UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 10-Q
þQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2017March 31, 2019
OR
¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from_____________to___________                 
Commission File Number 333-199861
MYLAN N.V.
(Exact name of registrant as specified in its charter)
The Netherlands 98-1189497
(State or other jurisdiction
of incorporation or organization)
 
(I.R.S. Employer
Identification No.)
Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, England
(Address of principal executive offices)
+44 (0) 1707-853-000
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  þ    No  ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  þ    No  ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer þ Accelerated filer ¨
       
Non-accelerated filer 
¨  (Do not check if a smaller reporting company)
 Smaller reporting company ¨
       
    Emerging growth company ¨
       
If an emerging growth company, indicate by check mark if the registrant has elected not to ususe the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  þ
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Ordinary shares, nominal value €0.01MYLThe NASDAQ Stock Market
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
As of November 2, 2017,May 1, 2019, there were 536,436,323515,437,080 of the issuer’s €0.01 nominal value ordinary shares outstanding.
 

MYLAN N.V. AND SUBSIDIARIES
INDEX TO FORM 10-Q
For the Quarterly Period Ended
September 30, 2017March 31, 2019

  
 Page
 PART I — FINANCIAL INFORMATION 
ITEM 1.Condensed Consolidated Financial Statements (unaudited) 
 
 
 
 
   
 
   
ITEM 2.
   
ITEM 3.
   
ITEM 4.
   
 PART II — OTHER INFORMATION 
ITEM 1.
   
ITEM 1A.
ITEM 5.
   
ITEM 6.
   
 

PART I — FINANCIAL INFORMATION

MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited; in millions, except per share amounts)
Three Months Ended Nine Months EndedThree Months Ended
September 30, September 30,March 31,
2017 2016 2017 20162019 2018
Revenues:          
Net sales$2,956.3
 $3,029.5
 $8,570.2
 $7,745.5
$2,460.6
 $2,650.4
Other revenues30.8
 27.6
 98.6

63.6
34.9

34.1
Total revenues2,987.1
 3,057.1
 8,668.8
 7,809.1
2,495.5
 2,684.5
Cost of sales1,809.0
 1,773.8
 5,180.3
 4,447.1
1,690.3
 1,700.2
Gross profit1,178.1
 1,283.3
 3,488.5
 3,362.0
805.2
 984.3
Operating expenses:          
Research and development182.3
 199.1
 580.9
 632.2
172.6
 204.9
Selling, general and administrative664.6
 656.9
 1,916.8
 1,787.6
607.9
 607.5
Litigation settlements and other contingencies, net15.2
 558.0
 (25.8) 556.4
0.7
 16.2
Total operating expenses862.1
 1,414.0
 2,471.9
 2,976.2
781.2
 828.6
Earnings (loss) from operations316.0
 (130.7) 1,016.6
 385.8
Earnings from operations24.0
 155.7
Interest expense131.8
 144.4
 406.3
 305.0
131.2
 131.7
Other expense, net4.6
 50.2
 34.4
 184.0
7.3
 13.5
Earnings (loss) before income taxes179.6
 (325.3) 575.9
 (103.2)
Income tax provision (benefit)91.3
 (205.5) 124.2
 (165.7)
Net earnings (loss)$88.3
 $(119.8) $451.7
 $62.5
Earnings (loss) per ordinary share:       
(Loss) Earnings before income taxes(114.5) 10.5
Income tax benefit(89.5) (76.6)
Net (loss) earnings$(25.0) $87.1
(Loss) Earnings per ordinary share:   
Basic$0.17
 $(0.23) $0.84
 $0.12
$(0.05) $0.17
Diluted$0.16
 $(0.23) $0.84
 $0.12
$(0.05) $0.17
Weighted average ordinary shares outstanding:          
Basic535.2
 523.6
 534.9
 505.9
515.0
 514.4
Diluted537.0
 523.6
 537.0
 515.2
515.0
 516.8



See Notes to Condensed Consolidated Financial Statements
3


Table of Contents

MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Earnings
(Unaudited; in millions)
 Three Months Ended Nine Months Ended
 September 30, September 30,
 2017 2016 2017 2016
Net earnings (loss)$88.3
 $(119.8) $451.7
 $62.5
Other comprehensive earnings (loss), before tax:       
Foreign currency translation adjustment423.0
 290.6
 1,831.9
 645.5
Change in unrecognized gain (loss) and prior service cost related to defined benefit plans1.1
 0.1
 2.4
 (0.3)
Net unrecognized (loss) gain on derivatives in cash flow hedging relationships(4.5) 22.8
 29.2
 (22.9)
Net unrecognized loss on derivatives in net investment hedging relationships(72.1) (10.4) (203.2) (10.4)
Net unrealized (loss) gain on marketable securities(8.9) 21.5
 3.5
 32.5
Other comprehensive earnings, before tax338.6
 324.6
 1,663.8
 644.4
Income tax (benefit) provision(5.8) 13.7
 11.3
 0.5
Other comprehensive earnings, net of tax344.4
 310.9
 1,652.5
 643.9
Comprehensive earnings$432.7
 $191.1
 $2,104.2
 $706.4
 Three Months Ended
 March 31,
 2019 2018
Net (loss) earnings$(25.0) $87.1
Other comprehensive (loss) earnings, before tax:   
Foreign currency translation adjustment(338.5) 261.9
Change in unrecognized gain (loss) and prior service cost related to defined benefit plans0.2
 (4.3)
Net unrecognized gain (loss) on derivatives in cash flow hedging relationships26.0
 (32.0)
Net unrecognized gain (loss) on derivatives in net investment hedging relationships58.1
 (59.2)
Net unrealized gain (loss) on marketable securities0.4
 (0.4)
Other comprehensive (loss) earnings, before tax(253.8) 166.0
Income tax provision (benefit)11.8
 (11.2)
Other comprehensive (loss) earnings, net of tax(265.6) 177.2
Comprehensive (loss) earnings$(290.6) $264.3




See Notes to Condensed Consolidated Financial Statements
4


Table of Contents

MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited; in millions, except share and per share amounts)
September 30,
2017
 December 31,
2016
March 31,
2019
 December 31,
2018
ASSETS
Assets      
Current assets:      
Cash and cash equivalents$614.9
 $998.8
$229.8
 $388.1
Accounts receivable, net3,220.2
 3,310.9
2,778.5
 2,881.0
Inventories2,548.1
 2,456.4
2,708.8
 2,580.2
Prepaid expenses and other current assets883.4
 756.4
545.2
 518.4
Total current assets7,266.6
 7,522.5
6,262.3
 6,367.7
Property, plant and equipment, net2,310.0
 2,322.2
2,151.4
 2,170.2
Intangible assets, net15,270.5
 14,447.8
12,955.5
 13,664.6
Goodwill9,984.7
 9,231.9
9,607.9
 9,747.8
Deferred income tax benefit559.8
 633.2
507.8
 572.2
Other assets427.3
 568.6
421.7
 212.4
Total assets$35,818.9
 $34,726.2
$31,906.6
 $32,734.9
      
LIABILITIES AND EQUITY
Liabilities      
Current liabilities:      
Trade accounts payable$1,276.1
 $1,348.1
Accounts payable$1,316.5
 $1,617.0
Short-term borrowings
 46.4
0.4
 1.9
Income taxes payable14.8
 97.7
23.2
 121.5
Current portion of long-term debt and other long-term obligations793.0
 290.0
703.5
 699.8
Other current liabilities2,900.1
 3,258.5
2,114.0
 2,147.6
Total current liabilities4,984.0
 5,040.7
4,157.6
 4,587.8
Long-term debt13,992.4
 15,202.9
13,086.9
 13,161.2
Deferred income tax liability2,138.4
 2,006.4
1,643.2
 1,722.0
Other long-term obligations1,412.5
 1,358.6
1,127.3
 1,096.8
Total liabilities22,527.3
 23,608.6
20,015.0
 20,567.8
Equity      
Mylan N.V. shareholders’ equity      
Ordinary shares — nominal value €0.01 per ordinary share
      
Shares authorized: 1,200,000,000      
Shares issued: 537,660,870 and 536,639,291 as of September 30, 2017 and December 31, 20166.0
 6.0
Shares issued: 539,943,344 and 539,289,665 as of March 31, 2019 and December 31, 20186.0
 6.0
Additional paid-in capital8,570.5
 8,499.3
8,606.5
 8,591.4
Retained earnings5,393.8
 4,942.1
5,989.3
 6,010.7
Accumulated other comprehensive loss(611.2) (2,263.7)(1,710.5) (1,441.3)
13,359.1
 11,183.7
12,891.3
 13,166.8
Noncontrolling interest
 1.4
Less: Treasury stock — at cost      
Ordinary shares: 1,311,193 as of September 30, 2017 and December 31, 201667.5
 67.5
Ordinary shares: 23,490,867 and 23,490,867 as of March 31, 2019 and December 31, 2018999.7
 999.7
Total equity13,291.6
 11,117.6
11,891.6
 12,167.1
Total liabilities and equity$35,818.9
 $34,726.2
$31,906.6
 $32,734.9


See Notes to Condensed Consolidated Financial Statements
5


Table of Contents

MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash FlowsEquity
(Unaudited; in millions)millions, except share amounts)
 Nine Months Ended
 September 30,
 2017 2016
Cash flows from operating activities:   
Net earnings$451.7
 $62.5
Adjustments to reconcile net earnings to net cash provided by operating activities:   
Depreciation and amortization1,279.8
 1,046.4
Share-based compensation expense64.2
 71.1
Deferred income tax expense (benefit)17.4
 (356.6)
Loss from equity method investments77.2
 85.5
Other non-cash items265.4
 226.1
Litigation settlements and other contingencies, net(45.2) 558.6
Write off of financing fees
 35.8
Unrealized losses on acquisition-related foreign currency derivatives
 128.6
Changes in operating assets and liabilities:   
Accounts receivable216.2
 183.3
Inventories(87.9) (336.7)
Trade accounts payable(187.4) (45.0)
Income taxes(149.3) 51.3
Other operating assets and liabilities, net(332.8) (13.2)
Net cash provided by operating activities1,569.3
 1,697.7
Cash flows from investing activities:   
Cash paid for acquisitions, net(71.6) (6,151.7)
Capital expenditures(156.4) (239.5)
Proceeds from the sale of assets31.1
 
Change in restricted cash12.6
 (50.5)
Purchase of marketable securities(8.9) (22.8)
Proceeds from the sale of marketable securities8.9
 15.8
Cash paid for Meda's unconditional deferred payment
 (308.0)
Settlement of acquisition-related foreign currency derivatives
 (128.6)
Payments for product rights and other, net(558.8) (196.3)
Net cash used in investing activities(743.1) (7,081.6)
Cash flows from financing activities:   
Payments of long-term debt(1,747.3) (1,067.0)
Change in short-term borrowings, net(48.3) 48.6
Taxes paid related to net share settlement of equity awards(7.4) (12.9)
Contingent consideration payments(10.1) (15.5)
Payments of financing fees(8.7) (95.3)
Proceeds from issuance of long-term debt555.8
 6,519.8
Proceeds from exercise of stock options12.8
 11.1
Acquisition of noncontrolling interest
 (1.0)
Other items, net(0.7) 1.6
Net cash (used in) provided by financing activities(1,253.9) 5,389.4
Effect on cash of changes in exchange rates43.8
 15.1
Net (decrease) increase in cash and cash equivalents(383.9) 20.6
Cash and cash equivalents — beginning of period998.8
 1,236.0
Cash and cash equivalents — end of period$614.9
 $1,256.6
     Additional Paid-In Capital Retained
Earnings
     Accumulated Other Comprehensive Loss Total
Equity
 Ordinary Shares   Treasury Stock  
 Shares Cost   Shares Cost  
Balance at December 31, 2018539,289,665
 $6.0
 $8,591.4
 $6,010.7
 23,490,867
 $(999.7) $(1,441.3) $12,167.1
Net loss
 
 
 (25.0) 
 
 
 (25.0)
Other comprehensive loss, net of tax
 
 
 
 
 
 (265.6) (265.6)
Issuance of restricted stock and stock options exercised, net653,679
 
 2.3
 
 
 
 
 2.3
Taxes related to the net share settlement of equity awards
 
 (5.2) 
 
 
 
 (5.2)
Share-based compensation expense
 
 18.0
 
 
 
 
 18.0
Cumulative effect of the adoption of new accounting standards
 
 
 3.6
 
 
 (3.6) 
Balance at March 31, 2019539,943,344
 $6.0
 $8,606.5
 $5,989.3
 23,490,867
 $(999.7) $(1,710.5) $11,891.6
                
Balance at December 31, 2017537,902,426
 $6.0
 $8,586.0
 $5,644.5
 13,695,251
 $(567.7) $(361.2) $13,307.6
Net earnings
 
 
 87.1
 
 
 
 87.1
Other comprehensive earnings, net of tax
 
 
 
 
 
 177.2
 177.2
Issuance of restricted stock and stock options exercised, net959,335
 
 10.6
 
 
 
 
 10.6
Taxes related to the net share settlement of equity awards
 
 (8.0) 
 
 
 
 (8.0)
Share-based compensation expense
 
 21.4
 
 
 
 
 21.4
Ordinary share repurchase
 
 
 
 9,795,616
 (432.0) 
 (432.0)
Cumulative effect of the adoption of new accounting standards
 
 
 13.7
 
 
 (7.5) 6.2
Other
 
 0.3
 (0.3) 
 
 
 
Balance at March 31, 2018538,861,761
 $6.0
 $8,610.3
 $5,745.0
 23,490,867
 $(999.7) $(191.5) $13,170.1


See Notes to Condensed Consolidated Financial Statements
6


Table of Contents

MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited; in millions)
 Three Months Ended
 March 31,
 2019 2018
Cash flows from operating activities:   
Net (loss) earnings$(25.0) $87.1
Adjustments to reconcile net (loss) earnings to net cash (used in) provided by operating activities:   
Depreciation and amortization500.5
 498.5
Share-based compensation expense18.0
 21.4
Deferred income tax expense6.7
 16.0
Loss from equity method investments17.0
 23.1
Other non-cash items(2.3) 38.0
Litigation settlements and other contingencies, net(3.7) 16.4
Changes in operating assets and liabilities:   
Accounts receivable62.8
 370.2
Inventories(183.0) (157.6)
Accounts payable(277.5) (92.8)
Income taxes(213.6) (155.7)
Other operating assets and liabilities, net60.4
 (42.8)
Net cash (used in) provided by operating activities(39.7) 621.8
Cash flows from investing activities:   
Cash paid for acquisitions, net(7.1) (63.3)
Capital expenditures(53.1) (30.7)
Proceeds from the sale of assets0.2
 
Purchase of available for sale securities and other investments(7.8) (7.5)
Proceeds from the sale of marketable securities7.6
 15.0
Payments for product rights and other, net(15.4) (342.4)
Net cash used in investing activities(75.6) (428.9)
Cash flows from financing activities:   
Proceeds from issuance of long-term debt0.1
 498.4
Payments of long-term debt(0.2) (498.0)
Purchase of ordinary shares
 (432.0)
Change in short-term borrowings, net(1.5) 309.1
Taxes paid related to net share settlement of equity awards(7.1) (8.9)
Contingent consideration payments(31.8) (0.2)
Payments of financing fees(1.2) (0.4)
Proceeds from exercise of stock options2.4
 10.8
Other items, net(0.8) (0.2)
Net cash used in financing activities(40.1) (121.4)
Effect on cash of changes in exchange rates(3.0) 3.7
Net (decrease) increase in cash, cash equivalents and restricted cash(158.4) 75.2
Cash, cash equivalents and restricted cash — beginning of period389.3
 369.9
Cash, cash equivalents and restricted cash — end of period$230.9
 $445.1

See Notes to Condensed Consolidated Financial Statements
7


Table of Contents
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited)


1.General
The accompanying unaudited Condensed Consolidated Financial Statementscondensed consolidated financial statements (“interim financial statements”) of Mylan N.V. and subsidiaries (“Mylan” or the “Company”) were prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q; therefore, as permitted under these rules, certain footnotes and other financial information included in audited financial statements were condensed or omitted. The interim financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the interim results of operations, comprehensive earnings, financial position, equity and cash flows for the periods presented.
These interim financial statements should be read in conjunction with the Consolidated Financial Statements and Notes thereto in Mylan N.V.’s Annual Report on Form 10-K for the year ended December 31, 20162018, as amended.amended (the “2018 Form 10-K”). The December 31, 20162018 Condensed Consolidated Balance Sheetcondensed consolidated balance sheet was derived from audited financial statements.
The interim results of operations, and comprehensive earnings for the three and nine months ended September 30, 2017 and cash flows for the ninethree months ended September 30, 2017March 31, 2019 are not necessarily indicative of the results to be expected for the full fiscal year or any other future period. Certain prior year amounts have been reclassified to conform to the current year presentation.
2.Revenue Recognition and Accounts Receivable
The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, the Company recognizes net revenue for product sales when title and riskcontrol of loss passthe promised goods or services is transferred to itsour customers and whenin an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. Revenues are recorded net of provisions for estimates,variable consideration, including discounts, sales allowances,rebates, governmental rebate programs, price adjustments, returns, chargebacks, promotional programs and other promotional programs are reasonably determinable.
Accounts receivablesales allowances. Accruals for these provisions are presented net of allowances relating to these provisions. No significant revisions were made toin the methodology usedcondensed consolidated financial statements as reductions in determining these provisions or the nature of the provisions during the nine months ended September 30, 2017. Such allowances were $1.92 billionnet sales and $2.05 billion at September 30, 2017 and December 31, 2016, respectively. Other current liabilities include $808.9 million and $809.0 million at September 30, 2017 and December 31, 2016, respectively, for certain sales allowances and other adjustments that are settled in cash.
Accounts receivable, net was comprised of the following at September 30, 2017 and December 31, 2016, respectively:
(In millions)September 30,
2017
 December 31,
2016
Trade receivables, net$2,822.6
 $3,015.4
Other receivables397.6
 295.5
Accounts receivable, net$3,220.2
 $3,310.9
Through its wholly owned subsidiary Mylan Pharmaceuticals Inc. (“MPI”), the Company has access toas a $400 million accounts receivable securitization facility (the “Receivables Facility”). The receivables underlying any borrowings are includedcontra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in the Condensed Consolidated Balance Sheetscash). There were $785.6 million and $1.13 billion of securitized accounts receivable at September 30, 2017 and December 31, 2016, respectively.
3.Recent Accounting Pronouncements
In August 2017,Wholesaler and distributor inventory levels of our products can fluctuate throughout the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update 2017-12, Derivativesyear due to the seasonality of certain products, the timing of product demand and Hedging (Topic 815):Targeted Improvements to Accounting for Hedging Activities. The objectiveother factors. Such fluctuations may impact the comparability of this updateour net sales between periods.
Consideration received from licenses of intellectual property is to improve the financial reporting of hedging relationships to better portray the economic results of an entity’s risk management activities in its financial statements. The amendments in this update also make certain targeted improvements to simplify the application of the hedge accounting guidance in current U.S. GAAPrecorded as revenue. Royalty or profit share amounts, which are based on feedback received from preparers, auditors, users, and other stakeholders. This guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with early adoption permitted, including adoption in any interim period. The Company is currently assessingsales of licensed products or technology, are recorded when the impact of the adoption of this guidance on its consolidated financial statements and disclosures.    

7

Table of Contents
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


In May 2017, the FASB issued Accounting Standards Update 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”), which amends the scope of modification accounting for share-based payment arrangements. ASU 2017-09 provides guidance on the types of changes to the termscustomer’s subsequent sales or conditions of share-based payment awards to which an entity would be required to apply modification accounting under Accounting Standards Codification 718. Specifically, an entity would not apply modification accounting if the fair value, vesting conditions and classification of the awards are the same immediately before and after the modification. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, with early adoption permitted, including adoption in any interim period. The Company is currently assessing the impact of the adoption of this guidance on its consolidated financial statements and disclosures.
In March 2017, the FASB issued Accounting Standards Update 2017-07, Compensation - Retirement Benefits (Topic 715): Improving the Presentation of Net Periodic Pension Cost and Net Periodic Postretirement Benefit Cost, which requires companies to disaggregate the service cost component from the other components of net benefit cost and disclose the amount of net benefit cost thatusages occur. Such consideration is included in the income statement or capitalized in assets, by line item. This guidance requires companies to report the service cost componentother revenue in the same line item(s) as other compensation costs and to report other pension-related costs (which include interest costs, amortization of pension-related costs from prior periods and gains or losses on plan assets) separately and exclude them from the subtotal of operating income. This guidance also allows only the service cost component to be eligible for capitalization when applicable. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. This guidance should be applied retrospectively for the presentation of the service cost component and the other components of net periodic pension cost and net periodic postretirement benefit cost in the income statement and prospectively, on and after the effective date, for the capitalization of the service cost component of net periodic pension cost and net periodic postretirement benefit in assets. The update allows a practical expedient that permits a company to use the amounts disclosed in its pension and other postretirement plan note for the prior comparative periods as the estimation basis for applying the retrospective presentation requirements. The Company is currently assessing the impact of the adoption of this guidance on its consolidated financial statements and disclosures.
In January 2017, the FASB issued Accounting Standards Update 2017-04, Intangibles - Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (“ASU 2017-04”), which simplifies the subsequent measurement of goodwill by eliminating Step 2 from the goodwill impairment test which previously required measurement of any goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. Under ASU 2017-04, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying value and recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; without exceeding the total amount of goodwill allocated to that reporting unit. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted. The Company has elected to early adopt this guidance as of January 1, 2017 and is applying it on a prospective basis. The adoption did not have a material impact on its condensed consolidated financial statements.
In January 2017, the FASB issued Accounting Standards Update 2017-01, Business Combinations (Topic 805) Clarifying the Definitionstatements of a Business, which narrows the definition of a business and requires an entity to evaluate if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets, which would not constitute the acquisition of a business. The guidance also requires a business to include at least one substantive process and narrows the definition of outputs. This guidance is effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, with early adoption permitted. The Company has elected to early adopt this guidance as of January 1, 2017 and will apply it on a prospective basis. The adoption did not have a material impact on its condensed consolidated financial statements.
In March 2016, the FASB issued Accounting Standards Update 2016-09, Compensation - Stock Compensation (Topic 718) (“ASU 2016-09”), which simplifies the accounting for share-based compensation payments. The new standard requires all excess tax benefits and tax deficiencies (including tax benefits of dividends on share-based payment awards) to be recognized as income tax expense or benefit on the income statement. The tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur. ASU 2016-09 also addresses the classification of excess tax benefits in the statement of cash flows. As required, the Company applied the provisions of ASU 2016-09 on a prospective basis as of January 1, 2017 and the adoption did not have a material impact on its condensed consolidated financial statements.operations.

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MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


In May 2014, the FASB issued Accounting Standards Update 2014-09, Revenue from Contracts with Customers (updated with Accounting Standards Update 2015-14, 2016-08, 2016-10, 2016-12 and 2016-20), which revises accounting guidance on revenue recognition that will supersede nearly all existing revenue recognition guidance under U.S. GAAP. Disaggregation
The core principal of this guidance is that an entity should recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. This guidance also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. This guidance is effective for fiscal years beginning after December 15, 2017, and for interim periods within those fiscal years, and can be applied using a full retrospective or modified retrospective approach. The Company has substantially completed its review of revenue arrangements and currently is finalizing the quantification of any impact. Although the Company is continuing to assess the impact of the new standard, based upon its preliminary assessment, the Company believes that there may be arrangements under which the Company will recognize revenue earlier under the new standard, however such arrangements are not expected to be a significant part offollowing table presents the Company’s operations. In addition, upon implementation there may be certain changes innet sales by therapeutic franchise for each of our reportable segments for the presentation of certain items, including changes related to the classification of certain costs in the consolidated statements of operations. The Company currently expects to adopt the standard using the modified retrospective approach.three months ended March 31, 2019 and 2018, respectively:
(In millions)North America Europe Rest of World Total
Three Months Ended March 31, 2019       
Central Nervous System & Anesthesia$135.7
 $190.3
 $64.0
 $390.0
Infectious Disease18.1
 58.8
 215.6
 292.5
Respiratory & Allergy238.6
 107.8
 43.7
 390.1
Cardiovascular46.9
 100.7
 34.2
 181.8
Gastroenterology34.2
 127.8
 77.5
 239.5
Diabetes & Metabolism151.0
 57.2
 39.2
 247.4
Dermatology13.9
 61.6
 20.4
 95.9
Women’s Healthcare78.9
 44.6
 15.1
 138.6
Oncology124.8
 17.6
 29.0
 171.4
Immunology10.1
 7.2
 6.4
 23.7
Other (1)
70.7
 121.7
 97.3
 289.7
Total$922.9
 $895.3
 $642.4
 $2,460.6
(In millions)North America Europe Rest of World Total
Three Months Ended March 31, 2018       
Central Nervous System & Anesthesia$199.6
 $225.4
 $82.9
 $507.9
Infectious Disease46.4
 64.5
 169.0
 279.9
Respiratory & Allergy113.9
 127.6
 46.6
 288.1
Cardiovascular90.4
 146.8
 39.5
 276.7
Gastroenterology44.1
 153.2
 66.1
 263.4
Diabetes & Metabolism109.6
 73.8
 24.8
 208.2
Dermatology94.5
 80.3
 24.9
 199.7
Women’s Healthcare93.1
 70.0
 19.2
 182.3
Oncology109.3
 18.8
 30.9
 159.0
Immunology14.0
 2.5
 8.4
 24.9
Other (1)
70.4
 75.5
 114.4
 260.3
Total$985.3
 $1,038.4
 $626.7
 $2,650.4
____________
4.
(1)
Acquisitions and Other Transactionsconsists of numerous therapeutic franchises, none of which individually exceeds 5% of consolidated net sales.
Meda AB
On February 10, 2016, the Company issued an offer announcement under the Nasdaq Stockholm’s Takeover Rules and the Swedish Takeover Act (collectively, the “Swedish Takeover Rules”) setting forth a public offer to the shareholders of Meda AB (publ.) (“Meda”) to acquire all of the outstanding shares of Meda (the “Offer”), with an enterprise value, including the net debt of Meda, of approximately Swedish kronor (“SEK” or “kr”) 83.6 billion (based on a SEK/USD exchange rate of 8.4158) or $9.9 billion at announcement. On August 2, 2016, the Company announced that the Offer was accepted by Meda shareholders holding an aggregate of approximately 343 million shares, representing approximately 94% of the total number of outstanding Meda shares, as of July 29, 2016, and the Company declared the Offer unconditional. On August 5, 2016, settlement occurred with respect to the Meda shares duly tendered by July 29, 2016 and, as a result, Meda became a controlled subsidiary of the Company. Pursuant to the terms of the Offer, each Meda shareholder that duly tendered Meda shares into the Offer received at settlement (1) in respect of 80% of the number of Meda shares tendered by such shareholder, 165kr in cash per Meda share, and (2) in respect of the remaining 20% of the number of Meda shares tendered by such shareholder, 0.386 of the Company’s ordinary shares per Meda share (subject to treatment of fractional shares as described in the offer document published on June 16, 2016). The non-tendered shares were required to be acquired for cash through a compulsory acquisition proceeding, in accordance with the Swedish Companies Act (Sw. aktiebolagslagen (2005:551)). The compulsory acquisition proceeding price accrued interest as required by the Swedish Companies Act. Meda’s shares were delisted from the Nasdaq Stockholm exchange on August 23, 2016.
On November 1, 2016, the Company made an offer to the remaining Meda shareholders to tender all their Meda shares for cash consideration of 161.31kr per Meda share (the “November Offer”) to provide such remaining shareholders with an opportunity to sell their shares in Meda to the Company in advance of the automatic acquisition of their shares for cash in connection with the compulsory acquisition proceeding. At the end of November 2016, Mylan completed the acquisition of approximately 19 million Meda shares duly tendered for aggregate cash consideration of approximately $330.3 million. In March 2017, the Company received full legal ownership to the remaining non-tendered Meda shares in exchange for a cash payment of approximately $71.6 million, equal to the uncontested portion of the compulsory acquisition price plus statutory interest, and the Company’s arrangement of a customary bank guarantee to secure the payment of any additional cash consideration that may be awarded to the former Meda shareholders in the compulsory acquisition proceeding. In October 2017, the arbitration tribunal awarded a price of 163.07kr per Meda share, plus statutory interest of 1.5% per annum, to the former Meda shareholders subject to the compulsory acquisition proceeding. Mylan expects to pay an additional approximately $0.9 million plus interest to such former Meda shareholders and, in accordance with Swedish law, pay the fees of the arbitrators and costs of other parties to the compulsory acquisition proceeding. Mylan expects that the award will become final in mid-December 2017, at which time Mylan will cause the bank guarantee to be released, definitively concluding the compulsory acquisition proceeding. As of September 30, 2017, the Company continues to maintain the bank guarantee as required by Swedish law.
On August 5, 2016, the total purchase price was approximately $6.92 billion, net of cash acquired, which includes cash consideration paid of approximately $5.3 billion, the issuance of approximately 26.4 million Mylan N.V. ordinary shares

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


atVariable Consideration and Accounts Receivable
The following table presents a fair valuereconciliation of approximately $1.3 billion based ongross sales to net sales by each significant category of variable consideration during the closing price of the Company’s ordinary shares on August 5, 2016, as reported by the NASDAQ Global Select Stock Market (“NASDAQ”) and an assumed liability of approximately $431.0 million related to the November Offer and the compulsory acquisition proceeding for the non-tendered Meda shares. In accordance with U.S. GAAP, the Company used the acquisition method of accounting to account for this transaction. Under the acquisition method of accounting, the assets acquired and liabilities assumed in the transaction have been recorded at their respective estimated fair values at the acquisition date.
During the ninethree months ended September 30, 2017, adjustmentsMarch 31, 2019 and 2018, respectively:
 Three Months Ended
 March 31,
(In millions)2019 2018
Gross sales$4,158.5
 $4,732.3
Gross to net adjustments:   
Chargebacks(703.7) (872.1)
Rebates, promotional programs and other sales allowances(856.2) (1,030.6)
Returns(45.8) (77.3)
Governmental rebate programs(92.2) (101.9)
Total gross to net adjustments$(1,697.9) $(2,081.9)
Net sales$2,460.6
 $2,650.4
No significant revisions were made to the preliminary purchase pricemethodology used in determining these provisions or the nature of the provisions during the three months ended March 31, 2019. Such allowances were comprised of the following at March 31, 2019 and December 31, 2018, respectively:
(In millions)March 31,
2019
 December 31,
2018
Accounts receivable, net$1,556.2
 $1,715.6
Other current liabilities604.1
 626.7
Total$2,160.3
 $2,342.3
Accounts receivable, net was comprised of the following at March 31, 2019 and December 31, 2018, respectively:
(In millions)March 31,
2019
 December 31,
2018
Trade receivables, net$2,367.4
 $2,416.5
Other receivables411.1
 464.5
Accounts receivable, net$2,778.5
 $2,881.0
Through its wholly owned subsidiary Mylan Pharmaceuticals Inc. (“MPI”), the Company has access to a $400 million accounts receivable securitization facility (the “Receivables Facility”). The receivables underlying any borrowings are reflected as “Measurement Period Adjustments”included in accounts receivable, net, in the table below. The allocationcondensed consolidated balance sheets. There were $372.2 million and $322.0 million of the $6.92 billion purchase price to the assets acquiredsecuritized accounts receivable at March 31, 2019 and liabilities assumed for Meda is as follows:
(In millions)
Preliminary Purchase Price Allocation as of December 31, 2016 (a)
 
Measurement Period Adjustments (b)
 Purchase Price Allocation as of September 30, 2017 (as adjusted)
Current assets (excluding inventories and net of cash acquired)$482.5
 $(9.2) $473.3
Inventories463.1
 5.0
 468.1
Property, plant and equipment177.5
 
 177.5
Identified intangible assets8,060.7
 
 8,060.7
Goodwill3,676.9
 7.7
 3,684.6
Other assets9.5
 (0.7) 8.8
Total assets acquired12,870.2
 2.8
 12,873.0
Current liabilities(1,105.9) (4.9) (1,110.8)
Long-term debt, including current portion(2,864.6) 
 (2,864.6)
Deferred tax liabilities(1,613.9) 0.7
 (1,613.2)
Pension and other postretirement benefits(322.3) 
 (322.3)
Other noncurrent liabilities(42.4) 1.4
 (41.0)
Net assets acquired$6,921.1
 $
 $6,921.1
____________
(a)
As previously reported in the Company’s December 31, 2016 Annual Report on Form 10-K, as amended.
(b)
The measurement period adjustments recorded during the nine months ended September 30, 2017 are primarily related to certain income tax adjustments and working capital related estimates to reflect facts and circumstances that existed as of the acquisition date.
The acquisition of Meda created a more diversified and expansive portfolio of branded and generic medicines along with a strong and growing portfolio of over-the-counter (“OTC”) products. The combined company has a balanced global footprint with significant scale in key geographic markets, particularly the U.S. and Europe. The acquisition of Meda also expanded our presence in emerging markets, which includes countries in Africa, as well as countries throughout Asia and the Middle East, and is complemented by Mylan’s presence in India, Brazil and Africa (including South Africa). The Company recorded a step-up in the fair value of inventory of approximately $107 million at the acquisition date, which was fully amortized as of December 31, 2016.
The identified intangible assets of $8.06 billion are comprised of product rights and licenses that have a weighted average useful life of 20 years. Significant assumptions utilized in the valuation of identified intangible assets were based on company specific information and projections which are not observable in the market and are thus considered Level 3 measurements as defined by U.S. GAAP. The goodwill of $3.68 billion arising from the acquisition consisted largely of the value of the employee workforce and the expected value of products to be developed in the future. Approximately $3.4 billion of goodwill recognized was allocated to the Europe segment, with approximately $290 million allocated to the North America segment, and approximately $6 million allocated to the Rest of World segment. None of the goodwill recognized in this transaction is currently expected to be deductible for income tax purposes.2018, respectively.

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MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


3.Recent Accounting Pronouncements
Adoption of New Accounting Standards
RenaissanceTopicals Business
On June 15,In February 2016, the Company completed the acquisition of the non-sterile, topicals-focused business (the “Topicals Business”Financial Accounting Standards Board (“FASB”) of Renaissance Acquisition Holdings, LLCissued Accounting Standards Update (“Renaissance”ASU”) for approximately $1.0 billion in cash at closing, including amounts deposited into escrow for potential contingent payments, subject to customary adjustments. The Topicals Business provided the Company with a complementary portfolio of approximately 25 products, an active pipeline of approximately 25 products, 2016-02, Leases (Topic 842), which supersedes FASB Topic 840, Leases (Topic 840) and an established U.S. sales and marketing infrastructure targeting dermatologists. The Topicals Business also provided an integrated manufacturing and development platform. In accordance with U.S. GAAP, the Company used the acquisition method of accounting to account for this transaction. Under the acquisition method of accounting, the assets acquired and liabilities assumed in the transaction were recorded at their respective estimated fair values at the acquisition date. The U.S. GAAP purchase price was $972.7 million, which includes estimated contingent consideration of approximately $16 million related to the potential $50 million payment contingent on the achievement of certain 2016 financial targets. The final resolution of the contingent consideration has not been completed at September 30, 2017. The $50 million contingent payment remains in escrow and is classified as restricted cash included in prepaid expenses and other current assets on the Condensed Consolidated Balance Sheets at September 30, 2017 and December 31, 2016.
The allocation of the $972.7 million purchase price to the assets acquired and liabilities assumedprovides principles for the Topicals Business isrecognition, measurement, presentation and disclosure of leases for both lessees and lessors. The new standard requires lessees to apply a dual approach, classifying leases as follows:
(In millions) 
Current assets (excluding inventories)$57.7
Inventories74.2
Property, plant and equipment54.8
Identified intangible assets467.0
In-process research and development275.0
Goodwill318.6
Other assets0.1
Total assets acquired1,247.4
Current liabilities(74.2)
Deferred tax liabilities(194.6)
Other noncurrent liabilities(5.9)
Net assets acquired$972.7
The acquisition of the Topicals Business broadened the Company’s dermatological portfolio. The amount allocated to in-process research and development (“IPR&D”) represents an estimate of the fair value of purchased in-process technology for research projects that, as of the closing date of the acquisition, had not reached technological feasibility and had no alternative future use. The fair value of IPR&D of $275.0 million waseither finance or operating leases based on the excessprinciple of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use (“ROU”) asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. In July 2018, the FASB issued ASU 2018-10, Codification Improvements to Topic 842 (Leases), and ASU 2018-11, Leases (Topic 842), Targeted Improvements, which provide (i) narrow amendments to clarify how to apply certain aspects of the new lease standard, (ii) entities with an additional transition method to adopt the new standard, and (iii) lessors with a practical expedient for separating components of a contract. In December 2018, the FASB issued ASU 2018-20, Leases (Topic 842): Narrow-Scope Improvements for Lessors, whichprovides certain narrow-scope improvements to Topic 842 as it relates to lessors. The Company adopted the provisions of Topic 842 as of January 1, 2019 on a modified retrospective basis applying the guidance to leases existing as of this effective date. We elected to apply the available package of transitional practical expedients which permitted us not to reassess under the new standard our prior conclusions regarding lease identification, lease classification and initial direct costs. We have also elected to apply the short-term lease recognition exemption which means we will not recognize ROU assets or lease liabilities for leases that qualify both at transition and on a go-forward basis. In addition, we have elected to apply the practical expedient to not separate lease and non-lease components for our leases except for those related to certain limited supply arrangements. The Company has determined that there was no cumulative-effect adjustment to beginning retained earnings method, on the condensed consolidated balance sheet. We will continue to report periods prior to January 1, 2019 in our financial statements under prior guidance as outlined in Topic 840. Refer to Note 8 Leases for additional information.
In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income(Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income (“ASU 2018-02”)which utilizes forecastsallows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the newly enacted federal corporate income tax rate under the comprehensive tax legislation enacted by the U.S. government on December 22, 2017 commonly referred to as the Tax Cuts and Jobs Act. The amount of the reclassification would be the difference between the historical corporate income tax rate and the newly enacted 21% corporate income tax rate. The Company applied the provisions of ASU 2018-02 as of January 1, 2019. Upon adoption, the Company recorded a cumulative effect adjustment of $3.6 million to retained earnings and accumulated other comprehensive loss.
In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The changes took effect for the Company as of January 1, 2019. The impact of the adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements and disclosures.
Accounting Standards Issued Not Yet Adopted
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses, which requires an organization to measure all expected cash inflows (including estimatescredit losses for ongoing costs)financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other contributory charges. A discount rate of 12.5% was utilizedorganizations will now use forward-looking information to discount net cash inflows to present values. IPR&Dbetter inform their credit loss estimates. The amendments in this ASU are effective for fiscal years beginning after December 15, 2019 and for interim periods therein. The Company is accounted for as an indefinite-lived intangible asset and will be subject to impairment testing until completion or abandonmentcurrently assessing the impact of the projects. Upon successful completionadoption of this guidance on its consolidated financial statements and launch of each product, the Company will make a determination of the estimated useful life of the individual asset. The acquired IPR&D projects are in various stages of completion and the estimated costs to complete these projects total approximately $48 million, which is expected to be incurred through 2019. There are risks and uncertainties associated with the timely and successful completion of the projects included in IPR&D, and no assurances can be given that the underlying assumptions used to estimate the fair value of IPR&D will not change or the timely completion of each project to commercial success will occur.
The identified intangible assets of $467.0 million are comprised of $454.0 million of product rights and licenses that have a weighted average useful life of 14 years and $13.0 million of contract manufacturing agreements that have a weighted average useful life of five years. Significant assumptions utilized in the valuation of identified intangible assets were based on company specific information and projections which are not observable in the market and are thus considered Level 3 measurements as defined by U.S. GAAP.disclosures.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


