Ireland
|
68-0683755
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification Number)
|
|
|
First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland
|
Not applicable
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Title of each class
|
Name of each exchange on which registered
|
Ordinary shares, nominal value $0.0001 per share
|
The NASDAQ Global Market, The Toronto Stock Exchange
|
Large accelerated filer
|
x
|
Accelerated filer
|
o
|
|
|
|
|
Non-accelerated filer
|
o
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
o
|
Ordinary shares, $0.0001 par value
|
Number of ordinary shares outstanding as of
|
August 2, 2016
|
:
|
222,766,688
|
|
|
|
Page
|
Forward-Looking Statements
|
||
|
|
|
PART I. FINANCIAL INFORMATION
|
|
|
Item 1.
|
Financial Statements
|
|
|
Condensed Consolidated Balance Sheets as of June 30, 2016 (Unaudited) and December 31, 2015
|
|
|
Condensed Consolidated Statements of Operations (Unaudited) Three and Six Months Ended June 30, 2016 and 2015
|
|
|
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) Three and Six Months Ended June 30, 2016 and 2015
|
|
|
Condensed Consolidated Statements of Cash Flows (Unaudited) Six Months Ended June 30, 2016 and 2015
|
|
|
Notes to Condensed Consolidated Financial Statements (Unaudited)
|
|
Item 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
|
Item 4.
|
Controls and Procedures
|
|
|
|
|
PART II. OTHER INFORMATION
|
|
|
Item 1.
|
Legal Proceedings
|
|
Item 1A.
|
Risk Factors
|
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
|
Item 3.
|
Defaults Upon Senior Securities
|
|
Item 4.
|
Mine Safety Disclosures
|
|
Item 5.
|
Other Information
|
|
Item 6.
|
Exhibits
|
|
|
|
|
Signatures
|
||
Exhibit Index
|
|
June 30,
2016 |
|
December 31,
2015 |
||||
ASSETS
|
|
|
|
||||
CURRENT ASSETS:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
667,822
|
|
|
$
|
272,348
|
|
Restricted cash and cash equivalents
|
388,560
|
|
|
585,379
|
|
||
Marketable securities
|
33
|
|
|
34
|
|
||
Accounts receivable
|
875,058
|
|
|
1,014,808
|
|
||
Inventories, net
|
626,320
|
|
|
752,493
|
|
||
Prepaid expenses and other current assets
|
45,992
|
|
|
55,052
|
|
||
Income taxes receivable
|
46,631
|
|
|
735,901
|
|
||
Assets held for sale (NOTE 3)
|
—
|
|
|
36,522
|
|
||
Total current assets
|
$
|
2,650,416
|
|
|
$
|
3,452,537
|
|
MARKETABLE SECURITIES
|
2,206
|
|
|
3,855
|
|
||
PROPERTY, PLANT AND EQUIPMENT, NET
|
673,294
|
|
|
675,624
|
|
||
GOODWILL
|
7,417,237
|
|
|
7,299,354
|
|
||
OTHER INTANGIBLES, NET
|
7,096,659
|
|
|
7,828,942
|
|
||
DEFERRED INCOME TAXES
|
9,532
|
|
|
10,423
|
|
||
OTHER ASSETS
|
86,191
|
|
|
79,601
|
|
||
TOTAL ASSETS
|
$
|
17,935,535
|
|
|
$
|
19,350,336
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
||||
CURRENT LIABILITIES:
|
|
|
|
||||
Accounts payable
|
$
|
318,459
|
|
|
$
|
347,503
|
|
Accrued expenses
|
1,040,519
|
|
|
1,162,612
|
|
||
Current portion of legal settlement accrual
|
1,455,259
|
|
|
1,606,726
|
|
||
Current portion of long-term debt
|
117,454
|
|
|
328,705
|
|
||
Income taxes payable
|
7,149
|
|
|
8,551
|
|
||
Liabilities held for sale (NOTE 3)
|
—
|
|
|
20,215
|
|
||
Total current liabilities
|
$
|
2,938,840
|
|
|
$
|
3,474,312
|
|
DEFERRED INCOME TAXES
|
142,089
|
|
|
871,040
|
|
||
LONG-TERM DEBT, LESS CURRENT PORTION, NET
|
8,199,888
|
|
|
8,251,657
|
|
||
LONG-TERM LEGAL SETTLEMENT ACCRUAL, LESS CURRENT PORTION, NET
|
155,474
|
|
|
549,098
|
|
||
OTHER LIABILITIES
|
237,706
|
|
|
236,253
|
|
||
COMMITMENTS AND CONTINGENCIES (NOTE 12)
|
|
|
|
|
|
||
SHAREHOLDERS’ EQUITY:
|
|
|
|
||||
Euro deferred shares, $0.01 par value; 4,000,000 shares authorized and issued
|
44
|
|
|
43
|
|
||
Ordinary shares, $0.0001 par value; 1,000,000,000 shares authorized; 222,765,414 and 222,124,282 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively
|
22
|
|
|
22
|
|
||
Additional paid-in capital
|
8,719,074
|
|
|
8,693,385
|
|
||
Accumulated deficit
|
(2,131,506
|
)
|
|
(2,341,215
|
)
|
||
Accumulated other comprehensive loss
|
(326,096
|
)
|
|
(384,205
|
)
|
||
Total Endo International plc shareholders’ equity
|
$
|
6,261,538
|
|
|
$
|
5,968,030
|
|
Noncontrolling interests
|
—
|
|
|
(54
|
)
|
||
Total shareholders’ equity
|
$
|
6,261,538
|
|
|
$
|
5,967,976
|
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
|
$
|
17,935,535
|
|
|
$
|
19,350,336
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
TOTAL REVENUES
|
$
|
920,887
|
|
|
$
|
735,166
|
|
|
$
|
1,884,426
|
|
|
$
|
1,449,294
|
|
COSTS AND EXPENSES:
|
|
|
|
|
|
|
|
||||||||
Cost of revenues
|
632,218
|
|
|
438,858
|
|
|
1,320,923
|
|
|
823,124
|
|
||||
Selling, general and administrative
|
193,070
|
|
|
154,491
|
|
|
371,425
|
|
|
366,069
|
|
||||
Research and development
|
50,589
|
|
|
18,984
|
|
|
92,281
|
|
|
36,881
|
|
||||
Litigation-related and other contingencies, net
|
5,259
|
|
|
6,875
|
|
|
10,459
|
|
|
19,875
|
|
||||
Asset impairment charges
|
39,951
|
|
|
70,243
|
|
|
169,576
|
|
|
77,243
|
|
||||
Acquisition-related and integration items
|
48,171
|
|
|
44,225
|
|
|
60,725
|
|
|
78,865
|
|
||||
OPERATING (LOSS) INCOME FROM CONTINUING OPERATIONS
|
$
|
(48,371
|
)
|
|
$
|
1,490
|
|
|
$
|
(140,963
|
)
|
|
$
|
47,237
|
|
INTEREST EXPENSE, NET
|
111,919
|
|
|
80,611
|
|
|
228,712
|
|
|
153,750
|
|
||||
LOSS ON EXTINGUISHMENT OF DEBT
|
—
|
|
|
—
|
|
|
—
|
|
|
980
|
|
||||
OTHER EXPENSE, NET
|
5,175
|
|
|
24,493
|
|
|
3,268
|
|
|
12,498
|
|
||||
LOSS FROM CONTINUING OPERATIONS BEFORE INCOME TAX
|
$
|
(165,465
|
)
|
|
$
|
(103,614
|
)
|
|
$
|
(372,943
|
)
|
|
$
|
(119,991
|
)
|
INCOME TAX BENEFIT
|
(555,277
|
)
|
|
(12,720
|
)
|
|
(673,992
|
)
|
|
(179,589
|
)
|
||||
INCOME (LOSS) FROM CONTINUING OPERATIONS
|
$
|
389,812
|
|
|
$
|
(90,894
|
)
|
|
$
|
301,049
|
|
|
$
|
59,598
|
|
DISCONTINUED OPERATIONS, NET OF TAX (NOTE 3)
|
(46,216
|
)
|
|
(159,632
|
)
|
|
(91,324
|
)
|
|
(385,842
|
)
|
||||
CONSOLIDATED NET INCOME (LOSS)
|
$
|
343,596
|
|
|
$
|
(250,526
|
)
|
|
$
|
209,725
|
|
|
$
|
(326,244
|
)
|
Less: Net income (loss) attributable to noncontrolling interests
|
18
|
|
|
(107
|
)
|
|
16
|
|
|
(107
|
)
|
||||
NET INCOME (LOSS) ATTRIBUTABLE TO ENDO INTERNATIONAL PLC
|
$
|
343,578
|
|
|
$
|
(250,419
|
)
|
|
$
|
209,709
|
|
|
$
|
(326,137
|
)
|
NET INCOME (LOSS) PER SHARE ATTRIBUTABLE TO ENDO INTERNATIONAL PLC ORDINARY SHAREHOLDERS—BASIC:
|
|
|
|
|
|
|
|
||||||||
Continuing operations
|
$
|
1.75
|
|
|
$
|
(0.49
|
)
|
|
$
|
1.35
|
|
|
$
|
0.34
|
|
Discontinued operations
|
(0.21
|
)
|
|
(0.86
|
)
|
|
(0.41
|
)
|
|
(2.18
|
)
|
||||
Basic
|
$
|
1.54
|
|
|
$
|
(1.35
|
)
|
|
$
|
0.94
|
|
|
$
|
(1.84
|
)
|
NET INCOME (LOSS) PER SHARE ATTRIBUTABLE TO ENDO INTERNATIONAL PLC ORDINARY SHAREHOLDERS—DILUTED:
|
|
|
|
|
|
|
|
||||||||
Continuing operations
|
$
|
1.75
|
|
|
$
|
(0.49
|
)
|
|
$
|
1.35
|
|
|
$
|
0.33
|
|
Discontinued operations
|
(0.21
|
)
|
|
(0.86
|
)
|
|
(0.41
|
)
|
|
(2.11
|
)
|
||||
Diluted
|
$
|
1.54
|
|
|
$
|
(1.35
|
)
|
|
$
|
0.94
|
|
|
$
|
(1.78
|
)
|
WEIGHTED AVERAGE SHARES:
|
|
|
|
|
|
|
|
||||||||
Basic
|
222,667
|
|
|
185,328
|
|
|
222,485
|
|
|
177,490
|
|
||||
Diluted
|
222,863
|
|
|
185,328
|
|
|
223,021
|
|
|
182,822
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||||||||||||||||||
CONSOLIDATED NET INCOME (LOSS)
|
|
|
$
|
343,596
|
|
|
|
|
$
|
(250,526
|
)
|
|
|
|
$
|
209,725
|
|
|
|
|
$
|
(326,244
|
)
|
||||||||
OTHER COMPREHENSIVE (LOSS) INCOME, NET OF TAX:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Net unrealized (loss) gain on securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Unrealized (loss) gain arising during the period
|
$
|
(147
|
)
|
|
|
|
$
|
201
|
|
|
|
|
$
|
(1,007
|
)
|
|
|
|
$
|
1,714
|
|
|
|
||||||||
Less: reclassification adjustments for loss (gain) realized in net income (loss)
|
—
|
|
|
(147
|
)
|
|
—
|
|
|
201
|
|
|
—
|
|
|
(1,007
|
)
|
|
—
|
|
|
1,714
|
|
||||||||
Foreign currency translation (loss) gain
|
|
|
(21,609
|
)
|
|
|
|
8,001
|
|
|
|
|
59,154
|
|
|
|
|
(123,347
|
)
|
||||||||||||
OTHER COMPREHENSIVE (LOSS) INCOME
|
|
|
$
|
(21,756
|
)
|
|
|
|
$
|
8,202
|
|
|
|
|
$
|
58,147
|
|
|
|
|
$
|
(121,633
|
)
|
||||||||
CONSOLIDATED COMPREHENSIVE INCOME (LOSS)
|
|
|
$
|
321,840
|
|
|
|
|
$
|
(242,324
|
)
|
|
|
|
$
|
267,872
|
|
|
|
|
$
|
(447,877
|
)
|
||||||||
Less: Net income (loss) attributable to noncontrolling interests
|
|
|
18
|
|
|
|
|
(107
|
)
|
|
|
|
16
|
|
|
|
|
(107
|
)
|
||||||||||||
Less: Other comprehensive income (loss) attributable to noncontrolling interests
|
|
|
(18
|
)
|
|
|
|
57
|
|
|
|
|
38
|
|
|
|
|
(549
|
)
|
||||||||||||
COMPREHENSIVE INCOME (LOSS) ATTRIBUTABLE TO ENDO INTERNATIONAL PLC
|
|
|
$
|
321,840
|
|
|
|
|
$
|
(242,274
|
)
|
|
|
|
$
|
267,818
|
|
|
|
|
$
|
(447,221
|
)
|
|
Six Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
OPERATING ACTIVITIES:
|
|
|
|
||||
Consolidated net income (loss)
|
$
|
209,725
|
|
|
$
|
(326,244
|
)
|
Adjustments to reconcile consolidated net income (loss) to Net cash provided by (used in) operating activities:
|
|
|
|
||||
Depreciation and amortization
|
476,911
|
|
|
249,181
|
|
||
Inventory step-up
|
87,970
|
|
|
84,253
|
|
||
Share-based compensation
|
29,585
|
|
|
24,753
|
|
||
Amortization of debt issuance costs and discount
|
14,483
|
|
|
10,580
|
|
||
Provision for bad debts
|
8,082
|
|
|
1,141
|
|
||
Deferred income taxes
|
(670,615
|
)
|
|
(244,152
|
)
|
||
Net loss (gain) on disposal of property, plant and equipment
|
1,310
|
|
|
(132
|
)
|
||
Change in fair value of contingent consideration
|
13,204
|
|
|
(3,328
|
)
|
||
Loss on extinguishment of debt
|
—
|
|
|
980
|
|
||
Asset impairment charges
|
190,904
|
|
|
318,865
|
|
||
Gain on sale of business and other assets
|
(735
|
)
|
|
—
|
|
||
Changes in assets and liabilities which (used) provided cash:
|
|
|
|
||||
Accounts receivable
|
133,654
|
|
|
(124,681
|
)
|
||
Inventories
|
29,830
|
|
|
(22,425
|
)
|
||
Prepaid and other assets
|
21,846
|
|
|
(8,940
|
)
|
||
Accounts payable
|
(22,067
|
)
|
|
4,349
|
|
||
Accrued expenses
|
(260,352
|
)
|
|
235,867
|
|
||
Other liabilities
|
(395,126
|
)
|
|
(228,938
|
)
|
||
Income taxes payable/receivable
|
686,091
|
|
|
(48,615
|
)
|
||
Net cash provided by (used in) operating activities
|
$
|
554,700
|
|
|
$
|
(77,486
|
)
|
INVESTING ACTIVITIES:
|
|
|
|
||||
Purchases of property, plant and equipment
|
(53,705
|
)
|
|
(38,621
|
)
|
||
Proceeds from sale of intellectual property and property, plant and equipment
|
2,523
|
|
|
—
|
|
||
Acquisitions, net of cash acquired
|
—
|
|
|
(915,945
|
)
|
||
Proceeds from sale of marketable securities and investments
|
—
|
|
|
24
|
|
||
Proceeds from notes receivable
|
—
|
|
|
17
|
|
||
Patent acquisition costs and license fees
|
(13,000
|
)
|
|
—
|
|
||
Proceeds from sale of business, net
|
4,108
|
|
|
4,712
|
|
||
Increase in restricted cash and cash equivalents
|
(327,359
|
)
|
|
(381,223
|
)
|
||
Decrease in restricted cash and cash equivalents
|
524,438
|
|
|
424,695
|
|
||
Net cash provided by (used in) investing activities
|
$
|
137,005
|
|
|
$
|
(906,341
|
)
|
|
Six Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
FINANCING ACTIVITIES:
|
|
|
|
||||
Proceeds from issuance of notes
|
—
|
|
|
1,200,000
|
|
||
Principal payments on term loans
|
(48,375
|
)
|
|
(26,188
|
)
|
||
Proceeds from draw of revolving debt
|
—
|
|
|
175,000
|
|
||
Repayments of revolving debt
|
(225,000
|
)
|
|
(175,000
|
)
|
||
Principal payments on other indebtedness, net
|
(3,365
|
)
|
|
(3,231
|
)
|
||
Repurchase of convertible senior subordinated notes
|
—
|
|
|
(247,760
|
)
|
||
Deferred financing fees
|
(500
|
)
|
|
(25,696
|
)
|
||
Payment for contingent consideration
|
(18,646
|
)
|
|
(7,383
|
)
|
||
Tax benefits of share awards
|
3,911
|
|
|
20,079
|
|
||
Payments of tax withholding for restricted shares
|
(10,396
|
)
|
|
(12,570
|
)
|
||
Exercise of options
|
1,952
|
|
|
23,440
|
|
||
Issuance of ordinary shares
|
2,729
|
|
|
2,302,281
|
|
||
Payments related to the issuance of ordinary shares
|
—
|
|
|
(66,956
|
)
|
||
Cash buy-out of noncontrolling interests
|
—
|
|
|
(39,608
|
)
|
||
Net cash (used in) provided by financing activities
|
$
|
(297,690
|
)
|
|
$
|
3,116,408
|
|
Effect of foreign exchange rate
|
$
|
1,459
|
|
|
$
|
(11,599
|
)
|
NET INCREASE IN CASH AND CASH EQUIVALENTS
|
$
|
395,474
|
|
|
$
|
2,120,982
|
|
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
272,348
|
|
|
408,753
|
|
||
CASH AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
667,822
|
|
|
$
|
2,529,735
|
|
SUPPLEMENTAL INFORMATION:
|
|
|
|
||||
Cash received from income taxes, net
|
$
|
698,584
|
|
|
$
|
50,535
|
|
Cash paid into Qualified Settlement Funds for mesh legal settlements
|
$
|
326,795
|
|
|
$
|
377,074
|
|
Cash paid out of Qualified Settlement Funds for mesh legal settlements
|
$
|
524,438
|
|
|
$
|
385,087
|
|
Other cash distributions for mesh legal settlements
|
$
|
5,438
|
|
|
$
|
10,829
|
|
SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
|
|
|
||||
Purchases of property, plant and equipment financed by capital leases
|
$
|
658
|
|
|
$
|
54
|
|
Accrual for purchases of property, plant and equipment
|
$
|
2,363
|
|
|
$
|
2,072
|
|
Acquisition financed by ordinary shares
|
$
|
—
|
|
|
$
|
1,519,318
|
|
Repurchase of convertible senior subordinated notes financed by ordinary shares
|
$
|
—
|
|
|
$
|
625,483
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Revenue
|
$
|
863
|
|
|
$
|
119,940
|
|
|
$
|
29,714
|
|
|
$
|
238,605
|
|
Litigation related and other contingencies, net
|
$
|
—
|
|
|
$
|
268,552
|
|
|
$
|
2,450
|
|
|
$
|
273,752
|
|
Asset impairment charges
|
$
|
149
|
|
|
$
|
—
|
|
|
$
|
21,328
|
|
|
$
|
222,753
|
|
Loss from discontinued operations before income taxes
|
$
|
(22,492
|
)
|
|
$
|
(257,642
|
)
|
|
$
|
(91,324
|
)
|
|
$
|
(487,500
|
)
|
Income tax expense (benefit)
|
$
|
23,724
|
|
|
$
|
(98,010
|
)
|
|
$
|
—
|
|
|
$
|
(101,658
|
)
|
Discontinued operations, net of tax
|
$
|
(46,216
|
)
|
|
$
|
(159,632
|
)
|
|
$
|
(91,324
|
)
|
|
$
|
(385,842
|
)
|
|
Six Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
Cash flows from discontinued operating activities:
|
|
|
|
||||
Net loss
|
$
|
(91,324
|
)
|
|
$
|
(385,842
|
)
|
Depreciation and amortization
|
$
|
—
|
|
|
$
|
11,555
|
|
Net cash used in discontinued investing activities:
|
|
|
|
||||
Purchases of property, plant and equipment
|
$
|
(138
|
)
|
|
$
|
(2,182
|
)
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||
|
2016
|
|
2016
|
||||
Employee separation, retention and other benefit-related costs
|
$
|
5,317
|
|
|
$
|
21,466
|
|
Asset impairment charges
|
149
|
|
|
21,328
|
|
||
Contract termination charges
|
(424
|
)
|
|
9,800
|
|
||
Other wind down costs
|
909
|
|
|
14,030
|
|
||
Total
|
$
|
5,951
|
|
|
$
|
66,624
|
|
|
Employee Separation, Retention and Other Benefit-Related Costs
|
|
Contract Termination Charges
|
|
Other Restructuring Costs
|
|
Total
|
||||||||
Liability balance as of January 1, 2016
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Expenses
|
21,466
|
|
|
9,800
|
|
|
7,351
|
|
|
38,617
|
|
||||
Cash distributions
|
(7,763
|
)
|
|
(5,342
|
)
|
|
(4,068
|
)
|
|
(17,173
|
)
|
||||
Liability balance as of June 30, 2016
|
$
|
13,703
|
|
|
$
|
4,458
|
|
|
$
|
3,283
|
|
|
$
|
21,444
|
|
|
Total
|
||
Liability balance as of January 1, 2016
|
$
|
17,914
|
|
Expenses
|
4,588
|
|
|
Cash distributions
|
(9,906
|
)
|
|
Liability balance as of June 30, 2016
|
$
|
12,596
|
|
|
Total
|
||
Liability balance as of January 1, 2016
|
$
|
—
|
|
Expenses
|
6,431
|
|
|
Cash payments
|
—
|
|
|
Liability balance as of June 30, 2016
|
$
|
6,431
|
|
|
Employee Separation, Retention and Other Benefit-Related Costs
|
|
Other Restructuring Costs
|
|
Total
|
||||||
Liability balance as of January 1, 2016
|
$
|
5,353
|
|
|
$
|
6,910
|
|
|
$
|
12,263
|
|
Cash distributions
|
(4,837
|
)
|
|
(760
|
)
|
|
(5,597
|
)
|
|||
Liability balance as of June 30, 2016
|
$
|
516
|
|
|
$
|
6,150
|
|
|
$
|
6,666
|
|
Revenue
|
$
|
155,367
|
|
Net loss attributable to Endo International plc
|
$
|
(110,838
|
)
|
Basic net loss per share
|
$
|
(0.62
|
)
|
Diluted net loss per share
|
$
|
(0.61
|
)
|
|
September 25, 2015
|
|
Measurement period adjustments
|
|
September 25, 2015
(As adjusted) |
||||||
Cash and cash equivalents
|
$
|
215,612
|
|
|
$
|
—
|
|
|
$
|
215,612
|
|
Accounts and other receivables
|
530,664
|
|
|
(13,500
|
)
|
|
517,164
|
|
|||
Inventories
|
330,406
|
|
|
(1,849
|
)
|
|
328,557
|
|
|||
Prepaid expenses and other current assets
|
31,124
|
|
|
—
|
|
|
31,124
|
|
|||
Deferred income tax assets, current
|
14,652
|
|
|
660
|
|
|
15,312
|
|
|||
Property, plant and equipment
|
256,293
|
|
|
4,744
|
|
|
261,037
|
|
|||
Intangible assets
|
3,627,000
|
|
|
(154,500
|
)
|
|
3,472,500
|
|
|||
Other assets
|
8,477
|
|
|
—
|
|
|
8,477
|
|
|||
Total identifiable assets
|
$
|
5,014,228
|
|
|
$
|
(164,445
|
)
|
|
$
|
4,849,783
|
|
Accounts payable and accrued expenses
|
$
|
551,614
|
|
|
$
|
(13,500
|
)
|
|
$
|
538,114
|
|
Deferred income tax liabilities
|
1,093,779
|
|
|
(60,995
|
)
|
|
1,032,784
|
|
|||
Other liabilities
|
16,057
|
|
|
—
|
|
|
16,057
|
|
|||
Total liabilities assumed
|
$
|
1,661,450
|
|
|
$
|
(74,495
|
)
|
|
$
|
1,586,955
|
|
Net identifiable assets acquired
|
$
|
3,352,778
|
|
|
$
|
(89,950
|
)
|
|
$
|
3,262,828
|
|
Goodwill
|
4,782,876
|
|
|
89,950
|
|
|
4,872,826
|
|
|||
Net assets acquired
|
$
|
8,135,654
|
|
|
$
|
—
|
|
|
$
|
8,135,654
|
|
|
Valuation (in millions)
|
|
Amortization period (in years)
|
||
Developed Technology:
|
|
|
|
||
Vasostrict
®
|
$
|
556.0
|
|
|
8
|
Aplisol
®
|
312.4
|
|
|
11
|
|
Developed - Other - Non-Partnered (Generic Non-Injectable)
|
230.4
|
|
|
7
|
|
Developed - Other - Partnered (Combined)
|
164.4
|
|
|
7
|
|
Nascobal
®
|
118.3
|
|
|
9
|
|
Developed - Other - Non-Partnered (Generic Injectable)
|
116.4
|
|
|
10
|
|
Other
|
517.9
|
|
|
9
|
|
Total
|
$
|
2,015.8
|
|
|
|
In Process Research & Development (IPR&D):
|
|
|
|
||
IPR&D 2019 Launch
|
$
|
401.0
|
|
|
n/a
|
IPR&D 2018 Launch
|
283.8
|
|
|
n/a
|
|
Ezetimibe
|
147.6
|
|
|
n/a
|
|
IPR&D 2016 Launch
|
133.3
|
|
|
n/a
|
|
Ephedrine Sulphate
|
128.6
|
|
|
n/a
|
|
Neostigmine vial
|
118.6
|
|
|
n/a
|
|
Other
|
243.8
|
|
|
n/a
|
|
Total
|
$
|
1,456.7
|
|
|
n/a
|
Total other intangible assets
|
$
|
3,472.5
|
|
|
n/a
|
|
Three Months Ended June 30, 2015
|
|
Six Months Ended June 30, 2015
|
||||
Unaudited pro forma consolidated results (in thousands, except per share data):
|
|
|
|
||||
Revenue
|
$
|
1,067,387
|
|
|
$
|
2,140,759
|
|
Net loss attributable to Endo International plc
|
$
|
(291,174
|
)
|
|
$
|
(391,636
|
)
|
Basic net loss per share
|
$
|
(1.57
|
)
|
|
$
|
(2.21
|
)
|
Diluted net loss per share
|
$
|
(1.57
|
)
|
|
$
|
(2.14
|
)
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Net revenues to external customers:
|
|
|
|
|
|
|
|
||||||||
U.S. Branded Pharmaceuticals
|
$
|
288,342
|
|
|
$
|
315,913
|
|
|
$
|
597,155
|
|
|
$
|
600,420
|
|
U.S. Generic Pharmaceuticals
|
565,358
|
|
|
338,326
|
|
|
1,148,748
|
|
|
695,288
|
|
||||
International Pharmaceuticals (1)
|
67,187
|
|
|
80,927
|
|
|
138,523
|
|
|
153,586
|
|
||||
Total net revenues to external customers
|
$
|
920,887
|
|
|
$
|
735,166
|
|
|
$
|
1,884,426
|
|
|
$
|
1,449,294
|
|
|
|
|
|
|
|
|
|
||||||||
Adjusted income from continuing operations before income tax:
|
|
|
|
|
|
|
|
||||||||
U.S. Branded Pharmaceuticals
|
$
|
122,420
|
|
|
$
|
169,067
|
|
|
$
|
291,201
|
|
|
$
|
327,861
|
|
U.S. Generic Pharmaceuticals
|
$
|
214,968
|
|
|
$
|
146,089
|
|
|
$
|
426,736
|
|
|
$
|
329,546
|
|
International Pharmaceuticals
|
$
|
20,615
|
|
|
$
|
19,201
|
|
|
$
|
42,369
|
|
|
$
|
35,767
|
|
(1)
|
Revenues generated by our
International Pharmaceuticals
segment are primarily attributable to Canada, Mexico and South Africa.
