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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 10-Q
☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2020
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)
Netherlands 98-1493528
(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)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class: Trading Symbol(s): Name of each exchange on which registered:
Ordinary shares, nominal value €0.01 MYL The NASDAQ Stock Market

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  ☑    No  ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files).    Yes  ☑    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.
Large accelerated filer ☑ Accelerated filer ☐
Non-accelerated filer
☐ 
Smaller reporting company ☐
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use 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  ☑
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
As of October 30, 2020, there were 541,545,862 of the issuer’s €0.01 nominal value ordinary shares outstanding.

Table of Contents
MYLAN N.V. AND SUBSIDIARIES
INDEX TO FORM 10-Q
For the Quarterly Period Ended
September 30, 2020
  
Page
PART I — FINANCIAL INFORMATION
ITEM 1. Condensed Consolidated Financial Statements (unaudited)
3
4
5
6
8
9
ITEM 2.
51
ITEM 3.
78
ITEM 4.
78
PART II — OTHER INFORMATION
ITEM 1.
79
ITEM 1A.
80
ITEM 6.
81
82
2
Table of Contents
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 Ended
September 30, September 30,
  2020 2019 2020 2019
Revenues:
Net sales $ 2,948.1  $ 2,928.2  $ 8,232.2  $ 8,207.0 
Other revenues 24.0  33.5  90.3  101.7 
Total revenues 2,972.1  2,961.7  8,322.5  8,308.7 
Cost of sales 1,813.6  1,889.3  5,232.2  5,498.5 
Gross profit 1,158.5  1,072.4  3,090.3  2,810.2 
Operating expenses:
Research and development 129.8  167.9  400.3  488.1 
Selling, general and administrative 658.4  632.7  1,983.2  1,909.2 
Litigation settlements and other contingencies, net 18.9  (51.9) 36.5  (30.3)
Total operating expenses 807.1  748.7  2,420.0  2,367.0 
Earnings from operations 351.4  323.7  670.3  443.2 
Interest expense 117.3  128.9  353.4  391.3 
Other (income) expense, net (7.5) 9.0  24.6  32.7 
Earnings (Loss) before income taxes 241.6  185.8  292.3  19.2 
Income tax provision (benefit) 55.9  (4.0) 46.4  22.9 
Net earnings (loss) $ 185.7  $ 189.8  $ 245.9  $ (3.7)
Earnings (Loss) per ordinary share:
Basic $ 0.36  $ 0.37  $ 0.48  $ (0.01)
Diluted $ 0.36  $ 0.37  $ 0.48  $ (0.01)
Weighted average ordinary shares outstanding:
Basic 516.9  516.0  516.8  515.5 
Diluted 517.7  516.2  517.3  515.5 


See Notes to Condensed Consolidated Financial Statements
3

Table of Contents
MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Earnings (Loss)
(Unaudited; in millions)
  Three Months Ended Nine Months Ended
September 30, September 30,
  2020 2019 2020 2019
Net earnings (loss) $ 185.7  $ 189.8  $ 245.9  $ (3.7)
Other comprehensive earnings (loss), before tax:
Foreign currency translation adjustment 687.7  (748.9) 483.1  (890.8)
Change in unrecognized (loss) gain and prior service cost related to defined benefit plans (1.6) (0.7) 3.4  (0.5)
Net unrecognized gain (loss) on derivatives in cash flow hedging relationships 32.5  (10.6) (0.2) 24.8 
Net unrecognized (loss) gain on derivatives in net investment hedging relationships (114.7) 111.8  (119.7) 133.6 
Net unrealized gain on marketable securities —  0.1  0.8  0.7 
Other comprehensive earnings (loss), before tax 603.9  (648.3) 367.4  (732.2)
Income tax provision (benefit) 2.8  1.2  (6.0) 14.1 
Other comprehensive earnings (loss), net of tax 601.1  (649.5) 373.4  (746.3)
Comprehensive earnings (loss) $ 786.8  $ (459.7) $ 619.3  $ (750.0)



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,
2020 		December 31,
2019
ASSETS
Assets
Current assets:
Cash and cash equivalents $ 664.5  $ 475.6 
Accounts receivable, net 2,964.1  3,058.8 
Inventories 3,022.0  2,670.9 
Prepaid expenses and other current assets 684.1  552.0 
Total current assets 7,334.7  6,757.3 
Property, plant and equipment, net 2,058.3  2,149.6 
Intangible assets, net 10,965.8  11,649.9 
Goodwill 9,817.3  9,590.6 
Deferred income tax benefit 658.1  703.1 
Other assets 408.9  405.0 
Total assets $ 31,243.1  $ 31,255.5 
LIABILITIES AND EQUITY
Liabilities
Current liabilities:
Accounts payable $ 1,447.8  $ 1,528.1 
Short-term borrowings 0.3  — 
Income taxes payable 343.3  213.0 
Current portion of long-term debt and other long-term obligations 3,237.8  1,508.1 
Other current liabilities 2,246.2  2,319.9 
Total current liabilities 7,275.4  5,569.1 
Long-term debt 9,101.5  11,214.3 
Deferred income tax liability 1,417.4  1,627.5 
Other long-term obligations 900.9  960.8 
Total liabilities 18,695.2  19,371.7 
Equity
Mylan N.V. shareholders’ equity
Ordinary shares — nominal value €0.01 per ordinary share
Shares authorized: 1,200,000,000
Shares issued: 541,550,055 and 540,746,871 as of September 30, 2020 and December 31, 2019
6.1  6.1 
Additional paid-in capital 8,688.3  8,643.5 
Retained earnings 6,277.0  6,031.1 
Accumulated other comprehensive loss (1,423.8) (1,797.2)
13,547.6  12,883.5 
Less: Treasury stock — at cost
Ordinary shares: 24,598,074 as of September 30, 2020 and December 31, 2019
999.7  999.7 
Total equity 12,547.9  11,883.8 
Total liabilities and equity $ 31,243.1  $ 31,255.5 

See Notes to Condensed Consolidated Financial Statements
5

Table of Contents
MYLAN N.V. AND SUBSIDIARIES
Condensed Consolidated Statements of Equity
(Unaudited; in millions, except share amounts)
Additional Paid-In Capital Retained
Earnings 		Accumulated Other Comprehensive Loss Total
Equity
  Ordinary Shares Treasury Stock
  Shares Cost Shares Cost
Balance at June 30, 2020 541,545,308  $ 6.1  $ 8,673.2  $ 6,091.5  24,598,074  $ (999.7) $ (2,024.9) $ 11,746.2 
Net earnings —  —  —  185.7  —  —  —  185.7 
Other comprehensive earnings, net of tax —  —  —  —  —  —  601.1  601.1 
Issuance of restricted stock and stock options exercised, net 4,747  —  —  —  —  —  —  — 
Share-based compensation expense —  —  15.1  —  —  —  —  15.1 
Other —  —  —  (0.2) —  —  —  (0.2)
Balance at September 30, 2020 541,550,055  $ 6.1  $ 8,688.3  $ 6,277.0  24,598,074  $ (999.7) $ (1,423.8) $ 12,547.9 
Additional Paid-In Capital Retained
Earnings 		Accumulated Other Comprehensive Loss Total
Equity
Ordinary Shares Treasury Stock
Shares Cost Shares Cost
Balance at December 31, 2019 540,746,871  $ 6.1  $ 8,643.5  $ 6,031.1  24,598,074  $ (999.7) $ (1,797.2) $ 11,883.8 
Net earnings —  —  —  245.9  —  —  —  245.9 
Other comprehensive earnings, net of tax —  —  —  —  —  —  373.4  373.4 
Issuance of restricted stock and stock options exercised, net 803,184  —  0.6  —  —  —  —  0.6 
Taxes related to the net share settlement of equity awards —  —  (5.6) —  —  —  —  (5.6)
Share-based compensation expense —  —  49.8  —  —  —  —  49.8 
Balance at September 30, 2020 541,550,055  $ 6.1  $ 8,688.3  $ 6,277.0  24,598,074  $ (999.7) $ (1,423.8) $ 12,547.9 
See Notes to Condensed Consolidated Financial Statements
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Additional Paid-In Capital Retained
Earnings 		Accumulated Other Comprehensive Loss Total
Equity
  Ordinary Shares Treasury Stock
  Shares Cost Shares Cost
Balance at June 30, 2019 540,459,996  $ 6.1  $ 8,617.3  $ 5,820.8  24,598,074  $ (999.7) $ (1,541.7) $ 11,902.8 
Net earnings —  —  —  189.8  —  —  —  189.8 
Other comprehensive loss, net of tax —  —  —  —  —  —  (649.5) (649.5)
Issuance of restricted stock and stock options exercised, net 279,505  —  4.2  —  —  —  —  4.2 
Share-based compensation expense —  —  16.1  —  —  —  —  16.1 
Balance at September 30, 2019 540,739,501  $ 6.1  $ 8,637.6  $ 6,010.6  24,598,074  $ (999.7) $ (2,191.2) $ 11,463.4 
Additional Paid-In Capital Retained
Earnings 		Accumulated Other Comprehensive Loss Total
Equity
Ordinary Shares Treasury Stock
Shares Cost Shares Cost
Balance at December 31, 2018 539,289,665  $ 6.0  $ 8,591.4  $ 6,010.7  23,490,867  $ (999.7) $ (1,441.3) $ 12,167.1 
Net loss —  —  —  (3.7) —  —  —  (3.7)
Other comprehensive loss, net of tax —  —  —  —  —  —  (746.3) (746.3)
Issuance of restricted stock and stock options exercised, net 1,449,836  —  8.1  —  —  —  —  8.1 
Taxes related to the net share settlement of equity awards —  —  (12.8) —  —  —  —  (12.8)
Share-based compensation expense —  —  50.9  —  —  —  —  50.9 
Cancellation of restricted stock —  0.1  —  —  1,107,207  —  —  0.1 
Cumulative effect of the adoption of new accounting standards —  —  —  3.6  —  —  (3.6) — 
Balance at September 30, 2019 540,739,501  $ 6.1  $ 8,637.6  $ 6,010.6  24,598,074  $ (999.7) $ (2,191.2) $ 11,463.4 


See Notes to Condensed Consolidated Financial Statements
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Condensed Consolidated Statements of Cash Flows
(Unaudited; in millions)
Nine Months Ended
September 30,
  2020 2019
Cash flows from operating activities:
Net earnings (loss) $ 245.9  $ (3.7)
Adjustments to reconcile net earnings (loss) to net cash provided by operating activities:
Depreciation and amortization 1,263.0  1,471.6 
Share-based compensation expense 49.8  50.9 
Deferred income tax benefit (210.4) (158.0)
Loss from equity method investments 37.4  43.6 
Other non-cash items 134.3  124.2 
Litigation settlements and other contingencies, net 43.6  13.5 
Changes in operating assets and liabilities:
Accounts receivable (27.3) (20.7)
Inventories (532.4) (477.6)
Accounts payable (99.7) (83.2)
Income taxes 115.2  (60.2)
Other operating assets and liabilities, net 176.2  216.6 
Net cash provided by operating activities 1,195.6  1,117.0 
Cash flows from investing activities:
Cash paid for acquisitions, net —  (148.7)
Capital expenditures (126.1) (139.6)
Purchase of available for sale securities and other investments (96.1) (19.5)
Proceeds from the sale of marketable securities 38.6  19.1 
Payments for product rights and other, net (97.3) (146.5)
Proceeds from the sale of assets 2.1  24.3 
Net cash used in investing activities (278.8) (410.9)
Cash flows from financing activities:
Proceeds from issuance of long-term debt 33.2  6.4 
Payments of long-term debt (588.9) (657.1)
Non-contingent payments for product rights (139.5) — 
Change in short-term borrowings, net 0.3  (1.9)
Taxes paid related to net share settlement of equity awards (7.1) (8.4)
Contingent consideration payments (48.5) (47.8)
Payments of financing fees (1.8) (2.7)
Proceeds from exercise of stock options 0.6  8.0 
Other items, net (3.1) (1.1)
Net cash used in financing activities (754.8) (704.6)
Effect on cash of changes in exchange rates 14.0  (16.4)
Net increase (decrease) in cash, cash equivalents and restricted cash 176.0  (14.9)
Cash, cash equivalents and restricted cash — beginning of period 491.1  389.3 
Cash, cash equivalents and restricted cash — end of period $ 667.1  $ 374.4 
See Notes to Condensed Consolidated Financial Statements
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Notes to Condensed Consolidated Financial Statements (Unaudited)

1.General
The accompanying unaudited condensed 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.
The global spread of the coronavirus disease 2019 (“COVID-19”) has created significant volatility, uncertainty and economic disruption affecting the markets we serve in North America, Europe and Rest of World, including Asia. Certain significant impacts of COVID-19 on our business are discussed in these notes to the condensed consolidated financial statements.
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, 2019, as amended (the “2019 Form 10-K”). The December 31, 2019 condensed consolidated balance sheet was derived from audited financial statements.
The interim results of operations and comprehensive earnings (loss) for the three and nine months ended September 30, 2020, and cash flows for the nine months ended September 30, 2020, are not necessarily indicative of the results to be expected for the full fiscal year or any other future period.

2.Revenue Recognition and Accounts Receivable
The Company recognizes revenue in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, the Company recognizes net revenue for product sales when control of the promised goods or services is transferred to our customers in 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 variable consideration, including discounts, rebates, governmental rebate programs, price adjustments, returns, chargebacks, promotional programs and other sales allowances. Accruals for these provisions are presented in the condensed consolidated financial statements as reductions in determining net sales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash).
Our net sales may be impacted by wholesaler and distributor inventory levels of our products, which can fluctuate throughout the year due to the seasonality of certain products, pricing, the timing of product demand, customer purchasing decisions and other factors. Such fluctuations may impact the comparability of our net sales between periods.
Consideration received from licenses of intellectual property is recorded as other revenues. Royalty or profit share amounts, which are based on sales of licensed products or technology, are recorded when the customer’s subsequent sales or usages occur. Such consideration is included in other revenue in the condensed consolidated statements of operations.
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The following table presents the Company’s net sales by therapeutic franchise for each of our reportable segments for the three and nine months ended September 30, 2020 and 2019, respectively:
(In millions) North America Europe Rest of World Total
Three Months Ended September 30, 2020
Central Nervous System & Anesthesia $ 181.8  $ 211.5  $ 81.1  $ 474.4 
Infectious Disease 37.3  197.2  272.6  507.1 
Respiratory & Allergy 284.9  103.1  74.4  462.4 
Cardiovascular 58.5  125.6  38.4  222.5 
Gastroenterology 41.8  166.2  91.7  299.7 
Diabetes & Metabolism 70.8  80.1  36.3  187.2 
Dermatology 33.2  72.8  20.3  126.3 
Women’s Healthcare 96.0  60.5  34.0  190.5 
Oncology 171.4  30.4  40.0  241.8 
Immunology 7.9  35.2  10.2  53.3 
Other (1)
45.2  41.2  96.5  182.9 
Total $ 1,028.8  $ 1,123.8  $ 795.5  $ 2,948.1 
Nine Months Ended September 30, 2020
Central Nervous System & Anesthesia $ 484.0  $ 631.0  $ 210.8  $ 1,325.8 
Infectious Disease 120.7  320.1  756.8  1,197.6 
Respiratory & Allergy 890.4  362.3  165.6  1,418.3 
Cardiovascular 184.4  372.7  102.9  660.0 
Gastroenterology 121.0  465.6  252.6  839.2 
Diabetes & Metabolism 187.4  231.7  89.7  508.8 
Dermatology 87.8  215.0  57.2  360.0 
Women’s Healthcare 275.9  180.6  84.9  541.4 
Oncology 470.8  71.2  103.8  645.8 
Immunology 26.9  88.3  27.2  142.4 
Other (1)
174.0  142.2  276.7  592.9 
Total $ 3,023.3  $ 3,080.7  $ 2,128.2  $ 8,232.2 
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
(In millions) North America Europe Rest of World Total
Three Months Ended September 30, 2019
Central Nervous System & Anesthesia $ 155.5  $ 214.3  $ 87.0  $ 456.8 
Infectious Disease 28.7  179.0  270.3  478.0 
Respiratory & Allergy 308.5  98.2  66.6  473.3 
Cardiovascular 63.3  126.2  41.3  230.8 
Gastroenterology 30.0  147.9  95.9  273.8 
Diabetes & Metabolism 91.3  68.9  34.2  194.4 
Dermatology 38.2  75.8  29.3  143.3 
Women’s Healthcare 100.4  60.5  26.1  187.0 
Oncology 196.1  22.0  42.8  260.9 
Immunology 12.3  20.3  10.3  42.9 
Other (1)
64.3  32.8  89.9  187.0 
Total $ 1,088.6  $ 1,045.9  $ 793.7  $ 2,928.2 
Nine Months Ended September 30, 2019
Central Nervous System & Anesthesia $ 426.4  $ 619.3  $ 243.9  $ 1,289.6 
Infectious Disease 77.3  299.7  783.0  1,160.0 
Respiratory & Allergy 805.3  327.9  166.5  1,299.7 
Cardiovascular 159.1  358.6  116.1  633.8 
Gastroenterology 94.9  434.9  276.3  806.1 
Diabetes & Metabolism 326.1  208.0  110.4  644.5 
Dermatology 77.6  217.7  70.7  366.0 
Women’s Healthcare 269.5  165.3  65.4  500.2 
Oncology 567.8  59.9  107.0  734.7 
Immunology 31.4  41.3  27.6  100.3 
Other (1)
199.6  198.1  274.4  672.1 
Total $ 3,035.0  $ 2,930.7  $ 2,241.3  $ 8,207.0 
____________
(1)    Other consists of numerous therapeutic franchises, none of which individually exceeds 5% of consolidated net sales.
Variable Consideration and Accounts Receivable
The following table presents a reconciliation of gross sales to net sales by each significant category of variable consideration during the three and nine months ended September 30, 2020 and 2019, respectively:
Three Months Ended Nine Months Ended
September 30, September 30,
(In millions) 2020 2019 2020 2019
Gross sales $ 4,986.4  $ 5,051.5  $ 13,868.0  $ 13,841.0 
Gross to net adjustments:
Chargebacks (967.0) (913.5) (2,616.9) (2,368.8)
Rebates, promotional programs and other sales allowances (926.3) (979.2) (2,592.3) (2,709.9)
Returns (76.6) (82.3) (193.2) (203.3)
Governmental rebate programs (68.4) (148.3) (233.4) (352.0)
Total gross to net adjustments $ (2,038.3) $ (2,123.3) $ (5,635.8) $ (5,634.0)
Net sales $ 2,948.1  $ 2,928.2  $ 8,232.2  $ 8,207.0 
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
No significant revisions were made to the methodology used in determining these provisions or the nature of the provisions during the three and nine months ended September 30, 2020. Such allowances were comprised of the following at September 30, 2020 and December 31, 2019, respectively:
(In millions) September 30,
2020 		December 31,
2019
Accounts receivable, net $ 1,502.6  $ 1,512.0 
Other current liabilities 697.9  796.5 
Total $ 2,200.5  $ 2,308.5 
Accounts receivable, net was comprised of the following at September 30, 2020 and December 31, 2019, respectively:
(In millions) September 30,
2020 		December 31,
2019
Trade receivables, net $ 2,587.8  $ 2,640.1 
Other receivables 376.3  418.7 
Accounts receivable, net $ 2,964.1  $ 3,058.8 
Receivables Facility and Note Securitization Facility
Through its wholly owned subsidiary Mylan Pharmaceuticals Inc., the Company has access to a $400 million accounts receivable securitization facility (the “Receivables Facility”) and a $200 million note securitization facility (the “Note Securitization Facility”). The receivables underlying any borrowings are included in accounts receivable, net, in the condensed consolidated balance sheets. There were $480.6 million and $407.0 million of securitized accounts receivable at September 30, 2020 and December 31, 2019, respectively.
On August 4, 2020, the Company entered into (i) an amendment to the Receivables Facility to permit the occurrence of the Combination (as defined below) and to make certain other updates and (ii) an amendment to the Note Securitization Facility to extend the maturity date to August 30, 2021.

We have entered into accounts receivable factoring agreements with financial institutions to sell certain of our non-U.S. accounts receivable. These transactions are accounted for as sales and result in a reduction in accounts receivable because the agreements transfer effective control over and risk related to the receivables to the buyers. Our factoring agreements do not allow for recourse in the event of uncollectibility, and we do not retain any interest in the underlying accounts receivable once sold. We derecognized $123.0 million and $90.1 million of accounts receivable as of September 30, 2020 and December 31, 2019, respectively, under these factoring arrangements.

3.Recent Accounting Pronouncements
Adoption of New Accounting Standards and Amended SEC Rules
In June 2016, the FASB issued Accounting Standards Update 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses (“ASU 2016-13”), which requires an organization to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. In May 2019, the FASB issued ASU 2019-05, Financial Instruments - Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”). ASU 2019-05 provides transition relief for ASU 2016-13 by providing entities with an alternative to irrevocably elect the fair value option for eligible financial assets measured at amortized cost upon adoption of ASU 2016-13. The Company applied the provisions of ASU 2016-13 and its subsequent revisions as of January 1, 2020 and the adoption did not have a material impact on its condensed consolidated financial statements and disclosures.
In August 2018, the FASB issued Accounting Standards Update 2018-13, Fair Value Measurement (Topic 820) Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-03”), which adds to and modifies certain disclosure requirements for fair value measurements including a requirement to disclose changes in unrealized gains and losses included in other comprehensive income for recurring Level 3 fair value measurements and a requirement to disclose the range and weighted average used to develop significant inputs for Level 3 fair value measurements.
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The Company applied the provisions of ASU 2018-13 as of January 1, 2020. The adoption of this guidance did not have a material impact on the Company’s disclosures.
In August 2018, the FASB issued Accounting Standards Update 2018-15, Intangibles - Goodwill and Other - Internal-Use Software: Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (“ASU 2018-15”). The objective of this update is to clarify and align the accounting and capitalization of implementation costs for hosting arrangements, regardless of whether they convey a license to the hosted software. The updated guidance will require an entity in a hosting arrangement that is a service contract, to follow guidance in ASC Topic 350, Intangibles-Goodwill and Other, to determine which implementation costs to capitalize as an asset and which costs to expense. The Company applied the provisions of ASU 2018-15 as of January 1, 2020. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements and disclosures.
In November 2018, the FASB issued Accounting Standards Update 2018-18, Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”). The amendments in ASU 2018-18 make targeted improvements to U.S. GAAP for collaborative arrangements by clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements. In addition, unit-of-account guidance in Topic 808 was aligned with the guidance in Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606. The Company applied the provisions of ASU 2018-18 as of January 1, 2020. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements and disclosures.
In March 2020, the SEC amended Rule 3-10 of Regulation S-X regarding the financial disclosure requirements for guarantors and issuers of guaranteed securities registered or being registered. Among other things, the amendments narrow the circumstances that require separate financial statements of subsidiary issuers and guarantors and streamline the alternative disclosures required in lieu of those financial statements. The effective date of the amendment is January 4, 2021 with earlier voluntary compliance permitted. We have chosen to voluntarily comply with the amended rules effective during the three months ended March 31, 2020 and have included the required disclosures as a component of Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations of this Form 10-Q as permitted by the amendments.
Accounting Standards Issued Not Yet Adopted
In January 2020, the FASB issued Accounting Standards Update 2020-01, Clarifying the Interactions Between Topic 321, Topic 323, and Topic 815 (“ASU 2020-01”), which clarifies that an entity should consider observable transactions that require it to either apply or discontinue the equity method of accounting for the purposes of applying the measurement alternative in accordance with Topic 321 immediately before applying or upon discontinuing the equity method. In addition, ASU 2020-01 states that for the purpose of applying paragraph 815-10-15-141(a) an entity should not consider whether, upon the settlement of the forward contract or exercise of the purchased option, individually or with existing investments, the underlying securities would be accounted for under the equity method in Topic 323 or the fair value option in accordance with the financial instruments guidance in Topic 825. ASU 2020-01 will be effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020 with early adoption in any interim period permitted. The Company is currently assessing the impact of the adoption of this guidance on its condensed consolidated financial statements and disclosures.
In March 2020, the FASB issued Accounting Standards Update 2020-04, Reference Rate Reform (Topic 848) Facilitation of the Effects of Reference Rate Reform on Financial Reporting (“ASU 2020-04”), which provides optional expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. ASU 2020-04 applies only to contracts, hedging relationships, and other transactions that reference the London Interbank Offered Rate (“LIBOR”) or another reference rate expected to be discontinued because of reference rate reform. Entities can apply the provisions of ASU 2020-04 immediately, as applicable, and generally the provisions of the guidance are available through December 31, 2022 as entities transition away from reference rates that are expected to be discontinued. The Company is currently assessing the impact of the adoption of this guidance on its condensed consolidated financial statements and disclosures.
In addition, the following recently issued accounting standard has not been adopted. Refer to the 2019 Form 10-K for additional information and its potential impact.
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Accounting Standard Update Effective Date
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

4.Acquisitions and Other Transactions
Upjohn Business Combination Agreement
On July 29, 2019, the Company, Pfizer Inc. (“Pfizer”), Upjohn Inc., a wholly-owned subsidiary of Pfizer (“Upjohn” or “Newco”), and certain other affiliated entities entered into a Business Combination Agreement (as amended, the “Business Combination Agreement”) pursuant to which the Company will combine with Pfizer’s Upjohn Business (the “Upjohn Business”) in a Reverse Morris Trust transaction (the “Combination”). Newco, which will be the parent entity of the combined Upjohn Business and Mylan business, will be renamed Viatris Inc. (“Viatris”) effective as of the closing of the Combination. The Upjohn Business is a global, primarily off-patent branded and generic established medicines business, which includes 20 primarily off-patent solid oral dose legacy brands, such as Lyrica, Lipitor, Celebrex and Viagra.
Prior to the Combination and pursuant to a Separation and Distribution Agreement (as amended, the “Separation Agreement”), dated as of July 29, 2019, between Pfizer and Newco, Pfizer will, among other things, transfer to Newco substantially all of the assets and liabilities comprising the Upjohn Business (the “Separation”) and, thereafter, Pfizer will distribute to Pfizer stockholders all of the issued and outstanding shares of Newco (the “Distribution”). When the Distribution and Combination are completed, Pfizer stockholders as of the record date of the Distribution will own 57% of the outstanding shares of Newco common stock, and Mylan shareholders as of immediately before the Combination will own 43% of the outstanding shares of Newco common stock, in each case on a fully diluted basis. Newco will make a cash payment to Pfizer equal to $12 billion, to be funded with the proceeds of debt incurred by Newco, as partial consideration for the contribution of the Upjohn Business from Pfizer to Newco.
The consummation of the Combination is subject to the satisfaction (or, if applicable, valid waiver) of various conditions, including (a) the expiration or termination of any applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder and the receipt of regulatory approvals in certain other jurisdictions, (b) the consummation of the Separation and the Distribution in accordance with the terms of the Separation Agreement, (c) the approval of the Combination by Mylan shareholders, (d) the absence of any legal restraint (including legal actions or proceedings pursued by U.S. state authorities in the relevant states) preventing the consummation of the transactions, (e) in the case of Pfizer’s and Newco’s obligations to consummate the transactions, (i) the distribution of $12 billion in cash from Upjohn to Pfizer in accordance with the terms of the Separation Agreement and (ii) the receipt by Pfizer of a U.S. Internal Revenue Service (“IRS”) ruling and tax opinion of its tax counsel with respect to the Combination, and (f) other customary closing conditions.
On March 17, 2020, Pfizer received the IRS ruling with respect to the Combination, which is generally binding, unless the relevant facts or circumstances change prior to closing. On June 30, 2020, Mylan’s shareholders voted to approve the Combination at the extraordinary general meeting of shareholders.
On September 14, 2020, the European Commission (the “Commission”) approved the divestiture buyers with which Mylan entered into agreements for the sale of certain of Mylan’s products in Europe, which was a requirement of the Commission’s conditional approval of the Combination in April 2020.
On October 30, 2020, Mylan and Pfizer announced that the U.S. Federal Trade Commission (the “FTC”) accepted a proposed consent order, which concluded the FTC’s review of the proposed Combination. The parties have now obtained all required antitrust clearances for the Combination. The Combination is expected to close on November 16, 2020.
On May 29, 2020, Mylan, Pfizer, Newco and certain of their affiliates entered into Amendment No. 1 to the Business Combination Agreement (the “BCA Amendment”), and Pfizer and Newco entered into Amendment No. 2 to the Separation and Distribution Agreement (the “SDA Amendment” and, together with the BCA Amendment, the “Amendments”). In light of the ongoing regulatory review process, including delays related to the COVID-19 pandemic, the Amendments provide, among other things, that the closing of the Combination shall not occur prior to October 1, 2020 (unless otherwise agreed to by Mylan and Pfizer) and that the Outside Date (as defined in the Business Combination Agreement) shall be December 31, 2020.
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
On June 16, 2020, Upjohn entered into a revolving credit agreement (the “Upjohn Revolving Credit Agreement”), by and among Upjohn, certain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent (in such capacity, the “Upjohn Revolving Administrative Agent”). The Upjohn Revolving Credit Agreement contains a revolving credit facility (the “Upjohn Revolving Credit Facility”) under which Upjohn may obtain extensions of credit in an aggregate principal amount not to exceed $4.0 billion, in U.S. dollars or alternative currencies including Euro, Sterling, Yen and any other currency that is approved by the Upjohn Revolving Administrative Agent and each lender under the Upjohn Revolving Credit Facility. The Upjohn Revolving Credit Facility will be available to Upjohn upon (a) its delivery of a certificate certifying that (i) the conditions to the consummation of the Combination have been satisfied or waived or are expected to be satisfied or waived on the date of funding of such facility or within one business day thereafter and (ii) the distribution by Pfizer to its stockholders of its shares of Upjohn’s common stock pursuant to the Separation Agreement is expected to be, the Combination is expected to be, and the contribution of the Upjohn Business to Upjohn has been or is expected to be consummated on the Upjohn Revolver Closing Date (as defined below) or within one business day thereafter (an “RMT Condition Certificate”) and (b) the satisfaction of certain customary conditions (the date such conditions are satisfied or waived being referred to as the “Upjohn Revolver Closing Date”). Subject to satisfaction of the foregoing conditions, up to $1.5 billion under the Upjohn Revolving Credit Facility will be available to Upjohn in a single draw on the Upjohn Revolver Closing Date for the sole purpose of funding a portion of the cash payment of $12.0 billion by Upjohn to Pfizer as partial consideration for Pfizer’s contribution of the Upjohn Business to Upjohn, as required by the Separation Agreement.
On June 16, 2020, Upjohn entered into a delayed draw term loan credit agreement (the “Upjohn Term Loan Credit Agreement”), by and among Upjohn, Mizuho Bank, Ltd. and MUFG Bank, Ltd., as administrative agent. The Upjohn Term Loan Credit Agreement provides for an 18-month $600.0 million principal amount delayed draw senior unsecured term loan facility (the “Upjohn Term Loan Credit Facility”).
The Upjohn Term Loan Credit Facility will be available to Upjohn upon its delivery of an RMT Condition Certificate and upon satisfaction of certain customary conditions. Upjohn intends to borrow the full $600.0 million aggregate principal amount available under the Upjohn Term Loan Credit Facility in order to fund a portion of the cash payment to Pfizer and related transaction fees and expenses, as required by the Separation Agreement.
On June 22, 2020, Upjohn completed a private offering of $7.45 billion aggregate principal amount of Upjohn’s senior, U.S. dollar-denominated notes (the “Upjohn U.S. Dollar Notes”) and on June 23, 2020, Upjohn Finance B.V. (“Finco”), a wholly-owned financing subsidiary of Upjohn, completed a private offering of €3.60 billion aggregate principal amount of Finco’s senior, euro-denominated notes (the “Upjohn Euro Notes” and, together with the Upjohn U.S. Dollar Notes, the “Upjohn Notes”), which are guaranteed on a senior unsecured basis by Upjohn. Upjohn intends to use the net proceeds from the offerings of the Upjohn Notes, together with the net proceeds from the Upjohn Term Loan Credit Facility, to fund in full the $12.0 billion cash payment to Pfizer and related transaction fees and expenses. The Upjohn Notes are initially guaranteed on a senior unsecured basis by Pfizer, which guarantees will be automatically and unconditionally terminated and released without consent of holders upon the consummation of the Distribution. Upon the consummation of the Combination, the Mylan entities (which will be subsidiaries of Upjohn following the Combination) that are issuers or guarantors of the outstanding senior unsecured notes issued by Mylan N.V. or Mylan Inc. (the “Mylan Notes”) will become guarantors of the Upjohn Notes, substantially concurrently with Upjohn becoming a guarantor of the Mylan Notes.
Upjohn had previously obtained commitments for the initial financing of the transaction in the form of a bridge loan from certain financial institutions. The bridge loan was subject to customary terms and conditions including a financial covenant. The commitments under the bridge loan commitment letter dated as of July 29, 2019 were reduced concurrently with the effectiveness of the Upjohn Revolving Credit Agreement and Upjohn Term Loan Credit Agreement, and were fully terminated upon the completion of each offering of Upjohn Notes.
Under the terms of the Business Combination Agreement and Separation Agreement, Mylan will be obligated to reimburse Pfizer for 43% of certain financing related costs if the Combination does not close and Viatris will be obligated to reimburse Pfizer for all such financing related costs if the Combination closes. As a result of the completion of the financing transactions described above, Mylan recorded $30.0 million and $115.0 million of expenses during the three and nine months ended September 30, 2020, respectively, which is included as a component of selling, general and administrative expenses (“SG&A”) in the condensed consolidated statements of operations to reflect Mylan’s obligation to reimburse Pfizer for 43% of those financing related costs.
In connection with the Separation Agreement and the Business Combination Agreement, Pfizer, Upjohn and Mylan previously agreed to review and negotiate a potential transfer of Pfizer’s Meridian Medical Technologies business (the “Meridian Business”) to Upjohn. The Meridian Business is Mylan’s supplier of EpiPen® Auto-Injectors pursuant to an
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
agreement that had an expiration date of December 31, 2020 (the “EpiPen Supply Agreement”). Instead of proceeding with the transfer of the Meridian Business, Pfizer and Mylan agreed in the third quarter of 2020 to extend the EpiPen Supply Agreement for an additional four-year period through December 31, 2024, with an option for Mylan (or Upjohn) to further extend the term for an additional one-year period thereafter. Mylan and Pfizer have also reached a preliminary agreement on the general terms under which Pfizer would transfer certain Pfizer assets that currently form part of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan to Mylan or, following the Combination, to Viatris. Any such proposed transaction would be subject to the finalization and execution of a definitive agreement that would contain customary closing conditions including, but not limited to, receipt of any necessary regulatory approvals.
Other Transactions
During the three months ended September 30, 2020 the Company entered into an agreement to acquire the related intellectual property and commercialization rights of Aspen Global Incorporated’s (“Aspen”) thrombosis business in Europe for € 641.9 million, subject to customary closing conditions and European regulatory clearances. The portfolio consists of well-established injectable anticoagulants sold in Europe under the brand names, and variations of the brand names, Arixtra, Fraxiparine, Mono-Embolex and Orgaran.
Upon closing of the transaction, the Company will make a payment of €263.2 million to Aspen with the remaining payment of €378.7 million due on June 25, 2021. The Commission approved the transaction on October 15, 2020, and the closing is expected to be completed in the fourth quarter of 2020.