The goodwill of $318.6 million arising fromIn addition, the acquisition consisted largely of the value of the employee workforce and the expected value of products to be developed in the future. All of the goodwill was assignedfollowing recently issued accounting standards have not been adopted. Refer to the North America segment. None of the goodwill recognized in this transaction is currently expected to be deductible for income tax purposes. The acquisition did not have a material impactCompany’s Annual Report on a pro forma basisForm 10-K for the threeyear ended December 31, 2018, as amended, for additional information and nine month periods ended September 30, 2016.
Unaudited Pro Forma Financial Results
The following table presents supplemental unaudited pro forma information for the acquisition of Meda, as if it had occurred on January 1, 2015. The unaudited pro forma results reflect certain adjustments related to past operating performance and acquisition accounting adjustments, such as increased amortization expense based on the fair value of assets acquired, the impact of transaction costs and the related income tax effects. The unaudited pro forma results do not include any anticipated synergies which may be achievable, or have been achieved, subsequent to the closing of the Meda transaction. Accordingly, the unaudited pro forma results are not necessarily indicative of the results that actually would have occurred had the acquisitions been completed on the stated dates above, nor are they indicative of the future operating results of Mylan N.V. and its subsidiaries.their potential impacts.
 Three Months Ended Nine Months Ended
 September 30, September 30,
(Unaudited, in millions, except per share amounts)2016 2016
Total revenues$3,168.6
 $9,008.2
Net (loss) earnings$(111.4) $132.0
(Loss) earnings per ordinary share:   
Basic$(0.21) $0.25
Diluted$(0.21) $0.25
Weighted average ordinary shares outstanding:   
Basic533.9
 526.9
Diluted533.9
 536.2
Accounting Standard UpdateEffective Date
ASU 2018-18: Collaborative Arrangements (Topic 808) - Clarifying the Interaction between Topic 808 and Topic 606
January 1, 2020
ASU 2018-14: Compensation-Retirement Benefits-Defined Benefit Plans-General (Subtopic 715-20) Disclosure Framework-Changes to the Disclosure Requirements for Defined Benefit Plans
January 1, 2021
ASU 2018-13: Fair Value Measurement (Topic 820) Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement
January 1, 2020
Other Transactions
4.Acquisitions and Other Transactions
On February 14, 2017,28, 2018, the Company and Revance Therapeutics, Inc. (“Revance”) entered into a jointcollaboration agreement (the “Revance Collaboration Agreement”) pursuant to which the Company and Revance will collaborate exclusively, on a world-wide basis (excluding Japan), to develop, manufacture and commercialize a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX®.
Under the Revance Collaboration Agreement, the Company will be primarily responsible for (a) clinical development activities outside of North America (excluding Japan) (the “ex-U.S. Mylan territories”), (b) regulatory activities, and marketing agreement(c) commercialization for any approved product. Revance will be primarily responsible for (a) non-clinical development activities, (b) clinical development activities in North America, and (c) manufacturing and supply of clinical drug substance and drug product; Revance will be solely responsible for an initial portion of non-clinical development costs. The remaining portion of any non-clinical development costs and clinical development costs for obtaining approval in the U.S. and Europe will be shared equally between the parties, and the Company will be responsible for all other clinical development costs and commercialization expenses. Upon closing, Revance received a respiratory product that resulted in approximately $50non-refundable upfront payment of $25.0 million. In addition, under the Revance Collaboration Agreement, Revance can receive potential development milestone payments of up to $100.0 million, in the aggregate, upon the achievement of specified clinical and regulatory milestones and potential tiered sales milestones of up to $225.0 million. In addition, Mylan will pay Revance royalties on sales of the biosimilar in the ex-U.S. Mylan territories. The Company accounted for this transaction as an asset acquisition of in-process research and development (“RIPR&D”) and the total upfront payment was expensed as a component of R&D expense induring the first quarter of 2017.year ended December 31, 2018.
On March 29, 2017,August 31, 2018, the Company announced that it had completed its acquisitionan agreement with certain subsidiaries of Novartis AG (“Novartis”) to purchase the worldwide rights to their global cystic fibrosis products consisting of the globalTOBI Podhaler® and TOBI® solution. Tobramycin is the standard of care for treatment of pseudomonas aeruginosa, a leading driver of infection in cystic fibrosis. These products further strengthen our existing presence in cystic fibrosis, especially with our Creon Franchise in Europe, Australia, Japan and Canada. The asset acquisition allows us to further extend our respiratory franchise into rare/orphan disease indications and broaden our portfolio into dry powdered inhalers and nebulized products. Tobi Podhaler™ is manufactured using a proprietary Pulmosphere technology for which we have acquired exclusive rights for use, hence we expect a high barrier for generic entry.
Under the terms of the agreement, Novartis is owed fixed consideration of $463.0 million which consists of $240.0 million which was paid at closing as well as deferred payments of $130.0 million included in other current liabilities and $93.0 million included in other long-term obligations, due in 2019 and 2020, respectively. Novartis is also eligible to receive a contingent payment of up to $20 million. The Company also entered into a supply agreement with Novartis to purchase the Cold-EEZE® brand cold remedy lineproducts for up to three years from ProPhase Labs, Inc. forthe date of closing. The Company has recorded a liability of approximately $50$91.0 million in cash. related to supply obligations.
The Company accounted for this transaction as an asset acquisition and recognized an intangible asset for the asset is being amortized over a useful lifeproduct rights of 15 years.
On June 2, 2017, the Company completed the acquisition of additional intellectual property rights and marketing authorizations in certain rest of world markets for a product that the Company previously licensed in certain European markets. The acquisition price was $128.0 million and the Company accounted for this transaction as an asset acquisition.$574.8 million. The intangible asset is being amortized over a useful life of fiveten years.
On June 19, 2017,During the year ended December 31, 2018, the Company completed the acquisition of a portfolio of four generic pharmaceuticalagreements to acquire certain intellectual property rights and marketing authorizations for products that were in the U.S.development stage, including agreements with Fujifilm Kyowa Kirin Biologics Co., Ltd. (“FKB”), Mapi Pharma Ltd., and Lupin Limited. The acquisition price was $277.9 million and the Company accounted for this transaction as an asset acquisition. The intangible asset recognized totaled $252.5 million with the remaining assets primarily consisting of receivables. The intangible asset is being amortized over a useful life of seven years.
On September 29, 2017, the Companyalso completed the acquisition of intellectual property rights and marketing authorizations related to a commercialized product in certain markets for $40 million. The Company accounted for this transaction as an asset acquisition and the asset is being amortized over a useful liferest of five years.
On October 3, 2017, the Company completed the acquisition of a U.S. based developer and manufacturer of active pharmaceutical ingredients (“API”) for approximately $189 million, which includes $15 million of contingent payments based

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onworld markets for $220.0 million, of which $160.0 million was paid at closing and $20.0 million was paid in the achievementfourth quarter of certain financial results2018, with the remaining amount due in 2019 and included in other current liabilities. The Company is accounting for these transactions as asset acquisitions and a useful life of five years is being used to amortize the asset related to the commercialized product. The Company recorded expense of approximately $53.7 million as a component of R&D expense related to non-refundable upfront payments for agreements for products in development during the year ended December 31, 2018. Certain of the acquired business followingagreements include additional development and commercial milestones.
On February 22, 2018, the closingCompany in-licensed European rights to Hulio™, a biosimilar to AbbVie Inc.'s (“AbbVie”) Humira® (adalimumab), including a sub-license to certain of AbbVie’s European patents, from FKB. On February 27, 2019, the transaction.Company updated its arrangements with FKB for the commercialization of Hulio™. Under the updated arrangements, Mylan has in-licensed exclusive global commercialization rights for Hulio™. The Company will accountaccounted for this transaction as thean asset acquisition of IPR&D and a business. Duenet non-contingent amount due to FKB of approximately $23.3 million was expensed as a component of R&D expense during the limited time since the acquisition date and limitations on access to the financial information prior to the acquisition date, the initial accounting for the business combination was incomplete at November 6, 2017. As a result,three months ended March 31, 2019.    
On December 1, 2018, the Company was unableand certain subsidiaries of Aspen Pharmacare Holdings Limited entered into an agreement for Mylan to provide amounts recognized asdistribute a portfolio of the acquisition dateprescription and over-the-counter (“OTC”) products in Australia and New Zealand. The agreement includes an option for major classes of assets and liabilities acquired resulting from the acquisition, including information relatedMylan to contingencies and goodwill. The Company anticipates that the majority of the goodwill will be assigned to the North America and Rest of World segments and does not currently expect the goodwill recognized to be deductible for income tax purposes. The acquisition does not have a material impact on the Company’s results of operations on a pro forma basis for the three and nine month periods ended September 30, 2017 and 2016.
As part of the Meda acquisition, the Company acquired the in-licensed rights to Betadine in certain European markets. These rights were set to expire on December 31, 2017. Under the licensing agreement, Meda had a binding option to acquire a perpetual license forpurchase the rights to Betadine under certain conditions.the portfolio for approximately $135.0 million. In October 2017,March 2019, the Company finalizedexercised the option, and the parties began negotiating an agreement to acquire the perpetual license. An estimated liabilityasset purchase agreement. The consideration of approximately $300$135.0 million for the purchaseincludes a payment due at closing of these rights was accrued for on the Meda acquisition opening balance sheet. The Company does not expect that a material adjustmentapproximately $64.0 million and an amount due one year later of approximately $71.0 million. An agreement is expected to this liability will be necessary upon closingfinalized in 2019. Completion of the transaction in early 2018.will be subject to customary closing conditions.
5.Share-Based Incentive Plan
The Company’s shareholders have approved the 2003 Long-Term Incentive Plan (as amended, the “2003 Plan”). Under the 2003 Plan, 55,300,000 ordinary shares are reserved for issuance to key employees, consultants, independent contractors and non-employee directors of the Company through a variety of incentive awards, including: stock options, stock appreciation rights (“SAR”), restricted ordinary shares restricted stockand units, performance awards (“PSU”), other stock-based awards and short-term cash awards. Stock option awards are granted with an exercise price equal to the fair market value of the ordinary shares underlying the stock options at the date of the grant, generally become exercisable over periods ranging from three to four years,, and generally expire in ten years. Since approval of the 2003 Plan, no further grants of stock options have been made under any other previous plan.
The following table summarizes stock option and SAR (together, “stock awards”) activity:
 Number of Shares Under Stock Awards Weighted Average Exercise Price per Share
Outstanding at December 31, 20167,699,441
 $33.38
Granted905,521
 42.93
Exercised(659,621) 19.62
Forfeited(381,659) 49.16
Outstanding at September 30, 20177,563,682
 $34.92
Vested and expected to vest at September 30, 20177,314,174
 $34.53
Exercisable at September 30, 20175,707,402
 $31.37
 Number of Shares Under Stock Awards Weighted Average Exercise Price per Share
Outstanding at December 31, 20186,815,278
 $36.61
Granted650,747
 27.67
Exercised(180,626) 13.43
Forfeited(202,181) 44.90
Outstanding at March 31, 20197,083,218
 $36.14
Vested and expected to vest at March 31, 20196,867,569
 $36.10
Exercisable at March 31, 20195,409,105
 $36.13
As of September 30, 2017,March 31, 2019, stock awards outstanding, stock awards vested and expected to vest and stock awards exercisable had average remaining contractual terms of 5.7 years, 5.6 years, 5.5 years and 4.74.5 years,, respectively. Also, at September 30, 2017,March 31, 2019, stock awards outstanding, stock awards vested and expected to vest and stock awards exercisable each had an aggregate intrinsic valuevalues of $36.6 million.$15.9 million, $15.8 million and $15.4 million, respectively.

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A summary of the status of the Company’s nonvested restricted ordinary shares and restricted stock unit awards, including PSUs (collectively, “restricted stock awards”), as of September 30, 2017March 31, 2019 and the changes during the ninethree months endedSeptember 30, 2017 March 31, 2019 are presented below:
Number of Restricted Stock Awards Weighted Average Grant-Date Fair Value per ShareNumber of Restricted Stock Awards Weighted Average Grant-Date Fair Value per Share
Nonvested at December 31, 20165,667,830
 $42.46
Nonvested at December 31, 20186,393,081
 $40.75
Granted1,402,907
 44.04
2,279,253
 27.45
Released(500,854) 52.29
(672,319) 43.70
Forfeited(274,034) 45.96
(2,892,752) 38.06
Nonvested at September 30, 20176,295,849
 $41.88
Nonvested at March 31, 20195,107,263
 $35.94
As of September 30, 2017,March 31, 2019, the Company had $139.7$130.6 million of total unrecognized compensation expense, net of estimated forfeitures, related to all of its stock-based awards, which will be recognizedwe expect to recognize over the remaining weighted average vesting period of 1.9 years.1.8 years. The total intrinsic value of stock awards exercised and restricted stock units released during the ninethree months endedSeptember 30, March 31, 2019 and 2018 was $22.1 million and $38.1 million, respectively.
In February 2014, Mylan’s Compensation Committee and the independent members of the Board of Directors adopted the One-Time Special Performance-Based Five-Year Realizable Value Incentive Program (the “2014 Program”) under the 2003 Plan. Under the 2014 Program, certain key employees received a one-time, performance-based incentive award (the “Awards”) either in the form of a grant of SARs or PSUs. The initial Awards were granted in February 2014 and contained a five-year cliff-vesting feature based on the achievement of various performance targets, external market conditions and the employee’s continued services. Additional Awards were granted in 2016 and 2017, subject to the same performance condition. The performance condition was not achieved by December 31, 2018 and 2016approximately 2.6 million Awards outstanding under the 2014 Program were canceled in the first quarter of 2019. There was $34.7 million and $49.1 million, respectively.no impact to share based compensation expense during the three months ended March 31, 2019 as all of the cumulative expense related to the Awards was reversed during the year ended December 31, 2018.
6.Pensions and Other Postretirement Benefits
Defined Benefit Plans
The Company sponsors various defined benefit pension plans in several countries. Benefits provided generally depend on length of service, pay grade and remuneration levels. The Company maintains two fully frozen defined benefit pension plans in the U.S., and employees in the U.S. and Puerto Rico are generally provided retirement benefits through defined contribution plans.
The Company also sponsors other postretirement benefit plans including plans that provide for postretirement supplemental medical coverage. Benefits from these plans are provided to employees and their spouses and dependents who meet various minimum age and service requirements. In addition, the Company sponsors other plans that provide for life insurance benefits and postretirement medical coverage for certain officers and management employees.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Net Periodic Benefit Cost
Components of net periodic benefit cost for the three and nine months ended September 30, 2017March 31, 2019 and 20162018 were as follows:
Pension and Other Postretirement BenefitsPension and Other Postretirement Benefits
Three Months Ended Nine Months EndedThree Months Ended
September 30, September 30,March 31,
(In millions)2017 2016 2017 20162019 2018
Service cost$5.0
 $4.8
 $15.1
 $12.6
$5.3
 $5.0
Interest cost3.7
 2.8
 11.2
 5.7
3.8
 3.6
Expected return on plan assets(3.5) (3.0) (10.6) (7.0)(3.0) (3.6)
Amortization of prior service costs0.1
 0.1
 0.2
 0.2
0.3
 0.1
Recognized net actuarial losses0.2
 0.2
 0.5
 0.7
Recognized net actuarial gains(0.2) 
Net periodic benefit cost$5.5
 $4.9
 $16.4
 $12.2
$6.2
 $5.1
The Company is making the minimum mandatory contributions to its U.S. defined benefit pension plans in the 20172019 plan year. The Company expects to make total benefit payments of approximately $30.4$33.7 million from pension and other postretirement benefit plans.plans in 2019. The Company anticipates making contributions to pension and other postretirement benefit plans of approximately $30.2$29.3 million in 2017.2019.

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7.Balance Sheet Components
Selected balance sheet components consist of the following:
Cash and restricted cash
(In millions)March 31,
2019
 December 31,
2018
Cash and cash equivalents$229.8
 $388.1
Restricted cash, included in prepaid expenses and other current assets1.1
 1.2
Cash, cash equivalents and restricted cash$230.9
 $389.3
Inventories
(In millions)September 30,
2017
 December 31,
2016
Raw materials$885.1
 $783.4
Work in process381.0
 436.0
Finished goods1,282.0
 1,237.0
Inventories$2,548.1
 $2,456.4
Prepaid and other current assets
(In millions)September 30,
2017
 December 31, 2016
Prepaid expenses$153.6
 $169.1
Restricted cash135.9
 148.1
Available-for-sale securities87.6
 83.7
Fair value of financial instruments82.5
 62.2
Trading securities32.7
 29.6
Other current assets391.1
 263.7
Prepaid expenses and other current assets$883.4
 $756.4
Prepaid expenses consist primarily of prepaid rent, insurance and other individually insignificant items.
Property, plant and equipment, net
(In millions)September 30,
2017
 December 31, 2016
Machinery and equipment$2,310.3
 $2,227.9
Buildings and improvements1,175.5
 1,106.5
Construction in progress277.0
 328.8
Land and improvements146.9
 144.7
Gross property, plant and equipment3,909.7
 3,807.9
Accumulated depreciation1,599.7
 1,485.7
Property, plant and equipment, net$2,310.0
 $2,322.2
Other assets
(In millions)September 30,
2017
 December 31, 2016
Equity method investments, clean energy investments$274.8
 $320.6
Equity method investments, Sagent Agila
 75.8
Other long-term assets152.5
 172.2
Other assets$427.3
 $568.6
(In millions)March 31,
2019
 December 31,
2018
Raw materials$987.0
 $955.7
Work in process415.4
 369.9
Finished goods1,306.4
 1,254.6
Inventories$2,708.8
 $2,580.2

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Trade accountsPrepaid and other current assets
(In millions)March 31,
2019
 December 31, 2018
Prepaid expenses$131.8
 $130.6
Restricted cash1.1
 1.2
Available-for-sale fixed income securities25.9
 25.0
Fair value of financial instruments40.1
 33.8
Equity securities35.8
 32.5
Other current assets310.5
 295.3
Prepaid expenses and other current assets$545.2
 $518.4
Prepaid expenses consist primarily of prepaid rent, insurance and other individually insignificant items.
Property, plant and equipment, net
(In millions)March 31,
2019
 December 31, 2018
Machinery and equipment$2,444.8
 $2,421.2
Buildings and improvements1,188.5
 1,182.3
Construction in progress249.0
 239.7
Land and improvements130.5
 131.3
Gross property, plant and equipment4,012.8
 3,974.5
Accumulated depreciation1,861.4
 1,804.3
Property, plant and equipment, net$2,151.4
 $2,170.2
Other assets
(In millions)March 31,
2019
 December 31, 2018
Equity method investments, clean energy investments$127.4
 $138.7
Operating lease right-of-use assets236.2
 
Other long-term assets58.1
 73.7
Other assets$421.7
 $212.4
Accounts payable
(In millions)September 30,
2017
 December 31,
2016
Accounts payable$799.0
 $939.5
Other payables477.1
 408.6
Trade accounts payable$1,276.1
 $1,348.1
Other current liabilities
(In millions)September 30,
2017
 December 31, 2016
Accrued sales allowances$808.9
 $809.0
Legal and professional accruals, including litigation accruals473.7
 720.4
Payroll and employee benefit plan accruals373.4
 409.8
Contingent consideration119.4
 256.9
Accrued interest167.7
 41.0
Restructuring55.8
 138.6
Equity method investments, clean energy investments67.0
 64.7
Fair value of financial instruments10.1
 15.3
Compulsory acquisition proceeding
 70.2
Other824.1
 732.6
Other current liabilities$2,900.1
 $3,258.5
On March 31, 2017, the Company announced that Meridian Medical Technologies (“Meridian”), a Pfizer company that manufactures the EpiPen® Auto-Injector, expanded a voluntary recall of select lots of EpiPen® Auto-Injector and EpiPen Jr® Auto-Injector to include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (“FDA”) (the “EpiPen® Auto-Injector Recall”). This recall was conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of the failure to activate the device due to a potential defect in a supplier component. Both reports were related to the single lot that was previously recalled. The expanded voluntary recall was initiated in the U.S. and also extends to additional markets in Europe, Asia, North and South America. The Company is replacing recalled devices at no cost to the consumer. Estimated costs to Mylan related to product recalls are based on a formal campaign soliciting return of the product and are accrued when they are deemed to be probable and can be reasonably estimated. As of September 30, 2017, the Company recorded an accrual for certain costs of the recall but there can be no assurance that future costs related to the recall will not exceed amounts recorded. In addition, Meridian is contractually obligated to reimburse Mylan for costs related to the EpiPen® Auto-Injector Recall, and the Company has recorded an asset for the recovery of such costs.
Other long-term obligations
(In millions)September 30,
2017
 December 31, 2016
Employee benefit liabilities$432.9
 $396.7
Contingent consideration351.7
 307.7
Equity method investments, clean energy investments264.8
 302.3
Tax contingencies247.7
 239.3
Other115.4
 112.6
Other long-term obligations$1,412.5
 $1,358.6
8.Equity Method Investments
The Company has five equity method investments in limited liability companies that own refined coal production plants (the “clean energy investments”), who’s activities qualify for income tax credits under Section 45 of the U.S. Internal Revenue Code of 1986, as amended.
(In millions)March 31,
2019
 December 31,
2018
Trade accounts payable$907.0
 $1,123.2
Other payables409.5
 493.8
Accounts payable$1,316.5
 $1,617.0

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Other current liabilities
(In millions)March 31,
2019
 December 31, 2018
Accrued sales allowances$604.1
 $626.7
Legal and professional accruals, including litigation accruals128.7
 128.1
Payroll and employee benefit liabilities311.4
 399.7
Contingent consideration114.9
 158.3
Accrued interest166.0
 62.4
Restructuring37.5
 62.3
Equity method investments, clean energy investments46.0
 45.1
Fair value of financial instruments9.7
 29.4
Operating lease liability80.0
 
Other615.7
 635.6
Other current liabilities$2,114.0
 $2,147.6
In the fourth quarter of 2018, the Company announced the voluntary recall of valsartan and certain combination valsartan medicines in various countries due to the detection of trace amounts of an impurity, N-nitrosodiethylamine contained in the active pharmaceutical ingredient Valsartan, USP, manufactured by Mylan India. The impact of this recall on the Company’s condensed consolidated statement of operations for the period ended March 31, 2019 was approximately $3.9 million, primarily related to recall costs and inventory reserves. Depending on the scope of regulatory actions, and severity of the impurity, the Company may face additional loss of revenues and profits and incur contractual or other litigation costs. There can be no assurance that future costs related to the recall will not exceed amounts recorded.
Other long-term obligations
(In millions)March 31,
2019
 December 31, 2018
Employee benefit liabilities$390.3
 $397.7
Contingent consideration180.2
 197.0
Equity method investments, clean energy investments90.0
 100.3
Tax related items, including contingencies76.0
 162.1
Operating lease liability154.3
 
Other236.5
 239.7
Other long-term obligations$1,127.3
 $1,096.8
8.Leases
The Company adopted the provisions of Topic 842 as of January 1, 2019 on a modified retrospective basis applying the guidance to leases existing as of this effective date. We have operating leases of real estate, consisting primarily of administrative offices, manufacturing and distribution facilities, and research and development facilities. We also have operating leases of certain equipment, primarily automobiles, and certain limited supply arrangements.
As of March 31, 2019, the Company recognized an ROU asset of $236.2 million and a total lease liability of $234.3 million. The Company’s ROU assets are recorded in other assets. The related lease liability balances are recorded in other current liabilities and other long-term obligations on the condensed consolidated balance sheet. Refer to Note 7 Balance Sheet Components for additional information. Operating lease costs for the three months ended March 31, 2019 were approximately $24.2 million, and are classified primarily as selling, general and administrative expenses and cost of sales.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Since December 2013,ROU assets and liabilities are recognized at the Company held a 50% interest in Sagent Agila LLC (“Sagent Agila”), which was a joint venture established to develop, manufacture and distribute certain generic injectable products in the U.S. In April 2017, the Company and Sagent Pharmaceuticals Inc. (“Sagent”) finalized an agreement to dissolve the joint venture. Under the terms of the agreement, Mylan received Sagent’s interest in the joint venture in exchange for an approved product right. The assets in the joint venture consisted entirely of product rights for commercialized generic injectables. As a result of this transaction, during the nine months ended September 30, 2017, the Company recognized a loss of $5.7 million as a component of net losses from equity method investments. Additionally, during the nine months ended September 30, 2017, the Company received a dividend payment of $8.4 million from Sagent Agila, which reduced the carryingpresent value of the equity investment. In the second quarter of 2017, the Company reclassified its investment in Sagent Agila to product rights and licenses and is amortizing the amountfuture minimum lease payments over the remaining estimated useful liveslease term at commencement date. As most of our leases do not provide an implicit rate, we use an applicable incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. Options to extend or terminate the ROU assets are reviewed at lease inception and these options are accounted for when they are reasonably certain of being exercised.
Other information related to leases was as follows:
As of March 31, 2019
Remaining lease terms1 year to 25 years
Weighted-average remaining lease term6 years
Weighted-average discount rate4.2%
As of March 31, 2019, we have additional operating leases, primarily for distribution facilities, that have not yet commenced totaling approximately $42.7 million. These leases are expected to commence in 2019 and have lease terms of 7 years to 15 years.    
As of March 31, 2019, maturities of lease liabilities were as follows:
(In millions) 
Year ending December 31, 
2019 (excluding the three months ended March 31, 2019)$55.4
202062.8
202141.6
202227.0
202319.7
Thereafter58.0
 $264.5
As of December 31, 2018, future minimum lease payments under operating lease commitments were as follows:
(In millions) 
Year ending December 31, 
2019$73.7
202054.7
202140.2
202228.5
202318.3
Thereafter54.2
 $269.6
9.Equity Method Investments
The Company currently has three equity method investments in limited liability companies that own refined coal production plants (the “clean energy investments”) whose activities qualify for income tax credits under Section 45 of the products.U.S. Internal Revenue Code of 1986, as amended (the “Code”).

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Summarized financial information, in the aggregate, for the Company’s significant equity method investments on a 100% basis for the three and nine months ended September 30, 2017March 31, 2019 and 20162018 are as follows:
Three Months Ended Nine Months EndedThree Months Ended
September 30, September 30,March 31,
(In millions)2017 2016 2017 20162019 2018
Total revenues$129.3
 $170.0
 $352.0
 $418.2
$86.9
 $129.0
Gross loss(2.4) (3.0) (8.8) (3.8)(1.0) (7.7)
Operating and non-operating expense6.5
 6.3
 16.9
 16.3
4.9
 5.6
Net loss$(8.9) $(9.3) $(25.7) $(20.1)$(5.9) $(13.3)
The Company’s net losses from its equity method investments includesinclude amortization expense related to the excess of the cost basis of the Company’s investment over the underlying assets of each individual investee. For the three months ended September 30, 2017March 31, 2019 and 2016,2018, the Company recognized net losses from equity method investments of $22.4$17.0 million and $29.7 million, respectively. For the nine months ended September 30, 2017 and 2016, the Company recognized net losses from equity method investments of $77.2 million and $85.5$23.1 million, respectively, which waswere recognized as a component of other expense, net in the Condensed Consolidated Statementscondensed consolidated statements of Operations.operations. The Company recognizes the income tax credits and benefits from the clean energy investments as part of its provision for income taxes.
9.10.(Loss) Earnings per Ordinary Share
Basic (loss) earnings per ordinary share is computed by dividing net (loss) earnings by the weighted average number of ordinary shares outstanding during the period. Diluted (loss) earnings per ordinary share is computed by dividing net (loss) earnings by the weighted average number of ordinary shares outstanding during the period increased by the number of additional shares that would have been outstanding related to potentially dilutive securities or instruments, if the impact is dilutive.
On April 15, 2016, in connection with the expiration and settlement of the Company’s equity classified warrants, the Company issued approximately 17.0 million Mylan N.V. ordinary shares. The dilutive impact of the warrants, prior to settlement, is included in the calculation of diluted earnings per ordinary share based upon the average market value of the Company’s ordinary shares during the period as compared to the exercise price. For the nine months ended September 30, 2016, 6.6 million warrants were included in the calculation of diluted earnings per ordinary share.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


Basic and diluted (loss) earnings per ordinary share are calculated as follows:
 Three Months Ended Nine Months Ended
 September 30, September 30,
(In millions, except per share amounts)2017 2016 2017 2016
Basic earnings (numerator):       
Net earnings (loss)$88.3
 $(119.8) $451.7
 $62.5
Shares (denominator):       
Weighted average ordinary shares outstanding535.2
 523.6
 534.9
 505.9
Basic earnings (loss) per ordinary share$0.17
 $(0.23) $0.84
 $0.12
Diluted earnings (numerator):       
Net earnings (loss)$88.3
 $(119.8) $451.7
 $62.5
Shares (denominator):       
Weighted average ordinary shares outstanding535.2
 523.6
 534.9
 505.9
Share-based awards and warrants1.8
 
 2.1
 9.3
Total dilutive shares outstanding537.0
 523.6
 537.0
 515.2
Diluted earnings (loss) per ordinary share$0.16
 $(0.23) $0.84
 $0.12
 Three Months Ended
 March 31,
(In millions, except per share amounts)2019 2018
Basic (loss) earnings (numerator):   
Net (loss) earnings$(25.0) $87.1
Shares (denominator):   
Weighted average ordinary shares outstanding515.0
 514.4
Basic (loss) earnings per ordinary share$(0.05) $0.17
    
Diluted (loss) earnings (numerator):   
Net (loss) earnings$(25.0) $87.1
Shares (denominator):   
Weighted average ordinary shares outstanding515.0
 514.4
Share-based awards
 2.4
Total dilutive shares outstanding515.0
 516.8
Net (loss) earnings per diluted ordinary share

$(0.05) $0.17
Additional stock awards and restricted stock awards were outstanding during the three and nine months ended September 30, 2017March 31, 2019 and 2016,2018, but were not included in the computation of diluted (loss) earnings per ordinary share for each respective period because the effect would be anti-dilutive. Excluded shares at September 30, 2017March 31, 2019 include certain share-based compensation awards and restricted ordinary shares whose performance conditions had not been fully met. Such excluded shares and anti-dilutive awards represented 8.9 million shares and 8.68.1 million shares for the three and nine months ended September 30, 2017, respectively,March 31, 2019 and 13.9 million shares and 7.3 million shares for the three and nine months ended September 30, 2016,2018, respectively.

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10.11.Goodwill and Intangible Assets
The changes in the carrying amount of goodwill for the ninethree months endedSeptember 30, 2017 March 31, 2019 are as follows:
(In millions)North America Segment Europe Segment Rest of World Segment Total
Balance at December 31, 2016:       
Goodwill$3,990.4
 $3,859.1
 $1,767.4
 $9,616.9
Accumulated impairment losses(385.0) 
 
 (385.0)
 3,605.4
 3,859.1
 1,767.4
 9,231.9
Reclassifications (1)
(199.0) 371.8
 (172.8) 
Measurement period adjustments
 7.7
 
 7.7
Divestiture
 (1.3) 
 (1.3)
Foreign currency translation52.9
 614.6
 78.9
 746.4
 $3,459.3
 $4,851.9
 $1,673.5
 $9,984.7
Balance at September 30, 2017:       
Goodwill$3,844.3
 $4,851.9
 $1,673.5
 $10,369.7
Accumulated impairment losses(385.0) 
 
 (385.0)
 $3,459.3
 $4,851.9
 $1,673.5
 $9,984.7
____________
(1)
(In millions)North America Segment Europe Segment Rest of World Segment Total
Balance at December 31, 2018:       
Goodwill$3,892.9
 $4,657.4
 $1,582.5
 $10,132.8
Accumulated impairment losses(385.0) 
 
 (385.0)
 3,507.9
 4,657.4
 1,582.5
 9,747.8
Foreign currency translation4.8
 (149.8) 5.1
 (139.9)
 $3,512.7
 $4,507.6
 $1,587.6
 $9,607.9
Balance at March 31, 2019:       
Goodwill$3,897.7
 $4,507.6
 $1,587.6
 $9,992.9
Accumulated impairment losses(385.0) 
 
 (385.0)
 $3,512.7
 $4,507.6
 $1,587.6
 $9,607.9
The reclassifications in the year-to-date period relate to the allocation of goodwill for the Meda acquisition.
Intangible assets consist of the following components at September 30, 2017March 31, 2019 and December 31, 2016:2018:
(In millions)Weighted Average Life (Years) Original Cost Accumulated Amortization Net Book Value
September 30, 2017       
Amortized intangible assets:       
Product rights and licenses15 $19,193.0
 $4,947.7
 $14,245.3
Patents and technologies20 116.7
 112.0
 4.7
Other (1)
6 505.3
 404.1
 101.2
   19,815.0
 5,463.8
 14,351.2
In-process research and development  919.3
 
 919.3
   $20,734.3
 $5,463.8
 $15,270.5
December 31, 2016       
Amortized intangible assets:       
Product rights and licenses15 $16,968.4
 $3,585.7
 $13,382.7
Patents and technologies20 116.6
 108.5
 8.1
Other (1)
6 465.9
 330.0
 135.9
   17,550.9
 4,024.2
 13,526.7
In-process research and development  921.1
 
 921.1
   $18,472.0
 $4,024.2
 $14,447.8
(In millions)Weighted Average Life (Years) Original Cost Accumulated Amortization Net Book Value
March 31, 2019       
Product rights, licenses and other (1)
15 $20,232.7
 $7,521.2
 $12,711.5
In-process research and development  244.0
 
 244.0
   $20,476.7
 $7,521.2
 $12,955.5
December 31, 2018       
Product rights, licenses and other (1)
15 $20,264.1
 $7,225.1
 $13,039.0
In-process research and development  625.6
 
 625.6
   $20,889.7
 $7,225.1
 $13,664.6
____________
(1) 
Represents amortizable intangible assets. Other intangible assets consistconsists principally of customer lists and contractual rights and other contracts.rights.
In December 2011, the Company completed the acquisition of the exclusive worldwide rights to develop, manufacture and commercialize a generic equivalent to GlaxoSmithKline’s Advair® Diskus and Seretide® Diskus incorporating Pfizer

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


Inc.’s proprietary dry powder inhaler delivery platform (the “respiratory delivery platform”). The Company accounted for this transaction as a purchase of a business and utilized the acquisition method of accounting. In conjunction with the Company’s Generic Drug User Fee Agreement goal date, on March 28, 2017,On January 30, 2019, the Company received a complete response letter fromU.S. Food and Drug Administration (“FDA”) approval of WixelaTM InhubTM (fluticasone propionate and salmeterol inhalation powder, USP) and the FDA regarding its Abbreviated New Drug Application (“ANDA”) forcommercial launch occurred in February 2019. The Company reclassified the respiratory delivery platform. As of September 30, 2017, the Company has an IPR&D asset of $347.2 million to product rights and licenses during the three months ended March 31, 2019 and began amortizing the asset over its estimated useful life.
As of March 31, 2019, the Company has a related contingent consideration liability of $361.0$276.4 million. Upon approval and launch of the product, during the three months ended March 31, 2019, the Company made $60.0 million in milestone payments. The Company performed an analysis and valuation of the IPR&D asset and the fair value of the related contingent consideration liability using a discounted cash flow model. The model contained certain key assumptions including: the expected product launch date,market share, the number of competitors, the timing of competition and a discount factor based on an industry specific weighted average cost of capital. Based on the analysis performed, the Company determined that the IPR&D asset was not impaired at September 30, 2017. Additionally, norecorded a fair value adjustment was required for the contingent considerationof $4.1 million during the three months ended September 30, 2017. In the second quarter of 2017, a fair value adjustment was required forMarch 31, 2019 to reduce the contingent consideration liability resulting in a gain of approximately $88.1 million based upon changes to assumptions relating to the timing of the product launch along with other competitive and market factors.liability. The fair value of the contingent consideration liability was determined based upon detailed valuations employing the income approach which utilized Level 3 inputs, as defined in Note 1112 - Financial Instruments and Risk Management. Resolution of the matters with the FDA, marketMarket conditions and other factors may result in significant future changes in the

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projections and assumptions utilized in the discounted cash flow model, which could lead to material adjustments to the amountsamount recorded for IPR&D and contingent consideration.
During the three months ended June 30, 2017,March 31, 2019, the Company performed its annualrecognized impairment reviewcharges of its IPR&D assets acquired as part of the Topicals Business and recorded an impairment charge in the amount of $13.0$29.5 million, which hashave been recorded as a component of amortization expense, infor the nine months ended September 30, 2017.impairment of certain IPR&D assets. The impairment charge recorded during the first quarter of 2019 related to certain assets acquired as part of the acquisition of the non-sterile, topicals-focused business of Renaissance Acquisition Holdings, LLC. The impairment charges resulted from the Company’s updated estimate of the fair value of thesecertain assets, which waswere based upon updatedrevised forecasts and future development plans, compared withplans. The impairment testing involved calculating the assigned fair values asvalue of the acquisition date, June 15, 2016. The fair value was determinedassets based upon detailed valuations employing the income approach which utilized Level 3 inputs, as defined in Note 1112 - Financial Instruments and Risk Management. These valuations reflect, among other things, the impact of changes to the development programs, the projected development and regulatory time frames and the current competitive environment. Changes in any of the Company’s assumptions may result in a further reduction to the estimated fair values of these IPR&D assets and could result in additional future impairment charges.
The Company has performed its annual goodwill impairment test as of April 1, 2017 on a quantitative basis for its four reporting units, North America Generics, North America Specialty, Europe and Rest of World. As of the date of our annual impairment test, the allocation of the Company’s total goodwill was as follows: North America Generics $2.89 billion, North America Specialty $0.35 billion, Europe $4.30 billion and Rest of World $1.79 billion. The fair value of the North America Generics, North America Specialty and Rest of World reporting units was substantially in excess of the respective unit’s carrying value. For the Europe reporting unit, the estimated fair value exceeded its carrying value by approximately $800 million or 6%. The excess fair value over the carrying value declined from the prior year primarily as a result of an increase in the discount rate utilized in the income approach from 8.5% to 9.0% and an increase in the estimated tax rate from 22.0% to 24.0%. Additionally, the net assets acquired as part of the Meda acquisition, the majority of which were allocated to the Europe reporting unit, were included in the April 1, 2017 impairment test for the first time. As it relates to the income approach for the Europe reporting unit at April 1, 2017, the Company forecasted cash flows for the next 5 years. During the forecast period, the revenue compound annual growth rate was approximately 4%. A terminal value year was calculated with a 2.0% revenue growth rate applied. Under the market-based approach, we utilized an estimated range of market multiples of 9.0 to 10.5 times EBITDA plus a control premium of 15%. If all other assumptions are held constant, a reduction in the terminal value growth rate by 2.0% or an increase in discount rate by 1.5% would result in an impairment charge for the Europe reporting unit.
In estimating each reporting unit’s fair value, the Company performed an extensive valuation analysis, utilizing both income and market-based approaches. The determination of the fair value of the reporting units requires the Company to make significant estimates and assumptions that affect the reporting unit’s expected future cash flows. These estimates and assumptions, utilizing Level 3 inputs, primarily include, but are not limited to, market multiples, control premiums, the discount rate, terminal growth rates, operating income before depreciation and amortization, and capital expenditures forecasts. Due to the inherent uncertainty involved in making these estimates, actual results could differ from those estimates. In addition, changes in underlying assumptions, especially as it relates to the key assumptions detailed, could have a significant impact on the fair value of the reporting units.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


Amortization expense, which is classified primarily within cost of sales in the Condensed Consolidated Statementscondensed consolidated statements of Operationsoperations for the three and nine months ended September 30, 2017March 31, 2019 and 20162018 totaled:
Three Months Ended Nine Months EndedThree Months Ended
September 30, September 30,March 31,
(In millions)2017 2016 2017 20162019 2018
Intangible asset amortization expense$369.4
 $364.3
 $1,065.6
 $852.9
$405.5
 $392.3
IPR&D intangible asset impairment charges29.5
 30.0
Total intangible asset amortization expense (including impairment charges)$435.0
 $422.3
Intangible asset amortization expense over the remainder of 20172019 and for the years ended December 31, 20182020 through 20212023 is estimated to be as follows:
(In millions)  
2017$339
20181,341
20191,248
$1,157
20201,129
1,403
20211,050
1,325
20221,255
20231,093
11.12.Financial Instruments and Risk Management
The Company is exposed to certain financial risks relating to its ongoing business operations. The primary financial risks that are managed by using derivative instruments are foreign currency risk and interest rate risk.
Foreign Currency Risk Management
In order to manage certain foreign currency risks, the Company enters into foreign exchange forward contracts to mitigate risk associated with changes in spot exchange rates of mainly non-functional currency denominated assets or liabilities. The foreign exchange forward contracts are measured at fair value and reported as current assets or current liabilities on the Condensed Consolidated Balance Sheetscondensed consolidated balance sheets. Any gains or losses on the foreign exchange forward contracts are recognized in earnings in the period incurred in the Condensed Consolidated Statementscondensed consolidated statements of Operationsoperations.
The Company has also entered into forward contracts to hedge forecasted foreign currency denominated sales from certain international subsidiaries. These contracts are designated as cash flow hedges to manage foreign currency transaction risk and are measured at fair value and reported as current assets or current liabilities on the Condensed Consolidated Balance Sheetscondensed consolidated balance sheets. Any changes in the fair value of designated cash flow hedges are includeddeferred in earnings or deferred through accumulated other comprehensive earnings (“AOCE”), depending on and are reclassified into earnings when the naturehedged item impacts earnings.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Net Investment Hedges
The Company may hedge the foreign currency risk associated with certain net investment positions in foreign subsidiaries by either borrowing directly in foreign currencies and effectivenessdesignating all or a portion of the offset. Any ineffectiveness inforeign currency debt as a cash flow hedging relationship is recognized immediately in earnings inhedge of the Condensed Consolidated Statementsapplicable net investment position or entering into foreign currency swaps that are designated as hedges of Operations.net investments.
During the nine months ended September 30, 2017, theThe Company has designated certain Euro borrowings as a hedge of its investment in certain Euro-functional currency subsidiaries in order to manage foreign currency translation risk. The notional amount of the net investment hedges was €1.9 billion and consisted of €1.0 billion aggregate principal amount of the 2.250% Euro Senior Notes due 2024 (the “2024 Euro Notes”), €750 million aggregate principal amount of 3.125% Euro Senior Notes due 2028 (the “2028 Euro Notes”) and €104 million of the €750 million aggregate principal amount of the 1.250% Euro Senior Notes due 2020 (the “2020 Euro Notes”).
Borrowings designated as net investment hedges are marked to marketmarked-to-market using the current spot exchange rate as of the end of the period, with gains and losses included in the foreign currency translation component of AOCE until the sale or substantial liquidation of the underlying net investments. The Company recorded no ineffectiveness from its net investment hedges for the nine months ended September 30, 2017. In addition, the Company manages the related foreign exchange risk of the €500 million aggregate principal amount of floating rate Senior Notes due 2018 (the “2018 Floating Rate Euro Notes”), €500 million aggregate principal amount of the Floating Rate Senior Notes due 2020 (the “2020 Floating Rate Euro Notes”) and the remaining portion of the 2020 Euro Notesborrowings not designated as net investment hedges through certain Euro denominated financial assets and forward contracts.currency swaps.

