          —          —          143.5        —          143.5   

Deferred tax assets

    —          —          —          —          600.8        —          600.8   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total current assets

  —        93,765.4      24,594.4      13,278.5      123,579.1      (243,879.0   11,338.4   

Property, plant and equipment, net

  —        —        —        59.2      2,738.0      —        2,797.2   

Investments and other assets

  —        20.5      143.0      37.0      317.8      —        518.3   

Investment in subsidiaries

  70,938.3      67,302.5      —        5,019.7      —        (143,260.5   —     

Deferred tax assets

  —        —        —        —        99.7      —        99.7   

Product rights and other intangibles

  —        —        —        —        74,201.1      —        74,201.1   

Goodwill

  —        —        —        —        50,826.4      —        50,826.4   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total assets

$ 70,938.3    $ 161,088.4    $ 24,737.4    $ 18,394.4    $ 251,762.1    $ (387,139.5 $ 139,781.1   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Current liabilities:

Accounts payable and accrued expenses

  —        9.2      81.1      131.2      5,564.0      —      $ 5,785.5   

Intercompany payables

  —        91,055.2      24.9      21,208.4      131,590.5      (243,879.0   —     

Payable to Parents

  —        —        —        —        826.2      —        826.2   

Income taxes payable

  —        —        —        101.6      —        —        101.6   

Current portion of long-term debt and capital leases

  —        1,401.6      —        —        222.5      —        1,624.1   

Deferred revenue

  —        —        —        —        27.1      —        27.1   

Current liabilities held for sale

  —        —        —        —        17.4      —        17.4   

Deferred tax liabilities

  —        —        —        —        65.2      —        65.2   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total current liabilities

  —        92,466.0      106.0      21,441.2      138,312.9      (243,879.0   8,447.1   

Long-term debt and capital leases

  —        7,661.9      24,633.5      4,271.4      6,133.7      —        42,700.5   

Deferred revenue

  —        —        —        —        53.5      —        53.5   

Other long-term liabilites

  —        —        —        —        1,218.1      —        1,218.1   

Other taxes payable

  —        —        —        984.1      —        —        984.1   

Deferred tax liabilities

  —        —        —        —        15,439.5      —        15,439.5   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities

  —        100,127.9      24,739.5      26,696.7      161,157.7      (243,879.0   68,842.8   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total equity

  70,938.3      60,960.5      (2.1   (8,302.3   90,604.4      (143,260.5   70,938.3   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities and equity

$ 70,938.3    $ 161,088.4    $ 24,737.4    $ 18,394.4    $ 251,762.1    $ (387,139.5 $ 139,781.1   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

73


Table of Contents

Warner Chilcott Limited

Consolidating Balance Sheets

As of December 31, 2014

($ in millions)

 

     Warner
Chilcott
Limited
(Parent
Guarantor)
     Actavis
Capital
S.a.r.l.
(Guarantor)
     Actavis
Funding
SCS
(Issuer)
     Actavis
Inc.
(Issuer
and
Guarantor)
    Non-
guarantors
     Eliminations     Consolidated
Warner
Chilcott
Limited
 

Cash and cash equivalents

   $ 0.1       $ 5.5       $ —         $ 1.5      $ 237.2       $ —        $ 244.3   

Marketable securities

     —           —           —           —          1.0         —          1.0   

Accounts receivable, net

     —           —           —           —          2,371.6         —          2,371.6   

Receivable from Parents

     —           —           —           —          269.8         —          269.8   

Inventories

     —           —           —           —          2,075.5         —          2,075.5   

Intercompany receivables

     —           22,987.9         3,659.0         18,720.9        52,730.5         (98,098.3     —     

Prepaid expenses and other current assets

     —           123.1         2.7         —          604.7         —          730.5   

Current assets held for sale

     —           —           —           —          949.2         —          949.2   

Deferred tax assets

     —           —           —           —          500.3         —          500.3   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total current assets

  0.1      23,116.5      3,661.7      18,722.4      59,739.8      (98,098.3   7,142.2   

Property, plant and equipment, net

  —        —        —        50.7      1,543.1      —        1,593.8   

Investments and other assets

  —        9.0      23.6      82.9      119.9      —        235.4   

Investment in subsidiaries

  28,076.9      24,064.7      —        4,761.1      —        (56,902.7   —     

Deferred tax assets

  —        —        —        —        107.4      —        107.4   

Product rights and other intangibles

  —        —        —        —        19,188.4      —        19,188.4   

Goodwill

  —        —        —        —        24,521.5      —        24,521.5   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total assets

$ 28,077.0    $ 47,190.2    $ 3,685.3    $ 23,617.1    $ 105,220.1    $ (155,001.0 $ 52,788.7   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Current liabilities:

Accounts payable and accrued expenses

  —        2.8      6.1      159.0      3,999.6      —      $ 4,167.5   

Intercompany payables

  —        25,953.8      2.0      26,774.7      45,367.8      (98,098.3   —     

Payable to Parents

  —        —        —        —        521.1      —        521.1   

Income taxes payable

  —        —        —        50.4      —        —        50.4   

Current portion of long—term debt and capital leases

  —        571.6      —        —        125.8      —        697.4   

Deferred revenue

  —        —        —        —        27.0      —        27.0   

Current liabilities held for sale

  —        —        —        —        25.9      —        25.9   

Deferred tax liabilities

  —        —        —        —        47.3      —        47.3   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total current liabilities

  —        26,528.2      8.1      26,984.1      50,114.5      (98,098.3   5,536.6   

Long-term debt and capital leases

  —        2,516.0      3,677.2      4,270.7      4,382.4      —        14,846.3   

Deferred revenue

  —        —        —        —        38.8      —        38.8   

Other long-term liabilities

  —        —        —        —        335.9      —        335.9   

Other taxes payable

  —        —        —        892.2      —        —        892.2   

Deferred tax liabilities

  —        —        —        —        3,061.9      —        3,061.9   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total liabilities

  —        29,044.2      3,685.3      32,147.0      57,933.5      (98,098.3   24,711.7   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total equity

  28,077.0      18,146.0      —        (8,529.9   47,286.6      (56,902.7   28,077.0   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total liabilities and equity

$ 28,077.0    $ 47,190.2    $ 3,685.3    $ 23,617.1    $ 105,220.1    $ (155,001.0 $ 52,788.7   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

 

74


Table of Contents

Warner Chilcott Limited

Consolidating Statements of Operations

For the Three Months Ended March 31, 2015

(Unaudited; in millions)

 

     Warner
Chilcott
Limited
(Parent
Guarantor)
    Actavis
Capital

S.a.r.l.
(Guarantor)
    Actavis
Funding
SCS
(Issuer)
    Actavis Inc.
(Issuer and
Guarantor)
    Non-guarantors     Eliminations     Consolidated
Warner Chilcott
Limited
 

Net revenues

   $ —        $ —        $ —        $ —        $ 4,234.2      $ —        $ 4,234.2   

Operating expenses:

              

Cost of sales (excludes amortization and impairment of acquired intangibles including product rights)

     —          —          —          —          1,713.4        —          1,713.4   

Research and development

     —          —          —          —          431.0        —          431.0   

Selling and marketing

     —          —          —          —          735.5        —          735.5   

General and administrative

     —          212.2        16.0        9.8        451.4        —          689.4   

Amortization

     —          —          —          —          925.4        —          925.4   

Asset sales, impairments and contingent consideration adjustment, net

     —          —          —          —          57.8        —          57.8   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     —          212.2        16.0        9.8        4,314.5        —          4,552.5   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating (loss)

     —          (212.2     (16.0     (9.8     (80.3     —          (318.3
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-operating income (expense):

              

Interest income / (expense), net

     —          52.4        (17.1     (43.8     (161.6     —          (170.1

Other income (expense), net

     —          (263.5     31.0        0.1        34.4        —          (198.0
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     —          (211.1     13.9        (43.7     (127.2     —          (368.1
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) before income taxes and noncontrolling interest

     —          (423.3     (2.1     (53.5     (207.5     —          (686.4

(Benefit) for income taxes

     —          —          —          (22.5     (155.2     —          (177.7

Losses / (earnings) of equity interest subsidiaries

     508.4        218.6        —          (258.6     —          (468.4     —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) / income

   $ (508.4   $ (641.9   $ (2.1   $ 227.6      $ (52.3   $ 468.4      $ (508.7
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss attributable to noncontrolling interest

     —          —          —          —          0.3        —          0.3   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) / income attributable to ordinary shareholders

   $ (508.4   $ (641.9   $ (2.1   $ 227.6      $ (52.0   $ 468.4      $ (508.4
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other Comprehensive (loss) / income

     (317.9     (230.9     —          —          (317.9     548.8        (317.9
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive (loss) / income

   $ (826.3   $ (872.8   $ (2.1   $ 227.6      $ (369.9   $ 1,017.2      $ (826.3
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

75


Table of Contents

Warner Chilcott Limited

Consolidating Statements of Operations

For the Three Months Ended March 31, 2014

(Unaudited; in millions)

 

     Warner
Chilcott
Limited
(Parent
Guarantor)
    Actavis
Capital
S.a.r.l.
(Guarantor)
    Actavis
Funding
SCS
(Issuer)
     Actavis
Inc. (Issuer
and
Guarantor)
    Non-guarantors     Eliminations     Consolidated
Warner
Chilcott
Limited
 

Net revenues

   $ —        $ —        $ —         $ —        $ 2,655.1      $ —        $ 2,655.1   

Operating expenses:

               

Cost of sales (excludes amortization and impairment of acquired intangibles including product rights)

     —          —          —           —          1,293.0        —          1,293.0   

Research and development

     —          —          —           —          171.5        —          171.5   

Selling and marketing

     —          —          —           —          283.1        —          283.1   

General and administrative

     —          —          —           32.3        244.1        —          276.4   

Amortization

     —          —          —           —          424.2        —          424.2   

Asset sales, impairments and contingent consideration adjustment, net

     —          —          —           —          (0.4     —          (0.4
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     —          —          —           32.3        2,415.5        —          2,447.8   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Operating income / (loss)

     —          —          —           (32.3     239.6        —          207.3   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Non-operating income (expense):

               

Interest income / (expense), net

     —          88.6        —           (45.3     (115.1     —          (71.8

Other income (expense), net

     —          (9.4     —           0.1        14.3        —          5.0   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     —          79.2        —           (45.2     (100.8     —          (66.8
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Income / (loss) before income taxes and noncontrolling interest

     —          79.2        —           (77.5     138.8        —          140.5   

Provision for income taxes

     —          —          —           (23.1     67.5        —          44.4   

(Earnings) / losses of equity interest subsidiaries

     (96.1     146.7        —           (293.1     —          242.5        —     
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Net income / (loss)

   $ 96.1      $ (67.5   $ —         $ 238.7      $ 71.3      $ (242.5   $ 96.1   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

(Income) / loss attributable to noncontrolling interest

     —          —          —           —          (0.2     —          (0.2
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Net income / (loss) attributable to ordinary shareholders

   $ 96.1      $ (67.5   $ —         $ 238.7      $ 71.1      $ (242.5   $ 95.9   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Other Comprehensive income / (loss)

     (6.8     (6.6     —           —          (6.8     13.4        (6.8
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive income / (loss)

   $ 89.3      $ (74.1   $ —         $ 238.7      $ 64.3      $ (229.1   $ 89.1   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

 

76


Table of Contents

Warner Chilcott Limited

Consolidating Statement of Cash Flows

For the Three Months Ended March 31, 2015

(Unaudited; in millions)

 

    Warner Chilcott
Limited (Parent
Guarantor)
    Actavis
Capital
S.a.r.l.
(Guarantor)
    Actavis
Funding
SCS
(Issuer)
    Actavis Inc.
(Issuer and
Guarantor)
    Non-guarantors     Eliminations     Consolidated
Warner Chilcott
Limited
 

Cash Flows From Operating Activities:

             

Net income / (loss)

  $ (508.4   $ (641.9   $ (2.1   $ 227.6      $ (52.3   $ 468.4      $ (508.7
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Reconciliation to net cash provided by operating activities:

             

(Earnings) / losses of equity interest subsidiaries

    508.4        218.6        —          (258.6     —          (468.4     —     

Depreciation

    —          —          —          0.1        57.1        —          57.2   

Amortization

    —          —          —          —          925.4        —          925.4   

Provision for inventory reserve

    —          —          —          —          30.3        —          30.3   

Share-based compensation

    —          —          —          12.0        213.5        —          225.5   

Deferred income tax benefit

    —          —          —          —          (304.3     —          (304.3

Loss / (gain) on sale of securities and assets, net

    —          —          —          —          —          —          —     

Loss / (gain) on asset sales and impairments, net

            57.8          57.8   

Amortization of inventory step up

    —          —          —          —          212.9        —          212.9   

Amortization of deferred financing costs

    —          264.2        2.5        1.0        0.6        —          268.3   

Accretion and contingent consideration

    —          —          —          —          28.8        —          28.8   

Other, net

    —          —          —          —          (6.5     —          (6.5

Changes in assets and liabilities (net of effects of acquisitions)

    (0.1     (5,654.9     (20,812.3     30.2        25,977.1        —          (460.0
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by operating activities

    (0.1     (5,814.0     (20,811.9     12.3        27,140.4        —          526.7   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows From Investing Activities:

             

Additions to property plant and equipment

    —          —          —          (11.5     (125.1     —          (136.6

Additions to product rights and other intangibles

    —          —          —          —          (8.5     —          (8.5

 

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    Warner Chilcott
Limited (Parent
Guarantor)
    Actavis
Capital
S.a.r.l.
(Guarantor)
    Actavis
Funding
SCS
(Issuer)
    Actavis Inc.
(Issuer and
Guarantor)
    Non-guarantors     Eliminations     Consolidated
Warner Chilcott
Limited
 

Proceeds from sale of investments and other assets

    —          —          —          —          790.5        —          790.5   

Additions to investments

    (9,000.8     (9,000.8     —          —          (15.0     18,001.6        (15.0

Proceeds from sales of property, plant and equipment

    —          —          —          —          74.9        —          74.9   

Acquisitions of business, net of cash acquired

    —          —          —          —          (34,646.2     —          (34,646.2
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash (used in) investing activities

    (9,000.8     (9,000.8     —          (11.5     (33,929.4     18,001.6        (33,940.9
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows From Financing Activities:

             

Proceeds from borrowings of long-term indebtedness

    —          5,500.0        20,955.6        —          —          —          26,455.6   

Proceeds from borrowings of credit facility

    —          2,810.0        —          —          —          —          2,810.0   

Debt issuance and other financing costs

    —          (167.1     (143.7     —          —          —          (310.8

Payments on debt, including capital lease obligations

    —          (2,334.1     —          —          (325.9     —          (2,660.0

Payments of contingent consideration

    —          —          —          —          (24.6     —          (24.6

Contribution from Parent

    9,000.8        9,000.8        —          —          9,000.8        (18,001.6     9,000.8   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by / (used in) financing activities

    9,000.8        14,809.6        20,811.9        —          8,650.3        (18,001.6     35,271.0   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Effect of currency exchange rate changes on cash and cash equivalents

    —          —          —          —          (4.8     —          (4.8

Movement in cash held for sale

    —          —          —          —          —          —          —     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net increase / (decrease) in cash and cash equivalents

    (0.1     (5.2     —          0.8        1,856.5        —          1,852.0   

Cash and cash equivalents at beginning of period

    0.1        5.5        —          1.5        237.2        —          244.3   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at end of period

  $ —        $ 0.3      $ —        $ 2.3      $ 2,093.7      $ —        $ 2,096.3   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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Warner Chilcott Limited

Consolidating Statement of Cash Flows

For the Three Months Ended March 31, 2014

(Unaudited; in millions)

 

     Warner
Chilcott
Limited
(Parent
Guarantor)
    Actavis
Capital
S.a.r.l.
(Guarantor)
    Actavis
Funding
SCS
(Issuer)
     Actavis Inc.
(Issuer and
Guarantor)
    Non-
guarantors
    Eliminations     Consolidated
Warner Chilcott
Limited
 

Cash Flows From Operating Activities:

               

Net income / (loss)

   $ 96.1      $ (67.5   $ —         $ 238.7      $ 71.3      $ (242.5   $ 96.1   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Reconciliation to net cash provided by operating activities:

               

(Earnings) / losses of equity interest subsidiaries

     (96.1     146.7        —           (293.1     —          242.5        —     

Depreciation

     —          —          —           0.1        55.5        —          55.6   

Amortization

     —          —          —           —          424.2        —          424.2   

Provision for inventory reserve

     —          —          —           —          38.1        —          38.1   

Share-based compensation

     —          —          —           0.7        16.0        —          16.7   

Deferred income tax benefit

     —          —          —           —          (149.9     —          (149.9

Loss / (gain) on sale of asset sales and impairments, net

     —          —          —           —          —          —          —     

Amortization of inventory step up

     —          —          —           —          124.6        —          124.6   

Amortization of deferred financing costs

     —          0.5        —           1.2        9.4        —          11.1   

Accretion and contingent consideration

     —          —          —           —          (7.0     —          (7.0

Other, net

     —          —          —           —          (11.3     —          (11.3

Changes in assets and liabilities (net of effects of acquisitions)

     —          324.0        —           55.6        (622.0     —          (242.4
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by operating activities

     —          403.7        —           3.2        (51.1     —          355.8   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows From Investing Activities:

               

Additions to property plant and equipment

     —          —          —           (2.1     (40.4     —          (42.5

Additions to product rights and other intangibles

     —          —          —           —          —          —          —     

Proceeds from sale of assets

     —          —          —           —          15.0        —          15.0   

Proceeds from sales of property, plant and equipment

     —          —          —           —          3.4        —          3.4   

Net proceeds from marketable securities

     —          —          —           —          —          —          —     

Acquisitions of business, net of cash acquired

     —          —          —           —          —          —          —     
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Net cash (used in) investing activities

     —          —          —           (2.1     (22.0     —          (24.1
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows From Financing Activities:

               

Proceeds from borrowings of long-term indebtedness

     —          —          —           —          —          —          —     

Debt issuance and other financing costs

     —          —          —           —          (20.3     —          (20.3

Payments on debt, including capital lease obligations

     —          (301.4     —           —          (24.7     —          (326.1

Payments of contingent consideration

     —          —          —           —          (7.8     —          (7.8
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by / (used in) financing activities

     —          (301.4     —           —          (52.8     —          (354.2
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Effect of currency exchange rate changes on cash and cash equivalents

     —          —          —           —          (2.1     —          (2.1

Movement in cash held for sale

     —          —          —           —          37.0        —          37.0   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Net increase / (decrease) in cash and cash equivalents

     —          102.3        —           1.1        (91.0     —          12.4   

Cash and cash equivalents at beginning of period

     0.1        0.3        —           1.4        321.7        —          323.5   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 0.1      $ 102.6      $ —         $ 2.5      $ 230.7      $ —        $ 335.9   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

 

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

The following discussion of our financial condition and the results of operations should be read in conjunction with the “Consolidated Financial Statements” and notes thereto included elsewhere in this Quarterly Report on Form 10-Q (“Quarterly Report”) and our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2014 (the “Annual Report”). This discussion contains forward-looking statements that are subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, among others, those identified under “Risk Factors” in our Annual Report, and elsewhere in this Quarterly Report.

References throughout to “we,” “our,” “us,” the “Company” or “Actavis” refer to financial information and transactions of Actavis plc. References to “Warner Chilcott Limited” refer to Warner Chilcott Limited, the Company’s indirect wholly owned subsidiary, and, unless the context otherwise requires, its subsidiaries. Warner Chilcott Limited is an indirect wholly-owned subsidiary of Actavis plc, the ultimate parent of the group. The results of Warner Chilcott Limited are consolidated into the results of Actavis plc. Due to the deminimis activity between Actavis plc and Warner Chilcott Limited, references throughout this filing relate to both Actavis plc and Warner Chilcott Limited. Warner Chilcott Limited representations relate only to itself and not to any other company.

Overview

We are a global specialty pharmaceutical company engaged in the development, manufacturing, marketing, and distribution of brand name (“brand”, “branded” or “specialty brand”), medical aesthetics, generic, branded generic, biosimilar and over-the-counter (“OTC”) pharmaceutical products. The Company has operations in more than 100 countries throughout North America (the United States of America (“U.S.”), Canada and Puerto Rico) and the rest of world. The Company operates manufacturing, distribution, R&D and administrative facilities in many of the world’s established and growing international markets, including North America, followed by its key international markets around the world (“ROW”). Additionally, we distribute generic and branded pharmaceutical products manufactured by third parties through our Anda Distribution segment.

2015 Significant Business Developments

During 2015, we completed the following transactions that impacted our results of operations and will continue to have an impact on our future operations.

On March 17, 2015, Actavis plc acquired Allergan, Inc. (“Allergan”) for approximately $77.0 billion including outstanding indebtedness assumed of $2.2 billion, cash consideration of $40.1 billion and equity consideration of $34.7 billion, which includes outstanding equity awards (the “Allergan Acquisition”). Under the terms of the agreement, Allergan shareholders received 111.2 million Actavis plc ordinary shares, 7.0 million of Actavis plc non-qualified stock options and 0.5 million Actavis plc share units. The addition of Allergan’s therapeutic franchises in ophthalmology, neurosciences and medical aesthetics/dermatology/plastic surgery will complement Actavis’ existing central nervous system, gastroenterology, women’s health and urology franchises. The combined company will also benefit significantly from Allergan’s global brand equity and consumer awareness of key products, including Botox ® and Restasis ® . The transaction also expands our presence and market and product reach across many international markets, with strengthened commercial positions across Canada, Europe, Southeast Asia and other high-value growth markets, including China, India, the Middle East and Latin America.

The consolidated results of the Company include the impact of the Allergan Acquisition from March 17, 2015, including the following select operating results for the three months ended March 31, 2015 ($ in million):

 

     Three Months
Ended
March 31, 2015
 

Net revenues

   $ 258.4   

Cost of sales (excludes amortization and impairment of acquired intangibles including product rights)

     117.0   

Selling and marketing

     149.7   

General and administrative

     407.9   

Operating expenses relating to the Allergan Acquisition include the financing, acquisition accounting valuation-related items, including stock-based compensation and restructuring charges associated with the acquisition.

Included in cost of sales in the table above is $71.0 million relating to the expensing of the fair value step-up of acquired inventories on March 17, 2015 as that inventory was sold through to the Company’s customers.

 

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As a result of the acquisition, the Company incurred the following transaction and integration costs in the three months ended March 31, 2015 ($ in millions):

 

     Three Months
Ended
March 31, 2015
 

Cost of sales

  

Stock-based compensation acquired for Allergan employees

   $ 6.9   

Acquisition, integration and restructuring related charges

   $ 14.5   

Research and development

  

Stock-based compensation acquired for Allergan employees

   $ 55.5   

Acquisition, integration and restructuring related charges

   $ 60.6   

Selling and marketing

  

Stock-based compensation acquired for Allergan employees

   $ 23.2   

Acquisition, integration and restructuring related charges

   $ 62.2   

General and administrative

  

Stock-based compensation acquired for Allergan employees

   $ 183.0   

Acquisition related expenditures

   $ 65.5   

Acquisition, integration and restructuring related charges

   $ 130.6   

Other income (expense)

  

Bridge loan facilities expense

   $ (263.0

Interest rate lock

   $ 31.0   
  

 

 

 

Total transaction and integration costs

$ 834.0   
  

 

 

 

Respiratory Sale

As part of the Forest Acquisition (defined below), we acquired certain assets that comprised a respiratory business. During the year ended December 31, 2014, we held for sale the respiratory assets of $734.0 million, including allocated goodwill to this unit of $309.1 million. On February 5, 2015, the Company announced the sale of its respiratory business to AstraZeneca plc (“AstraZeneca”) for consideration of $600.0 million upon closing, additional funds to be received for the sale of certain of our inventory to AstraZeneca and low single-digit royalties above a certain revenue threshold. AstraZeneca also paid Actavis an additional $100.0 million, and Actavis has agreed to a number of contractual consents and approvals, including certain amendments to the ongoing collaboration agreements between AstraZeneca and Actavis (the “Respiratory Sale”). The transaction closed on March 2, 2015. As a result of the final terms of the agreement, in the quarter ended March 31, 2015, the Company recognized an incremental charge in cost of sales (including the acquisition accounting fair value mark-up of inventory) relating to inventory that will not be sold to AstraZeneca of $35.3 million. The Company also recognized a gain on the sale of the business of $33.5 million which is included as a component of other income (expense).

Pharmatech

As part of the Forest Acquisition, the Company acquired certain manufacturing plants and contract manufacturing agreements within our Aptalis Pharmaceutical Technologies (“Pharmatech”) entities. In accordance with acquisition accounting, the assets were fair valued on July 1, 2014 as assets held in use, including market participant synergies anticipated under the concept of “highest and best use”. During the fourth quarter of 2014, the decision was made to hold these assets for sale as one complete unit, without integrating the unit and realizing anticipated synergies. During the year ended December 31, 2014, the Company recognized an impairment on assets held for sale of $189.9 million (the “Pharmatech Transaction”) which included a portion of goodwill allocated to this business unit. On April 1, 2015, the Company and TPG, a global private investment firm, completed the majority of the divestiture of the Pharmatech business.

 

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Australia

During the first quarter of 2015, the Company entered into an agreement with Amneal Pharmaceuticals LLC to divest the Australian generics business for upfront consideration of $5.0 million plus future royalties which closed on May 1, 2015 (the “Australia Transaction”). As a result of the agreement, the Company impaired intangible assets of $36.1 million, miscellaneous assets and goodwill allocated to the business of $2.5 million. The Company held for sale the remaining value of intellectual property and inventory.

2014 Significant Business Developments

During 2014, we completed the following transactions that impacted our results of operations and will continue to have an impact on our future operations.

Durata Therapeutics Acquisition

On November 17, 2014, we completed our tender offer to purchase all of the outstanding shares of Durata Therapeutics, Inc. (“Durata”), an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses (the “Durata Acquisition”). Actavis purchased all outstanding shares of Durata, which were valued at approximately $724.5 million, including the assumption of debt, as well as one contingent value right (“CVR”) per share, entitling the holder to receive additional cash payments of up to $5.00 per CVR if certain regulatory or commercial milestones related to Durata’s lead product Dalvance™ are achieved. The CVR had an acquisition date fair value of $49.0 million. We accounted for the acquisition as a business combination requiring that the assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date. On March 2, 2015, the Company announced that the European Commission has granted Actavis’ subsidiary Durata Therapeutics International B.V., marketing authorization for Xydalba™ (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. The approval triggered the first CVR payment in the quarter ended March 31, 2015 of $30.9 million. The difference between the fair value of the CVR on the date of acquisition of $24.5 million and the payment made of $30.9 million, or $6.4 million, was recorded as an operating expense in the quarter ended March 31, 2015.

Furiex Acquisition

On July 2, 2014, the Company completed an agreement to acquire Furiex Pharmaceuticals, Inc. (“Furiex”) in an all-cash transaction (the “Furiex Acquisition”) valued at $1,156.2 million (including the assumption of debt) and up to approximately $360.0 million in a CVR that may be payable based on the designation of eluxadoline, Furiex’s lead product, as a controlled drug following approval (if any) which had an acquisition accounting fair value of $88.0 million on the date of acquisition (included in the value of $1,156.2 million). We accounted for the acquisition as a business combination requiring that the assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date.

Eluxadoline is a first-in-class, locally-acting mu opioid receptor agonist and delta opioid receptor antagonist for treating symptoms of diarrhea-predominant irritable bowel syndrome (IBS-d), a condition that affects approximately 28 million patients in the United States and Europe. The CVR payment is based on the status of eluxadoline, as a controlled drug following approval, if any, as follows:

 

    If eluxadoline is determined to be a schedule III (C-III) drug, there will be no additional consideration for the CVR.

 

    If eluxadoline is determined to be a schedule IV (C-IV) drug, CVR holders are entitled to $10 in cash for each CVR held.

 

    If eluxadoline is determined to be a schedule V (C-V) drug, CVR holders are entitled to $20 in cash for each CVR held.

 

    If eluxadoline is determined to not be subject to DEA scheduling, CVR holders are entitled to $30 in cash for each CVR held.

In connection with the close of the Furiex Acquisition, the Company closed the transaction related to the sale of Furiex’s royalties on Alogliptin and Priligy ® to Royalty Pharma for $408.6 million with no income statement impact.

Acquisition of Forest Laboratories

On July 1, 2014, Actavis plc acquired Forest Laboratories, Inc. (“Forest”) for $30.9 billion including outstanding indebtedness assumed of $3.3 billion, equity consideration of $20.6 billion, which includes outstanding equity awards, and cash consideration of $7.1 billion (the “Forest Acquisition”). Under the terms of the transaction, Forest shareholders received 89.8 million Actavis plc ordinary shares, 6.1 million Actavis plc non-qualified stock options and 1.1 million Actavis plc share units. We accounted for the acquisition as a business combination requiring that the assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date. Forest was a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. Forest marketed a portfolio of branded drug products and developed new medicines to treat patients suffering from diseases principally in the following therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, anti-infective, and cystic fibrosis.

 

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As a result of the Forest Acquisition, the Company incurred the following transaction and integration costs in the three months ended March 31, 2015 ($ in millions):

 

     Three Months
Ended
March 31, 2015
 

Cost of sales

  

Stock-based compensation acquired for Forest employees

   $ 1.2   

Severance related charges

     1.0   

Research and development

  

Stock-based compensation acquired for Forest employees

     16.0   

Severance related charges

     8.8   

Selling and marketing

  

Stock-based compensation acquired for Forest employees

     19.6   

Severance related charges

     16.8   

General and administrative

  

Stock-based compensation acquired for Forest employees

     21.1   

Other integration charges

     1.6   

Severance related charges

     11.4   
  

 

 

 

Total transaction and integration costs

$ 97.5   
  

 

 

 

Western European Divestiture

During the year ended December 31, 2013, we held for sale our then current commercial infrastructure in France, Italy, Spain, Portugal, Belgium, Germany and the Netherlands, including products, marketing authorizations and dossier license rights. On January 17, 2014, we announced our intention to enter into an agreement with Aurobindo Pharma Limited (“Aurobindo”) to sell these businesses. On April 1, 2014, the Company completed the sale of the assets in Western Europe.

2013 Significant Business Developments

During 2013, we completed the following transactions that impacted our results of operations and will continue to have an impact on our future operations.

Acquisition of Warner Chilcott

On October 1, 2013, the Company completed the acquisition of Warner Chilcott plc (“Warner Chilcott”) in a stock for stock transaction for a value, including the assumption of debt, of $9.2 billion (the “Warner Chilcott Acquisition”). Warner Chilcott was a leading specialty pharmaceutical company focused on the women’s healthcare, gastroenterology, urology and dermatology segments of the branded pharmaceuticals market, primarily in North America.

Operating results

Segments

As of and for the three months ended March 31, 2015, the Company organized its business into three operating segments: North American Brands, North American Generics and International and Anda Distribution. The North American Brands segment includes patent-protected and off-patent products that the Company sells and markets as brand pharmaceutical products and over-the-counter products within North America. The North American Generics and International segment includes certain trademarked off-patent products that the Company sells and markets as off-patent pharmaceutical products that are therapeutically equivalent to proprietary products within North America. Also included in this segment are international revenues which include patent-protected and off-patent products that the Company sells and markets as brand pharmaceutical products, certain trademarked off-patent products that the Company sells and markets as off-patent pharmaceutical products that are therapeutically equivalent to proprietary products, over the counter products and revenues from our third-party Medis business. The Anda Distribution segment distributes generic and brand pharmaceutical products manufactured by third parties, as well as by the Company, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians’ offices. The Anda Distribution segment operating results exclude sales of products developed, acquired, or licensed by the North American Brands and North American Generics and International segments.

 

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Table of Contents

In addition to the segments above, in connection with the Allergan Acquisition, the Company managed the acquired Allergan business as a separate segment from March 17, 2015 through March 31, 2015. The Company is considering revising its segment structure in future periods.

The Company evaluates segment performance based on segment contribution. Segment contribution represents segment net revenues less cost of sales (excluding amortization and impairment of acquired intangibles including product rights), selling and marketing expenses and general and administrative expenses. The Company does not evaluate total assets, capital expenditures, R&D expenses, amortization and asset sales and impairments, net by segment as not all such information has been accounted for at the segment level, or such information has not been used by all segments.

Segment net revenues, segment operating expenses and segment contribution information for the Company’s segments consisted of the following for the three months ended March 31, 2015 and 2014 ($ in millions):

 

     Three Months Ended March 31, 2015     Three Months Ended March 31, 2014  
     North America
Brands
    North America
Generics and
International
    Anda
Distribution
    Allergan     Total     North America
Brands
    North America
Generics and
International
    Anda
Distribution
    Total  

Product sales

   $ 1,720.3      $ 1,756.4      $ 461.6      $ 255.2      $ 4,193.5      $ 572.0      $ 1,634.7      $ 390.2      $ 2,596.9   

Other revenue

     15.7        21.8        —          3.2        40.7        22.0        36.2        —          58.2   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net revenues

     1,736.0        1,778.2        461.6        258.4        4,234.2        594.0        1,670.9        390.2        2,655.1   

Operating expenses:

                  

Cost of sales (1)

     372.0        826.8        404.0        110.6        1,713.4        185.5        776.3        331.2        1,293.0   

Selling and marketing

     411.1        174.5        31.4        118.5        735.5        87.6        170.0        25.5        283.1   

General and administrative

     281.8        118.1        9.1        284.0        693.0        71.5        195.0        9.3        275.8   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Contribution

   $ 671.1      $ 658.8      $ 17.1      $ (254.7   $ 1,092.3      $ 249.4      $ 529.6      $ 24.2      $ 803.2   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Contribution margin

     38.7 %       37.0 %       3.7 %       (98.6 )%       25.8 %       42.0     31.7     6.2     30.3
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Research and development

             431.0              171.5   

Amortization

             925.4              424.2   

Asset sales and impairments, net

             57.8              (0.4
          

 

 

         

 

 

 

Operating (loss) income

           $ (321.9         $ 207.9   
          

 

 

         

 

 

 

Operating margin

             (7.6 )%             7.8

 

 

(1) Excludes amortization and impairment of acquired intangibles including product rights.

North American Brands Segment

The following table presents net contribution for the North American Brands segment for the three months ended March 31, 2015 and 2014 ($ in millions):

 

     Three Months Ended               
     March 31,     Change  
     2015     2014     Dollars      %  

Product sales

   $ 1,720.3      $ 572.0      $ 1,148.3         200.8

Other revenue

     15.7        22.0        (6.3      (28.6 )% 
  

 

 

   

 

 

   

 

 

    

 

 

 

Net revenues

  1,736.0      594.0      1,142.0      192.3

Operating expenses:

Cost of sales (1)

  372.0      185.5      186.5      100.5

Selling and marketing

  411.1      87.6      323.5      369.3

General and administrative

  281.8      71.5      210.3      294.1
  

 

 

   

 

 

   

 

 

    

 

 

 

Segment contribution

$ 671.1    $ 249.4    $ 421.7      169.1
  

 

 

   

 

 

   

 

 

    

 

 

 

Segment margin

  38.7   42.0   (3.3 )% 

 

(1)   Cost of sales excludes amortization and impairment of acquired intangibles.

 

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The following table presents the impact from the Forest Acquisition in the North American Brands segment for the three months ended March 31, 2015 as the acquisition had no impact on the results for the quarter ended March 31, 2014 (in millions):

 

     Forest
Acquisition
 

Total revenue

   $ 1,151.4   
  

 

 

 

Operating expenses:

Cost of sales (1)

  310.1   

Selling and marketing

  303.9   

General and administrative

  77.6   
  

 

 

 

Segment contribution

$ 459.8   
  

 

 

 

 

(1) Cost of sales excludes amortization and impairment of acquired intangibles including product rights.

Net Revenues

The following table presents net revenues for the reporting units in the North American Brands segment for the three months ended March 31, 2015 and 2014 (in millions):

 

     Three Months         
     March 31,      Change  
     2015      2014      Dollars      %  

North American Brands

           

CNS

           

Namenda ® IR

   $ 245.4       $ —         $ 245.4         100.0

Namenda XR ®

     150.6         —           150.6         100.0

Viibyrd ® / Fetzima ®

     79.6         —           79.6         100.0

Saphris ®

     42.0         —           42.0         100.0

Other CNS

     24.0         —           24.0         100.0
  

 

 

    

 

 

    

 

 

    

 

 

 

Total CNS

  541.6      —        541.6      100.0 %  

Gastroenterology

Delzicol ® /Asacol ® HD

  136.2      140.8      (4.6   (3.3 )% 

Linzess ® /Constella ™

  96.2      —        96.2      100.0

Carafate ® / Sulcrate ®

  54.3      —        54.3      100.0

Canasa ® / Salofalk ®

  37.3      —        37.3      100.0

Zenpep ® , Ultrase ® & Viokace ®

  40.2      —        40.2      100.0

Other Gastroenterology

  12.4      —        12.4      100.0
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Gastroenterology

  376.6      140.8      235.8      167.5 %  

Women’s Health

Lo Loestrin ® Fe

  83.3      62.4      20.9      33.5

Minastrin ® 24 Fe

  65.4      47.9      17.5      36.5

Estrace ® Cream

  71.9      53.3      18.6      34.9

Other Women’s Health

  46.9      49.0      (2.1   (4.3 )% 
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Women’s Health

  267.5      212.6      54.9      25.8 %  

Cardiovascular, Respiratory & Acute Care

Bystolic ®

  164.1      —        164.1      100.0

Daliresp ® (1)

  23.6      —        23.6      100.0

Tudorza ® (1)

  28.2      —        28.2      100.0
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Cardiovascular, Respiratory & Acute Care

  215.9      —        215.9      100.0 %  

Urology

  68.3      72.1      (3.8 )     (5.3 )%  

Infectious Disease

  37.8      —        37.8      100.0 %  

Dermatology/Established Brands

  228.3      168.5      59.8      35.5 %  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total North American Brands

$ 1,736.0    $ 594.0    $ 1,142.0      192.3
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Products were divested March 2, 2015 as part of the Respiratory Sale.

 

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North American Brands revenues are classified based on the current mix of promoted products within the respective categories. Movement of products between categories may occur from time to time based on changes in promotional activities.

Net revenues in our North American Brands segment include product sales and other revenue derived from branded products. Our North American Brands segment product line includes a variety of products and dosage forms. In July 2014, as a result of the Forest Acquisition, the Company also began recognizing revenues on key North American brands, including, but not limited to, Bystolic  ® , Canasa ® , Carafate ® , Daliresp ® , Fetzima ® , Linzess ® , Namenda ® IR, Namenda XR ® , Saphris ® , Teflaro ® and Viibryd ® .

The increase in the North American Brands net revenues is primarily due to the Forest Acquisition, which contributed three months of sales in 2015 compared to no sales in the prior period.

Cost of Sales

Cost of sales includes production and packaging costs for the products we manufacture, third party acquisition costs for products manufactured by others, profit-sharing or royalty payments for products sold pursuant to licensing agreements, inventory reserve charges and excess capacity utilization charges, where applicable. Cost of sales does not include amortization or impairment costs for acquired product rights or other acquired intangibles.

The increase in cost of sales was due to higher product sales driving the corresponding cost of sales, primarily as a result of the Forest Acquisition, including the impact of selling through a portion of the inventory associated with the fair value step-up of the July 1, 2014 Forest inventory acquired of $122.5 million and the write-off of inventory relating to respiratory products (including the fair value step-up) of $35.3 million. The quarter ended March 31, 2014 included the cost of sales as a result of selling through a portion of the inventory associated with the fair value step-up of the October 1, 2013 Warner Chilcott inventory acquired of $112.7 million.

Selling and Marketing Expenses

Selling and marketing expenses consist mainly of personnel-related costs, product promotion costs, distribution costs, professional service costs, insurance, depreciation and travel costs.

The increase in selling and marketing expenses was due in part to increased operating costs related to the expansion of the Company’s size, including costs incurred by Forest for ongoing operating expenses of $267.5 million, as well as acquisition related expenses, which includes stock-based compensation charges (including the fair value adjustment of the awards as part of acquisition accounting) of $19.6 million, and severance related charges of $16.8 million.

General and Administrative Expenses

General and administrative expenses consist mainly of personnel-related costs, facilities costs, transaction costs, insurance, depreciation, litigation and settlement costs and professional services costs which are general in nature.

The increase in general and administrative expenses was due in part to increased operating costs related to the expansion of the Company’s size, including costs incurred by Forest for ongoing operating expenses of $56.5 million, as well as acquisition related expenses, which includes stock-based compensation charges (including the fair value adjustment of the awards as part of acquisition accounting) of $21.1 million, and severance and integration related charges. Also impacting the three months ended March 31, 2015, are costs incurred in connection with the Allergan Acquisition including acquisition related costs of $65.5 million and severance and severance related costs of $21.0 million.

 

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North American Generics and International Segment

The following table presents net contribution for the North American Generics and International segment for the three months ended March 31, 2015 and 2014 ($ in millions):

 

     Three Months Ended               
     March 31,     Change  
     2015     2014     Dollars      %  

Product sales

   $ 1,756.4      $ 1,634.7      $ 121.7         7.4

Other revenue

     21.8        36.2        (14.4      (39.8 )% 
  

 

 

   

 

 

   

 

 

    

 

 

 

Net revenues

  1,778.2      1,670.9      107.3      6.4

Operating expenses:

Cost of sales (1)

  826.8      776.3      50.5      6.5

Selling and marketing

  174.5      170.0      4.5      2.6

General and administrative

  118.1      195.0      (76.9   (39.4 )% 
  

 

 

   

 

 

   

 

 

    

 

 

 

Segment contribution

$ 658.8    $ 529.6    $ 129.2      24.4
  

 

 

   

 

 

   

 

 

    

 

 

 

Segment margin

  37.0   31.7   5.4

 

(1)   Cost of sales excludes amortization and impairment of acquired intangibles including product rights.

The following table presents the impact from the Forest Acquisition in the North American Generics and International segment for the three months ended March 31, 2015 as the acquisition had no impact on the results for the quarter ended March 31, 2014 (in millions):

 

     Forest
Acquisition
 

Net revenues

   $ 51.0   
  

 

 

 

Operating expenses:

Cost of sales (1)

  31.2   

Selling and marketing

  9.2   

General and administrative

  1.8   
  

 

 

 

Segment contribution

$ 8.8   
  

 

 

 

 

(1) Cost of sales excludes amortization and impairment of acquired intangibles including product rights.

Net Revenues

Net revenues in our North American Generics and International segment consisted of the following ($ in millions):

 

     Three Months Ended                
     March 31,      Change  
     2015      2014      Dollars      %  

North American Generics

   $ 1,220.2       $ 1,024.2       $ 196.0         19.1

International

     558.0         646.7         (88.7      (13.7 )% 
  

 

 

    

 

 

    

 

 

    

 

 

 

Net revenues

$ 1,778.2    $ 1,670.9    $ 107.3      6.4

 

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The North American Generics and International segment includes certain trademarked off-patent products that the Company sells and markets as off-patent pharmaceutical products that are therapeutically equivalent to proprietary products within North America. Also included in this segment are international revenues which include patent-protected and off-patent products that the Company sells and markets as brand pharmaceutical products, certain trademarked off-patent products that the Company sells and markets as off-patent pharmaceutical products that are therapeutically equivalent to proprietary products, over the counter products and revenues from our third party Medis business.

Our North American Generics and International segment product line includes a variety of products and dosage forms. Indications for this line include, but are not limited to, pregnancy prevention, pain management, depression, hypertension, attention-deficit/hyperactivity disorder and smoking cessation. Dosage forms include oral solids, semi-solids, liquids, gels, transdermals, injectables, inhalation and oral transmucosals. Our generic products are the therapeutic equivalent to their brand name counterparts and are generally sold at prices significantly less than the branded product. As such, generic products provide an effective and cost-efficient alternative to brand products. When patents or other regulatory exclusivity no longer protect a branded product, or if we are successful in developing a bioequivalent, non-infringing version of a branded product, opportunities exist to introduce off-patent or generic counterparts to the branded product. Additionally, we distribute Authorized Generics to the extent such arrangements are complementary to our core business. Our portfolio of generic products includes products we have internally developed, products we have licensed from third parties and products we distribute for third parties.

Within North American Generics, revenue by product moves based on the timing of launches, including an exclusivity period in certain circumstances, and the amount of generic competition in the market. An increase in competition can decrease both volume and the price received for each product. The increase in North American Generics revenues was primarily the result of changes in product mix. Within our international revenues, the quarter ended March 31, 2014 included revenues from our Western European assets divested in the second quarter of 2014 of $112.1 million, versus the revenue impact of our continuing involvement of $31.5 million in the quarter ended March 31, 2015. The remaining decrease in international revenues is primarily due to the foreign exchange rate impact from the strengthening of the U.S. Dollar, offset, in part, by the impact of the Forest Acquisition.

Cost of Sales

Cost of sales includes production and packaging costs for the products we manufacture, third party acquisition costs for products manufactured by others, profit-sharing or royalty payments for products sold pursuant to licensing agreements, inventory reserve charges and excess capacity utilization charges, where applicable. Cost of sales does not include amortization or impairment costs for acquired product rights or other acquired intangibles.

The increase in cost of sales was due to higher North American Generics product sales driving the corresponding cost of sales. In addition, cost of sales was impacted by an increase relating to the Forest Acquisition ($31.2 million), including the impact of selling through a portion of the inventory associated with the fair value step-up of the July 1, 2014 Forest inventory acquired of $14.3 million and charges related to fair value adjustments for contingent consideration relating primarily to the approval of Liletta ® , offset, in part, by a reduction in international cost of sales due to the period-over-period decline resulting from the divestiture of our then current Western European assets in the second quarter of 2014, as well as the foreign exchange movements. Also included in the quarter ended March 31, 2014 was the impact of selling through a portion of the inventory associated with the fair value step-up of the October 1, 2013 Warner Chilcott inventory acquired of $11.9 million.

Selling and Marketing Expenses

Selling and marketing expenses consist mainly of personnel-related costs, product promotion costs, distribution costs, professional service costs, insurance, depreciation and travel costs. The increase in selling and marketing costs is due to the impact of the Forest Acquisition of $9.2 million, the increase in the size of the North American generics business and restructuring costs incurred in connection with the Allergan Acquisition of $12.2 million, offset, in part, by a decrease in spending in our divested Western European assets of $26.6 million.

General and Administrative Expenses

General and administrative expenses consist mainly of personnel-related costs, facilities costs, transaction costs, insurance, depreciation, litigation and settlement costs and professional services costs, which are general in nature. The decrease in general and administrative expenses is the result of foreign exchange rate movements, currency gains of $39.7 million on foreign denominated financing arrangements related to the integration of the Allergan transaction, the reduction in operating costs for the Western European business divested in the second quarter of 2014 and continued cost savings resulting from the restructuring of legacy Actavis and Warner Chilcott entities, offset, in part, by restructuring charges due to the Allergan Acquisition of $25.6 million, fees related to the issuance of international debt as a result of the Allergan Acquisition of $12.9 million, and the impact of foreign exchange on contingent consideration of $15.0 million.

 

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Anda Distribution Segment

The following table presents net contribution for the Anda Distribution segment for the three months ended March 31, 2015 and 2014 ($ in millions):

 

     Three Months
Ended
              
     March 31,     Change  
     2015     2014     Dollars      %  

Net revenues

   $ 461.6      $ 390.2      $ 71.4         18.3

Operating expenses:

         

Cost of sales (1)

     404.0        331.2        72.8         22.0

Selling and marketing

     31.4        25.5        5.9         23.1

General and administrative

     9.1        9.3        (0.2      (2.2 )% 
  

 

 

   

 

 

   

 

 

    

 

 

 

Segment contribution

$ 17.1    $ 24.2    $ (7.1   (29.3 )% 
  

 

 

   

 

 

   

 

 

    

 

 

 

Segment margin

  3.7   6.2   (2.5 )% 

 

(1)   Cost of sales excludes amortization and impairment of acquired intangibles.

Net Revenues

Our Anda Distribution segment distributes generic and brand pharmaceutical products manufactured by third parties, as well as by Actavis, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians’ offices. Sales are principally generated through our national accounts relationships, an in-house telemarketing staff and through internally developed ordering systems. The Anda Distribution segment operating results exclude sales by Anda of products developed, acquired, or licensed by North American Brands and North American Generics and International segments.

The increase in net revenues was primarily due to an increase in U.S. base product sales due to volume and price increases ($60.3 million) and an increase in third-party launches ($11.1 million).

Cost of Sales

Cost of sales includes third-party acquisition costs, profit-sharing or royalty payments for products sold pursuant to licensing agreements and inventory reserve charges, where applicable. Cost of sales does not include amortization or impairment costs for other acquired intangibles.

The increase in cost of sales within our Anda Distribution segment was due to higher product sales. Cost of sales as a percentage of revenue increased to 87.5% compared to 84.9% in the prior year period primarily due to product and customer mix.

Selling and Marketing Expenses

Selling and marketing expenses consist mainly of personnel costs, facilities costs, insurance and freight costs which support the Anda Distribution segment sales and marketing functions.

The increase in selling and marketing expenses relate to higher freight costs and higher personnel costs.

General and Administrative Expenses

General and administrative expenses consist mainly of personnel-related costs, facilities costs, insurance, depreciation, litigation and settlement costs and professional services costs which are general in nature.

Research and Development Expenses

R&D expenses consist predominantly of personnel-related costs, active pharmaceutical ingredient costs, contract research, biostudy and facilities costs associated with product development. R&D expenses consisted of the following components in the three months ended March 31, 2015 and 2014 ($ in millions):

 

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     Three Months
Ended March 31,
     Change  
     2015      2014      Dollars      %  

Ongoing operating expenses

   $ 284.0       $ 174.6       $ 109.4         62.7

Contingent consideration adjustments, net

     0.5         (7.3      7.8         (106.8 )% 

Operating results for assets held for sale

     —           2.7         (2.7      (100.0 )% 

Brand related milestone payments and upfront option payments

     10.0         —           10.0         100.0

Accelerated depreciation and product transfer costs

     —           0.9         (0.9      (100.0 )% 

Acquisiton accounting fair market value adjustment to stock-based compensation

     66.3         —           66.3         100.0

Acquisition, integration, and restructuring charges

     70.2         0.6         69.6         n.m.   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total expenditures

$ 431.0    $ 171.5    $ 259.5      151.3
  

 

 

    

 

 

    

 

 

    

 

 

 

The increase in ongoing operating expenses is primarily due to the impact of the Forest and Allergan acquisitions.

Amortization

 

     Three Months
Ended March 31,
    Change  
($ in millions)    2015     2014     Dollars      %  

Amortization

   $ 925.4      $ 424.2      $ 501.2         118.2

as % of net revenues

     21.9     16.0     

Amortization for the quarter ended March 31, 2015 increased as compared to the prior year period primarily as a result of increased amortization of identifiable assets acquired in the Forest Acquisition of $459.4 million and the Allergan acquisition of $142.4 million.

Asset sales and impairments, net

 

     Three Months
Ended March 31,
     Change  
($ in millions)    2015      2014      Dollars      %  

Asset sales and impairments, net

   $ 57.8       $ (0.4    $ 58.2         n.m.   

Asset sales and impairments, net for the three months ended March 31, 2015 primarily included the impairment of assets relating to our Australian portfolio of $44.5 million as well as impairments relating to assets held for sale.

Asset sales and impairments, net for the three months ended March 31, 2014 primarily included the reversal of impairment losses due to movements in working capital related to our Western European assets held for sale of $3.4 million and the gain on the sale of Columbia Laboratories, Inc. of $4.3 million, offset, in part, by the impairment on our Lincolnton assets held for sale of $5.7 million as well as the impairment of select intangible assets of $1.5 million.

 

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Interest Income

 

     Three Months
Ended
March 31,
     Change  
($ in millions)    2015      2014      Dollars      %  

Interest income

   $ 1.8       $ 1.0       $ 0.8         80.0

Interest income represents interest earned on cash and cash equivalents held during the respective periods.

Interest Expense

 

     Three Months
Ended March 31,
     Change  
($ in millions)    2015      2014      Dollars      %  

Interest expense—Floating Rate Notes

   $ 1.3       $ —         $ 1.3         100.0

Interest expense—Fixed Rate Notes

     139.5         57.6         81.9         142.2

Interest expense—WC Term Loan

     6.5         7.6         (1.1      (14.5 )% 

Interest expense—ACT Term Loan

     14.4         6.1         8.3         136.1

Interest expense—AGN Term Loan

     4.1         —           4.1         100.0

Interest expense—Bridge Loan

     2.0         —           2.0         100.0

Interest expense—Revolving Credit Facility

     1.7         0.7         1.0         142.9

Interest expense—Other

     2.4         0.8         1.6         200.0
  

 

 

    

 

 

    

 

 

    

Interest expense

$ 171.9    $ 72.8    $ 99.1      136.1
  

 

 

    

 

 

    

 

 

    

Interest expense increased for the three months ended March 31, 2015 over the prior year primarily due to interest from the indebtedness incurred as part of the Allergan Acquisition of $48.3 million and indebtedness incurred from the Forest Acquisition of $70.5 million.

Other (expense) income, net

 

     Three Months
Ended March 31,
     Change  
($ in millions)    2015      2014      Dollars      %  

Bridge loan commitment fee

   $ (263.0    $ (9.4 )      (253.6      n.m.   

Gain on sale of investments

     —           4.3        (4.3      (100.0 )% 

Interest rate lock

     31.0                 31.0         100.0

Other income

     34.0         10.1         23.9         236.6
  

 

 

    

 

 

    

 

 

    

Other (expense) income, net

$ (198.0 $ 5.0    $ (203.0
  

 

 

    

 

 

    

 

 

    

Bridge Loan Commitment Fee

During the three months ended March 31, 2015, in connection with the Allergan Acquisition, we incurred costs associated with bridge loan commitments of $263.0 million. In the three months ended March 31, 2014, in connection with the Forest Merger Agreement, we secured a bridge loan commitment of up to $7.0 billion and incurred associated commitment costs of $20.3 million. During the quarter ended March 31, 2014, we recorded an expense of $9.4 million, of which $7.5 million related to the termination of $2.0 billion of the bridge loan commitments.

Gain on Sale of Investment

During the quarter ended March 31, 2014, we sold our minority interest in Columbia Laboratories Inc. for $8.5 million. As a result, we recognized a gain on the sale of $4.3 million.

Interest rate lock

During the three months ended March 31, 2015, the Company entered into interest rate locks on a portion of the $21.0 billion of debt issued as part of the Allergan Acquisition. As a result of the interest rate locks, the Company recorded income of $31.0 million.

 

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Other Income

In the three months ended March 31, 2015, we recorded a gain on the sale of the Respiratory Business of $33.5 million.

In the quarter ended March 31, 2014, we recorded income of $5.0 million, in connection with the agreement entered into on January 24, 2014 with Nitrogen DS Limited, one of the sellers associated with the Actavis group acquisition, in which we received payment from Nitrogen DS Limited in exchange for their right to transfer, sell, or assign or otherwise dispose of 50% of the locked up Actavis shares owned.

(Benefit) / Provision for Income Taxes

 

     Three Months Ended
March 31,
    Change  
($ in millions)    2015     2014     Dollars      %  

(Benefit) / Provision for income taxes

   $ (177.7   $ 44.4      $ (222.1      (500.2 )% 

Effective tax rate

     (25.8 )%      31.5     

The Company’s effective tax rate for the three months ended March 31, 2015 was (25.8)% compared to 31.5% for the three months ended March 31, 2014. The effective tax rate for the three months ended March 31, 2015 was impacted by income earned in low tax jurisdictions, losses in certain jurisdictions for which no tax benefit is provided and the amortization of intangibles and the step-up in inventory benefited at rates other than the Irish statutory rate. The effective tax rate for the quarter ended March 31, 2014 was impacted by income earned in low tax jurisdictions, losses in certain jurisdictions for which no tax benefit is provided and the amortization of intangibles and the step-up in inventory benefited at rates other than the Irish statutory rate. Additionally, the tax provision for the quarter ended March 31, 2014 included a benefit of $9.7 million related to certain changes to the Company’s uncertain tax positions.

Liquidity and Capital Resources

Working Capital Position

Working capital at March 31, 2015 and December 31, 2014 is summarized as follows:

 

($ in millions):    March 31,
2015
     December 31,
2014
     Increase
(Decrease)
 

Current Assets:

        

Cash and cash equivalents

   $ 2,114.9       $ 250.0       $ 1,864.9   

Marketable securities

     16.0         1.0         15.0   

Accounts receivable, net

     3,992.8         2,372.3         1,620.5   

Inventories

     3,125.1         2,075.5         1,049.6   

Prepaid expenses and other current assets

     1,024.1         733.4         290.7   

Current assets held for sale

     143.5         949.2         (805.7

Deferred tax assets

     600.8         500.3         100.5   
  

 

 

    

 

 

    

 

 

 

Total current assets

  11,017.2      6,881.7      4,135.5   
  

 

 

    

 

 

    

 

 

 

Current liabilities:

Accounts payable and accrued expenses

$ 5,820.1    $ 4,170.6    $ 1,649.5   

Income taxes payable

  101.6      50.4      51.2   

Current portion of long-term debt and capital leases

  1,624.1      697.4      926.7   

Deferred revenue

  27.1      27.0      0.1   

Current liabilities held for sale

  17.4      25.9      (8.5

Deferred tax liabilities

  65.2      47.3      17.9   
  

 

 

    

 

 

    

 

 

 

Total current liabilities

  7,655.5      5,018.6      2,636.9   
  

 

 

    

 

 

    

 

 

 

Working Capital

$ 3,361.7    $ 1,863.1    $ 1,498.6   
  

 

 

    

 

 

    

 

 

 

Working Capital excluding assets held for sale, net

$ 3,235.6    $ 939.8    $ 2,295.8   
  

 

 

    

 

 

    

 

 

 

Adjusted Current Ratio

  1.42      1.19   
  

 

 

    

 

 

    

 

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Working capital excluding assets held for sale, net, increased $2,295.8 million to $3,235.6 million at March 31, 2015 compared to $939.8 million at December 31, 2014. Excluding cash, the increase was $430.9 million. This increase is due to working capital acquired as part of the Allergan Acquisition of $1,179.1 million excluding cash. In addition to the non-cash acquired working capital, the Company’s current portion of debt increased by $810.0 million due to the cash bridge facility repaid in April of 2015. Movements in cash were primarily due to cash earnings less the net cash acquired in the Allergan Acquisition.

Cash Flows from Operations

Summarized cash flow from operations is as follows:

 

     Three Months Ended
March 31,
 
($ in millions)    2015      2014  

Net cash provided by operating activities

   $ 525.0       $ 439.6   

Cash flows from operations represent net income adjusted for certain non-cash items and changes in assets and liabilities. Cash provided by operating activities increased $85.4 million in the quarter ended March 31, 2015 versus the prior year period, due primarily to an increase in net income, adjusted for non-cash activity of $385.0 million ($947.0 million and $562.0 million of adjusted cash net income in the quarters ended March 31, 2015 and 2014, respectively), offset, in part, by an increase in working capital, primarily accounts receivable due to updated payment terms in certain distribution channels.

Management expects that available cash balances and the remaining 2015 cash flows from operating activities will provide sufficient resources to fund our operating liquidity needs and expected 2015 capital expenditure funding requirements.

Investing Cash Flows

Our cash flows from investing activities are summarized as follows:

 

     Three Months Ended
March 31,
 
($ in millions)    2015      2014  

Net cash (used in) investing activities

   $ (33,940.9    $ (24.1

Investing cash flows consist primarily of cash used in acquisitions of businesses and intangibles (primarily product rights), capital expenditures for property, plant and equipment and purchases of investments and marketable securities partially offset by proceeds from the sale of investments and marketable securities. Included in the quarter ended March 31, 2015 was cash used in connection with the Allergan Acquisition, net of cash acquired, of $34,646.2 million and capital expenditures for property, plant and equipment of $136.6 million, offset, in part by cash received from the sale of assets, primarily the respiratory business, of $790.5 million.

Included in the quarter ended March 31, 2014 was cash used in connection with capital expenditures for property, plant and equipment of $42.5 million, offset, in part by cash received from the sale of assets of $15.0 million.

Financing Cash Flows

Our cash flows from financing activities are summarized as follows:

 

     Three Months Ended
March 31,
 
($ in millions)    2015      2014  

Net cash provided by / (used in) financing activities

   $ 35,285.6       $ (368.0

Financing cash flows consist primarily of borrowings and repayments of debt, repurchases of ordinary shares and proceeds from the exercise of stock options. Cash provided by financing activities in the quarter ended March 31, 2015 included the issuance of indebtedness of $29,265.6 million, the issuance of ordinary shares of $4,071.1 million and the issuance of Mandatory Convertible Preferred Shares of $4,929.7 million in connection with the Allergan Acquisition, offset in part by payments of debt of $2,660.0 million and debt issuance costs of $310.8 million. Included in the three months ended March 31, 2014 were payments of outstanding indebtedness of $326.1 million including $265.0 million on the revolving credit facility, debt issuance costs of $20.3 million and the repurchase of ordinary shares to satisfy tax withholding obligations in connection with vested restricted stock issued to employees of $57.0 million, offset, in part, by the excess tax benefit relating to stock-based compensation of $36.8 million.

Debt and Borrowing Capacity

Total debt and capital leases consisted of the following (in millions):

 

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     Balance As of           Fair Market
Value As of
 
     March 31, 2015     December 31, 2014     March 31, 2015      December 31, 2014  

Senior Notes:

         

Floating Rate Notes

         

$500.0 million floating rate notes due September 1, 2016

   $ 500.0      $ —         $ 501.0       $ —     

$500.0 million floating rate notes due March 12, 2018

     500.0        —           503.9         —     

$500.0 million floating rate notes due March 12, 2020

     500.0        —           508.2         —     
  

 

 

   

 

 

   

 

 

    

 

 

 
     1,500.0        —           1,513.1         —     
  

 

 

   

 

 

   

 

 

    

 

 

 

Fixed Rate Notes

         

$800.0 million 5.750% notes due April 1, 2016

     800.0        —          836.9         —     

$500.0 million 1.300% notes due June 15, 2017

     500.0        500.0        497.0         489.0   

$1,000.0 million 1.850% notes due March 1, 2017

     1,000.0        —          1,007.7         —     

$1,200.0 million 1.875% notes due October 1, 2017

     1,200.0        1,200.0        1,201.0         1,187.3   

$3,000.0 million 2.350% notes due March 12, 2018

     3,000.0        —          3,039.9         —     

$250.0 million 1.350%% notes due March 15, 2018

     250.0        —          247.3         —     

$1,050.0 million 4.375% notes due February 1, 2019

     1,050.0        1,050.0        1,125.3         1,111.4   

$500.0 million 2.450% notes due June 15, 2019

     500.0        500.0        499.8         498.2   

$400.0 million 6.125% notes due August 15, 2019

     400.0        400.0        459.6         457.9   

$3,500.0 million 3.000% notes due March 12, 2020

     3,500.0        —          3,584.4         —     

$650.0 million 3.375% notes due September 15, 2020

     650.0        —          674.1         —     

$750.0 million 4.875% notes due February 15, 2021

     750.0        750.0        824.6         808.9   

$1,200.0 million 5.000% notes due December 15, 2021

     1,200.0        1,200.0        1,328.6         1,301.0   

$3,000.0 million 3.450% notes due March 15, 2022

     3,000.0        —          3,069.3         —     

$1,700.0 million 3.250% notes due October 1, 2022

     1,700.0        1,700.0        1,704.6         1,647.5   

$350.0 million 2.800% notes due March 15, 2023

     350.0        —          332.2         —     

$1,200.0 million 3.850% notes due June 15, 2024

     1,200.0        1,200.0        1,238.9         1,215.5   

$4,000.0 million 3.800% notes due March 15, 2025

     4,000.0        —          4,122.0         —     

$2,500.0 million 4.550% notes due March 15, 2035

     2,500.0        —          2,613.0         —     

$1,000.0 million 4.625% notes due October 1, 2042

     1,000.0        1,000.0        1,028.6         980.1   

$1,500.0 million 4.850% notes due June 15, 2044

     1,500.0        1,500.0        1,608.3         1,539.9   

$2,500.0 million 4.750% notes due March 15, 2045

     2,500.0        —          2,646.5         —     
  

 

 

   

 

 

   

 

 

    

 

 

 
     32,550.0        11,000.0        33,689.6         11,236.7   
  

 

 

   

 

 

   

 

 

    

 

 

 

Total Senior Notes Gross

     34,050.0        11,000.0        35,202.7         11,236.7   
  

 

 

   

 

 

   

 

 

    

 

 

 

Unamortized premium

     286.6        239.9        —           —     

Unamortized discount

     (116.0     (52.1     —           —     
  

 

 

   

 

 

   

 

 

    

 

 

 

Total Senior Notes Net

     34,220.6        11,187.8        35,202.7         11,236.7   
  

 

 

   

 

 

   

 

 

    

 

 

 

Term Loan Indebtedness:

         

WC Term Loan

         

WC Three Year Tranche variable rate debt maturing October 1, 2016

     306.9        506.9        

WC Five Year Trance variable rate debt maturing October 1, 2018**

     622.1        744.7        
  

 

 

   

 

 

      
     929.0        1,251.6        
  

 

 

   

 

 

      

ACT Term Loan

         

2017 Term Loan variable rate debt maturing October 31, 2017**

     903.4        932.6        

2019 Term Loan variable rate debt maturing July 1, 2019**

     1,850.0        1,900.0        
  

 

 

   

 

 

      
     2,753.4        2,832.6        
  

 

 

   

 

 

      

AGN Term Loan

         

AGN Three Year Tranche variable rate debt maturing March 17, 2018

     2,750.0        —          

AGN Five Year Tranche variable rate debt maturing March 17, 2020**

     2,750.0        —          
  

 

 

   

 

 

      
     5,500.0        —          
  

 

 

   

 

 

      

Total Term Loan Indebtedness

     9,182.4        4,084.2        
  

 

 

   

 

 

      

Other Indebtedness

         

Bridge Loan Facility

     810.0        —          

Revolver borrowings

     —          255.0        

Other

     98.4        —          
  

 

 

   

 

 

      

Total Other Borrowings

     908.4        255.0        
  

 

 

   

 

 

      

Capital Leases

     13.2        16.7        
  

 

 

   

 

 

      

Total Indebtedness

   $ 44,324.6      $ 15,543.7        
  

 

 

   

 

 

      

 

** The indebtedness requires a quarterly repayment of 2.5%.

 

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Fair market value in the table above is determined in accordance with ASC Topic 820 “Fair Value Measurement” (“ASC 820”) under Level 2 based upon quoted prices for similar items in active markets. The book value of the outstanding term loan indebtedness approximates fair value as the debt is at variable interest rates and re-prices frequently.

Unless otherwise indicated, the remaining loan balances after the quarterly required payments are due upon maturity.

Floating Rate Notes

On March 4, 2015, Actavis Funding SCS, a limited partnership (société en commandite simple) organized under the laws of the Grand Duchy of Luxembourg and an indirect wholly-owned subsidiary of Actavis plc, issued floating rate notes due 2016 (the “2016 Floating Rate Notes”), floating rate notes due 2018 (the “2018 Floating Rate Notes”), floating rate notes due 2020 (the “2020 Floating Rate Notes”), 1.850% notes due 2017 (the “1.850% 2017 Notes”), 2.350% notes due 2018 (the “2.350% 2018 Notes”), 3.000% notes due 2020 (the “3.000% 2020 Notes”), 3.450% notes due 2022 (the “3.450% 2022 Notes”), 3.800% notes due 2025 (the “3.800% 2025 Notes”), 4.550% notes due 2035 (the “4.550% 2035 Notes”) and 4.750% notes due 2045 (the “4.750% 2045 Notes”). The notes will be fully and unconditionally guaranteed by Actavis Funding SCS’s indirect parents, Warner Chilcott Limited and Actavis Capital S.a.r.l. (“Actavis Capital”), and by Actavis, Inc., a subsidiary of Actavis Capital, on an unsecured and unsubordinated basis. Actavis plc has not guaranteed the notes.

The 2016 Floating Rate Notes, the 2018 Floating Rate Notes and the 2020 Floating Rate Notes will bear interest at a floating rate equal to three-month LIBOR plus 0.875%, 1.080% and 1.255% per annum, respectively. Interest on the 2016 Floating Rate Notes will be payable quarterly on March 1, June 1, September 1 and December 1 of each year, beginning on June 1, 2015. Interest on the 2018 Floating Rate Notes and the 2020 Floating Rate Notes will be payable quarterly on March 12, June 12, September 12 and December 12 of each year, beginning on June 12, 2015.

Fixed Rate Notes

The Company has issued fixed rate notes over multiple issuances for various business needs. Interest on the various notes is generally payable semi-annually with various payment dates.

The following represents the activity to the fixed rate notes during the three months ended March 31, 2015:

 

    Actavis Funding SCS issued the 1.850% 2017 Notes, the 2.350% 2018 Notes, the 3.000% 2020 Notes, the 3.450% 2022 Notes, the 3.800% 2025 Notes, the 4.550% 2035 Notes and the 4.750% 2045 Notes; and

 

    On May 7, 2015, Actavis Funding SCS and Wells Fargo entered into a second supplemental indenture amending the indenture dated as of March 12, 2015 between Actavis Funding SCS and Warner Chilcott Limited, Actavis Capital S.à r.l., and Actavis, Inc., as guarantors (collectively, the “Guarantors”), and Wells Fargo as supplemented and amended by the first supplemental indenture dated as of March 12, 2015 between Actavis Funding SCS, the Guarantors and Wells Fargo (the “Indenture”). The second supplemental indenture amends certain inconsistencies in the terms of the notes offered under the Indenture.

 

    On March 17, 2015 in connection with the Allergan Acquisition, the Company acquired, and subsequently guaranteed, along with Warner Chilcott Limited, the indebtedness of Allergan comprised of the $350.0 million 2.800% senior notes due 2023, the $650.0 million 3.375% senior notes due 2020, the $250.0 million 1.350% senior notes due 2018 and the $800.0 million 5.750% senior notes due 2016. Interest payments are due on the $350.0 million senior notes semi-annually on the principal amount of the notes at a rate of 2.80% 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 at the time of the redemption, if the redemption occurs prior to December 15, 2022 (three months prior to the maturity of the 2023 senior notes). If the redemption occurs on or after December 15, 2022, then such redemption is not subject to the make-whole provision. Interest payments are due on the $650.0 million senior notes semi-annually on the principal amount of the notes at a rate of 3.375% 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 at the time of the redemption. Interest payments are due on the $250.0 million senior notes semi-annually on the principal amount of the notes at a rate of 1.350% 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 at the time of the redemption. Interest payments are due on the $800.0 million senior notes semi-annually on the principal amount of the notes at a rate of 5.750% 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 at the time of the redemption. The fair value of the acquired senior notes was determined to be $2,087.5 million as of March 17, 2015. As such, as part of acquisition accounting, the company recorded a premium of $37.5 million to be amortized as contra interest over the life of the notes.

Term Loan Indebtedness

WC Term Loan

On December 17, 2014, Actavis plc and certain of its subsidiaries entered into a second amendment agreement (the “WC Term Loan Amendment”) among Actavis plc, Warner Chilcott Limited, Warner Chilcott Finance, LLC, Actavis WC 2 S.à r.l. (“Actavis WC 2”), Warner Chilcott Company, LLC (“WCCL”), Warner Chilcott Corporation (“WC Corporation” and together with Actavis WC 2 and WCCL, the “WC Borrowers”), Bank of America, N.A. (“BofA”), as administrative agent, and the lenders party thereto. The WC Term Loan Amendment amends and restates Actavis plc’s existing amended and restated WC term loan credit and guaranty

 

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agreement, dated as of June 9, 2014 (such agreement, prior to its amendment and restatement pursuant to the WC Term Loan Amendment, the “2014 WC Term Loan”), among the WC Borrowers, Actavis plc, Warner Chilcott Limited, Warner Chilcott Finance, LLC, the lenders from time to time party thereto and BofA, as administrative agent, which amended and restated Actavis plc’s existing WC term loan credit and guaranty agreement, dated as of August 1, 2013 (such agreement, prior to its amendment and restatement pursuant to the 2014 WC Term Loan Amendment, the “Existing WC Term Loan”) among the WC Borrowers, Warner Chilcott Finance, LLC, Actavis Limited, BofA, as administrative agent and a syndicate of banks participating as lenders.

Pursuant to the Existing WC Term Loan, on October 1, 2013 (the “WC Closing Date”), the lenders party thereto provided term loans in a total aggregate principal amount of $2.0 billion, comprised of (i) a $1.0 billion tranche that will mature on October 1, 2016 (the “WC Three Year Tranche”) and (ii) a $1.0 billion tranche that will mature on October 1, 2018 (the “WC Five Year Tranche”). The proceeds of borrowings under the Existing WC Term Loan Agreement, together with $41.0 million of cash on hand, were used to finance the repayment in full of all amounts outstanding under Warner Chilcott’s then-existing Credit Agreement, dated as of March 17, 2011, as amended by Amendment No. 1 on August 20, 2012, among the WC Borrowers, Warner Chilcott Holdings Company III, Limited, BofA, as administrative agent and a syndicate of banks participating as lenders.

Borrowings under the WC Term Loan Agreement bear interest at the applicable borrower’s choice of a per annum rate equal to either (a) a base rate plus an applicable margin per annum varying from (x) 0.00% per annum to 0.75% per annum under the WC Three Year Tranche and (y) 0.125% per annum to 0.875% per annum under the WC Five Year Tranche, depending on the publicly announced debt ratings for non-credit-enhanced, senior unsecured long-term indebtedness of Actavis plc (such applicable debt rating the “Debt Rating”) or (b) a Eurodollar rate, plus an applicable margin varying from (x) 1.00% per annum to 1.75% per annum under the WC Three Year Tranche and (y) 1.125% per annum to 1.875% per annum under the WC Five Year Tranche, depending on the Debt Rating.