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Total consolidated loss from continuing operations before income tax
|
$
|
(165,465
|
)
|
|
$
|
(103,614
|
)
|
|
$
|
(372,943
|
)
|
|
$
|
(119,991
|
)
|
Corporate unallocated costs (1)
|
161,737
|
|
|
115,050
|
|
|
314,810
|
|
|
226,118
|
|
||||
Upfront and milestone payments to partners
|
2,688
|
|
|
2,135
|
|
|
4,105
|
|
|
4,802
|
|
||||
Asset impairment charges (2)
|
39,951
|
|
|
70,243
|
|
|
169,576
|
|
|
77,243
|
|
||||
Acquisition-related and integration items (3)
|
48,171
|
|
|
44,225
|
|
|
60,725
|
|
|
78,865
|
|
||||
Separation benefits and other cost reduction initiatives (4)
|
22,174
|
|
|
5,780
|
|
|
60,630
|
|
|
47,587
|
|
||||
Amortization of intangible assets
|
212,844
|
|
|
116,987
|
|
|
424,513
|
|
|
212,256
|
|
||||
Inventory step-up and certain manufacturing costs that will be eliminated pursuant to integration plans
|
29,103
|
|
|
48,948
|
|
|
97,579
|
|
|
88,864
|
|
||||
Non-cash interest expense related to the 1.75% Convertible Senior Subordinated Notes
|
—
|
|
|
253
|
|
|
—
|
|
|
1,632
|
|
||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
980
|
|
||||
Impact of Voltaren
®
Gel generic competition
|
—
|
|
|
—
|
|
|
(7,750
|
)
|
|
—
|
|
||||
Certain litigation-related charges, net (5)
|
5,259
|
|
|
6,875
|
|
|
10,459
|
|
|
19,875
|
|
||||
Costs associated with unused financing commitments
|
—
|
|
|
2,261
|
|
|
—
|
|
|
14,071
|
|
||||
Acceleration of Auxilium employee equity awards at closing
|
—
|
|
|
—
|
|
|
—
|
|
|
37,603
|
|
||||
Other than temporary impairment of equity investment
|
—
|
|
|
18,869
|
|
|
—
|
|
|
18,869
|
|
||||
Foreign currency impact related to the remeasurement of intercompany debt instruments
|
417
|
|
|
2,792
|
|
|
1,672
|
|
|
(18,298
|
)
|
||||
Other, net
|
1,124
|
|
|
3,553
|
|
|
(3,070
|
)
|
|
2,699
|
|
||||
Total segment adjusted income from continuing operations before income tax:
|
$
|
358,003
|
|
|
$
|
334,357
|
|
|
$
|
760,306
|
|
|
$
|
693,175
|
|
(1)
|
Corporate unallocated costs include interest expense, net, certain corporate overhead costs, such as headcount and facility expenses and certain other income and expenses.
|
(2)
|
Asset impairment charges primarily related to charges to write down intangible assets as further described in
Note 9. Goodwill and Other Intangibles
.
|
(3)
|
Acquisition-related and integration items include costs directly associated with previous acquisitions of
$24.3 million
and
$47.5 million
for the
three and six months
ended
June 30, 2016
, respectively, compared to
$46.7 million
and
$82.2 million
for the comparable
2015
periods. In addition, during the
three and six months
ended
June 30, 2016
, there is also a charge for changes in fair value of contingent consideration of
$23.9 million
and
$13.2 million
, respectively. During the
three and six months
ended June 30,
2015
, acquisition-related and integration costs are net of a benefit due to changes in the fair value of contingent consideration of
$2.5 million
and
$3.3 million
, respectively.
|
(4)
|
Separation benefits and other cost reduction initiatives include charges to increase excess inventory reserves of
$6.4 million
and
$33.3 million
related to the 2016
U.S. Generic Pharmaceuticals
restructuring initiative, employee separation costs of
$8.4 million
and
$15.2 million
and other restructuring costs of
$7.1 million
and
$11.8 million
for the
three and six months
ended
June 30, 2016
, respectively. Amounts in the comparable
2015
periods include employee separation costs of
$4.8 million
and
$37.2 million
, respectively, and a
$7.9 million
charge recorded during the six months ended June 30, 2015, upon the cease use date of our Auxilium subsidiary’s former corporate headquarters, representing the liability for our remaining obligations under the respective lease agreement, net of estimated sublease income. These amounts were primarily recorded as Cost of revenues and
Selling, general and administrative
expense in our
Condensed Consolidated Statements of Operations
. See
Note 4. Restructuring
for discussion of our material restructuring initiatives.
|
(5)
|
These amounts include charges for Litigation-related and other contingencies, net as further described in
Note 12. Commitments and Contingencies
.
|
•
|
Level 1—Quoted prices in active markets for identical assets or liabilities.
|
•
|
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
|
•
|
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
|
Fair Value Measurements at Reporting Date using:
|
||||||||||||||
June 30, 2016
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
212,532
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
212,532
|
|
Time deposits
|
—
|
|
|
165,000
|
|
|
—
|
|
|
165,000
|
|
||||
Equity securities
|
2,239
|
|
|
—
|
|
|
—
|
|
|
2,239
|
|
||||
Total
|
$
|
214,771
|
|
|
$
|
165,000
|
|
|
$
|
—
|
|
|
$
|
379,771
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Acquisition-related contingent consideration—short-term
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
51,211
|
|
|
$
|
51,211
|
|
Acquisition-related contingent consideration—long-term
|
—
|
|
|
—
|
|
|
84,585
|
|
|
84,585
|
|
||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
135,796
|
|
|
$
|
135,796
|
|
|
Fair Value Measurements at Reporting Date using:
|
||||||||||||||
December 31, 2015
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
51,145
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
51,145
|
|
Equity securities
|
3,889
|
|
|
—
|
|
|
—
|
|
|
3,889
|
|
||||
Total
|
$
|
55,034
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
55,034
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Acquisition-related contingent consideration—short-term
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
65,265
|
|
|
$
|
65,265
|
|
Acquisition-related contingent consideration—long-term
|
—
|
|
|
—
|
|
|
78,237
|
|
|
78,237
|
|
||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
143,502
|
|
|
$
|
143,502
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Beginning of period
|
$
|
124,511
|
|
|
$
|
184,261
|
|
|
$
|
143,502
|
|
|
$
|
46,005
|
|
Amounts acquired
|
—
|
|
|
18,435
|
|
|
—
|
|
|
166,535
|
|
||||
Amounts settled
|
(12,646
|
)
|
|
(3,851
|
)
|
|
(22,120
|
)
|
|
(8,574
|
)
|
||||
Transfers (in) and/or out of Level 3
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Measurement period adjustments
|
—
|
|
|
(7,243
|
)
|
|
—
|
|
|
(11,556
|
)
|
||||
Changes in fair value recorded in earnings
|
23,892
|
|
|
(2,520
|
)
|
|
13,204
|
|
|
(3,328
|
)
|
||||
Effect of currency translation
|
39
|
|
|
—
|
|
|
1,210
|
|
|
—
|
|
||||
End of period
|
$
|
135,796
|
|
|
$
|
189,082
|
|
|
$
|
135,796
|
|
|
$
|
189,082
|
|
|
Balance as of December 31, 2015
|
|
Acquisitions
|
|
Fair Value Adjustments and Accretion
|
|
Payments and Other
|
|
Balance as of June 30, 2016
|
||||||||||
Qualitest acquisition
|
$
|
1,137
|
|
|
$
|
—
|
|
|
$
|
(1,137
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
Sumavel acquisition
|
631
|
|
|
—
|
|
|
55
|
|
|
—
|
|
|
686
|
|
|||||
Auxilium acquisition
|
26,435
|
|
|
—
|
|
|
661
|
|
|
(6,986
|
)
|
|
20,110
|
|
|||||
Lehigh Valley Technologies, Inc. acquisitions
|
97,003
|
|
|
—
|
|
|
12,831
|
|
|
(15,134
|
)
|
|
94,700
|
|
|||||
Other
|
18,296
|
|
|
—
|
|
|
2,004
|
|
|
—
|
|
|
20,300
|
|
|||||
Total
|
$
|
143,502
|
|
|
$
|
—
|
|
|
$
|
14,414
|
|
|
$
|
(22,120
|
)
|
|
$
|
135,796
|
|
|
Available-for-sale
|
||||||||||||||
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized (Losses) |
|
Fair Value
|
||||||||
June 30, 2016
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
212,532
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
212,532
|
|
Total included in cash and cash equivalents
|
$
|
165,001
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
165,001
|
|
Total included in restricted cash and cash equivalents
|
$
|
47,531
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
47,531
|
|
Equity securities
|
$
|
26
|
|
|
$
|
7
|
|
|
$
|
—
|
|
|
$
|
33
|
|
Total other short-term available-for-sale securities
|
$
|
26
|
|
|
$
|
7
|
|
|
$
|
—
|
|
|
$
|
33
|
|
Equity securities
|
$
|
1,766
|
|
|
$
|
440
|
|
|
$
|
—
|
|
|
$
|
2,206
|
|
Long-term available-for-sale securities
|
$
|
1,766
|
|
|
$
|
440
|
|
|
$
|
—
|
|
|
$
|
2,206
|
|
|
Available-for-sale
|
||||||||||||||
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized (Losses) |
|
Fair Value
|
||||||||
December 31, 2015
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
51,145
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
51,145
|
|
Total included in cash and cash equivalents
|
$
|
3
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3
|
|
Total included in restricted cash and cash equivalents
|
$
|
51,142
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
51,142
|
|
Equity securities
|
$
|
24
|
|
|
$
|
10
|
|
|
$
|
—
|
|
|
$
|
34
|
|
Total other short-term available-for-sale securities
|
$
|
24
|
|
|
$
|
10
|
|
|
$
|
—
|
|
|
$
|
34
|
|
Equity securities
|
$
|
1,766
|
|
|
$
|
2,089
|
|
|
$
|
—
|
|
|
$
|
3,855
|
|
Long-term available-for-sale securities
|
$
|
1,766
|
|
|
$
|
2,089
|
|
|
$
|
—
|
|
|
$
|
3,855
|
|
|
Fair Value Measurements at Reporting Date using:
|
|
Total Expense for the Six Months Ended June 30, 2016
|
||||||||||||
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
|
|||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Certain Astora property, plant and equipment (Note 3)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(5,041
|
)
|
Certain U.S. Generic Pharmaceuticals intangible assets (Note 9)
|
—
|
|
|
—
|
|
|
50,459
|
|
|
(169,576
|
)
|
||||
Certain Astora intangible assets (Note 3)
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,287
|
)
|
||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
50,459
|
|
|
$
|
(190,904
|
)
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Raw materials (1)
|
$
|
222,808
|
|
|
$
|
210,038
|
|
Work-in-process (1)
|
97,323
|
|
|
177,821
|
|
||
Finished goods (1)
|
306,189
|
|
|
364,634
|
|
||
Total
|
$
|
626,320
|
|
|
$
|
752,493
|
|
|
Carrying Amount
|
||||||||||||||
|
U.S. Branded Pharmaceuticals
|
|
U.S. Generic Pharmaceuticals
|
|
International Pharmaceuticals
|
|
Total
|
||||||||
Balance as of December 31, 2015:
|
|
|
|
|
|
|
|
||||||||
Goodwill
|
$
|
1,676,276
|
|
|
$
|
5,789,934
|
|
|
$
|
592,424
|
|
|
$
|
8,058,634
|
|
Accumulated impairment losses
|
(673,500
|
)
|
|
—
|
|
|
(85,780
|
)
|
|
(759,280
|
)
|
||||
Balance as of December 31, 2015
|
$
|
1,002,776
|
|
|
$
|
5,789,934
|
|
|
$
|
506,644
|
|
|
$
|
7,299,354
|
|
Measurement period adjustments
|
—
|
|
|
89,950
|
|
|
1,366
|
|
|
91,316
|
|
||||
Effect of currency translation on gross balance
|
—
|
|
|
—
|
|
|
29,025
|
|
|
29,025
|
|
||||
Effect of currency translation on accumulated impairment
|
—
|
|
|
—
|
|
|
(2,458
|
)
|
|
(2,458
|
)
|
||||
Balance as of June 30, 2016:
|
|
|
|
|
|
|
|
||||||||
Goodwill
|
$
|
1,676,276
|
|
|
$
|
5,879,884
|
|
|
$
|
622,815
|
|
|
$
|
8,178,975
|
|
Accumulated impairment losses
|
(673,500
|
)
|
|
—
|
|
|
(88,238
|
)
|
|
(761,738
|
)
|
||||
|
$
|
1,002,776
|
|
|
$
|
5,879,884
|
|
|
$
|
534,577
|
|
|
$
|
7,417,237
|
|
Cost basis:
|
Balance as of December 31, 2015
|
|
Acquisitions
(1) |
|
Impairments
(2) |
|
Other
(3) |
|
Effect of Currency Translation
|
|
Balance as of June 30, 2016
|
||||||||||||
Indefinite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
In-process research and development
|
$
|
1,742,880
|
|
|
$
|
(114,200
|
)
|
|
$
|
(55,100
|
)
|
|
$
|
(5,156
|
)
|
|
$
|
3,208
|
|
|
$
|
1,571,632
|
|
Total indefinite-lived intangibles
|
$
|
1,742,880
|
|
|
$
|
(114,200
|
)
|
|
$
|
(55,100
|
)
|
|
$
|
(5,156
|
)
|
|
$
|
3,208
|
|
|
$
|
1,571,632
|
|
Definite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Licenses (weighted average life of 12 years)
|
$
|
676,867
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(211,147
|
)
|
|
$
|
—
|
|
|
$
|
465,720
|
|
Customer relationships (weighted average life of 15 years)
|
11,318
|
|
|
—
|
|
|
(3,460
|
)
|
|
(7,858
|
)
|
|
—
|
|
|
—
|
|
||||||
Tradenames (weighted average life of 12 years)
|
7,537
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(74
|
)
|
|
7,463
|
|
||||||
Developed technology (weighted average life of 12 years)
|
6,731,573
|
|
|
(32,300
|
)
|
|
(127,303
|
)
|
|
(1,847
|
)
|
|
26,113
|
|
|
6,596,236
|
|
||||||
Total definite-lived intangibles (weighted average life of 12 years)
|
$
|
7,427,295
|
|
|
$
|
(32,300
|
)
|
|
$
|
(130,763
|
)
|
|
$
|
(220,852
|
)
|
|
$
|
26,039
|
|
|
$
|
7,069,419
|
|
Total other intangibles
|
$
|
9,170,175
|
|
|
$
|
(146,500
|
)
|
|
$
|
(185,863
|
)
|
|
$
|
(226,008
|
)
|
|
$
|
29,247
|
|
|
$
|
8,641,051
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Accumulated amortization:
|
Balance as of December 31, 2015
|
|
Amortization
|
|
Impairments
|
|
Other
|
|
Effect of Currency Translation
|
|
Balance as of June 30, 2016
|
||||||||||||
Definite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Licenses
|
$
|
(508,225
|
)
|
|
$
|
(29,761
|
)
|
|
$
|
—
|
|
|
$
|
211,147
|
|
|
$
|
—
|
|
|
$
|
(326,839
|
)
|
Customer relationships
|
(7,858
|
)
|
|
—
|
|
|
—
|
|
|
7,858
|
|
|
—
|
|
|
—
|
|
||||||
Tradenames
|
(6,544
|
)
|
|
(45
|
)
|
|
—
|
|
|
—
|
|
|
10
|
|
|
(6,579
|
)
|
||||||
Developed technology
|
(818,606
|
)
|
|
(394,707
|
)
|
|
—
|
|
|
5,367
|
|
|
(3,028
|
)
|
|
(1,210,974
|
)
|
||||||
Total definite-lived intangibles
|
$
|
(1,341,233
|
)
|
|
$
|
(424,513
|
)
|
|
$
|
—
|
|
|
$
|
224,372
|
|
|
$
|
(3,018
|
)
|
|
$
|
(1,544,392
|
)
|
Total other intangibles
|
$
|
(1,341,233
|
)
|
|
$
|
(424,513
|
)
|
|
$
|
—
|
|
|
$
|
224,372
|
|
|
$
|
(3,018
|
)
|
|
$
|
(1,544,392
|
)
|
Net other intangibles
|
$
|
7,828,942
|
|
|
|
|
|
|
|
|
|
|
$
|
7,096,659
|
|
(1)
|
Includes measurement period adjustments relating to the Par acquisition, partially offset by the capitalization of payments relating to XIAFLEX
®
.