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 and 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.
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, 2019 6,347,709  $ 36.97 
Granted 814,351  17.37 
Exercised (27,615) 21.13 
Forfeited (337,285) 25.37 
Outstanding at September 30, 2020 6,797,160  $ 35.26 
Vested and expected to vest at September 30, 2020 6,589,725  $ 35.57 
Exercisable at September 30, 2020 5,159,754  $ 38.75 
As of September 30, 2020, stock awards outstanding, stock awards vested and expected to vest and stock awards exercisable had average remaining contractual terms of 5.3 years, 5.2 years and 4.2 years, respectively. Also, at September 30, 2020, stock awards outstanding, stock awards vested and expected to vest and stock awards exercisable had no aggregate intrinsic values.
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
A summary of the status of the Company’s nonvested restricted stock unit awards, including PSUs (collectively, “restricted stock awards”), as of September 30, 2020 and the changes during the nine months ended September 30, 2020 are presented below:
Number of Restricted Stock Awards Weighted Average Grant-Date Fair Value per Share
Nonvested at December 31, 2019 4,105,689  $ 34.42 
Granted 2,978,412  17.46 
Released (1,104,737) 36.57 
Forfeited (306,108) 39.50 
Nonvested at September 30, 2020 5,673,256  $ 24.83 
As of September 30, 2020, the Company had $78.9 million of total unrecognized compensation expense, net of estimated forfeitures, related to all of its stock-based awards, which we expect to recognize over the remaining weighted average vesting period of 1.5 years. The total intrinsic value of stock awards exercised and restricted stock units released during the nine months ended September 30, 2020 and 2019 was $19.1 million and $37.9 million, respectively.

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.
Net Periodic Benefit Cost
Components of net periodic benefit cost for the three and nine months ended September 30, 2020 and 2019 were as follows:
Pension and Other Postretirement Benefits
Three Months Ended Nine Months Ended
September 30, September 30,
(In millions) 2020 2019 2020 2019
Service cost $ 5.3  $ 5.3  $ 15.9  $ 15.9 
Interest cost 2.9  3.8  8.7  11.5 
Expected return on plan assets (3.3) (3.0) (10.1) (9.1)
Amortization of prior service costs —  0.3  —  0.8 
Recognized net actuarial losses (gains) 0.1  (0.2) 0.4  (0.6)
Net periodic benefit cost $ 5.0  $ 6.2  $ 14.9  $ 18.5 
The Company is making the minimum mandatory contributions to its U.S. defined benefit pension plans in the 2020 plan year. The Company expects to make total benefit payments of approximately $35.2 million from pension and other postretirement benefit plans in 2020. The Company anticipates making contributions to pension and other postretirement benefit plans of approximately $35.1 million in 2020.
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7.Balance Sheet Components
Selected balance sheet components consist of the following:
Cash and restricted cash
(In millions) September 30,
2020 		December 31,
2019 		September 30,
2019
Cash and cash equivalents $ 664.5  $ 475.6  $ 358.9 
Restricted cash, included in prepaid expenses and other current assets 2.6  15.5  15.5 
Cash, cash equivalents and restricted cash $ 667.1  $ 491.1  $ 374.4 
Inventories
(In millions) September 30,
2020 		December 31,
2019
Raw materials $ 892.6  $ 886.8 
Work in process 426.6  417.2 
Finished goods 1,702.8  1,366.9 
Inventories $ 3,022.0  $ 2,670.9 
Prepaid and other current assets
(In millions) September 30,
2020 		December 31, 2019
Prepaid expenses $ 189.1  $ 156.7 
Restricted cash 2.6  15.5 
Available-for-sale fixed income securities 39.1  26.8 
Fair value of financial instruments 51.1  43.3 
Equity securities 40.9  39.0 
Other current assets 361.3  270.7 
Prepaid expenses and other current assets $ 684.1  $ 552.0 
Prepaid expenses consist primarily of prepaid rent, insurance and other individually insignificant items.
Property, plant and equipment, net
(In millions) September 30,
2020 		December 31, 2019
Machinery and equipment $ 2,603.1  $ 2,523.7 
Buildings and improvements 1,219.8  1,197.3 
Construction in progress 271.9  277.3 
Land and improvements 125.5  124.6 
Gross property, plant and equipment 4,220.3  4,122.9 
Accumulated depreciation 2,162.0  1,973.3 
Property, plant and equipment, net $ 2,058.3  $ 2,149.6 
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Other assets
(In millions) September 30,
2020 		December 31, 2019
Equity method investments, clean energy investments $ 57.6  $ 92.2 
Operating lease right-of-use assets 227.9  254.6 
Other long-term assets 123.4  58.2 
Other assets $ 408.9  $ 405.0 
Accounts payable
(In millions) September 30,
2020 		December 31,
2019
Trade accounts payable $ 900.8  $ 1,061.9 
Other payables 547.0  466.2 
Accounts payable $ 1,447.8  $ 1,528.1 
Other current liabilities
(In millions) September 30,
2020 		December 31, 2019
Accrued sales allowances $ 697.9  $ 796.5 
Legal and professional accruals, including litigation accruals 117.5  138.2 
Payroll and employee benefit liabilities 503.2  467.1 
Contingent consideration 124.8  120.4 
Accrued interest 179.1  59.1 
Restructuring 17.1  26.0 
Equity method investments, clean energy investments 50.1  47.7 
Fair value of financial instruments 17.1  12.9 
Operating lease liability 68.5  76.7 
Other 470.9  575.3 
Other current liabilities $ 2,246.2  $ 2,319.9 
Other long-term obligations
(In millions) September 30,
2020 		December 31, 2019
Employee benefit liabilities $ 412.2  $ 408.9 
Contingent consideration 88.4  130.3 
Equity method investments, clean energy investments 13.5  57.2 
Tax related items, including contingencies 137.3  109.6 
Operating lease liability 156.9  175.7 
Other 92.6  79.1 
Other long-term obligations $ 900.9  $ 960.8 

8.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 U.S. Internal Revenue Code of 1986, as amended (the “Code”).
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During the three months ended September 30, 2020 and 2019, the Company reduced its long-term obligations for its three investments as a result of lower than anticipated production levels and lower expected future variable debt payments to the respective project sponsor. The Company recognized a net gain of approximately $15 million and $7 million, respectively, which was recognized as a component of the net loss of the equity method investments in the condensed consolidated statements of operations.
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, 2020 and 2019 are as follows:
Three Months Ended Nine Months Ended
September 30, September 30,
(In millions) 2020 2019 2020 2019
Total revenues $ 113.5  $ 101.6  $ 288.8  $ 274.1 
Gross loss (1.4) (1.1) (3.6) (3.1)
Operating and non-operating expense 5.2  5.2  14.4  14.3 
Net loss $ (6.6) $ (6.3) $ (18.0) $ (17.4)
The Company’s net losses from its equity method investments include 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, 2020 and 2019, the Company recognized net losses from equity method investments of $2.9 million and $10.4 million, respectively. For the nine months ended September 30, 2020 and 2019, the Company recognized net losses from equity method investments of $37.4 million and $43.6 million, respectively, which were recognized as a component of other expense, net in the condensed consolidated statements of operations. The Company recognizes the income tax credits and benefits from the clean energy investments as part of its provision for income taxes.

9.Earnings (Loss) per Ordinary Share
Basic earnings (loss) per ordinary share is computed by dividing net earnings (loss) by the weighted average number of ordinary shares outstanding during the period. Diluted earnings (loss) per ordinary share is computed by dividing net earnings (loss) 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.
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Basic and diluted earnings (loss) per ordinary share are calculated as follows:
  Three Months Ended Nine Months Ended
September 30, September 30,
(In millions, except per share amounts) 2020 2019 2020 2019
Basic earnings (loss) (numerator):
Net earnings (loss) $ 185.7  $ 189.8  $ 245.9  $ (3.7)
Shares (denominator):
Weighted average ordinary shares outstanding 516.9  516.0  516.8  515.5 
Basic earnings (loss) per ordinary share $ 0.36  $ 0.37  $ 0.48  $ (0.01)
Diluted earnings (loss) (numerator):
Net earnings (loss) $ 185.7  $ 189.8  $ 245.9  $ (3.7)
Shares (denominator):
Weighted average ordinary shares outstanding 516.9  516.0  516.8  515.5 
Share-based awards 0.8  0.2  0.5  — 
Total dilutive shares outstanding 517.7  516.2  517.3  515.5 
Net earnings (loss) per diluted ordinary share
$ 0.36  $ 0.37  $ 0.48  $ (0.01)
Additional stock awards and restricted stock awards were outstanding during the three and nine months ended September 30, 2020 and 2019, but were not included in the computation of diluted earnings per ordinary share for each respective period because the effect would be anti-dilutive. Excluded shares at September 30, 2020 include certain share-based compensation awards whose performance conditions had not been fully met. Such excluded shares and anti-dilutive awards represented 8.8 million shares and 9.8 million shares for the three and nine months ended September 30, 2020, respectively, and 10.0 million shares and 9.9 million shares for the three and nine months ended September 30, 2019, respectively.

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10.Goodwill and Intangible Assets
The changes in the carrying amount of goodwill for the nine months ended September 30, 2020 are as follows:
(In millions) North America Segment Europe Segment Rest of World Segment Total
Balance at December 31, 2019:
Goodwill $ 3,708.4  $ 4,548.6  $ 1,718.6  $ 9,975.6 
Accumulated impairment losses (385.0) —  —  (385.0)
3,323.4  4,548.6  1,718.6  9,590.6 
Foreign currency translation 33.8  197.5  (4.6) 226.7 
$ 3,357.2  $ 4,746.1  $ 1,714.0  $ 9,817.3 
Balance at September 30, 2020:
Goodwill $ 3,742.2  $ 4,746.1  $ 1,714.0  $ 10,202.3 
Accumulated impairment losses (385.0) —  —  (385.0)
$ 3,357.2  $ 4,746.1  $ 1,714.0  $ 9,817.3 

Intangible assets consist of the following components at September 30, 2020 and December 31, 2019:
(In millions) Weighted Average Life (Years) Original Cost Accumulated Amortization Net Book Value
September 30, 2020
Product rights, licenses and other (1)
15 $ 20,738.7  $ 9,890.1  $ 10,848.6 
In-process research and development 117.2  —  117.2 
$ 20,855.9  $ 9,890.1  $ 10,965.8 
December 31, 2019
Product rights, licenses and other (1)
15 $ 20,109.1  $ 8,579.5  $ 11,529.6 
In-process research and development 120.3  —  120.3 
$ 20,229.4  $ 8,579.5  $ 11,649.9 
____________
(1)Represents amortizable intangible assets. Other intangible assets consists principally of customer lists and contractual rights.
During the three and nine months ended September 30, 2019, the Company recognized impairment charges of $1.9 million and $71.8 million, respectively, which have been recorded as a component of amortization expense, primarily for the impairment of certain finite-lived and in-process research and development (“IPR&D”) assets acquired as part of the acquisition of the non-sterile, topicals-focused business of Renaissance Acquisition Holdings, LLC. No impairment charges were recognized during the three and nine months ended September 30, 2020. The impairment testing involved calculating the fair value of the assets based upon detailed valuations employing the income approach which utilized Level 3 inputs, as defined in Note 11 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 assets and could result in additional future impairment charges.
The Company reviews goodwill for impairment annually on April 1st or more frequently if events or changes in circumstances indicate that the carrying value of goodwill may not be recoverable. As a result of the decline in the Company’s share price during the first quarter of 2020, and the general uncertainty and volatility in the economic environments in which the Company operates, including the impacts of the COVID-19 pandemic, the Company performed an interim goodwill impairment test as of March 31, 2020. The Company performed the annual goodwill impairment test as of April 1, 2020. There were no significant changes from the interim goodwill test performed at March 31, 2020 and the results were consistent with the interim goodwill impairment test.
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The Company has performed both the interim and annual goodwill impairment tests on a quantitative basis for its four reporting units, North America Generics, North America Brands, Europe and Rest of World. In estimating each reporting unit’s fair value, the Company performed an extensive valuation analysis, utilizing both income and market-based approaches, except for the North America Brands reporting unit where the fair value was estimated utilizing the income approach. 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.
As of March 31, 2020 and April 1, 2020, the allocation of the Company’s total goodwill was as follows: North America Generics $2.60 billion, North America Brands $0.65 billion, Europe $4.43 billion and Rest of World $1.65 billion.
As of March 31, 2020 and April 1, 2020, the Company determined that the fair value of the North America Generics, North America Brands and Rest of World reporting units was substantially in excess of the respective unit’s carrying value. However, when compared to the April 1, 2019 test, the fair value of our overall business declined because of future forecasts and the decline in our share price.
For the Europe reporting unit, the estimated fair value exceeded its carrying value by approximately $1.3 billion or 11.0% for both the interim and annual goodwill impairment test. The excess fair value for the Europe reporting unit is consistent with the result of the Company’s 2019 annual impairment test. As it relates to the income approach for the Europe reporting unit at March 31, 2020 and April 1, 2020, the Company forecasted cash flows for the next 5 years. During the forecast period, the revenue compound annual growth rate was approximately 7.5%. A terminal year value was calculated with a 2.0% revenue growth rate applied. The discount rate utilized was 11.0% and the estimated tax rate was 25.5%. Under the market-based approach, we utilized an estimated range of market multiples of 8.0 to 9.5 times EBITDA plus a control premium of 15.0%. If all other assumptions are held constant, a reduction in the terminal value growth rate by 3.5% or an increase in discount rate by 3.5% would result in an impairment charge for the Europe reporting unit.
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.
Amortization expense, which is classified primarily within cost of sales in the condensed consolidated statements of operations for the three and nine months ended September 30, 2020 and 2019 totaled:
Three Months Ended Nine Months Ended
September 30, September 30,
(In millions) 2020 2019 2020 2019
Intangible asset amortization expense $ 368.1  $ 405.6  $ 1,070.9  $ 1,210.3 
IPR&D intangible asset impairment charges —  —  —  29.5 
Finite-lived intangible asset impairment charges —  1.9  —  42.3 
Total intangible asset amortization expense (including impairment charges) $ 368.1  $ 407.5  $ 1,070.9  $ 1,282.1 
Intangible asset amortization expense over the remainder of 2020 and for the years ended December 31, 2021 through 2024 is estimated to be as follows (excludes the potential impact of the Combination):
(In millions)
2020 $ 369 
2021 1,404 
2022 1,333 
2023 1,166 
2024 1,052 

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11.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 sheets. Any gains or losses on the foreign exchange forward contracts are recognized in earnings in the period incurred in the condensed consolidated statements of operations.
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 sheets. Any changes in the fair value of designated cash flow hedges are deferred in accumulated other comprehensive earnings (“AOCE”) and are reclassified into earnings when the hedged item impacts earnings.
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 designating all or a portion of the foreign currency debt as a hedge of the applicable net investment position or entering into foreign currency swaps that are designated as hedges of net investments.
The 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. Borrowings designated as net investment hedges are marked-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. In addition, the Company manages the related foreign exchange risk of the Euro borrowings not designated as net investment hedges through certain Euro denominated financial assets and forward 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:
Notional Amount Designated as a Net Investment Hedge
(in millions) Principal Amount September 30,
2020 		December 31,
2019
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 
Total € 3,000.0  € 2,354.0  € 2,354.0 
Interest Rate Risk Management
The Company enters into interest rate swaps from time to time in order to manage interest rate risk associated with the Company’s fixed-rate and floating-rate debt. Interest 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 sheets. For fair value hedges, the changes in the fair value of both the hedging instrument and the underlying debt obligations are included in interest expense. For cash flow hedges, the change in fair value of the hedging instrument is deferred through AOCE and is reclassified into earnings when the hedged item impacts earnings.
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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 sheets. Accordingly, there are no offsetting amounts that net assets against liabilities.
The Effect of Derivative Instruments in the Condensed Consolidated Balance Sheets
Fair Values of Derivative Instruments
Derivatives Designated as Hedging Instruments
  Asset Derivatives
  September 30, 2020 December 31, 2019
(In millions) Balance Sheet Location Fair Value Balance Sheet Location Fair Value
Interest rate swaps Prepaid expenses and other current assets $ —  Prepaid expenses and other current assets $ 22.3 
Foreign currency forward contracts Prepaid expenses and other current assets 12.5  Prepaid expenses and other current assets 12.5 
Total $ 12.5  $ 34.8 
  Liability Derivatives
  September 30, 2020 December 31, 2019
(In millions) Balance Sheet Location Fair Value Balance Sheet Location Fair Value
Foreign currency forward contracts Other current liabilities —  Other current liabilities — 
Total $ —  $ — 

The Effect of Derivative Instruments in the Condensed Consolidated Balance Sheets
Fair Values of Derivative Instruments
Derivatives Not Designated as Hedging Instruments
  Asset Derivatives
  September 30, 2020 December 31, 2019
(In millions) Balance Sheet Location Fair Value Balance Sheet Location Fair Value
Foreign currency forward contracts Prepaid expenses and other current assets $ 38.6  Prepaid expenses and other current assets $ 8.5 
Total $ 38.6  $ 8.5 
  Liability Derivatives
  September 30, 2020 December 31, 2019
(In millions) Balance Sheet Location Fair Value Balance Sheet Location Fair Value
Foreign currency forward contracts Other current liabilities $ 17.1  Other current liabilities $ 12.9 
Total $ 17.1  $ 12.9 
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The Effect of Derivative Instruments in the Condensed Consolidated Statement 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,
2020 2019 2020 2019
Interest rate swaps Interest expense $ —  $ 3.3  $ 22.1  $ 24.3 
Total $ —  $ 3.3  $ 22.1  $ 24.3 
  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,
2020 2019 2020 2019
2023 Senior Notes (3.125% coupon) Interest expense $ —  $ (3.3) $ (22.1) $ (24.3)
Total $ —  $ (3.3) $ (22.1) $ (24.3)
In the first quarter of 2020, the Company terminated interest rate swaps designated as a fair value hedge resulting in net proceeds of approximately $45 million. The amount included in the above tables represents the fair value adjustment recognized at the date the interest rate swaps were settled.
The Effect of Derivative Instruments in the Condensed Consolidated Statements of Comprehensive Earnings (Loss)
Derivatives in Cash Flow Hedging Relationships
  Amount of Gain (Loss) Recognized in AOCE (Net of Tax) on Derivative
  Three Months Ended Nine Months Ended
September 30, September 30,
(In millions) 2020 2019 2020 2019
Foreign currency forward contracts $ 29.5  $ (8.4) $ (0.5) $ 10.9 
Total $ 29.5  $ (8.4) $ (0.5) $ 10.9 
The Effect of Derivative Instruments in the Condensed Consolidated Statements of Comprehensive Earnings (Loss)
Derivatives in Net Investment Hedging Relationships
  Amount of Gain (Loss) Recognized in AOCE
(Net of Tax) on Derivative
  Three Months Ended Nine Months Ended
September 30, September 30,
(In millions) 2020 2019 2020 2019
Foreign currency borrowings and forward contracts $ (109.0) $ 106.2  $ (113.8) $ 126.9 
Total $ (109.0) $ 106.2  $ (113.8) $ 126.9 
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The Effect of Derivative Instruments in the Condensed Consolidated Statement of Operations
Derivatives in Cash Flow Hedging Relationships
  Location of Gain (Loss) Reclassified from AOCE into Earnings Amount of Gain (Loss) Reclassified from AOCE into Earnings
  Three Months Ended Nine Months Ended
September 30, September 30,
(In millions) 2020 2019 2020 2019
Foreign currency forward contracts Net sales $ 5.1  $ 0.4  $ 2.3  $ (1.2)
Interest rate swaps Interest expense (1.2) (1.8) (3.4) (5.4)
Total $ 3.9  $ (1.4) $ (1.1) $ (6.6)
At September 30, 2020, the Company expects that approximately $39.0 million of pre-tax net losses on cash flow hedges will be reclassified from AOCE into earnings during the next twelve months.
The Effect of Derivative Instruments in the Condensed Consolidated Statement of Operations
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) 2020 2019 2020 2019
Foreign currency option and forward contracts Other expense, net $ 9.8  $ 15.5  $ 22.9  $ (12.0)
Total $ 9.8  $ 15.5  $ 22.9  $ (12.0)
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.
Financial assets and liabilities carried at fair value are classified in the tables below in one of the three categories described above:
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
  September 30, 2020
(In millions) Level 1 Level 2 Level 3 Total
Recurring fair value measurements
Financial Assets
Cash equivalents:
Money market funds $ 0.9  $ —  $ —  $ 0.9 
Total cash equivalents 0.9  —  —  0.9 
Equity securities:
Exchange traded funds 40.2  —  —  40.2 
Marketable securities 0.7  —  —  0.7 
Total equity securities 40.9  —  —  40.9 
Available-for-sale fixed income investments:
Corporate bonds —  19.4  —  19.4 
U.S. Treasuries —  12.8  —  12.8 
Agency mortgage-backed securities —  1.8  —  1.8 
Asset backed securities —  4.5  —  4.5 
Other —  0.6  —  0.6 
Total available-for-sale fixed income investments —  39.1  —  39.1 
Foreign exchange derivative assets —  51.1  —  51.1 
Total assets at recurring fair value measurement $ 41.8  $ 90.2  $ —  $ 132.0 
Financial Liabilities
Foreign exchange derivative liabilities —  17.1  —  17.1 
Contingent consideration —  —  213.2  213.2 
Total liabilities at recurring fair value measurement $ —  $ 17.1  $ 213.2  $ 230.3 
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
  December 31, 2019
(In millions) Level 1 Level 2 Level 3 Total
Recurring fair value measurements
Financial Assets
Cash equivalents:
Money market funds $ 0.7  $ —  $ —  $ 0.7 
Total cash equivalents 0.7  —  —  0.7 
Equity securities:
Exchange traded funds 38.3  —  —  38.3 
Marketable securities 0.7  —  —  0.7 
Total equity securities 39.0  —  —  39.0 
Available-for-sale fixed income investments:
Corporate bonds —  10.8  —  10.8 
U.S. Treasuries —  9.5  —  9.5 
Agency mortgage-backed securities —  2.3  —  2.3 
Asset backed securities —  3.6  —  3.6 
Other —  0.6  —  0.6 
Total available-for-sale fixed income investments —  26.8  —  26.8 
Foreign exchange derivative assets —  21.0  —  21.0 
Interest rate swap derivative assets —  22.3  —  22.3 
Total assets at recurring fair value measurement $ 39.7  $ 70.1  $ —  $ 109.8 
Financial Liabilities
Foreign exchange derivative liabilities $ —  $ 12.9  $ —  $ 12.9 
Contingent consideration —  —  250.7  250.7 
Total liabilities at recurring fair value measurement $ —  $ 12.9  $ 250.7  $ 263.6 
For financial assets and liabilities that utilize Level 2 inputs, the Company utilizes both direct and indirect observable price quotes, including the 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.
•Equity 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. 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.
•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.
•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.
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
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 Pfizer’s proprietary dry powder inhaler delivery platform and certain other acquisitions. The measurement is calculated using unobservable inputs based on the Company’s own assumptions primarily related to probability and timing of future development and commercial milestones and future profit sharing payments which are discounted using a market rate of return. At September 30, 2020 and December 31, 2019, discount rates ranging from 3.5% to 10.5% were utilized in the valuations. 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, 2019 to September 30, 2020 is as follows:
(In millions)
Current Portion (1)
Long-Term Portion (2)
Total Contingent Consideration
Balance at December 31, 2019 $ 120.4  $ 130.3  $ 250.7 
Payments (82.1) —  (82.1)
Reclassifications 52.7  (52.7) — 
Accretion —  9.0  9.0 
Fair value loss (3)
33.8  1.8  35.6 
Balance at September 30, 2020 $ 124.8  $ 88.4  $ 213.2 
____________
(1)Included in other current liabilities in the condensed consolidated balance sheets.
(2)Included in other long-term obligations in the condensed consolidated balance sheets.
(3)Included in litigation settlements and other contingencies, net in the condensed consolidated statements of operations.
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.

12.Debt
Short-Term Borrowings
    The Company had no short-term borrowings as of September 30, 2020 and December 31, 2019. The following provides an overview of the Company’s short-term credit facilities.
Receivables Facility and Note Securitization Facility
The Company has the $400 million Receivables Facility which expires in April 2022. The Company also has the $200 million Note Securitization Facility which expires on August 30, 2021. Borrowings outstanding under the Receivables Facility bear interest at a commercial paper rate plus 0.925% and under the Note Securitization Facility at a rate per annum quoted from time to time by MUFG Bank, Ltd. plus 1.00% 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 with which the Company was compliant as of September 30, 2020. As of September 30, 2020, the Company had no amounts outstanding under the Receivables Facility or the Note Securitization Facility.
Commercial Paper Program
The Company maintains a $1.65 billion commercial paper program (the “Commercial Paper Program”) to support its working capital requirements and for general corporate purposes. There were no commercial paper notes (the “CP Notes”) outstanding under this program as of September 30, 2020 and December 31, 2019. Amounts available under the Commercial
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Paper Program may be borrowed, repaid and re-borrowed from time to time, with the aggregate principal amount of the CP Notes outstanding under the Commercial Paper Program at any time not to exceed $1.65 billion. The Company’s Revolving Credit 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 Commercial Paper Program will terminate upon the consummation of the Combination. We expect that Viatris will establish a commercial paper program on substantially similar terms following the consummation of the Combination.
Long-Term Debt
A summary of long-term debt is as follows:
(In millions) Interest Rate as of September 30, 2020 September 30,
2020 		December 31,
2019
Current portion of long-term debt:
2020 Floating Rate Euro Notes (a) **
—  560.6 
2020 Euro Senior Notes **
1.250  % 878.9  840.1 
2020 Senior Notes **
3.750  % 50.0  50.0 
2021 Senior Notes **
3.150  % 2,249.6  — 
Other 6.5  8.3 
Deferred financing fees (2.4) (1.4)
Current portion of long-term debt $ 3,182.6  $ 1,457.6 
Non-current portion of long-term debt:
2021 Senior Notes **
3.150  % —  2,249.2 
2023 Senior Notes (b) *
3.125  % 785.4  771.8 
2023 Senior Notes *
4.200  % 499.3  499.1 
2024 Euro Senior Notes **
2.250  % 1,170.4  1,119.3 
2025 Euro Senior Notes *
2.125  % 585.1  559.6 
2026 Senior Notes **
3.950  % 2,239.3  2,238.1 
2028 Euro Senior Notes **
3.125  % 872.7  834.3 
2028 Senior Notes *
4.550  % 748.5  748.4 
2043 Senior Notes *
5.400  % 497.3  497.2 
2046 Senior Notes **
5.250  % 999.9  999.8 
2048 Senior Notes *
5.200  % 747.7  747.7 
Other 5.5  8.9 
Deferred financing fees (49.6) (59.1)
Long-term debt $ 9,101.5  $ 11,214.3 
____________
(a)    The 2020 Floating Rate Euro Notes were repaid at maturity in the second quarter of 2020. The instrument bore interest at a rate of three-month EURIBOR plus 0.50% per annum, reset quarterly.
(b)    In the first quarter of 2020, the Company terminated interest rate swaps designated as a fair value hedge resulting in net proceeds of approximately $45 million. The fair value adjustment will be amortized to interest expense over the remaining term of the notes.
*     Instrument was issued by Mylan Inc.
**     Instrument was issued by Mylan N.V.
For additional information, see Note 10 Debt in Mylan N.V.’s 2019 Form 10-K.
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Revolving Credit Facility
The Company has a $2.0 billion revolving credit facility which is scheduled to expire in July 2023 (the “Revolving Credit Facility”). The Revolving Credit Facility contains 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 (“maximum leverage ratio”). On June 16, 2020, the Company entered into an amendment to the Revolving Credit Facility to temporarily increase the maximum leverage ratio to 4.25 to 1.00 after the March 31, 2020 reporting period through the December 31, 2020 reporting period with a maximum leverage ratio of 3.75 to 1.00 thereafter. The Company is in compliance at September 30, 2020 and expects to remain in compliance for the next twelve months. The Revolving Credit Facility will terminate upon completion of the Combination.
Fair Value
At September 30, 2020 and December 31, 2019, the aggregate fair value of the Company’s outstanding notes was approximately $13.7 billion and $13.4 billion, respectively. The fair values of the outstanding notes were valued at quoted market prices from broker or dealer quotations and were classified as Level 2 in the fair value hierarchy.
Mandatory minimum repayments remaining on the notional amount of outstanding long-term debt at September 30, 2020 were as follows for each of the periods ending December 31:
(In millions) Total
2020 $ 929 
2021 2,250 
2022 — 
2023 1,250 
2024 1,172 
Thereafter 6,715 
Total $ 12,316 

13.Comprehensive Loss
Accumulated other comprehensive loss, as reflected on the condensed consolidated balance sheets, is comprised of the following:
(In millions) September 30,
2020 		December 31,
2019
Accumulated other comprehensive loss:
Net unrealized gain on marketable securities, net of tax $ 1.4  $ 0.6 
Net unrecognized loss and prior service cost related to defined benefit plans, net of tax (14.5) (17.4)
Net unrecognized loss on derivatives in cash flow hedging relationships, net of tax (31.3) (31.6)
Net unrecognized loss on derivatives in net investment hedging relationships, net of tax (188.0) (74.3)
Foreign currency translation adjustment (1,191.4) (1,674.5)
$ (1,423.8) $ (1,797.2)
Components of accumulated other comprehensive loss, before tax, consist of the following, for the three and nine months ended September 30, 2020 and 2019:

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Three Months Ended September 30, 2020
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, 2020, net of tax $ (55.7) $ (79.0) $ 1.3  $ (12.4) $ (1,879.1) $ (2,024.9)
Other comprehensive earnings (loss) before reclassifications, before tax 36.4  (114.7) —  (1.7) 687.7  607.7 
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 (5.1) (5.1) (5.1)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense 1.2  1.2  1.2 
Amortization of actuarial loss included in SG&A 0.1  0.1 
Net other comprehensive earnings (loss), before tax 32.5  (114.7) —  (1.6) 687.7  603.9 
Income tax provision (benefit) 8.1  (5.7) (0.1) 0.5  —  2.8 
Balance at September 30, 2020, net of tax $ (31.3) $ (188.0) $ 1.4  $ (14.5) $ (1,191.4) $ (1,423.8)

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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Three Months Ended September 30, 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 June 30, 2019, net of tax $ (33.0) $ (110.2) $ 0.7  $ 1.7  $ (1,400.9) $ (1,541.7)
Other comprehensive earnings (loss) before reclassifications, before tax (12.0) 111.8  0.1  (0.8) (748.9) (649.8)
Amounts reclassified from accumulated other comprehensive loss, before tax:
Loss on foreign exchange forward contracts classified as cash flow hedges, included in net sales (0.4) (0.4) (0.4)
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 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 (10.6) 111.8  0.1  (0.7) (748.9) (648.3)
Income tax provision (benefit) (4.0) 5.5  —  (0.3) —  1.2 
Balance at September 30, 2019, net of tax $ (39.6) $ (3.9) $ 0.8  $ 1.3  $ (2,149.8) $ (2,191.2)
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued


Nine Months Ended September 30, 2020
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, 2019, net of tax $ (31.6) $ (74.3) $ 0.6  $ (17.4) $ (1,674.5) $ (1,797.2)
Other comprehensive (loss) earnings before reclassifications, before tax (1.3) (119.7) 0.8  3.0  483.1  365.9 
Amounts reclassified from accumulated other comprehensive (loss) earnings, before tax:
Loss on foreign exchange forward contracts classified as cash flow hedges, included in net sales (2.3) (2.3) (2.3)
Loss on interest rate swaps classified as cash flow hedges, included in interest expense 3.4  3.4  3.4 
Amortization of actuarial loss included in SG&A 0.4  0.4 
Net other comprehensive (loss) earnings, before tax (0.2) (119.7) 0.8  3.4  483.1  367.4 
Income tax (benefit) provision (0.5) (6.0) —  0.5  —  (6.0)
Balance at September 30, 2020, net of tax $ (31.3) $ (188.0) $ 1.4  $ (14.5) $ (1,191.4) $ (1,423.8)
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Nine Months Ended September 30, 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 18.2  133.6  0.7  (0.7) (890.8) (739.0)
Amounts reclassified from accumulated other comprehensive loss, before tax:
Loss on foreign exchange forward contracts classified as cash flow hedges, included in net sales 1.2  1.2  1.2 
Loss on interest rate swaps classified as cash flow hedges, included in interest expense 5.4  5.4  5.4 
Amortization of prior service costs included in SG&A 0.8  0.8 
Amortization of actuarial loss included in SG&A (0.6) (0.6)
Net other comprehensive earnings (loss), before tax 24.8  133.6  0.7  (0.5) (890.8) (732.2)
Income tax provision (benefit) 7.9  6.6  (0.1) (0.3) —  14.1 
Cumulative effect of the adoption of new accounting standards (3.4) —  —  (0.2) —  (3.6)
Balance at September 30, 2019, net of tax $ (39.6) $ (3.9) $ 0.8  $ 1.3  $ (2,149.8) $ (2,191.2)

14.Segment Information
Mylan reports segment information on a geographic basis. This approach reflects the company’s focus on bringing its broad and diversified portfolio of generic, branded generic, brand-name and over-the-counter products to people in markets everywhere. Our North America segment comprises our operations in the U.S. and Canada. Our Europe segment encompasses our operations in 35 countries, including France, Italy, Germany, the United Kingdom (“U.K.”) and Spain. Our Rest of World segment reflects our operations in more than 120 countries, including Japan, Australia, China, Brazil, Russia, India, South Africa and certain markets in the Middle 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 research and development (“R&D”) and direct SG&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 are reported separately or outside of segment profitability. Items below the earnings from operations line on the Company’s condensed consolidated statements of operations are not presented by segment, since they are excluded from the measure of segment profitability. The
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
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 Note 2 Summary of Significant Accounting Policies included in the 2019 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 Eliminations Consolidated
Three Months Ended September 30, 2020
Net sales $ 1,028.8  $ 1,123.8  $ 795.5  $ —  $ 2,948.1 
Other revenue 17.4  3.4  3.2  —  24.0 
Intersegment revenue 39.3  23.6  126.6  (189.5) — 
Total $ 1,085.5  $ 1,150.8  $ 925.3  $ (189.5) $ 2,972.1 
Segment profitability $ 497.9  $ 348.1  $ 120.3  $ —  $ 966.3 
Intangible asset amortization expense (368.1)
Globally managed research and development costs (31.0)
Corporate costs and special items (196.9)
Litigation settlements & other contingencies (18.9)
Earnings from operations $ 351.4 
Nine Months Ended September 30, 2020
Net sales $ 3,023.3  $ 3,080.7  $ 2,128.2  $ —  $ 8,232.2 
Other revenue 51.8  11.1  27.4  —  90.3 
Intersegment revenue 133.4  83.2  387.9  (604.5) — 
Total $ 3,208.5  $ 3,175.0  $ 2,543.5  $ (604.5) $ 8,322.5 
Segment profitability $ 1,447.5  $ 873.2  $ 321.6  $ —  $ 2,642.3 
Intangible asset amortization expense (1,070.9)
Globally managed research and development costs (121.0)
Corporate costs and special items (743.6)
Litigation settlements & other contingencies (36.5)
Earnings from operations $ 670.3 
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Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
(In millions) North America Europe Rest of World Eliminations Consolidated
Three Months Ended September 30, 2019
Net sales $ 1,088.6  $ 1,045.9  $ 793.7  $ —  $ 2,928.2 
Other revenue 17.6  3.8  12.1  —  33.5 
Intersegment revenue 13.9  23.2  134.0  (171.1) — 
Total $ 1,120.1  $ 1,072.9  $ 939.8  $ (171.1) $ 2,961.7 
Segment profitability $ 489.9  $ 325.1  $ 170.3  $ —  $ 985.3 
Intangible asset amortization expense (405.6)
Intangible asset impairment charges (1.9)
Globally managed research and development costs (47.3)
Corporate costs and special items (258.7)
Litigation settlements & other contingencies 51.9 
Earnings from operations $ 323.7 
Nine Months Ended September 30, 2019
Net sales $ 3,035.0  $ 2,930.7  $ 2,241.3  $ —  $ 8,207.0 
Other revenue 58.8  12.3  30.6  —  101.7 
Intersegment revenue 64.6  66.3  382.1  (513.0) — 
Total $ 3,158.4  $ 3,009.3  $ 2,654.0  $ (513.0) $ 8,308.7 
Segment profitability $ 1,342.3  $ 723.7  $ 435.2  $ —  $ 2,501.2 
Intangible asset amortization expense (1,210.3)
Intangible asset impairment charges (71.8)
Globally managed research and development costs (167.8)
Corporate costs and special items (638.4)
Litigation settlements & other contingencies 30.3 
Earnings from operations $ 443.2 

15.Restructuring
    2020 Restructuring Program
On February 27, 2020, the Company announced that it has formalized the next steps in its efforts to sustain long-term value creation through the proactive transformation of its business. This transformation initiative includes a new global restructuring program. The program is intended to support the Company’s effort to improve operating performance and meet anticipated market demands by ensuring that the Company is appropriately structured and resourced to deliver sustainable value to customers, patients, other stakeholders and shareholders. Key activities under the program include supply chain network optimization intended to maximize the efficiency of the Company’s global manufacturing and distribution network capacity and further optimizing functional capabilities that support business growth.
The Company is currently developing the details of the initiatives, including workforce actions and other restructuring activities. Further details will be disclosed as plans are finalized, including the estimated amount or range of amounts to be incurred by major cost type and future cash expenditures associated with those initiatives. As a result of the COVID-19 pandemic and the related uncertainty and complexity of the current environment, the Company has delayed the implementation of the 2020 restructuring program.
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    2016 Restructuring Program
On December 5, 2016, the Company announced a restructuring program representing 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.
During the second quarter of 2018, the Company commenced 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 other manufacturing sites of a number of products, a reduction of the workforce and extensive process and facility remediation. The restructuring actions other than for this plant are substantially complete. At this time, the total expenses related to the additional restructuring and remediation activities at the Morgantown plant cannot be reasonably estimated.
The following table summarizes the restructuring charges and the reserve activity from December 31, 2019 to September 30, 2020:
(In millions) Employee Related Costs Other Exit Costs Total
Balance at December 31, 2019: $ 26.4  $ 2.8  $ 29.2 
Charges (1)
2.9  4.7  7.6 
Cash payment (6.0) (0.9) (6.9)
Utilization —  (3.7) (3.7)
Foreign currency translation (0.4) (0.1) (0.5)
Balance at March 31, 2020: $ 22.9  $ 2.8  $ 25.7 
Charges (1)
0.4  23.2  23.6 
Cash payment (3.8) (3.2) (7.0)
Utilization —  (20.0) (20.0)
Foreign currency translation 0.4  0.1  0.5 
Balance at June 30, 2020: $ 19.9  $ 2.9  $ 22.8 
Charges (1)
4.7  9.8  14.5 
Cash payment (3.6) (2.2) (5.8)
Utilization —  (7.5) (7.5)
Foreign currency translation —  —  — 
Balance at September 30, 2020: $ 21.0  $ 3.0  $ 24.0 
____________
(1)     For the three months ended September 30, 2020, total restructuring charges in North America, Europe and Rest of World were approximately $11.9 million, $2.3 million and $0.3 million, respectively. For the nine months ended September 30, 2020, total restructuring charges in North America, Europe, Rest of World, and corporate were approximately $19.9 million, $23.7 million, $1.6 million, and $0.5 million, respectively.
At September 30, 2020 and December 31, 2019, accrued liabilities for restructuring and other cost reduction programs were primarily included in other current liabilities in the condensed consolidated balance sheets.
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16.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, except for obligations reflected as acquisition related contingent consideration. Refer to Note 11 Financial Instruments and Risk Management for further discussion of contingent consideration. Our potential maximum development milestones not accrued for at September 30, 2020 totaled approximately $425 million. We estimate that the amounts that may be paid during the next twelve months to be approximately $40 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-based milestones or royalty or profit share 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 or profit share obligations may be significant depending upon the level of commercial sales for each product.
On February 28, 2018, the Company and Revance Therapeutics, Inc. (“Revance”) entered into a collaboration 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®.
On August 22, 2019, the Company and Revance entered into an amendment (the “Amendment”) to the Revance Collaboration Agreement, pursuant to which Revance had agreed to extend the period of time for the Company to decide whether to continue the development and commercialization of a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX® beyond the initial development plan to prepare for and conduct the Biosimilar Initial Advisory Meeting (BIAM) with the U.S. Food and Drug Administration (“FDA”). In accordance with the Amendment, the Company was required to notify Revance of its decision on or before the later of (i) April 30, 2020 or (ii) thirty calendar days from the date that Revance provides Mylan with certain deliverables. On June 1, 2020, the Company and Revance announced a decision to continue the development program for a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX®. As a result, during the nine months ended September 30, 2020, the Company recorded $30 million of R&D expense for a milestone payment that was due upon the decision to continue the program.
There have been no other significant changes to our collaboration and licensing agreements as disclosed in our 2019 Form 10-K.

17.Income Taxes
CARES Act
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted and signed into law. The CARES Act includes several provisions, including increasing the amount of deductible interest, allowing companies to carryback certain Net Operating Losses (“NOLs”) and increasing the amount of NOLs that corporations can use to offset income. We anticipate that the applicable provisions of the CARES Act will reduce our 2020 income tax expense by approximately $27.0 million, of which $16.5 million has been recorded as of September 30, 2020. We will continue to monitor and assess the impact the CARES Act may have on our business and financial results.
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,
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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 IRS examinations. The years 2015 through 2018 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.
During the second quarter of 2019, we reached an agreement in principle with the IRS to resolve all issues relating to our positions on the February 27, 2015 acquisition by Mylan N.V. of Mylan Inc. and Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business. Under the agreement in principle, which was finalized as part of a closing agreement with the IRS on October 11, 2019, our status as a non-U.S. corporation for U.S. Federal income tax purposes has been confirmed, and we have adjusted the interest rates used for intercompany loans. During the second quarter of 2019, the Company recorded a reserve of approximately $140.0 million as part of its liability for uncertain tax positions, with a net impact to the income tax provision of approximately $129.9 million related to this matter. Once the agreement with the IRS was finalized in the fourth quarter of 2019, the Company increased the reserve by $15.0 million with a corresponding increase to the income tax provision.
Several international audits are currently in progress. In some cases, the tax auditors have proposed adjustments to our tax positions including with respect to intercompany transactions, and we are in ongoing discussions with the auditors regarding the validity of their positions. The Company has recorded a reserve for uncertain tax positions of $126.9 million and $89.2 million, including interest and penalties, in connection with its international audits at September 30, 2020 and December 31, 2019, respectively. In certain cases, these audits can also result in non-tax consequences. For example, under French law, certain tax matters are automatically referred for criminal investigation.
The Company’s major state taxing jurisdictions remain open from fiscal year 2013 through 2019, with several state audits currently in progress. The Company’s major international taxing jurisdictions remain open from 2012 through 2019, 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 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. Both parties delivered their final post-trial briefs on June 27, 2019 and are awaiting the court’s final decision.
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 nine months ended September 30, 2019, primarily due to the settlement in principle reached with the IRS and the expiration of federal and foreign statutes of limitations expirations, the Company increased its net liability for unrecognized tax benefits by approximately $46.1 million.
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18.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 Specialties Private Limited, Abbott Laboratories’ 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 adverse 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 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.
Modafinil Antitrust Litigation
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. Mylan has settled all of these lawsuits.
The Company recorded approximately $18.0 million of expense related to this matter in the second quarter of 2019, which was subsequently paid during the year ended December 31, 2019. At December 31, 2019, the Company had a total accrual of approximately $14.4 million related to this matter, which is included in other current liabilities in the condensed consolidated balance sheets. The amount accrued was paid during 2020.
On July 10, 2015, the Louisiana Attorney General filed a lawsuit in the 19th Judicial District Court in Louisiana 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 EDPA. On December 8, 2016, the District Court dismissed the lawsuit with prejudice, which the State of Louisiana appealed. The appeals court subsequently remanded the lawsuit to the District Court to include certain language in order to make the District Court’s dismissal decision final and appealable.
The Company believes that it has strong defenses to the remaining case. Although it is reasonably possible that the Company may incur additional losses from this matter, any amount cannot be reasonably estimated at this time.

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Pioglitazone
Beginning in December 2013, Mylan, Takeda, and several other drug manufacturers were named as defendants in civil lawsuits consolidated in the U.S. District Court for the Southern District of New York (“SDNY”) 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 related to Actos® and Actoplus Met®. Mylan’s motion to dismiss the indirect purchasers’ complaint was granted and no appeal was filed as to Mylan. Following the appellate decision relating to other defendants, the direct purchasers filed an amended complaint against Mylan and the other manufacturers. Mylan’s motion to dismiss was granted with prejudice on October 8, 2019.
Trade Agreements Act (“TAA”)
On April 9, 2018, a subsidiary of Mylan N.V. received a civil investigative demand from the Commercial Litigation Branch of the U.S. Department of Justice (“DOJ”) concerning 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 declined to intervene in the lawsuit and has closed its investigation. Plaintiffs filed a Notice of Voluntary Dismissal of Mylan, which the Court granted on October 13, 2020 and dismissed the case against Mylan.

EpiPen® Auto-Injector
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”) (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 have been 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 Company historically classified EpiPen® Auto-Injector as a non-covered drug with the VA based upon long standing written guidance from the federal government. The Company has voluntarily reclassified the EpiPen® Auto-Injector as a covered drug, effective from April 1, 2017. The Company is fully cooperating with the VA.
EpiPen® Auto-Injector Civil Litigation
Mylan Specialty and other Mylan-affiliated entities have been named as defendants in putative indirect purchaser 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 named as defendants in some of the class actions. These lawsuits were filed in the various federal and state 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. Mylan filed a motion to dismiss the consolidated amended complaint, which was granted in part and denied in part. On December 7, 2018, the plaintiffs filed a motion for class certification. On February 27, 2020, the District Court issued an order denying in part and granting in part plaintiffs’ motion for class certification. The District Court declined to certify consumer protection and unjust enrichment damages classes, as well as an injunctive relief class. The District Court certified an antitrust class that applies to 17 states and a RICO class. We filed a petition for permission to appeal the class certification decision on March 12, 2020, which was denied. On July 15, 2020, Defendants filed a motion for summary judgment as to the remaining claims asserted by plaintiffs. The motion is pending. A trial date has been scheduled for April 2021. We believe that the remaining claims in these lawsuits are without merit and intend to defend against them vigorously.
On February 14, 2020, Mylan Specialty and other Mylan-affiliated entities, together with other non-Mylan affiliated companies, were named as defendants in a putative direct purchaser class action filed in the U.S. District Court for the District of Kansas relating to the pricing and/or marketing of the EpiPen® Auto-Injector. The plaintiff in this case asserts federal antitrust claims which are based on allegations that are similar to those in the putative indirect purchaser class actions discussed above. On June 18, 2020, the District Court granted Mylan’s motion to compel pre-suit mediation, which did not result in a resolution of this matter. On September 10, 2020, the plaintiff filed an amended complaint. Mylan filed a motion to dismiss the amended complaint on October 13, 2020. On November 3, 2020, the plaintiff filed a second amended complaint that is
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substantially similar to the allegations in the amended complaint thereby mooting the motion to dismiss.We believe that the claims in this lawsuit are without merit and intend to defend against them vigorously.

Beginning in March 2020, Mylan Inc. and Mylan Specialty, together with other non-Mylan affiliated companies, were named as defendants in putative direct purchaser class actions filed in the U.S. District Court for the District of Minnesota relating to contracts with certain pharmacy benefit managers concerning EpiPen® Auto-Injector. The plaintiffs claim that the alleged conduct resulted in the exclusion or restriction of competing products and the elimination of pricing constraints in violation of RICO and federal antitrust law. These actions have been consolidated and, on August 21, 2020, Defendants filed a motion to dismiss, which remains pending. We believe that the 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 in the U.S. District Court for the District of New Jersey. This lawsuit has been transferred into the aforementioned MDL. In this lawsuit, Sanofi alleges exclusive dealings and anti-competitive marketing practices in violation of the antitrust laws in connection with the sale and marketing of the EpiPen® Auto-Injector. On November 1, 2018, Sanofi filed a Motion for a Suggestion of Remand of the case to the U.S. District Court for the District of New Jersey. On January 23, 2019, the Court denied Sanofi’s motion without prejudice. On June 28, 2019, Mylan filed a motion for summary judgment as to the claims asserted by Sanofi and Sanofi filed both a motion for partial summary judgment with respect to its claims against Mylan and for summary judgment with respect to Mylan’s counterclaims. These motions remain pending. We believe that Sanofi’s claims in this lawsuit are without merit and intend to defend against them vigorously.
The Company has a total accrual of approximately $10.0 million related to this matter at September 30, 2020, which is included in other current liabilities in the condensed consolidated balance sheets. The Company believes that it has strong defenses to current and future potential civil litigation, as well as governmental investigations, discussed in this “EpiPen® Auto-Injector” section of this Note 18 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, financial condition, results of operations, cash flows and/or ordinary share price in future periods.
Drug Pricing Matters
Department of Justice
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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Civil Litigation
Beginning in 2016, the Company, along with other manufacturers, has been named as a defendant in lawsuits generally alleging anticompetitive conduct with respect to generic drugs. The lawsuits have been filed by plaintiffs, including putative classes of direct purchasers, indirect purchasers, and indirect resellers, as well as individual direct and indirect purchasers and certain counties. They allege harm under federal and state laws, including federal and state antitrust laws, state consumer protection laws and unjust enrichment claims. Some of the lawsuits also name as defendants Mylan’s President, including allegations against him with respect to doxycycline hyclate delayed release, and one of Mylan’s sales employees, including allegations against him with respect to certain generic drugs. The lawsuits have been consolidated in an MDL proceeding in the EDPA. Defendants filed motions 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, which was denied on August 15, 2019. On July 14, 2020, the Court ordered that certain plaintiffs’ complaints regarding three individual drug products proceed as bellwethers. Mylan is named in those plaintiffs’ complaints that regard one of the three individual drug products. A scheduling order has not yet been issued for these matters.
The Company believes that the claims in these lawsuits 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 generic doxycycline) and communications with competitors about such products. On December 14, 2016, attorneys general of certain states originally 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. The complaint has subsequently been amended, including on June 18, 2018, to add attorneys general alleging violations of federal and state antitrust laws, as well as violations of various states’ consumer protection laws. This lawsuit has been transferred to the aforementioned MDL proceeding in the EDPA. The operative complaint includes attorneys general of forty-seven states, the District of Columbia and the Commonwealth of Puerto Rico. Mylan is alleged to have engaged in anticompetitive conduct with respect to doxycycline hyclate delayed release, doxycycline monohydrate, glipizide-metformin, and verapamil. The amended complaint also includes claims asserted by attorneys general of thirty-seven states and the Commonwealth of Puerto Rico against certain individuals, including Mylan’s President, with respect to doxycycline hyclate delayed release. On February 21, 2019, Defendants filed motions to dismiss the amended complaint’s allegations of anticompetitive conduct with respect to multiple drug products, which was denied on August 15, 2019, and the ability of the state attorneys general to seek certain forms of relief under federal antitrust law, which remains pending. On May 31, 2019, Defendants filed a motion to dismiss certain state law claims, which remains pending.
On May 10, 2019, certain attorneys general filed a new complaint against various drug manufacturers and individuals, including Mylan and one of its sales employees, alleging anticompetitive conduct with respect to additional generic drugs. On November 1, 2019, the May 10, 2019 complaint was amended, adding additional states as plaintiffs. The operative complaint is brought by attorneys general of forty-eight states, certain territories and the District of Columbia. The amended complaint also includes claims asserted by attorneys general of forty-three states and certain territories against several individuals, including a Mylan sales employee. On July 14, 2020, the Court ordered that this complaint proceed as a bellwether. A scheduling order has not yet been issued for this matter. On November 2, 2020, Defendants filed motions to dismiss the amended complaint.

On June 10, 2020, attorneys general of forty-six states, certain territories and the District of Columbia filed a new complaint against drug manufacturers, including Mylan, and individual defendants (none from Mylan), alleging anticompetitive conduct with respect to additional generic drugs.
We believe that the claims in these lawsuits are without merit and intend to defend against them vigorously.
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Securities Related Litigation
U.S. 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 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, 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). 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 March 29, 2019. On June 17, 2019, plaintiffs filed a third amended complaint, including certain current and former directors and employees/officers and additional allegations in connection with purportedly anticompetitive conduct with respect to certain generic drugs. On July 31, 2019, defendants filed a motion to dismiss certain of the claims in the third amended complaint, which was granted in part and denied in part on April 6, 2020. On August 30, 2019, plaintiffs filed a motion for class certification, which was granted on April 6, 2020. The certified class covers all persons or entities that purchased Mylan common stock between February 21, 2012 and May 24, 2019 excluding defendants, current and former officers and directors of Mylan, members of their immediate families and their legal representatives, heirs, successors or assigns, and any entity in which defendants have or had a controlling interest.
On February 26, 2019, MYL Litigation Recovery I LLC (“MYL Plaintiff”) (an assignee of entities that purportedly purchased stock of Mylan N.V.) filed an additional complaint against Mylan N.V., Mylan Inc., and 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 third amended complaint identified above. MYL Plaintiff’s complaint seeks damages as well as the plaintiff’s costs. On June 5, 2019, defendants filed a motion to dismiss certain of MYL Plaintiff’s claims, which was granted in part and denied in part on March 30, 2020. On May 6, 2020, MYL Plaintiff filed an amended complaint against Mylan N.V., Mylan Inc., and certain of their current and former officers and directors, including allegations in connection with purportedly anticompetitive conduct with respect to EpiPen® Auto-Injector.
MYL Plaintiff subsequently filed a summons on October 30, 2020, naming Mylan N.V., Mylan Inc., and certain current and former directors and employees/officers in New York State Court, County of New York, claiming investment losses suffered as a result of purportedly false and misleading statements in connection with allegedly anticompetitive conduct concerning generic pharmaceuticals.

On February 14, 2020, the Abu Dhabi Investment Authority filed a complaint against Mylan N.V. and Mylan Inc. in the SDNY asserting allegations pertaining to EpiPen® Auto-Injector and certain generic drugs under the federal securities laws that overlap with those asserted in the third amended complaint identified above. The Abu Dhabi Investment Authority’s complaint seeks damages as well as the plaintiff’s fees and costs. On June 26, 2020, defendants filed a motion to dismiss certain of plaintiff’s claims. The motion is pending.
Beginning in April 2020, Mylan N.V., its directors and certain of its officers were named as defendants in lawsuits filed in federal court, including a putative class action, alleging certain federal securities law violations for purportedly failing to disclose or misrepresenting material information in the definitive proxy statement filed by Mylan N.V. with the SEC in connection with the Combination. The lawsuits generally seek various relief including (i) enjoining the defendants from proceeding with consummating, or closing the Combination and any vote on the Combination unless and until Mylan discloses and disseminates the purportedly material information; (ii) in the event the Combination is consummated, rescinding it and
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setting it aside or awarding rescissory damages; and (iii) reasonable attorneys and expert fees. Plaintiffs in each of these cases have dismissed their cases against defendants.
On June 26, 2020, a putative class action complaint was filed by the Public Employees Retirement System of Mississippi against Mylan N.V. and certain of its directors and officers (collectively for the purposes of this paragraph, the “defendants”) in the U.S. District Court for the Western District of Pennsylvania on behalf of certain purchasers of securities of Mylan N.V. The complaint alleges 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’s Morgantown manufacturing plant and inspections at the plant by the FDA. The complaint alleges that Mylan N.V.’s stock traded at artificially inflated prices as a result of the allegedly misleading statements and omissions. Plaintiff seeks certification of a class of purchasers of Mylan N.V. securities between February 16, 2016 and May 7, 2019. The complaint seeks damages, as well as the plaintiff’s fees and costs.
We believe that the claims in these 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 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 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 (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 the IEC Fund Action are without merit and intend to defend against them vigorously.
Opioids
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. In November 2019, a subsidiary of Mylan N.V. received a subpoena from the New York Department of Financial Services as part of an industry-wide inquiry into the effect of opioid prescriptions on New York health insurance premiums. Mylan is fully cooperating with these subpoena requests.
Mylan along with other manufacturers, distributors, pharmacies, pharmacy benefit managers, and individual healthcare providers is a defendant in more than 1,000 cases in the United States and Canada filed by various plaintiffs, including counties, cities and other local governmental entities, asserting civil claims related to sales, marketing and/or distribution practices with respect to prescription opioid products. In addition, lawsuits have been filed as putative class actions including on behalf of children with Neonatal Abstinence Syndrome due to alleged exposure to opioids. The lawsuits generally seek equitable relief and monetary damages (including punitive and/or exemplary damages) based on a variety of legal theories, including various statutory and/or common law claims, such as negligence, public nuisance and unjust enrichment. The vast majority of these lawsuits have been consolidated in an MDL in the U.S. District Court for the Northern District Court of Ohio. A liability-only trial has been scheduled for November 2021 in a coordinated proceeding in West Virginia state court involving Mylan and numerous other manufacturers, distributors, and pharmacies. A trial has also been scheduled in a proceeding in Jefferson County, Missouri on June 6, 2022 involving Mylan and numerous other manufacturers, distributors and pharmacies. Mylan believes that the claims in these lawsuits are without merit and intends to defend against them vigorously.

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European Commission Proceedings

Perindopril
On July 9, 2014, the European Commission (the “Commission”) issued a decision finding that Mylan Laboratories Limited and Mylan, as well as several other companies, 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 EU. A hearing on the appeal before the General Court of the EU was held in June 2017 and the Commission’s decision was affirmed. Mylan appealed the decision to the European Court of Justice (“CJEU”). Mylan has received a notice from an organization representing health insurers in the Netherlands stating an intention to commence follow-on litigation and asserting damages.
Citalopram
On June 19, 2013, the Commission issued a decision finding that Generics [U.K.] Limited, (“GUK”) as well as several other companies, had violated EU competition rules relating to the product Citalopram and fined GUK approximately €7.8 million, jointly and severally with Merck KGaA. GUK appealed the Commission’s decision to the General Court of the EU. The case is currently on appeal to the CJEU. The U.K. applied and was granted permission to intervene in this proceeding. GUK has received notices from European national health services and health insurers stating an intention to commence follow-on litigation and asserting damages. The national health service in England and Wales has instituted litigation against all parties to the Commission’s decision, including GUK. This litigation has been stayed pending the CJEU’s decision.
GUK has also sought indemnification from Merck KGaA with respect to the €7.8 million portion of the fine for which Merck KGaA and GUK were held jointly and severally liable. Merck KGaA has counterclaimed against GUK 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. The proceedings have been stayed pending the CJEU appeal decision.
The Company has accrued approximately €7.4 million as of each of December 31, 2019 and September 30, 2020 related to this matter. 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.
U.K. Competition and Markets Authority
Paroxetine
On August 12, 2011, GUK received notice that the Office of Fair Trading (subsequently changed to the Competition and Markets Authority (the “CMA”)) opened 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 EU, with respect to alleged agreements related to Paroxetine. The CMA issued a decision on February 12, 2016, finding that, GUK, Merck KGaA and other companies were liable for infringing EU and U.K. competition rules. With respect to Merck KGaA and 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 GUK is jointly and severally liable for approximately £2.7 million, which has been accrued for as of December 31, 2019 and September 30, 2020. The matter is currently on appeal to the Competition Appeals Tribunal (“CAT”), which on March 8, 2018, referred certain questions of law to the CJEU. The CJEU sought written observations from GUK, which were filed in September 2018. A hearing on the questions and the parties’ observations was held before the CJEU on September 19, 2019. On January 30, 2020, the CJEU ruled on the questions of law referred to it and the proceedings before the CAT had resumed.
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Italy Investigation
The Public Prosecutor’s Office in Milan, Italy is conducting an investigation of Mylan S.p.A. and other pharmaceutical companies concerning interactions with an Italian hospital and sales of certain reimbursable drugs. Mylan S.p.A. has resolved the investigation with no admission of liability or wrongdoing. 

Product Liability
Mylan N.V., and certain of its subsidiaries, along with numerous other manufacturers, retailers, and others, are parties to litigation relating to alleged trace amounts of nitrosamine impurities in certain products, including valsartan and ranitidine. The vast majority of these lawsuits in the United States are pending in two MDLs, namely an MDL pending in the United States District Court for the District of New Jersey concerning valsartan and an MDL pending in the United States District Court for the Southern District of Florida concerning raniditine. The lawsuits against Mylan in the MDLs include putative class actions seeking the refund of the purchase price and other economic damages allegedly sustained by consumers and end payors as well as individual claims for personal injuries allegedly caused by ingestion of the medications. Similar lawsuits pertaining to valsartan have been filed in Canada and other countries. Mylan has also received claims and inquiries related to these products, as well as requests to indemnify purchasers of Mylan’s active pharmaceutical ingredient and/or finished dose forms of these products. We believe the claims in these matters are without merit and intend to defend against them vigorously.
The Company is involved in a number of other product liability lawsuits and claims related to alleged personal injuries arising out of certain products manufactured and/or distributed by the Company. The Company believes that it has meritorious defenses to these lawsuits and claims and intends to 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 $14.5 million and $12.8 million at December 31, 2019 and September 30, 2020, respectively, for these additional product liability matters. 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
The Company has used its business judgment in connection with the decision to launch its insulin glargine and dimethyl fumarate products described below and has also used its business judgment in certain other situations to decide to market and sell certain 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 generic and biosimilar products. Mylan 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.
Insulin Glargine
On October 24, 2017, Sanofi and affiliated entities (collectively for the purposes of this section, “Sanofi”), sued Mylan in the U.S. District Court for the District of New Jersey asserting that Mylan GmbH’s new drug application for insulin glargine injection 100 Units/mL vials and prefilled injection pens (SEMGLEE® vial and pens) infringed 18 U.S. patents.