The Company is subject to, and, at March 31, 2015, was in compliance with, all financial and operational covenants under the terms of the WC Term Loan.

ACT Term Loan

On December 17, 2014, Actavis plc and certain of its subsidiaries entered into a third amendment agreement (the “ACT Term Loan Amendment”) among Actavis plc, Warner Chilcott Limited, Actavis Capital, Actavis, Inc., Actavis Funding SCS, BofA, as administrative agent, and the lenders party thereto. The ACT Term Loan Amendment amends and restates Actavis plc’s existing second amended and restated Actavis term loan credit and guaranty agreement, dated as of March 31, 2014 (such agreement, prior to its amendment and restatement pursuant to the ACT Term Loan Amendment, the “2014 ACT Term Loan Agreement” and together with the Existing ACT Term Loan Agreement (defined below), the “ACT Term Loan”) among Actavis Capital, Actavis plc, Warner Chilcott Limited, Actavis, Inc., Actavis Funding SCS, BofA, as administrative agent, and the lenders from time to time party thereto, which amended and restated Actavis plc’s existing amended and restated Actavis term loan credit and guaranty agreement, dated as of October 1, 2013 (such agreement, prior to its amendment and restatement pursuant to the ACT Term Loan Amendment, the “Existing ACT Term Loan Agreement”) among Actavis Capital, Actavis plc, Actavis, Inc., BofA, as administrative agent, and the lenders from time to time party thereto.

The Existing ACT Term Loan Agreement amended and restated Actavis, Inc.’s $1,800.0 million senior unsecured term loan credit facility, dated as of June 22, 2012. At the closing of the Existing ACT Term Loan Agreement, an aggregate principal amount of $1,572.5 million was outstanding (the “2017 Term Loan”). The 2017 Term Loan matures on October 31, 2017.

On March 31, 2014, Actavis plc, Actavis Capital, Actavis, Inc., BofA, as Administrative Agent, and a syndicate of banks participating as lenders entered into the 2014 ACT Term Loan Agreement to amend and restate the Existing ACT Term Loan Agreement. On July 1, 2014, in connection with the Forest Acquisition, the Company borrowed $2.0 billion of term loan indebtedness under tranche A-2 of the 2014 ACT Term Loan Agreement, which is due July 1, 2019 (the “2019 Term Loan”).

The ACT Term Loan provides that loans thereunder will bear interest, at the Company’s choice, of a per annum rate equal to either (a) a base rate, plus an applicable margin per annum varying from (x) 0.00% per annum to 1.00% per annum with respect to the 2017 term-loan and (y) 0.125% per annum to 0.875% per annum with respect to the 2019 term-loan, depending on the Debt Rating or (b) a Eurodollar rate, plus an applicable margin varying from (x) 1.00% per annum to 2.00% per annum with respect to the 2017 term-loan and (y) 1.125% per annum to 1.875% per annum with respect to the 2019 term-loan, depending on the Debt Rating.

The Company is subject to, and at March 31, 2015 was in compliance with, all financial and operational covenants under the terms of the ACT Term Loan.

AGN Term Loan

On December 17, 2014, Actavis and certain of its subsidiaries entered into a senior unsecured term loan credit agreement (the “AGN Term Loan”), among Actavis Capital, as borrower, Actavis plc, Warner Chilcott Limited, Actavis, Inc., Actavis Funding SCS, the lenders from time to time party thereto (the “Term Lenders”), JPMorgan Chase Bank, N.A. (“JPMCB”), as administrative agent and the other financial institutions party thereto. Under the AGN Term Loan, the Term Lenders provided (i) a $2.75 billion tranche maturing on March 17, 2018 (the “AGN Three Year Tranche”) and (ii) a $2.75 billion tranche and maturing on March 17, 2020 (the “AGN Five Year Tranche”). The proceeds of borrowings under the AGN Term Loan were to be used to finance, in part, the cash component of the Allergan Acquisition consideration and certain fees and expenses incurred in connection with the Allergan Acquisition.

 

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Borrowings under the AGN Term Loan bear interest at our choice of a per annum rate equal to either (a) a base rate plus an applicable margin per annum varying from (x) 0.00% per annum to 1.00% per annum under the AGN Three Year Tranche and (y) 0.125% per annum to 1.250%% per annum under the AGN Five Year Tranche, depending on the Debt Rating or (b) a Eurodollar rate, plus an applicable margin varying from (x) 1.00% per annum to 2.00% per annum under the AGN Three Year Tranche and (y) 1.125% per annum to 2.250% per annum under the AGN Five Year Tranche, depending on the Debt Rating. The outstanding principal amount of loans under the AGN Three Year Tranche is not subject to quarterly amortization and shall be payable in full on the maturity date. The outstanding principal amount of loans under the AGN Five Year Tranche is payable in equal quarterly amounts of 2.50% per quarter prior to March 17, 2020, with the remaining balance payable on March 17, 2020.

The obligations of Actavis Capital under the Term Loan Credit Agreement are guaranteed by Warner Chilcott Limited, Actavis, Inc. and Actavis Funding SCS and will be guaranteed by any subsidiary of Actavis plc (other than Actavis Capital or a direct subsidiary of Actavis plc) that becomes a guarantor of third party indebtedness in an aggregate principal amount exceeding $350.0 million (unless, in the case of a foreign subsidiary, such guarantee would give rise to adverse tax consequences as reasonably determined by Actavis plc).

Bridge Loan Facility

On December 17, 2014, Actavis and certain of its subsidiaries entered into a 364-day senior unsecured bridge credit agreement (the “Bridge Loan Facility”), among Actavis Capital, as borrower, Actavis plc, Warner Chilcott Limited, Actavis, Inc., Actavis Funding SCS, the lenders from time to time party thereto (the “Bridge Lenders”), JPMCB, as administrative agent and the other financial institutions party thereto. Under the Bridge Loan Facility, the Bridge Lenders committed to provide, subject to certain conditions, unsecured bridge financing, of which $2.8 billion was drawn to finance the Allergan Acquisition on March 17, 2015. As of March 31, 2015, $810.0 million of the Bridge Loan Facility was outstanding. The outstanding balance of the Bridge Loan Facility was repaid on April 9, 2015.

Borrowings under the Bridge Loan Facility bore interest at our choice of a per annum rate equal to either (a) a base rate plus an applicable margin per annum varying from 0.00% per annum to 2.50% per annum, depending on the Debt Rating and the number of days for which the loans remain outstanding from the date of funding thereunder or (b) a Eurodollar rate, plus an applicable margin varying from 1.00% per annum to 3.50% per annum, depending on the Debt Rating and the number of days for which the loans remain outstanding from the date of funding thereunder.

Revolving Credit Facility

On December 17, 2014, Actavis plc and certain of its subsidiaries entered into a revolving credit loan and guaranty agreement (the “Revolver Agreement”) among Actavis Capital, as borrower, Actavis plc, Warner Chilcott Limited, Actavis, Inc., Actavis Funding SCS, the lenders from time to time party thereto (the “Revolving Lenders”), JPMCB as administrative agent, J.P. Morgan Europe Limited, as London agent, and the other financial institutions party thereto. Under the Revolver Agreement, the Revolving Lenders have committed to provide an unsecured revolving credit facility in an aggregate principal amount of up to $1.0 billion.

The Revolver Agreement provides that loans thereunder will bear interest, at our choice, of a per annum rate equal to either (a) a base rate, plus an applicable margin per annum varying from 0.00% per annum to 1.00% per annum depending on the Debt Rating or (b) a Eurodollar rate, plus an applicable margin varying from 0.875% per annum to 2.00% per annum depending on the Debt Rating. Additionally, to maintain availability of funds, the Company pays an unused commitment fee, which according to the pricing grid is set at 0.075% to 0.250% per annum, depending on the Debt Rating, of the unused portion of the revolver. The Revolving Credit Agreement will mature on December 17, 2019.

The obligations under the Revolver Agreement are guaranteed by Actavis plc, Warner Chilcott Limited, Actavis, Inc. and Actavis Funding SCS and will be guaranteed by any subsidiary of Actavis (other than Actavis Capital) that becomes a guarantor of third party indebtedness in an aggregate principal amount exceeding $350.0 million (unless, in the case of a foreign subsidiary, such guarantee would give rise to adverse tax consequences as reasonably determined by Actavis plc).

The Company is subject to, and as of March 31, 2015 was in compliance with, all financial and operational covenants under the terms of the Revolving Credit Facility. At March 31, 2015, there was no outstanding borrowings under the Revolving Credit Facility and letters of credit outstanding were $29.2 million. The net availability under the Revolving Credit Facility was $970.8 million.

 

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Off-Balance Sheet Arrangements

We do not have any material off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, net revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The following discussion provides forward-looking quantitative and qualitative information about our potential exposure to market risk. Market risk represents the potential loss arising from adverse changes in the value of financial instruments. The risk of loss is assessed based on the likelihood of adverse changes in fair values, cash flows or future earnings. We are exposed to market risk for changes in the market values of our investments (Investment Risk), the impact of interest rate changes (Interest Rate Risk) and the impact of foreign currency exchange changes (Foreign Currency Exchange Risk).

We maintain our portfolio of cash equivalents and short-term investments in a variety of securities, including both government and government agency obligations with ratings of A or better and money market funds. Our investments in marketable securities are governed by our investment policy which seeks to preserve the value of our principal, provide liquidity and maximize return on the Company’s investment against minimal interest rate risk. Consequently, our interest rate and principal risk are minimal on our non-equity investment portfolio. The quantitative and qualitative disclosures about market risk are set forth below.

Investment Risk

As of March 31, 2015, our total investments in marketable and equity securities of other companies, including equity method investments were $258.8 million (included in marketable securities and investments and other assets). The fair values of these investments are subject to significant fluctuations due to volatility of the stock market and changes in general economic conditions.

We regularly review the carrying value of our investments and identify and recognize losses, for income statement purposes, when events and circumstances indicate that any declines in the fair values of such investments below our accounting basis are other than temporary.

Interest Rate Risk

Our exposure to interest rate risk relates primarily to our non-equity investment portfolio and our floating rate debt. Our cash is invested in bank deposits and A-rated or better money market mutual funds.

Our portfolio of marketable securities includes U.S. treasury and agency securities classified as available-for-sale securities, with no security having a maturity in excess of two years. These securities are exposed to interest rate fluctuations. Because of the short-term nature of these investments, we are subject to minimal interest rate risk and do not believe that an increase in market rates would have a significant negative impact on the realized value of our portfolio.

Floating Rate Debt

At March 31, 2015, borrowings outstanding under the floating rate notes and term loan indebtedness were $10,682.4 million. Assuming a one percent increase in the applicable interest rate, annual interest expense would increase by approximately $106.8 million over the next twelve months.

Fixed Rate Debt

The Company has outstanding borrowings under its fixed rate notes. Changes in market interest rates generally affect the fair value of fixed-rate debt, but do not impact earnings or cash flows.

Foreign Currency Exchange Risk

We operate and transact business in various foreign countries and are, therefore, subject to the risk of foreign currency exchange rate fluctuations. The Company manages this foreign currency risk, in part, through operational means including managing foreign currency revenues in relation to same currency costs as well as managing foreign currency assets in relation to same currency liabilities. The Company is also exposed to the potential earnings effects from intercompany foreign currency assets and liabilities that arise from normal trade receivables and payables and other intercompany loans. The Company seeks to limit exposure to foreign exchange risk, including those involving intercompany trade receivables and payables by settling outstanding amounts through normal payment terms, or through foreign exchange forward contracts or options.

 

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Net foreign currency gains and losses did not have a material effect on the Company’s results of operations for the quarters ended March 31, 2015 or 2014, respectively.

Other

We do not believe that inflation has had a significant impact on our revenues or operations.

At this time, we have no material commodity price risks.

 

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

The Company maintains “disclosure controls and procedures,” as such term is defined under Rule 13a-15(e) of the Exchange Act, that are designed to provide reasonable assurance that information required to be disclosed in the Company’s Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including its Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective.

As required by SEC Rule 13a-15(b), the Company carried out an evaluation, under the supervision and with the participation of the Company’s management, including the Company’s Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures. Based on this evaluation, the Company’s Principal Executive Officer and Principal Financial Officer concluded that the Company’s disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting

Management of the Company, with the participation of its Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures over financial reporting for the period covered by this Form 10–Q. Based on this assessment, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that as of March 31, 2015, the Company’s disclosure controls and procedures are effective. The Company implemented a new financial reporting consolidation system in the first quarter of 2015. The Company completed testing of this financial reporting system prior to its launch, continues to monitor impacted financial and business processes and believes that an effective control environment has been maintained post-implementation.

There have been no other changes in the Company’s internal control over financial reporting, during the fiscal quarter ended March 31, 2015, that has materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

For information regarding legal proceedings, refer to “PART I, ITEM 3. LEGAL PROCEEDINGS,” of our Annual Report on Form 10-K for the year ended December 31, 2014 and “ Legal Matters” in “NOTE 19 — Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Quarterly Report.

 

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ITEM 1A. RISK FACTORS

Risks Related to Our Business

If we are unable to successfully develop or commercialize new products, our operating results will suffer.

Our future results of operations depend to a significant extent upon our ability to successfully develop and commercialize new brand and generic products in a timely manner. There are numerous difficulties in developing and commercializing new products, including:

 

    developing, testing and manufacturing products in compliance with regulatory standards in a timely manner;

 

    receiving requisite regulatory approvals for such products in a timely manner, or at all;

 

    the availability, on commercially reasonable terms, of raw materials, including API and other key ingredients;

 

    preclusion from commercialization by the proprietary rights of others;

 

    developing products that are economical to manufacture and commercialize;

 

    time consuming and costly nature of developing and commercializing new products;

 

    costly legal actions brought by our competitors, that may delay or prevent the development and commercialization of new products;

 

    experiencing delays as a result of limited resources at the FDA or other regulatory agencies;

 

    changing review and approval policies and standards at the FDA and other regulatory agencies; and

 

    commercializing generic products may be substantially delayed by the listing with the FDA of patents that have the effect of potentially delaying approval of a generic product by up to 30 months.

As a result of these and other difficulties, products currently in development by us may or may not receive timely regulatory approvals, or approvals at all, necessary for marketing by us or other third-party partners. This risk particularly exists with respect to the development of proprietary products because of the uncertainties, higher costs and lengthy time frames associated with R&D of such products and the inherent unproven market acceptance of such products. Our operating results and financial condition may fluctuate as the amount we spend to research and develop, promote, acquire or license new products, technologies and businesses changes. Additionally, we face heightened risks in connection with our development of extended release or controlled release generic products because of the technical difficulties and regulatory requirements related to such products. Additionally, with respect to generic products for which we are the first applicant to request approval on the basis that an innovator patent is invalid or not infringed (a Paragraph IV filing), our ability to obtain 180 days of generic market exclusivity may be contingent on our ability to obtain FDA approval or tentative approval

 

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within 30 months of the FDA’s acceptance of our application for filing. We therefore risk forfeiting such market exclusivity if we are unable to obtain such approval or tentative approval on a timely basis. If any of our products or the products of our third-party partners are not approved timely or, when acquired or developed and approved, cannot be successfully manufactured or commercialized in a timely manner, our operating results could be adversely affected. We cannot guarantee that any investment we make in developing products will be recouped, even if we are successful in commercializing those products. Refer to “ Our branded pharmaceutical expenditures may not result in commercially successful products .”

Our operating results and financial condition may fluctuate.

Our operating results and financial condition may fluctuate from quarter to quarter and year to year for a number of reasons. As a result, we believe that period-to-period comparisons of our results of operations are not necessarily meaningful, and these comparisons should not be relied upon as an indication of future performance. In particular, as a pharmaceutical company that manufactures and sells both branded and generic products, the development and launch of new competitive products or generics by ourselves may result in fluctuations in our financial performance, particularly as we work to balance our product offerings in light of our recent and future growth via acquisitions. Our operating results and financial condition are also subject to fluctuation from all of the risks described throughout this section. These fluctuations may adversely affect our results of operations and financial conditions.

If we do not successfully integrate newly acquired businesses into our business operations, our business could be adversely affected.

We will need to successfully integrate the operations of recently acquired businesses, including Allergan, Forest and Furiex, with our business operations. As a result of these recent and any other future or pending acquisitions, we have undergone substantial changes in a short period of time and our business has changed and broadened in size and the scope of products we offer. Integrating the operations of multiple new businesses with that of our own is a complex, costly and time-consuming process, which requires significant management attention and resources to integrate the business practice and operations. The integration process may disrupt the businesses and, if implemented ineffectively, would preclude realization of the full benefits expected by us. Our failure to meet the challenges involved in integrating the businesses in order to realize the anticipated benefits of the acquisitions could cause an interruption of, or a loss of momentum in, our activities and could adversely affect our results of operations. Prior to each acquisition, the acquired business operated independently, with its own business, corporate culture, locations, employees and systems. There may be substantial difficulties, costs and delays involved in any integration of other businesses with that of our own. These may include:

 

    distracting management from day-to-day operations;

 

    potential incompatibility of corporate cultures;

 

    an inability to achieve synergies as planned;

 

    risks associated with the assumption of contingent or other liabilities of acquisition targets;

 

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    adverse effects on existing business relationships with suppliers or customers;

 

    inheriting and uncovering previously unknown issues, problems and costs from the acquired company;

 

    delays between our expenditures to acquire new products, technologies or businesses and the generation of revenues from those acquired products, technologies or businesses;

 

    realization of assets and settlement of liabilities at amounts equal to estimated fair value as of the acquisition date of any acquisition or disposition;

 

    revenue recognition related to licensing agreements and/or strategic collaborations;

 

    costs and delays in implementing common systems and procedures (including technology, compliance programs, financial systems, distribution and general business operations, among others); and

 

    increased difficulties in managing our business due to the addition of international locations.

These risks may be heightened in cases where the majority of the former businesses’ operations, employees and customers are located outside of the United States. Any one or all of these factors may increase operating costs or lower anticipated financial performance. Many of these factors are also outside of our control. In addition, dispositions of certain key products, technologies and other rights may affect our business operations.

In addition, even if the operations of the businesses are integrated successfully, we may not realize the full benefits of the acquisition, including the synergies, cost savings or sales or growth opportunities that we expect. These benefits may not be achieved within the anticipated time frame, or at all. Additional unanticipated costs may be incurred in the integration of the businesses. All of these factors could cause a reduction to our earnings per share, decrease or delay the expected accretive effect of the transaction, and negatively impact the price of our ordinary shares.

The failure to integrate the business operations of the acquired business successfully would have a material adverse effect on our business, financial condition and results of operations.

Our substantial debt and other financial obligations could impair our financial condition and our ability to fulfill our debt obligations. Any refinancing of this substantial debt could be at significantly higher interest rates.

Our substantial indebtedness and other financial obligations could:

 

    impair our ability to obtain financing or additional debt in the future for working capital, capital expenditures, acquisitions or general corporate purposes;

 

    impair our ability to access capital and credit markets on terms that are favorable to us;

 

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    have a material adverse effect on us if we fail to comply with financial and affirmative and restrictive covenants in our debt agreements and an event of default occurs as a result of a failure that is not cured or waived;

 

    require us to dedicate a substantial portion of our cash flow for interest payments on our indebtedness and other financial obligations, thereby reducing the availability of our cash flow to fund working capital and capital expenditures;

 

    limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate; and

 

    place us at a competitive disadvantage compared to our competitors that have proportionally less debt.

Additionally, certain of our financing agreements may contain cross-default or other similar provisions whereby a default under one financing agreement could result in a default under our other financing agreements.

If we are unable to meet our debt service obligations and other financial obligations, we could be forced to restructure or refinance our indebtedness and other financial transactions, seek additional equity capital or sell our assets. We might then be unable to obtain such financing or capital or sell our assets on satisfactory terms, if at all. Any refinancing of our indebtedness could be at significantly higher interest rates, and/or incur significant transaction fees. Refer to “Liquidity and Capital Resources – Floating Rate Notes,” “Liquidity and Capital Resources – Fixed Rate Notes” and “Liquidity and Capital Resources – Term Loan Indebtedness” for a detailed discussion of our outstanding indebtedness.

Any acquisitions of businesses, technologies, or products or other significant transactions could adversely affect our relationships with employees, vendors or key customers.

We regularly review potential acquisitions of technologies, products and businesses complementary to our business. Acquisitions typically entail many risks and could result in difficulties in integrating operations, personnel, technologies and products. Refer to “ If we do not successfully integrate newly acquired businesses into our business operations our business could be adversely affected .” In connection with acquisitions, we could experience disruption in our business, technology and information systems, financial systems, vendors customer or employee base, including diversion of management’s attention from our continuing operations, among others. Refer to “ Certain aspects of our operations are highly dependent on third party service providers .” There is also a risk that key employees of companies that we acquire or key employees necessary to successfully commercialize technologies and products that we acquire may seek employment elsewhere, including with our competitors. Furthermore, there may be overlap between our products or customers and the companies that we acquire that may create conflicts in relationships or other commitments detrimental to the integrated businesses.

 

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We are subject to U.S. federal and state healthcare fraud and abuse and health information privacy and security laws, and the failure to comply with such laws may adversely affect our business.

In the United States, many of our products are reimbursed under federal and state health care programs such as Medicaid, Medicare, TriCare, and/or state pharmaceutical assistance programs, and as a result, certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. We could be subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include, but are not limited to: (i) the U.S. Anti-Kickback Statute, which constrains our marketing practices, educational programs, pricing policies and relationships with healthcare providers or other entities, by prohibiting, among other things, soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, either the referral of an individual or the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; (ii) federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payers that are false or fraudulent; (iii) the U.S. Health Insurance Portability and Accountability Act of 1996, (“HIPAA”), which among other things created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters, and HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information and places restrictions on the use of such information for marketing communications; (iv) the U.S. Physician Payments Sunshine Act, which among other things, requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under a federal healthcare program to report annually information related to “payments or other transfers of value” made to physicians and teaching hospitals, and ownership and investment interests held by certain healthcare professionals and their immediate family members; and (v) state and foreign law equivalents of each of the above U.S. laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. Violations of the fraud and abuse laws may result in severe penalties against the responsible employees and Actavis, including jail sentences, large fines, and the exclusion of our products from reimbursement under federal and state programs. Defense of litigation claims and government investigations can be costly, time-consuming, and distract management, and it is possible that Actavis could incur judgments or enter into settlements that would require us to change the way we operate our business. We are committed to conducting the sales and marketing of our products in compliance with the healthcare fraud and abuse laws, but certain applicable laws may impose liability even in the absence of specific intent to defraud. Furthermore, should there be ambiguity, a governmental authority may take a position contrary to a position we have taken, or should an employee violate these laws without our knowledge, a governmental authority may impose civil and/or criminal sanctions.

 

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For example, in December 2009, we learned that numerous pharmaceutical companies, including certain of our subsidiaries, were named as defendants in a federal qui tam action pending in the United States District Court for the District of Massachusetts alleging that the defendants falsely reported to the United States that certain pharmaceutical products were eligible for Medicaid reimbursement and thereby allegedly caused false claims for payment to be made through the Medicaid program. A similar action was filed by the State of Louisiana in August 2013 and additional lawsuits are possible. Any adverse outcome in these actions, or the imposition of penalties or sanctions for failing to comply with the fraud and abuse laws, could adversely affect us and may have a material adverse effect on our business, results of operations, financial condition and cash flows. Some of the statutes and regulations that govern our activities, such as federal and state anti-kickback and false claims laws, are broad in scope, and while exemptions and safe harbors protecting certain common activities exist, they are often narrowly drawn. While we manage our business activities to comply with these statutory provisions, due to their breadth, complexity and, in certain cases, uncertainty of application, it is possible that our activities could be subject to challenge by various government agencies. In particular, the FDA, the U.S. Department of Justice and other agencies have increased their enforcement activities with respect to the sales, marketing, research and similar activities of pharmaceutical companies in recent years, and many pharmaceutical companies have been subject to government investigations related to these practices. A determination that we are in violation of these and/or other government regulations and legal requirements may result in civil damages and penalties, criminal fines and prosecution, administrative remedies, the recall of products, the total or partial suspension of manufacture and/or distribution, seizure of products, injunctions, whistleblower lawsuits, failure to obtain approval of pending product applications, withdrawal of existing product approvals, exclusion from participation in government healthcare programs and other sanctions.

Beginning in February 2012, Warner Chilcott, along with several then current and former employees in its sales organization and certain third parties, received subpoenas from the United States Attorney for the District of Massachusetts. The subpoena Warner Chilcott received sought information and documentation relating to a wide range of matters, including sales and marketing activities, payments to people who are in a position to recommend drugs, medical education, consultancies, prior authorization processes, clinical trials, off-label promotion and employee training (including with respect to laws and regulations concerning off-label information and physician remuneration), in each case relating to a number of our current products. Warner Chilcott is currently defending qui tam litigations based on allegations relating to its sales practices. In addition, Forest is also currently responding to subpoenas seeking information relating to its sales and marketing activities, including payments to people who are in a position to recommend drugs and off-label promotion and the Company is defending litigations based on similar allegations. Refer to Legal Matters in “NOTE 19 — Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” for more information. We cannot predict or determine the impact of this inquiry on our future financial condition or results of operations. The U.S. Attorney’s investigations and any other threatened or actual government enforcement action could also generate adverse publicity and require that we devote substantial resources that could be used productively on other aspects of our business.

 

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Furthermore, in connection with a settlement of certain claims brought by the U.S. government, Forest operated under a Corporate Integrity Agreement (the “CIA”) with the Office of Inspector General of Health and Human Services that requires us to maintain Forest’s compliance program and to undertake a set of defined corporate integrity obligations until September 2015. The CIA also provides for an independent third-party review organization to assess and report on our compliance program. While we expect to fully and timely comply with all of our assumed obligations under the CIA, the failure to do so could result in substantial penalties and being excluded from government healthcare programs.

Any of these types of investigations or enforcement actions could affect our ability to commercially distribute our products and could materially and adversely affect our business, financial condition, results of operations and cash flows.

If generic products that compete with any of our branded pharmaceutical products are approved and sold, sales of our products will be adversely affected.

As a result of our acquisitions of Forest, Warner Chilcott and Allergan, specialty branded products now comprise a larger percentage of our total revenues. Generic equivalents for branded pharmaceutical products are typically sold at lower costs than the branded products. After the introduction of a competing generic product, a significant percentage of the prescriptions previously written for the branded product are often written for the generic version. In addition, legislation enacted in most U.S. states and Canadian provinces allows or, in some instances mandates, that a pharmacist dispense an available generic equivalent when filling a prescription for a branded product, in the absence of specific instructions from the prescribing physician. Pursuant to the provisions of the Hatch-Waxman Act, manufacturers of branded products often bring lawsuits to enforce their patent rights against generic products released prior to the expiration of branded products’ patents, but it is possible for generic manufacturers to offer generic products while such litigation is pending. Refer to “ If we are unable to adequately protect our technology or enforce our patents, our business could suffer .” As a result, branded products typically experience a significant loss in revenues following the introduction of a competing generic product, even if subject to an existing patent. Our branded pharmaceutical products are or may become subject to competition from generic equivalents because there is no proprietary protection for some of the branded pharmaceutical products we sell, because our patent protection expires or because our patent protection is not sufficiently broad or enforceable. In addition, we may not be successful in our efforts to extend the proprietary protection afforded our branded products through the development and commercialization of proprietary product improvements and new and enhanced dosage forms.

Our Actonel ® products no longer have patent protection in Canada or the Western European countries in which we sell these products, and Asacol ® is not protected by a patent in the United Kingdom. Our Actonel ® once-a-month product lost U.S. patent protection in June 2014 (including a 6-month pediatric extension of regulatory exclusivity) and generic versions of our Loestrin ® 24 Fe product entered the market in January 2014 pursuant to settlement agreements previously entered into. In addition, other products such as Estrace ® Cream, Asacol ® 400 mg, Femhrt ® and Carafate ® are not protected by patents in the United States where we sell these products. Generic equivalents are currently available in Canada and Western Europe for Actonel ® and in the United States for certain versions of our Femhrt ® products, Femcon ® Fe and certain other less significant products.

 

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During the next few years, additional products of ours including some of our large revenue drivers, like Bystolic ® , Linzess ® and Viibryd ® , will lose patent protection or likely become subject to generic competition. Generic versions of our Asacol ® HD 800 mg product may enter the market as early as November 2015 pursuant to an agreement previously entered into and generic versions of our Enablex ® product may enter the market as early as March 2016 pursuant to settlement agreements previously entered into. Some of our products may also become subject to generic competition prior to the expiration of patent protection in the event a generic competitor elects to launch its generic equivalent product “at-risk.” Competition from generic equivalents could result in a material impairment of our intangible assets or the acceleration of amortization on our non-impaired intangible assets and may have a material adverse impact on our revenues, financial condition, results of operations and cash flows.

Our branded pharmaceutical expenditures may not result in commercially successful products.

Developing and commercializing branded pharmaceutical products is generally more costly than generic products. In the future, and particularly following the acquisitions of Warner Chilcott, Forest and Allergan, we anticipate continuing and increasing our product development expenditures for our North American Brands business segment, including products acquired in acquisitions. In order to grow and achieve success in our business, we must continually identify, develop, acquire and license new products that we can ultimately market. There are many difficulties and uncertainties inherent in pharmaceutical research and development, and there is a high rate of failure inherent in new drug discovery and development. Failure can occur at any point in the process, including late in the process after substantial investment. New product candidates that appear promising in development may fail to reach the market or may have only limited commercial success because of efficacy or safety concerns, inability to obtain necessary regulatory approvals and payer reimbursement, limited scope of approved uses, difficulty or excessive costs to manufacture, or infringement of the patents or intellectual property rights of others. Products that do reach the market may ultimately be subject to recalls or other suspensions in sales. Delays and uncertainties in the FDA approval process and the approval processes in other countries can result in delays in product launches and lost market opportunity. Because there is a high rate of failure inherent in the research and development process of new products, there is a significant risk that funds invested by the Company in research and development will not generate financial returns. The Company cannot be certain when or whether any of its products currently under development will be approved or launched or whether, once launched, such products will be commercially successful.

We may be required to spend several years and incur substantial expense in completing certain clinical trials. The length of time, number of trial sites and patients required for clinical trials vary substantially, and we may have difficulty finding a sufficient number of sites and subjects to participate in our trials. Delays in planned clinical trials can result in increased development costs, delays in regulatory approvals and delays in product candidates reaching the market. We rely on independent third-party clinical

 

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investigators to recruit subjects and conduct clinical trials in accordance with applicable study protocols and laws and regulations. If regulatory authorities determine that we have not complied with regulations in the R&D of a product candidate, they may refuse to accept trial data from the site, not approve the product candidate, and we would not be able to market and sell it. If we are not able to market and sell our products or product candidates after significant expenditures to develop and test them, our business and results of operations could be materially and adversely affected.

We currently have products in various stages of development. We also have new hormonal contraceptive therapy products in various stages of development from preclinical development to Phase 3 development, as well as osteoporosis products in preclinical and clinical development and dermatology and infectious disease products in various stages of clinical development, among others. Such clinical trials are costly and may not result in successful outcomes. The results of preclinical studies and early clinical studies may not be predictive of the results of later-stage clinical studies. Product candidates that have shown promising results in early-stage clinical studies may still suffer significant setbacks in subsequent clinical studies. There is a high rate of failure for products proceeding through clinical studies, and product candidates in later stages of clinical studies may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical studies. Clinical studies may not proceed as planned or be completed on schedule, if at all. The rate of completion of clinical trials is significantly dependent upon a number of factors, including the rate of patient enrollment. We may not be able to attract a sufficient number of sites or enroll a sufficient number of patients in a timely manner in order to complete clinical trials. Moreover, nonclinical and clinical data are often susceptible to varying interpretations and analyses, and our data may not provide adequate efficacy and safety information to obtain regulatory approval of our candidates. We cannot be sure that our business expenditures, including but not limited to our expenditures related to our Esmya™ product, products acquired in the Warner Chilcott Acquisition, the Forest Acquisition, and the Allergan Acquisition or products of our third-party partners, among others, will result in the successful discovery, development or launch of brand products that will prove to be commercially successful or will improve the long-term profitability of our business. If such business expenditures do not result in successful discovery, development or launch of commercially successful brand products our results of operations and financial condition could be materially adversely affected.

Our investments in biosimilar products may not result in products that are approved by the FDA or other ex- U.S. regulatory authorities and, even if approved by such authorities, may not result in commercially successful products.

In 2011, we entered into a collaboration agreement with Amgen Inc. to develop and commercialize, on a worldwide basis, biosimilar versions of Herceptin ® , Avastin ® , Rituxan/Mab Thera ® , and Erbitux ® (the “Amgen Collaboration Agreement”). Under the agreement, we will be required to invest up to $246.7 million (as of March 31, 2015) in furtherance of the development and regulatory approval of such products, and such amount is subject to change or adjustment as specified in the agreement. Although Amgen, our development partner, has substantial expertise and experience in the development of biological products, significant uncertainty remains concerning the regulatory pathway in the United States and in other countries to obtain regulatory approval of biosimilar products, and the commercial

 

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pathway to successfully market and sell such products. In the United States, an abbreviated pathway for approval of biosimilar products was established by the Biologics Price Competition and Innovation Act of 2009, or BPCIA, enacted on March 23, 2010, as part of the ACA. The BPCIA established this abbreviated pathway under section 351(k) of the Public Health Services Act, or PHSA. Subsequent to the enactment of the BPCIA, the FDA issued draft guidance regarding the demonstration of biosimilarity as well as the submission and review of biosimilar applications. However, there have been no biosimilar products approved under the 251(k) pathway to date. Further, many other markets outside of the U.S. do not yet have a legislative or regulatory pathway for the approval of biosimilar products. The BPCIA prohibits the FDA from accepting an application for a biosimilar candidate to a reference product within four years of the reference product’s licensure by the FDA. In addition, the BPCIA provides innovative biologics with twelve years of exclusivity from the data of their licensure, during which time the FDA cannot approve any application for a biosimilar candidate to the reference product. Additionally, biosimilar products will likely be subject to extensive patent clearances and/or patent infringement litigation, which could delay or prevent the commercial launch of a product for many years. Further, our collaboration with Amgen may not result in products that meet the requirements established by the FDA or other ex-U.S. regulatory authorities. If our collaboration does result in biosimilar products that obtain FDA or other ex-U.S. regulatory authority approval, such product(s) may not be commercially successful and/or may not generate profits in amounts that are sufficient to offset the amount invested to obtain such approvals. Market success of biosimilar products will depend on demonstrating to patients, physicians and payors that such products are safe and efficacious compared to other existing products yet offer a more competitive price or other benefit over existing therapies. If our collaboration with Amgen does not result in the development and timely approval of biosimilar products or if such products, once developed and approved, are not commercially successful, our results of operations, financial condition and cash flows could be materially adversely affected.

We expect to face increasing competition from biosimilar products in the future, particularly if foreign governments adopt more permissive approval frameworks and competitors begin to obtain broader marketing approval for biosimilar products. A growing number of companies have announced their intentions to develop biosimilar versions of existing biotechnology products. We are unable to predict the precise impact of the pending introduction of biosimilar products on our products, and additional competition could have a material adverse effect on our business and results of operations.

If we are unsuccessful in our joint ventures and other collaborations, our operating results could suffer.

We have made substantial investments in joint ventures and other collaborations, including our collaboration agreements with Amgen and Sanofi, and may use these and other methods to develop or commercialize products in the future. These arrangements typically involve other pharmaceutical companies as partners that may be competitors of ours in certain markets. In many instances, we will not control these joint ventures or collaborations or the commercial exploitation of the licensed products, and cannot assure you that these ventures will be profitable. Joint venture agreements may place limitations or restrictions on marketing our products. Any such marketing restrictions could affect future revenues and have a material adverse effect on our operations. Our results of operations may

 

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suffer if existing joint venture or collaboration partners withdraw, or if these products are not timely developed, approved or successfully commercialized and we cannot guarantee the successful outcome of such efforts, nor that they will result in any intellectual property rights or products that inure to our benefit.

If we are unable to adequately protect our technology or enforce our patents, our business could suffer.

Our success with the brand products that we develop will depend, in part, on our ability to obtain patent protection for these products. We currently have a number of U.S. and foreign patents issued and pending. However, issuance of a patent is not conclusive evidence of its validity or enforceability. We cannot be sure that we will receive patents for any of our pending patent applications or any patent applications we may file in the future, or that our issued patents will be upheld if challenged. If our current and future patent applications are not approved or, if approved, our patents are not upheld in a court of law if challenged, it may reduce our ability to competitively utilize our patented products. Also, such patents may or may not provide competitive advantages for their respective products or they may be challenged or circumvented by our competitors, in which case our ability to commercially market these products may be diminished. Patent disputes may be lengthy and a potential violator of our patents may bring a potentially infringing product to market during the dispute, subjecting us to competition and damages due to infringement of the competitor product. For example, patents covering our Androderm ® , Asacol ® 400 mg product, Actonel ® once-a-week product, INFed ® products and our Carafate ® product have expired and we have no further patent protection on these products. During the next five years, additional products acquired pursuant to the Warner Chilcott Acquisition and the Forest Acquisition will lose patent protection or likely become subject to generic competition, including Bystolic ® , Linzess ® and Viibryd ® . Therefore, it is possible that a competitor may launch a generic version of any of these products at any time, which would result in a significant decline in that product’s revenue and profit.

Generic versions of our Loestrin ® 24 Fe product entered the market in January 2014 pursuant to settlement agreements previously entered into; generic versions of our Asacol ® HD 800 mg product may enter the market as early as November 2015 pursuant to an agreement previously entered into; our immediate release Namenda product will lose U.S. patent protection in 2015; and generic versions of our Enablex ® product may enter the market as early as March 2016 pursuant to settlement agreements previously entered into. Some of our products may also become subject to generic competition prior to the expiration of patent protection in the event a generic competitor elects to launch its generic equivalent product “at-risk.”

Generic competitors to our branded products may also challenge the validity or enforceability of the patents protecting our products or otherwise seek to circumvent them. For example, Warner Chilcott received a challenge relating to its Atelvia ® (risedronate) 35 mg tablets product. In October 2011 and March 2012, Warner Chilcott received separate Paragraph IV certification notice letters from Watson

 

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Laboratories, Inc. – Florida (“Watson”), Teva Pharmaceutical Industries, Ltd. (“Teva”) and Ranbaxy Laboratories Ltd. (“Ranbaxy”) indicating that each had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of Atelvia ® 35 mg tablets. Warner Chilcott brought actions against each of Watson, Teva and Ranbaxy, charging each with infringement. In October 2013, Watson divested its ANDA to Amneal Pharmaceuticals (“Amneal”). In September 2013, Warner Chilcott received a Paragraph IV certification notice letter from Impax Laboratories, Inc. (“Impax”) indicating that it had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of Atelvia ® . Warner Chilcott filed a lawsuit against Impax in October 2013, asserting infringement. The Company has settled with Ranbaxy, Amneal and Impax; however, trial against Teva began on July 14, 2014 and ended on July 18, 2014. Similarly, Forest also recently brought actions against certain manufacturers of generic drugs for infringement of several patents covering our Savella ® , Namenda ® XR and Canasa ® products. We believe that ANDAs were filed before the patents covering Canasa ® were listed in the Orange Book, which generally means that ANDAs are not subject to the 30-month stay of the approval under the Hatch-Waxman Act. While we intend to vigorously defend these and other patents and pursue our legal rights, we can offer no assurance as to when the pending or any future litigation will be decided, whether such lawsuits will be successful or that a generic equivalent of one or more of our products will not be approved and enter the market. In addition, patents covering our branded pharmaceutical products may be challenged in proceedings other than court proceedings, including inter partes review (IPR) at the patent and trademark office. In 2011, Congress amended the patent laws and created a new way to challenge the validity of patents: the inter partes review. IPR proceedings take place in the Patent Office and have both advantages and disadvantages when compared to district court proceedings. Although IPR proceedings are limited to certain types of invalidity challenges, the Patent Office applies different standards that make it easier for challengers to invalidate patents. Moreover, IPR proceedings generally take no more than 18 months, which means it is much faster than challenging a patent’s validity in a district court proceeding. In addition, an IPR challenge can be mounted even after a patent has been upheld in court. For example, the Company has recently received an IPR challenge to the patent covering its Lo Loestrin ® Fe product notwithstanding that the patent’s validity was upheld by the Federal Circuit Court of Appeals. Refer to Legal Matters in “NOTE 19 — Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements”.

In addition to patent protection, our business relies on our protection of other intellectual property rights, trade secrets, and other proprietary technologies. We rely on trademark, copyright, and patent law, trade-secret protection, and confidentiality and/or license agreements with our employees, customers, partners and others to protect our proprietary rights. The protection of our proprietary technology may require the expenditure of significant financial and managerial resources. We may not be able to discover or determine the extent of any unauthorized use of our proprietary rights, and we may not be able to prevent third parties from misappropriating or infringing upon our proprietary rights.

We rely on certain information, processes, and know-how that are not protected by patents or other intellectual property rights. We seek to protect this information through trade secret or confidentiality agreements, as well as through other measures. These measures may not provide adequate protection for our unpatented technology.

 

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If we are unable to adequately protect our technology, trade secrets or propriety know-how, or enforce our intellectual property rights, our results of operations, financial condition and cash flows could suffer.

Our branded pharmaceutical products will face increased competition with generic products, including our own.

As a result of our recent acquisitions, we have expanded our branded pharmaceutical products, and we face increased competition from generic pharmaceutical manufacturers, including in some circumstances us. Because the regulatory approval process in the United States and European Union exempts generic products from costly and time-consuming clinical trials to demonstrate their safety and efficacy and rely instead on the safety and efficacy of prior products, manufacturers of generic products can invest far less in research and development. As a result, our branded products will face intense price competition from generic forms of the product once market exclusivity has expired. Upon the expiration of market exclusivity, we may lose the majority of our revenues of that product in a very short period of time.

In addition, our branded products may conflict with our existing generic products. Because the revenues from branded products and generic products are derived using contradictory strategies, investments made in one sector may conflict with the other. For example, we now own Loestrin ® / Loestrin ® Fe as both a branded product and a generic product, which may directly or indirectly compete as sales of one product will inherently reduce sales of the other and decrease overall revenues. We may face the same pressures for multiple products. The expansion of our branded pharmaceutical products may result in increased competition from generic manufacturers and our own generics business.

If pharmaceutical companies are successful in limiting the use of generics through their legislative, regulatory and other efforts, our sales of generic products may suffer.

Many pharmaceutical companies increasingly have used state and federal legislative and regulatory means to delay generic competition. These efforts have included:

 

    making changes to the formulation of the brand product and arguing that potential generic competitors must demonstrate bioequivalency or comparable abuse-resistance to the reformulated brand product;

 

    pursuing new patents for existing products which may be granted just before the expiration of earlier patents, which could extend patent protection for additional years or otherwise delay the launch of generics;

 

    selling the brand product as an Authorized Generic, either by the brand company directly, through an affiliate or by a marketing partner;

 

    using the Citizen Petition process (e.g., under 21 C.F.R. s. 10.30) to request amendments to FDA standards or otherwise delay generic drug approvals;

 

    seeking changes to U.S. Pharmacopeia, an organization which publishes industry recognized compendia of drug standards;

 

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    attempting to use the legislative and regulatory process to have drugs reclassified or rescheduled;

 

    using the legislative and regulatory process to set definitions of abuse deterrent formulations to protect brand company patents and profits;

 

    attaching patent extension amendments to non-related federal legislation;

 

    engaging in state-by-state initiatives to enact legislation that restricts the substitution of some generic drugs, which could have an impact on products that we are developing;

 

    entering into agreements with pharmacy benefit management companies which have the effect of blocking the dispensing of generic products; and

 

    seeking patents on methods of manufacturing certain API.

If pharmaceutical companies or other third parties are successful in limiting the use of generic products through these or other means, our sales of generic products may decline. If we experience a material decline in generic product sales, our results of operations, financial condition and cash flows will suffer.

If competitors are successful in limiting competition for certain generic products through their legislative, regulatory and litigation efforts, our sales of certain generic products may suffer.

Certain of our competitors have challenged our ability to distribute Authorized Generics during the competitors’ 180-day period of ANDA exclusivity under the Hatch-Waxman Act. Under the challenged arrangements, we have obtained rights to market and distribute under a brand manufacturer’s new drug application “NDA” a generic alternative of the brand product. Some of our competitors have challenged the propriety of these arrangements by filing Citizen Petitions with the FDA, initiating lawsuits alleging violation of the antitrust and consumer protection laws, and seeking legislative intervention. For example, legislation has been introduced in the U.S. Senate that would prohibit the marketing of Authorized Generics during the 180-day period of ANDA exclusivity under the Hatch-Waxman Act. If distribution of Authorized Generic versions of brand products is otherwise restricted or found unlawful, our results of operations, financial condition and cash flows could be materially adversely affected.

From time to time we may need to rely on licenses to proprietary technologies, which may be difficult or expensive to obtain.

We may need to obtain licenses to patents and other proprietary rights held by third parties to develop, manufacture and market products. If we are unable to timely obtain these licenses on commercially reasonable terms, our ability to commercially market our products may be inhibited or prevented, which could have a material adverse effect on our business, results of operations, financial condition and cash flows. For example, because we license significant intellectual property with respect to certain of our products, including Namenda XR ® , Linzess ® and Viibryd ® , any loss or suspension of our rights to licensed intellectual property could materially adversely affect our business, financial condition, cash flows and results of operations.

 

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Third parties may claim that we infringe their proprietary rights and may prevent us from manufacturing and selling some of our products.

The manufacture, use and sale of new products that are the subject of conflicting patent rights have been the subject of substantial litigation in the pharmaceutical industry. These lawsuits relate to the validity, enforceability and infringement of patents or proprietary rights of third parties. We may have to defend ourselves against charges that we violated patents or proprietary rights of third parties. This is especially true in the case of generic products on which the patent covering the brand product is expiring, an area where infringement litigation is prevalent, and in the case of new brand products where a competitor has obtained patents for similar products. Litigation may be costly, unpredictable, time-consuming, often involves complex legal, scientific and factual questions, and could divert the attention of our management and technical personnel. In addition, if it is determined that we infringe the rights of others, we could lose our right to develop, manufacture or market products, product launches could be delayed or we could be required to pay monetary damages or royalties to license proprietary rights from third parties. For example, we are currently engaged in litigation with Endo Pharmaceuticals Inc. concerning whether our generic version of the original (now discontinued) formulation of Opana ER infringes U.S. Patent Nos. 8,309,122 and 8,329,216, and we continue to market our generic product. We are also engaged in litigation with Teva Pharmaceuticals USA, Inc. and Mayne Pharma International Pty Ltd. (“Mayne”) concerning whether our manufacture and sale of Namenda XR, which we acquired in the Forest Acquisition, infringes U.S. Patent No. 6,194,000.

Further, in August 2012, Bayer Pharma AG (together with its affiliates, “Bayer”) filed a complaint against Warner Chilcott alleging that its manufacture, use, offer for sale, and/or sale of Lo Loestrin ® Fe infringes Bayer’s U.S. Patent No. 5,980,940. In the complaint, Bayer seeks injunctive relief and unspecified monetary damages for the alleged infringement. In December 2012, Bayer amended the complaint to add a claim seeking to invalidate the Company’s U.S. Patent No. 7,704,984, which covers the Lo Loestrin ® Fe product. Although the parties to patent and intellectual property disputes in the pharmaceutical industry have often settled their disputes through licensing or similar arrangements, the costs associated with these arrangements may be substantial and could include ongoing royalties. Refer to Legal Matters in “NOTE 19 — Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements”.

Furthermore, we cannot be certain that the necessary licenses would be available to us on commercially reasonable terms, or at all. As a result, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could result in substantial monetary damage awards and could prevent us from manufacturing and selling a number of our products, which could have a material adverse effect on our business, results of operations, financial condition and cash flows.

Certain aspects of our operations are highly dependent upon third-party service providers.

We rely on suppliers, vendors and other third-party service providers to research, develop, manufacture, commercialize, promote and sell our products. Reliance on third-party manufacturers reduces our oversight and control of the manufacturing process. Some of these third-party providers are

 

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subject to legal and regulatory requirements, privacy and security risks, and market risks of their own. The failure of a critical third-party service provider to meet its obligations could have a material adverse impact on our operations and results. If any third-party service providers have violated or are alleged to have violated any laws or regulations during the performance of their obligations to us, it is possible that we could suffer financial and reputation harm or other negative outcomes, including possible legal consequences.

In particular, product deliveries within our Anda Distribution business are highly dependent on overnight delivery services to deliver our products in a timely and reliable manner, typically by overnight service. Our Anda Distribution business ships a substantial portion of products via one courier’s air and ground delivery service. If the courier terminates our contract or if we cannot renew the contract on favorable terms or enter into a contract with an equally reliable overnight courier to perform and offer the same service level at similar or more favorable rates, our business, results of operations, financial condition and cash flows could be materially adversely affected.

Our Anda Distribution operations compete directly with significant customers of our generic and brand businesses.

In our Anda Distribution business, we compete with McKesson Corporation (“McKesson”), AmerisourceBergen Corporation (“AmerisourceBergen”) and Cardinal Health, Inc. (“Cardinal”). These companies are significant customers of our North American Brands and North American Generics businesses, including the acquired Forest products and collectively accounted for approximately 62% and 29% of our annual revenues in the years ended December 31, 2014 and 2013, respectively. Our activities related to our Anda Distribution business, as well as the acquisition of other businesses that compete with our customers, may result in the disruption of our business, which could harm relationships with our current customers, employees or suppliers, and could adversely affect our expenses, pricing, third-party relationships and revenues. Further, a loss of a significant customer of our North American Brands and North American Generics businesses could have a material adverse effect on our business, results of operations, financial condition and cash flows.

If we are unable to obtain sufficient supplies from key manufacturing sites or suppliers that in some cases may be the only source of finished products or raw materials, our ability to deliver our products to the market may be impeded.

We are required to identify the supplier(s) of all the raw materials for our products in our applications with the FDA and other regulatory agencies. To the extent practicable, we attempt to identify more than one supplier in each drug application. However, some products and raw materials are available only from a single source and, in many of our drug applications, only one supplier of products and raw materials or site of manufacture has been identified, even in instances where multiple sources exist. Some of these products have historically or may in the future account for a significant portion of our revenues, such as Namenda ® , INFed ® , metoprolol succinate extended release tablets, methylphenidate hydrochloride extended release tablets, and a significant number of our oral contraceptive and controlled substance products. In addition, certain manufacturing facilities in Ireland are the exclusive

 

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qualified manufacturing facilities for finished dosage forms of many of our products, including Namenda ® , Bystolic ® and Savella ® . We expect to continue to rely on our third-party manufacturing partners, such as Ortho-McNeil- Janssen Pharmaceuticals, Inc. for methylphenidate ER, Contract Pharmaceuticals Limited Canada (“CPL”) for Estrace ® Cream and Norwich Pharmaceuticals Inc. (“NPI”) for Actonel ® and Atelvia ® . GlaxoSmithKline plc (“GSK”) currently manufactures our Asacol ® 400 mg product sold in the United Kingdom. CPL, which manufactures our Estrace ® Cream product, recently closed its manufacturing facility in Buffalo, New York and transferred its operations at that location to its facilities in Mississauga, Canada. Such transfers are subject to regulatory approvals, and the failure to obtain such approvals in a timely manner may delay production at the new facility and result in an interruption in our product supply. From time to time, certain of our manufacturing sites or outside suppliers have experienced regulatory or supply-related difficulties that have inhibited their ability to deliver products and raw materials to us, causing supply delays or interruptions. The availability and prices of raw materials and supplies are subject to volatility and are influenced by worldwide economic conditions, speculative action, world supply and demand balances, inventory levels, availability of substitute materials, currency exchange rates, anticipated or perceived shortages, product contamination, among other factors. To the extent any difficulties experienced by our manufacturing sites or suppliers cannot be resolved or extensions of our key supply agreements cannot be negotiated within a reasonable time and on commercially reasonable terms, or if raw materials for a particular product become unavailable from an approved supplier and we are required to qualify a new supplier with the FDA or other regulatory agency, or if we are unable to do so, our profit margins and market share for the affected product could decrease or be eliminated, as well as delay our development and sales and marketing efforts. Such outcomes could have a material adverse effect on our business, results of operations, financial condition and cash flows.

Our manufacturing sites outside of the United States and our arrangements with foreign suppliers are subject to certain additional risks, including the availability of government clearances, export duties, political instability, war, acts of terrorism, currency fluctuations and restrictions on the transfer of funds. For example, we obtain a significant portion of our raw materials from foreign suppliers. Arrangements with international raw material suppliers are subject to, among other things, FDA and foreign regulatory body regulation, customs clearances, various import duties and other government clearances, as well as potential shipping delays due to inclement weather, political instability, strikes or other matters outside of our control. Acts of governments outside the U.S. may affect the price or availability of raw materials needed for the development or manufacture of our products. In addition, recent changes in patent laws in jurisdictions outside the U.S. may make it increasingly difficult to obtain raw materials for R&D prior to the expiration of the applicable U.S. or foreign patents.

Our policies regarding returns, allowances and chargebacks, and marketing programs adopted by wholesalers, may reduce our revenues in future fiscal periods.

Consistent with generic industry practice we have liberal return policies and have been willing to give customers post-sale inventory allowances. Under these arrangements, from time to time, we may give our customers credits on our generic products that our customers hold in inventory after we have decreased the market prices of the same generic products. Therefore, if new competitors enter the

 

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marketplace and significantly lower the prices of any of their competing products, we may reduce the price of our product. As a result, we may be obligated to provide significant credits to our customers who are then holding inventories of such products, which could reduce sales revenue and gross margin for the period the credit is provided. Like our competitors, we also give credits for chargebacks to wholesale customers that have contracts with us for their sales to hospitals, group purchasing organizations, pharmacies or other retail customers. A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to us by our wholesale customer for a particular product and the negotiated price that the wholesaler’s customer pays for that product. Although we establish reserves based on our prior experience and our best estimates of the impact that these policies may have in subsequent periods, we cannot ensure that our reserves are adequate or that actual product returns, allowances and chargebacks will not exceed our estimates, which could have a material adverse effect on our results of operations, financial condition, cash flows and the market price of our stock.

Investigations of the calculation of average wholesale prices may adversely affect our business.

Many government and third-party payers, including Medicare, Medicaid, Health Maintenance Organization (“HMOs”) and Managed Care Organization (“MCOs”), have historically reimbursed doctors, pharmacies and others for the purchase of certain prescription drugs based on a drug’s average wholesale price (“AWP”) or wholesale acquisition cost (“WAC”). In the past several years, state and federal government agencies have conducted ongoing investigations of manufacturers’ reporting practices with respect to AWP and WAC, in which they have suggested that reporting of inflated AWP’s or WAC’s has led to excessive payments for prescription drugs. For example, beginning in July 2002, we and certain of our subsidiaries, as well as numerous other pharmaceutical companies, were named as defendants in various state and federal court actions alleging improper or fraudulent practices related to the reporting of AWP and/or WAC of certain products, and other improper acts, in order to increase prices and market shares. Similarly, Forest is a defendant in four pending state actions alleging that manufacturers’ reporting of AWP did not correspond to actual provider costs of prescription drugs. Additional actions are possible. These actions, if successful, could adversely affect us and may have a material adverse effect on our business, results of operations, financial condition and cash flows.

The design, development, manufacture and sale of our products involves the risk of product liability claims by consumers and other third parties, and insurance against such potential claims is expensive and may be difficult to obtain.

The design, development, manufacture and sale of our products involve an inherent risk of product liability claims and the associated adverse publicity. For example, as of December 31, 2014, as a result of our acquisition of Forest we were subject to approximately 200 legal actions asserting product liability claims relating to the use of Celexa ® or Lexapro. These cases include claims for wrongful death from suicide or injury from suicide attempts while using Celexa ® or Lexapro as well as claims that Celexa ® or Lexapro caused various birth defects. While we believe there is no merit to these cases, litigation is inherently subject to uncertainties and we may be required to expend substantial amounts in the defense or resolution of certain of these matters. We regularly monitor the use of our products for

 

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trends or increases in reports of adverse events or product complaints, and regularly report such matters to the FDA. In some, but not all cases, an increase in adverse event reports may be an indication that there has been a change in a product’s specifications or efficacy. Such changes could lead to a recall of the product in question or, in some cases, increases in product liability claims related to the product in question. If the coverage limits for product liability insurance policies are not adequate or if certain of our products are excluded from coverage, a claim brought against us, whether covered by insurance or not, could have a material adverse effect on our business, results of operations, financial condition and cash flows. We also rely on self-insurance to cover product liability claims, and these claims may exceed amounts we have reserved under our self-insurance program.

We are also subject to a variety of other types of claims, proceedings, investigations and litigation initiated by government agencies or third parties. These include compliance matters, product regulation or safety, taxes, employee benefit plans, employment discrimination, health and safety, environmental, antitrust, customs, import/export, government contract compliance, financial controls or reporting, intellectual property, allegations of misrepresentation, false claims or false statements, commercial claims, claims regarding promotion of our products and services, or other similar matters. Any such claims, proceedings, investigations or litigation, regardless of the merits, might result in substantial costs, restrictions on product use or sales, or otherwise injure our business.

The loss of our key personnel could cause our business to suffer.

The success of our present and future operations will depend, to a significant extent, upon the experience, abilities and continued services of key personnel. For example, although we have other senior management personnel, a significant loss of the services of Brent Saunders, our Chief Executive Officer, or Paul Bisaro, our Executive Chairman, or other senior executive officers without having or hiring a suitable successor, could cause our business to suffer. We cannot assure you that we will be able to attract and retain key personnel. We have entered into employment agreements with many of our senior executive officers but such agreements do not guarantee that our senior executive officers will remain employed by us for a significant period of time, or at all. We do not carry key-employee life insurance on any of our officers.

Significant balances of intangible assets, including product rights and goodwill acquired, are subject to impairment testing and may result in impairment charges, which will adversely affect our results of operations and financial condition.

A significant amount of our total assets is related to acquired intangibles and goodwill. As of March 31, 2015, the carrying value of our product rights and other intangible assets was $74,201.1 million and the carrying value of our goodwill was $50,826.4 million.

Our product rights are stated at cost, less accumulated amortization. We determine original fair value and amortization periods for product rights based on our assessment of various factors impacting estimated useful lives and cash flows of the acquired products. Such factors include the product’s position in its life cycle, the existence or absence of like products in the market, various other competitive and regulatory issues and contractual terms. Significant adverse changes to any of these

 

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factors would require us to perform an impairment test on the affected asset and, if evidence of impairment exists, we would be required to take an impairment charge with respect to the asset. For assets that are not impaired, the Company may adjust the remaining useful lives. Such a charge could have a material adverse effect on our results of operations and financial condition.

Our other significant intangible assets include acquired core technology and customer relationships, which are intangible assets with definite lives, our Anda trade name and acquired IPR&D intangible products, acquired in recent business acquisitions, which are intangible assets with indefinite lives.

Our acquired core technology and customer relationship intangible assets are stated at cost, less accumulated amortization. We determined the original fair value of our other intangible assets by performing a discounted cash flow analysis, which is based on our assessment of various factors. Such factors include existing operating margins, the number of existing and potential competitors, product pricing patterns, product market share analysis, product approval and launch dates, the effects of competition, customer attrition rates, consolidation within the industry and generic product lifecycle estimates. Our other intangible assets with definite lives are tested for impairment when there are significant changes to any of these factors. If evidence of impairment exists, we would be required to take an impairment charge with respect to the impaired asset. Such a charge could have a material adverse effect on our results of operations and financial condition.

Goodwill, our Anda trade name intangible asset and our IPR&D intangible assets are tested for impairment annually, or when events occur or circumstances change that could potentially reduce the fair value of the reporting unit or intangible asset. Impairment testing compares the fair value of the reporting unit or intangible asset to its carrying amount. A goodwill, trade name or IPR&D impairment, if any, would be recorded in operating income and could have a material adverse effect on our results of operations and financial condition. For example, in 2013 the Company recognized a goodwill impairment charge of $647.5 million.

We may need to raise additional funds in the future which may not be available on acceptable terms or at all.

We may consider issuing additional debt or equity securities in the future to fund potential acquisitions or investments, to refinance existing debt, or for general corporate purposes. If we issue equity, convertible preferred equity or convertible debt securities to raise additional funds, our existing shareholders may experience dilution, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing shareholders. If we incur additional debt, it may increase our leverage relative to our earnings or to our equity capitalization, requiring us to pay additional interest expenses and potentially lowering our credit ratings. We may not be able to market such issuances on favorable terms, or at all, in which case, we may not be able to develop or enhance our products, execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated customer requirements.

 

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Our business could suffer as a result of manufacturing difficulties or delays.

The manufacture of certain of our products and product candidates, particularly our controlled-release products, transdermal products, injectable products, and our oral contraceptive products, is more difficult than the manufacture of immediate-release products. Successful manufacturing of these types of products requires precise manufacturing process controls, API that conforms to very tight tolerances for specific characteristics and equipment that operates consistently within narrow performance ranges. Manufacturing complexity, testing requirements, and safety and security processes combine to increase the overall difficulty of manufacturing these products and resolving manufacturing problems that we may encounter.

Our manufacturing and other processes utilize sophisticated equipment, which sometimes require a significant amount of time to obtain and install. Our business could suffer if certain manufacturing or other equipment, or a portion or all of our facilities were to become inoperable for a period of time. This could occur for various reasons, including catastrophic events such as earthquake, monsoon, hurricane or explosion, unexpected equipment failures or delays in obtaining components or replacements thereof, contamination by microorganisms or viruses, labor disputes or shortages, contractual disputes with our suppliers and contract manufacturers, as well as construction delays or defects and other events, both within and outside of our control. Interruption of our efficient manufacture and supply of products may cause delays in shipments and supply constraints. Our inability to timely manufacture any of our significant products could have a material adverse effect on our results of operations, financial condition and cash flows.

Our manufacturing processes and those of our third-party contract manufacturers must undergo a potentially lengthy FDA or other regulatory approval process and are subject to continued review by the FDA and other regulatory authorities. It can take longer than five years to build, validate and license a new manufacturing plant and it can take longer than three years to qualify and license a new contract manufacturer. If regulatory authorities determine that we or our third-party contract manufacturers or certain of our third-party service providers have violated regulations or if they restrict, suspend or revoke our prior approvals, they could prohibit us from manufacturing our products or conducting clinical trials or selling our marketed products until we or the affected third-party contract manufacturers or third-party service providers comply, or indefinitely. Because our third-party contract manufacturers and certain of our third-party service providers are subject to the FDA and foreign regulatory authorities, alternative qualified third-party contract manufacturers and third-party service providers may not be available on a timely basis or at all. If we or our third-party contract manufacturers or third-party service providers cease or interrupt production or if our third-party contract manufacturers and third-party service providers fail to supply materials, products or services to us, we may experience delayed shipments, supply constraints, stock-outs and/or recalls of our products.

Our business will continue to expose us to risks of environmental liabilities.

Our product and API development programs, manufacturing processes and distribution logistics involve the controlled use of hazardous materials, chemicals and toxic compounds in our owned and leased facilities. As a result, we are subject to numerous and increasingly stringent federal, state and local environmental laws and regulations concerning, among other things, the generation, handling, storage,

 

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transportation, treatment and disposal of toxic and hazardous materials and the discharge of pollutants into the air and water. Our programs and processes expose us to risks that an accidental contamination could result in (i) our noncompliance with such environmental laws and regulations and (ii) regulatory enforcement actions or claims for personal injury and property damage against us. 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 material and adverse effect on our business, results of operations, financial condition, and cash flows. In addition, environmental permits and controls are required for some of our operations, and these permits are subject to modification, renewal and revocation by the issuing authorities. Any modification, revocation or non-renewal of our environmental permits could have a material adverse effect on our ongoing operations, business and financial condition. Our environmental capital expenditures and costs for environmental compliance may increase in the future as a result of changes in environmental laws and regulations or increased development or manufacturing activities at any of our facilities.

Global economic conditions could harm us.

Recent global market and economic conditions have been unprecedented and challenging with tighter credit conditions and recession in most major economies during recent years. Continued concerns about the systemic impact of potential long-term and wide-spread recession, energy costs, geopolitical issues particularly in areas in which we operate, the availability and cost of credit, and the global real estate markets have contributed to increased market volatility and diminished expectations for western and emerging economies. These conditions, combined with volatile oil prices, declining business and consumer confidence and increased unemployment, have contributed to volatility of unprecedented levels.

As a result of these market conditions, the cost and availability of credit has been and may continue to be adversely affected by illiquid credit markets and wider credit spreads. Concern about the stability of the markets generally and the strength of counterparties specifically has led many lenders and institutional investors to reduce, and in some cases, cease to provide credit to businesses and consumers. These factors have resulted in a decrease in spending by businesses and consumers alike, and a corresponding decrease in global infrastructure spending. Continued turbulence in the U.S. and international markets and economies and prolonged declines in business consumer spending may adversely affect our liquidity and financial condition, and the liquidity and financial condition of our customers, including our ability to refinance maturing liabilities and access the capital markets to meet liquidity needs.

Global efforts towards health care cost containment continue to exert pressure on product pricing and market access. In many international markets, government-mandated pricing actions have reduced prices of generic and patented drugs.

 

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Global economic conditions could adversely affect the ability of third-party distributors, partners, manufacturers and suppliers to obtain liquidity required to buy inventory or raw materials and to perform their obligations under agreements with us, which could disrupt our operations.

In particular, some countries within emerging markets may be especially vulnerable to periods of global financial instability or may have very limited resources to spend on healthcare or may be or will be in the future subject to economic sanctions, and our business in these countries may be disproportionately affected by economic changes. In addition, many of these countries have currencies that fluctuate substantially and if such currencies devalue and the Company cannot offset the devaluations, the Company’s financial performance within such countries could be adversely affected.

Our foreign operations may become less attractive if political and diplomatic relations between the United States and any country where we conduct business operations deteriorates.

The relationship between the United States and the foreign countries where we conduct business operations may weaken over time. Changes in the state of the relations between any such country and the United States are difficult to predict and could adversely affect our future operations. This could lead to a decline in our profitability. Any meaningful deterioration of the political, economic and diplomatic relations between the United States and the relevant country could have a material adverse effect on our operations.

Our global operations, particularly following the Allergan Acquisition, the Actavis Group Acquisition, the Warner Chilcott Acquisition and the Forest Acquisition (including Furiex and Aptalis), expose us to risks and challenges associated with conducting business internationally.

We operate on a global basis with offices or activities in Europe, Africa, Asia, South America, Australia and North America. We face several risks inherent in conducting business internationally, including compliance with international and U.S. laws and regulations that apply to our international operations. These laws and regulations include data privacy requirements, labor relations laws, tax laws, competition regulations, import and trade restrictions, economic sanctions, export requirements, U.S. laws such as the Foreign Corrupt Practices Act, the UK Bribery Act 2010 and other local laws that prohibit corrupt payments to governmental officials or certain payments or remunerations to customers. Given the high level of complexity of these laws there is a risk that some provisions may be breached by us, for example through fraudulent or negligent behavior of individual employees, our failure to comply with certain formal documentation requirements, or otherwise. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers or our employees, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, our business and our operating results. Our success depends, in part, on our ability to anticipate these risks and manage these challenges. These factors or any combination of these factors may adversely affect our revenue or our overall financial performance. Violations of these

 

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laws and regulations could result in fines, criminal sanctions against us, our officers or our employees, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, our business and our operating results. Our success depends, in part, on our ability to anticipate these risks and manage these difficulties. Further, certain of our employees, including employees located in certain jurisdictions in Canada, Europe and Asia, are represented by collective bargaining or other labor agreements or arrangements that provide bargaining or other rights to employees. Such employment rights require us to expend greater time and expense in making changes to employees’ terms of employment or carrying out staff reductions. In addition, any national or other labor disputes in these regions could result in a work stoppage or strike by our employees that could delay or interrupt our ability to supply products and conduct operations. Due to the nature of these collective bargaining agreements, we will have no control over such work stoppages or strikes by such employees, and a strike may occur even if the employees do not have any grievances against us. Any interruption in manufacturing or operations could interfere with our business and could have a material adverse effect on our revenues.

In addition to the foregoing, engaging in international business inherently involves a number of other difficulties and risks, including:

 

    longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;

 

    political and economic instability or sanctions in areas in which we operate;

 

    potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers;

 

    regulations related to customs and import/export matters (including sanctions);

 

    tax issues, such as tax law changes and variations in tax laws;

 

    challenges in collecting accounts receivable from customers in the jurisdictions in which we operate;

 

    complying with laws, rules and regulations relating to the manufacturing, marketing, distribution and sale of pharmaceutical products in the jurisdictions in which we do or will operate;

 

    operating under regulations in jurisdictions related to obtaining eligibility for government or private payor reimbursement for our products at the wholesale/retail level;

 

    competition from local, regional and international competitors;

 

    difficulties and costs of staffing and managing foreign operations, including cultural and language differences and additional employment regulations, union workforce negotiations and potential disputes in the jurisdictions in which we operate;

 

    difficulties associated with compliance with a variety of laws and regulations governing international trade, including the Foreign Corrupt Practices Act;

 

    difficulties protecting or procuring intellectual property rights; and

 

    fluctuations in foreign currency exchange rates.

 

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These factors or any combination of these factors could have a material adverse effect on our results of operations and financial condition.

We have exposure to tax liabilities.

As a multinational corporation, we are subject to income taxes as well as non-income based taxes in various jurisdictions. Significant judgment is required in determining our worldwide provision for income taxes and other tax liabilities. We are subject to costs and other potential outcomes from tax audits. The Company believes that its accrual for tax contingencies is adequate for all open years based on past experience, interpretations of tax law, and judgments about potential actions by tax authorities; however, due to the complexity of tax contingencies, the ultimate resolution of any tax matters may result in payments greater or less than amounts accrued.

Changes in tax laws or tax rulings may have a significantly adverse impact on our effective tax rate. Proposals by the current U.S. administration for fundamental U.S. international tax reform, including without limitation provisions that would limit the ability of U.S. multinationals to deduct interest on related party debt, if enacted, could have a significant adverse impact on our effective tax rate.

We would be adversely affected if, either based on current law or in the event of a change in law, the Internal Revenue Service did not agree that Actavis plc is a foreign corporation for U.S. federal tax purposes. In addition, future changes to international tax laws not specifically related to inversions could adversely affect us.

Actavis plc believes that, under current law, it is treated as a foreign corporation for U.S. federal tax purposes, because it is an Irish incorporated entity. However, the IRS may assert that Actavis plc should be treated as a U.S. corporation for U.S. federal tax purposes pursuant to Section 7874. Under Section 7874, a corporation created or organized outside the United States (i.e., a foreign corporation) will be treated as a U.S. corporation for U.S. federal tax purposes when (i) the foreign corporation directly or indirectly acquires substantially all of the assets held directly or indirectly by a U.S. corporation (including the indirect acquisition of assets of the U.S. corporation by acquiring all the outstanding shares of the U.S. corporation), (ii) the shareholders of the acquired U.S. corporation hold at least 80% (by either vote or value) of the shares of the foreign acquiring corporation after the acquisition by reason of holding shares in the U.S. acquired corporation (including the receipt of the foreign corporation’s shares in exchange for the U.S. corporation’s shares), and (iii) the foreign corporation’s “expanded affiliated group” does not have substantial business activities in the foreign corporation’s country of organization or incorporation relative to such expanded affiliated group’s worldwide activities. For purposes of Section 7874, multiple acquisitions of U.S. corporations by a foreign corporation, if treated as part of a plan or series of related transactions, may be treated as a single acquisition. If multiple acquisitions of U.S. corporations are treated as a single acquisition, all shareholders of the acquired U.S. corporations would be aggregated for purposes of the test set forth above concerning such shareholders holding at least 80% (by either vote or value) of the shares of the foreign acquiring corporation after the acquisitions by reason of holding shares in the acquired U.S. corporations.

 

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Actavis believes that the test set forth above to treat Actavis as a foreign corporation was satisfied in connection with the acquisition of Actavis, Inc., a Nevada corporation, and Warner Chilcott plc, a company incorporated under the laws of Ireland (the “Warner Chilcott Transaction”) on October 1, 2013. However, the law and Treasury regulations promulgated under Section 7874 are relatively new and somewhat unclear, and thus it cannot be assured that the IRS will agree that the ownership requirements to treat Actavis as a foreign corporation were met. Moreover, even if such ownership requirements were met in the Warner Chilcott Transaction and the subsequent acquisition of all of the common stock of Forest Laboratories Inc., a company incorporated under the laws of the State of Delaware (the “Forest Transaction”), the IRS may assert that, even though the Merger is a separate transaction from the Warner Chilcott Transaction and the Forest Transaction, the Merger should be integrated with the Warner Chilcott Transaction and the Forest Transaction as a single transaction. In the event the IRS were to prevail with such assertion, Actavis would be treated as a U.S. corporation for U.S. federal tax purposes and significant adverse tax consequences would result for Actavis.

In addition, changes to the inversion rules in Section 7874 or the U.S. Treasury Regulations promulgated thereunder or other IRS guidance could adversely affect Actavis plc’s status as a foreign corporation for U.S. federal tax purposes, and any such changes could have prospective or retroactive application to Actavis, Allergan, their respective stockholders, shareholders and affiliates, and/or the Allergan Acquisition. For example, in March 2014, the President of the United States proposed legislation that would amend the anti-inversion rules. In September 2014, the U.S. Treasury and the IRS issued additional guidance stating that they intend to issue regulations that will address certain inversion transactions.

Even if Actavis is respected as a foreign corporation for U.S. federal tax purposes, Actavis might be adversely impacted by recent proposals that have aimed to make other changes in the taxation of multinational corporations. For example, the Organisation for Economic Co-operation and Development has released proposals to create an agreed set of international rules for fighting base erosion and profit shifting. As a result, the tax laws in the United States, Ireland, and other countries in which we and our affiliates do business could change on a prospective or retroactive basis, and any such changes could adversely affect Actavis and its affiliates (including Allergan and its affiliates after the Allergan Acquisition).