|
(2)
|
Includes the impairment of certain intangible assets of our
U.S. Generic Pharmaceuticals
segment of approximately
$169.6 million
, and the impairment of certain intangible assets in connection with the wind down of our Astora business, with a net impairment of approximately
$16.3 million
, which is reported as
Discontinued operations, net of tax
in the
Condensed Consolidated Statements of Operations
for the
six months
ended
June 30, 2016
. See
Note 3. Discontinued Operations and Held for Sale
for further information relating to the Astora wind down.
|
(3)
|
Includes the removal of approximately
$214.0 million
of fully amortized intangible assets relating to expired or terminated licensing agreements in our
U.S. Branded Pharmaceuticals
segment, including the 2008 Voltaren
®
Gel agreement described in
Note 10. License and Collaboration Agreements
and Natesto
TM
. In addition,
$10.0 million
of fully amortized assets were removed in connection with the wind down of our Astora business described above. Additionally, certain IPR&D assets of
$5.2 million
were placed in service and transferred into developed technology, while certain other developed technology assets were removed due to their sale or disposal during the period presented.
|
2016
|
$
|
805,089
|
|
2017
|
$
|
681,732
|
|
2018
|
$
|
600,710
|
|
2019
|
$
|
542,887
|
|
2020
|
$
|
517,927
|
|
|
Gross
Carrying Amount |
||
December 31, 2015
|
$
|
9,170,175
|
|
Impairment of certain Astora intangible assets
|
(26,318
|
)
|
|
Capitalization of payments relating to XIAFLEX
®
|
8,000
|
|
|
Sale of certain International Pharmaceuticals intangible assets
|
(1,959
|
)
|
|
Impairment of certain U.S. Generic Pharmaceuticals intangible assets
|
(169,576
|
)
|
|
Measurement period adjustments relating to acquisitions closed during 2015 (NOTE 5)
|
(154,500
|
)
|
|
Removal of fully amortized intangible assets relating to expired or terminated licensing agreements
|
(214,018
|
)
|
|
Effect of currency translation
|
29,247
|
|
|
June 30, 2016
|
$
|
8,641,051
|
|
|
June 30, 2016
|
|
December 31, 2015
|
||||||||||||
|
Principal Amount
|
|
Unamortized Discount and Deferred Loan Costs
|
|
Principal Amount
|
|
Unamortized Discount and Deferred Loan Costs
|
||||||||
7.25% Senior Notes due 2022
|
$
|
400,000
|
|
|
$
|
(11,709
|
)
|
|
$
|
400,000
|
|
|
$
|
(12,535
|
)
|
5.75% Senior Notes due 2022
|
700,000
|
|
|
(9,385
|
)
|
|
700,000
|
|
|
(10,088
|
)
|
||||
5.375% Senior Notes due 2023
|
750,000
|
|
|
(9,898
|
)
|
|
750,000
|
|
|
(10,511
|
)
|
||||
6.00% Senior Notes due 2023
|
1,635,000
|
|
|
(26,230
|
)
|
|
1,635,000
|
|
|
(27,694
|
)
|
||||
6.00% Senior Notes due 2025
|
1,200,000
|
|
|
(21,770
|
)
|
|
1,200,000
|
|
|
(22,713
|
)
|
||||
Term Loan A Facility Due 2019
|
983,125
|
|
|
(11,410
|
)
|
|
1,017,500
|
|
|
(13,831
|
)
|
||||
Term Loan B Facility Due 2022
|
2,786,000
|
|
|
(46,515
|
)
|
|
2,800,000
|
|
|
(49,900
|
)
|
||||
Revolving Credit Facility
|
—
|
|
|
—
|
|
|
225,000
|
|
|
—
|
|
||||
Other debt
|
134
|
|
|
—
|
|
|
134
|
|
|
—
|
|
||||
Total long-term debt, net
|
$
|
8,454,259
|
|
|
$
|
(136,917
|
)
|
|
$
|
8,727,634
|
|
|
$
|
(147,272
|
)
|
Less current portion, net
|
117,454
|
|
|
—
|
|
|
328,705
|
|
|
—
|
|
||||
Total long-term debt, less current portion, net
|
$
|
8,336,805
|
|
|
$
|
(136,917
|
)
|
|
$
|
8,398,929
|
|
|
$
|
(147,272
|
)
|
|
Qualified Settlement Funds
|
|
Product Liability
|
||||
Balance as of December 31, 2015
|
$
|
578,970
|
|
|
$
|
2,086,176
|
|
Additional charges
|
—
|
|
|
2,450
|
|
||
Cash contributions to Qualified Settlement Funds
|
326,795
|
|
|
—
|
|
||
Cash distributions to settle disputes from Qualified Settlement Funds
|
(524,438
|
)
|
|
(524,438
|
)
|
||
Cash distributions to settle disputes
|
—
|
|
|
(5,438
|
)
|
||
Other
|
255
|
|
|
—
|
|
||
Balance as of June 30, 2016
|
$
|
381,582
|
|
|
$
|
1,558,750
|
|
|
Three Months Ended June 30,
|
||||||||||||||||||||||
|
2016
|
|
2015
|
||||||||||||||||||||
|
Before-
Tax Amount |
|
Tax Benefit (Expense)
|
|
Net-of-Tax
Amount |
|
Before-Tax
Amount |
|
Tax (Expense) Benefit
|
|
Net-of-
Tax Amount |
||||||||||||
Net unrealized (loss) gain on securities:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized (loss) gain arising during the period
|
$
|
(234
|
)
|
|
$
|
87
|
|
|
$
|
(147
|
)
|
|
$
|
451
|
|
|
$
|
(250
|
)
|
|
$
|
201
|
|
Net unrealized gain (loss) on foreign currency:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Foreign currency translation gain (loss) arising during the period
|
(7,866
|
)
|
|
(13,743
|
)
|
|
(21,609
|
)
|
|
10,516
|
|
|
(2,515
|
)
|
|
8,001
|
|
||||||
Other comprehensive (loss) income
|
$
|
(8,100
|
)
|
|
$
|
(13,656
|
)
|
|
$
|
(21,756
|
)
|
|
$
|
10,967
|
|
|
$
|
(2,765
|
)
|
|
$
|
8,202
|
|
|
Six Months Ended June 30,
|
||||||||||||||||||||||
|
2016
|
|
2015
|
||||||||||||||||||||
|
Before-
Tax Amount |
|
Tax Benefit (Expense)
|
|
Net-of-Tax
Amount |
|
Before-Tax
Amount |
|
Tax (Expense) Benefit
|
|
Net-of-
Tax Amount |
||||||||||||
Net unrealized (loss) gain on securities:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized (loss) gain arising during the period
|
$
|
(1,620
|
)
|
|
$
|
613
|
|
|
$
|
(1,007
|
)
|
|
$
|
2,649
|
|
|
$
|
(935
|
)
|
|
$
|
1,714
|
|
Net unrealized gain (loss) on foreign currency:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Foreign currency translation gain (loss) arising during the period
|
46,706
|
|
|
12,448
|
|
|
59,154
|
|
|
(120,863
|
)
|
|
(2,484
|
)
|
|
(123,347
|
)
|
||||||
Other comprehensive income (loss)
|
$
|
45,086
|
|
|
$
|
13,061
|
|
|
$
|
58,147
|
|
|
$
|
(118,214
|
)
|
|
$
|
(3,419
|
)
|
|
$
|
(121,633
|
)
|
|
June 30,
2016 |
|
December 31,
2015 |
||||
Net unrealized gains
|
$
|
808
|
|
|
$
|
1,815
|
|
Foreign currency translation loss
|
(326,904
|
)
|
|
(386,020
|
)
|
||
Accumulated other comprehensive loss
|
$
|
(326,096
|
)
|
|
$
|
(384,205
|
)
|
|
Attributable to:
|
||||||||||
|
Endo
International plc |
|
Noncontrolling
interests |
|
Total
Shareholders’ Equity |
||||||
Shareholders’ equity at January 1, 2016
|
$
|
5,968,030
|
|
|
$
|
(54
|
)
|
|
$
|
5,967,976
|
|
Net income
|
209,709
|
|
|
16
|
|
|
209,725
|
|
|||
Other comprehensive income
|
58,109
|
|
|
38
|
|
|
58,147
|
|
|||
Compensation related to share-based awards
|
29,585
|
|
|
—
|
|
|
29,585
|
|
|||
Tax withholding for restricted shares
|
(10,396
|
)
|
|
—
|
|
|
(10,396
|
)
|
|||
Exercise of options
|
1,952
|
|
|
—
|
|
|
1,952
|
|
|||
Issuance of ordinary shares related to the employee stock purchase plan
|
2,729
|
|
|
—
|
|
|
2,729
|
|
|||
Other
|
1,820
|
|
|
—
|
|
|
1,820
|
|
|||
Shareholders’ equity at June 30, 2016
|
$
|
6,261,538
|
|
|
$
|
—
|
|
|
$
|
6,261,538
|
|
|
Attributable to:
|
||||||||||
|
Endo
International plc |
|
Noncontrolling
interests |
|
Total
Shareholders’ Equity |
||||||
Shareholders’ equity at January 1, 2015
|
$
|
2,374,757
|
|
|
$
|
33,456
|
|
|
$
|
2,408,213
|
|
Net loss
|
(326,137
|
)
|
|
(107
|
)
|
|
(326,244
|
)
|
|||
Other comprehensive loss
|
(121,084
|
)
|
|
(549
|
)
|
|
(121,633
|
)
|
|||
Compensation related to share-based awards
|
24,753
|
|
|
—
|
|
|
24,753
|
|
|||
Tax withholding for restricted shares
|
(12,570
|
)
|
|
—
|
|
|
(12,570
|
)
|
|||
Exercise of options
|
23,440
|
|
|
—
|
|
|
23,440
|
|
|||
Buy-out of noncontrolling interests, net of contributions
|
(6,876
|
)
|
|
(32,732
|
)
|
|
(39,608
|
)
|
|||
Ordinary shares issued in connection with the Auxilium acquisition
|
1,519,320
|
|
|
—
|
|
|
1,519,320
|
|
|||
Fair value of equity component of acquired Auxilium Notes
|
278,014
|
|
|
—
|
|
|
278,014
|
|
|||
Conversion of Auxilium Notes
|
145,101
|
|
|
—
|
|
|
145,101
|
|
|||
Ordinary shares issued
|
2,302,281
|
|
|
—
|
|
|
2,302,281
|
|
|||
Equity issuance fees
|
(66,956
|
)
|
|
—
|
|
|
(66,956
|
)
|
|||
Other
|
17,827
|
|
|
—
|
|
|
17,827
|
|
|||
Shareholders’ equity at June 30, 2015
|
$
|
6,151,870
|
|
|
$
|
68
|
|
|
$
|
6,151,938
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Foreign currency loss (gain), net
|
$
|
1,554
|
|
|
$
|
2,578
|
|
|
$
|
2,550
|
|
|
$
|
(20,556
|
)
|
Equity loss from unconsolidated subsidiaries, net
|
3,828
|
|
|
900
|
|
|
1,484
|
|
|
1,751
|
|
||||
Other than temporary impairment of equity investment
|
—
|
|
|
18,869
|
|
|
—
|
|
|
18,869
|
|
||||
Costs associated with unused financing commitments
|
—
|
|
|
2,261
|
|
|
—
|
|
|
14,071
|
|
||||
Other miscellaneous, net
|
(207
|
)
|
|
(115
|
)
|
|
(766
|
)
|
|
(1,637
|
)
|
||||
Other expense, net
|
$
|
5,175
|
|
|
$
|
24,493
|
|
|
$
|
3,268
|
|
|
$
|
12,498
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
||||||||
Income (loss) from continuing operations
|
$
|
389,812
|
|
|
$
|
(90,894
|
)
|
|
$
|
301,049
|
|
|
$
|
59,598
|
|
Less: Net income (loss) from continuing operations attributable to noncontrolling interests
|
18
|
|
|
(107
|
)
|
|
16
|
|
|
(107
|
)
|
||||
Income (loss) from continuing operations attributable to Endo International plc ordinary shareholders
|
$
|
389,794
|
|
|
$
|
(90,787
|
)
|
|
$
|
301,033
|
|
|
$
|
59,705
|
|
Loss from discontinued operations attributable to Endo International plc ordinary shareholders, net of tax
|
(46,216
|
)
|
|
(159,632
|
)
|
|
(91,324
|
)
|
|
(385,842
|
)
|
||||
Net income (loss) attributable to Endo International plc ordinary shareholders
|
$
|
343,578
|
|
|
$
|
(250,419
|
)
|
|
$
|
209,709
|
|
|
$
|
(326,137
|
)
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
For basic per share data—weighted average shares
|
222,667
|
|
|
185,328
|
|
|
222,485
|
|
|
177,490
|
|
||||
Dilutive effect of ordinary share equivalents
|
195
|
|
|
—
|
|
|
535
|
|
|
2,091
|
|
||||
Dilutive effect of various convertible notes and warrants
|
1
|
|
|
—
|
|
|
1
|
|
|
3,241
|
|
||||
For diluted per share data—weighted average shares
|
222,863
|
|
|
185,328
|
|
|
223,021
|
|
|
182,822
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||||||||||
|
$
|
|
% of Revenue
|
|
$
|
|
% of Revenue
|
|
$
|
|
% of Revenue
|
|
$
|
|
% of Revenue
|
||||||||
Cost of revenues
|
$
|
632,218
|
|
|
69
|
|
$
|
438,858
|
|
|
60
|
|
$
|
1,320,923
|
|
|
70
|
|
$
|
823,124
|
|
|
57
|
Selling, general and administrative
|
193,070
|
|
|
21
|
|
154,491
|
|
|
21
|
|
371,425
|
|
|
20
|
|
366,069
|
|
|
25
|
||||
Research and development
|
50,589
|
|
|
5
|
|
18,984
|
|
|
3
|
|
92,281
|
|
|
5
|
|
36,881
|
|
|
3
|
||||
Litigation-related and other contingencies, net
|
5,259
|
|
|
1
|
|
6,875
|
|
|
1
|
|
10,459
|
|
|
1
|
|
19,875
|
|
|
1
|
||||
Asset impairment charges
|
39,951
|
|
|
4
|
|
70,243
|
|
|
10
|
|
169,576
|
|
|
9
|
|
77,243
|
|
|
5
|
||||
Acquisition-related and integration items
|
48,171
|
|
|
5
|
|
44,225
|
|
|
6
|
|
60,725
|
|
|
3
|
|
78,865
|
|
|
5
|
||||
Total costs and expenses*
|
$
|
969,258
|
|
|
105
|
|
$
|
733,676
|
|
|
100
|
|
$
|
2,025,389
|
|
|
107
|
|
$
|
1,402,057
|
|
|
97
|
*
|
Percentages may not add due to rounding.
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Interest expense
|
$
|
113,097
|
|
|
$
|
80,980
|
|
|
$
|
230,567
|
|
|
$
|
154,829
|
|
Interest income
|
(1,178
|
)
|
|
(369
|
)
|
|
(1,855
|
)
|
|
(1,079
|
)
|
||||
Interest expense, net
|
$
|
111,919
|
|
|
$
|
80,611
|
|
|
$
|
228,712
|
|
|
$
|
153,750
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Foreign currency loss (gain), net
|
$
|
1,554
|
|
|
$
|
2,578
|
|
|
$
|
2,550
|
|
|
$
|
(20,556
|
)
|
Equity loss from unconsolidated subsidiaries, net
|
3,828
|
|
|
900
|
|
|
1,484
|
|
|
1,751
|
|
||||
Other than temporary impairment of equity investment
|
—
|
|
|
18,869
|
|
|
—
|
|
|
18,869
|
|
||||
Costs associated with unused financing commitments
|
—
|
|
|
2,261
|
|
|
—
|
|
|
14,071
|
|
||||
Other miscellaneous, net
|
(207
|
)
|
|
(115
|
)
|
|
(766
|
)
|
|
(1,637
|
)
|
||||
Other expense, net
|
$
|
5,175
|
|
|
$
|
24,493
|
|
|
$
|
3,268
|
|
|
$
|
12,498
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Net revenues to external customers:
|
|
|
|
|
|
|
|
||||||||
U.S. Branded Pharmaceuticals
|
$
|
288,342
|
|
|
$
|
315,913
|
|
|
$
|
597,155
|
|
|
$
|
600,420
|
|
U.S. Generic Pharmaceuticals
|
565,358
|
|
|
338,326
|
|
|
1,148,748
|
|
|
695,288
|
|
||||
International Pharmaceuticals (1)
|
67,187
|
|
|
80,927
|
|
|
138,523
|
|
|
153,586
|
|
||||
Total net revenues to external customers
|
$
|
920,887
|
|
|
$
|
735,166
|
|
|
$
|
1,884,426
|
|
|
$
|
1,449,294
|
|
(1)
|
Revenues generated by our
International Pharmaceuticals
segment are primarily attributable to Canada, Mexico and South Africa.
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Pain Management:
|
|
|
|
|
|
|
|
||||||||
Lidoderm®
|
$
|
27,039
|
|
|
$
|
30,186
|
|
|
$
|
46,751
|
|
|
$
|
55,346
|
|
OPANA® ER
|
38,554
|
|
|
43,097
|
|
|
83,224
|
|
|
89,956
|
|
||||
Percocet®
|
35,708
|
|
|
32,444
|
|
|
69,301
|
|
|
68,743
|
|
||||
Voltaren® Gel
|
27,290
|
|
|
51,006
|
|
|
63,037
|
|
|
96,477
|
|
||||
|
$
|
128,591
|
|
|
$
|
156,733
|
|
|
$
|
262,313
|
|
|
$
|
310,522
|
|
Specialty Pharmaceuticals:
|
|
|
|
|
|
|
|
||||||||
Supprelin® LA
|
$
|
21,211
|
|
|
$
|
17,796
|
|
|
$
|
38,463
|
|
|
$
|
34,078
|
|
XIAFLEX®
|
42,419
|
|
|
39,952
|
|
|
86,464
|
|
|
67,918
|
|
||||
|
$
|
63,630
|
|
|
$
|
57,748
|
|
|
$
|
124,927
|
|
|
$
|
101,996
|
|
Branded Other Revenues
|
96,121
|
|
|
101,432
|
|
|
209,915
|
|
|
187,902
|
|
||||
Total U.S. Branded Pharmaceuticals
|
$
|
288,342
|
|
|
$
|
315,913
|
|
|
$
|
597,155
|
|
|
$
|
600,420
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
U.S. Generic Pharmaceuticals
|
|
|
|
|
|
|
|
||||||||
U.S. Generics Base (1)
|
$
|
331,095
|
|
|
$
|
214,241
|
|
|
$
|
678,524
|
|
|
$
|
458,511
|
|
Sterile Injectables
|
126,245
|
|
|
—
|
|
|
249,934
|
|
|
—
|
|
||||
New Launches and Alternative Dosages (2)
|
108,018
|
|
|
124,085
|
|
|
220,290
|
|
|
236,777
|
|
||||
Total U.S. Generic Pharmaceuticals
|
$
|
565,358
|
|
|
$
|
338,326
|
|
|
$
|
1,148,748
|
|
|
$
|
695,288
|
|
(1)
|
U.S. Generics Base
includes solid oral-extended release, solid oral-immediate release and pain/controlled substances products.