Two of the asserted patents claim insulin glargine formulations (U.S. Patent Numbers 7,476,652 and 7,713,930, “formulation patents”) and were the only patents asserted against Mylan’s SEMGLEE® vial product. Mylan filed petitions for inter partes review (“IPR”) with the U.S. Patent Trial and Appeal Board (“PTAB”) with respect to these two patents. On December 12, 2018, the PTAB issued final written decisions in the IPR proceedings finding Sanofi’s formulation patents unpatentable (i.e., invalid). Sanofi appealed, and on November 19, 2019, the Court of Appeals for the Federal Circuit affirmed the PTAB’s final written decisions. The Supreme Court of the United States denied Sanofi’s petition for review of the IPR proceedings on October 5, 2020.
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The 16 other asserted patents relate to a pen injection device (“device patents”) and were asserted only against Mylan’s SEMGLEE® pen injection device. Prior to trial, Sanofi dismissed 12 of those device patents from the case and granted Mylan a covenant not to sue with respect to them. On June 17, 2019, following the District Court’s claim construction order, the District Court entered judgment of non-infringement with respect to the asserted claims of three of the four remaining device patents (U.S. Patent Numbers 8,603,044, 8,679,069, 8,992,486).
Only one device patent remained for trial (U.S. Patent Number 9,526,844). On March 9, 2020, the Court issued an opinion after trial finding all asserted claims of the ‘844 patent not infringed and invalid for lack of written description.
On September 10, 2018, Mylan filed IPR petitions challenging five device patents (the ‘844, ‘044, ‘069, ‘486, and ‘008 patents). On April 2, 2020 and May 29, 2020, the PTAB issued final written decisions in the IPR proceedings finding all challenged claims unpatentable except for two claims of the ‘008 patent for which Sanofi granted Mylan a covenant not to sue as described above. In July 2020, Sanofi filed appeals of all IPR decisions, which remain pending.
On June 11, 2020, the FDA approved Mylan’s SEMGLEE® vial and pen products, which Mylan began selling on August 31, 2020.
Dimethyl Fumarate

On June 30, 2017, Biogen MA Inc. and Biogen International GmbH (collectively, “Biogen”) sued Mylan Pharmaceuticals Inc. (“MPI”) in the U.S. District Court for the Northern District of West Virginia asserting that MPI’s abbreviated new drug application for dimethyl fumarate delayed-release capsules containing 120 mg and 240 mg of dimethyl fumarate (generic for Tecfidera®) infringed six U.S. patents that Biogen had listed in the Orange Book: 6,509,376, 7,320,999, 7,619,001, 7,803,840, 8,759,393, and 8,399,514. All patents except for the ‘514 expired during the litigation and were dismissed from the case.

After a trial involving only the ’514 patent on June 18, 2020, the District Court issued a judgment finding all claims of the ’514 patent invalid for lack of adequate written description. Biogen appealed and moved for an injunction pending appeal. The Court of Appeals for the Federal Circuit issued an interim injunction while it considered Biogen’s motion. On July 30, 2020, the Court of Appeals for the Federal Circuit denied Biogen’s motion and terminated the interim injunction. The appeal remains pending.

On July 13, 2018, Mylan filed an IPR petition challenging the ’514 patent based only on obviousness. On February 5, 2020, the PTAB issued a final written decision finding the claims not obvious. Mylan is appealing that decision.

On August 17, 2020, the FDA approved Mylan’s dimethyl fumarate delayed-release capsules, which Mylan began selling on August 18, 2020.


Other Litigation
The Company is involved in various other legal proceedings that are considered normal to its business. The Company has approximately $8.0 million accrued related to these various other legal proceedings at September 30, 2020.
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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, 2019, as amended (the “2019 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, 2020, and cash flows for the nine months ended September 30, 2020 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.” Such forward-looking statements may include, without limitation, statements about the proposed Combination (as defined below), the expected timetable for completing the Combination, the benefits and synergies of the Combination, future opportunities for the combined company and products and any other statements regarding Mylan’s, the Upjohn Business’s (as defined below) or the combined company’s future operations, financial or operating results, capital allocation, dividend policy, debt ratio, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competitions, 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:
•with respect to the Combination, the parties’ ability to meet expectations regarding the timing, completion and accounting and tax treatments of the Combination, changes in relevant tax and other laws, the parties’ ability to consummate the Combination, the conditions to the completion of the Combination not being satisfied or waived on the anticipated timeframe or at all, the integration of Mylan and the Upjohn Business being more difficult, time consuming or costly than expected, Mylan’s and the Upjohn Business’s failure to achieve expected or targeted future financial and operating performance and results, the possibility that the combined company may be unable to achieve expected benefits, synergies and operating efficiencies in connection with the Combination within the expected timeframes or at all or to successfully integrate Mylan and the Upjohn Business, customer loss and business disruption being greater than expected following the Combination, the retention of key employees being more difficult following the Combination, changes in third-party relationships and changes in the economic and financial conditions of the business of Mylan or the Upjohn Business;
•the potential impact of public health outbreaks, epidemics and pandemics, such as the COVID-19 pandemic;
•actions and decisions of healthcare and pharmaceutical regulators;
•failure to achieve expected or targeted future financial and operating performance and results;
•uncertainties regarding future demand, pricing and reimbursement for our or the Upjohn Business’s products;
•any regulatory, legal, or other impediments to Mylan’s or the Upjohn Business’s ability to bring new products to market, including, but not limited to, where Mylan or the Upjohn Business 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”);
•success of clinical trials and Mylan’s or the Upjohn Business’s ability to execute on new product opportunities;
•any changes in or difficulties with our or the Upjohn Business’s manufacturing facilities, including with respect to remediation and restructuring activities, supply chain or inventory or the ability to meet anticipated demand;
•the scope, timing, and outcome of any ongoing legal proceedings, including government investigations, and the impact of any such proceedings on our or the Upjohn Business’s financial condition, results of operations, and/or cash flows;
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•the ability to meet expectations regarding the accounting and tax treatments of acquisitions;
•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 or the Upjohn Business’s 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;
•the impact of competition;
•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 connection with business transformation initiatives, strategic acquisitions, strategic initiatives or restructuring programs within the expected timeframes or at all;
•uncertainties and matters beyond the control of 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 the 2019 Form 10-K, the Form 10-Q for the quarter ended June 30, 2020 and our other filings with the SEC. These risks, as well as other risks associated with Mylan, the Upjohn Business, the combined company and the Combination are also more fully discussed in the Registration Statement on Form S-4, as amended, which includes a proxy statement/prospectus, which was filed by Upjohn (as defined below) with the SEC on October 25, 2019 and declared effective by the SEC on February 13, 2020, the Registration Statement on Form 10, which includes an information statement, which was filed by Upjohn with the SEC on June 12, 2020 and declared effective by the SEC on June 30, 2020, a final information statement furnished with the Form 8-K filed by Upjohn with the SEC on August 6, 2020, a definitive proxy statement, which was filed by Mylan with the SEC on February 13, 2020, and a prospectus, which was filed by Upjohn with the SEC on February 13, 2020. 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 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’s Regulation Fair Disclosure (Reg FD). The contents of our website are not incorporated by reference in this Form 10-Q and shall not be deemed “filed” under the Securities Exchange 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 other than as required by law.

Company Overview
Mylan is a global pharmaceutical company committed to setting new standards in healthcare and providing 7 billion people access to high quality medicine. We offer a portfolio of more than 7,500 products, including prescription generic, branded generic, brand-name drugs and over-the-counter (“OTC”) remedies. We market our products in more than 165 countries and territories. Our approximately 35,000-strong global workforce is dedicated to delivering better health for a better world.
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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 marketplace whose economic and political 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.
That 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.
Certain Market and Industry Factors
As more fully explained in the 2019 Form 10-K, the global pharmaceutical industry is a highly competitive and highly regulated industry. As a result, we face a number of industry-specific factors and 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 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.
Additionally, a number of markets in which we operate outside 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 active pharmaceutical ingredients can also have a negative impact on our sales and profitability. Sales continue to be negatively affected by the impact of tender systems in certain countries.
Recent Developments
IMPACT OF THE CORONAVIRUS PANDEMIC ON OUR BUSINESS AND RESULTS OF OPERATIONS
As a leading global pharmaceutical company, Mylan is committed to continue doing its part in support of public health needs amid the evolving COVID-19 pandemic. The Company’s priorities remain protecting the health and safety of our workforce, continuing to produce critically needed medicines, deploying resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, supporting the communities in which we operate and maintaining the health of our overall business.
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The following section discusses the important measures the Company is taking in light of the COVID-19 pandemic.
Employee Health and Safety
•Mylan continues to align with government and health authority guidelines in an effort to safeguard our workforce and continues to make assessments on an ongoing basis.
•While Mylan’s business operations are currently considered essential based on government guidelines throughout the world due to the important role pharmaceutical manufacturers play within the global healthcare system, many Mylan administrative offices continue operating under work from home protocols.
•Because protecting the health and safety of our workforce remains paramount, Mylan has taken extra precautions at manufacturing facilities to aid in the protection of site personnel and operations, including the implementation of social distancing guidelines, daily health assessments and split shifts where feasible.
•Customer facing field personnel have moved to a remote engagement model to ensure continued support for healthcare professionals, patient care and access to needed products.
•Global restrictions have been placed on travel and in-person meetings.
•Mylan has taken steps to protect the safety of study participants, our employees and staff at clinical trial sites and ensure regulatory compliance and scientific integrity of trial data.
Continuing to Produce Critically Needed Medicines
Manufacturing and Supply
•Mylan has activated worldwide business continuity plans to seek to ensure that our global supply chain platform continues to operate without significant disruption.
•All of our manufacturing facilities, and those of our key global partners, are currently operational and, at this time, we are not experiencing any significant disruptions to our supply chain, including the availability of active pharmaceutical ingredients. Also, we are currently not experiencing any negative impact on our customer service levels.
•Mylan continues to engage with regulatory authorities around the world who are committed to maintaining ongoing regulatory processes while also continuing to make available our global research and development ("R&D"), regulatory and manufacturing expertise and capacity to partners who may be in need of additional resources.
Commercial Operations
•Although the majority of our products globally have not seen a significant decline in customer utilization, as has been publicly reported for several markets and product categories, we are currently experiencing certain fluctuations in COVID-19 related demand trends. We will continue to monitor trends closely as we work to ensure patients have access to needed medicine.
•Inventory levels, both ours and those in our distribution channel, remain in-line with normal levels and are currently assessed to be sufficient for anticipated demand.
Deploying Resources and Expertise in the Fight Against COVID-19
Product Development

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•On May 12, 2020, Mylan announced a global collaboration with Gilead Sciences, Inc. to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19. Under the terms of the license agreement Mylan has rights to manufacture and distribute remdesivir in 127 low-and middle-income countries, including India.
•On July 6, 2020, Mylan announced that the Drug Controller General of India (the “DCGI”) approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the evolving COVID-19 pandemic.
Maintaining the Health of Our Overall Business
Access to Capital Markets and Liquidity
While currently we are not experiencing any negative liquidity trends related to the COVID-19 pandemic, we continue to closely monitor developments and the potential negative impact on our operating performance and our ability to access the capital markets.
Due to the Company’s ability to generate significant cash flows from operations, as well as its revolving credit agreement, other short-term borrowing facilities and access to capital markets, we believe that we currently have, and will maintain, the ability to meet foreseeable liquidity needs.
Impact on Results of Operations
The global spread of COVID-19 has created significant volatility, uncertainty and economic disruption affecting the markets we serve in North America, Europe and Rest of World, which has had and continues to have an impact on our current year results of operations. The extent to which the COVID-19 pandemic will impact our business, operations and financial results in future periods will depend on numerous evolving factors that are beyond our control and that we may not be able to accurately predict. For additional information, see “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations.”
Restructuring Programs
On February 27, 2020, the Company announced that it has formalized the next steps in its efforts to sustain long-term value creation through the proactive transformation of its business. This transformation initiative includes a new global restructuring program (the “2020 restructuring program”). The program is intended to support the Company’s effort to improve operating performance and meet anticipated market demands by ensuring that the Company is appropriately structured and resourced to deliver sustainable value to customers, patients, other stakeholders and shareholders. Key activities under the program include supply chain network optimization intended to maximize the efficiency of the Company’s global manufacturing and distribution network capacity and further optimizing functional capabilities that support business growth.
The Company is currently developing the details of the initiatives, including workforce actions and other restructuring activities. Further details will be disclosed as plans are finalized, including the estimated amount or range of amounts to be incurred by major cost type and future cash expenditures associated with those initiatives. As a result of the COVID-19 pandemic and the related uncertainty and complexity of the current environment, the Company has delayed the implementation of the 2020 restructuring program which is leading to higher than expected costs in 2020.
The Company previously announced a restructuring program representing a series of actions in certain locations that are anticipated to further streamline its operations globally. The restructuring actions, other than the additional restructuring and remediation activities at the Morgantown, West Virginia plant described below, are substantially complete.
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 the 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 facility remediation. The Company continues to incur incremental manufacturing variances related to these and other activities. In the fourth quarter of 2018, the Company received a warning letter related to the previously
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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. On May 11, 2020 we received the close-out of the warning letter.
For the nine months ended September 30, 2020, the Company incurred expenses amounting to approximately $192.3 million for incremental manufacturing variances, site remediation and restructuring charges related to the Morgantown plant, as well as continued product rationalization. At this time, the total expenses related to ongoing 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.
Upjohn Business Combination Agreement
On July 29, 2019, the Company, Pfizer Inc. (“Pfizer”), Upjohn Inc., a wholly-owned subsidiary of Pfizer (“Upjohn” or “Newco”), and certain other affiliated entities entered into a Business Combination Agreement (as amended, the “Business Combination Agreement”) pursuant to which the Company will combine with Pfizer’s Upjohn Business (the “Upjohn Business”) in a Reverse Morris Trust transaction (the “Combination”). Newco, which will be the parent entity of the combined Upjohn Business and Mylan business, will be renamed Viatris Inc. (“Viatris”) effective as of the closing of the Combination. The Upjohn Business is a global, primarily off-patent branded and generic established medicines business, which includes 20 primarily off-patent solid oral dose legacy brands, such as Lyrica, Lipitor, Celebrex and Viagra.
Prior to the Combination and pursuant to a Separation and Distribution Agreement (as amended, the “Separation Agreement”), dated as of July 29, 2019, between Pfizer and Newco, Pfizer will, among other things, transfer to Newco substantially all of the assets and liabilities comprising the Upjohn Business (the “Separation”) and, thereafter, Pfizer will distribute to Pfizer stockholders all of the issued and outstanding shares of Newco (the “Distribution”). When the Distribution and Combination are completed, Pfizer stockholders as of the record date of the Distribution will own 57% of the outstanding shares of Newco common stock, and Mylan shareholders as of immediately before the Combination will own 43% of the outstanding shares of Newco common stock, in each case on a fully diluted basis. Newco will make a cash payment to Pfizer equal to $12 billion, to be funded with the proceeds of debt incurred by Newco, as partial consideration for the contribution of the Upjohn Business from Pfizer to Newco.
The consummation of the Combination is subject to the satisfaction (or, if applicable, valid waiver) of various conditions, including (a) the expiration or termination of any applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder and the receipt of regulatory approvals in certain other jurisdictions, (b) the consummation of the Separation and the Distribution in accordance with the terms of the Separation Agreement, (c) the approval of the Combination by Mylan shareholders, (d) the absence of any legal restraint (including legal actions or proceedings pursued by U.S. state authorities in the relevant states) preventing the consummation of the transactions, (e) in the case of Pfizer’s and Newco’s obligations to consummate the transactions, (i) the distribution of $12 billion in cash from Upjohn to Pfizer in accordance with the terms of the Separation Agreement and (ii) the receipt by Pfizer of a U.S. Internal Revenue Service (“IRS”) ruling and tax opinion of its tax counsel with respect to the Combination, and (f) other customary closing conditions.
On March 17, 2020, Pfizer received the IRS ruling with respect to the Combination, which is generally binding, unless the relevant facts or circumstances change prior to closing. On June 30, 2020, Mylan’s shareholders voted to approve the Combination at the extraordinary general meeting of shareholders.
On September 14, 2020, the European Commission (the “Commission”) approved the divestiture buyers with which Mylan entered into agreements for the sale of certain of Mylan’s products in Europe, which was a requirement of the Commission’s conditional approval of the Combination in April 2020.
On October 30, 2020, Mylan and Pfizer announced that the U.S. Federal Trade Commission (the “FTC”) accepted a proposed consent order, which concluded the FTC’s review of the proposed Combination. The parties have now obtained all required antitrust clearances for the Combination. The Combination is expected to close on November 16, 2020.

On May 29, 2020, Mylan, Pfizer, Newco and certain of their affiliates entered into Amendment No. 1 to the Business Combination Agreement (the “BCA Amendment”), and Pfizer and Newco entered into Amendment No. 2 to the Separation and Distribution Agreement (the “SDA Amendment” and, together with the BCA Amendment, the “Amendments”). In light of the
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ongoing regulatory review process, including delays related to the COVID-19 pandemic, the Amendments provide, among other things, that the closing of the Combination shall not occur prior to October 1, 2020 (unless otherwise agreed to by Mylan and Pfizer) and that the Outside Date (as defined in the Business Combination Agreement) shall be December 31, 2020.

On June 16, 2020, Upjohn entered into a revolving credit agreement (the “Upjohn Revolving Credit Agreement”), by and among Upjohn, certain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent (in such capacity, the “Upjohn Revolving Administrative Agent”). The Upjohn Revolving Credit Agreement contains a revolving credit facility (the “Upjohn Revolving Credit Facility”) under which Upjohn may obtain extensions of credit in an aggregate principal amount not to exceed $4.0 billion, in U.S. dollars or alternative currencies including Euro, Sterling, Yen and any other currency that is approved by the Upjohn Revolving Administrative Agent and each lender under the Upjohn Revolving Credit Facility. The Upjohn Revolving Credit Facility will be available to Upjohn upon (a) its delivery of a certificate certifying that (i) the conditions to the consummation of the Combination have been satisfied or waived or are expected to be satisfied or waived on the date of funding of such facility or within one business day thereafter and (ii) the distribution by Pfizer to its stockholders of its shares of Upjohn’s common stock pursuant to the Separation Agreement is expected to be, the Combination is expected to be, and the contribution of the Upjohn Business to Upjohn has been or is expected to be consummated on the Upjohn Revolver Closing Date (as defined below) or within one business day thereafter (an “RMT Condition Certificate”) and (b) the satisfaction of certain customary conditions (the date such conditions are satisfied or waived being referred to as the “Upjohn Revolver Closing Date”). Subject to satisfaction of the foregoing conditions, up to $1.5 billion under the Upjohn Revolving Credit Facility will be available to Upjohn in a single draw on the Upjohn Revolver Closing Date for the sole purpose of funding a portion of the cash payment of $12.0 billion by Upjohn to Pfizer as partial consideration for Pfizer’s contribution of the Upjohn Business to Upjohn, as required by the Separation Agreement.
On June 16, 2020, Upjohn entered into a delayed draw term loan credit agreement (the “Upjohn Term Loan Credit Agreement”), by and among Upjohn, Mizuho Bank, Ltd. and MUFG Bank, Ltd., as administrative agent. The Upjohn Term Loan Credit Agreement provides for an 18-month $600.0 million principal amount delayed draw senior unsecured term loan facility (the “Upjohn Term Loan Credit Facility”).
The Upjohn Term Loan Credit Facility will be available to Upjohn upon its delivery of an RMT Condition Certificate and upon satisfaction of certain customary conditions. Upjohn intends to borrow the full $600.0 million aggregate principal amount available under the Upjohn Term Loan Credit Facility in order to fund a portion of the cash payment to Pfizer and related transaction fees and expenses, as required by the Separation Agreement.
On June 22, 2020, Upjohn completed a private offering of $7.45 billion aggregate principal amount of Upjohn’s senior, U.S. dollar-denominated notes (the “Upjohn U.S. Dollar Notes”) and on June 23, 2020, Upjohn Finance B.V. (“Finco”), a wholly-owned financing subsidiary of Upjohn, completed a private offering of €3.60 billion aggregate principal amount of Finco’s senior, euro-denominated notes (the “Upjohn Euro Notes” and, together with the Upjohn U.S. Dollar Notes, the “Upjohn Notes”), which are guaranteed on a senior unsecured basis by Upjohn. Upjohn intends to use the net proceeds from the offerings of the Upjohn Notes, together with the net proceeds from the Upjohn Term Loan Credit Facility, to fund in full the $12.0 billion cash payment to Pfizer and related transaction fees and expenses. The Upjohn Notes are initially guaranteed on a senior unsecured basis by Pfizer, which guarantees will be automatically and unconditionally terminated and released without consent of holders upon the consummation of the Distribution. Upon the consummation of the Combination, the Mylan entities (which will be subsidiaries of Upjohn following the Combination) that are issuers or guarantors of the outstanding senior unsecured notes issued by Mylan N.V. or Mylan Inc. (the “Mylan Notes”) will become guarantors of the Upjohn Notes, substantially concurrently with Upjohn becoming a guarantor of the Mylan Notes.
Upjohn had previously obtained commitments for the initial financing of the transaction in the form of a bridge loan from certain financial institutions. The bridge loan was subject to customary terms and conditions including a financial covenant. The commitments under the bridge loan commitment letter dated as of July 29, 2019 were reduced concurrently with the effectiveness of the Upjohn Revolving Credit Agreement and Upjohn Term Loan Credit Agreement, and were fully terminated upon the completion of each offering of Upjohn Notes.
Under the terms of the Business Combination Agreement and Separation Agreement, Mylan will be obligated to reimburse Pfizer for 43% of certain financing related costs if the Combination does not close and Viatris will be obligated to reimburse Pfizer for all such financing related costs if the Combination closes. As a result of the completion of the financing transactions described above, Mylan recorded $30.0 million and $115.0 million of expenses during the three and nine months ended September 30, 2020, respectively, which is included as a component of selling, general and administrative expenses (“SG&A”) in the condensed consolidated statements of operations to reflect Mylan’s obligation to reimburse Pfizer for 43% of those financing related costs.
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In connection with the Separation Agreement and the Business Combination Agreement, Pfizer, Upjohn and Mylan previously agreed to review and negotiate a potential transfer of Pfizer’s Meridian Medical Technologies business (the “Meridian Business”) to Upjohn. The Meridian Business is Mylan’s supplier of EpiPen® Auto-Injectors pursuant to an agreement that had an expiration date of December 31, 2020 (the “EpiPen Supply Agreement”). Instead of proceeding with the transfer of the Meridian Business, Pfizer and Mylan agreed in the third quarter of 2020 to extend the EpiPen Supply Agreement for an additional four-year period through December 31, 2024, with an option for Mylan (or Upjohn) to further extend the term for an additional one-year period thereafter. Mylan and Pfizer have also reached a preliminary agreement on the general terms under which Pfizer would transfer certain Pfizer assets that currently form part of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan to Mylan or, following the Combination, to Viatris. Any such proposed transaction would be subject to the finalization and execution of a definitive agreement that would contain customary closing conditions including, but not limited to, receipt of any necessary regulatory approvals.

Financial Summary
The tables below are a summary of the Company’s financial results for the three and nine months ended September 30, 2020 compared to the prior year periods:
Three Months Ended
September 30,
(In millions, except per share amounts) 2020 2019 Change % Change
Total revenues $ 2,972.1  $ 2,961.7  $ 10.4  —  %
Gross profit 1,158.5  1,072.4  86.1  8  %
Earnings from operations 351.4  323.7  27.7  9  %
Net earnings 185.7  189.8  (4.1) (2) %
Net earnings per diluted ordinary share $ 0.36  $ 0.37  $ (0.01) (3) %
Nine Months Ended
September 30,
(In millions, except per share amounts) 2020 2019 Change % Change
Total revenues $ 8,322.5  $ 8,308.7  $ 13.8  —  %
Gross profit 3,090.3  2,810.2  280.1  10  %
Earnings from operations 670.3  443.2  227.1  51  %
Net earnings (loss) 245.9  (3.7) 249.6  nm
Net earnings (loss) per diluted ordinary share $ 0.48  $ (0.01) $ 0.49  nm
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” net sales and total revenues. These 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 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.
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 EBITDA (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.”
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Results of Operations
Three Months Ended September 30, 2020 Compared to Three Months Ended September 30, 2019
Three Months Ended
September 30,
(In millions) 2020 2019 % Change
2020 Currency Impact (1)
2020 Constant Currency Revenues
Constant Currency % Change (2)
Net sales
North America $ 1,028.8  $ 1,088.6  (5) % $ 0.8  $ 1,029.6  (5) %
Europe 1,123.8  1,045.9  7  % (57.9) 1,065.9  2  %
Rest of World 795.5  793.7  —  % 18.7  814.2  3  %
Total net sales 2,948.1  2,928.2  1  % $ (38.4) $ 2,909.7  (1) %
Other revenues (3)
24.0  33.5  (28) % (0.2) 23.8  (29) %
Consolidated total revenues (4)
$ 2,972.1  $ 2,961.7  —  % $ (38.6) $ 2,933.5  (1) %
____________
(1)Currency impact is shown as unfavorable (favorable).
(2)The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2020 constant currency net sales or revenues to the corresponding amount in the prior year.
(3)For the three months ended September 30, 2020, other revenues in North America, Europe, and Rest of World were approximately $17.4 million, $3.4 million, and $3.2 million, respectively. For the three months ended September 30, 2019, other revenues in North America, Europe, and Rest of World were approximately $17.6 million, $3.8 million, and $12.1 million, respectively.
(4)Amounts exclude intersegment revenue that eliminates on a consolidated basis.
Total Revenues
For the current quarter, Mylan reported total revenues of $2.97 billion, compared to $2.96 billion for the comparable prior year period, representing an increase of $10.4 million, or less than 1%. Total revenues include both net sales and other revenues from third parties. Net sales for the current quarter were $2.95 billion, compared to $2.93 billion for the comparable prior year period, representing an increase of $19.9 million, or 1%. Other revenues for the current quarter were $24.0 million, compared to $33.5 million for the comparable prior year period.
The increase in net sales was primarily the result of an increase in net sales in the Europe segment of 7% and a slight increase in net sales in the Rest of World segment. These were partially offset by a decrease in net sales in the North America segment of 5%. Mylan’s net sales were favorably impacted by net sales from new products of $170.1 million, as well as the effect of foreign currency translation on current period net sales of approximately $38.4 million, or 1%. The impact of foreign currency translation on current period net sales primarily reflects changes in the U.S. Dollar as compared to the currencies of Mylan’s subsidiaries in the European Union, partially offset by the negative impact of subsidiaries in India. On a constant currency basis, net sales decreased by approximately $18.5 million, or 1%. This decrease was primarily driven by lower volumes, and to a lesser extent, pricing from net sales of existing products, partially offset by new product sales. In the third quarter of 2020, we estimate that the COVID-19 pandemic negatively impacted our net sales by approximately 3%, primarily driven by lower retail pharmacy demand, lower non-COVID-19 related patient hospital visits and a lower number of in person meetings with prescribers and payors, as well as the impact on the back to school sales of the EpiPen® Auto-Injector.
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 26% for the three months ended September 30, 2020 and 2019, respectively. This percentage may fluctuate based upon the timing of new product launches, seasonality and the timing of the discontinuation of products.
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Net sales are derived from our three geographic reporting segments: North America, Europe and Rest of World. The graph below shows net sales by segment for the three months ended September 30, 2020 and 2019 and the net change period over period:
MYL-20200930_G1.JPG
North America Segment
Net sales from North America decreased by $59.8 million or 5% during the three months ended September 30, 2020 when compared to the prior year period. This decrease was primarily driven by lower volumes, and to a lesser extent, pricing from net sales of existing products partially offset by new product sales, including sales from the launch of dimethyl fumarate capsules, a substitutable generic of Biogen Inc.'s Tecfidera®. The decrease in net sales of existing products was primarily driven by lower EpiPen® Auto-Injector volumes partially due to the negative impact of COVID-19 which resulted in lower back to school sales and changes in the competitive environment, including for Levothyroxine Sodium. These decreases were partially offset by increased volumes on Wixela™ Inhub™. The impact of foreign currency translation on current period net sales was insignificant within North America.
Europe Segment
Net sales from Europe increased by $77.9 million or 7% during the three months ended September 30, 2020 when compared to the prior year period. This increase was primarily due to the favorable impact of foreign currency translation of approximately $57.9 million or 5%, and new product sales. The favorable impact of these items was partially offset by lower volumes from net sales of existing products primarily due to the negative impact of COVID-19. Pricing was relatively stable in the quarter when compared to the prior year period. Constant currency net sales increased by approximately $20.0 million, or 2%, when compared to the prior year period.
Rest of World Segment
Net sales from Rest of World increased by $1.8 million or less than 1% during the three months ended September 30, 2020 when compared to the prior year period. This increase was primarily driven by new product sales, including sales of Remdesivir in India. This increase was partially offset by lower pricing, primarily due to government price reductions in Japan and Australia, and volumes from net sales of existing products, and the unfavorable impact of foreign currency translation. While volumes of existing products in the Company’s anti-retroviral franchise were higher compared to the prior year period, this increase was offset by lower volumes from net sales of existing products, partially driven by the negative impact of COVID-19 primarily in China, Russia and Japan. Overall, net sales from Rest of World were unfavorably impacted by the effect of foreign currency translation by approximately $18.7 million, or 2%. Constant currency net sales increased by approximately $20.5 million, or 3% when compared to the prior year period.
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Cost of Sales and Gross Profit
Cost of sales decreased from $1.89 billion for the three months ended September 30, 2019 to $1.81 billion for the three months ended September 30, 2020. Cost of sales was primarily impacted by purchase accounting related amortization of acquired intangible assets 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, 2020 was $1.16 billion and gross margins were 39%. For the three months ended September 30, 2019, gross profit was $1.07 billion and gross margins were 36%. Gross margins were positively impacted by margins on sales of new products of 380 basis points, primarily in the North America segment, and lower amortization expense from acquired intangible assets of 160 basis points. These items were partially offset by lower gross margins from the net sales of existing products of 260 basis points, primarily in the North America segment. Adjusted gross margins were 55% for the three months ended September 30, 2020, compared to 53% for the three months ended September 30, 2019.
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, 2020 compared to the three months ended September 30, 2019 is as follows:
Three Months Ended
September 30,
(In millions) 2020 2019
U.S. GAAP cost of sales $ 1,813.6  $ 1,889.3 
Deduct:
Purchase accounting amortization and other related items (368.5) (408.6)
Acquisition related items (9.4) (0.8)
Restructuring and related costs (8.7) (11.4)
Share-based compensation expense (0.4) (0.3)
Other special items (83.6) (70.9)
Adjusted cost of sales $ 1,343.0  $ 1,397.3 
Adjusted gross profit (a)
$ 1,629.1  $ 1,564.4 
Adjusted gross margin (a)
55  % 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
R&D expense for the three months ended September 30, 2020 was $129.8 million, compared to $167.9 million for the comparable prior year period, a decrease of $38.1 million. This decrease was primarily due to lower expenditures related to the reprioritization of global programs, and higher payments in the prior year period related to licensing arrangements for products in development.
Selling, General & Administrative Expense
SG&A expense for the current quarter was $658.4 million, compared to $632.7 million for the comparable prior year period, an increase of $25.7 million. The increase was primarily the result of higher consulting fees and other expenses primarily related to the pending Combination totaling approximately $74.0 million in the current year period, including approximately $30.0 million related to obligations to reimburse Pfizer for certain financing costs under the Business Combination Agreement and Separation Agreement (the “Combination Agreements”). Partially offsetting this increase were lower selling and promotional expenses, including through our active management and certain lower expenses as a result of COVID-19.
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Litigation Settlements and Other Contingencies, Net
During the three months ended September 30, 2020 and 2019, the Company recorded a net charge of $18.9 million and net gain of $51.9 million, respectively.
The following table includes the losses/(gains) recognized in litigation settlements and other contingencies, net during the three months ended September 30, 2020 and September 30, 2019:
Three Months Ended
September 30,
(In millions) 2020 2019
Respiratory delivery platform contingent consideration adjustment $ 16.9  $ — 
Litigation settlements, net 2.0  (51.9)
Total litigation settlements and other contingencies, net $ 18.9  $ (51.9)
During the three months ended September 30, 2020, the Company recorded a $16.9 million loss for fair value adjustments related to Pfizer’s proprietary dry powder inhaler delivery platform (the “respiratory delivery platform”) contingent consideration and a net charge of approximately $2.0 million related to a number of litigation matters. During the three months ended September 30, 2019, the Company recognized a gain of approximately $51.9 million primarily related to the previously disclosed Celgene Corporation (“Celgene”) settlement of $62.0 million partially offset by certain litigation related charges.
Interest Expense
Interest expense for the three months ended September 30, 2020 totaled $117.3 million, compared to $128.9 million for the three months ended September 30, 2019, a decrease of $11.6 million. The decrease is primarily due to lower average long-term debt balances during the current quarter as compared to the prior year period.
Other (Income) Expense, Net
Other income, net, was $7.5 million for the three months ended September 30, 2020, compared to expense of $9.0 million for the comparable prior year period. Other (income) expense, net includes losses from equity affiliates, foreign exchange gains and losses and interest and dividend income. Other (income) expense, net was comprised of the following for the three months ended September 30, 2020 and 2019, respectively:
Three Months Ended
September 30,
(In millions) 2020 2019
Losses from equity affiliates, primarily clean energy investments $ 2.9  $ 10.4 
Foreign exchange gains, net (8.8) (0.4)
Other gains, net (1.6) (1.0)
Other (income) expense, net $ (7.5) $ 9.0 
Income Tax Provision (Benefit)
For the three months ended September 30, 2020, the Company recognized an income tax provision of $55.9 million, an increase of $59.9 million over the $4.0 million benefit for the comparable prior year period. During the current quarter, the Company recognized an expense as a result of adjustments to reserve for uncertain tax positions and the assessment of the realizability of deferred tax assets. During the three months ended September 30, 2019, the Company recorded a $42.0 million benefit resulting from refinements to previous estimates in conjunction with the filing of the Company’s 2018 U.S. federal tax return, which revised the estimated impact of the Company’s valuation allowance on its interest limitation deductions and the estimate of available foreign tax credits. Also impacting the current year income tax benefit was the changing mix of income earned in jurisdictions with differing tax rates.