Moreover, U.S. and foreign tax authorities may carefully scrutinize companies that result from cross-border business combination, such as Actavis plc, which may lead such authorities to assert that Actavis plc owes additional taxes.

Foreign currency fluctuations could adversely affect our business and financial results.

We do business and generate sales in numerous countries outside the United States. The Company has also entered and will continue to enter into acquisition, licensing, borrowing, hedging or other financial transactions that may give rise to currency and interest rate exposure. As such, foreign currency fluctuations may affect the costs that we incur in such international operations. Some of our operating expenses are incurred in non-U.S. dollar currencies. The appreciation of non-U.S. dollar currencies in those countries where we have operations against the U.S. dollar could increase our costs and could harm our results of operations and financial condition.

 

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We have incurred and will continue to incur significant transaction, integration and restructuring costs in connection with recent transactions, including the Allergan Acquisition, the Actavis Group Acquisition, the Warner Chilcott Acquisition and the Forest Acquisition.

We have incurred significant transaction costs related to the Allergan Acquisition, the Actavis Group Acquisition, the Warner Chilcott Acquisition and the Forest Acquisition and will continue to incur significant transaction costs related to past acquisitions. In addition, we will incur integration costs and restructuring costs as we integrate the businesses. While Actavis has assumed that a certain level of transaction and coordination expenses will be incurred, there are a number of factors beyond Actavis’ control that could affect the total amount or the timing of these transaction and coordination expenses. Many of the expenses that will be incurred, by their nature, are difficult to estimate accurately. Although we expect that the realization of benefits and efficiencies related to the integration of the businesses may offset these transaction costs, integration costs and restructuring costs over time, no assurances can be made that this net benefit will be achieved in the near term, or at all. The failure to realize the expected benefits and efficiencies related to the integration of the businesses could adversely affect our financial condition and results of operations.

In addition, as a result of acquiring businesses, technologies or products, or entering into other significant transactions, we may experience significant charges to earnings for merger and related expenses. These costs may include substantial fees for investment bankers, attorneys, accountants, advisors, consultants and severance and other closure costs associated with regulator-mandated divestitures and the elimination of duplicate or discontinued products, operations and facilities. Charges that we may incur in connection with acquisitions could adversely affect our results of operations for particular quarterly or annual periods.

Substantial amounts of our information concerning our products, customers, employees and ongoing business are stored digitally and are subject to threats of theft, tampering, or other intrusion.

We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent upon information technology systems, infrastructure and data. This digital information includes, but is not limited to, confidential and proprietary information as well as personal information regarding our customers and employees. Data maintained in digital form is subject to the risk of intrusion, tampering, and theft. Cyber-attacks are increasing in frequency, sophistication and intensity. Cyber-attacks could include the deployment of harmful malware, denial-of-service attacks, worms, social engineering and other means to affect service reliability and threaten data confidentiality, integrity and availability. We have established physical, electronic, and organizational measures to safeguard and secure our systems to prevent a data compromise, and rely on commercially available systems, software, tools, and monitoring to provide security for the processing, transmission and storage of digital information. However, the development and maintenance of these systems is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security

 

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measures become increasingly more sophisticated. Despite our efforts, the possibility of a future data compromise cannot be eliminated entirely, and risks associated with intrusion, tampering, and theft remain. Data privacy or security breaches by employees or others may pose a risk that data, including intellectual property or personal information, may be exposed to unauthorized individuals or to the public. In addition, we provide confidential, proprietary and personal information to third parties when it is necessary to pursue our business objectives. While we obtain assurances that these third parties will protect this information and, where appropriate, monitor the protections employed by these third parties, there is a risk the confidentiality of data held by third parties may be compromised. If our data systems are compromised, our business operations may be impaired, we may lose profitable opportunities or the value of those opportunities may be diminished, and we may lose revenue as a result of unlicensed use of our intellectual property. If personal information of our customers or employees is misappropriated, our reputation with our customers and employees may be injured resulting in loss of business and/or morale, and we may incur costs to remediate possible injury to our customers and employees or be required to pay fines or take other action with respect to judicial or regulatory actions arising out of such incidents.

A failure of our internal control over financial reporting could materially impact our business or share price.

The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting. An internal control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all internal control systems, internal control over financial reporting may not prevent or detect misstatements. Any failure to maintain an effective system of internal control over financial reporting could limit our ability to report our financial results accurately and timely or to detect and prevent fraud, and could expose us to litigation or adversely affect the market price of the Actavis plc Ordinary Shares.

As of December 31, 2013, management concluded that there was a material weakness in internal controls over financial reporting as it did not design or maintain effective internal controls with respect to segregation of duties and related information technology general controls regarding user access and change management activities. Specifically, the controls were not designed to provide reasonable assurance that incompatible access within the system, including the ability to record transactions, was appropriately segregated, impacting the validity, accuracy and completeness of all key accounts and disclosures. The locations impacted were principally related to the international entities acquired as part of the Actavis Group in 2012. The Company has remediated the material weaknesses as of December 31, 2014.

 

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Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.

All pharmaceutical companies, including Actavis, are subject to extensive, complex, costly and evolving government regulation. For the U.S., this is principally administered by the FDA and to a lesser extent by the Drug Enforcement Agency “DEA” and state government agencies, as well as by varying regulatory agencies in foreign countries where products or product candidates are being manufactured and/or marketed. The Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other federal statutes and regulations, and similar foreign statutes and regulations, govern or influence the development, testing, manufacturing, packing, labeling, storing, record keeping, safety, approval, advertising, promotion, sale, distribution and import/ export of our products. Foreign regulatory authorities impose similar requirements focused on drug safety and effectiveness. Obtaining and maintaining regulatory approval has been and will continue to be increasingly difficult, time-consuming and costly. In addition, changes in applicable federal, state and foreign laws and regulations or the implementation of new laws and regulations could affect our ability to obtain or maintain approval of our products and could have a material adverse effect on the Company’s business.

Once regulatory approval has been obtained, agencies continue to have substantial authority to require additional testing, perform inspections, change product labeling or mandate withdrawals of our products. Failure to comply with applicable regulatory requirements may subject us to administrative or judicially-imposed sanctions. These sanctions may include, among others, warning letters, fines, civil penalties, criminal penalties, injunctions, debarment, product seizure or detention, product recalls and total or partial suspension of production, sale and promotion. In addition, we may voluntarily elect to recall or restrict the use of a product. Any recall or restriction could divert managerial and financial resources and might harm our reputation.

Under these statutes and regulations, we are subject to periodic inspection of our facilities, procedures and operations and/or the testing of our products by the FDA and similar ex-U.S. authorities, the DEA and other authorities, which conduct periodic inspections to confirm that we are in compliance with all applicable requirements. In addition, the FDA and foreign regulatory agencies conduct pre-approval and post-approval reviews and plant inspections to determine whether our systems and processes are in compliance with cGMP and other regulations. Following such inspections, the FDA or other agency may issue observations, notices, citations and/or Warning Letters that could cause us to modify certain activities identified during the inspection. FDA guidelines specify that a Warning Letter is issued only for violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result in an enforcement action. We are also required to report adverse events associated with our products to the FDA and other regulatory authorities. Unexpected or serious health or safety concerns would result in product liability claims, labeling changes, recalls, market withdrawals or other regulatory actions, including withdrawal of product approvals. Safety problems can arise as our product candidates are evaluated in clinical trials or as our marketed products are used in clinical practice. We are required to communicate to regulatory agencies adverse events reported to us regarding our products.

Our manufacturing facility in Corona, California is currently subject to a consent decree of permanent injunction. We cannot assure that the FDA will determine we have adequately corrected deficiencies at our Corona manufacturing site, that subsequent FDA inspections at any of our manufacturing sites will

 

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not result in additional inspectional observations at such sites, that approval of any of the pending or subsequently submitted NDAs, ANDAs or supplements to such applications by Actavis plc or our subsidiaries will be granted or that the FDA will not seek to impose additional sanctions against Actavis plc or any of its subsidiaries. The range of possible sanctions includes, among others, FDA issuance of adverse publicity, product recalls or seizures, fines, total or partial suspension of production and/or distribution, suspension of the FDA’s review of product applications, enforcement actions, injunctions, and civil or criminal prosecution. Any such sanctions, if imposed, could have a material adverse effect on our business, operating results, financial condition and cash flows. Under certain circumstances, the FDA also has the authority to revoke previously granted drug approvals. Similar sanctions as detailed above may be available to the FDA under a consent decree, depending upon the actual terms of such decree. Although we have instituted internal compliance programs, if these programs do not meet regulatory agency standards or if compliance is deemed deficient in any significant way, it could materially harm our business. Certain of our vendors are subject to similar regulation and periodic inspections and may be operating under consent decrees.

In order to market our products in the United States and other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. The process for obtaining governmental approval to manufacture and market pharmaceutical products is rigorous, time-consuming, uncertain and 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 or third-party approvals prior to manufacturing, marketing and shipping our products. There is always the chance that we will not obtain FDA or other necessary approvals, or that the rate, timing and cost of obtaining such approvals, will adversely affect our product introduction plans or results of operations. Additionally, any regulatory approvals we receive may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval or may contain requirements for potentially costly additional clinical trials and surveillance to monitor the safety and efficacy of the product. We may only market or promote our products for their approved indications, and our labeling, promotional activities and advertising are subject to extensive regulation and oversight. We carry inventories of certain product(s) in anticipation of launch, and if such product(s) are not subsequently launched, we may be required to write-off the related inventory.

Our Anda Distribution operations and our customers are subject to various regulatory requirements, including requirements of the DEA, FDA, state boards of pharmacy and city and county health regulators, among others. These include licensing, registration, recordkeeping, security and reporting requirements. The DEA requires our Anda Distribution business to monitor customer orders of DEA Scheduled Drugs and to report suspicious orders to the DEA. Any determination by the DEA that we have failed to comply with applicable laws and regulations could result in DEA suspending, terminating or refusing to renew Anda Distribution’s license to distribute Scheduled Drugs. Additionally, although physicians may prescribe FDA approved products for an “off label” indication, we are permitted to market our products only for the indications for which they have been approved. Some of our products are prescribed off label and the FDA, the U.S. Department of Justice, the U.S. Attorney or other regulatory authorities could take enforcement actions if they conclude that we or our distributors have

 

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engaged in off label marketing. In addition, several states and the federal government have begun to enforce anti-counterfeit drug pedigree laws which require the tracking of all transactions involving prescription drugs beginning with the manufacturer, through the supply chain, and down to the pharmacy or other health care provider dispensing or administering prescription drug products. For example, effective July 1, 2006, the Florida Department of Health began enforcement of the drug pedigree requirements for distribution of prescription drugs in the State of Florida. Pursuant to Florida law and regulations, wholesalers and distributors, including our subsidiary, Anda Pharmaceuticals, are required to maintain records documenting the chain of custody of prescription drug products they distribute beginning with the purchase of products from the manufacturer. These entities are required to provide documentation of the prior transaction(s) to their customers in Florida, including pharmacies and other health care entities. Several other states have proposed or enacted legislation to implement similar or more stringent drug pedigree requirements. In addition, federal law requires that a “non-authorized distributor of record” must provide a drug pedigree documenting the prior purchase of a prescription drug from the manufacturer or from an “authorized distributor of record”. In cases where the wholesaler or distributor selling the drug product is not deemed an “authorized distributor of record” it would need to maintain such records. The FDA had announced its intent to impose additional drug pedigree requirements (e.g., tracking of lot numbers and documentation of all transactions) through implementation of drug pedigree regulations which were to have taken effect on December 1, 2006. However, a federal appeals court has issued a preliminary injunction to several wholesale distributors granting an indefinite stay of these regulations pending a challenge to the regulations by these wholesale distributors.

In addition to government agencies that promulgate regulations and guidelines directly applicable to us, other professional societies, practice management groups, insurance carriers, physicians, private health or science foundations and organizations involved in various diseases from time to time may also publish guidelines or recommendations to healthcare providers, administrators and payers, and patient communities. For example, the treatment practices of physicians that currently prescribe our products may change. Recommendations by government agencies or other groups and organizations may relate to such matters as usage, dosage, route of administration and use of related therapies, as well as reimbursement of our products by government and private payers. Any recommendations or guidelines that result in decreased use, dosage or reimbursement of our products could materially and adversely affect our product sales, business and operating results.

The supply of APIs into Europe may be negatively affected by recent regulations promulgated by the European Union.

As of July 2, 2013, all API’s imported into the EU must be certified as complying with the good manufacturing practice (“GMP”) standards established by the EU, as stipulated by the International Conference for Harmonization. These new regulations place the certification requirement on the regulatory bodies of the exporting countries. Accordingly, as of July 2, 2013, the national regulatory authorities of each exporting country must: (i) insure that all manufacturing plants within their borders that export API into the EU comply with EU manufacturing standards and; (ii) for each API exported, present a written document confirming that the exporting plant conforms to EU manufacturing

 

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standards. The imposition of this responsibility on the governments of the nations exporting API may cause a shortage of API necessary to manufacture our products, as certain governments may not be willing or able to comply with the regulation in a timely fashion, or at all. A shortage in API may cause us to have to cease manufacture of certain products, or to incur costs and delays to qualify other suppliers to substitute for those API manufacturers unable to export. This could adversely affect the Company and could have a material adverse effect on our business, results of operations, financial condition and cash flow.

 

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Federal regulation of arrangements between manufacturers of brand and generic products could adversely affect our business.

As part of the Medicare Prescription Drug and Modernization Act of 2003 (the “MMA”) companies are required to file with the FTC and the Department of Justice certain types of agreements entered into between brand and generic pharmaceutical companies related to the manufacture, marketing and sale of generic versions of brand drugs. This requirement, as well as new legislation pending in the U.S. Congress related to settlements between brand and generic drug manufacturers, could affect the manner in which generic drug manufacturers resolve intellectual property litigation and other disputes with brand pharmaceutical companies and could result generally in an increase in private-party litigation against pharmaceutical companies or additional investigations or proceedings by the FTC or other governmental authorities. The impact of this requirement, the pending legislation and the potential private-party lawsuits associated with arrangements between brand name and generic drug manufacturers, is uncertain and could adversely affect our business. For example, on April 5, 2013, two putative class actions were filed against Actavis, Inc. and certain affiliates alleging that Watson Pharmaceuticals, Inc.’s 2009 patent lawsuit settlement with Warner Chilcott related to Loestrin ® 24 Fe (norethindrone acetate/ethinyl estradiol tablets and ferrous fumarate tablets, “Loestrin ® 24”) is unlawful. The complaints, both asserted on behalf of putative classes of end-payors, generally allege that Watson and another generic manufacturer improperly delayed launching generic versions of Loestrin ® 24 in exchange for substantial payments from Warner Chilcott, which at the time was an unrelated company, in violation of federal and state antitrust and consumer protection laws. Further, in January 2009, the FTC and the State of California filed a lawsuit against us alleging that our settlement with Solvay related to our ANDA for a generic version of Androgel ® is unlawful. Numerous private parties purporting to represent various classes of plaintiffs filed similar lawsuits. Similar lawsuits have been filed against us challenging the lawfulness of our settlements related to generic versions of Actos ® , Androgel ® , Cipro ® , and Lidoderm ® . We have also received requests for information and Statements of Objection in connection with investigations into settlements and other arrangements between competing pharmaceutical companies by the Federal Trade Commission and the European Competition Commission. In the past, we have also received requests for information and Statements of Objection in connection with investigations into settlements and other arrangements between competing pharmaceutical companies by the Federal Trade Commission and the European Competition Commission. In May 2014, Forest received a Civil Investigatory Demand from the FTC requesting information about Forest’s agreements with ANDA filers for Bystolic ® . In February 2014, Forest received an Investigatory Subpoena from the New York Attorney General’s Office requesting information regarding, among other things, plans to discontinue the sale of Namenda tablets. Any adverse outcome of these actions or investigations, or actions or investigations related to other settlements we have entered into, could have a material adverse effect on our business, results of operations, financial condition and cash flows. Refer to Legal Matters in “NOTE 19 — Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements”.

 

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Healthcare reform and a reduction in the coverage and reimbursement levels by governmental authorities, HMOs, MCOs or other third-party payers may adversely affect our business.

Demand for our products depends in part on the extent to which coverage and reimbursement is available from third-party payers, such as the Medicare and Medicaid programs and private payors. In order to commercialize our products, we have obtained from government authorities and private health insurers and other organizations, such as HMOs and MCOs, recognition for coverage and reimbursement at varying levels for the cost of certain of our products and related treatments. Third-party payers increasingly challenge pricing of pharmaceutical products. Further, the trend toward managed healthcare in the U.S., the growth of organizations such as HMOs and MCOs and legislative proposals to reform healthcare and government insurance programs create uncertainties regarding the future levels of coverage and reimbursement for pharmaceutical products. Such cost containment measures and healthcare reform could reduce reimbursement of our pharmaceutical products, resulting in lower prices and a reduction in the product demand. This could affect our ability to sell our products and could have a material adverse effect on our business, results of operations, financial condition and cash flows.

There is uncertainty surrounding implementation of legislation involving payments for pharmaceuticals under government programs such as Medicare, Medicaid and Tricare. Depending on how existing provisions are implemented, the methodology for certain payment rates and other computations under the Medicaid Drug Rebate program reimbursements may be reduced or not be available for some of our products. Additionally, any reimbursement granted may not be maintained or limits on reimbursement available from third-party payers may reduce demand for, or negatively affect the price of, those products. Ongoing uncertainty and challenges to the ACA, including but not limited to, modification in calculation of rebates, mandated financial or other contributions to close the Medicare Part D coverage gap “donut hole,” calculation of AMP, and other provisions could have a material adverse effect on our business. In addition, various legislative and regulatory initiatives in states, including proposed modifications to reimbursements and rebates, product pedigree and tracking, pharmaceutical waste “take-back” initiatives, and therapeutic category generic substitution carve-out legislation may also have a negative impact on the Company. We maintain a full-time government affairs department in Washington, DC, which is responsible for coordinating state and federal legislative activities, and places a major emphasis in terms of management time and resources to ensure a fair and balanced legislative and regulatory arena.

There is additional uncertainty surrounding the insurance coverage mandate that goes into effect in the U.S. in 2015 and 2016. Employers may seek to reduce costs by reducing or eliminating employer group healthcare plans or transferring a greater portion of healthcare costs to their employees. Job losses or other economic hardships may also result in reduced levels of coverage for some individuals, potentially resulting in lower levels of healthcare coverage for themselves or their families. These economic conditions may affect patients’ ability to afford health care as a result of increased co-pay or deductible obligations, greater cost sensitivity to existing co-pay or deductible obligations, lost healthcare insurance coverage or for other reasons. We believe such conditions have led and could continue to lead to changes in patient behavior and spending patterns that negatively affect usage of certain of our products, including some patients delaying treatment, rationing prescription medications, leaving

 

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prescriptions unfilled, reducing the frequency of visits to healthcare facilities, utilizing alternative therapies, or foregoing healthcare insurance coverage. Such changes may result in reduced demand for our products, which could materially and adversely affect the sales of our products, our business and results of operations.

The pharmaceutical industry is highly competitive and our future revenue growth and profitability are dependent on our timely development and launches of new products ahead of our competitors.

We face strong competition in all of our businesses. The intensely competitive environment requires an ongoing, extensive search for technological innovations and the ability to market products effectively, including the ability to communicate the effectiveness, safety and value of brand products to healthcare professionals in private practice, group practices and MCOs. Our competitors vary depending upon product categories, and within each product category, upon dosage strengths and drug-delivery systems. Based on total assets, annual revenues, and market capitalization, we are smaller than certain of our national and international competitors in the brand and distribution product arenas. Most of our competitors have been in business for a longer period of time than us, have a greater number of products on the market and have greater financial and other resources than we do. Furthermore, recent trends in this industry are toward further market consolidation of large drug companies into a smaller number of very large entities, further concentrating financial, technical and market strength and increasing competitive pressure in the industry. If we directly compete with them for the same markets and/or products, their financial strength could prevent us from capturing a profitable share of those markets. It is possible that developments by our competitors will make our products or technologies noncompetitive or obsolete. In addition, competitive forces may result in changes to the mix of products that we sell during a given time period or lower demand for our products than expected.

Some of our competitors have technical, competitive or other advantages over us for the development of technologies and processes. We face increased competition from new infection prevention, sterile processing, contamination control, surgical support, cleaning consumables, gastrointestinal endoscopy accessories, contract sterilization, and other products and services entering the market. These advantages may make it difficult for us to compete with them to successfully discover, develop and market new products and for our current products to compete with new products that these competitors may bring to market. As a result, our products may compete against products that have lower prices, equivalent or superior performance, a better safety profile, are easier to administer, achieve earlier entry into the market or that are otherwise competitive with our products.

Revenues and gross profit derived from the sales of generic pharmaceutical products tend to follow a pattern based on certain regulatory and competitive factors. As patents for brand name products and related exclusivity periods expire, the first generic manufacturer to receive regulatory approval for generic equivalents of such products is generally able to achieve significant market penetration. Therefore, our ability to increase or maintain revenues and profitability in our generics business is largely dependent on our success in challenging patents and developing non-infringing formulations of proprietary products. As competing manufacturers receive regulatory approvals on similar products or as brand manufacturers launch generic versions of such products (for which no separate regulatory

 

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approval is required), market share, revenues and gross profit typically decline, in some cases dramatically. Accordingly, the level of market share, revenue and gross profit attributable to a particular generic product normally is related to the number of competitors in that product’s market and the timing of that product’s regulatory approval and launch, in relation to competing approvals and launches. Consequently, we must continue to develop and introduce new products in a timely and cost-effective manner to maintain our revenues and gross margins. We may have fewer opportunities to launch significant generic products in the future, as the number and size of proprietary products that are subject to patent challenges is expected to decrease in the next several years compared to historical levels. Additionally, as new competitors enter the market, there may be increased pricing pressure on certain products, which would result in lower gross margins. This is particularly true in the case of certain Asian and other overseas generic competitors, who may be able to produce products at costs lower than the costs of domestic manufacturers. If we experience substantial competition from Asian or other overseas generic competitors with lower production costs, our profit margins will suffer.

We also face strong competition in our Anda Distribution business, where we compete with a number of large wholesalers and other distributors of pharmaceuticals, including McKesson, AmerisourceBergen and Cardinal, which market both brand and generic pharmaceutical products to their customers. These companies are significant customers of our North American Brands and North American Generics businesses. As generic products generally have higher gross margins for distributors, each of the large wholesalers, on an increasing basis, are offering pricing incentives on brand products if the customers purchase a large portion of their generic pharmaceutical products from the primary wholesaler. As Anda does not offer a full line of brand products to our customers, we have been at times competitively disadvantaged and must compete with these wholesalers based upon our very competitive pricing for generic products, greater service levels and our well-established telemarketing relationships with our customers, supplemented by our electronic ordering capabilities. The large wholesalers have historically not used telemarketers to sell to their customers, but recently have begun to do so. Additionally, generic manufacturers are increasingly marketing their products directly to smaller chains and thus increasingly bypassing wholesalers and distributors. Increased competition in the generic industry as a whole may result in increased price erosion in the pursuit of market share.

Sales of our products may continue to be adversely affected by the continuing consolidation of our distribution network and the concentration of our customer base.

Our principal customers in our brand and generic pharmaceutical operations are wholesale drug distributors and major retail drug store chains. These customers comprise a significant part of the distribution network for pharmaceutical products in the U.S. This distribution network is continuing to undergo significant consolidation marked by mergers and acquisitions among wholesale distributors and the growth of large retail drug store chains. As a result, a small number of large wholesale distributors and large chain drug stores control a significant share of the market. We expect that consolidation of drug wholesalers and retailers will increase pricing and other competitive pressures on drug manufacturers, including the Company.

 

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The loss of any of these customers could have a material adverse effect on our business, results of operations, financial condition and cash flows. In addition, none of our customers are party to any long-term supply agreements with us, and thus are able to change suppliers freely should they wish to do so.

We might face additional regulation in the U.S. if our drug candidate eluxadoline, which we acquired in the Furiex acquisition, is classified as a controlled substance by the DEA; we may be required to make additional payments in connection with the Furiex acquisition based on the outcome of any DEA schedule decision with respect to eluxadoline.

The DEA regulates drugs that are controlled substances. Controlled substances are those drugs that appear on one of the five schedules promulgated and administered by the DEA under the Controlled Substances Act (the “CSA”). Any drug that acts on the central nervous system has the potential to become a controlled substance, and scheduling by the DEA is an independent process that might delay the commercial launch of a drug even after FDA approval of the NDA. The CSA governs, among other things, the inventory distribution, recordkeeping, handling, security and disposal of controlled substances.

Eluxadoline is a novel, orally active, investigational agent that was filed with the FDA, with combined mu opioid receptor agonist and delta opioid receptor antagonist activity. Because it likely acts on the central nervous system, eluxadoline has the potential to be scheduled as a controlled substance by the DEA. However, our animal and clinical studies indicate eluxadoline is not absorbed into the blood in an appreciable amount via an oral route of administration, thus limiting delivery to the central nervous system. If the DEA schedules eluxadoline as a controlled substance, we will be subject to periodic and on-going inspections by the DEA and similar state drug enforcement authorities to assess our on-going compliance with the DEA’s regulations. Any failure to comply with these regulations could lead to a variety of sanctions, including the revocation, or a denial of renewal, of any DEA registrations, injunctions, or civil or criminal penalties. Additionally, if the DEA schedules a drug because it is addictive, doctors might be reluctant to prescribe that drug. It is possible that the DEA will schedule eluxadoline as a controlled substance, and, based on the type of scheduling, doctors might not prescribe eluxadoline as frequently as they would otherwise, which could negatively impact our revenues.

In addition, under the terms of the agreements we entered into at the time of the Furiex acquisition, we may be required to make contingent payments to the former Furiex shareholders based on the outcome of any DEA scheduling decision with respect to eluxadoline. These payments would be approximately $120.0 million, in the aggregate, if eluxadoline is designated on Schedule IV of the CSA and would increase up to $360.0 million, in the aggregate, if eluxadoline is not designated on any schedule of the CSA.

Developments after a product reaches the market may adversely affect sales of our products.

Even after regulatory approval, certain developments may decrease demand for our products, including the following:

 

    the re-review of products that are already marketed;

 

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    new scientific information and evolution of scientific theories;

 

    the recall or loss of marketing approval of products that are already marketed;

 

    changing government standards or public expectations regarding safety, efficacy or labeling changes; and

 

    greater scrutiny in advertising and promotion.

In the past, clinical trials and post-marketing surveillance of certain marketed drugs of the Company and of competitors within the industry have raised concerns that have led to recalls, withdrawals or adverse labeling of marketed products. If previously unknown side effects are discovered or if there is an increase in negative publicity regarding known side effects of any of our products, it could significantly reduce demand for the product or require us to take actions that could negatively affect sales, including removing the product from the market, restricting its distribution or applying for labeling changes.

In addition, certain health authorities, regulators and agencies have increased their focus on safety when assessing the balance of benefits and risks of drugs. Some health authorities appear to have become more cautious when making decisions about approvability of new products and are re-reviewing select products that are already marketed, adding further to the uncertainties in the regulatory processes. There is also greater regulatory scrutiny, especially in the U.S., on advertising and promotion and, in particular, direct-to-consumer advertising.

Additional Risks Related to the Re-domiciliation of Actavis to Ireland

As a result of different shareholder voting requirements in Ireland relative to laws in effect in certain states in the United States, we may have less flexibility with respect to certain aspects of capital management than companies organized in the United States.

Under Irish law, our authorized share capital can be increased by an ordinary resolution of our shareholders and the directors may issue new ordinary or preferred shares up to a maximum amount equal to the authorized but unissued share capital, without shareholder approval, once authorized to do so by our articles of association or by an ordinary resolution of our shareholders. Additionally, subject to specified exceptions, Irish law grants statutory preemption rights to existing shareholders to subscribe for new issuances of shares for cash, but allows shareholders to authorize the waiver of the statutory preemption rights by way of special resolution with respect to any particular allotment of shares. Accordingly, our articles of association contain, as permitted by Irish company law, a provision authorizing the board to issue new shares for cash without offering preemption rights. The authorization of the directors to issue shares and the authorization of the waiver of the statutory preemption rights must both be renewed by the shareholders at least every five years, and we cannot provide any assurance that these authorizations will always be approved, which could limit our ability to issue equity and thereby adversely affect the holders of our securities.

 

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We are incorporated in Ireland, and Irish law differs from the laws in effect in the United States and may afford less protection to, or otherwise adversely affect, our shareholders.

Our shareholders may have more difficulty protecting their interests than would shareholders of a corporation incorporated in a jurisdiction of the United States. As an Irish company, we are governed by the Irish Companies Acts (the “Companies Act”). The Companies Act differs in some material respects from laws generally applicable to U.S. corporations and shareholders, including the provisions relating to interested directors, mergers, amalgamations and acquisitions, takeovers, shareholder lawsuits and indemnification of directors. For example, under Irish law, the duties of directors and officers of a company are generally owed to the company only. As a result, shareholders of Irish companies do not have the right to bring an action against the directors or officers of a company, except in limited circumstances. In addition, depending on the circumstances, you may be subject to different or additional tax consequences under Irish law as a result of your acquisition, ownership and/or disposition of our ordinary shares, including, but not limited to, Irish stamp duty, dividend withholding tax and capital acquisitions tax.

We are an Irish company and it may be difficult for you to enforce judgments against us or certain of our officers and directors.

We are incorporated in Ireland and a substantial portion of our assets are located in jurisdictions outside the United States. In addition, some of our officers and directors reside outside the United States, and some or all of their respective assets are or may be located in jurisdictions outside of the United States. Therefore, it may be difficult for investors to effect service of process against us or such officers or directors or to enforce against us or them judgments of U.S. courts predicated upon civil liability provisions of the U.S. federal securities laws.

There is no treaty between Ireland and the United States providing for the reciprocal enforcement of foreign judgments. The following requirements must be met before the foreign judgment will be deemed to be enforceable in Ireland:

 

    the judgment must be for a definite sum;

 

    the judgment must be final and conclusive; and

 

    the judgment must be provided by a court of competent jurisdiction.

An Irish court will also exercise its right to refuse judgment if the foreign judgment was obtained by fraud, if the judgment violated Irish public policy, if the judgment is in breach of natural justice or if it is irreconcilable with an earlier judgment. Further, an Irish court may stay proceedings if concurrent proceedings are being brought elsewhere. Judgments of U.S. courts of liabilities predicated upon U.S. federal securities laws may not be enforced by Irish courts if deemed to be contrary to public policy in Ireland.

 

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A transfer of Company Ordinary Shares, other than by means of the transfer of book-entry interests in the Depository Trust Company (“DTC”), may be subject to Irish stamp duty.

Transfers of Company Ordinary Shares effected by means of the transfer of book entry interests in DTC will not be subject to Irish stamp duty. However, if you hold your Company Ordinary Shares directly rather than beneficially through DTC, any transfer of your Company Ordinary Shares could be subject to Irish stamp duty (currently at the rate of 1% of the higher of the price paid or the market value of the shares acquired). Payment of Irish stamp duty is generally a legal obligation of the transferee. The potential for stamp duty could adversely affect the price of your shares.

In certain limited circumstances, dividends we pay may be subject to Irish dividend withholding tax.

While we do not currently contemplate paying dividends upon our ordinary shares, in certain limited circumstances, dividend withholding tax (currently at a rate of 20%) may arise in respect of dividends, if any, paid on our ordinary shares. A number of exemptions from dividend withholding tax exist such that shareholders resident in the U.S. and shareholders resident in certain countries may be entitled to exemptions from dividend withholding tax.

Shareholders resident in the U.S. that hold their shares through DTC will not be subject to dividend withholding tax provided the addresses of the beneficial owners of such shares in the records of the brokers holding such shares are recorded as being in the U.S. (and such brokers have further transmitted the relevant information to a qualifying intermediary appointed by us). Similarly, shareholders resident in the U.S. that hold their shares outside of DTC will not be subject to dividend withholding tax if, in the case of former Actavis, Inc. shareholders, they provide a IRS Form 6166 to our transfer agent to confirm their U.S. residence and claim an exemption, or, in the case of former Warner Chilcott shareholders, such shareholders previously filed valid dividend withholding tax forms with Warner Chilcott or its transfer agent in respect of their Warner Chilcott shareholdings. All new U.S. resident shareholders in Actavis plc that hold their shares outside of DTC and shareholders resident in certain other countries (irrespective of whether they hold their shares through DTC or outside DTC) will not be subject to dividend withholding tax provided the beneficial owners of such shares have furnished completed and valid dividend withholding tax forms or an IRS Form 6166, as appropriate, to our transfer agent or their brokers (and such brokers have further transmitted the relevant information to our transfer agent). However, other shareholders may be subject to dividend withholding tax, which could adversely affect the price of your shares.

Dividends received by Irish residents and certain other shareholders may be subject to Irish income tax.

Shareholders entitled to an exemption from Irish dividend withholding tax on dividends received from us will not be subject to Irish income tax in respect of those dividends, unless they have some connection with Ireland other than their shareholding in us (for example, they are resident in Ireland). Shareholders who are not resident nor ordinarily resident in Ireland but who are not entitled to an exemption from Irish dividend withholding tax will generally have no further liability to Irish income tax on those dividends which suffer dividend withholding tax.

 

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Company Ordinary Shares received by means of a gift or inheritance could be subject to Irish capital acquisitions tax.

Irish capital acquisitions tax (“CAT”) could apply to a gift or inheritance of Company Ordinary Shares irrespective of the place of residence, ordinary residence or domicile of the parties. This is because Company Ordinary Shares are regarded as property situated in Ireland. The person who receives the gift or inheritance has primary liability for CAT. Gifts and inheritances passing between spouses are exempt from CAT. Children have a tax-free threshold of €225,000 in respect of taxable gifts or inheritances received from their parents.

Risks Related to the Business of the Combined Company

The market price for Actavis ordinary shares following the closing of the Allergan Acquisition may be affected by factors different from those that historically have affected Allergan common stock and Actavis ordinary shares.

Upon completion of the Allergan Acquisition, holders of shares of Allergan common stock (other than the holders of excluded shares and dissenting shares) became holders of Actavis ordinary shares. Actavis’ businesses differ from those of Allergan, and accordingly the results of operations of Actavis are affected by some factors that are different from those previously affecting the results of operations of Allergan. In addition, upon completion of the Allergan Acquisition, holders of Actavis ordinary shares became holders of shares in the combined company. The results of operations of the combined company may also be affected by factors different from those previously affecting Actavis.

For a period of time following the consummation of the Allergan Acquisition, Actavis will be subject to business uncertainties that could adversely affect its business

Uncertainty about the effect of the Allergan Acquisition on employees, customers and suppliers may have an adverse effect on Actavis. These uncertainties may impair Actavis’ ability to attract, retain and motivate key personnel for a period of time following the consummation of the Allergan Acquisition, and could cause customers, suppliers and others who deal with Actavis to seek to change existing business relationships with Actavis. If key employees depart because of issues related to the uncertainty and difficulty of integration or a desire not to remain with the businesses, the business of the combined company could be seriously harmed.

Actavis may fail to realize all of the anticipated benefits of the Allergan Acquisition or those benefits may take longer to realize than expected. Actavis may also encounter significant difficulties in integrating the two businesses.

The ability of Actavis to realize the anticipated benefits of the Allergan Acquisition will depend, to a large extent, on Actavis’ ability to integrate the two businesses. The combination of two independent businesses is a complex, costly and time-consuming process. As a result, Actavis is required to devote significant management attention and resources to integrate, the business practices and operations of Actavis and Allergan. The integration process may disrupt the businesses and, if implemented

 

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ineffectively, would restrict the realization of the full expected benefits. The failure to meet the challenges involved in integrating the two businesses and to realize the anticipated benefits of the transactions could cause an interruption of, or a loss of momentum in, the activities of the combined company and could adversely affect the results of operations of the combined company.

In addition, the overall integration of the businesses may result in material unanticipated problems, expenses, liabilities, competitive responses, loss of customer and other business relationships, and diversion of management’s attention. Refer to “ If we do not successfully integrate newly acquired businesses into our business operations, our business could be adversely affected .”

Many of these factors are outside of the control of Actavis and any one of them could result in increased costs, decreases in the amount of expected revenues and diversion of management’s time and energy, which could materially impact the business, financial condition and results of operations of the combined company. In addition, even if the operations of the businesses of Actavis and Allergan are integrated successfully, the full benefits of the transactions may not be realized, including the synergies, cost savings or sales or growth opportunities that are expected. These benefits may not be achieved within the anticipated time frame, or at all. Further, additional unanticipated costs may be incurred in the integration of the businesses of Actavis and Allergan. All of these factors could cause dilution to the earnings per share of Actavis, decrease or delay the expected accretive effect of the transactions, and negatively impact the price of Actavis ordinary shares. As a result, it cannot be assured that the combination of Actavis and Allergan will result in the realization of the full benefits anticipated from the transactions.

Actavis has incurred and will incur direct and indirect costs as a result of the Allergan Acquisition.

Actavis has incurred substantial expenses in connection with and as a result of completing the merger and, over a period of time following the completion of the merger, Actavis further expects to incur substantial expenses in connection with coordinating the businesses, operations, policies and procedures of Actavis and Allergan. While Actavis has assumed that a certain level of transaction expenses will be incurred, factors beyond Actavis’ control could affect the total amount or the timing of these expenses. Many of the expenses that will be incurred, by their nature, are difficult to estimate accurately.

Actavis has incurred a substantial amount of debt to finance the aggregate Cash Consideration Portion and certain other amounts to be paid in connection with the Allergan Acquisition, which could adversely affect Actavis’ business, including by restricting its ability to engage in additional transactions or to incur additional indebtedness or resulting in a downgrade or other adverse action with respect to Actavis’ credit rating.

In connection with the Allergan Acquisition, subsidiaries of Actavis (i) borrowed $5.5 billion under the Term Facilities, (ii) issued and sold $21.0 billion in aggregate principal amount of notes and (iii) borrowed $2.8 billion in loans under the cash bridge facility. The combined company has a significant amount of indebtedness outstanding. Actavis’ net consolidated borrowing costs, which cannot be predicted at this time, will depend on rates in effect from time to time, the structure of the

 

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indebtedness, taxes and other factors. This substantial level of indebtedness could have important consequences to Actavis’ business, including, but not limited to:

 

    reducing the benefits Actavis expects to receive from the Allergan Acquisition;

 

    making it more difficult for Actavis to satisfy its obligations;

 

    limiting Actavis’ ability to borrow additional funds and increasing the cost of any such borrowing;

 

    increasing Actavis’ vulnerability to, and reducing its flexibility to respond to, general adverse economic and industry conditions;

 

    limiting Actavis’ flexibility in planning for, or reacting to, changes in its business and the industry in which it operates;

 

    placing Actavis at a competitive disadvantage as compared to its competitors, to the extent that they are not as highly leveraged; and

 

    restricting Actavis from pursuing certain business opportunities.

Actavis’ credit ratings impact the cost and availability of future borrowings and, accordingly, Actavis’ cost of capital. Actavis’ ratings at any time will reflect each rating organization’s then opinion of Actavis’ financial strength, operating performance and ability to meet its debt obligations. Following the announcement of the Allergan Acquisition, Standard & Poor’s Rating Services, Moody’s Investor Service, Inc. and Fitch Ratings, Inc. each reaffirmed its respective ratings of Actavis. However, there can be no assurance that Actavis will achieve a particular rating or maintain a particular rating in the future. Any reduction in Actavis’ credit ratings may limit Actavis’ ability to borrow at interest rates consistent with the interest rates that were available to Actavis prior to the Allergan Acquisition. If Actavis’ credit ratings are downgraded or put on watch for a potential downgrade, Actavis may not be able to sell additional debt securities or borrow money in the amounts, at the times or interest rates or upon the more favorable terms and conditions that might be available if Actavis’ current credit ratings are maintained. Any impairment of Actavis’ ability to obtain future financing on favorable terms could have an adverse effect on Actavis’ ability to refinance, to the extent the cash bridge facility is not otherwise repaid using Allergan’s cash on hand, the cash bridge facility.

 

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The Allergan Acquisition may not be accretive and may cause dilution to Actavis’ earnings per share, which may negatively affect the market price of Actavis ordinary shares.

Although Actavis currently anticipates that the Allergan Acquisition will be accretive to earnings per share (on a non-GAAP adjusted earnings basis) after the Allergan Acquisition, this expectation is based on preliminary estimates, which may change materially.

Actavis issued approximately 111 million ordinary shares to pay the aggregate stock portion of the merger consideration to Allergan stockholders and reserved for issuance approximately 25 million ordinary shares in connection with its assumption of Allergan equity-based awards at the closing of the Allergan Acquisition. Actavis also issued ordinary shares and mandatory convertible preferred shares to finance a portion of the aggregate cash portion of the merger consideration.

In addition, Actavis could also encounter additional transaction-related costs or other factors such as the failure to realize all of the benefits anticipated in the Allergan Acquisition. All of these factors could cause dilution to Actavis’ earnings per share or decrease or delay the expected accretive effect of the Allergan Acquisition and cause a decrease in the market price of Actavis ordinary shares.

Legislative or other governmental action relating to the denial of U.S. federal or state governmental contracts to U.S. companies that redomicile abroad could adversely affect Actavis’ business.

Various U.S. federal and state legislative and other proposals that would deny governmental contracts to U.S. companies (and subsidiaries of U.S. companies) that move (or have moved) their corporate location abroad may affect Actavis if adopted. The likelihood that any such proposals might be adopted, the nature of regulations that might be promulgated, or the effect such adoptions and increased regulatory scrutiny might have on Actavis’ business cannot be predicted.

 

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

Recent Sale of Unregistered Securities; Uses of Proceeds from Registered Securities

None.

 

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Issuer Purchases of Equity Securities

During the quarter ended March 31, 2015, we repurchased 216,984 of our ordinary shares to satisfy tax withholding obligations in connection with the vesting of restricted shares issued to employees as follows:

 

Period

   Total
Number
of Shares
Purchased
     Average
Price
Paid per
Share
     Total
Number of
Shares
Purchased
as Part of
Publically
Announced
Program
     Approximate
Dollar Value
of Shares
that May Yet
Be
Purchased
Under the
Program
 

January 1 - 31, 2015

     13,095       $ 261.89         —           —     

February 1 - 28, 2015

     16,276       $ 284.53         —          —    

March 1 - 31, 2015

     187,613       $ 298.59         —          —    
  

 

 

    

 

 

       

January 1 - March 31, 2015

  216,984    $ 295.32      —        —     
  

 

 

    

 

 

       

 

ITEM 6. EXHIBITS

Reference is hereby made to the Exhibit Index on page 146.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on May 11, 2015.

 

ACTAVIS PLC

WARNER CHILCOTT LIMITED

By:

/s/ Maria Teresa Hilado

Name: Maria Teresa Hilado
Title:

Chief Financial Officer

(Principal Financial Officer)

By:

/s/ James C. D’Arecca

Name: James C. D’Arecca
Title:

Chief Accounting Officer

(Principal Accounting Officer)

 

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EXHIBIT INDEX

 

Exhibit

  

Description

    4.1    Indenture, dated as of April 12, 2006, among Allergan, Inc. and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.2 to Allergan, Inc.’s Current Report on Form 8-K, filed with the SEC on April 12, 2006).
    4.2    First Supplemental Indenture, dated as of April 16, 2015, among Allergan, Inc., Actavis plc, Warner Chilcott Limited and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the SEC on April 22, 2015).
    4.3    Form of 5.75% Senior Note due 2016 (incorporated by reference to (and included in) the Indenture dated as of April 12, 2006 among Allergan, Inc. and Wells Fargo Bank, National Association, as trustee, at Exhibit 4.2 to Allergan, Inc.’s Current Report on Form 8-K, filed with the SEC on April 12, 2006).
    4.4    Registration Rights Agreement, dated as of April 12, 2006, among 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 with the SEC on April 12, 2006).
    4.5    Indenture, dated as of August 24, 2009, among Watson Pharmaceuticals, Inc. and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.1 to Watson Pharmaceuticals, Inc.’s Current Report on Form 8-K, filed with the SEC on August 24, 2009).
    4.6    First Supplemental Indenture, dated as of August 24, 2009, among Watson Pharmaceuticals, Inc. and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.2 to Watson Pharmaceuticals, Inc.’s Current Report on Form 8-K, filed with the SEC on August 24, 2009).
    4.7    Second Supplemental Indenture, dated as of May 7, 2010, among Watson Pharmaceuticals, Inc. and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 10.2 to Watson Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q, filed with the SEC on May 10, 2010).
    4.8    Third Supplemental Indenture, dated as of October 2, 2012, among Watson Pharmaceuticals, Inc. and Wells Fargo Bank, National Associate, as trustee (incorporated by reference to Exhibit 4.2 to Watson Pharmaceuticals, Inc’s Current Report on Form 8-K, filed with the SEC on October 2, 2012).
    4.9    Fourth Supplemental Indenture, dated as of October 1, 2013, among Actavis, Inc., Actavis plc and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed with the SEC on October 2, 2013).
    4.10    Fifth Supplemental Indenture, dated as of April 16, 2015, by and among Actavis, Inc., Actavis plc, Warner Chilcott Limited and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K, filed with the SEC on April 22, 2015).

 

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    4.11 Indenture, dated as of September 14, 2010, among Allergan, Inc. and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.1 to Allergan, Inc.’s Current Report on Form 8-K filed with the SEC on September 14, 2010).
    4.12 First Supplemental Indenture, dated as of September 14, 2010, among Allergan, Inc. and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.2 to Allergan, Inc.’s Current Report on Form 8-K filed with the SEC on September 14, 2010).
    4.13 Second Supplemental Indenture, dated as of April 16, 2015, by and among Allergan, Inc., Actavis plc, Warner Chilcott Limited and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the SEC on April 22, 2015).
    4.14 Form of 3.375% Note due 2020 (incorporated by reference to (and included in) the Supplemental Indenture dated as of September 14, 2010 among Allergan, Inc. and Wells Fargo Bank, National Association, as trustee, at Exhibit 4.2 to Allergan, Inc.’s Current Report on Form 8-K, filed with the SEC on September 14, 2010).
    4.15 Indenture, dated as of March 12, 2013, among Allergan, Inc. and Wells Fargo, National Association, as trustee (incorporated by reference to Exhibit 4.1 to Allergan, Inc.’s Current Report on Form 8-K filed with the SEC on March 12, 2013).
    4.16 First Supplemental Indenture, dated as of March 12, 2013, among Allergan, Inc. and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.2 to Allergan, Inc.’s Current Report on Form 8-K filed with the SEC on March 12, 2013).
    4.17 Second Supplemental Indenture, dated as of April 16, 2015, by and among Allergan, Inc., Actavis plc, Warner Chilcott Limited and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K, filed with the SEC on April 22, 2015).
    4.18 Indenture, dated as of March 12, 2015, among Actavis Funding SCS and Warner Chilcott Limited, Actavis Capital S.à r.l. and Actavis, Inc., as guarantors and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the SEC on March 12, 2015).
    4.19 First Supplemental Indenture, dated as of March 12, 2015, among Actavis Funding SCS and Warner Chilcott Limited, Actavis Capital S.à r.l. and Actavis, Inc., as guarantors and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the SEC on March 12, 2015).
    4.20* Second Supplemental Indenture, dated as of May 7, 2015, among Actavis Funding SCS and Wells Fargo Bank, National Association, as trustee.
  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 Allergan, Inc. Change in Control Policy (Effective April 2010) (incorporated by reference to Exhibit 10.2 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2010).

 

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  10.3# Allergan, Inc. Deferred Directors’ Fee Program (Restated December 2010) (incorporated by reference to Exhibit 10.11 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2010).
  10.4# Allergan, Inc. 1989 Incentive Compensation Plan (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).
  10.5# First Amendment to Allergan, Inc. 1989 Incentive Compensation Plan (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).
  10.6# Second Amendment to Allergan, Inc. 1989 Incentive Compensation Plan (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).
  10.7# Third Amendment to Allergan, Inc. 1989 Incentive Compensation Plan (Restated November 2000) (incorporated by reference to Exhibit 10.15 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2010).
  10.8 Allergan, Inc. Pension Plan (Restated 2013) (incorporated by reference to Exhibit 10.15 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2012).
  10.9 First Amendment to the Allergan, Inc. Pension Plan (Restated 2013) (Incorporated by reference to Exhibit 10.14 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2013).
  10.10 Second Amendment to the Allergan, Inc. Pension Plan (Restated 2013 (Incorporated by reference to Exhibit 10.1 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 31, 2014).
  10.11 Third Amendment to Allergan, Inc. Pension Plan (Restated 2013) (Incorporated by reference to Exhibit 10.2 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 31, 2014.
  10.12# Allergan, Inc. Supplemental Executive Benefit Plan and Supplemental Retirement Income Plan (Restated 2011) (incorporated by reference to Exhibit 10.3 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended September 30, 2011).
  10.13# First Amendment to Allergan, Inc. Supplemental Executive Benefit Plan (incorporated by reference to Exhibit 10.18 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2011).
  10.14# Allergan, Inc. Executive Severance Pay Plan (Effective January 2011) (incorporated by reference to Exhibit 10.1 to Allergan, Inc.’s Current Report on Form 8-K filed on December 21, 2010).
  10.15# Allergan, Inc. 2011 Executive Bonus Plan (incorporated by reference to Annex A to Allergan, Inc.’s Proxy Statement filed on March 8, 2011).
  10.16# Allergan, Inc. 2011 Executive Bonus Plan - 2015 Performance Objectives (incorporated by reference to Exhibit 10.21 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2014).

 

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  10.17# Allergan, Inc. 2015 Management Bonus Plan (incorporated by reference to Exhibit 10.22 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2014).
  10.18# Allergan, Inc. Executive Deferred Compensation Plan (Restated 2009) (incorporated by reference to Exhibit 10.23 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2008).
  10.19# Form of 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).
  10.20# Form of Non-Qualified Stock Option Grant Notice for Employees under the Allergan, Inc. 2008 Incentive Award Plan (Amended February 2010) (incorporated by reference to Exhibit 10.32 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2009).
  10.21# Amended and Restated Allergan, Inc. 2011 Incentive Award Plan (incorporated by reference to Exhibit 99.5 to Actavis plc’s Post-Effective Amendment No. 1 on Form S-8 to Form S-4 (No. 333-201242), filed on March 17, 2015).
  10.22# Form of Non-Qualified Stock Option Grant Notice for Employees under the Allergan, Inc. 2011 Incentive Award Plan (incorporated by reference to Exhibit 10.6 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 31, 2011).
  10.23# Form of Restricted Stock Award Grant Notice for Employees under the Allergan, Inc. 2011 Incentive Award Plan (incorporated by reference to Exhibit 10.7 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 31, 2011).
  10.24# Form of Restricted Stock Award Grant Notice for Employees (Management Bonus Plan) under the Allergan, Inc. 2011 Incentive Award Plan (incorporated by reference to Exhibit 10.8 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 31, 2011).
  10.25# Form of Restricted Stock Unit Award Grant Notice for Employees under the Allergan, Inc. 2011 Incentive Award Plan (incorporated by reference to Exhibit 10.9 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 31, 2011).
  10.26# Form of Restricted Stock Unit Award Grant Notice for Employees (Management Bonus Plan) under the Allergan, Inc. 2011 Incentive Award Plan (incorporated by reference to Exhibit 10.10 to Allergan, Inc.’s Report on Form 10-Q for the Quarter ended March 31, 2011).
  10.27# Form of Performance-Based Restricted Stock Unit Award Grant Notice for Employees under the Allergan, Inc. 2011 Incentive Award Plan (incorporated by reference to Exhibit 10.40 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2011).
  10.28# Form of 2014 Performance-Based Restricted Stock Unit Award Grant Agreement for Employees under the Allergan, Inc. 2011 Incentive Award Plan ( incorporated by reference to Exhibit 10.1 to Allergan, Inc.’s Report on Form 10-Q for the Quarter Ended September 30, 2014)
  10.29# Form of Non-Qualified Stock Option Grant Agreement for Employees under the Allergan, Inc. 2011 Incentive Award Plan (Amended February 2014) (incorporated by reference to Exhibit 10.40 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2013).

 

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  10.30# Form of Restricted Stock Unit Grant Agreement for Employees under the Allergan, Inc. 2011 Incentive Award Plan (Amended February 2014) (incorporated by reference to Exhibit 10.41 to Allergan, Inc.’s Annual Report on form 10-K for the Fiscal Year ended December 31, 2013).
  10.31# Form of Restricted Stock Unit Grant Agreement for Employees (Management Bonus Plan) under the Allergan, Inc. 2011 Incentive Award Plan (Amended February 2014) (incorporated by reference to Exhibit 10.42 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2013).
  10.32# Form of Restricted Stock Unit Award Grant Agreement for Employees under the Allergan, Inc. 2011 Incentive Award Plan (Amended February 2015) (incorporated by reference to Exhibit 10.48 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2014).
  10.33# Form of Restricted Stock Unit Award Grant Agreement for Employees (Management Bonus Plan) under the Allergan, Inc. 2011 Incentive Award Plan (Amended February 2015) (incorporated by reference to Exhibit 10.49 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2014).
  10.34# Form of Non-Qualified Stock Option Grant Agreement for Employees under the Allergan, Inc. 2011 Incentive Award Plan (Amended February 2015) (incorporated by reference to Exhibit 10.50 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2014).
  10.35*# Form of Non-Qualified Stock Option Grant Agreement for Employees under the Amended and Restated Allergan, Inc. 2011 Incentive Award Plan (March 2015).
  10.36*# Form of Performance-Based Restricted Stock Unit Award Grant Agreement for Employees under the Amended and Restated Allergan, Inc. 2011 Incentive Award Plan (March 2015).
  10.37*# Form of Restricted Stock Unit Award Grant Agreement for Employees under the Amended and Restated Allergan, Inc. 2011 Incentive Award Plan (March 2015).
  10.38*# Separation Agreement, entered into as of March 21, 2015, by and between David Buchen and Actavis, Inc.
  10.39*# Consulting Agreement, entered into as of March 21, 2015, by and between David Buchen and Actavis plc.
  10.40*# Retention Agreement, entered into as of May 19, 2014 by and between David Buchen and Actavis plc.
  10.41*** 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).
  10.42*** Amendment No. 1 to Botox ®  - Japan License Agreement, dated as of March 9, 2010, among Allergan, Inc., Allergan Sales, LLC, Allergan K.K., Allergan NK, and Glaxo Group Limited (incorporated by reference to Exhibit 10.2 to Allergan, Inc.’s Current Report on Form 8-K filed on March 11, 2010).

 

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  10.43*** License, Transfer, and Development Agreement, dated as of March 31, 2010, among Serenity Pharmaceuticals LLC and Allergan Sales, LLC, Allergan USA, Inc., and Allergan, Inc. (incorporated by reference to Exhibit 10.1 to Allergan, Inc.’s Current Report on Form 8-K filed on April 2, 2010).
  10.44*** License and Collaboration Agreement, dated as of May 3, 2011, among Allergan, Inc., Allergan Sales, LLC, and Molecular Partners AG (incorporated by reference to Exhibit 10.15 to Allergan, Inc.’s Annual Report on Form 10-K for the Fiscal Year ended December 31, 2012).
  10.45*** Agreement and Plan of Merger, dated as of July 18, 2011, among Allergan, Inc., Erythema Acquisition, Inc., Vicept Therapeutics, Inc. and the Shareholders’ Representative (incorporated by reference to Exhibit 2.1 to Allergan, Inc.’s Current Report on Form 8-K filed on July 22, 2011).
  10.46 Settlement Agreement, dated as of August 31, 2010, among Allergan, Inc., Allergan USA, Inc., the United States Department of Justice and the other parties listed therein (incorporated by reference to Exhibit 10.1 to Allergan, Inc.’s Current Report on Form 8-K filed on September 1, 2010).
  10.47 Corporate Integrity Agreement, dated as of August 30, 2010, between Allergan, Inc. and the Office of Inspector General of the Department of Health and Human Services (incorporated by reference to Exhibit 10.2 to Allergan, Inc.’s Current Report on Form 8-K filed on September 1, 2010).
  10.48 Plea Agreement, dated as of October 5, 2010, between Allergan, Inc. and the United States Attorney’s Office for the Northern District of Georgia as counsel for the United States (incorporated by reference to Exhibit 10.70 to Allergan, Inc.’s Current Report on Form 10-Q for the Quarter ended September 30, 2011).
  10.49 Actavis Cash Bridge Loan Credit and Guaranty Agreement, dated as of March 11, 2015, by and among Actavis plc, Warner Chilcott Limited, Actavis Capital S.à r.l., Actavis, Inc., Actavis Funding SCS, the lenders from time to time party thereto, JPMorgan Chase Bank, National Association, as Administrative Agent and the other financial institutions party thereto (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on March 13, 2015).
  10.50 Form of Deed of Indemnification, Actavis plc (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on March 18, 2015).

 

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  10.51 Form of Indemnification Agreement, Actavis W.C. Holding Inc. (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on March 18, 2015).
  10.52* *** Asset Purchase Agreement, by and among Forest Laboratories, LLC, Forest Laboratories Canada Inc., and Forest Laboratories Holdings Limited, as Sellers, Actavis plc and Astrazeneca UK Limited, as Purchaser, dated as of February 4, 2015.
  31.1* Certification of Chief Executive Officer pursuant to Rule 13a-14a of the Securities Exchange Act of 1934.
  31.2* Certification of Chief Financial Officer pursuant to Rule 13a-14a of the Securities Exchange Act of 1934.
  32.1** Certification of Chief Executive Officer pursuant to 18 U.S.C. of Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
  32.2** Certification of Chief Financial Officer pursuant to 18 U.S.C. of the Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS XBRL Instance Document.
101.SCH XBRL Taxonomy Extension Scheme Document.
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF XBRL Taxonomy Extension Label Definition Document.
101.LAB XBRL Taxonomy Extension Label Linkbase Document.
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document.

 

# Indicates a management contract or compensatory plan or arrangement.
* Filed herewith.
** Furnished herewith and not “filed” for purposes of Section 18 of the Exchange Act.
*** Confidential treatment was requested with respect to the omitted portions of this Exhibit, which portions have been filed separately with the U.S. Securities and Exchange Commission and were granted confidential treatment.

 

152

Exhibit 4.20

SECOND SUPPLEMENTAL INDENTURE

THIS SECOND SUPPLEMENTAL INDENTURE, dated as of May 7, 2015 (this “ Second Supplemental Indenture ”), is between Actavis Funding SCS , a limited partnership ( société en commandite simple ) organized under the laws of the Grand Duchy of Luxembourg, having its registered office at 46A, avenue J.F. Kennedy, L-1855 Luxembourg, Grand Duchy of Luxembourg registered with the Luxembourg Register of Commerce and Companies under number B187.310, having a share capital of $20,000 (the “ Company ”) and Wells Fargo Bank, National Association, a national banking association organized under the laws of the United States of America, as trustee (the “ Trustee ”).

W I T N E S S E T H

WHEREAS, the Company has heretofore executed and delivered to the Trustee an Indenture, dated as of March 12, 2015 (the “ Base Indenture ”), providing for the issuance by the Company from time to time of its unsecured debentures, notes, bonds or other evidences of indebtedness (hereinafter called the “Securities”), to be issued in one or more series and to have such other provisions as provided in one or more supplemental indentures;

WHEREAS, the Company has heretofore executed and delivered to the Trustee a first supplemental indenture dated as of March 12, 2015 to the Base Indenture (the “ First Supplemental Indenture ” and, together with the Base Indenture, the “ Indenture ”), providing for the issuance of (i) “Floating Rate Notes due 2016” (the “ 2016 Floating Rate Notes ”), limited initially to $500,000,000 in aggregate principal amount, (ii) “Floating Rate Notes due 2018” (the “ 2018 Floating Rate Notes ”), limited initially to $500,000,000 in aggregate principal amount, (iii) “Floating Rate Notes due 2020” (the “ 2020 Floating Rate Notes ” and, together with the 2016 Floating Rate Notes and the 2018 Floating Rate Notes, the “ Floating Rate Notes ”), limited initially to $500,000,000 in aggregate principal amount, (iv) “1.850% Senior Notes due 2017” (the “ 2017 Notes ”), limited initially to $1,000,000,000 in aggregate principal amount, (v) “2.350% Senior Notes due 2018” (the “ 2018 Notes ”), limited initially to $3,000,000,000 in aggregate principal amount, (vi) “3.000% Senior Notes due 2020” (the “ 2020 Notes ”), limited initially to $3,500,000,000 in aggregate principal amount, (vii) “3.450% Senior Notes due 2022” (the “ 2022 Notes ”), limited initially to $3,000,000,000 in aggregate principal amount, (viii) “3.800% Senior Notes due 2025” (the “ 2025 Notes ”), limited initially to $4,000,000,000 in aggregate principal amount, (ix) “4.550% Senior Notes due 2035” (the “ 2035 Notes ”), limited initially to $2,500,000,000 in aggregate principal amount, and (x) “4.750% Senior Notes due 2045” (the “ 2045 Notes ” and, together with the Floating Rate Notes, the 2017 Notes, the 2018 Notes, the 2020 Notes, the 2022 Notes, the 2025 Notes and the 2035 Notes, the “ Notes ”), limited initially to $2,500,000,000 in aggregate principal amount;

WHEREAS, Section 7.01(g) of the Base Indenture permits the Company and the Trustee, without the consent of any Holder of Securities, to enter into one or more supplemental indentures to conform the text of the Indenture, the Securities of any series or the Security Guarantees to any provision of the “Description of the Actavis Funding SCS Debt Securities” or the “Description of the Notes,” as applicable, in the related prospectus or prospectus supplement for such series to the extent that such provision in the “Description of the Actavis Funding SCS Debt Securities” or the “Description of the Notes,” as applicable, was intended to be a verbatim recitation of a provision of the Indenture or the Securities of such series which intent shall be evidenced by an Officer’s Certificate to that effect;

WHEREAS, the amendments contained herein in this Second Supplemental Indenture conform the text of the Indenture, as modified by the First Supplemental Indenture, to the provisions of the “Description of the Notes” of the prospectus supplement related to the Notes dated March 3, 2015 to the prospectus dated February 19, 2015; and


WHEREAS, pursuant to Section 7.01 of the Base Indenture, the Trustee is authorized to execute and deliver this Second Supplemental Indenture.

NOW, THEREFORE, in consideration of the foregoing and for other good and valuable consideration, the receipt of which is hereby acknowledged, the parties mutually covenant and agree for the equal and ratable benefit of the Holders as follows:

SECTION 1. Capitalized Terms . Capitalized terms used herein without definition shall have the meanings assigned to them in the Indenture and the rules of construction contained in the Base Indenture will apply equally to this Second Supplemental Indenture.

SECTION 2. Amendments to the First Supplemental Indenture.

(a) The following definitions are added to Section 1 of the First Supplemental Indenture in alphabetical order:

(i) “Comparable Treasury Issue” means the United States Treasury security selected by an Independent Investment Banker as having a maturity (actual or interpolated) comparable to the remaining term of the Securities to be redeemed that would be utilized, at the time of selection and in accordance with customary financial practice, in pricing new issues of corporate debt securities of comparable maturity to the remaining term of the Securities to be redeemed.

(ii) “Comparable Treasury Price” means, with respect to any redemption date, (1) the average of the bid and asked prices for the Comparable Treasury Issue, expressed in each case as a percentage of its principal amount, on the third business day preceding such redemption date, as contained in the daily statistical release, or any successor release, published by the Federal Reserve Bank of New York and designated “Composite 3:30 p.m. Quotations for U.S. Government Securities” or (2) if the release, or any successor release, is not published or does not contain these prices on that business day, (a) the average of the Reference Treasury Dealer Quotations for such redemption date, after excluding the highest and lowest of the Reference Treasury Dealer Quotations, or (b) if the Company obtains fewer than three Reference Treasury Dealer Quotations, the average of all of these quotations.

(iii) “Independent Investment Banker” means the Reference Treasury Dealer appointed by the Company.

(iv) “Reference Treasury Dealer” means each of (1) J.P. Morgan Securities LLC and Mizuho Securities USA Inc. and their respective successors and (2) a primary U.S. government securities dealer (a “Primary Treasury Dealer”) selected by Wells Fargo Securities, LLC and its successors, provided that if at any time any of the foregoing is not a Primary Treasury Dealer, the Company will substitute that entity with another nationally recognized investment banking firm that the Company selects that is a Primary Treasury Dealer.

(v) “Reference Treasury Dealer Quotations” means, with respect to each Reference Treasury Dealer and any redemption date, the average, as determined by the Company, of the bid and asked prices for the Comparable Treasury Issue (expressed in each case as a percentage of its principal amount) quoted in writing to the Company by such Reference Treasury Dealer at 3:30 p.m., New York City time, on the third business day preceding such redemption date.


(vi) “Remaining Scheduled Payments” means, with respect to each Security to be redeemed, the remaining scheduled payments of the principal thereof and interest thereon that would be due after the related redemption date for such redemption; provided, however, that, if such redemption date is not an interest payment date with respect to such Security, the amount of the next succeeding scheduled interest payment thereon will be reduced by the amount of interest accrued thereon to such redemption date.

(vii) “Treasury Rate” means, for any redemption date, the rate per annum equal to the semi-annual equivalent yield to maturity, computed as the second business day immediately preceding that redemption date, of the Comparable Treasury Issue, assuming a price for the Comparable Treasury Issue (expressed as a percentage of its principal amount) equal to the Comparable Treasury Price for that redemption date.

SECTION 3. Effect of Second Supplemental Indenture. This Second Supplemental Indenture is a supplemental indenture within the meaning of the Base Indenture. The provisions of this Second Supplemental Indenture are intended to supplement those of the Indenture as in effect immediately prior to the execution and delivery hereof. The Indenture shall remain in full force and effect except to the extent that the provisions of the Indenture are expressly modified by the terms of this Second Supplemental Indenture. The Indenture, as supplemented and amended by this Second Supplemental Indenture, is in all respects ratified, confirmed and approved and, with respect to the Notes, the Indenture, as supplemented and amended by this Second Supplemental Indenture, shall be read, taken and construed as one and the same instrument.

SECTION 4. Governing Law. The internal law of the State of New York shall govern and be used to construe this Second Supplemental Indenture without giving effect to applicable principles of conflicts of law to the extent that the application of the laws of another jurisdiction would be required thereby.

SECTION 5. Trustee’s Disclaimer. The Trustee shall not be responsible in any manner whatsoever for or in respect of the validity or sufficiency of this Second Supplemental Indenture or for or in respect of the recitals contained herein, all of which recitals are made solely by the Company.

SECTION 6. Trust Indenture Act Controls. If any provision hereof limits, qualifies or conflicts with the duties imposed by the Trust Indenture Act § 318(c), the imposed duties shall control.

SECTION 7. Consent to Jurisdiction and Service of Process. Section 14.17 of the Base Indenture (Consent to Jurisdiction and Service of Process) shall apply to this Second Supplemental Indenture.

SECTION 8. Counterpart Originals. The parties may sign any number of copies of this Second Supplemental Indenture. Each signed copy shall be an original, but all of them together represent the same agreement. Delivery of an executed counterpart of a signature page to this Second Supplemental Indenture by telecopier, facsimile or other electronic transmission (i.e. a “pdf” or “tif”) shall be effective as delivery of a manually executed counterpart thereof. The exchange of copies of this Second Supplemental Indenture and of signature pages by facsimile or PDF transmission shall constitute effective execution and delivery of this Second Supplemental Indenture as to the parties hereto and may be used in lieu of the original Second Supplemental Indenture and signature pages for all purposes.

[Signature Page Follows]


IN WITNESS WHEREOF, the parties hereto have caused this Second Supplemental Indenture to be duly executed, as of the date first above written.

 

ACTAVIS FUNDING SCS, as the Company

 

For and on behalf of Actavis International Holding S.à r.l., in its capacity as General Partner of the Company, itself represented by:

By: /s/ Stephen M. Kaufhold
Stephen M. Kaufhold
Title: Class A Manager
By: /s/ Fabrice Rota
Fabrice Rota
Title: Class B Manager

[Signature Page to Second Supplemental Indenture]


IN WITNESS WHEREOF, the parties hereto have caused this Second Supplemental Indenture to be duly executed, as of the date first above written.

 

WELLS FARGO BANK, NATIONAL ASSOCIATION, as Trustee
By: /s/ John C. Stohlmann
Name: John C. Stohlmann
Title: Vice President

[Signature Page to Second Supplemental Indenture]

Exhibit 10.35

 

LOGO

I NSTRUCTIONS

Stock Options

A Long Term Incentive Award

(The Agreement begins after this page)

You will be deemed to have accepted this Stock Option award and agreed to be bound by the terms and conditions of the Notice of Grant, the Restricted Stock Unit Agreement and the Plan (as defined in such Notice) unless you inform the Company in writing that you wish to decline the Restricted Stock Unit award.

To decline the Stock Option Award, please send written notice of your decision to decline this Stock Option award to the Stock Plan Administrator as follows:

 

    via e-email

 

    tara.alford@actavis.com

 

    via inter-office mail

 

    Stock Plan Administrator, Morris Corporate Center III, Building A, Third Floor

 

    or via regular mail to

Actavis plc

Attn: Stock Plan Administrator

400 Interpace Parkway

Morris Corporate Center III

Parsippany, NJ 07054

In order to be effective, your written notice to decline Stock Option Award must be received by the Stock Plan Administrator prior to the date that is 30 days immediately following the Date of Grant set forth on the Notice of Grant. The company, including its stock plan administration, will not be responsible for any delivery delay of your notice for any reason.

If you do not decline this Stock Option award within 30 days immediately following the Date of Grant, you will be deemed to have accepted this Stock Option award. Should you choose to decline this grant; the grant will be updated to reflect your decision.


NOTICE OF GRANT

Congratulations, you (“Holder”) have been granted an option to purchase Common Stock of Actavis plc, a public limited company organized under the laws of Ireland (the “Company”), as successor to Actavis, Inc. The Option is subject to the terms and conditions of the Award Agreement and The Amended and Restated Allergan, Inc. 2011 Incentive Award Plan, as amended from time to time (the “Plan”), which are attached hereto as Exhibit 1-A and 1-B, and of which this Notice of Grant is a part. By accepting (or being deemed to have accepted) the Option award, you represent and warrant to the Company that you have read the Award Agreement (including, the case of Holders residing outside the United States (“Foreign Holders”), the Foreign Country Appendix) and the Plan and agree to be bound by their terms. Capitalized terms not otherwise defined in this Notice of Grant shall be as defined in the Plan and the Award Agreement.

Subject to the terms of the Award Agreement and the Plan, the terms of this Option are set forth below:

Type of Option: NONQUALIFIED STOCK OPTION

 

Holder’s Name:    Total Number of Option Shares:
Date of Grant:    Purchase Price Per Share:

Subject to the terms of the Award Agreement (including, in the case of Foreign Holders, the Foreign Country Appendix) and the Plan, this Option shall become exercisable in accordance with the following schedule:

 

On and After This Date

   This Option Shall be Exercisable With Respect to
the Following Number of Shares in Each Period
Becoming Fully Vested on the Date Shown.
 

Total Shares:

     [                    


EXHIBIT 1-A

AWARD AGREEMENT

THIS AWARD AGREEMENT (the “Agreement”), dated as of the Date of Grant appearing on the Notice of Grant hereof, is made by and between Actavis plc, a public limited company organized under the laws of Ireland (the “Company”), as successor to Allergan, Inc., and the Employee whose name and signature appear on the Notice of Grant hereof (“Holder”).

WHEREAS, the Company wishes to grant Holder an option (the “Option”) to purchase ordinary shares of the Company, par value $0.0001 per share (the “Common Stock”), pursuant to the terms of the Notice of Grant, this Agreement (including, in the case of Foreign Holders, the Foreign Country Appendix) and the Amended and Restated Allergan, Inc. 2011 Incentive Award Plan (the terms of which are hereby incorporated by reference and made a part of this Agreement, the “Plan”); and

WHEREAS, it has been determined that it would be to the advantage and best interest of the Company and its shareholders to grant Holder the Option as an inducement to enter into or remain in the service of the Company or its Subsidiaries and as an incentive for increased efforts during such service.

NOW, THEREFORE, in consideration of the mutual covenants herein contained and other good and valuable consideration, receipt of which is hereby acknowledged, the parties hereto do hereby agree as follows:

ARTICLE I

GRANT OF OPTION

Section 1.1 Grant of Option and Purchase Price . The Company grants to Holder the option to purchase any part or all of an aggregate of that many shares of Common Stock as set forth on the Notice of Grant hereto, upon the terms and conditions set forth in this Agreement (including, in the case of Foreign Holders, the Foreign Country Appendix). The per share purchase price of the shares of Common Stock covered by the Option shall be as set forth on the Notice of Grant hereto, without commission or other charge.

Section 1.2 Consideration to Company . In consideration of the granting of this Option by the Company, Holder agrees to render faithful and efficient services to the Company or a Subsidiary, with such duties and responsibilities as the Company shall from time to time prescribe, for a period of at least one (1) year from the date this Option is granted. Nothing in this Agreement or in the Plan shall confer upon Holder any right to continue in the employ or engagement of the Company or any Subsidiary, or shall interfere with or restrict in any way the rights of the Company and its Subsidiaries, which are hereby expressly reserved, to discharge or terminate the engagement with Holder at any time for any reason whatsoever, with or without Cause.

ARTICLE II

PERIOD OF EXERCISABILITY

Section 2.1 Exercisability . Subject to Section 2.2, Section 2.4, Section 4.5 and the terms of any written agreement between the Company and Holder relating to the exercisability of the Option, the Option shall become exercisable as set forth in the Notice of Grant hereto. No portion of the Option which is unexercisable at Termination of Service shall thereafter become exercisable. Each such installment which becomes exercisable pursuant to this Section 2.1 or Section 2.4 shall remain exercisable until it becomes unexercisable under Section 6.5 of the Plan.