|
(2)
|
New Launches and Alternative Dosages
includes liquids, semi-solids, patches, powders, ophthalmics, sprays and new product launches. Products are included in New Launches during the calendar year of launch and the subsequent calendar year such that the period of time any product will be considered a New Launch will range from thirteen to twenty-four months. New Launches contributed
$32.9 million
and
$64.0 million
of revenues to the
three
and
six months
ended
June 30, 2016
, respectively, and
$9.9 million
and
$16.3 million
of revenues to the
three
and
six months
ended
June 30, 2015
, respectively. The table below presents the most significant revenue producing New Launch Products from the respective most recent two calendar launches years:
|
Year of
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||
Launch
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
2014
|
|
N/A
|
|
- Valsartan/HCTZ
- Lorazepam
- Telemisartan |
|
N/A
|
|
- Valsartan/HCTZ
- Lorazepam
- Telemisartan |
2015
|
|
- Ethacrynate Sodium
- Pramipexole DHCI - Propranolol - Testosterone Gel Sachets - Lamotrigine ODT |
|
- Pramipexole DHCI
- Tolcapone Tabs
- Guanfacine ER Tabs
- Zafirlukast - Valsartan |
|
- Ethacrynate Sodium
- Propranolol - Dutas/Tams Caps - Testosterone Gel Sachets - Pramipexole DHCI |
|
- Pramipexole DHCI
- Tolcapone Tabs
- Guanfacine ER Tabs
- Zafirlukast - Hydrocortisone Cream |
2016
|
|
- Darifenacin HBr ER Tabs
- Frova AG - Dantrolene Caps |
|
N/A - No impact on 2015
|
|
- Darifenacin HBr ER Tabs
- Frova AG - Dantrolene Caps |
|
N/A - No impact on 2015
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Adjusted income (loss) from continuing operations before income tax:
|
|
|
|
|
|
|
|
||||||||
U.S. Branded Pharmaceuticals
|
$
|
122,420
|
|
|
$
|
169,067
|
|
|
$
|
291,201
|
|
|
$
|
327,861
|
|
U.S. Generic Pharmaceuticals
|
$
|
214,968
|
|
|
$
|
146,089
|
|
|
$
|
426,736
|
|
|
$
|
329,546
|
|
International Pharmaceuticals
|
$
|
20,615
|
|
|
$
|
19,201
|
|
|
$
|
42,369
|
|
|
$
|
35,767
|
|
Corporate unallocated
|
$
|
(161,737
|
)
|
|
$
|
(115,050
|
)
|
|
$
|
(314,810
|
)
|
|
$
|
(226,118
|
)
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Total consolidated loss from continuing operations before income tax
|
$
|
(165,465
|
)
|
|
$
|
(103,614
|
)
|
|
$
|
(372,943
|
)
|
|
$
|
(119,991
|
)
|
Corporate unallocated costs (1)
|
161,737
|
|
|
115,050
|
|
|
314,810
|
|
|
226,118
|
|
||||
Upfront and milestone payments to partners
|
2,688
|
|
|
2,135
|
|
|
4,105
|
|
|
4,802
|
|
||||
Asset impairment charges (2)
|
39,951
|
|
|
70,243
|
|
|
169,576
|
|
|
77,243
|
|
||||
Acquisition-related and integration items (3)
|
48,171
|
|
|
44,225
|
|
|
60,725
|
|
|
78,865
|
|
||||
Separation benefits and other cost reduction initiatives (4)
|
22,174
|
|
|
5,780
|
|
|
60,630
|
|
|
47,587
|
|
||||
Amortization of intangible assets
|
212,844
|
|
|
116,987
|
|
|
424,513
|
|
|
212,256
|
|
||||
Inventory step-up and certain manufacturing costs that will be eliminated pursuant to integration plans
|
29,103
|
|
|
48,948
|
|
|
97,579
|
|
|
88,864
|
|
||||
Non-cash interest expense related to the 1.75% Convertible Senior Subordinated Notes
|
—
|
|
|
253
|
|
|
—
|
|
|
1,632
|
|
||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
980
|
|
||||
Impact of Voltaren
®
Gel generic competition
|
—
|
|
|
—
|
|
|
(7,750
|
)
|
|
—
|
|
||||
Certain litigation-related charges, net (5)
|
5,259
|
|
|
6,875
|
|
|
10,459
|
|
|
19,875
|
|
||||
Costs associated with unused financing commitments
|
—
|
|
|
2,261
|
|
|
—
|
|
|
14,071
|
|
||||
Acceleration of Auxilium employee equity awards at closing
|
—
|
|
|
—
|
|
|
—
|
|
|
37,603
|
|
||||
Other than temporary impairment of equity investment
|
—
|
|
|
18,869
|
|
|
—
|
|
|
18,869
|
|
||||
Foreign currency impact related to the remeasurement of intercompany debt instruments
|
417
|
|
|
2,792
|
|
|
1,672
|
|
|
(18,298
|
)
|
||||
Other, net
|
1,124
|
|
|
3,553
|
|
|
(3,070
|
)
|
|
2,699
|
|
||||
Total segment adjusted income from continuing operations before income tax:
|
$
|
358,003
|
|
|
$
|
334,357
|
|
|
$
|
760,306
|
|
|
$
|
693,175
|
|
(1)
|
Corporate unallocated costs include interest expense, net, certain corporate overhead costs, such as headcount and facility expenses and certain other income and expenses.
|
(2)
|
Asset impairment charges primarily related to charges to write down intangible assets as further described in
Note 9. Goodwill and Other Intangibles
.
|
(3)
|
Acquisition-related and integration items include costs directly associated with previous acquisitions of
$24.3 million
and
$47.5 million
for the
three and six months
ended
June 30, 2016
, respectively, compared to
$46.7 million
and
$82.2 million
for the comparable
2015
periods. In addition, during the
three and six months
ended
June 30, 2016
, there is also a charge for changes in fair value of contingent consideration of
$23.9 million
and
$13.2 million
, respectively. During the
three and six months
ended June 30,
2015
, acquisition-related and integration costs are net of a benefit due to changes in the fair value of contingent consideration of
$2.5 million
and
$3.3 million
, respectively.
|
(4)
|
Separation benefits and other cost reduction initiatives include charges to increase excess inventory reserves of
$6.4 million
and
$33.3 million
related to the 2016
U.S. Generic Pharmaceuticals
restructuring initiative, employee separation costs of
$8.4 million
and
$15.2 million
and other restructuring costs of
$7.1 million
and
$11.8 million
for the
three and six months
ended
June 30, 2016
, respectively. Amounts in the comparable
2015
periods include employee separation costs of
$4.8 million
and
$37.2 million
, respectively, and a
$7.9 million
charge recorded during the six months ended June 30, 2015, upon the cease use date of our Auxilium subsidiary’s former corporate headquarters, representing the liability for our remaining obligations under the respective lease agreement, net of estimated sublease income. These amounts were primarily recorded as Cost of revenues and
Selling, general and administrative
expense in our
Condensed Consolidated Statements of Operations
. See
Note 4. Restructuring
for discussion of our material restructuring initiatives.
|
(5)
|
These amounts include charges for Litigation-related and other contingencies, net as further described in
Note 12. Commitments and Contingencies
.
|
|
June 30, 2016
|
|
December 31, 2015
|
||||
Total current assets
|
$
|
2,650,416
|
|
|
$
|
3,452,537
|
|
Less: total current liabilities
|
(2,938,840
|
)
|
|
(3,474,312
|
)
|
||
Working capital
|
$
|
(288,424
|
)
|
|
$
|
(21,775
|
)
|
Current ratio
|
-0.9:1
|
|
|
-1.0:1
|
|
|
Six Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
Net cash flow provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
554,700
|
|
|
$
|
(77,486
|
)
|
Investing activities
|
137,005
|
|
|
(906,341
|
)
|
||
Financing activities
|
(297,690
|
)
|
|
3,116,408
|
|
||
Effect of foreign exchange rate
|
1,459
|
|
|
(11,599
|
)
|
||
Net increase in cash and cash equivalents
|
$
|
395,474
|
|
|
$
|
2,120,982
|
|
|
Six Months Ended June 30,
|
||||||
|
2016
|
|
2015
|
||||
Payments for mesh-related product liability and other litigation matters
|
$
|
557,523
|
|
|
$
|
395,916
|
|
Unused commitment fees
|
—
|
|
|
14,071
|
|
||
Separation and restructuring payments
|
55,793
|
|
|
31,550
|
|
||
Transaction costs and certain integration charges paid in connection with acquisitions
|
49,033
|
|
|
78,089
|
|
||
U.S. Federal tax refunds received
|
(707,303
|
)
|
|
(70,300
|
)
|
||
Total
|
$
|
(44,954
|
)
|
|
$
|
449,326
|
|
|
ENDO INTERNATIONAL PLC
|
|
(Registrant)
|
|
|
|
/s/ RAJIV DE SILVA
|
Name:
|
Rajiv De Silva
|
Title:
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
|
|
/s/ SUKETU P. UPADHYAY
|
Name:
|
Suketu P. Upadhyay
|
Title:
|
Executive Vice President and Chief Financial Officer
|
|
(Principal Financial Officer)
|
1.
|
DEFINITIONS
|
1.1.
|
“
Adjusted Product Price
” shall have the meaning set forth in Section 3.8 hereof.
|
1.1.
|
“
ANDA
” shall have the meaning set forth in Section 2.1.3 hereof.
|
1.2.
|
“
Affiliate
” shall mean any entity or individual which directly or indirectly controls, is controlled by, or is under common control with a Party. An entity shall be regarded as in control of another entity if it owns or directly or indirectly controls at least fifty (50%) of the voting interests of the other entity, or, in the absence of the ownership of at least fifty percent (50%) of the voting interests of an entity, has the power to direct or cause the direction of the management and policies of such entity, as applicable.
|
1.3.
|
“
Agreement
” shall have the meaning set forth in the Preamble hereof.
|
1.4.
|
“
API (active pharmaceutical ingredient)
” shall mean any substance or mixture of substances intended to be used in the manufacture of drug product and that
,
when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.
|
1.5.
|
“
Applicable Laws
” means all laws, statutes, rules, regulations, orders, judgments, injunctions and/or ordinances of any Governmental Agency.
|
1.6.
|
“
Batch Record
” shall mean the written procedures for production, process control and testing of the Products designed to assure that the Products has the identity, strength, quality, and purity they purport or are represented to possess and is used to ensure uniformity from batch to batch and compliance with cGMPs.
|
1.7.
|
“
Business Day
” means a day other than a Saturday, Sunday or a day that is a statutory holiday in Dublin, Ireland or the United States of America.
|
1.8.
|
“
cGMP
” means those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices by the FDA or European Medicines Agency (EMA) in accordance with FDA or European regulations, guidelines, other administrative interpretations, and rulings in connection therewith, including but not limited to those regulations cited in 21 C.F.R. parts 210 and 211, all as they may be amended from time to time.
|
1.9.
|
“
Confidential Information
” shall have the meaning set forth in Section 14 hereof.
|
1.10.
|
“
Contract Year
” shall mean, for the first year, the period commencing on the Effective Date up to and including December 31 of the same calendar year, and for each year thereafter, shall mean a calendar year beginning on January 1 and ending on December 31.
|
1.11.
|
“
DEA
” shall mean the Drug Enforcement Administration of the U.S. Department of Justice, or any successor entity.
|
1.12.
|
“
DMF
” means Supplier’s Drug Master File for each Product.
|
1.13.
|
“
Effective Date
” shall have the meaning set forth in the Preamble hereof.
|
1.14.
|
“
Endo Facility
” means Endo’s Dublin, Ireland or other location designated by Endo.
|
1.15.
|
“
Environmental Laws
” means all applicable laws, directives, rules, ordinances, codes, guidelines, regulations, governmental, administrative or judicial orders or decrees or other legal requirements of any kind, whether currently in existence or hereafter promulgated, enacted, adopted or amended, relating to (i) safety (including
|
1.16.
|
“
Environmental Losses
” means any and all fines, penalties, costs, liabilities, damages or losses incurred by Endo or an Affiliate of Endo, or for which Endo or an Affiliate of Endo is liable or obligated pursuant to any Environmental Law or Release or threatened Release of Hazardous Materials (i) arising out of the operation or ownership of the facilities of Supplier, the facilities of any Affiliate of Supplier, or the facilities of any subcontractor of Supplier or such subcontractor’s Affiliates or (ii) relating to, arising from, or in any way connected with, the testing, manufacture, packaging, generation, processing, storage, transportation, distribution, treatment, disposal or other handling of Product or materials used in the manufacture or packaging of Product, or associated by-products, raw materials, intermediates, Wastes or returned Product, by Supplier, Affiliates of Supplier, or subcontractors of Supplier or such subcontractor’s Affiliates, or their respective officers, directors, employees, agents or contractors but not any transportation or handling of Products after released to an Endo-designated carrier.
|
1.17.
|
“
FCPA
” shall have the meaning set forth in Section 8.1.5 hereof.
|
1.18.
|
“
FD&C Act
” shall mean the United States Federal Food, Drug and Cosmetic Act, as amended.
|
1.19.
|
“
FDA
” shall mean the United States Food and Drug Administration, or any successor entity.
|
1.20.
|
“
Finished Product
” means any finished pharmaceutical product in human dosage form that contains any Product finished to the extent specified in the PSS (defined herein) and is intended for commercial sale by Endo.
|
1.21.
|
“
Force Majeure Event
” shall have the meaning set forth in Section 15 hereof.
|
1.22.
|
“
Free Goods Issue
” means key starting materials, API, or bulk drug product to be supplied by Endo to Supplier free of charge for the purposes of this Agreement and as described in the Product Supply Scope for the Product, as may be amended by the mutual agreement of the Parties duly signed in writing.
|
1.23.
|
“
Governmental Agency
” means any court, agency, authority, department, regulatory body or other instrumentality of any government or country or of any national, federal, state, provincial, regional, county, city or other political subdivision of any such government or any supranational organization of which any such country is a member, which has competent and binding authority to decide, mandate, regulate, enforce, or otherwise control the activities of the Parties or their Affiliates contemplated by this Agreement, including, without limitation, the FDA and the DEA.
|
1.24.
|
“
Hazardous Materials
” means any and all materials (including without limitation substances, chemicals compounds, mixtures, products, byproducts, biologic agents, living or genetically modified materials, wastes, pollutants and contaminants), that are (A) used by Supplier in performing services under this Agreement and are identified in any of the following clauses of this Section 1.26; (B) (i) listed, classified, characterized or regulated pursuant to Environmental Laws; (ii) identified or classified as “hazardous”, “dangerous”, “toxic”, “pollutant”, “contaminant”, “waste”, “irritant”, “corrosive”, “flammable”, “radioactive”, “reactive”, “carcinogenic”, “mutagenic”, “bioaccumulative”, or “persistent” in the environment; or (iii) in quantity or concentration capable of causing harm or injury to human health, natural resources or the environment, if Released or resulting in human exposure; or (C) petroleum products and their derivatives, asbestos-containing material, lead-based paint, polychlorinated biphenyls, urea formaldehyde, or viral, bacterial or fungal material.
|
1.25.
|
“
Inability to Supply
” shall have the meaning set forth in Section 3.6 hereof.
|
1.26.
|
“
Initial Term
” shall have the meaning set forth in Section 11.1 hereof.
|
1.27.
|
“
Laws
” means all international, national, federal, state, provincial and local laws, statutes, codes, rules, regulations, ordinances, orders, decrees or other pronouncements of any governmental, administrative or judicial authority having the effect of law, including, without limitation, Environmental Laws.
|
1.28.
|
“
Lock Period
” shall have the meaning set forth in each Product Supply Scope.
|
1.29.
|
“
Manufacture
” and “
Manufacturing Services
” means the manufacturing, quality control, quality assurance and stability testing, packaging and related services, as contemplated in this Agreement, required to produce the Products.
|
1.30.
|
“
Manufacturing Process
” shall mean any and all processes (or any step in any process) used or planned to be used by Supplier to Manufacture the Products, as evidenced in the Batch Records.
|
1.31.
|
“
Manufacturing Site
” means the facility, owned and operated by Supplier that is located at 3525 North Regal, Spokane, Washington.
|
1.32.
|
“
Master Production Plan
” shall have the meaning set forth in Section 3.1 hereof.
|
1.33.
|
“
NDA
” shall have the meaning set forth in Section 2.1.3. hereof.
|
1.34.
|
“
Officials
” shall have the meaning set forth in Section 8.1.5 hereof.
|
1.35.
|
“
Payment
” shall have the meaning set forth in Section 4.1 hereof.
|
1.36.
|
“
Procurement Quota
” means the quota allotted to Endo or the Supplier on behalf of Endo by the DEA pursuant to applicable DEA regulations so as to permit shipment of Product from Supplier to Endo or the Supplier.
|
1.37.
|
“
Product
” or “
Products
” means medical device(s)/API(s)/bulk Product/finished dosage form pharmaceuticals manufactured specifically for Endo and as more specifically described in Product Supply Scope attached hereto as Exhibit 1.
|
1.38.
|
“
Product Price
” means the price to be charged by Supplier for Product manufactured and supplied hereunder as delivered to Endo, which price shall include the cost of materials (except Free Goods Issue), manufacturing, standard quality control and quality assurance costs, testing, documentation, packaging, shipping materials, Manufacturing related transportation and taxes and which price is set forth in the Product Supply Scope.
|
1.39.
|
“Purchase Order” means an order from Endo specifying requested Purchase Order
Delivery Dates, cost and quantities of the Products to be Manufactured by Supplier.
|
1.40.
|
“
Purchase Order Delivery Date
” shall mean a date for which delivery of any Product is stated in a Purchase Order and confirmed by Supplier. Unless the Parties otherwise agree in writing, on Delivery Date Product shall be released by both Parties and prepared for shipment per Section 3.4.
|
1.41.
|
“Product Supply Scope
(PSS)” means the document attached to this Agreement as Exhibit 1 that defines Product costs and product specific manufacturing requirements including: Product pricing, price lock period, batch size, safety stock requirements.
|
1.42.
|
“
Quality Agreement
” shall mean a separate Quality Agreement entered into by the Parties.
|
1.43.
|
“
Raw Material
” means, collectively, raw materials, all excipients, packaging components, required to be used in order to produce the Products in accordance with the Specifications.
|
1.44.
|
“
Release
” means any release, spill, emission, leaking, pumping, injection, deposit, disposal, discharge, dispersal, leaching or migration into the indoor or outdoor environment, including the uncontrolled presence or the movement of Hazardous Materials through the ambient air, soil, subsurface water, groundwater, wetlands, lands or subsurface strata.
|
1.45.
|
“
Services
” shall mean Manufacturing Services Supplier performs for Endo as requested from time to time. All Manufacturing Services performed by Supplier for Endo shall be on a project basis. For each project, Supplier will submit a written proposal to Endo outlining the services to be provided and the estimated costs for performing such services (the “Project”). Upon approval of the Project by Endo, the Parties will complete and execute a Product Supply Scope for each Project similar to the form attached hereto as Exhibit 1. Upon execution by both Parties, each PSS shall be deemed to be incorporated into this Agreement by Reference. Supplier will undertake the performance of the Project only upon full execution of a PSS by Endo and Supplier.
|
1.46.
|
“
Specifications
” means the quality assurance and quality release specifications for Raw Materials and Product approved by Endo and Supplier.
|
1.47.
|
“
Third Party
” shall mean any person or entity other than Endo, Supplier and their respective Affiliates.
|
1.48.
|
“
Waste
” means all wastes which arise from the manufacture, handling or storage of Product hereunder, prior to release of Product to an Endo-designated carrier, or which is otherwise produced by Supplier or any of its Affiliates through the implementation of this Agreement, including Hazardous Materials.
|
2.
|
MANUFACTURING SERVICES
|
2.1.
|
Supplier will perform the Manufacturing Services for, and ship the Products to, Endo in accordance with this Agreement. In performing the Manufacturing Services and supplying the Products to Endo:
|
2.1.1.
|
Quality Control and Quality Assurance.
Supplier will perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to Endo will be the responsibility of Supplier’s quality assurance group. Supplier will perform its batch review and release responsibilities in accordance with Supplier’s standard operating procedures. To obtain Endo’s written authorization to ship; Supplier shall provide to Endo via dublinsupplyops@endo.com mailbox the following documents in English:
|
2.1.1.1.
|
Certificate of analysis; and
|
2.1.1.2.
|
Certificate of compliance; and
|
2.1.1.3.
|
Endo formatted notice of production; and
|
2.1.1.4.
|
Executed batch records: The form and style of batch documents, including but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and Supplier data printouts. Specific Product-related information contained in those batch documents is the exclusive property of Endo.
|
2.1.2.
|
Process and Specification Changes.
Except required by Applicable Law, Supplier shall not make any changes to its process, raw materials, supply sources, Specifications, manufacturing locations or facilities used to make Product for Endo under this Agreement, including, without limitation, any such changes that may require Endo to provide notification to regulatory authorities, without the prior written consent of Endo, which consent shall not be unreasonably withheld or unduly delayed.
|
2.1.2.1.
|
Endo Requested Changes. In the event Endo requests to change the Specifications or the Quality Agreement; Endo shall promptly advise Supplier in writing of such intention. Such amendments will only be implemented following a technical review by Supplier and in the event that such changes directly impact Supplier’s scheduling or costs, Supplier shall promptly advise Endo as to any scheduling and/or price adjustments caused by such changes. Prior to implementation of such changes, the Parties agree to negotiate in good faith in an attempt to reach agreement on (1) the new price for any Product which embodies such changes, provided that the price shall not change more than the direct effect of such changes on Supplier’s costs for the Product, and (2) any other amendments to this Agreement which may be necessitated by such changes (e.g., an adjustment to the lead time for Purchase Orders). Once agreement is reached on items (1) and (2) above; Endo shall have the option of proceeding with the requested changes or not. If Endo elects to proceed with such changes, Endo shall reimburse Supplier for the actual out-of- pocket expenses incurred by Supplier as a result of such changes, including, but not limited to, reimbursing Supplier for its out-of-pocket
|
2.1.2.2.
|
Changes Required by Applicable Law. If Supplier is required to change the Specifications in order to comply with Applicable Law or Governmental Agency, Supplier will promptly notify Endo of such changes and the cost of such changes. If either Party is unable or unwilling to make such changes, Endo will have the option of terminating the Product PSS with *** notice to Supplier and Supplier will have the option of terminating this Agreement with *** notice to Endo
|
2.1.3.
|
Technical Data.
Supplier shall provide to Endo, without charge, all data and reports generated for Product as needed and required for Endo’s New Drug Application (“NDA”) or abbreviated New Drug Application (“ANDA”) or other FDA or Governmental Agency requests and/or requirements, in each case relating to any Finished Product.
|
2.1.4.
|
Raw Materials.
Supplier will purchase and test all Raw Materials as required by the Specifications.
|
2.1.5.
|
Packaging.
Supplier will purchase packaging materials and package the Products in specified batch sizes as specified by Endo in a manner suitable for safe and lawful shipment.
|
2.1.6.
|
Validation Activities.
Supplier shall prepare the documentation, protocols, and procedures. Supplier shall validate its pharmaceutical manufacturing processes, tests, and methods as well as associated facilities, equipment and systems, keep such processes, tests, methods, facilities, equipment and systems, keep such processes, tests, methods, facilities, equipment, and systems current, and make results of validation and annual reviews of such processes, tests, methods, facilities, equipment, and systems available on site for audit or review by Endo in accordance with the Quality Agreement.
|
2.1.7.
|
DMFs.
Supplier shall maintain all DMF(s) in compliance with FDA regulations and shall make reasonable commercial efforts to update such DMF(s) to accommodate any additional references thereto in any amendments that may be made to Endo’s NDA(s) or ANDA(s) or any accompanying supplements. For the avoidance of doubt, Supplier is under no obligation to make any changes to a DMF absent mutual agreement. Supplier shall furnish Endo with a Letter of Authorization granting Endo permission to cite the Supplier’s DMF in filings.
|
2.1.8.
|
Compliance.
Supplier shall comply with all Applicable Laws applicable to or related to the use, possession, handling, transportation, sale or disposal of the Products.
|
3.
|
MASTER PRODUCTION PLAN AND PURCHASE ORDERS, PURCHASE OF
PRODUCT; DELIVERIES
|
3.1.
|
Master Production Plan and Purchase.