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Nine Months Ended September 30, 2020 Compared to Nine Months Ended September 30, 2019
Nine Months Ended
September 30,
(In millions) 2020 2019 % Change
2020 Currency Impact (1)
2020 Constant Currency Revenues
Constant Currency % Change (2)
Net sales
North America $ 3,023.3  $ 3,035.0  —  % $ 4.1  $ 3,027.4  —  %
Europe 3,080.7  2,930.7  5  % (3.3) 3,077.4  5  %
Rest of World 2,128.2  2,241.3  (5) % 92.7  2,220.9  (1) %
Total net sales 8,232.2  8,207.0  —  % 93.5  8,325.7  1  %
Other revenues (3)
90.3  101.7  (11) % —  90.3  (11) %
Consolidated total revenues (4)
$ 8,322.5  $ 8,308.7  —  % $ 93.5  $ 8,416.0  1  %
____________
(1)Currency impact is shown as unfavorable (favorable).
(2)The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2020 constant currency net sales or revenues to the corresponding amount in the prior year.
(3)For the nine months ended September 30, 2020, other revenues in North America, Europe, and Rest of World were approximately $51.8 million, $11.1 million, and $27.4 million, respectively. For the nine months ended September 30, 2019, other revenues in North America, Europe, and Rest of World were approximately $58.8 million, $12.3 million, and $30.6 million, respectively.
(4)Amounts exclude intersegment revenue that eliminates on a consolidated basis.
Total Revenues
For the nine months ended September 30, 2020, Mylan reported total revenues of $8.32 billion, compared to $8.31 billion for the comparable prior year period, representing an increase of $13.8 million, or less than 1%. Total revenues include both net sales and other revenues from third parties. Net sales for the nine months ended September 30, 2020 were $8.23 billion, compared to $8.21 billion for the comparable prior year period, representing an increase of $25.2 million, or less than 1%. Other revenues for the nine months ended September 30, 2020 were $90.3 million, compared to $101.7 million for the comparable prior year period.
The increase in net sales was primarily the result of an increase in net sales in the Europe segment of 5% which was partially offset by a decrease in net sales in the Rest of World segment of 5% and a slight decrease in net sales in the North America segment. Mylan’s net sales were unfavorably 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. The unfavorable impact of foreign currency translation on current year net sales was approximately $93.5 million, or 1%. On a constant currency basis, the increase in net sales was approximately $118.7 million, or 1% for the nine months ended September 30, 2020. This increase was primarily driven by new product sales of $342.8 million, and to a lesser extent, higher volumes of existing products, partially offset by lower pricing on sales of existing products. We have estimated that the net impact of the COVID-19 pandemic decreased net sales during the nine months ended September 30, 2020 by approximately 2%, caused by the same drivers for the three month period.
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 23% and 24% for the nine months ended September 30, 2020 and 2019, respectively. This percentage may fluctuate based upon the timing of new product launches, seasonality and the timing of the discontinuation of products.
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Net sales are derived from our three geographic reporting segments: North America, Europe and Rest of World. The graph below shows net sales by segment for the nine months ended September 30, 2020 and 2019 and the net change period over period:
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North America Segment
Net sales from North America decreased by $11.7 million or less than 1% during the nine months ended September 30, 2020 when compared to the prior year period. This decrease was due primarily to lower pricing on sales of existing products, partially offset by new product sales and, to a lesser extent, higher volumes on sales of existing products. Lower pricing on sales of existing products was driven by changes in the competitive environment, including for Levothyroxine Sodium, and lower volumes primarily driven by the EpiPen® Auto-Injector, partially offset by increased Wixela™ Inhub™ volumes. The impact of foreign currency translation on current period net sales was insignificant within North America.
Europe Segment
Net sales from Europe increased by $150.0 million or 5% during the nine months ended September 30, 2020 when compared to the prior year period. This increase was primarily the result of new product sales and higher net sales of existing products, partially as a result of increased volumes which were driven by the resolution of supply disruptions encountered in the prior year period. The remainder of the increase in net sales was the result of expected net sales growth in the region partially offset by the negative impact of COVID-19. Pricing was relatively stable when compared to the prior year period. Net sales were also favorably impacted by the effect of foreign currency translation of approximately $3.3 million, or less than 1%. Constant currency net sales increased by approximately $146.7 million, or 5%, when compared to the prior year period.
Rest of World Segment
Net sales from Rest of World decreased by $113.1 million or 5% during the nine months ended September 30, 2020 when compared to the prior year period. The decrease was primarily due to the unfavorable impact of foreign currency translation and, to a lesser extent, by lower pricing on net sales of existing products, primarily driven by government price reductions in Japan and Australia. The decrease in net sales was also due to lower volumes on net sales of existing products related to the estimated negative impact from COVID-19 in China, Russia and Japan. Partially offsetting lower net sales of existing products were new product sales, including Remdesivir in India and emerging markets. Overall, net sales from Rest of World were unfavorably impacted by the effect of foreign currency translation of approximately $92.7 million, or 4%. Constant currency net sales decreased by approximately $20.4 million, or 1%, when compared to the prior year period.
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Cost of Sales and Gross Profit
Cost of sales decreased from $5.50 billion for the nine months ended September 30, 2019 to $5.23 billion for the nine months ended September 30, 2020. Cost of sales was primarily impacted by purchase accounting related amortization of acquired intangible assets and other special items, which are described further in the section titled Use of Non-GAAP Financial Measures. Gross profit for the nine months ended September 30, 2020 was $3.09 billion and gross margins were 37%. For the nine months ended September 30, 2019, gross profit was $2.81 billion and gross margins were 34%. Gross margins were positively impacted by lower amortization expense from acquired intangible assets and intangible asset impairment charges realized in the prior year period of 265 basis points. In addition, gross margins were positively impacted as a result of higher gross profit from sales of new products of 255 basis points, primarily in North America and, to a lesser extent, sales of existing products in Europe. Gross margins were negatively impacted as a result of lower gross profit from sales of existing products in Rest of World and North America of 240 basis points. In addition, gross margins were negatively impacted by incremental costs incurred as a result of the COVID-19 pandemic, including a special bonus for plant employees. Adjusted gross margins were 54% for the nine months ended September 30, 2020, compared to 53% for the nine months ended September 30, 2019.

A reconciliation between cost of sales, as reported under U.S. GAAP, and adjusted cost of sales and adjusted gross margin for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019 is as follows:
Nine Months Ended
September 30,
(In millions) 2020 2019
U.S. GAAP cost of sales $ 5,232.2  $ 5,498.5 
Deduct:
Purchase accounting amortization and other related items (1,072.5) (1,284.0)
Acquisition related items (11.5) (2.9)
Restructuring and related costs (17.6) (72.2)
Share-based compensation expense (1.1) (0.8)
Other special items (299.3) (268.1)
Adjusted cost of sales $ 3,830.2  $ 3,870.5 
Adjusted gross profit (a)
$ 4,492.3  $ 4,438.2 
Adjusted gross margin (a)
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
R&D expense for the nine months ended September 30, 2020 was $400.3 million, compared to $488.1 million for the comparable prior year period, a decrease of $87.8 million. This decrease was primarily due to lower expenditures related to the reprioritization of global programs, and higher payments in the prior year period related to licensing arrangements for products in development.
Selling, General & Administrative Expense
SG&A expense for the nine months ended September 30, 2020 was $1.98 billion, compared to $1.91 billion for the comparable prior year period, an increase of $74.0 million. The increase was due primarily to higher consulting fees along with other expenses primarily related to the pending Combination totaling approximately $235.5 million in the current year period, including approximately $115.0 million related to obligations to reimburse Pfizer for certain financing costs under the Combination Agreements. Partially offsetting this increase were lower selling and promotional expenses, including through our active management and certain lower expenses as a result of COVID-19.
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Litigation Settlements and Other Contingencies, Net
During the nine months ended September 30, 2020 and 2019, the Company recorded a net charge of $36.5 million and net gain of $30.3 million, respectively.
The following table includes the losses/(gains) recognized in litigation settlements and other contingencies, net during the nine months ended September 30, 2020 and September 30, 2019:
Nine Months Ended
September 30,
(In millions) 2020 2019
Respiratory delivery platform contingent consideration adjustment $ 35.6  $ (28.9)
Litigation settlements, net 0.9  (1.4)
Total litigation settlements and other contingencies, net $ 36.5  $ (30.3)
During the nine months ended September 30, 2020, the Company recorded a $35.6 million loss for fair value adjustments related to respiratory delivery platform contingent consideration. Additionally, the Company recorded a net charge of approximately $0.9 million related to a number of litigation matters. Litigation settlements for the nine months ended September 30, 2019, consisted of litigation related gains of approximately $1.4 million primarily related to a favorable litigation settlement related to the previously disclosed Celgene matter of $62.0 million offset by litigation related charges for settlements reached related to the modafinil antitrust matter of $18.0 million and the settlement with the SEC in connection with the SEC staff’s investigation of the Company’s public disclosures regarding its 2016 settlement with the Department of Justice concerning the EpiPen Medicaid Drug Rebate Program of $30.0 million. Additionally, the Company recognized a gain of $28.9 million for fair value adjustments related to the respiratory delivery platform contingent consideration.
Interest Expense
Interest expense for the nine months ended September 30, 2020 totaled $353.4 million, compared to $391.3 million for the nine months ended September 30, 2019, a decrease of $37.9 million. The decrease is primarily due to lower average long-term debt balances during the current year.
Other (Income) Expense, Net
Other expense, net was $24.6 million for the nine months ended September 30, 2020, compared to $32.7 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 nine months ended September 30, 2020 and 2019, respectively:
Nine Months Ended
September 30,
(In millions) 2020 2019
Losses from equity affiliates, primarily clean energy investments $ 37.4  $ 43.6 
Foreign exchange losses/(gains), net 8.6  (4.4)
Other gains, net (21.4) (6.5)
Other expense, net $ 24.6  $ 32.7 
Included in other gains for the nine months ended September 30, 2020 was a $16.5 million gain for a fair value adjustment relate to a non-marketable investment which the Company holds.
Income Tax Provision (Benefit)
For the nine months ended September 30, 2020, the Company recognized an income tax provision of $46.4 million, compared to a tax provision of $22.9 million for the comparable prior year period, an increase of $23.5 million. During the nine months ended September 30, 2020, the Company recognized a net charge as a result of adjustments to reserves for uncertain tax positions, partially offset by changes in the assessment of the realizability of deferred tax assets. During the nine months ended September 30, 2019, the Company reached a settlement in principle with the IRS to resolve federal tax matters related to the
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February 27, 2015 acquisition by Mylan N.V. of Mylan Inc. and Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business, including adjusting the interest rates used for intercompany loans and confirming our status as a non-U.S. corporation for U.S. federal income tax purposes, and recorded a reserve of approximately $140.0 million as part of its liability for uncertain tax positions, with a net impact to the income tax provision of approximately $129.9 million related to this matter. During the nine months ended September 30, 2019, primarily due to the settlement in principle reached with the IRS and the expiration of federal and foreign statutes of limitations, the Company increased its net liability for unrecognized tax benefits by approximately $46.1 million. Also impacting the current year income tax expense was the changing mix of income earned in jurisdictions with differing tax 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. Primarily 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. Beginning in 2020, management’s annual incentive compensation is derived, in part, based on adjusted EBITDA (as defined below).
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
Adjusted net 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 is an important internal financial metric 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 this measure. Actual internal and forecasted operating results and annual budgets used by management include adjusted net earnings.
EBITDA and Adjusted EBITDA
EBITDA and adjusted EBITDA are non-GAAP financial measures that the Company believes are appropriate to provide additional information to investors to demonstrate the Company’s ability to comply with financial debt covenants and assess the Company’s ability to incur additional indebtedness. The Company also believes that adjusted EBITDA better focuses management on the Company’s underlying operational results and true business performance and, beginning in 2020, is used, in part, for management’s incentive compensation. We calculate “EBITDA” as U.S. GAAP net earnings (loss) adjusted for net contribution attributable to equity method investments, income tax provision (benefit), interest expense and depreciation and amortization. EBITDA is further adjusted for share-based compensation expense, litigation settlements and other contingencies, net, and restructuring and other special items to determine “adjusted EBITDA”. These adjustments are permitted under our credit agreement in calculating Adjusted EBITDA for determining compliance with our debt covenants.
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The significant items excluded from adjusted cost of sales, adjusted net earnings, EBITDA and adjusted EBITDA 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, EBITDA and adjusted EBITDA. These amounts include the amortization of intangible assets, inventory step-up and intangible asset impairment charges, including for in-process research and development. For the acquisition of businesses accounted for under the provisions of the Financial Accounting Standards Board Accounting Standards Codification 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 EBITDA because they generally occur at irregular intervals and are not indicative of the Company’s ongoing operations.
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 EBITDA 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 their exclusion is helpful to understanding the underlying, ongoing operational performance of the business.
Share-based Compensation Expense
Share-based compensation expense is excluded from adjusted net earnings and adjusted EBITDA. 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.
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 EBITDA, 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 the U.S. Internal Revenue Code of 1986, as amended; only included in adjusted net earnings is the net tax effect of the entity’s activities;
•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;
•Certain costs to further develop and optimize our global enterprise resource planning systems, operations and supply chain; and
•The impact of changes related to uncertain tax positions is excluded from adjusted net earnings. In addition, tax adjustments to adjusted earnings are recorded to present items on an after-tax basis consistent with the presentation of adjusted net earnings.
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
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excludes these amounts from adjusted net earnings and adjusted EBITDA 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 Note 18 Litigation included in Part I, Item 1 of this Form 10-Q are generally excluded from adjusted net earnings and adjusted EBITDA. 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
A reconciliation between net earnings (loss) as reported under U.S. GAAP, and adjusted net earnings for the periods shown follows:
Three Months Ended September 30, Nine Months Ended September 30,
(In millions) 2020 2019 2020 2019
U.S. GAAP net earnings (loss) $ 185.7  $ 189.8  $ 245.9  $ (3.7)
Purchase accounting related amortization (primarily included in cost of sales) 368.5  408.5  1,072.5  1,283.9 
Litigation settlements and other contingencies, net 18.9  (51.9) 36.5  (30.3)
Interest expense (primarily clean energy investment financing and accretion of contingent consideration) 5.3  6.6  16.6  20.8 
Clean energy investments pre-tax loss 2.9  10.4  37.4  43.6 
Acquisition related costs (primarily included in SG&A) (a)
72.3  43.0  218.2  56.6 
Restructuring related costs (b)
14.5  0.8  47.0  78.3 
Share-based compensation expense 15.1  16.1  49.8  50.9 
Other special items included in:
Cost of sales (c)
83.6  70.9  299.3  268.1 
Research and development expense (d)
3.7  40.3  45.8  100.5 
Selling, general and administrative expense 7.5  8.4  12.9  33.1 
Other expense, net —  —  (16.4) — 
Tax effect of the above items and other income tax related items (98.3) (138.5) (344.3) (342.7)
Adjusted net earnings $ 679.7  $ 604.4  $ 1,721.2  $ 1,559.1 
Significant items include the following:

(a)    Acquisition related costs consist primarily of transaction costs including legal and consulting fees and integration activities. The increase for the three and nine months ended September 30, 2020 relates to transaction costs for the pending Combination, including approximately $30.0 million and $115.0 million, respectively, related to the Company’s obligation to reimburse Pfizer for certain financing costs under the Combination Agreements.
(b)    For the three months ended September 30, 2020, charges of approximately $8.7 million are included in cost of sales, approximately $0.1 million is included in R&D, and approximately $5.7 million is included in SG&A. For the nine months ended September 30, 2020, charges of approximately $17.6 million are included in cost of sales, approximately $0.3 million is included in R&D, and approximately $29.0 million is included in SG&A. Refer to Note 15 Restructuring included in Part I, Item 1 of this Form 10-Q for additional information.
(c)    Costs incurred during the three and nine months ended September 30, 2020 include incremental manufacturing variances and site remediation activities as a result of the activities at the Company’s Morgantown plant of approximately $57.8 million and $179.6 million, respectively. In addition, the three and nine months ended September 30, 2020 includes incremental manufacturing variances incurred as a result of the COVID-19 pandemic of approximately $8.0 million and $32.0 million, respectively. Also, the nine months ended September 30, 2020 includes $27.0 million related to a special bonus for plant employees as a result of the COVID-19 pandemic. The three months ended September 30, 2019 includes costs related to incremental manufacturing variances and site remediation activities as a result of the activities at the Company’s Morgantown plant of approximately $50.0 million. The nine months ended September 30, 2019 includes charges for certain incremental manufacturing variances and site
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remediation activities as a result of the activities at the Company’s Morgantown plant, product recall costs, including inventory write-offs, and charges related to the cancellation of a contract.
(d)    R&D expense for the three and nine months ended September 30, 2020 consists primarily of amounts for product development arrangements, including with Revance Therapeutics Inc., of approximately $3.0 million and $41.0 million, respectively. R&D expense for the three months ended September 30, 2019 consists primarily of payments for product development. R&D expense for the nine months ended September 30, 2019 consists primarily of payments for product development arrangements of approximately $46.8 million, including $18.5 million for the expansion of the Yupelri® agreement and $23.3 million related to non-refundable upfront licensing amounts for a product in development. The remaining expense relates to on-going development collaborations.
Reconciliation of U.S. GAAP Net Earnings to EBITDA and Adjusted EBITDA
Below is a reconciliation of U.S. GAAP net earnings (loss) to EBITDA and adjusted EBITDA for the three and nine months ended September 30, 2020 compared to the prior year period:
Three Months Ended September 30, Nine Months Ended September 30,
(In millions) 2020 2019 2020 2019
U.S. GAAP net earnings (loss) $ 185.7  $ 189.8  $ 245.9  $ (3.7)
Add / (deduct) adjustments:
Clean energy investments pre-tax loss 2.9  10.4  37.4  43.6 
Income tax provision (benefit) 55.9  (4.0) 46.4  22.9 
Interest expense (a)
117.3  128.9  353.4  391.3 
Depreciation and amortization (b)
432.3  469.7  1,263.0  1,471.6 
EBITDA $ 794.1  $ 794.8  $ 1,946.1  $ 1,925.7 
Add / (deduct) adjustments:
Share-based compensation expense 15.1  16.1  49.8  50.9 
Litigation settlements and other contingencies, net 18.9  (51.9) 36.5  (30.3)
Restructuring, acquisition related and other special items (c)
181.6  163.8  606.6  534.1 
Adjusted EBITDA $ 1,009.7  $ 922.8  $ 2,639.0  $ 2,480.4 
(a)    Includes clean energy investment financing and accretion of contingent consideration.
(b)    Includes purchase accounting related amortization.
(c)    See items detailed in the Reconciliation of U.S. GAAP Net Earnings to Adjusted Net Earnings.

Liquidity and Capital Resources
Our primary source of liquidity is net cash provided by operating activities, which was $1.20 billion for the nine months ended September 30, 2020. 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.
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Operating Activities
Net cash provided by operating activities increased by $78.6 million to $1.20 billion for the nine months ended September 30, 2020, as compared to net cash provided by operating activities of $1.12 billion for the nine months ended September 30, 2019. Net cash provided by operating activities is derived from 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.
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The net increase in net cash provided by operating activities was principally due to the following:
•an increase in net earnings of approximately $249.6 million, principally as a result of an increase in earnings from operations; and
•a net increase in the amount of cash provided by changes in income taxes of $175.4 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:
•a net decrease in the non-cash impact of depreciation and amortization of $208.6 million;
•a net decrease in the amount of cash used through accounts receivable of $6.6 million, reflecting the timing of sales and cash collections;
•a net increase of $54.8 million in the amount of cash used through changes in inventory balances;
•a net increase in the amount of cash used through changes in trade accounts payable of $16.5 million as a result of the timing of cash payments; and
•a net decrease in the amount of cash provided by changes in other operating assets and liabilities of $40.4 million.
Investing Activities
Net cash used in investing activities was $278.8 million for the nine months ended September 30, 2020, as compared to $410.9 million for the nine months ended September 30, 2019, a net decrease of $132.1 million.

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In 2020, significant items in investing activities included the following:
•payments for product rights and other, net totaling approximately $97.3 million, primarily related to deferred non-contingent purchase payments for the acquisition of intellectual property rights and marketing authorizations;
•purchase of marketable securities and other investments of $96.1 million; and
•capital expenditures, primarily for equipment and facilities, totaling approximately $126.1 million. While there can be no assurance that current expectations will be realized, capital expenditures for the 2020 calendar year are expected to be approximately $200 million to $250 million.
In 2019, significant items in investing activities included the following:
•cash paid for acquisitions, net totaling approximately $148.7 million primarily related to the deferred non-contingent purchase payments due to Novartis AG for the purchase of the worldwide rights to the TOBI Podhaler® and TOBI® solution global cystic fibrosis products;
•payments for product rights and other, net totaling approximately $146.5 million primarily related to the acquisitions of intellectual property rights and marketing authorizations;
•proceeds from the sale of assets of $24.3 million; and
•capital expenditures, primarily for equipment and facilities, totaling approximately $139.6 million.
Financing Activities
Net cash used in financing activities was $754.8 million for the nine months ended September 30, 2020, as compared to $704.6 million for the nine months ended September 30, 2019, a net increase of $50.2 million.

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In 2020, significant items in financing activities included the following:
•long-term debt payments of approximately $588.9 million consisting primarily of the redemption of $555.2 million principal amount of the 2020 Floating Rate Euro Notes;
•non-contingent payments for product rights totaling approximately $139.5 million primarily related to the acquisitions of intellectual property rights and marketing authorizations in prior periods; and
•payments totaling approximately $48.5 million (of the $82.1 million) in profit share and milestone payments related to the respiratory delivery platform contingent consideration. The remaining payments related to the respiratory delivery platform contingent consideration are included as a component of other operating assets and liabilities, net within net cash from operating activities.
In 2019, significant items in financing activities included the following:
•long-term debt payments of approximately$657.1 million consisting primarily of the redemption of $550.0 million principal amount of 2.500% Senior Notes due 2019 and repayment of the remaining approximately $100.0 million balance of the 2016 Term Facility;
•payments totaling $47.8 million (of the $79.0 million) in profit share and milestone payments related to the respiratory delivery platform contingent consideration. The remaining payments related to the respiratory delivery
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platform contingent consideration are included as a component of other operating assets and liabilities, net within net cash from operating activities; and
•a net decrease in short-term borrowings of $1.9 million.
Capital Resources
Our cash and cash equivalents totaled $664.5 million at September 30, 2020, and the majority of these funds are held by our non-U.S. subsidiaries. The Company anticipates having sufficient liquidity, including existing borrowing capacity under its Revolving Credit Facility, Commercial Paper Program, Receivables Facility and the Note Securitization Facility (which are each defined in Note 2 Revenue Recognition and Accounts Receivable or Note 12 Debt in Part I, Item 1 of this Form 10-Q) combined with cash to be generated from operations, to fund foreseeable cash needs without requiring the repatriation of non-U.S. cash.
The Company has access to $2.0 billion under the Revolving Credit Facility which matures in 2023. Up to $1.65 billion of the Revolving Credit Facility may be used to support borrowings under our Commercial Paper Program. As of September 30, 2020, the Company had no amounts outstanding under the Commercial Paper Program.
The Company has the $400 million Receivables Facility which expires in April 2022. The Company also has the $200 million Note Securitization Facility which expires on August 30, 2021. Borrowings outstanding under the Receivables Facility bear interest at a commercial paper rate plus 0.925% and under the Note Securitization Facility at a rate per annum quoted from time to time by MUFG Bank, Ltd. plus 1.00% 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 with which the Company was compliant as of September 30, 2020. As of September 30, 2020, the Company had no amounts outstanding under the Receivables Facility or the Note Securitization Facility.
We have entered into accounts receivable factoring agreements with financial institutions to sell certain of our non-U.S. accounts receivable. These transactions are accounted for as sales and result in a reduction in accounts receivable because the agreements transfer effective control over and risk related to the receivables to the buyers. Our factoring agreements do not allow for recourse in the event of uncollectibility, and we do not retain any interest in the underlying accounts receivable once sold. We derecognized $123.0 million and $90.1 million of accounts receivable as of September 30, 2020 and December 31, 2019, respectively, under these factoring arrangements.
At September 30, 2020, our long-term debt, including the current portion, totaled $12.28 billion, as compared to $12.67 billion at December 31, 2019. Total long-term debt is calculated net of deferred financing fees which were $52.0 million and $60.5 million at September 30, 2020 and December 31, 2019, respectively.
For additional information regarding our debt and debt agreements refer to Note 12 Debt in Part I, Item 1 of this Form 10-Q.
Long-term Debt Maturity
Mandatory minimum repayments remaining on the outstanding notional amount of long-term debt at September 30, 2020 was as follows for each of the periods ending December 31:
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The Company has a $2.0 billion revolving credit facility which is scheduled to expire in July 2023. The Revolving Credit Facility contains 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 (“maximum leverage ratio”). On June 16, 2020 the Company entered into an amendment to the Revolving Credit Facility to temporarily increase the maximum leverage ratio to 4.25 to 1.00 after the March 31, 2020 reporting period through the December 31, 2020 reporting period with a maximum leverage ratio of 3.75 to 1.00 thereafter. The Company is in compliance at September 30, 2020 and expects to remain in compliance for the next twelve months.
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, except for obligations reflected as acquisition related contingent consideration. Refer to Note 11 Financial Instruments and Risk Management in Part I, Item 1 of this Form 10-Q for additional information. Our potential maximum development milestones not accrued for at September 30, 2020 totaled approximately $425 million. We estimate that the amounts that may be paid during the next twelve months to be approximately $40 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-based milestones or royalty or profit share 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 or profit share obligations may be significant depending upon the level of commercial sales for each product.
We 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 of these relates to the potential future consideration related to the respiratory delivery platform. These payments are contingent upon the occurrence of certain future events and, given the nature of these events, it is unclear when, if ever, we may be required to pay such amounts. The amount of the contingent consideration liabilities was $213.2 million at September 30, 2020. In addition, the Company expects to incur approximately $10 million to $15 million of non-cash accretion expense related to the increase in the net present value of the contingent consideration liabilities in 2020.
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Supplemental Guarantor Financial Information
Mylan N.V. is the issuer of the 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 fully and unconditionally guaranteed on a senior unsecured basis by Mylan Inc. Mylan Inc. is the issuer of the 3.125% Senior Notes due 2023, 4.200% Senior Notes due 2023, 4.550% Senior Notes due 2028, 5.400% Senior Notes due 2043 and 5.200% Senior Notes due 2048 (collectively, the “Mylan Inc. Senior Notes” and, together with the Mylan N.V. Senior Notes, the “Senior Notes”), which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan N.V.
The respective obligations of Mylan N.V. and Mylan Inc. as guarantors of the Senior Notes, as applicable, are senior unsecured obligations of the applicable guarantor and rank pari passu in right of payment with all of such guarantor’s existing and future senior unsecured obligations that are not expressly subordinated to such guarantor’s guarantee of the applicable series of Senior Notes, rank senior in right of payment to any future obligations of such guarantor that are expressly subordinated to such guarantor’s guarantee of the applicable series of Senior Notes, and are effectively subordinated to such guarantor’s existing and future secured obligations to the extent of the value of the collateral securing such obligations. The respective obligations of Mylan N.V. and Mylan Inc. as guarantors of the Senior Notes, as applicable, are structurally subordinated to all of the existing and future liabilities, including trade payables, of the existing and future subsidiaries of such guarantor that do not guarantee the applicable series of Senior Notes.
The guarantees by Mylan Inc. of the Mylan N.V. Senior Notes will terminate under the following customary circumstances: (1) a sale or disposition of Mylan Inc. in a transaction that complies with the applicable indenture such that Mylan Inc. ceases to be a subsidiary of Mylan N.V.; (2) legal defeasance or covenant defeasance, each as described in the applicable indenture, or if Mylan N.V.’s obligations under the applicable indenture are discharged; or (3) the earlier to occur of (i) the release of Mylan N.V.’s guarantee under all applicable Mylan Inc. debt and (ii) Mylan Inc. no longer having any obligations in respect of any Mylan Inc. debt.
The guarantee obligations of Mylan N.V. and Mylan Inc. under the Senior Notes are subject to certain limitations and terms similar to those applicable to other guarantees of similar instruments, including that (i) the guarantees are subject to fraudulent transfer and conveyance laws and (ii) each guarantee is limited in amount to an amount not to exceed the maximum amount that can be guaranteed by the applicable guarantor without rendering the guarantee, as it relates to such guarantor, voidable under applicable fraudulent transfer and conveyance laws or similar laws affecting the rights of creditors generally. In addition, Dutch and English insolvency laws to which Mylan N.V. is or may be subject may not be as favorable to holders of Senior Notes as United States or other insolvency laws, and, because it is a Dutch company, it may be more difficult for holders of Senior Notes to obtain or enforce judgments against Mylan N.V.
Because Mylan N.V. is a holding company, its only material assets are its ownership interests in its subsidiaries, and those subsidiaries conduct substantially all of its operations. As a result, Mylan N.V.’s ability to make payments on its obligations under the Senior Notes will depend on its subsidiaries’ cash flow and their ability to make payments to Mylan N.V., which will depend on their earnings, applicable covenants in debt and other agreements, business and tax considerations and applicable law (including local law regulating payments of dividends and distributions).
In March 2020, the SEC amended Rule 3-10 of Regulation S-X regarding the financial disclosure requirements for guarantors and issuers of guaranteed securities registered or being registered. Among other things, the amendments narrow the circumstances that require separate financial statements of subsidiary issuers and guarantors and streamline the alternative disclosures required in lieu of those financial statements. The effective date of the amendment is January 4, 2021 with earlier voluntary compliance permitted. We have chosen to voluntarily comply with the amended rules effective during the three months ended March 31, 2020.