The following table summarizes the principal amounts of the Company’s outstanding Euro borrowings and the notional amounts of the Euro borrowings designated as net investment hedges:
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued



   Notional Amount Designated as a Net Investment Hedge
(in millions) Principal Amount March 31,
2019
 December 31,
2018
2.250% Euro Senior Notes due 2024 1,000.0
 1,000.0
 1,000.0
3.125% Euro Senior Notes due 2028 750.0
 750.0
 750.0
1.250% Euro Senior Notes due 2020 750.0
 104.0
 104.0
2.125% Euro Senior Notes due 2025 500.0
 500.0
 500.0
Floating Rate Euro Notes due 2020 500.0
 
 
Total 3,500.0
 2,354.0
 2,354.0
Interest Rate Risk Management
The Company enters into interest rate swaps in order to manage interest rate risk associated with the Company’s fixed-rate and floating-rate debt. TheseInterest rate swaps that meet specific accounting criteria are accounted for as fair value or cash flow hedges. All derivative instruments used to manage interest rate risk are measured at fair value and reported as current assets or current liabilities in the Condensed Consolidated Balance Sheetscondensed consolidated balance sheets.
Cash Flow Hedging Relationships
The Company’s interest rate swaps designated as cash flow hedges fix the interest rate on a portion of the Company’s variable-rate debt or hedge part of the Company’s interest rate exposure associated with variability in future cash flows attributable to changes in interest rates or foreign currencies. Any changes in fair value are included in earnings or deferred through AOCE, depending on the nature and effectiveness of the offset. Any ineffectiveness in a cash flow hedging relationship is recognized immediately in earnings in the Condensed Consolidated Statements of Operations.
Fair Value Hedging Relationships
The Company’s interest rate swaps designated as For fair value hedges, convert the fixed rate on a portion of the Company’s fixed-rate senior notes to a variable rate. Any changes in the fair value of these derivative instruments, as well asboth the offsettinghedging instrument and the underlying debt obligations are included in interest expense. For cash flow hedges, the change in fair value of the portion ofhedging instrument is deferred through AOCE and is reclassified into earnings when the fixed-rate debt being hedged is included in interest expense.item impacts earnings.
Credit Risk Management
The Company regularly reviews the creditworthiness of its financial counterparties and does not expect to incur a significant loss from the failure of any counterparties to perform under any agreements. The Company is not subject to any obligations to post collateral under derivative instrument contracts. Certain derivative instrument contracts entered into by the Company are governed by master agreements, which contain credit-risk-related contingent features that would allow the counterparties to terminate the contracts early and request immediate payment should the Company trigger an event of default on other specified borrowings. The Company records all derivative instruments on a gross basis in the Condensed Consolidated Balance Sheetscondensed consolidated balance sheets. Accordingly, there are no offsetting amounts that net assets against liabilities.
The Effect of Derivative Instruments on theCondensed Consolidated Balance Sheets
Fair Values of Derivative Instruments
Derivatives Designated as Hedging Instruments
 Asset Derivatives
 September 30, 2017 December 31, 2016
(In millions)Balance Sheet Location Fair Value Balance Sheet Location Fair Value
Interest rate swapsPrepaid expenses and other current assets $25.3
 Prepaid expenses and other current assets $26.2
Foreign currency forward contractsPrepaid expenses and other current assets 43.8
 Prepaid expenses and other current assets 21.9
Total  $69.1
   $48.1

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


The Effect of Derivative Instruments on the Condensed Consolidated Balance Sheetscondensed consolidated balance sheets
Fair Values of Derivative Instruments
Derivatives Designated as Hedging Instruments
 Asset Derivatives
 March 31, 2019 December 31, 2018
(In millions)Balance Sheet Location Fair Value Balance Sheet Location Fair Value
Interest rate swapsPrepaid expenses and other current assets $11.1
 Prepaid expenses and other current assets $3.6
Foreign currency forward contractsPrepaid expenses and other current assets 12.2
 Prepaid expenses and other current assets 
Total  $23.3
   $3.6
 Liability Derivatives
 March 31, 2019 December 31, 2018
(In millions)Balance Sheet Location Fair Value Balance Sheet Location Fair Value
Foreign currency forward contractsOther current liabilities 
 Other current liabilities 12.1
Total  $
   $12.1

The Effect of Derivative Instruments on thecondensed consolidated balance sheets
Fair Values of Derivative Instruments
Derivatives Not Designated as Hedging Instruments
Asset DerivativesAsset Derivatives
September 30, 2017 December 31, 2016March 31, 2019 December 31, 2018
(In millions)Balance Sheet Location Fair Value Balance Sheet Location Fair ValueBalance Sheet Location Fair Value Balance Sheet Location Fair Value
Foreign currency forward contractsPrepaid expenses and other current assets $13.4
 Prepaid expenses and other current assets $14.0
Prepaid expenses and other current assets $16.8
 Prepaid expenses and other current assets $30.2
Total $13.4
 $14.0
 $16.8
 $30.2
 Liability Derivatives
 September 30, 2017 December 31, 2016
(In millions)Balance Sheet Location Fair Value Balance Sheet Location Fair Value
Foreign currency forward contractsOther current liabilities $10.1
 Other current liabilities $15.3
Total  $10.1
   $15.3
The Effect of Derivative Instruments on theCondensed Consolidated Statements of Operations
Derivatives in Fair Value Hedging Relationships
 
Location of Gain (Loss)
Recognized in Earnings
on Derivatives
 Amount of Gain (Loss) Recognized in Earnings on Derivatives
(In millions) Three Months Ended Nine Months Ended
 September 30, September 30,
 2017 2016 2017 2016
Interest rate swapsInterest expense $(2.5) $(9.7) $(1.0) $30.2
Total  $(2.5) $(9.7) $(1.0) $30.2
 
Location of Gain (Loss)
Recognized in Earnings
on Hedged Items
 Amount of Gain (Loss) Recognized in Earnings on Hedged Items
(In millions) Three Months Ended Nine Months Ended
 September 30, September 30,
 2017 2016 2017 2016
2023 Senior Notes (3.125% coupon)Interest expense $2.5
 $9.7
 $1.0
 $(30.2)
Total  $2.5
 $9.7
 $1.0
 $(30.2)
The Effect of Derivative Instruments on theCondensed Consolidated Statements of Comprehensive Earnings
Derivatives in Cash Flow Hedging Relationships
 Amount of Gain (Loss) Recognized in AOCE (Net of Tax) on Derivative (Effective Portion)
 Three Months Ended Nine Months EndedLiability Derivatives
 September 30, September 30,March 31, 2019 December 31, 2018
(In millions) 2017 2016 2017 2016Balance Sheet Location Fair Value Balance Sheet Location Fair Value
Foreign currency forward contracts $(8.8) $2.9
 $7.5
 $(16.3)Other current liabilities $9.7
 Other current liabilities $17.3
Interest rate swaps (3.3) (0.9) (2.0) (38.0)
Total $(12.1) $2.0
 $5.5
 $(54.3) $9.7
 $17.3

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


The Effect of Derivative Instruments on the Condensed Consolidated Statementscondensed consolidated statements of Comprehensive Earningsoperations
Derivatives in Fair Value Hedging Relationships
 
Location of Gain (Loss)
Recognized in Earnings
on Derivatives
 Amount of Gain (Loss) Recognized in Earnings on Derivatives
(In millions) Three Months Ended
 March 31,
 2019 2018
Interest rate swapsInterest expense $7.5
 $(16.0)
Total  $7.5
 $(16.0)
 
Location of Gain (Loss)
Recognized in Earnings
on Hedged Items
 Amount of Gain (Loss) Recognized in Earnings on Hedged Items
(In millions) Three Months Ended
 March 31,
 2019 2018
2023 Senior Notes (3.125% coupon)Interest expense $(7.5) $16.0
Total  $(7.5) $16.0
The Effect of Derivative Instruments on thecondensed consolidated statements of comprehensive earnings
Derivatives in Cash Flow Hedging Relationships
  Amount of Gain (Loss) Recognized in AOCE (Net of Tax) on Derivative
  Three Months Ended
  March 31,
(In millions) 2019 2018
Foreign currency forward contracts $15.5
 $(15.1)
Total $15.5
 $(15.1)
The Effect of Derivative Instruments on thecondensed consolidated statements of comprehensive earnings
Derivatives in Net Investment Hedging Relationships
 Amount of Gain (Loss) Recognized in AOCE
(Net of Tax) on Derivative
(Effective Portion)
 Amount of Gain (Loss) Recognized in AOCE
(Net of Tax) on Derivative
 Three Months Ended Nine Months Ended Three Months Ended
 September 30, September 30, March 31,
(In millions) 2017 2016 2017 2016 2019 2018
Foreign currency borrowings and forward contracts $(72.1) $(8.1) $(203.2) $(8.1) $55.2
 $(59.2)
Total $(72.1) $(8.1) $(203.2) $(8.1) $55.2
 $(59.2)

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

The Effect of Derivative Instruments on the Condensed Consolidated Statementscondensed consolidated statements of Operationsoperations
Derivatives in Cash Flow Hedging Relationships
 Location of Gain (Loss) Reclassified from AOCE into Earnings (Effective Portion) Amount of Gain (Loss) Reclassified from AOCE into Earnings (Effective Portion)
  Three Months Ended Nine Months Ended
  September 30, September 30,
(In millions) 2017 2016 2017 2016
Foreign currency forward contractsNet sales $2.0
 $(10.7) $(3.8) $(34.2)
Interest rate swapsInterest expense (1.9) (2.3) (5.5) (6.6)
Total  $0.1
 $(13.0) $(9.3) $(40.8)
Location of Gain (Loss) Excluded from the Assessment of Hedge Effectiveness Amount of Gain (Loss) Excluded from the Assessment of Hedge EffectivenessLocation of Gain (Loss) Reclassified from AOCE into Earnings (Effective Portion) Amount of Gain (Loss) Reclassified from AOCE into Earnings
 Three Months Ended Nine Months Ended Three Months Ended
 September 30, September 30, March 31,
(In millions) 2017 2016 2017 2016 2019 2018
Foreign currency forward contractsOther expense, net $3.3
 $8.9
 $6.9
 $26.0
Net sales $0.3
 $4.8
Interest rate swapsInterest expense (1.8) (1.9)
Total $3.3
 $8.9
 $6.9
 $26.0
 $(1.5) $2.9
At September 30, 2017March 31, 2019, the Company expects that approximately $11$47.0 million of pre-tax net gainslosses on cash flow hedges will be reclassified from AOCE into earnings during the next twelve months.
The Effect of Derivative Instruments on the Condensed Consolidated Statementscondensed consolidated statements of Operationsoperations
Derivatives Not Designated as Hedging Instruments
 Location of Gain (Loss) Recognized in Earnings on Derivatives Amount of Gain (Loss) Recognized in Earnings on Derivatives
  Three Months Ended Nine Months Ended
  September 30, September 30,
(In millions) 2017 2016 2017 2016
Foreign currency option and forward contractsOther expense, net $(43.0) $(36.8) $(60.1) $(98.3)
Total  $(43.0) $(36.8) $(60.1) $(98.3)

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


 Location of Gain (Loss) Recognized in Earnings on Derivatives Amount of Gain (Loss) Recognized in Earnings on Derivatives
  Three Months Ended
  March 31,
(In millions) 2019 2018
Foreign currency option and forward contractsOther expense, net $(5.8) $44.0
Total  $(5.8) $44.0
Fair Value Measurement
Fair value is based on the price that would be received from the sale of an identical asset or paid to transfer an identical liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, a fair value hierarchy has been established that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
Level 2: Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities.
Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible, as well as considers counterparty credit risk in its assessment of fair value.

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Financial assets and liabilities carried at fair value are classified in the tables below in one of the three categories described above:
September 30, 2017March 31, 2019
(In millions)Level 1 Level 2 Level 3 TotalLevel 1 Level 2 Level 3 Total
Recurring fair value measurements              
Financial Assets              
Cash equivalents:              
Money market funds$170.8
 $
 $
 $170.8
$0.6
 $
 $
 $0.6
Total cash equivalents170.8
 
 
 170.8
0.6
 
 
 0.6
Trading securities:       
Equity securities — exchange traded funds32.7
 
 
 32.7
Total trading securities32.7
 
 
 32.7
Equity securities:       
Exchange traded funds35.0
 
 
 35.0
Marketable securities0.8
 
 
 0.8
Total equity securities35.8
 
 
 35.8
Available-for-sale fixed income investments:              
Corporate bonds
 17.0
 
 17.0

 10.3
 
 10.3
U.S. Treasuries
 7.4
 
 7.4

 9.9
 
 9.9
Agency mortgage-backed securities
 4.3
 
 4.3

 1.6
 
 1.6
Asset backed securities
 1.9
 
 1.9

 3.2
 
 3.2
Other
 1.7
 
 1.7

 0.9
 
 0.9
Total available-for-sale fixed income investments
 32.3
 
 32.3

 25.9
 
 25.9
Available-for-sale equity securities:       
Marketable securities55.3
 
 
 55.3
Total available-for-sale equity securities55.3
 
 
 55.3
Foreign exchange derivative assets
 57.2



57.2

 29.0



29.0
Interest rate swap derivative assets
 25.3
 
 25.3

 11.1
 
 11.1
Total assets at recurring fair value measurement$258.8

$114.8

$

$373.6
$36.4

$66.0

$

$102.4
Financial Liabilities              
Foreign exchange derivative liabilities$
 $10.1
 $
 $10.1

 9.7
 
 9.7
Contingent consideration
 
 471.1
 471.1

 
 295.1
 295.1
Total liabilities at recurring fair value measurement$
 $10.1
 $471.1
 $481.2
$
 $9.7
 $295.1
 $304.8


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December 31, 2016December 31, 2018
(In millions)Level 1 Level 2 Level 3 TotalLevel 1 Level 2 Level 3 Total
Recurring fair value measurements              
Financial Assets              
Cash equivalents:              
Money market funds$433.7
 $
 $
 $433.7
$71.0
 $
 $
 $71.0
Total cash equivalents433.7
 
 
 433.7
71.0
 
 
 71.0
Trading securities:       
Equity securities — exchange traded funds29.6
 
 
 29.6
Total trading securities29.6
 
 
 29.6
Equity securities:       
Exchange traded funds31.7
 
 
 31.7
Marketable securities0.8
 
 
 0.8
Total equity securities32.5
 
 
 32.5
Available-for-sale fixed income investments:              
Corporate bonds
 17.5
 
 17.5

 9.9
 
 9.9
U.S. Treasuries
 6.0
 
 6.0

 9.4
 
 9.4
Agency mortgage-backed securities
 4.0
 
 4.0

 1.6
 
 1.6
Asset backed securities
 1.6
 
 1.6

 3.2
 
 3.2
Other
 2.3
 
 2.3

 0.9
 
 0.9
Total available-for-sale fixed income investments
 31.4
 
 31.4

 25.0
 
 25.0
Available-for-sale equity securities:       
Marketable securities52.3
 
 
 52.3
Total available-for-sale equity securities52.3
 
 
 52.3
Foreign exchange derivative assets
 35.9
 
 35.9

 30.2
 
 30.2
Interest rate swap derivative assets
 26.2
 
 26.2

 3.6
 
 3.6
Total assets at recurring fair value measurement$515.6
 $93.5
 $
 $609.1
$103.5
 $58.8
 $
 $162.3
Financial Liabilities              
Foreign exchange derivative liabilities$
 $15.3
 $
 $15.3
$
 $29.4
 $
 $29.4
Contingent consideration
 
 564.6
 564.6

 
 355.3
 355.3
Total liabilities at recurring fair value measurement$
 $15.3
 $564.6
 $579.9
$
 $29.4
 $355.3
 $384.7
For financial assets and liabilities that utilize Level 2 inputs, the Company utilizes both direct and indirect observable price quotes, including the LIBORLondon Interbank Offered Rate (“LIBOR”) yield curve, foreign exchange forward prices and bank price quotes. Below is a summary of valuation techniques for Level 1 and Level 2 financial assets and liabilities:
Cash equivalents — valued at observable net asset value prices.
TradingEquity securities, exchange traded funds — valued at the active quoted market prices from broker or dealer quotations or transparent pricing sources at the reporting date. Unrealized gains and losses attributable to changes in fair value are included in other expense, net, in the condensed consolidated statements of operations.
Equity securities, marketable securities — valued using quoted stock prices from public exchanges at the reporting date. Unrealized gains and losses attributable to changes in fair value are included in other expense, net, in the condensed consolidated statements of operations.
Available-for-sale fixed income investments — valued at the quoted market prices from broker or dealer quotations or transparent pricing sources at the reporting date.
Available-for-sale equity securities — valued using quoted stock prices from public exchanges at the reporting date. Unrealized gains and losses attributable to changes in fair value, net of income taxes, are included in accumulated other comprehensive loss as a component of shareholders’ equity.
Foreign exchange derivative assets and liabilities — valued using quoted forward foreign exchange prices and spot rates at the reporting date. Counterparties to these contracts are highly rated financial institutions.
Interest rate swap derivative assets and liabilities — valued using the LIBOR/EURIBOR yield curves at the reporting date. Counterparties to these contracts are highly rated financial institutions.

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Contingent Consideration
The fair value measurement of contingent consideration is determined using Level 3 inputs. The Company’s contingent consideration represents a component of the total purchase consideration for the respiratory delivery platform the acquisition of Agila Specialties Private Limited (“Agila”), the acquisition of certain female healthcare businesses from Famy Care Limited (such businesses “Jai Pharma Limited”), the acquisition of the Topicals Business and certain other acquisitions. The measurement is calculated using unobservable inputs based on the Company’s own assumptions. For the respiratory delivery platform, Jai Pharma Limited, the Topicals Business and certain other acquisitions, significant unobservable inputs in the valuation include the probability and timing of future development and commercial milestones and future profit sharing payments. When valuing the contingent consideration related to the respiratory delivery platform, and Jai Pharma Limited, the value of the obligations areis derived from a probability assessment based on expectations of when certain milestones or profit share payments occur which are discounted using a market rate of return. At September 30, 2017March 31, 2019 and December 31, 2016,2018, a discount rates ranging from 0.5% to 10.0% wererate of 11.0% was utilized in the valuations.valuation. Significant changes in unobservable inputs could result in material changes to the contingent consideration liability.
A rollforward of the activity in the Company’s fair value of contingent consideration from December 31, 20162018 to September 30, 2017March 31, 2019 is as follows:
(In millions)
Current Portion (1)
 
Long-Term Portion (2)
 Total Contingent Consideration
Current Portion (1)
 
Long-Term Portion (2)
 Total Contingent Consideration
Balance at December 31, 2016$256.9
 $307.7
 $564.6
Balance at December 31, 2018$158.3
 $197.0
 $355.3
Payments(36.1) (0.2) (36.3)(60.0) 
 (60.0)
Reclassifications(38.5) 38.5
 
13.1
 (13.1) 
Accretion
 20.8
 20.8

 3.9
 3.9
Fair value adjustments (3)
(62.9) (15.1) (78.0)
Balance at September 30, 2017$119.4
 $351.7
 $471.1
Fair value loss (gain) (3)
3.5
 (7.6) (4.1)
Balance at March 31, 2019$114.9
 $180.2
 $295.1
____________
(1) 
Included in other current liabilities on the Condensed Consolidated Balance Sheets.condensed consolidated balance sheets.
(2) 
Included in other long-term obligations on the Condensed Consolidated Balance Sheets.condensed consolidated balance sheets.
(3) 
Included in litigation settlements and other contingencies, net in the Condensed Consolidated Statementscondensed consolidated statements of Operations.operations.
20172019 Significant Changes to Contingent Consideration: During the ninethree months ended September 30, 2017,March 31, 2019, the Company recorded a fair value gainmade payments of $88.1approximately $60.0 million related to the respiratory delivery platform contingent consideration offset by a fair value loss of $9.9 million related to Jai Pharma Limited contingent consideration. In addition, the Company made payments of approximately $12.5 million related to the Agila contingent consideration and payments of approximately $20.0 million related to the Jai Pharma Limited contingent consideration.
Although the Company has not elected the fair value option for other financial assets and liabilities, any future transacted financial asset or liability will be evaluated for the fair value election.

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12.13.Debt
Long-Term DebtReceivables Facility
A summaryThe Company has a $400 million Receivables Facility (the “Receivables Facility”), which originally expired on April 25, 2019. On April 25, 2019, the Company entered into an amendment to the Receivables Facility to extend the expiration date to April 22, 2022.
Under the terms of long-term debtthe Receivables Facility, our subsidiary, MPI, sells certain accounts receivable to Mylan Securitization LLC (“Mylan Securitization”), a wholly-owned special purpose entity which in turn sells a percentage ownership interest in the receivables to financial institutions and commercial paper conduits sponsored by financial institutions. Mylan Securitization’s assets have been pledged to The Bank of Tokyo-Mitsubishi UFJ, Ltd., as agent, in support of its obligations under the Receivables Facility. Any amounts outstanding under the facility are recorded as borrowings and the underlying receivables are included in accounts receivable, net, in the condensed consolidated balance sheets of the Company.
Note Securitization Facility
On April 25, 2019, the Company entered into an additional facility for borrowings up to $200 million (the “Note Securitization Facility”). Under the terms of each of the Receivables Facility and Note Securitization Facility, certain of our accounts receivable secure the amounts borrowed and cannot be used to pay our other debts or liabilities. The amount that we may borrow at a given point in time is as follows:
(In millions)Interest Rate as of September 30, 2017 September 30,
2017
 December 31,
2016
Current portion of long-term debt:     
Meda 2.0kr billion Term Loan  $
 $219.6
2018 Senior Notes *
2.600% 649.8
 
Meda Medium Term Notes due 20182.356% 72.2
 
Other  2.2
 3.7
Deferred financing fees  (1.4) 
Current portion of long-term debt  $722.8
 $223.3
      
Non-current portion of long-term debt:     
2016 Term Loans due 2019(a) ** 
2.610% $100.0
 $1,600.0
Meda Medium Term Notes due 20191.173% 91.4
 146.4
2018 Floating Rate Euro Notes(b) **
0.541% 590.7
 526.0
2018 Senior Notes *
2.600% 
 649.6
2018 Senior Notes **
3.000% 499.7
 499.6
2019 Senior Notes **
2.500% 999.4
 999.1
2019 Senior Notes *
2.550% 499.6
 499.5
2020 Floating Rate Euro Notes(c) **
0.172% 590.7
 
2020 Euro Senior Notes **
1.250% 883.1
 785.7
2020 Senior Notes **
3.750% 499.9
 499.9
2021 Senior Notes **
3.150% 2,248.0
 2,247.7
2023 Senior Notes *
3.125% 774.4
 775.3
2023 Senior Notes *
4.200% 498.7
 498.6
2024 Euro Senior Notes **
2.250% 1,178.6
 1,049.2
2026 Senior Notes **
3.950% 2,234.6
 2,233.5
2028 Euro Senior Notes **
3.125% 877.7
 781.1
2043 Senior Notes *
5.400% 497.1
 497.0
2046 Senior Notes **
5.250% 999.8
 999.8
Other  7.2
 7.1
Deferred financing fees  (78.2) (92.2)
Long-term debt  $13,992.4
 $15,202.9
____________
(a)
The 2016 Term Loans bear interestdetermined based on the amount of qualifying accounts receivable that are present at LIBOR plus a base rate, which margins can fluctuate based on the Company’s credit ratings. The Company voluntarily prepaid $400 million of the aggregate principal amount of the 2016 Term Loans in the fourth quarter of 2016. An additional $1.50 billion was voluntarily prepaid during the nine months ended September 30, 2017 utilizing proceeds from the issuance of the 2020 Floating Rate Euro Notes and cash on-hand.
(b)
Instrument bears interest at a rate of three-month EURIBOR plus 0.870% per annum, reset quarterly.
(c)
Instrument bears interest at a rate of three-month EURIBOR plus 0.50% per annum, reset quarterly.
*
Instrument was issued by Mylan Inc.
**
Instrument was issued by Mylan N.V.
For additional information, see Note 8 Debt in Mylan N.V.’s Annual Report filed on Form 10-K for the year ended December 31, 2016, as amended.

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such point in time. Borrowings outstanding under the Receivables Facility bear interest at a commercial paper rate plus 0.775% and under the Note Securitization Facility at LIBOR plus 0.75% and are included as a component of Short-term borrowings, while the accounts receivable securing these obligations remain as a component of accounts receivable, net, in our condensed consolidated balance sheets. In addition, the agreements governing the Receivables Facility and Note Securitization Facility contain various customary affirmative and negative covenants, and customary default and termination provisions.
Commercial Paper Program
On June 8, 2017,July 27, 2018, the Company established an unsecured commercial paper program (the “CP“Commercial Paper Program”) pursuant to which the CompanyMylan Inc. may issue short-term, unsecured commercial paper notes (the “CP Notes”) that are guaranteed by the Company pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act of 1933, as amended. amended (the “Securities Act”), which replaced Mylan N.V.’s previous commercial paper program established on June 8, 2017 (the “Previous Commercial Paper Program”) on substantially identical terms to the Previous Commercial Paper Program. Amounts available under the Commercial Paper Program may be borrowed, repaid and re-borrowed from time to time, with the aggregate principal amount of the commercial paper notes outstanding under the Commercial Paper Program at any time not to exceed $1.65 billion. The net proceeds of issuances of the CP Notes are expected to be used for general corporate purposes. The Company’s 2018 Revolving Facility (as defined below) will be available to pay the CP Notes, if necessary. The maturities of the CP Notes will vary but will not exceed 364 days from the date of issue.
The Company uses net proceeds from its Commercial Paper Program, Receivables Facility and Note Securitization Facility as a source of liquidity for general corporate purposes, including for business development transactions, working capital and share repurchases. Borrowings under the Commercial Paper Program, Receivables Facility and the Note Securitization Facility may vary during a particular period, as a result of fluctuations in working capital requirements and timing of cash receipts.

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Long-Term Debt
A summary of long-term debt is as follows:
(In millions)Interest Rate as of March 31, 2019 March 31,
2019
 December 31,
2018
Current portion of long-term debt:     
2016 Term Facility (a) **
3.874% $100.0
 $100.0
2019 Senior Notes **
2.500% 550.0
 549.9
Other  5.5
 6.2
Deferred financing fees  (0.6) (0.9)
Current portion of long-term debt  $654.9
 $655.2
      
Non-current portion of long-term debt:     
2020 Floating Rate Euro Notes (b) **
  $560.9
 $573.3
2020 Euro Senior Notes **
1.250% 839.9
 858.1
2020 Senior Notes **
3.750% 499.9
 499.9
2021 Senior Notes **
3.150% 2,248.8
 2,248.7
2023 Senior Notes *
3.125% 760.5
 752.9
2023 Senior Notes *
4.200% 499.0
 498.9
2024 Euro Senior Notes **
2.250% 1,119.7
 1,144.2
2025 Euro Senior Notes *
2.125% 559.7
 572.0
2026 Senior Notes **
3.950% 2,236.9
 2,236.5
2028 Euro Senior Notes **
3.125% 834.3
 852.5
2028 Senior Notes *
4.550% 748.3
 748.2
2043 Senior Notes *
5.400% 497.2
 497.2
2046 Senior Notes **
5.250% 999.8
 999.8
2048 Senior Notes *
5.200% 747.6
 747.6
Other  4.9
 5.1
Deferred financing fees  (70.5) (73.7)
Long-term debt  $13,086.9
 $13,161.2
____________
(a)
The 2016 Term Facility bears interest at LIBOR plus a base rate, which margins can fluctuate based on the Company’s credit ratings.
(b)
Instrument bears interest at a rate of three-month EURIBOR plus 0.50% per annum, reset quarterly.
*
Instrument was issued by Mylan Inc.
**
Instrument was issued by Mylan N.V.
For additional information, see Note 9 12Debt in the Company’s Quarterly Report filed onMylan N.V.’s 2018 Form 10-Q for the quarter ended June 30, 2017. At September 30, 2017, the Company had no amounts outstanding under the CP program.10-K.
2016 Revolving Facility, Receivables2018 Revolving Facility and 2016 Term Facility
At September 30, 2017 and December 31,On November 22, 2016, the Company had no amounts outstanding under the $2.0 billionentered into a revolving credit facility among the Company, as borrower, Mylan Inc., as a guarantor, certain lenders and issuing banks and Bank of America, N.A., as the administrative agent, pursuant to which the Company may obtain extensions of credit in an aggregate principal amount not to exceed $2.0 billion (the “2016 Revolving Facility”) and had no short-term borrowings under. On the $400 million Receivables Facility in the Condensed Consolidated Balance Sheets. At September 30, 2017,same day, the Company had $100 million outstanding under the $2.0 billionentered into a term credit facility among the Company, as borrower, Mylan Inc., as a guarantor, certain lenders and Goldman Sachs Bank USA, as administrative agent, pursuant to which the Company has outstanding $100.0 million in term loans (the “2016 Term Facility”). For additional information, see Note 8 Debt at March 31, 2019. On July 27, 2018, the Company entered into a revolving credit facility among Mylan Inc., as borrower, the Company, as a guarantor, certain lenders

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and issuing banks and Bank of America, N.A., as the administrative agent, which replaced the 2016 Revolving Facility on substantially identical terms to the 2016 Revolving Facility and pursuant to which Mylan Inc. may obtain extensions of credit in an aggregate principal amount not to exceed $2.0 billion (the “2018 Revolving Facility”).
The Company’s 2016 Term Facility and 2018 Revolving Facility each contains customary affirmative covenants for facilities of this type, including among others, covenants pertaining to the Company’s Annual Report fileddelivery of financial statements, notices of default and certain material events, maintenance of corporate existence and rights, property, and insurance and compliance with laws, as well as customary negative covenants for facilities of this type, including limitations on Form 10-K for the year ended December 31, 2016, as amended.incurrence of subsidiary indebtedness, liens, mergers and certain other fundamental changes, investments and loans, acquisitions, transactions with affiliates, payments of dividends and other restricted payments and changes in our lines of business.
The 2016 Term Facility and 20162018 Revolving Facility contain a maximum consolidated leverage ratio financial covenant requiring maintenance of a maximum ratio of 3.75 to 1.00 for consolidated total indebtedness as of the end of any quarter to consolidated EBITDA for the trailing four quarters as defined in the related credit agreements (“leverage ratio”).
The Company is2016 Term Facility was amended in compliance at September 30, 2017.
Following the Meda acquisition (a qualifying acquisition), theNovember 2017 to allow a leverage ratio changed toof 4.25 to 1.00 through June 30, 2017.the December 31, 2018 reporting period and a leverage ratio of 3.75 to 1.00 thereafter. The 2018 Revolving Facility similarly provides for a leverage ratio of 4.25 to 1.00 through the December 31, 2018 reporting period and a leverage ratio of 3.75 to 1.00 thereafter. On November 3, 2017,February 22, 2019, the Company, as a guarantor, and Mylan Inc., as borrower, entered into an amendment (the "Revolving Loan Amendment") to the 2018 Revolving Facility. In addition, on February 22, 2019, the Company entered into amendmentsan amendment (the "Term Loan Amendment") to the agreements for the 2016 Term FacilityFacility. The Revolving Loan Amendment and 2016 Revolving Facility to extendthe Term Loan Amendment extended the leverage ratio covenant of 4.25 to 1.00 through the December 31, 20182019 reporting period.period, with a leverage ratio of 3.75 to 1.00 thereafter. The Company is in compliance at March 31, 2019 and expects to remain in compliance for the next twelve months.
Euro Notes
On May 24, 2017, the Company completed its offering of €500 million aggregate principal amount of 2020 Floating Rate Euro Notes. For additional information, see Note 12Debt in the Company’s Quarterly Report filed on Form 10-Q for the quarter ended June 30, 2017.
During the nine months ended September 30, 2017, the Company recorded mark-to-market losses related to the 2018 Floating Rate Euro Notes, 2020 Floating Rate Euro Notes, 2020 Euro Notes, 2024 Euro Notes and 2028 Euro Notes of approximately $64.8 million, $36.2 million, $97.1 million, $129.5 million and $97.1 million, respectively. Refer to Note 11Financial Instruments and Risk Management for further discussion of the foreign currency risk management of these instruments.
Fair Value
At September 30, 2017March 31, 2019 and December 31, 2016,2018, the aggregate fair value of the Company’s 2.600% Senior Notes due 2018, 3.000% Senior Notes due 2018, 2.500% Senior Notes due 2019, 2.550% Senior Notes due 2019, 3.750% Senior Notes due 2020, 3.150% Senior Notes due 2021, 3.125% Senior Notes due 2023, 4.200% Senior Notes due 2023, 3.950% Senior Notes due 2026, 5.400% Senior Notes due 2043 and 5.250% Senior Notes due 2046 (collectively, the “Senior Notes”), 1.250% Euro Senior Notes due 2020, 2.250% Euro Senior Notes due in 2024, 3.125% Euro Senior Notes due in 2028, 2018 Floating Rate Euro Notes and 2020 Floating Rate Euro Notes (collectively, the “Euro Notes”)outstanding notes was approximately $15.0$13.5 billion and $13.2$13.1 billion, respectively. The fair values of the Senior Notes and Euro Notesoutstanding notes were valued at quoted market prices from broker or dealer quotations and were classified as Level 2 in the fair value hierarchy. Based on quoted market rates of interest and maturity schedules of similar debt issues, the fair valuesvalue of the Company’s 2016 Term Loans and the Meda borrowings,Facility determined based on Level 2 inputs, approximate theirapproximates its carrying valuesvalue at September 30, 2017March 31, 2019 and December 31, 2016.2018.
Mandatory minimum repayments remaining on the notional amount of outstanding long-term debt at March 31, 2019 were as follows for each of the periods ending December 31:
(In millions)Total
2019$650
20201,902
20212,250
2022
20231,250
Thereafter7,774
Total$13,826

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Mandatory minimum repayments remaining on the notional amount of outstanding long-term debt at September 30, 2017 are as follows for each of the periods ending December 31:
(In millions)Total
2017$
20181,813
20191,691
20201,977
20212,250
Thereafter7,068
Total$14,799
13.14.Comprehensive Earnings
Accumulated other comprehensive loss, as reflected on the Condensed Consolidated Balance Sheets,condensed consolidated balance sheets, is comprised of the following:
(In millions)September 30,
2017
 December 31,
2016
Accumulated other comprehensive loss:   
Net unrealized gain on marketable securities, net of tax$16.6
 $14.5
Net unrecognized gains (losses) and prior service cost related to defined benefit plans, net of tax1.4
 (0.5)
Net unrecognized losses on derivatives in cash flow hedging relationships, net of tax(18.8) (38.6)
Net unrecognized losses on derivatives in net investment hedging relationships, net of tax(204.6) (1.4)
Foreign currency translation adjustment(405.8) (2,237.7)
 $(611.2) $(2,263.7)

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Components of accumulated other comprehensive loss, before tax, consist of the following, for the three and nine months endedSeptember 30, 2017 and 2016:
 Three Months Ended September 30, 2017
Gains and Losses on Derivatives in Cash Flow Hedging Relationships Gains and Losses on Net Investment Hedges Gains and Losses on Marketable Securities Defined Pension Plan Items Foreign Currency Translation Adjustment Totals
(In millions)Foreign Currency Forward Contracts Interest Rate Swaps Total          
Balance at June 30, 2017, net of tax    $(17.1) $(132.5) $22.3
 $0.5
 $(828.8) $(955.6)
Other comprehensive (loss) earnings before reclassifications, before tax    (4.4) (72.1) (8.9) 0.8
 423.0
 338.4
Amounts reclassified from accumulated other comprehensive earnings (loss), before tax:               
Loss on foreign exchange forward contracts classified as cash flow hedges, included in net sales(2.0)   (2.0)         (2.0)
Gain on interest rate swaps classified as cash flow hedges, included in interest expense  1.9
 1.9
         1.9
Amortization of prior service costs included in SG&A          0.1
   0.1
Amortization of actuarial loss included in SG&A          0.2
   0.2
Net other comprehensive (loss) earnings, before tax    (4.5) (72.1) (8.9) 1.1
 423.0
 338.6
Income tax (benefit) provision    (2.8) 
 (3.2) 0.2
 
 (5.8)
Balance at September 30, 2017, net of tax    $(18.8) $(204.6) $16.6
 $1.4
 $(405.8) $(611.2)


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 Nine Months Ended September 30, 2017
Gains and Losses on Derivatives in Cash Flow Hedging Relationships Gains and Losses on Net Investment Hedges Gains and Losses on Marketable Securities Defined Pension Plan Items Foreign Currency Translation Adjustment Totals
(In millions)Foreign Currency Forward Contracts Interest Rate Swaps Total          
Balance at December 31, 2016, net of tax    $(38.6) $(1.4) $14.5
 $(0.5) $(2,237.7) $(2,263.7)
Other comprehensive earnings (loss) before reclassifications, before tax    19.9
 (203.2) 3.5
 1.7
 1,831.9
 1,653.8
Amounts reclassified from accumulated other comprehensive (loss) earnings, before tax:               
Gain on foreign exchange forward contracts classified as cash flow hedges, included in net sales3.8
   3.8
         3.8
Gain on interest rate swaps classified as cash flow hedges, included in interest expense  5.5
 5.5
         5.5
Amortization of prior service costs included in SG&A          0.2
   0.2
Amortization of actuarial loss included in SG&A          0.5
   0.5
Net other comprehensive earnings (loss), before tax    29.2
 (203.2) 3.5
 2.4
 1,831.9
 1,663.8
Income tax provision    9.4
 
 1.4
 0.5
 
 11.3
Balance at September 30, 2017, net of tax    $(18.8) $(204.6) $16.6
 $1.4
 $(405.8) $(611.2)

(In millions)March 31,
2019
 December 31,
2018
Accumulated other comprehensive loss:   
Net unrealized gain on marketable securities, net of tax$0.4
 $
Net unrecognized gains and prior service cost related to defined benefit plans, net of tax1.6
 1.7
Net unrecognized losses on derivatives in cash flow hedging relationships, net of tax(39.3) (53.1)
Net unrecognized losses on derivatives in net investment hedging relationships, net of tax(75.7) (130.9)
Foreign currency translation adjustment(1,597.5) (1,259.0)
 $(1,710.5) $(1,441.3)