Orders Endo shall deliver to Supplier a Master Production Plan on or before the last working day of each calendar month during the Term that covers a *** period, which includes *** rolling binding, non-cancellable purchase orders, a firm PO, if required for the *** non-binding forecast (the “Master Production Plan”).
|
3.2.
|
Purchase Quantities.
Quantities actually shipped pursuant to a given Purchase Order may vary from the quantities reflected in such Purchase Order by *** and still be deemed to be in compliance with such Purchase Order; provided, that Endo shall only be invoiced and required to pay for the quantities of the Products which Supplier actually delivers to Endo. Changes from committed Purchase Order Delivery Dates will be acceptable ***
. If Supplier does not meet the committed Purchase Order Delivery Date, Supplier is deemed not
able to meet its obligations under this Agreement
per Section 3.5, Late Delivery.
|
3.3.
|
Adjustments to Master Production Plan and Purchase Orders.
Any change to the accepted Purchase Order amount or Purchase Order Delivery Date cannot occur without both Parties agreeing to change in writing duly signed by their authorized signatories.
|
3.4.
|
Delivery Terms and Purchase Order Delivery Date.
Terms of delivery for the Products shall be *** (ICC Incoterms® 2010). By the Purchase Order Delivery Date, title and risk of loss and/or damage to the Products shall pass to ***. All Products shall be properly prepared for safe and lawful shipment by Supplier and accompanied by appropriate transportation and other agreed upon documentation.
|
3.5.
|
Late Delivery.
Provided Endo has provided acceptable Free Goods Issue within the PSS specified lead time, notwithstanding the foregoing, in the event that Product is delivered after the Purchase Order Delivery Date specified in the applicable Purchase Order, and such late delivery has not been delivered by the
***
the specified Purchase Order Delivery Date, then Endo may begin charging Supplier a late delivery charge. Late delivery charge will be for
***
that the delivery is late equal to the following percentages of the Product Price payable to Endo in respect to such Product, as determined pursuant to PSS,
***
|
3.6.
|
Inability to Supply.
Starting with ***, Supplier is considered to be in an “Inability to Supply” status. In the event of any Inability to Supply: (i) Supplier shall fulfill Purchase Orders with such quantities of conforming Product as are available; (ii) unless and until such Inability to Supply is remedied, Endo shall be *** under this Agreement to ***. Nothing in this Section 3.6 shall relieve Supplier of any other obligation or liability under this Agreement.
|
3.7.
|
Alternate Suppliers.
Nothing in this Agreement shall prevent, prohibit or restrict Endo from purchasing the Products from any Third Party.
|
3.8.
|
Price Change.
Effective after the Lock Period as set out in the PSS for the Product, Product Price may be adjusted
***
in Producer Price Index (PPI) for Total Manufacturing Industries as published by the United States Department of Labor Bureau. The Adjusted Product Price is calculated by
***
|
4.
|
PAYMENT: TAXES
|
4.1.
|
Payment.
Endo shall pay Supplier only for the Services requested by Endo and identified in the PSS. If Supplier anticipates that a project shall exceed the costs identified in the PSS, Supplier shall notify Endo, as soon as possible, of such additional costs. Endo must approve such additional costs in writing prior to Supplier incurring any such costs. Supplier shall submit invoices to Endo upon Product ready
|
4.2.
|
Taxes.
Notwithstanding anything contained herein, the Manufacturing Services do not include sales, use, consumption, or excise taxes of any taxing authority. The amount of such taxes, if any, will be added to the Manufacturing Services in effect at the time of the delivery of the Product thereof and shall be reflected in the invoices submitted to Endo by Supplier pursuant to this Agreement. Endo shall pay the amount of such taxes to Supplier in accordance with the payment provisions of this Agreement.
|
5.
|
RECALLS
|
5.1.
|
Control of Recall.
All recalls of any Finished Product, and EMA and FDA contacts relating to any such recalls shall be the responsibility of, and under the control of, Endo. Endo shall notify the EMA, FDA, DEA, and any foreign regulatory agencies of any recall, and shall be responsible for coordinating all necessary activities regarding the action taken. In the event that either Party has reason to believe that any Finished Products should be recalled or withdrawn from distribution, such Party shall promptly inform the other in writing prior to taking any such action. Endo shall have the responsibility for making the final decision regarding any recall, withdrawal or field correction relating to any Finished Product.
|
5.2.
|
Supplier Fault.
If any Finished Product is recalled as a result of Supplier’s failure to supply any Product in accordance with this Agreement or manufacturing defect in the Product due to negligence of Supplier, then Supplier shall reimburse Endo for all documented out-of-pocket expenses incurred by Endo or its Affiliates as a result of such recall. Endo shall give Supplier prompt written notice of any Finished Product recalls that Endo believes were caused or may have been caused by such failure by Supplier.
|
5.3.
|
Sharing of Recall Expenses.
If each Party contributes to the cause for a recall, the expenses actually incurred as a result of such recall will be shared in proportion to each Party’s responsibility.
|
6.
|
INTELLECTUAL PROPERTY
|
6.1.
|
Endo Property.
|
6.1.3.
|
All materials, inventions, know-how, methodologies, trademarks, Specifications, information, data, writings and other property in any form whatsoever, which is provided or otherwise made available to Supplier by or on behalf of Endo, whether or not it is used by Supplier with respect to the performance of its obligations hereunder, and which was owned or Controlled by Endo prior to being provided or made available to Supplier, shall remain the property of Endo (the “Endo Property”). Without limiting the foregoing, Endo shall retain all rights, title and interest in and to such Endo Property, including without limitation all patents, copyrights, trademarks, trade secrets and other intellectual property and proprietary rights and any ideas, concepts, designs, inventions and expressions embodied in or appurtenant to such Endo Property. Endo hereby grants to Supplier a non-transferable, non-exclusive license to use any Endo Property supplied to Supplier hereunder solely to the extent and for the duration necessary to enable Supplier to perform its obligations hereunder. Supplier shall not acquire any other right, title or interest in or to the Endo Property as a result of its performance hereunder. “Controlled” means, with respect to any material, item of information or intellectual property right, the possession, whether by ownership or license, of the right to grant a license or other right with respect thereto without violating the contractual or intellectual property rights of any third party.
|
6.1.4.
|
Any improvements or modifications to Endo Property (“Improvements”), and any creative ideas, proprietary information, developments, or inventions developed, conceived, created, authored or reduced to practice by or on behalf of Supplier during the Term and related to the activities carried out in the performance of this Agreement (“Developments”), either alone or in concert with Endo or any third parties, shall be the exclusive property of Endo, and Endo shall own all rights, title and interest in and to such Improvements and Developments. Such ownership shall inure to the benefit of Endo from the date of the conception, creation, reduction to practice or fixation in a tangible medium of expression of the Improvements or Developments, as the case may be. All copyrightable aspects of such Improvements and Developments shall be considered “Work Made For Hire” as defined in §101 of the 1976 Copyright Act (as amended), and all rights, title and interest in and to such Improvements and Developments hereby is and shall be transferred to and vested in Endo without any additional compensation to Supplier or its Personnel. In the event that any Improvements or Developments do not qualify to be Work Made For Hire, Supplier hereby irrevocably transfers, assigns and conveys, and shall cause its Personnel to irrevocably transfer, assign and convey, all rights, title and interest in and to such Improvements or Developments to Endo, at no cost to Endo, free and clear of any liens and encumbrances, and Supplier agrees to execute, and shall cause its Personnel to execute, all documents necessary, in Endo’s discretion, to do so. All such assignments shall include, but are not limited to, those relating to existing or prospective copyrights, patent rights and all other intellectual property rights in any country. Supplier also agrees that it shall, and shall cause its Personnel to, promptly notify Endo of any intellectual property developed or otherwise included as
|
7.
|
Supplier Property
|
7.1.
|
All materials, inventions, know-how, methodologies, trademarks, information, data, writings and other property, in any form whatsoever, which is provided to Endo by or on behalf of Supplier, or which was used by Supplier with respect to the performance of its obligations hereunder, and which was owned or Controlled by Supplier prior to its performance hereunder, shall remain the property of Supplier (the “Supplier Property”). For avoidance of doubt, Supplier Property excludes any Endo Property, Improvements and Developments. Endo shall acquire no right, title or interest in Supplier Property as a result of Supplier’s or Endo’s performance hereunder. In producing Improvements and Developments, Supplier shall not incorporate into such Improvements and Developments any Supplier Property or other materials in which Supplier or any third party has pre-existing proprietary rights (collectively, “Pre- Existing Materials”), except such Pre-Existing Materials as may be approved in advance by Endo in writing. Any such Pre-Existing Materials incorporated into the Improvements and Developments but not approved in advance by Endo in writing shall be deemed Improvements and Developments. With respect to Pre-Existing Materials incorporated into Improvements and Developments which are approved in advance by Endo in writing, Supplier hereby grants to Endo, in the case of Supplier’s Pre-Existing Materials, or shall obtain for Endo, in the case of third party Pre- Existing Materials, a non-transferable, non-exclusive license to use, disclose, reproduce, modify, prepare derivative works, publicly perform and display, transmit, sublicense, sell, offer for sale and distribute (including the right to sublicense, sell, offer for sale and distribute through multiple tiers), practice, make, have made, import and otherwise make use of such Pre-Existing Materials in connection with the Product, Improvements and Developments. Such rights shall extend to Endo’s present and future Affiliates, successors and assigns.
|
8.
|
REPRESENTATIONS AND WARRANTIES
|
8.1.
|
Supplier represents and warrants
:
|
8.1.3.
|
that it has the experience, capability and resources to efficiently and expeditiously provide the Manufacturing Services under this Agreement, and that the Manufacturing Services shall be performed in a workmanlike manner with professional diligence and skill and in conformance with applicable specifications or requirements as set forth in this Agreement or the PSS.
|
8.1.4.
|
that it is not a party to any agreement that would prevent it from fulfilling its obligations under this Agreement or any PSS, and that it shall not enter into an agreement to provide services that would restrict its ability to perform under this Agreement during its term.
|
8.1.5.
|
that Supplier is not now nor has in the past been suspended, proposed for debarment or debarred by the United States Food and Drug Administration or any other government or regulatory authority; Supplier has never been convicted of a felony
|
8.1.6.
|
that it and its employees, subcontractors, agents, representatives, and invitees shall comply with all applicable laws, regulations, rules, requirements, ordinances and other requirements of local and state authorities and the federal government during the term of and in the performance of this Agreement, and that Supplier’s actions in establishing and performing this Agreement have been and will be consistent with ethical business practices and without the influence of any association with an Endo employee, officer or director that would amount to a conflict of interest.
|
8.1.7.
|
that Supplier shall not make any payment, either directly or indirectly, of money or other assets, including but not limited to the compensation Supplier derives from this Agreement, or provide any gifts, entertainment or other thing of value (hereinafter collectively referred to as a “Payment”) to government or political party rolling forecast, employees of state-owned entities, including employees of state-owned medical/clinical facilities, officials of international organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (collectively, “Officials”) where such payment would constitute violation of any law, including, the U.S. Foreign Corrupt Practices Act of 1977, 15 U.S.C.
§§
78dd-l, et seq. (“FCPA”). In addition, regardless of legality, Supplier shall make no Payment either directly or indirectly to Officials if such payment is for the purpose of influencing decisions or actions with respect to the subject matter of this Agreement or any other aspect of Endo’s business.
|
8.1.8.
|
that as of the Effective Date, it has not received written notice from a Third Party asserting that Supplier’s Product or the Manufacturing Process of a Product infringe a claim of a patent owned or controlled by such party.
|
8.1.9.
|
to Endo that the Products, at the time of delivery to Endo shall (a) be of merchantable quality, and be free from defects in material and workmanship; (b) conform to the Specifications, as then in effect, (c) have been Manufactured in compliance with all Applicable Laws and in accordance with cGMPs; (d) not be (i) adulterated or misbranded by Supplier within the meaning of the FD&C Act or (ii) an article that may not be introduced into interstate commerce under the provisions of Section 404 or 505 of the FD&C Act; (e) meet all standards and requirements under Applicable Laws to be lawfully shipped and sold; and (f) date of manufacture shall not be more than the PSS defined number of days from
Purchase Order
Delivery Date on accepted
Purchase Order
.
|
8.2.
|
Supplier and Endo represent and warrant to the other that the execution, delivery and performance of this Agreement have been authorized by all necessary corporate action, do not conflict with or result in a material breach of the articles of incorporation or by-laws of such Party or any material agreement by which such Party is bound, or any law, regulation or decree of any governmental entity or court that has jurisdiction over such Party.
|
8.3.
|
Supplier and Endo warrant that they shall report any suspected or actual violation of any anti-bribery/anti-corruption laws to the other party immediately.
|
8.4.
|
Endo represents warrants and covenants that it will not request or require Supplier to perform any assignments or tasks in a manner that would violate any applicable law or regulation or to handle any substances or materials that do not have specific safe handling instructions. Endo shall be solely responsible for its decision to use or report (or not use or report) data or information provided by Supplier. Endo will cooperate with Supplier in taking any actions that Supplier reasonably believes are necessary to comply with any regulatory obligations that are agreed by the parties to be transferred by Endo to Supplier in accordance herewith (at Endo’s sole cost and expense). Supplier shall inform Endo of the result of any regulatory inspection which directly concerns or affects the Manufacturing Services (to the extent that such information is capable of being disclosed by Supplier without breaching any obligation of confidentiality, law or regulatory requirement).
|
8.5.
|
Disclaimer
. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON- INFRINGEMENT.
|
8.6.
|
Alleged Infringement.
If subsequent to the Effective Date, Supplier’s Product or process of manufacture of a Product becomes or is likely to become the subject of an infringement claim, Supplier may at its sole option: (i) procure the right to use the applicable intellectual property in the process for manufacture of such Product; (ii) modify the process of manufacture; or (iii) if, in Supplier’s opinion, neither (i) nor (ii) above are commercially reasonable, Supplier may terminate Supplier’s obligations (and the Company’s rights) hereunder with respect to such Product.
|
8.7.
|
Reservation of Rights.
All rights to and interests in Supplier’s and its Affiliates’ intellectual property, including any improvements thereto, will remain solely with Supplier and its Affiliates and no right or interest therein is transferred or granted to Endo except as expressly provided for herein. Endo agrees that it does not acquire a license or any other right to Supplier or its Affiliate’s intellectual property or improvements thereto. Without limiting the foregoing, Supplier and its Affiliates expressly reserve all patent rights directed to end products or to APl(s) in combination
|
8.8.
|
Legal Compliance.
Each Party shall comply in all material respects with all Applicable Laws applicable to the conduct of its business pursuant to this Agreement, including, but not limited to, the FD&C Act.
|
9.
|
ENVIRONMENTAL REPRESENTATIONS AND WARRANTIES
|
9.1.
|
Environmental Representations.
|
9.1.3.
|
Supplier hereby represents and warrants that as of the Effective Date of this Agreement there is no pending or likely governmental enforcement action or private claim against Supplier, no Release or threatened Release of Hazardous Materials, nor any other environmental conditions, events or circumstances that are reasonably likely to limit, impede or otherwise jeopardize the Supplier’s ability to meet its obligations under this Agreement.
|
9.1.4.
|
Supplier shall perform all of the services provided herein in compliance with all Environmental Laws and all necessary environmental or other licenses, registrations, notifications, certificates, approvals, authorizations or permits required under Environmental Laws and any private permission. Supplier shall abate any condition or practice, regardless of whether such condition or practice constitutes non- compliance with Environmental Laws that poses a significant threat to human health, safety, or the environment, or would be reasonably likely to limit, impede, or otherwise jeopardize Supplier’s ability to fulfill its obligations to Endo.
|
9.1.5.
|
Supplier shall be solely responsible for all Environmental Losses incurred during the manufacturing of the Product under this Agreement.
|
9.2.
|
Permits, Licenses and Authorization; notice to Endo.
|
9.2.1.
|
Supplier shall be solely responsible for obtaining, and shall obtain in a timely manner, and maintain in good standing, all necessary environmental or other licenses, registrations, notifications, certificates, approvals, authorizations or permits required under Environmental Laws and any private permissions, whether
de novo
documents or modifications to existing documents, which are necessary to perform the services hereunder, and shall bear all costs and expenses associated therewith.
|
9.2.2.
|
Supplier shall provide copies of all items referenced in Section 9.2.1. to Endo upon request by Endo.
|
9.2.3.
|
Supplier shall provide Endo with immediate verbal notice, confirmed in writing within ***, in the event of any significant condition incident, which shall include any event, occurrence, or circumstance, including any governmental or private action, which could materially impact Supplier’s ability to fulfill its obligations under this Agreement. These include, but are not limited to: (i) material revocation or
|
9.3.
|
Hazardous Materials and Waste
.
|
9.3.1.
|
The generation, collection, storage, handling, transportation, movement of all Hazardous Materials and Waste, as applicable, in compliance with Environmental Laws as well as the investigation, remediation and monitoring of Release or threatened Release of Hazardous Materials shall be the sole responsibility of Supplier at it sole cost and expense. Without limiting other legally applicable requirements, Supplier shall prepare, execute and maintain, as the generator of Waste, all registrations, notices, shipping documents and manifests required under Environmental Laws and in accordance therewith. Supplier shall utilize only reputable and lawful waste transportation and disposal vendors, and shall not knowingly utilize any such vendor whose operations endanger human health or the environment.
|
9.3.2.
|
Supplier acknowledges that the selection of Waste transportation, treatment, and disposal vendors belongs to it alone, subject only to the condition stated in this Section 9.3.
|
9.4.
|
S
upplier’s Waste Liability.
Supplier agrees to release Endo from any liability and waive any claim, pursuant to statute, code, or common law, that Endo is liable to it or to any third party, for any Environmental Loss arising out of the management of Supplier’s Waste.
|
9.5.
|
Equipment
. Supplier shall be solely responsible for the safe operation and maintenance of all equipment used to fulfill its obligations under this Agreement, and all associated employee training, regardless of whether the equipment is owned by Endo, Supplier, or a third party.
|
9.6.
|
Survival
. The representations, warranties and obligations of Supplier under this Section 9 shall survive termination or expiration of this Agreement.
|
10.
|
CO-OPERATION
|
10.1.
|
Governmental Agencies
. Each Party may communicate with any Governmental Agency regarding the Products if, in the opinion of that Party’s counsel, the
|
10.2.
|
Records and Accounting by Supplier
. Supplier will keep records of the Manufacture, testing, and shipping of the Products, and retain samples of the Products as are necessary to comply with Applicable Law, as well as to assist with resolving Product complaints and other similar investigations. Copies of the records and samples will be retained for a period of one year following the date of Product expiry, or longer if required by Applicable Law, at which time Endo will be contacted concerning the delivery and destruction of the documents and/or samples of Products.
|
10.3.
|
Inspection.
Endo may inspect the Manufacturing Site, Supplier facilities, Manufacturing reports, and Manufacturing records relating to this Agreement ***. This limit does not apply to audits for cause. The right of inspection provided in this Section 10.3 does not include a right to access or inspect Supplier’s financial records that are unrelated to Supplier’s performance under this Agreement. If there are regulatory inspections due to new market filings submitted by Endo, the Supplier will communicate in writing to Endo any proposed regulatory inspection audit costs ***.
|
10.4.
|
Access.
Supplier will give Endo access, together with Supplier representatives, to the Manufacturing Site in which the Products are Manufactured, stored, handled, or shipped to permit Endo to verify that the Manufacturing Services are being performed in accordance with the Specifications, cGMPs, and Applicable Laws.
|
10.5.
|
Notification of Regulatory Inspections.
Supplier will notify Endo within five (5) Business Day (if it is permitted by Law) of any inspections by any Governmental Agency specifically involving or potentially affecting the Products. Supplier will also notify Endo of receipt of any form 483’s or warning letters or any other significant regulatory action which Supplier’s quality assurance group determines could impact the regulatory status of the Products.
|
11.
|
TERM; TERMINATION
|
11.1.
|
Term
.
Unless sooner terminated pursuant to the terms hereof, the term of this Agreement shall commence on the Effective Date and shall continue for three (3) years unless terminated early pursuant to this Section (the “Initial Term”). After the expiration of the Initial Term, this Agreement shall automatically renew for
|
11.2.
|
At Will Termination.
This Agreement may be terminated at any time for any reason by either Party with *** to the other Party. *** In the event of any termination of this Agreement or any individual PSS, ***.
|
11.3.
|
Termination for Default; Finished Product Withdrawal, Inability to Supply.
|
11.3.1.
|
Default. This Agreement may be terminated by either Party in the event of the material breach or default by the other Party of the terms and conditions hereof; provided that the other Party shall first give to the defaulting Party written notice of the proposed termination or cancellation of this Agreement, specifying the grounds therefor. Upon receipt of such notice, the defaulting Party shall have *** to respond by curing such default; or by delivering to the other Party a certificate that such breach is not capable of being cured within such *** and that the breaching Party is working diligently to cure such breach; but in no event shall the time period for curing such breach exceed an additional ***. If the breaching Party does not so respond or fails so to work diligently and to cure such breach within the additional time set forth above, then the other Party may either suspend the Agreement indefinitely or terminate the Agreement. Termination of this Agreement pursuant to this Section 11.3.1 shall not affect any other rights or remedies which may be available to the non-defaulting Party.
|
11.3.3.
|
Inability to Supply. at Endo’s sole discretion, Endo may terminate this Agreement immediately by written notice to Supplier upon the occurrence of an Inability to Supply.
|
11.4.
|
Bankruptcy; Insolvency.