The following table presents unaudited summarized financial information of Mylan N.V. and Mylan Inc. on a combined basis as of and for the nine months ended September 30, 2020 and as of and for the year ended December 31, 2019. All intercompany balances have been eliminated in consolidation. This unaudited combined summarized financial information is presented utilizing the equity method of accounting.
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Combined Summarized Balance Sheet Information of Mylan N.V. and Mylan Inc.
(In millions) September 30, 2020 December 31, 2019
ASSETS
Current assets $ 97.9  $ 152.2 
Non-current assets 40,061.9  41,602.4 
LIABILITIES AND EQUITY
Current liabilities 18,436.6  15,414.9 
Non-current liabilities 9,175.3  14,455.9 
Combined Summarized Statement of Operations Information of Mylan N.V. and Mylan Inc.
(In millions) Nine Months Ended September 30, 2020 Year Ended December 31, 2019
Revenues $ —  $ — 
Gross Profit —  — 
Loss from Operations (708.8) (790.3)
Net earnings 245.8  16.8 
Other Commitments
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 Specialties Private Limited, Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business, and certain other acquisitions. We have approximately $42.8 million accrued for legal contingencies at September 30, 2020.
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 an indemnified claim, could have a material adverse effect on the 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 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.
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Application of Critical Accounting Policies

There have been no changes to the Critical Accounting Policies disclosed in our 2019 Form 10-K. The following discussion supplements our Critical Accounting Policy for Acquisitions, Intangible Assets, Goodwill and Contingent Consideration as it relates to the goodwill impairment tests performed as of March 31, 2020 and April 1, 2020.
The Company reviews goodwill for impairment annually on April 1st or more frequently if events or changes in circumstances indicate that the carrying value of goodwill may not be recoverable. As a result of the decline in the Company’s share price during the first quarter of 2020, and the general uncertainty and volatility in the economic environments in which the Company operates, including the impacts of the COVID-19 pandemic, the Company performed an interim goodwill impairment test as of March 31, 2020. The Company performed the annual goodwill impairment test as of April 1, 2020. There were no significant changes from the interim goodwill test performed at March 31, 2020 and the results were consistent with the interim goodwill impairment test.

The Company has performed both the interim and annual goodwill impairment tests on a quantitative basis for its four reporting units, North America Generics, North America Brands, Europe and Rest of World. In estimating each reporting unit’s fair value, the Company performed an extensive valuation analysis, utilizing both income and market-based approaches, except for the North America Brands reporting unit where the fair value was estimated utilizing the income approach. 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.
As of March 31, 2020 and April 1, 2020, the allocation of the Company’s total goodwill was as follows: North America Generics $2.60 billion, North America Brands $0.65 billion, Europe $4.43 billion and Rest of World $1.65 billion.
As of March 31, 2020 and April 1, 2020, the Company determined that the fair value of the North America Generics, North America Brands and Rest of World reporting units was substantially in excess of the respective unit’s carrying value. However, when compared to the April 1, 2019 test, the fair value of our overall business declined because of future forecasts and the decline in our share price.
For the Europe reporting unit, the estimated fair value exceeded its carrying value by approximately $1.3 billion or 11.0% for both the interim and annual goodwill impairment test. The excess fair value for the Europe reporting unit is consistent with the result of the Company’s 2019 annual impairment test. As it relates to the income approach for the Europe reporting unit at March 31, 2020 and April 1, 2020, the Company forecasted cash flows for the next 5 years. During the forecast period, the revenue compound annual growth rate was approximately 7.5%. A terminal year value was calculated with a 2.0% revenue growth rate applied. The discount rate utilized was 11.0% and the estimated tax rate was 25.5%. Under the market-based approach, we utilized an estimated range of market multiples of 8.0 to 9.5 times EBITDA plus a control premium of 15.0%. If all other assumptions are held constant, a reduction in the terminal value growth rate by 3.5% or an increase in discount rate by 3.5% would result in an impairment charge for the Europe reporting unit.
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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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, 2019, 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 Accounting Officer (the person performing similar functions as the Principal Financial Officer for this purpose), of the effectiveness of the design and operation of the Company’s disclosure controls and procedures as of September 30, 2020. Based upon that evaluation, the Principal Executive Officer and the Principal Accounting Officer concluded that the Company’s disclosure controls and procedures were effective.
Management has not identified any changes in the Company’s internal control over financial reporting that occurred during the third quarter of 2020 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
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PART II — OTHER INFORMATION
ITEM 1.    LEGAL PROCEEDINGS
For information regarding legal proceedings, refer to Note 18 Litigation, in the accompanying Notes to interim financial statements in this Form 10-Q.
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ITEM 1A.     RISK FACTORS
Except for the risk factor disclosed in Part II, Item 1A of Mylan’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which is hereby incorporated by reference into this Part II, Item 1A of this Form 10-Q, 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, 2019, as amended.
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ITEM 6. EXHIBITS
2.1
Amendment No. 3, dated as of September 18, 2020, to the Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc..^
Separation Agreement, entered into on August 5, 2020, by and between Mylan Inc. and Kenneth Parks.*
Asset Purchase Agreement, dated as of September 7, 2020, between Aspen Global Incorporated and Mylan Ireland Limited.^
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List of Subsidiary Guarantors and Issuers of Guaranteed Securities, filed as Exhibit 22 to the Form 10-Q for the quarter ended March 31, 2020, 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.
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Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS Inline XBRL Instance Document
101.SCH Inline XBRL Taxonomy Extension Schema
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase
101.DEF Inline XBRL Taxonomy Definition Linkbase
101.LAB Inline XBRL Taxonomy Extension Label Linkbase
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase
104 Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document (included in Exhibit 101).
* Denotes management contract or compensatory plan or arrangement.
^ Annexes, schedules and/or exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. Mylan agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request.

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Mylan N.V.
(Registrant)
By: /s/ HEATHER BRESCH
  Heather Bresch
  Chief Executive Officer
  (Principal Executive Officer)
November 6, 2020
/s/ PAUL B. CAMPBELL
  Paul B. Campbell
  Chief Accounting Officer and Corporate Controller
  (Principal Accounting Officer)
November 6, 2020
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Exhibit 2.1
EXECUTION VERSION

AMENDMENT NO. 3 TO THE
SEPARATION AND DISTRIBUTION AGREEMENT

This Amendment No. 3 (this “Amendment”) to the Separation and Distribution Agreement, dated as of July 29, 2019, as amended (the “Agreement”), is made as of September 18, 2020 by and between Pfizer Inc., a Delaware corporation (“Pluto”) and Upjohn Inc., a Delaware corporation and wholly owned Subsidiary of Pluto (“Spinco”). Each of the foregoing parties is referred to herein as a “Party” and collectively as the “Parties.”
WHEREAS, the Parties entered into the Agreement on July 29, 2019;
WHEREAS, the Parties entered into Amendment No. 1 to the Separation and Distribution Agreement on February 18, 2020;
WHEREAS, the Parties entered into Amendment No. 2 to the Separation and Distribution Agreement on May 29, 2020; and
WHEREAS, in accordance with the terms and conditions of the Agreement, the Parties now wish to amend the Agreement in the manner set forth in this Amendment.
NOW, THEREFORE, in consideration of the foregoing recitals and other good and valuable consideration, the receipt, adequacy and sufficiency of which is hereby acknowledged by each Party, the Parties hereto agree as follows:
SECTION 1. Definitions. Capitalized terms used in this Amendment but not defined herein shall have the meanings given to them in the Agreement.
SECTION 2. Amendments to the Agreement.
(a)Section 1.01 of the Agreement is hereby amended by adding the following definition in the appropriate alphabetical location:
“License and Supply Agreements” has the meaning set forth in Section 2.08(d).
(b)Schedule 2.02(b)(vi) to the Agreement is hereby amended as set forth on Annex A.


(c)Section 2.08 of the Agreement is hereby amended by adding a new Section 2.08(d) as follows:
“(d)    Each of Pluto, Spinco and Utah agrees that it will use its reasonable best efforts to cooperate in good faith to negotiate and finalize as promptly as practicable one or more agreements (in each case, including the schedules and exhibits thereto) pursuant to which Pluto shall license to Spinco the commercialization rights in the United States for, and supply to Spinco, the Spinco Products (which license shall exclude, for the avoidance of doubt, the right to commercialize any authorized generic or generic under the marketing authorizations set forth in items 4 and 5 of Schedule 2.02(b)(vi)) for which Pluto or another member of the Pluto Group shall hold the applicable New Drug Application or Abbreviated New Drug Application as of the Distribution Time, excluding any such marketing authorization to be transferred to Spinco or another member of the Spinco Group pursuant to Section 2.04 (the “License and Supply Agreements”), and each of Pluto, Spinco and Utah, as applicable, will execute and deliver, and cause each of their applicable Subsidiaries to execute and deliver, as applicable, the License and Supply Agreements on or prior to the Distribution Date.”

(d)Schedule 5.01(c) to the Agreement is hereby amended as set forth on Annex B.
SECTION 3. Limited Amendment. Each Party acknowledges and agrees that this Amendment constitutes an instrument in writing duly signed by the Parties under Section 10.03 of the Agreement. Except as specifically amended hereby, the Agreement shall continue in full force and effect in accordance with the provisions thereof as in existence on the date hereof. From and after the date hereof, all references to the Agreement, and each reference in the Agreement to “this Agreement,” “hereof,” “herein,” “hereby,” “hereto,” “herewith,” “hereunder” and derivative or similar words, shall refer to the Agreement as amended hereby. Each reference in the Agreement, as amended hereby, to “the date of this Agreement”, “the date hereof” or any similar reference shall continue to refer to July 29, 2019.
SECTION 4. Miscellaneous. The provisions of Article X of the Agreement shall apply to this Amendment, mutatis mutandis, and are incorporated by reference as if fully set forth herein.
[Signature page follows]




IN WITNESS WHEREOF, the Parties have caused this Amendment to be duly executed by their respective authorized officers as of the day and year first above written.

PFIZER INC.
By: /s/ Douglas Giordano
Name: Douglas Giordano
Title: Senior Vice President
UPJOHN INC.
By: /s/ Alison L.M. O’Neill
Name: Alison L.M. O’Neill
Title: Vice President




























[Signature Page to Amendment No. 3 to the Separation and Distribution Agreement]







MYLAN N.V.
By: /s/ Thomas Salus
Name: Thomas Salus
Title: Assistant Secretary



































[Signature Page to Amendment No. 3 to the Separation and Distribution Agreement]





Annex A















































Annex B



Exhibit 10.1
EXECUTION VERSION

SEPARATION AGREEMENT AND RELEASE
This Separation Agreement and Release (“Agreement”) is made by and between Kenneth S. Parks (“Executive”) and Mylan Inc. (together with its affiliates, the “Company”) (collectively referred to as the “Parties” or individually referred to as a “Party”).
RECITALS
WHEREAS, Executive and the Company executed a Transition and Succession Agreement on June 6, 2016 (the “Transition and Succession Agreement”), which, among other matters, provides for certain terms and conditions regarding Executive's employment with, and separation from, the Company in connection with a “change of control” (as defined in the Transition and Succession Agreement), including without limitation obligations that survive the termination of the Transition and Succession Agreement and termination of Executive's employment with the Company, as specified in Section 21 of this Agreement, and an Executive Employment Agreement on February 25, 2019 (the “Employment Agreement”), which, among other matters, provides for certain terms and conditions regarding Executive's employment with, and separation from, the Company; and
WHEREAS, Upjohn Inc., Pfizer, Inc. and Mylan N.V. entered into a Business Combination Agreement, dated July 29, 2019 (the “BCA”), pursuant to which Upjohn Inc. and Mylan N.V. will combine to form Viatris (the “Proposed Combination”); and
WHEREAS, the closing of the Proposed Combination (the “Closing”, and the date of Closing, the “Closing Date”) will constitute a “Change of Control” for purposes of the Transition and Succession Agreement; and
WHEREAS, Executive will separate from employment with the Company effective as of September l, 2020 (the “Separation Date”) in connection with the Proposed Combination; and
WHEREAS, the Company and Executive wish to set forth the terms of such separation from employment with the Company.
NOW, THEREFORE, in consideration of the mutual promises made herein and intending to be legally bound hereby, the Company and Executive hereby agree as follows:
COVENANTS
1.Consideration and Other Terms of Separation. Effective as of the Separation Date, Executive shall resign from all positions as an executive, officer, employee or director of the Company and all of its parents, subsidiaries and affiliates, and Executive shall cease to be the Chief Financial Officer of the Company or any of its parents, subsidiaries and affiliates. Provided
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that Executive executes this Agreement and complies with its terms (including the Second Release requirement pursuant to Section 4 below), and does not commit a material breach of this Agreement, as described in Section 12 below:
a.Severance Payment. Executive shall be paid (i) an amount equal to $800,000 and (ii) solely in the event the Closing occurs, an amount equal to the amount specified in Section 5 of the Transition and Succession Agreement less the amount set forth in clause (i) (approximately $5,753,800), in each case, in a lump sum on the first business day after the date that is six months following the Separation Date (or, in the case of the amount specified in clause (ii), if later, as soon as practicable following the Closing Date), subject to applicable deductions and withholdings required by applicable law.
b.Treatment of Equity- Based Award.
i.        Each outstanding equity-based award held by Executive as of the Separation Date shall remain outstanding as of the Separation Date; provided, however, that each such award shall not continue to vest in accordance with its terms following the Separation Date.
ii.In the event the Closing does not occur, each equity-based award that is outstanding and unvested as of the Separation Date shall be forfeited as of the date of the termination of the BCA.
iii.Solely in the event the Closing occurs, Executive shall become vested in each unvested restricted stock unit, performance-based restricted stock unit and stock option held by Executive as of the Separation Date, with any applicable performance conditions deemed achieved at target levels (except with respect to any performance-based restricted stock units for which actual performance is certified prior to the Closing Date, in which case such performance-based restricted stock units shall vest based on such determined performance level). Each such restricted stock unit and performance-based restricted stock unit will be settled on the first business day after the date that is six months following the Separation Date (or, if later, as soon as practicable following the Closing Date), subject to applicable deductions and withholdings required by applicable law. For the avoidance of doubt, any outstanding equity-based awards held by Executive as of the Closing shall be treated in accordance with the terms of the BCA.
iv.    Solely in the event the Closing occurs, each vested stock option held by Executive as of the Separation Date, and each stock option that vests pursuant to Section l(b)(iii), shall remain exercisable for the remaining term of such stock option pursuant to the applicable award agreement (i.e., ten years from the grant date). In the event the Closing does not occur, each vested stock option held by Executive as of the Separation Date shall remain exercisable for thirty (30) days following the date of the termination of the BCA.
c.Pro Rata Annual Incentive Payment for 2020. Executive shall be paid a pro rata annual bonus for 2020, which shall be determined by reference to the bonus Executive would have earned based on actual performance for 2020 and prorated to reflect the number of
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days elapsed in the 2020 fiscal year through the Separation Date. The pro rata bonus shall be paid as soon as practicable following the Company's Board of Directors' certification of applicable performance metrics for 2020, but in no event later than March 15, 2021.
d.Benefits. Executive (and Executive's dependents) shall continue to be eligible to receive the health insurance benefits provided to them immediately prior to the Separation Date, subject to Executive's payment of any employee contributions, co-payments and similar costs, until September 1, 2021 (or, if earlier, the date Executive obtains health insurance benefits from a subsequent employer).
e.40l(k) Restoration Plan. Executive shall be paid the accrued and vested benefit under the Company's 401(k) Restoration Plan on the first business day after the date that is six months following the Separation Date.
f.Vacation Pay. The Company shall pay Executive for all unused and accrued vacation time as of the Separation Date, less applicable deductions and withholdings required by applicable law. This payment shall be made in a lump sum and shall be paid on the Company's next regularly scheduled payroll date after the Separation Date.
g.Other Benefits. Executive's participation in all other benefits and incidents of employment, including, but not limited to, the accrual of bonuses, vacation, and paid time off, and any additional 40l(k) plan contributions, shall cease as of the Separation Date. Vested amounts payable to Executive under the Company's 40l(k) and other retirement plans or agreements will be paid in accordance with the terms of such plans and agreements and applicable law. All payments hereunder shall be subject to applicable deductions and withholdings as required by applicable law.
h.Section 280G. The Company has engaged Ernst & Young LLP (“EY”) to perform calculations and make the determination required under Section 8 of the Transition and Succession Agreement, and the payments and benefits described in this Section 1 may be subject to reduction in connection with such determination and in accordance with Section 8 of the Transition and Succession Agreement. Determinations of EY shall be conclusive and binding.
2.Payment of Salary and Receipt of All Benefits. Executive acknowledges and represents that, other than the consideration to be paid pursuant to this Agreement, Executive's final regular pay on the Company's next regularly scheduled payroll date after the Separation Date and payment for all unused and accrued vacation time as of the Separation Date (which will be included in Executive's final regular pay on the Company's next regularly scheduled payroll date after the Separation Date, subject to applicable deductions and withholding), the Company has paid or provided all salary, wages, bonuses, accrued vacation/paid time off, premiums, leaves, reimbursable expenses, stock, stock options, vesting, shares pursuant to vested restricted stock units, and any and all other benefits and compensation due to Executive by the Company and its affiliates. To receive reimbursement for any final Company-related travel expenses, Executive must submit a final report of all such outstanding expenses within thirty (30) calendar days after the Separation Date, accompanied by receipts and otherwise subject to the Company's expense reimbursement policy.
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3.First Complete General Release of Claim. In consideration of the payments to be made under this Agreement, which Executive acknowledges Executive would not otherwise be entitled to receive, Executive agrees that the foregoing consideration represents settlement in full of all outstanding obligations owed to Executive by the Company and its current and former officers, directors, employees, agents, investors, attorneys, shareholders, administrators, affiliates, direct and indirect parents and subsidiaries, benefit plans, plan administrators, insurers, trustees, divisions, and subsidiaries, predecessor and successor corporations and assigns, and all persons acting with or on behalf of them (collectively, the “Releasees”). Executive, on Executive's own behalf and on behalf of Executive's heirs, family members , executors, agents, and assigns, hereby and forever releases and discharges the Releasees from any and all claims, complaints, charges, duties, obligations, demands, or causes of action relating to any matters of any kind, whether presently known or unknown, suspected or unsuspected, that Executive may possess against any of the Releasees arising from any omissions, acts, failures to act, facts, or damages that have occurred up until and including the date Executive executes this Agreement, including, without limitation:
a.any and all claims relating to or arising from Executive's employment relationship with the Company and/or any of the Releasees and the termination of that relationship;
b.any and all claims relating to, or arising from, Executive's right to purchase, or actual purchase of shares of stock of the Company and/or any of the Releasees, including, without limitation, any claims for fraud, misrepresentation, breach of fiduciary duty, breach of duty under applicable state corporate law, and securities fraud under any state or federal law;
c.any and all claims for wrongful discharge of employment; termination in violation of public policy; discrimination; harassment; retaliation; breach of contract, both express and implied; breach of covenant of good faith and fair dealing, both express and implied; promissory estoppel; negligent or intentional infliction of emotional distress; fraud; negligent or intentional misrepresentation; negligent or intentional interference with contract or prospective economic advantage; unfair business practices; defamation; libel; slander; negligence; personal injury; assault; battery; invasion of privacy; false imprisonment; conversion; and disability benefits;
d.any and all claims under any policy, agreement, understanding or promise, written or oral, formal or informal, between any Releasee and Executive existing as of the date hereof (whether or not known or arising before, on or after the date Executive executes this Agreement);
e.any and all claims for violation of any federal, state, or municipal statute, including, but not limited to, Title VII of the Civil Rights Act of 1964; the Civil Rights Act of 1991; the Rehabilitation Act of 1973; the Americans with Disabilities Act of 1990; the Equal Pay Act; the Fair Labor Standards Act; the Fair Credit Reporting Act; the Age Discrimination in Employment Act of 1967; the Older Workers Benefit Protection Act; the Employee Retirement Income Security Act of 1974; the Worker Adjustment and Retraining Notification Act; the
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Family and Medical Leave Act; the Sarbanes-Oxley Act of 2002; the laws and Constitution of the Commonwealth of Pennsylvania, each as amended, or any other federal, state or local law, regulation ordinance or common law;
f.any and all claims for violation of the federal or any state constitution;
g.any and all claims arising out of any other laws and regulations relating to employment or employment discrimination;
h.any claim for any loss, cost, damage, or expense arising out of any dispute over the non-withholding or other tax treatment of any of the proceeds received by Executive as a result of this Agreement;
i.any and all claims for attorneys' fees and costs; and
j.any other claims whatsoever.
Executive agrees that the Release set forth in this section shall be and remain in effect in all respects as a complete general release as to the matters released. This Release does not extend to any obligations incurred under this Agreement, Executive's indemnification rights under Executive's Employment Agreement and Transition and Succession Agreement, any claims accruing after the execution of this Agreement, or any rights Executive may have under any D&O insurance policy maintained by the Company and/or any of the Releasees. This Release does not release claims that cannot be released as a matter of law, including, but not limited to, Executive's right to file a charge with or participate in a charge by the Equal Employment Opportunity Commission, or any other local, state, or federal administrative body or government agency that is authorized to enforce or administer laws related to employment, against the Company (with the understanding that any such filing or participation does not give Executive the right to recover any monetary damages against the Company and/or any of the Releasees; and Executive's release of claims herein bars Executive from recovering such monetary relief from the Company and/or any of the Releasees). Executive represents that Executive has made no assignment or transfer of any right, claim, complaint, charge, duty, obligation, demand, cause of action, or other matter waived or released by this Section 3.
4.Second Release of Claims. Executive agrees that the foregoing consideration is subject to his execution, not later than 21 days following the Separation Date, of a second release of claims (the “Second Release”) in the form attached hereto as Appendix A, and the non­ revocation of the Second Release during the period specified therein. If Executive fails to execute and deliver the Second Release within 21 days following the Separation Date, or if Executive revokes the Second Release as provided therein, Executive shall forfeit his right to receive the compensation and benefits provided under this Agreement.
5.Acknowledgment that Waiver of Claims is Knowing and Voluntary. Executive acknowledges that Executive is waiving and releasing any rights Executive may have under the Age Discrimination in Employment Act of 1967 (“ADEA'') and that this waiver and release is knowing and voluntary. Executive agrees that this waiver and release does not apply to any
5

rights or claims that may arise under the ADEA after the date Executive executes this Agreement. Executive acknowledges that the consideration given for this waiver and release is in addition to anything of value to which Executive was already entitled. Executive further acknowledges that Executive has been advised by this writing that: (a) Executive should consult with an attorney prior to executing this Agreement; and (b) nothing in this Agreement prevents or precludes Executive from challenging or seeking a determination in good faith of the validity of this waiver under the ADEA, nor does it impose any condition precedent, penalties, or costs for doing so, unless specifically authorized by federal law.
6.Unknown Claims. Executive acknowledges that Executive has been advised to consult with legal counsel and that Executive is familiar with the principle that a general release does not extend to claims that the releaser does not know or suspect to exist in Executive's favor at the time of executing the release, which, if known by Executive, must have materially affected Executive's settlement with the Releasee. Executive, being aware of said principle, agrees to expressly waive any rights Executive may have to that effect, as well as under any other statute or common law principles of similar effect.
7.No Pending or Future Lawsuits. Executive represents that Executive has no lawsuits, claims, or actions pending in Executive's name, or on behalf of any other person or entity, against the Company or any of the other Releasees. Executive also represents that Executive does not intend to bring any claims on Executive's own behalf or on behalf of any other person or entity against the Company or any of the other Releasees.

8.Confidentiality. Executive reaffirms and agrees to observe and abide by the “Agreement Relating to Patents, Copyrights, Inventions, Confidentiality and Proprietary Information” entered into between Executive and the Company and any and all amendments and supplements thereto, surviving Section 5 of the Employment Agreement and surviving Section 9(a) of the Transition and Succession Agreement (collectively, the “Confidentiality Agreement”). For the avoidance of doubt, Confidential Information thereunder includes, without limitation, information or materials regarding the Company's plans, strategies, governance or operations, including any discussions or deliberations relating thereto.

9.Trade Secrets and Confidential Information/Company Property/Inquiries. Executive's signature below constitutes Executive's representation that as of the Separation Date, Executive shall (a) remove from any and all devices, records, files, folders, cameras, media, internet sites, electronic or digital devices, and any and all other sources, all documents, tapes, photographs, recordings, images, reproductions, electronic files, and other items provided to Executive by the Company and/or any of the Releasees, developed or obtained by Executive in connection with Executive's employment with the Company, or otherwise belonging to the Company and/or any of the Releasees, and (b) return all documents, tapes, photographs, recordings, images, reproductions, electronic files, and other items provided to Executive by the Company, developed or obtained by Executive in connection with Executive's employment with the Company, or otherwise belonging to the Company, including but not limited to any personal computer(s), BlackBerry, iPhone, iPad, tapes, photographs, recordings, images, reproductions, electronic files, and other items. Executive further represents that Executive will not misuse or
6

disclose any of the Company's and/or any of the Releasees' confidential, proprietary, or trade secret information to any third party other than a law enforcement or authorized regulatory agency of the United States Government or any state or local government. In addition, Executive will abide by the Company's external communication policy, such that in the event Executive receives any media, financial community or other third-party inquiries regarding the Company, except as provided in Section 10 of this Agreement, Executive will not respond (nor will Executive initiate any such contact) and will promptly notify the Company's Global Public Affairs Department at 724.514.1968 or gpa@mylan.com, or any successor department.

10.Limits on Cooperation; Compliance. Executive agrees that Executive will not knowingly encourage, counsel, or assist any attorneys or their clients in the presentation or prosecution of any disputes, differences, grievances, claims, charges, or complaints by any third party, other than a law enforcement or authorized regulatory agency of the United States Government or any state or local government, against any of the Releasees. Executive may, however, respond to a lawful subpoena or other court order to do so or as related directly to the ADEA waiver in this Agreement or as otherwise required by law. Executive agrees both to promptly notify the Company upon receipt of any such subpoena or court order, and to furnish, within three (3) business days of its receipt, a copy of such subpoena or other court order. If approached by anyone, other than a law enforcement or authorized regulatory agency of the United States Government or any state or local government, for counsel or assistance in the presentation or prosecution of any disputes, differences, grievances, claims, charges, or complaints against any of the Releasees, Executive shall state no more than that Executive cannot provide counsel or assistance. If approached for counsel or assistance as aforementioned, whether by private parties or law enforcement or regulatory agencies, Executive shall promptly notify the Company of such an occurrence, and provide information to the Company regarding any such communication. While Executive may respond to inquiries by law enforcement or regulatory agencies, Executive shall notify any such agencies of Executive's obligations with respect to confidentiality under this Agreement, the Confidentiality Agreement, the Transition and Succession Agreement, and any other applicable agreements, and Executive shall continue to honor such obligations in the course of responding to law enforcement or regulatory agency inquiries, as lawfully permitted. Executive understands that nothing contained in this Agreement limits Executive's ability to file a charge or complaint with the Securities and Exchange Commission (the “SEC”) pursuant to Section 21F of the Securities Exchange Act of 1934, as amended, limits Executive's ability to communicate with the SEC pursuant to such provision or limits Executive's right to receive an award for information provided to the SEC pursuant to such provision. Furthermore, Executive hereby represents that Executive is not aware of any violation of any Company policy or the Company's Code of Conduct in any event which could cause harm (financial or otherwise) to the Company or any of its subsidiaries, parents or affiliates or their respective properties, shareholders, employees or prospects, other than matters which Executive has previously reported to the Office of Global Compliance or the Mylan Legal Department.
Executive shall use Executive's best efforts to consult with the Company and respond to the Company's reasonable requests for information or follow-up assistance pertaining to work Executive performed on behalf of the Company and/or any subsidiary or affiliate, or other matters in which Executive was involved or of which Executive was otherwise aware, prior to
7

the Separation Date. Executive's obligations hereunder shall include without limitation Executive's response to requests of legal counsel for the Company and/or any subsidiary or affiliate regarding any legal matters or proceedings of any kind currently pending or which may arise after the Separation Date. The Company will reimburse Executive for any expenses incurred by Executive in connection with such requests or assistance if approved by the Company's Legal Department and supported by required documentation. No payment made to Executive hereunder is intended to be or shall be interpreted as a payment for testimony in any legal matter. Executive understands that Executive is to provide Executive's good faith assistance, and agrees to provide truthful responses to any requests for information or testimony.
11.Non-Disparagement. Executive agrees to refrain from any disparaging statements, including but not limited to statements that amount to libel or slander, about the Company, its direct and indirect parents, subsidiaries or affiliated companies, and/or any of its or their current or former employees, officers, or directors, and/or any of the other Releasees including, without limitation, the business, products, intellectual property, financial standing, future, or other employment, compensation, benefit, or personnel practices of the Company and/or any of the Releasees. Executive further agrees to refrain from any disparaging statements, including but not limited to libel or slander, about any of the Releasees that pertain to any personal or confidential matters that may cause embarrassment to any of the Releasees or may result in any adverse effect on the professional or personal reputation of any of the Releasees. The foregoing restrictions shall not apply to any testimony that Executive is compelled by law to give (whether written or verbal). The Company agrees to instruct its executive officers to refrain from any disparaging statements, including but not limited to libel or slander, about Executive that pertain to any personal or confidential matters that may cause embarrassment to Executive or may result in any adverse effect on the professional or personal reputation of Executive. The foregoing restrictions shall not apply to any testimony that any executive officer of the Company is compelled to give by law (whether written or verbal).
12.Breach.
a.Material Breach of Agreement. In addition to the rights provided in Section 20 below, if Executive commits a material breach of this Agreement, which shall include without limitation any breach of Sections 8, 9, 10 and 11 of this Agreement, and any breach of the Confidentiality Agreement, surviving Section 6 (non-competition and non-solicitation) of the Employment Agreement and surviving Sections 9(b) and 9(c) (non-competition and non­solicitation) of the Transition and Succession Agreement, the Company shall be entitled to immediately recover and/or cease providing the payments and consideration provided to Executive under this Agreement (including, for the avoidance of doubt, canceling any equity awards Executive holds) and to obtain damages, except as provided by law.
b.Executive also acknowledges and agrees that Executive's compliance with Sections 8, 9, 10 and 11 of this Agreement, the Confidentiality Agreement, surviving Section 6 (non-competition and non-solicitation) of the Employment Agreement and surviving Sections 9(b) and 9(c) (non-competition and non-solicitation) of the Transition and Succession Agreement is of the essence. The Parties agree that if the Company and/or any of the Releasees
8

proves that Executive breached, intends to breach, or will breach any of these provisions (Sections 8, 9, 10 or 11 of this Agreement, the Confidentiality Agreement, surviving Section 6 (non-competition and non-solicitation) of the Employment Agreement or surviving Sections 9(b) and 9(c) (non-competition and non-solicitation) of the Transition and Succession Agreement), without limiting any other remedies available to the Company and/or any of the Releasees, the Company and/or any of the Releasees shall be entitled to an injunction restraining Executive from any future or further breaches and an award of its costs spent enforcing the applicable provision(s), including all reasonable attorneys' fees associated with the enforcement action as provided in Section 20, without regard to whether the Company and/or any of the Releasees can establish actual damages from Executive's breach. Any such individual breach or disclosure shall not excuse Executive from Executive's obligations hereunder, nor permit Executive to make additional disclosures.
Executive expressly agrees and warrants that Executive will not, in violation of the terms of Sections 8, 9, 10 or 11 of this Agreement, the Confidentiality Agreement, surviving Section 6 (non-competition and non-solicitation) of the Employment Agreement or surviving Sections 9(b) and 9(c) (non-competition and non-solicitation) of the Transition and Succession Agreement, disclose, orally or in writing, directly or indirectly, any of the Company's confidential, proprietary or trade secret information to any third party other than a law enforcement or authorized regulatory agency of the United States Government or any state or local government. Executive warrants that Executive has not encouraged or assisted any attorneys or their clients in the presentation or prosecution of any disputes against the Company and/or any of the Releasees.
13.No Admission of Liability/Compromise. No action taken by the Company and/or any of the Releasees, either previously or in connection with this Agreement, shall be deemed or construed to be (a) an admission of the truth or falsity of any actual or potential claims or (b) an acknowledgment or admission by the Company and/or any of the Releasees of any fault or liability.
14.Costs. The Parties shall each bear their own costs, attorneys' fees, and other fees incurred in connection with the preparation of this Agreement.

15.Choice of Law and Forum. This Agreement shall be construed and enforced according to, and the rights and obligations of the parties shall be governed in all respects by, the laws of the Commonwealth of Pennsylvania without reference to the principles of conflicts of law thereof. Any controversy, dispute or claim arising out of or relating to this Agreement, or the breach hereof, including a claim for injunctive relief, or any claim which, in any way arises out of or relates to, Executive's employment with the Company or separation from said employment (whether such dispute arises under any federal, state or local statute or regulation, or at common law), including but not limited to statutory claims for discrimination, shall be resolved by arbitration in accordance with the then current rules of the American Arbitration Association respecting employment disputes pertaining at the time the dispute arises; provided, however, that either party may seek an injunction in aid of arbitration with respect to enforcement of Sections 8, 9, 10 and/or 11 of this Agreement from any court of competent jurisdiction. The Parties agree that the hearing of any such dispute will be held in Pennsylvania. The decision of
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the arbitrator(s) will be final and binding on all parties and any award rendered shall be enforceable upon confirmation by a court of competent jurisdiction. Any arbitration proceedings, decision or award rendered hereunder, and the validity, effect and interpretation of this arbitration provision shall be governed by the Federal Arbitration Act, 9 U.S.C. § 1 et seq. Executive and the Company expressly consent to the jurisdiction of any such arbitrator over them.