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


Components of accumulated other comprehensive loss, before tax, consist of the following, for the three months ended March 31, 2019 and 2018:
 Three Months Ended September 30, 2016
Gains and Losses on Derivatives in Cash Flow Hedging Relationships Gains and Losses on Net Investment Hedges Gains and Losses on Marketable Securities Defined Pension Plan Items Foreign Currency Translation Adjustment Totals
(In millions)Foreign Currency Forward Contracts Interest Rate Swaps Total          
Balance at June 30, 2016, net of tax    $(46.7) $
 $6.0
 $(15.2) $(1,375.4) $(1,431.3)
Other comprehensive earnings (loss) before reclassifications, before tax    9.8
 (10.4) 21.5
 (0.2) 290.6
 311.3
Amounts reclassified from accumulated other comprehensive (loss) earnings, before tax:               
Gain on foreign exchange forward contracts classified as cash flow hedges, included in net sales10.7
   10.7
         10.7
Gain on interest rate swaps classified as cash flow hedges, included in interest expense  2.3
 2.3
         2.3
Amortization of prior service costs included in SG&A          
   
Amortization of actuarial gain included in SG&A          0.3
   0.3
Net other comprehensive earnings (loss), before tax    22.8
 (10.4) 21.5
 0.1
 290.6
 324.6
Income tax provision (benefit)    8.0
 (2.3) 8.0
 
 
 13.7
Balance at September 30, 2016, net of tax    $(31.9) $(8.1) $19.5
 $(15.1) $(1,084.8) $(1,120.4)

 Three Months Ended March 31, 2019
Gains and Losses on Derivatives in Cash Flow Hedging Relationships Gains and Losses on Net Investment Hedges Gains and Losses on Marketable Securities Defined Pension Plan Items Foreign Currency Translation Adjustment Totals
(In millions)Foreign Currency Forward Contracts Interest Rate Swaps Total          
Balance at December 31, 2018, net of tax    $(53.1) $(130.9) $
 $1.7
 $(1,259.0) $(1,441.3)
Other comprehensive earnings (loss) before reclassifications, before tax    24.5
 58.1
 0.4
 0.1
 (338.5) (255.4)
Amounts reclassified from accumulated other comprehensive loss, before tax:               
Gain on foreign exchange forward contracts classified as cash flow hedges, included in net sales(0.3)   (0.3)         (0.3)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense  1.8
 1.8
         1.8
Amortization of prior service costs included in selling, general and administrative expense (“SG&A”)          0.3
   0.3
Amortization of actuarial loss included in SG&A          (0.2)   (0.2)
Net other comprehensive earnings (loss), before tax    26.0
 58.1
 0.4
 0.2
 (338.5) (253.8)
Income tax provision    8.8
 2.9
 
 0.1
 
 11.8
Cumulative effect of the adoption of new accounting standards    (3.4) 
 
 (0.2) 
 (3.6)
Balance at March 31, 2019, net of tax    $(39.3) $(75.7) $0.4
 $1.6
 $(1,597.5) $(1,710.5)

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


 Nine Months Ended September 30, 2016
Gains and Losses on Derivatives in Cash Flow Hedging Relationships Gains and Losses on Net Investment Hedges Gains and Losses on Marketable Securities Defined Pension Plan Items Foreign Currency Translation Adjustment Totals
(In millions)Foreign Currency Forward Contracts Interest Rate Swaps Total          
Balance at December 31, 2015, net of tax    $(18.1) $
 $(1.0) $(14.9) $(1,730.3) $(1,764.3)
Other comprehensive (loss) earnings before reclassifications, before tax    (63.7) (10.4) 32.5
 (1.2) 645.5
 602.7
Amounts reclassified from accumulated other comprehensive (loss) earnings, before tax:               
Gain on foreign exchange forward contracts classified as cash flow hedges, included in net sales34.2
   34.2
         34.2
Gain on interest rate swaps classified as cash flow hedges, included in interest expense  6.6
 6.6
         6.6
Amortization of prior service costs included in SG&A          0.2
   0.2
Amortization of actuarial gain included in SG&A          0.7
   0.7
Net other comprehensive (loss) earnings, before tax    (22.9) (10.4) 32.5
 (0.3) 645.5
 644.4
Income tax (benefit) provision    (9.1) (2.3) 12.0
 (0.1) 
 0.5
Balance at September 30, 2016, net of tax    $(31.9) $(8.1) $19.5
 $(15.1) $(1,084.8) $(1,120.4)
14.Shareholders’ Equity
A summary of the changes in shareholders’ equity for the nine months endedSeptember 30, 2017 and 2016 is as follows:
(In millions)Total
Mylan N.V.
Shareholders' Equity
 Noncontrolling Interest Total
December 31, 2016$11,116.2
 $1.4
 $11,117.6
Net earnings451.7
 
 451.7
Other comprehensive earnings, net of tax1,652.5
 
 1,652.5
Stock option activity12.8
 
 12.8
Share-based compensation expense64.2
 
 64.2
Issuance of restricted stock, net of shares withheld(5.8) 
 (5.8)
Other
 (1.4) (1.4)
September 30, 2017$13,291.6
 $
 $13,291.6

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


(In millions)Total
Mylan N.V.
Shareholders' Equity
 Noncontrolling Interest Total
December 31, 2015$9,764.4
 $1.4
 $9,765.8
Net earnings62.5
 
 62.5
Other comprehensive earnings, net of tax643.9
 
 643.9
Stock option activity11.1
 
 11.1
Share-based compensation expense71.1
 
 71.1
Issuance of restricted stock, net of shares withheld(9.6) 
 (9.6)
Tax benefit of stock option plans2.2
 
 2.2
Issuance of ordinary shares to purchase Meda1,281.7
 
 1,281.7
Other
 0.1
 0.1
September 30, 2016$11,827.3
 $1.5
 $11,828.8
 Three Months Ended March 31, 2018
Gains and Losses on Derivatives in Cash Flow Hedging Relationships Gains and Losses on Net Investment Hedges Gains and Losses on Marketable Securities Defined Pension Plan Items Foreign Currency Translation Adjustment Totals
(In millions)Foreign Currency Forward Contracts Interest Rate Swaps Total          
Balance at December 31, 2017, net of tax    $(3.7) $(239.8) $10.1
 $6.0
 $(133.8) $(361.2)
Other comprehensive (loss) earnings before reclassifications, before tax    (29.1) (59.2) (0.4) (4.4) 261.9
 168.8
Amounts reclassified from accumulated other comprehensive loss, before tax:               
Gain on foreign exchange forward contracts classified as cash flow hedges, included in net sales(4.8)   (4.8)         (4.8)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense  1.9
 1.9
         1.9
Amortization of prior service costs included in SG&A          0.1
   0.1
Net other comprehensive (loss) earnings, before tax    (32.0) (59.2) (0.4) (4.3) 261.9
 166.0
Income tax benefit    (10.6) 
 (0.1) (0.5) 
 (11.2)
Cumulative effect of the adoption of new accounting standards    2.5
 
 (10.0) 
 
 (7.5)
Balance at March 31, 2018, net of tax    $(22.6) $(299.0) $(0.2) $2.2
 $128.1
 $(191.5)
15.Segment Information
As a result of our acquisition of Meda and the integration of our portfolio across our branded, generics and OTC platforms in all of our regions, effective October 1, 2016, the Company expanded its reportable segments. The Company has three reportable segmentsMylan reports segment information on a geographic basis as follows: basis. This approach reflects the company’s focus on bringing its broad and diversified portfolio of generic, branded generic, brand-name and OTC products to people in markets everywhere. Our North America Europe and Rest of World. Our North America segment is made up ofcomprises our operations in the U.S. and Canada and includes the operations of our previously reported Specialty segment.Canada. Our Europe segment is made up ofencompasses our operations in 35 countries, withinincluding France, Italy, Germany, the region.United Kingdom (“U.K.”) and Spain. Our Rest of World segment is primarily made up ofreflects our operations in more than 120 countries, including Japan, Australia, China, Brazil, Russia, India, Australia, JapanSouth Africa and New Zealand. Also includedcertain markets in our Rest of World segment are our operations in emerging markets, which include countries in Africa (including South Africa) as well as Brazil and other countries throughout Asia and the Middle East. Comparative segment financial information has been recast for prior periods to conform to this revised segment reporting.East and Southeast Asia.
The Company’s chief operating decision maker is the Chief Executive Officer, who evaluates the performance of its segments based on total revenues and segment profitability. Segment profitability represents segment gross profit less direct R&D expenses and direct selling, general and administrative (“SG&A”) expenses.&A. Certain general and administrative and R&D expenses not allocated to the segments, including certain special items, net charges for litigation settlements and other contingencies, amortization of intangible assets, impairment charges and other expenses not directly attributable to the segments and certain intercompany transactions, including eliminations, are reported in Corporate/Other. Additionally, amortizationseparately or outside of intangible assets and other purchase accounting related items, as well as certain other significant special items, are included in Corporate/Other.segment profitability. Items below the earnings from operations line on the Company’s Condensed Consolidated Statementscondensed consolidated statements of Operationsoperations are not presented by segment, since they are excluded from the measure of segment profitability. The Company does not report depreciation expense, total assets and capital expenditures by segment, as such information is not used by the chief operating decision maker.
The accounting policies of the segments are the same as those described in the “Summary of Significant Accounting Policies” included in Mylan N.V.’s Annual Report on Form 10-K for the year ended December 31, 2016, as amended. Intersegment revenues are accounted for at current market values and are eliminated at the consolidated level.

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The accounting policies of the segments are the same as those described in Note 2 “Summary of Significant Accounting Policies” included in the 2018 Form 10-K, and Note 3 “Recent Accounting Pronouncements, Adoption of New Accounting Standards” included in this Form 10-Q. Intersegment revenues are accounted for at current market values and are eliminated at the consolidated level.
Presented in the table below is segment information for the periods identified and a reconciliation of segment information to total consolidated information.
(In millions)North America Europe Rest of World Corporate / Other ConsolidatedNorth America Europe Rest of World Eliminations Consolidated
Three Months Ended September 30, 2017         
Third party net sales$1,172.2
 $1,040.8
 $743.3
 $
 $2,956.3
Three Months Ended March 31, 2019         
Net sales$922.9
 $895.3
 $642.4
 $
 $2,460.6
Other revenue20.0
 8.9
 1.9
 
 30.8
22.1
 4.7
 8.1
 
 34.9
Intersegment15.5
 18.4
 87.7
 (121.6) 
Intersegment revenue15.6
 20.8
 113.3
 (149.7) 
Total$1,207.7
 $1,068.1
 $832.9
 $(121.6) $2,987.1
$960.6
 $920.8
 $763.8
 $(149.7) $2,495.5
                  
Segment profitability$575.8
 $290.3
 $133.9
 $(684.0) $316.0
$394.5
 $204.1
 $93.8
 $
 $692.4
                  
Nine Months Ended September 30, 2017       
Third party net sales$3,666.7
 $2,887.1
 $2,016.4
 $
 $8,570.2
Other revenue67.3
 25.0
 6.3
 
 98.6
Intersegment60.5
 87.6
 275.4
 (423.5) 
Total$3,794.5
 $2,999.7
 $2,298.1
 $(423.5) $8,668.8
         
Segment profitability$1,810.5
 $776.8
 $437.1
 $(2,007.8) $1,016.6
Intangible asset amortization expense        (405.5)
Intangible asset impairment charges        (29.5)
Globally managed research and development costs        (70.6)
Corporate costs and special items        (162.1)
Litigation settlements & other contingencies        (0.7)
Earnings from operations        $24.0
(In millions)North America Europe Rest of World Corporate / Other ConsolidatedNorth America Europe Rest of World Eliminations Consolidated
Three Months Ended September 30, 2016         
Third party net sales$1,505.5
 $841.2
 $682.8
 $
 $3,029.5
Other revenue21.6
 3.9
 2.1
 
 27.6
Intersegment10.3
 53.2
 105.0
 (168.5) 
Total$1,537.4
 $898.3
 $789.9
 $(168.5) $3,057.1
         
Segment profitability$784.7
 $252.6
 $115.6
 $(1,283.6) $(130.7)
         
Nine Months Ended September 30, 2016         
Third party net sales$4,064.5
 $2,026.4
 $1,654.6
 $
 $7,745.5
Three Months Ended March 31, 2018         
Net sales$985.3
 $1,038.4
 $626.7
 $
 $2,650.4
Other revenue54.3
 4.5
 4.8
 
 63.6
21.1
 9.5
 3.5
 
 34.1
Intersegment revenue24.5
 104.0
 291.9
 (420.4) 
12.3
 25.6
 86.7
 (124.6) 
Total$4,143.3
 $2,134.9
 $1,951.3
 $(420.4) $7,809.1
$1,018.7
 $1,073.5
 $716.9
 $(124.6) $2,684.5
                  
Segment profitability$2,141.2
 $495.1
 $221.5
 $(2,472.0) $385.8
$459.9
 $258.2
 $106.6
 $
 $824.7
         
Intangible asset amortization expense        (392.3)
Intangible asset impairment charges        (30.0)
Globally managed research and development costs        (76.9)
Corporate costs and special items        (153.6)
Litigation settlements & other contingencies        (16.2)
Earnings from operations        $155.7

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


16.Subsidiary Guarantors
The following tables present condensed consolidating financial information for (a) Mylan N.V., the issuer of the 3.000% Senior Notes due 2018, 2.500% Senior Notes due 2019, 3.750% Senior Notes due 2020, 3.150% Senior Notes due 2021, 3.950% Senior Notes due 2026 and 5.250% Senior Notes due 2046 (collectively, the “Mylan N.V. Senior Notes”), which are guaranteed on a senior unsecured basis by Mylan Inc.; (b) Mylan Inc., the issuer of the 2.600% Senior Notes due 2018, 2.550% Senior Notes due 2019, 3.125% Senior Notes due 2023, 4.200% Senior Notes due 2023, and4.550% Senior Notes due 2028, 5.400% Senior Notes due 2043 and 5.200% Senior Notes due 2048 (collectively, the “Mylan Inc. Senior Notes”), which are guaranteed on a senior unsecured basis by Mylan N.V.; and (c) all other subsidiaries of the Company on a combined basis, none of which guarantee the Mylan N.V. Senior Notes or guarantee the Mylan Inc. Senior Notes (“Non-Guarantor Subsidiaries”). The consolidating adjustments primarily relate to eliminations of investments in subsidiaries and intercompany balances and transactions. The condensed consolidating financial statements present investments in subsidiaries using the equity method of accounting.
The following financial information presents the unaudited Condensed Consolidating Statementscondensed consolidating statements of Operationsoperations for the three and nine months ended September 30, 2017March 31, 2019 and 2016,2018, the unaudited Condensed Consolidating Statementscondensed consolidating statements of Comprehensive Earningscomprehensive earnings for the three and nine months ended September 30, 2017March 31, 2019 and 2016,2018, the unaudited Condensed Consolidating Balance Sheetscondensed consolidating balance sheets as of September 30, 2017March 31, 2019 and December 31, 20162018 and the unaudited Condensed Consolidating Statementscondensed consolidating statements of Cash Flowscash flows for the ninethree months ended September 30, 2017March 31, 2019 and 2016.2018. This unaudited condensed consolidating financial information has been prepared and presented in accordance with SEC Regulation S-X Rule 3-10 “Financial Statements of Guarantors and Issuers of Guaranteed Securities Registered or Being Registered.”

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF OPERATIONS
Three Months Ended March 31, 2019
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Revenues:           
Net sales$
 $
 $
 $2,460.6
 $
 $2,460.6
Other revenues
 
 
 34.9
 
 34.9
Total revenues
 
 
 2,495.5
 
 2,495.5
Cost of sales
 
 
 1,690.3
 
 1,690.3
Gross profit
 
 
 805.2
 
 805.2
Operating expenses:           
Research and development
 
 
 172.6
 
 172.6
Selling, general and administrative9.1
 138.7
 
 460.1
 
 607.9
Litigation settlements and other contingencies, net
 
 
 0.7
 
 0.7
Total operating expenses9.1
 138.7
 
 633.4
 
 781.2
(Loss) earnings from operations(9.1) (138.7) 
 171.8
 
 24.0
Interest expense81.7
 43.5
 
 6.0
 
 131.2
Other (income) expense, net(58.1) (60.1) 
 125.5
 
 7.3
(Loss) earnings before income taxes(32.7) (122.1) 
 40.3
 
 (114.5)
Income tax (benefit) provision(5.6) 1.8
 
 (85.7) 
 (89.5)
Earnings of equity interest subsidiaries2.1
 102.6
 
 
 (104.7) 
Net (loss) earnings$(25.0) $(21.3) $
 $126.0
 $(104.7) $(25.0)





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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF OPERATIONS
Three Months Ended September 30, 2017March 31, 2018
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations ConsolidatedMylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Revenues:                      
Net sales$
 $
 $
 $2,956.3
 $
 $2,956.3
$
 $
 $
 $2,650.4
 $
 $2,650.4
Other revenues
 
 
 30.8
 
 30.8

 
 
 34.1
 
 34.1
Total revenues
 
 
 2,987.1
 
 2,987.1

 
 
 2,684.5
 
 2,684.5
Cost of sales
 
 
 1,809.0
 
 1,809.0

 
 
 1,700.2
 
 1,700.2
Gross profit
 
 
 1,178.1
 
 1,178.1

 
 
 984.3
 
 984.3
Operating expenses:                      
Research and development
 
 
 182.3
 
 182.3

 
 
 204.9
 
 204.9
Selling, general and administrative6.5
 184.3
 
 473.8
 
 664.6
9.8
 130.7
 
 467.0
 
 607.5
Litigation settlements and other contingencies, net
 17.0
 
 (1.8) 
 15.2

 7.0
 
 9.2
 
 16.2
Total operating expenses6.5
 201.3
 
 654.3
 
 862.1
9.8
 137.7
 
 681.1
 
 828.6
(Loss) earnings from operations(6.5) (201.3) 
 523.8
 
 316.0
(9.8) (137.7) 
 303.2
 
 155.7
Interest expense93.3
 26.7
 
 11.8
 
 131.8
93.5
 26.9
 
 11.3
 
 131.7
Other (income) expense, net(122.3) (44.7) 
 171.6
 
 4.6
(114.0) (57.7) 
 185.2
 
 13.5
Earnings (loss) before income taxes22.5
 (183.3) 
 340.4
 
 179.6
10.7
 (106.9) 
 106.7
 
 10.5
Income tax provision (benefit)2.4
 (0.6) 
 89.5
 
 91.3
Earnings of equity interest subsidiaries68.2
 129.9
 
 
 (198.1) 
Income tax benefit(7.3) (17.7) 
 (51.6) 
 (76.6)
Earnings (losses) of equity interest subsidiaries69.1
 (8.3) 
 
 (60.8) 
Net earnings (loss)$88.3
 $(52.8) $
 $250.9
 $(198.1) $88.3
$87.1
 $(97.5) $
 $158.3
 $(60.8) $87.1

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF OPERATIONSCOMPREHENSIVE EARNINGS
NineThree Months Ended September 30, 2017March 31, 2019
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Revenues:           
Net sales$
 $
 $
 $8,570.2
 $
 $8,570.2
Other revenues
 
 
 98.6
 
 98.6
Total revenues
 
 
 8,668.8
 
 8,668.8
Cost of sales
 
 
 5,180.3
 
 5,180.3
Gross profit
 
 
 3,488.5
 
 3,488.5
Operating expenses:           
Research and development
 
 
 580.9
 
 580.9
Selling, general and administrative32.4
 477.6
 
 1,406.8
 
 1,916.8
Litigation settlements and other contingencies, net
 17.0
 
 (42.8) 
 (25.8)
Total operating expenses32.4
 494.6
 
 1,944.9
 
 2,471.9
(Loss) earnings from operations(32.4) (494.6) 
 1,543.6
 
 1,016.6
Interest expense285.6
 77.8
 
 42.9
 
 406.3
Other (income) expense, net(331.3) (161.5) 
 527.2
 
 34.4
Earnings (loss) before income taxes13.3
 (410.9) 
 973.5
 
 575.9
Income tax provision1.4
 5.1
 
 117.7
 
 124.2
Earnings of equity interest subsidiaries439.8
 788.8
 
 
 (1,228.6) 
Net earnings$451.7
 $372.8
 $
 $855.8
 $(1,228.6) $451.7

(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Net (loss) earnings$(25.0) $(21.3) $
 $126.0
 $(104.7) $(25.0)
Other comprehensive (loss) earnings, before tax:           
Foreign currency translation adjustment(338.5) 
 
 (338.5) 338.5
 (338.5)
Change in unrecognized gain and prior service cost related to defined benefit plans0.2
 0.1
 
 0.1
 (0.2) 0.2
Net unrecognized gain on derivatives in cash flow hedging relationships26.0
 1.8
 
 24.2
 (26.0) 26.0
Net unrecognized gain on derivatives in net investment hedging relationships58.1
 12.3
 
 
 (12.3) 58.1
Net unrealized gain on marketable securities0.4
 
 
 0.4
 (0.4) 0.4
Other comprehensive (loss) earnings, before tax(253.8) 14.2
 
 (313.8) 299.6
 (253.8)
Income tax provision (benefit)11.8
 (3.3) 
 15.1
 (11.8) 11.8
Other comprehensive (loss) earnings, net of tax(265.6) 17.5
 
 (328.9) 311.4
 (265.6)
Comprehensive loss$(290.6) $(3.8) $
 $(202.9) $206.7
 $(290.6)

39

Table of Contents
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF OPERATIONSCOMPREHENSIVE EARNINGS
Three Months Ended September 30, 2016March 31, 2018
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Revenues:           
Net sales$
 $
 $
 $3,029.5
 $
 $3,029.5
Other revenues
 
 
 27.6
 
 27.6
Total revenues
 
 
 3,057.1
 
 3,057.1
Cost of sales
 
 
 1,773.8
 
 1,773.8
Gross profit
 
 
 1,283.3
 
 1,283.3
Operating expenses:           
Research and development
 
 
 199.1
 
 199.1
Selling, general and administrative43.1
 134.0
 
 479.8
 
 656.9
Litigation settlements and other contingencies, net
 
 
 558.0
 
 558.0
Total operating expenses43.1
 134.0
 
 1,236.9
 
 1,414.0
(Loss) earnings from operations(43.1) (134.0) 
 46.4
 
 (130.7)
Interest expense70.7
 40.9
 
 32.8
 
 144.4
Other (income) expense, net(31.4) (102.7) 
 184.3
 
 50.2
Loss from operations(82.4) (72.2) 
 (170.7) 
 (325.3)
Income tax provision (benefit)
 8.1
 
 (213.6) 
 (205.5)
(Loss) earnings of equity interest subsidiaries(37.4) 442.9
 
 
 (405.5) 
Net (loss) earnings$(119.8) $362.6
 $
 $42.9
 $(405.5) $(119.8)
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Net earnings (loss)$87.1
 $(97.5) $
 $158.3
 $(60.8) $87.1
Other comprehensive earnings, before tax:           
Foreign currency translation adjustment261.9
 
 
 261.9
 (261.9) 261.9
Change in unrecognized (loss) gain and prior service cost related to defined benefit plans(4.3) 0.1
 
 (4.4) 4.3
 (4.3)
Net unrecognized (loss) gain on derivatives in cash flow hedging relationships(32.0) 1.9
 
 (33.9) 32.0
 (32.0)
Net unrecognized loss on derivatives in net investment hedging relationships(59.2) 
 
 
 
 (59.2)
Net unrealized (loss) gain on marketable securities(0.4) (0.6) 
 0.2
 0.4
 (0.4)
Other comprehensive earnings, before tax166.0
 1.4
 
 223.8
 (225.2) 166.0
Income tax benefit(11.2) (0.4) 
 (10.8) 11.2
 (11.2)
Other comprehensive earnings, net of tax177.2
 1.8
 
 234.6
 (236.4) 177.2
Comprehensive earnings (loss)$264.3
 $(95.7) $
 $392.9
 $(297.2) $264.3


40

Table of Contents
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF OPERATIONSBALANCE SHEET
Nine Months Ended September 30, 2016As of March 31, 2019
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Revenues:           
Net sales$
 $
 $
 $7,745.5
 $
 $7,745.5
Other revenues
 
 
 63.6
 
 63.6
Total revenues
 
 
 7,809.1
 
 7,809.1
Cost of sales
 
 
 4,447.1
 
 4,447.1
Gross profit
 
 
 3,362.0
 
 3,362.0
Operating expenses:           
Research and development
 
 
 632.2
 
 632.2
Selling, general and administrative75.8
 499.2
 
 1,212.6
 
 1,787.6
Litigation settlements and other contingencies, net
 
 
 556.4
 
 556.4
Total operating expenses75.8
 499.2
 
 2,401.2
 
 2,976.2
(Loss) earnings from operations(75.8) (499.2) 
 960.8
 
 385.8
Interest expense115.1
 126.3
 
 63.6
 
 305.0
Other expense (income), net53.6
 (305.7) 
 436.1
 
 184.0
(Loss) earnings before income taxes(244.5) (319.8) 
 461.1
 
 (103.2)
Income tax provision (benefit)
 22.1
 
 (187.8) 
 (165.7)
Earnings of equity interest subsidiaries307.0
 1,055.7
 
 
 (1,362.7) 
Net earnings$62.5
 $713.8
 $
 $648.9
 $(1,362.7) $62.5

(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
ASSETS           
Assets           
Current assets:           
Cash and cash equivalents$
 $
 $
 $229.8
 $
 $229.8
Accounts receivable, net
 13.1
 
 2,765.4
 
 2,778.5
Inventories
 
 
 2,708.8
 
 2,708.8
Intercompany receivables324.4
 516.4
 
 12,694.6
 (13,535.4) 
Prepaid expenses and other current assets5.8
 107.5
 
 431.9
 
 545.2
Total current assets330.2
 637.0
 
 18,830.5
 (13,535.4) 6,262.3
Property, plant and equipment, net
 252.5
 
 1,898.9
 
 2,151.4
Investments in subsidiaries18,692.3
 13,208.9
 
 
 (31,901.2) 
Intercompany notes and interest receivable6,224.4
 10,847.6
 
 3,038.5
 (20,110.5) 
Intangible assets, net
 
 
 12,955.5
 
 12,955.5
Goodwill
 17.1
 
 9,590.8
 
 9,607.9
Other assets0.2
 93.3
 
 836.0
 
 929.5
Total assets$25,247.1
 $25,056.4
 $
 $47,150.2
 $(65,547.1) $31,906.6
            
LIABILITIES AND EQUITY           
Liabilities           
Current liabilities:           
Accounts payable$
 $42.6
 $
 $1,273.9
 $
 $1,316.5
Short-term borrowings
 
 
 0.4
 
 0.4
Income taxes payable
 
 
 23.2
 
 23.2
Current portion of long-term debt and other long-term obligations649.4
 0.2
 
 53.9
 
 703.5
Intercompany payables1,545.7
 11,988.3
 
 1.4
 (13,535.4) 
Other current liabilities95.0
 215.8
 
 1,803.2
 
 2,114.0
Total current liabilities2,290.1
 12,246.9
 
 3,156.0
 (13,535.4) 4,157.6
Long-term debt9,299.5
 3,782.5
 
 4.9
 
 13,086.9
Intercompany notes payable1,765.9
 3,687.9
 
 14,656.7
 (20,110.5) 
Other long-term obligations
 75.9
 
 2,694.6
 
 2,770.5
Total liabilities13,355.5
 19,793.2
 
 20,512.2
 (33,645.9) 20,015.0
            
Total equity11,891.6
 5,263.2
 
 26,638.0
 (31,901.2) 11,891.6
            
Total liabilities and equity$25,247.1
 $25,056.4
 $
 $47,150.2
 $(65,547.1) $31,906.6

41

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MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF COMPREHENSIVE EARNINGSBALANCE SHEET
Three Months Ended September 30, 2017As of December 31, 2018
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Net earnings (loss)$88.3
 $(52.8) $
 $250.9
 $(198.1) $88.3
Other comprehensive earnings (loss), before tax:           
Foreign currency translation adjustment423.0
 
 
 423.0
 (423.0) 423.0
Change in unrecognized gain and prior service cost related to defined benefit plans1.1
 0.1
 
 1.2
 (1.3) 1.1
Net unrecognized (loss) gain on derivatives in cash flow hedging relationships(4.5) 1.9
 
 (6.4) 4.5
 (4.5)
Net unrecognized loss on derivatives in net investment hedging relationships(72.1) 
 
 
 
 (72.1)
Net unrealized loss on marketable securities(8.9) (8.9) 
 
 8.9
 (8.9)
Other comprehensive earnings (loss), before tax338.6
 (6.9) 
 417.8
 (410.9) 338.6
Income tax (benefit) provision(5.8) 2.5
 
 (8.0) 5.5
 (5.8)
Other comprehensive earnings (loss), net of tax344.4
 (9.4) 
 425.8
 (416.4) 344.4
Comprehensive earnings (loss)$432.7
 $(62.2) $
 $676.7
 $(614.5) $432.7
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
ASSETS           
Assets           
Current assets:           
Cash and cash equivalents$
 $18.2
 $
 $369.9
 $
 $388.1
Accounts receivable, net
 24.3
 
 2,856.7
 
 2,881.0
Inventories
 
 
 2,580.2
 
 2,580.2
Intercompany receivables342.9
 518.7
 
 13,107.1
 (13,968.7) 
Prepaid expenses and other current assets5.6
 71.3
 
 441.5
 
 518.4
Total current assets348.5
 632.5
 
 19,355.4
 (13,968.7) 6,367.7
Property, plant and equipment, net
 259.7
 
 1,910.5
 
 2,170.2
Investments in subsidiaries18,995.9
 13,129.5
 
 
 (32,125.4) 
Intercompany notes and interest receivable6,287.4
 10,732.6
 
 2,519.8
 (19,539.8) 
Intangible assets, net
 
 
 13,664.6
 
 13,664.6
Goodwill
 17.1
 
 9,730.7
 
 9,747.8
Other assets0.3
 68.9
 
 715.4
 
 784.6
Total assets$25,632.1
 $24,840.3
 $
 $47,896.4
 $(65,633.9) $32,734.9
            
LIABILITIES AND EQUITY           
Liabilities           
Current liabilities:           
Accounts payable$
 $70.6
 $
 $1,546.4
 $
 $1,617.0
Short-term borrowings
 
 
 1.9
 
 1.9
Income taxes payable
 
 
 121.5
 
 121.5
Current portion of long-term debt and other long-term obligations649.0
 0.2
 
 50.6
 
 699.8
Intercompany payables1,618.8
 12,326.4
 
 23.5
 (13,968.7) 
Other current liabilities21.0
 216.0
 
 1,910.6
 
 2,147.6
Total current liabilities2,288.8
 12,613.2
 
 3,654.5
 (13,968.7) 4,587.8
Long-term debt9,370.1
 3,786.2
 
 4.9
 
 13,161.2
Intercompany notes payable1,806.1
 3,094.2
 
 14,639.5
 (19,539.8) 
Other long-term obligations
 48.6
 
 2,770.2
 
 2,818.8
Total liabilities13,465.0
 19,542.2
 
 21,069.1
 (33,508.5) 20,567.8
            
Total equity12,167.1
 5,298.1
 
 26,827.3
 (32,125.4) 12,167.1
            
Total liabilities and equity$25,632.1
 $24,840.3
 $
 $47,896.4
 $(65,633.9) $32,734.9

42

Table of Contents
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF COMPREHENSIVE EARNINGSCASH FLOWS
NineThree Months Ended September 30, 2017March 31, 2019
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Net earnings$451.7
 $372.8
 $
 $855.8
 $(1,228.6) $451.7
Other comprehensive earnings (loss), before tax:           
Foreign currency translation adjustment1,831.9
 
 
 1,831.9
 (1,831.9) 1,831.9
Change in unrecognized gain and prior service cost related to defined benefit plans2.4
 0.3
 
 2.1
 (2.4) 2.4
Net unrecognized gain on derivatives in cash flow hedging relationships29.2
 5.5
 
 23.7
 (29.2) 29.2
Net unrecognized loss on derivatives in net investment hedging relationships(203.2) 
 
 
 
 (203.2)
Net unrealized gain (loss) on marketable securities3.5
 3.7
 
 (0.2) (3.5) 3.5
Other comprehensive earnings, before tax1,663.8
 9.5
 
 1,857.5
 (1,867.0) 1,663.8
Income tax provision (benefit)11.3
 (3.5) 
 14.8
 (11.3) 11.3
Other comprehensive earnings, net of tax1,652.5
 13.0
 
 1,842.7
 (1,855.7) 1,652.5
Comprehensive earnings$2,104.2
 $385.8
 $
 $2,698.5
 $(3,084.3) $2,104.2

(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Cash flows from operating activities:           
Net cash (used in) provided by operating activities$(47.5) $(437.5) $
 $445.3
 $
 $(39.7)
Cash flows from investing activities:           
Capital expenditures
 (11.2) 
 (41.9) 
 (53.1)
Purchase of available for sale securities and other investments
 
 
 (7.8) 
 (7.8)
Proceeds from the sale of assets
 
 
 0.2
 
 0.2
Proceeds from the sale of marketable securities
 
 
 7.6
 
 7.6
Cash paid for acquisitions, net
 
 
 (7.1) 
 (7.1)
Investments in affiliates
 (5.7) 
 
 5.7
 
Dividends from affiliates3.9
 
 
 
 (3.9) 
Loans to affiliates(79.0) 
 
 (701.4) 780.4
 
Repayments of loans from affiliates147.0
 
 
 289.2
 (436.2) 
Payments for product rights and other, net
 
 
 (15.4) 
 (15.4)
Net cash provided by (used in) investing activities71.9
 (16.9) 
 (476.6) 346.0
 (75.6)
Cash flows from financing activities:           
Payments of financing fees(0.1) (1.1) 
 
 
 (1.2)
Change in short-term borrowings, net
 
 
 (1.5) 
 (1.5)
Proceeds from issuance of long-term debt
 
 
 0.1
 
 0.1
Payments of long-term debt
 
 
 (0.2) 
 (0.2)
Proceeds from exercise of stock options2.4
 
 
 
 
 2.4
Taxes paid related to net share settlement of equity awards(7.1) 
 
 
 
 (7.1)
Contingent consideration payments
 
 
 (31.8) 
 (31.8)
Capital contribution from affiliates
 
 
 5.7
 (5.7) 
Capital payments to affiliates
 
 
 (3.9) 3.9
 
Payments on borrowings from affiliates(42.3) (253.4) 
 (140.5) 436.2
 
Proceeds from borrowings from affiliates22.7
 690.7
 
 67.0
 (780.4) 
Other items, net
 
 
 (0.8) 
 (0.8)
Net cash (used in) provided by financing activities(24.4) 436.2
 
 (105.9) (346.0) (40.1)
Effect on cash of changes in exchange rates
 
 
 (3.0) 
 (3.0)
Net decrease in cash, cash equivalents and restricted cash
 (18.2) 
 (140.2) 
 (158.4)
Cash, cash equivalents and restricted cash — beginning of period
 18.2
 
 371.1
 
 389.3
Cash, cash equivalents and restricted cash — end of period$
 $
 $
 $230.9
 $
 $230.9

43

Table of Contents
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF COMPREHENSIVE EARNINGSCASH FLOWS
Three Months Ended September 30, 2016March 31, 2018
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Net (loss) earnings$(119.8) $362.6
 $
 $42.9
 $(405.5) $(119.8)
Other comprehensive earnings (loss), before tax:           
Foreign currency translation adjustment290.6
 1.5
 
 289.0
 (290.5) 290.6
Change in unrecognized gain (loss) and prior service cost related to defined benefit plans0.1
 0.2
 
 (0.1) (0.1) 0.1
Net unrecognized gain on derivatives in cash flow hedging relationships22.8
 2.3
 
 20.5
 (22.8) 22.8
Net unrecognized loss on derivatives in net investment hedging relationships(10.4) 
 
 (10.4) 10.4
 (10.4)
Net unrealized gain (loss) on marketable securities21.5
 21.5
 
 (0.1) (21.4) 21.5
Other comprehensive earnings, before tax324.6
 25.5
 
 298.9
 (324.4) 324.6
Income tax provision13.7
 8.7
 
 3.9
 (12.6) 13.7
Other comprehensive earnings, net of tax310.9
 16.8
 
 295.0
 (311.8) 310.9
Comprehensive earnings$191.1
 $379.4
 $
 $337.9
 $(717.3) $191.1
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Cash flows from operating activities:           
Net cash (used in) provided by operating activities$(28.1) $(128.3) $
 $778.2
 $
 $621.8
Cash flows from investing activities:           
Capital expenditures
 (5.8) 
 (24.9) 
 (30.7)
Purchase of available for sale securities and other investments
 
 
 (7.5) 
 (7.5)
Proceeds from the sale of marketable securities
 
 
 15.0
 
 15.0
Cash paid for acquisitions, net
 
 
 (63.3) 
 (63.3)
Investments in affiliates
 (6.0) 
 
 6.0
 
Dividends from affiliates56.9
 
 
 
 (56.9) 
Loans to affiliates(409.2) 
 
 (1,316.6) 1,725.8
 
Repayments of loans from affiliates425.7
 
 
 677.4
 (1,103.1) 
Payments for product rights and other, net
 (0.1) 
 (342.3) 
 (342.4)
Net cash provided by (used in) investing activities73.4
 (11.9) 
 (1,062.2) 571.8
 (428.9)
Cash flows from financing activities:           
Payments of financing fees
 (0.4) 
 
 
 (0.4)
Purchase of ordinary shares(432.0) 
 
 
 
 (432.0)
Change in short-term borrowings, net
 
 
 309.1
 
 309.1
Proceeds from issuance of long-term debt496.5
 
 
 1.9
 
 498.4
Payments of long-term debt(496.5) 
 
 (1.5) 
 (498.0)
Proceeds from exercise of stock options10.8
 
 
 
 
 10.8
Taxes paid related to net share settlement of equity awards(8.9) 
 
 
 
 (8.9)
Contingent consideration payments
 
 
 (0.2) 
 (0.2)
Capital contribution from affiliates
 
 
 6.0
 (6.0) 
Capital payments to affiliates
 
 
 (56.9) 56.9
 
Payments on borrowings from affiliates
 (837.4) 
 (265.7) 1,103.1
 
Proceeds from borrowings from affiliates384.8
 978.6
 
 362.4
 (1,725.8) 
Other items, net
 
 
 (0.2) 
 (0.2)
Net cash (used in) provided by financing activities(45.3) 140.8
 
 354.9
 (571.8) (121.4)
Effect on cash of changes in exchange rates
 
 
 3.7
 
 3.7
Net increase in cash, cash equivalents and restricted cash
 0.6
 
 74.6
 
 75.2
Cash, cash equivalents and restricted cash — beginning of period
 23.8
 
 346.1
 
 369.9
Cash, cash equivalents and restricted cash — end of period$
 $24.4
 $
 $420.7
 $
 $445.1

44

Table of Contents
MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF COMPREHENSIVE EARNINGS
Nine Months Ended September 30, 2016The following tables provide a reconciliation of cash and cash equivalents, as reported on our unaudited condensed consolidating balance sheets, to cash, cash equivalents and restricted cash, as reported on our unaudited condensed consolidating statements of cash flows (in millions):
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Net earnings$62.5
 $713.8
 $
 $648.9
 $(1,362.7) $62.5
Other comprehensive earnings (loss), before tax:           
Foreign currency translation adjustment645.5
 
 
 645.5
 (645.5) 645.5
Change in unrecognized (loss) gain and prior service cost related to defined benefit plans(0.3) 0.2
 
 (0.6) 0.4
 (0.3)
Net unrecognized (loss) gain on derivatives in cash flow hedging relationships(22.9) (49.8) 
 26.9
 22.9
 (22.9)
Net unrealized loss on derivatives in net investment hedging relationships(10.4) 
 
 (10.4) 10.4
 (10.4)
Net unrealized gain on marketable securities32.5
 31.5
 
 0.9
 (32.4) 32.5
Other comprehensive earnings (loss), before tax644.4
 (18.1) 
 662.3
 (644.2) 644.4
Income tax provision (benefit)0.5
 (6.8) 
 6.3
 0.5
 0.5
Other comprehensive earnings (loss), net of tax643.9
 (11.3) 
 656.0
 (644.7) 643.9
Comprehensive earnings$706.4
 $702.5
 $
 $1,304.9
 $(2,007.4) $706.4
 March 31, 2019
 Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Cash and cash equivalents$
 $
 $
 $229.8
 $
 $229.8
Restricted cash, included in prepaid expenses and other current assets
 
 
 1.1
 
 1.1
Cash, cash equivalents and restricted cash$
 $
 $
 $230.9
 $
 $230.9
 December 31, 2018
 Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Cash and cash equivalents$
 $18.2
 $
 $369.9
 $
 $388.1
Restricted cash, included in prepaid expenses and other current assets
 
 
 1.2
 
 1.2
Cash, cash equivalents and restricted cash$
 $18.2
 $
 $371.1
 $
 $389.3


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MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING BALANCE SHEET
As of September 30, 2017
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
ASSETS           
Assets           
Current assets:           
Cash and cash equivalents$
 $82.2
 $
 $532.7
 $
 $614.9
Accounts receivable, net
 4.8
 