Either Party may terminate this Agreement upon the occurrence of either of the following:
|
11.4.1.
|
the entry of a decree or order for relief by a court having jurisdiction in respect of the other Party in an involuntary case under the Federal Bankruptcy Code, as now constituted or hereafter amended, or under any other applicable federal or state insolvency or other similar law and the continuance of any such decree or order unstayed and in effect for a period of sixty (60) consecutive days; or
|
11.4.2.
|
the filing by the other Party of a petition for relief under the Federal Bankruptcy Code, as now constituted or hereafter amended, or any other applicable federal or state insolvency or other similar law.
|
11.5.
|
Termination by Mutual Agreement
This Agreement may be terminated at any time upon mutual written agreement between the Parties duly signed by their authorized signatories.
|
11.6.
|
Expiration: Termination; Consequences.
|
11.6.1.
|
Upon receipt of written notice to terminate this Agreement, both Parties shall promptly meet to finalize a plan to conclude/wind-down Supplier’s activities within ***. Within a reasonable time after any termination of this Agreement, Supplier shall deliver to Endo all work product and Materials resulting from the performance of the Manufacturing Services. Upon receipt of notice of termination of the PSS, Supplier shall cease all work and collect and deliver to Endo whatever work product and Materials then exists in the manner prescribed by Endo in the notice. Any advance payments or other funds held by Supplier that are unearned at the end of the *** shall be returned to Endo within ***. If, however, Endo fails to pay undisputed invoices when due, in addition to its other rights under this Agreement, in law or under equity, Supplier will ***. If Supplier in its discretion determines that its continued performance of Manufacturing Services could constitute a potential or actual violation of regulatory requirements, then Supplier may terminate this Agreement by giving notice stating the effective date of such termination.
|
11.6.2.
|
Upon expiration or termination of this Agreement, whichever is sooner (but in the case of termination, only if directed by the terminating Party in the notice of termination), Supplier shall Manufacture and ship, and Endo shall purchase in accordance with the provisions hereof, any and all amounts of Products ordered by Endo hereunder prior to the date on which such notice is given; provided that, upon termination in respect of a specific Product pursuant to Section 11.3.2. hereof or upon termination pursuant to Section 11.3.3. hereof, Endo shall no longer be obligated to the then current Master Production Plan and shall have no obligation to purchase any further amounts of the applicable Product(s) from Supplier.
|
12.
|
NONCONFORMING PRODUCTS
|
12.2.
|
Disposition of Nonconforming Product.
In any case where Endo expects to make a claim against Supplier with respect to damaged or otherwise nonconforming Product, Endo shall not dispose of such Product without written authorization and instructions of Supplier either to dispose of the Product or to return the Product to Supplier.
|
13.
|
INDEMNIFICATION AND INSURANCE
|
13.1.
|
Indemnification by Endo.
Endo shall indemnify, defend and hold Supplier, its Affiliates and their respective directors, officers, employees, agents, successors and assigns, harmless from and against any damages, judgments, claims, suits, actions liabilities, costs and expenses (including, but not limited to, reasonable attorneys’ fees) resulting from any Third Party claims or suits arising out of (a) Endo’s breach of this Agreement including any of its warranties or representations hereunder, or (b) Endo’s negligent act or omissions or willful misconduct.
|
13.2.
|
Indemnification by Supplier.
Except as otherwise provided in Section 13.1 above, Supplier shall indemnify, defend and hold Endo, its Affiliates and their respective directors, officers, employees, agents, successors and assigns harmless from and against any damages, judgments, claims, suits, actions, liabilities, costs and expenses (including, but not limited to reasonable attorneys’ fees) resulting from any Third Party claims or suits arising out of (a) Supplier’s breach of this Agreement, (b) Supplier’s breach of any of its warranties or representations hereunder, or (c) Supplier’s negligent acts or omissions or willful misconduct.
|
13.3.
|
Limitation of Liability and Claims.
IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, INCLUDING, BUT NOT LIMITED TO, ANY CLAIM FOR DAMAGES BASED UPON LOST PROFITS OR LOST BUSINESS OPPORTUNITY.
|
13.4.
|
Notwithstanding anything contained in this Agreement, Supplier's aggregate liability to Endo and its Affiliates under this Agreement shall be ***.
|
13.5.
|
Insurance.
Each Party shall maintain during the performance of this Agreement the following insurance or self-insurance in amounts no less than that specified for each type:
|
13.5.1.
|
General liability insurance with combined limits of not less than *** and *** for bodily injury, including death, and property damage;
|
13.5.2.
|
Worker’s compensation insurance in the amounts required by the law of the state(s) in which such Party’s workers are located and employer’s liability insurance with limits of not less than ***;
|
13.5.3.
|
In the event that the use of a Supplier-owned motor vehicle is required in the performance of this Agreement, automobile liability insurance with combined limits of not less than *** and *** for bodily injury, including death, and property damage is required; and
|
13.5.4.
|
Product liability insurance with limits not less than ***.
|
13.6.
|
Evidence of Insurance.
Each Party shall provide the other with evidence of its insurance upon written request. Each Party shall provide to the other thirty (30) days, prior written notice of any cancellation or change in its coverage.
|
14.
|
CONFIDENTIALITY
|
14.1.
|
Each of Endo and Supplier agrees not to publish, disclose or use for any purpose other than its performance hereunder any of the other Party’s confidential or proprietary information, including, without limitation, information stored on audio or video tapes and disks, or information or knowledge visually acquired by or generated by Endo or Supplier personnel in the form of written notes and memoranda memorializing information or knowledge acquired visually, aurally or orally as might be the case, in the course, for example, of one Party’s inspection of the other’s Manufacturing or Product records (collectively, “Confidential Information”). Confidential Information includes, without limitation, the terms and conditions of this Agreement. Confidential Information shall also include information of the Endo or Supplier that a reasonable person would consider confidential or proprietary under the circumstances.
|
14.2.
|
Each Party shall limit disclosure of Confidential Information received hereunder to only those of its (or its Affiliates’) officers and employees who are directly concerned with the performance of this Agreement. Each Party shall advise such officers or employees upon disclosure of any Confidential Information to them of the confidential nature of the Confidential Information and the terms and conditions of this Article, and shall use all reasonable safeguards to prevent unauthorized disclosure of the Confidential Information by such officers and employees.
|
14.3.
|
Both Parties agree that the following shall not be considered Confidential Information subject to this Agreement:
|
14.3.1.
|
information that is in the public domain by publication or otherwise, provided that such publication is not in violation of this Agreement by receiving party;
|
14.3.2.
|
information that the receiving Party can establish in writing was in the receiving Party’s possession prior to the time of disclosure by the disclosing Party and was not acquired, directly or indirectly, from the disclosing Party;
|
14.3.3.
|
information that the receiving Party lawfully receives from a Third Party; provided that such Third Party was not legally required to hold such information in confidence;
|
14.3.4.
|
information that, prior to the disclosing Party’s disclosure thereof, was independently developed by the receiving Party without reference to or reliance on any Confidential Information as established by appropriate documentation; and
|
14.3.5.
|
information that the receiving Party is compelled to disclose by a court, administrative agency, or other tribunal; provided that in such case the receiving Party shall immediately give as much advance notice as feasible to the disclosing Party to enable the disclosing Party to exercise its legal rights to prevent and/or limit such disclosure. In any event, the receiving Party shall disclose only that portion of the Confidential Information that is legally required to be disclosed.
|
14.4.
|
All Confidential Information shall remain the property of the disclosing Party. At the termination of this Agreement upon the request of disclosing party, receiving party shall immediately return or destroy any disclosing party Confidential Information in receiving party’s possession, custody or control, except that receiving party may keep one (1) copy for archival purposes.
|
14.5.
|
Each Party acknowledges and expressly agrees that the remedy at law for any breach by it of the terms of this Section 14 shall be inadequate and that the full amount of damages which would result from such breach are not readily susceptible to being measured in monetary terms. Accordingly, in the event of a breach or threatened breach by either Party of this Section 14, the other Party shall be entitled to immediate injunctive relief prohibiting any such breach and requiring the immediate return of all Confidential Information. The remedies set forth in this Section 14 shall be in addition to any other remedies available for any such breach or threatened breach, including the recovery of damages from the breaching Party.
|
14.6.
|
The terms and conditions of this Agreement, but not the fact of its existence, shall constitute Confidential Information of either Party, except that either Party may disclose such terms and conditions to its Affiliates in accordance with Section 14.2 hereof.
|
14.7.
|
The confidentiality obligations of receiving party hereunder shall continue during the term of this Agreement and shall survive for *** from the expiration or termination of this Agreement.
|
15.
|
FORCE MAJEURE
|
15.1.
|
Effects of Force Majeure.
Except for Endo’s obligation to make payments under this Agreement, neither Party shall be held liable or responsible for failure or delay in fulfilling or performing any of its obligations under this Agreement in case such failure or delay is due to any condition beyond the reasonable control of the affected Party including, without limitation, Acts of God, Government/FDA actions or guidance and/or foreign equivalents, strikes or other labor disputes, lockout, war, riot, earthquake, tornado, hurricane, fire, civil disorder, explosion, accident, flood, sabotage, lack of or inability to obtain adequate fuel, power, materials, labor containers, transportation, supplies or equipment, breakage or failure of machinery or apparatus, national defense requirements, or Raw Material’s supplier strike, lockout or injunction (a “Force Majeure Event”). Such excuse shall continue as long as the Force Majeure Event continues, provided that Endo may cancel without penalty any and all Purchase Orders in the event Supplier is unable to fulfill an outstanding Purchase Order within *** of its scheduled Purchase Order Delivery Date due to a Force Majeure Event. Upon cessation of such Force Majeure Event, Supplier shall promptly resume performance on all Purchase Orders which have not been terminated.
|
15.2.
|
Notice of Force Majeure Event.
In the event either Party is delayed or rendered unable to perform due to a Force Majeure Event, the affected Party shall give notice thereof and its expected duration to the other Party promptly after the occurrence of the Force Majeure Event; and thereafter, the obligations of the affected Party will be suspended during the continuance of the Force Majeure Event. The affected Party shall take commercially reasonable steps to remedy the Force Majeure Event with all reasonable dispatch, but such obligation shall not require the settlement of strikes or labor controversies on terms unfavorable to the affected Party.
|
16.
|
PRESS RELEASES; USE OF NAMES
|
16.1.
|
Use of Names.
Except as expressly provided or contemplated hereunder and except as otherwise required by Applicable Law, no right is granted pursuant to this Agreement to either Party to use in any manner the trademarks or name of the other Party, or any other trade name, service mark, or trademark owned by or licensed to the other Party in connection with the performance of this Agreement.
|
16.2.
|
Notwithstanding the above, as may be required by Applicable Law, Endo, Supplier and their respective Affiliates shall be permitted to use the other Party’s name and to disclose the existence of this Agreement in connection with securities or other required public filings, but shall request confidential treatment of sensitive business terms contained herein.
|
17.
|
DISPUTE RESOLUTION; VENUE
|
17.1.
|
Dispute Resolution.
The Parties recognize that a bona fide dispute may from time to time arise while this Agreement is in effect which relates to either Party’s rights and/
|
17.2.
|
ANY LEGAL SUIT, ACTION OR PROCEEDING ARISING OUT OF OR BASED UPON THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY MAY BE INSTITUTED IN THE FEDERAL COURTS OF THE UNITED STATES OF AMERICA LOCATED IN THE STATE OF NEW YORK, AND EACH PARTY IRREVOCABLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF SUCH COURTS IN ANY SUCH SUIT, ACTION OR PROCEEDING. SERVICE OF PROCESS, SUMMONS, NOTICE OR OTHER DOCUMENT BY MAIL TO SUCH PARTY’S ADDRESS SET FORTH HEREIN SHALL BE EFFECTIVE SERVICE OF PROCESS FOR ANY SUIT, ACTION OR OTHER PROCEEDING BROUGHT IN ANY SUCH COURT. THE PARTIES IRREVOCABLY AND UNCONDITIONALLY WAIVE ANY OBJECTION TO THE LAYING OF VENUE OF ANY SUIT, ACTION OR ANY PROCEEDING IN SUCH COURTS AND IRREVOCABLY WAIVE AND AGREE NOT TO PLEAD OR CLAIM IN ANY SUCH COURT THAT ANY SUCH SUIT, ACTION OR PROCEEDING BROUGHT IN ANY SUCH COURT HAS BEEN BROUGHT IN AN INCONVENIENT FORUM.
|
17.3.
|
EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY WHICH MAY ARISE UNDER THIS AGREEMENT IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES AND, THEREFORE, EACH SUCH PARTY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LEGAL ACTION ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (A) NO REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT SEEK TO ENFORCE THE FOREGOING WAIVER IN THE EVENT OF A LEGAL ACTION, (B) SUCH PARTY HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER, (C) SUCH PARTY MAKES THIS WAIVER VOLUNTARILY, AND (D) SUCH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION.
|
18.
|
MISCELLANEOUS
|
18.1.
|
Independent Contractors.
The relationship between Endo and Supplier is that of independent contractors and nothing herein shall be deemed to constitute the relationship of partners, joint venturers, nor of principal and agent between Endo and Supplier. Neither Party shall have any express or implied right or authority to assume
|
18.2.
|
Assignment; Subcontractors.
This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party; provided that either Party may, without such consent, assign this Agreement (a) in connection with the transfer or sale of all or substantially all of the assets of such Party or the line of business of which this Agreement forms a part, (b) in the event of the merger or consolidation of a Party hereto with another; or (c) to any Affiliate of the assigning Party. Any purported assignment in violation of the preceding sentence shall be void. Any permitted assignee shall assume all obligations of its assignor under this Agreement. No assignment shall relieve either Party of responsibility for the performance of any obligation which accrued prior to the effective date of such assignment. Supplier may not use subcontractors to perform any part of this Agreement without Endo’s prior written consent, which consent shall not be unreasonably withheld or unduly delayed.
|
18.3.
|
Continuing Obligations.
Termination, assignment or expiration of this Agreement shall not relieve either Party from full performance of any obligations including payment obligations incurred prior thereto.
|
18.4.
|
Waiver.
Neither Party’s waiver of any breach or failure to enforce any of the terms and conditions of this Agreement, at any time, shall in any way affect, limit or waive such Party’s right thereafter to enforce and compel strict compliance with every term and condition of this Agreement.
|
18.5.
|
Severability.
Each Party hereby expressly agrees that it has no intention to violate any public policy, statutory or common laws, rules, regulations, treaty or decision of any government agency or executive body thereof of any country or community or association of countries, and that if any word, sentence, paragraph, clause or combination thereof in this Agreement is found by a court or executive body with judicial powers having jurisdiction over this Agreement or either Party hereto, in a final unappealled order, to be in violation of any such provisions in any country or community or association of countries, such words, sentences, paragraphs, clauses or combination shall be inoperative in such country or community or association of countries and the remainder of this Agreement shall remain binding upon the Parties, so long as enforcement of the remainder does not violate the Parties’ overall intentions in this transaction.
|
18.6.
|
Exhibits, Schedules and Attachments.
Any and all exhibits, schedules and attachments referred to herein form an integral part of this Agreement and are incorporated into this Agreement by such reference.
|
18.7.
|
Notice.
All notices and other communications required or permitted to be given under this Agreement shall be in writing and shall be delivered personally or sent by (a) registered or certified mail, return receipt requested, (b) a nationally-recognized courier service guaranteeing next-day delivery, charges prepaid or (c) e-mail, as the case may be. Any such notices shall be addressed to the receiving Party at such Party’s address set forth below, or at such other address as may from time to time be furnished by similar notice by either Party.
|
If to Endo:
|
Endo Ventures Limited Minerva House Simmonscourt Road Ballsbridge, Dublin 4, Ireland
|
18.8.
|
Counterparts.
This Agreement and any amendment or supplement hereto may be executed in any number of counterparts and any Party hereto may execute any such counterpart, each of which when executed and delivered shall be deemed to be an original and all of which counterparts taken together shall constitute but one and the same instrument. The execution of this Agreement and any such amendment or supplement by any Party hereto will not become effective until counterparts hereof have been executed by both Parties hereto.
|
18.9.
|
Governing Law; Entire Agreement.
The validity, interpretation and performance of this Agreement shall be governed and construed in accordance with the laws of the State of New York without regard to the choice of laws and conflicts of laws provisions thereof. This Agreement constitutes the full understanding of the Parties and a complete and exclusive statement of the terms of their agreement for the purpose of this Agreement. No terms, conditions, understanding, or agreement purporting to modify or vary the terms of this Agreement shall be binding unless hereafter made in writing and signed by the Party to be bound. No modification to this Agreement shall be effected by the acknowledgement or acceptance of any Purchase Order or shipping instruction forms or similar documents containing terms or conditions at variance with or in addition to those set forth herein.
|
18.10.
|
Headings.
Paragraph headings and captions used herein are for convenience of reference only and shall not be used in the construction or interpretation of this Agreement.
|
18.11.
|
Survival.
Section 8, 11.5, 13.1, 13.2, 13.3, 13.4, 15, 17 and 18 shall survive for five years from the termination or expiration of this Agreement.
|
18.12.
|
Exhibits.
The following Exhibit is attached hereto and incorporated herein by reference:
|
ENDO VENTURES LIMITED
|
|
JUBILANT HOLLISTERSTIER LLC
|
|
|
|
By: /s/Michael Moes
|
|
By: /s/Amit Arora
|
Name: Michael Moes
|
|
Name: Amit Arora
|
Title: Director
|
|
Title: Business Head & CMO
|
1.
|
Services to be Provided and Schedule for Providing Services:
Supplier will render such Services as described below:
|
a.
|
Product
.
|
b.
|
Services
. Supplier will provide the following Services to Endo:
|
c.
|
Free Goods Issue:
|
d.
|
Supplier Liability of Free Goods Issue
.
|
e.
|
Authorized Sub-contractors:
(list)
|
f.
|
Equipment.
|
2.
|
Main Contact at Supplier:
The individual set forth below in this Paragraph shall be Supplier’s primary contact with regard to Services under this PSS:
|
|
|
Title:
|
|
Telephone:
|
|
E-mail:
|
|
Name:
|
|
Title:
|
|
Telephone:
|
|
E-mail:
|
|
3.
|
Fee Rate and Payment Schedule:
Endo shall pay Supplier for the Services performed hereunder in accordance with the payment schedule provided below:
|
a.
|
Product Price in U. S. Dollars:
|
b
.
|
Lock Period:
|
4.
|
The provisions of the Agreement are incorporated by reference and made part of this PSS. This PSS and any attachments, together with the Agreement, shall constitute the entire agreement of the parties with regard to the Services. To the extent that the terms of the PSS and the Agreement are inconsistent, the terms of the Agreement shall control.
|
|
ENDO
|
|
SUPPLIER
|
|
|
|
|
By:
|
|
By:
|
|
Name:
|
Michael Moes
|
Name:
|
|
Title:
|
Director
|
Title:
|
|
1.
|
Establishment and Purpose.
|
2.
|
Administration of the Plan.
|
3.
|
Definitions.
|
4.
|
Stock Subject to the Plan.
|
5.
|
Eligibility.
|
6.
|
Awards Under the Plan.
|
7.
|
Termination of Service.
|
8.
|
Effect of Change in Control.
|
9.
|
Miscellaneous.
|
10.
|
No Special Employment Rights; No Right to Award.
|
11.
|
Securities Matters.
|
12.
|
Withholding Taxes.
|
13.
|
Non-Competition and Confidentiality.
|
14.
|
Notification of Election Under Section 83(b) of the Code.
|
15.
|
Amendment or Termination of the Plan.
|
16.
|
Transfers Upon Death; Nonassignability.
|
17.
|
Effective Date and Term of Plan.
|
18.
|
Applicable Law.
|
19.
|
Participant Rights.
|
20.
|
Unfunded Status of Awards.
|
21.
|
No Fractional Shares.
|
22.
|
Interpretation.
|
1.
|
Term
. The term of this Agreement shall be for the period commencing on August 4, 2016 (the “
Effective Date
”) and ending, subject to earlier termination as set forth in Section 6, on the third anniversary thereof (the “
Employment Term
”).
|
2.
|
Employment
. During the Employment Term:
|
(a)
|
Executive shall serve as Executive Vice President and Chief Financial Officer of Endo and shall be assigned with the customary duties and responsibilities of such position as may reasonably be assigned to Executive from time to time by the Chief Executive Officer of Endo. Executive shall report directly to Endo’s Chief Executive Officer. Executive shall perform the duties, undertake the responsibilities and exercise the authority customarily performed, undertaken and exercised by persons situated in a similar executive capacity. If, at any time, Executive is elected as a director of Endo or as a director or officer of any of Endo’s affiliates, Executive will fulfill Executive’s duties as such director or officer without additional compensation;
provided
, that at the time of Executive’s termination of employment with the Company for any reason, Executive shall resign from the Board of Directors of Endo (the “
Board
”) and or the board of directors of any of Endo’s affiliates.
|
(b)
|
Executive shall devote substantially full-time attention to the business and affairs of the Company and its affiliates. Executive may (i) serve on corporate, civil, charitable or non-profit boards or committees, subject in all cases to the prior approval of the Board and other applicable written policies of the Company and its affiliates as in effect from time to time, and (ii) manage personal and family investments, participate in industry organizations and deliver lectures at educational institutions, so long as no such service or activity unreasonably
|
(c)
|
Executive shall be subject to and shall abide by each of the personnel and compliance policies of the Company and its affiliates applicable and communicated in writing to senior executives.
|
3.
|
Special Equity Compensation
.
|
(a)
|
Initial Performance Share Unit Grant
. On August 11, 2016 (the “
Grant Date
”), Executive shall receive performance share units (“
Initial PSUs
”) under Endo’s 2015 Stock Incentive Plan or any successor plan thereto (the “
Plan
”). The number of Initial PSUs shall be equal to $812,500, divided by the Fair Market Value (as defined in the Plan) of an Endo ordinary share as of the Grant Date (rounded down to the nearest whole share). The Initial PSUs shall vest on the third anniversary of the Grant Date, provided Executive is then employed by the Company or one of its affiliates and subject to the achievement of the applicable performance goals, as determined by the Compensation Committee of the Board (the “
Committee
”), which shall be consistent with the methodology used in respect of performance-vested grants made to Executive in 2016, subject to adjustment for a performance period ending on the third anniversary of the Grant Date. All Initial PSUs shall be subject to the terms and conditions of the Plan and applicable award agreement.