Section 2.2 Expiration of Option . (a) Subject to subsection (b), the Option may not be exercised to any extent by anyone after the first to occur of the following events:

(i) The expiration of ten (10) years from the date the Option was granted;

(ii) Except in the case of Holder’s Disability or as set forth in Sections 2.2(a)(iv) and (v), the expiration of three (3) months from the date of Holder’s Termination of Service, unless Holder dies within said three month period;

(iii) In the case of Holder’s Disability, the expiration of one (1) year from the date of Holder’s Termination of Service by reason of Holder’s Disability;

(iv) The expiration of one (1) year from the date of Holder’s death;

(v) Upon Holder’s Termination of Service, by the Company or a Subsidiary of the Company for Cause, at the discretion of the Administrator effective upon written notice to Holder; or

(vi) Notwithstanding (ii), above, the expiration of three (3) years from the date of Holder’s Termination of Service by the Company or a Subsidiary of the Company other than for Cause or by the Holder for Good Reason, provided in each case that such Termination of Service occurs within twenty-four (24) months following a Change in Control of the Company.

(b) If, upon Holder’s Termination of Service, Holder has completed five or more years of continuous service with the Company or a Subsidiary, subsection (a) shall not apply, and the Option may not be exercised to any extent by anyone after the first to occur of the following events:

(i) The expiration of ten (10) years from the date the Option was granted; or

(ii) The expiration of two (2) years from the date of Holder’s Termination of Service.

(c) For purposes of this Section 2.2, “Termination of Service” has the definition contained in the Plan; provided, however, that upon the mutual written agreement of the Company and the Holder, Holder’s cessation of employment shall not be considered a Termination of Service if Holder continues to hold the position of a member of the Board as of the employment termination date, or becomes a member of the Board as of the employment termination date. Any reference to a Termination of Service shall thereinafter be the date upon which Holder ceases to be a member of the Board.

Section 2.3 Special Tax Consequences . Holder acknowledges that, to the extent that the aggregate Fair Market Value of stock with respect to which “incentive stock options” (within the meaning of Section 422 of the Code, but without regard to Section 422(d) of the Code), including the Option, are exercisable for the first time by Holder during any calendar year under the Plan and all other incentive stock option plans of the Company, any Subsidiary and any parent corporation thereof (within the meaning of Section 422 of the Code)) exceeds $100,000, such options shall not be treated as “incentive stock options” to the extent required by Section 422 of the Code. Holder further acknowledges that the rule set forth in the preceding sentence shall be applied by taking options into account in the order in which they were granted. For purposes of these rules, the Fair Market Value of stock shall be determined as of the time the option with respect to such stock is granted.


Section 2.4 Change in Control . Notwithstanding any provision to the contrary, in the event of a Change in Control, each outstanding Option shall remain outstanding, be assumed, or a Substitute Award shall be substituted by the successor corporation, or a parent or Subsidiary of the successor corporation. If the Option continues to be outstanding following the effective date of the Change in Control, then the Option shall continue to vest pursuant to the terms contained in the attached Notice of Grant, provided that in the event of a Qualified Termination of the Holder’s employment by the Company, a Subsidiary or the successor corporation during the two (2) year period following the Change in Control, any unvested Options will immediately become vested and exercisable to the extent permitted by law.

ARTICLE III

EXERCISE OF OPTION

Section 3.1 Person Eligible to Exercise . During the lifetime of Holder, only Holder may exercise the Option or any portion thereof. After the death of Holder, any exercisable portion of the Option may, prior to the time when the Option becomes unexercisable under Section 6.5 of the Plan, be exercised by Holder’s personal representative or by any person empowered to do so under the deceased Holder’s will or under the then applicable laws of descent and distribution.

Section 3.2 Partial Exercise . Any exercisable portion of the Option or the entire Option, if then wholly exercisable, may be exercised in whole or in part as to whole shares only at any time prior to the time when the Option or portion thereof becomes unexercisable under Section 6.5 of the Plan.

Section 3.3 Manner of Exercise . The Option, or any exercisable portion thereof, may be exercised solely by delivery to the stock administrator of the Company, or such other person or entity designated by the Administrator, or his, her or its office, as applicable, of all of the following prior to the time when the Option or such portion becomes unexercisable under Section 6.5 of the Plan:

(a) A written or electronic notice complying with the applicable rules established by the Administrator stating that the Option, or a portion thereof, is exercised. The notice shall be signed by Holder or other person then entitled to exercise the Option or such portion; and

(b) (i) Full cash payment to the stock administrator of the Company for the shares with respect to which such Option or portion is exercised;

(ii) With the consent of the Administrator (which consent may be withheld in its sole and absolute discretion), (A) shares of the Company’s Common Stock owned by Holder, duly endorsed for transfer to the Company, with a Fair Market Value on the date of delivery equal to the aggregate exercise price of the Option or exercised portion thereof, or (B) shares of the Company’s Common Stock issuable to Holder upon exercise of the Option, with a Fair Market Value on the date of delivery equal to the aggregate exercise price of the Option or exercised portion thereof;

(iii) With the consent of the Administrator (which consent may be withheld in its sole and absolute discretion), a notice that Holder has placed a market sell order with a broker with respect to shares of the Company’s Common Stock then issuable upon exercise of the Option, and that the broker has been directed to pay a sufficient portion of the net proceeds of the sale to the Company in satisfaction of the Option exercise price; or

(iv) With the consent of the Administrator (which consent may be withheld in its sole and absolute discretion), any combination of the consideration provided in the foregoing subparagraphs (i), (ii) and (iii); and


(c) Full payment to the Company (or other employer corporation) of all amounts which, under federal, state or local tax law, it is required to withhold upon exercise of the Option. With the consent of the Administrator (which consent may be withheld in its sole and absolute discretion), all or part of such payment may be made in the form of (i) shares of the Company’s Common Stock owned by Holder, duly endorsed for transfer, with a Fair Market Value equal to the sums required to be withheld, or (ii) shares of the Company’s Common Stock issuable to Holder upon exercise of the Option with a Fair Market Value equal to the sums required to be withheld; provided , that the number of shares of Common Stock which may be withheld with respect to the issuance, vesting, exercise or payment of the Option (or which may be repurchased from Holder within six months after such shares of Common Stock were acquired by Holder from the Company) in order to satisfy Holder’s federal and state income and payroll tax liabilities with respect to the issuance, vesting, exercise or payment of the Option shall be limited to the number of shares which have a Fair Market Value on the date of withholding or repurchase equal to the aggregate amount of such liabilities based on the minimum statutory withholding rates for federal and state tax income and payroll tax purposes that are applicable to such supplemental taxable income; and

(d) In the event the Option or portion shall be exercised pursuant to Section 3.1 by any person or persons other than Holder, appropriate proof of the right of such person or persons to exercise the Option.

Section 3.4 Conditions to Issuance of Stock Certificates . The shares of stock deliverable upon the exercise of the Option, or any portion thereof, may be either previously authorized but unissued shares or, to the extent applicable to the Company, issued shares which have then been reacquired by the Company and are held as treasury shares available for re-issue. Such shares shall be fully paid and nonassessable. The Company shall not be required to issue or deliver any certificate or certificates for shares of stock purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of the following conditions:

(a) The admission of such shares to listing on all stock exchanges on which such class of stock is then listed; and

(b) The completion of any registration or other qualification of such shares under any state or federal law or under rulings or regulations of the Securities and Exchange Commission or of any other governmental regulatory body, which the Administrator shall, in its absolute discretion, deem necessary or advisable; and

(c) The obtaining of any approval or other clearance from any state or federal governmental agency which the Administrator shall, in its absolute discretion, determine to be necessary or advisable; and

(d) The lapse of such reasonable period of time following the exercise of the Option as the Administrator may from time to time establish for reasons of administrative convenience; and

(e) The receipt by the Company of full payment for such shares, including payment of all amounts which, under federal, state or local tax law, the Company (or other employer corporation) is required to withhold upon exercise of the Option.

Section 3.5 Rights as Shareholder . Holder shall not be, nor have any of the rights or privileges of, a shareholder of the Company in respect of any shares purchasable upon the exercise of any part of the Option unless and until certificates representing such shares have been issued by the Company to Holder.


ARTICLE IV

OTHER PROVISIONS

Section 4.1 Administration . The Administrator shall have the power to interpret the Plan and this Agreement, and to adopt such rules for the administration, interpretation and application of the Plan as are consistent therewith, to interpret, amend or revoke any such rules and to amend this Agreement provided that the rights or obligations of Holder are not affected adversely. All actions taken and all interpretations and determinations made by the Administrator in good faith shall be final and binding upon Holder, the Company and all other interested persons. No member of the Administrator shall be personally liable for any action, determination or interpretation made in good faith with respect to the Plan or the Option.

Section 4.2 Option Not Transferable . Neither the Option nor any interest or right therein or part thereof shall be sold, pledged, assigned or transferred in any manner other than by will or the laws of descent and distribution or, subject to the consent of the Administrator, pursuant to a DRO, unless and until the shares underlying such Option have been issued. Neither the Option nor any interest or right therein or part thereof shall be liable for the debts, contracts or engagements of Holder or his successors in interest or shall be subject to disposition by transfer, alienation, anticipation, pledge, encumbrance, assignment or any other means whether such disposition be voluntary or involuntary or by operation of law by judgment, levy, attachment, garnishment or any other legal or equitable proceedings (including bankruptcy), and any attempted disposition thereof shall be null and void and of no effect, except to the extent that such disposition is permitted by the preceding sentence.

During the lifetime of Holder, only he may exercise an Option (or any portion thereof) granted to him under the Plan, unless it has been disposed of with the consent of the Administrator pursuant to a DRO. After the death of Holder, any exercisable portion of an Option may, prior to the time when such portion becomes unexercisable under the Plan or this Agreement, be exercised by his personal representative or by any person empowered to do so under the deceased Holder’s will or under the then applicable laws of descent and distribution.

Section 4.3 Notices . Any notice to be given under the terms of this Agreement to the Company shall be addressed to the Company, and any notice to be given to Holder shall be addressed to him at the address given beneath his signature hereto. By a notice given pursuant to this Section 4.3, either party may hereafter designate a different address for notices to be given to him. Any notice which is required to be given to Holder shall, if Holder is then deceased, be given to Holder’s personal representative if such representative has previously informed the Company of his status and address by written notice under this Section 4.3. Any notice shall be deemed duly given when enclosed in a properly sealed envelope or wrapper addressed as aforesaid, deposited (with postage prepaid) in a post office or branch post office regularly maintained by the United States Postal Service.

Section 4.4 Titles and Construction . Titles are provided herein for convenience only and are not to serve as a basis for interpretation or construction of this Agreement. This Agreement shall be administered, interpreted and enforced under the internal laws of the State of Delaware, without regard to conflicts of laws thereof.

Section 4.5 Conformity to Securities Laws . Holder acknowledges that the Plan is intended to conform to the extent necessary with all provisions of the Securities Act and the Exchange Act and any and all regulations and rules promulgated by the Securities and Exchange Commission thereunder, including without limitation Rule 16b-3. Notwithstanding anything herein to the contrary, the Plan shall be administered, and the Option is granted and may be exercised, only in such a manner as to conform to such laws, rules and regulations. To the extent permitted by applicable law, the Plan and this Agreement shall be deemed amended to the extent necessary to conform to such laws, rules and regulations.


Section 4.6 Foreign Country Appendix . In the case of Foreign Holders, notwithstanding any provisions in this Award Agreement, the Option award shall be subject to any special terms and conditions set forth in the Foreign Country Appendix to this Award Agreement for Holder’s country of residence. Moreover, if Holder relocates to one of the countries included in the Foreign Country Appendix, the special terms and conditions for such country will apply to Holder, to the extent the Company determines that the application of such terms and conditions is necessary or advisable in order to comply with local law or facilitate the administration of the Plan. The Foreign Country Appendix constitutes part of this Award Agreement.

Section 4.7 Authorization to Release Necessary Personal Information .

(a) In the case of Foreign Holders, Holder hereby authorizes and directs Holder’s employer or the entity to which Holder provides services to collect, use and transfer in electronic or other form, any personal information (the “Data”) regarding Holder’s employment or services, the nature and amount of Holder’s compensation and the fact and conditions of Holder’s participation in the Plan (including, but not limited to, Holder’s name, home address, telephone number, date of birth, social security number (or other applicable social or national identification number), salary, nationality, job title, number of shares of Common Stock held and the details of all Options or any other entitlement to shares of Common Stock awarded, cancelled, exercised, vested, unvested or outstanding) for the purpose of implementing, administering and managing Holder’s participation in the Plan. Holder understands that the Data may be transferred to the Company or any of its Subsidiaries, or to any third parties assisting in the implementation, administration and management of the Plan, including any requisite transfer to a broker or other third party assisting with the grant of Options under the Plan or with whom shares of Common Stock or cash acquired upon sale of the shares of Common Stock may be deposited. Holder acknowledges that recipients of the Data may be located in different countries, and those countries may have data privacy laws and protections different from those in the country of Holder’s residence. Furthermore, Holder acknowledges and understands that the transfer of the Data to the Company or any of its Subsidiaries, or to any third parties, is necessary for Holder’s participation in the Plan.

(b) Holder may at any time withdraw the consents herein, by contacting Holder’s local human resources representative in writing. Holder further acknowledges that withdrawal of consent may affect Holder’s ability to realize benefits from the Options, and Holder’s ability to participate in the Plan.

ARTICLE V

DEFINITIONS

Whenever the following terms are used in this Agreement, they shall have the meaning specified below. The masculine pronoun shall include the feminine and neuter, and the singular the plural, where the context so indicates. All capitalized terms used herein without definition shall have the meanings ascribed to such terms in the Plan.

“Cause” shall mean (i) “Cause”, as defined in the employment agreement, if any, between the Company or a Subsidiary of the Company and Holder, as in effect from time to time, or (ii) in the absence of such an employment agreement or definition, as determined by the Administrator in its sole discretion, (A) Holder’s conviction of, or no contest plea to, a felony or a misdemeanor involving moral turpitude or the equivalent conviction in any other jurisdiction, or (B) Holder’s gross negligence or misconduct, or material violation of the Company’s policies (including without limitation the Company’s policy on insider trading), or a material breach of Holder’s duties or loyalty to the Company, or (C) Holder’s fraud, embezzlement or criminal conduct that is damaging to the Company, or (D) Holder’s willful or continued failure to substantially perform his or her duties to the Company.


COUNTRY APPENDIX

TO EXHIBIT 1-A

ADDITIONAL TERMS AND CONDITIONS

Capitalized terms, unless explicitly defined in this Country Appendix, shall have the meanings given to them in the Agreement or in the Plan.

Terms and Conditions

This Country Appendix includes special terms and conditions that govern the Option if Holder resides and/or works in one of the countries listed below. If Holder is a citizen or resident (or is considered as such for local law purposes) of a country other than the country in which Holder is currently residing and/or working, or if Holder transfers to another country after receiving the Option, the Company shall, in its discretion, determine to what extent the special terms and conditions contained herein shall be applicable to Holder.

Notifications

This Country Appendix also includes information regarding securities, exchange control, tax and certain other issues of which Holder should be aware with respect to Holder’s participation in the Plan. The information is based on the securities, exchange control, tax and other laws in effect in the respective countries as of April 2015. Such laws are often complex and change frequently. As a result, the Company strongly recommends that Holder not rely on the information contained herein as the only source of information relating to the consequences of Holder’s participation in the Plan because the information may be out of date at the time Holder exercises the Option or at the time Holder sells any shares of Common Stock acquired under the Plan. In addition, the information is general in nature and may not apply to Holder’s particular situation, and the Company is not in a position to assure Holder of any particular result. Therefore, Holder is advised to seek appropriate professional advice as to how the relevant laws in Holder’s country may apply to Holder’s individual situation.

If Holder is a citizen or resident (or is considered as such for local tax purposes) of a country other than the country in which Holder is currently residing and/or working, or if Holder transfers to another country after the grant of the Option, the information contained herein may not be applicable to Holder in the same manner.


AUSTRALIA

Terms and Conditions

Exercisability . The following provision supplements Section 2.1 of the Agreement:

Notwithstanding any provision of the Plan, the Notice of Grant and this Agreement, Holder will not be permitted to exercise the portion of the Option that vested on such date unless, as of such date, the Fair Market Value of stock underlying the Option exceeds the exercise price per share for the Option (i) as of such vesting date, and (ii) for the ten (10) consecutive U.S. trading days immediately preceding such vesting date. In the event that any vested portion of the Option is not exercisable on the vesting date as a result of the immediately preceding sentence, then the Option will not be exercisable until such date that is the first U.S. trading day following the first period of ten (10) consecutive U.S. trading days on which the Fair Market Value per share underlying the Option has exceeded the exercise price per share for the Option.

Expiration of Options . The following provision replaces Section 2.2(a)(i) of the Agreement:

The expiration of six (6) years and eleven (11) months from the Date of Grant.

Notifications

Securities Law Information . If Holder acquires shares of Common Stock under the Plan and offers such shares for sale to a person or entity resident in Australia, the offer may be subject to disclosure requirements under Australian law. Holder is advised to obtain legal advice regarding the disclosure obligations prior to making any such offer.

Exchange Control Information . Exchange control reporting is required for cash transactions exceeding AUD10,000 and for international fund transfers. If an Australian bank is assisting with the transaction, the bank will file the report on behalf of Holder.

BULGARIA

Notifications

Exchange Control Information . If Holder exercises the Option through a cash purchase exercise, in order to remit funds out of Bulgaria, he will need to declare the purpose of the remittance to the local bank that is transferring the funds abroad. If the amount Holder wishes to transfer exceeds BGN100,000, he will need to complete a standard form statistical declaration and provide it to the bank involved in the money transfer. Holder should check with his local bank on the requirements for the information or documents that have to be provided.

If Holder exercises the Option by way of a cashless exercise market sell order with a broker with respect to shares of the Company’s Common Stock then issuable upon exercise of the Option, the declaration described in the proceding paragraph will not be required because no funds will be remitted out of Bulgaria.


CANADA

Terms and Conditions

Matter of Exercise . Notwithstanding any provision in this Agreement to the contrary and Section 6.2(d)(ii) of the Plan, under no circumstances shall Holder be permitted to exercise the Option by way of a net exercise whereby shares of the Company’s Common Stock are held back to cover the exercise price and/or Tax-Related Items withholding.

In addition, notwithstanding any provision in this Agreement to the contrary and Section 6.2(d)(i) of the Plan, under no circumstances shall Holder be permitted to pay the exercise price for the Option with shares of Common Stock previously acquired by Holder. Furthermore, Holder undertakes not to use the shares acquired upon exercise of the Option to pay the exercise price for any options that may be granted to Holder in the future.

Expiration of Option . The following provision replaces Section 2.2(c)(i) of the Agreement:

(i) Holder’s employer-employee relationship will be considered Terminated as of the date that is the earlier of: (1) the date of Termination of Employment, (2) the date Holder receives notice of termination from the Employer, or (3) the date Holder is no longer actively providing services regardless of any notice period or period of pay in lieu of such notice required under applicable law (including, but not limited to statutory law, regulatory law and/or common law) and whether or not later to be found invalid or in breach of labor laws in the jurisdiction where Holder is employed or the terms of Holder’s employment or service agreement, if any);

The following provisions will apply to Holder if he is a resident of Quebec:

Language Consent . The parties acknowledge that it is their express wish that the Agreement, as well as all addenda, documents, notices, and legal proceedings entered into, given or instituted pursuant hereto or relating directly or indirectly hereto, be drawn up in English.

Les parties reconnaissent avoir exigé la rédaction en anglais de cette Convention, ainsi que de tous documents exécutés, avis donnés et procédures judiciaries intentées, directement ou indirectement, relativement à ou suite à la présente convention.

Data Privacy . The following provision supplements Section 4.8 of the Agreement:

Holder hereby authorizes the Company and the Company’s representatives to discuss and obtain all relevant information from all personnel, professional or non-professional, involved in the administration of the Plan. Holder further authorizes the Company, the Employer, its other Subsidiaries and the Administrator to disclose and discuss the Plan with their advisors. Holder further authorizes the Company, the Employer and any other Subsidiary of the Company to record such information and to keep such information in Holder’s employee file.

Notifications

Securities Law Information . Holder acknowledges that he is permitted to sell shares of Common Stock acquired under the Plan through the designated broker appointed under the Plan, if any, provided the sale of the shares acquired under the Plan takes place outside of Canada through the facilities of a stock exchange on which the shares of Common Stock are listed ( i.e. , the New York Stock Exchange).


Foreign Asset/Account Reporting Information . Canadian residents are required to report to the tax authorities any foreign property held outside of Canada (including options, shares) on form T1135 (Foreign Income Verification Statement) if the total cost of such foreign property exceeds C$100,000 at any time during the calendar year. Unvested Option also must be reported (generally at nil cost) on Form 1135 if the C$100,000 threshold is exceeded due to other foreign property held by Holder. The Form T1135 must be filed at the same time Holder files his annual tax return. Holder should consult his personal legal advisor to ensure compliance with applicable reporting obligations.

FRANCE

Terms and Conditions

Language . By accepting the Agreement providing for the terms and conditions of the Option grant, Holder confirms having read and understood the documents relating to the Option and the Plan which were provided in English language. Holder accepts the terms of those documents accordingly.

En acceptant le Contrat décrivant les termes et conditions de l’attribution d’Option, le Détenteur confirme avoir lu et compris les documents relatifs à cette attribution à l’Option et au Plan qui ont été communiqués en langue anglaise. Le Détenteur accepte les termes de ces documents en connaissance de cause.

Notifications

Foreign Asset/Account Reporting Information . If Holder holds shares of Common Stock outside France or maintain a foreign bank account, Holder is required to report such to the French tax authorities on his annual tax return.

ICELAND

Terms and Conditions

Manner of Exercise . The following provision supplements Section 3.3(b) of the Agreement:

Notwithstanding anything to the contrary in the Agreement, due to legal restrictions in Iceland, Holder will be required to pay the exercise price and par value (if applicable) for any shares of Common Stock subject to the Option by a cashless exercise market sell-all order with a broker with respect to shares of the Company’s Common Stock then issuable upon exercise of the Option, such that all shares will be sold immediately upon exercise and the cash proceeds of sale, less the exercise price and par value (if applicable), any Tax-Related Items and broker’s fees or commissions, will be remitted to Holder. The Company reserves the right to provide additional methods of exercise depending on local developments.

Notifications

Exchange Control Information . Holder should consult with his personal advisor to ensure compliance with applicable exchange control regulations in Iceland as such regulations are subject to frequent change. Holder is responsible for ensuring compliance with all exchange control laws in Iceland.


INDIA

Terms and Conditions

Manner of Exercise . The following provision supplements Section 3.3(b) of the Agreement:

Notwithstanding anything to the contrary in the Agreement, due to legal restrictions in India, Holder will not be permitted to pay the exercise price or par value (if applicable) through any form of payment whereby some, but not all, of the shares of Common Stock purchased upon exercise of the Option are sold to pay the exercise price. However, Holder will be permitted to pay the exercise price and par value (if applicable) through any other form of payment set forth in the Agreement. The Company reserves the right to provide additional methods of exercise depending on local developments.

Notifications

Exchange Control Information . Holder who are Indian residents are required to repatriate to India any proceeds from the sale of shares acquired under the Plan within ninety (90) days of receipt and any dividends within one hundred and eighty (180) days of payment. Holder subject to these repatriation obligations should obtain a foreign inward remittance certificate (“FIRC”) or other similar form from the bank where Holder deposits the funds and should maintains the FIRC or other form as evidence of the repatriation of funds in the event the Reserve Bank of India or Holder’s employer requests proof of repatriation.

Foreign Asset/Account Reporting Information . Any foreign bank accounts and any foreign financial assets (including shares of Common Stock held outside India) should be reported by Holder on his annual tax return. Holder is solely responsible for complying with this reporting obligation and should speak to his personal tax advisor to the extent he has questions in this regard.

MALTA

Terms and Conditions

Securities Law Warning . Holder acknowledges, understands and agrees that the Option, the Agreement, the Plan and all other materials Holder may receive regarding his participation in the Plan do not constitute advertising or an offering of securities in Malta and are deemed accepted by Holder only upon receipt of Holder’s electronic or written acceptance in the United States. The issuance of the shares of Common Stock under the Plan has not and will not be registered in Malta and, therefore, the shares of Common Stock described in any Plan documents may not be offered or placed in public circulation in Malta.

Holder further acknowledges, understands and agrees that in no event will shares of Common Stock acquired upon exercise of the Option be delivered to Holder in Malta; all shares of Common Stock acquired upon exercise of the Option will be maintained on Holder’s behalf in the United States.

SWEDEN

There are no country-specific provisions.

SWITZERLAND

Notifications

Securities Law Information . The grant of the Option is considered a private offering in Switzerland and is, therefore, not subject to registration in Switzerland.


UNITED KINGDOM

Terms and Conditions

Responsibility for Taxes . The following provision supplements Section 3.7 of the Agreement:

Holder agrees that if payment or withholding of income tax due is not made within ninety (90) days of the end of the U.K. tax year in which the taxable event occurred or such other period specified in Section 222(1)(c) of the U.K. Income Tax (Earnings and Pensions) Act 2003 (the “Due Date”), then the amount of any uncollected income tax shall constitute a loan owed by Holder to the Employer, effective on the Due Date. Holder agrees that the loan will bear interest at the then-current Official Rate of Her Majesty’s Revenue and Customs (“HMRC”) and will be immediately due and repayable by Holder, and the Company and/or the Employer may recover it at any time thereafter by any of the means referred to in Section 3.7 of the Agreement. Notwithstanding the foregoing, if Holder is an executive officer or director of the Company (within the meaning of Section 13(k) of the Exchange Act), Holder shall not be eligible for a loan from the Company to cover the income tax due. In the event that Holder is an executive officer or director and income tax is not collected from or paid by Holder by the Due Date, the amount of any uncollected income tax may constitute a benefit to Holder on which additional income tax and National Insurance contributions (“NICs”) may be payable. Holder understands that he will be responsible for reporting and paying any income tax due on this additional benefit directly to HMRC under the self-assessment regime and for reimbursing the Company and/or the Employer (as appropriate) for the value of employee NICs due on this additional benefit which the Company and/or the Employer may recover from Holder by any of the means set forth in Section 3.7 of the Agreement.

Joint Election . As a condition of participation in the Plan and the exercise of the Option, the Holder agrees to accept any liability for secondary Class 1 NICs that may be payable by the Company or the Employer in connection with the Option and any event giving rise to Tax-Related Items (the “Employer NICs”). The Employer NICs may be collected by the Company or the Employer using any of the methods described in the Plan or the Agreement for Tax-Related Items withholding.

Without prejudice to the foregoing, the Optionee agrees to execute a joint election with the Company and/or the Employer (a “Joint Election”), the form of such Joint Election being formally approved by HMRC, and any other consent or elections required to accomplish the transfer of the Employer NICs liability to the Optionee. The Optionee further agrees to execute such other elections as may be required by any successor to the Company and/or the Employer for the purpose of continuing the effectiveness of the Optionee’s Joint Election.

UNITED STATES

Notifications

Foreign Asset/Account Reporting Information . The Foreign Account Tax Compliance Act (“FATCA”) pertains to U.S. taxpayers who participate in or hold equity-based awards in one or more equity compensation plans offered by the Company, including the Option. Under FATCA, the Company is considered a “non-U.S. issuer” with the result that Holder may have reporting obligations on Form 8938 when filing his annual income tax return (Form 1040). Information regarding Form 8938 is available at
www.irs.gov/pub/irs-pdf/i8938.pdf .


These reporting obligations apply to the extent the aggregate value of Holder’s holdings (when aggregated with other specified foreign financial assets held by Holder) exceed certain thresholds. The threshold amounts of the value of the equity holdings (and other foreign assets) that trigger the reporting obligations depend on Holder’s filing status ( e.g. , unmarried/married filing separately) and whether Holder resides in the U.S. or outside of the U.S. Shares of Common Stock issued by a non-U.S. issuer that are held in a financial account maintained by a U.S. financial institution (such as a brokerage firm) are not subject to these reporting requirements. However, it is not clear under current guidance whether rights to acquire shares of Common Stock, such as the Option ( i.e. , as opposed to shares of Common Stock Holder owns), are eligible for this exception. Holder should consult his personal tax advisor to determine whether these FATCA reporting requirements apply to him as a result of his equity holdings in the Company, including the Option or shares of Common Stock Holder acquires under the Plan.

Exhibit 10.36

 

LOGO

I NSTRUCTIONS

Restricted Stock Units

A Long Term Incentive Award

(The Agreement begins after this page)

You will be deemed to have accepted this Restricted Stock Unit award and agreed to be bound by the terms and conditions of the Notice of Grant, the Restricted Stock Unit Agreement and the Plan (as defined in such Notice) unless you inform the Company in writing that you wish to decline the Restricted Stock Unit award.

To decline the Restricted Stock Unit Award, please send written notice of your decision to decline this Restricted Stock Unit award to the Stock Plan Administrator as follows:

 

    via e-email

 

    tara.alford@actavis.com

 

    via inter-office mail

 

    Stock Plan Administrator, Morris Corporate Center III, Building A, Third Floor

 

    or via regular mail to

Actavis plc

Attn: Stock Plan Administrator

Morris Corporate Center III

Building A

400 Interpace Parkway

Parsippany, NJ 07054

In order to be effective, your written notice to decline the Restricted Stock Unit Award must be received by the Stock Plan Administrator prior to the date that is 30 days immediately following the Date of Grant set forth on the Notice of Grant. The company, including its stock plan administration, will not be responsible for any delivery delay of your notice for any reason.


If you do not decline this Restricted Stock Unit award within 30 days immediately following the Date of Grant, you will be deemed to have accepted this Restricted Stock Unit award. Should you choose to decline this grant; the grant will be updated to reflect your decision.

NOTICE OF GRANT

Congratulations, you (“Holder”) have been granted an award of restricted stock units (the “Restricted Stock Units” or “RSUs”). Each Restricted Stock Unit represents the right to receive one share of Common Stock of Actavis plc, a public limited company organized under the laws of Ireland (the “Company”), as successor to Actavis, Inc., or in certain jurisdictions, the cash equivalent thereof. The Restricted Stock Unit award is subject to the terms and conditions of the Award Agreement and The Amended and Restated Allergan, Inc. 2011 Incentive Award Plan, as amended from time to time (the “Plan”), which are attached hereto as Exhibits 1-A and 1-B, respectively, and of which this Notice of Grant is a part. By accepting (or being deemed to have accepted) the Restricted Stock Unit award (including, in the case of Holders residing outside the United States (“Foreign Holders”), the Foreign Country Appendix), you represent and warrant to the Company that you have read the Award Agreement (including, in the case of Foreign Holders, the Foreign Country Appendix) and the Plan and agree to be bound by their terms and conditions. Capitalized terms not otherwise defined in this Notice of Grant shall be as defined in the Plan and the Award Agreement.

Subject to the terms and conditions of the Award Agreement (including, in the case of Foreign Holders, the Foreign Country Appendix) and the Plan, the terms and conditions of this Restricted Stock Unit award are set forth below:

 

Holder’s Name:

Target Number of RSUs

Granted (the “Three-Year

Performance Vesting RSUs” or

“RSUs”):

 

Date of Grant:

Award Type and Terms : This Restricted Stock Unit award is comprised of RSUs which are subject to a performance condition (“ Performance Condition ”) which shall determine the number of Three-Year Performance Vesting RSUs eligible for vesting under the terms hereof. The Performance Condition is the Company’s achievement of specified compound annual growth rate (“ CAGR” ) targets above the Threshold for the Measurement Period, as more specifically delineated in the “Three-Year Performance Vesting RSU” section below. At the conclusion of the Measurement Period, the Committee will determine the Performance Multiple, if any, in accordance with the terms stated in this Notice of Grant. The Committee will then determine the Holder’s total RSUs eligible for vesting in accordance with the Vesting Period section below by multiplying Holder’s RSUs by the Performance Multiple (the “ Total Vesting RSUs ”).

Three-Year Performance-Vesting RSUs

Subject to the terms and restrictions of the Award Agreement and the Plan, Three-Year Performance-Vesting RSUs shall be eligible to become vested as follows (with linear interpolation between performance levels):


The “ Performance Condition ” is the Company’s achievement of the applicable CAGR over the Measurement Period, the achievement of which will subject the Three Year Performance Vesting RSUs granted to Holder to the relevant Performance Multiple. For the sake of clarity, in the event the CAGR is less than Threshold, the Performance Multiple shall be 0%.

CAGR ” is the compound average growth rate of the Company over the Measurement Period, as measured by use of the Adjusted Share Price for both the initial and final measurement dates.

Performance Multiple ” is the percentage of the RSUs which shall be eligible for vesting at the conclusion of the Measurement Period in accordance with the applicable CAGR.

The below chart represents the applicable CAGR and Performance Multiples for purpose of calculating the Total Vesting RSUs

 

Title

   CAGR    Adjusted Share
Price
   Performance Multiple

Threshold

        

Half-Target

        

Target

        

Double Target

        

Triple Target Maximum

        

NOTE, any Three-Year Performance-Vesting RSUs that do not achieve the Performance Multiple in accordance with this schedule shall be forfeited as of the date at the conclusion of the Performance Period.

For purposes of the Three-Year Performance-Vesting RSUs:

(A) Measurement Period . The Measurement Period for the Holder’s Three-Year Performance Vesting RSUs will begin on July 1, 2014, and end on September 1, 2017 (the “ Performance End Date ”.

(B) Performance Multiple . The Performance Multiple applicable to the RSUs shall be based on the Company’s achievement of the Performance Condition in an amount as specified herein.

(C) Interpolation . If the Adjusted Share Price on the measurement date as set forth herein is between the Threshold and the Half-Target, the Half-Target and Target, the Target and the Double Target, or the Double Target and the Triple Target Maximum, the Performance Multiple applicable to the RSUs shall be the number that is the mathematical linear interpolation between the Performance Multiple applicable at the defined ends of the applicable spectrum.


(D) “ Adjusted Share Price ” means the sum of (i) the average of the closing price of the Shares during the forty-five (45) consecutive trading days ending on the day prior to the specified measurement date; and (ii) the value that would be derived from the number of Shares (including fractions thereof) that would have been purchased had an amount equal to each dividend paid on a share of common stock after the grant date and prior to the applicable measurement date been deemed invested on the dividend payment date, based on the closing price of the common stock on such dividend payment date.

Vesting Period . Subject to the provisions of the Plan and this Award, and further provided that the Performance Condition has been satisfied, the Three-Year Performance Vesting RSUs shall vest ratably as follows, provided that vesting will cease upon the earlier of (a) a Termination of Employment, except otherwise stated herein in Section 2.3 or 2.4 of the Award Agreement, or (b) Holder’s breach of any applicable agreement with the Company: 1/3 of the total Grant shall vest on each of December 31, 2017, 2018, and 2019 (each, a “ Vesting Date ”, and any RSUs that become vested, a “ Vested RSU ”). For the avoidance of doubt, if the Performance Condition is not satisfied, Holder’s RSUs shall not vest and shall expire as of the conclusion of the Measurement Period without any consideration therefor.

Accelerated Measurement Dates . Notwithstanding the foregoing provisions, if:

(i) For any consecutive four fiscal quarters of the Company, beginning with the fiscal quarter ending on June 30, 2015 and ending with the fiscal quarter ending on December 31, 2016, the average closing price of the Company’s ordinary shares is equal to or exceeds the share price which corresponds to the Target share price, then the Holder’s RSUs which shall be deemed to have satisfied the Performance Criteria at the end of the Measurement Period, subject to the termination provisions contained herein, shall be equal to 25% of the RSUs; and

(ii) On June 1, 2017, the Adjusted Share Price is equal to or exceeds the share price which corresponds to the Target share price, then the Holder’s RSUs which shall be deemed to have satisfied the Performance Condition at the end of the Measurement Period, subject to the termination provisions contained herein, shall be equal to the sum of (x) the RSUs calculated under (i), above, and (y) 25% of the RSUs which would be deemed to have satisfied the performance criteria as computed per this Agreement (collectively, the “ Minimum Measurement ”).

Determination of Vested RSUs . The total number of Vested RSUs shall be the greater of (1) the Minimum Measurement and (2) the actual Performance Multiple computed as per this Agreement.

Payment of Shares . Any Vested RSUs will be due and payable within thirty (30) days after an applicable Vesting Date, in Shares at a ratio of shares per Restricted Stock Unit in accordance with the Performance Multiple (as defined herein), subject to the provisions of Section 12(a) of the Plan.

Change in Control . If this Agreement does not continue to be outstanding following the effective date of a Change in Control and has not been substituted or replaced with a Qualified Substitute Award, the Total Vesting RSUs that a Holder will be entitled to receive as of the effective date of such Change in Control shall be equal to the greater of (i) the number of RSUs that would vest based on the share price paid per share of the Company in connection with the Change in Control (the “Change in Control Price”) which corresponds to the Performance Multiple as provided in in this Notice of Grant; and (ii) the number of RSUs that would vest assuming that the Performance Multiple is considered met at Target, but pro-


rated to reflect the Holder’s period of employment by the Company during the Measurement Period. If this Agreement continues to be outstanding following the effective date of a Change in Control (i.e., the agreement is assumed by the acquiring entity), then the Total Vesting RSUs will be determined as described above in this Section entitled “Change in Control” and the RSUs will continue to be subject to the time vesting conditions set forth in the Section entitled “Vesting Period” of this Agreement, except that the RSUs shall become immediately vested upon a Qualified Termination of the Holder’s employment by the successor employer within the two (2) year period following the date of the Change in Control. The Total Vesting RSUs which vest pursuant to this Section entitled “Change in Control” shall become due and payable in Shares as per the Section entitled “Accelerated Measurement Dates.”

 

GRANT NO:

 

%%ACCOUNT_ID%-% / Restricted Stock Units


EXHIBIT 1-A

AWARD AGREEMENT

In consideration of services to be rendered by you (the “ Grantee ”) to Actavis plc, an Irish public limited company, as successor in interest to Allergan, Inc., a Delaware company (the “ Company ”), you have been awarded a grant (the “ Grant ”) of Performance Shares (each Performance Share, a “ Stock Unit ”) under the Amended and Restated Allergan, Inc. 2011 Incentive Award Plan (the “ Plan ”), which is incorporated herein by reference, covering a number of ordinary shares of the Company, par value $0.0001 per share (the “ Shares ”) as further described herein, subject to the terms and conditions of this agreement (the “ Agreement ”) and the Plan. Each capitalized term used herein will have the meaning specified in the Plan, unless another meaning is specified in this Agreement.

2. PERFORMANCE TERMS.

 

  (a) Grant Date and number of Stock Units

Grant Date: Specified in Notice of Grant hereto

Number of Stock Units Subject to Award: Specified in Notice of Grant hereto (the “ Target Stock Units ”)

(b) Performance Condition . The Target Stock Units are subject to a performance condition (“ Performance Condition ”) which shall determine the number of Target Stock Units eligible for vesting under the terms hereof. The Performance Condition is the Company’s achievement of specified compound annual growth rate (“ CAGR ”) targets above the Threshold for the Measurement Period, as more specifically delineated in the attached Exhibit A . At the conclusion of the Measurement Period, the Committee will determine the Performance Multiple, if any, in accordance with Exhibit A . The Committee will then determine your total Target Stock Units eligible for vesting in accordance with Section 1(c) by multiplying your Target Stock Units by the Performance Multiple (as defined in Exhibit A ) (the “ Total Vesting Stock Units ”).

(A) Measurement Period . The measurement period (the “ Measurement Period ”) for your Target Stock Units will begin on July 1, 2014, and end on September 1, 2017 (the “ Performance End Date ”).

(B) Performance Multiple . The Performance Multiple applicable to the Stock Units shall be based on the Company’s achievement of the Performance Condition in an amount as specified in Exhibit A .

(C) Interpolation . If the Adjusted Share Price on the measurement date as set forth on Exhibit A is between the Threshold and the Half-Target, the Half-Target and Target, the Target and the Double Target, or the Double Target and the Triple Target Maximum, the Performance Multiple applicable to the Stock Units shall be the number that is the mathematical linear interpolation between the Performance Multiple applicable at the defined ends of the applicable spectrum.


(D) “ Adjusted Share Price ” means the sum of (i) the average of the closing price of the Shares during the forty-five (45) consecutive trading days ending on the day prior to the specified measurement date; and (ii) the value that would be derived from the number of Shares (including fractions thereof) that would have been purchased had an amount equal to each dividend paid on an ordinary share after the grant date and prior to the applicable measurement date been deemed invested on the dividend payment date, based on the closing price of an ordinary share on such dividend payment date.

(c) Vesting Period. Subject to the provisions of the Plan and this Award, and further provided that the Performance Condition has been satisfied, your Total Vesting Stock Units shall vest ratably as follows, provided that vesting will cease upon the earlier of (a) your Termination of Service except otherwise stated herein in Section 2, or (b) your breach of any applicable agreement with the Company: 1/3 of the total Grant shall vest on each of December 31, 2017, 2018, and 2019 (each, a “ Vesting Date ”, and any Stock Units that become vested, a “ Vested Stock Unit ”). For the avoidance of doubt, if the Performance Condition is not satisfied, your Stock Units shall not vest and shall expire as of the conclusion of the Measurement Period without any consideration therefor, except as otherwise stated herein.

(d) Accelerated Measurement Dates . Notwithstanding the foregoing provisions, if:

(i) For any consecutive four fiscal quarters of the Company, beginning with the fiscal quarter ending on June 30, 2015 and ending with the fiscal quarter ending on December 31, 2016, the average closing price of the Company’s ordinary shares is equal to or exceeds the share price which corresponds to the Target share price, then the Grantee’s Stock Units which shall be deemed to have satisfied the Performance Criteria at the end of the Measurement Period, subject to the termination provisions contained herein, shall be equal to 25% of the Target Stock Units; and

(ii) On June 1, 2017, the Adjusted Share Price is equal to or exceeds the share price which corresponds to the Target share price, then the Grantee’s Stock Units which shall be deemed to have satisfied the Performance Condition at the end of the Measurement Period, subject to the termination provisions contained herein, shall be equal to the sum of (x) the Stock Units calculated under (i), above, and (y) 25% of the Stock Units which would be deemed to have satisfied the performance criteria as Computed per this Agreement and Exhibit A (collectively, the “ Minimum Measurement” ).

(e) The Total Vesting Stock Units shall be the greater of (1) the Minimum Measurement and (2) the actual Performance Multiple computed as per this Agreement and Exhibit A .

(f) Payment of Shares . Any Vested Stock Units will be due and payable within thirty (30) days after an applicable Vesting Date, in Shares at a ratio of shares per Stock Unit in accordance with the Performance Multiple (as defined herein), subject to the provisions of Article 9 of the Plan.


3. DISABILITY, QUALIFYING TERMINATION, OR DEATH OF GRANTEE.

(a) Disability or Qualifying Termination . In the event of the Grantee’s Termination of Service during the Measurement Period as a result of Disability or a Qualifying Termination (as defined herein), the Total Vesting Stock Units as determined at the conclusion of the Measurement Period in accordance with Section 1 hereof and Exhibit A , will be multiplied by a fraction, the numerator of which is the number of days from the beginning date of the Measurement Period through the date of such Termination of Service and the denominator of which is the total number of days between the grant date and December 31, 2019 (“ Adjusted Vesting Stock Units ”). The Adjusted Vesting Stock Units shall (1) be payable within 60 days following the end of the Measurement Period, in the event of the Grantee’s Disability, or (2) remain eligible for vesting on the Vesting Dates, as provided in Section 1(c), in the event of the Grantee’s Qualifying Termination. In the event of the Grantee’s Termination of Service as a result of Disability or a Qualifying Termination subsequent to the end of the Measurement Period, the Grantee shall remain eligible to vest in the Total Vesting Stock Units on the same schedule as if the Grantee had remained employed, subject to the terms of Section 1(c), above.

(b) Death. In the event of the Grantee’s Termination of Service during the Measurement Period as a result death, the Target Performance Multiple in accordance with Exhibit A shall be considered met as of the termination date, and the resulting Total Vesting RSUs shall vest on the same schedule as if the Grantee had remained employed through each Vesting Date. In the event of the Grantee’s Termination of Service as a result of death subsequent to the end of the Measurement Period, the Grantee shall remain eligible to vest in the Total Vesting Stock Units on the same schedule as if the Grantee had remained employed, subject to the terms of Section 1(c), above.

(c) Unvested Units . Following any vesting pursuant to this Section 2, any Stock Units which have not vested shall be retired and the Grantee shall have no further rights with respect to such Stock Units or the underlying Shares.

(d) Qualifying Termination . For all purposes hereunder, a “Qualifying Termination” shall mean a Termination of Service either by the Company without “Cause”, or by the Grantee with “Good Reason”, as both terms are defined in the Grantee’s employment agreement; or, in the absence of any such employment agreement as of the termination date, as those terms are defined in the applicable severance plan of the Company.

(i) Notwithstanding anything contained herein to the contrary, upon the mutual written agreement of the Company and the Grantee, Grantee’s Termination of Service shall not be considered a termination hereto if Grantee continues to hold the position of a member of the Board as of the termination date, or becomes a member of the Board as of the termination date. Any reference to termination date hereunder shall thereinafter be the date upon which Grantee ceases to be a member of the Board.

4. CHANGE IN CONTROL.

(a) If this Agreement does not continue to be outstanding following the effective date of a Change in Control and has not been substituted or replaced with a Substitute Award, the Total Vesting Stock Units that a Grantee will be entitled to receive as of the effective


date of such Change in Control shall be equal to the greater of (i) the number of Stock Units that would vest based on the share price paid per share of the Company in connection with the Change in Control (the “ Change in Control Price ”) which corresponds to the Performance Multiple as provided in the attached Exhibit A ; and (ii) the number of Stock Units that would vest assuming that the Performance Multiple is considered met at Target, but pro-rated to reflect the Grantee’s period of employment by the Company during the Measurement Period.

(b) If this Agreement continues to be outstanding following the effective date of a Change in Control (i.e., the Agreement is assumed by the acquiring entity), then the Total Vesting Stock Units will be determined as described under subsection (a) of this Section 3 and the Stock Units will continue to be subject to the time vesting conditions set forth in Section 1(c) of this Agreement, except that the Stock Units shall become immediately vested upon a Qualified Termination of the Grantee’s employment by the successor employer within the two (2) year period following the date of the Change in Control. The Total Vesting Stock Units which vest pursuant to this Section 3 shall become due and payable in Shares as per Section 1(d).

5. FORFEITURE OF UNVESTED STOCK UNITS UPON TERMINATION OF SERVICE. Except to the extent Stock Units have vested pursuant to Section 2 or 3, in the event of the Grantee’s Termination of Service for any reason during the Measurement Period or prior to an applicable Vesting Date, all then-unvested Stock Units subject to the Grant shall be forfeited by the Grantee without compensation as of the termination date and the Grantee shall have no further rights with respect to such Stock Units or the underlying Shares. In the event of the Grantee’s Termination of Service for any reason, the Committee may, in its sole discretion and when it finds that such an action would be in the best interests of the Company, waive the Performance Conditions as to all or any portion of the Target Stock Units (and any such Target Stock Units as to which the Performance Conditions have been waived shall vest as of the date specified by the Committee) except in connection with an employment termination for gross misconduct and except with respect to a Grant which the Company intended to qualify as “performance-based compensation” under Section 162(m) of the Code.

6. TIMING OF PAYMENT. The Company will make payment to the Grantee of the Shares as soon as reasonably practicable after such payment vests under this Agreement. If Shares are to be paid to the Grantee pursuant to this Agreement, the Stock Plan Administrator will instruct the Company’s transfer agent and stock registrar to deliver for the account of the Grantee (and his or her permitted transferee) as designated on the records of the Company such Shares. Notwithstanding anything to the contrary contained in this Section 5, so long as a payment with respect to a Stock Unit constitutes “non-qualified deferred compensation” for purposes of Section 409A of the Code, no payment will be made with respect to any Stock Unit Award to any Grantee on account of such Grantee’s termination date if, on such date, the Grantee is a “specified employee” of the Company or its subsidiaries (within the meaning of Section 409A(a)(2)(B)(i) of the Code and as determined by the Committee) until the date which is six months after the Grantee’s termination date (or, if earlier than the end of such six month period, the date of such Grantee’s death). In lieu of designating specified employees for purposes of Section 409A of the Code, the Board in its discretion may identify all employees of the Company and its subsidiaries as “specified employees” for purposes of this provision. The provisions of this Section 5 will not apply to payments under an Award of Stock Units that occur pursuant to a Change in Control or in connection with the dissolution of the Company.


7. RESTRICTIONS ON TRANSFER. The Stock Units subject to the Grant shall not be transferable during the Measurement Period and prior to vesting, other than by will or the laws of descent and distribution, and except that the Grantee may transfer the Stock Units by gift to one or more members of the Grantee’s immediate family, including trusts for the benefit of such family members and partnerships or limited liability companies in which such family members are the only owners. In the event the Grantee wishes to transfer the Stock Units during the Measurement Period by gift as permitted by this Section, the Grantee shall provide the Stock Plan Administrator notice of any such transfer in form and substance reasonably satisfactory to the Company and the Stock Plan Administrator, and no transferee shall have any rights in the Stock Units until such notice has been accepted by the Stock Plan Administrator. Transferred Stock Units shall be subject to all of the same terms and conditions of the Plan and this Agreement as if such Stock Units had not been transferred. More particularly (but without limiting the generality of the foregoing), during the Measurement Period the Stock Units may not be assigned, transferred (except as provided above), pledged or hypothecated in any way, shall not be assignable by operation of law and shall not be subject to execution, attachment, pledge, hypothecation or other disposition contrary to the provisions hereof, and the levy of any execution, attachment or similar process upon the Stock Units shall be null and void and without effect. Subsequent to vesting, the Stock Units and/or shares granted thereunder shall be subject to such transfer restrictions as adopted by the Company in its generally applicable policies, plans, or procedures.

8. EMPLOYMENT. In consideration of the awarding of the Grant and regardless of whether the Performance Conditions shall be satisfied, the Grantee will fulfill all the duties and obligations of his or her employment by the Company or any of its Subsidiaries. Nothing in this Agreement shall confer upon the Grantee any right to similar grants in future years or any right to be continued in the employ of the Company or any of its Subsidiaries or shall interfere in any way with the right of the Company or any such Subsidiary to terminate or otherwise modify the terms of the Grantee’s employment.

9. EFFECT ON OTHER BENEFITS. In no event shall the value of the Stock Units covered by the Grant awarded under this Agreement at any time be included as compensation or earnings for purposes of determining any other compensation, retirement benefit or other benefit offered to employees of the Company or its subsidiaries under any benefit plan of the Company unless otherwise specifically provided for in such benefit plan.

10. AVAILABLE SHARES; LEGAL COMPLIANCE. The Company shall pay all original issue and transfer taxes with respect to the issuance of the Stock Units and the underlying Shares and all other fees and expenses necessarily incurred by the Company in connection therewith and will use its best efforts to comply with all laws and regulations which, in the opinion of counsel for the Company, shall be applicable thereto.

11. TAXES. Except as provided below, the Grantee must pay the Company in cash upon demand any and all amounts due for the purpose of satisfying the Company’s liability under applicable law to withhold or deduct federal, state, or local income tax, employment tax, pension plan contributions and any and all other withholdings or deductions (plus interest or penalties thereon, if any, caused by a delay in making such payment) required by reason of the receipt of the Grant, the vesting of the Stock Units or the issuance of Shares hereunder. By accepting this


Grant, the Grantee consents and directs that the Stock Plan Administrator may, but is not obligated to, withhold the number of Shares having an aggregate fair market value as of the date preceding the required withholding sufficient to satisfy the Grantee’s obligations hereunder and to deliver such Shares to the Company. In addition, the Company shall, to the extent permitted by law, have the right to deduct such withholding amount from any payment of any kind otherwise due to the Grantee.

12. CONDITION PRECEDENT TO GRANT. In the event that the award of the Grant shall be subject to, or shall require, any prior exchange listing, shareholder approval or other condition or act, pursuant to the applicable laws, regulations or policies of any stock exchange, federal or local government or its agencies or representatives, then the Grant hereunder shall not be deemed awarded until the fulfillment of such condition.

13. NO RIGHTS AS A STOCKHOLDER PRIOR TO ISSUANCE OF SHARES. Neither the Grantee nor any other person shall become the beneficial owner of any Shares that may become payable with respect to the Stock Units subject to this Grant, nor have any rights to dividends or other rights as a stockholder with respect to any such Shares (including voting rights), until and after such Shares, if any, are issued to the Grantee, in the time and manner specified in Section 1, 2, 3 or 4.

14. ADMINISTRATION. The Committee shall have full authority and discretion, subject only to the express terms of the Plan, to decide all matters relating to the administration and interpretation of the Plan and this Agreement and the Grantee agrees to accept all such Committee determinations as final, conclusive and binding. The Company may retain a third-party plan administrator or may designate an internal department to assist in the administration of the Plan. The term “ Stock Plan Administrator ” as used herein shall mean such third-party plan administrator or such internal department as designated by the Company from time to time.

15. COSTS. The Company shall not charge any Grantee for any part of the Company’s cost to administer and operate the Plan. If the Company retains a third-party plan administrator to assist in the administration of the Plan, the Grantee may be charged fees by such third-party plan administrator in connection with any transactions which the Grantee effects through such third-party plan administrator.

16. AMENDMENT. This Agreement shall be subject to the terms of the Plan, as may be amended by the Company from time to time, except that no amendment of the Plan adopted after the date of this Agreement shall impair the Grantee’s rights hereunder without his or her consent. In addition to the foregoing, this Agreement may be amended by the Committee, provided that no such amendment shall impair the Grantee’s rights hereunder without his or her consent.

17. DATA PRIVACY. By entering into this Agreement, the Grantee (a) authorizes the Company or any Subsidiary and the Stock Plan Administrator or any agent of the Company providing recordkeeping services for the Plan to disclose to each other such information and data as either of them shall request in order to facilitate the awarding of Grants and the administration of the Plan; (b) waives any data privacy rights the Grantee may have with respect to such information; and (c) authorizes the Company and the Stock Plan Administrator or any agent of the Company providing recordkeeping services for the Plan to store and transmit such information in electronic form.


18. NOTICES. All notices and communications by the Grantee in connection with this Agreement or the Stock Units granted hereunder shall be delivered to the Stock Plan Administrator and to the Company. Notices to the Stock Plan Administrator shall be delivered in accordance with its established procedures as set forth on the website of the Stock Plan Administrator and notices to the Company shall be delivered in writing by electronic mail, nationally recognized overnight courier or certified mail, postage prepaid to the attention of:

Actavis plc

Attn: Stock Plan Administrator

Morris Corporate Center III

Building A

400 Interpace Parkway

Parsippany, NJ 07054.

All notices and communications by the Stock Plan Administrator or the Company to the Grantee in connection with this Agreement shall be given in writing and shall be delivered electronically to the Grantee’s e-mail address appearing on the records of the Company, or by nationally recognized overnight courier or certified mail, postage prepaid to the Grantee’s residence or to such other address as may be designated in writing by the Grantee.

19. ENTIRE AGREEMENT AND WAIVER. This Agreement and the Plan contain the entire understanding of the parties and supersede any prior understanding and agreements between them representing the subject matter hereof. To the extent that there is an inconsistency between the terms of the Plan and this Agreement, the terms of the Plan shall control. There are no other representations, agreements, arrangements or understandings, oral or written, between the parties hereto relating to the subject matter hereof which are not fully expressed herein or in the Plan. Any waiver or any right or failure to perform under this Agreement shall be in writing signed by the party granting the waiver and shall not be deemed a waiver of any subsequent failure to perform.

20. SEVERABILITY AND VALIDITY. The various provisions of this Agreement are severable and any determination of invalidity or unenforceability of any one provision shall have no effect on the remaining provisions.

21. GOVERNING LAW. The interpretation, enforceability and validity of this Agreement shall be governed by the substantive laws (but not the choice of law rules) of the State of Delaware.

22. HEADINGS. Section and other headings contained in this Agreement are for reference purposes only and are in no way intended to describe, interpret, define or limit the scope, extent or intent of the Grant or any provision hereof.


EXHIBIT A

For purposes of this Exhibit A :

The “ Performance Condition ” is the Company’s achievement of the applicable CAGR over the Measurement Period, the achievement of which will subject the Stock Units granted to Grantee to the relevant Performance Multiple. For the sake of clarity, in the event the CAGR is less than Threshold, the Performance Multiple shall be 0%.

CAGR ” is the compound average growth rate of the Company over the Measurement Period, as measured by use of the Adjusted Share Price for both the initial and final measurement dates.

Performance Multiple ” is the percentage of the Target Stock Units which shall be eligible for vesting at the conclusion of the Measurement Period in accordance with the applicable CAGR.

The below chart represents the applicable CAGR and Performance Multiples for purpose of calculating the Total Vesting Stock Units as further provided in the Section 1(b) of the Grant.

 

Title

   CAGR    Adjusted Share
Price
   Performance Multiple

Threshold

        

Half-Target

        

Target

        

Double Target

        

Triple Target Maximum

        


COUNTRY APPENDIX

TO EXHIBIT 1-A

ADDITIONAL TERMS AND CONDITIONS

Capitalized terms, unless explicitly defined in this Country Appendix, shall have the meanings given to them in the Award Agreement or in the Plan.

Terms and Conditions

This Appendix includes additional terms and conditions that govern the Restricted Stock Units granted to Holder under the Plan if Holder resides in one of the countries listed below. If Holder is a citizen or resident (or is considered as such for local law purposes) of a country other than the country in which Holder is currently residing and/or working, or if Holder transfers to another country after receiving the Restricted Stock Units, the Company shall, in its discretion, determine to what extent the special terms and conditions contained herein shall be applicable to Holder.

Notifications

This Appendix also includes information regarding securities, exchange control, tax and certain other issues of which Holder should be aware with respect to his participation in the Plan. The information is based on the securities, exchange control, tax and other laws in effect in the respective countries as of April 2015. Such laws are often complex and change frequently. As a result, the Company strongly recommends that Holder not rely on the information in this Appendix as the only source of information relating to the consequences of his participation in the Plan because the information may be out of date at the time that the Restricted Stock Units vest or Holder sells shares of Common Stock acquired under the Plan.

In addition, the information contained herein is general in nature and may not apply to Holder’s particular situation and the Company is not in a position to assure Holder of a particular result. Accordingly, Holder are advised to seek appropriate professional advice as to how the relevant laws in his country may apply to his individual situation.

Finally, if Holder is a citizen or resident (or is considered as such for local tax purposes) of a country other than the one in which Holder is currently residing and/or working, or if Holder transfers to another country after the grant of the Restricted Stock Units, the information contained herein may not be applicable to Holder in the same manner.

AUSTRALIA

Terms and Conditions

Australian Offer Document . The offer of Restricted Stock Units is intended to comply with the provisions of the Corporations Act 2001, ASIC Regulatory Guide 49 and ASIC Class Order CO 14/1000. Additional details are set forth in the Offer Document for the offer of Restricted Stock Units to Australian resident employees, which will be provided to Holder with this Award Agreement.

Notifications

Securities Law Information . If Holder acquires shares of Common Stock pursuant to Restricted Stock Units and offers these shares for sale to a person or entity resident in Australia, the offer may be subject to disclosure requirements under Australian law. Holder should obtain legal advice on disclosure obligations prior to making any such offer.

Exchange Control Information . Exchange control reporting is required for cash transactions exceeding A$10,000 and international fund transfers. The Australian bank assisting with the transaction will file the report. If there is no Australian bank involved in the transfer, Holder will be required to file the report.


AUSTRIA

Notifications

Exchange Control Information . If Holder holds shares of Common Stock obtained through the Plan outside of Austria, Holder may be required to submit reports to the Austrian National Bank as follows: (i) on a quarterly basis if the value of the shares as of any given quarter meets or exceeds €30,000,000; and (ii) on an annual basis if the value of the shares as of December 31 meets or exceeds €5,000,000. The quarterly reporting date is as of the last day of the respective quarter; the deadline for filing the quarterly report is the fifteenth day of the month following the end of the respective quarter. The deadline for filing the annual report is January 31 of the following year.

When shares are sold, Holder may be required to comply with certain exchange control obligations if the cash proceeds from the sale are held outside Austria. If the transaction volume of all Holder’s accounts abroad meets or exceeds €3,000,000, the movements and balances of all accounts must be reported monthly, as of the last day of the month, on or before the fifteenth day of the following month.

AZERBAIJAN

Notifications

Securities Law Information . Holder understands that the Award Agreement, the Plan and all other materials he may receive regarding his participation in the Plan do not constitute advertising or offering of securities in Azerbaijan. The issuance of securities pursuant to the Plan has not been and will not be registered in Azerbaijan and, therefore, the securities described in any Plan-related documents may not be used for sale or public circulation in Azerbaijan. Further, Holder understands that the shares of Common Stock issued upon vesting of the Restricted Stock Units will be deposited into a Company-designated brokerage account in the U.S. as soon as practical after the applicable vesting date and in no event will shares issued upon vesting of the Restricted Stock Units be delivered to Holder in Azerbaijan. Any disposition or sale of such shares must take place outside Azerbaijan, which will be the case if the shares are sold on the New York Stock Exchange.

BELGIUM

Notifications

Foreign Asset/Account Reporting Information . Holder is required to report any securities ( e.g. , shares of Common Stock acquired under the Plan) or bank accounts (including brokerage accounts) held outside of Belgium on his annual tax return. Holder is also required to complete a separate report providing the National Bank of Belgium with details regarding any such account, including the account number, the name of the bank in which such account is held and the country in which such account is located.

BRAZIL

Terms and Conditions

Nature of Grant . The following provision supplements Section 1.2 of the Award Agreement:

In accepting the Restricted Stock Units, Holder acknowledges, understands and agrees that (i) Holder is making an investment decision, (ii) Holder will be entitled to vest in, and receive shares of Common Stock pursuant to, the Restricted Stock Units only if the vesting conditions are met and any necessary services are rendered by Holder between the Date of Grant and the vesting date, and (iii) the value of the underlying shares is not fixed and may increase or decrease without compensation to Holder.

Compliance with Law . In accepting the Restricted Stock Units, Holder agrees to comply with all applicable Brazilian laws and report and pay any and all applicable taxes associated with the vesting and settlement of the Restricted Stock Units, the sale of any shares acquired under the Plan, and the receipt of any dividends.


Notifications

Exchange Control Information . If Holder is a resident or domiciled in Brazil, he will be required to submit an annual declaration of assets and rights held outside of Brazil to the Central Bank of Brazil if the aggregate value of such assets and rights is equal to or greater than US$100,000. The assets and rights that must be reported include shares of Common Stock acquired under the Plan.

BULGARIA

Notifications

Exchange Control Information . If Holder receives a payment related to the Plan in Bulgaria in excess of BGN 100,000 (or its equivalent in another currency, e.g. , U.S. dollars), Holder should submit a form with information regarding the source of the income to the bank receiving such payment (for statistical purposes) upon transfer or within 30 days as of receipt. Holder should contact his bank in Bulgaria for additional information regarding this requirement.

CANADA

Terms and Conditions

Settlement Upon Vesting . The following provision supplements Section 2.3 of the Award Agreement:

Notwithstanding anything to the contrary in the Award Agreement or the Plan, the Restricted Stock Units will be settled in shares of Common Stock only, not cash.

Forfeiture upon Termination of Services . The following sentence replaces the first sentence of the second paragraph of Section 2.2 of the Award Agreement:

For purposes of the Restricted Stock Units, Holder’s employer-employee or service relationship will be considered terminated as of the date that is the earlier of: (1) the date of Termination of Employment, (2) the date Holder receives notice of termination from the Employer, or (3) the date Holder is no longer actively providing services, regardless of any notice period or period of pay in lieu of such notice required under applicable law (including, but not limited to statutory law, regulatory law and/or common law).

The following provisions will apply to Holder if he is a resident of Quebec:

Language Consent . The parties acknowledge that it is their express wish that the Award Agreement, as well as all addenda, documents, notices, and legal proceedings entered into, given or instituted pursuant hereto or relating directly or indirectly hereto, be drawn up in English.

Les parties reconnaissent avoir exigé la rédaction en anglais de cette Convention, ainsi que de tous documents exécutés, avis donnés et procédures judiciaries intentées, directement ou indirectement, relativement à ou suite à la présente convention.

Data Privacy . The following provision supplements Section 3.9 of the Award Agreement:

Holder hereby authorizes the Company and the Company’s representatives to discuss and obtain all relevant information from all personnel, professional or non-professional, involved in the administration of the Plan. Holder further authorizes the Company, the Employer, its other Subsidiaries and the Administrator to disclose and discuss the Plan with their advisors. Holder further authorizes the Company, the Employer and any other Subsidiary of the Company to record such information and to keep such information in Holder’s employee file.

Notifications

Securities Law Information . Holder acknowledges that he is permitted to sell shares of Common Stock acquired under the Plan through the designated broker appointed under the Plan, if any, provided the sale of the shares acquired under Plan takes place outside of Canada through the facilities of a stock exchange on which the shares of Common Stock are listed ( i.e. , the New York Stock Exchange).


Foreign Asset/Account Reporting Information . Holder must report annually on Form T1135 (Foreign Income Verification Statement) the foreign property (including shares of Common Stock acquired under the Plan) he holds, if the total value of such foreign property exceeds C$100,000 at any time during the year. Unvested Restricted Stock Units also must be reported (generally at nil cost) on Form 1135 if the C$100,000 threshold is exceeded due to other foreign property held by Holder. The Form T1135 must be filed at the same time Holder files his annual tax return. Holder should consult his personal legal advisor to ensure compliance with applicable reporting obligations.

CHINA

Terms and Conditions

The following Terms and Conditions apply only to Holder if he is subject to the exchange control restrictions and regulations in China, including the requirements imposed by the State Administration of Foreign Exchange (“SAFE”), as determined by the Company in its sole discretion.

Vesting Schedule and Forfeiture Upon Termination . The following supplements Sections 2.1 and 2.2 of the Award Agreement:

Notwithstanding to anything to the contrary in the Award Agreement or the Plan, the Restricted Stock Units shall not vest unless and until the Company, the Employer or any other Subsidiary of the Company in China receives all necessary approvals from the SAFE or its local counterpart under the Implementing Rules of the Measures for Administration of Foreign Exchange of Individuals to offer such awards in China. Once SAFE approval has been received and provided Holder continues to be an Employee of the Company or a Subsidiary of the Company, Holder will receive a vesting credit for that portion of the Restricted Stock Units that would have vested prior to obtaining SAFE approval, if applicable, and the remaining portion of the Restricted Stock Units will vest in accordance with the Award Agreement. If Holder ceases to be an Employee prior to the receipt of SAFE approval, any unvested Restricted Stock Units will be forfeited.

Sale of Shares . Due to local regulatory requirements, upon the vesting of Restricted Stock Units, Holder agrees to the immediate sale of any shares of Common Stock issued under the Restricted Stock Units. Holder further agrees that the Company is authorized to instruct its designated broker to assist with the mandatory sale of such shares of Common Stock (on his behalf pursuant to this authorization) and Holder expressly authorizes the Company’s designated broker to complete the sale of such shares of Common Stock. Holder acknowledges that the Company’s designated broker is under no obligation to arrange for the sale of the shares of Common Stock at any particular price. Upon the sale of the shares of Common Stock, the Company agrees to pay Holder the cash proceeds from the sale of the shares of Common Stock, less any brokerage fees or commissions and subject to any obligation to satisfy any Tax-Related Items. Holder understands that the proceeds from the sale of shares may need to be repatriated to China pursuant to the below provision, and Holder agrees to comply with all requirements the Company may impose in order to facilitate compliance with exchange control requirements in China prior to receipt of the cash proceeds. Holder acknowledges that he is not aware of any material nonpublic information with respect to the Company or any securities of the Company as of the date of the Award Agreement.

Exchange Control Requirements . Holder understands and agrees that, pursuant to local exchange control requirements, Holder will be required to repatriate the cash proceeds from the immediate sale of the shares of Common Stock and the receipt of any dividends to China. Holder further understands that, under local law, such repatriation of the cash proceeds may need to be effectuated through a special exchange control account established by the Company, the Employer or Subsidiary of the Company, and Holder hereby consents and agrees that any proceeds from the sale of any shares of Common Stock Holder acquires upon the vesting of Restricted Stock Units may be transferred to such special account prior to being delivered to him.


Holder also understands that the Company will deliver the proceeds to him as soon as possible, but there may be delays in distributing the funds to him due to exchange control requirements in China. Proceeds will be paid to Holder in U.S. dollars. Holder will be required to set up a U.S. dollar bank account in China so that the proceeds may be deposited into this account.

Holder further agrees to comply with any other requirements that may be imposed by the Company in the future in order to facilitate compliance with exchange control requirements in China.

Notifications

Exchange Control Information . Holder may be required to report to SAFE all details of his foreign financial assets and liabilities, as well as details of any economic transactions conducted with non-PRC residents.

DENMARK

Notifications

Exchange Control and Tax Reporting Information . Holder may hold shares of Common Stock acquired under the Plan in a safety-deposit account ( e.g. , a brokerage account) with either a Danish bank or with an approved foreign broker or bank. If the shares are held with a non-Danish broker or bank, Holder is required to inform the Danish Tax Administration about the safety-deposit account. For this purpose, Holder must file a Declaration V ( Erklaering V ) with the Danish Tax Administration. Holder must sign the Declaration V and the broker or bank may sign the Declaration V. By signing the Declaration V, the bank/broker undertakes an obligation, without further request each year not later than on February 1 of the year following the calendar year to which the information relates, to forward certain information to the Danish Tax Administration concerning the content of the safety-deposit account. In the event that the applicable broker or bank with which the safety-deposit account is held does not wish to, or, pursuant to the laws of the country in question, is not allowed to assume such obligation to report, Holder acknowledges that he is solely responsible for providing certain details regarding the foreign brokerage or bank account and any shares acquired under the Plan and held in such account to the Danish Tax Administration as part of Holder’s annual income tax return. By signing the Form V, Holder at the same time authorizes the Danish Tax Administration to examine the account. A sample of the Declaration V can be found at the following website: www.skat.dk/getFile.aspx?Id=47392 .

In addition, when Holder opens a brokerage account (or a deposit account) outside of Denmark, the account will be treated as a deposit account because cash can be held in the account. Therefore, Holder must also file a Declaration K ( Erklaering K ) with the Danish Tax Administration. Both Holder and the bank/broker must sign the Declaration K, unless an exemption from the broker/bank signature requirement is granted by the Danish Tax Administration. It is possible to seek the exemption on the Form K, which Holder should do at the time he submits the Form K. By signing the Declaration K, the bank/broker undertakes an obligation, without further request each year, not later than on February 1 of the year following the calendar year to which the information relates, to forward certain information to the Danish Tax Administration concerning the content of the deposit account. In the event that the applicable financial institution (broker or bank) with which the account is held, does not wish to, or, pursuant to the laws of the country in question, is not allowed to assume such obligation to report, Holder acknowledges that he is solely responsible for providing certain details regarding the foreign brokerage or bank account to the Danish Tax Administration as part of Holder’s annual income tax return. By signing the Declaration K, Holder at the same time authorizes the Danish Tax Administration to examine the account. A sample of Declaration K can be found at the following website: www.skat.dk/getFile.aspx?Id=42409&newwindow=true .

Foreign Asset/Account Reporting Information . If Holder establishes an account holding shares of Common Stock or cash outside of Denmark, Holder must report the account to the Danish Tax Administration. The form which should be used in this respect can be obtained from a local bank. These obligations are separate from and in addition to the obligations described above.


EGYPT

Notifications

Exchange Control Information . If Holder transfers funds into Egypt in connection with the Restricted Stock Units, Holder should transfer the funds through a registered bank in Egypt.

FINLAND

There are no country-specific provisions.

FRANCE

Terms and Conditions

Language . By signing and returning this Award Agreement, Holder confirms having read and understood the documents relating to the grant and the Plan which were provided to Holder in English language. Holder accepts the terms of those documents accordingly.

En signant et renvoyant le présent Contrat d’Attribution, le Détenteur confirme avoir lu et compris les documents relatifs à l’attribution et au Plan qui ont été communiqués au Détenteur en langue anglaise. Le Détenteur accepte les termes de ces documents en connaissance de cause.

Notifications

Tax Information . The Restricted Stock Units are not intended to be French tax-qualified awards.

Foreign Asset/Account Reporting Information . If Holder holds shares of Common Stock outside France or maintain a foreign bank account, Holder should report to the French tax authorities on his annual tax return.

GERMANY

Notifications

Exchange Control Information . Cross-border payments in excess of €12,500 must be reported monthly to the German Federal Bank. If Holder makes or receives a payment in excess of this amount, Holder is responsible for electronically reporting to the German Federal Bank by the fifth day of the month following the month in which the payment occurs. The form of report ( Allgemeine Meldeportal Statistik ) can be accessed via German Federal Bank’s website (www.bundesbank.de) and is available in both German and English.

GREECE

There are no country specific provisions.

HONG KONG

Terms and Conditions

Settlement Upon Vesting . The following provision supplements Section 2.3 of the Award Agreement:

Notwithstanding anything to the contrary in the Award Agreement or the Plan, the Restricted Stock Units will be settled in shares of Common Stock only, not cash.

Sale of Shares . To facilitate compliance with securities laws in Hong Kong, Holder agrees not to sell any shares of Common Stock issued at vesting of the Restricted Stock Units within six months of the Date of Grant.

Nature of Grant . The Company specifically intends that the Plan will not be an occupational retirement scheme for purposes of the Occupational Retirement Schemes Ordinance (“ORSO”). Notwithstanding the foregoing, if the Plan is deemed to constitute an occupational retirement scheme for the purposes of ORSO, the grant of Restricted Stock Units shall be void.


Notifications

Securities Law Information . Warning: The Restricted Stock Units and shares of Common Stock issued at vesting do not constitute a public offering of securities under Hong Kong law and are available only to Employees of the Company and its Subsidiaries. The Award Agreement, including this Appendix, the Plan and other incidental award documentation have not been prepared in accordance with and are not intended to constitute a “prospectus” for a public offering of securities under the applicable securities legislation in Hong Kong, nor has the award documentation been reviewed by any regulatory authority in Hong Kong. The Restricted Stock Units are intended only for the personal use of each eligible Employee of the Employer, the Company or any Subsidiary of the Company and may not be distributed to any other person. If Holder is in any doubt about any of the contents of the Award Agreement, including this Appendix, or the Plan, Holder should obtain independent professional advice.