 3,215.4
 
 3,220.2
Inventories
 
 
 2,548.1
 
 2,548.1
Intercompany receivables329.2
 447.8
 
 12,224.7
 (13,001.7) 
Prepaid expenses and other current assets9.9
 250.4
 
 623.1
 
 883.4
Total current assets339.1
 785.2
 
 19,144.0
 (13,001.7) 7,266.6
Property, plant and equipment, net
 300.7
 
 2,009.3
 
 2,310.0
Investments in subsidiaries19,248.7
 10,991.2
 
 
 (30,239.9) 
Intercompany notes and interest receivable7,832.5
 10,156.1
 
 1,722.6
 (19,711.2) 
Intangible assets, net
 
 
 15,270.5
 
 15,270.5
Goodwill
 17.1
 
 9,967.6
 
 9,984.7
Other assets4.4
 91.5
 
 891.2
 
 987.1
Total assets$27,424.7
 $22,341.8
 $
 $49,005.2
 $(62,952.8) $35,818.9
            
LIABILITIES AND EQUITY           
Liabilities           
Current liabilities:           
Trade accounts payable$
 $36.3
 $
 $1,239.8
 $
 $1,276.1
Short-term borrowings
 
 
 
 
 
Income taxes payable
 3.7
 
 11.1
 
 14.8
Current portion of long-term debt and other long-term obligations
 648.6
 
 144.4
 
 793.0
Intercompany payables650.4
 12,290.5
 
 60.8
 (13,001.7) 
Other current liabilities138.0
 363.3
 
 2,398.8
 
 2,900.1
Total current liabilities788.4
 13,342.4
 
 3,854.9
 (13,001.7) 4,984.0
Long-term debt11,641.3
 2,252.7
 
 98.4
 
 13,992.4
Intercompany notes payable1,703.4
 3,296.2
 
 14,711.6
 (19,711.2) 
Other long-term obligations
 58.4
 
 3,492.5
 
 3,550.9
Total liabilities14,133.1
 18,949.7
 
 22,157.4
 (32,712.9) 22,527.3
            
Total equity13,291.6
 3,392.1
 
 26,847.8
 (30,239.9) 13,291.6
            
Total liabilities and equity$27,424.7
 $22,341.8
 $
 $49,005.2
 $(62,952.8) $35,818.9

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MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING BALANCE SHEET
As of December 31, 2016
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
ASSETS           
Assets           
Current assets:           
Cash and cash equivalents$0.3
 $12.3
 $
 $986.2
 $
 $998.8
Accounts receivable, net
 12.3
 
 3,298.6
 
 3,310.9
Inventories
 
 
 2,456.4
 
 2,456.4
Intercompany receivables215.9
 416.0
 
 10,506.6
 (11,138.5) 
Prepaid expenses and other current assets
 256.4
 
 500.0
 
 756.4
Total current assets216.2
 697.0
 
 17,747.8
 (11,138.5) 7,522.5
Property, plant and equipment, net
 360.3
 
 1,961.9
 
 2,322.2
Investments in subsidiaries15,606.2
 8,277.8
 
 
 (23,884.0) 
Intercompany notes and interest receivable7,952.3
 9,817.3
 
 16.7
 (17,786.3) 
Intangible assets, net
 
 
 14,447.8
 
 14,447.8
Goodwill
 17.1
 
 9,214.8
 
 9,231.9
Other assets5.2
 51.9
 
 1,144.7
 
 1,201.8
Total assets$23,779.9
 $19,221.4
 $
 $44,533.7
 $(52,808.8) $34,726.2
            
LIABILITIES AND EQUITY           
Liabilities           
Current liabilities:           
Trade accounts payable$3.9
 $69.6
 $
 $1,274.6
 $
 $1,348.1
Short-term borrowings
 
 
 46.4
 
 46.4
Income taxes payable
 
 
 97.7
 
 97.7
Current portion of long-term debt and other long-term obligations
 0.2
 
 289.8
 
 290.0
Intercompany payables416.0
 10,722.5
 
 
 (11,138.5) 
Other current liabilities90.9
 388.8
 
 2,778.8
 
 3,258.5
Total current liabilities510.8
 11,181.1
 
 4,487.3
 (11,138.5) 5,040.7
Long-term debt12,151.5
 2,897.6
 
 153.8
 
 15,202.9
Intercompany notes payable
 3,870.9
 
 13,915.4
 (17,786.3) 
Other long-term obligations
 58.1
 
 3,306.9
 
 3,365.0
Total liabilities12,662.3
 18,007.7
 
 21,863.4
 (28,924.8) 23,608.6
            
Total equity11,117.6
 1,213.7
 
 22,670.3
 (23,884.0) 11,117.6
            
Total liabilities and equity$23,779.9
 $19,221.4
 $
 $44,533.7
 $(52,808.8) $34,726.2

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MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF CASH FLOWS
Nine Months Ended September 30, 2017
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Cash flows from operating activities:           
Net cash (used in) provided by operating activities$(175.1) $(338.8) $
 $2,083.2
 $
 $1,569.3
Cash flows from investing activities:           
Capital expenditures
 (31.4) 
 (125.0) 
 (156.4)
Change in restricted cash
 
 
 12.6
 
 12.6
Purchase of marketable securities
 
 
 (8.9) 
 (8.9)
Proceeds from the sale of assets
 
 
 31.1
 
 31.1
Proceeds from the sale of marketable securities
 
 
 8.9
 
 8.9
Cash paid for acquisitions, net(71.6) 
 
 
 
 (71.6)
Investments in affiliates
 (21.1) 
 
 21.1
 
Dividends from affiliates168.1
 
 
 
 (168.1) 
Loans to affiliates(143.7) (364.1) 
 (2,558.0) 3,065.8
 
Repayments of loans from affiliates1,066.4
 0.3
 
 943.6
 (2,010.3) 
Payments for product rights and other, net
 (0.3) 
 (558.5) 
 (558.8)
Net cash provided by (used in) investing activities1,019.2
 (416.6) 
 (2,254.2) 908.5
 (743.1)
Cash flows from financing activities:           
Payments of financing fees(8.3) (0.4) 
 
 
 (8.7)
Change in short-term borrowings, net
 
 
 (48.3) 
 (48.3)
Proceeds from issuance of long-term debt554.5
 
 
 1.3
 
 555.8
Payments of long-term debt(1,500.0) 
 
 (247.3) 
 (1,747.3)
Proceeds from exercise of stock options12.8
 
 
 
 
 12.8
Taxes paid related to net share settlement of equity awards(7.4) 
 
 
 
 (7.4)
Contingent consideration payments
 
 
 (10.1) 
 (10.1)
Capital contribution from affiliates
 
 
 21.1
 (21.1) 
Capital payments to affiliates
 
 
 (168.1) 168.1
 
Payments on borrowings from affiliates
 (1,664.4) 
 (345.9) 2,010.3
 
Proceeds from borrowings from affiliates104.0
 2,497.5
 
 464.3
 (3,065.8) 
Other items, net
 (7.4) 
 6.7
 
 (0.7)
Net cash (used in) provided by financing activities(844.4) 825.3
 
 (326.3) (908.5) (1,253.9)
Effect on cash of changes in exchange rates
 
 
 43.8
 
 43.8
Net (decrease) increase in cash and cash equivalents(0.3) 69.9
 
 (453.5) 
 (383.9)
Cash and cash equivalents — beginning of period0.3
 12.3
 
 986.2
 
 998.8
Cash and cash equivalents — end of period$
 $82.2
 $
 $532.7
 $
 $614.9

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MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


UNAUDITED CONDENSED CONSOLIDATING STATEMENT OF CASH FLOWS
Nine Months Ended September 30, 2016
(In millions)Mylan N.V. Mylan Inc. Guarantor Subsidiaries Non-Guarantor Subsidiaries Eliminations Consolidated
Cash flows from operating activities:           
Net cash (used in) provided by operating activities$(1.6) $724.7
 $
 $974.6
 $
 $1,697.7
Cash flows from investing activities:           
Capital expenditures
 (64.8) 
 (174.7) 
 (239.5)
Change in restricted cash
 (49.5) 
 (1.0) 
 (50.5)
Purchase of marketable securities
 (4.1) 
 (18.7) 
 (22.8)
Cash paid for Meda’s unconditional deferred payment
 
 
 (308.0) 
 (308.0)
Proceeds from the sale of marketable securities
 
 
 15.8
 
 15.8
Cash paid for acquisitions, net(5,278.5) (931.3) 
 58.1
 
 (6,151.7)
Settlement of acquisition-related foreign currency derivatives(128.6) 
 
 
 
 (128.6)
Investments in affiliates
 (43.6) 
 
 43.6
 
Dividends from affiliates135.6
 
 
 
 (135.6) 
Loans to affiliates(7,971.9) (417.0) 
 (726.3) 9,115.2
 
Repayments of loans from affiliates6,838.3
 442.6
 
 1,031.3
 (8,312.2) 
Payments for product rights and other, net
 (0.4) 
 (195.9) 
 (196.3)
Net cash used in investing activities(6,405.1) (1,068.1) 
 (319.4) 711.0
 (7,081.6)
Cash flows from financing activities:           
Payments of financing fees(95.3) 
 
 
 
 (95.3)
Change in short-term borrowings, net
 
 
 48.6
 
 48.6
Proceeds from issuance of long-term debt6,478.8
 
 
 41.0
 
 6,519.8
Payments of long-term debt
 (500.0) 
 (567.0) 
 (1,067.0)
Proceeds from exercise of stock options11.1
 
 
 
 
 11.1
Taxes paid related to net share settlement of equity awards(12.9) 
 
 
 
 (12.9)
Contingent consideration payments
 
 
 (15.5) 
 (15.5)
Capital contribution from affiliates
 
 
 43.6
 (43.6) 
Capital payments to affiliates
 
 
 (135.6) 135.6
 
Payments on borrowings from affiliates
 (1,361.8) 
 (6,950.4) 8,312.2
 
Proceeds from borrowings from affiliates25.0
 1,380.8
 
 7,709.4
 (9,115.2) 
Acquisition of noncontrolling interest
 
 
 (1.0) 
 (1.0)
Other items, net
 (12.9) 
 14.5
 
 1.6
Net cash provided by (used in) financing activities6,406.7
 (493.9) 
 187.6
 (711.0) 5,389.4
Effect on cash of changes in exchange rates
 
 
 15.1
 
 15.1
Net (decrease) increase in cash and cash equivalents
 (837.3) 
 857.9
 
 20.6
Cash and cash equivalents — beginning of period
 870.5
 
 365.5
 
 1,236.0
Cash and cash equivalents — end of period$
 $33.2
 $
 $1,223.4
 $
 $1,256.6

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MYLAN N.V. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


17.Restructuring
On December 5, 2016, the Company announced a restructuring programs in certain locationsprogram representing initial steps in a series of actions in certain locations that are anticipated to further streamline its operations globally. Since 2015, the Company has made a number of significant acquisitions, and as part of the holistic, global integration of these acquisitions, the Company is focused on how to best optimize and maximize all of its assets across the organization and across all geographies.
Charges for restructuring and ongoing cost reduction initiatives are recorded in the period the Company commits to a restructuring or cost reduction plan, or executes specific actions contemplated by the plan and all criteria for liability recognition have been met.
TheDuring the second quarter of 2018, the Company continuescommenced comprehensive restructuring and remediation activities, which are aimed at reducing the complexity at the Morgantown, West Virginia plant and include the discontinuation and transfer to develop the detailsother manufacturing sites of a number of products, a reduction of the cost reduction initiatives, including workforce actions and other potential restructuring activities beyond the programs announced, including potential shutdown or consolidation of certain operations.extensive process and facility remediation. The continued restructuring actions are expected to be implemented through fiscal yearother than for this plant were substantially complete as of December 31, 2018. In the fourth quarter of 2017, the Company committed to additional actions and now anticipates total aggregate pre-tax charges for committed restructuring activities ranging between $375.0 million and $450.0 million, inclusive of the 2016 and year to date 2017 restructuring charges of $262.4 million. As additional restructuring activities are undertaken, the Company expects to incur additional costs including employee related costs, such as severance and continuation of healthcare and other benefits; asset impairments; accelerated depreciation; costs associated with contract terminations; and other closure costs. At this time, the expenses related to the additional restructuring activities at the Morgantown, West Virginia plant cannot be reasonably estimated.
The following table summarizes the restructuring charges and the reserve activity from December 31, 20162018 to September 30, 2017:March 31, 2019:
(In millions)Employee Related Costs Other Exit Costs TotalEmployee Related Costs Other Exit Costs Total
Balance at December 31, 2016:$138.6
 $1.6
 $140.2
Charges9.6
 13.5
 23.1
Reclassifications(8.3) 8.3
 
Balance at December 31, 2018:$60.8
 $11.8
 $72.6
Charges (1)
1.8
 18.1
 19.9
Reclassification due to new leasing standard
 (8.1) (8.1)
Cash payment(54.2) (1.0) (55.2)(26.4) (1.4) (27.8)
Utilization
 (19.8) (19.8)
 (16.7) (16.7)
Foreign currency translation(9.8) 
 (9.8)(1.1) 
 (1.1)
Balance at March 31, 2017:$75.9
 $2.6
 $78.5
Charges13.2
 3.0
 16.2
Cash payment(32.4) (1.9) (34.3)
Utilization
 (1.8) (1.8)
Foreign currency translation(4.4) 
 (4.4)
Balance at June 30, 2017:$52.3
 $1.9
 $54.2
Charges (1)
20.0
 53.4
 73.4
Reclassifications
 
 
Cash payment(14.2) (0.7) (14.9)
Utilization
 (53.4) (53.4)
Foreign currency translation(3.3) 
 (3.3)
Balance at September 30, 2017:$54.8
 $1.2
 $56.0
Balance at March 31, 2019:$35.1
 $3.7
 $38.8
____________
(1)
For the three months ended September 30, 2017,March 31, 2019, total restructuring charges in North America, Europe and Rest of World and Corporate / Other were approximately $5.6$11.2 million, $16.3 million, $19.1$7.8 million and $32.4 million respectively. For the nine months ended September 30, 2017, total restructuring charges in North America, Europe, Rest of World and Corporate / Other were approximately $12.8 million, $32.9 million, $33.7 million and $33.3$0.9 million, respectively.
At March 31, 2019 and December 31, 2018, accrued liabilities for restructuring and other cost reduction programs were primarily included in other current liabilities on the condensed consolidated balance sheets.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


At September 30, 2017 and December 31, 2016, accrued liabilities for restructuring and other cost reduction programs were primarily included in other current liabilities on the Condensed Consolidated Balance Sheets.
18.Collaboration and Licensing Agreements
We periodically enter into collaboration and licensing agreements with other pharmaceutical companies for the development, manufacture, marketing and/or sale of pharmaceutical products. Our significant collaboration agreements are primarily focused on the development, manufacturing, supply and commercialization of multiple, high-value generic biologic compounds, insulin analog products and respiratory products, among other complex products. Under these agreements, we have future potential milestone payments and co-development expenses payable to third parties as part of our licensing, development and co-development programs. Payments under these agreements generally become due and are payable upon the satisfaction or achievement of certain developmental, regulatory or commercial milestones or as development expenses are incurred on defined projects. Milestone payment obligations are uncertain, including the prediction of timing and the occurrence of events triggering a future obligation and are not reflected as liabilities in the Condensed Consolidated Balance Sheets,condensed consolidated balance sheets, except for milestone and royalty obligations reflected as acquisition related contingent consideration. Refer to Note 12 11Financial Instruments and Risk Management for contingent considerationadditional information. Our potential maximum development milestones not accrued for at March 31, 2019 totaled approximately $440.0 million, which includes the new agreements entered into as described in Note 4 Acquisitions and Other Transactions. We estimate the amounts recorded.that may be paid through the end of 2019 to be approximately $55.0 million. These agreements may also include potential sales-based milestones and call for us to pay a percentage of amounts earned from the sale of the product as a royalty or a profit share. The amounts disclosed do not include sales basedsales-based milestones or royalty obligations on future sales of product as the timing and amount of future sales levels and costs to produce products subject to these obligations is not reasonably estimable. These sales-based milestones or royalty obligations may be significant depending upon the level of commercial sales for each product.
There have been no other significant changes to our collaboration and licensing agreements as disclosed in our Annual Report on2018 Form 10-K for the year ended December 31, 2016, as amended.10-K.
19.Income Taxes
Tax Examinations
The Company is subject to income taxes and tax audits in many jurisdictions. A certain degree of estimation is thus required in recording the assets and liabilities related to income taxes. Tax audits and examinations can involve complex issues, interpretations, and judgments and the resolution of matters that may span multiple years, particularly if subject to litigation or negotiation.
Although the Company believes that adequate provisions have been made for these uncertain tax positions, the Company’s assessment of uncertain tax positions is based on estimates and assumptions that the Company believes are reasonable but the estimates for unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes, and variations from such estimates could materially affect the Company’s financial condition, results of operations or cash flows in the period of resolution, settlement or when the statutes of limitations expire.
Mylan is subject to ongoing U.S. Internal Revenue Service (“IRS”) examinations and is a voluntary participant in the IRS Compliance Assurance Process (“CAP”), which allows Mylan to work collaboratively with the IRS to identify and review tax matters on an ongoing basis. The years 2015, 2016 and 2017 are open years under examination. The years 2012, 2013 and 2014 have one matter open, and a Tax Court petition has been filed regarding the matter and a trial was held in December 2018 and is discussed further below. On February 27, 2015, Mylan N.V. acquired Mylan Inc. and Abbott Laboratories’ (“Abbott”) non-U.S. developed markets specialty and branded generics business (collectively, the “EPD Business Acquisition”). In connection with the EPD Business Acquisition, we entered into intercompany transactions with our affiliates that affect our U.S. tax liability. Mylan N.V. is not incorporated in the U.S. and expects to be treated as a non-U.S. corporation for U.S. federal income tax purposes. As part of our ongoing participation and cooperation in the CAP, we have received and responded to various IRS requests for information about, among other matters, the EPD Business Acquisition, including the interest rates used for intercompany loans and our status as a non-U.S. corporation for U.S. federal income tax purposes, and we have been meeting with the IRS to discuss our respective positions on these matters and potential resolution of them. The IRS has indicated that depending upon the outcome of these ongoing discussions, as previously disclosed, they may challenge our positions on the EPD Business Acquisition. We remain confident in our positions and, should the IRS choose to challenge our positions, we would vigorously defend our positions through all available channels. If the IRS chooses to challenge our positions, and if the IRS succeeds, we would be subject to significantly greater U.S. tax liability, beginning February 27, 2015, than currently contemplated as a non-U.S. corporation, which would have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

The Company’s major state taxing jurisdictions remain open from fiscal year 2008 through 2018, with several state audits currently in progress. The Company’s major international taxing jurisdictions remain open from 2012 through 2018, some of which are indemnified by Strides Arcolab Limited (“Strides Arcolab”) for tax assessments.
Tax Court Proceedings
The Company's U.S. federal income tax returns for 2007 through 2011 had been subject to proceedings in U.S. Tax Court involving a dispute with the IRS regarding whether the proceeds received by the Company in connection with the 2008 sale of its rights in nebivolol constituted a capital gain or ordinary income. The Company and the IRS filed a joint stipulation of settled issues with the Tax Court that resolved all issues in this dispute and the Tax Court issued the final order closing the case during the three months ended March 31, 2018.
The Company's U.S. federal income tax returns for 2012 through 2014 had been subject to proceedings in U.S. Tax Court involving a dispute with the IRS regarding whether certain costs related to Abbreviated New Drug Applications were eligible to be expensed and deducted immediately or required to be amortized over longer periods. A trial was held in U.S. Tax Court in December 2018. Post-trial briefing is expected to conclude on June 27, 2019.
Accounting for Uncertainty in Income Taxes
The impact of an uncertain tax position that is more likely than not of being sustained upon audit by the relevant taxing authority must be recognized at the largest amount that is more likely than not to be sustained. No portion of an uncertain tax position will be recognized if the position has less than a 50% likelihood of being sustained.
During the three months ended March 31, 2019, primarily due to the expiration of federal and foreign statutes of limitations expirations, the Company reduced its net liability for unrecognized tax benefits by approximately $83.8 million. During the three months ended March 31, 2018, as a result of federal and state audits and settlements and expirations of certain state, federal, and foreign statutes of limitations, the Company reduced its liability for unrecognized tax benefits by approximately $86.0 million, which resulted in a net benefit to the income tax provision of approximately $53.0 million.
20.Litigation
The Company is involved in various disputes, governmental and/or regulatory inquiries, investigations and proceedings, tax proceedings and litigation matters, both in the U.S. and abroad, that arise from time to time, some of which could result in losses, including damages, fines and/or civil penalties, and/or criminal charges against the Company. These matters are often complex and have outcomes that are difficult to predict. The Company is also party to certain proceedings and litigation matters for which it may be entitled to indemnification under the respective sale and purchase agreements relating to the acquisitions of the former Merck Generics business, Agila Abbott Laboratories’Specialties Private Limited, Abbott’s non-U.S. developed markets specialty and branded generics business, and certain other acquisitions.
While the Company believes that it has meritorious defenses with respect to the claims asserted against it and intends to vigorously defend its position, the process of resolving these matters is inherently uncertain and may develop over a long period of time,, and so it is not possible to predict the ultimate resolution of any such matter. It is possible that an unfavorable resolution of any of the ongoing matters or the inability or denial of Merck KGaA, Strides Arcolab, Abbott, Laboratories, or another indemnitor or insurer to pay an indemnified claim, could have a material effect on the Company’s business, financial condition, results of operations, cash flows and/or ordinary share price.
Some of these governmental inquiries, investigations, proceedings and litigation matters with which the Company is involved are described below, and unless otherwise disclosed,, the Company is unable to predict the outcome of the matter or to provide an estimate of the range of reasonably possible material losses. The Company records accruals for loss contingencies to the extent we conclude it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company is also involved in other pending proceedings that,for which, in the opinion of the Company based upon facts and circumstances known at the time, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to the Company’s business, financial position, results of operations, cash flows and/or ordinary share price. If and when any reasonably possible losses associated with the resolution of such other pending proceedings, in the opinion of the Company, become material, the Company will disclose such matters.
Legal costs are recorded as incurred and are classified in SG&A in the Company’s Condensed Consolidated Statements of Operations.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


LorazepamLegal costs are recorded as incurred and Clorazepate
On June 1, 2005, a jury verdict was rendered against Mylan, MPI, and co-defendants Cambrex Corporation and Gyma Laboratoriesare classified in SG&A in the U.S. District Court for the DistrictCompany’s condensed consolidated statements of Columbia in the amount of approximately $12.0 million, which was accrued for by the Company. The jury found that Mylan and its co-defendants willfully violated Massachusetts, Minnesota and Illinois state antitrust laws in connection with active pharmaceutical ingredient supply agreements entered into between the Company and its API supplier (Cambrex) and broker (Gyma) for two drugs, Lorazepam and Clorazepate, in 1997, and subsequent price increases on these drugs in 1998. The case was brought by four health insurers who opted out of earlier class action settlements agreed to by the Company in 2001 and represents the last remaining antitrust claims relating to Mylan’s 1998 price increases for Lorazepam and Clorazepate. Following the verdict, the Company filed a motion for judgment as a matter of law, a motion for a new trial, a motion to dismiss two of the insurers and a motion to reduce the verdict. On December 20, 2006, the Company’s motion for judgment as a matter of law and motion for a new trial were denied and the remaining motions were denied on January 24, 2008. In post-trial filings, the plaintiffs requested that the verdict be trebled and that request was granted on January 24, 2008. On February 6, 2008, a judgment was issued against Mylan and its co-defendants in the total amount of approximately $69.0 million, which, in the case of three of the plaintiffs, reflects trebling of the compensatory damages in the original verdict (approximately $11.0 million in total) and, in the case of the fourth plaintiff, reflects their amount of the compensatory damages in the original jury verdict plus doubling this compensatory damage award as punitive damages assessed against each of the defendants (approximately $58.0 million in total), some or all of which may be subject to indemnification obligations by Mylan. Plaintiffs are also seeking an award of attorneys’ fees and litigation costs in unspecified amounts and prejudgment interest of approximately $8.0 million. The Company and its co-defendants appealed to the U.S. Court of Appeals for the D.C. Circuit and have challenged the verdict as legally erroneous on multiple grounds. The appeals were held in abeyance pending a ruling on the motion for prejudgment interest, which has been granted. Mylan has contested this ruling along with the liability finding and other damages awards as part of its appeal, which was filed in the Court of Appeals for the D.C. Circuit. On January 18, 2011, the Court of Appeals issued a judgment remanding the case to the District Court for further proceedings based on lack of diversity with respect to certain plaintiffs. On June 13, 2011, Mylan filed a certiorari petition with the U.S. Supreme Court requesting review of the judgment of the D.C. Circuit. On October 3, 2011, the certiorari petition was denied. The case is now proceeding before the District Court. On January 14, 2013, following limited court-ordered jurisdictional discovery, the plaintiffs filed a fourth amended complaint containing additional factual averments with respect to the diversity of citizenship of the parties, along with a motion to voluntarily dismiss 775 (of 1,387) self-funded customers whose presence would destroy the District Court’s diversity jurisdiction. The plaintiffs also moved for a remittitur (reduction) of approximately $8.1 million from the full damages award. Mylan’s brief in response to the new factual averments in the complaint was filed on February 13, 2013. On July 29, 2014, the court granted both plaintiffs�� motion to amend the complaint and their motion to dismiss 775 self-funded customers. The Court granted the plaintiffs’ motion for remittitur on August 18, 2017, reducing approximately $9.5 million from the full damages award. The Court entered final judgment on August 30, 2017 in the amount of approximately $67 million (not including post-judgment interest and fees and costs). Mylan filed a notice of appeal on September 15, 2017 with the United States Court of Appeals for the District of Columbia Circuit. The total accrual for this matter at September 30, 2017 is approximately $29 million, which includes a $17 million charge recorded in the third quarter of 2017 as a result of the final judgment.
In connection with the Company’s appeal of the judgment, the Company submitted a surety bond underwritten by a third-party insurance company in the amount of $74.5 million in February 2008. On May 30, 2012, the District Court ordered the amount of the surety bond reduced to $66.6 million.
Pricing and Medicaid Litigation
Dey L.P. (now known as Mylan Specialty L.P. and herein as “Mylan Specialty”), a wholly owned subsidiary of the Company, was named as a defendant in several class actions brought by consumers and third-party payors. Mylan Specialty reached a settlement of these class actions, which was approved by the court and all claims have been dismissed. Additionally, a complaint was filed under seal by a plaintiff on behalf of the United States of America against Mylan Specialty in August 1997. In August 2006, the Government filed its complaint-in-intervention and the case was unsealed in September 2006. The Government asserted that Mylan Specialty was jointly liable with a co-defendant and sought recovery of alleged overpayments, together with treble damages, civil penalties and equitable relief. Mylan Specialty completed a settlement of this action in December 2010. These cases all have generally alleged that Mylan Specialty falsely reported certain price information concerning certain drugs marketed by Mylan Specialty, that Mylan Specialty caused false claims to be made to Medicaid and to Medicare, and that Mylan Specialty caused Medicaid and Medicare to make overpayments on those claims.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


Under the terms of the purchase agreement with Merck KGaA, Mylan is fully indemnified for the claims in the preceding paragraph and Merck KGaA is entitled to any income tax benefit the Company realizes for any deductions of amounts paid for such pricing litigation. Under the indemnity, Merck KGaA is responsible for all settlement and legal costs, and, as such, these settlements had no impact on the Company’s Consolidated Statements of Operations. At September 30, 2017, the Company has accrued approximately $63.3 million in other current liabilities, which represents its estimate of the remaining amount of anticipated income tax benefits due to Merck KGaA. We are not aware of any outstanding related claims.operations.
Modafinil Antitrust Litigation and FTC Inquiry
Beginning in April 2006, Mylan and four other drug manufacturers were named as defendants in civil lawsuits filed in or transferred to the U.S. District Court for the Eastern District of Pennsylvania (“EDPA”) by a variety of plaintiffs purportedly representing direct and indirect purchasers of the drug modafinil and in a lawsuit filed by Apotex, Inc., a manufacturer of generic drugs. These actions alleged violations of federal antitrust and state laws in connection with the generic defendants’ settlement of patent litigation with Cephalon relating to modafinil. On March 24, 2015, Mylan reached a settlement in principle withhas settled the lawsuits filed by the putative indirect purchasers,direct purchaser class and on November 20, 2015, Mylanretailer opt-out plaintiffs and Apotex and has entered into a settlement agreement with the putative indirect purchasers for approximately $16 million. Plaintiffs have not yet moved for preliminary approval of that settlement. In December 2016, Mylan reached a settlement with the putative direct purchaser class and the retailer opt-out plaintiffs for $165$14.4 million, of which approximately $68.5 million was paid before December 31, 2016. The settlement with the retailer opt-out plaintiffs has been completed. On February 3, 2017, the putative direct purchaser class moved for preliminary approval of the settlement. The direct purchaser class’ motion for preliminary approval of the settlement was denied on August 29, 2017. The parties are engaging in a continuing dialogueis subject to resolve this matter according to the terms of the settlement agreement. On June 8, 2017, Mylan and Apotex agreed to a settlement in principle. The settlement with Apotex has been completed. The Company has also received subpoenas from certain state Attorneys General requesting documents related to the modafinil patent litigation.
On June 29, 2015, the City of Providence, Rhode Island filed suit in the District of Rhode Island against the same parties named as defendants in litigation pending in the Eastern District of Pennsylvania, including Mylan, asserting state law claims based on the same underlying allegations. All defendants, including Mylan, moved to dismiss the suit on October 15, 2015, and the case was subsequently settled.court approval.
On July 10, 2015, the Louisiana Attorney General filed a lawsuit in the 19th Judicial District Court in Louisiana a petition against Mylan and three other drug manufacturers asserting state law claims based on the same underlying allegations as those made in the litigation then pending in the EasternEDPA. On December 8, 2016, the District of Pennsylvania. The petition was filed byCourt dismissed the lawsuit with prejudice, which the State of Louisiana purportedly in its capacity as an indirect purchaser. On May 16, 2016,appealed. The appeals court subsequently remanded the Judiciallawsuit to the District Court deferred Mylan’s declinatory exception of no personal jurisdictionto include certain language in order to make the District Court’s dismissal decision final and its peremptory exception of prescription, and granted in part and denied in part Mylan’s peremptory exceptions of no cause of action and no right of action. On June 30, 2016, the plaintiff filed a supplemental and amended petition. The defendants filed a motion to strike and joint peremptory exceptions to the amended petition. On July 21, 2016, the plaintiff filed in the First Circuit Court of Appeal its application for a supervisory writ regarding the granting of defendant’s exceptions, which the defendants opposed. The appeal was denied on October 31, 2016. On April 20, 2016, the State of Louisiana filed a motion to consolidate the pending action with four other actions against other pharmaceutical manufacturers concerning products not related to modafinil, which Mylan opposed. On June 27, 2016, the Judicial District Court declined to consolidate Mylan’s case with the other four actions, with leave to renew the consolidation request after filing the above-referenced amended petition. On July 21, 2016, the plaintiff filed a motion to reurge consolidation. Subsequently, the action to which plaintiff seeks to join Mylan was stayed, resulting in a stay of the consolidation motion. On December 8, 2016, Mylan’s peremptory exceptions of no cause of action with respect to the supplemental and amended petition were granted in their entirety and with prejudice and judgment was entered. On February 17, 2017, the plaintiff filed in the 19th Judicial District Court a motion for appeal, which the Judicial District Court granted on February 21, 2017. The appeal was lodged with the First Circuit Court of Appeal on April 4, 2017. Briefing on the appeal has been completed and an oral argument was held November 1, 2017.appealable.
On July 28, 2016, United Healthcare filed a complaint against Mylan Inc. and four other drug manufacturers in the United States District Court for the District of Minnesota, asserting state law claims based on the same underlying allegations as those made in the litigation then pending in the Eastern District of Pennsylvania.EDPA. On January 6, 2017, the case was transferred to the Eastern District of Pennsylvania. Mylan filed its answer to the complaint on March 31, 2017.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


EDPA and is still pending. MPI has since been included as an additional party. The trial date previously scheduled for July 2019 has been canceled.
The Company believes that it has strong defenses to these remaining cases. Although it is reasonably possible that the Company may incur additional losses from these matters, any amount cannot be reasonably estimated at this time.
In addition, by letter dated July 11, 2006, Mylan was notified by the U.S. Federal Trade Commission (“FTC”) of an investigation relating to the settlement of the modafinil patent litigation. In its letter, the FTC requested certain information from Mylan, MPI and Mylan Technologies, Inc. pertaining to the patent litigation and the settlement thereof. On March 29, 2007, the FTC issued a subpoena, and on April 26, 2007, the FTC issued a civil investigative demand to Mylan, requesting additional information from the Company relating to the investigation. Mylan has cooperated fully with the government’s investigation and completed all requests for information. On February 13, 2008, the FTC filed a lawsuit against Cephalon in the U.S. District Court for the District of Columbia and the case was subsequently transferred to the U.S. District Court for the Eastern District of Pennsylvania. On July 1, 2010, the FTC issued a third party subpoena to Mylan, requesting documents in connection with its lawsuit against Cephalon. Mylan has responded to the subpoena. The lawsuit against Cephalon settled and a Stipulated Order for Permanent Injunction and Equitable Monetary Relief was entered by the Court on June 17, 2015.
The Company has a total accrual of approximately $112.5$14.4 million related to this matter at September 30, 2017,March 31, 2019, which is included in other current liabilities in the Condensed Consolidated Balance Sheets.condensed consolidated balance sheets.
Pioglitazone
Beginning in December 2013, Mylan, Takeda, and several other drug manufacturers have been named as defendants in civil lawsuits consolidated in the U.S. District Court for the Southern District of New York by plaintiffs which purport to represent direct and indirect purchasers of branded or generic Actos® and Actoplus Met®. These actions allege violations of state and federal competition laws in connection with the defendants’ settlements of patent litigation in 2010 relatingrelated to Actos and Actoplus Met®. Plaintiffs filed an amended complaint on August 22, 2014. Mylan and the other defendants filed motions to dismiss the amended complaint on October 10, 2014. Two additional complaints were subsequently filed by plaintiffs purporting to represent classes of direct purchasers of branded or generic Actos® and Actoplus Met®. On September 23, 2015, the District Court granted defendants’ motionsMylan’s motion to dismiss the indirect purchasers amended complaints with prejudice. The indirect purchasers filed a notice ofpurchasers’ complaint was granted and no appeal on October 22, 2015; however they have since abandoned and dismissed their appeal of the District Court’s dismissal of claims asserted against Mylan. The putative direct purchaser class filed an amended complaint on January 8, 2016. Defendants’ motion to dismiss was filed on January 28, 2016 and the briefing has been completed. The case was stayed pending the resolution of the indirect purchasers’ appeal against the defendants remaining in that case. A decision was issued by the Second Circuit on February 8, 2017, reversing in part and affirming in part, the District Court’s decision as to Mylan. Following the remaining defendants. Following thisappellate decision relating to other defendants, the direct purchasers filed an amended complaint;complaint against Mylan and the other manufacturers. Mylan’s motion to dismiss the amended complaint is pending.
SEC Investigation
On September 10, 2015, Mylan N.V. received a subpoena from the SECSEC’s Division of Enforcement seeking documents with regard to certain related party matters. Mylan is fully cooperating with the SEC.
EpiPen® Auto-Injector and Certain Congressional Matters
Classificationsubsequently received additional requests for information. The SEC’s Division of EpiPen® Auto-Injector and EpiPen Jr® Auto-Injector
In November 2014,Enforcement informed the Company in February 2019 that it had completed its investigation with no recommended further action.
Trade Agreements Act (“TAA”)
On April 9, 2018, a subsidiary of Mylan N.V. received a subpoenacivil investigative demand from the Commercial Litigation Branch of the U.S. Department of Justice (“DOJ”) relatedconcerning its TAA compliance for certain products. The company fully cooperated with DOJ. On September 14, 2018, the United States District Court for the Southern District of Ohio unsealed a qui tam lawsuit filed against the Mylan N.V. subsidiary concerning its TAA compliance for the same products identified in DOJ’s civil investigative demand. DOJ has declined to the classification of the EpiPen® Auto-Injector for purposes of the Medicaid Drug Rebate Program. The Company complied with various information requests received from the DOJ pursuant to the subpoena. The questionintervene in the underlying matter was whether EpiPen® Auto-Injector should be classified with the Centers for Medicarelawsuit and Medicaid Services (“CMS”) as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen® Auto-Injector had been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007 based on longstanding written guidance from the federal government. Beginning in August 2016, questions regarding the pricing of the EpiPen® Auto-Injector significantly increased and the Company has received orclosed its investigation. The lawsuit has been the subject of additional inquiries, including with respectstayed and we believe that its claims are without merit and intend to the classification of EpiPen® Auto-Injector for purposes of the Medicaid Drug Rebate Program and certain other federal programs, from committees and members of Congress and from other federal and state governmental agencies.defend against them vigorously.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


Subsequent to these developments, on October 7, 2016, Mylan agreed to the terms of a $465 million settlement, plus interest, with the DOJ and other government agencies related to the classification of the EpiPen® Auto-Injector for purposes of the Medicaid Drug Rebate Program (the “Medicaid Drug Rebate Program Settlement”). On August 17, 2017, two of Mylan’s subsidiaries - Mylan Inc. and Mylan Specialty L.P. - signed an agreement with the DOJ and two relators finalizing the $465 million settlement. The settlement agreement provides for resolution of all potential Medicaid rebate liability claims by the federal government, as well as potential claims by certain hospitals and other covered entities that participate in the 340B Drug Pricing Program. The settlement agreement allocates money to the Medicaid programs of all 50 states and establishes a framework for resolving all potential state Medicaid rebate liability claims within 60 days. All 50 states plus the District of Columbia have agreed to the settlement, and therefore, all potential state Medicaid rebate liability claims have been resolved. In connection with the settlement, Mylan Inc. and Mylan Specialty L.P. entered into a Corporate Integrity Agreement (the “CIA”) with the Office of Inspector General of the Department of Health and Human Services (“OIG-HHS”). The CIA has a five-year term and requires, among other things, that an independent review organization annually review various matters relating to the Medicaid Drug Rebate Program. Neither the settlement agreement nor the CIA contains an admission or finding of wrongdoing. In connection with the settlement, Mylan Specialty L.P. has reclassified EpiPen® Auto-Injector as an innovator product for purposes of the Medicaid Drug Rebate Program effective April 1, 2017. The Company recorded an accrual of $465 million related to the settlement during the year ended December 31, 2016 and recorded an additional accrual for interest related to the settlement amount during the nine months ended September 30, 2017.Certain Congressional Matters
Department of Veterans Affairs Request for Information
On June 30, 2017, the Company responded to a request for information from the Department of Veterans Affairs (VA)(“VA”) (acting on behalf of itself and other government agencies) requesting certain historical pricing data related to the EpiPen® Auto-Injector. The Company and the VA are engaged in a continuing dialogue regarding the classification of the EpiPen® Auto-Injector as a covered drug under Section 603 of the Veterans Health Care Act of 1992, Public Law 102-585. The EpiPen® Auto-Injector has been classified as a non covered drug with the VA based upon long standing written guidance from the federal government. The Company is fully cooperating with the VA.
SEC Request for Information/SubpoenaSubpoenas
On October 7, 2016, Mylan received a document request from the SEC’s Division of Enforcement at the SEC seeking communications with CMSthe Centers for Medicare and Medicaid Services and documents concerning Mylan products sold and related to the Medicaid Drug Rebate Program (“MDRP”), and any related complaints. On November 15, 2016, Mylan received a follow-up letter, modifying the initial document request, seeking information on and public disclosures regarding the $465 million Medicaid Drug Rebate Program SettlementCompany’s previously disclosed settlement with the DOJ (“the MDRP Settlement”) and the classification of the EpiPen® Auto-Injector under the Medicaid Drug Rebate Program. On February 6, 2017,MDRP. Mylan has received a subpoena from the SECsubpoenas and additional requests for information in this matter seeking additional documents. Mylan isand will continue to fully cooperatingcooperate with the SEC.
On April 25, 2017, Mylan received a comment letter from the staff of the SEC’s Division of Corporation Finance (“Corporation Finance”) with respect to Mylan’s Annual Report on Form 10-K for the year ended December 31, 2016, requesting information regarding Mylan’s accounting treatment forof the Medicaid Drug Rebate ProgramMDRP Settlement, including with respect to the DOJ.determinations that the settlement amount should be recorded as a charge against earnings in the third quarter of 2016 rather than against any earlier periods, and that the settlement amount should be classified as an expense rather than a reduction of revenue. The Company responded to the comment letter in May 2017 and we will continue to cooperate fullyrespond to any additional correspondence from Corporation Finance. We believe that our accounting treatment for the aforementioned settlement is appropriate and consistent with the SEC.all applicable accounting standards.
FTC Request for Information
On November 18, 2016, Mylan received a request from the FTCU.S. Federal Trade Commission (“FTC”) Bureau of Competition seeking documents and information relating to its preliminary investigation into potential anticompetitive practices relating to epinephrine auto-injectors. Mylan is fully cooperating with the FTC.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