|
(b)
|
Initial Restricted Stock Unit Grant
. On the Grant Date, Executive shall receive restricted stock units under the Plan (the “
Initial RSUs
”). The number of Initial RSUs shall be equal to $1,625,000, divided by the Fair Market Value of an Endo ordinary share as of the Grant Date (rounded down to the nearest whole share). The Initial RSUs shall vest ratably over a three-year period, at a rate of one-third (33 1/3%) of the total Initial RSUs on each of the three anniversaries of the Grant Date, provided Executive is employed on such dates by the Company or one of its affiliates. All Initial RSUs shall be subject to the terms and conditions of the Plan and applicable award agreement.
|
(c)
|
Initial Stock Option Grant
. On the Grant Date, Executive shall receive nonqualified stock options under the Plan (the “
Initial Stock Options
”) valued at $812,500 using a Black Scholes valuation based on the closing price of Endo’s ordinary shares on the Grant Date with methodology determined by the Committee in its sole discretion (rounded down to the nearest whole share). The Initial Stock Options shall vest ratably over a three-year period, at a rate of one-
|
4.
|
Annual Compensation
.
|
(a)
|
Base Salary
. The Company agrees to pay or cause to be paid to Executive during the Employment Term a base salary at the rate of $655,000 per annum or such increased amount in accordance with this Section 4(a) (hereinafter referred to as the “
Base Salary
”). Such Base Salary shall be payable in accordance with the Company’s customary practices applicable to its executives. Such Base Salary shall be reviewed at least annually by the Board or by the Committee, and may be increased in the sole discretion of the Committee, but not decreased.
|
(b)
|
Incentive Compensation
. For each fiscal year of the Company ending during the Employment Term, beginning with the 2016 fiscal year, Executive shall be eligible to receive a target annual cash bonus of 60% of the Base Salary (such target bonus, as may hereafter be increased, the “
Target Bonus
”) with the opportunity to receive a maximum annual cash bonus in accordance with the terms of the applicable annual cash bonus plan as in effect from time to time, subject to the achievement of performance targets set by the Committee. Such annual cash bonus (“
Incentive Compensation
”) shall be paid in no event later than the 15th day of the third month following the end of the taxable year (of the Company or Executive, whichever is later) in which the performance targets have been achieved. If the parties (following good faith negotiation) fail to enter into a new employment agreement following expiration of the Employment Term and Executive terminates his employment within ninety (90) days following expiration of the Employment Term under circumstances that would have constituted Good Reason (as defined in Section 6(e)) had such termination occurred during the Employment Term or if, during such 90-day period, the Company terminates Executive’s employment under circumstances that would not have constituted Cause (as defined in Section 6(c)) had such termination occurred during the Employment Term, then the Company shall pay Executive a Pro-Rata Bonus (as defined in Section 8(b)(ii) hereof) in a lump sum at the time bonuses are payable to other senior executives of the Company.
|
(c)
|
Long-Term Compensation
. During the Employment Term, Executive shall be eligible to receive equity-based compensation to be awarded, in the sole discretion of the Committee, for each fiscal year or part thereof during the Employment
|
5.
|
Other Benefits
.
|
(a)
|
Employee Benefits
. During the Employment Term, Executive shall be entitled to participate in all employee benefit plans, practices and programs maintained by the Company or its affiliates and made available to employees generally, including, without limitation, all pension, retirement, profit sharing, savings, medical, hospitalization, disability, dental, life or travel accident insurance benefit plans, to the extent Executive is eligible under the terms of such plans. Executive’s participation in such plans, practices and programs shall be on the same basis and terms as are applicable to employees of the Company generally. Executive is responsible for any taxes (other than taxes that are the Company’s responsibility) that may be due based upon the value of the benefits provided.
|
(b)
|
Executive Benefits
. During the Employment Term, Executive shall be entitled to participate in all executive benefit or incentive compensation plans now maintained or hereafter established by the Company or its affiliates for the purpose of providing compensation and/or benefits to comparable executive employees of the Company including, but not limited to, the Company’s deferred
|
(c)
|
Fringe Benefits and Perquisites
. During the Employment Term, Executive shall be entitled to all fringe benefits and perquisites generally made available by the Company or its affiliates to its senior executives in accordance with current Company policy. For the avoidance of doubt, Executive shall not be entitled to any excise tax gross-up under Section 280G or Section 4999 of the Internal Revenue Code of 1986, as amended (the “
Code
”) (or any successor provision), or any other tax gross-up.
|
(d)
|
Business Expenses
. Upon submission of proper invoices in accordance with the Company’s normal procedures, Executive shall be entitled to receive prompt reimbursement of all reasonable out-of-pocket business, entertainment and travel expenses incurred by Executive in connection with the performance of Executive’s duties hereunder. Such reimbursement shall be made in no event later than the end of the calendar year following the calendar year in which the expenses were incurred.
|
(e)
|
Office and Facilities
. During the Employment Term, Executive shall be provided with an appropriate office at the Company’s headquarters, with such secretarial and other support facilities as are commensurate with Executive’s status with the Company and its affiliates, which facilities shall be adequate for the performance of Executive’s duties hereunder.
|
(f)
|
Vacation and Sick Leave
. Executive shall be entitled, without loss of pay, to absent himself voluntarily from the performance of Executive’s employment under this Agreement, pursuant to the following:
|
(i)
|
Executive shall be entitled to annual vacation in accordance with the vacation policies of the Company as in effect from time to time, which shall in no event be less than four weeks per year; vacation must be taken at such time or times as approved by the Chief Executive Officer; and
|
(ii)
|
Executive shall be entitled to sick leave (without loss of pay) in accordance with the Company’s policies as in effect from time to time.
|
6.
|
Termination
. The Employment Term and Executive’s employment hereunder may be terminated under the circumstances set forth below;
provided
,
however
, that notwithstanding anything contained herein to the contrary, Executive shall not be considered to have terminated employment with the Company for purposes of this Agreement unless Executive would be considered to have incurred a “separation from service” from the Company within the meaning of Section 409A of the Code.
|
(a)
|
Disability
. The Company may terminate Executive’s employment, on written notice to Executive after having reasonably established Executive’s Disability. For purposes of this Agreement, Executive will be deemed to have a “
Disability
” if, as a result of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, Executive is unable to perform the core functions of Executive’s position (with or without reasonable accommodation) or is receiving income replacement benefits for a period of six months or more under the Company’s long-term disability plan. Executive shall be entitled to the compensation and benefits provided for under this Agreement for any period prior to Executive’s termination by reason of Disability during which Executive is unable to work due to a physical or mental infirmity in accordance with the Company’s policies for similarly-situated executives.
|
(b)
|
Death
. Executive’s employment shall be terminated as of the date of Executive’s death.
|
(c)
|
Cause
. The Company may terminate Executive’s employment for Cause (as defined below), effective as of the date of the Notice of Termination (as defined in Section 7 below) and as evidenced by a resolution adopted by two-thirds of the independent members of the Board. “Cause” shall mean, for purposes of this Agreement: (a) the continued failure by Executive substantially to perform Executive’s duties under this Agreement (other than any such failure resulting from Disability or other illness); (b) Executive makes, or is found to have made, a certification relating to the Company’s financial statements that Executive knows is false; (c) the criminal felony indictment of Executive by a court of competent jurisdiction; (d) the engagement by Executive in misconduct that has caused, or in the good faith judgment of the Board may cause if not discontinued, material harm (financial or otherwise) to the Company or any of its affiliates, such harm to include, without limitation, (i) the willful disclosure of material secret or
|
(d)
|
Without Cause
. The Company may terminate Executive’s employment without Cause. The Company shall deliver to Executive a Notice of Termination (as defined in Section 7 below) not less than thirty (30) days prior to the termination of Executive’s employment without Cause and the Company shall have the option of terminating Executive’s duties and responsibilities prior to the expiration of such thirty-day notice period provided the Company pays Base Salary through the end of such notice period.
|
(e)
|
Good Reason
. Executive may terminate employment with the Company for Good Reason (as defined below) by delivering to the Company a Notice of Termination (as defined in Section 7 below) not less than thirty (30) days prior to the termination of Executive’s employment for Good Reason. The Company shall have the option of terminating Executive’s duties and responsibilities prior to the expiration of such thirty-day notice period. For purposes of this Agreement, “
Good Reason
” means any of the following: (i) a diminution in Executive’s Base Salary, Target Bonus (provided that in no event shall a failure to earn a bonus equal or in excess of the Target Bonus by reason of failure to achieve applicable performance goals be deemed Good Reason) or a material diminution in benefits; (ii) a material, adverse change to Executive’s position, duties or responsibilities without Executive’s express written consent; (iii) any change in reporting structure such that Executive is required to report to someone other than Endo’s
|
(f)
|
Without Good Reason
. Executive may voluntarily terminate Executive’s employment without Good Reason by delivering to the Company a Notice of Termination not less than thirty (30) days prior to the termination of Executive’s employment and the Company shall have the option of terminating Executive’s duties and responsibilities prior to the expiration of such thirty-day notice period.
|
7.
|
Notice of Termination
. Any purported termination by the Company or by Executive shall be communicated by written Notice of Termination to the other party hereto. For purposes of this Agreement, a “
Notice of Termination
” shall mean a notice that indicates a termination date, the specific termination provision in this Agreement relied upon and sets forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of Executive’s employment under the provision so indicated. For purposes of this Agreement, no such purported termination of Executive’s employment hereunder shall be effective without such Notice of Termination (unless waived by the party entitled to receive such notice).
|
8.
|
Compensation Upon Termination
. Upon termination of Executive’s employment during the Employment Term, Executive shall be entitled to the following benefits:
|
(a)
|
Termination by the Company for Cause or by Executive Without Good Reason
. If Executive’s employment is terminated by the Company for Cause or by Executive without Good Reason, the Company shall pay Executive all amounts earned or accrued hereunder through the termination date, including:
|
(i)
|
any accrued and unpaid Base Salary, payable on the next payroll date;
|
(ii)
|
any Incentive Compensation earned but unpaid in respect of any completed fiscal year preceding the termination date, payable at the time incentive compensation is paid to other senior executives;
|
(iii)
|
reimbursement for any and all monies advanced or expenses incurred in connection with Executive’s employment for reasonable and necessary expenses incurred by Executive on behalf of the Company for the period ending on the termination date, which amount shall be reimbursed within thirty (30) days of the Company’s receipt of proper documentation from Executive;
|
(iv)
|
any accrued and unpaid vacation pay, payable on the next payroll date;
|
(v)
|
any previous compensation that Executive has previously deferred (including any interest earned or credited thereon), in accordance with the terms and conditions of the applicable deferred compensation plans or arrangements then in effect, to the extent vested as of Executive’s termination date, paid pursuant to the terms of such plans or arrangements; and
|
(vi)
|
any amount or benefit as provided under any benefit plan or program in accordance with the terms thereof; (the foregoing items in Sections 8(a)(i) through 8(a)(vi) being collectively referred to as the “
Accrued Compensation
”).
|
(b)
|
Termination by the Company for Disability
. If Executive’s employment is terminated by the Company for Disability, the Company shall pay Executive:
|
(i)
|
the Accrued Compensation;
|
(ii)
|
an amount equal to the Incentive Compensation that Executive would have been entitled to receive in respect of the fiscal year in which Executive’s termination date occurs, had Executive continued in employment until the end of such fiscal year, which amount, determined based on actual performance for such year relative to the performance goals applicable to Executive (but without any exercise of negative discretion with respect to Executive in excess of that applied to either senior executives of the Company generally or in accordance with the Company’s historical past practice), shall be multiplied by a fraction (A) the numerator of which is the number of days in such fiscal year through the termination date and (B) the denominator of which is 365 (the “
Pro-Rata Bonus
”) and shall be
|
(iii)
|
continued coverage for Executive and Executive’s dependents under any health, medical, dental, vision or life insurance program or policy in which Executive was eligible to participate as of the time of Executive’s employment termination, for two (2) years following such termination on the same basis as active employees, which such two year period shall run concurrently with the COBRA period, and which coverage shall become secondary to any coverage provided to Executive by a subsequent employer and to any Medicare coverage for which Executive becomes eligible;
provided
,
however
, the parties agree to cooperate such that the continued coverage is, to the extent practicable, provided in a manner so as to minimize adverse tax consequences to the Company.
|
(c)
|
Termination By Reason of Death
. If Executive’s employment is terminated by reason of Executive’s death, the Company shall pay Executive’s beneficiaries:
|
(i)
|
the Accrued Compensation;
|
(ii)
|
the Pro-Rata Bonus; and
|
(iii)
|
continued coverage for Executive’s dependents under any health, medical, dental, vision or life insurance program or policy in which Executive was eligible to participate as of the time of Executive’s employment termination, for two (2) years following such termination on terms no less favorable to Executive’s dependents (including with respect to payment for the costs thereof) than those in effect immediately prior to such termination, which such two year period shall run concurrently with the COBRA period.
|
(d)
|
Termination by the Company Without Cause or by Executive for Good Reason
. If Executive’s employment by the Company shall be terminated by the Company without Cause (other than on account of Executive’s Disability or death) or by Executive for Good Reason, then, subject to Section 14(f) of this Agreement, Executive shall be entitled to the benefits provided in this Section 8(d):
|
(i)
|
the Accrued Compensation;
|
(ii)
|
the Pro-Rata Bonus;
|
(iii)
|
in lieu of any further Base Salary or other compensation and benefits for periods subsequent to the termination date, an amount in cash, which amount shall be payable in a lump sum payment within sixty (60) days following such termination (subject to Section 9(c)), equal to two (2) times the sum of (A) Executive’s Base Salary and (B) the Target Bonus; and
|
(iv)
|
accelerated vesting, non-forfeitability and exercisability, as of the termination date, of the Initial RSUs, the Initial Stock Options and, solely to the extent provided for in the applicable award agreement, the Initial PSUs;
|
(v)
|
continued coverage under any health, medical, dental, vision or life insurance program or policy in which Executive was eligible to participate as of the time of Executive’s employment termination for two (2) years following such termination on the same basis as active employees, which such two year period shall run concurrently with the COBRA period, and which coverage shall become secondary to any coverage provided to Executive by a subsequent employer and to any Medicare coverage for which Executive becomes eligible. Notwithstanding the above, in the event such continued coverage, by reason of change in the applicable law, may, in the Company’s reasonable view, result in tax or other penalties on the Company, this provision shall terminate and the parties shall, in good faith, negotiate for a substitute provision that provides substantially similar benefit to Executive but does not result in such tax or other penalties.
|
(e)
|
No Mitigation
. Executive shall not be required to mitigate the amount of any payment provided for under this Section 8 by seeking other employment or otherwise and, except as provided in Section 8(b)(iii) and 8(d)(v) above, no such payment shall be offset or reduced by the amount of any compensation or benefits provided to Executive in any subsequent employment. Further, the Company’s obligations to make any payments hereunder shall not be subject to or affected by any set-off, counterclaim or defense which the Company may have against Executive.
|
9.
|
Certain Tax Treatment
.
|
(a)
|
Golden Parachute Tax
. To the extent that the payments and benefits provided under this Agreement and benefits provided to, or for the benefit of, Executive under any other plan or agreement of the Company or any of its affiliates (such payments or benefits are collectively referred to as the “
Payments
”) would be subject to the excise tax (the “
Excise Tax
”) imposed under Section 4999 of the Code or any successor provision thereto, or any similar tax imposed by state or local law, then Executive may, in his sole discretion, (except as provided herein below) waive the right to receive any payments or distributions (or a portion thereof) by the Company in the nature of compensation to or for Executive’s benefit if and to the extent necessary so that no Payment to be made or benefit to be provided to Executive shall be subject to the Excise Tax (such reduced amount is hereinafter referred to as the “
Limited Payment Amount
”), but only if such reduction results in a higher after-tax payment to Executive after taking into account the Excise Tax and any additional taxes (including federal, state and local income taxes, employment, social security and Medicare taxes and all other applicable taxes) Executive would pay if such Payments and benefits were not reduced. If so waived, the Company shall reduce or eliminate the Payments provided under Section 8, to effect the provisions of this Section 9 based upon Section 9(b) below. The determination of the amount of Payments that would be required to be reduced to the Limited Payment Amount pursuant to this Agreement and the amount of such Limited Payment Amount shall be made, at the Company’s expense, by a reputable accounting firm selected by Executive and reasonably acceptable to the Company (the “
Accounting Firm
”). The Accounting Firm shall provide its determination (the “
Determination
”), together with detailed supporting calculations and documentation to the Company and Executive within ten (10) days of the date of termination, if applicable, or such other time as specified by mutual agreement of the Company and Executive, and if the Accounting Firm determines that no Excise Tax is payable by Executive with respect to the Payments, it shall furnish Executive with an opinion reasonably acceptable to Executive that no Excise Tax will be imposed with respect to any such Payments. The Determination shall be binding, final and conclusive upon the Company and Executive, absent manifest error. For purposes of making the calculations required by this Section 9(a), the Accounting Firm may make reasonable assumptions and approximations concerning applicable taxes and rates, and rely on reasonable, good faith interpretations concerning the application of the Code, and other applicable legal authority. In furtherance of the above, to the extent requested by Executive, the Company shall cooperate in good faith in valuing, and the Accounting Firm shall value, services to be provided by Executive (including Executive refraining from performing services pursuant to
|
(b)
|
Ordering of Reduction
. In the case of a reduction in the Payments pursuant to Section 9(a), the Payments will be reduced in the following order: (i) payments that are payable in cash that are valued at full value under Treasury Regulation Section 1.280G-1, Q&A 24(a) will be reduced (if necessary, to zero), with amounts that are payable last reduced first; (ii) payments and benefits due in respect of any equity valued at full value under Treasury Regulation Section 1.280G-1, Q&A 24(a), with the highest values reduced first (as such values are determined under Treasury Regulation Section 1.280G-1, Q&A 24) will next be reduced; (iii) payments that are payable in cash that are valued at less than full value under Treasury Regulation Section 1.280G-1, Q&A 24, with amounts that are payable last reduced first, will next be reduced; (iv) payments and benefits due in respect of any equity valued at less than full value under Treasury Regulation Section 1.280G-1, Q&A 24, with the highest values reduced first (as such values are determined under Treasury Regulation Section 1.280G-1, Q&A 24) will next be reduced; and (v) all other non-cash benefits not otherwise described in clauses (ii) or (iv) will be next reduced pro-rata.
|
(c)
|
Section 409A
. The parties intend for the payments and benefits under this Agreement to be exempt from Section 409A of the Code or, if not so exempt, to be paid or provided in a manner which complies with the requirements of such section, and intend that this Agreement shall be construed and administered in accordance with such intention. In the event the Company determines that a payment or benefit under this Agreement may not be in compliance with Section 409A of the Code, subject to Section 5(c) herein, the Company shall reasonably confer with Executive in order to modify or amend this Agreement to comply with Section 409A of the Code and to do so in a manner to best preserve the economic benefit of this Agreement. Notwithstanding anything contained herein to the contrary, to the extent required in order to avoid accelerated taxation and/or tax penalties under Section 409A of the Code, (i) no amounts shall be paid to Executive under Section 8 of this Agreement until Executive would be considered to have incurred a “separation from service” from the Company within the meaning of Section 409A of the Code, (ii) amounts that would otherwise be payable and benefits that would otherwise be provided pursuant to this Agreement during the six-month period immediately following Executive’s separation from service shall instead be paid on the first business day after the date that is six (6)
|
10.
|
Records and Confidential Data
.
|
(a)
|
Executive acknowledges that in connection with the performance of Executive’s duties during the Employment Term, the Company and its affiliates will make available to Executive, or Executive will develop and have access to, certain Confidential Information (as defined below) of the Company and its affiliates. Executive acknowledges and agrees that any and all Confidential Information learned or obtained by Executive during the course of Executive’s employment by the Company or otherwise, whether developed by Executive alone or in conjunction with others or otherwise, shall be and is the property of the Company and its affiliates.
|
(b)
|
Confidential Information (as defined below) will be kept confidential by Executive, will not be used in any manner that is detrimental to the Company or its affiliates, will not be used other than in connection with Executive’s discharge of Executive’s duties hereunder, and will be safeguarded by Executive from unauthorized disclosure;
provided
,
however
, that Confidential Information may be disclosed by Executive (v) to the Company and its affiliates, or to any authorized agent or representative of any of them, (w) in connection with performing his duties hereunder, (x) without limiting Section 10(g) of this Agreement, when required to do so by law or requested by a court, governmental agency, legislative body, arbitrator or other person with apparent jurisdiction to order him to divulge, disclose or make accessible such information, provided that Executive, to the
|
(c)
|
On Executive’s last day of employment with the Company, or at such earlier date as requested by the Company, (i) Executive will return to the Company all written Confidential Information (as defined below) that has been provided to, or prepared by, Executive; (ii) at the election of the Company, Executive will return to the Company or destroy all copies of any analyses, compilations, studies or other documents prepared by Executive or for Executive’s use containing or reflecting any Confidential Information; and (iii) Executive will return all Company property. Executive shall deliver to the Company a document certifying his compliance with this Section 10(c).
|
(d)
|
For the purposes of this Agreement, “
Confidential Information
” shall mean all confidential and proprietary information of the Company and its affiliates, including, without limitation,
|
(i)
|
trade secrets concerning the business and affairs of the Company and its affiliates, product specifications, data, know-how, formulae, compositions, processes, non-public patent applications, designs, sketches, photographs, graphs, drawings, samples, inventions and ideas, past, current, and planned research and development, current and planned manufacturing or distribution methods and processes, customer lists, current and anticipated customer requirements, price lists, market studies, business plans, computer software and programs (including object code and source code), computer software and database technologies, systems, structures, and architectures (and related formulae, compositions, processes, improvements, devices, know-how, inventions, discoveries, concepts, ideas, designs, methods and information);
|
(ii)
|
information concerning the business and affairs of the Company and its affiliates (which includes unpublished financial statements, financial projections and budgets, unpublished and projected sales, capital spending budgets and plans, the names and backgrounds of key personnel, to the
|
(iii)
|
notes, analysis, compilations, studies, summaries, and other material prepared by or for the Company or its affiliates containing or based, in whole or in part, on any information included in the foregoing. For purposes of this Agreement, Confidential Information shall not include and Executive’s obligations shall not extend to (i) information that is generally available to the public, (ii) information obtained by Executive other than pursuant to or in connection with this employment, (iii) information that is required to be disclosed by law or legal process, and (iv) Executive’s rolodex and similar address books, including electronic address books, containing contact information.