16.Tax Consequences. The Company makes no representations or warranties with respect to the tax consequences of the payments and any other consideration provided to Executive or made on Executive's behalf under the terms of this Agreement. Executive agrees and understands that Executive is responsible for payment, if any, of local, state, and/or federal taxes on the payments and any other consideration provided hereunder by the Company and any penalties or assessments thereon. Executive further agrees to indemnify and hold the Company harmless from any claims, demands, deficiencies, penalties, interest, assessments, executions, judgments, or recoveries by any government agency against the Company for any amounts claimed due on account of (a) Executive's failure to pay or delayed payment of federal or state taxes, or (b) damages sustained by the Company by reason of any such claims, including attorneys' fees and costs.
The intent of the parties is that payments and benefits under this Agreement comply with Section 409A of the Internal Revenue Code (the “Code”) to the extent subject thereto, and, accordingly, to the maximum extent permitted, this Agreement shall be interpreted and administered to be in compliance therewith. Notwithstanding anything contained herein to the contrary, to the extent required in order to avoid accelerated taxation and/or tax penalties under Section 409A of the Code, Executive shall not be considered to have terminated employment with the Company for purposes of this Agreement and no payments shall be due to Executive under Section 1 of this Agreement until Executive would be considered to have incurred a “separation from service” from the Company within the meaning of Section 409A of the Code. For purposes of this Agreement, each amount to be paid or benefit to be provided shall be construed as a separate identified payment for purposes of Section 409A of the Code, and any payments described in Section 1 that are due within the “short term deferral period” as defined in Section 409A of the Code shall not be treated as deferred compensation unless applicable law requires otherwise. To the extent required in order to avoid accelerated taxation and/or tax penalties under Section 409A of the Code, amounts that would otherwise be payable and benefits that would otherwise be provided pursuant to this Agreement during the six-month period immediately following Executive's termination of employment shall instead be paid on the first business day after the date that is six months following the Separation Date (or death, if earlier). To the extent required to avoid an accelerated or additional tax under Section 409A of the Code, amounts reimbursable to Executive under this Agreement shall be paid to Executive on or before the last day of the year following the year in which the expense was incurred and the amount of expenses eligible for reimbursement (and in-kind benefits provided to Executive) during any one year may not affect amounts reimbursable or provided in any subsequent year; provided, however, that with respect to any reimbursements for any taxes which Executive would become entitled to under the terms of the Agreement, the payment of such reimbursements shall be made
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by the Company no later than the end of the calendar year following the calendar year in which Executive remits the related taxes.
17.Authority. The Company represents and warrants that the undersigned has the authority to act on behalf of the Company and to bind the Company and all who may claim through it to the terms and conditions of this Agreement. Executive represents and warrants that Executive has the capacity to act on Executive's own behalf and on behalf of all who might claim through Executive to bind them to the terms and conditions of this Agreement. Each Party warrants and represents that there are no liens or claims of lien or assignments in law or equity or otherwise of or against any of the claims or causes of action released herein.
18.No Representations. Executive represents that Executive has had an opportunity to consult with an attorney and has carefully read and understands the scope and effect of the provisions of this Agreement. Executive has not relied upon any representations or statements made by the Company that are not specifically set forth in this Agreement.

19.Severability. In the event that any provision or any portion of any provision hereof or any surviving agreement made a part hereof becomes or is declared by a court of competent jurisdiction or arbitrator to be illegal, unenforceable, or void, this Agreement shall continue in full force and effect without said provision or portion of provision.

20.Attorneys' Fees. Except with regard to a legal action challenging or seeking a determination in good faith of the validity of the waiver herein under the ADEA or otherwise prohibited by law, in the event that either Party brings an action to enforce or effect its rights under this Agreement, the prevailing Party shall be entitled to recover its costs and expenses, including the costs of mediation, arbitration, litigation, court fees, and reasonable attorneys' fees incurred in connection with such an action. Such costs and expenses shall be paid to the prevailing party as soon as practicable after the legal action is resolved and in no event later than March 15 of the year following resolution of the legal action.
21.Entire Agreement. This Agreement, the surviving provisions of the Employment Agreement (i.e., Sections 5, 6, 7, 8 and 10) and the surviving provisions of the Transition and Succession Agreement (i.e., Sections 8, 9(a), 9(b), 9(c), 11, and 12) and the Confidentiality Agreement represent the entire agreement and understanding between the Company and Executive concerning the subject matter of this Agreement and Executive's employment with and separation from the Company and the events leading thereto and associated therewith, and supersede and replace any and all prior negotiations, representations, agreements and understandings concerning the subject matter of such agreements, Executive's relationship with the Company, and Executive's obligations following employment with the Company. Executive acknowledges, reaffirms and agrees to observe and abide by all obligations that survive termination of the Employment Agreement.
22.No Oral Modification. This Agreement may only be amended in a writing signed by Executive and the Company.
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23.Governing Law. The laws of the Commonwealth of Pennsylvania govern this Agreement, without regard for choice-of-law provisions. Executive consents to personal and exclusive jurisdiction and venue in the Commonwealth of Pennsylvania.

24.Effective Date. This Agreement will become immediately effective upon Executive's execution and delivery of this Agreement to the Company, provided that if Executive fails to comply with this Agreement (including the Second Release requirement pursuant to Section 4), Executive will not receive the amounts or benefits set forth in Section 1, and this Agreement will never go into effect.

25.Counterparts. This Agreement may be executed in counterparts and by facsimile, and each counterpart and facsimile shall have the same force and effect as an original and shall constitute an effective, binding agreement on the part of each of the undersigned.

26.Voluntary Execution of Agreement. Executive understands and agrees that Executive executed this Agreement voluntarily, without any duress or undue influence on the part or behalf of the Company and/or any of the Releasees or any third party, with the full intent of releasing all of Executive's claims against the Company and any of the other Releasees. Executive acknowledges that: (a) Executive has read this Agreement; (b) Executive has been represented in the preparation, negotiation and execution of this Agreement by legal counsel of Executive's own choice or has elected not to retain legal counsel; (c) Executive understands the terms and consequences of this Agreement and of the releases it contains; (d) Executive is fully aware of the legal and binding effect of this Agreement and (e) Executive has been given the toll-free telephone number of the Pennsylvania Bar Association to help Executive identify a qualified lawyer (800-692-7375).
IN WITNESS WHEREOF, the Parties have executed this Agreement on the respective dates set forth below.
Dated: August 5, 2020        By:     /s/ Kenneth S. Parks
                    Kenneth S. Parks


MYLAN INC.:
Dated: August 5, 2020    By:     /s/ Brian S. Roman    
                         Brian S. Roman
                         Global General Counsel

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APPENDIX A
Second Release
This release (this “Second Release”) is made by Kenneth S. Parks (“Executive”) as of the date set forth below in connection with the Separation Agreement and Release between Executive and Mylan Inc. (together with its affiliates, the “Company”), made August 5, 2020 (the “Separation Agreement”), and in connection with Executive's separation from employment with the Company. Capitalized terms used but not defined herein shall have the meaning ascribed to them in the Separation Agreement.
1.In consideration of the payments to be made under the Separation Agreement, which Executive acknowledges Executive would not otherwise be entitled to receive, Executive agrees that the consideration provided under the Separation Agreement represents settlement in full of all outstanding obligations owed to Executive by the Company and its current and former officers, directors, employees, agents, investors, attorneys, shareholders, administrators, affiliates, direct and indirect parents and subsidiaries, benefit plans, plan administrators, insurers, trustees, divisions, and subsidiaries, predecessor and successor corporations and assigns, and all persons acting with or on behalf of them (collectively, the “Releasees”). Executive, on Executive's own behalf and on behalf of Executive's heirs, family members, executors, agents, and assigns, hereby and forever releases and discharges the Releasees from any and all claims, complaints, charges, duties, obligations, demands, or causes of action relating to any matters of any kind, whether presently known or unknown, suspected or unsuspected, that Executive may possess against any of the Releasees arising from any omissions, acts, failures to act, facts, or damages that have occurred up until and including the date Executive executes this Second Release, including, without limitation:
a.any and all claims relating to or arising from Executive's employment relationship with the Company and/or any of the Releasees and the termination of that relationship;
b.any and all claims relating to, or arising from, Executive's right to purchase, or actual purchase of shares of stock of the Company and/or any of the Releasees, including, without limitation, any claims for fraud, misrepresentation, breach of fiduciary duty, breach of duty under applicable state corporate law, and securities fraud under any state or federal law;
c.any and all claims for wrongful discharge of employment; termination in violation of public policy; discrimination; harassment; retaliation; breach of contract, both express and implied; breach of covenant of good faith and fair dealing, both express and implied; promissory estoppel; negligent or intentional infliction of emotional distress; fraud; negligent or intentional misrepresentation; negligent or intentional interference with contract or prospective economic advantage; unfair business practices; defamation; libel; slander; negligence; personal injury; assault; battery; invasion of privacy; false imprisonment; conversion; and disability benefits;


d.any and all claims under any policy, agreement, understanding or promise, written or oral, formal or informal, between any Releasee and Executive existing as of the date hereof (whether or not known or arising before, on or after the date Executive executes this Second Release);
e.any and all claims for violation of any federal, state, or municipal statute, including, but not limited to, Title VII of the Civil Rights Act of 1964; the Civil Rights Act of 1991; the Rehabilitation Act of 1973; the Americans with Disabilities Act of 1990; the Equal Pay Act; the Fair Labor Standards Act; the Fair Credit Reporting Act; the Age Discrimination in Employment Act of 1967; the Older Workers Benefit Protection Act; the Employee Retirement Income Security Act of 1974; the Worker Adjustment and Retraining Notification Act; the Family and Medical Leave Act; the Sarbanes-Oxley Act of 2002; the laws and Constitution of the Commonwealth of Pennsylvania, each as amended, or any other federal, state or local law, regulation ordinance or common law;
f.any and all claims for violation of the federal or any state constitution;
g.any and all claims arising out of any other laws and regulations relating to employment or employment discrimination;
h.any claim for any loss, cost, damage, or expense arising out of any dispute over the non-withholding or other tax treatment of any of the proceeds received by Executive as a result of the Separation Agreement;
i.any and all claims for attorneys' fees and costs; and
j.    any other claims whatsoever.
Executive agrees that this Second Release shall be and remain in effect in all respects as a complete general release as to the matters released. This Second Release does not extend to any obligations incurred under the Separation Agreement, Executive's indemnification rights under Executive's Employment Agreement and Transition and Succession Agreement, any claims accruing after the execution of the Separation Agreement, or any rights Executive may have under any D&O insurance policy maintained by the Company and/or any of the Releasees. This Second Release does not release claims that cannot be released as a matter of law, including, but not limited to, Executive's right to file a charge with or participate in a charge by the Equal Employment Opportunity Commission, or any other local, state, or federal administrative body or government agency that is authorized to enforce or administer laws related to employment, against the Company (with the understanding that any such filing or participation does not give Executive the right to recover any monetary damages against the Company and/or any of the Releasees; and Executive's release of claims herein bars Executive from recovering such monetary relief from the Company and/or any of the Releasees). Executive represents that Executive has made no assignment or transfer of any right, claim, complaint, charge, duty, obligation, demand, cause of action, or other matter waived or released by this Second Release.


2.Executive acknowledges that Executive is waiving and releasing any rights Executive may have under the Age Discrimination in Employment Act of 1967 (“ADEA'') and that this Second Release is knowing and voluntary. Executive agrees that this Second Release does not apply to any rights or claims that may arise under the ADEA after the date Executive executes this Second Release. Executive acknowledges that the consideration given for this Second Release is in addition to anything of value to which Executive was already entitled. Executive further acknowledges that Executive has been advised by this writing that: (a) Executive should consult with an attorney prior to executing this Second Release; (b) Executive has twenty-one (21) days within which to consider this Second Release; (c) Executive has seven (7) days following the execution of this Second Release to revoke this Second Release and may do so by writing to the Company's General Counsel; (d) this Second Release shall not be effective until after the revocation period has expired without revocation; and (e) nothing in this Second Release prevents or precludes Executive from challenging or seeking a determination in good faith of the validity of this waiver under the ADEA, nor does it impose any condition precedent, penalties, or costs for doing so, unless specifically authorized by federal law. In the event Executive signs this Second Release and returns it to the Company in less than the 21-day period identified above, Executive hereby acknowledges that Executive has freely and voluntarily chosen to waive the time period allotted for considering this Second Release.
3.Executive acknowledges that Executive has been advised to consult with legal counsel and that Executive is familiar with the principle that a general release does not extend to claims that the releaser does not know or suspect to exist in Executive's favor at the time of executing the release, which, if known by Executive, must have materially affected Executive's settlement with the Releasee. Executive, being aware of said principle, agrees to expressly waive any rights Executive may have to that effect, as well as under any other statute or common law principles of similar effect.
4.Executive hereby acknowledges and agrees that the covenant with respect to pending or future lawsuits set forth in Section 7 of the Separation Agreement applies to all claims released pursuant to this Second Release.
I HAVE READ, UNDERSTAND, AND VOLUNTARILY AGREE TO THE TERMS OF THIS RELEASE.
SIGNATURE:        /s/ Kenneth S. Parks                DATE: September 1, 2020
            Kenneth S. Parks



Exhibit 10.2
EXECUTION VERSION



DATED 7 September 2020


ASPEN GLOBAL INCORPORATED

and

MYLAN IRELAND LIMITED


__________________________________
ASSET PURCHASE AGREEMENT





            


CONTENTS
Page
1.    Interpretation
5
2.    Sale and purchase of the Commercialisation Business Assets
33
3.    Conditions Precedent; Termination
36
4.    Pre-Completion undertakings
40
5.    Consideration
44
6.    Orgaran New Business Opportunities
44
7.    Guarantees
44
8.    Tax and VAT
45
9.    Completion
47
10.    Action after Completion
48
11.    Wrong Pockets
50
12.    Transfer of Initial Stock
52
13.    Transfer of the Commercialisation Business Contracts, the Shared Commercialisation Business Contracts and Transferring Tenders
52
14.    Assumed and Excluded Liabilities
55
15.    First Right of Negotiation
58
16.    Transfer of Product Registrations and related matters
59
17.    Receivables
60
18.    Insurance
60
19.    Employees
61
20.    Seller Warranties and Indemnification; Purchaser’s Remedies
61
21.    Purchaser Warranties and Indemnification; Seller’s Remedies
62
22.    Commercialisation Business Records and Historical Employee Information
65
23.    Intellectual Property
66
24.    Seller’s undertakings
66
25.    Reserved
68
26.    Purchaser’s undertakings
68
27.    No set-off
71
28.    Effect of Completion
71
29.    Capacity of Seller and Purchaser
71
30.    Indemnification and conduct of claims
72
31.    Notices
75
32.    Public Announcements
76
33.    Confidentiality
76
34.    Authorised Disclosure
77
35.    Costs and expenses
78
36.    Counterparts
78
37.    Severability
78
38.    Injunctive Relief
78
39.    Survival
79
40.    Independent Contractors
79
1


41.    Assignment
79
42.    Entire Agreement; Amendments.
80
43.    No Third Party Beneficiaries
80
44.    Remedies
80
45.    Waiver
80
46.    Headings
81
47.    Interpretation
81
48.    Construction
81
49.    Governing Law
81
50.    Dispute Resolution
82
51.    Jurisdiction
82
52.    Further Acts
82
53.    Agent for service
82