Federal Securities Litigation
Purported class action complaints were filed in October 2016 against Mylan N.V., Mylan Inc. and certain of their current and former directors and officers (collectively, for purposes of this paragraph, the “defendants”) in the United States District Court for the Southern District of New York (“SDNY”) on behalf of certain purchasers of securities of Mylan N.V. and/or Mylan Inc. on the NASDAQ. The complaints alleged that defendants made false or misleading statements and omissions of purportedly material fact, in violation of federal securities laws, in connection with disclosures relating to Mylan N.V. and Mylan Inc.’s classification of their EpiPen® Auto-Injector as a non-innovator drug for purposes of the Medicaid Drug Rebate Program.MDRP. The complaints sought damages, as well as the plaintiffs’ fees and costs. On March 20, 2017, after the actions were consolidated, a consolidated amended complaint was filed, alleging substantially similar claims and seeking substantially similar relief, but adding allegations that defendants made false or misleading statements and omissions of purportedly material fact in connection with allegedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs, and alleging violations of both federal securities laws (on behalf of a purported class of certain purchasers of securities of Mylan N.V. and/or Mylan Inc. on the NASDAQ) and Israeli securities laws (on behalf of a purported class of certain purchasers of securities of Mylan N.V. on the Tel Aviv Stock Exchange). Defendants’On March 28, 2018, defendants’ motion to dismiss the consolidated amended complaint was granted in part (including the dismissal of claims arising under Israeli securities laws) and denied in part. On July 6, 2018, the Plaintiffs filed a second amended complaint, including certain current and former directors and officers and additional allegations in connection with purportedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs. On August 6, 2018, defendants filed a motion to dismiss the second amended complaint, which was granted in part and denied in part on May 30, 2017March 29, 2019. On February 26, 2019, MYL Litigation Recovery I LLC (an assignee of entities that

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

purportedly purchased stock of Mylan N.V.) filed an additional complaint against Mylan N.V., Mylan Inc., and has been fully briefed.certain of their current and former directors and officers in the SDNY asserting allegations pertaining to EpiPen® Auto-Injector under the federal securities laws that overlap in part with those asserted in the second amended complaint identified above. The Complaint seeks damages as well as the plaintiff’s costs. We believe that the claims in the consolidated amended complaintthese lawsuits are without merit and intend to defend against them vigorously.
Israeli Securities Litigation
On October 13, 2016, a purported shareholder of Mylan N.V. filed a lawsuit, together with a motion to certify the lawsuit as a class action on behalf of certain Mylan N.V. shareholders on the Tel Aviv Stock Exchange, against Mylan N.V. and four of its directors and officers (collectively, for purposes of this paragraph, the “defendants”) in the Tel Aviv District Court (Economic Division) (the “Friedman Action”). The plaintiff alleges that the defendants made false or misleading statements and omissions of purportedly material fact in Mylan N.V.’s reports to the Tel Aviv Stock Exchange regarding Mylan N.V.’s classification of its EpiPen® Auto-Injector for purposes of the Medicaid Drug Rebate Program,MDRP, in violation of both U.S. and Israeli securities laws, the Israeli Companies Law and the Israeli Torts Ordinance. The plaintiff seeks damages, among other remedies. On January 19, 2017, the Court stayed this case until a final judgment is issued in the securities litigation currently pending in the United States District Court for the Southern District of New York. On April 30, 2017, another purported shareholder of Mylan N.V. filed a separate lawsuit, together with a motion to certify the lawsuit as a class action on behalf of certain Mylan N.V. shareholders on the Tel Aviv Stock Exchange, in the Tel Aviv District Court (Economic Division), alleging substantially similar claims and seeking substantially similar relief against the defendants and other directors and officers of Mylan N.V., but alleging also that this group of defendants made false or misleading statements and omissions of purportedly material fact in connection with allegedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs, and alleging violations of both U.S. federal securities laws and Israeli law.law (the “IEC Fund Action”). On April 10, 2018, the Tel Aviv District Court granted the motion filed by plaintiffs in both the Friedman Action and the IEC Fund Action, voluntarily dismissing the Friedman Action and staying the IEC Fund Action until a judgment is issued in the purported class action securities litigation pending in the U.S. We believe that the claims in these lawsuits are without merit and intend to defend against them vigorously.
EpiPen® Auto-Injector Civil Litigation
Beginning in August 2016, Mylan Specialty L.P. and other Mylan-affiliated entities have been named as defendants in fifteen putative class actions relating to the pricing and/or marketing of the EpiPen® Auto-Injector. The plaintiffs in these cases assert violations of various federal and state antitrust and consumer protection laws, the Racketeer Influenced and Corrupt Organizations Act, (“RICO”), as well as common law claims. Plaintiffs’ claims include purported challenges to the prices charged for the EpiPen® Auto-Injector and/or the marketing of the product in packages containing two auto-injectors, as well as allegedly anti-competitive conduct. A Mylan officer and other non-Mylan affiliated companies were also have been named as defendants in some of the class actions. These lawsuits were filed in the U.S. District Courts for the Northern District of California, Northern District of Illinois, District of Kansas, Eastern District of Michigan, Western District of Washington, District of New Jersey, the Southern District of Alabama,various federal and the Western District of Pennsylvania, as well as the Hamilton County, Ohio Court of Common Pleas (later removed to the Southern District of Ohio). All of these lawsuitsstate courts and have either been dismissed or transferred into a multidistrict litigation (“MDL”) in the U.S. District Court for the District of Kansas and have been consolidated throughconsolidated. Mylan filed a motion to dismiss the filing of anconsolidated amended complaint, on October 17, 2017.which was granted in part and denied in part. On December 7, 2018, the Plaintiffs filed a motion for class certification. This motion remains pending. A trial date has been scheduled for JulyNovember 2020. We believe that the remaining claims in these lawsuits are without merit and intend to defend against them vigorously.
On April 24, 2017, Sanofi-Aventis U.S., LLC (“Sanofi”) filed a lawsuit against Mylan Inc. and Mylan Specialty L.P. in the U.S. District Court for the District of New Jersey. This lawsuit has been transferred into the aforementioned MDL in the U.S. District Court for the District of Kansas.MDL. In this lawsuit, Sanofi alleges exclusive dealings and anti-competitive marketing

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


practices in violation of the antitrust laws in connection with the sale and marketing of the EpiPen® Auto-Injector. Mylan’sOn November 1, 2018, Sanofi filed a Motion to Dismiss is pending. We believe thatfor a Suggestion of Remand of the claims in this lawsuit are without merit and intendcase to defend against them vigorously.
On September 29, 2017, plaintiffs in a pending putative class action brought against certain pharmacy benefit managers (“PBMs”) defendants in the U.S. District Court for the District of Kansas filed aNew Jersey. On January 23, 2019, the Court denied Sanofi’s motion for leave to file an amended complaint that would add Mylan N.V., Mylan Specialty, and Mylan Pharmaceuticals Inc. as additional defendants to this case. In the proposed amended complaint, plaintiffs bring claims under the Employee Retirement Income Security Act of 1974 for allegedly knowingly participating in conduct related to the pricing of EpiPen products that plaintiffs assert was a breach of fiduciary duties by the PBMs. The motion remains pending.without prejudice. We believe that theSanofi’s claims in this lawsuit are without merit and intend to defend against them vigorously.
EpiPen® Auto-Injector State AG Investigations
Beginning in August 2016, theThe Company and certain of its affiliated entities have received subpoenas and informal requests from various state attorneys general seeking information and documents relating to the pricing and/or marketing of the EpiPen® Auto-Injector. The Company has cooperated and is fully cooperating with the various state attorneys general.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

U.S. Congress/State Requests for Information and Documents
Beginning in August 2016, Mylan has received several requests for information and documents from various Committees of the U.S. Congress and federal and state lawmakers concerning the marketing, distribution and sales of Mylan products. Mylan has cooperated and intends to continue cooperating with federal and state lawmakers as appropriate in response to their requests.
The Company has a total accrual of approximately $228.4$10.0 million related to this matter at September 30, 2017,March 31, 2019, which is included in other current liabilities in the Condensed Consolidated Balance Sheets.condensed consolidated balance sheets. During the three monthsyear ended September 30,December 31, 2017, the Company made payments of approximately $255.2$472.7 million related to this matter. Subsequent to September 30, 2017, the Company made additional payments of approximately $217.5 million, which was accrued for at September 30, 2017. The Company believes that it has strong defenses to current and future potential civil litigation, as well as governmental investigations and enforcement proceedings, discussed in this “EpiPen® Auto-Injector and Certain Congressional Matters” section of this Note 1920 Litigation. Although it is reasonably possible that the Company may incur additional losses from these matters, any amount cannot be reasonably estimated at this time. In addition, the Company expects to incur additional legal and other professional service expenses associated with such matters in future periods and will recognize these expenses as services are received. The Company believes that the ultimate amount paid for these services and claims could have a material effect on the Company's business, consolidated financial condition, results of operations, cash flows and/or ordinary share price in future periods.
Opioid Subpoena, Missouri State AG Civil Investigative Demand and Congressional RequestOpioids
On July 27, 2017, Mylan N.V. received a subpoena from the DOJ seeking information relating to opioids manufactured, marketed or sold by Mylan during the period from January 1, 2013 to December 31, 2016. On August 29, 2017, Mylan N.V. received a civil investigative demand from the Attorney General of the State of Missouri seeking information relating to opioids manufactured, marketed or sold by Mylan during the period from January 1, 2010 to the present and related subject matter. Mylan is fully cooperating with these subpoena requests.
Mylan also has responded to a letterbeen named in the U.S. and Canada, along with numerous other manufacturers, distributors, pharmacies, pharmacy benefit managers, and/or individual healthcare professionals, in civil lawsuits, including numerous cases in the MDL pending in the United States District Court for the Northern District of Ohio, brought by plaintiffs, including local governmental entities, generally asserting statutory and/or common law claims arising from the ranking membermanufacture, distribution, marketing, promotion, and sale of purported prescription opioids. The lawsuits seek damages, including punitive and/or exemplary damages, injunctive relief, attorneys’ fees and costs, and other relief. Mylan believes that the U.S. Senate Committee on Homeland Securityclaims in these lawsuits are without merit and Governmental Affairs seeking information relatingintends to sales, marketing and educational strategies for opioid products manufactured by Mylan.defend against them vigorously.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


Drug Pricing Matters
Department of JusticeSubpoena
On December 3, 2015, a subsidiary of Mylan N.V. received a subpoena from the Antitrust Division of the DOJ seeking information relating to the marketing, pricing, and sale of our generic Doxycycline products and any communications with competitors about such products.
On September 8, 2016, a subsidiary of Mylan N.V., as well as certain employees and a member of senior management, received subpoenas from the DOJ seeking additional information relating to the marketing, pricing and sale of our generic Cidofovir, Glipizide-metformin, Propranolol and Verapamil products and any communications with competitors about such products. Related search warrants also were executed.
On May 10, 2018, a subsidiary of Mylan N.V. received a civil investigative demand from the Civil Division of the DOJ seeking information relating to the pricing and sale of its generic drug products.
The Company is fully cooperating with the DOJ.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Civil Litigation
On March 2,Beginning in 2016, a putative class action was filed in the United States District Court for the Eastern District of Pennsylvania (“EDPA”) by indirect purchasers against Mylan and severalCompany, along with other manufacturers, has been named as a defendant in lawsuits generally alleging anticompetitive conduct with respect to certain generic doxycycline and digoxin products.drugs. The complaint alleges harm under federal antitrust laws, state antitrust laws, state consumer protection laws and theories of unjust enrichment. Subsequently, additional cases werelawsuits have been filed by putative classes of indirect purchasers, direct purchasers and an indirect reseller. These cases were consolidated in an MDL proceeding in the EDPA. Similar lawsuits were filed by direct and indirect purchasers in the EDPA, the Southern District of New York, the District of Puerto Rico and the District of New Jersey involving Mylan’s and other manufacturer’s pravastatin, divalproex, levothyroxine, propranolol, clomipramine, albuterol, benazepril and amitriptyline products (as well as non-Mylan products clobatesol, desonide, fluocinonide, econazole, lidocaine/prilocaine, glyburide, ursodiol and baclofen). All of the above-referenced lawsuits have also been consolidated in the MDL proceeding in the EDPA. Putative classes of direct purchasers, indirect purchasers, and indirect resellers, as well as individual direct and indirect purchasers. They allege harm under federal and state antitrust laws, state consumer protection laws and unjust enrichment claims.  Some of the lawsuits also name Mylan’s President as a defendant and include allegations against him with respect to doxycycline hyclate delayed release.  The lawsuits have been consolidated in an MDL proceeding in the EDPA. Defendants filed consolidatedmotions to dismiss certain complaints that each allege anticompetitive conduct with respect to single drug products. On October 16, 2018, the Court denied the motions with respect to the federal law claims. On February 15, 2019, the Court granted in part and denied in part the motions with respect to the state law claims. On February 21, 2019, Defendants filed a motion to dismiss certain complaints that allege anticompetitive conduct with respect to multiple drug products, referenced above on August 15, 2017. Mylan is no longer a named defendant in the pravastatin lawsuits. Defendants’ Motions to Dismiss briefing is ongoing.which remains pending. The Company believes that the claims in these lawsuits are without merit and intends to defend against them vigorously.
A complaint was filed on January 31, 2017 by putative classes of direct and indirect purchasers against Mylan Pharmaceuticals Inc. and other pharmaceutical manufacturers in the United States District Court for the District of Connecticut. Plaintiffs generally allege anticompetitive conduct and RICO violations with respect to, among other things, certain Doxycycline products. This case has been transferred to the above-mentioned MDL. Mylan Pharmaceuticals Inc. believes that the claims in this lawsuit are without merit and intends to defend against them vigorously.
Attorneys General Litigation
On December 21, 2015, the Company received a subpoena and interrogatories from the Connecticut Office of the Attorney General seeking information relating to the marketing, pricing and sale of certain of the Company’s generic products (including Doxycycline)generic doxycycline) and communications with competitors about such products. On December 14, 2016, attorneys general of twenty states filed a complaint in the United States District Court for the District of Connecticut against several generic pharmaceutical drug manufacturers, including Mylan, alleging anticompetitive conduct with respect to, among other things, Doxycycline Hyclate Delayed Release. On March 1, 2017, thedoxycycline hyclate delayed release. The complaint was subsequently amended to add thecertain attorneys general of twenty additional states; the complaint alleges violationalleging violations of federal and state antitrust laws, as well as violationviolations of various states’ consumer protection laws. On July 17, 2017, another complaint containing similar allegations as those contained in the complaints referenced above was filed by four additional states and the District of Columbia. This lawsuit has been transferred to the aforementioned MDL proceeding in the EDPA. On October 31, 2017, attorneys general of forty-five states, the District of Columbia and the Commonwealth of Puerto Rico filed a motion for leave to file a consolidated amended complaint (“proposed amended complaint”) against various drug manufacturers, including Mylan. The proposed amended complaint was permitted and was filed on June 18, 2018 and included two additional states. Mylan is alleged to have engaged in anticompetitive conduct with respect to Doxycycline Hyclate Delayed Release, Doxycycline Monohydrate, Glipizide-Metformin,doxycycline hyclate delayed release, doxycycline monohydrate, glipizide-metformin, and Verapamil.verapamil. The proposed amended complaint also includes claims asserted by attorneys general of thirty-fourthirty-seven states and the Commonwealth of Puerto Rico against certain individuals, including Rajiv Malik,Mylan’s President, of Mylan, with respect to Doxycycline Hyclate Delayed Release.doxycycline hyclate delayed release. The allegations in the proposed amended complaint are similar to those in the previously filed complaints. On February 21, 2019, Defendants filed motions to dismiss the amended complaint’s allegations of anticompetitive conduct with respect to multiple drug products and the ability of the state attorneys general to seek certain forms of relief under federal antitrust law, which remains pending. We believe that the claims in this lawsuit are without merit and intend to defend against them vigorously.
In May 2019, attorneys general from certain states notified Mylan that the states intend to file a new complaint alleging anticompetitive conduct with respect to additional generic drugs.
Valsartan
Mylan N.V., and Rajiv Malikthree of its subsidiaries (Mylan Inc., Mylan Laboratories Ltd. and Mylan Pharmaceuticals Inc.), along with numerous other manufacturers, retailers and others, have been named as defendants in lawsuits in the United States and other countries stemming from recalls of valsartan-containing medications. The United States litigation, which will take place in an MDL in the District of New Jersey, includes class action allegations seeking the refund of the purchase price and other economic damages allegedly sustained by consumers who purchased valsartan-containing products as well as claims for personal injuries allegedly caused by ingestion of the medication. Moreover, Mylan has received requests to indemnify purchasers of Mylan’s active pharmaceutical ingredient and/or finished dose forms of the product. We believe that the claims in these lawsuits are without merit and intend to defend against them vigorously.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


Tax Court Proceeding
The Company's U.S. federal income tax returns for 2007 through 2011 have been subject to proceedings in U.S. Tax Court involving a dispute with the IRS regarding whether the proceeds received by the Company in connection with the 2008 sale of its rights in nebivolol constituted a capital gain or ordinary income. On May 16, 2017, the Company and the IRS filed a joint stipulation of settled issues with the Tax Court that resolved all issues in this dispute. The final computations resulting from the stipulation are being prepared by the Company and the IRS, and will be filed with the Tax Court. The Company expects that a portion of its unrecognized tax benefits will be reduced as a result of the resolution of this dispute.
European Commission Proceedings
Perindopril
On or around July 8, 2009,9, 2014, the European Commission (the “Commission”) stated that it had initiated antitrust proceedings pursuant to Article 11(6) of Regulation No. 1/2003 and Article 2(1) of Regulation No. 773/2004 to explore possible infringement of Articles 81 and 82 EC and Articles 53 and 54 of the European Economic Area Agreement by Les Laboratoires Servier (“Servier”) as well as possible infringement of Article 81 EC by the Company’s Indian subsidiary, Mylan Laboratories Limited, and four other companies, each of which entered into agreements with Servier relating to the product Perindopril. On July 30, 2012, the Commission issued a Statement of Objections to Servier SAS, Servier Laboratories Limited, Les Laboratories Servier, Adir, Biogaran, Krka, d.d. Novo mesto, Lupin Limited, Mylan Laboratories Limited, Mylan, Niche Generics Limited, Teva UK Limited, Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals Europe B.V. and Unichem Laboratories Limited. Mylan Inc. and Mylan Laboratories Limited filed responses to the Statement of Objections. On July 9, 2014, the Commission issued a decision finding that Mylan Laboratories Limited and Mylan, as well as theseveral other companies, noted above (with the exception of Adir, a subsidiary of Servier), had violated European Union (“EU”) competition rules relating to the product Perindopril and fined Mylan Laboratories Limited approximately €17.2 million, including approximately €8.0 million jointly and severally with Mylan Inc. The Company paid approximately $21.7 million related to this matter during the fourth quarter of 2014. In September 2014, the Company filed an appeal of the Commission’s decision to the General Court of the European Union.EU. A hearing on the appeal before the General Court of the European UnionEU was held in June 2017 and athe Commission’s decision is pending.was affirmed. Mylan has appealed the decision to the European Court of Justice (“CJEU”).
Citalopram
On March 19, 2010, Mylan and Generics [U.K.] Limited, a wholly owned subsidiary of the Company, received notice that the Commission had opened proceedings against Lundbeck with respect to alleged unilateral practices and/or agreements related to Citalopram in the European Economic Area. On July 25, 2012 a Statement of Objections was issued to Lundbeck, Merck KGaA, Generics [U.K.] Limited, Arrow, Resolution Chemicals, Xelia Pharmaceuticals, Alpharma, A.L. Industrier and Ranbaxy. Generics [U.K.] Limited filed a response to the Statement of Objections and vigorously defended itself against allegations contained therein. On June 19, 2013, the Commission issued a decision finding that Generics [U.K.] Limited,, (“GUK”) as well as theseveral other companies, noted above, had violated European UnionEU competition rules relating to the product Citalopram and fined Generics [U.K.] LimitedGUK approximately €7.8€7.8 million,, jointly and severally with Merck KGaA. Generics [U.K.] LimitedGUK appealed the Commission’s decision to the General Court of the EU and a hearing took placeEU. The case is currently on October 8, 2015. On September 8, 2016, the General Court dismissed all appeals against the European Commission’s decision. Mylan filed an appeal of the decision on November 18, 2016 to the European Court of Justice.CJEU. The United Kingdom hasU.K. applied and was granted permission to intervene in this proceeding. The Company has accrued approximately $8.8 million and $8.2€7.4 million as of September 30, 2017each of March 31, 2019 and December 31, 2016, respectively,2018 related to this matter. Generics [U.K.] LimitedGUK has received notices from NHS Departments across the United KingdomEuropean national health services and health insurers stating an intention to commence follow-on litigation and asserting damages. Generics [U.K.] LimitedGUK has also sought indemnification from Merck KGaA with respect to the €7.8 million portion of the fine for which Merck KGaA and Generics [U.K.] LimitedGUK were held jointly and severally liable. Merck KGaA has counterclaimed against Generics [U.K.] LimitedGUK seeking the same indemnification. In June 2018, the Frankfurt Regional Court issued a judgment dismissing GUK claims against Merck KGaA and ordered GUK to indemnify Merck KGaA with respect to the amount for which the parties were held jointly and severally liable. GUK has appealed this decision. A hearing took place on January 24, 2019. It is reasonably possible that we will incur additional losses above the amount accrued but we cannot estimate a range of such reasonably possible losses at this time. There are no assurances, however, that settlements reached and/or adverse judgments received, if any, will not exceed amounts accrued.

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


U.K. Competition and Markets Authority
Paroxetine
On August 12, 2011, Generics [U.K.] LimitedGUK received notice that the Office of Fair Trading (subsequently changed to the Competition and Markets Authority (the “CMA”)) was openingopened an investigation to explore the possible infringement of the Competition Act 1998 and Articles 101 and 102 of the Treaty on the Functioning of the European Union,EU, with respect to alleged agreements related to Paroxetine. On April 19, 2013, a Statement of Objections was issued to Beecham Group plc, GlaxoSmithKline UK Limited, GlaxoSmithKline plc and SmithKline Beecham Limited (formerly, SmithKline Beecham plc) (together, “GlaxoSmithKline”), Generics [U.K.] Limited, Merck KGaA, Actavis UK Limited (formerly, Alpharma Limited), Xellia Pharmaceuticals ApS (formerly, Alpharma ApS) and Alpharma LLC (formerly, Zoetis Products LLC, Alpharma LLC, and Alpharma Inc.) (together, “Alpharma”), and Ivax LLC (formerly, Ivax Corporation) and Norton Healthcare Limited (which previously traded as Ivax Pharmaceuticals UK) (together, “Ivax”). Generics [U.K.] Limited filed a response to the Statement of Objections, defending itself against the allegations contained therein. The CMA issued a Supplementary Statement of Objections (“SSO”) to the above-referenced parties on October 21, 2014 and a hearing with regard to the SSO took place on December 19, 2014. The CMA issued a decision on February 12, 2016, finding that, GlaxoSmithKline, Generics [U.K.] Limited,GUK, Merck KGaA and Alpharma,other companies were liable for infringing EU and U.K. competition rules. With respect to Merck KGaA and Generics [U.K.] Limited,GUK, the CMA issued a penalty of approximately £5.8 million, for which Merck KGaA is liable for the entire amount; and of that amount Generics [U.K.] LimitedGUK is jointly and severally liable for approximately £2.7 million, which washas been accrued for at September 30, 2017. Generics [U.K.] Limited has appealed the decision.as of March 31, 2019. The hearing beforematter is currently on appeal to the Competition Appeals Tribunal, concludedwhich on March 30, 2017 and8, 2018, referred certain questions of law to the parties are presently awaiting a decision.CJEU. The CJEU sought written observations from GUK, which were filed in September 2018.
NefopamItaly Investigation
On October 10, 2017,April 18, 2018, certain employees of Mylan N.V.S.p.A. were served with search warrants issued by the Public Prosecutor’s Office in Milan, Italy seeking information concerning interactions with an Italian hospital and Meda Pharmaceuticals Limited received notice that the CMA was opening an investigation to explore the possible infringementsales of the Competition Act 1998 and Article 101 of the Treaty on the Functioning of the European Union, with respect to alleged agreements related to Nefopam, a product from Meda’s portfolio. On October 16, 2017, the CMA issued a notice under Section 26 of the Competition Act 1998 tocertain reimbursable Mylan N.V. and Meda Pharmaceuticals Limited to provide specified information and produce specified documents.S.p.A. drugs. The Company is fully cooperatingassisting its employees in their cooperation with the CMA.investigation.   
Product Liability
The Company is involved in a number of product liability lawsuits and claims related to alleged personal injuries arising out of certain products manufactured and/or distributed by the Company, including but not limited to Phenytoin, Alendronate Sodium and Reglan.Company. The Company believes that it has meritorious defenses to these lawsuits and claims and is vigorously defending itself with respectintends to those matters.defend against them vigorously. From time to time, the Company has agreed to settle or otherwise resolve certain lawsuits and claims on terms and conditions that are in the best interests of the Company. The Company has accrued approximately $10.2 million and $10.9 million and $31.5 million at September 30, 2017March 31, 2019 and December 31, 2016,

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

2018, respectively. It is reasonably possible that we will incur additional losses and fees above the amount accrued but we cannot estimate a range of such reasonably possible losses or legal fees related to these claims at this time. There are no assurances, however, that settlements reached and/or adverse judgments received, if any, will not exceed amounts accrued.
Intellectual Property
MPI filed with the FDA a Paragraph IV certification stating that approval of MPI’s ANDA for glatiramer acetate injection, 20 mg/mL will not infringe any valid claim of patents owned or controlled by Teva Pharmaceuticals USA, Inc., Yeda Research and Development Co., or their affiliates (“Plaintiffs”), listed in the FDA’s Orange Book. There are currently no unexpired patents for the product listed in the FDA’s Orange Book. On October 3, 2017, Mylan received final FDA approval and launched its 20 mg/mL glatiramer acetate product in the United States.
MPI filed with the FDA a Paragraph IV certification stating that approval of MPI’s ANDA for glatiramer acetate injection, 40 mg/mL will not infringe any valid claim of patents owned or controlled by the Plaintiffs listed in the FDA’s Orange Book. On October 6, 2014, Plaintiffs filed suit against MPI and Mylan Inc. in the District Court for the District of Delaware seeking monetary damages, injunctive relief, attorneys’ fees, costs and other relief. In February and March 2015, Mylan filed petitions with the Patent Trial and Appeal Board requesting inter partes review of the claims of three asserted patents. On August 24, 2016 and September 1, 2016, respectively, the Patent Trial and Appeal Board issued final written

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decisions finding all claims of three asserted patents unpatentable as obvious. After Plaintiffs’ requests for reconsideration of those decisions, the Patent Trial and Appeal Board issued revised final written decisions addressing issues raised in the requests for reconsideration and again finding all claims of three asserted patents unpatentable as obvious. On January 30, 2017, the Delaware District Court found, after trial, the asserted claims of the four patents-in-suit invalid as obvious. Plaintiffs have appealed both decisions, and those appeals are pending. On January 17, 2017, Plaintiffs filed suit against Mylan in the District Court for the Northern District of West Virginia asserting claims related to a process patent not listed in the FDA’s Orange Book seeking monetary damages, injunctive relief, attorneys’ fees, costs and other relief. The West Virginia District Court granted Mylan’s request to transfer the case to the Delaware District Court, and the case remains pending. A trial date has been scheduled for October 9, 2018. On October 3, 2017, Mylan received final FDA approval and launched its 40 mg/mL glatiramer acetate product in the United States.
On October 19, 2017, Teva Pharmaceutical Industries Ltd. (“Teva”) commenced an action with the Irish High Court against Mylan Teoranta alleging that Mylan’s glatiramer acetate 40mg/mL product, which is manufactured in Ireland, approved by the FDA and is currently being sold in the U.S., infringes two European patents, EP (IE) 2 949 335 and EP (IE) 3 050 556. Teva is seeking damages and/or an account of profits fromsubsequently dropped its infringement allegation related to the EP (IE) 3 050 556 patent.  The matter has now been resolved and Mylan forwill continue its production activities with respect to the alleged infringement. Teva has also requested the Irish High Court to enjoin Mylan Teoranta from making, offering, putting on the market and/or using its glatiramer acetateU.S. 40mg/mL product in Ireland pending final determinationIreland.
On September 22, 2017, Amgen Inc. and Amgen Manufacturing Limited (“Amgen”) sued Mylan Inc., Mylan N.V., Mylan GMBH, and MPI in the Western District of Pennsylvania asserting that Mylan’s Fulphila® infringes U.S. patent numbers 8,273,707 and 9,643,997. On June 4, 2018, the FDA approved Mylan’s Fulphila® (pegfilgrastim-jmdb), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon. In July 2018, Mylan began selling Fulphila®. Amgen is seeking monetary damages, injunctive relief, attorneys’ fees, costs and other relief.
On July 31, 2015, BTG International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc., and Janssen Research & Development, LLC (“Janssen”) sued Mylan Inc. and Mylan Pharmaceuticals, Inc., along with numerous other ANDA applicants, in the District of New Jersey asserting that Mylan’s and the other ANDA applicants’ abiraterone acetate ANDA products infringe U.S. Patent number 8,822,438 (“’438”).  On June 30, 2016, Mylan filed an Inter Partes Review (“IPR”) petition challenging the validity of the action. A’438 patents’ claims.  On January 17, 2018, the U.S. Patent and Trademark Appeal Board issued Final Written Decisions in the IPR finding all claims of the ’438 patent unpatentable as obvious.  On October 26, 2018, the district court issued an opinion similarly finding the ’438 patents’ claims invalid as obvious.  On October 31, 2018, the FDA approved Mylan’s abiraterone acetate ANDA.  Mylan, along with certain other ANDA applicants, began selling their abiraterone acetate ANDA products in November.
Janssen has appealed both the district court and IPR decisions to the Federal Circuit.  Both matters have been consolidated and a hearing was held on Teva’s Ireland injunction requestMarch 14, 2019.  Janssen is set for January 2018.seeking monetary damages, injunctive relief, attorneys’ fees, costs and other relief, including pre- and post-judgment interest.  Janssen is further asserting that the district court erred in not enforcing estoppel provisions against the prevailing ANDA filers in the IPR proceedings.
The Company has used its business judgment in connection with the decision to launch the 40mg/mL glatiramer acetate, productFulphila® and abiraterone acetate products and has also used its business judgment in certain other situations to decide to market and sell products, in each case based on its belief that the applicable patents are invalid and/or that its products do not infringe, notwithstanding the fact that allegations of patent infringement(s) or other potential third party rights have not been finally resolved by the courts. The risk involved in doing so can be substantial because the remedies available to the owner of a patent for infringement may include, a reasonable royalty on sales or damages measured by the profits lost by the patent owner. If there is a finding of willful infringement, damages may be increased up to three times. Moreover, because of the discount pricing typically involved with bioequivalent products, patented branded products generally realize a substantially higher profit margin than bioequivalentgeneric and biosimilar products. AnMylan intends to defend against any such patent infringement claims vigorously. However, an adverse decision could have an adverse effect that is material to our business, financial condition, results of operations, cash flows and/or ordinary share price.
Other Litigation
The Company is involved in various other legal proceedings that are considered normal to its business. The Company has approximately $8.8$6.3 million accrued related to these various other legal proceedings at September 30, 2017.March 31, 2019.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis addresses material changes in the financial condition and results of operations of Mylan N.V. and subsidiaries for the periods presented. Unless context requires otherwise, the “Company”, “Mylan”, “our”, or “we” refer to Mylan N.V. and its subsidiaries. This discussion and analysis should be read in conjunction with the Consolidated Financial Statements, the related Notes to Consolidated Financial Statements and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Mylan N.V.’s Annual Report on Form 10-K for the year ended December 31, 2016,2018, as amended (the “2018 Form 10-K”), the unaudited interim financial statements and related Notes included in Part I — ITEM 1 of this Quarterly Report on Form 10-Q (“Form 10-Q”) and our other Securities and Exchange Commission (the “SEC”) filings and public disclosures. The interim results of operations and comprehensive earnings for the three and nine months ended September 30, 2017March 31, 2019, and cash flows for the ninethree months ended September 30, 2017March 31, 2019 are not necessarily indicative of the results to be expected for the full fiscal year or any other future period.
This Form 10-Q contains “forward-looking statements.” These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about the acquisition of Meda AB (publ.) (“Meda”) by Mylan (the “Meda Transaction”), Mylan’s acquisition (the “EPD Transaction”) of Mylan Inc. and Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business (the “EPD Business”), the potential benefits and synergies of the EPD Transaction and the Meda Transaction, future opportunities for Mylan and products, and any other statements regarding Mylan’s future operations, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competition, and other expectations and targets for future periods. These may often be identified by the use of words such as “will,” “may,” “could,” “should,” “would,” “project,” “believe,” “anticipate,” “expect,” “plan,” “estimate,” “forecast,” “potential,” “pipeline,” “intend,” “continue,” “target,” “seek” and variations of these words or comparable words. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the ability to meet expectations regarding the accounting and tax treatments of the EPD Transaction and the Meda Transaction; changes in relevant tax and other laws, including but not limited to changes in the U.S. tax code and healthcare and pharmaceutical laws and regulations in the U.S. and abroad; actions and decisions of healthcare and pharmaceutical regulators; the integration of the EPD Business and Meda being more difficult, time-consuming, or costly than expected; operating costs, customer loss, and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients, or suppliers) being greater than expected following the EPD Transaction and the Meda Transaction; the retention of certain key employees of the EPD Business and Meda being difficult; the possibility that Mylan may be unablefailure to achieve expected synergies and operating efficiencies in connection with the EPD Transaction, the Meda Transaction, and the December 2016 announced restructuring program in certain locations, within the expected time-frames or at all and to successfully integrate the EPD Business and Meda; expected or targeted future financial and operating performance and results; the capacityuncertainties regarding future demand, pricing and reimbursement for our products; any regulatory, legal, or other impediments to Mylan’s ability to bring new products to market, including, but not limited to, where Mylan uses its business judgment and decides to manufacture, market, and/or sell products, directly or through third parties, notwithstanding the fact that allegations of patent infringement(s) have not been finally resolved by the courts (i.e., an “at-risk launch”); any regulatory, legal, or other impediments to Mylan’s ability to bring new products, including but not limited to generic Advair and Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL, to market, including ongoing and unresolved allegations of patent infringement around our launch of Glatiramer Acetate Injection 40 mg/mL;success of clinical trials and Mylan’s ability to execute on new product opportunities, including but not limited to generic Advair and Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL;opportunities; any changes in or difficulties with our manufacturing facilities, including with respect to our remediation and restructuring activities, supply chain or inventory of, andor our ability to manufacture and distribute, the EpiPen® Auto-Injector and EpiPen Jr® Auto-Injector (collectively, “EpiPen® Auto-Injector”) to meet anticipated demand; the potential impact of any change in patient access to the EpiPen® Auto-Injector and the introduction of a generic version of the EpiPen® Auto-Injector; the scope, timing, and outcome of any ongoing legal proceedings, including government investigations, and the impact of any such proceedings on our financial condition, results of operations, and/or cash flows; the ability to meet expectations regarding the accounting and tax treatments of acquisitions, including Mylan’s acquisition of Mylan Inc. and Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business (the “EPD Business”); changes in relevant tax and other laws, including but not limited to changes in the U.S. tax code and healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any significant breach of data security or data privacy or disruptions to our information technology systems; the ability to protect intellectual property and preserve intellectual property rights; the effect of any changes in customer and supplier relationships and customer purchasing patterns; the ability to attract and retain key personnel; changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan; the inherent challenges, risks, and costs in identifying, acquiring, and integrating complementary or strategic acquisitions of other companies, products, or assets being more difficult, time-consuming or costly than anticipated; the possibility that Mylan may be unable to achieve expected synergies and operating efficiencies in achieving anticipated synergies;connection with strategic acquisitions, strategic initiatives or restructuring programs within the expected time-frames or at all; uncertainties and matters beyond the control of management;management, including but not limited to general political and economic conditions and global exchange rates; and inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and related standards or on an adjusted basis. For more detailed information on the risks and uncertainties associated with Mylan’s business activities, see the risks described in Mylan’s Annual Report onthe 2018 Form 10-K, for the year ended December 31, 2016, as amended and our other

filings with the SEC. You can access Mylan’s filings with the SEC through the SEC website at www.sec.gov or through our website, and Mylan strongly encourages you to do so. Mylan routinely posts information that may be important to investors on our website at investor.mylan.com, and we may use this website address as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC'sSEC’s Regulation Fair Disclosure (Reg FD). The contents of our website are not incorporated by reference in this Report on Form 10-Q and shall not be deemed “filed” under the Securities Exchange Act.Act of 1934, as amended. Mylan undertakes no obligation to update any statements herein for revisions or changes after the filing date of this Form 10-Q.10-Q other than as required by law.

ExecutiveCompany Overview
Mylan is a leading global pharmaceutical company which develops, licenses, manufactures, markets and distributes generic, brand name and over-the-counter (“OTC”) products in a variety of dosage forms and therapeutic categories. Mylan is committed to setting new standards in healthcare by creating better health for a better world, and our mission is to provide the world’s providing 7 billion people access to high quality medicine. To do so, we innovate to satisfy unmet needs; make reliability and service excellenceWe offer a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership.
Mylan offers onegrowing portfolio of the industry’s broadest product portfolios, including generic, brand name and OTC products in a variety of dosage forms and therapeutic categories. The Company’s product portfolio includes more than 7,500 marketed products, globally,including prescription generic, branded generic, brand-name drugs and reaches customersover-the-counter (“OTC”) remedies. We market our products in more than 165 countries and territories. We operateEvery member of our approximately 35,000-strong global workforce is dedicated to delivering better health for a better world.
Over the last several years, Mylan has transformed itself through a clear, consistent and differentiated strategy into a company that is built to last. Fueling that durability is a business model anchored in providing access, Mylan’s core purpose.
Providing access requires that we satisfy the needs of an incredibly diverse global high quality vertically-integrated manufacturing platform around the worldmarketplace whose economic and onepolitical systems, approaches to delivering and paying for healthcare, languages and traditions, and customer and patient requirements vary by location and over time.
With these considerations in mind, we built and scaled our commercial, operational and scientific platforms to meet customers’ evolving needs in ways that are globally consistent and locally sensitive. As a result, not only are we succeeding in expanding people’s access to medicine, we are continually diversifying our business.
This diversification is what drives our durability. Durability allows us to withstand and overcome competitive pressures while continuing to innovate. It also allows us to generate consistent financial results, including reliable cash flows capable of supporting ongoing investments in long-term growth.
Financial Summary
The tables below are a summary of the world’s largest activeCompany’s financial results for the three months ended March 31, 2019 compared to the prior year periods:
 Three Months Ended
 March 31,
(In millions, except per share amounts)2019 2018 Change % Change
Total revenues$2,495.5
 $2,684.5
 $(189.0) (7)%
Gross profit805.2
 984.3
 (179.1) (18)%
Earnings from operations24.0
 155.7
 (131.7) (85)%
Net (loss) earnings(25.0) 87.1
 (112.1) (129)%
Net (loss) earnings per diluted ordinary share$(0.05) $0.17
 $(0.22) (129)%
Certain Market and Industry Factors
As more fully explained in the 2018 Form 10-K, the global pharmaceutical ingredient (“API”) operations. We also operateindustry is a stronghighly competitive and innovative researchhighly regulated industry. As a result, we face a number of industry-specific factors and development (“R&D”) network that has consistently delivered a robust product pipeline, including complex products such as injectables.challenges, which can significantly impact our results. The following discussion highlights some of these key factors and market conditions.
Generic products, particularly in the U.S., generally contribute most significantly to revenues and gross margins at the time of their launch, and even more so in periods of market exclusivity, or in periods of limited generic competition. As such, the timing of new product introductions can have a significant impact on the Company’s financial results. The entrance into the market of additional competition generally has a negative impact on the volume and pricing of the affected products. Additionally, pricing is often affected by factors outside of the Company’s control.
For branded products, the majority of the product’s commercial value is usually realized during the period in which the product has market exclusivity. In the U.S. and some other countries, when market exclusivity expires and generic versions of a product are approved and marketed, there can often be very substantial and rapid declines in the branded product’s sales. OTC products also participate in a competitive environment that includes both branded and private label products. In the OTC space, value is realized through innovation, access and consumer activation.