|
(e)
|
Nothing herein or elsewhere shall preclude Executive from retaining and using (i) his personal papers and other materials of a personal nature, including, without limitation, photographs, contacts, correspondence, personal diaries, and personal files (so long as no such materials are covered by any Company hold order), (ii) documents relating to his personal entitlements and obligations, and (iii) information that is necessary for his personal tax purposes.
|
(f)
|
Executive’s obligations under this Section 10 shall survive the termination of the Employment Term.
|
(g)
|
Pursuant to Section 1833(b) of the Defend Trade Secrets Act of 2016, Executive acknowledges that Executive shall not have criminal or civil liability under any federal or State trade secret law for the disclosure of a trade secret that (i) is made (A) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney and (B) solely for the purpose of reporting or investigating a suspected violation of law; or (ii) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. Nothing in this Agreement is intended to conflict with Section 1833(b) of the Defend Trade Secrets Act of 2016 or create liability for disclosures of trade secrets that are expressly allowed by such Section.
|
11.
|
Covenant Not to Solicit, Not to Compete, Not to Disparage, to Cooperate in Litigation and Not to Cooperate with Non-Governmental Third Parties
.
|
(a)
|
Covenant Not to Solicit
. To protect the Confidential Information and other trade secrets of the Company and its affiliates as well as the goodwill and competitive business of the Company and its affiliates, Executive agrees, during the
|
(b)
|
Covenant Not to Compete
.
|
(i)
|
The Company and its affiliates are currently engaged in the business of branded and generic pharmaceuticals, with a focus on product development, clinical development, manufacturing, distribution and sales & marketing. To protect the Confidential Information and other trade secrets of the Company and its affiliates as well as the goodwill and competitive business of the Company and its affiliates, Executive agrees, during the Employment Term and for a period of eighteen (18) months after Executive’s cessation of employment with the Company, that Executive will not anywhere in the world where, at the time of Executive’s termination of employment, the Company develops, manufactures, distributes, markets or sells its products, except in the course of Executive’s employment hereunder, directly or indirectly manage, operate, control, or participate in the management, operation, or control of, be employed by, associated with, or in any manner connected with, lend Executive’s name to, or render services or advice to, any third party or any business whose products or services compete in whole or in part with the products or services (both on the market and in development) material to the Company or any business unit on the termination date that constitutes more than 5% of the Company’s revenue on the termination date (a “Competing Business”);
provided
,
however
, that Executive may in any event (x) own up to a 5% passive ownership interest in any public or private entity and (y) serve on the board of any Competing Business that
|
(ii)
|
For purposes of this Section 11(b), any third party or any business whose products compete includes any entity with which the Company or its affiliates has had a product(s) licensing agreement during the Employment Term and any entity with which the Company or any of its affiliates is at the time of termination actively negotiating, and eventually concludes within twelve (12) months of the Employment Term, a commercial agreement.
|
(iii)
|
Notwithstanding the foregoing, it shall not be a violation of this Section 11(b), for Executive to provide services to (or engage in activities involving): (A) a subsidiary, division or affiliate of a Competing Business where such subsidiary, division or affiliate is not engaged in a Competing Business and Executive does not provide services to, or have any responsibilities regarding, the Competing Business; (B) any entity that is, or is a general partner in, or manages or participates in managing, a private or public fund (including, without limitation, a hedge fund) or other investment vehicle, which is engaged in venture capital investments, leveraged buy-outs, investments in public or private companies, other forms of private or alternative equity transactions, or in public equity transactions, and that might make an investment which Executive could not make directly, provided that in connection therewith, Executive does not provide services to, engage in activities involved with, or have any responsibilities regarding a Competing Business; and (C) an affiliate of a Competing Business if Executive does not provide services, directly or indirectly, to such Competing Business and the basis of the affiliation is solely due to common ownership by a private equity or similar investment fund;
provided
, that, in each case, Executive shall remain bound by all other post-employment obligations under this Agreement including, but not limited to, Executive’s obligations under Sections 10, 11(a), (c) and (d) herein;
provided
, further, that Executive’s provision of services to (or engagement in activities involving) any entity described in clauses (A) or (B) of this Section 11(b)(iii) shall be subject to the prior approval of the Board.
|
(c)
|
Nondisparagement
. Executive covenants that during and following the Employment Term, Executive will not disparage or encourage or induce others to
|
(d)
|
Cooperation in Any Investigations and Litigation; No Cooperation with Non-Governmental Third Parties
. Executive agrees that Executive will reasonably cooperate with the Company and its affiliates, and its counsel, in connection with any investigation, inquiry, administrative proceeding or litigation relating to any matter in which Executive was involved or of which Executive has knowledge as a result of Executive’s service with the Company by providing truthful information. Such cooperation shall be subject to Executive’s business and personal commitments and shall not require Executive to cooperate against his own legal interests or the legal interests of any future employer of Executive. The Company agrees to promptly reimburse Executive for reasonable expenses reasonably incurred by Executive, in connection with Executive’s cooperation pursuant to this Section 11(d) (including travel expenses at the level of travel permitted by this Agreement and reasonable attorney fees in the event Executive reasonably determines that separate legal counsel for Executive is appropriate). Such reimbursements shall be made as soon as practicable, and in no event later
|
(e)
|
Blue Pencil
. It is the intent and desire of Executive and the Company that the provisions of this Section 11 be enforced to the fullest extent permissible under the laws and public policies as applied in each jurisdiction in which enforcement is sought. If any particular provision of this Section 11 shall be determined to be invalid or unenforceable, such covenant shall be amended, without any action on the part of either party hereto, to delete therefrom the portion so determined to be invalid or unenforceable, such deletion to apply only with respect to the operation of such covenant in the particular jurisdiction in which such adjudication is made.
|
(f)
|
Survive
. Executive’s obligations under this Section 11 shall survive the termination of the Employment Term.
|
12.
|
Remedies for Breach of Obligations under Sections 10 or 11 hereof
. Executive acknowledges that the Company and its affiliates will suffer irreparable injury, not readily
|
13.
|
Representations and Warranties
.
|
(a)
|
The Company represents and warrants that (i) it is fully authorized by action of the Board (and of any other person or body whose action is required) to enter into this Agreement and to perform its obligations under it, (ii) the execution, delivery and performance of this Agreement by it does not violate any applicable law, regulation, order, judgment or decree or any agreement, arrangement, plan or corporate governance document (x) to which it is a party or (y) by which it is bound, and (iii) upon the execution and delivery of this Agreement by the parties, this Agreement shall be its valid and binding obligation, enforceable against it in accordance with its terms, except to the extent that enforceability may be limited by applicable bankruptcy, insolvency or similar laws affecting the enforcement of creditors’ rights generally.
|
(b)
|
Executive represents and warrants to the Company that the execution and delivery by Executive of this Agreement do not, and the performance by Executive of Executive’s obligations hereunder will not, with or without the giving of notice or the passage of time, or both: (a) violate any judgment, writ, injunction, or order of any court, arbitrator, or governmental agency applicable to Executive; or (b) conflict with, result in the breach of any provisions of or the termination of, or constitute a default under, any agreement to which Executive is a party or by which Executive is or may be bound.
|
14.
|
Miscellaneous
.
|
(a)
|
Successors and Assigns
.
|
(i)
|
This Agreement shall be binding upon and shall inure to the benefit of the Company, its successors and permitted assigns and the Company shall require any successor or permitted assign to expressly assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform if no such succession or assignment had taken place. The Company may not assign or delegate any rights or obligations hereunder except to a successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of the Company. The term the “Company” as used herein shall include a corporation or other entity acquiring all or substantially all the assets and business of the Company (including this Agreement) whether by operation of law or otherwise.
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(ii)
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Neither this Agreement nor any right or interest hereunder shall be assignable or transferable by Executive, Executive’s beneficiaries or legal representatives, except by will or by the laws of descent and distribution. This Agreement shall inure to the benefit of and be enforceable by Executive’s legal personal representatives.
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(b)
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Fees and Expenses
. The Company shall pay reasonable and documented legal fees and related expenses, up to a maximum amount of $15,000, incurred by Executive in connection with the negotiation of this Agreement and related employment arrangements. Such reimbursement shall be made as soon as practicable, but in no event later than the end of the calendar year following the calendar year in which the expenses were incurred. Executive is responsible for any taxes that may be due based upon the value of the fees and expenses reimbursed by the Company. Executive acknowledges that Executive has had the opportunity to consult with legal counsel of Executive’s choice in connection with the drafting, negotiation and execution of this Agreement and related employment arrangements.
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(c)
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Notice
. For the purposes of this Agreement, notices and all other communications provided for in the Agreement (including the Notice of Termination) shall be in writing and shall be deemed to have been duly given when personally delivered or sent by Certified mail, return receipt requested, postage prepaid, addressed to the respective addresses last given by each party to the other;
provided
, that all notices to the Company shall be directed to the attention of the Chief Legal Officer of the Company with a copy to the Chairman of the Committee. All notices and communications shall be deemed to have been received on the date of delivery thereof or on the third business day after the mailing thereof, except that notice of change of address shall be effective only upon receipt.
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(d)
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Indemnification
. Executive shall be indemnified by the Company as, and to the extent, to the maximum extent permitted by applicable law as provided in the memorandum and articles of association of Endo. In addition, the Company agrees to continue and maintain, at the Company’s sole expense, a directors’ and officers’ liability insurance policy covering Executive both during and the Employment Term and while the potential liability exists (but in no event longer than six (6) years, if such limitation applies to all other individuals covered by such policy) after the Employment Term, that is no less favorable than the policy covering Board members and other executive officers of the Company from time to time. The obligations under this paragraph shall survive any termination of the Employment Term.
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(e)
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Withholding
. The Company shall be entitled to withhold the amount, if any, of all taxes of any applicable jurisdiction required to be withheld by an employer with respect to any amount paid to Executive hereunder. The Company, in its sole and absolute discretion, shall make all determinations as to whether it is obligated to withhold any taxes hereunder and the amount thereof.
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(f)
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Release of Claims
. The termination benefits described in Section 8(d) and Section 8(e) of this Agreement shall be conditioned on Executive delivering to the Company, a signed release of claims in the form of Exhibit A hereto within forty-five (45) days or twenty-one (21) days, as may be applicable under the Age Discrimination in Employment Act of 1967, as amended by the Older Workers Benefit Protection Act, following Executive’s termination date, and not revoking Executive’s consent to such release of claims within seven (7) days of such execution;
provided
,
however
, that Executive shall not be required to release any rights Executive may have to be indemnified by, or be covered under any directors’ and officers’ liability insurance of, the Company under Section 14(d) of this Agreement and provided further that, following a Change in Control, Executive’s requirement to deliver a release shall be contingent on the Company delivering to Executive a release of claims in the form of Exhibit A hereto.
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(g)
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Resignation as Officer or Director
. Upon a termination of employment for any reason, Executive shall, resign each position (if any) that Executive then holds as an officer or director of the Company and any of its affiliates. Executive’s execution of this Agreement shall be deemed the grant by Executive to the officers of the Company of a limited power of attorney to sign in Executive’s name and on Executive’s behalf any such documentation as may be required to be executed solely for the limited purposes of effectuating such resignations.
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(h)
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Executive Acknowledgement
. Executive acknowledges Common Stock Ownership Guidelines for Non-Employee Directors and Executive Management of Endo International plc, as may be amended from time to time, and Endo’s compensation recoupment policy, as may be amended from time to time.
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(i)
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Modification
. No provision of this Agreement may be modified, waived or discharged unless such waiver, modification or discharge is agreed to in writing and signed by Executive and the Company. No waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any condition or provision of this Agreement to be performed by such other party shall be deemed a waiver of similar or dissimilar provisions or conditions at the same or at any prior or subsequent time. No agreement or representations, oral or otherwise, express or implied, with respect to the subject matter hereof have been made by either party which are not expressly set forth in this Agreement.
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(j)
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Effect of Other Law
. Anything herein to the contrary notwithstanding, the terms of this Agreement shall be modified to the extent required to meet the provisions of the Sarbanes-Oxley Act of 2002, Section 409A, or other federal law applicable to the employment arrangements between Executive and the Company. Any delay in providing benefits or payments, any failure to provide a benefit or payment, or any repayment of compensation that is required under the preceding sentence shall not in and of itself constitute a breach of this Agreement;
provided
,
however
, that the Company shall provide economically equivalent payments or benefits to Executive to the extent permitted by law.
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(k)
|
Governing Law
. This Agreement shall be governed by and construed and enforced in accordance with the laws of the State of Delaware applicable to contracts executed in and to be performed entirely within such State, without giving effect to the conflict of law principles thereof. Any dispute hereunder may be adjudicated in any Federal or state court sitting in the State of Delaware or, at the Company’s election, in any other state in which Executive maintains Executive’s principal residence or Executive’s principal place of business.
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(l)
|
No Conflicts
. (A) Executive represents and warrants to the Company that Executive is not a party to or otherwise bound by any agreement or arrangement (including, without limitation, any license, covenant, or commitment of any nature), or subject to any judgment, decree, or order of any court or administrative agency, that would conflict with or will be in conflict with or in any way preclude, limit or inhibit Executive’s ability to execute this Agreement or to carry out Executive’s duties and responsibilities hereunder. (B) The Company represents
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(m)
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Severability
. The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision shall not affect the validity or enforceability of the other provisions hereof.
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(n)
|
Inconsistencies
. In the event of any inconsistency between any provision of this Agreement and any provision of any employee handbook, personnel manual, program, policy, or arrangement of the Company or its affiliates (including, without limitation, any provisions relating to notice requirements and post-employment restrictions), the provisions of this Agreement shall control, unless Executive otherwise agrees in a writing that expressly refers to the provision of this Agreement whose control he is waiving.
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(o)
|
Beneficiaries/References
. In the event of Executive’s death or a judicial determination of his incompetence, references in this Agreement to Executive shall be deemed, where appropriate, to refer to his beneficiary, estate or other legal representative.
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(p)
|
Survivorship
. Except as otherwise set forth in this Agreement, the respective rights and obligations of the parties hereunder shall survive the Employment Term and any termination of Executive’s employment. Without limiting the generality of the forgoing, the provisions of Section 8, 10, 11, and 12 shall survive the Employment Term.
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(q)
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Entire Agreement
. This Agreement constitutes the entire agreement between the parties hereto and supersedes all prior agreements, if any, understandings and arrangements, oral or written, between the parties hereto with respect to the subject matter hereof.
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(r)
|
Counterparts
. This Agreement may be executed in one or more counterparts, each of which will be deemed to be an original copy of this Agreement and all of which, when taken together, will be deemed to constitute one and the same agreement.
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15.
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Certain Rules of Construction
.
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(a)
|
The headings and subheadings set forth in this Agreement are inserted for the convenience of reference only and are to be ignored in any construction of the terms set forth herein.
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(b)
|
Wherever applicable, the neuter, feminine or masculine pronoun as used herein shall also include the masculine or feminine, as the case may be.
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(c)
|
The term “including” is not limiting and means “including without limitation.”
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(d)
|
References in this Agreement to any statute or statutory provisions include a reference to such statute or statutory provisions as from time to time amended, modified, reenacted, extended, consolidated or replaced (whether before or after the date of this Agreement) and to any subordinate legislation made from time to time under such statute or statutory provision.
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(e)
|
References to “writing” or “written” include any non-transient means of representing or copying words legibly, including by facsimile or electronic mail.
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(f)
|
References to “$” are to United States Dollars.
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By: /S/ RAJIV DE SILVA
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Name: Rajiv De Silva
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Title: President and CEO
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By: /S/ SUKETU P. UPADHYAY
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Name: Suketu P. Upadhyay
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Title: EVP, Chief Financial Officer
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1.
|
FOR AND IN CONSIDERATION of the payments and benefits provided in Section 8(d)(ii), (iii), (iv) and (v) of the Employment Agreement between Executive and the Company dated as of August 3, 2016, (the “
Employment Agreement
”), Executive, for himself, his successors and assigns, executors and administrators, now and forever hereby releases and discharges the Company, together with all of its past and present parents, subsidiaries, and affiliates, together with each of their officers, directors, stockholders, partners, employees, agents, representatives and attorneys, and each of their subsidiaries, affiliates, estates, predecessors, successors, and assigns (hereinafter collectively referred to as the “
Releasees
”) from any and all rights, claims, charges, actions, causes of action, complaints, sums of money, suits, debts, covenants, contracts, agreements, promises, obligations, damages, demands or liabilities of every kind whatsoever, in law or in equity, whether known or unknown, suspected or unsuspected, which Executive or Executive’s executors, administrators, successors or assigns ever had, now has or may hereafter claim to have by reason of any matter, cause or thing whatsoever; arising from the beginning of time up to the date Executive executes the Release: (i) relating in any way to Executive’s employment relationship with the Company or any of the Releasees, or the termination of Executive’s employment relationship with the Company or any of the Releasees; (ii) arising under or relating to the Employment Agreement; (iii) arising under any federal, local or state statute or regulation, including, without limitation, the Age Discrimination in Employment Act of 1967, as amended by the Older Workers Benefit Protection Act, Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act of 1990, the Employee Retirement Income Security Act of 1974, the Equal Pay Act, any claim arising under the provisions of the False Claims Act; 31 U.S.C.A. § 3730, including, but not limited to, any right to personal gain with respect to any claim asserted under its “qui tam” provisions, Sections 1981 through 1988 of Title 42 of the United States Code, the Immigration Reform and Control Act, the Workers Adjustment and Retraining Notification Act, the Occupational Safety and Health Act, the Family and Medical Leave Act, the Fair Labor Standards Act of 1938, Executive Order 11246, the Pennsylvania Human Relations Act, the Pennsylvania Whistleblower Law and/or the applicable state or local law or ordinance against discrimination, each as amended; (iv) relating to wrongful employment termination or breach of contract; or (v) arising under or relating to any policy, agreement, understanding or promise, written or oral, formal or informal, between the Company and any of the Releasees and Executive;
provided
,
however
, that notwithstanding the foregoing, nothing contained in the Release shall in any way diminish or impair: (a) any rights Executive may have, from and after the date the Release is executed; (b) any rights to indemnification that may exist from time to time
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2.
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Executive understands and agrees that, except for the Excluded Claims, Executive has knowingly relinquished, waived and forever released any and all rights to any personal recovery in any action or proceeding that may be commenced on Executive’s behalf arising out of the aforesaid employment relationship or the termination thereof, including, without limitation, claims for back pay, front pay, liquidated damages, compensatory damages, general damages, special damages, punitive damages, exemplary damages, costs, expenses and attorneys’ fees.
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3.
|
Executive acknowledges and agrees that Executive has been advised to consult with an attorney of Executive’s choosing prior to signing the Release. Executive understands and agrees that Executive has the right and has been given the opportunity to review the Release with an attorney of Executive’s choice should Executive so desire. Executive
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4.
|
It is understood and agreed by Executive that any payment made to Executive is not to be construed as an admission of any liability whatsoever on the part of the Company or any of the other Releasees, by whom liability is expressly denied.
|
5.
|
The Release is executed by Executive voluntarily and is not based upon any representations or statements of any kind made by the Company or any of the other Releasees as to the merits, legal liabilities or value of Executive’s claims. Executive further acknowledges that Executive has had a full and reasonable opportunity to consider the Release and that Executive has not been pressured or in any way coerced into executing the Release.
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6.
|
The exclusive venue for any disputes arising hereunder shall be the state or federal courts located in the State of Delaware or, at the Company’s election, in any other state in which Executive maintains Executive’s principal residence or Executive’s principal place of business, and each of the parties hereto irrevocably waives, to the fullest extent permitted by law, any objection which it may now or hereafter have to the laying of the venue of any such proceeding brought in such a court and any claim that any such proceeding brought in such a court has been brought in an inconvenient forum. Each of the parties hereto also agrees that any final and unappealable judgment against a party hereto in connection with any action, suit or other proceeding may be enforced in any court of competent jurisdiction, either within or outside of the United States. A certified or exemplified copy of such award or judgment shall be conclusive evidence of the fact and amount of such award or judgment.
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7.
|
The Release and the rights and obligations of the parties hereto shall be governed and construed in accordance with the laws of the State of Delaware. If any provision hereof is unenforceable or is held to be unenforceable, such provision shall be fully severable, and this document and its terms shall be construed and enforced as if such unenforceable provision had never comprised a part hereof, the remaining provisions hereof shall remain in full force and effect, and the court construing the provisions shall add as a part hereof a provision as similar in terms and effect to such unenforceable provision as may be enforceable, in lieu of the unenforceable provision.
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8.
|
The Release shall inure to the benefit of and be binding upon the Company and its successors and assigns.
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ENDO HEALTH SOLUTIONS INC.
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Suketu P. Upadhyay
|
|
|
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Dated:
|
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Dated:
|
|
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/S/ RAJIV DE SILVA
|
|
Rajiv De Silva
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
Date:
|
August 9, 2016
|
|
|
/S/ SUKETU P. UPADHYAY
|
|
Suketu P. Upadhyay
|
|
Executive Vice President, Chief Financial Officer
(Principal Financial Officer)
|
|
|
|
Date:
|
August 9, 2016
|
|
|
|
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|
|
/S/ RAJIV DE SILVA
|
|
Name:
|
|
Rajiv De Silva
|
|
Title:
|
|
President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
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/S/ SUKETU P. UPADHYAY
|
|
Name:
|
|
Suketu P. Upadhyay
|
|
Title:
|
|
Executive Vice President, Chief Financial Officer
(Principal Financial Officer) |