ICELAND

Notifications

Exchange Control Information . Holder should consult with his personal advisor to ensure compliance with applicable exchange control regulations in Iceland as such regulations are subject to frequent change. Holder is responsible for ensuring compliance with all exchange control laws in Iceland.

INDIA

Notifications

Exchange Control Information . Holder understands that Holder must repatriate any proceeds from the sale of shares of Common Stock acquired under the Plan to India within 90 days of receipt or any dividends within 180 days of receipt. Holder must obtain a foreign inward remittance certificate (“FIRC”) from the bank where Holder deposits the foreign currency and should maintain the FIRC as evidence of the repatriation of funds in the event the Reserve Bank of India or the Employer requests proof of repatriation. It is Holder’s responsibility to comply with applicable exchange control laws in India.

Because exchange control restrictions in India change frequently, Holder is advised to consult with his personal advisor before taking any action under the Plan.

Foreign Asset/Account Reporting Information . Holder understands that he is required to declare any foreign bank accounts and any foreign financial assets (including shares of Common Stock held outside India) in his annual tax return. Holder understands that he is solely responsible for complying with this reporting obligation and that Holder is advised to confer with his personal tax advisor in this regard.

INDONESIA

Notifications

Exchange Control Information . If Holder remits funds (including proceeds from the sale of shares of Common Stock) into Indonesia, the Indonesian bank through which the transaction is made will submit a report of the transaction to the Bank of Indonesia for statistical reporting purposes. For transactions of US$10,000 or more, a more detailed description of the transaction must be included in the report and Holder may be required to provide information about the transaction ( e.g. , his relationship with the transferor of the funds, the source of the funds, etc.) to the bank in order for the bank to complete the report. Although the bank through which the transaction is made is required to make the report, Holder must complete a “Transfer Report Form.” The Transfer Report Form should be provided to him by the bank through which the transaction is to be made.


IRELAND

Terms and Conditions

Restriction on Type of Shares Issued to Directors . If Holder is a director or shadow director of the Company or an Irish Subsidiary of the Company, his Restricted Stock Units will be paid in newly issued shares of Common Stock only. Treasury shares will not be used to satisfy such Restricted Stock Units.

Notifications

Director Notification Obligation . If Holder is a director, shadow director or secretary of the Company or an Irish Subsidiary of the Company, Holder must notify the Company and/or the Irish Subsidiary of the Company in writing within five business days of receiving or disposing of an interest in the Company ( e.g. , Restricted Stock Units, etc.), or within five business days of becoming aware of the event giving rise to the notification requirement or within five days of becoming a director or secretary if such an interest exists at the time. This notification requirement also applies with respect to the interests of a spouse or children under the age of 18 (whose interests will be attributed to the director, shadow director or secretary).

There are pending changes to this obligation which provide that the requirement applies only if the interest received or disposed of exceeds 1% of the Company. Holder should consult his personal legal advisor as to whether or not this notification requirement applies to him.

ISLE OF MAN

There are no country specific provisions.

ITALY

Terms and Conditions

Data Privacy . The following provision replaces in its entirety Section 3.9 of the Award Agreement:

Holder understands that the Company, the Employer and any other Subsidiary of the Company may hold certain personal information about Holder, including, but not limited to, Holder’s name, home address and telephone number, date of birth, social insurance or other identification number, salary, nationality, job title, any shares or directorships held in the Company or any Subsidiary of the Company, details of all Restricted Stock Units, or any other entitlement to shares awarded, canceled, exercised, vested, unvested or outstanding in Holder’s favor (“Data”), for the exclusive purpose of implementing, managing and administering the Plan.

Holder also understands that providing the Company with Data is necessary for the performance of the Plan and that Holder’s refusal to provide Data would make it impossible for the Company to perform its contractual obligations and may affect Holder’s ability to participate in the Plan. The controller of personal data processing is Actavis plc. with registered offices at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054, U.S., and, pursuant to Legislative Decree no. 196/2003, its representative in Italy is Bogdan Oghina, with registered offices at Viale Pasteur, 10, 20014 Nerviano Italy.

Holder understands that Data will not be publicized. Holder understands that Data may also be transferred to the independent registered public accounting firm engaged by the Company. Holder further understands that the Company and/or its Subsidiaries, will transfer Data among themselves as necessary for the purpose of implementing, administering and managing Holder’s participation in the Plan, and that the Company and its Subsidiaries may each further transfer Data to banks, other financial institutions, brokers or other third parties assisting the Company in the implementation, administration, and management of the Plan, including any requisite transfer of Data to a broker or other third party with whom Holder may elect to deposit any shares of Common Stock acquired at vesting of the Restricted Stock Units. Such recipients may receive, possess, process, retain, and transfer Data in electronic or other form, for the purposes of implementing, administering, and managing Holder’s participation in the Plan. Holder understands that these recipients may be located in or outside the European Economic


Area, such as in the United States or elsewhere. Should the Company exercise its discretion in suspending all necessary legal obligations connected with the management and administration of the Plan, it will delete Data as soon as it has completed all the necessary legal obligations connected with the management and administration of the Plan.

Holder understands that Data processing related to the purposes specified above shall take place under automated or non-automated conditions, anonymously when possible, that comply with the purposes for which Data is collected and with confidentiality and security provisions, as set forth by applicable laws and regulations, with specific reference to Legislative Decree no. 196/2003.

The processing activity, including communication, the transfer of Data abroad, including outside of the European Economic Area, as herein specified and pursuant to applicable laws and regulations, does not require Holder’s consent thereto, as the processing is necessary to performance of contractual obligations related to implementation, administration, and management of the Plan. Holder understands that, pursuant to Section 7 of the Legislative Decree no. 196/2003, Holder has the right to, including but not limited to, access, delete, update, correct, or terminate, for legitimate reason, the Data processing.

Furthermore, Holder is aware that Data will not be used for direct-marketing purposes. In addition, Data provided can be reviewed and questions or complaints can be addressed by contacting Holder’s local human resources representative.

Plan Document Acknowledgement . Holder acknowledges that Holder has read and specifically and expressly approves, without limitation, the following sections of the Award Agreement: “Nature of Grant,” “Responsibility for Taxes,” “Data Privacy” as replaced by the above consent, “Governing Law and Venue,” “Language,” and “Imposition of Other Requirements.”

Notifications

Foreign Asset/Account Reporting Information . If at any time during the fiscal year Holder holds foreign financial assets (including cash and shares of Common Stock) which may generate income taxable in Italy, Holder is required to report these assets on his annual tax return (UNICO Form, RW Schedule) for the year during which the assets are held, or on a special form if no tax return is due. These reporting obligations will also apply to Italian residents who are the beneficial owners of foreign financial assets under Italian money laundering provisions.

Foreign Asset Tax Information . The value of the financial assets held outside of Italy by Italian residents is subject to a foreign asset tax. Financial assets include shares of Common Stock acquired under the Plan. The taxable amount will be the fair market value of the financial assets assessed at the end of the calendar year.

LATVIA

There are no country specific provisions.

LITHUANIA

There are no country specific provisions.

MALTA

There are no country specific provisions.

MEXICO

Terms and Conditions

Labor Law Policy and Acknowledgment . By participating in the Plan, Holder expressly recognizes that Actavis plc, with registered offices at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054, U.S. , is solely responsible for the administration of the Plan and that Holder’s participation in the Plan and acquisition of shares of Common Stock does not constitute a relationship as


an Employee with the Company since Holder is participating in the Plan on a wholly commercial basis and his sole Employer is Allergan Servicios Profesionales de SA de CV (“Actavis-Mexico”). Based on the foregoing, Holder expressly recognizes that the Plan and the benefits that he may derive from participation in the Plan do not establish any rights between him and the Employer, Actavis-Mexico, and do not form part of the employment conditions and/or benefits provided by Actavis-Mexico and any modification of the Plan or its termination shall not constitute a change or impairment of the terms and conditions of Holder’s relationship as an employee.

Holder further understands that his participation in the Plan is as a result of a unilateral and discretionary decision of the Company. Therefore, the Company reserves the absolute right to amend and/or discontinue Holder’s participation at any time without any liability to Holder.

Finally, Holder hereby declares that Holder does not reserve to himself any action or right to bring any claim against the Company for any compensation or damages regarding any provision of the Plan or the benefits derived under the Plan, and Holder therefore grants a full and broad release to the Company, the Employer, its other Subsidiaries, branches, representation offices, its shareholders, officers, agents or legal representatives with respect to any claim that may arise.

Política de Ley Laboral y Reconocimiento. Participando en el Plan, el Tenedor de la acción reconoce expresamente que Actavis plc., , es el único responsable de la administración del Plan y que la participación del Tenedor de la acción en el mismo y la compra de acciones bursátiles no constituye de ninguna manera una relación laboral entre Usted y la Compañía dado que su participación en el Plan deriva únicamente de una relación comercial y que su único empleador es Allergan Servicios Profesionales de SA de CV (“Activas-Mexico”). Derivado de lo anterior,el Tenedor de la acción expresamente reconoce que el Plan y los beneficios que pudieran derivar del mismo no establecen ningún derecho entre el Tenedor de la acción y el empleador, Activas-Mexico, y no forman parte de las condiciones laborales y/o prestaciones otorgadas por Activas-Mexico, y cualquier modificación al Plan o la terminación del mismo no podrá ser interpretada como una modificación o degradación de los términos y condiciones de su trabajo.

Asimismo, entiendo que su participación en el Plan es resultado de la decisión unilateral y discrecional de la Compañía. Por lo tanto, la Compañía se reserva el derecho absoluto para modificar y/o terminar la participación del Tenedor de la acción en cualquier momento, sin ninguna responsabilidad ante el Tenedor de la acción.

Finalmente, el Tenedor de la acción manifiesta que no se reserva ninguna acción o derecho que origine una demanda en contra de la Compañía por cualquier compensación o daño en relación con cualquier disposición del Plan o de los beneficios derivados del mismo, y en consecuencia el Tenedor de la acción otorga un amplio y total finiquito a la Compañía, sucursales, oficinas de representación, sus accionistas, directores, agentes y representantes legales con respecto a cualquier demanda que pudiera surgir.

MOLDOVA

Notifications

Exchange Control Information . Holder must repatriate all proceeds received from the sale of shares of Common Stock to Moldova within a reasonable time from receipt.

NETHERLANDS

There are no country specific provisions.

NEW ZEALAND

There are no country specific provisions.

NORWAY

There are no country specific provisions.


POLAND

Notifications

Exchange Control Information . If Holder holds foreign securities (including shares of Common Stock) and maintains accounts abroad, Holder will be required to file certain reports with the National Bank of Poland on the transactions and balances of the securities and cash deposited in such accounts if the value of such transactions or balances exceeds PLN 7,000,000 in the aggregate. If required, Holder must file reports on the transactions and balances of the accounts on a quarterly basis on special forms available on the website of the National Bank of Poland.

In addition, if Holder transfers funds in excess of €15,000 into Poland in connection with the sale of shares of Common Stock under the Plan, the funds must be transferred via a bank account held at a bank in Poland. Holder is required to retain the documents connected with a foreign exchange transaction for a period of five years, as measured from the end of the year in which such transaction occurred.

PUERTO RICO

There are no country specific provisions.

ROMANIA

Notifications

Exchange Control Information . If Holder deposits the proceeds from the sale of shares of Common Stock issued to him at vesting and settlement of the Restricted Stock Units in a bank account in Romania, he may be required to provide the Romanian bank with appropriate documentation explaining the source of the funds. Holder should consult his personal advisor to determine whether he will be required to submit such documentation to the Romanian bank.

SERBIA

Notifications

Exchange Control Information . Pursuant to the Law on Foreign Exchange Transactions, Holder is permitted to acquire shares of Common Stock under the Plan, but a report may need to be made of the acquisition of such shares, the value of the shares at vesting and, on a quarterly basis, any changes in the value of the shares. An exemption from this reporting obligation may apply if the shares are acquired for no consideration. As the exchange control regulations in Serbia may change without notice, Holder should consult with his personal advisor with respect to all applicable reporting obligations.

SINGAPORE

Notifications

Securities Law Information . The award of Restricted Stock Units is being made in reliance of section 273(1)(f) of the Securities and Futures Act (Chapter 289) (“SFA”) the “Qualifying Persons” exemption under the SFA. The Plan has not been lodged or registered as a prospectus with the Monetary Authority of Singapore. Holder should note that the award of Restricted Stock Units is subject to section 257 of the SFA and Holder will not be able to make (i) any subsequent sale of shares of Common Stock in Singapore or (ii) any offer of such subsequent sale of shares subject to the Restricted Stock Units in Singapore, unless such sale or offer in is made pursuant to the exemptions under Part XIII Division (1) Subdivision (4) (other than section 280) of the SFA.

Director Notification Obligation . If Holder is a chief executive officer, director, associate director or shadow director of a Subsidiary of the Company or other related entity in Singapore, Holder is subject to certain notification requirements under the Singapore Companies Act. Among these requirements is an obligation to notify the Singapore Subsidiary of the Company in writing when Holder receives an interest


( e.g. , Restricted Stock Units or shares of Common Stock) in the Company or any related company. In addition, Holder must notify the Singapore Subsidiary of the Company when Holder sell shares of Common Stock or shares of any related company (including when Holder sell shares issued upon vesting of the Restricted Stock Units). These notifications must be made within two business days of acquiring or disposing of any interest in the Company or any related company. In addition, a notification of Holder’s interests in the Company or any related company must be made within two business days of becoming a chief executive officer or a director.

SLOVAKIA

Notifications

Foreign Asset / Account Reporting Information . Slovak Republic residents who carry on business activities as an independent entrepreneur ( podnikatel ) must report foreign assets (including any shares of Common Stock) to the National Bank of Slovakia (provided that the value of the foreign assets exceeds an amount of €2,000,000). These reports must be submitted on a monthly basis by the 15th day of the respective calendar month, as well as on a quarterly basis by the 15th day of the calendar month following the respective calendar quarter, using notification form DEV (NBS) 1-12, which may be found at the National Bank of Slovakia’s website at www.nbs.sk.

SOUTH AFRICA

Terms and Conditions

Responsibility for Taxes . The following provision supplements Section 3.8 of the Award Agreement:

By accepting the Restricted Stock Units, Holder agrees that, immediately upon the vesting of the Restricted Stock Units, Holder will notify the Company of the amount of any gain realized. If Holder fails to advise the Company of the gain realized upon vesting, Holder may be liable for any applicable fines and penalties. Holder will be solely responsible for paying any difference between the actual tax liability and the amount withheld.

Notifications

Exchange Control Information . If no transfer of funds from South Africa is required under the Restricted Stock Units, no filing or reporting requirements should apply when the Restricted Stock Units vest. However, because the exchange control regulations are subject to change, Holder should consult with his personal advisor prior to the vesting and settlement of the Restricted Stock Units to ensure compliance with current regulations. Holder is responsible for ensuring compliance with all exchange control laws in South Africa.

SPAIN

Terms and Conditions

Nature of Grant . By accepting the Stock Units, Holder acknowledges and agrees to be bound by the terms of the Plan and the Award Agreement, including this Appendix. Holder understands and agrees that the Company offers Restricted Stock Units without any previously existing obligation based on the terms and conditions in the Plan and the Award Agreement and conditioned on Holder’s express acceptance of those terms and conditions. But for Holder’s agreement to those terms and conditions, the Restricted Stock Units would not be granted.

Forfeiture upon Termination of Services . The following provision supplements Section 2.2 of the Award Agreement:

Holder acknowledges and agrees that the Restricted Stock Units will automatically cease vesting and be forfeited without any compensation whatsoever in the event of any type of Termination of Employment, regardless of the reason for the termination. The Plan does not under any circumstances permit vesting


after Termination of Employment including but not limited to cases of death, disability, retirement, unfair dismissal, constructive dismissal, resignation, or any other cases of termination. Given the possible required forfeiture under the Plan and Award Agreement, Holder should have no expectation that the Restricted Stock Units will eventually vest.

Holder understands and agrees that for purposes of the Restricted Stock Units, the date that Holder ceases providing active services to the Company, the Employer or any Subsidiary of the Company in the case of dismissal that is formalized pursuant to Spanish law will be the date of termination indicated in the letter of dismissal provided by the Employer, without prejudice to (i) any notice period that may be required by local law during which compensation may be due, (ii) any additional period during which social security payment obligations may continue, (iii) any post-termination interim salary (“ salarios de tramitación ”) that may be due, (iv) any official termination date that may apply under local law or due to court resolution or due to any settlement agreement agreed for other purposes, and/or (v) any other rights or obligations that may continue to exist under local law after the Termination of Employment. Upon Termination of Employment, Holder shall forfeit any Restricted Stock Units effective the date active services cease.

Language . A translation into Spanish of the Plan and the Award Agreement, including this Appendix, are attached to this document. In the event of any discrepancy between the meaning of the Spanish and English versions of the documents, the English version will prevail.

Notifications

Securities Law Information . No “offer of securities to the public,” as defined under Spanish law, has taken place or will take place in the Spanish territory regarding the Restricted Stock Units. No public offering prospectus has been, nor will it be, registered with the Comisión Nacional del Mercado de Valores (Spanish Securities Exchange Commission) (“CNMV”). Neither the Plan nor the Award Agreement constitutes a public offering prospectus and neither has been, nor will either be, registered with the CNMV.

Exchange Control Information . To participate in the Plan, Holder must comply with exchange control regulations in Spain. Holder is required to declare electronically to the Bank of Spain any securities accounts (including brokerage accounts held abroad), as well as the shares of Common Stock held in such accounts, depending on the value of the transactions during the prior tax year or the balances in such accounts as of December 31 of the prior tax year.

Holder also must declare any shares of Common Stock that are acquired under the Plan to the Dirección General de Comercio e Inversiones of the Ministry of Industry, Tourism and Commerce (the “DGCI”). After the initial declaration, the declaration must be filed with the DGCI on a Form D-6 on an annual basis each January while the shares are owned. However, if the value of the shares acquired under the Plan or the amount of the sale proceeds exceeds €1,502,530, the declaration must be filed within one month of the acquisition or sale, as applicable.

When receiving foreign payments exceeding €50,000 derived from the participation in the Plan ( e.g. , dividends or sales proceeds), Holder must inform the financial institution receiving the payment of the basis upon which such payment is made. Holder will need to provide the institution with certain information, including (i) his/her name, address and tax identification number, (ii) the name and corporate domicile of the Company, (iii) the amount of the payment and the currency used, (iv) the country of origin, (v) the reasons for the payment, and (vi) any further information that may be required.


Foreign Asset/Account Reporting Information . Holder understands that if he holds rights or assets ( e.g. , shares or cash held in a bank or brokerage account) outside of Spain with a value in excess of €50,000 per type of right or asset ( e.g. , shares of Common Stock, cash, etc.) as of December 31, he is required to report certain information regarding such rights and assets on tax form 720. After such rights and/or assets are initially reported, the reporting obligation will only apply for subsequent years if the value of any previously-reported rights or assets increases by more than €20,000. The reporting must be completed by the following March 31.

SWEDEN

There are no country specific provisions.

SWITZERLAND

Notifications

Securities Law Information . The grant of the Restricted Stock Units is considered a private offering in Switzerland and is, therefore, not subject to registration in Switzerland.

TURKEY

Notifications

Securities Law Information . The sale of shares of Common Stock acquired under the Plan is not permitted within Turkey. The sale of shares of Common Stock acquired under the Plan must occur outside of Turkey. The shares of Common Stock are currently traded on the New York Stock Exchange in the U.S. under the ticker symbol “ACT” and shares may be sold on this exchange.

UNITED ARAB EMIRATES

Notifications

Securities Law Information . Holder in the Plan is being offered only to eligible Employees and is in the nature of providing equity incentives to Employees in the United Arab Emirates. The Plan and the Award Agreement are intended for distribution only to such Employees and must not be delivered to, or relied on by, any other person. Prospective purchasers of the securities offered should conduct their own due diligence on the securities. The Emirates Securities and Commodities Authority has no responsibility for reviewing or verifying any documents in connection with the Plan. Neither the Ministry of Economy nor the Dubai Department of Economic Development have approved the Plan or the Award Agreement nor taken steps to verify the information set out therein, and have no responsibility for such documents.

UNITED KINGDOM

Terms and Conditions

Settlement Upon Vesting . The following provision supplements Section 2.3 of the Award Agreement:

Notwithstanding anything to the contrary in the Award Agreement or the Plan, the Restricted Stock Units will be settled in shares of Common Stock only, not cash.

Responsibility for Taxes . The following provision supplements Section 3.8 of the Award Agreement:

Holder agrees that, if Holder does not pay or the Employer or the Company does not withhold from Holder the full amount of income tax that Holder owes at vesting of the Restricted Stock Units, or the release or assignment of the Restricted Stock Units for consideration, or the receipt of any other benefit in connection with the Restricted Stock Units (the “Taxable Event”) within 90 days of the U.K. tax year within which the Taxable Event occurs, or such other period specified in Section 222(1)(c) of the U.K. Income Tax (Earnings and Pensions) Act 2003 (the “Due Date”), then the amount that should have been withheld shall constitute a loan owed by Holder to the Employer, effective as of the Due Date. Holder agrees that the loan will bear interest at the Her Majesty’s Revenue and Customs’ (“HMRC’s”) official rate and will be immediately due and repayable by Holder, and the Company and/or the Employer may recover it at any time thereafter by any of the means set forth in Section 3.8 of the Award Agreement.


Notwithstanding the foregoing, if Holder is an executive officer or director (as within the meaning of Section 13(k) of the Exchange Act), the terms of the immediately foregoing provision will not apply. In the event that Holder is an executive officer or director and income tax is not collected from or paid by Holder by the Due Date, the amount of any uncollected income tax may constitute a benefit to Holder on which additional income tax and National Insurance contributions (“NICs”) may be due. Holder will be responsible for reporting and accounting for any income tax due on this additional benefit directly to HMRC under the self-assessment regime and for reimbursing the Company or the Employer, as applicable, for the value of any NICs due on this additional benefit.

Joint Election . As a condition of participation in the Plan, the Holder agrees to accept any liability for secondary Class 1 NICs that may be payable by the Company or the Employer (or any successor to the Company or the Employer) in connection with the Restricted Stock Units and any event giving rise to Tax-Related Items (the “Employer NICs”). The Employer NICs may be collected by the Company or the Employer using any of the methods described in the Plan or in Section 3.8 the Agreement.

Without prejudice to the foregoing, the Holder agrees to execute a joint election with the Company and/or the Employer (a “Joint Election”), the form of such Joint Election being formally approved by HMRC, and any other consent or elections required by the Company or the Employer in respect of the Employer NICs liability. The Holder further agrees to execute such other elections as may be required by any successor to the Company and/or the Employer for the purpose of continuing the effectiveness of the Holder’s Joint Election.

UNITED STATES

Notifications

Foreign Asset/Account Reporting Information . The Foreign Account Tax Compliance Act (“FATCA”) pertains to U.S. taxpayers who participate in or hold equity-based awards in one or more equity compensation plans offered by the Company, including Restricted Stock Units. Under FATCA, the Company is considered a “non-U.S. issuer” with the result that Holder may have reporting obligations on Form 8938 when filing his annual income tax return (Form 1040). Information regarding Form 8938 is available at www.irs.gov/pub/irs-pdf/i8938.pdf .

These reporting obligations apply to the extent the aggregate value of Holder’s holdings (when aggregated with other specified foreign financial assets held by Holder) exceed certain thresholds. The threshold amounts of the value of the equity holdings (and other foreign assets) that trigger the reporting obligations depend on Holder’s filing status ( e.g. , unmarried/married filing separately) and whether Holder resides in the U.S. or outside of the U.S. Shares of Common Stock issued by a non-U.S. issuer that are held in a financial account maintained by a U.S. financial institution (such as a brokerage firm) are not subject to these reporting requirements. However, it is not clear under current guidance whether rights to acquire shares of Common Stock, such as Restricted Stock Units ( i.e. , as opposed to shares of Common Stock Holder owns), are eligible for this exception. Holder should consult his personal tax advisor to determine whether these FATCA reporting requirements apply to him as a result of his equity holdings in the Company, including the Restricted Stock Units or shares of Common Stock Holder acquires under the Plan.


ANNEX 1 TO FOREIGN COUNTRY APPENDIX

Countries where cash must be paid in settlement of RSUs

Albania

Belarus

Czech Republic

Estonia

Hungary

Japan

Kazakhstan

Kosovo

Malaysia

Mongolia

Russian Federation

Saudi Arabia

South Africa

Thailand

Ukraine

Uzbekistan

Vietnam

Exhibit 10.37

 

LOGO

I NSTRUCTIONS

Restricted Stock Units

A Long Term Incentive Award

(The Agreement begins after this page)

You will be deemed to have accepted this Restricted Stock Unit award and agreed to be bound by the terms and conditions of the Notice of Grant, the Restricted Stock Unit Agreement and the Plan (as defined in such Notice) unless you inform the Company in writing that you wish to decline the Restricted Stock Unit award.

To decline the Restricted Stock Unit Award, please send written notice of your decision to decline this Restricted Stock Unit award to the Stock Plan Administrator as follows:

 

    via e-email

 

    tara.alford@actavis.com

 

    via inter-office mail

 

    Stock Plan Administrator, Morris Corporate Center III, Building A, Third Floor

 

    or via regular mail to

Actavis plc

Attn: Stock Plan Administrator

400 Interpace Parkway

Morris Corporate Center III

Parsippany, NJ 07054

In order to be effective, your written notice to decline the Restricted Stock Unit Award must be received by the Stock Plan Administrator prior to the date that is 30 days immediately following the Date of Grant set forth on the Notice of Grant. The company, including its stock plan administration, will not be responsible for any delivery delay of your notice for any reason.

If you do not decline this Restricted Stock Unit award within 30 days immediately following the Date of Grant, you will be deemed to have accepted this Restricted Stock Unit award. Should you choose to decline this grant; the grant will be updated to reflect your decision.


NOTICE OF GRANT

Congratulations, you (“Holder”) have been granted an award of restricted stock units (the “Restricted Stock Units” or “RSUs”). Each Restricted Stock Unit represents the right to receive one ordinary share of Actavis plc, a public limited company organized under the laws of Ireland (the “Company”), as successor to Actavis, Inc, or in certain jurisdictions, the cash equivalent thereof. The Restricted Stock Unit award is subject to the terms and conditions of the Award Agreement and and The Amended and Restated Allergan, Inc. 2011 Incentive Award Plan, as amended from time to time (the “Plan”), which are attached hereto as Exhibits 1-A and 1-B, respectively, and of which this Notice of Grant is a part. By accepting (or being deemed to have accepted) the Restricted Stock Unit award (including, in the case of Holders residing outside the United States (“Foreign Holders”), the Foreign Country Appendix), you represent and warrant to the Company that you have read the Award Agreement (including, in the case of Foreign Holders, the Foreign Country Appendix) and the Plan and agree to be bound by their terms and conditions. Capitalized terms not otherwise defined in this Notice of Grant shall be as defined in the Plan and the Award Agreement.

Subject to the terms and conditions of the Award Agreement (including, in the case of Foreign Holders, the Foreign Country Appendix) and the Plan, the terms and conditions of this Restricted Stock Unit award are set forth below:

 

Holder’s Name:    Number of RSUs Granted:
Date of Grant:   

Subject to the terms and restrictions of the Award Agreement (including, in the case of Foreign Holders, the Foreign Country Appendix) and the Plan, the Restricted Stock Units shall be eligible to become vested in accordance with the following schedule:

 

On and After This Date

   The Restricted Stock Units Shall
Becoming Fully Vested on the Date Shown.
 

Total Shares:

     [                


EXHIBIT 1-A

RESTRICTED STOCK UNIT AWARD AGREEMENT

THIS AWARD AGREEMENT, dated as of the Date of Grant appearing on the Notice of Grant, is made by and between Actavis plc, a public limited company organized under the laws of Ireland (the “Company”), as successor to Allergan, Inc., and the Employee, Director or Consultant whose name and signature appear on the Notice of Grant and Signature Page hereof (“Holder”).

WHEREAS, the Company wishes to grant to Holder an award of restricted stock units (the “Restricted Stock Units” or “RSUs”), pursuant to the terms and conditions and restrictions of the Notice of Grant, this Award Agreement (including, in the case of Foreign Holders, the Foreign Country Appendix) and The Allergan Inc. 2011 Incentive Award Plan, as amended from time to time (the terms of which are hereby incorporated by reference and made a part of this Award Agreement, the “Plan”); and

WHEREAS, it has been determined that it would be to the advantage and best interest of the Company and its shareholders to grant Holder the Restricted Stock Units as an inducement to enter into or remain in the service of the Company or its Subsidiaries and as an incentive for increased efforts during such service.

NOW, THEREFORE, in consideration of the mutual covenants herein contained and other good and valuable consideration, receipt of which is hereby acknowledged, the parties hereto do hereby agree as follows:

ARTICLE I

GRANT OF RESTRICTED STOCK UNITS

Section 1.1 Grant of Restricted Stock Units . In consideration of the recitals, Holder’s agreement to remain in the employ or service of the Company or a Subsidiary, and for other good and valuable consideration, the Company grants to Holder an award of Restricted Stock Units as specified in the Notice of Grant upon the terms and conditions set forth in this Award Agreement (including, the in the case of Foreign Holders, the Foreign Country Appendix).

Section 1.2 Consideration to the Company . As partial consideration for the grant of the Restricted Stock Units by the Company, Holder agrees to render faithful and efficient services to the Company or a Subsidiary. Nothing in this Award Agreement or in the Plan shall confer upon Holder any right to continue in the employ or services of the Company or any Subsidiary, or as a director of the Company, or shall interfere with or restrict in any way the rights of the Company and any Subsidiary, which are hereby expressly reserved, to discharge Holder at any time for any reason whatsoever, with or without cause, except to the extent expressly provided otherwise in a written employment or other agreement between Holder and the Company and any Subsidiary.

Section 1.3 Adjustments in Restricted Stock Units . The Administrator may adjust the Restricted Stock Units in accordance with the provisions of Section 14.2 of the Plan.


ARTICLE II

VESTING AND PAYMENT OF RESTRICTED STOCK UNITS

Section 2.1 Vesting Schedule . Subject to Section 2.2 hereof and except as may be otherwise provided pursuant to Company policy, a valid employment agreement or otherwise, in each case as and to the extent applicable, the Restricted Stock Units will vest and become nonforfeitable with respect to each portion thereof upon satisfaction of the conditions specified in the applicable vesting schedule set forth on the Notice of Grant, subject to Holder’s continued employment or services through the applicable vesting dates, as a condition to the vesting of the applicable installment of the RSUs and the rights and benefits under this Award Agreement. For the avoidance of doubt, for purposes of determining the vesting date, any performance conditions will be considered to be satisfied (to the extent that they are determined to be satisfied) as of the last day of the applicable performance period. Unless otherwise determined by the Administrator, partial employment or service, even if substantial, during any vesting period will not entitle Holder to any proportionate vesting or avoid or mitigate a termination of rights and benefits upon or following a Termination of Service, Consultancy or Directorship as provided in Section 2.2 hereof or under the Plan.

Section 2.2 Forfeiture, Termination and Cancellation upon Termination of Services . Except as may be otherwise provided pursuant to Company policy, a valid employment agreement or otherwise, in each case as and to the extent applicable, in the event of Holder’s Termination of Service, Consultancy or Directorship, all unvested RSUs subject to this Award Agreement as of the date of such Termination shall thereupon be automatically forfeited, terminated and cancelled as of the applicable termination date without payment of any consideration by the Company, and Holder, or Holder’s beneficiaries or personal representatives, as the case may be, shall have no further rights hereunder.

Section 2.3 Payment Upon Vesting . As soon as administratively practicable following the vesting of any Restricted Stock Units pursuant to Section 2.1, but in no event later than seventy-five (75) days after such vesting date (for the avoidance of doubt, this deadline is intended to comply with the “short-term deferral” exemption from Section 409A of the Code for Holders subject thereto), the Company shall deliver to Holder (or any transferee permitted under the Plan): (a) a number of fully vested shares of Common Stock equal to the number of Restricted Stock Units that vest on the applicable vesting date or (b) an amount of cash with a value equal to the Fair Market Value of a number of shares of Common Stock equal to the number of Restricted Stock Units that vest on the applicable vesting date, in the Company’s discretion in each case unless such Restricted Stock Units terminate prior to the given vesting date pursuant to Section 2.2 hereof. Notwithstanding the foregoing, in the event shares of Common Stock are otherwise payable pursuant to the preceding sentence but cannot be issued pursuant to Section 3.2 (a), (b) (c) or (d) hereof, then the shares of Common Stock shall be issued pursuant to the preceding sentence as soon as administratively practicable after the Administrator determines that shares of Common Stock can again be issued in accordance with Section 3.2 (a), (b) (c) or (d) hereof.

Section 2.4 Grant is Not Transferable . Except as provided herein, Holder (and Holder’s legal representative) shall not sell, exchange, transfer, alienate, hypothecate, pledge, encumber or assign the Restricted Stock Units subject to this Award Agreement other than by will or the laws of descent and distribution, unless and until the shares of Common Stock underlying the Restricted Stock Units have been issued. Neither the Restricted Stock Units subject to this Award Agreement nor any interest or right therein or part thereof shall be liable for the debts, contracts, or engagements of Holder or his successors in interest or shall be subject to disposition by transfer, alienation, anticipation, pledge, encumbrance, assignment or any other means whether such disposition be voluntary or involuntary or by operation of law by judgment, levy, attachment, garnishment or any other legal or equitable proceedings (including bankruptcy) and any attempted disposition thereof shall be null and void and of no effect; provided , however , that, this Section 2.4 shall not prevent transfers subject to the consent of the Administrator, pursuant to a DRO or an analogous non-United States order or procedure.


ARTICLE III

OTHER PROVISIONS

Section 3.1 Administration . The Administrator shall have the power to interpret the Plan and this Award Agreement, and to adopt such rules for the administration, interpretation and application of the Plan as are consistent therewith, to interpret, amend or revoke any such rules and to amend this Award Agreement, provided that the rights or obligations of Holder are not affected adversely. All actions taken and all interpretations and determinations made by the Administrator in good faith shall be final and binding upon Holder, the Company and all other interested persons. No member of the Administrator shall be personally liable for any action, determination or interpretation made in good faith with respect to the Plan or the Restricted Stock Units.

Section 3.2 Conditions to Issuance of Stock Certificates . Any Common Stock issuable hereunder may be either previously authorized but unissued shares or issued shares which have then been reacquired by the Company and are held as treasury shares available for re-issue. Such shares shall be fully paid and nonassessable. The Company shall not be required to issue or deliver any certificate or certificates (or any account or other evidence representing issuance) for shares of Common Stock or other cash, stock or other property pursuant to this Award Agreement prior to fulfillment of all of the following conditions:

(a) The admission of such shares to listing on all stock exchanges on which such class of stock is then listed, if applicable; and

(b) The completion of any registration or other qualification of such shares under any applicable law or under rulings or regulations of the Securities and Exchange Commission or of any other governmental regulatory body, if applicable, or the receipt of further representations from Holder as to investment intent or completion of other actions necessary to perfect exemptions, as the Administrator shall, in its absolute discretion, deem necessary or advisable; and

(c) The obtaining of any approval or other clearance from any governmental agency which the Administrator shall, in its absolute discretion, determine to be necessary or advisable; and

(d) The lapse of such reasonable period of time as the Administrator may from time to time establish for reasons of administrative convenience; and

(e) The receipt by the Company of payment of any applicable withholding tax in accordance with Section 3.7.

Section 3.3 Rights as Shareholder . Holder shall not be, nor have any of the rights or privileges of, a shareholder of the Company, including, without limitation, voting rights and rights to dividends, in respect of the Restricted Stock Units or any shares of Common Stock issuable thereunder unless and until any such shares shall have been issued by the Company and held of record by Holder pursuant to Section 2.3. No adjustment to the Restricted Stock Units will be made for a dividend or other right for which the record date is prior to the date, if any, the shares of Common Stock are issued, except as provided in Section 14.2 of the Plan. Except as otherwise provided herein, upon the delivery of Common Stock, hereunder, Holder shall have all the rights of a shareholder with respect to the Common Stock, including the right to vote the Common Stock and the right to receive all dividends or other distributions paid or made with respect to the Common Stock.


Section 3.4 Notices . Any notice to be given under the terms of this Award Agreement to the Company shall be addressed to the Company in care of its Secretary, and any notice to be given to Holder shall be addressed to him at the address given beneath his signature hereto. By a notice given pursuant to this Section 4.4, either party may hereafter designate a different address for notices to be given to him. Any notice which is required to be given to Holder shall, if Holder is then deceased, be given to Holder’s personal representative if such representative has previously informed the Company of his status and address by written notice under this Section 4.4. Any notice shall be deemed duly given when enclosed in a properly sealed envelope or wrapper addressed as aforesaid, deposited (with postage prepaid) in a post office or branch post office regularly maintained by the United States Postal Service.

Section 3.5 Titles and Construction . Titles are provided herein for convenience only and are not to serve as a basis for interpretation or construction of this Award Agreement. This Award Agreement shall be administered, interpreted and enforced under the internal laws of the State of New Jersey, without regard to conflicts of laws thereof.

Section 3.6 Conformity to Securities Laws . Holder acknowledges that the Plan and this Award Agreement are intended to conform to the extent necessary with all provisions of all applicable laws, rules and regulations (including, but not limited to the Securities Act and the Exchange Act and any and all regulations and rules promulgated by the Securities and Exchange Commission thereunder, including without limitation the applicable exemptive conditions of Rule 16b-3) and to such approvals by any listing, regulatory or other governmental authority as may, in the opinion of counsel for the Company, be necessary or advisable in connection therewith. Notwithstanding anything herein to the contrary, the Plan shall be administered, and the Restricted Stock Units and Restricted Stock award granted, only in such a manner as to conform to such laws, rules and regulations. To the extent permitted by applicable law, the Plan, this Award Agreement and the Restricted Stock Units and Restricted Stock award shall be deemed amended to the extent necessary to conform to such laws, rules and regulations.

Section 3.7 Tax Withholding . In the case of Employees, the Company (or a Subsidiary) shall be entitled to require payment in cash or deduction from any shares of Common Stock or cash payable under this Restricted Stock Unit award or other compensation payable to Holder of any sums required pursuant to applicable tax law to be withheld with respect to the issuance, vesting or payment of this Restricted Stock Unit award or the shares of Common Stock or cash. Except as otherwise provided by the Administrator in its discretion, in satisfaction of the foregoing requirement, the Company shall withhold shares of Common Stock or cash payable under this Restricted Stock Unit award and Holder hereby elects to transfer and deliver to the Company such cash or shares of Common Stock having a Fair Market Value equal to the sums required to be withheld. Notwithstanding any other provision of the Plan and this Award Agreement, the shares of Common Stock or cash which may be withheld with respect to the issuance, vesting or payment of this Restricted Stock Unit award or the shares of Common Stock in order to satisfy Holder’s income taxes and payroll tax liabilities and, in the case of Foreign Holders, social insurance, with respect to the issuance, vesting or payment of this Restricted Stock Unit award or the shares of Common Stock or cash shall be limited to the number of shares which have a Fair Market Value, or cash with a value, on the date of withholding equal to the aggregate amount of such liabilities based on the minimum statutory withholding rates for income tax and payroll tax purposes that are applicable to such supplemental taxable income, or such other rate as may be required by applicable law, rule or regulation as determined by the Administrator. If Common Stock is payable under this Restricted Stock Unit Award, the Company shall not be obligated to deliver any new certificate representing shares of Common Stock to Holder or Holder’s legal representative or enter such share of Common Stock in


book entry form unless and until Holder or Holder’s legal representative shall have paid or otherwise satisfied in full the amount of all taxes applicable to the taxable income of Holder resulting from the grant of the Restricted Stock Units or the issuance or vesting of shares of Common Stock. In the case of Directors and Consultants, Holder shall be solely responsible for all applicable income and self-employment taxes and other wage deductions incurred in connection with the issuance, vesting or payment of this Restricted Stock Unit Award or the shares of Common Stock or cash payable hereunder. Unless required to do by applicable law, the Company shall not pay or withhold any taxes of any kind with respect to Restricted Stock Unit Awards of Directors and Consultants.

Section 3.8 Authorization to Release Necessary Personal Information .

(a) In the case of Foreign Holders, Holder hereby authorizes and directs Holder’s employer or the entity to which Holder provides services to collect, use and transfer in electronic or other form, any personal information (the “Data”) regarding Holder’s employment or services, the nature and amount of Holder’s compensation and the fact and conditions of Holder’s participation in the Plan (including, but not limited to, Holder’s name, home address, telephone number, date of birth, social security number (or other applicable social or national identification number), salary, nationality, job title, number of shares of Common Stock held and the details of all Restricted Stock Units or any other entitlement to shares of Common Stock awarded, cancelled, exercised, vested, unvested or outstanding) for the purpose of implementing, administering and managing Holder’s participation in the Plan. Holder understands that the Data may be transferred to the Company or any of its Subsidiaries, or to any third parties assisting in the implementation, administration and management of the Plan, including any requisite transfer to a broker or other third party assisting with the grant of Restricted Stock Units under the Plan or with whom shares of Common Stock or cash acquired upon settlement of Restricted Stock Units may be deposited. Holder acknowledges that recipients of the Data may be located in different countries, and those countries may have data privacy laws and protections different from those in the country of Holder’s residence. Furthermore, Holder acknowledges and understands that the transfer of the Data to the Company or any of its Subsidiaries, or to any third parties, is necessary for Holder’s participation in the Plan.

(b) Holder may at any time withdraw the consents herein, by contacting Holder’s local human resources representative in writing. Holder further acknowledges that withdrawal of consent may affect Holder’s ability to realize benefits from the Restricted Stock Units, and Holder’s ability to participate in the Plan.

Section 3.9 No Entitlement or Claims for Compensation .

(a) Holder’s rights, if any, in respect of or in connection with Restricted Stock Unit or any other award is derived solely from the discretionary decision of the Company to permit Holder to participate in the Plan and to benefit from a discretionary award. By accepting this Restricted Stock Unit award, Holder expressly acknowledges that there is no obligation on the part of the Company to continue the Plan and/or grant any additional awards to Holder. This Restricted Stock Unit award is not intended to be compensation of a continuing or recurring nature, or part of Holder’s normal or expected compensation, and in no way represents any portion of Holder’s salary, compensation or other remuneration for purposes of pension benefits, severance, redundancy, resignation or any other purpose.

(b) Neither the Plan nor this Restricted Stock Unit award or any other award granted under the Plan shall be deemed to give Holder a right to remain an Employee, Consultant or Director of the Company, a Subsidiary or parent or any other affiliate. The Company and its Subsidiaries, parents and affiliates, as applicable, reserve the right to Terminate the Consultancy, Directorship or Employment of Holder, as applicable, at any time, with or without cause, and for any reason, subject to applicable


laws, the Company’s Certificate of Incorporation and Bylaws and a written employment or other agreement (if any), and Holder shall be deemed irrevocably to have waived any claim to damages or specific performance for breach of contract or dismissal, compensation for loss of office, tort or otherwise with respect to the Plan, this Restricted Stock Unit award or any outstanding award that is forfeited and/or is terminated by its terms or to any future award.

Section 3.10 Electronic Delivery . The Company may, in its sole discretion, decide to deliver any documents related to Holder’s current or future participation in the Plan by electronic means or to request Holder’s consent to participate in the Plan by electronic means. Holder hereby consents to receive such documents by electronic delivery and agrees to participate in the Plan through an on-line or electronic system established and maintained by the Company or a third party designated by the Company.

Section 3.11 Foreign Country Appendix . In the case of Foreign Holders, notwithstanding any provisions in this Award Agreement, the Restricted Stock Unit award shall be subject to any special terms and conditions set forth in the Foreign Country Appendix to this Award Agreement for Holder’s country of residence. Moreover, if Holder relocates to one of the countries included in the Foreign Country Appendix, the special terms and conditions for such country will apply to Holder, to the extent the Company determines that the application of such terms and conditions is necessary or advisable in order to comply with local law or facilitate the administration of the Plan. The Foreign Country Appendix constitutes part of this Award Agreement.

Section 3.12 Authorization to Release Necessary Personal Information .

(a) In the case of Foreign Holders, Holder hereby authorizes and directs Holder’s employer or the entity to which Holder provides services to collect, use and transfer in electronic or other form, any personal information (the “Data”) regarding Holder’s employment or services, the nature and amount of Holder’s compensation and the fact and conditions of Holder’s participation in the Plan (including, but not limited to, Holder’s name, home address, telephone number, date of birth, social security number (or other applicable social or national identification number), salary, nationality, job title, number of shares of Common Stock held and the details of all awards of Restricted Stock Units or any other entitlement to shares of Common Stock awarded, cancelled, exercised, vested, unvested or outstanding) for the purpose of implementing, administering and managing Holder’s participation in the Plan. Holder understands that the Data may be transferred to the Company or any of its Subsidiaries, or to any third parties assisting in the implementation, administration and management of the Plan, including any requisite transfer to a broker or other third party assisting with the grant of Restricted Stock Units under the Plan or with whom shares of Common Stock or cash acquired upon sale of the Common Stock may be deposited. Holder acknowledges that recipients of the Data may be located in different countries, and those countries may have data privacy laws and protections different from those in the country of Holder’s residence. Furthermore, Holder acknowledges and understands that the transfer of the Data to the Company or any of its Subsidiaries, or to any third parties, is necessary for Holder’s participation in the Plan.

(b) Holder may at any time withdraw the consents herein, by contacting Holder’s local human resources representative in writing. Holder further acknowledges that withdrawal of consent may affect Holder’s ability to realize benefits from the award of Restricted Stock Units, and Holder’s ability to participate in the Plan.


ARTICLE IV

DEFINITIONS

All capitalized terms used herein without definition shall have the meanings ascribed to such terms in the Plan. The masculine pronoun shall include the feminine and neuter, and the singular the plural, where the context so indicates.


COUNTRY APPENDIX

TO EXHIBIT 1-A

ADDITIONAL TERMS AND CONDITIONS

Capitalized terms, unless explicitly defined in this Country Appendix, shall have the meanings given to them in the Award Agreement or in the Plan.

Terms and Conditions

This Appendix includes additional terms and conditions that govern the Restricted Stock Units granted to Holder under the Plan if Holder resides in one of the countries listed below. If Holder is a citizen or resident (or is considered as such for local law purposes) of a country other than the country in which Holder is currently residing and/or working, or if Holder transfers to another country after receiving the Restricted Stock Units, the Company shall, in its discretion, determine to what extent the special terms and conditions contained herein shall be applicable to Holder.

Notifications

This Appendix also includes information regarding securities, exchange control, tax and certain other issues of which Holder should be aware with respect to his participation in the Plan. The information is based on the securities, exchange control, tax and other laws in effect in the respective countries as of April 2015. Such laws are often complex and change frequently. As a result, the Company strongly recommends that Holder not rely on the information in this Appendix as the only source of information relating to the consequences of his participation in the Plan because the information may be out of date at the time that the Restricted Stock Units vest or Holder sells shares of Common Stock acquired under the Plan.

In addition, the information contained herein is general in nature and may not apply to Holder’s particular situation and the Company is not in a position to assure Holder of a particular result. Accordingly, Holder are advised to seek appropriate professional advice as to how the relevant laws in his country may apply to his individual situation.

Finally, if Holder is a citizen or resident (or is considered as such for local tax purposes) of a country other than the one in which Holder is currently residing and/or working, or if Holder transfers to another country after the grant of the Restricted Stock Units, the information contained herein may not be applicable to Holder in the same manner.


AUSTRALIA

Terms and Conditions

Australian Offer Document . The offer of Restricted Stock Units is intended to comply with the provisions of the Corporations Act 2001, ASIC Regulatory Guide 49 and ASIC Class Order CO 14/1000. Additional details are set forth in the Offer Document for the offer of Restricted Stock Units to Australian resident employees, which will be provided to Holder with this Award Agreement.

Notifications

Securities Law Information . If Holder acquires shares of Common Stock pursuant to Restricted Stock Units and offers these shares for sale to a person or entity resident in Australia, the offer may be subject to disclosure requirements under Australian law. Holder should obtain legal advice on disclosure obligations prior to making any such offer.

Exchange Control Information . Exchange control reporting is required for cash transactions exceeding A$10,000 and international fund transfers. The Australian bank assisting with the transaction will file the report. If there is no Australian bank involved in the transfer, Holder will be required to file the report.

AUSTRIA

Notifications

Exchange Control Information . If Holder holds shares of Common Stock obtained through the Plan outside of Austria, Holder may be required to submit reports to the Austrian National Bank as follows: (i) on a quarterly basis if the value of the shares as of any given quarter meets or exceeds €30,000,000; and (ii) on an annual basis if the value of the shares as of December 31 meets or exceeds €5,000,000. The quarterly reporting date is as of the last day of the respective quarter; the deadline for filing the quarterly report is the fifteenth day of the month following the end of the respective quarter. The deadline for filing the annual report is January 31 of the following year.

When shares are sold, Holder may be required to comply with certain exchange control obligations if the cash proceeds from the sale are held outside Austria. If the transaction volume of all Holder’s accounts abroad meets or exceeds €3,000,000, the movements and balances of all accounts must be reported monthly, as of the last day of the month, on or before the fifteenth day of the following month.

AZERBAIJAN

Notifications

Securities Law Information . Holder understands that the Award Agreement, the Plan and all other materials he may receive regarding his participation in the Plan do not constitute advertising or offering of securities in Azerbaijan. The issuance of securities pursuant to the Plan has not been and will not be registered in Azerbaijan and, therefore, the securities described in any Plan-related documents may not be used for sale or public circulation in Azerbaijan. Further, Holder understands that the shares of Common Stock issued upon vesting of the Restricted Stock Units will be deposited into a Company-designated brokerage account in the U.S. as soon as practical after the applicable vesting date and in no event will shares issued upon vesting of the Restricted Stock Units be delivered to Holder in Azerbaijan. Any disposition or sale of such shares must take place outside Azerbaijan, which will be the case if the shares are sold on the New York Stock Exchange.


BELGIUM

Notifications

Foreign Asset/Account Reporting Information . Holder is required to report any securities ( e.g. , shares of Common Stock acquired under the Plan) or bank accounts (including brokerage accounts) held outside of Belgium on his annual tax return. Holder is also required to complete a separate report providing the National Bank of Belgium with details regarding any such account, including the account number, the name of the bank in which such account is held and the country in which such account is located.

BRAZIL

Terms and Conditions

Nature of Grant . The following provision supplements Section 1.2 of the Award Agreement:

In accepting the Restricted Stock Units, Holder acknowledges, understands and agrees that (i) Holder is making an investment decision, (ii) Holder will be entitled to vest in, and receive shares of Common Stock pursuant to, the Restricted Stock Units only if the vesting conditions are met and any necessary services are rendered by Holder between the Date of Grant and the vesting date, and (iii) the value of the underlying shares is not fixed and may increase or decrease without compensation to Holder.

Compliance with Law . In accepting the Restricted Stock Units, Holder agrees to comply with all applicable Brazilian laws and report and pay any and all applicable taxes associated with the vesting and settlement of the Restricted Stock Units, the sale of any shares acquired under the Plan, and the receipt of any dividends.

Notifications

Exchange Control Information . If Holder is a resident or domiciled in Brazil, he will be required to submit an annual declaration of assets and rights held outside of Brazil to the Central Bank of Brazil if the aggregate value of such assets and rights is equal to or greater than US$100,000. The assets and rights that must be reported include shares of Common Stock acquired under the Plan.

BULGARIA

Notifications

Exchange Control Information . If Holder receives a payment related to the Plan in Bulgaria in excess of BGN 100,000 (or its equivalent in another currency, e.g. , U.S. dollars), Holder should submit a form with information regarding the source of the income to the bank receiving such payment (for statistical purposes) upon transfer or within 30 days as of receipt. Holder should contact his bank in Bulgaria for additional information regarding this requirement.


CANADA

Terms and Conditions

Settlement Upon Vesting . The following provision supplements Section 2.3 of the Award Agreement:

Notwithstanding anything to the contrary in the Award Agreement or the Plan, the Restricted Stock Units will be settled in shares of Common Stock only, not cash.

Forfeiture upon Termination of Services . The following sentence replaces the first sentence of the second paragraph of Section 2.2 of the Award Agreement:

For purposes of the Restricted Stock Units, Holder’s employer-employee or service relationship will be considered terminated as of the date that is the earlier of: (1) the date of Termination of Employment, (2) the date Holder receives notice of termination from the Employer, or (3) the date Holder is no longer actively providing services, regardless of any notice period or period of pay in lieu of such notice required under applicable law (including, but not limited to statutory law, regulatory law and/or common law).

The following provisions will apply to Holder if he is a resident of Quebec:

Language Consent . The parties acknowledge that it is their express wish that the Award Agreement, as well as all addenda, documents, notices, and legal proceedings entered into, given or instituted pursuant hereto or relating directly or indirectly hereto, be drawn up in English.

Les parties reconnaissent avoir exigé la rédaction en anglais de cette Convention, ainsi que de tous documents exécutés, avis donnés et procédures judiciaries intentées, directement ou indirectement, relativement à ou suite à la présente convention.

Data Privacy . The following provision supplements Section 3.9 of the Award Agreement:

Holder hereby authorizes the Company and the Company’s representatives to discuss and obtain all relevant information from all personnel, professional or non-professional, involved in the administration of the Plan. Holder further authorizes the Company, the Employer, its other Subsidiaries and the Administrator to disclose and discuss the Plan with their advisors. Holder further authorizes the Company, the Employer and any other Subsidiary of the Company to record such information and to keep such information in Holder’s employee file.

Notifications

Securities Law Information . Holder acknowledges that he is permitted to sell shares of Common Stock acquired under the Plan through the designated broker appointed under the Plan, if any, provided the sale of the shares acquired under Plan takes place outside of Canada through the facilities of a stock exchange on which the shares of Common Stock are listed ( i.e. , the New York Stock Exchange).

Foreign Asset/Account Reporting Information . Holder must report annually on Form T1135 (Foreign Income Verification Statement) the foreign property (including shares of Common Stock acquired under the Plan) he holds, if the total value of such foreign property exceeds C$100,000 at any time during the year. Unvested Restricted Stock Units also must be reported (generally at nil cost) on Form 1135 if the C$100,000 threshold is exceeded due to other foreign property held by Holder. The Form T1135 must be filed at the same time Holder files his annual tax return. Holder should consult his personal legal advisor to ensure compliance with applicable reporting obligations.


CHINA

Terms and Conditions

The following Terms and Conditions apply only to Holder if he is subject to the exchange control restrictions and regulations in China, including the requirements imposed by the State Administration of Foreign Exchange (“SAFE”), as determined by the Company in its sole discretion.

Vesting Schedule and Forfeiture Upon Termination . The following supplements Sections 2.1 and 2.2 of the Award Agreement:

Notwithstanding to anything to the contrary in the Award Agreement or the Plan, the Restricted Stock Units shall not vest unless and until the Company, the Employer or any other Subsidiary of the Company in China receives all necessary approvals from the SAFE or its local counterpart under the Implementing Rules of the Measures for Administration of Foreign Exchange of Individuals to offer such awards in China. Once SAFE approval has been received and provided Holder continues to be an Employee of the Company or a Subsidiary of the Company, Holder will receive a vesting credit for that portion of the Restricted Stock Units that would have vested prior to obtaining SAFE approval, if applicable, and the remaining portion of the Restricted Stock Units will vest in accordance with the Award Agreement. If Holder ceases to be an Employee prior to the receipt of SAFE approval, any unvested Restricted Stock Units will be forfeited.

Sale of Shares . Due to local regulatory requirements, upon the vesting of Restricted Stock Units, Holder agrees to the immediate sale of any shares of Common Stock issued under the Restricted Stock Units. Holder further agrees that the Company is authorized to instruct its designated broker to assist with the mandatory sale of such shares of Common Stock (on his behalf pursuant to this authorization) and Holder expressly authorizes the Company’s designated broker to complete the sale of such shares of Common Stock. Holder acknowledges that the Company’s designated broker is under no obligation to arrange for the sale of the shares of Common Stock at any particular price. Upon the sale of the shares of Common Stock, the Company agrees to pay Holder the cash proceeds from the sale of the shares of Common Stock, less any brokerage fees or commissions and subject to any obligation to satisfy any Tax-Related Items. Holder understands that the proceeds from the sale of shares may need to be repatriated to China pursuant to the below provision, and Holder agrees to comply with all requirements the Company may impose in order to facilitate compliance with exchange control requirements in China prior to receipt of the cash proceeds. Holder acknowledges that he is not aware of any material nonpublic information with respect to the Company or any securities of the Company as of the date of the Award Agreement.

Exchange Control Requirements . Holder understands and agrees that, pursuant to local exchange control requirements, Holder will be required to repatriate the cash proceeds from the immediate sale of the shares of Common Stock and the receipt of any dividends to China. Holder further understands that, under local law, such repatriation of the cash proceeds may need to be effectuated through a special exchange control account established by the Company, the Employer or Subsidiary of the Company, and Holder hereby consents and agrees that any proceeds from the sale of any shares of Common Stock Holder acquires upon the vesting of Restricted Stock Units may be transferred to such special account prior to being delivered to him.


Holder also understands that the Company will deliver the proceeds to him as soon as possible, but there may be delays in distributing the funds to him due to exchange control requirements in China. Proceeds will be paid to Holder in U.S. dollars. Holder will be required to set up a U.S. dollar bank account in China so that the proceeds may be deposited into this account.

Holder further agrees to comply with any other requirements that may be imposed by the Company in the future in order to facilitate compliance with exchange control requirements in China.

Notifications

Exchange Control Information . Holder may be required to report to SAFE all details of his foreign financial assets and liabilities, as well as details of any economic transactions conducted with non-PRC residents.

DENMARK

Notifications

Exchange Control and Tax Reporting Information . Holder may hold shares of Common Stock acquired under the Plan in a safety-deposit account ( e.g. , a brokerage account) with either a Danish bank or with an approved foreign broker or bank. If the shares are held with a non-Danish broker or bank, Holder is required to inform the Danish Tax Administration about the safety-deposit account. For this purpose, Holder must file a Declaration V ( Erklaering V ) with the Danish Tax Administration. Holder must sign the Declaration V and the broker or bank may sign the Declaration V. By signing the Declaration V, the bank/broker undertakes an obligation, without further request each year not later than on February 1 of the year following the calendar year to which the information relates, to forward certain information to the Danish Tax Administration concerning the content of the safety-deposit account. In the event that the applicable broker or bank with which the safety-deposit account is held does not wish to, or, pursuant to the laws of the country in question, is not allowed to assume such obligation to report, Holder acknowledges that he is solely responsible for providing certain details regarding the foreign brokerage or bank account and any shares acquired under the Plan and held in such account to the Danish Tax Administration as part of Holder’s annual income tax return. By signing the Form V, Holder at the same time authorizes the Danish Tax Administration to examine the account. A sample of the Declaration V can be found at the following website: www.skat.dk/getFile.aspx?Id=47392 .

In addition, when Holder opens a brokerage account (or a deposit account) outside of Denmark, the account will be treated as a deposit account because cash can be held in the account. Therefore, Holder must also file a Declaration K ( Erklaering K ) with the Danish Tax Administration. Both Holder and the bank/broker must sign the Declaration K, unless an exemption from the broker/bank signature requirement is granted by the Danish Tax Administration. It is possible to seek the exemption on the Form K, which Holder should do at the time he submits the Form K. By signing the Declaration K, the bank/broker undertakes an obligation, without further request each year, not later than on February 1 of the year following the calendar year to which the information relates, to forward certain information to the Danish Tax Administration concerning the content of the deposit account. In the event that the applicable financial institution (broker or bank) with which the account is held, does not wish to, or, pursuant to the laws of the country in question, is not allowed to assume such obligation to report, Holder acknowledges that he is solely responsible for providing certain details regarding the foreign brokerage or bank account to the Danish Tax Administration as part of Holder’s annual income tax return. By signing the Declaration K, Holder at the same time authorizes the Danish Tax Administration to examine the account. A sample of Declaration K can be found at the following website: www.skat.dk/getFile.aspx?Id=42409&newwindow=true .


Foreign Asset/Account Reporting Information . If Holder establishes an account holding shares of Common Stock or cash outside of Denmark, Holder must report the account to the Danish Tax Administration. The form which should be used in this respect can be obtained from a local bank. These obligations are separate from and in addition to the obligations described above.

EGYPT

Notifications

Exchange Control Information . If Holder transfers funds into Egypt in connection with the Restricted Stock Units, Holder should transfer the funds through a registered bank in Egypt.

FINLAND

There are no country-specific provisions.

FRANCE

Terms and Conditions

Language . By signing and returning this Award Agreement, Holder confirms having read and understood the documents relating to the grant and the Plan which were provided to Holder in English language. Holder accepts the terms of those documents accordingly.

En signant et renvoyant le présent Contrat d’Attribution, le Détenteur confirme avoir lu et compris les documents relatifs à l’attribution et au Plan qui ont été communiqués au Détenteur en langue anglaise. Le Détenteur accepte les termes de ces documents en connaissance de cause.

Notifications

Tax Information . The Restricted Stock Units are not intended to be French tax-qualified awards.

Foreign Asset/Account Reporting Information . If Holder holds shares of Common Stock outside France or maintain a foreign bank account, Holder should report to the French tax authorities on his annual tax return.

GERMANY

Notifications

Exchange Control Information . Cross-border payments in excess of €12,500 must be reported monthly to the German Federal Bank. If Holder makes or receives a payment in excess of this amount, Holder is responsible for electronically reporting to the German Federal Bank by the fifth day of the month following the month in which the payment occurs. The form of report ( Allgemeine Meldeportal Statistik ) can be accessed via German Federal Bank’s website (www.bundesbank.de) and is available in both German and English.


GREECE

There are no country specific provisions.

HONG KONG

Terms and Conditions

Settlement Upon Vesting . The following provision supplements Section 2.3 of the Award Agreement:

Notwithstanding anything to the contrary in the Award Agreement or the Plan, the Restricted Stock Units will be settled in shares of Common Stock only, not cash.

Sale of Shares . To facilitate compliance with securities laws in Hong Kong, Holder agrees not to sell any shares of Common Stock issued at vesting of the Restricted Stock Units within six months of the Date of Grant.

Nature of Grant . The Company specifically intends that the Plan will not be an occupational retirement scheme for purposes of the Occupational Retirement Schemes Ordinance (“ORSO”). Notwithstanding the foregoing, if the Plan is deemed to constitute an occupational retirement scheme for the purposes of ORSO, the grant of Restricted Stock Units shall be void.

Notifications

Securities Law Information . Warning: The Restricted Stock Units and shares of Common Stock issued at vesting do not constitute a public offering of securities under Hong Kong law and are available only to Employees of the Company and its Subsidiaries. The Award Agreement, including this Appendix, the Plan and other incidental award documentation have not been prepared in accordance with and are not intended to constitute a “prospectus” for a public offering of securities under the applicable securities legislation in Hong Kong, nor has the award documentation been reviewed by any regulatory authority in Hong Kong. The Restricted Stock Units are intended only for the personal use of each eligible Employee of the Employer, the Company or any Subsidiary of the Company and may not be distributed to any other person. If Holder is in any doubt about any of the contents of the Award Agreement, including this Appendix, or the Plan, Holder should obtain independent professional advice.

ICELAND

Notifications

Exchange Control Information . Holder should consult with his personal advisor to ensure compliance with applicable exchange control regulations in Iceland as such regulations are subject to frequent change. Holder is responsible for ensuring compliance with all exchange control laws in Iceland.


INDIA

Notifications

Exchange Control Information . Holder understands that Holder must repatriate any proceeds from the sale of shares of Common Stock acquired under the Plan to India within 90 days of receipt or any dividends within 180 days of receipt. Holder must obtain a foreign inward remittance certificate (“FIRC”) from the bank where Holder deposits the foreign currency and should maintain the FIRC as evidence of the repatriation of funds in the event the Reserve Bank of India or the Employer requests proof of repatriation. It is Holder’s responsibility to comply with applicable exchange control laws in India.

Because exchange control restrictions in India change frequently, Holder is advised to consult with his personal advisor before taking any action under the Plan.

Foreign Asset/Account Reporting Information . Holder understands that he is required to declare any foreign bank accounts and any foreign financial assets (including shares of Common Stock held outside India) in his annual tax return. Holder understands that he is solely responsible for complying with this reporting obligation and that Holder is advised to confer with his personal tax advisor in this regard.

INDONESIA

Notifications

Exchange Control Information . If Holder remits funds (including proceeds from the sale of shares of Common Stock) into Indonesia, the Indonesian bank through which the transaction is made will submit a report of the transaction to the Bank of Indonesia for statistical reporting purposes. For transactions of US$10,000 or more, a more detailed description of the transaction must be included in the report and Holder may be required to provide information about the transaction ( e.g. , his relationship with the transferor of the funds, the source of the funds, etc.) to the bank in order for the bank to complete the report. Although the bank through which the transaction is made is required to make the report, Holder must complete a “Transfer Report Form.” The Transfer Report Form should be provided to him by the bank through which the transaction is to be made.

IRELAND

Terms and Conditions

Restriction on Type of Shares Issued to Directors . If Holder is a director or shadow director of the Company or an Irish Subsidiary of the Company, his Restricted Stock Units will be paid in newly issued shares of Common Stock only. Treasury shares will not be used to satisfy such Restricted Stock Units.

Notifications

Director Notification Obligation . If Holder is a director, shadow director or secretary of the Company or an Irish Subsidiary of the Company, Holder must notify the Company and/or the Irish Subsidiary of the Company in writing within five business days of receiving or disposing of an interest in the Company ( e.g. , Restricted Stock Units, etc.), or within five business days of becoming aware of the event giving rise to the notification requirement or within five days of becoming a director or secretary if such an interest exists at the time. This notification requirement also applies with respect to the interests of a spouse or children under the age of 18 (whose interests will be attributed to the director, shadow director or secretary).

There are pending changes to this obligation which provide that the requirement applies only if the interest received or disposed of exceeds 1% of the Company. Holder should consult his personal legal advisor as to whether or not this notification requirement applies to him.


ISLE OF MAN

There are no country specific provisions.

ITALY

Terms and Conditions

Data Privacy . The following provision replaces in its entirety Section 3.9 of the Award Agreement:

Holder understands that the Company, the Employer and any other Subsidiary of the Company may hold certain personal information about Holder, including, but not limited to, Holder’s name, home address and telephone number, date of birth, social insurance or other identification number, salary, nationality, job title, any shares or directorships held in the Company or any Subsidiary of the Company, details of all Restricted Stock Units, or any other entitlement to shares awarded, canceled, exercised, vested, unvested or outstanding in Holder’s favor (“Data”), for the exclusive purpose of implementing, managing and administering the Plan.

Holder also understands that providing the Company with Data is necessary for the performance of the Plan and that Holder’s refusal to provide Data would make it impossible for the Company to perform its contractual obligations and may affect Holder’s ability to participate in the Plan. The controller of personal data processing is Actavis plc. with registered offices at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054, U.S., and, pursuant to Legislative Decree no. 196/2003, its representative in Italy is Bogdan Oghina, with registered offices at Viale Pasteur, 10, 20014 Nerviano Italy.

Holder understands that Data will not be publicized. Holder understands that Data may also be transferred to the independent registered public accounting firm engaged by the Company. Holder further understands that the Company and/or its Subsidiaries, will transfer Data among themselves as necessary for the purpose of implementing, administering and managing Holder’s participation in the Plan, and that the Company and its Subsidiaries may each further transfer Data to banks, other financial institutions, brokers or other third parties assisting the Company in the implementation, administration, and management of the Plan, including any requisite transfer of Data to a broker or other third party with whom Holder may elect to deposit any shares of Common Stock acquired at vesting of the Restricted Stock Units. Such recipients may receive, possess, process, retain, and transfer Data in electronic or other form, for the purposes of implementing, administering, and managing Holder’s participation in the Plan. Holder understands that these recipients may be located in or outside the European Economic Area, such as in the United States or elsewhere. Should the Company exercise its discretion in suspending all necessary legal obligations connected with the management and administration of the Plan, it will delete Data as soon as it has completed all the necessary legal obligations connected with the management and administration of the Plan.

Holder understands that Data processing related to the purposes specified above shall take place under automated or non-automated conditions, anonymously when possible, that comply with the purposes for which Data is collected and with confidentiality and security provisions, as set forth by applicable laws and regulations, with specific reference to Legislative Decree no. 196/2003.

The processing activity, including communication, the transfer of Data abroad, including outside of the European Economic Area, as herein specified and pursuant to applicable laws and regulations, does not require Holder’s consent thereto, as the processing is necessary to performance of contractual


obligations related to implementation, administration, and management of the Plan. Holder understands that, pursuant to Section 7 of the Legislative Decree no. 196/2003, Holder has the right to, including but not limited to, access, delete, update, correct, or terminate, for legitimate reason, the Data processing. Furthermore, Holder is aware that Data will not be used for direct-marketing purposes. In addition, Data provided can be reviewed and questions or complaints can be addressed by contacting Holder’s local human resources representative.

Plan Document Acknowledgement . Holder acknowledges that Holder has read and specifically and expressly approves, without limitation, the following sections of the Award Agreement: “Nature of Grant,” “Responsibility for Taxes,” “Data Privacy” as replaced by the above consent, “Governing Law and Venue,” “Language,” and “Imposition of Other Requirements.”

Notifications

Foreign Asset/Account Reporting Information . If at any time during the fiscal year Holder holds foreign financial assets (including cash and shares of Common Stock) which may generate income taxable in Italy, Holder is required to report these assets on his annual tax return (UNICO Form, RW Schedule) for the year during which the assets are held, or on a special form if no tax return is due. These reporting obligations will also apply to Italian residents who are the beneficial owners of foreign financial assets under Italian money laundering provisions.

Foreign Asset Tax Information . The value of the financial assets held outside of Italy by Italian residents is subject to a foreign asset tax. Financial assets include shares of Common Stock acquired under the Plan. The taxable amount will be the fair market value of the financial assets assessed at the end of the calendar year.

LATVIA

There are no country specific provisions.

LITHUANIA

There are no country specific provisions.

MALTA

There are no country specific provisions.

MEXICO

Terms and Conditions

Labor Law Policy and Acknowledgment . By participating in the Plan, Holder expressly recognizes that Actavis plc, with registered offices at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054, U.S. , is solely responsible for the administration of the Plan and that Holder’s participation in the Plan and acquisition of shares of Common Stock does not constitute a relationship as an Employee with the Company since Holder is participating in the Plan on a wholly commercial basis and his sole Employer is Allergan Servicios Profesionales de SA de CV (“Actavis-Mexico”). Based on


the foregoing, Holder expressly recognizes that the Plan and the benefits that he may derive from participation in the Plan do not establish any rights between him and the Employer, Actavis-Mexico, and do not form part of the employment conditions and/or benefits provided by Actavis-Mexico and any modification of the Plan or its termination shall not constitute a change or impairment of the terms and conditions of Holder’s relationship as an employee.

Holder further understands that his participation in the Plan is as a result of a unilateral and discretionary decision of the Company. Therefore, the Company reserves the absolute right to amend and/or discontinue Holder’s participation at any time without any liability to Holder.

Finally, Holder hereby declares that Holder does not reserve to himself any action or right to bring any claim against the Company for any compensation or damages regarding any provision of the Plan or the benefits derived under the Plan, and Holder therefore grants a full and broad release to the Company, the Employer, its other Subsidiaries, branches, representation offices, its shareholders, officers, agents or legal representatives with respect to any claim that may arise.

Política de Ley Laboral y Reconocimiento. Participando en el Plan, el Tenedor de la acción reconoce expresamente que Actavis plc., , es el único responsable de la administración del Plan y que la participación del Tenedor de la acción en el mismo y la compra de acciones bursátiles no constituye de ninguna manera una relación laboral entre Usted y la Compañía dado que su participación en el Plan deriva únicamente de una relación comercial y que su único empleador es Allergan Servicios Profesionales de SA de CV (“Activas-Mexico”). Derivado de lo anterior,el Tenedor de la acción expresamente reconoce que el Plan y los beneficios que pudieran derivar del mismo no establecen ningún derecho entre el Tenedor de la acción y el empleador, Activas-Mexico, y no forman parte de las condiciones laborales y/o prestaciones otorgadas por Activas-Mexico, y cualquier modificación al Plan o la terminación del mismo no podrá ser interpretada como una modificación o degradación de los términos y condiciones de su trabajo.

Asimismo, entiendo que su participación en el Plan es resultado de la decisión unilateral y discrecional de la Compañía. Por lo tanto, la Compañía se reserva el derecho absoluto para modificar y/o terminar la participación del Tenedor de la acción en cualquier momento, sin ninguna responsabilidad ante el Tenedor de la acción.

Finalmente, el Tenedor de la acción manifiesta que no se reserva ninguna acción o derecho que origine una demanda en contra de la Compañía por cualquier compensación o daño en relación con cualquier disposición del Plan o de los beneficios derivados del mismo, y en consecuencia el Tenedor de la acción otorga un amplio y total finiquito a la Compañía, sucursales, oficinas de representación, sus accionistas, directores, agentes y representantes legales con respecto a cualquier demanda que pudiera surgir.

MOLDOVA

Notifications

Exchange Control Information . Holder must repatriate all proceeds received from the sale of shares of Common Stock to Moldova within a reasonable time from receipt.

NETHERLANDS

There are no country specific provisions.


NEW ZEALAND

There are no country specific provisions.

NORWAY

There are no country specific provisions.

POLAND

Notifications

Exchange Control Information . If Holder holds foreign securities (including shares of Common Stock) and maintains accounts abroad, Holder will be required to file certain reports with the National Bank of Poland on the transactions and balances of the securities and cash deposited in such accounts if the value of such transactions or balances exceeds PLN 7,000,000 in the aggregate. If required, Holder must file reports on the transactions and balances of the accounts on a quarterly basis on special forms available on the website of the National Bank of Poland.