Certain markets within Europe in which we do business outside of the U.S. have undergone government-imposed price reductions, and further government-imposed price reductions are expected in the future. Such measures, along with the tender systems discussed below, are likely to have a negative impact on sales and gross profit in these markets. However, government initiatives in certain markets that appear to favor generic products could help to mitigate this unfavorable effect by increasing rates of generic substitution and penetration. In France, we remain the generics market leader.
AAdditionally, a number of markets in which we operate in Europeoutside of the U.S. have implemented, or may implement, tender systems for generic pharmaceuticals in an effort to lower prices. Generally speaking, tender systems can have an unfavorable impact on sales and profitability. Under such tender systems, manufacturers submit bids that establish prices for generic pharmaceutical products. Upon winning the tender, the winning company will receive priority placement for a period of time. The tender system often results in companies underbidding one another by proposing low pricing in order to win the tender. The loss of a tender by a third party to whom we supply APIactive pharmaceutical ingredient can also have a negative impact on our sales and profitability. Sales continue to be negatively affected by the impact of tender systems.
Assystems in Europe, both Australia and Japan have undergone government-imposed price reductions that have had, and could continue to have, a negative impact on sales and gross profit in these markets.
The acquisition of Meda significantly increased our operations and revenues throughout Europe, but particularly in France, Italy, Germany and Sweden. Additionally, through the acquisition, we have significantly expanded and strengthened our presence in emerging markets including China, Southeast Asia and the Middle East. These markets provide opportunities for future growth and expansion and are complemented by Mylan’s historical presence in India, Brazil and certain countries in Africa (including South Africa).countries.

Effective October 1, 2016, the Company expanded its reportable segments and now reports in three segments on a geographic basis as follows: North America, Europe and Rest of World. Comparative segment financial information have been recast for prior periods to conform to this revised segment structure.
From time to time, a limited number of our products may represent a significant portion of our net sales, gross profit and net earnings. Generally, this is due to the timing of new product introductions and the amount, if any, of additional competition in the market. Our top ten products in terms of sales, in the aggregate, represented approximately 23% and 30% of the Company’s net sales for the three months ended September 30, 2017 and 2016, respectively. For the nine months ended September 30, 2017 and 2016, our top ten products in terms of sales, in the aggregate, represented approximately 22% and 30%, respectively.
Recent Developments
In the fourth quarter of 2016, theThe Company previously announced a restructuring programs in certain locationsprogram representing initial steps in a series of actions in certain locations that are anticipated to further streamline our operations globally. The Company continues to developrestructuring program, other than the detailsadditional restructuring and remediation activities at the Morgantown, West Virginia plant described below, was substantially complete as of December 31, 2018. As a result of the cost reduction initiatives, including workforceoverall actions and other potentialtaken under the restructuring activities beyond the programs already announced. During the three and nine months ended September 30, 2017, the Company recorded pre-tax charges of $73.4 million and $112.7 million, respectively. Included within the charges during the nine months ended September 30, 2017 were $64.9 million for non-cash asset impairment charges with the remaining charges primarily related to severance and employee benefits. For the charges recognized during the three months ended September 30, 2017, $53.4 million were non-cash asset impairment charges and the remaining charges were primarily related to severance and employee benefits. The continued restructuring actions are expected to be implementedprogram through fiscal year 2018. In the fourth quarter of 2017, the Company committed to additional actions and now anticipates total aggregate pre-tax charges for committed restructuring activities ranging between $375.0 million and $450.0 million, inclusive of the 2016 and year to date 2017 restructuring charges of $262.4 million. In addition,March 31, 2019, management believes the potential annual savings from these committed restructuring activities will be between approximately $350.0$400.0 million and $425.0$475.0 million once fully implemented,realized, with the majority of these savings improving operating cash flow.
In April 2018, the U.S. Food and Drug Administration (the “FDA”) completed an inspection at Mylan’s plant in Morgantown, West Virginia and made observations through a Form 483. The Company submitted a comprehensive response to the FDA and committed to a robust improvement plan. In addition, based upon the Company’s recognition of the continued evolution of industry dynamics and regulatory expectations, during the second quarter of 2018, the Company commenced comprehensive restructuring and remediation activities, which are aimed at reducing complexity at the Morgantown plant and include the discontinuation and transfer to other manufacturing sites of a number of products, a reduction of the workforce and extensive process and plant remediation. In the fourth quarter of 2018, the Company received a warning letter related to the previously disclosed observations at the plant. The issues raised in the warning letter are being addressed within the context of the Company’s comprehensive restructuring and remediation activities.
The Morgantown plant continues to supply products for the U.S. market while we execute on and assess the restructuring and remediation activities. However, these activities have led to a temporary disruption in supply of certain products. Importantly, the profitability of the transferred and discontinued products is not proportionate to the reduced volumes of those products as the Company expects that manufacturing costs related to transferred products will be reduced and many of the discontinued products have lower than average gross margins. In addition, as it relates to North America, no significant new product revenue is forecasted from the Morgantown plant in 2019, and we are forecasting that only five of our top 50 and only one out of the top 10 gross margin generating products will be manufactured in Morgantown in 2019.
For the three months ended March 31, 2019, the Company incurred expenses amounting to approximately $69.6 million for incremental manufacturing variances, site remediation and restructuring charges related to the Morgantown plant. At this time, the total expenses related to the additional restructuring and remediation activities at the Morgantown plant cannot be reasonably estimated.
Mylan remains committed to maintaining the highest quality manufacturing standards at its facilities around the world and to continuous assessment and improvement in a time of evolving industry dynamics and regulatory expectations.
On August 17, 2017,January 30, 2019, the Company announced that its subsidiaries, Mylan Inc.received FDA approval of WixelaTM InhubTM (fluticasone propionate and Mylan Specialty L.P.salmeterol inhalation powder, USP), signed an agreement with the U.S. Departmentfirst generic of Justice ("DOJ") and two relators finalizing the $465 million settlement, plus interest, with the DOJ and other government agencies related to the classification of the EpiPen® Auto-Injector for purposes of the Medicaid Drug Rebate Program that Mylan had agreed to the terms of on October 7, 2016 (the “Medicaid Drug Rebate Program Settlement”)GlaxoSmithKline’s Advair Diskus®. The settlement resolves claims relating to the classification of EpiPen® Auto-Injector for purposes of the Medicaid Drug Rebate Program.
In October 2017, the Company announced the U.S.commercial launch of the first Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection that is an AP-rated substitutable generic version of Teva's Copaxone® 40 mg/mL, as well as Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva's Copaxone® 20 mg/mL. These products are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. The Company also announcedWixelaTM InhubTM occurred in October 2017 that its partner, Synthon, received marketing authorization approval in Europe for Glatiramer Acetate Injection 40 mg/mL. Mylan is partnered with Synthon, the developer and supplier of its European Glatiramer Acetate Injection products, and has exclusive distribution and supply rights in certain key European markets.

Financial Summary
The tables below are a summary of the Company’s financial results for the three and nine months ended September 30, 2017 compared to the prior year period:
 Three Months Ended
 September 30,
(In millions, except per share amounts)2017 2016 Change % Change
Total revenues$2,987.1
 $3,057.1
 $(70.0) (2)%
Gross profit1,178.1
 1,283.3
 (105.2) (8)%
Earnings (loss) from operations316.0
 (130.7) 446.7
 342 %
Net earnings (loss)88.3
 (119.8) 208.1
 174 %
Diluted earnings per ordinary share$0.16
 $(0.23) $0.39
 170 %
 Nine Months Ended
 September 30,
(In millions, except per share amounts)2017 2016 Change % Change
Total revenues$8,668.8
 $7,809.1
 $859.7
 11%
Gross profit3,488.5
 3,362.0
 126.5
 4%
Earnings from operations1,016.6
 385.8
 630.8
 164%
Net earnings451.7
 62.5
 389.2
 623%
Diluted earnings per ordinary share$0.84
 $0.12
 $0.72
 600%
February 2019.
A detailed discussion of the Company’s financial results can be found below in the section titled “Results of Operations.” As part of this discussion, we also report sales performance using the non-GAAP financial measures of “constant currency” third party net sales and total revenues. This measure providesThese measures provide information on the change in net sales and total revenues

assuming that foreign currency exchange rates had not changed between the prior and current period. The comparisons presented at constant currency rates reflect comparative local currency sales at the prior year’s foreign exchange rates. We routinely evaluate our third party net sales and total revenues performance at constant currency so that sales results can be viewed without the impact of foreign currency exchange rates, thereby facilitating a period-to-period comparison of our operational activities, and believe that this presentation also provides useful information to investors for the same reason. The following table compares third party net sales on an actual and constant currency basis for each reportable segment and consolidated total revenues on an actual and constant currency basis for the three and nine months ended September 30, 2017 and 2016.
More information about non-GAAP measures used by the Company as part of this discussion, including adjusted cost of sales, adjusted gross margins, adjusted net earnings and adjusted EPS (all of which are defined below) can be found in “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Use of Non-GAAP Financial Measures.

Results of Operations
Three Months Ended September 30, 2017March 31, 2019 Compared to Three Months Ended September 30, 2016March 31, 2018
Three Months EndedThree Months Ended
September 30,March 31,
(In millions)2017 2016 % Change 
2017 Currency Impact (1)
 2017 Constant Currency Revenues 
Constant Currency % Change (2)
2019 2018 % Change 
2019 Currency Impact (1)
 2019 Constant Currency Revenues 
Constant Currency % Change (2)
Third party net sales           
Net sales           
North America (3)
$1,172.2
 $1,505.5
 (22)% $(3.1) $1,169.1
 (22)%$922.9
 $985.3
 (6)% $2.7
 $925.6
 (6)%
Europe (3)
1,040.8
 841.2
 24 % (45.5) 995.3
 18 %895.3
 1,038.4
 (14)% 77.5
 972.8
 (6)%
Rest of World (3)
743.3
 682.8
 9 % (6.2) 737.1
 8 %642.4
 626.7
 3 % 51.8
 694.2
 11 %
Total third party net sales (3)
2,956.3
 3,029.5
 (2)% $(54.8) $2,901.5
 (4)%
Total net sales2,460.6
 2,650.4
 (7)% 132.0
 2,592.6
 (2)%
                      
Other third party revenues30.8
 27.6
 12 % (0.5) 30.3
 10 %
Other revenues (3)
34.9
 34.1
 2 % 0.9
 35.8
 5 %
Consolidated total revenues(4)$2,987.1
 $3,057.1
 (2)% $(55.3) $2,931.8
 (4)%$2,495.5
 $2,684.5
 (7)% $132.9
 $2,628.4
 (2)%
____________
(1) 
Currency impact is shown as unfavorable (favorable).
(2) 
The constant currency percentage change is derived by translating third party net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 20172019 constant currency third party net sales or revenues to the corresponding amount in the prior year.
(3) 
Effective October 1, 2016,For the Company expanded its reportable segments as follows:three months ended March 31, 2019, other revenues in North America, Europe, and Rest of World. AsWorld were approximately $22.1 million, $4.7 million, and $8.1 million, respectively.
(4)
Amounts exclude intersegment revenue that eliminates on a result, the amounts previously reported under the Specialty segment have been recast to North America and amounts related to Brazil are included in Rest of World for all periods presented.consolidated basis.
Total Revenues
For the current quarter,three months ended March 31, 2019, Mylan reported total revenues of $2.99$2.50 billion,, compared to $3.06$2.68 billion for the comparable prior year period, representing a decrease of $70.0$189.0 million, or 2%7%. Total revenues include both net sales and other revenues from third parties. Third party netNet sales for the current quarterthree months ended March 31, 2019 were $2.96$2.46 billion,, compared to $3.03$2.65 billion for the comparable prior year period, representing a decrease of $73.2$189.8 million, or 2%7%. Other third party revenues for the current quarterthree months ended March 31, 2019 were $30.8$34.9 million,, compared to $27.6$34.1 million for the comparable prior year period, an increase of $3.2 million.period.
The decrease in total revenues was due primarily to a 22% decline in third party net sales in the North America segment. This result was partially offset by third party net sales growthincluded a decrease in the Europe segment of 24%,14% and a decrease in the North America segment of 6%. These decreases were partially offset by an increase in the Rest of World segment of 9%3%. The incremental impact on third partyMylan’s net sales from the acquisition of Meda was approximately $163.6 million. Net sales of existing products and new product introductions decreased in total by approximately $291.6 million. The decrease from existing products was due primarily to lower pricing and, to a lesser extent, lower volumes in the current period. Mylan’s current quarter total revenues were favorablyunfavorably impacted by the effect of foreign currency translation, primarily reflecting changes in the U.S. Dollar as compared to the currencies of Mylan’s subsidiaries in India, Australia, and the European Union and India, which was partially offset by theUnion. The unfavorable impact from changes in the Japanese Yen. The favorable impact of foreign currency translation on current quarter total revenuesyear net sales was approximately $55.3$132.0 million, or 5%, resulting in a decrease in constant currency total revenuesnet sales of approximately $125.3$57.8 million, or 4%2%. This decrease was primarily driven by net sales from existing products, partially offset by new product sales, primarily as a result of lower volumes, and to a lesser extent, pricing.
From time to time, a limited number of our products may represent a significant portion of our net sales, gross profit and net earnings. Generally, this is due to the timing of new product introductions and the amount, if any, of additional competition in the market. Our top ten products in terms of net sales, in the aggregate, represented approximately 25% and 17% for the three months ended March 31, 2019 and 2018, respectively. This percentage may fluctuate based upon the timing of new product launches, seasonality and the timing of the discontinuation of products.


Third party netNet sales are derived from our three geographic reporting segments: North America, Europe and Rest of World. The graph below shows third party net sales by segment for the three months ended September 30, 2017March 31, 2019 and 20162018 and the increase (decrease)net change period over period:
myl10q_20170xchart-34309.jpgchart-7403ed931f165db0b53.jpg
North America Segment
Third party net sales from North America decreased by $333.3 million or 22% during the three months ended September 30, 2017 when compared to the prior year period, including the decrease in sales of the EpiPen® Auto-Injector of $245.1 million. Incremental net sales from the acquisition of Meda were approximately $8.2 million in the current quarter. Net sales were negatively impacted in the current quarter due to a decline in sales of existing products as a result of lower pricing and volume, partially offset by new product introductions. As anticipated, our North American generics business experienced higher price erosion than previous quarters, including the impact of the loss of market exclusivity of armodafinil. Sales of the EpiPen® Auto-Injector declined in the current quarter as a result of the impact of the launch of the authorized generic, higher governmental rebates as a result of the Medicaid Drug Rebate Program Settlement, and increased competition. The impact of foreign currency translation on current period third party net sales was less than 1% within North America.
Europe Segment
Third party net sales from Europe increased by $199.6 million or 24% during the three months ended September 30, 2017 when compared to the prior year period. The increase included the result of the incremental net sales from the acquisition of Meda which totaled approximately $117.2 million. The remaining increase in net sales was the result of new product introductions combined with favorable volume and pricing on existing products. The favorable impact of foreign currency translation on current period third party net sales was $45.5 million, or 5% within Europe. Constant currency third party net sales increased by approximately $154.1 million, or 18% when compared to the prior year period.
Rest of World Segment
Third party net sales from Rest of World increased by $60.5 million, or 9% during the three months ended September 30, 2017 when compared to the prior year period. This increase was partially driven by incremental net sales from the acquisition of Meda which totaled approximately $38.2 million. In addition, net sales were positively impacted by new products and increased net sales in emerging markets, which were driven primarily by higher volumes. These increases were partially offset by lower pricing and volumes on existing products from our anti-retroviral (“ARV”) franchise, including active pharmaceutical ingredients. Net sales in Australia increased as a result of sales of new products. Net sales in Japan increased slightly as a result of sales of new products and favorable volumes. Overall, third party net sales from Rest of World were favorably impacted by the effect of foreign currency translation by approximately $6.2 million, or 1% during the three months ended September 30, 2017. Constant currency third party net sales increased by approximately $54.3 million, or 8%.
In addition to third party net sales, the Rest of World segment supplies finished dosage form (“FDF”) generic products and API, primarily from Mylan India, to Mylan subsidiaries in conjunction with the Company’s vertical integration strategy. Intercompany sales related to this strategy were approximately $117.4 million and $133.9 million in the three months ended September 30, 2017 and 2016, respectively. These intercompany sales are eliminated in consolidation and therefore are not included in the consolidated third party net sales.

Cost of Sales and Gross Profit
Cost of sales increased from $1.77 billion for the three months ended September 30, 2016 to $1.81 billion for the three months ended September 30, 2017. Significant components of cost of sales were purchase accounting related amortization of acquired intangible assets, acquisition related costs, restructuring and other special items, which are described further in the section titled Use of Non-GAAP Financial Measures. Gross profit for the three months ended September 30, 2017 was $1.18 billion and gross margins were 39%. For the three months ended September 30, 2016, gross profit was $1.28 billion and gross margins were 42%. Gross margins were negatively impacted in the current quarter by lower gross profit from the sales of existing products in North America, including the EpiPen® Auto-Injector which reduced gross profit by approximately 435 basis points, partially offset by lower purchase accounting amortization by approximately 200 basis points as a result of the prior year amortization of the step-up in the fair value of acquired inventory. Adjusted gross margins were approximately 53% for the three months ended September 30, 2017, compared to approximately 57% for the three months ended September 30, 2016. For the quarter ended September 30, 2017, adjusted gross margins were negatively impacted in the current quarter as a result of lower gross profit from the sales of existing products in North America, including the EpiPen® Auto-Injector which reduced adjusted gross profit by approximately 335 basis points, partially offset by the contributions from acquired businesses and new product introductions.
A reconciliation between cost of sales, as reported under U.S. GAAP, and adjusted cost of sales and adjusted gross margin for the three months ended September 30, 2017 compared to the three months ended September 30, 2016 is as follows:
 Three Months Ended
 September 30,
(In millions)2017 2016
U.S. GAAP cost of sales$1,809.0
 $1,773.8
Deduct:   
Purchase accounting amortization and other related items(361.4) (421.5)
Restructuring related costs(21.0) (9.7)
Acquisition related items0.2
 (8.5)
Other special items(12.3) (12.0)
Adjusted cost of sales$1,414.5
 $1,322.1
    
Adjusted gross profit (a)
$1,572.6
 $1,735.0
    
Adjusted gross margin (a)
53% 57%
____________
(a)
Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues.
Operating Expenses
Research & Development Expense
R&D expense for the three months ended September 30, 2017 was $182.3 million, compared to $199.1 million for the comparable prior year period, a decrease of $16.8 million. This decrease was primarily due to lower expenditures related to the Company’s respiratory programs due to the timing of clinical activities when compared to the prior year period. The decrease was partially offset by the incremental impact of the Meda acquisition of approximately $4.1 million in the current quarter.

Selling, General & Administrative Expense
Selling, general and administrative expense (“SG&A”) for the current quarter was $664.6 million, compared to $656.9 million for the comparable prior year period, an increase of $7.7 million. The increase included additional expense related to the Meda acquisition which increased SG&A by approximately $35.5 million in the current quarter. Partially offsetting this increase were lower acquisition related costs, including consulting and legal costs, and the benefit of integration activities in the current quarter.
Litigation Settlements and Other Contingencies, Net
During the three months ended September 30, 2017 and 2016, the Company recorded a charge, net of $15.2 million and $558.0 million, respectively. The net charge for the three months ended September 30, 2017, consists primarily of an increase to an accrual for an anti-trust related matter. The net charge in the prior year period was primarily related to the Medicaid Drug Rebate Program Settlement and the settlement with Strides Arcolab regarding substantially all outstanding regulatory, warranty and indemnity claims (the “Strides Settlement”) related to the acquisition of Agila Specialties Private Limited (“Agila”).
Interest Expense
Interest expense for the three months ended September 30, 2017 totaled $131.8 million, compared to $144.4 million for the three months ended September 30, 2016, a decrease of $12.6 million. The decrease in the current quarter is primarily due to lower long-term debt balances in relation to the prior year period.
Other Expense, Net
Other expense, net, was $4.6 million in the current quarter, compared to $50.2 million for the comparable prior year period. Other expense, net, includes losses from equity affiliates, foreign exchange gains and losses, interest, and other investment gains and losses. Other expense, net was comprised of the following for the three months ended September 30, 2017 and 2016, respectively:
 Three Months Ended September 30,
(In millions)2017 2016
Losses from equity affiliates, primarily clean energy investments$22.4
 $29.7
Foreign exchange (gains)/losses, net(14.9) 27.8
Other gains, net(2.9) (7.3)
Other expense, net$4.6
 $50.2
In the prior year period, other expense, net included foreign exchange losses of $27.8 million which included $44.4 million of mark-to-market losses related to the Company’s SEK non-designated foreign currency contracts related to the Meda acquisition partially offset by foreign currency gains.
Income Tax Provision (Benefit)
For the three months ended September 30, 2017, the Company recognized an income tax provision of $91.3 million, compared to an income tax benefit of $205.5 million for the comparable prior year period. The effective tax rate for the three months ended September 30, 2017 versus the comparable prior year period was impacted by the changing mix of income earned in jurisdictions with differing tax rates, and changes in 2017 valuation allowances applied to certain tax attributes. In addition, during the third quarter of 2016, the Company received approvals from the relevant Indian regulatory authorities to legally merge its wholly owned subsidiary, Jai Pharma Limited, into Mylan Laboratories Limited. The merger resulted in the recognition of a deferred tax asset of $150 million for the tax deductible goodwill in excess of the book goodwill with a corresponding benefit to income tax provision for the three months ended September 30, 2016. In addition to the benefit recognized for the merger of the aforementioned entities, the effective tax rate for the three months ended September 30, 2016 was impacted by the accrual for the Medicaid Drug Rebate Program Settlement.

Nine Months Ended September 30, 2017 Compared to Nine Months Ended September 30, 2016
 Nine Months Ended
 September 30,
(In millions)2017 2016 % Change 
2017 Currency Impact (1)
 2017 Constant Currency Revenues 
Constant Currency % Change (2)
Third party net sales           
North America (3)
$3,666.7
 $4,064.5
 (10)% $(2.3) $3,664.4
 (10)%
Europe (3)
2,887.1
 2,026.4
 42 % (2.4) 2,884.7
 42 %
Rest of World (3)
2,016.4
 1,654.6
 22 % (27.0) 1,989.4
 20 %
Total third party net sales (3)
8,570.2
 7,745.5
 11 % (31.7) 8,538.5
 10 %
            
Other third party revenues98.6
 63.6
 55 % 
 98.6
 55 %
Consolidated total revenues$8,668.8
 $7,809.1
 11 % $(31.7) $8,637.1
 11 %
____________
(1)
Currency impact is shown as unfavorable (favorable).
(2)
The constant currency percentage change is derived by translating third party net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2017 constant currency third party net sales or revenues to the corresponding amount in the prior year.
(3)
Effective October 1, 2016, the Company expanded its reportable segments as follows: North America, Europe and Rest of World. As a result, the amounts previously reported under the Specialty segment have been recast to North America and amounts related to Brazil are included in Rest of World for all periods presented.
Total Revenues
For the nine months ended September 30, 2017, Mylan reported total revenues of $8.67 billion, compared to $7.81 billion for the comparable prior year period, representing an increase of $859.7 million, or 11%. Total revenues include both net sales and other revenues from third parties. Third party net sales for the nine months ended September 30, 2017 were $8.57 billion, compared to $7.75 billion for the comparable prior year period, representing an increase of $824.7 million, or 11%. Other third party revenues for the nine months ended September 30, 2017 were $98.6 million, compared to $63.6 million for the comparable prior year period, an increase of $35.0 million. The increase in other third party revenues was principally the result of an increase in royalty income from arrangements acquired in the Meda acquisition.
The increase in total revenues included third party net sales growth in the Europe segment of 42%, and in the Rest of World segment of 22%. Third party net sales decreased in the North America segment by 10%. Contributing to the overall increase in total revenues were net sales from the acquisitions of Meda and the non-sterile, topicals-focused business (the “Topicals Business”) of Renaissance Acquisition Holdings, LLC of approximately $1.40 billion. This increase was partially offset by a net decrease in net sales from existing products and lower new product introductions of approximately $609.4 million. The decrease from existing products was due primarily to lower pricing and, to a lesser extent, lower volumes in the current period. Mylan’s total revenues were favorably impacted by the effect of foreign currency translation, primarily reflecting changes in the U.S. Dollar as compared to the currencies of Mylan’s subsidiaries in India, Australia, and the European Union, which was partially offset by the unfavorable impact from changes in Japan and the United Kingdom. The favorable impact of foreign currency translation on current year total revenues was approximately $31.7 million. Constant currency total revenue growth for the nine months ended September 30, 2017 was approximately $828.0 million, or 11%.

Third party net sales are derived from our three geographic reporting segments: North America, Europe and Rest of World. The graph below shows third party net sales by segment for the nine months ended September 30, 2017 and 2016 and the increase (decrease) period over period:
myl10q_20170xchart-34175.jpg
North America Segment
Third party netNet sales from North America decreased by $397.8$62.4 million or 10%6% during the ninethree months ended September 30, 2017March 31, 2019 when compared to the prior year including theperiod. This decrease in sales of the EpiPen® Auto-Injector of $523.5 million. Net sales ofwas due primarily to lower volumes on existing products, decreased due to lower pricing and volume. This was partially offsetprimarily driven by net sales from the acquisitions of Meda and the Topicals Business, totaling approximately $340.0 million. As anticipated, for the nine months ended September 30, 2017, the U.S. generics products experienced price erosionchanges in the high-single-digits. Sales of the EpiPen® Auto-Injector declined in the nine month period as a result ofcompetitive environment and the impact of the launch of the authorized generic, higher governmental rebates as a result of the Medicaid Drug Rebate Program Settlement,Morgantown plant remediation activities, partially offset by new product sales, including WixelaTM InhubTM and Fulphila™ (biosimilar to Neulasta®), and increased competition.market share on Glatiramer Acetate Injection. Pricing also declined when compared to the prior year period. The impact of foreign currency translation on the current period third party net sales was insignificant within North America.
Europe Segment
Third party netNet sales from Europe decreased by $143.1 million or 14% during the three months ended March 31, 2019 when compared to the prior year period. This decrease was primarily the result of the unfavorable impact of foreign currency translation, lower volumes of existing products driven by the timing of purchases of our products by customers and temporary business disruptions due to the adoption of serialization across Europe and, to a lesser extent, pricing. The unfavorable impact of foreign currency translation was approximately $77.5 million or 8%. Partially offsetting these items were new product sales in the current period. Constant currency net sales decreased by approximately $65.6 million or 6%, when compared to the prior year period.
Rest of World Segment
Net sales from Rest of World increased by $860.7$15.7 million or 42%3% during the ninethree months ended September 30, 2017March 31, 2019 when compared to the prior year period. This increase was primarily the result of netnew product sales from the acquisition of Meda of approximately $833.2 million during the nine months ended September 30, 2017. Net salesand higher volumes of existing products increasedproducts. The increase in net sales as a result of new product sales was primarily due to new product sales in Australia, Japan and favorable pricing, slightlyChina. Increased volume of existing products was primarily driven by the Company’s anti-retroviral therapy franchise. This increase was partially offset primarily by lower volume. Overall, the favorableunfavorable impact of foreign currency translation and, to a lesser extent, by lower pricing on current period third party net sales was not significant to the Europe segment.
Rest of World Segment
Third partyexisting products. Overall, net sales from Rest of World were unfavorably impacted by the effect of foreign currency translation of approximately $51.8 million, or 8%. Constant currency net sales increased by $361.8approximately $67.5 million or 22% during the nine months ended September 30, 201711% when compared to the prior year period. This increase was primarily the result of net sales from the acquisition of Meda totaling approximately $229.2 million. In addition, net sales from existing products increased principally as a result of higher volumes in Australia, emerging markets, and from our ARV franchise. Throughout the segment, sales from new products, particularly from our ARV franchise and in Australia, and higher volumes on existing products more than offset lower pricing. Sales from existing products in Japan were flat as higher volumes were offset by unfavorable pricing. The favorable impact of foreign currency translation was $27.0 million, or 2%. Constant currency third party net sales increased by approximately $334.8 million, or 20%.
In addition to third party net sales, the Rest of World segment also supplies FDF generic products and API, primarily from Mylan India, to Mylan subsidiaries in conjunction with the Company’s vertical integration strategy. Intercompany sales related to this strategy were approximately $331.1 million and $308.3 million in the nine months ended September 30, 2017 and 2016, respectively. These intercompany sales are eliminated in consolidation and are not included in the consolidated third party net sales.

Cost of Sales and Gross Profit
Cost of sales increaseddecreased from $4.45$1.70 billion for the ninethree months ended September 30, 2016March 31, 2018 to $5.18$1.69 billion for the ninethree months ended September 30, 2017.March 31, 2019. Cost of sales was primarily impacted by purchase accounting related amortization of acquired intangible assets acquisition related costs, restructuring, and other special items, which are described further in the section titled Use of Non-GAAP Financial MeasuresMeasures.. Gross profit for the ninethree months ended September 30, 2017March 31, 2019 was $3.49 billion$805.2 million and gross margins were 40%32%. For the ninethree months ended September 30, 2016,March 31, 2018, gross profit was $3.36 billion$984.3 million and gross margins were 43%37%. Gross margins were negatively impacted inby approximately 60 basis points related to the incremental amortization from product acquisitions. Gross margins were also negatively affected by approximately 280 basis points as a result of incremental manufacturing expenses, site remediation expenses and incremental restructuring charges incurred during the current period by increased amortization expenseprincipally as a result of the acquisitions of Meda andactivities at the Topicals Business by approximately 162 basis points, lower gross profit from the sales of existing products in North America, including the EpiPen® Auto-Injector which reduced gross profit by approximately 318 basis points, partially offset by the contributions from the acquisitions noted above. Adjusted gross margins were approximately 53% for the nine months ended September 30, 2017, compared to approximately 56% for the nine months ended September 30, 2016. AdjustedCompany’s Morgantown plant. In addition, gross margins were negatively impacted in the current period as a result of lower gross profit from thefor sales of existing products in North America, including the EpiPen® Auto-Injector which reduced adjusted gross profit by approximately 245 basis points, partially offset by the contributionsimpact from new product sales, primarily in North America. Adjusted gross margins were 54% for the acquisitions noted above.three months ended March 31, 2019, compared to 53% for the three months ended March 31, 2018.
A reconciliation between cost of sales, as reported under U.S. GAAP, and adjusted cost of sales and adjusted gross margin for the ninethree months ended September 30, 2017March 31, 2019 compared to the ninethree months ended September 30, 2016March 31, 2018 is as follows:
Nine Months EndedThree Months Ended
September 30,March 31,
(In millions)2017 20162019 2018
U.S. GAAP cost of sales$5,180.3
 $4,447.1
$1,690.3
 $1,700.2
Deduct:      
Purchase accounting amortization and other related items(1,054.9) (914.8)(435.4) (420.9)
Acquisition related items(1.9) (39.8)(0.5) (0.2)
Restructuring related costs(37.3) (13.8)
Restructuring and related costs(14.5) (4.4)
Other special items(39.2) (34.1)(85.1) (10.0)
Adjusted cost of sales$4,047.0
 $3,444.6
$1,154.8
 $1,264.7
      
Adjusted gross profit (a)
$4,621.8
 $4,364.5
$1,340.7
 $1,419.8
      
Adjusted gross margin (a)
53% 56%54% 53%
____________
(a) 
Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues.
Operating Expenses
Research & Development Expense
Research and development (“R&D&D”) expense for the ninethree months ended September 30, 2017March 31, 2019 was $580.9$172.6 million, compared to $632.2$204.9 million for the comparable prior year period, a decrease of $51.3$32.3 million. TheThis decrease was primarily due to lower expenditures related to the Company’s respiratoryreprioritization of global programs, and biologics programs due to the timing of clinical activities when compared to the prior year period. Offsetting the decrease was the impact from the acquisitions of Meda and the Topicals Business, which increased R&D expense by approximately $33.9 millionhigher payments in the current year period.
Additionally, during the nine months ended September 30, 2017, the Company entered into a joint development and marketing agreement for a respiratory product resulting in approximately $50 million in R&D expense. In the prior year period the Company made an upfront payment to Momenta Pharmaceuticals, Inc. (“Momenta”) for $45 million related to the Company’s collaboration agreement with Momenta which was entered into on January 8, 2016.

licensing arrangements for products in development.
Selling, General & Administrative Expense
Selling, general and administrative (“SG&A&A”) expense for the ninethree months ended September 30, 2017March 31, 2019 was $1.92 billion,$607.9 million, compared to $1.79 billion$607.5 million for the comparable prior year period, an increase of $129.2$0.4 million. TheThis increase iswas primarily due primarily to additional expense related to the acquisitions of Medacontinued investment in selling and the Topicals Businessmarketing activities, which increased SG&Awas partially offset by approximately $284.0 million. Partially offsetting this increase were lower acquisition related costs, including consulting and legal costs, and the benefit of integration activities in the current period.savings from restructuring activities.

Litigation Settlements and Other Contingencies, Net
During the ninethree months ended September 30, 2017,March 31, 2019 and 2018, the Company recorded net charges of $0.7 million and $16.2 million, respectively, for litigation settlements and other contingencies. During the three months ended March 31, 2019, the Company recognized litigation related charges of approximately $4.8 million for a number of matters, which was partially offset by a gain of $4.1 million for fair value adjustments related to the respiratory delivery platform contingent consideration. During the three months ended March 31, 2018, the Company recorded litigation related charges of approximately $13.3 million, primarily related to an antitrust matter and a patent infringement matter. In addition, the Company recorded a net gainloss of $25.8 million, while during the nine months ended September 30, 2016, the Company recorded a net charge of $556.4 million, respectively. The net gain recognized during the nine months ended September 30, 2017, consists of a gain of approximately $88.1$2.7 million for a fair value adjustmentadjustments related to the respiratory development platform contingent consideration for the exclusive worldwide rights to develop, manufacture and commercialize a generic equivalent to GlaxoSmithKline’s Advair Diskus® and Seretide Diskus® incorporating Pfizer Inc.’s proprietary dry powder inhaler delivery platform (the “respiratory delivery platform”). The fair value adjustment was the result of changes to assumptions relating to the timing of the product launch along with other competitive and market factors. Offsetting this gain were litigation accruals of approximately $52.5 million primarily related to the modafinil settlement, the Medicaid Drug Rebate Program Settlement, an increase to an accrual for an anti-trust related matter, and a fair value loss of $9.9 million related to contingent consideration for the acquisition of certain female healthcare businesses from Famy Care Limited (such businesses “Jai Pharma Limited”).  The net charge recognized during the nine months ended September 30, 2016 was primarily related to the Medicaid Drug Rebate Program Settlement and the Strides Settlement.consideration.
Interest Expense
Interest expense for the ninethree months ended September 30, 2017March 31, 2019 totaled $406.3$131.2 million, compared to $305.0$131.7 million for the ninethree months ended September 30, 2016, an increaseMarch 31, 2018, a decrease of $101.3$0.5 million. The increase in the current yeardecrease is primarily due to approximately $218.1 millionthe repayment of the 2018 Floating Rate Euro Notes and the 2018 Senior Notes. This decrease was partially offset by slightly higher than average long-term debt balances during the three months ended March 31, 2019 as compared to the prior year period and interest related to the issuance of the senior notes in June 20162025 Euro Senior Notes, the 2028 Euro Senior Notes and the Euro senior notes issued in November 2016. This increase was partially offset by the repayment of the 1.800%2048 Senior Notes due 2016 andin the 1.350% Senior Notes due 2016 in June and Novembersecond quarter of 2016, respectively.2018.
Other Expense, Net
Other expense, net was $34.4$7.3 million for the ninethree months ended September 30, 2017,March 31, 2019, compared to $184.0$13.5 million for the comparable prior year period. Other expense, net includes losses from equity affiliates, foreign exchange gains and losses and interest and dividend income. Other expense, net was comprised of the following for the ninethree months ended September 30, 2017March 31, 2019 and 2016,2018, respectively:
 Nine Months Ended
 September 30,
(In millions)2017 2016
Losses from equity affiliates, primarily clean energy investments$77.2
 $85.5
Foreign exchange (gains)/losses, net(33.0) 81.6
Write off of deferred financing fees
 33.2
Other gains, net(9.8) (16.3)
Other expense, net$34.4
 $184.0
In the prior year period, other expense, net included foreign exchange losses of $81.6 million which included $128.6 million of unrealized mark-to-market losses related to the Company’s SEK non-designated foreign currency contracts that were entered into to economically hedge the SEK purchase price for the Meda acquisition, partially offset by foreign currency gains and the write off of approximately $33.2 million of financing fees related to the termination of the bridge credit agreement relating to the Meda acquisition.

 Three Months Ended
 March 31,
(In millions)2019 2018
Losses from equity affiliates, primarily clean energy investments$17.0
 $23.1
Foreign exchange gains, net(4.4) (15.6)
Other (gains)/losses, net(5.3) 6.0
Other expense, net$7.3
 $13.5
Income Tax Provision (Benefit)Benefit
For the ninethree months ended September 30, 2017,March 31, 2019, the Company recognized an income tax provisionbenefit of $124.2$89.5 million, compared to an income tax benefit of $165.7$76.6 million for the comparable prior year period. Theperiod, an increase of $12.9 million or 17%. During the three months ended March 31, 2019, primarily due to the expiration of federal and foreign statutes of limitations, the Company reduced its net liability for unrecognized tax benefits by approximately $83.8 million. In the prior year period, as a result of federal and state audits and settlements and expirations of certain state, federal, and foreign statutes of limitations, the Company reduced its liability for unrecognized tax benefits by approximately $86.0 million, which resulted in a net benefit to the income tax provision forof approximately $53.0 million. Also impacting the nine months ended September 30, 2017 versus the comparable priorcurrent year periodincome tax benefit was impacted by the changing mix of income earned in jurisdictions with differing tax rates, changes in 2017 valuation allowances applied to certain tax attributes, statutory releases of certain tax uncertainties, and the revaluation of deferred tax assets and liabilities in countries that changed their statutory corporate tax rate. During the nine months ended September 30, 2016, the Company received approvals from the relevant Indian regulatory authorities to legally merge its wholly owned subsidiary, Jai Pharma Limited, into Mylan Laboratories Limited. The merger resulted in the recognition of a deferred tax asset of $150 million for the tax deductible goodwill in excess of the book goodwill with a corresponding benefit to income tax provision for the nine months ended September 30, 2016. In addition to the benefit recognized for the merger of the aforementioned entities, the effective tax rate for the nine months ended September 30, 2016 was also impacted by the Medicaid Drug Rebate Program Settlement, a changing mix of income earned in jurisdictions with differing tax rates, and statutory releases of certain tax uncertainties.rates.
Use of Non-GAAP Financial Measures
Whenever the Company uses non-GAAP financial measures, we provide a reconciliation of the non-GAAP financial measures to their most directly comparable U.S. GAAP financial measure. Investors and other readers are encouraged to review the related U.S. GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable U.S. GAAP measure and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with U.S. GAAP. Additionally, since these are not measures determined in accordance with U.S. GAAP, non-GAAP financial measures have no standardized meaning across companies, or as prescribed by U.S. GAAP and, therefore, may not be comparable to the calculation of similar measures or measures with the same title used by other companies.