In addition, if Holder transfers funds in excess of €15,000 into Poland in connection with the sale of shares of Common Stock under the Plan, the funds must be transferred via a bank account held at a bank in Poland. Holder is required to retain the documents connected with a foreign exchange transaction for a period of five years, as measured from the end of the year in which such transaction occurred.

PUERTO RICO

There are no country specific provisions.

ROMANIA

Notifications

Exchange Control Information . If Holder deposits the proceeds from the sale of shares of Common Stock issued to him at vesting and settlement of the Restricted Stock Units in a bank account in Romania, he may be required to provide the Romanian bank with appropriate documentation explaining the source of the funds. Holder should consult his personal advisor to determine whether he will be required to submit such documentation to the Romanian bank.


SERBIA

Notifications

Exchange Control Information . Pursuant to the Law on Foreign Exchange Transactions, Holder is permitted to acquire shares of Common Stock under the Plan, but a report may need to be made of the acquisition of such shares, the value of the shares at vesting and, on a quarterly basis, any changes in the value of the shares. An exemption from this reporting obligation may apply if the shares are acquired for no consideration. As the exchange control regulations in Serbia may change without notice, Holder should consult with his personal advisor with respect to all applicable reporting obligations.

SINGAPORE

Notifications

Securities Law Information . The award of Restricted Stock Units is being made in reliance of section 273(1)(f) of the Securities and Futures Act (Chapter 289) (“SFA”) the “Qualifying Persons” exemption under the SFA. The Plan has not been lodged or registered as a prospectus with the Monetary Authority of Singapore. Holder should note that the award of Restricted Stock Units is subject to section 257 of the SFA and Holder will not be able to make (i) any subsequent sale of shares of Common Stock in Singapore or (ii) any offer of such subsequent sale of shares subject to the Restricted Stock Units in Singapore, unless such sale or offer in is made pursuant to the exemptions under Part XIII Division (1) Subdivision (4) (other than section 280) of the SFA.

Director Notification Obligation . If Holder is a chief executive officer, director, associate director or shadow director of a Subsidiary of the Company or other related entity in Singapore, Holder is subject to certain notification requirements under the Singapore Companies Act. Among these requirements is an obligation to notify the Singapore Subsidiary of the Company in writing when Holder receives an interest ( e.g. , Restricted Stock Units or shares of Common Stock) in the Company or any related company. In addition, Holder must notify the Singapore Subsidiary of the Company when Holder sell shares of Common Stock or shares of any related company (including when Holder sell shares issued upon vesting of the Restricted Stock Units). These notifications must be made within two business days of acquiring or disposing of any interest in the Company or any related company. In addition, a notification of Holder’s interests in the Company or any related company must be made within two business days of becoming a chief executive officer or a director.

SLOVAKIA

Notifications

Foreign Asset / Account Reporting Information . Slovak Republic residents who carry on business activities as an independent entrepreneur ( podnikatel ) must report foreign assets (including any shares of Common Stock) to the National Bank of Slovakia (provided that the value of the foreign assets exceeds an amount of €2,000,000). These reports must be submitted on a monthly basis by the 15th day of the respective calendar month, as well as on a quarterly basis by the 15th day of the calendar month following the respective calendar quarter, using notification form DEV (NBS) 1-12, which may be found at the National Bank of Slovakia’s website at www.nbs.sk.


SOUTH AFRICA

Terms and Conditions

Responsibility for Taxes . The following provision supplements Section 3.8 of the Award Agreement:

By accepting the Restricted Stock Units, Holder agrees that, immediately upon the vesting of the Restricted Stock Units, Holder will notify the Company of the amount of any gain realized. If Holder fails to advise the Company of the gain realized upon vesting, Holder may be liable for any applicable fines and penalties. Holder will be solely responsible for paying any difference between the actual tax liability and the amount withheld.

Notifications

Exchange Control Information . If no transfer of funds from South Africa is required under the Restricted Stock Units, no filing or reporting requirements should apply when the Restricted Stock Units vest. However, because the exchange control regulations are subject to change, Holder should consult with his personal advisor prior to the vesting and settlement of the Restricted Stock Units to ensure compliance with current regulations. Holder is responsible for ensuring compliance with all exchange control laws in South Africa.

SPAIN

Terms and Conditions

Nature of Grant . By accepting the Stock Units, Holder acknowledges and agrees to be bound by the terms of the Plan and the Award Agreement, including this Appendix. Holder understands and agrees that the Company offers Restricted Stock Units without any previously existing obligation based on the terms and conditions in the Plan and the Award Agreement and conditioned on Holder’s express acceptance of those terms and conditions. But for Holder’s agreement to those terms and conditions, the Restricted Stock Units would not be granted.

Forfeiture upon Termination of Services . The following provision supplements Section 2.2 of the Award Agreement:

Holder acknowledges and agrees that the Restricted Stock Units will automatically cease vesting and be forfeited without any compensation whatsoever in the event of any type of Termination of Employment, regardless of the reason for the termination. The Plan does not under any circumstances permit vesting after Termination of Employment including but not limited to cases of death, disability, retirement, unfair dismissal, constructive dismissal, resignation, or any other cases of termination. Given the possible required forfeiture under the Plan and Award Agreement, Holder should have no expectation that the Restricted Stock Units will eventually vest.

Holder understands and agrees that for purposes of the Restricted Stock Units, the date that Holder ceases providing active services to the Company, the Employer or any Subsidiary of the Company in the case of dismissal that is formalized pursuant to Spanish law will be the date of termination indicated in the letter of dismissal provided by the Employer, without prejudice to (i) any notice period that may be required by local law during which compensation may be due, (ii) any additional period during which social security payment obligations may continue, (iii) any post-termination interim salary (“ salarios de tramitación ”) that may be due, (iv) any official termination date that may apply under local law or due to court


resolution or due to any settlement agreement agreed for other purposes, and/or (v) any other rights or obligations that may continue to exist under local law after the Termination of Employment. Upon Termination of Employment, Holder shall forfeit any Restricted Stock Units effective the date active services cease.

Language . A translation into Spanish of the Plan and the Award Agreement, including this Appendix, are attached to this document. In the event of any discrepancy between the meaning of the Spanish and English versions of the documents, the English version will prevail.

Notifications

Securities Law Information . No “offer of securities to the public,” as defined under Spanish law, has taken place or will take place in the Spanish territory regarding the Restricted Stock Units. No public offering prospectus has been, nor will it be, registered with the Comisión Nacional del Mercado de Valores (Spanish Securities Exchange Commission) (“CNMV”). Neither the Plan nor the Award Agreement constitutes a public offering prospectus and neither has been, nor will either be, registered with the CNMV.

Exchange Control Information . To participate in the Plan, Holder must comply with exchange control regulations in Spain. Holder is required to declare electronically to the Bank of Spain any securities accounts (including brokerage accounts held abroad), as well as the shares of Common Stock held in such accounts, depending on the value of the transactions during the prior tax year or the balances in such accounts as of December 31 of the prior tax year.

Holder also must declare any shares of Common Stock that are acquired under the Plan to the Dirección General de Comercio e Inversiones of the Ministry of Industry, Tourism and Commerce (the “DGCI”). After the initial declaration, the declaration must be filed with the DGCI on a Form D-6 on an annual basis each January while the shares are owned. However, if the value of the shares acquired under the Plan or the amount of the sale proceeds exceeds €1,502,530, the declaration must be filed within one month of the acquisition or sale, as applicable.

When receiving foreign payments exceeding €50,000 derived from the participation in the Plan ( e.g. , dividends or sales proceeds), Holder must inform the financial institution receiving the payment of the basis upon which such payment is made. Holder will need to provide the institution with certain information, including (i) his/her name, address and tax identification number, (ii) the name and corporate domicile of the Company, (iii) the amount of the payment and the currency used, (iv) the country of origin, (v) the reasons for the payment, and (vi) any further information that may be required.

Foreign Asset/Account Reporting Information . Holder understands that if he holds rights or assets ( e.g. , shares or cash held in a bank or brokerage account) outside of Spain with a value in excess of €50,000 per type of right or asset ( e.g. , shares of Common Stock, cash, etc.) as of December 31, he is required to report certain information regarding such rights and assets on tax form 720. After such rights and/or assets are initially reported, the reporting obligation will only apply for subsequent years if the value of any previously-reported rights or assets increases by more than €20,000. The reporting must be completed by the following March 31.


SWEDEN

There are no country specific provisions.

SWITZERLAND

Notifications

Securities Law Information . The grant of the Restricted Stock Units is considered a private offering in Switzerland and is, therefore, not subject to registration in Switzerland.

TURKEY

Notifications

Securities Law Information . The sale of shares of Common Stock acquired under the Plan is not permitted within Turkey. The sale of shares of Common Stock acquired under the Plan must occur outside of Turkey. The shares of Common Stock are currently traded on the New York Stock Exchange in the U.S. under the ticker symbol “ACT” and shares may be sold on this exchange.

UNITED ARAB EMIRATES

Notifications

Securities Law Information . Holder in the Plan is being offered only to eligible Employees and is in the nature of providing equity incentives to Employees in the United Arab Emirates. The Plan and the Award Agreement are intended for distribution only to such Employees and must not be delivered to, or relied on by, any other person. Prospective purchasers of the securities offered should conduct their own due diligence on the securities. The Emirates Securities and Commodities Authority has no responsibility for reviewing or verifying any documents in connection with the Plan. Neither the Ministry of Economy nor the Dubai Department of Economic Development have approved the Plan or the Award Agreement nor taken steps to verify the information set out therein, and have no responsibility for such documents.

UNITED KINGDOM

Terms and Conditions

Settlement Upon Vesting . The following provision supplements Section 2.3 of the Award Agreement:

Notwithstanding anything to the contrary in the Award Agreement or the Plan, the Restricted Stock Units will be settled in shares of Common Stock only, not cash.

Responsibility for Taxes . The following provision supplements Section 3.8 of the Award Agreement:

Holder agrees that, if Holder does not pay or the Employer or the Company does not withhold from Holder the full amount of income tax that Holder owes at vesting of the Restricted Stock Units, or the release or assignment of the Restricted Stock Units for consideration, or the receipt of any other benefit in connection with the Restricted Stock Units (the “Taxable Event”) within 90 days of the U.K. tax year within which the Taxable Event occurs, or such other period specified in Section 222(1)(c) of the U.K. Income Tax (Earnings and Pensions) Act 2003 (the “Due Date”), then the amount that should have been withheld shall constitute a loan owed by Holder to the Employer, effective as of the Due Date. Holder agrees that the loan will bear interest at the Her Majesty’s Revenue and Customs’ (“HMRC’s”) official rate and will be immediately due and repayable by Holder, and the Company and/or the Employer may recover it at any time thereafter by any of the means set forth in Section 3.8 of the Award Agreement.


Notwithstanding the foregoing, if Holder is an executive officer or director (as within the meaning of Section 13(k) of the Exchange Act), the terms of the immediately foregoing provision will not apply. In the event that Holder is an executive officer or director and income tax is not collected from or paid by Holder by the Due Date, the amount of any uncollected income tax may constitute a benefit to Holder on which additional income tax and National Insurance contributions (“NICs”) may be due. Holder will be responsible for reporting and accounting for any income tax due on this additional benefit directly to HMRC under the self-assessment regime and for reimbursing the Company or the Employer, as applicable, for the value of any NICs due on this additional benefit.

Joint Election . As a condition of participation in the Plan, the Holder agrees to accept any liability for secondary Class 1 NICs that may be payable by the Company or the Employer (or any successor to the Company or the Employer) in connection with the Restricted Stock Units and any event giving rise to Tax-Related Items (the “Employer NICs”). The Employer NICs may be collected by the Company or the Employer using any of the methods described in the Plan or in Section 3.8 the Agreement.

Without prejudice to the foregoing, the Holder agrees to execute a joint election with the Company and/or the Employer (a “Joint Election”), the form of such Joint Election being formally approved by HMRC, and any other consent or elections required by the Company or the Employer in respect of the Employer NICs liability. The Holder further agrees to execute such other elections as may be required by any successor to the Company and/or the Employer for the purpose of continuing the effectiveness of the Holder’s Joint Election.

UNITED STATES

Notifications

Foreign Asset/Account Reporting Information . The Foreign Account Tax Compliance Act (“FATCA”) pertains to U.S. taxpayers who participate in or hold equity-based awards in one or more equity compensation plans offered by the Company, including Restricted Stock Units. Under FATCA, the Company is considered a “non-U.S. issuer” with the result that Holder may have reporting obligations on Form 8938 when filing his annual income tax return (Form 1040). Information regarding Form 8938 is available at www.irs.gov/pub/irs-pdf/i8938.pdf .

These reporting obligations apply to the extent the aggregate value of Holder’s holdings (when aggregated with other specified foreign financial assets held by Holder) exceed certain thresholds. The threshold amounts of the value of the equity holdings (and other foreign assets) that trigger the reporting obligations depend on Holder’s filing status ( e.g. , unmarried/married filing separately) and whether Holder resides in the U.S. or outside of the U.S. Shares of Common Stock issued by a non-U.S. issuer that are held in a financial account maintained by a U.S. financial institution (such as a brokerage firm) are not subject to these reporting requirements. However, it is not clear under current guidance whether rights to acquire shares of Common Stock, such as Restricted Stock Units ( i.e. , as opposed to shares of Common Stock Holder owns), are eligible for this exception. Holder should consult his personal tax advisor to determine whether these FATCA reporting requirements apply to him as a result of his equity holdings in the Company, including the Restricted Stock Units or shares of Common Stock Holder acquires under the Plan.


ANNEX 1 TO FOREIGN COUNTRY APPENDIX

Countries where cash must be paid in settlement of RSUs

Albania

Belarus

Czech Republic

Estonia

Hungary

Japan

Kazakhstan

Kosovo

Malaysia

Mongolia

Russian Federation

Saudi Arabia

South Africa

Thailand

Ukraine

Uzbekistan

Vietnam

Exhibit 10.38

Execution Version

This Separation Agreement must be executed and delivered to the attention of Eric Stern, VP, Compensation and Benefits, Actavis, Inc. 400 Interpace Parkway, Parsippany, NJ 07054 by March 24, 2015.

SEPARATION AGREEMENT

This Separation Agreement (the “Agreement”) is entered into between David Buchen (“Executive”) and Actavis, Inc. (“Actavis” or the “Company”) as of March 21, 2015.

In consideration of the mutual covenants and agreements hereinafter set forth, and intending to be legally bound, the parties agree as follows:

1. Termination of Employment. Executive hereby acknowledges the termination of his employment with the Company effective as of the close of business on May 1, 2015 (the “Termination Date”). Executive will not be required to, and will not in fact, render any services on behalf of the Company after the Termination Date. After the Termination Date, Executive will cease to be an employee of the Company and will not be eligible to receive any salary or benefits of employment, except as described in this Agreement.

2. Severance Pay and Benefits. In consideration for, subject to and conditioned on (a) Executive’s execution of this Agreement and compliance with its terms and conditions, and (b) Executive’s execution on or within twenty-one (21) days following the Termination Date and Executive’s non-revocation thereof of the Waiver and Release of Claims set forth in Attachment A (the “Release”), Executive is eligible to receive the severance pay and benefits (the “Payment”) being offered pursuant to that certain Retention Agreement entered into as of May 19, 2014 between Executive and the Company (“Retention Agreement”) and the Key Employee Agreement entered into as of February 28, 2000, between Executive and Actavis (f/k/a Watson Pharmaceuticals, Inc.) (“Key Employee Agreement”), as amended from time to time, as follows:

 

    a severance payment equal to the sum of: (i) two times Executive’s base salary as in effect on June 30, 2014 ($1,207,500.00); (ii) two times Executive’s 2014 performance year bonus ($1,552,500.00); and (iii) Executive’s target, prorated 2015 Annual Incentive Plan Bonus (“AIP Bonus”) ($191,666.67), in an amount totaling, $2,951,666.67, minus applicable tax withholdings, to be paid in a lump sum within thirty (30) days following the Release becoming irrevocable pursuant to its terms and conditions;

 

    continued group health insurance benefits for Executive and Executive’s eligible dependents for twenty-four (24) months under COBRA at active employee rates, as may be adjusted from time to time;

 

    outplacement services for twelve (12) months with a nationally recognized service selected by the Company; and

Additionally, in consideration for, subject to and conditioned on (a) Executive’s execution of this Agreement and compliance with its terms and conditions, and (b) Executive’s execution of the Release on or within twenty-one (21) days following the Termination Date and Executive’s non-revocation thereof, Executive will be entitled to the following:

 

    continued vesting for twenty-four (24) months of certain outstanding restricted share units granted on May 8, 2014 and time-vested restricted share units granted on July 1, 2014, in accordance with the terms of those grants;

 

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    a cash payment of $2,500,000.00, minus applicable tax withholdings, which represents fifty (50) percent of the Executive’s target Merger Success Award granted on July 1, 2014, to be paid in a lump sum within thirty (30) days following the Release becoming irrevocable pursuant to its terms and conditions; and

 

    certain relocation benefits as set forth on Attachment B of this Agreement.

Executive will receive an AIP Bonus for 2014, based on company and individual performance, which will be paid during the Company’s regular AIP Bonus payout schedule. Additionally, Executive’s July 1, 2014 performance share unit grant will vest and become payable to Executive in accordance with the terms of that grant.

Except if Executive’s employment is terminated by the Company without Cause (as defined in the Retention Agreement) prior to the Termination Date, Executive acknowledges that in order to receive the payments and benefits specified under this paragraph (including, without limitation, the Payment), Executive must be employed on an active, full-time, exclusive basis by the Company through the Termination Date.

In addition, if Executive’s employment is terminated by reason of Executive’s death prior to the Termination Date, Executive shall be entitled to:

 

    continued vesting for twenty-four (24) months of certain outstanding restricted share units granted on May 8, 2014 and time-vested restricted share units granted on July 1,2014; and

 

    a cash payment of $2,500,000.00, minus applicable tax withholdings, which represents fifty (50) percent of the Executive’s target Merger Success Award granted on July 1, 2014, to be paid in a lump sum within thirty (30) days following the Termination Date.

3. Return of Property and Confidentiality of this Agreement. Executive represents and covenants that on or prior to the Termination Date, Executive will return to the Company all Company property, including, but not limited to, all equipment, vehicles, product samples, computers, pass codes, keys, swipe cards, credit cards, documents, or other materials, in whatever form or format that Executive received, prepared, or helped prepare; provided, however, that, following the Termination Date, Executive shall be permitted to retain, at his sole cost and expense, his Company provided laptop, ipad and iphone, subject, in all cases, to Executive’s compliance with his obligations not to disclose or retain any proprietary or confidential information (whether pursuant to any written agreement, Company policy or applicable law, including, without limitation, the applicable provisions of the Company’s Code of Conduct, the Agreement, the Invention Agreement and the Confidentiality Agreement), provided, further, that upon the expiration, cancellation or termination of the Consulting Agreement by and between Executive and Actavis plc in accordance with its terms, Executive shall promptly return his Company provided laptop to the Company. Executive represents and covenants that Executive will not retain, whether in hard copy or electronic form, any copies, duplicates, reproductions, computer disks, or excerpts thereof, of the Company’s or any of its customers’ documents. Further, Executive agrees that except for Executive’s attorneys, accountants, spouse, and any government agencies, Executive will keep this Agreement and its terms confidential and will not reveal its contents to anyone, unless otherwise required or authorized by law.

 

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4. Resignation from Directorships and Company Positions. Effective as of the Termination Date, Executive agrees to and hereby does resign from any and all offices and directorships with the Company and all of its direct and indirect subsidiaries and affiliates, and agrees to execute all documents reasonably requested by the Company to effectuate such resignations.

5. Cooperation. Executive agrees to fully cooperate with all reasonable requests from the Company or its attorneys for information or assistance in any lawsuit or investigation involving the Company. Executive further agrees to cooperate with reasonable requests for information relating to projects, assignments, or functions about which Executive possesses knowledge as a result of Executive’s employment. Executive agrees that upon receipt of any subpoena relating in any way to the Company, and/or receipt of any contact from a government agent relating in any way to the Company, Executive will immediately notify the Company’s Chief Legal Officer and will fax, e-mail or hand deliver a copy of the subpoena to the Chief Legal Officer within forty-eight (48) hours of service upon Executive and prior to responding, testifying or providing documents or information in response to the subpoena. Executive shall be reimbursed for reasonable expenses incurred by Executive in providing cooperation under this paragraph (e.g., travel, lodging, and meal expenses), provided that Executive provides appropriate invoices and/or receipts for any such expenses. The Company shall have the right, but not the obligation, to appoint counsel to represent the Executive in connection with providing cooperation under this paragraph, and the fees and expenses of such counsel shall be at the sole expense of the Company. The obligations of Executive pursuant to this Section 5 shall apply at all times, including, without limitation, following the Termination Date.

6. Non-Disparagement. Prior to and following the Termination Date, Executive agrees not to, at any time, take any action through any medium or in any forum, to directly or indirectly disparage or otherwise bring into question or disrepute the employees, products, business reputation, abilities, or capabilities of any of the Releasees. This provision includes, without limitation, email, any electronic media, and any postings to the Internet. Notwithstanding the foregoing, it shall not be a breach of this paragraph for Executive to comply with the lawful orders or processes of the court, including the obligation to testify truthfully in any legal proceeding. Additionally, this paragraph does not apply to communications with government agencies and/or the Company.

7. Governing Law; Dispute Arising out of this Agreement. Except to the extent governed by federal law, this Agreement shall be governed by and construed under the laws of the State of New Jersey, without reference to New Jersey’s choice of law principles. Any dispute or controversy arising out of or related to this Agreement shall be resolved exclusively by final and binding arbitration to be held in the state and county where Executive principally worked immediately prior to Executive’s termination. To the extent not inconsistent with the laws of the State of New Jersey, such arbitrations shall be conducted pursuant to the Rules for Arbitration of Employment Disputes of the American Arbitration Association, and the parties agree that each side shall initially bear their own costs and fees, but that the arbitrator may award reasonable costs and attorney’s fees to the prevailing party.

 

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8. Entire Agreement; Continuing Validity of Certain Existing Agreements and Confidentiality and Non-Solicitation Obligations. This Agreement and the Release contains and constitutes the entire understanding and agreement of the parties with respect to the subject matter of this Agreement; provided , however , that Executive acknowledges and affirms that Executive shall remain bound by the applicable provisions of the Company’s Code of Conduct, and any Employee Proprietary Information and Invention Agreement (“Invention Agreement”) or other confidentiality agreement (“Confidentiality Agreement”) which Executive signed in connection with Executive’s employment. Executive is reminded of the obligation for a period of one (1) year following Executive’s Termination Date, not to directly or indirectly, solicit for employment (or cause or seek to cause to leave the employment of the Company) any employee of the Company. Further, in the event that Executive and any of the Company entities are parties to a previously-executed written employment agreement (“Employment Agreement”), and to the extent the terms of that Employment Agreement do not conflict with the terms of this Agreement and survive termination of Executive’s employment, those terms of the Employment Agreement shall continue in full force and effect. Apart from such continuing terms of any pre-existing Invention Agreement, Confidentiality Agreement, or Employment Agreement, this Agreement supersedes and cancels all previous agreements that may have been made in connection with Executive’s employment with the Company, including without limitation, the Key Employee Agreement and the Retention Agreement.

9. Severability and Modifications. The provisions of this Agreement are severable and if any part is found to be unenforceable the other portions shall remain fully valid and enforceable. However, if any provision set forth in the Release is held to be invalid, illegal, void and/or unenforceable by a court of competent jurisdiction, Executive agrees immediately to duly execute and deliver to the Company a release and waiver that is legal and enforceable to the fullest extent of the law and consistent with the intent of the parties. This Agreement may not be released, discharged, abandoned, supplemented, changed or modified in any manner, orally or otherwise, except by an instrument in writing of concurrent or subsequent date signed by Executive and a duly authorized officer of Actavis. Executive’s or the Company’s failure to insist upon strict compliance with any provision of this Agreement or the failure to assert any right that Executive or the Company may have under this Agreement shall not be deemed a waiver of such provision or right or any other provision or right under this Agreement.

10. Construction of Agreement. The parties agree that there shall be no presumption that any ambiguity in this Agreement is to be construed against the drafter.

11. Section 409A. All amounts payable under this Agreement are intended to comply with the “short term deferral” exception from Section 409A of the Internal Revenue Code (“Section 409A”) specified in Treas. Reg. § 1.409A-1(b)(4) (or any successor provision) or the “separation pay plan” exception specified in Treas. Reg. § 1.409A-1(b)(9) (or any successor provision), or both of them, to the maximum extent possible, and shall be interpreted in a manner consistent with the applicable exceptions. Notwithstanding the foregoing, to the extent that any amounts payable in accordance with this Agreement are subject to Section 409A, this Agreement shall be interpreted and administered in such a way as to comply with Section 409A to the maximum extent possible. Each installment payment of compensation under this Agreement shall be treated as a separate payment of compensation for purposes of applying Section 409A. “Termination of employment” or words of similar import, as used in this Agreement shall mean, with respect to any payments subject to Section 409A, the Executive’s “separation from service” as defined by Section 409A. Nothing in this Agreement shall be construed as a guarantee of any particular tax treatment to the Executive. The Executive shall be solely responsible for the tax consequences with respect to all amounts payable under this Agreement, and in no event shall the Company have any responsibility or liability if this Agreement does not meet any applicable requirements of Code section 409A.

[ remainder of this page has been left blank intentionally ]

 

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DAVID BUCHEN ACTAVIS, INC.
By: /s/ David Buchen By: /s/ Karen L. Ling
Print Name: David Buchen Print Name: Karen L. Ling
Date: March 22, 2015 Date: March 21, 2015

 

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ATTACHMENT A

WAIVER AND RELEASE OF CLAIMS

(DO NOT SIGN UNTIL ON OR AFTER THE TERMINATION DATE)

This Waiver and Release of Claims (“Release”) is hereby made between David Buchen (“Executive”) and Actavis, Inc. (“Company”).

I. RECITALS

WHEREAS, Executive and the Company have entered into a separation agreement dated March [●], 2015 (the “Agreement”), pursuant to which Executive is eligible to receive severance and certain benefits (the “Severance Benefits”), subject to and conditioned upon his execution of a general release.

WHEREAS, Executive and the Company desire to enter into this Release, in satisfaction of such condition under the Agreement.

II. TERMS AND CONDITIONS

NOW, THEREFORE, in consideration of the mutual covenants and other good and valuable consideration contained herein, the parties hereby agree as follows:

1. Separation. Executive’s employment with the Company ended effective May 1, 2015 (the “Termination Date”). The Company and Executive agree that such separation entitles Executive to receive the Severance Benefits subject to his execution and non-revocation of this Release, as provided under the Agreement.

2. Release of Claims. Executive, on behalf of Executive and Executive’s representatives, successors and assigns, completely releases and forever discharges the Company, and its predecessors, successors and assigns, parent, divisions, subsidiaries, affiliated companies, including without limitation Actavis plc and the Company (together with Actavis plc, “Actavis”), third party manufacturers, or insurers, and any other entity directly or indirectly controlled by them, and their current and former officers, directors, agents, employees, representatives, attorneys, both individually and in their professional capacities, successors and assigns of all of the foregoing, past and present, and the various Actavis benefit plans, committees, trustees, fiduciaries, and trusts (hereinafter all collectively referred to as the “Releasees”) from any and all claims, rights, demands, actions, obligations, liens, costs, expenses, orders, judgments, attorneys’ fees and causes of action, of whatever kind or nature, arising on or prior to the date Executive signs this Release, which Executive may now have, or has ever had, against any Releasee arising from or in any way connected with the employment relationship between Executive and the Company or any of its affiliates, or any acts or omissions occurring during the employment relationship or the termination thereof and at any time after the termination of employment up to and including the date on which Executive signs this Release. Without limiting the foregoing, the above Release includes, but is not limited to, all “wrongful discharge,” “whistleblower” and discrimination claims; all claims relating to any contracts of employment, express or implied; any claims for defamation, misrepresentation or negligence; any claim for monies or severance pay; any tort claim of any nature, including claims for alleged infliction of emotional distress; any claim under any laws or regulations relating to employment matters including, but not

 

Attachment A – Page 1


limited to the following, as amended: (1) Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000(e) et seq.; (2) the Age Discrimination in Employment Act, as amended, 29 U.S.C. § 621 et seq. (the “ADEA”); (3) Section 1981 of the Civil Rights Act of 1866, 42 U.S.C. § 1981; (4) the Equal Pay Act of 1963, 29 U.S.C. § 206; (5) Executive Order 11141; (6) Section 503 of the Rehabilitation Act of 1973, 29 U.S.C. § 701, et seq.; (7) the Americans With Disabilities Act, 42 U.S.C. § 12101, et seq.; (8) the Employee Retirement Income Security Act of 1974, as amended, 29 U.S.C. § 1001, et seq. (except for any vested benefits under any tax qualified benefit plan); (9) the Immigration Reform and Control Act, 8 U.S.C. §101 et seq.; (10) the Workers Adjustment and Retraining Notification Act, 29 U.S.C. §2101, et seq.; (11) the Fair Credit Reporting Act, 15 U.S.C. § 1681, et seq.; (12) The Sarbanes-Oxley Act of 2002, to the extent permitted by law; (13) Section 885 of the American Jobs Creation Act of 2004 and any applicable guidance thereunder (Internal Revenue Code Section 409A); (14) the Family and Medical Leave Act; (15) the New Jersey Conscientious Employee Protection Act; and any other federal, state or local law, rule, regulation, or ordinance; any public policy, contract, tort, or common law; or any claims for vacation, sick or personal leave pay, short term or long term disability benefits, or payment pursuant to any practice, policy, handbook or manual; or any basis for recovering costs, fees, or other expenses including attorneys’ fees incurred in these matters, but not including any claim (a) to enforce the terms of this Release or the Agreement, (b) any claims relating to accrued benefits earned and vested as of the Termination Date under an employee benefit plan maintained by any Releasee, or (c) Executive’s rights to indemnification under any written indemnification agreement by and between Executive and any Releasee, the Company’s by-laws or certificate of incorporation or under any policy of insurance carried by any Releasee or existing under applicable law.

Executive hereby warrants and represents that Executive shall not seek nor be entitled to recover from any of the Releasees for any claim released herein. Executive further represents and warrants that Executive is not a party to any proceedings currently pending before any federal, state or local court or agency asserting any claims against any of the Releasees. Executive further represents and warrants that Executive has disclosed all information known to Executive, concerning any wrongful conduct by any of the Releasees, including but not limited to any violation of any federal, state or local law or regulation, and any breach of contract.

3. Covenant Not to Sue. Except as may be necessary to enforce the Agreement or this Release, and to the fullest extent permitted by law, Executive agrees not to permit, authorize, initiate, join or continue any lawsuit, complaints, grievances, arbitrations or proceedings, whether as a named plaintiff, class member, collective action plaintiff or opt-in, or otherwise (collectively, “Proceedings”), against Releasees based in whole or in part on any claim covered by this Release. Executive is not prohibited from initiating a proceeding before a state or federal anti-discrimination agency, but Executive does hereby waive any right he may have to benefit in any manner from any relief (whether monetary, equitable, or otherwise) arising out of any past, present or future proceeding before a state or federal anti-discrimination agency.

4. EEOC Matters. Nothing in this Release shall be interpreted or applied to affect or limit Executive’s otherwise lawful right to bring an administrative charge with the U.S. Equal Employment Opportunity Commission (“EEOC”) or other federal, state, or local administrative agency, or to testify, assist, or participate in any investigation, hearing, or proceeding conducted by the EEOC or other federal, state, or local administrative agency. Executive agrees that Executive has released the Releasees from any and all liability from the laws, statutes, and common law listed above. As such, the Company may assert its rights under the Release of

 

Attachment A – Page 2


Claims in this Release as a defense to any administrative, judicial or other proceeding or lawsuit filed against the Releasees. Further, Executive is not and will not be entitled to any monetary relief resulting from any proceeding brought by Executive or the EEOC or any other person or entity on Executive’s behalf, including but not limited to any federal, state, or local agency.

The parties also acknowledge that nothing in this Release shall be interpreted or applied in a manner that affects or limits Executive’s otherwise lawful ability to challenge, under the Older Workers Benefit Protection Act (“OWBPA”) (29 U.S.C. §626), the knowing and voluntary nature of his release of any age claims against the Releasees before a court, the EEOC, or any other federal, state, or local agency.

5. Release of Claims under the ADEA, Right to Review and Revoke. As required under OWPBA, Executive expressly acknowledges and agrees that this Release includes a waiver and release of all claims which Executive has or may have under the ADEA. The following terms and conditions apply to and are part of the waiver and release of ADEA claims under this Release:

(a) The waiver and release of claims under the ADEA contained in this Release does not cover rights or claims that may arise after the date on which Executive signs this Release.

(b) Executive is hereby advised to consult a lawyer before signing this Release. Executive is granted twenty-one (21) days after Executive is presented with this Release to decide whether or not to sign this Release. If Executive signs this Release before the expiration of the twenty-one (21) day period, he waives the balance of that period.

(c) Executive will have the right to revoke the waiver and release of claims under the ADEA for a period of seven (7) days after signing this Release, and this Release shall not become effective or enforceable unless and until this revocation period has expired without revocation by Executive.

(d) Any revocation by Executive must be in writing and received by Eric Stern, VP, Compensation and Benefits, Actavis, Inc., 400 Interpace Parkway, Parsippany, New Jersey, 07054 on or before the seventh (7 th ) day after this Release is executed by Executive. Executive hereby acknowledges and agrees that Executive is knowingly and voluntarily waiving and releasing Executive’s rights and claims only in exchange for consideration (something of value) in addition to anything of value to which Executive is already entitled.

6. Review Period Not Extended by Changes. Executive agrees that any modifications made to this Release, material or otherwise, do not restart or affect in any manner the original 21-day consideration period.

7. Non-Admission. The parties agree that neither the Release nor the furnishing of the consideration for the Release shall be deemed or construed at any time for any purpose as an admission by Releasees of wrongdoing or evidence of any liability or unlawful conduct of any kind.

 

Attachment A – Page 3


Return of Property and Confidentiality of this Release. Executive represents that as of the Termination Date, Executive has returned to the Company all Company property, including, but not limited to, all equipment, vehicles, product samples, computers, pass codes, keys, swipe cards, credit cards, documents, or other materials, in whatever form or format that Executive received, prepared, or helped prepare; provided, however, that, following the Termination Date, Executive shall be permitted to retain, at his sole cost and expense, his Company provided laptop, ipad and iphone, subject, in all cases, to Executive’s compliance with his obligations not to disclose or retain any confidential information (whether pursuant to any written agreement, Company policy or applicable law, including, without limitation, the applicable provisions of the Company’s Code of Conduct, the Agreement, the Invention Agreement and the Confidentiality Agreement), provided, further, that upon the expiration, cancellation or termination of the Consulting Agreement by and between Executive and Actavis plc in accordance with its terms, Executive shall promptly return his Company provided laptop to the Company. Executive represents that Executive has not retained, whether in hard copy or electronic form, any copies, duplicates, reproductions, computer disks, or excerpts thereof, of the Company’s or any of its customers’ documents. Further, Executive agrees that except for Executive’s attorneys, accountants, spouse, and any government agencies, Executive will keep this Release and its terms confidential and will not reveal its contents to anyone, unless otherwise required or authorized by law.

8. Choice of Law, Interpretation and Severability. Executive and the Company agree that this Release shall be governed by New Jersey law and may be modified by the Company, from time to time, to reflect any applicable changes in New Jersey law. Executive and the Company agree that this Release shall not be construed against any party on account of authorship and, if a court finds any part of this Release to be illegal or invalid, the illegal or invalid portion of the Release shall be severed and the rest of the Release will be enforceable.

9. Execution. This Release may be executed in two or more facsimiled counterparts, each of which shall be equivalent to an original, but which collectively shall constitute one Release.

10. Entire Release. Except as otherwise set forth herein, the terms contained in this Release and the Agreement constitute the entire agreement between the parties with respect to the subject matter hereof and supersede all prior agreements relating thereto whether written or oral.

 

AGREED TO AND ACCEPTED BY:

 

David Buchen

ACTAVIS, INC.
       
Date:   Name:  
Title:  

 

Attachment A – Page 4


LOGO Attachment B

U.S. RELOCATION SUPPORT

 

Household Goods Shipment

•    Packing, loading, transporting, and insuring

 

•    Customary crating

 

•    Appliance services

 

•    Two automobiles, if over 500 miles

 

•    No bulky articles

 

•    90 days of storage, if needed

En Route Trip

•    Coach airfare

Departure Home Sale Assistance
(current homeowners only)

•    Customary seller non-recurring closing costs

Destination Home Purchase Assistance
(current homeowners only)

•    Customary buyer non-recurring closing costs (no points/pre-paids)

 

•    Maximum of 3% of the purchase price (includes 1% for loan origination fee)

Tax Gross-Up Benefit

•    Equalization

Exhibit 10.39

Execution Version

CONSULTING AGREEMENT

This Consulting Agreement is entered into as of March 21, 2015 (this “ Agreement ”) by and between Actavis plc (the “ Company ”), and David Buchen (the “ Consultant ” and, together with the Company, the “ Parties ”).

RECITALS

WHEREAS, the Company, Avocado Acquisition Inc., an indirect wholly owned subsidiary of the Company, and Allergan Inc. (“ Allergan ”) have entered into that certain Agreement and Plan of Merger, dated as of November 16, 2014 (the “ Merger Agreement ”), pursuant to which Allergan will become a wholly-owned subsidiary of the Company upon consummation of the Merger (as defined in the Merger Agreement);

WHEREAS, the Consultant has served the Company and its affiliates, including as the Company’s Chief Legal Officer and Executive Vice President Commercial, North American Generics and International, and has considerable knowledge and experience with respect to the Company’s operations;

WHEREAS, the Consultant and the Company have agreed that the Consultant’s employment with the Company and its affiliates will terminate on May 1, 2015 (the “ Employment Cessation Date ”);

WHEREAS, the Company has determined that it is in its best interests for the Consultant to make available his continued services and expertise to the Company following the Employment Cessation Date, for the consideration and on the terms and conditions set forth below; and

NOW, THEREFORE, in consideration of the mutual promises, covenants, representations and warranties made herein and intending to be legally bound, the Parties hereto agree as follows:

Section 1 Engagement

1.1 Services . Upon the terms and subject to the conditions of this Agreement, the Company hereby engages the Consultant, and the Consultant hereby accepts such engagement, as an independent contractor to provide the services set forth in Annex A and any other such consulting services as may be requested from time to time by the Executive Vice President Chief Operating Officer (collectively, the “ Services ”). Notwithstanding any provision of this Agreement to the contrary, the Company and the Consultant currently intend and anticipate that (i) as of the Employment Cessation Date, the Consultant shall have a “separation from service” (within the meaning of Section 409A of the Internal Revenue Code of 1986, as amended (the “ Code ”)) from the Company and (ii) the amount of time the Consultant shall provide the Services during the Term shall be less than twenty percent (20%) of the average level of bona fide services performed by the Consultant during the thirty-six (36) month period preceding the Employment Cessation Date.


1.2 Location . During the Term, the Consultant shall be available to provide the Services remotely (via phone, e-mail or fax), provided, however that at the option of the Company, Consultant shall be required to attend meetings with the Company’s management from time to time as reasonably requested by the Company.

1.3 Term of Agreement . This term of this Agreement shall commence upon the Employment Cessation Date and shall continue until May 1, 2016 (the “ Termination Date ”), unless earlier terminated in accordance with Section 1.4 (the “ Term ”).

1.4 Termination . The Company may terminate this Agreement and the Term at any time for Cause (as defined below) and either Party may terminate this Agreement without Cause, pursuant to a Notice of Termination (as defined below), which, in the case of a termination without Cause shall be delivered at least ten (10) days prior to the Date of Termination (as defined below). The Company may also terminate this Agreement and the Term on account of the Consultant’s Disability and the Parties may terminate the Term upon mutual agreement. The Term will terminate automatically in the event of the Consultant’s death (as defined below). Any termination of this Agreement and the Term, other than a termination on account of the Consultant’s death, shall be communicated by a written “Notice of Termination” to the other party hereto delivered in accordance with Section 1.4.

1.4.1 For purposes of this letter, “ Cause ” shall mean (i) any refusal by the Consultant to perform the Services, after written notice thereof by the Company and a reasonable opportunity to cure, not to exceed 30 days (provided such refusal is reasonably susceptible to cure); (ii) any act of dishonesty, fraud, embezzlement, theft or misappropriation by the Consultant in connection with or related to the performance of the Services hereunder or the indictment of or plea of nolo contendere by the Consultant to any felony or crime involving moral turpitude; (iii) any gross negligence or willful misconduct by the Consultant in connection with the performance of the Services; or (iv) any breach by the Consultant of any of the material terms contained in this Agreement or any agreement between the Consultant and the Company or its affiliates, after written notice thereof by the Company and a reasonable opportunity to cure, not to exceed 30 days (provided such breach is reasonably susceptible to cure). For purposes of this Agreement, “ Disability ” shall mean the Consultant’s inability to perform the Services due to illness or injury for a period of 90 consecutive calendar days or 90 calendar days in any 180 day period.

1.4.2 For purposes of the Agreement, “ Date of Termination ” shall mean, if the Agreement is terminated (i) by the Company with Cause or by either Party without Cause or by the Company due to the Consultant’s Disability, the date specified in the Notice of Termination, which, in the case of a termination without Cause, shall not be less than 10 days after the date the Notice of Termination is delivered, or (ii) if the Agreement is terminated for any other reason, the date on which a Notice of Termination is given or any later date (within thirty (30) days, or any alternative time period agreed upon by the parties, after the giving of such notice) set forth in such Notice of Termination.

 

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1.5 Effect of Termination . Upon termination of this Agreement prior to the expiration of the Term, within thirty (30) days after the Date of Termination, the Company shall pay the Executive a pro-rata Consulting Fee for the portion of the month prior to the Date of Termination and expense reimbursements as of the Date of Termination, following which the Company’s obligations to pay the Consulting Fee shall immediately cease, and the Consultant shall not be required to render any further Services; provided , however, that if the Company terminates this Agreement for Cause, the Company’s obligations to pay the Consulting Fee shall immediately cease as of the Date of Termination.

1.6 Relationship of Parties . The Consultant is an independent contractor of the Company, and this Agreement shall not be construed to create any association, partnership, joint venture, employee or agency relationship between the Consultant and the Company (or any of its affiliates) for any purpose. Except to the extent specifically authorized in advance by the Company in writing, the Consultant (a) shall have no authority (and shall not hold itself out as having authority) to represent, bind or act on behalf or in the name of the Company or any of its affiliates, and (b) shall not make any agreements or representations on behalf of the Company or any of its affiliates. Without limiting the generality of the foregoing, except as otherwise provided in the Employment Agreement and/or the Separation Agreement (each as defined below), the Consultant will not be eligible to participate in any vacation, group medical or life insurance, disability, profit sharing or retirement benefits or any other fringe benefits or benefit plans offered by the Company or any of its affiliates to its employees. The Company will not be responsible for withholding or paying any income, payroll, Social Security or other federal, state or local taxes, making any insurance contributions, including unemployment or disability, or obtaining worker’s compensation insurance on behalf of the Consultant. The Consultant shall be responsible for, and shall indemnify the Company against, all such taxes or contributions, including penalties and interest. The Consultant may not engage any person in connection with the performance of the Services without the Company’s prior written consent. The Consultant shall be fully responsible for any such persons and in no event shall the Consultant be relieved of its obligations under this Agreement as a result of its use or engagement of any such persons.

Section 2 Compensation

2.1 Consulting Fee . As consideration for the provision of Services and the rights granted to the Company under this Agreement, the Consultant shall be paid a monthly consulting fee of $19,000, payable in arrears, no later than the fifteenth (15th) day of the following month (the “ Consulting Fee ”).

2.2 Expense Reimbursement . The Company agrees to reimburse the Consultant for reasonable and appropriately documented out-of-pocket expenses actually incurred and paid by the Consultant but only to the extent (a) directly related to the Consultant’s performance of the Services, (b) incurred in accordance with the Company’s expense reimbursement policies and (c) approved in writing in advance by the Company. All reimbursements provided under this Agreement shall be made or provided in accordance with the requirements of Section 409A of the Code to the extent that such reimbursements are subject to Section 409A of the Code, including, where applicable, the requirements that (a) any reimbursement is for expenses incurred during the Term, (b) the amount of expenses eligible for reimbursement during a calendar year may not affect the expenses eligible for reimbursement in any other calendar year, (c) the reimbursement of an eligible expense will be made on or before the last day of the calendar year following the year in which the expense is incurred and (d) the right to reimbursement is not subject to set off or liquidation or exchange for any other benefit.

 

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2.3 Withholding, etc . Amounts payable under this Agreement shall be without deduction or withholding of any kind other than any tax or other deduction or withholding determined by the Company to be required by law. Except as otherwise provided herein, the Company shall be entitled to set-off against and deduct from any amount payable to the Consultant hereunder any amount which it in good faith considers to be due to the Company or any of it’s affiliates under the terms of this Agreement or any other agreement involving the Parties or their respective affiliates.

Section 3 Certain Agreements

3.1 Non-Competition . Nothing in this Agreement shall restrict the Consultant from being engaged or employed in any other business, trade, profession or other activity; provided , that, during the Term, to the maximum extent permitted by Law, the Consultant shall not, directly or indirectly, engage in, become financially interested in, be employed by or have any business connection other than as a member of the board of directors or similar governing body, with any other person, corporation, firm, partnership or other entity whatsoever (a “Competitor”) known by him to Compete with the Company, anywhere in the world, in any line of business engaged in (or planned to be engaged in) by the Company or any of its affiliates, in each case, without the Company’s prior written consent; provided , further , that nothing in this Agreement shall prohibit you from holding, as a passive investor and for investment purposes only, no more than five percent (5%) of the capital stock of any publicly traded company or any privately held company (without any other involvement in the management or operation of such business). For the purposes of this paragraph 3.1, a Competitor shall be deemed to “Compete” if it engages in the development, manufacture, and sale (other than at the retail level) of branded and generic drug products and that is in material and direct competition with any of the five (5) products that, over the four (4) fiscal quarters immediately preceding your Termination Date, accounted for the greatest amount of revenues for the Company or any of its affiliates, taken as a whole.

3.2 Confidentiality . The Consultant shall (a) use the Confidential Information solely to the extent necessary in the performance of the Services and not for any other purpose, (b) not disclose any Confidential Information other than in connection with the provision of Services, (c) promptly return all Confidential Information to the Company (or, at the election of the Company, destroy such Confidential Information) without retaining any copies thereof and (d) not reverse engineer, decompile, test or analyze the Confidential Information without the prior written consent of the Company. In the event that the Consultant is requested or required by law, judicial or governmental order, deposition, interrogatory, request for documents, subpoena, civil investigative demand or other legal process to disclose any of the Confidential Information, the Consultant must first provide the Company with prompt written notice of such requirement so that the Company (or any of its affiliates) may seek an appropriate protective order. If the Consultant is nevertheless legally required (as confirmed by the opinion of the Company’s counsel) to disclose Confidential Information, then the Consultant shall only disclose that portion of the Confidential Information that is legally required to be disclosed (as confirmed by the opinion of the Company’s counsel). In such an event, the Consultant shall take reasonable efforts to obtain assurance that confidential treatment will be accorded to that portion of the Confidential Information being disclosed. In no event shall the Consultant oppose action by the Company (or any of its affiliates) to obtain an appropriate protective order or other reliable assurance that confidential treatment will be accorded the Confidential Information. For purposes

 

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of this section, “ Confidential Information ” means all non-public information concerning the Company or any of its affiliates (whether prepared by the Company or otherwise, whether oral or written, in whatever form or data storage medium and whether or not specifically identified as “confidential”), including plans and strategies, financial and accounting information, product-related information, computer programs, code and software, technical drawings and schematics, technical expertise, know-how, processes, ideas, inventions (whether patentable or not), agreements and reports (together with all analyses, compilations, forecasts, studies, summaries, notes, data and other documents and materials, in whatever form maintained and whether prepared by the Company, the Consultant or other persons, which contain or reflect, or are based on or generated from, in whole or in part, any such information).

3.3 Proprietary Items . The Consultant will not remove from the Company or any of the Company’s premises (except to the extent such removal is for purposes of the performance of Consultant’s duties hereunder at home or while traveling, or except as otherwise specifically authorized by the Company) any document, record, notebook, plan, model, component, device, or computer software, whether embodied in a disk or in any other form (collectively, the “ Proprietary Items ”). The Consultant recognizes that, as between the Company, on the one hand, and the Consultant, on the other hand, all of the Proprietary Items, whether or not developed by the Consultant, are the exclusive property of the Company. Upon any termination of the Term or this Agreement, or upon the Company’s request at any time, the Consultant will return to the Company all of the Proprietary Items in the Consultant’s possession or subject to the Consultant’s control, and the Consultant shall not retain any copies or other physical embodiment of any of the Proprietary Items.

3.4 Other . Nothing in this Section 3 shall limit any other non-compete, non-solicitation, confidentiality, intellectual property-related or other covenants or restrictions to which the Consultant may be subject under any other agreement, including Section 8 of the Key Employee Agreement between the Consultant and Watson Pharmaceuticals Inc., dated February 28, 2000, as amended (the “ Employment Agreement ”), the Separation Agreement and Release between Consultant and the Company, dated March __, 2015 (the “ Separation Agreement ”) or otherwise. This Section 3 shall survive the termination of this Agreement.

Section 4 Miscellaneous

4.1 Notice . All notices, approvals and other communications required or contemplated under this Agreement shall be in writing and shall be deemed to have been duly given (a) when received if delivered personally, (b) when sent by cable, telecopy, telegram or facsimile (which is confirmed by the intended recipient), and (c) when sent by overnight courier service or when mailed by certified or registered mail, return receipt requested, with postage prepaid, to the Parties at the following addresses:

 

In the case of Consultant: to the most recent address on file with the Company
In the case of the Company: Actavis plc
Morris Corporate Center III
400 Interpace Parkway
Parsippany, New Jersey 07054
Attention: Chief Legal Officer & Secretary

 

5


with a copy to: Actavis plc
1 Grand Canal Square
Docklands
Dublin 2

Ireland

Attention: Chief Legal Officer & Secretary

or such other persons or addresses as either Party may from time to time designate by notice to the other.

4.2 Assignment; Binding Effect . No Party shall assign or transfer or purport to assign or transfer any of its rights or obligations under this Agreement without the prior written consent of the other Party; provided , however , that the Company shall be permitted to assign or transfer any of its rights or obligations hereunder to any affiliate of the Company without the written consent of the Consultant. This Agreement shall inure to the benefit of the Parties and their respective permitted successors and assigns and is binding upon the Parties and their respective successors and assigns.

4.3 Amendment; Waiver . This Agreement may be amended, changed or supplemented only by a written agreement executed and delivered by the Parties. Any waiver of, or consent to depart from, the requirements of any provision of this Agreement shall be effective only if it is in writing and signed by the Party giving it, and only in the specific instance and for the specific purpose for which it has been given. Except as otherwise provided by this Agreement, no failure on the part of any Party to exercise, and no delay in exercising any right under this Agreement shall operate as a waiver of such right.

4.4 Entire Agreement . This Agreement (including the Annex), Section 8 of the Employment Agreement and the Separation Agreement constitute the entire agreement between the Parties pertaining to the subject matter hereof and supersedes all prior agreements, negotiations, discussions and understandings, written or oral, between the Parties with respect to such subject matter.

4.5 Severability . If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. The Parties shall negotiate in good faith to amend this Agreement to give effect to the purpose and intent of the provision found to be invalid, illegal or unenforceable.

4.6 Governing Law; Dispute Resolution . This Agreement shall be governed by and construed in accordance with the laws of the State of New Jersey, without regard to principles of conflict of laws. The parties agree that any controversy or claim not resolved by the Parties arising out of or relating to this Agreement shall be resolved, to the fullest extent permitted by law, by final, binding and confidential arbitration held in Morris County, New Jersey and conducted, to the extent not inconsistent with the laws of the State of New Jersey, pursuant to the Rules for Arbitration of Employment Disputes of the American Arbitration Association, and the parties agree that each side shall initially bear their own costs and fees, but that the arbitrator may award reasonable costs and attorney’s fees to the prevailing party.

 

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4.7 Costs . Except as otherwise provided in this Agreement, each Party is responsible for its own costs and expenses incurred in connection with performing and observing its obligations and covenants under this Agreement.

4.8 Remedies . The Consultant expressly acknowledges and agrees that the terms of this Agreement are reasonable and necessary for the protection of the legitimate business interests of the Company. The Consultant acknowledges and agrees that the Company would be irreparably harmed by a breach of this Agreement by the Consultant and that money damages are an inadequate remedy for an actual or threatened breach of this Agreement. Therefore, the Consultant agrees to the granting of specific performance of this Agreement and injunctive or other equitable relief in favor of the Company as a remedy for any such breach, without proof of actual damages, and the Consultant further waives any requirement for the securing or posting of any bond in connection with any such remedy. Such remedy shall not be deemed to be the exclusive remedy for any such breach, but shall be in addition to all other remedies available at law or equity to the Company.

4.9 Counterparts . This Agreement may be executed in any number of counterparts which, taken together, constitute one and the same agreement.

4.10 No Third Party Beneficiaries . Except as expressly contemplated by this Agreement, nothing in this Agreement shall confer any rights upon any person other than the Parties and their respective successors and permitted assigns.

[ remainder of this page has been left blank intentionally ]

 

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IN WITNESS WHEREOF, the Company and the Consultant have each caused this Agreement to be duly executed pursuant to due authorization, all as of the day and year first above written.

 

ACTAVIS PLC
By: /s/ Karen L. Ling
Name: Karen L. Ling
Title: Chief Human Resources Officer

 

CONSULTANT
By: /s/ David A. Buchen
Name: David A. Buchen

 


Annex A

Services

The Consultant is engaged to provide the following services:

Exhibit 10.40

May 19, 2014

David Buchen

15 Jacob Arnold Road

Morristown, NJ 07960

Dear David:

You have been identified as a key contributor to the success of Actavis plc, its subsidiaries and affiliates (the “Company”) and the success of its pending acquisition of Forest Laboratories, Inc. (the “Forest Transaction”). In recognition of your contributions, the Company is pleased to offer you a special retention, as set forth below, which is contingent upon your acceptance of the terms of this letter.

Special Retention Award

In the event your employment is terminated at any time by you for “Good Reason” (as defined in the February 28, 2000 Key Employment Agreement between you and Actavis, Inc. (f/k/a Watson Pharmaceuticals, Inc.), as amended from time to time (the “Employment Agreement”)), the following benefits will be due to you: (i) a lump sum equal to the sum of two times your current annual base salary and two times your annual incentive bonus (calculated based on the higher of your target bonus or the highest bonus you have received in the two years prior to your termination); (ii) any earned but unpaid bonus for the year preceding your termination; (iii) a pro-rated bonus (based on your target bonus) for the year in which your termination occurs; (iv) continued group health insurance benefits for up to twenty four months; and (v) outplacement services for one year with a nationally recognized service selected by the Company, which shall be paid or reimbursed promptly by the Company, but in no event later than the calendar year immediately following the calendar year which such expenses are incurred. In the event your employment is terminated at any time by the Company without “Cause” (as defined in the Employment Agreement), you shall be paid the forgoing compensation and benefits, unless that on the date of your termination the Company then provides the Company’s senior executives with more valuable severance and compensation and benefits, in the aggregate, than the forgoing compensation and benefits, in which case you shall be paid such more valuable benefits. In addition, provided that you are employed by the Company on January 2, 2015, you shall be paid the forgoing compensation and benefits if you are not the Chief Legal Officer & Secretary of Actavis plc, with all commensurate duties and responsibilities of such office and title, on such date and if you elect to terminate your employment with the Company, for any reason or no reason, no later than the earlier of (a) the first anniversary of the consummation of the Forest Transaction or (b) December 1, 2015. The forgoing severance benefits and compensation shall be paid to you subject to your delivery, execution and non-revocation of a Release and such amounts shall be paid to you within 30 days after your qualifying termination of employment, and if the 30-day period during which the severance benefits may be paid spans two calendar years, the payment shall be made in the later calendar year.


This letter does not change, in any way, the nature of your employment relationship with the Company. You or the Company may terminate your employment at any time, for any reason, with or without Cause, except to the extent otherwise expressly provided by any written agreement between you and the Company. The compensation and benefits provided in this letter are intended to be compliant with Section 409A of the Internal Revenue Code and the provisions hereof shall be interpreted and administered consistently with such intent. Additionally, this letter is in addition to, and does not alter, supersede or replace any prior retention agreement between you and the Company

We are confident we can count on your continued support. On behalf of the Company, I thank you for your contributions to the Company’s success. Please indicate your acknowledgement and acceptance of this offer by signing and returning a copy of the letter.

 

Sincerely yours,
/s/ Paul M. Bisaro
Paul M. Bisaro
Chairman and Chief Executive Officer

Date


Acknowledgement

I have read, understand and accept the terms set forth in this letter.

 

/s/ David A. Buchen May 23, 2014
Date


Appendix A

“Cause” For the purposes of this offer of the Retention Bonus, “Cause” shall mean the occurrence of any of the following events on or after acceptance of this offer, and upon written notice to Executive and a reasonable opportunity for the Executive to cure such event (which opportunity shall be thirty (30) days unless the event is not susceptible to being cured, within the judgment of the Board): (i) fraud, misappropriation, embezzlement or other act of material misconduct against the Company or any of its affiliates; (ii) gross neglect, willful malfeasance or gross misconduct against the Company or any of its affiliates; (iii) conviction or plea of guilty or nolo contendere to a felony which felony, conviction, or plea materially impacts the Company economically or the Company’s reputation, as reasonably determined by the Board; (iv) willful and knowing violation of any rules or regulations of any governmental or regulatory body material to the business of the Company; (v) failure to cooperate, if requested by the Board, with any investigation or inquiry into Executive’s or the Company’s business practices, whether internal or external, including, but not limited to Executive’s refusal to be deposed or to provide testimony at any trial or inquiry unless such refusal is made upon the advice of the Company’s general counsel or its external counsel; or (vi) substantial and willful failure to render services in accordance with the terms of Executive’s employment (other than as a result of illness, accident, or other physical or mental incapacity) or other material breach of Executive’s duties and responsibilities). For the purposes of clauses (ii), (iv) and (vi) of this definition, no act, or failure to act, on Executive’s part shall be deemed “willful” unless done, or omitted to be done, by Executive not in good faith and with reasonable belief that Executive’s act, or failure to act, was in the best interest of the Company. Notwithstanding the foregoing, the Company shall not have “Cause” to terminate Executive’s employment in connection with any of the foregoing events to the extent that the Company shall have either consented to such event or the extent that ninety (90) days shall have elapsed following the date that the Company becomes aware of such event without delivering notice to the Executive (“Cause Notice”).

“Good Reason” For the purposes of this letter, “Good Reason” shall mean any one of the following events which occurs on or after acceptance of this offer: (i) any material reduction of the Executive’s then existing annual base salary, except to the extent the annual base salary of all other executive officers at levels similar to the Executive of the Company is similarly reduced (provided such reduction does not exceed fifteen percent (15%) of Executive’s then existing annual base salary); (ii) any material reduction in the package of benefits and incentives, taken as a whole, provided to the Executive (except that employee contributions may be raised to the extent of any cost increases imposed by third parties) or any action by the Company which would materially and adversely affect the Executive’s participation or reduce the Executive’s benefits under any such plans, except to the extent that such benefits and incentives of all other executive officers at a similar level of the Company are similarly reduced; (iii) any material diminution of the Executive’s duties and responsibilities, taken as a whole, excluding for this purpose an isolated, insubstantial or inadvertent action not taken in bad faith which is remedied by the Company immediately after notice thereof is given by the Executive; (iv) a requirement that the Executive materially relocate to a work site that would increase the Executive’s one-way commute distance by more than thirty-five (35) miles from his then principal residence, unless the Executive accepts such relocation opportunity; (v) any material breach by the Company of its obligations under


this Agreement; or (vi) any failure by the Company to obtain the assumption of this Agreement by any successor or assign of the Company. Notwithstanding the foregoing, the Executive may not resign his employment for Good Reason unless: (A) the Executive has provided the Company with at least 30 days prior written notice of the Executive’s intent to resign for Good Reason; and (B) the Company has not remedied the alleged violation(s) within 30 days following its receipt of the written notice of intent to resign for Good Reason.

Exhibit 10.52

Execution Version

STRICTLY CONFIDENTIAL

 

 

 

[***] = Certain confidential information contained in this document, marked by brackets, 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.

ASSET PURCHASE AGREEMENT

by and among

FOREST LABORATORIES, LLC,

FOREST LABORATORIES CANADA INC., and

FOREST LABORATORIES HOLDINGS LIMITED

as Sellers,

ACTAVIS PLC,

and

ASTRAZENECA UK LIMITED,

as Purchaser

Dated as of February 4, 2015

 

 

 

 


TABLE OF CONTENTS

 

     Page  

ARTICLE 1 DEFINITIONS AND CONSTRUCTION

     1   

    1.1

   Definitions      1   

    1.2

   Interpretation Provisions      15   

    1.3

   Performance of Obligations by Affiliates      16   

ARTICLE 2 PURCHASE AND SALE

     16   

    2.1

   Purchase and Sale of Acquired Assets      16   

    2.2

   Excluded Assets      17   

    2.3

   Assumed Liabilities      18   

    2.4

   Excluded Liabilities      19   

ARTICLE 3 PURCHASE PRICE; CLOSING

     21   

    3.1

   Purchase Price      21   

    3.2

   Closing      21   

    3.3

   Seller Closing Deliveries      21   

    3.4

   Purchaser Closing Deliveries      22   

    3.5

   Tax Allocation      22   

    3.6

   Risk of Loss      22   

    3.7

   Royalties      22   

ARTICLE 4 REPRESENTATIONS AND WARRANTIES OF THE SELLERS

     24   

    4.1

   Organization, Power and Standing      24   

    4.2

   Authority, Non-Contravention, Required Filings      24   

    4.3

   Financial Information      26   

    4.4

   Title to Properties and Assets      26   

    4.5

   Intellectual Property Rights      26   

    4.6

   Acquired Contracts      29   

    4.7

   Compliance with Law; Permits; Regulatory Matters      29   

    4.8

   Litigation      31   

    4.9

   Inventory      31   

    4.10

   Recalls; Product Liability      32   

    4.11

   Taxes      33   

    4.12

   Brokers      33   

    4.13

   Exclusivity of Representations      33   

 

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     Page  

ARTICLE 5 REPRESENTATIONS AND WARRANTIES OF PURCHASER

     33   

    5.1

   Organization, Power and Standing      33   

    5.2

   Authority, Non-Contravention, Required Filings      33   

    5.3

   Sufficient Funds Available      35   

    5.4

   Brokers      35   

    5.5

   Exclusivity of Representations      35   

ARTICLE 6 COVENANTS AND AGREEMENTS

     35   

    6.1

   Conduct Prior to Closing      35   

    6.2

   Access to Information; Confidentiality      37   

    6.3

   Transfer of Acquired Regulatory Approvals      38   

    6.4

   Third Party Consents      39   

    6.5

   Governmental Consents      39   

    6.6

   Support      41   

    6.7

   Trade Notification      41   

    6.8

   Intellectual Property License      41   

    6.9

   Use of Licensed Names and NDCs      42   

    6.10

   Assistance in Collecting Certain Amounts      43   

    6.11

   Regulatory Documentation and Marketing Records      44   

    6.12

   Post-Closing Responsibility for Products Sold in the Territory      44   

    6.13

   Health Care Reform Fees      44   

    6.14

   Withholding Tax      45   

    6.15

   Transfer Taxes      45   

    6.16

   Apportioned Obligations      45   

    6.17

   VAT      45   

    6.18

   Wrong Pockets      46   

    6.19

   Non-Compete; Termination of Discussions      46   

    6.21

   Negotiation and Completion of Ancillary Agreements      47   

    6.22

   Certain Agreements      47   

    6.23

   Aclidinium Canada Matters      47   

ARTICLE 7 CONDITIONS

     47   

    7.1  

   Conditions to the Obligation of the Parties      47   

 

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     Page  

    7.2

   Conditions to the Obligations of Purchaser      47   

    7.3

   Conditions to the Obligations of the Sellers      48   

ARTICLE 8 TERMINATION

     49   

    8.1

   Termination      49   

    8.2

   Effect of Termination      50   

    8.3

   Withdrawal of Certain Filings      50   

ARTICLE 9 INDEMNIFICATION AND SURVIVAL

     50   

    9.1

   Survival      50   

    9.2

   Indemnification      50   

    9.3

   Limitations on Indemnification      51   

    9.4

   Sole and Exclusive Remedy      52   

    9.5

   Procedure for Claims      52   

    9.6

   Setoff Rights      53   

ARTICLE 10 PARENT GUARANTEE

     54   

    10.1

   Representations and Warranties of Seller Parent      54   

    10.2

   Seller Parent Guarantee      54   

ARTICLE 11 MISCELLANEOUS

     55   

    11.1

   Public Announcements      55   

    11.2

   Expenses      55   

    11.3

   Notices      55   

    11.4

   Entire Agreement; Modification      56   

    11.5

   Severability      57   

    11.6

   No Waiver; Cumulative Remedies      57   

    11.7

   Governing Law; Submission to Jurisdiction; Waiver of Jury Trial      57   

    11.8

   Counterparts      58   

    11.9

   Assignments      58   

    11.10

   Reservation of Rights; No Implied Licenses      58   

    11.11

   No Third Party Beneficiaries      58   

    11.12

   Further Assurances      58   

    11.13

   Equitable Relief      58   

 

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Schedules and Exhibits

Seller Disclosure Letter

 

Exhibit A

Form of Aclidinium Novation and Consent Agreement

Exhibit B

Form of Aclidinium US Termination Agreement

Exhibit C

Form of Assignment Agreement

Exhibit D

Form of Bill of Sale

Exhibit E

Form of Domain Name Assignment

Exhibit F

Form of Patent Assignment

Exhibit G

Form of Purchaser FDA Transfer Letters

Exhibit H

Form of Seller FDA Transfer Letters

Exhibit I

Form of Supply Agreements

Exhibit J

Form of Trademark Assignment

Exhibit K

Form of Transition Services Agreement

Exhibit L

Product Obligations and Reporting

Exhibit M

Certain Matters

Exhibit N

Aclidinium Canada Matters

 

i


ASSET PURCHASE AGREEMENT

This ASSET PURCHASE AGREEMENT (this “ Agreement ”), is made as of February 4, 2015, by and among Forest Laboratories, LLC, a Delaware limited liability company and successor-in-interest to Forest Laboratories, Inc. (“ Forest ”), Forest Laboratories Holdings Limited, a corporation organized under the Laws of Ireland (“ FLH ”) and Forest Laboratories Canada Inc., a corporation organized under the Laws of Canada (collectively, with Forest and FLH, the “ Sellers ”, and each, a “ Seller ”), AstraZeneca UK Limited, a private limited company registered in England and Wales (“ Purchaser ”), and, solely with respect to Articles 10 and 11 , Actavis plc, a public limited company organized under the laws of Ireland (“ Seller Parent ”). Each of the Sellers and Purchaser, and solely for purposes of Article 10 and 11 , Seller Parent, may be referred to, individually, as a “ Party ” or, collectively, as the “ Parties .”

WHEREAS , the Sellers and/or their respective Affiliates own, license or otherwise hold the rights to develop, promote, market, distribute and/or sell the Products (as defined below) and are engaged in the Exploitation (as defined below) of the Products in the Territory (such rights, the “ Product Business ”);

WHEREAS , on October 31, 2014, Almirall S.A. and Purchaser completed a strategic transaction in which Almirall S.A. transferred the rights to its respiratory franchise to Purchaser;

WHEREAS , prior to or concurrent with the execution of this Agreement, (i) the Sellers, Purchaser and Almirall S.A., or one or more of their respective Affiliates, have entered into an agreement pursuant to which they have agreed to, among other things, novate and assign the Aclidinium US Agreements from Almirall S.A. to Purchaser or one of its Affiliates, in the form of Exhibit A (the “ Aclidinium Novation and Consent Agreement ”); and (ii) the Sellers, Purchaser, or one or more of their respective Affiliates, have entered into a letter agreement addressing certain consents and waivers between the parties thereto (the “ Letter Agreement ”); and

WHEREAS , the Sellers desire to sell, assign or otherwise transfer and/or cause their respective Affiliates to sell, assign, or otherwise transfer, and Purchaser desires to purchase and accept, the Acquired Assets (as defined below), subject to the terms and conditions described in this Agreement.

NOW, THEREFORE , in consideration of the premises and the mutual covenants and agreements contained herein, the Parties, intending to be legally bound hereby, do agree as follows:

ARTICLE 1

DEFINITIONS AND CONSTRUCTION

1.1 Definitions . For purposes of this Agreement, the following terms shall have the meanings designated to them under this Article 1 , unless otherwise specifically indicated:

Accounts Receivable ” shall mean all accounts receivable, notes receivable and other indebtedness due and owed by any Third Party to any of the Sellers or their respective Affiliates arising from, or held in connection with, the sale or distribution of the Products by or on behalf of the Sellers or any of their respective Affiliates prior to the Closing.


Aclidinium Agreements ” shall mean the Aclidinium Canada Agreement and the Aclidinium US Agreements.

Aclidinium Canada Agreement ” shall mean the Co-Promotion Agreement, dated August 9, 2012, by and between Purchaser (as successor by assignment to Almirall, S.A.) and Forest Laboratories Canada Inc.

Aclidinium Novation and Consent Agreement ” shall have the meaning set forth in the Recitals.

Aclidinium Products ” shall mean the products Exploited by the Sellers or their respective Affiliates pursuant to the Aclidinium Agreements, including Tudorza Pressair and the Development Product, and the ICS Combination Product referred to in the Aclidinium Agreements.

Aclidinium US Agreements ” shall mean, collectively, (a) the License, Development, Commercialization and Cooperation Agreement dated as of April 7, 2006, by and between Almirall S.A. (formerly known as Almirall Prodesfarma, S.A. and Laboratorios Almirall, S.A.), acting in its own name and on behalf of its Affiliates (“ Almirall ”), and Forest Laboratories Holdings Limited, acting in its own name and on behalf of its Affiliates; (b) the Technical Agreement dated January 16, 2012 between Almirall and Forest Laboratories Holdings Limited; and (c) all amendments, supplements, agreements, documents or instruments identified as Aclidinium US Agreements as set forth on Schedule 1.1(a) of the Seller Disclosure Letter.

Aclidinium US Termination Agreement ” shall mean the Termination Agreement to be entered into between Purchaser and the Sellers or one or more of their respective Affiliates on the Closing Date, in substantially the form of Exhibit B .

Acquired Assets ” shall have the meaning set forth in Section 2.1 .

Acquired Business ” shall have the meaning set forth in Section 6.20(a) .

Acquired Contracts ” shall mean the (a)(i) Contracts exclusively related to any Product and (ii) Contracts exclusively related to any Acquired Intellectual Property Rights, including, in each case ((i) and (ii)), those Contracts listed on Schedule 1.1(b) of the Seller Disclosure Letter, and (b) any confidentiality or similar agreement entered into between the Sellers or any of their respective Affiliates or Representatives, on the one hand, and any Third Party with respect to any potential Competing Transaction, on the other hand. For the avoidance of doubt, the Acquired Contracts shall not include the Aclidinium Agreements or the Excluded Contracts; provided , that to the extent any Contract that constitutes an Acquired Contract hereunder has not been made available to Purchaser or its advisers in connection with the transactions contemplated hereby, Purchaser shall have a period of ten (10) Business Days following the date hereof (or, if later, the tenth (10th) Business Day following the date on which such Contract is made available to Purchaser or such advisors) to determine whether such Contract will be an Acquired Contract or an Excluded Contract.

 

2


Acquired Equipment ” shall mean the backup filling line equipment owned by Forest Laboratories Ireland Ltd. and used or held for use in the Manufacture of Tudorza Pressair, as described on Schedule 1.1(c) .

Acquired Intellectual Property Rights ” shall mean all Intellectual Property used exclusively in or relating exclusively to the Exploitation of any of the Products and that is owned by any of the Sellers or any of their respective Affiliates, including that listed on Schedule 1.1(d) of the Seller Disclosure Letter.

Acquired Inventory ” shall mean (a) all finished goods inventory (including samples) of the Products labeled for commercial sale in an amount equal to the lesser of [***] supply (based on the Sellers’ forecast set forth on Schedule 1.1(e) , which shall be consistent with past practice) and the amount in the possession or control of, or otherwise held by or on behalf of, any of the Sellers or their respective Affiliates as of the Closing, (b) all bulk tablets of Daliresp, whether or not packaged, and (c) all inventory of clinical supplies of Product and placebos for use in the RESPOND Study and the ASCEND Study, in the case of (b) and (c), in the possession or control of, or otherwise held by or on behalf of, any of the Sellers and/or their respective Affiliates as of the Closing. For the avoidance of doubt, all finished goods inventory that is not Acquired Inventory shall be an Excluded Asset hereunder.

Acquired Marketing Records ” shall mean all Marketing Records exclusively related to the Exploitation (other than the Supply Chain Actions) of any Product, in each case, that are in any of the Sellers’ or any of their respective Affiliates’ possession or control (other than Contracts related to the DTC Campaigns), to the extent transferable in compliance with applicable Laws or privacy policies.

Acquired Regulatory Approvals ” shall mean all Regulatory Approvals held by any of the Sellers or their respective Affiliates exclusively with respect to any Product, including the Regulatory Approvals listed on Schedule 1.1(f) of the Seller Disclosure Letter.

Acquired Regulatory Documentation ” shall mean all Regulatory Documentation exclusively related to the Exploitation (other than the Supply Chain Actions) of any Product in the possession or control of any of the Sellers or their respective Affiliates as of the Closing.

Action ” shall mean any action, claim, suit, litigation, proceeding, arbitration, mediation, audit, hearing, investigation or dispute.

Affiliate ” shall mean, as to any specified Person, any other Person which, directly or indirectly, controls, is controlled by, or is under common control with, such specified Person. For purposes of this definition, “control,” “controlled by” or “under common control with” shall mean the possession of the power to direct or cause the direction of management and policies of such Person, whether through direct or indirect the ownership of voting securities or otherwise.

Agreement ” shall have the meaning set forth in the Preamble.

 

3


Ancillary Agreements ” shall mean, collectively, the Assignment Agreement, the Bill of Sale, the Supply Agreements, the Transition Services Agreement, the Domain Name Assignment, the Trademark Assignment, the Patent Assignment, the Pharmacovigilance Agreement, the Purchaser FDA Transfer Letters, the Seller FDA Transfer Letters and the Aclidinium US Termination Agreement.

Apportioned Obligations ” shall have the meaning set forth in Section 6.17

ASCENT Study ” shall mean the post-marketing requirement study (LAS MD-45; FDA Reference No. PMR 1903-1) to evaluate the effect of aclidinium bromide on long-term cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD (ASCENT COPD), a double-blind, randomized, placebo controlled, parallel-group study to evaluate the effect of aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD.

Assignment Agreement ” shall mean one or more agreements for the assignment to Purchaser or one or more of Purchaser’s Affiliates of any of the Sellers’ and/or their respective Affiliates’ rights in, to and under the Acquired Contracts and the other intangible Acquired Assets, and the assumption by Purchaser or any of its applicable Affiliates of the Assumed Liabilities, to be entered into between one or more of the Sellers or their respective Affiliates, as applicable, and Purchaser or one or more of Purchaser’s Affiliates on the Closing Date, in substantially the form of Exhibit C .

Assumed Liabilities ” shall have the meaning set forth in Section 2.3 .

Bill of Sale ” shall mean one or more bills of sale for the conveyance of the tangible Acquired Assets, to be entered into between one or more of the Sellers or their respective Affiliates, as applicable, and Purchaser or one or more of Purchaser’s Affiliates on the Closing Date, in substantially the form of Exhibit D .

Business Day ” shall mean any day that is not a Saturday, a Sunday or other day on which banks are required or authorized by Law to remain closed in New York, New York.

Calendar Quarter ” shall have the meaning set forth in Exhibit L .

Calendar year ” shall mean each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar year of this Agreement shall commence on the Closing Date and end on December 31 of the year in which the Closing Date occurs.

cGCP ” shall mean the ethical, scientific, and quality standards required by the FDA for designing, conducting, recording, and reporting human clinical trials, as set forth in FDA regulations in 21 C.F.R. Parts 50, 54, 56, and 312, or as otherwise required by applicable Law.

cGLP ” shall mean the legal, scientific, and quality standards required by the FDA for designing, conducting, recording, and reporting nonclinical studies intended to support applications for research or marketing permits, as set forth in FDA regulations in 21 C.F.R. Part 58, or as otherwise required by applicable Law.

 

4


cGMP ” shall mean the FDA’s current Good Manufacturing Practice Regulations at 21 C.F.R. Parts 210 and 211, 21 U.S.C. 351(a), and the respective counterpart requirements promulgated by Governmental Entities in countries outside the United States where the Product (or any component thereof) is or was previously Manufactured.

Chosen Courts ” shall have the meaning set forth in Section 11.7 .

Claim ” shall have the meaning set forth in Section 9.5 .

Closing ” shall have the meaning set forth in Section 3.2 .

Closing Date ” shall have the meaning set forth in Section 3.2 .

Competing Activity ” shall mean [***].

Competing Transaction ” shall mean any purchase by or sale or other disposition to a Third Party of all or any portion of the Sellers’ or their respective Affiliates’ rights to develop, promote, market, distribute or sell the Products in the Territory or the Acquired Assets (other than sales of Product inventory in the ordinary course of business).

Competition Laws ” shall mean the HSR Act and other similar Laws of any jurisdiction.

Confidential Information ” shall mean, as to a Party, (a) all information disclosed by such Party (or its Representatives or Affiliates) to the Receiving Party in connection with this Agreement, any Ancillary Agreement and the transactions contemplated hereby and thereby, including all information with respect to the Disclosing Party’s licensors, licensees or Affiliates, (b) all information disclosed to the Receiving Party by the Disclosing Party under the Confidentiality Agreement and (c) all memoranda, notes, analyses, compilations, studies and other materials prepared by or for the Receiving Party to the extent containing or reflecting the information in the preceding clause (a) or (b). Notwithstanding the foregoing, Confidential Information shall not include information that: (i) at the time of disclosure by the Disclosing Party or its Representatives, is generally available to the public or is otherwise in the public domain; (ii) becomes generally available to the public or otherwise becomes part of the public domain after disclosure by the Disclosing Party or its Representatives without breach of this Agreement by the Receiving Party or its Representatives; (iii) was in the possession of the Receiving Party or its Representatives at the time of disclosure by the Disclosing Party or its representatives and that was not, to the Receiving Party’s knowledge, subject to any obligation of confidentiality or non-use owed to the Receiving Party; (iv) was received by the Receiving Party or its Representatives from a Third Party not known by the Receiving Party to be subject to an obligation of confidentiality to the Disclosing Party with respect to such information; or (v) was independently discovered or developed by the Receiving Party or its Representatives without use of the Disclosing Party’s Confidential Information, as demonstrated by written documentation.

Confidentiality Agreement ” shall mean the confidentiality agreement as of January 25, 2015 between Purchaser and Actavis, Inc.

 

5


Consent ” shall mean any and all notices to, consents, approvals, clearances, ratifications, permissions, authorizations or waivers from Third Parties, including from any Governmental Entity.

Contract ” shall mean all written or oral agreements, contracts, subcontracts, leases or subleases (whether for real or personal property), purchase orders, covenants not to compete, confidentiality agreements, licenses, sublicenses, instruments, notes, guarantees, assignments, options and warranties to which any of the Sellers or their respective Affiliates is a party or by which any of the Sellers or their respective Affiliates or any of the Acquired Assets are bound.

Court Order ” shall mean any judgment, decision, decree, consent decree, writ, injunction, ruling or order of any Governmental Entity that is binding on any Person or its property under applicable Laws.

Daliresp ” shall mean Daliresp ® (roflumilast).

Damages ” shall mean any and all damages, judgments, awards, liabilities, losses, obligations, claims of any kind or nature, fines and costs and expenses (including amounts paid in settlement, court costs and reasonable fees and expenses of attorneys, accountants, other advisors and of litigation, arbitration or other dispute resolution procedures).

Defending Party ” shall have the meaning set forth in Section 9.5 .

Development Product ” shall mean the aclidinium-formoterol fixed-dose combination product.

Disclosing Party ” shall have the meaning set forth in Section 6.2(a) .

DOJ ” shall mean the U.S. Department of Justice or any successor entity thereto.

Domain Name Assignment ” shall mean one or more Domain Name Assignments assigning to Purchaser or one or more of Purchaser’s Affiliates the domain names set forth on Schedule 1.1(d) of the Seller Disclosure Letter from a Seller or a Sellers’ Affiliate that is the owner thereof, substantially in the form of Exhibit E .

DTC Campaigns ” shall mean the (a) regional direct-to-consumer advertising campaign with respect to the Products launched by the Sellers in February 2015 and (b) national direct-to-consumer advertising campaign with respect to the Products planned for launch by the Sellers in 2015.

Eligible Insurance Proceeds ” shall have the meaning set forth in Section 9.3(c) .

Encumbrance ” shall mean any lien, mortgage, deed of trust, right-of-way, right of setoff, assessment, security interest, pledge, lease, attachment, adverse claim, levy, charge, easement, restriction, license, hypothecation, preference, imperfection of title, right of possession, encumbrance or other similar restriction or any conditional sale Contract, title retention Contract or other Contract giving rise to any of the foregoing.

 

6


Excluded Assets ” shall have the meaning set forth in Section 2.2 .

Excluded Contracts ” shall mean (a) the Contracts that are exclusively related to any Product and set forth on Schedule 1.1(g) of the Seller Disclosure Letter and (b) all Contracts related to the DTC Campaigns.

Excluded Liabilities ” shall have the meaning set forth in Section 2.4 .

Execution Date Agreements ” shall mean the Aclidinium Novation and Consent Agreement, and the Letter Agreement.

Exploitation ” (and related terms such as “ Exploit ”) shall mean, with respect to any Product or other product, the research, development (including seeking, obtaining or maintaining Regulatory Approvals), the Supply Chain Actions, distribution, sale, licensing, outsourcing, advertising, marketing and promotion of such Product or product, as applicable.

FDA ” shall mean the U.S. Food and Drug Administration, or any successor entity thereto.

FDCA ” shall mean the U.S. Federal Food, Drug, and Cosmetic Act, as amended.

FTC ” shall mean the U.S. Federal Trade Commission or any successor entity thereto.

Fundamental Representations ” shall mean, with respect to Sellers, the representations in Sections 4.1 , 4.2(a) , 4.2(b) , 4.4(a) , 4.4(d) , 4.5(e) and 4.12 and, with respect to Purchaser, the representations in Sections 5.1 5.2(a) , 5.2(b) and 5.4 .

GAAP ” shall mean U.S. generally accepted accounting principles.

General Survival Period ” shall have the meaning set forth in Section 9.1(a) .

Governmental Entity ” shall mean any national, supranational, international, federal, state, local, provincial or other governmental, regulatory or administrative authority, agency or commission or any court, tribunal, or judicial or arbitral body of competent jurisdiction.

Health Care Reform Fees ” or “ HCR Fees ” shall mean the fees described in Section 9008 of the Patient Protection and Affordable Care Act, Pub. L. No. 111-148, as amended by Section 1404 of the Health Care and Education Reconciliation Act of 2010, Pub. L. No. 111-152.

HSR Act ” shall mean the U.S. Hart Scott Rodino Antitrust Improvements Act of 1976, as amended.

IFRS ” shall mean International Financial Reporting Standards.

IND ” shall mean an Investigational New Drug Application filed with the FDA pursuant to 21 C.F.R. part 312, or the equivalent application or filing filed with any equivalent agency or Governmental Entity outside the United States necessary to commence and conduct human clinical trials in such jurisdiction.

 

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Indemnification Cap ” shall have the meaning set forth in Section 9.3(a).

Indemnified Parties ” shall have the meaning set forth in Section 9.2(b) .

Indemnifying Party ” shall have the meaning set forth in Section 9.5 .

Independent Accountant ” shall mean an independent internationally recognized accounting firm mutually agreed upon by the Sellers and Purchaser.

In-Licensed Intellectual Property ” shall mean any Third Party Intellectual Property used exclusively in or relating exclusively to the Exploitation of any of the Products and that is licensed or sublicensed to any of the Sellers or their respective Affiliates.

Intellectual Property ” shall mean all U.S. or foreign intellectual property rights of any kind or nature, including all: (a) patents and patent applications (and any patents that issue as a result of those patent applications) and any renewals, reissues, reexaminations, extensions, continuations, continuations-in-part, divisions, certificates of invention and substitutions relating to any of the patents and patent applications (“ Patents ”); (b) trademarks, service marks, trade dress, logos, slogans, brand names, trade names, corporate names, whether registered or unregistered together with any registrations and applications for registration thereof and all goodwill connected with or symbolized by any of the foregoing, (c) URL and domain name registrations ((b) and (c), collectively, (“ Trademarks ”); (d) social media handles and other similar social media identifiers; (e) copyrights and rights under copyright, whether registered or unregistered (“ Copyrights ”); (f) proprietary information and know-how meeting the definition of a trade secret under the Uniform Trade Secrets Act or other applicable Law (“ Trade Secrets ”); and (g) Know-How.

Know-How ” shall mean existing and available technical information, know-how and data, including inventions (whether patentable or not), improvements, technology, processes, processing methods, manufacturing techniques, and all proprietary or confidential information, discoveries, and formulae, including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical, safety, quality control, preclinical and clinical data.

Labeling ” shall mean, with respect to a Product, such Product’s label, packaging and package inserts accompanying such Product, and any other written, printed, or graphic materials accompanying such Product, including patient instructions or patient indication guides.

Law ” shall mean any federal, state, local, municipal, foreign or other law, statute, constitution, principle of common law, resolution, ordinance, code, edict, decree, rule, Court Order, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Entity.

Letter Agreement ” shall have the meaning set forth in the Recitals.

Liability ” shall mean, with respect to any Person, any direct or indirect liability, indebtedness, obligation (including obligations relating to research, clinical studies, clinical trials and post-marketing commitment studies regarding the Products) commitment, expense, claim, deficiency, guaranty or endorsement of or by such Person of any type, whether accrued, absolute, contingent, matured, unmatured, liquidated, unliquidated, known or unknown.

 

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Licensed Names ” shall mean the corporate trademarks, corporate trade names, corporate names, corporate trade dress and corporate logos that any of the Sellers or their respective Affiliates own and have the right to license in connection with a Product or the Product Business as of the date hereof, but that are not used exclusively in connection with a Product or the Product Business, including those set forth on Schedule 1.1(h) of the Seller Disclosure Letter that, as of the Closing, are used in the labels, packaging, advertising, marketing, sales and promotional materials for any Product.

Licensed Patents ” shall have the meaning set forth in Section 4.5(a) .

Limited License Period ” shall have the meaning set forth in Section 6.9(a) .

Manufacture ” and “ Manufacturing ” shall mean all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, and shipping and holding (prior to distribution) of the Products or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.

Marketing Records ” shall mean all product labeling; product informational letters; advertising, marketing, market research, sales and promotional materials, pricing lists, consulting deliverables, call center scripts, materials and plans related to media, training (including any related outlines and quizzes/answers, if any), trade shows (including displays); post-marketing clinical data; and other related literature, catalogs, publications, videos and materials, including customer lists.

Material Adverse Effect ” shall mean any event, occurrence, effect, matter, change, development, condition or state of facts (“ Effect ”) that, either alone or considered together with all other Effects, is or would reasonably be expected to (x) be materially adverse to the Product Business and the Acquired Assets, taken together as a whole or (y) prevent or materially delay the consummation by the Sellers of the transactions contemplated by this Agreement; provided , however , that, in determining whether a Material Adverse Effect has occurred pursuant to the preceding clause (x), there shall be excluded from this definition any Effect to the extent that it results from (a) changes or conditions affecting the respiratory treatment industry or the economy in the Territory, (b) any generally applicable change in Law or in GAAP, or in the interpretation of any of the foregoing, (c) conditions arising out of acts of terrorism, war conditions or other force majeure events and (d) the announcement or pendency of the transactions contemplated by this Agreement or any action expressly required to be taken by any of the Sellers pursuant to the terms of this Agreement or any action taken by any of the Sellers with Purchaser’s written consent ( provided , that in such case the applicable Seller has provided timely written notice to Purchaser that withholding such consent would result in a Material Adverse Effect), so long as any such Effect described in clauses (a), (b) or (c) does not disproportionately adversely affect the Product Business and the Acquired Assets, taken together as a whole, as compared to other Persons engaged in the sale of products similar to the Products in the Territory (in which case the incremental disproportionate effect or effects may be taken into account in determining whether a Material Adverse Effect has occurred).

 

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[***]

NDC ” shall mean the “National Drug Code” registered by a company with the FDA with respect to a pharmaceutical product.

Net Sales ” shall mean [***].

Net Sales Cap ” shall mean [***].

Net Sales Period ” shall mean (i) the initial period beginning on [***] and ending at [***] (the “ Initial Net Sales Period ”) and (ii) calendar years [***] through and including [***].

Net Sales Royalty ” shall have the meaning set forth in Section 3.7(a) .

Net Sales Statement ” shall have the meaning set forth in Section 3.7(a) .

 

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Net Sales Threshold ” shall mean the following amounts:

[***]

Nonassigned Asset ” shall have the meaning set forth in Section 6.4 .

Non-Competition Party ” shall have the meaning set forth in Section 6.20(a).

Non-Defending Party ” shall have the meaning set forth in Section 9.5 .

Obligations ” shall have the meaning set forth in Section 10.2(b) .

Organizational Documents ” shall mean, as to any Person, its certificate of incorporation and by-laws, its certificate of formation and limited liability company agreement, or any equivalent documents under the Law of such Person’s jurisdiction of organization.

Owned Registered IP ” shall have the meaning set forth in Section 4.5(a) .

Party ” or “ Parties ” shall have the meaning set forth in the Preamble.

Patent Assignment ” shall mean the Patent Assignment assigning to Purchaser the Patents included in the Acquired Intellectual Property Rights, including United States patent applications (a) 13/733,187 (ROFLUMILAST COMPOSITIONS FOR THE TREATMENT OF COPD); (b) 61/582,564 (ROFLUMILAST COMPOSITIONS FOR THE TREATMENT OF COPD) and (c) such other Patents set forth on Schedule 1.1(d) of the Seller Disclosure Letter, to be entered into by Forest Laboratories Holdings Limited or such other Seller or Affiliate of the Sellers that is the owner thereof, substantially in the form of Exhibit F attached hereto.

[***]

Permits ” shall mean all certifications (including those of standards-setting organizations), licenses, permits, franchises, approvals, authorizations, exemptions, notices to, consents or orders of, or filings with, any trade association, any standards-setting organization, or any Governmental Entity, necessary for the ownership or use of the Acquired Assets or the conduct of the Product Business.

Permitted Encumbrance ” shall mean (a) statutory liens arising out of operation of Law with respect to a Liability incurred in the ordinary course of business which is not yet due, payable or delinquent, (b) with respect to the Acquired Assets, liens that, individually or in the aggregate, do not detract from the value other than in a deminimis manner, or interfere with the current use, of the asset property or right subject to the lien, (c) liens for current Taxes, assessments and governmental charges not yet due, payable, or delinquent, (d) with respect to the Acquired Contracts, the express terms and conditions set forth in the Acquired Contracts, (e) Encumbrances arising out of or imposed pursuant to Laws applicable to the pharmaceutical industry in the Territory or by any Governmental Entity with jurisdiction over the regulation of pharmaceutical products in the Territory and (f) Encumbrances that will be discharged prior to Closing.

 

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Person ” shall mean any person or entity, whether an individual, trustee, corporation, limited liability company, general partnership, limited partnership, trust, unincorporated organization, business association, firm, joint venture, executor, administrator or other legal personal representative, or any other legal entity, including a Governmental Entity.

Pharmacovigilance Agreement ” shall have the meaning set forth in Section 6.21 .

Post-Closing Tax Period ” shall have the meaning set forth in Section 6.17

Pre-Closing Period ” shall have the meaning set forth in Section 6.1 .

Pre-Closing Tax Period ” shall have the meaning set forth in Section 6.17 .

Product Business ” shall have the meaning set forth in the Recitals.

Product Specifications ” shall mean the quality specifications for the Manufacture, release and final testing of a Product and its components.

Products ” shall mean (i) the Aclidinium Products including Tudorza Pressair and (ii) the Roflumilast Products including Daliresp, and in each case, with respect to the foregoing, (a) any line extensions, new dosage forms, new presentations, new dosage strengths, new routes of administration and formulations thereof, and (b) any back-ups, improvements or next generation products thereof, including any product containing any metabolite, salt, variant, derivative, analog or pro-drug (including ester pro-drug form) of aclidinium bromide or roflumilast.

Purchase Price ” shall have the meaning set forth in Section 3.1 .

Purchaser ” shall have the meaning set forth in the Preamble.

Purchaser Confidential Information ” shall have the meaning set forth in Section 6.2(c) .

Purchaser FDA Transfer Letters ” means letters from Purchaser or its Affiliates to the FDA assuming responsibility for the Acquired Regulatory Approvals from one or more of the Sellers or their respective Affiliates, as applicable, in substantially the form of Exhibit G .

Purchaser Indemnified Parties ” shall have the meaning set forth in Section 9.2(a) .

Purchaser Permitted Purpose ” shall have the meaning set forth in Section 6.2(d) .

Qualifying Loss ” shall mean $[***].

Receiving Party ” shall have the meaning set forth in Section 6.2(a) .

Regulatory Approval ” shall mean (a) any approval by the FDA of any “new drug application” or “premarket approval application” (as such terms are used under the FDCA) with respect to a product, (b) any INDs with respect to a product, and (c) any other approval, license, registration, authorization or decision of or by a Governmental Entity necessary to lawfully Exploit (other than to the Supply Chain Actions) a product, in each case ((a), (b) and (c)), together with approval of any subsequent submissions, supplements or amendments thereto or any applications therefor.

 

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Regulatory Documentation ” shall mean original documents or, to the extent original documents are not reasonably available, copies thereof, in any format, of all Regulatory Approvals, Product Specifications and correspondence with any Governmental Entity (including minutes and official contact reports relating to any communications with any Governmental Entity) exclusively related to any product, including research files, raw data, expert reports, research lab notes, regulatory applications, formulation data, any other data (including clinical and pre-clinical data), submissions and filings in connection with the foregoing, and, to the extent related to the Territory, relevant supporting documents including all regulatory drug lists, materials submitted to the FDA under FDA Form 2253 and final versions of advertising and promotion materials (to the extent not included in the Marketing Records) and adverse drug experience reports (periodic and expedited).

Representatives ” shall have the meaning set forth in Section 6.2(a) .

RESPOND Study ” shall mean the post-marketing commitment study (ROF-MD-07; FDA Reference No. PMC 1738-1) for roflumilast in Chronic Obstructive Pulmonary Disease (COPD) patients treated with fixed dose combinations of long-acting ß2-agonist (LABA) and Inhaled Corticosteroid (ICS), a 52-week, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the effect of roflumilast 500 µg on exacerbation rate in subjects with Chronic Obstructive Pulmonary Disease (COPD) treated with a fixed-dose combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS).

Roflumilast Agreements ” shall mean the Collaboration and Distribution Agreement dated August 7, 2009 between Nycomed GmbH and Forest Laboratories Holdings Limited (the “ Takeda License ”) and all amendments, supplements, agreements, documents or instruments identified as Roflumilast Agreements as set forth on Schedule 1.1(a) of the Seller Disclosure Letter.

Roflumilast Products ” shall mean the products Exploited by the Sellers or their respective Affiliates pursuant to the Roflumilast Agreements, including Daliresp.

Royalty Products ” shall mean [***].

Seller ” or “ Sellers ” shall have the meaning set forth in the Preamble.

Seller Confidential Information ” shall have the meaning set forth in Section 6.2(d) .

Seller Disclosure Letter ” shall have the meaning set forth in Article 4 .

Seller FDA Transfer Letters ” means letters from one or more of the Sellers or their respective Affiliates, as applicable, to the FDA, transferring the rights to the Acquired Regulatory Approvals to Purchaser or its Affiliates, in substantially the form of Exhibit H .

Seller Indemnified Parties ” shall have the meaning set forth in Section 9.2(b) .

 

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Seller Licensed IP Rights ” shall mean, other than the Seller Names, any and all Intellectual Property rights in the Territory or, with respect to the research, development or Manufacture of Products, outside of the Territory (as applicable), that (a) are owned or otherwise controlled, and licensable or sublicensable to a Third Party by any of the Sellers and/or their respective Affiliates immediately after the Closing and (b) are used in the Exploitation of any Product, as of the date hereof or during the period between the date hereof and the Closing Date.

Seller Names ” shall mean any Trademarks that any of the Sellers or their respective Affiliates own or have the right to use and license (other than pursuant to the Acquired Contracts) other than any Trademarks specifically included in the Acquired Intellectual Property Rights.

Seller Parent ” shall have the meaning set forth in the Preamble.

Seller Permitted Purpose ” shall have the meaning set forth in Section 6.2(c) .

Supply Agreement ” shall mean, subject to Section 6.21 , one or more Supply Agreements, in substantially the form attached as Exhibit I .

Supply Chain Actions ” shall mean, with respect to any product, the Manufacture, import or export of such product.

Supply Provider ” shall have the meaning set forth in Section 6.18 .

Supply Recipient ” shall have the meaning set forth in Section 6.18 .

Taxes ” shall mean any federal, state, local or foreign income, gross receipts, branch profits, license, payroll, employment, excise, severance, stamp, occupation, premium, windfall profits, environmental, customs duties, capital stock, franchise, profits, withholding, social security, unemployment, disability, real property, personal property, sales, use, transfer, registration, ad valorem, value added, alternative or add-on minimum or estimated tax or other similar tax, including any interest, penalty or addition thereto.

Tax Return ” shall mean any report, declaration, return, information return, claim for refund, document or statement relating to Taxes, including any schedule or attachment thereto, and including any amendments thereof.

Termination Date ” shall have the meaning set forth in Section 8.1(a)(v) .

Territory ” shall mean the United States of America including its territories and possessions, and, with respect to the Aclidinium Products and the portion of the Product Business relating to the Aclidinium Products, Canada.

Third Party ” shall mean any Person other than the Parties or their respective Affiliates and permitted successors and assigns.

Third Party Claim ” shall have the meaning set forth in Section 9.5 .

 

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Trademark Assignment ” shall mean one or more Trademark Assignments assigning to Purchaser the trademarks and services marks set forth on Schedule 1.1(d) of the Seller Disclosure Letter, from a Seller or a Sellers’ Affiliate that is the owner thereof, substantially in the form of Exhibit J .

Transfer Taxes ” shall mean all sales, use, value added, stamp, registration, filing, transfer or similar taxes, together with interest, penalties and additions thereto, but not including taxes on net income or gain or VAT.

Transition Quarter ” shall have the meaning set forth in Exhibit L .

Transition Services Agreement ” shall mean, subject to Section 6.21 , that certain Transition Services Agreement, in substantially the form attached as Exhibit K .

Tudorza Pressair ” shall mean Tudorza ® Pressair TM (aclidinium bromide inhalation powder).

VAT ” shall mean any value-added or similar tax (including, for the avoidance of doubt, any goods and services tax or harmonized sales tax) incurred in connection with this Agreement and the transactions contemplated hereby.

1.2 Interpretation Provisions .

(a) The words “hereof,” “hereto,” “hereby,” “herein” and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement, and Article, Section, Schedule and Exhibit references are to this Agreement unless otherwise specified.

(b) The terms “include” and “including,” and variations thereof, are not limiting but rather shall be deemed to be followed by the words “without limitation.”

(c) References to statutes shall include all regulations promulgated thereunder and references to statutes or regulations shall be construed as including all statutory and regulatory provisions consolidating, amending or replacing the statute or regulation.

(d) The captions and headings of this Agreement are for convenience of reference only and shall not affect the construction of this Agreement.

(e) Whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include the masculine and feminine genders.

(f) The Parties participated jointly in the negotiation and drafting of this Agreement and the language used in this Agreement shall be deemed to be the language chosen by the Parties to express their mutual intent. If an ambiguity or question of intent or interpretation arises, then this Agreement will accordingly be construed as drafted jointly by the Parties, and no presumption or burden of proof will arise favoring or disfavoring any Party to this Agreement by virtue of the authorship of any of the provisions of this Agreement.

 

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(g) The Schedules and Exhibits to this Agreement are a material part hereof and shall be treated as if fully incorporated into the body of this Agreement.

(h) References to “written” or “in writing” include in electronic form.

(i) “Extent” in the phrase “to the extent” means the degree to which a subject or other thing extends, and such phrase does not mean simply “if”. “Or” means “and/or” unless the context requires otherwise.

(j) References to monetary amounts are denominated in United States Dollars.

(k) References to “made available” means, with respect to any document, that such document was (i) accessible by Purchaser and its Representatives in the Project Ryder electronic data room maintained by or on behalf of Sellers at least twenty-four (24) hours prior to the date hereof or (ii) delivered to Purchaser or its Representatives by any of the Sellers or their respective Affiliates or Representatives at least twenty-four (24) hours prior to the date hereof.

(l) The phrase “to the Sellers’ knowledge” or “knowledge of the Sellers” (or similar phrases) shall mean the actual knowledge of the individuals listed on Schedule 1.2(l) of the Seller Disclosure Letter, after due inquiry by such individuals of other personnel of Sellers’ in their respective functional areas.

1.3 Performance of Obligations by Affiliates . Any obligation of a Party under or pursuant to this Agreement may be satisfied, met or fulfilled, in whole or in part, at such Party’s sole and exclusive option, either by such Party directly, or by any Affiliate of such Party that such Party causes to satisfy, meet or fulfill such obligation, in whole or in part. Notwithstanding the foregoing, this Section 1.3 shall not be construed to relieve any Party from any of its obligations under this Agreement. Purchaser shall be entitled to rely on performance or notice given by any Seller or any Affiliate of any Seller with respect to the Sellers’ obligations hereunder, as performance or notice by all Sellers hereunder.

ARTICLE 2

PURCHASE AND SALE

2.1 Purchase and Sale of Acquired Assets . Subject to the terms and conditions set forth in this Agreement, at and effective as of the Closing, each of the Sellers shall, and/or shall cause its Affiliates to, sell, convey, assign, transfer and deliver to Purchaser or its Affiliates, and Purchaser shall, or shall cause its Affiliates to, purchase and accept, all of such Seller’s and/or its Affiliate’s rights, title and interest in and to the Acquired Assets, free and clear of all Encumbrances, other than Permitted Encumbrances (other than Encumbrances referred to in clause (f) of the definition of Permitted Encumbrances). As used in this Agreement, “ Acquired Assets ” shall mean:

(a) the Acquired Regulatory Approvals;

 

16


(b) the Acquired Contracts;

(c) the Acquired Intellectual Property Rights;

(d) the Acquired Inventory;

(e) the Acquired Equipment;

(f) the Acquired Marketing Records and Acquired Regulatory Documentation, but excluding any attorney work product, attorney-client communications and other items protected by attorney-client or other legal privilege;

(g) all guaranties, warranties, indemnities, rights of contribution, rights to refunds, rights of reimbursement and other rights of recovery and similar rights that have been made by any predecessors in title, manufacturers or suppliers and other Third Parties relating to the Assumed Liabilities or the Acquired Assets (regardless of whether such rights are currently exercisable);

(h) all claims (including claims for past, present and future infringement, dilution, misappropriation or other impairment or violation of Intellectual Property rights and to receive damages, proceeds or other legal or equitable protections and remedies with respect to any of the foregoing), counterclaims, defenses, causes of action, demands, judgments, rights of recovery, rights of set-off, rights of subrogation and all other rights of any kind against any Third Party, to the extent relating to the In-Licensed Intellectual Property, any Assumed Liabilities or the Acquired Assets, regardless of whether or not such claims or causes of action have been asserted by the Sellers or any of their respective Affiliates;

(i) all rights in or with respect to the collection of any proceeds from any insurance claim (excluding any claim under any self-insured policy) submitted by any of the Sellers or their respective Affiliates for any damage to or loss of any of the tangible Acquired Assets arising out of any circumstance or event occurring or arising between the date of this Agreement and the Closing Date to the extent that such damages or losses have not been cured by the Sellers or any of their respective Affiliates; and

(j) the assets, property and/or rights listed on Schedule 2.1 of the Seller Disclosure Letter.

Purchaser acknowledges that, to the extent that Sellers and, as applicable, their Affiliates, comply with the obligations set forth in Section 11.12 , the Supply Agreements (including the Technology Transfer Plans contemplated by the Supply Agreements) and the Transition Services Agreement with respect to the communication to Purchaser of the Know-How included in the Acquired Assets and related cooperation and technology transfer activities, Sellers shall have complied with their obligation hereunder to transfer such Know How to Purchaser.

2.2 Excluded Assets . The Acquired Assets shall not include, and there shall be excluded from the sale, conveyance, assignment, transfer or delivery to Purchaser hereunder, and each of the Sellers and their respective Affiliates shall retain all of their existing right, title and interest in and to, any assets, properties, rights or interests other than those specifically listed or

 

17


described in Section 2.1 (all such assets, properties, rights or interests not so listed or described, collectively, the “ Excluded Assets ”). For the avoidance of doubt, the Excluded Assets shall include, and the Acquired Assets shall not include:

(a) any Accounts Receivable;

(b) any losses, loss carryforwards and rights to receive refunds, credits and loss carryforwards with respect to any and all Taxes of any of the Sellers or their respective Affiliates;

(c) the corporate books and records of any of the Sellers or their respective Affiliates other than the Marketing Records and Regulatory Documentation transferred pursuant to Section 2.1(e) ;

(d) except as provided in Section 2.1(h) , any current and prior insurance policies and all rights of any nature with respect thereto;

(e) the Seller Names;

(f) the Excluded Contracts and all other Contracts of any of the Sellers or any of their respective Affiliates other than the Acquired Contracts;

(g) all tangible personal property of Sellers and their respective Affiliates other than the Acquired Inventory, Acquired Equipment and other tangible Acquired Assets;

(h) all guaranties, warranties, indemnities, rights of contribution, rights to refunds, rights of reimbursement and other rights of recovery and similar rights that have been made by any predecessors in title, manufacturers or suppliers and other Third Parties to the extent relating to the Excluded Assets; and

(i) all claims, counterclaims, defenses, causes of action, demands, judgments, rights of recovery, rights of set-off, rights of subrogation and all other rights of any kind against any Third Party, to the extent relating to any Excluded Liabilities or the Excluded Assets.

2.3 Assumed Liabilities . Subject to the terms and conditions set forth in this Agreement, at the Closing the Sellers shall, or shall cause their respective Affiliates to, assign, and Purchaser or an Affiliate of Purchaser shall assume and agree to pay or otherwise perform or discharge when due, the Assumed Liabilities. As used in this Agreement, the term “ Assumed Liabilities ” shall mean (i) any and all Liabilities of the Sellers or any of their respective Affiliates arising out of the use, ownership, possession or operation of the Acquired Assets by Purchaser or its Affiliates to the extent arising out of, based upon or resulting from any fact, circumstance, occurrence, act or omission occurring after the Closing, (ii) any and all Liabilities arising out of the conduct of the Product Business, in each case, by Purchaser or its Affiliates after the Closing and (iii) without limiting the foregoing, any and all of the following Liabilities, but, in each case ((i) through (iii)), excluding any Liabilities described in Section 2.4:

 

18


(a) all Liabilities of the Sellers or any of their respective Affiliates arising under the Acquired Regulatory Approvals to the extent arising out of, based upon or resulting from any fact, circumstance, occurrence, act or omission occurring or arising after the Closing;

(b) all Liabilities of the Sellers or any of their respective Affiliates arising under, or to be paid or performed under, the Aclidinium Agreements or the Acquired Contracts arising after the Closing;

(c) all Liabilities of the Sellers or any of their respective Affiliates arising out of or relating to any Action, commenced after Closing and irrespective of the legal theory asserted, arising out of or relating to (i) (A) any Exploitation of the Products by Purchaser or any of its Affiliates after the Closing, or (B) the Acquired Assets, in each case ((A) and (B)), to the extent relating to actions taken or omissions by Purchaser or any of its Affiliates after the Closing or (ii) any product liability, Patent infringement, breach of warranty or similar claim for injury to person or property to the extent the same result from the use or misuse of any Product that is sold by or on behalf of Purchaser or any of its Affiliates after the Closing (other than any such Liabilities described in this clause (ii) that arise out of or relate to any Product included in the Acquired Inventory, except to the extent that such Liabilities arise out of the handling, storage, labeling, packaging, advertising, marketing, promotion or delivery of such Product by Purchaser, its Affiliates or its or their respective employees, subcontractors or agents after the Closing);

(d) subject to Exhibit L , all Liabilities of the Sellers or any of their respective Affiliates to customers of the Product Business to the extent (i) relating to any Product sold by or on behalf of Purchaser or any of its Affiliates after the Closing or (ii) with respect to any Product sold by or on behalf of any of the Sellers or any of their respective Affiliates prior to Closing but delivered to such customers after the Closing, to the extent arising out of any damage or defect to the Product caused by the handling, storage or delivery of such Product by Purchaser, its Affiliates or its or their respective employees, subcontractors or agents after the Closing;

(e) subject to Exhibit L , all Liabilities of the Sellers or any of their respective Affiliates to the extent arising out of or relating to the recall or market withdrawal of any Product or post-sale warning in respect of any Product sold by or on behalf of Purchaser or any of its Affiliates after the Closing; and

(f) subject to Exhibit L , all Liabilities of the Sellers or any of their respective Affiliates arising out of or relating to the return of any Product, including all Liabilities for any credits, rebates, refunds or other amounts payable in respect of any returned Product, to the extent such Product is sold by or on behalf of Purchaser or any of its Affiliates after the Closing.

2.4 Excluded Liabilities . Except for the Assumed Liabilities, Purchaser shall not assume, nor become responsible for, and Sellers or their respective Affiliates shall retain and be responsible for and shall pay, perform and discharge when due, any Liability of any of the Sellers or their respective Affiliates, including Liabilities in respect of or relating to the Product Business or the Acquired Assets (collectively, the “ Excluded Liabilities ”). Notwithstanding anything in this Agreement to the contrary, Excluded Liabilities shall include, and Assumed Liabilities shall not include:

(a) all Liabilities to the extent related to the Excluded Assets;

 

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(b) all Liabilities for any amounts incurred or payable by the Sellers or their respective Affiliates under the Acquired Contracts or the Aclidinium Agreements prior to the Closing;

(c) all Liabilities relating to defaults, breaches or other actions or omissions by the Sellers or their respective Affiliates under the Acquired Contracts or the Aclidinium Agreements prior to the Closing;

(d) all Liabilities arising out of or relating to any Action, regardless of when commenced or made and irrespective of the legal theory asserted, arising out of or relating to (i) any Exploitation by or on behalf of the Sellers or any of their respective Affiliates of the Products prior to the Closing (except to the extent arising out of the handling, storage, labeling, packaging, advertising, marketing, promotion or delivery of such Product by Purchaser, its Affiliates or its or their respective employees, subcontractors or agents after the Closing), (ii) the Acquired Assets, to the extent relating to actions taken or omissions by the Sellers or any of their respective Affiliates or its or their respective employees, subcontractors or agents prior to the Closing or (iii) any product liability, Patent infringement, breach of warranty or similar claim for injury to person or property to the extent the same result from the use or misuse of any Product that (A) is sold by or on behalf of the Sellers or any of their respective Affiliates prior to the Closing or (B) is included in the Acquired Inventory and sold by or on behalf of Purchaser or any of its Affiliates after the Closing (other than any such Liabilities described in this clause (B) to the extent arising out of the handling, storage, labeling, packaging, advertising, marketing, promotion or delivery of such Product by Purchaser, its Affiliates or its or their respective employees, subcontractors or agents after the Closing);

(e) subject to Exhibit L , all Liabilities to customers to the extent relating to any Product sold by or on behalf of the Sellers or any of their respective Affiliates prior to Closing (other than Liabilities described in clause (ii) of Section 2.3(d) );

(f) all Liabilities to suppliers or other Third Parties for materials and services for use in connection with Products sold by or on behalf of the Sellers or any of their respective Affiliates prior to the Closing;

(g) subject to Exhibit L , all Liabilities arising out of or relating to the recall or market withdrawal of any Product or post-sale warning in respect of any Product sold by or on behalf of any of the Sellers or their respective Affiliates prior to the Closing;

(h) subject to Exhibit L , all Liabilities arising out of or relating to the return of any Product, including all Liabilities for any credits, rebates, refunds or other amounts payable in respect of any returned Product sold by or on behalf of any of the Sellers or their respective Affiliates prior to the Closing;

(i) (i) all Liabilities related to Taxes incurred by any of the Sellers or their respective Affiliates, and (ii) all Liabilities related to Taxes with respect to any of the Acquired Assets, in respect of taxable periods, or portions thereof, ending before the Closing but, in each case (i) and (ii), not including Health Care Reform Fees, Transfer Taxes, Apportioned Obligations, or VAT, which shall be allocated between the Sellers and Purchaser pursuant to Sections 6.14 , 6.16 , 6.17 and 6.18 ;

 

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(j) all Liabilities arising out of any failure of the Seller or any of their respective Affiliates to comply with applicable bulk sales Laws;

(k) all Liabilities arising out of or relating to the DTC Campaigns; or

(l) all Liabilities of any of the Sellers or any of their respective Affiliates under this Agreement, any Ancillary Agreement or the Execution Date Documents.

ARTICLE 3

PURCHASE PRICE; CLOSING

3.1 Purchase Price . On the terms and subject to the conditions set forth in this Agreement, in consideration of the sale of the Acquired Assets, at the Closing, in addition to the assumption of the Assumed Liabilities, Purchaser shall pay to Forest, on behalf of itself and as agent for the other Sellers, an amount in cash equal to US $600,000,000 (the “ Purchase Price ”).

3.2 Closing . On the terms and subject to the conditions set forth in this Agreement, the sale, conveyance, assignment, transfer and delivery of the Acquired Assets and the assumption of the Assumed Liabilities contemplated by this Agreement (collectively, the “ Closing ”) shall take place at the offices of Debevoise & Plimpton LLP, 919 Third Avenue, New York, New York 10022 at 10:00 A.M., New York City time, on the date that is three (3) Business Days after the satisfaction or waiver of the conditions precedent to Closing specified in Article 7 (other than those conditions that by their nature are to be satisfied by actions taken at the Closing, but subject the satisfaction or waiver of such conditions), or at such other time and place as Purchaser and the Sellers mutually agree in writing. The date on which the Closing occurs is referred to as the “ Closing Date .”

3.3 Seller Closing Deliveries . At the Closing, the Sellers shall deliver, or cause to be delivered, to Purchaser (or, in the case of the Seller FDA Transfer Letters, to the applicable Governmental Entity, with a copy to Purchaser) the following:

(a) each of the Ancillary Agreements to which any of the Sellers or their respective Affiliates is a party, duly executed by one or more of the Sellers and/or their respective Affiliates, as applicable;

(b) a certificate, dated the Closing Date, signed by a duly authorized officer of Forest, certifying the fulfillment of the conditions set forth in Sections 7.2(a) and 7.2(b) ; and

(c) subject to Sections 6.11 and 6.12 , the Acquired Assets.

 

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3.4 Purchaser Closing Deliveries . At the Closing, Purchaser shall deliver, or cause to be delivered, to the Sellers (or, in the case of the Purchaser FDA Transfer Letters, to the applicable Governmental Entity, with a copy to the Sellers) the following:

(a) an amount equal to the Purchase Price by wire transfer of immediately available funds to a bank account or accounts designated by the Sellers at least three (3) Business Days prior to the Closing Date;

(b) each of the Ancillary Agreements to which Purchaser or its Affiliates is a party, duly executed by Purchaser or the applicable Affiliate of Purchaser; and

(c) a certificate, dated the Closing Date, signed by a duly authorized officer of Purchaser, certifying the fulfillment of the conditions set forth in Sections 7.3(a) and 7.3(b) .

3.5 Tax Allocation .

(a) An allocation of the Purchase Price, the Assumed Liabilities (to the extent relevant in determining the purchase price for Tax purposes) and other relevant items shall be allocated among the Acquired Assets in accordance with the principles set forth on Schedule 3.5(a) of the Seller Disclosure Letter. The Parties agree that the transfer of the Acquired Assets constitutes a sale of the Acquired Assets for Tax purposes and that the Purchase Price, the Net Sales Royalties and Assumed Liabilities allocable to the Acquired Assets are received as purchase price in exchange for such sale.

(b) Except as required by applicable Law, the Sellers and Purchaser shall report the Tax consequences of the transactions contemplated by this Agreement (including in respect of Net Sales Royalties, if any) in a manner consistent with the principles set for in Schedule 3.5(a) of the Seller Disclosure Letter, as it may be revised from time to time, and the Tax characterization described in Section 3.5(a) and shall not take any position inconsistent therewith in preparing any Tax returns.

(c) Purchaser and the Sellers shall cooperate, as and to the extent reasonably requested by Forest (in the case of Purchaser) and Purchaser (in the case of the Sellers), and shall retain and, upon Forest’s request (in the case of Purchaser) and Purchaser’s request (in the case of the Sellers), furnish or cause to be furnished to Forest (in the case of Purchaser) and Purchaser (in the case of the Sellers), as promptly as practicable, such information and assistance relating to the Acquired Assets and the Assumed Liabilities as is reasonably necessary for the preparation and filing of any Tax Return, claim for any Tax refund or other required or optional filings relating to Tax matters, for the preparation for any Tax audit, for the preparation for any Tax protest, or for the prosecution or defense of any suit or other proceeding relating to Tax matters.

3.6 Risk of Loss . As of the Closing, title to the Acquired Assets shall be transferred to Purchaser. After the Closing, without prejudice to Purchaser’s rights under Article 9 , Purchaser shall bear all risk of loss associated with the Acquired Assets and shall be solely responsible for procuring adequate insurance to protect the Acquired Assets against any such loss.

3.7 Royalties .

(a) Net Sales Royalty . If the Net Sales Threshold applicable to a Net Sales Period is achieved during such Net Sales Period, Purchaser shall pay to FLH, as additional consideration for the Acquired Assets transferred by FLH, a royalty of [***] of the lesser of (x)

 

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the Net Sales during such Net Sales Period in excess of the applicable Net Sales Threshold, if any, and (y) the difference between the Net Sales Cap and the applicable Net Sales Threshold for such Net Sales Period (the “ Net Sales Royalty ”). Purchaser shall pay the Net Sales Royalty, if any, within forty-five (45) Business Days following the end of such Net Sales Period. Concurrently with the payment of any Net Sales Royalty (or, if Purchaser believes that no such payment is due in respect of a Net Sales Period, within forty-five (45) Business Days following the end of such Net Sales Period), Purchaser shall deliver to FLH a written statement of Purchaser setting forth in reasonable detail a calculation of Net Sales during the immediately preceding Net Sales Period (each, a “ Net Sales Statement ”).

(b) Net Sales Audit Rights .

(i) From and after delivery of a Net Sales Statement, upon reasonable advance written notice from FLH, Purchaser shall permit the Independent Accountant to have access at reasonable times during normal business hours to the books and records of Purchaser and its Affiliates as may be reasonably necessary to evaluate and verify the accuracy of the Net Sales calculations set forth in the Net Sales Statement and the figures underlying such calculations; provided , that (x) the Independent Accountant that conducts an audit pursuant to this Section 3.7 shall enter into a customary confidentiality agreement reasonably satisfactory to Purchaser with respect to the confidential information of Purchaser or its Affiliates to be furnished pursuant to this Section 3.7 which shall, among other things, provide that the Independent Accountant shall disclose only the results of the audit to the Sellers, and (y) such access does not unreasonably interfere with the conduct of the business of Purchaser or any of its Affiliates. Such audits may not be conducted more than once with respect to any single Net Sales Period and may not be conducted for any single Net Sales Period more than two (2) years after the end of such Net Sales Period. The cost of any audit, including the fees and charges of the Independent Accountant, shall be borne by the Sellers or their respective Affiliates unless the audit reveals a variance of more than [***] from the amount of Net Sales disclosed in the Net Sales Statement, in which case Purchaser shall bear the cost of the audit.

(ii) The results of any such audit shall be delivered in writing to Purchaser and to FLH and shall be final, conclusive and binding upon the Parties; provided , that the Independent Accountant shall only report whether the applicable Net Sales Statement was accurate and the amount of any discrepancy. If the audit shows that (x) Purchaser underpaid FLH in respect of any prior Net Sales Royalty, then Purchaser shall pay to FLH within ten (10) Business Days following the receipt of such audit results the aggregate amount of such shortfall or (y) Purchaser overpaid FLH in respect of any prior Net Sales Royalty, then, at Purchaser’s option, (A) Purchaser may credit the aggregate amount of such overpayment against the subsequent Net Sales Royalty payable to FLH or (B) request that FLH, and FLH shall, pay to Purchaser within ten (10) Business Days following the receipt of such audit results the aggregate amount of such overpayment.

 

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ARTICLE 4

REPRESENTATIONS AND WARRANTIES OF THE SELLERS

Each of the Sellers hereby makes the following representations and warranties to Purchaser, except as otherwise set forth in the written disclosure schedules attached hereto (the “ Seller Disclosure Letter ”); it being understood that all disclosure made in any particular schedule shall be deemed made in all other schedules in the Seller Disclosure Letter if it is reasonably apparent on the face of such disclosure that such disclosure applies or would apply to such other representations and warranties. The schedules in the Seller Disclosure Letter are numbered to correspond to the various Sections and subsections of this Article 4 setting forth certain exceptions to the representations and warranties contained in this Article 4 and certain other information called for by this Agreement:

4.1 Organization, Power and Standing . Each of the Sellers is a corporation or limited liability company, as applicable, duly organized or continued, validly existing and in good standing under the Laws of its jurisdiction of incorporation or formation. Each of the Sellers has the requisite corporate or limited liability company power, as applicable, and authority to own and operate the Acquired Assets and the Product Business. Each of the Sellers is duly qualified to do business and in good standing in each jurisdiction where the ownership of the Acquired Assets and operation of the Product Business requires such qualification, except where the failure to be so qualified or in such good standing would not, individually or in the aggregate, have a Material Adverse Effect.

4.2 Authority, Non-Contravention, Required Filings .

(a) Each of the Sellers and their respective Affiliates has the requisite corporate or other entity power and authority to execute and deliver this Agreement and each of the Execution Date Agreements, as applicable, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. As of the Closing, one or more of the Sellers and/or their respective Affiliates, as applicable, will have the requisite corporate or other entity power and authority to execute and deliver each Ancillary Agreement and to perform its or their obligations thereunder and to consummate the transactions contemplated thereby. The execution and delivery of this Agreement and each of the Execution Date Agreements, as applicable, by the Sellers and/or their respective Affiliates, the performance by the Sellers and their respective Affiliates, as applicable, of their obligations hereunder and thereunder and the consummation by the Sellers and their respective Affiliates, as applicable, of the transactions contemplated hereby and thereby have been duly authorized by all necessary corporate action on the part of each of the Sellers and such Affiliates. As of the Closing, the execution and delivery of each Ancillary Agreement by one or more of the Sellers and/or their respective Affiliates, as applicable, the performance by such Seller or its Affiliates of its obligations thereunder and the consummation by such Seller and/or its Affiliates of the transactions contemplated thereby, will have been duly authorized by all necessary corporate or other entity action on the part of such Seller and/or such Affiliates.

(b) This Agreement and each of the Execution Date Agreements have been duly executed and delivered by the Sellers and/or their respective Affiliates, as applicable, and constitute valid and binding obligations of each such Seller and/or Affiliate, enforceable against it in accordance with their respective terms, and, as of the Closing, each Ancillary Agreement will have been duly executed and delivered by one or more of the Sellers and/or their respective Affiliates, as applicable, and will constitute a valid and binding obligation of each such Seller and/or Affiliate, enforceable against it in accordance with its terms, in each case subject to (i) the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar Laws relating to or affecting the enforcement of creditors’ rights generally and (ii) general equitable principles (whether considered in a proceeding in equity or at Law).

 

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(c) The execution and delivery of this Agreement and each of the Execution Date Agreements by each of the Sellers and/or their respective Affiliates, as applicable, do not, and the execution and delivery of each Ancillary Agreement by one or more of the Sellers and/or their respective Affiliates, as applicable, as of the Closing, the performance by such Seller and/or such Affiliates of its obligations hereunder or thereunder, and the consummation by such Seller and/or such Affiliates of the transactions contemplated hereby or thereby will not (i) contravene or conflict with any provision of the Organizational Documents of such Seller and/or its Affiliates, (ii) subject to the Sellers’ receipt or giving of the Consents listed in Schedule 4.2(c) of the Seller Disclosure Letter constitute a breach, violate the terms, conditions or provisions of, or result in a default under, or give to any Third Party any rights of termination, amendment, acceleration or cancellation under (A) any Acquired Contract, (B) any of the Aclidinium Agreements, or (C) any Contract to which any of the Acquired Assets is subject, in each case ((A), (B) and (C)), or any right or obligation thereunder, (iii) result in the creation of any Encumbrance other than any Permitted Encumbrance upon any of the Acquired Assets, (iv) assuming compliance with the matters referred to in Section 4.2(d) , violate in any respect any provision of any Law to which such Seller and/or such Affiliates or any of the Acquired Assets is subject or (v) materially conflict with, adversely alter or impair any of the Sellers’ or any of their respective Affiliates’ right in, to or under any Acquired Intellectual Property Rights or, to the Sellers’ knowledge, any In-Licensed Intellectual Property or the validity, enforceability, use, right to use, registration, right to register, ownership, priority, duration, scope or effectiveness of any of the Acquired Intellectual Property Rights or, to the Sellers’ knowledge, any of the In-Licensed Intellectual Property or otherwise trigger termination of any licensed rights in, or any additional payment obligations with respect to, any of the Acquired Intellectual Property Rights or, to the Sellers’ knowledge, any of the In-Licensed Intellectual Property, except, in the case of clause (ii) or (iv) above, for any such breaches, violations, defaults, amendments, accelerations, cancellations, terminations or other occurrences, if any, that would not, individually or in the aggregate, reasonably be expected to materially and adversely affect the Acquired Assets and the Product Business, taken together as a whole, or prevent or materially delay the ability of the Sellers to consummate the transactions contemplated by this Agreement.

(d) No Permit or Consent, waiting period expiration or termination, approval or authorization of, or designation, declaration or filing with, any Governmental Entity on the part of any of the Sellers or their respective Affiliates is required in connection with the execution or delivery by the Sellers and/or their respective Affiliates, as applicable, of this Agreement or any of the Execution Date Agreements, the execution and delivery by one or more of the Sellers and/or their respective Affiliates, as applicable, of each Ancillary Agreement as of the Closing, or the consummation of the transactions contemplated hereby or thereby other than (i) any filings and/or notices under the Competition Laws, (ii) the Seller FDA Transfer Letters, and (iii) such permits, consents, approvals, authorizations, designations, declarations or filings the absence of which would not, individually or in the aggregate, reasonably be expected to prevent or materially delay the ability of the Sellers to consummate the transactions contemplated by this Agreement.

 

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4.3 Financial Information . The information set forth on Schedule 4.3 of the Seller Disclosure Letter (a) fairly presents in all material respects the annual gross sales, net sales and cost of goods sold with respect to each Product as of the dates and for the periods indicated therein, (b) has been prepared based on the Sellers’ or (to the extent applicable and made available to the Sellers) their wholesalers’ financial books and records and (c) has been derived from the books and records of the Sellers maintained in accordance with GAAP and internal controls and policies of the Sellers or their respective Affiliates, as applicable.

4.4 Title to Properties and Assets .

(a) As of the Closing, one or more of the Sellers and/or their respective Affiliates will have good and valid title to the Acquired Assets, in each case free and clear of all Encumbrances, other than Permitted Encumbrances.

(b) The Acquired Equipment is in good operating condition for the purposes for which it is currently being used or intended to be used, subject to ordinary wear and tear.

(c) The Acquired Marketing Records and Acquired Regulatory Documentation constitute all Marketing Records and Regulatory Documentation owned by the Sellers or any of their respective Affiliates, in each case, relating exclusively to the Products or the Exploitation (other than the Supply Chain Actions) of the Products. The Acquired Marketing Records and Acquired Regulatory Documentation constitute all Marketing Records and Regulatory Documentation necessary and sufficient for the Exploitation (other than the Supply Chain Actions) of the Products as they are presently being Exploited (other than the Supply Chain Actions) by the Sellers and their respective Affiliates. The In-Licensed Intellectual Property constitutes all of the Intellectual Property licensed to the Sellers or any of their respective Affiliates, in each case relating exclusively to the Products. The Acquired Intellectual Property Rights, together with the In-Licensed Intellectual Property, the licenses granted pursuant to Sections 6.8 and 6.9 and any Intellectual Property provided to Purchaser or its Affiliates under the Ancillary Agreements, constitute all Intellectual Property rights necessary and sufficient for the Exploitation of the Products as they are presently being Exploited by the Sellers and their respective Affiliates.

(d) The sale and transfer of the Acquired Assets to Purchaser or its Affiliates hereunder constitutes the sale of all or substantially all of the assets of FLH to which the Takeda License relates.

(e) None of the Sellers or any of their respective Affiliates own or license any product or product candidate (other than the Products), the Exploitation of which would constitute a Competing Activity.

4.5 Intellectual Property Rights .

(a) Schedule 4.5(a)(i) of the Seller Disclosure Letter sets forth a true and complete list as of the date hereof of all Acquired Intellectual Property Rights that have issued or registered or that are the subject of an application for registration or issuance (“ Owned Registered IP ”). To the Sellers’ knowledge, Schedule 4.5(a)(ii) of the Seller Disclosure Letter sets forth a true and complete list, as of the date hereof, of all licensed Patents that have issued or

 

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registered or that are the subject of an application for registration or issuance (“ Licensed Patents ”). Schedule 4.5(a) of the Seller Disclosure Letter lists, as applicable, with respect to the Owned Registered IP and the Licensed Patents, as applicable, (i) the registration, issuance and application numbers and dates, and, with respect to any domain names, the expiration date, (ii) the identity of the legal and record owner(s) thereof (including any co-owner(s) or joint owner(s)) and (iii) the jurisdiction. With respect to each item of Owned Registered IP and the Licensed Patents, (x) such item is subsisting and, to the Sellers’ knowledge, valid and enforceable and (y) all necessary fees due and all documents and recordations with the relevant Governmental Entity (or registrar in the case of domain names) in connection therewith have been paid and filed for the purposes of prosecuting, perfecting, maintaining and enforcing such item; provided , that the representations and warranties made in this sentence with respect to the Licensed Patents are made to the Sellers’ knowledge. Each of the Patents included in the Owned Registered IP and, to the Sellers’ knowledge, the Licensed Patents, properly identifies each inventor of the claims thereof as determined in accordance with the Laws of the jurisdiction in which such Patent is issued or pending.

(b) To the Sellers’ knowledge, the activities conducted by the Sellers or their respective Affiliates with respect to the Exploitation of the Products in the Territory as currently conducted and as conducted since [***], do not infringe upon, misappropriate or otherwise violate any Intellectual Property rights of Third Parties.

(c) Since [***], none of the Sellers or any of their respective Affiliates has received any written or, to the Sellers’ knowledge, unwritten charge, complaint, claim, demand, notice or other written or, to the Sellers’ knowledge, unwritten communication alleging that the activities conducted by the Sellers or their respective Affiliates with respect to the Exploitation of the Products in the Territory infringe upon, misappropriate or violate any Intellectual Property rights of Third Parties (including any written or, to the Sellers’ knowledge, unwritten claim that a Seller or any of its respective Affiliates must license or refrain from using any Intellectual Property rights of any Third Party).

(d) To the Sellers’ knowledge no Third Party is infringing, misappropriating or otherwise violating any Acquired Intellectual Property Rights or In-Licensed Intellectual Property in the Territory.

(e) One or more of the Sellers and/or their respective Affiliates owns (i) all right, title, and interest in and to the Acquired Intellectual Property Rights and (ii) has a valid and enforceable exclusive (to the extent the license purports to be exclusive) license to the In-Licensed Intellectual Property subject to (A) the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar Laws relating to or affecting the enforcement of creditors’ rights generally and (B) general equitable principles (whether considered in a proceeding in equity or at Law, in each case ((i) and (ii)), free and clear of any Encumbrance, other than Permitted Encumbrances.

(f) The Acquired Intellectual Property Rights and, to the Sellers’ knowledge, the In-Licensed Intellectual Property, are not subject to any outstanding Court Order.

 

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(g) No Action is pending or, to the Sellers’ knowledge, threatened against any of the Sellers or their respective Affiliates, or against any of the Acquired Intellectual Property Rights or, to the Sellers’ knowledge, any of the In-Licensed Intellectual Property, which (i) challenges or seeks to deny or restrict the legality, validity, enforceability, scope, duration, priority, right to use, use, right to register, registration or ownership of the Acquired Intellectual Property Rights or the In-Licensed Intellectual Property, as applicable, (ii) is based on a Paragraph IV patent certification under 21 U.S.C. 355(b)(2)(A)(IV) or 355(j)(2)(A)(vii)(IV) relative to any Patents listed in the Acquired Regulatory Approvals or the In-Licensed Intellectual Property, as applicable or (iii) challenges the right, title or interest of the Sellers or their respective Affiliates in, to or under the Acquired Intellectual Property Rights or the In-Licensed Intellectual Property.

(h) Except pursuant to an Acquired Contract or an Aclidinium Agreement, none of the Sellers or any of their respective Affiliates has agreed to indemnify any Person for or against any infringement, misappropriation or other violation of Intellectual Property of Third Parties with respect to any Product.

(i) None of the Sellers or any of their respective Affiliates has granted any licenses, sublicenses, options, interests or other rights (including covenants not to sue and immunities from suit) in or with respect to the Acquired Intellectual Property Rights or In-Licensed Intellectual Property to any Third Parties.

(j) The Sellers and their respective Affiliates have taken commercially reasonable steps to protect, preserve and maintain their rights, title and interests in and to the Acquired Intellectual Property Rights and to protect, preserve and maintain the confidentiality and security of all non-public Acquired Intellectual Property Rights and all non-public In-Licensed Intellectual Property.

(k) The Sellers obtain all of their respective rights and interests in and to the In-Licensed Intellectual Property solely through Contracts included in the Acquired Contracts and the Aclidinium Agreements. Schedule 4.5(k) of the Seller Disclosure Letter sets forth a true and complete list of all Contracts pursuant to which the Sellers and their respective Affiliates obtain any rights with respect to the In-Licensed Intellectual Property. Other than pursuant to a Contract set forth on Schedule 4.5(k) of the Seller Disclosure Letter, there are no royalties, license fees or other payment obligations of any of the Sellers or any of their Affiliates, including indemnity obligations, but excluding maintenance fees payable to Governmental Entities, with respect to the Products or any In-Licensed Intellectual Property.

(l) No Acquired Intellectual Property Rights has been developed using any funding or other resources provided by any Governmental Entity or institution of higher education.

Notwithstanding any provision in this Agreement to the contrary, Section 4.2(c)(v) and this Section 4.5 contain the sole and exclusive representations and warranties in this Agreement regarding the non-infringement, non-misappropriation and non-violation of Intellectual Property rights of Third Parties.

 

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4.6 Acquired Contracts .

(a) Each of the Acquired Contracts represents a valid and binding obligation of one or more of the Sellers and/or its Affiliate(s) party thereto and, to the knowledge of the Sellers, each other party thereto, and is enforceable against such Seller and/or its Affiliate and, to the knowledge of the Sellers, each other party thereto, in accordance with its terms, and is in full force and effect, subject to (i) the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar Laws relating to or affecting the enforcement of creditors’ rights generally and (ii) general equitable principles (whether considered in a proceeding in equity or at Law). None of the Sellers or any of their respective Affiliates is in material breach of or material default under any of the Acquired Contracts and, to the Sellers’ knowledge, no other party thereto is in material breach of or material default under any Acquired Contract, and none of the Sellers or any of their respective Affiliates have given or received written or, to the Sellers’ knowledge, unwritten notice to or from any party to an Acquired Contract relating to any such alleged breach or default. None of the Sellers or any of their respective Affiliates has received any written or, to the Sellers’ knowledge, unwritten notice that a party to any Acquired Contract intends to cancel, withdraw, modify or amend such Acquired Contract, nor have the Sellers or any of their respective Affiliates given such a written notice to a party to any Acquired Contract. True and complete copies of all Acquired Contracts (including all schedules, exhibits, appendices, amendments, modifications and waivers relating thereto) have been made available to Purchaser or its advisors with respect to the transactions contemplated by this Agreement, except (x) to the extent such Contracts have been redacted to (A) enable compliance with Laws relating to antitrust or the safeguarding of data privacy or (B) exclude commercially sensitive financial information or (y) as expressly indicated on Schedule 1.1(b) of the Disclosure Schedules. This Section 4.6(a) shall not apply to the Aclidinium Agreements.

(b) Each of the Aclidinium Agreements represents a valid and binding obligation of one or more of the Sellers and/or its Affiliate(s) party thereto, and is enforceable against such Seller and/or its Affiliate in accordance with its terms, and is in full force and effect, subject to (i) the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar Laws relating to or affecting the enforcement of creditors’ rights generally and (ii) general equitable principles (whether considered in a proceeding in equity or at Law). None of the Sellers or any of their respective Affiliates is in breach of or default under any of the Aclidinium Agreements, except for any breach or default which would not, individually or in the aggregate, reasonably be expected to materially and adversely affect the Product Business and the Acquired Assets, taken together as a whole.

4.7 Compliance with Law; Permits; Regulatory Matters .

(a) Each of the Sellers and their respective Affiliates are, and since [***], have been, in compliance with all Laws applicable to the ownership and use of the Acquired Assets and the operation of the Product Business, including (i) the FDCA and any applicable Laws governing the approval, Manufacture, sale, marketing, promotion, or distribution of drugs and the purchase or prescription of or reimbursement for drugs by any Governmental Entity, private health plan or entity, or individual and (ii) all applicable Laws regulating the pharmaceutical industry, except, in each case, where the failure to so comply would not, individually or in the aggregate, reasonably be expected to materially and adversely affect the Acquired Assets and the Product Business, taken together as a whole.

 

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(b) None of the Sellers or any of their respective Affiliates or, to the Sellers’ knowledge, any Third Party engaged by the Sellers or their respective Affiliates, has received since [***] any written or, to the Sellers’ knowledge, unwritten notice of any inspectional observation (including 483 observations) or any warning or untitled letters, in each case, from any Governmental Entity relating to any Product, and none of the Sellers or any of their respective Affiliates has received any other written or, to the Sellers’ knowledge, unwritten notices from or issued by any Governmental Entity that alleges a lack of compliance with applicable Laws of the FDA or other comparable Governmental Entity by the Sellers or their respective Affiliates relating to any Product. Since [***], none of the Sellers nor their respective Affiliates have had any Product or site at which the Products are manufactured (whether owned by the Sellers or their respective Affiliates or that of a contract manufacturer for the Products) subject to an FDA (or other comparable Governmental Entity) shutdown or import or export prohibition. The Sellers and their respective Affiliates have provided Purchaser with copies of all written communications made between the Sellers or their respective Affiliates and any Governmental Entity relating to the activities described in FDA’s August 1, 2012 letter to Dr. James Pan, Associate Director, Regulatory Affairs, Forest Laboratories, Inc.

(c) The Sellers or their respective Affiliates are the sole and exclusive owner of each of the Acquired Regulatory Approvals and have not granted any right of reference that is currently in effect with respect thereto. Each such Acquired Regulatory Approval (i) has been validly issued or acknowledged by the appropriate Governmental Entity and is in full force and effect and (ii) is transferable to Purchaser. Since [***], neither Sellers nor their respective Affiliates have received written or, to the Sellers’ knowledge, unwritten notice from any Governmental Entity that there are any circumstances currently existing that would reasonably be expected to lead to (x) any loss of or refusal to renew any Acquired Regulatory Approvals relating to a Product or (y) renewal on terms less advantageous to the Sellers or their respective Affiliates than the terms of those Acquired Regulatory Approvals currently in force.

(d) All reports, documents, claims and notices required to be filed, maintained or furnished to the FDA or any other drug regulatory agency by any of the Sellers or their respective Affiliates with respect to any Product have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), except as would not, individually or in the aggregate, reasonably be expected to materially and adversely affect the Acquired Assets and the Product Business, taken together as a whole. The Sellers or their respective Affiliates possess, and are in material compliance with, all Permits necessary to conduct the Product Business as currently conducted, except where the failure to possess or comply with any such Permit would not, individually or in the aggregate, reasonably be expected to materially and adversely affect the Product Business and the Acquired Assets, taken together as a whole.

(e) Since [***], all human clinical trials with respect to the Products conducted by the Sellers or any of their respective Affiliates or, to the knowledge of the Sellers, by any Third Party on behalf of any Seller or any of their respective Affiliates, have, in each case, been and are being conducted in all material respects in compliance with all applicable Law

 

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and protocols, including cGCP and the provisions relating to the registration and reporting of results of clinical trials contained in Section 402 of the Public Health Service Act. Neither the Sellers nor any of their respective Affiliates, nor, to the knowledge of the Sellers, any Third Party acting on behalf of the Sellers or any of their respective Affiliates, have received any written or, to the Sellers’ knowledge, unwritten notice that (i) any Governmental Entity or Institutional Review Board has initiated, or threatened to initiate, any clinical hold or other action to suspend any clinical trial or suspend or terminate any IND sponsored by or on behalf of the Sellers or their respective Affiliates, or otherwise restrict the preclinical research on or clinical study of any Product or (ii) to the effect that any protocol is not appropriately designed to support approval of any Products or indications that the ongoing clinical trials are intended to support.

(f) The Sellers and their respective Affiliates have made available to Purchaser (i) true and complete copies of all new drug applications and INDs for the Products, (ii) copies of all material correspondence since [***] to or from any Governmental Entity or Institutional Review Board, and all other material documents concerning communications to or from any Governmental Entity or Institutional Review Board, in each case concerning (A) any Product, (B) Sellers’ or any of their respective Affiliates’ compliance with Law relating to any Product, or (C) the likelihood or timing of approval of any Product; and (iii) all material information in their possession or control concerning the safety, efficacy, side effects or toxicity of any Product (including information and documentation regarding studies, investigations or tests) that has been submitted to a Governmental Entity since [***].

(g) None of the Sellers nor any of their respective Affiliates, nor, to the knowledge of the Sellers, (i) any of their respective officers or employees or (ii) any Third Party, in each case, who has undertaken any activities with respect to the Exploitation of the Products, has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar Law, or (B) exclusion from participating in any federal health care programs under Section 1128 of the Social Security Act or any similar Law.

(h) None of the Sellers or their respective Affiliates is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any Governmental Entity.

4.8 Litigation . There is no Action pending or, to the Sellers’ knowledge, threatened against any of the Sellers or their respective Affiliates with respect to any Product, the Product Business or the Acquired Assets. None of the Sellers or any of their respective Affiliates is a party or, to the knowledge of the Sellers, subject to the provisions of any Court Order with respect to any Product, the Acquired Assets or the Product Business.

4.9 Inventory .

(a) Schedule 4.9(a) of the Seller Disclosure Letter sets forth a listing of the Acquired Inventory in the possession or control of, or otherwise held by or on behalf of, any of the Sellers or their respective Affiliates, as of December 31, 2014. Such inventory as of such date consisted in all material respects of inventory of a quantity and quality sufficient for use and

 

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sale in the ordinary course of business, is merchantable and fit for the purpose for which it was produced or manufactured, and none of which was obsolete, subject only to customary reserves for inventory write-downs in the ordinary course of business. The Acquired Inventory was Manufactured in accordance with cGMP and in compliance with the applicable Product Specifications. At the time of transfer to Purchaser, (i) the Acquired Inventory will not be adulterated or misbranded within the meaning of the FDCA, or will be articles which may not, under the provisions of Section 404, 505 or 512 of the FDCA, be introduced into interstate commerce and (ii) the finished Aclidinium Products and Roflumilast Products included in the Acquired Inventory will have a remaining shelf life at Closing of at least twenty-four (24) months and eighteen (18) months, respectively.

(b) Schedule 4.9(b) of the Seller Disclosure Letter sets forth the finished Product inventory levels held by the Sellers’ and their respective Affiliates’ wholesaler customers as of the last day of the month for each of the six (6) months prior to the date of this Agreement, broken out by Product and by month.

(c) Since [***], the Sellers and their respective Affiliates have not (i) materially altered their activities and practices with respect to inventory levels of the Products maintained at the wholesale, chain, institutional or retail levels, including their practices with respect to samples of any Products, or (ii) sold, transferred or given any supplies or samples of any Products to any Third Party except in the ordinary course of business and in a manner that is consistent with past practice.

4.10 Recalls; Product Liability .

(a) Since [***], there has not been any product recall, market withdrawal, replacement or “dear doctor” letter conducted by or on behalf of the Sellers or their respective Affiliates concerning the Products in the Territory or, to the Sellers’ knowledge, any jurisdiction outside of the Territory, or, to the knowledge of the Sellers, any product recall, market withdrawal, replacement or “dear doctor” letter conducted by or on behalf of any Third Party as a result of any alleged defect in any Product.

(b) To the Sellers’ knowledge, there are no (i) defects in design or Manufacture of any Products which would reasonably be expected to adversely affect performance or create an unusual risk of injury to persons or property, in each case, except as described in Product Labeling or (ii) citations, decisions, adjudications or statements by any Governmental Entity in the Territory or consent decrees stating that any Product is defective or unsafe or fails to meet any standards promulgated by any such Governmental Entity.

(c) Since [***], the Products have been Manufactured by Sellers or their respective Affiliates (to the extent applicable) in material compliance with cGMP and in compliance with the applicable Product Specifications and, to the knowledge of the Sellers, by any Third Party on behalf of any Seller or any of their respective Affiliates (to the extent applicable), in compliance in all material respects with cGMP and in compliance with the applicable Product Specifications.

 

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4.11 Taxes . The Sellers have timely paid, or will timely pay, all Taxes required to be paid by them on or before the Closing Date with respect to the Acquired Assets, the non-payment of which would result in an Encumbrance on any Acquired Asset or would result in Purchaser becoming liable or responsible therefor. Nothing in this Section 4.11 is intended to override the allocation of responsibility for Health Care Reform Fees, Transfer Taxes, Apportioned Obligations or VAT set forth in Sections 6.14 , 6.16 , 6.17 and 6.18 .

4.12 Brokers . None of the Sellers has incurred, nor will they incur, directly or indirectly, any Liability for brokers’ or finders’ fees or agents’ commissions or any similar charges in connection with this Agreement or the consummation of the transactions contemplated hereby for which Purchaser or its Affiliates will be liable.

4.13 Exclusivity of Representations . SELLERS ACKNOWLEDGE AND AGREE THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN ARTICLE 5 , THE ANCILLARY AGREEMENTS TO BE ENTERED INTO AT THE CLOSING AND THE CERTIFICATE DELIVERED BY PURCHASER PURSUANT TO SECTION 3.4(c) , PURCHASER HAS MADE NO REPRESENTATION OR WARRANTY WHATSOEVER RELATED TO THE TRANSACTIONS CONTEMPLATED HEREBY AND SELLERS HAVE NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 4.16 SHALL, IN ANY WAY LIMIT THE SELLERS’ RIGHTS PURSUANT TO THIS AGREEMENT OR ANY ANCILLARY AGREEMENT OR IN ANY ACTION WITH RESPECT TO A CLAIM FOR FRAUD BASED UPON THE REPRESENTATIONS AND WARRANTIES OF PURCHASER, INTENTIONAL MISREPRESENTATION OR WILLFUL MISCONDUCT.