Management uses these measures internally for forecasting, budgeting, measuring its operating performance, and incentive-based awards. In addition, primarilyPrimarily due to acquisitions and other significant events which may impact comparability of our periodic operating results, we believe that an evaluation of our ongoing operations (and comparisons of our current operations with historical and future operations) would be difficult if the disclosure of our financial results was limited to financial measures prepared only in accordance with U.S. GAAP. We believe that non-GAAP financial measures are useful supplemental information for our investors and when considered together with our U.S. GAAP financial measures and the reconciliation to the most directly comparable U.S. GAAP financial measure, provide a more complete understanding of the factors and trends affecting our operations. The financial performance of the Company is measured by senior management, in part, using adjusted metrics as described below, along with other performance metrics. Management’s annual incentive compensation is derived, in part, based on the adjusted EPS (as defined below) metric.
Adjusted Cost of Sales and Adjusted Gross Margin
We use the non-GAAP financial measure “adjusted cost of sales” and the corresponding non-GAAP financial measure “adjusted gross margin.” The principal items excluded from adjusted cost of sales include restructuring, acquisition related and other special items and purchase accounting amortization and other related items, which are described in greater detail below.
Adjusted Net Earnings and Adjusted EPS
Adjusted net earnings (“adjusted earnings”) is a non-GAAP financial measure and provides an alternative view of performance used by management. Management believes that, primarily due to acquisition activity and other significant events, an evaluation of the Company’s ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with U.S. GAAP. Management believes that adjusted net earnings and adjusted net earnings per diluted share (“adjusted EPS”) are two of the most important internal financial metrics related to the ongoing operating performance of the Company, and are therefore useful to investors and that their understanding of our performance is enhanced by these adjusted measures. Actual internal and forecasted operating results and annual budgets used by management include adjusted net earnings and adjusted EPS.

The significant items excluded from adjusted cost of sales, adjusted net earnings and adjusted EPS include:
Purchase Accounting Amortization and Other Related Items
The ongoing impact of certain amounts recorded in connection with acquisitions of both businesses and assets is excluded from adjusted cost of sales, adjusted net earnings and adjusted EPS. These amounts include the amortization of intangible assets, inventory step-up and intangible asset impairment charges, including in-process research and development. For the acquisition of businesses accounted for under the provisions of the Financial Accounting Standards Board Accounting Standards Codification (“ASC”) Topic 805, these purchase accounting impacts are excluded regardless of the financing method used for the acquisitions, including the use of cash, long-term debt, the issuance of ordinary shares, contingent consideration or any combination thereof.
Upfront and Milestone-Related R&D Expenses
These expenses and payments are excluded from adjusted net earnings and adjusted EPS because they generally occur at irregular intervals and are not indicative of the Company’s ongoing operations. Also included in this adjustment are certain expenses related to the Company’s collaboration agreement with Momenta including certain milestone related costs. Such costs include payments related to Mylan’s future decisions, on a product by product basis, to continue with the development of such product in the collaboration after certain R&D work is performed. Related amounts are excluded from adjusted earnings as Mylan considers such payments as additional upfront buy-in payments for the products.
Accretion of Contingent Consideration Liability and Other Fair Value Adjustments
The impact of changes to the fair value of contingent consideration and accretion expense are excluded from adjusted net earnings and adjusted EPS because they are not indicative of the Company’s ongoing operations due to the variability of the amounts and the lack of predictability as to the occurrence and/or timing and management believes ittheir exclusion is helpful to understanding the underlying, ongoing operational performance of the business.
Share-based Compensation
Beginning in 2019, share-based compensation expense is excluded from adjusted net earnings and adjusted EPS. Our share-based compensation programs have become increasingly weighted toward performance-based compensation, which leads to variability and to a lack of predictability as to the occurrence and/or timing of amounts incurred. As such, management

believes the exclusion of such amounts on an ongoing basis is helpful to understanding the underlying operational performance of the business. The impact of share-based compensation was insignificant to the financial results for the year ended December 31, 2018 due primarily to this variability.
Restructuring, Acquisition Related and Other Special Items
Costs related to restructuring, acquisition and integration activities and other actions are excluded from adjusted cost of sales, adjusted net earnings and adjusted EPS, as applicable. These amounts include items such as:
Costs related to formal restructuring programs and actions, including costs associated with facilities to be closed or divested, employee separation costs, impairment charges, accelerated depreciation, incremental manufacturing variances, equipment relocation costs and other restructuring related costs;
Certain acquisition related remediation and integration and planning costs, as well as other costs associated with acquisitions such as advisory and legal fees and certain financing related costs, and other business transformation and/or optimization initiatives, which are not part of a formal restructuring program, including employee separation and post-employment costs;
The pre-tax loss of the Company’s clean energy investments, whose activities qualify for income tax credits under Section 45 of the U.S. Internal Revenue Code of 1986, as amended (the “Code”);amended; only included in adjusted net earnings and adjusted EPS is the net tax effect of the entity’s activities;
The pre-tax mark-to-market gains and losses of the Company’s investments in marketable equity securities historically accounted for as available for sale securities; only included in adjusted net earnings and adjusted EPS are cumulative realized gains and losses;
Other costs, incurred from time to time, related to certain special events or activities that lead to gains or losses, including, but not limited to, incremental manufacturing variances, asset write-downs, or liability adjustments; and
Certain costs to further develop and optimize our global enterprise resource planning systems, operations and supply chain.
The Company has undertaken restructurings and other optimization initiatives of differing types, scope and amount during the covered periods and, therefore, these charges should not be considered non-recurring; however, management excludes these amounts from adjusted net earnings and adjusted EPS because it believes it is helpful to understanding the underlying, ongoing operational performance of the business.
Litigation Settlements, Net
Charges and gains related to legal matters, such as those discussed in the Notes to interim financial statements — Note 1920 Litigation included in Part I, Item 1 of this Form 10-Q are generally excluded from adjusted net earnings and adjusted EPS. Normal, ongoing defense costs of the Company made in the normal course of our business are not excluded.

Reconciliation of U.S. GAAP Net Earnings to Adjusted Net Earnings and U.S. GAAP EPS to Adjusted EPS

A reconciliation between net earnings and diluted earnings per share, as reported under U.S. GAAP, and adjusted net earnings and adjusted EPS for the periods shown follows:
Three Months Ended September 30, Nine Months Ended September 30,Three Months Ended March 31,
(In millions, except per share amounts)2017 2016 2017 20162019 2018
U.S. GAAP net earnings and U.S. GAAP EPS$88.3
 $0.16
 $(119.8) $(0.23) $451.7
 $0.84
 $62.5
 $0.12
U.S. GAAP net (loss) earnings and U.S. GAAP EPS$(25.0) $(0.05) $87.1
 $0.17
Purchase accounting related amortization (primarily included in cost of sales) (a)
370.7
   427.1
   1,074.9
   931.8
  435.4
   423.4
  
Litigation settlements, net (b)
15.2
   468.0
   52.5
   466.4
  
Interest expense (primarily related to clean energy investment financing)5.5
   5.5
   19.5
   18.9
  
Accretion of contingent consideration liability and other fair value adjustments (c)
4.9
   100.4
   (57.6)   120.7
  
Litigation settlements and other contingencies, net0.7
   16.2
  
Interest expense (primarily clean energy investment financing and accretion of contingent consideration)7.3
   9.7
  
Clean energy investments pre-tax loss22.4
   23.8
   66.4
   69.4
  17.0
   23.0
  
Acquisition related costs (primarily included in SG&A and cost of sales) (d)
15.2
   110.5
   60.1
   346.7
  
Restructuring related costs (e)
73.4
   24.2
   112.7
   45.1
  
Acquisition related costs (primarily included in SG&A) (b)
8.1
   2.3
  
Restructuring related costs (c)
19.9
   45.4
  
Share-based compensation expense (d)
18.0
   
  
Other special items included in:                      
Cost of sales(e)12.3
   12.0
   39.2
   34.1
  85.1
   10.0
  
Research and development expense (f)
15.2
   22.0
   90.1
   98.4
  33.1
   46.6
  
Selling, general and administrative expense4.0
   (2.0)   12.7
   0.3
  13.9
   1.8
  
Other expense, net(g)(3.3)   (1.4)   1.8
   1.3
  
   17.4
  
Tax effect of the above items and other income tax related items(34.1)   (343.9)   (244.5)   (490.5)  (191.6)   (187.3)  
Adjusted net earnings and adjusted EPS$589.7
 $1.10
 $726.4
 $1.38
 $1,679.5
 $3.13
 $1,705.1
 $3.31
$421.9
 $0.82
 $495.6
 $0.96
Weighted average diluted ordinary shares outstanding537.0
   523.6
   537.0
   515.2
  516.7
   516.8
  
____________
Significant items for the three and nine months ended September 30, 2017March 31, 2019 include the following:
(a)(a) 
The increase in purchase accounting related amortization for the nine month period is primarily due to the amortization expense associated with the intangible assets related to the Topicals Business and Meda acquisitions. The decreasecertain product rights acquisitions which occurred in purchase accounting related amortization for the three month period is primarily related to approximately $56 million of inventory step-up amortization related to the Topicals Business and Meda acquisitions in the prior year period.2018.
(b) 
Litigation settlements, net decrease is due to an accrual for the Medicaid Drug Rebate Settlement in the prior year periods.
(c)
Change to contingent consideration liability is due to a gain recognized for the fair value adjustment of $88.1 million for the respiratory delivery platform contingent liability included in the nine months ended September 30, 2017. The three and nine months ended September 30, 2016 include approximately $90 million related to the Strides Settlement.
(d)
Acquisition related costs incurred in 2016 primarily relate to the acquisition of the Topicals Business (June 2016) and costs related to the Meda acquisition. These costs primarily related to consulting, professional, and legal costs. Acquisition related costs incurred in 2017 consist primarily of integration activities.
(e)(c) 
For the three months ended March 31, 2019, approximately $14.5 million is included in cost of sales, approximately $0.1 million is included in R&D, and approximately $5.3 million is included in SG&A. Refer to Note 17 Restructuring included in Part I, Item 1 inof this Form 10-Q. Of10-Q for additional information.
(d)
Beginning in 2019, share-based compensation expense is excluded from adjusted net earnings and adjusted EPS. The full year impact for the totalyear ended December 31, 2018 was insignificant. As such, the 2018 quarterly amount approximately $21.0 million is included in cost of sales, $1.1 million is included in R&D, and $51.3 million is included in SG&Awas not added back to U.S. GAAP net earnings for the quarter ended March 31, 2018.
(e)
The three months ended September 30, 2017. ForMarch 31, 2019 increases relate primarily to expenses of $58.8 million for certain incremental manufacturing variances and site remediation activities as a result of the nine months ended September 30, 2017, approximately $37.3 million is included in cost of sales, $2.4 million is included in R&D and $73.0 million is included in SG&A.activities at the Company’s Morgantown plant.
(f) 
For the three months ended March 31, 2019, R&D expense includes $23.3 million related to non-refundable upfront licensing amounts for products in development with the remaining expense relating on-going development collaborations. Refer to Note 4 Acquisitions and Other Transactions included in Part I, Item 1 of this Form 10-Q for additional information. R&D expense for the three months ended September 30, 2017March 31, 2018 includes $8.0two non-refundable upfront payments totaling approximately $43.0 million for development agreements entered into during the quarter.
(g)
The 2018 amount primarily related to Momenta collaboration expense. Formark-to-market losses of investments in equity securities historically accounted for as available-for-sale securities and the nine months ended September 30, 2017, R&D expense includes an upfront expense of approximately $50 million related to a joint development and marketing agreement for a respiratory product, $22.5 million related to Momentacumulative realized gains on such investments.

collaboration expense and other similar smaller agreements. For the nine months ended September 30, 2016, R&D expense includes a $45 million upfront payment to Momenta and $15 million of milestone payments to Theravance Biopharma. In addition, included in this amount for the three and nine months ended September 30, 2016 is approximately $9.0 million and $22.3 million, respectively, of R&D expense incurred related to the Company’s collaboration with Momenta.
Liquidity and Capital Resources
Our primary source of liquidity is net cash provided by operations,operating activities, which was $1.57 billiona net use of cash of $39.7 million for the ninethree months ended September 30, 2017.March 31, 2019. We believe that net cash provided by operating activities and available liquidity will continue to allow us to meet our needs for working capital, capital expenditures and interest and principal payments on debt obligations. Nevertheless, our ability to satisfy our working capital requirements and debt service obligations, or fund planned capital expenditures, will substantially depend upon our future operating performance (which will be affected by prevailing economic conditions), and financial, business and other factors, some of which are beyond our control.

Operating Activities
Net cash provided by operating activities decreased by $128.4$661.5 million to $1.57 billiona net use of cash of $39.7 million for the ninethree months ended September 30, 2017,March 31, 2019, as compared to net cash provided by operating activities of $1.70 billion$621.8 million for the ninethree months ended September 30, 2016. CashMarch 31, 2018. Net cash provided by operating activities is derived byfrom net (loss) earnings adjusted for non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash, including changes in cash primarily reflecting the timing of cash collections from customers, payments to vendors and employees and tax payments in the ordinary course of business.
myl10q_20170xchart-34057.jpgchart-ae834cb462b354ae908.jpg
The net decrease in net cash provided by operating activities was principally due to the following:
a net decrease in non-cash itemsthe amount of $136.7cash provided by accounts receivable of $307.4 million, principally a resultreflecting the timing of a decrease in litigation settlementssales and other contingencies expense, net of $603.8 million related to the accrual for the Medicaid Drug Rebate Program Settlement and the Strides Settlement related to the acquisition of Agila recognized in the prior year period and a decrease of $128.6 million related to unrealized losses on acquisition-related foreign currency derivatives recognized in the prior year period partially offset by increased depreciation and amortization as a result of acquisitions of $233.4 million and an increase in the deferred income tax benefit of $374.0 million;
a decrease in other operating assets and liabilities, net of $319.6 million, principally a result of payments made of approximately $255.2 million related to the Medicaid Drug Rebate Program Settlement and payments of other accruals;cash collections;
a net increase in the amount of cash used through changes in trade accounts payable of $142.4$184.7 million as a result of the timing of cash payments;
a decrease in net earnings of approximately $112.1 million, principally as a result of a decrease in earnings from operations;
a net decrease in non-cash expenses of $77.2 million. The net decrease in non-cash expenses was primarily due to a net decrease in the deferred income tax expense of $9.3 million, a decrease in share-based compensation expense of $3.4 million, a net decrease in other non-cash items of $40.3 million and a decrease in the loss from equity method investments of $6.1 million, partially offset by increased depreciation and amortization of $2.0 million;
a net increase in the amount of cash used through changes in income taxes of $200.6$57.9 million as a result of the level and timing of estimated tax payments made during the current period.
These items were partially offset by the following:
an increase in net earnings for the nine months ended September 30, 2017 of $389.2 million when compared to the prior year period, principally as a result of an increase in earnings from operations;period; and
a net decreaseincrease of $248.8$25.4 million in the amount of cash used through changes in inventory balances; andbalances.

These items were partially offset by a net increase in the amount of cash provided by accounts receivable, including estimated sales allowanceschanges in other operating assets and liabilities of $32.9 million, reflecting the timing of sales, cash collections and disbursements related to sales allowances.$103.2 million.
Investing Activities
CashNet cash used in investing activities was $743.1$75.6 million for the ninethree months ended September 30, 2017,March 31, 2019, as compared to $7.08 billion$428.9 million for the ninethree months ended September 30, 2016,March 31, 2018, a net decrease of $6.34 billion.$353.3 million.
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In 2017,2019, significant items in investing activities included the following:
cash paid for acquisitions, net totaling approximately $71.6 million related to the acquisition of the remaining non-tendered shares of Meda in the compulsory acquisition proceeding;
payments for product rights and other, net totaling approximately $558.8 million, which included a payment of $50.0 million related to the acquisition of intellectual property rights for the Cold-EEZE® brand cold remedy line, payments of $168.0 million related to the acquisition of additional intellectual property rights and marketing authorizations outside of the U.S. and a payment of $277.9 million related to the acquisition of a portfolio of generic product rights in the U.S.;
proceeds from the sale of certain European assets for approximately $31.1$15.4 million;
restricted cash decrease of $12.6 million in the current year due to amounts released from escrow for the payment of certain claims related to the Agila Specialties Private Limited (“Agila”) contingent consideration; and
capital expenditures, primarily for equipment and facilities, totaling approximately $156.4$53.1 million. While there can be no assurance that current expectations will be realized, capital expenditures for the 20172019 calendar year are expected to be approximately $300$250 million to $350$400 million.
In 2016,2018, significant items in investing activities included the following:
cash paid for acquisitions, net totaling approximately $6.15 billion related to the Company’s acquisitions of Meda and the Topicals Business;
restricted cash increase of approximately $50.5$63.3 million related to amounts deposited in escrowdeferred non-contingent purchase price payments for potential contingent consideration payments in connection with the acquisition of the Topicals Business;Apicore Inc.;
payments for product rights and other, net totaling approximately $196.3$342.4 million, which included paymentsa payment of $57.9 million to acquire a marketed pharmaceutical product and $90$325.0 million related to the acquisition ofperpetual rights to Betadine in certain European intellectual property rightsmarkets and marketing authorizations;other products; and
capital expenditures, primarily for equipment and facilities, totaling approximately $239.5 million;$30.7 million.
cash paid for Meda's unconditional deferred payment of approximately $308.0 million; and
cash paid for settlement of acquisition-related foreign currency derivatives of approximately $128.6 million.
Financing Activities
CashNet cash used in financing activities was $1.25 billion$40.1 million for the ninethree months ended September 30, 2017,March 31, 2019, compared to net cash provided byused in financing activities of $5.39 billion$121.4 million for the ninethree months ended September 30, 2016,March 31, 2018, a net decrease of $6.64 billion.$81.3 million.

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In 2017,2019, significant items in financing activities included the following:
proceedspayments totaling approximately $31.8 million of €500the $60.0 million in milestone payments related to the issuancerespiratory delivery platform contingent consideration. The remaining payments related to the respiratory delivery platform contingent consideration are included as a component of the 2020 Floating Rate Euro Notes;
voluntarily prepayments of $1.5 billion of the 2016 Term Loansother operating assets and $245 million of the Meda 2.0kr billion Term Loan; and
liabilities, net repayments of short-term borrowings of $48.3 million.within net cash from operating activities.
In 2016,2018, significant items in financing activities included the following:
proceeds from
long-term debt proceeds of $6.5 billion which was attributable to the Company’s issuance of $1.00 billion aggregate principal amount of 2.500% Senior Notes due 2019, $2.25 billion aggregate principal amount of 3.150% Senior Notes due 2021, $2.25 billion aggregate principal amount of 3.950% Senior Notes due 2026, and $1.00 billion aggregate principal amount of 5.250% Senior Notes due 2046 in the second quarter of 2016 in anticipation of the completion of the offer to acquire all of the outstanding shares of Meda;
payments of the principal amount of $500.0 million on the 1.800% Senior Notes due 2016 which matured on June 24, 2016 and $567.0 million of Meda’s bank loans;
net short-term borrowings of $48.6 million; and
payments of financing fees which totaled $95.3approximately $498.4 million primarily related to borrowings under the 2016 Revolving Facility (as defined in Note 13 Debt included in Part I, Item 1 of this Form 10-Q);

the Company repurchased 9.8 million ordinary shares at a bridge credit agreement related to cost of approximately $432.0 million completingthe Meda acquisition.previously authorized share repurchase program;
long-term debt payments of approximately $498.0 million consisting primarily of repayments of borrowings under the 2016 Revolving Facility; and
a net increase in short-term borrowings of $309.1 million.
Capital Resources
Our cash and cash equivalents at our non-U.S. operations totaled $516.8$229.8 million at September 30, 2017. A portionMarch 31, 2019, and the majority of these funds represented earnings considered to be permanently reinvested to support the growth strategies ofare held by our non-U.S. subsidiaries. The Company anticipates having sufficient U.S. liquidity, including existing borrowing capacity under its revolving credit facility dated as of November 22, 2016 (as amended, supplemented or otherwise modified from time to time, the “20162018 Revolving Facility”), amongFacility, the Company, certain affiliates and subsidiaries of the Company from time to time party thereto as guarantors, each lender from time to time party thereto and Bank of America, N.A., as administrative agent, including the commercial paper program, andCommercial Paper Program, the Receivables Facility (asand the Note Securitization Facility (each as defined below)below other than the 2018 Revolving Facility and the Commercial Paper Program, which are defined in Note 13 Debt in Part I, Item 1 of this Form 10-Q) combined with cash to be generated from operations, to fund foreseeable U.S. cash needs without requiring the repatriation of non-U.S. cash. If these funds are ultimately needed for the Company’s operations in the U.S., the Company may be required to accrue and pay U.S. taxes to repatriate these funds. If funds are needed from the Company’s subsidiaries that do not have an ultimate U.S. parent, the Company will generally not be required to accrue and pay taxes to repatriate these funds because its foreign parent would not be subject to tax on receipt of these distributions.
The Company has access to $2.0 billion under the 20162018 Revolving Facility which also includes a $200 million subfacility for the issuance of letters of credit and a $175 million sublimit for swingline borrowings. As of September 30, 2017, we had $192.1 million available under the $200 million subfacility on our 2016 Revolving Facility for the issuance of letters of credit.matures in 2023. Up to $1.65 billion of the 20162018 Revolving Facility may be used to support future borrowingborrowings under our commercial paper program.

Commercial Paper Program.
In addition to the 20162018 Revolving Facility, MPI,Mylan Pharmaceuticals Inc., a wholly owned subsidiary of the Company, has a $400 million receivables facility (the “Receivables Facility”), which will expire in January 2018. Although from time-to-time, the available amount oforiginally expired on April 25, 2019. On April 25, 2019, we entered into an amendment to the Receivables Facility may be less than $400 million based on accounts receivable concentration limits and other eligibility requirements. Underto extend the terms of the Receivables Facility, MPI sells certain accounts receivableexpiration date to Mylan Securitization LLC, a wholly owned special purpose entity which in turn sells a percentage of ownership interest in the receivables to financial institutions and commercial paper conduits sponsored by financial institutions.April 22, 2022. As of September 30, 2017,March 31, 2019, the Company had no amounts outstanding under the Receivables Facility.
On April 25, 2019, we entered into an additional facility for borrowings up to $200 million (the “Note Securitization Facility”). Under the terms of each of the Receivables Facility and Note Securitization Facility, certain of our accounts receivable secure the amounts borrowed and cannot be used to pay our other debts or liabilities. The amount that we may borrow at a given point in time is determined based on the amount of qualifying accounts receivable that are present at such point in time. Borrowings outstanding under the Receivables Facility bear interest at a commercial paper rate plus 0.775% and under the Note Securitization Facility at LIBOR plus 0.75% and are included as a component of Short-term borrowings, while the accounts receivable securing these obligations remain as a component of accounts receivable, net, in our condensed consolidated balance sheets. In addition, the agreements governing the Receivables Facility and Note Securitization Facility contain various customary affirmative and negative covenants, and customary default and termination provisions.
At September 30, 2017,March 31, 2019, our long-term debt, including the current portion, totaled $13.99$13.74 billion, as compared to $15.20$13.82 billion at December 31, 2016.2018. Total long-term debt is calculated net of deferred financing fees which were $79.6$71.1 million and $92.2$74.6 million at September 30, 2017March 31, 2019 and December 31, 2016,2018, respectively. The decrease in long-term debt was due to the prepayment of a portion of the 2016 Term Loans during the nine months ended September 30, 2017 offset by the issuance of the 2020 Floating Rate Euro Notes. The total long-term debt balance at September 30, 2017 was comprised primarily of $100 million of term loans, $91.4 million of Medium Term Notes acquired from Meda, $12.69 billion of fixed rate senior notes and $1.18 billion of floating rate senior notes. In addition, at September 30, 2017, we had $722.8 million of long-term debt classified as current and payable within the next twelve months, as compared to $223.3 million at December 31, 2016. The increase to the current portion of long-term debt is due to the reclassification of the 2.600% Senior Notes due 2018 which mature in June 2018 offset by the prepayment of the Meda 2.0kr billion Term Loan. In addition to the current portion of long-term debt, the Company has significant debt maturities in the fourth quarter of 2018, as the Floating Rate Euro Notes mature in November 2018 and the 3.000% Senior Notes due 2018 mature in December 2018. The Company intends to utilize available liquidity to fund these repayments.
For additional information regarding our debt and debt agreements refer to Note 13 12Debt in Part I, Item 1 inof this Form 10-Q.
Long-term Debt Maturity
Mandatory minimum repayments remaining on the outstanding notional amount of long-term debt at September 30, 2017 areMarch 31, 2019 was as follows for each of the periods ending December 31:
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The Company’s term loan credit facility dated as2016 Term Facility (as defined in Note 13 Debt in Part I, Item 1 of November 22, 2016 (as amended, supplemented or otherwise modified from time to time, the “2016 Term Facility”), among the Company, certain affiliatesthis Form 10-Q) and subsidiaries of the Company from time to time party thereto as guarantors, each lender from time to time party thereto and Goldman Sachs Bank USA, as administrative agent and 20162018 Revolving Facility containeach contains customary affirmative covenants for facilities of this type, including among others, covenants pertaining to the delivery of financial statements, notices of default and certain material events, maintenance of corporate existence and rights, property, and insurance and compliance with laws, as well as customary negative covenants for facilities of this type, including limitations on the incurrence of subsidiary indebtedness, liens, mergers and certain other fundamental changes, investments and loans, acquisitions, transactions with affiliates, payments of dividends and other restricted payments and changes in our lines of business.
The 2016 Term Facility and 20162018 Revolving Facility contain a maximum consolidated leverage ratio financial covenant requiring maintenance of a maximum ratio of 3.75 to 1.00 for consolidated total indebtedness as of the end of any quarter to consolidated EBITDA for the trailing four quarters as defined in the related credit agreements (“leverage ratio”).
The Company is2016 Term Facility was amended in compliance at September 30, 2017.
Following the Meda acquisition (a qualifying acquisition), theNovember 2017 to allow a leverage ratio changedof 4.25 to 1.00 through the December 31, 2018 reporting period and a leverage ratio of 3.75 to 1.00 thereafter. The 2018 Revolving Facility similarly provides for a leverage ratio to 4.25 to 1.00 through June 30, 2017.the December 31, 2018 reporting period and a leverage ratio of 3.75 to 1.00 thereafter. On November 3, 2017,February 22, 2019, the Company, as a guarantor, and Mylan Inc., as borrower, entered into an amendment (the "Revolving Loan Amendment") to the 2018 Revolving Facility. In addition, on February 22, 2019, the Company entered into amendmentsan amendment (the "Term Loan Amendment") to the agreements for the 2016 Term FacilityFacility. The Revolving Loan Amendment and 2016

Revolving Facility to extendthe Term Loan Amendment extended the leverage ratio covenant of 4.25 to 1.00 through the December 31, 20182019 reporting period.period, with a leverage ratio of 3.75 to 1.00 thereafter. The Company is in compliance at March 31, 2019 and expects to remain in compliance for the next twelve months.
Business Acquisitions, Collaboration and Licensing Agreements
We periodically enter into collaboration and licensing agreements with other pharmaceutical companies for the development, manufacture, marketing and/or sale of pharmaceutical products. Our significant collaboration agreements are primarily focused on the development, manufacturing, supply and commercialization of multiple, high-value generic biologic compounds, insulin analog products and respiratory products, among other complex products. Under these agreements, we have future potential milestone payments and co-development expenses payable to third parties as part of our licensing, development and co-development programs. Payments under these agreements generally become due and are payable upon the satisfaction or achievement of certain developmental, regulatory or commercial milestones or as development expenses are incurred on defined projects. Milestone payment obligations are uncertain, including the prediction of timing and the occurrence of events triggering a future obligation and are not reflected as liabilities in the Condensed Consolidated Balance Sheets,condensed consolidated balance sheets, except for milestone and royalty obligations reflected as acquisition related contingent consideration. Refer to Note 12 Financial Instruments and Risk Management in Part I, Item of this Form 10-Q for additional information. Our potential maximum development milestones not accrued for at March 31, 2019 totaled approximately $440.0 million, which includes the new agreements entered into during 2019. We estimate that the amounts that may be paid in the next twelve months to be approximately $55 million. These agreements may also include potential sales basedsales-based milestones and call for us to pay a percentage of amounts earned from the sale of the product as a royalty or a profit share. The amounts disclosed do not include sales-based milestones or royalty obligations on future sales of product as the timing and amount of future sales levels and costs to produce products subject to these obligations is not reasonably estimable. These sales basedsales-based milestones or royalty obligations may be significant depending upon the level of commercial sales for each product.
OurWe are contractually obligated to make potential future development, regulatory and commercial milestone, royalty and/or profit sharing payments in conjunction with acquisitions we have entered into with third parties. The most significant contingent paymentof these relates to the potential future consideration related to our December 2011 acquisition of the respiratory delivery platform. These payments are contingent upon the occurrence of certain future events and, given the ultimate success of the respective projects. Given the inherent uncertaintynature of these events, it is unclear when, if ever, we may be required to pay such amounts or pay amounts in excess of those accrued. The Company has also recorded contingent consideration related to the acquisition of the Topicals Business, the acquisition of Jai Pharma Limited, the acquisition of Agila Specialties Private Limited (“Agila”) and certain other acquisitions.amounts. The amount of the contingent consideration recordedliabilities was $471.1 million and $564.6$295.1 million at September 30, 2017 and DecemberMarch 31, 2016, respectively.2019. In addition, the Company expects to incur approximately $25$15 million to $30$20 million of annualnon-cash accretion expense related to the increase in the net present value of the contingent consideration liability.
In conjunction with the Company’s Generic Drug User Fee Agreement goal date, on March 28, 2017, the Company received a complete response letter from the FDA regarding its Abbreviated New Drug Application for the respiratory delivery platform. As of September 30, 2017, the Company has an IPR&D asset of $347.2 million and a related contingent consideration liability of $361.0 million. The Company performed an analysis and valuation of the IPR&D asset and the fair value of the related contingent consideration liability using a discounted cash flow model. The model contained certain key assumptions including: the expected product launch date, the number of competitors, the timing of competition and a discount factor based on an industry specific weighted average cost of capital. Based on the analysis performed, the Company determined that the IPR&D asset was not impaired at September 30, 2017. Additionally, no fair value adjustment was required for the contingent consideration during the three months ended September 30, 2017. In the second quarter of 2017, a fair value adjustment was required for the contingent consideration liability resultingliabilities in a gain of approximately $88.1 million based upon changes to assumptions relating to the timing of the product launch along with other competitive and market factors. The fair value of the contingent consideration liability was determined based upon detailed valuations employing the income approach which utilized Level 3 inputs, as defined in Note 11 - Financial Instruments and Risk Management. Resolution of the matters with the FDA, market conditions and other factors may result in significant future changes in the projections and assumptions utilized in the discounted cash flow model, which could lead to material adjustments to the amounts recorded for IPR&D and contingent consideration.
In October 2017, the Company finalized an agreement to acquire the perpetual license to Betadine in certain European markets. An estimated liability of approximately $300 million for the purchase of these rights was accrued for on the Meda acquisition opening balance sheet. The Company does not expect that a material adjustment to this liability will be necessary upon closing of the transaction in early 2018.
On October 3, 2017, the Company completed the acquisition of a U.S. based developer and manufacturer of API for approximately $189 million, which includes $15 million of contingent payments based on the achievement of certain financial results of the acquired business following the closing of the transaction.
We are actively pursuing, and are currently involved in, joint projects related to the development, distribution and marketing of both generic and branded products. Many of these arrangements provide for payments by us upon the attainment

of specified milestones. While these arrangements help to reduce the financial risk for unsuccessful projects, fulfillment of specified milestones or the occurrence of other obligations may result in fluctuations in cash flows.2019.
Other Commitments
We areThe Company is involved in various disputes, governmental and/or regulatory inquiries, investigations and proceedings, tax proceedings and litigation matters, both in the U.S. and abroad, that arise from time to time, some of which could result in financial losses, including damages, fines and/or othercivil penalties, and/or criminal charges (civil and criminal) against the Company, including the possibility of not being ableCompany. These matters are often complex and have outcomes that are difficult to conduct business in a specific jurisdiction. While it is not possible to predict the outcome of such proceedings, an adverse outcome in any of these proceedings could materially affect our business, financial condition, results of operations, and cash flows and could cause the market value of our ordinary shares to decline. We have approximately $402 million accrued for legal contingencies at September 30, 2017. In October, we paid approximately $217.5 million related to the Medicaid Drug Rebate Program Settlement.predict. The Company is also party to certain proceedings and litigation matters for which it may be entitled to indemnification under the respective sale and purchase agreements relating to

the acquisitions of the former Merck Generics business, Agila andSpecialties Private Limited, the EPD Business, and certain other acquisitions. TheWe have approximately $53 million accrued for legal contingencies at March 31, 2019.
While the Company believes that it has meritorious defenses with respect to the claims asserted against it and intends to vigorously defend its position, the process of resolving these matters is inherently uncertain and may develop over a long period of time, and so it is not possible to predict the ultimate resolution of any such matter. It is possible that an unfavorable resolution of any of the ongoing matters or the inability or denial of Merck KGaA, Strides Arcolab Limited, Abbott Laboratories, or another indemnitor or insurer to pay on an indemnified claim, could have a material adverse effect on ourthe Company’s business, financial condition, results of operations, cash flows and/or ordinary share price.
In the normal course of business, Mylan periodically enters into employment, legal settlement and other agreements which incorporate indemnification provisions. While the maximum amount to which Mylan may be exposed under such agreements cannot be reasonably estimated, the Company maintains insurance coverage, which management believes will effectively mitigate the Company’s obligations under these indemnification provisions. No amounts have been recorded in the condensed consolidated financial statements with respect to the Company’s obligations under such agreements.
The Company has also entered into employment and other agreements with certain executives and other employees that provide for compensation, retirement and certain other benefits. These agreements provide for severance payments under certain circumstances. Additionally, the Company has split-dollar life insurance agreements with certain retired executives.
We are continuously evaluating the potential acquisition of products, as well as companies, as a strategic part of our future growth. Consequently, we may utilize current cash reserves or incur additional indebtedness to finance any such acquisitions, which could impact future liquidity. In addition, on an ongoing basis, we review our operations including the evaluation of potential divestitures of products and businesses as part of our future strategy. Any divestitures could impact future liquidity.
ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
For a discussion of the Company’s market risk, see “Item 7A. Quantitative and Qualitative Disclosures about Market Risk” in Mylan N.V.’s Annual Report filed on Form 10-K for the year ended December 31, 2016,2018, as amended.
ITEM 4.CONTROLS AND PROCEDURES
An evaluation was performed under the supervision and with the participation of the Company’s management, including the Principal Executive Officer and the Principal Financial Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures as of September 30, 2017.March 31, 2019. Based upon that evaluation, the Principal Executive Officer and the Principal Financial Officer concluded that the Company’s disclosure controls and procedures were effective.
Management has not identified the following changeany changes in the Company’s internal control over financial reporting (“ICFR”) that occurred during the first quarter of 2019 that hashave materially affected, or isare reasonably likely to materially affect, the Company’s ICFR. During the quarter ended September 30, 2017, the Company continued to implement and utilize a new Enterprise Resource Planning (“ERP”) system in certain countries, which, when completed, will handle the business,internal control over financial and administrative processes for the Company. The Company has modified and will continue to modify its internal controls relating to its business and financial processes throughout the entire ERP system implementation, which is expected to progress through the end of 2017. While the Company believes that this new system and the related changes to internal controls will ultimately strengthen its ICFR, there are inherent risks in implementing any new ERP system and the Company will continue to evaluate and test control changes in order to provide certification as of its fiscal year ending December 31, 2017 on the effectiveness of its ICFR.reporting.

PART II — OTHER INFORMATION
ITEM 1.LEGAL PROCEEDINGS
For information regarding legal proceedings, refer to Note 1920 Litigation, in the accompanying Notes to interim financial statements in this Quarterly Report.Form 10-Q.
ITEM 1A.
RISK FACTORS
There have been no material changes in the Company’s risk factors from those disclosed in Mylan’s Annual Report on Form 10-K for the year ended December 31, 2016,2018, as amended.
ITEM 5.
OTHER INFORMATION
On November 3, 2017, the Company entered into an amendment (the “Revolving Loan Amendment”) to the 2016 Revolving Facility. In addition, on November 3, 2017, the Company entered into an amendment (the “Term Loan Amendment”) to the 2016 Term Facility. The Revolving Loan Amendment and the Term Loan Amendment increased the maximum consolidated leverage ratio from 3.75 to 1.00 to 4.25 to 1.00 through the December 31, 2018 reporting period in the maximum consolidated leverage ratio financial covenant, which requires maintenance of a maximum ratio of consolidated total indebtedness as of the end of any quarter to consolidated EBITDA for the trailing four quarters (as defined in the 2016 Revolving Facility and 2016 Term Facility). The Company is in compliance with this covenant at September 30, 2017, and expects to remain in compliance for the next twelve months.
The foregoing description does not purport to be complete and its qualified in its entirety by reference to the Revolving Loan Amendment and Term Loan Amendment, which are attached hereto as Exhibit 10.3 and Exhibit 10.4, respectively, and which are incorporated herein by reference.

ITEM 6. EXHIBITS
  
SettlementThird Amended and Restated Executive Employment Agreement, with the U.S. Departmententered into on February 25, 2019, and effective as of JusticeApril 1, 2019, by and two relators finalizing the Medicaid drug rebate settlement, dated August 16, 2017,between Mylan Inc. and Heather Bresch, filed as Exhibit 10.110.19(c) to Form 10-K for the Report on Form 8-K filed with the SEC on August 21, 2017,fiscal year ended December 31, 2018, and incorporated herein by reference.
reference.*
  
Corporate IntegrityThird Amended and Restated Executive Employment Agreement, between the Officeentered into on February 25, 2019, and effective as of Inspector General of the Department of HealthApril 1, 2019, by and Human Services andbetween Mylan Inc. and Mylan Specialty L.P., dated August 16, 2017,Rajiv Malik, filed as Exhibit 10.210.20(c) to the Report on Form 8-K filed with10-K for the SEC on August 21, 2017,fiscal year ended December 31, 2018, and incorporated herein by reference.
reference.*
  
Amendment,Executive Employment Agreement, dated as of September 30, 2017,February 25, 2019, and effective as of April 1, 2019, by and between Mylan Inc. and Anthony Mauro, filed as Exhibit 10.21(b) to the revolving credit facilityForm 10-K for the fiscal year ended December 31, 2018, and incorporated herein by reference.*
Executive Employment Agreement, dated as of NovemberFebruary 25, 2019, and effective as of April 1, 2019, by and between Mylan Inc. and Kenneth S. Parks, filed as Exhibit 10.22(b) to the Form 10-K for the fiscal year ended December 31, 2018, and incorporated herein by reference.*
Consulting Agreement, entered into on February 25, 2019, by and between Mylan Inc. and Daniel M. Gallagher, filed as Exhibit 10.23(b) to the Form 10-K for the fiscal year ended December 31, 2018, and incorporated herein by reference.*
Form of Performance-Based Restricted Stock Unit Award Agreement under the 2003 Long-Term Incentive Plan for Heather Bresch and Rajiv Malik for awards granted on or after February 19, 2019.*
Form of Stock Option Agreement under the 2003 Long-Term Incentive Plan for Heather Bresch and Rajiv Malik for awards granted on or after February 19, 2019.*
Form of Restricted Stock Unit Award Agreement under the 2003 Long-Term Incentive Plan for Heather Bresch and Rajiv Malik for awards granted on or after February 19, 2019.*
Amendment No. 1, dated as of February 22, 2016,2019, to the Revolving Credit Agreement dated as of July 27, 2018, among Mylan Inc., as borrower, Mylan N.V., as a guarantor, the Company, certain affiliates and subsidiaries of the Company from time to timeother guarantors party thereto, as guarantors, each lendercertain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent.agent, filed as Exhibit 10.34(b) to the Form 10-K for the fiscal year ended December 31, 2018, and incorporated herein by reference.
  
Amendment No. 2, dated as of September 30, 2017,February 22, 2019, to the term loan credit facilityTerm Credit Agreement dated as of November 22, 2016, among the Company, certain affiliates and subsidiaries of the Company from time to time party thereto as guarantors, each lender from time to time party thereto and Goldman Sachs Bank USA, as administrative agent.agent, filed as Exhibit 10.35(c) to the Form 10-K for the fiscal year ended December 31, 2018, and incorporated herein by reference.
  
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
  
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

  
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
  
101.INSXBRL Instance Document
  
101.SCHXBRL Taxonomy Extension Schema
  
101.CALXBRL Taxonomy Extension Calculation Linkbase
  
101.DEFXBRL Taxonomy Definition Linkbase
  
101.LABXBRL Taxonomy Extension Label Linkbase
  
101.PREXBRL Taxonomy Extension Presentation Linkbase
* Denotes management contract or compensatory plan or arrangement

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
  
Mylan N.V.
(Registrant)
   
 By:/s/ HEATHER BRESCH
  Heather Bresch
  Chief Executive Officer
  (Principal Executive Officer)
November 6, 2017May 7, 2019
  /s/ KENNETH S. PARKS
  Kenneth S. Parks
  Chief Financial Officer
  (Principal Financial Officer)
November 6, 2017May 7, 2019

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