ARTICLE 5

REPRESENTATIONS AND WARRANTIES OF PURCHASER

Purchaser hereby makes the following representations and warranties to each of the Sellers:

5.1 Organization, Power and Standing . Purchaser is a private limited company duly organized, validly existing and in good standing under the Laws of England and Wales. Purchaser has the requisite entity power and authority to own and operate its business as presently conducted. Purchaser is duly qualified to do business and in good standing in each jurisdiction where the operations of its business requires such qualification, except where the failure to be so qualified or in such good standing would not, individually or in the aggregate, reasonably be expected to prevent or materially delay the ability of Purchaser to consummate the transactions contemplated by this Agreement.

5.2 Authority, Non-Contravention, Required Filings .

(a) Each of Purchaser and/or its Affiliates, as applicable, has the requisite entity power and authority to execute and deliver this Agreement, each Execution Date Agreement and each Ancillary Agreement and to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution

 

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and delivery of this Agreement, each Execution Date Agreement and each Ancillary Agreement by Purchaser and/or its Affiliates, as applicable, and the performance by Purchaser and/or its Affiliates, as applicable, of its obligations hereunder and thereunder and the consummation by Purchaser and/or its Affiliates, as applicable, of the transactions contemplated hereby and thereby, have been duly authorized by all necessary entity action on the part of Purchaser and/or its Affiliates, as applicable.

(b) This Agreement and each Execution Date Agreement have been duly executed and delivered by Purchaser and/or its Affiliates, as applicable, and constitute valid and binding obligations of each of Purchaser and/or its Affiliates, as applicable, enforceable against it in accordance with their respective terms, and, as of the Closing, each Ancillary Agreement will have been duly executed and delivered by Purchaser and/or its Affiliates, as applicable, and will constitute a valid and binding obligation of each of Purchaser and/or such Affiliates, enforceable against it in accordance with its terms, in each case subject to (i) the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar Laws relating to or affecting the enforcement of creditors’ rights generally and (ii) general equitable principles (whether considered in a proceeding in equity or at Law).

(c) The execution and delivery of this Agreement and each Execution Date Agreement by Purchaser and/or its Affiliates, as applicable, do not, and the execution and delivery of each Ancillary Agreement as of the Closing, the performance by Purchaser and/or its Affiliates, as applicable, of its obligations hereunder and thereunder and the consummation by Purchaser and/or its Affiliates, as applicable, of the transactions contemplated hereby and thereby will not (i) contravene or conflict with any provision of the Organizational Documents of Purchaser and/or its Affiliates, as applicable, (ii) contravene, conflict with, constitute a breach, violate the terms, conditions or provisions of, or result in a default under, or give to others any rights of termination, amendment, acceleration or cancellation of any contract or agreement to which Purchaser and/or its Affiliates, as applicable, is a party or is otherwise bound, or (iii) assuming compliance with the matters referred to in Section 5.2(d) , violate in any respect any provision of any Law to which Purchaser and/or its Affiliates, as applicable, is subject, except, in the case of clause (ii) or (iii) above, for any such breaches, violations, defaults or other occurrences, if any, that would not, individually or in the aggregate, reasonably be expected to prevent or materially delay the ability of Purchaser to consummate the transactions contemplated by this Agreement.

(d) No permit, consent, waiting period expiration or termination, approval or authorization of, or designation, declaration or filing with, any Governmental Entity on the part of Purchaser or any of its Affiliates is required in connection with the execution or delivery by Purchaser or any of its Affiliates of this Agreement, any Execution Date Agreement or any Ancillary Agreement or the consummation of the transactions contemplated hereby or thereby other than (i) any filings and/or notices under the Competition Laws, (ii) the Purchaser FDA Transfer Letters, and (ii) such permits, consents, approvals, authorizations, designations, declarations or filings the absence of which would not, individually or in the aggregate, reasonably be expected to prevent or materially delay the ability of Purchaser to consummate the transactions contemplated hereby or thereby.

 

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5.3 Sufficient Funds Available . Purchaser has, or will have as of the Closing, sufficient funds available to pay the Purchase Price and to perform its obligations to be performed as of the Closing (including payment of the Purchase Price) and to pay the fees and expenses Purchaser incurred in connection with such obligations and the transactions contemplated by this Agreement.

5.4 Brokers . Purchaser has not incurred, nor will it incur, directly or indirectly, any Liability for brokers’ or finders’ fees or agents’ commissions or any similar charges in connection with this Agreement or the consummation of the transactions contemplated hereby for which any of the Sellers or their respective Affiliates will be liable.

5.5 Exclusivity of Representations . PURCHASER ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN ARTICLE 4 , THE ANCILLARY AGREEMENTS TO BE ENTERED INTO AT THE CLOSING AND THE CERTIFICATE DELIVERED BY FOREST PURSUANT TO SECTION 3.3(b) , SELLERS HAVE MADE NO REPRESENTATION OR WARRANTY WHATSOEVER RELATED TO THE TRANSACTIONS CONTEMPLATED HEREBY AND PURCHASER HAS NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 5.5 SHALL, IN ANY WAY, LIMIT PURCHASER’S RIGHTS PURSUANT TO THIS AGREEMENT OR ANY ANCILLARY AGREEMENT OR IN ANY ACTION WITH RESPECT TO A CLAIM FOR FRAUD BASED UPON THE REPRESENTATIONS AND WARRANTIES OF THE SELLERS, INTENTIONAL MISREPRESENTATION OR WILLFUL MISCONDUCT.

ARTICLE 6

COVENANTS AND AGREEMENTS

6.1 Conduct Prior to Closing .

(a) During the period beginning on the date of this Agreement and ending on the earlier of (x) the Closing Date and (y) the date of termination of this Agreement in accordance with Article 8 (the “ Pre-Closing Period ”), each of the Sellers shall, and shall cause its Affiliates to, (a) conduct its business with respect to each Product and the Acquired Assets in the ordinary course and in accordance with applicable Law and (b) use commercially reasonable efforts to preserve the Product Business and otherwise maintain the tangible Acquired Assets in good condition. Except as set forth on Schedule 6.1(a) of the Seller Disclosure Letter, the Sellers shall not, and shall cause their respective Affiliates not to, without the consent of Purchaser in writing (not to be unreasonably withheld, conditioned or delayed), do any of the following:

(i) mortgage, lease, pledge or otherwise Encumber any Acquired Assets or sell, transfer, license, lease, permit to lapse or otherwise dispose of any Acquired Assets except for sales of inventory in the ordinary course of business;

(ii) (A) terminate or fail to renew any Acquired Contract, or make any material amendment to or waive any material right or remedy under any such Contract, (B) knowingly take, or fail to take, any action that would constitute a breach, violate the terms, conditions or provisions of, or result in a default under, or give to others any rights of termination, amendment, acceleration or cancellation of any Acquired Contract or (C) enter into any Contract that would be an Acquired Contract;

 

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(iii) (A) abandon, lapse or allow to lapse any Acquired Intellectual Property Rights, (B) fail to make any filings, prosecute in good faith or maintain any Acquired Intellectual Property Rights or (C) grant any license, sublicense or other right with respect to any Acquired Intellectual Property Rights or In-Licensed Intellectual Property, other than in the ordinary course of business;

(iv) vary any inventory practices with respect to any Product (including samples) in a manner inconsistent with the ordinary course of business or fail to produce and maintain inventory levels and amounts consistent with the ordinary course of business;

(v) commence, compromise or settle any Action to the extent related to the Product Business or the Acquired Assets;

(vi) fail to pay any applicable Taxes imposed on the Acquired Assets or with respect to the Product Business as such Taxes become due or payable;

(vii) (A) materially revise or modify any promotional material (including any Labeling) included in the Acquired Regulatory Documentation or (B) add, remove or otherwise alter any references to the Products in any website controlled by any of the Sellers or their respective Affiliates or any of the content of such references in any such website, in each case ((A) and (B)), except as required by a Governmental Entity or as otherwise required by applicable Law;

(viii) terminate or materially modify any ongoing clinical trial (including any post approval study) with respect to any Product, except in the event of a safety concern or as otherwise necessary to comply with any Governmental Entity or applicable Law; or

(ix) agree or commit to do any of the foregoing.

(b) Notification of Certain Matters .

(i) During the Pre-Closing Period, Forest, on behalf of itself and the other Sellers, shall promptly notify Purchaser, and Purchaser shall promptly notify Forest, on behalf of itself and as agent for the other Sellers, of (A) any Action that shall be instituted or threatened (in a writing delivered to such Party) against such Party to restrain, prohibit or otherwise challenge the legality of any transaction contemplated by this Agreement or (B) any Effect of which the Sellers have knowledge that would make the timely satisfaction of any of the conditions set forth in Article 7 of this Agreement impossible or unlikely.

(ii) No notice delivered pursuant to this Section 6.1(b) shall (i) operate to waive or limit any of the rights or remedies of Purchaser hereunder for the matters disclosed therein or (ii) constitute an admission that anything disclosed in such notice is material, or is required to be disclosed pursuant to this Section 6.1(b) .

 

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6.2 Access to Information; Confidentiality .

(a) During the Pre-Closing Period, each of the Sellers shall afford Purchaser and its officers, employees, agents, attorneys, consultants, advisors and other representatives (collectively, “ Representatives ”), continued reasonable access to the employees of the Sellers and/or their respective Affiliates to discuss the Product Business and access to the books, records, documents and other information in the possession or control of any of the Sellers or their respective Affiliates to the extent relating to the Product Business, the Assumed Liabilities or the Acquired Assets; provided , however , that none of the Sellers shall be obligated to provide such information if doing so would (i) based on advice of such Seller’s counsel, create any potential Liability under applicable Laws, including Competition Laws, or would jeopardize the protection of any attorney-client or other legal privilege, or (ii) in the reasonable judgment of such Seller, would (A) result in the disclosure of any trade secrets of Third Parties or (B) violate a Contract or obligation of confidentiality owing to a Third Party; provided , that the applicable Seller uses commercially reasonable efforts to obtain waivers thereof. Purchaser acknowledges and agrees that any information provided to Purchaser or its Representatives pursuant to this Section 6.2(a) or otherwise by or on behalf of any of the Sellers or its Representatives in connection with this Agreement or the transactions contemplated hereby shall be subject to the terms and conditions of the Confidentiality Agreement.

(b) Following the Closing, subject to Section 11.1 , all Confidential Information provided by Purchaser, on the one hand, or the Sellers, on the other hand, (or their respective Representatives or Affiliates) (collectively, the “ Disclosing Party ” with respect to such information) to the Sellers, on the one hand, or Purchaser, on the other hand, (or their respective Representatives or Affiliates) (collectively, the “ Receiving Party ” with respect to such information) shall be subject to and treated in accordance with the terms of this Section 6.2(a) through Section 6.2(e) ; provided, that nothing in this Section 6.2(a) through Section 6.2(e) shall be construed as preventing or in any way inhibiting either Party from complying with applicable Law governing activities and obligations undertaken pursuant to this Agreement or any Ancillary Agreement.

(c) From and after the Closing, (i) all Confidential Information obtained by the Sellers (or their respective Affiliates or Representatives) from Purchaser (or its Affiliates or Representatives) and (ii) all Confidential Information to the extent relating to the Product Business, the Acquired Assets and the Assumed Liabilities ((i) and (ii), collectively, the “ Purchaser Confidential Information ”) shall be deemed to be Confidential Information disclosed by Purchaser to the Sellers for purposes of this Section 6.2 and shall be used by the Sellers solely as required to (A) perform their obligations or exercise or enforce their rights under this Agreement or any Ancillary Agreement or (B) comply with applicable Law (each of (A) and (B), a “ Seller Permitted Purpose ”), and for no other purpose. For a period of seven (7) years after the Closing Date, the Sellers shall not disclose, or permit the disclosure of, any of the Purchaser Confidential Information to any Person except those Persons to whom such disclosure is necessary in connection with any Seller Permitted Purpose and the Sellers shall not use the Purchaser Confidential Information except in connection with the Seller Permitted Purpose; provided , however , that with respect to any Purchaser Confidential Information that is a Trade Secret, the Sellers shall not disclose, or permit the disclosure of, such information for the period of time that it is considered a Trade Secret under the Uniform Trade Secrets Act or other

 

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applicable Law, other than in accordance with Section 6.2(e) . The Sellers shall treat, and shall cause their respective Affiliates and the Representatives of the Sellers or any of their respective Affiliates to treat, the Purchaser Confidential Information as confidential, using the same degree of care as the Sellers normally employ to safeguard their own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.

(d) From and after the Closing, all Confidential Information obtained by Purchaser (or its Affiliates or Representatives) from the Sellers (or their respective Affiliates or Representatives) other than the Purchaser Confidential Information (the “ Seller Confidential Information ”) shall be used by Purchaser solely as required to (i) perform its obligations or exercise or enforce its rights under this Agreement or any Ancillary Agreement, or (ii) comply with applicable Law (each of (i) and (ii), a “ Purchaser Permitted Purpose ”), and for no other purpose. For a period of seven (7) years after the Closing Date, Purchaser shall not disclose, or permit the disclosure of, any of the Seller Confidential Information to any Person except those Persons to whom such disclosure is necessary in connection with a Purchaser Permitted Purpose and Purchaser shall not use, or permit the use of, the Seller Confidential Information, except in connection with a Purchaser Permitted Purpose; provided , however , that with respect to any Seller Confidential Information that is a Trade Secret, Purchaser shall not disclose, or permit the disclosure of, such information for the period of time that it is considered a Trade Secret under the Uniform Trade Secrets Act or other applicable Law, other than in accordance with Section 6.2(e) . Purchaser shall treat, and will cause its Affiliates and the Representatives of Purchaser or any of its Affiliates to treat, Seller Confidential Information as confidential, using the same degree of care as Purchaser normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.

(e) In the event Purchaser, on the one hand, or any of the Sellers, on the other hand, is requested pursuant to, or required by, applicable Law to disclose any of the Sellers’ or Purchaser’s, respectively, Confidential Information ( i.e ., Seller Confidential Information or Purchaser Confidential Information, as applicable), it will notify the other Party in a timely manner so that such Party may seek a protective order or other appropriate remedy or, in such Party’s sole discretion, waive compliance with the confidentiality provisions of this Agreement. Each Party will cooperate in all reasonable respects in connection with any reasonable actions to be taken for the foregoing purpose. In any event, the Party requested or required to disclose such Confidential Information may furnish it as requested or required pursuant to applicable Law (subject to any such protective order or other appropriate remedy) without liability hereunder, provided that such Party furnishes only that portion of the Confidential Information which such Party is advised by an opinion of its counsel is legally required, and if confidential treatment is available such Party exercises reasonable efforts to obtain reliable assurances that confidential treatment will be accorded such Confidential Information.

6.3 Transfer of Acquired Regulatory Approvals . The Sellers and Purchaser shall establish a mutually acceptable and prompt communication and interaction process to ensure the orderly transfer of the Acquired Regulatory Approvals at the Closing, including the transfer of the Regulatory Documentation comprising or referenced in the Acquired Regulatory Approvals in formats acceptable to Purchaser. Subject to the Transition Services Agreement, each of the Sellers and Purchaser shall use reasonable best efforts to take any actions required by any Governmental Entity necessary to effect the transfer of the Acquired Regulatory Approvals from

 

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one or more of the Sellers and/or their respective Affiliates, as applicable, to Purchaser, and shall cooperate with each other in order to effectuate the foregoing transfer of the Acquired Regulatory Approvals. Subject to Section 6.2 , each of the Sellers may retain an archival copy of any Acquired Regulatory Approval including supplements and records.

6.4 Third Party Consents . Notwithstanding anything in this Agreement to the contrary, this Agreement shall not constitute an agreement to assign or transfer any Acquired Contract or any other Acquired Asset that is not assignable or transferable without the Consent of any Third Party to the extent that such Consent shall not have been obtained prior to the Closing; provided , however , that each of the Sellers shall, and shall cause its Affiliates to, use, both prior to and for twelve (12) months after the Closing Date, commercially reasonable efforts to obtain, and Purchaser shall use its commercially reasonable efforts to assist and cooperate with each of the Sellers in connection therewith, all necessary Consents to the assignment and transfer thereof; provided , further , that (a) none of the Sellers, Purchaser or any of their respective Affiliates shall be required to pay money to any Third Party, commence any litigation or offer or grant any other accommodation (financial or otherwise) to any Third Party in connection with such efforts and (b) to the extent the foregoing shall require any action by any of the Sellers or their respective Affiliates that would, or would continue to, affect any Product or Acquired Asset after the Closing, such action shall require the prior written consent of Purchaser (which consent shall not be unreasonably withheld, conditioned or delayed if such limitations are applicable to the underlying consent right of the Sellers or their respective Affiliates). With respect to any Acquired Contract or any other Acquired Asset that is not assigned or transferred to Purchaser at the Closing by reason of this Section 6.4 (a “ Nonassigned Asset ”), for a period beginning on the Closing Date and ending on the earlier of (i) the time such requisite Consent is obtained and the foregoing is transferred and assigned to Purchaser and (ii) the first anniversary of the Closing Date, each of the Sellers shall, and shall cause its Affiliates to, use commercially reasonable efforts to provide to Purchaser substantially comparable benefits thereof and shall enforce, at the request of and for the benefit of Purchaser, any rights of any of the Sellers or their respective Affiliates arising thereunder against any Third Party, including the right to seek any available remedies or to elect to terminate in accordance with the terms thereof upon the advice of Purchaser. As a condition to a Seller providing Purchaser with the benefits of any Nonassigned Asset, Purchaser shall perform, at the direction of such Seller, the obligations of such Seller or any of its respective Affiliates thereunder or in connection therewith, on a pro-rata basis commensurate with the benefit received by Purchaser under such Nonassigned Asset, as compared with the overall benefit received under such Nonassigned Asset by or on behalf of such Seller or any of its respective Affiliates.

6.5 Governmental Consents .

(a) During the Pre-Closing Period, each of the Parties agrees, subject to Section 6.5(b) , to use its commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary for it to do under applicable Laws to consummate and make effective the transactions contemplated by this Agreement, which actions shall include making all required registrations and filings with, and seeking all required approvals of, Governmental Entities and furnishing all information required by applicable Law or requested by such Governmental Entities. Without limiting the foregoing, as soon as reasonably practicable after the date of this Agreement, the Sellers and Purchaser shall make all

 

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filings required under the Competition Laws, including preparing and filing with the FTC and the DOJ the notifications required with respect to the transaction contemplated by this Agreement pursuant to the HSR Act, which notifications shall specifically request early termination of the waiting period prescribed by the HSR Act. The Parties shall use their respective commercially reasonable efforts to file such notifications within ten (10) Business Days after the date of this Agreement or, if not filed within that period, as soon thereafter as reasonably practicable (it being understood that only a failure to use commercially reasonable efforts, and not a failure to file within such ten (10) Business Day period or by any subsequent date, shall constitute a breach of this Agreement) and to secure the expiration or termination of any applicable waiting period (including the waiting period under the HSR Act), or obtain the required approval, under any Competition Law.

(b) Subject to appropriate confidentiality protections, protection of attorney-client or other legal privileges, and other applicable Laws relating to the exchange of information, the Sellers will furnish to Purchaser and Purchaser will furnish to Forest (on behalf of the Sellers) such information and assistance as the Sellers or Purchaser, as applicable, may reasonably request in connection with the matters set forth in Section 6.5(a) and will keep the Sellers or Purchaser, as applicable, reasonably informed with respect to any Consent by or sought from any Governmental Entity in connection with this Agreement. All meetings, discussions, contacts, correspondence or filings by or on behalf of any Party with any Governmental Entity in connection with the transactions contemplated hereby (but, for the avoidance of doubt, not including any interactions between any of the Sellers or Purchaser with Governmental Entities in the ordinary course of business or the primary purpose of which relates to one or more other transactions) shall be disclosed to Forest (on behalf of the Sellers) or Purchaser, as applicable, in advance, if legally permissible and practicable and not otherwise attorney-client privileged, it being the intent that the Parties will consult and cooperate with one another, and consider in good faith the views of one another, in connection with any such matters. The Sellers shall give notice to Purchaser and Purchaser shall give notice to the Sellers with respect to any material meeting, discussion, contact, correspondence or filing with any Governmental Entity in connection with the matters set forth in Section 6.5(a) , with such notice being sufficient to provide Forest (on behalf of the Sellers) or Purchaser, as applicable, with reasonable opportunity to attend and participate in, or comment on, such meeting, discussion, contact, correspondence or filing. During the Pre-Closing Period, Purchaser shall promptly notify the Sellers and the Sellers shall promptly notify Purchaser in writing of any pending or, to the knowledge of Purchaser or the Sellers, as applicable, threatened Action by any Governmental Entity (i) challenging or seeking material damages in connection with the consummation of the transactions contemplated by this Agreement or (ii) seeking to restrain or prohibit the consummation of the transactions contemplated by this Agreement.

(c) Without limiting the foregoing and notwithstanding anything to the contrary set forth herein, Purchaser shall (i) not enter into any transaction that would reasonably be expected to increase the difficultly of obtaining the approval of any Governmental Entity with respect to the transactions contemplated by this Agreement, (ii) use commercially reasonable efforts to (A) prevent the entry of any Court Order and have vacated, lifted, reversed or overturned any Court Order that would prevent, enjoin, prohibit, restrict or delay the consummation of the transactions contemplated by this Agreement and (B) resolve as promptly as reasonably practicable any objections asserted by any Governmental Entity with respect to the

 

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transactions contemplated by this Agreement, provided that nothing in this clause (ii) shall be deemed to require Purchaser or any of its Affiliates to agree to take any action that would reasonably be expected to be material and adverse to the (x) Acquired Assets and the Product Business, taken together as a whole or (y) Purchaser’s existing respiratory product franchise.

6.6 Support . Following the Closing, Purchaser and its Affiliates, on the one hand, and the Sellers and their respective Affiliates, on the other hand, shall reasonably cooperate with each other in the defense or settlement of any Liabilities or Actions claimed or commenced by Third Parties involving any Product, the Acquired Assets, the Assumed Liabilities, the Product Business, this Agreement or the Ancillary Agreements, in each case for which Purchaser or the Sellers, as the case may be, has or have responsibility under this Agreement by providing Purchaser and Purchaser’s legal counsel or the Sellers and the Sellers’ legal counsel, as the case may be, reasonable access to employees, records, documents, data, equipment, facilities, products, parts, prototypes and other information primarily related to any Product, the Acquired Assets, the Assumed Liabilities or the Product Business as Purchaser or the Sellers may reasonably request, to the extent maintained or under the possession or control of the requested Party (other than any Actions between Purchaser and its Affiliates, on the one hand, and the Sellers or their respective Affiliates, on the other hand, arising out of the transactions contemplated by this Agreement or the Ancillary Agreements, with respect to which applicable rules of discovery shall apply); provided , however , that such access shall not unreasonably interfere with Purchaser’s or its Affiliates’, or the Sellers’ or their respective Affiliates’, as the case may be, respective businesses; provided , further , that any Party may restrict the foregoing access to the extent that (a) such restriction is required by applicable Law, (b) such access or provision of information would reasonably be expected to result in a violation of confidentiality obligations to a Third Party; provided, that such Party uses commercially reasonable efforts to obtain waivers thereof or (c) disclosure of any such information would be reasonably likely to result in the loss or waiver of the attorney-client or other legal privilege. The requesting Party shall reimburse the other Party or Parties, as the case may be, for reasonable out-of-pocket expenses paid by the other Party or Parties, as the case may be, to Third Parties in performing its or their obligations under this Section 6.6 .

6.7 Trade Notification . From the date hereof through the Closing, the Sellers and Purchaser shall cooperate in good faith to agree in writing on the method and content of the notifications to customers and suppliers of the sale of the Acquired Assets to Purchaser hereunder; provided , that the Sellers shall have the sole right to deliver such notifications to customers prior to the Closing. Purchaser (prior to the Closing) and the Sellers (prior to and after the Closing) shall not make any other communications or give any other notices to customers or suppliers relating to the transactions contemplated hereby that are inconsistent with the terms of such written agreement.

6.8 Intellectual Property License . Effective as of the Closing, each of the Sellers, on behalf of itself and its Affiliates, hereby grants to Purchaser and its Affiliates, and Purchaser (on behalf of itself and its Affiliates) hereby accepts (a) an exclusive (except for use by Seller or its Affiliates to perform their respective obligations under the Ancillary Agreements), transferable, sublicensable through multiple tiers, perpetual, irrevocable, fully paid-up and royalty-free right and license to exploit or otherwise use and practice the Seller Licensed IP Rights solely for the Exploitation of Products in the Territory in the manner and to the extent used by the Sellers and

 

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their respective Affiliates as of the Closing, and (b) a non-exclusive, transferable, sublicensable through multiple tiers, perpetual, irrevocable, fully paid-up and royalty-free right and license to exploit or otherwise use and practice the Seller Licensed IP Rights solely for the (x) research, development or Manufacture of Products, in each case, within or outside the Territory and (y) Exploitation of Products in the Territory. Purchaser agrees, and agrees to cause its Affiliates, transferees and sublicensees to, maintain and protect the Trade Secrets included in the Seller Licensed IP Rights using at least the same degree of care Purchaser uses to protect its own proprietary information of like nature, but in no case using less than reasonable care appropriate under the circumstances.

6.9 Use of Licensed Names and NDCs .

(a) Subject to and in compliance with the terms and conditions hereof, and effective as of the Closing, each of the Sellers, on behalf of itself and its Affiliates, hereby grants to Purchaser and its Affiliates, and Purchaser (on behalf of itself and its Affiliates) hereby accepts a limited, non-exclusive, non-transferable, non-sublicensable, royalty-free, fully paid-up, right and license to use (i) any Licensed Names and (ii) any NDC of Sellers or their respective Affiliates included in the Labeling for a Product, which Labeling exists as of the Closing, in each case ((i) and (ii)), for a period beginning on the Closing Date and ending on the last day of the Transition Quarter (the “ Limited License Period ”), in either case, to the extent necessary to allow Purchaser and its Affiliates to Exploit the Products in the Territory after the Closing or in compliance with applicable Law. Notwithstanding the foregoing, Purchaser acknowledges and agrees that the license granted under this Section 6.9 is being granted solely for transitional purposes and, except as otherwise provided in the Supply Agreement, Purchaser shall, and shall cause its Affiliates to, cease any and all use of such NDCs and the Licensed Names included in the Labeling for a Product as soon as reasonably practicable after the Closing Date, but in no event later than the last day of the Limited License Period. To the extent Purchaser or any of its Affiliates is utilizing the license granted by the Sellers in this Section 6.9 , Purchaser shall, and shall cause its Affiliates to, adhere to Sellers’ quality standards communicated to Purchaser by Sellers with respect to the nature and quality of the Products and, at the Sellers’ reasonable request, furnish to the Sellers representative samples of the Labeling for any Product and other materials bearing any of the Licensed Names for quality control purposes.

(b) Promptly upon the expiration of the Limited License Period, Purchaser shall, and shall cause its Affiliates to, destroy and dispose of all of the Labeling for a Product in its possession or subject to its control that bears any Licensed Names or NDCs.

(c) Notwithstanding anything to the contrary, in no event shall Purchaser or any of its Affiliates (i) use any Licensed Names or NDCs other than in accordance with the license granted in Section 6.9(a) or in any manner or for any purpose materially different from the use of such Licensed Names or NDCs by the Sellers and their respective Affiliates immediately prior to the Closing to Exploit the applicable Product or (ii) except as set forth in the Supply Agreement, manufacture or produce, or cause or permit any Third Party to manufacture or produce, any new Labeling for a Product or advertising, marketing, sales and promotional materials using or otherwise incorporating any Licensed Names or NDCs in any manner.

 

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(d) Purchaser hereby acknowledges and agrees that one or more of the Sellers and/or their respective Affiliates owns all right, title and interest in and to the Licensed Names and the NDCs, and that all goodwill arising from the use of the Licensed Names and the NDCs will inure exclusively to the benefit of such Seller and/or its Affiliate, and if Purchaser or any of its Affiliates obtains any goodwill, right, title or interest in or to any of the Licensed Names or any of the NDCs, Purchaser hereby irrevocably assigns, and causes each of its Affiliates to irrevocably assign, to the Sellers all such goodwill, rights, title and interests. During the Limited License Period, Purchaser shall not, and shall cause its Affiliates not to, (i) take any action that will reasonably be expected to prejudice the distinctiveness or validity of, or otherwise adversely affect, disparage, dilute or invalidate the Licensed Names or the NDCs or (ii) adopt or use any other Trademark which may be substantially identical, deceptively similar or confusingly similar to the Licensed Names.

6.10 Assistance in Collecting Certain Amounts .

(a) For a period of twelve (12) months after the Closing Date, Purchaser shall use its commercially reasonable efforts to assist, cooperate with and consult with the Sellers and their respective Affiliates, and the Sellers shall consult with Purchaser in connection with the Sellers’ and their respective Affiliates’ (i) collection of all Accounts Receivable related to any Product, including those that are not evidenced by instruments or invoices, existing as of the Closing, and Purchaser shall remit promptly to the Sellers any payments or other sums received by Purchaser that constitute Excluded Assets and (ii) payment of all accounts payable related to any Product, including those that are not evidenced by instruments or invoices, existing as of the Closing. Each of the Sellers shall, and shall cause its Affiliates to, remit promptly to Purchaser any payments or other sums received by any of the Sellers or their respective Affiliates after the Closing and relating to any Product sold by or on behalf of Purchaser after the Closing or that otherwise constitute Acquired Assets.

(b) Payments Under Acquired Contracts .

(i) If any of the Sellers or their respective Affiliates receives any deposit or payment that relates to obligations under any Acquired Contracts to be performed or satisfied after the Closing by Purchaser, then the Sellers shall pay to Purchaser, within twenty (20) Business Days following the Closing Date, an amount equal to the portion of such deposit or payment in advance that relates to such obligations to be performed after the Closing.

(ii) If any of the Sellers or their respective Affiliates receives any good or service under any Acquired Contract or otherwise which is billed to Purchaser after the Closing, Purchaser, at its option, may forward the applicable invoice to Sellers for payment or pay such invoice and, upon request and presentation of reasonable supporting documentation, the Sellers shall reimburse Purchaser for the amount of such payment within twenty (20) Business Days following the date of such request.

(iii) If any of the Sellers or their respective Affiliates makes any deposit or payment prior to the Closing under any Acquired Contract in respect of supplies of goods for the Product Business not received prior to the Closing, Purchaser shall reimburse to such Seller or its Affiliate, within twenty (20) Business Days following the Closing Date, an amount equal to the portion of such deposit or payment that relates to the goods to be received after the Closing by Purchaser.

 

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6.11 Regulatory Documentation and Marketing Records . On the Closing Date, the Sellers shall transfer to Purchaser the [***], in formats acceptable to Purchaser. The Sellers shall deliver [***], in formats acceptable to Purchaser. Notwithstanding anything to the contrary, subject to Section 6.2 , each of the Sellers may retain an archival copy of all such Acquired Regulatory Documentation and Acquired Marketing Records to the extent necessary to perform their obligations under the Transition Services Agreement and for regulatory, tax, accounting, or litigation purposes or as otherwise required by Law or any of the Sellers’ or their respective Affiliates’ internal policies for record-keeping purposes.

6.12 Acquired Equipment . Purchaser shall pay or reimburse the Sellers for their reasonable costs to complete the fabrication of the Acquired Equipment, which costs shall not exceed [***]. Within the time frames and in accordance with the technology transfer plan contemplated by the Supply Agreement, the Sellers shall, subject to a customary indemnity agreement relating to real property damage, remove from the Sellers’ premises the Acquired Equipment.

6.13 Post-Closing Responsibility for Products Sold in the Territory . The Parties shall, promptly following the date hereof, negotiate in good faith and agree upon their respective obligations following the Closing relating to (i) the processing and payment of, and financial responsibility for, returns of the Products and chargebacks, rebates and price reductions and (ii) government price reporting, in each case based upon the indicative terms set forth in Exhibit L . From and after the Closing, each of the Parties shall perform their respective obligations set forth in Exhibit L , as finalized in accordance with the prior sentence.

6.14 Health Care Reform Fees . Each Party will be solely responsible for any HCR Fees billed to it which are based on sales of any Product with an NDC of such Party, except that Purchaser will be responsible for any HCR Fees attributable to any sales on or after the Closing Date of Products under Sellers’ NDCs (which also include Sellers’ labeler codes). For the avoidance of doubt, each Seller is responsible for HCR Fees for sales of the Products labeled with such Seller’s NDCs, except as otherwise stated in this Section 6.14 , and Purchaser is responsible for HCR Fees for sales of the Products labeled with Purchaser’s NDCs. The Sellers, or their Affiliates, shall invoice Purchaser for HCR Fees, if any, billed to the Sellers or their Affiliates for which Purchaser is responsible under this Section 6.14 following receipt of the final fee invoice, calculation, notice, invoice, judgment, assessment, or similar item from the IRS or any other relevant Governmental Entity which includes such HCR Fees and shall include in such invoice adequate documentation to allow Purchaser to confirm that such HCR Fees were allocated appropriately. Purchaser shall promptly after receipt thereof, and in all events within fifteen (15) days of such receipt, pay such invoice. For the avoidance of doubt, the HCR Fee for a relevant calendar year is the final adjusted HCR Fee calculated using the actual sales from such calendar year.

 

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6.15 Withholding Tax . Purchaser shall not deduct or withhold any Taxes from any amounts payable pursuant to this Agreement unless such deduction or withholding of Taxes is required under applicable Law. If any applicable Law requires the deduction or withholding of any Tax from any such payments, then Purchaser shall be entitled to make such deduction or withholding and shall timely pay the full amount deducted or withheld to the relevant Governmental Entity in accordance with applicable Law and all amounts so deducted or withheld and paid to the relevant Governmental Entity shall be considered paid to the relevant Seller for all purposes of this Agreement; provided that prior to making any deduction or withholding from any payment under this Agreement, the Purchaser shall provide at least ten (10) days’ prior written notice to the relevant Seller of the amounts subject to deduction or withholding and provide to the Sellers a reasonable opportunity to furnish forms, certificates or other items that would reduce or eliminate such deduction or withholding; provided further that Purchaser shall reasonably cooperate with the Sellers to minimize any such deduction or withholding. As soon as practicable after any deduction or withholding is made, Purchaser shall deliver to the relevant Seller the original or copy of the official receipt issued by the relevant Governmental Entity evidencing such payment or other evidence of such payment reasonably satisfactory to such Seller. This Section 6.15 shall not apply to Transfer Taxes or VAT, which are governed exclusively by Section 6.16 and 6.18 .

6.16 Transfer Taxes . Notwithstanding any provision of this Agreement to the contrary, all Transfer Taxes arising in connection with the transactions contemplated under this Agreement shall be borne [***]. Purchaser shall file, or shall cause to be filed, to the extent permitted by applicable Law, all Tax Returns as may be required to comply with the provisions of such Tax Laws relating to Transfer Taxes and shall within thirty (30) days following the expiration of the applicable deadline provide evidence satisfactory to the relevant Seller that such Tax Returns and filings with respect to Transfer Taxes have been duly and timely filed and the relevant Transfer Taxes duly and timely paid. The relevant Sellers shall cooperate with Purchaser in connection with all such filings and shall file those Tax Returns that the Purchaser is not permitted to file. The non-paying Party, or Parties with respect to the Sellers, shall reimburse the paying Party, or Parties with respect to the Sellers, for its or their share of any such Transfer Taxes within ten (10) days of written demand therefor.

6.17 Apportioned Obligations . All real property, personal property and similar ad valorem obligations levied with respect to the Acquired Assets for a taxable period which includes (but does not end on) the Closing Date (collectively, the “ Apportioned Obligations ”) shall be apportioned between the Sellers and Purchaser based on the number of days of such taxable period ending on the Closing Date (the “ Pre-Closing Tax Period ”) and the number of days after the Closing Date (such portion of such taxable period, the “ Post-Closing Tax Period ”). The Sellers, jointly and severally, shall be liable for the proportionate amount of such Apportioned Obligations that is attributable to the Pre-Closing Tax Period, and Purchaser shall be liable for the proportionate amount of such Apportioned Obligations that is attributable to the Post-Closing Tax Period. The non-paying Party, or Parties with respect to the Sellers, shall reimburse the paying Party, or Parties with respect to the Sellers, for its or their share of any such Apportioned Obligations within ten (10) days of written demand therefor.

6.18 VAT . All consideration specified for supplies of goods or services made, or deemed to be made, under this Agreement shall be exclusive of any and all applicable VAT. With respect to each such supply of goods or services, the party hereto that makes such supply (or whose Affiliate makes such supply) (the “ Supply Provider ”) shall provide, or cause its Affiliate making such supply to provide, to the party hereto that receives such supply (or whose

 

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Affiliate receives such supply) (the “ Supply Recipient ”), or to the Affiliate of the Supply Recipient receiving such supply, a properly completed and executed VAT invoice (or other valid and customary VAT documentation) with respect to the relevant supply of goods or services, promptly and in accordance with applicable Law. After the receipt of such invoice or documentation, the Supply Recipient shall pay, or cause its Affiliate receiving such supply to pay, to the Supply Provider or its Affiliate making such supply, in addition to the specified consideration, all VAT required under applicable Law to be charged by the Supply Provider or its Affiliate in relation to such supply, in accordance with applicable Law (but in no event later than the tenth Business Day after such receipt). If any payment made by one Party to another Party pursuant to this Agreement is deemed by the Excise Tax Act (Canada) to include VAT, the amount of such payment shall be increased accordingly.

6.19 Wrong Pockets . Until the first anniversary of the Closing Date, if either Purchaser, on the one hand, or the Sellers, on the other hand, becomes aware that any of the Acquired Assets has not been transferred to Purchaser or its Affiliate or that any of the Excluded Assets has been transferred to Purchaser or its Affiliate (other than as contemplated in the Ancillary Agreements), Purchaser or the Sellers, as applicable, shall promptly notify the other and the Parties shall, as soon as reasonably practicable, ensure that such property is transferred, with any necessary prior Third Party consent or approval, to (a) Purchaser or its applicable Affiliate, in the case of any Acquired Asset which was not transferred to Purchaser at the Closing; or (b) the applicable Seller, in the case of any Excluded Asset which was transferred to Purchaser at the Closing.

6.20 Non-Compete; Termination of Discussions .

(a) The Sellers covenant and agree that, until [***], they shall not, and they shall cause their respective Affiliates (collectively, the “ Non-Competition Parties ”) not to, directly or indirectly, engage in (including by granting any license, sublicense, right to distribute, right of reference or covenant not to sue to any Third Party to engage in), a Competing Activity; provided , however , that the foregoing shall not [***].

(b) The Sellers shall, and shall cause their respective Affiliates and Representatives to, immediately cease and cause to be terminated, all discussions or negotiations with any Persons conducted heretofore with respect to a Competing Transaction and terminate any access of any such Person to the electronic data room maintained by the Sellers and issue instructions to such Persons (in accordance, if applicable, with the terms and conditions of any confidentiality agreement between the Sellers or any of their respective Affiliates, on the one hand, and such Person, on the other hand) to promptly return or destroy any of the Sellers’ or their respective Affiliates’ confidential information. Until the earlier of the Closing or and such time as this Agreement is terminated in accordance with Article 8 , the Sellers shall promptly notify Purchaser in writing of any Competing Transaction, any request for information with respect to any Competing Transaction, or any written inquiry, proposal or offer with respect to a Competing Transaction.

 

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6.21 Negotiation and Completion of Ancillary Agreements . Promptly following the date hereof, the Parties shall negotiate in good faith and use commercially reasonable efforts to:

(a) finalize the Transition Services Agreement and the Supply Agreements and the schedules and exhibits relating to each of the foregoing prior to the Closing; and

(b) agree on the form of a pharmacovigilance agreement, to be dated as of the Closing, setting forth the Parties’ responsibilities for, among other things, (i) handling of the global safety database for the Products, (ii) reporting and related processes and (iii) adverse event reporting obligations (the “ Pharmacovigilance Agreement ”).

6.22 Certain Agreements . The Parties hereby agree to the matters set forth on Exhibit M .

6.23 Aclidinium Canada Matters . The Parties hereby agree to the matters set forth on Exhibit N .

ARTICLE 7

CONDITIONS

7.1 Conditions to the Obligation of the Parties . The respective obligations of the Parties hereunder to consummate the transactions contemplated by this Agreement are subject to the fulfillment, at or before the Closing, of each of the following conditions (all or any of which may be waived, to the extent legally permissible, in writing in whole or in part by the Parties in their sole discretion).

(a) Government Consents . Any Consents from Governmental Entities necessary for the consummation of the transactions contemplated hereby shall have been obtained, or the waiting periods (and any extensions thereof) under any applicable Competition Laws shall have expired or been terminated.

(b) No Order . No Governmental Entity shall have enacted, issued, promulgated, enforced or entered any Law or Court Order (whether temporary, preliminary or permanent) which is then in effect and has the effect of making the transactions contemplated by this Agreement or by the Ancillary Agreements illegal or otherwise enjoining or prohibiting the consummation of such transactions.

(c) No Litigation . No action, suit or proceeding seeking to prohibit, enjoin or make illegal the consummation of the transactions contemplated by this Agreement shall have been initiated by a Governmental Entity.

(d) Aclidinium Novation and Consent Agreement . The Aclidinium Novation and Consent Agreement shall be in full force and effect.

7.2 Conditions to the Obligations of Purchaser . The obligations of Purchaser hereunder to consummate the transactions contemplated by this Agreement are subject to the fulfillment, at or before the Closing, of each of the following conditions (all or any of which may be waived in writing in whole or in part by Purchaser in its sole discretion).

 

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(a) Representations and Warranties . (i) Each of the representations and warranties of the Sellers in Article 4 , other than the Fundamental Representations in Article 4 , shall be true and correct (without giving effect to materiality, Material Adverse Effect or any similar qualification contained therein) as of the Closing as if made at such time (except to the extent that any such representation and warranty expressly speaks as of an earlier date, in which case such representation and warranty shall be true and correct in all material respects as of such earlier date), unless the failure of any such representations and warranties to be true and correct would not have, individually or in the aggregate, a Material Adverse Effect, and (ii) each Fundamental Representation in Article 4 shall be true and correct (without giving effect to materiality, Material Adverse Effect or any similar qualification contained therein) in all material respects as of the Closing as if made at such time (except to the extent that any such representation and warranty expressly speaks as of an earlier date, in which case such representation and warranty shall be true and correct as of such earlier date).

(b) Covenants . The covenants and agreements contained in this Agreement to be complied with by the Sellers on or before the Closing shall have been complied with in all material respects.

(c) No Material Adverse Effect . Since the date of this Agreement, no Material Adverse Effect shall have occurred.

(d) Closing Deliveries . The Sellers shall have delivered to Purchaser each of the items listed in Section 3.3 .

7.3 Conditions to the Obligations of the Sellers . The obligations of the Sellers hereunder to consummate the transactions contemplated by this Agreement are subject to the fulfillment, at or before the Closing, of each of the following conditions (all or any of which may be waived in writing in whole or in part by the Sellers in their sole discretion):

(a) Representations and Warranties . (i) Each of the representations and warranties of Purchaser in Article 5 , other than the Fundamental Representations in Article 5 , shall be true and correct (without giving effect to materiality or any similar qualification contained therein) as of the Closing as if made at such time (except to the extent that any such representation and warranty expressly speaks as of an earlier date, in which case such representation and warranty shall be true and correct as of such earlier date), unless the failure of any such representations and warranties to be true and correct would not, individually or in the aggregate, prevent or materially delay the ability of Purchaser to consummate the transactions contemplated by this Agreement, and (ii) each Fundamental Representation in Article 5 shall be true and correct in all material respects (without giving effect to materiality or any similar qualification contained therein) as of the Closing as if made at such time (except to the extent that any such representation and warranty expressly speaks as of an earlier date, in which case such representation and warranty shall be true and correct as of such earlier date).

(b) Covenants . The covenants and agreements contained in this Agreement to be complied with by Purchaser on or before the Closing shall have been complied with in all material respects.

(c) Closing Deliveries . Purchaser shall have delivered to the Sellers each of the items listed in Section 3.4 .

 

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ARTICLE 8

TERMINATION

8.1 Termination .

(a) Notwithstanding anything to the contrary in this Agreement, this Agreement may be terminated and the transactions contemplated by this Agreement abandoned at any time prior to the Closing:

(i) by mutual written consent of Forest (on behalf of itself and the other Sellers), on the one hand, and Purchaser, on the other hand;

(ii) by Purchaser if a breach of any representation or warranty or failure to perform any covenant or agreement on the part of the Sellers set forth in this Agreement shall have occurred that would cause any of the conditions set forth in Section 7.2 not to be satisfied, and such breach is incapable of being cured within thirty (30) days following Purchaser’s delivery of notice to Forest (on behalf of itself and the other Sellers) of such breach or failure to perform, provided that Purchaser may terminate this Agreement pursuant to this clause (ii) only if, at the time of termination, Purchaser is not in material breach of any of its representations, warranties, covenants or agreements contained in this Agreement;

(iii) by Forest (on behalf of itself and the other Sellers) if a breach of any representation or warranty or failure to perform any covenant or agreement on the part of Purchaser set forth in this Agreement shall have occurred that would cause any of the conditions set forth in Section 7.3 not to be satisfied, and such breach is incapable of being cured within thirty (30) days following Forest’s delivery of notice to Purchaser of such breach or failure to perform, provided that Forest (on behalf of itself and the other Sellers) may terminate this Agreement pursuant to this clause (iii) only if, at the time of termination, Sellers are not in material breach of any of their representations, warranties, covenants or agreements contained in this Agreement;

(iv) by either Forest (on behalf of itself and the other Sellers) or Purchaser if any Governmental Entity shall have issued a Court Order or taken any other Action enjoining or otherwise prohibiting the transactions contemplated by this Agreement and such Court Order or other Action shall have become final and non-appealable; or

(v) by either Forest (on behalf of itself and the other Sellers) or Purchaser if the Closing does not occur on or prior to September 30, 2015 (the “ Termination Date ”); provided that Forest, on the one hand, and Purchaser, on the other hand, may terminate this Agreement pursuant to this clause (v) only if, at the time of termination, the Sellers or Purchaser (as the case may be) are or is (as the case may be) not in material breach of any of their (in the case of Sellers) or its (in the case of Purchaser) representations, warranties, covenants or agreements contained in this Agreement.

(b) In the event of termination by a Party pursuant to Section 8.1 , written notice thereof shall forthwith be given to Purchaser (in the case of termination by the Sellers) or Forest (on behalf of the Sellers) (in the case of termination by Purchaser) and the transactions contemplated by this Agreement shall be terminated, without further action by any Party.

 

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8.2 Effect of Termination . In the event of termination of this Agreement as provided in Section 8.1 , any obligation to complete the Closing or the other transactions contemplated by this Agreement shall terminate and this Agreement forthwith shall become void and there shall be no Liability on the part of any Party except that Sections 6.2(a) through (e) , 6.22 , 6.23 , 11.1 and 11.7 shall survive any termination of this Agreement. Nothing herein shall relieve any Party from Liability for any material breach of this Agreement occurring prior to such termination.

8.3 Withdrawal of Certain Filings . As soon as practicable following a termination of this Agreement for any reason, but in no event later than thirty (30) days after such termination, Purchaser or the Sellers shall, to the extent practicable, withdraw all filings, applications and other submissions relating to the transactions contemplated by this Agreement filed or submitted by or on behalf of Purchaser or the Sellers, as applicable, with any Governmental Entity or other Person.

ARTICLE 9

INDEMNIFICATION AND SURVIVAL

9.1 Survival .

(a) The representations and warranties made by the Sellers in this Agreement (other than the Fundamental Representations) shall survive the Closing until the date that is [***] after the Closing Date (the “ General Survival Period ”). The Fundamental Representations and the representations and warranties in Section 4.11 shall survive the Closing indefinitely or, if applicable, until the date that is sixty (60) days after the expiration of the applicable statute of limitations. The covenants and agreements to be performed by or on behalf of a Party prior to the Closing shall survive the Closing until the expiration of the General Survival Period. The covenants and agreements that by their terms are to be performed by or on behalf of a Party after the Closing shall survive until the date that such covenants and agreements are fully performed.

(b) The termination of the representations, warranties, covenants and agreements provided herein shall not affect the rights of a Party in respect of any Claim made by such Party in a writing and received by Purchaser (in the case of a Claim made by the Sellers) or the Sellers (in the case of a Claim made by Purchaser) prior to the expiration of the applicable survival period.

9.2 Indemnification .

(a) Subject in all cases to the limits on indemnification in this Article 9 , following the Closing, the Sellers, jointly and severally, shall indemnify and hold harmless Purchaser, its Affiliates and each of their respective officers, directors, employees and agents (collectively, “ Purchaser Indemnified Parties ”) from and against, and compensate and reimburse the Purchaser Indemnified Parties for, any and all Damages incurred by any such Purchaser Indemnified Party that arise out of or result from (i) the breach of any representation or warranty of the Sellers contained in this Agreement or in any certificate delivered by any Seller pursuant to this Agreement (without giving effect to any “Material Adverse Effect” or other materiality threshold or qualifier contained therein for purposes of determining the amount of any Damages with respect thereto, but not for purposes of determining whether any such breach has occurred), (ii) the breach of any covenant or agreement of the Sellers contained in this Agreement or (iii) the Excluded Liabilities.

 

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(b) Subject in all cases to the limits on indemnification in this Article 9 , following the Closing, Purchaser shall indemnify and hold harmless each of the Sellers, its Affiliates and each of their respective officers, directors, employees and agents (collectively, “ Seller Indemnified Parties ” and, together with Purchaser Indemnified Parties, “ Indemnified Parties ”) from and against, and compensate and reimburse the Seller Indemnified Parties for, any and all Damages incurred by any such Seller Indemnified Party that arise out of or result from (i) the breach of any representation or warranty of Purchaser contained in this Agreement or in any certificate delivered by Purchaser pursuant to this Agreement (without giving effect to any materiality threshold or qualifier contained therein for purposes of determining the amount of any Damages with respect thereto, but not for purposes of determining whether any such breach has occurred), (ii) the breach of any covenant or agreement of Purchaser contained in this Agreement or (iii) the Assumed Liabilities.

9.3 Limitations on Indemnification .

(a) Notwithstanding anything to the contrary in this Agreement, the Sellers shall not be liable to the Purchaser Indemnified Parties in respect of any Damages incurred or suffered by such Purchaser Indemnified Party (i) in respect of claims under Section 9.2(a)(i) that is not a Qualifying Loss and (ii) until such time as the aggregate amount of all Damages claimed by the Purchaser Indemnified Parties under Section 9.2(a)(i) (other than with respect to Fundamental Representations, as to which this limitation shall not apply) exceeds an aggregate amount equal to [***], and then only for such Qualifying Losses in excess of [***]. The aggregate liability of Sellers in respect of claims for indemnification pursuant to Section 9.2(a)(i) (x) shall not exceed [***] (the “ Indemnification Cap ”) in respect of all representations and warranties other than Fundamental Representations and (y) shall not exceed the aggregate amount of the Purchase Price in respect of the Fundamental Representations.

(b) Notwithstanding anything to the contrary in this Agreement, Purchaser shall not be liable to the Seller Indemnified Parties in respect of any Damages incurred or suffered by such Seller Indemnified Party (i) in respect of claims under Section 9.2(b)(i) that is not a Qualifying Loss and (ii) until such time as the aggregate amount of Damages claimed by the Seller Indemnified Parties under Section 9.2(b)(i) (other than with respect to Fundamental Representations, as to which this limitation shall not apply) exceeds an aggregate amount equal to [***], and then only for such Qualifying Losses in excess of [***]. The aggregate liability of Purchaser in respect of claims for indemnification pursuant to Section 9.2(b)(i) (x) shall not exceed the Indemnification Cap in respect of all representations and warranties other than Fundamental Representations and (y) shall not exceed the aggregate amount of the Purchaser Price in respect of the Fundamental Representations.

(c) With respect to each indemnification obligation in this Agreement: (i) each such obligation shall be calculated net of any net Tax benefit actually realized in the year of loss or the [***] succeeding taxable years; (ii) all Damages shall be net of any insurance proceeds actually received by the Indemnified Party from a bona fide Third Party insurer, net of costs reasonably incurred by the Indemnified Party in seeking such collection and any increase in

 

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premiums as a result of the associated claim (“ Eligible Insurance Proceeds ”), to the extent that the Damages paid by the Indemnifying Party under this Article 9 in respect of the indemnification claim fully compensate the Indemnified Party for all Damages suffered in connection with such claim; (iii) in no event shall an Indemnifying Party have liability to the Indemnified Party for any consequential, special, incidental, indirect or punitive damages, except if and to the extent any such damages are payable by an Indemnified Party pursuant to a Third Party Claim; and (iv) all payments made by an Indemnifying Party to an Indemnified Party in respect of any claim pursuant to Section 9.2 shall be treated as adjustments to the Purchase Price for Tax purposes.

(d) In any case where an Indemnified Party recovers from a Third Party any Eligible Insurance Proceeds and/or any other amount in respect of any Damages for which an Indemnifying Party has actually paid or reimbursed such Indemnified Party pursuant to this Article 9 , such Indemnified Party shall promptly pay over to the Indemnifying Party such Eligible Insurance Proceeds and/or the amount so recovered (after deducting therefrom the amount of expenses incurred by it in procuring such recovery), but not in excess of the sum of (i) any amount previously paid by the Indemnifying Party to or on behalf of the Indemnified Party in respect of such claim and (ii) any amount expended by the Indemnifying Party in pursuing or defending any claim arising out of such matter.

9.4 Sole and Exclusive Remedy . Following the Closing, recovery pursuant to Section 9.2 and Exhibit N shall be the sole and exclusive remedy of the Indemnified Parties for any and all Damages related to this Agreement or the transactions contemplated hereby; provided , that nothing herein shall limit in any way any such party’s remedies in respect of actual fraud in connection with this Agreement or the transactions contemplated hereby. This Section 9.4 shall not affect any Party’s ability to exercise any rights or remedies available to such Party under any Ancillary Agreement with respect to claims arising under such Ancillary Agreement.

9.5 Procedure for Claims . If a claim for indemnification pursuant to Section 9.2 (a “ Claim ”) is to be made by an Indemnified Party entitled to indemnification hereunder, the Indemnified Party claiming indemnification shall give written notice to the other Party (the “ Indemnifying Party ”) reasonably promptly after the Indemnified Party becomes aware of any fact, condition or event that may give rise to Damages for which indemnification may be sought under Section 9.2 , or receipt by the Indemnified Party of notice of a claim involving the assertion of a claim by a Third Party that may give rise to Damages for which indemnification may be sought under Section 9.2 (whether pursuant to a lawsuit, other legal action or otherwise, a “ Third Party Claim ”). The failure of any Indemnified Party to give timely notice hereunder shall not affect its rights to indemnification hereunder, except and only to the extent that the Indemnifying Party suffers damage caused by such failure. The Indemnifying Party shall have thirty (30) days (or such lesser number of days set forth in the notice as may be required by court proceeding in the event of a litigated matter) after receipt of the notice to notify the Indemnified Party that it desires to defend the Indemnified Party against such Third Party Claim; provided , that the Indemnifying Party shall not be entitled to defend any Third Party Claim that seeks remedies other than money damages without the written agreement of the Indemnified Party. In the case of a Third Party Claim, the party conducting the defense (the “ Defending Party ”) shall determine and conduct the defense, compromise or settlement of such Third Party Claim and (i) the other

 

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party (the “ Non-Defending Party ”) shall make available to the Defending Party any documents and materials in its or its Affiliates’ possession or control that may be necessary to the defense of such Third Party Claim ( provided , that the Non-Defending Party shall not be required to furnish any such documents or materials which would (in the reasonable judgment of such party upon advice of counsel) be reasonably likely to (A) constitute a waiver of the attorney-client or other privilege held by such party or any of its Affiliates, (B) violate any applicable Laws, or (C) breach any agreement of such party or any of its Affiliates with any Third Party; provided , that such Non-Defending Party shall use reasonable best efforts to obtain any required consents and take such other reasonable action (such as the entry into a joint defense agreement or other arrangement to avoid loss of attorney-client privilege) to permit such disclosure) and (ii) the Defending Party shall keep the Non-Defending Party reasonably informed of all material developments and events relating to such Third Party Claim. The Non-Defending Party, at its sole option and expense, may participate in any defense and investigation of such Third Party Claim or settlement negotiations with respect to such Third Party Claim; provided that if the Indemnifying Party assumes control of such defense and the Indemnified Party reasonably concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting interests with respect to such Third Party Claim, the reasonable fees and expenses of counsel to the Indemnified Party solely in connection therewith shall be considered “Damages” for purposes of this Agreement; provided , further , that in no event shall the Indemnifying Party be responsible for the fees and expenses of more than one (1) counsel for all Indemnified Parties. Except with the written consent of the Non-Defending Party (not to be unreasonably withheld, conditioned or delayed), the Defending Party shall not, in the defense of a Third Party Claim, consent to the entry of any judgment or enter into any compromise or settlement (1) which does not include as an unconditional term thereof the giving to the Indemnified Party by the Third Party of a release from all liability with respect to such suit, claim, action, or proceeding; (2) unless there is no finding or admission of (A) any violation of Law by the Indemnified Party (or any Affiliate thereof), (B) any Liability on the part of the Indemnified Party (or any Affiliate thereof) not indemnified hereunder or (C) any violation of the rights of any Person and no effect on any other claims of a similar nature that may be made by the same Third Party against the Indemnified Party (or any Affiliate thereof); or (iii) which exceeds the Indemnification Cap. With respect to Claims other than Third Party Claims, after the giving of any notice of a Claim pursuant to this Section 9.5 , the amount of indemnification to which an Indemnified Party shall be entitled under this Article 9 shall be determined: (I) by the written agreement between the Indemnified Party and the Indemnifying Party; (II) in accordance with Section 11.7 ; or (III) by any other means to which the Indemnified Party and the Indemnifying Party shall agree.

9.6 Setoff Rights . Purchaser shall have the right to setoff of any amounts due and payable, or any Liabilities arising, under this Agreement or any Ancillary Agreement against any Net Sales Royalties due and payable under this Agreement.

 

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ARTICLE 10

PARENT GUARANTEE

10.1 Representations and Warranties of Seller Parent . Seller Parent represents and warrants to Purchaser as of the date hereof as follows:

(a) Organization and Qualification of Seller Parent . Seller Parent is a public limited company duly organized, validly existing and in good standing under the Laws of Ireland.

(b) Authority of Seller Parent . Seller Parent has the requisite company power and authority to execute and deliver this Agreement and to perform its obligations hereunder and to consummate the transactions contemplated hereby. The execution and delivery by Seller Parent of this Agreement, the performance by Seller Parent of its obligations hereunder and the consummation by Seller Parent of the transactions contemplated hereby have been duly authorized by all necessary action on the part of Seller Parent. This Agreement has been duly executed and delivered by Seller Parent, and this Agreement constitutes a valid and binding obligation of Seller Parent enforceable against Seller Parent in accordance with its terms, in each case subject to (i) the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar Laws relating to or affecting the enforcement of creditors’ rights generally and (ii) general equitable principles (whether considered in a proceeding in equity or at Law).

(c) No Conflicts; Consents . The execution and delivery of this Agreement by Seller Parent and the performance by Seller Parent of its obligations hereunder and the consummation by Seller Parent of the transactions contemplated hereby, will not: (i) contravene or conflict with any provision of the Organizational Documents of Seller Parent, (ii) contravene, conflict with, constitute a breach, violate the terms, conditions or provisions of, or result in a default under, or give to others any rights of termination, amendment, acceleration or cancellation of any contract or agreement to which Seller Parent is a party or is otherwise bound, or (iii) violate in any respect any provision of any Law to which Seller Parent is subject.

10.2 Seller Parent Guarantee .

(a) Seller Parent hereby irrevocably, absolutely and unconditionally guarantees (x) the full and punctual payment of any amount or amounts due and payable by the Sellers under this Agreement, including those contained in Article 9 , and under each Ancillary Agreement to which any Seller or any of their respective Affiliates is a party, and (y) the timely satisfaction and performance of all of the Sellers’ and their respective Affiliates’ covenants, agreements and obligations contained in this Agreement and each Ancillary Agreement to which any Seller or any of their Affiliates is a party, in each case, subject to the conditions hereunder and thereunder ((x) and (y), collectively, the “ Obligations ”). Upon any failure by any Seller or any of their respective Affiliates to pay punctually any such amount referred to in the foregoing clause (x), Seller Parent shall forthwith on written demand of Purchaser pay the amount not so paid; provided , however that any and all defenses or counterclaims available to the Sellers or their applicable Affiliates shall also be available to Seller Parent.

(b) Purchaser and any of its Affiliates that are party to any Ancillary Agreement shall not be obligated to file any claim relating to the Obligations in the event that the Sellers become subject to any insolvency, bankruptcy, reorganization or other similar proceeding affecting a Seller or any Affiliate of any Seller, and the failure of Purchaser or any of its Affiliates to so file shall not affect Seller Parent’s obligations hereunder. In the event that any payment to Purchaser or its Affiliates in respect of the Obligations is rescinded or must otherwise be returned for any reason whatsoever, Seller Parent shall remain liable hereunder with respect to the Obligations as if such payment had not been made. This is an unconditional guarantee of payment and not of collectibility.

 

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(c) To the fullest extent permitted by Law, Seller Parent hereby expressly waives any and all rights or defenses arising by reason of any Law which would otherwise require any election of remedies by a Purchaser or its Affiliates. Seller Parent waives promptness, diligence, notice of the acceptance of the guarantee provided in this Section 10.2 and of the Obligations, presentment, demand for payment, notice of non-performance, default, dishonor and protest, notice of the incurrence of any Obligations and all other notices of any kind, all defenses which may be available by virtue of any valuation, stay, moratorium law or other similar Law now or hereafter in effect, any right to require the marshalling of assets of the Sellers or any other Person interested in the transactions contemplated by this Agreement and the Ancillary Agreements, and all suretyship defenses generally.

ARTICLE 11

MISCELLANEOUS

11.1 Public Announcements . No Party shall issue or make any public announcement, press release or other public disclosure regarding this Agreement or the transactions contemplated hereby without the prior approval of Forest (in the case of Purchaser) or Purchaser (in the case of any Seller), which approval shall not be unreasonably withheld, conditioned or delayed, except for any such disclosure that is, in the opinion of the disclosing Party’s counsel, required by applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed. If a Party is, in the opinion of its counsel, required by applicable Law or the rules of a stock exchange on which its securities are listed to make a public disclosure, such Party shall submit the proposed disclosure in writing as far in advance of the disclosure as practicable, to Forest (with respect to Purchaser) and Purchaser (with respect to any Seller) and provide Forest or Purchaser, as the case may be, a reasonable opportunity to comment thereon. The disclosing Party shall consider in good faith any comments provided by the reviewing Party or Parties. The contents of any public announcement, press release or other public disclosure that has been reviewed and approved or that is consistent with the foregoing may then be re-released by any Party. Notwithstanding the foregoing, without a requirement for advance notice or re-approval, Purchaser, on the one hand, and the Seller, on the other hand, may, following the date hereof, make internal announcements to their respective employees and Affiliates or public announcements, in each case, that are consistent with a communications plan agreed upon by the Parties. From and after the Closing, the foregoing restrictions in this Section 11.1 shall not apply to Purchaser.

11.2 Expenses . Whether or not the transactions contemplated hereby are consummated and, except as otherwise specified herein or in any Ancillary Agreement, each Party shall bear its own expenses with respect to the transactions contemplated by this Agreement.

11.3 Notices . Unless otherwise specified herein, all notices required or permitted to be given under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be delivered personally, sent by a nationally recognized overnight courier service, or transmitted by facsimile, and shall be deemed to be effective upon receipt. Any such notices

 

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shall be addressed to the receiving Party at such Party’s address, or fax number set forth below, or at such other address, or fax number as may from time to time be furnished by similar notice by the Sellers, on the one hand, or Purchaser, on the other hand:

If to the Sellers or Seller Parent:

 

Actavis plc
Morris Corporate Center III
400 Interpace Parkway
Parsippany, NJ 07054
Attention: Chief Legal Officer
Facsimile: [***]

With a copy (which shall not constitute notice) to:

 

Debevoise & Plimpton LLP
919 Third Avenue
New York, NY 10022
Attn: Andrew L. Bab
Fax: (212) 521-7323

If to Purchaser:

 

AstraZeneca UK Ltd.
2 Kingdom Street
London
W2 6BD
United Kingdom
Attn: Company Secretary
Fax: [***]

With a copy (which shall not constitute notice) to:

 

Covington & Burling LLP
One CityCenter, 850 Tenth Street N.W.
Washington, DC 20001

Attn: Catherine J. Dargan

          Michael J. Riella

Fax: (202) 662-6291

11.4 Entire Agreement; Modification . This Agreement (including all Schedules, Exhibits and attachments hereto), the Execution Date Agreements, the Ancillary Agreements, the Confidentiality Agreement (which shall terminate at the Closing) and the other agreements, certificates and documents delivered in connection herewith or therewith or otherwise in connection with the transactions contemplated hereby and thereby, contain the entire agreement between the Parties with respect to the subject matter hereof and thereof and supersede all

 

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previous agreements, negotiations, commitments and writings between the Parties with respect to the subject matter hereof and thereof. In the event of any inconsistency between this Agreement and any Schedules hereto or any certificate delivered in connection herewith, the terms of this Agreement shall govern. This Agreement may not be modified, amended, altered or supplemented except upon the execution and delivery of a written agreement executed by all Parties.

11.5 Severability . If any provision of this Agreement or any other document delivered under this Agreement is prohibited or unenforceable in any jurisdiction, it shall be ineffective in such jurisdiction only to the extent of such prohibition or unenforceability, and such prohibition or unenforceability shall not invalidate the balance of such provision to the extent it is not prohibited or unenforceable nor the remaining provisions hereof, nor render unenforceable such provision in any other jurisdiction, unless the effect of rendering such provision ineffective would be to substantially deviate from the expectations and intent of the Parties in entering into this Agreement. In the event any provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the Parties shall use reasonable best efforts to substitute a valid, legal and enforceable provision which, insofar as practical, implements the purposes hereof.

11.6 No Waiver; Cumulative Remedies . Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no failure or delay on the part of the Sellers, on the one hand, and Purchaser, on the other hand, in exercising any right, power or remedy hereunder shall operate as a waiver thereof; nor shall any single or partial exercise of any such right, power or remedy preclude any other or further exercise thereof or the exercise of any other right, power or remedy hereunder. No waiver of any provision hereof shall be effective unless the same shall be in writing and signed by the Party giving such waiver. The remedies herein provided are cumulative and not exclusive of any remedies provided by applicable Law except as expressly set forth herein.

11.7 Governing Law; Submission to Jurisdiction; Waiver of Jury Trial . This Agreement (other than Exhibit N ), and any dispute arising out of, relating to or in connection with this Agreement (other than Exhibit N ) shall be governed by and construed in accordance with the Laws of the State of Delaware, without giving effect to any choice or conflict of Law provision or rule (whether of the State of Delaware or any other jurisdiction) that would cause the application of the substantive Laws of any jurisdiction other than the State of Delaware. Subject to Exhibit N , each Party hereto (i) consents to submit itself to the exclusive jurisdiction of the Court of Chancery of the State of Delaware or, solely if such court lacks subject matter jurisdiction, the United States District Court sitting in New Castle County in the State of Delaware (the “ Chosen Courts ”), with respect to any dispute arising out of, relating to or in connection with this Agreement or any transaction contemplated hereby, (ii) agrees that it will not attempt to deny or defeat such personal jurisdiction by motion or other request for leave from any such court, and (iii) agrees that it will not bring any action arising out of, relating to or in connection with this Agreement, the Ancillary Agreements or any transaction contemplated by this Agreement, in any court other than any such court (other than appeals from the Chosen Courts). The Parties irrevocably and unconditionally waive any objection to the laying of venue of any Action arising out of this Agreement or the transactions contemplated hereby in the Chosen Courts, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such Action brought in any such court has been brought in an

 

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inconvenient forum. Each Party hereby agrees that service of any process, summons, notice or document by U.S. registered mail to the respective addresses set forth in Section 11.3 shall be effective service of process for any proceeding arising out of, relating to or in connection with this Agreement or the transactions contemplated hereby. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE ANCILLARY AGREEMENTS OR THE TRANSACTIONS CONTEMPLATED HEREBY.

11.8 Counterparts . This Agreement and any amendment or supplement hereto may be executed in any number of counterparts, each of which shall be deemed an original, and all of which taken together shall constitute one and the same instrument. This Agreement shall become binding when any number of counterparts, individually or taken together, shall bear the signatures of all Parties. This Agreement may be executed and delivered by facsimile or any other electronic means, including “.pdf” or “.tiff” files, and any facsimile or electronic signature shall constitute an original for all purposes.

11.9 Assignments . None of the Parties shall be permitted to assign this Agreement or any of its rights or obligations under this Agreement without Forest’s (in the case of Purchaser) or Purchaser’s (in the case of the Sellers) express, prior written consent, except that each Party may assign this Agreement or any of its rights hereunder, in whole or in part, to an Affiliate without the other Parties’ consent; provided , that no such assignment shall relieve such Party of any of its obligations under this Agreement and no such assignment shall result in an increase in Transfer Taxes or withholding (or similar Taxes) on payments to the Sellers hereunder. Any such purported assignment or sublicense in violation of this Agreement shall be null and void ab initio.

11.10 Reservation of Rights; No Implied Licenses . All rights in or to Intellectual Property not expressly assigned, licensed, covenanted or otherwise conveyed to Purchaser under this Agreement are reserved by the Sellers and their respective Affiliates. Nothing contained in this Agreement shall be construed as conferring any rights by implication, estoppel or otherwise, under any Intellectual Property, other than the rights expressly granted under this Agreement.

11.11 No Third Party Beneficiaries . Except as otherwise expressly provided in Sections 6.8 , 9.2(a) or Section 9.2(b) , this Agreement is for the sole benefit of the Parties and their permitted assigns and nothing herein, express or implied, shall give or be construed to give to any Person, other than the Parties and such permitted assigns, any legal or equitable rights hereunder.

11.12 Further Assurances . Subject to the terms and conditions of this Agreement, at any time or from time to time after the execution of this Agreement, each of the Parties, at its own expense, shall execute and deliver such instruments of transfer, provide such materials and information and take such other actions as may reasonably be necessary, proper or advisable, to the extent permitted by Law, to fulfill its obligations under this Agreement.

11.13 Equitable Relief . The Parties agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached, and that the Parties shall be entitled to an injunction

 

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or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement. Each Party hereby waives (a) any requirement that the other Parties post a bond or other security as a condition for obtaining any such relief, and (b) any defenses in any action for specific performance, including the defense that a remedy at law would be adequate.

(Signature Page Follows)

 

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IN WITNESS WHEREOF , this Agreement has been executed and delivered by the authorized officers of Purchaser and the Sellers as of the date first above written.

 

FOREST LABORATORIES, LLC
By: /s/ Sigurd Kirk
Name: Sigurd Kirk
Title: Senior Vice President, Corporate Business Development
FOREST LABORATORIES HOLDINGS LIMITED
By: /s/ Robert Bailey
Name: Robert Bailey
Title: Authorized Signatory
FOREST LABORATORIES CANADA INC.
By: /s/ Robert Bailey
Name: Robert Bailey
Title: Secretary
ASTRAZENECA UK LIMITED
By: /s/ Adrian Kemp

Name: Adrian Kemp

Title: Company Secretary

ACTAVIS PLC
By: /s/ Sigurd Kirk
Name: Sigurd Kirk
Title: Senior Vice President, Corporate Business Development

[ Signature Page to Asset Purchase Agreement ]

 

Exhibit 31.1

Certification of Chief Executive Officer

Pursuant to Rule 13a-14(a) Under the Securities Exchange Act of 1934

I, Brenton L. Saunders, President and Chief Executive Officer, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Actavis plc and Warner Chilcott Limited;

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 and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer 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 function):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 11, 2015

 

By:

/s/    BRENTON L. SAUNDERS

Brenton L. Saunders
President and Chief Executive Officer
(Principal Executive Officer)

Exhibit 31.2

Certification of Chief Financial Officer

Pursuant to Rule 13a-14(a) Under the Securities Exchange Act of 1934

I, Maria Teresa Hilado, Chief Financial Officer, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Actavis plc and Warner Chilcott Limited;

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 and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer 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 function):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 11, 2015
By:

/s/    MARIA TERESA HILADO

Maria Teresa Hilado
Chief Financial Officer
(Principal Financial Officer)

Exhibit 32.1

Certification of Chief Executive Officer

Pursuant to 18 U.S.C. of Section 1350, as Adopted by

Section 906 of the Sarbanes-Oxley Act of 2002

The undersigned officer of Actavis plc and Warner Chilcott Limited (the “Companies”), hereby certifies, to such officer’s knowledge, that:

(i) the Quarterly Report on Form 10-Q of the Companies for the quarter ended March 31, 2015 (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 Companies.

 

Date: May 11, 2015
By:

/s/    BRENTON L. SAUNDERS

Brenton L. Saunders
President and Chief Executive Officer
(Principal Executive Officer)

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Exhibit 32.2

Certification of Chief Financial Officer

Pursuant to 18 U.S.C. of Section 1350, as Adopted by

Section 906 of the Sarbanes-Oxley Act of 2002

The undersigned officer of Actavis plc and Warner Chilcott Limited (the “Companies”), hereby certifies, to such officer’s knowledge, that:

(i) the Quarterly Report on Form 10-Q of the Companies for the quarter ended March 31, 2015 (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 Companies.

 

Date: May 11, 2015
By:

/s/    MARIA TERESA HILADO

Maria Teresa Hilado
Chief Financial Officer
(Principal Financial Officer)

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.