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THIS AGREEMENT is made the 7th day of September, 2020 (the “Effective Date”)
BETWEEN:
ASPEN GLOBAL INCORPORATED, a company incorporated in Mauritius (registered number 078138) whose registered office is at GBS Plaza, Cnr La Salette and Royal Roads, Grand Bay Mauritius (the “Seller”) on behalf of itself and those Affiliates of the Seller that hold or have a right to acquire from a third party any of the Commercialisation Business Assets; (such Affiliates together, the “Designated Sellers” and each a “Designated Seller”);
AND
MYLAN IRELAND LIMITED, a company incorporated in Ireland, whose registered office is at South Bank House, Barrow Street, 6th Floor, Dublin 4, Ireland (the “Purchaser”);
The Seller and the Purchaser are herein referred to each as a “Party” and, collectively, as the “Parties”.
WHEREAS:
(A)Certain members of the Aspen Group (as defined in this Agreement) carry on the Commercialisation Business (as defined in this Agreement).
(B)The Seller, on behalf of itself and the Designated Sellers, has agreed to sell, and the Seller has agreed to procure the sale of, and the Purchaser has agreed to purchase, or procure the purchase of, and pay, or procure payment, for, the Commercialisation Business and the Commercialisation Business Assets (as defined in this Agreement) for the consideration and on the terms and subject to the conditions set out in this Agreement.
NOW IT IS AGREED as follows:
1.Interpretation
1.1In this Agreement and the Schedules and Attachments to it:
“Additional Employee”
has the meaning given in Schedule 21;
“Affiliate”
means, with respect to any Person, any other Person directly or indirectly Controlling or Controlled by, or under direct or indirect common Control with, such Person;
“Agency”
means any applicable Governmental Authority involved in the regulation of or the granting of approvals for the manufacturing, Promotion, Distribution, import, export, reimbursement and/or pricing of any Products in the Territory;
“Agreed Form”    
in relation to any document means the document in a form agreed by the Parties as at the Effective Date;
“Agreed Rate”
means a rate equal to the lesser of (i) one (1) percent per month, provided that such interest charge shall apply only instead of, and not in addition to, any statutory interest, or (ii) the maximum interest rate permitted by Applicable Law on such undisputed amount for each month or portion thereof that such undisputed amount is overdue;
“Agreement”
means the agreement set out in this document, incorporating the schedules, exhibits and attachments hereto;
“Ancillary Transaction Agreements”
means the Supply Agreement, the Initial PO Units Side Letter, the Distribution and Supply Agreement and any other documents entered into pursuant to the foregoing agreements, and this Agreement;
“Anti-corruption Laws”
has the meaning given in Schedule 4;
“Annual Bonus Scheme”
means any plan or scheme maintained or sponsored by the Seller or any member of the Aspen Group pursuant to which employees are paid a 13th cheque or other amount based on company and/or employee performance;
“API”
means the active pharmaceutical ingredient of each Product;
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“Applicable Employment Laws”
means the binding/mandatory employment laws within the Territory of the Seller’s Affiliates and Purchaser’s Affiliates acting as employers of Employees to be transferred by Law;
“Applicable Laws”
means, with respect to any Person (including Affiliates of the Seller or the Purchaser), property, transaction or matter, any regulation (including EU regulation), statute, law (including common law), subordinate legislation, act, treaty, ordinance, decree, directive, rule, circular, code, order, recommendation, notice, direction, code of practice, judgement or decision enacted, issued or promulgated by, or entered into with, any Governmental Authority and which has the force of law, relating or applicable to that Person, property, transaction or matter;
“Aspen Business”
means the business of any member of the Aspen Group including for the avoidance of doubt the business of any member of the Aspen Group of Manufacturing and Commercialising products under the Brand Names in a Retained Territory (but excluding the Commercialisation Business);
“Aspen Group”
means the Seller, the Seller’s Affiliates (including, for the avoidance of doubt, any Designated Seller) and the Seller’s Associated Undertakings from time to time;
“Aspen Group Insurance Policies”
means insurance policies taken out and maintained by or on behalf of members of the Aspen Group;
“Aspen House Marks”
means:
(i)any of the Trade Marks set out in Attachment 1;
(ii)any Trade Marks confusingly similar to those Trade Marks set out in Attachment 1; and
(iii)the corporate name of any member of the Aspen Group,
in each case whether registered or unregistered;
“Aspen Retained De Commercialised Products”
means the Products that are in the process of being discontinued, or which are to be discontinued, in certain Countries of the Territory, listed in Schedule 9;
“Aspen Supply Chain Contract”
means an agreement between Aspen or a member of the Aspen Group, and a Third Party for the supply of API, bulk Product, medical devices, finished Product or any other component used in the Manufacture of one or more Products;
“Assignment”
has the meaning given in Clause 8.6;
“Associated Undertaking”
in relation to any Person, means any Undertaking in which (a) that Person, (b) any subsidiary or subsidiary undertaking of that Person, (c) any holding company of that Person or (d) any subsidiary or subsidiary undertaking of any such holding company (for the purposes of this definition, hereinafter referred to as “Party Y”) has an interest from time to time of twenty percent (20%) or more, the question of whether such an interest exists to be determined by whether Party Y:
(i)has an interest in twenty percent (20%) or more of the shares of such Undertaking; or
(ii)is entitled, through shareholding or otherwise, to receive twenty percent (20%) or more of the income of such Undertaking on any distribution by it of all of its income or is entitled to receive twenty percent (20%) or more of the assets of such Undertaking on a winding up; or
(iii)holds, through shareholding or otherwise, twenty percent (20%) or more of the voting rights in such Undertaking;
“Assumed Employee Liabilities”
has the meaning given in Schedule 21;
“Assumed Liabilities”
has the meaning given in Clause 14.2;
“Assurance”
means any warranty, representation, statement, assurance, covenant, agreement, undertaking, indemnity, guarantee or commitment set forth on Schedule 20;
“Authorised Representatives”
has the meaning given in Clause 33.2;
“Brand Names”
means the Trade Marks set out in Schedule 16;
“Business Day”
means any day that is not a Saturday, Sunday or a day on which banking institutions in Mauritius and Ireland are not open for general business;
“Clinical Trial”
means any clinical trial in respect of the Products, undertaken by or on behalf of the Aspen Group or the Purchaser Group, following the Completion Date, but excluding for the avoidance of doubt, the Ongoing Clinical Trials;
“Collecting Seller”
has the meaning given in Clause 17.2;
“Commercialisation Business”
means the business carried on by the relevant members of the Aspen Group as at Effective Date in respect of the Commercialisation of the Products in the Territory, but excluding (i) the Excluded Assets (ii), for the avoidance of doubt, the business carried on in respect of the Commercialisation of products under the Brand Names in the Retained Territory and (iii) the French Business;
“Commercialisation Business Assets”
has the meaning given in Clause 2.2;
“Commercialisation Business Consideration”
means six hundred and forty-one million, eight hundred and eighty-five thousand Euros (EUR 641,885,000);
“Commercialisation Business Contracts”
means (i) the contracts set out in Part A of Schedule 11; and (ii) the Italfarmaco Agreements;
“Commercialisation Business Goodwill”
means all the goodwill arising from the Commercialisation Business, including the exclusive right for the Purchaser to represent itself as carrying on the Commercialisation Business in succession to the Aspen Group;
“Commercialisation Business Records”
means, solely to the extent any member of the Aspen Group has any proprietary right in relation thereto:
(i)all books and records exclusively containing or relating to Transferring IPR or Transferring Know-How or on which such Transferring IPR or Transferring Know-How is recorded or stored (including all documents and other material, whether human or computer or machine readable);
(ii)copies of the documents (or such other format as may be agreed between the Seller and the Purchaser) recording the PDA Data;
(iii)copies of those documents comprising the Data Room where such documents relate exclusively to the Commercialisation Business;
(iv)the deeds, documents of title, certificates and records relating exclusively to the Transferring IPR;
(v)all regulatory files and data from pre-clinical and clinical studies and (in any case in any form or medium), all dossiers and technical documents relating to the Product Registrations;
(vi)copies of all consumer complaint reports exclusively relating to the Commercialisation Business;
(vii)copies of all agreements and material correspondence with any Governmental Authority relating exclusively to the Commercialisation Business, including relating to the current pricing and reimbursement of the Products in the Territory;
(viii)copies of all Periodic Safety Update Reports for the Products in the Territory for the two (2) years prior to the Completion Date;
(ix)artwork proprietary to the Aspen Group which is used exclusively in the Commercialisation Business immediately prior to the Completion Date;
(x)customer lists, list of all physicians and pharmacists, sales, marketing and promotional information; and
(xi)correspondence, orders and enquiries,
but excluding any Excluded Commercialisation Business Records;
“Commercialise”
means to Promote, Distribute, sell, and/or offer for sale a product and any related actions and “Commercialised” “Commercialising” and “Commercialisation” shall be construed accordingly;
“Company Plan”
means the Aspen International Phantom Share Scheme;
“Competent Authority”
means any supra-national, national, state, municipal or local government (including any sub-division, court, administrative agency or commission or other authority thereof) or any governmental or quasi-governmental or private body exercising any regulatory, taxing, importing or other governmental or quasi-governmental authority (including any tribunal, securities exchange, competition or antitrust authority, or supervisory body);
“Competing Product”
means, with respect to any Product, any product that has the same API, the same indications and is in the same dosage form as the applicable Product;
“Competition Authority” means any Competent Authority, in any jurisdiction, which is responsible for applying merger control or other competition or antitrust legislation in such jurisdiction and, for the avoidance of doubt, includes the notion of “competent authority” as that term is used in the EU Merger Regulation;
“Competition Conditions”
means the conditions set out in Part A of Schedule 2;
“Completion”
means completion of the sale and purchase of the Commercialisation Business Assets under this Agreement;
“Completion Date”
has the meaning given in Clause 9.1;
“Completion Time”
means 11.59 p.m. on the Completion Date;
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“Confidential Information”
means with respect to a Party and its Affiliates (i) all information of any kind whatsoever (including without limitation, data, compilations, formulae, models, patent disclosures, procedures, processes, projections, protocols, results of experimentation and testing, specifications, strategies, techniques and all non- public intellectual property rights), and all tangible and intangible embodiments thereof of any kind whatsoever (including without limitation, apparatus, compositions, documents, drawings, machinery, patent applications, records and reports), that is disclosed by or on behalf of such Party to the other Party hereunder. This Agreement and the terms and conditions hereof shall be the Confidential Information of both Parties; (ii) the existence, provisions or subject matter of this Agreement or any other document or agreement entered into pursuant hereto or thereto; (iii) the content of any discussions or negotiations relating to this Agreement; (iv) all other information or material, including, without limitation, any documents, notes, analyses, studies, summaries, samples, drawings, diagrams, designs, flowcharts, databases, models, plans, software (including source and object codes), contracts and agreements, received, obtained or generated under or pursuant to this Agreement which relates to the other Party, its business or products its Affiliates, and their respective businesses, affairs and condition, whether financial, operational or otherwise; (v) any and all information or material relevant to this Agreement as may be shared by a Party in relation to a Third Party; and (vi) any and all information or material relevant to this Agreement that a Party comes into contact with through, inter alia, visual inspections, audits, site visits, independent third parties, and/or otherwise;
“Contract Transfer”
means the date of assignment, novation, or novation in part (as applicable) of the Commercialisation Business Contract or Transferring Tender, or Relevant Part of the Shared Commercialisation Business Contract from the Contract Transferor to the Purchaser or its Affiliate pursuant to Schedule 11;
“Contract Transferor”
means any member of the Aspen Group who is party to a Commercialisation Business Contract, Shared Commercialisation Business Contract (whether or not identified as such in Schedule 11), Transferring Tender or Non-Transferring Tender;
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“Control”
means, when used with respect to a Person: (i) ownership (directly or indirectly) of more than fifty percent (50%) or at least fifty percent (50%) plus one of the shares or stock entitled to vote for the election of directors or governing body of such Person or (ii) the ability otherwise to direct, cause the direction of or control the actions of such Person or the management or policies of such Person, whether through direct or indirect ownership of voting securities, by contract or otherwise, and “Controlled by”, “Controlling” and “under common Control with” shall have correlative meanings;
“Countries”
means those countries in the Territory in which a Product (determined on a Product-by-Product basis) is sold by or on behalf of the Aspen Group as at Completion; and “Country” means any of them;
“CTA 2010”
means the Corporation Tax Act 2010;
“Current Good Manufacturing Practices” or “cGMPs”
means the principles and guidelines of Good Manufacturing Practice for medicinal products for human use as promulgated under Applicable Laws, including Commission Directive 2003/94/EC, and Volume 4 of The Rules Governing Medicinal Products in the European Union;
“Data Room”
means those documents, information and materials listed in the Agreed Form data room index attached to the Disclosure Letter and written to an encrypted USB, which USB will be delivered to the Purchaser by, or on behalf of, the Seller within thirty (30) days of the Effective Date;
“De-Commercialisation Activities”
has the meaning given in Clause 13.5;
“Designated Purchaser”
means a company in the Purchaser’s Group designated by the Purchaser as the purchaser of some or all of the Commercialisation Business Assets at least ten (10) Business Days prior to the Completion Date;
“Designated Seller”
has the meaning given in the citation of the Parties above;
“Disclosure Letter”
means the letter having the same date as this Agreement, written by the Seller to the Purchaser in relation to the Seller Warranties for the purposes of Paragraph 8 of Schedule 5, in the Agreed Form as at the Effective Date;
“Distribution”
means, with respect to each Product, the action of selling, receiving, warehousing, storing, handling, picking, packing, transporting and where applicable, importing and exporting of the Products and all related activities, and “Distribute” shall have a corresponding meaning;
“Distribution and Supply Agreement”
means that certain Distribution and Supply Agreement by and between Purchaser and Seller;
“Dispute”
has the meaning given in Clause 50;
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“Dossier IPR”
means all Intellectual Property owned by the Aspen Group that subsists in the dossiers of the Product Registrations, including any and all updates from time to time, but excluding the Aspen House Marks and the Excluded IPR;
“Effective Date”
has the meaning given in the preamble above;
“Eligible Employee”
has the meaning given in Schedule 21;
“Employees to be Transferred by Law”
has the meaning given in Schedule 21;
“Employee Transfer Date”
has the meaning given in Schedule 21;
“Encumbrance”
means any claim, mortgage, charge, pledge, lien, assessment, assignment, option, deed of trust, lease, levy, license, hypothecation, security interest, title retention, restriction on transferability, defect in title, charge or other encumbrance or arrangement of any kind, whether voluntarily incurred or arising by operation of law or any conditional sale or title retention agreement or other agreement, the effect of which is the creation of security, or any other right to acquire or option, any right of first refusal or any right of pre-emption, or any arrangement to create any of the same;
“Euros”, “euros” and “€”
each means the single lawful currency of the European Union used in accordance with the treaties of the European Union as amended from time to time;
“EU Merger Regulation”
has the meaning given in Schedule 2;
“Exchange Rate”
means the amount calculated in Euros using the average of the daily exchange rates for the applicable currency as posted on Bloomberg for the twelve (12) month period immediately preceding the calculation thereof;
“Excluded Assets”
has the meaning given in Clause 2.3;
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“Excluded Commercialisation Business Records”
means:
(i)any and all books and records which are not used exclusively in, or do not arise exclusively out of, the Commercialisation Business (including any information relating to any Shared Commercialisation Business Contracts);
(ii)any and all books and records and information relating to any Excluded Asset or Excluded Liability;
(iii)any and all books and records and information (including any books and records and information which would otherwise fall within Paragraphs (i), (ii) or (iii) of the definition of “Commercialisation Business Records”) which any member of the Aspen Group is required by law to retain; and
(iv)any and all books and records and information (including any books and records and information which would otherwise fall within Paragraphs (i), (ii) or (iii) of the definition of “Commercialisation Business Records”) which contain information in which any member of the Aspen Group has legal privilege;
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“Excluded Contracts”
means:
(i)contracts with employees assigned to the Commercialisation Business;
(ii)for the avoidance of doubt, any contract, agreement or arrangement entered into by a member of the Aspen Group for the lease of a vehicle (on an individual, as opposed to a fleet basis), mobile phone, tablet and/or laptop for use by a Transaction Affected Employee;
(iii)all other contracts, arrangements, agreements, engagements, guarantees, licences, purchase orders, customer orders, packaging contracts and other commitments in relation to the Commercialisation Business other than any Commercialisation Business Contract or the Relevant Part of any Shared Commercialisation Business Contract;
(iv)the Excluded Third Party Supply Agreements; and
(v)any contract relating to the renting or leasing of Property;
“Excluded Employee Liabilities”
has the meaning given in Schedule 21, subject to Applicable Employment Laws;
“Excluded IPR”
means all Intellectual Property other than Transferring IPR, Transferring Know-How, Licensed Know-How, Third Party IPR, and Licensed IPR;
“Excluded Liabilities”
has the meaning given in Clause 14.5;
“Excluded Third Party Supply Agreements”
means all supply contracts with third parties in relation to the Manufacture of the Products;
“Exercise Notice”
has the meaning given in Clause 15.3;
“Exercise Period”
means the period of 15 (fifteen) Business Days from the date of the Option Trigger Event Notice;
 “Facilities Agreement”
means the facilities agreement, dated 17 May 2018, for Aspen Finance Proprietary Limited, Pharmacare Limited and Aspen Asia Pacific Pty Ltd and arranged by MUFG Bank, Ltd. and Nedbank Limited and other banks;
“Financial Year”
means a year beginning on 1 July and ending on 30 June;
“First Right Option”
has the meaning given in Clause 15.1;
“First Right Option Exercise Date”
has the meaning given in Clause 15.6;
“Foreign Investment Authority” means any Competent Authority, in any jurisdiction, which is responsible for applying foreign investment control or other foreign investment legislation in such jurisdiction;
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 “Foreign Investment Conditions”
means the conditions set out in Part B of Schedule 2;
“French Business”
means the French Distribution Goodwill and the French employees;
“French Distribution Goodwill”
means all of the goodwill arising from the distribution of the Products in France;
“French Inventory”
means the Inventory in respect of France;
“Governmental Authority”
means any court, administrative body, local authority or other governmental or quasi-governmental authority with competent jurisdiction, any supranational, national, regional, federal, state, district, provincial, local or other governmental, regulatory or administrative authority, Agency, body, commission or other court of competent jurisdiction, tribunal, arbitral body, self-regulated entity, private body exercising any regulatory, taxing, importing, executive, legislative, judicial, quasi-judicial, regulatory, administrative or other quasi-governmental authority or other legislature, governmental, administrative or Agency, department, body, bureau, council or commission or any other supranational, national, regional, state, provincial, local or other governmental authority or instrumentality, in each case having jurisdiction in the Territory;
“Government Official”
has the meaning given in Schedule 4;
“Group”
means the Purchaser’s Group and/or the Aspen Group (as the context requires);
“Historical Employee Information”
means information in relation to a Transaction Affected Employee that relates to the employment by a member of the Aspen Group of the relevant Transaction Affected Employee prior to Completion and which is, at the time of the Seller’s receipt of the notice from the Purchaser pursuant to Clause 22.5, in the possession and control of the Aspen Group;
“Incremental Employee”
has the meaning given in Schedule 21;
“Independent Actuary”
has the meaning given in Schedule 20;
“Initial PO Units Side Letter”
means that certain side letter signed by the Parties on or about the Effective Date for the transfer from Seller to Purchaser of the Initial PO Units (as defined therein);
“Initial Stock”
has the meaning given in Schedule 24;
“Intellectual Property”
means Know-How, Trade Marks, Patents, rights in designs (including rights in three dimensional designs), copyrights (including rights in computer software), database rights, (whether or not any of these is registered and including, for clarity, applications for registration of any such thing) and all rights or forms of protection of a similar nature or having equivalent or similar effect to any of these which may subsist anywhere in the world, and any and all claims or causes of action (pending, threatened or which could be filed) arising out of or related to any infringement or misappropriation of any of the foregoing;
“Inventory”
means all inventory including Initial Stock and any other form, whether in process of packaging, in process of Manufacture and/or in raw materials;
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“Italfarmaco Agreements”
means the Italfarmaco Agreements set out in Part C of Schedule 11;
“JV Entity”
has the meaning given in Clause 24.3(C);
“Know-How”
means any and all technology, know-how, materials and technical information, including data, inventions (whether or not patented or patentable), knowledge, ideas, developments, prototypes, invention disclosures, designs, sequences, methods, techniques, materials, compositions, chemistries, algorithms, modifications, software, drawings, equipment, protocols, configuration and process information, specifications, models, works of authorship, improvements, expertise, instructions, processes, formulae, formulation information, analytical methodology, chemical specifications, testing techniques and any other technical subject matter;
“License”
has the meaning given in Schedule 4;
“Licensed API”
means all Intellectual Property owned or controlled by the Aspen Group that relates to the APIs, including but not limited to Heparin, Fondaparinux Crude, Fondaparinux Sodium, Danaparoid Crude, Danaparoid Sodium, Nadroparin and Certoparin;
“Licensed IPR”
means all Intellectual Property owned or controlled by the Aspen Group that relates to or is necessary or useful for (i) the Manufacture of the APIs or Products and/or Aspen Retained De-Commercialised Products, (ii) the Commercialisation of the Products in or for the Territory, and/or (iii) Commercialisation of the Aspen Retained De-Commercialised Products; for clarity, Licensed IPR includes, but is not limited to the Licensed API (other than Licensed API that constitutes Know-How), and excludes the Transferring Know-How, Third Party IPR, Transferring IPR, Licensed Know-How and the Excluded IPR;
“Licensed Know-How”
means all Know-How owned or controlled by the Aspen Group that relates to or is necessary or useful for (i) the Manufacture of the API and/or the Products, and/or Aspen Retained De-Commercialised Products, (ii) the Commercialisation of the Products in or for the Territory, and/or (iii) the Commercialisation of the Aspen Retained De-Commercialised Products; for clarity, Licensed Know-How includes, but is not limited to the Licensed API that constitutes Know-How, and excludes the Transferring Know-How, Transferring IPR, Third Party IPR, Licensed IPR and the Excluded IPR;
“Long Stop Date”
means 31 December 2020 (or such later date as the Parties may agree);
“Loss” or “Losses”
means all actions, claims, demands, proceedings, judgements, liabilities, loss, damages, payments, cost, fees and expenses (including, without limitation, reasonable attorney’s fees and expenses), interest, awards, fines and penalties;
“Manufacture” or “Manufacturing” or “Manufactured”
means, as applicable, the making, planning, purchasing of materials for, production, processing, compounding, storage, filling, packaging, labelling, leafleting, warehousing (prior to batch release), batch testing, waste disposal, quality release, sample retention, stability testing and batch release of products;
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“Material Adverse Effect”
means any effect which is, or would reasonably be expected to be, materially adverse to, (i) the Products, the Commercialisation Business or Commercialisation Business Assets or (ii) the ability of a Party to consummate the transactions contemplated by this Agreement in either case, other than any effect arising out of, relating to, resulting from or in connection with (a) any change in any Country or foreign economic or political conditions in general or financial markets in general, (b) any change that affects the pharmaceutical industry, (c) any natural disaster or act of nature; or any hostility, act of war, sabotage, terrorism, military action or any escalation or worsening thereof; or any pandemic, epidemic or other viral outbreak, (d) any change in Applicable Law or accounting rules or the interpretation thereof, (e) the failure of the Products to meet any budgets, projections or other financial forecasts; provided, that the failure to meet any such projections or other financial forecast(s) shall not prevent or otherwise affect a determination that the underlying cause(s) of any such failure has had or would reasonably be expected to have a Material Adverse Effect, or (f) the compliance with the terms of, or the taking any action required or contemplated by, this Agreement, except, in the case of each of paragraphs (a), (b), (c) and (d), to the extent any such change or event has a materially disproportionate effect on a Party and its Affiliates compared to other participants in the pharmaceutical industry or on the Products, collectively, compared to a group of other similar products in the pharmaceutical industry (in which case only such disproportionate effect may be taken into account in determining whether there has been a Material Adverse Effect;
“Material Contract”
means the Italfarmaco Agreements;
“Missing Asset or Liability”
has the meaning given in Clause 11.5;
“Negotiation Period”
means the period commencing on the First Right Option Exercise Date and terminating 30 (thirty) days thereafter;
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“Net Sales”
means the aggregate of the gross amounts invoiced to customers for the sale of the Products, less (i) all withholding taxes, value added taxes or similar sales taxes, including such amounts which are to be paid on the basis of the sales prices of the Products; (ii) all amounts to be paid or credited to such customers by reason of returns, rejection or recalls of the Products; (iii) all trade discounts granted to such customers, including rebates but excluding settlement discounts, each as determined in accordance with International Financial Reporting Standards;
“Non-Transferring Tenders”
means:
(i)the public Tenders; and
(ii)any private Tenders pending Third Party consent to assign or novate same to the Purchaser;
as listed in Part A of Schedule 10;
“Notices”
has the meaning given in Clause 31;
“Notification”
has the meaning given in Schedule 21;
“ONBO Trigger Event”
has the meaning given in Schedule 7;
“Ongoing Clinical Trials”
means the clinical trial being undertaken by or on behalf of the Aspen Group pursuant to an investigational new drug (IND) application held by the Seller as at the Effective Date in respect of Danaparoid; and (ii) the non-interventional study being undertaken in Germany by or on behalf of the Seller as at the Effective Date, in respect of Certoparin 8,000 IU ‘once daily’ for treatment of venous thromboembolism patients with severely impaired renal function;
“Option Business”
means (i) in respect of the People's Republic of China, the Aspen Group’s business exclusively associated with the exploitation of products (past, present or future) under the Brand Names Arixtra, Fraxiparine, Mono-Embolex and Orgaran and (ii) in respect of the Russian Federation, the Aspen Group’s business exclusively associated with the exploitation of products (past, present or future) under the Brand Names Arixtra, Fraxipraine, Mono-Embolex, Orgaran and Embolex as at the date of the Option Trigger Event Notice (which business shall comprise, inter alia, the relevant goodwill, contracts with third parties, Intellectual Property, product registrations, business records and employees dedicated to the sale of the products under the said Brand Names);
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“Option Trigger Event”
means either (i) the commencement of a process initiated by the Seller (or its Affiliates) for the sale, transfer and assignment of the Option Business or for the sale, transfer and assignment of assets and/or businesses of which the Option Business constitutes more than fifty (50%) of the net sales of the entire assets and/or businesses which form the scope of the potential transaction; or (ii) an unsolicited approach from a Third Party to the Seller (or its Affiliates) for the purchase, acquisition and assumption of the Option Business or for the purchase, acquisition and assumption of assets and/or businesses of which the Option Business constitutes more than fifty (50%) of the net sales of the entire assets and/or businesses which form the scope of the potential transaction;
“Option Trigger Event Notice”
has the meaning given in Clause 15.2;
“Orgaran New Business Development Opportunity Payment”
has the meaning given in Schedule 7;
“Orgaran New Business Opportunities”
means the identified new business opportunities as set out in Schedule 7;
“Paying Party”
has the meaning given in Clause 30.7;
“Party A”
has the meaning given in Clause 8.9;
“Patents”
means any of the following: (i) any issued patent, including any inventor’s certificate, utility model, industrial design, substitution, extension, confirmation, reissue, re-examination, renewal or any like governmental grant for protection of inventions; (ii) any pending application for any of the foregoing, including any continuation, divisional, substitution, addition, continuation-in-part, provisional and converted provisional application; and (iii) to the extent required for the Manufacture of the Products outside of the Territory for Commercialisation in the Territory, any foreign patents or patent applications, or any other patents or patent applications of any kind, corresponding to any of the foregoing; for the avoidance of doubt, any reference in this Agreement to any Patent listed on any Schedule to this Agreement includes all of the foregoing with respect to such listed Patent, whether or not existing as of the Effective Date;
 “PDA Data”
means the names, contact details and appointment details for the health care professionals with whom a Transaction Affected Employee has an appointment scheduled for the purposes of promoting any of the Products, and stored on the PDA device used by the Transaction Affected Employee immediately prior to the Completion Time;
“Pending Product Registrations”
means those Product Registrations set forth on Part B of Schedule 21.
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“Pension Scheme”
means each of the pension, retirement, gratuity and termination indemnity schemes, plans or arrangements set out in the Data Room;
“Pension Shortfall”
has the meaning given in Schedule 21;
“Pension Surplus”
has the meaning given in Schedule 21;
“Periodic Safety Update Reports”
means the periodical reports containing the records referred to in Article 104 of Directive 2001/83/EC and in Article 24(3) of Regulation (EC) No 726/2004;
“Permitted Encumbrances”
means (i) all liens for taxes or assessments which are not yet due or delinquent or the validity of which are being contested in good faith and (ii) all landlords’, workmen’s, repairmen’s, warehousemen’s and carriers’ liens and other similar liens imposed by law, incurred in the ordinary course of business;
“Person”
means any individual, partnership, limited partnership, limited liability company, joint venture, syndicate, sole proprietorship, corporation, body corporate, unincorporated association, trust, trustee, executor, administrator or other legal Personal representative, Governmental Authority or any other legal entity;
“Planned Transfer”
has the meaning given in the Supply Agreement;
“Press Announcements”
means the press announcements to be issued by each of the Seller and the Purchaser in a form agreed between the Seller and the Purchaser prior to the Effective Date and included at Attachment 2;
“Prior CDA”
has the meaning given in Clause 33.134.1;
“Proceedings”
means any proceeding, investigation, suit, claim, re-examination or action arising out of or in connection with this Agreement, whether contractual or non-contractual, or the negotiation, existence, validity or enforceability of this Agreement, including for the avoidance of doubt arbitration proceedings;
“Products”
means the finished dose form products sold under the Brand Names in the Territory, in the SKU forms and in the Countries set out for each such SKU in Schedule 8 (as the same may be increased by new SKUs in relation to the Brand Names developed for a Country or Countries in the Territory prior to Completion);
“Product Registrations”
means each of the product registrations (including all pending and dormant product registrations), approvals, licences, registrations and authorisations relating exclusively to the Commercialisation Business issued by Governmental Authorities in the Territory, a list of which as at the Effective Date is set out in Schedule 18;
“Product Registration Holder”
means the member of the Aspen Group or its nominee which holds the relevant Product Registration;
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“Promote”
means any activity to market, promote or communicate the sale, supply or use of a product, including advertising, discussing the product with doctors, patients and other potential customers, making announcements, arranging and attending medical/scientific meetings and invitations or sponsorship to attend medical/scientific meetings and any other activities normally undertaken by a pharmaceutical company’s sales force to implement marketing plans and strategies aimed at encouraging the appropriate use of a particular prescription or other pharmaceutical product, provided that “Promote” shall not include any actions undertaken in connection with obtaining the Product Registrations, and “Promotion” and other connected terms shall have a corresponding meaning;
“Property”
means freehold, leasehold or other immoveable property;
“Proposed Transaction”
means the transaction set out in this Agreement;
“Purchaser Fundamental Warranties”
has the meaning given in Schedule 5;
“Purchaser Indemnitee”
has the meaning given in Clause 30.2;
“Purchaser Warranties”
means the warranties set out in Clause 21;
“Purchaser’s Ancillary Transaction Agreements”
has the meaning given in Clause 21.2(A);
“Purchaser’s Group”
means the Purchaser, the Purchaser’s Affiliates and the Purchaser’s Associated Undertakings from time to time;
“Receivables”
means all outstanding payments due to the Seller or to any other member of the Aspen Group as at Completion for goods or services supplied or rights licensed by it or on its behalf in the ordinary and usual course of carrying on the Commercialisation Business (and in each case including such part of such amounts as relate to VAT);
“Receiving Party”
has the meaning given in Clause 30.7(B);
“Registered IPR”
means all Transferring IPR and Licensed IPR that have been registered, filed, certified or otherwise perfected or recorded with or by any Governmental Authority or public registry or depository service;
“Relevant Aspen Group Employee”
means any employee of any member of the Aspen Group from time to time (other than the Employees to be Transferred by Law, or the Subsequent Transferring Employees who:
(i)is, or has been, directly or indirectly involved in the Commercialisation Business or its sale; or
(ii)is, has been, or will be, directly or indirectly involved in Schedule 23 or the preparation and/or implementation of the Transition Plan;
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“Relevant Indemnified Party”
has the meaning given in Clause 30.4;
“Relevant Indemnifying Party”
has the meaning given in Clause 30.4;
“Relevant Part”
means the relevant part of the Shared Commercialisation Business Contract or Tender (as applicable) which relates exclusively to the Commercialisation Business (or the relevant part of the Commercialisation Business that is transferred to the Purchaser on Completion);
“Relevant Period”
means the period of twelve (12) calendar months ended on the Effective Date;
“Required Asset or Liability”
has the meaning given in Clause 11.3;
“Restricted Act”
has the meaning given in Clause 24.1;
“Retained Territory”
means all countries in the world, except for the Territory;
“Retirement Indemnities”
means retirement indemnities due to employees when they retire as provided in the pharmaceutical industry;
“Seller Indemnitee”
has the meaning given in Clause 30.3;
“Seller Fundamental Warranties”
means the warranties set out in Paragraphs 1.1 to 1.6 (Capacity of the Seller and the Designated Sellers), 2.1 to 2.4 (Ownership and Sufficiency of Assets), and Paragraph 7 (inclusive) (Product Registrations), of Schedule 4;
“Seller Tier 2 Fundamental Warranties”
means the warranties set out in paragraphs 6 (Intellectual Property), 9.1 and 9.7 to 9.13 (Compliance with Laws; Regulatory Matters) of Schedule 4;
“Seller Warranties”
means the warranties set out in Schedule 4;
“Seller’s Ancillary Transaction Agreements”
has the meaning given in Paragraph 1.2 of Schedule 4;
“Seller’s Bank Account”
means the bank account of the Seller, details of which are set out in Schedule 19;
“Seller’s Solicitors”
means Slaughter and May, One Bunhill Row, London, EC1Y 8YY, United Kingdom;
“Seller Tax Warranties”
means the warranties set out in Paragraph Schedule 411 of Schedule 4;
“Separation”
means the separation of a Shared Commercialisation Business Contract, the effect of which shall be that, with effect from whichever is the later of Completion and the date of the relevant separation, the benefit and burden of the Relevant Part is severed from such Shared Commercialisation Business Contract and an agreement or arrangement equivalent to such Shared Commercialisation Business Contract is entered into between the relevant counterparty and the Purchaser or its Affiliate in respect of the Relevant Part;
“Service Document”
means a claim form, application notice, order, judgment or other document relating to any Proceedings;
“Shared Commercialisation Business Contracts”
means the contracts set out in Part B of Schedule 11, which relate both:
(i)to the Commercialisation Business or any part of the Commercialisation Business to be transferred to the Purchaser (or any Designated Purchaser); and
(ii)to any other business of the Aspen Group (including, for the avoidance of doubt, the business of Commercialising products under the Brand Names in the Retained Territory), any part of the Commercialisation Business which is not transferred to the Purchaser (or any Designated Purchaser) on Completion, any product other than the Products or any Excluded Asset,
and “Shared Commercialisation Business Contract” shall mean any of them;
“SKU”
means a stock keeping unit;
“Subsequent Transferring Employees”
has the meaning given in Schedule 21;
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“Supply Agreement”
means the manufacturing and supply agreement entered into by Aspen Notre Dame de Bondeville (an Affiliate of the Seller), and the Purchaser;
“Tax” or “Taxation”
collectively, means: (i) any fiscal charges or taxes of any nature whatsoever due by either Party in any jurisdiction, including capital gains tax, dividends tax, employees tax and employment-related levies and income tax; (ii) any duty or levy, including customs duty, securities transfer tax, skills development levies, stamp duty and unemployment insurance fund contributions in any jurisdiction; (iii) all forms of withholding taxes in any jurisdiction; and/or (iii) any taxation arising from new assessments and/or the reopening of any previous assessments, imposed by any Applicable Law administered by the Tax Authorities, including any interest or penalties or other taxes or auxiliary payments imposed or levied as a result of any of the above;
“Tax Authority”
means any Governmental Authority exercising any authority to impose, regulate or administer the imposition of Tax in any jurisdiction;
“Tax Return”
means any declaration, statement, report, return or other document filed or required to be filed with any Tax Authority in connection with the assessment, collection or determination of any Tax or the administration of any Applicable Laws relating to any Tax;
“Technical Transfer”
means the transfer of the Transferring Know-How and Licensed Know-How in respect of the Products;
“Tenders”
means any contracts, arrangements or agreements, to which a member of the Aspen Group is a party (itself or through an agent) with a Third Party, entered into following a call for a tender by the relevant Third Party, for the supply by Aspen Group of products including the Products in a Country in the Territory, and which are current or unperformed as at Completion or in respect of which any member of the Aspen Group has any liability or obligation (whether actual or contingent, known or unknown), as listed in Schedule 10;
 “Territory”
means Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Kosovo, Latvia, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malta, Moldova, Monaco, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom;
“Third Party”
means any Person other than the Parties or their respective Affiliates and permitted successors and assigns;
“Third Party Claim”
has the meaning given in Clause 30.4;
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“Third Party IPR”
means the Intellectual Property that is licensed or sub-licensed to a member of the Aspen’s Group as listed in
Schedule 13;
“Trade Marks”
means trademarks, service marks, brand names, logos, devices, symbols, designs, get up and/or trade dress (or any combination thereof), any registrations or applications for registration therefor;
“Transaction Affected Employees”
means collectively the Employees to be Transferred by Law, the Subsequent Transferring Employees and the Additional Employees;
“Transaction Liability Cap”
means the amount equal to thirty percent (30%) of the Commercialisation Business Consideration;
“Transfer Taxes”
means any federal, state, country, local, use, transfer, conveyance, documentary transfer, stamp, recording, registration or other similar Tax (including any notarial fee) imposed in connection with, or otherwise relating to, this Agreement, including any interest or penalties or other taxes or auxiliary payments imposed or levied;
“Transferring Domain Name Assignment”
means the assignment in the Agreed Form in respect of the Transferring Domain Names;
“Transferring Domain Names”
means the domain names listed in Schedule 15;
“Transferring IPR”
means any and all Intellectual Property owned by the Aspen Group that exclusively relates to the Manufacture or Commercialisation of the Products, and the Aspen Retained De-Commercialised Products; provided that the Dossier IPR will transfer to the Purchaser of the relevant product registration in respect of such Aspen Retained De-Commercialised Product pursuant to Clause 13.6, in or for the Territory, including, but not limited to, the Dossier IPR, the Transferring Domain Names, the Transferring Marks and the Transferring Patents and Registered Designs, but excluding the Excluded IPR, the Aspen House Marks and the Transferring Know-How;
“Transferring Know-How”
means any and all Know-How owned by the Aspen Group that relates exclusively to the Manufacture or Commercialisation of the Products in or for the Territory, but excluding the Excluded IPR and Aspen House Marks;
“Transferring IPR Assignments”
means the assignments in the Agreed Form in respect of the Transferring IPR which is the subject of a registration or an application for registration;
“Transferring Marks”
means the Trade Marks listed in Schedule 14;
“Transferring Patents and Registered Designs”
means the Patents and Registered Designs in Schedule 17;
“Transferring Tenders”
means the Tenders other than the Non-Transferring Tenders;
“Transition Plan”
has the meaning given in Schedule 23;
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“VAT”
means goods and services tax, sales tax or other value-added tax or its equivalent imposed by any Tax Authority in any jurisdiction, including any interest or penalties or other taxes or auxiliary payments imposed or levied;
“Warranted Product Registrations”
means the Product Registrations listed in Part A of Schedule 18;
“Warranties”
means the Seller Warranties and the Purchaser Warranties; and
“Working Hours”
means 9.00 a.m. to 5.00 p.m.
1.2In this Agreement and the Schedules and Attachments to it, unless otherwise specified:
A.a reference to any statute, regulation or statutory provision shall be construed as a reference to the same as it may have been, or may from time to time be, consolidated, amended, modified, extended or re-enacted except to the extent that any such amendment, modification, extension or re-enactment after the Effective Date would increase or extend the liability of any Person under or pursuant to this Agreement;
B.references to a “company” shall be construed so as to include any corporation or other body corporate, wherever and however incorporated or established;
C.references to the singular shall include the plural and vice-versa;
D.a “holding company” and a “subsidiary” mean a holding company and subsidiary as defined in section 1159 of the Companies Act 2006 and a company shall be treated, for the purposes only of the membership requirement contained in subsections 1159(1)(b) and (c) of the Companies Act 2006, as a member of another company even if its shares in that other company are registered in the name of (i) another Person (or its nominee), whether by way of security or in connection with the taking of security, or (ii) its nominee;
E.a “subsidiary undertaking” means a subsidiary undertaking as defined in section 1162 of the Companies Act 2006 and a company shall be treated, for the purposes only of the membership requirement contained in subsections 1162(2)(b) and (d) of the Companies Act 2006, as a member of another company even if its shares in that other company are registered in the name of (i) another Person (or its nominee), whether by way of security or in connection with the taking of security, or (ii) its nominee;
F.the expressions “allotment”, “debentures” and “Undertaking” shall have the meaning given in the Companies Act 2006;
G.a Person shall be treated as being connected with another if that Person is connected with another within the meaning of sections 1122 and 1123 CTA 2010;
H.any question as to whether a Person “controls” another (including for the purposes of the definition of “Affiliate”) shall be determined in accordance with the provisions of section 1124 CTA 2010 (and “controlled” shall be construed accordingly);
I.references to writing shall include any modes of reproducing words in a legible and non-transitory form, and accordingly shall exclude e-mail and other transitory modes;
J.references to times of day are to London time;
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K.any reference to a “day” (including within the phrase “Business Day”) shall mean a period of twenty four (24) hours running from midnight to midnight;
L.references to “so far as the Seller is aware”, the knowledge, information, belief or awareness of the Seller or any similar expression shall be construed as a reference to the actual knowledge, awareness, information or belief as at the Effective Date of Gus Attridge, Peter Gibb, Lorraine Hill, Shivani Singh and Kurt Drieselmann, in each case having made due and reasonable enquiry of their direct reports;
M.references to “so far as the Purchaser is aware” the knowledge, information, belief or awareness of the Purchaser or any similar expression shall be construed as a reference to the actual knowledge, awareness, information or belief as at the Effective Date of David Bayles, in each case having made due and reasonable enquiry of their direct reports;
N.unless the context otherwise requires, where any provision of this Agreement or any Schedule or Attachment to it is qualified or phrased by reference to materiality, such reference shall, unless specified to the contrary, be construed as a reference to materiality in the context of the Commercialisation Business, taken as a whole;
O.references to any English legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any legal concept or thing shall, in respect of any jurisdiction other than England, be treated as including what most nearly approximates in that jurisdiction to the English legal term;
P.references in any Warranty to any monetary sum expressed in Euros shall, where such sum is referable in whole or in part to a particular jurisdiction, be deemed to be a reference to an equivalent amount in the local currency of that jurisdiction translated at the Exchange Rate;
Q.the rule known as the ejusdem generis rule shall not apply, and accordingly, general words introduced by the word “other” shall not be given a restrictive meaning by reason of the fact that they are preceded by words indicating a particular class of acts, matters or things;
R.the use of the words “includes” or “including” shall be deemed to say also “without limitation”; and
S.general words shall not be given a restrictive meaning by reason of the fact that are followed by particular examples intended to be embraced by the general words;
T.any indemnity or covenant to pay (the “Payment Obligation”) being given on an “after-Tax basis” or expressed to be “calculated on an after-Tax basis” means that the amount payable pursuant to such Payment Obligation (the “Payment”) shall be calculated in such a manner as will ensure that, after taking into account:
i.the amount of any withholding Tax which must be deducted from the Payment by law and any Tax which becomes payable by the recipient of the Payment (or a member of the Aspen Group or the Purchaser’s Group, as the case may be) as a result of the Payment being subject to Tax in the hands of that Person; and
ii.the amount and timing of any Tax benefit which is obtained by the recipient of the Payment (or a member of the Aspen Group or the Purchaser’s Group, as the case
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may be) to the extent that such Tax benefit is attributable to the matter giving rise to the Payment Obligation or to the receipt of the Payment,
U.which amount and timing is to be determined by the auditors of the recipient at the shared expense of the Seller and the Purchaser and is to be certified as such to the Party making the Payment, the recipient of the Payment is in no better and no worse Tax position as that in which it would have been if the matter giving rise to the Payment Obligation had not occurred;
V.unless specified to the contrary, references to “indemnify” and “indemnifying” any Person against any circumstance include indemnifying and holding that Person harmless on an after-Tax basis and:
i.the provisions of Clause 30 shall apply to such indemnification;
ii.references to the Purchaser indemnifying each member of the Aspen Group shall constitute undertakings by the Purchaser to the Seller for itself and on behalf of each other member of the Aspen Group; and
iii.references to the Seller indemnifying each member of the Purchaser’s Group shall constitute undertakings by the Seller to the Purchaser for itself and on behalf of each other member of the Purchaser’s Group;
W.other than in Clause 35 of this Agreement, references to “costs” and/or “expenses” incurred by a Person shall not include any amount in respect of such costs or expenses for which either that Person or any member of its Group for the purposes of any VAT is entitled to credit or repayment; and
X.where any provision is qualified or phrased by reference to the “ordinary course of business”, that reference shall be construed as meaning the customary and usual course of trading for the business of the Commercialisation Business during the twelve (12) months prior to the Effective Date.
2Sale and purchase of the Commercialisation Business Assets
2.1On the terms and subject to the conditions set out in this Agreement:
A.the Seller agrees to sell or procure the sale of the Commercialisation Business and of the Commercialisation Business Assets;
B.the Seller, on behalf of itself and each Designated Seller (as applicable), agrees to sell, and does hereby sell, the Commercialisation Business Assets to the Purchaser or the Designated Purchaser(s) (as applicable); and
C.the Purchaser agrees to:
i.purchase, and does hereby purchase, or procure the purchase by the relevant Designated Purchaser(s) of, the Commercialisation Business and the Commercialisation Business Assets; and
ii.assume all Assumed Liabilities,
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in each case free from all Encumbrances (other than Permitted Encumbrances) as at and with effect from Completion (or as otherwise provided in this Agreement), without prejudice to the Aspen Group’s rights to Commercialise products under the Brand Names in the Retained Territory and/or Manufacture the Products in the Territory for Commercialisation in the Retained Territory, and to perform its obligations under the Supply Agreement.
2.2For the purposes of Clause 2.1 and this Agreement, the “Commercialisation Business Assets” shall mean:
A.the Commercialisation Business Goodwill;
B.(subject to Clause 2.3(O)), the benefit (subject to the burden) of the Commercialisation Business Contracts, the Relevant Part of the Shared Commercialisation Business Contracts, the Non-Transferring Tenders, the Transferring Tenders (subject to Third Party consents and in accordance with Clause 13) the Product Registrations (which shall be transferred subject to and in accordance with Clause 16 and the terms of B; and
C.the Transferring IPR and Transferring Know-How (which shall be transferred subject to and in accordance with the terms of Clause 2.4 and Clause 23;
D.the Commercialisation Business Records.

2.3There shall be excluded from the term “Commercialisation Business Assets” any assets or rights not listed in Clause 2.2, those assets and rights expressly excluded by the definition of any category of Commercialisation Business Assets listed above, and the following assets (the “Excluded Assets”):
A.the Excluded Contracts;
B.the Excluded IPR;
C.any other Intellectual Property which does not constitute Transferring IPR or Transferring Know-How;
D.the Excluded Commercialisation Business Records;
E.the Receivables;
F.the Aspen Retained De-Commercialised Products, provided that in the event that the Purchaser elects to take transfer of a product registration in respect of an Aspen Retained De-Commercialised Products pursuant to Clause 13.6, such Aspen Retained De-Commercialised Product shall no longer be considered an Excluded Asset;
G.cash in hand or in a bank account of any member of the Aspen Group;
H.subject to Clause 18, the benefit of any rights in respect of any insurance policy (whether issued by any Third Party or any other Person) of the Seller or any Designated Seller or any other member of the Aspen Group relating to the Commercialisation Business or any of the Commercialisation Business Assets;
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I.any and all causes of action and claims of any member of the Aspen Group in either case arising out of or relating to any Excluded Liability or any of the Excluded Assets;
any and all (i) causes of action and/or claims of any member of the Aspen Group existing at Completion (including remedies thereunder), and (ii) amounts due to any member of the Aspen Group in respect of claims, actions or judgments, which in either case relate to the Commercialisation Business or any of the Commercialisation Business Assets but only to the extent arising in respect of, or otherwise attributable to, the period before the Completion Time.
J.any books and records or other information to the extent relating to the sale or proposed sale of the whole or part of the Commercialisation Business including such information which relates to the negotiation of the transactions contemplated by this Agreement;
K.any Property in which the Seller or any other member of the Aspen Group has any right, title or interest;
L.all current and former employees, consultants, individual independent contractors, temporary workers or similar individuals of the Seller or any member of the Aspen Group, and all such individuals who have or are currently performing services for the Seller or any member of the Aspen Group, other than the Transaction Affected Employees;
M.any right to repayment of any Tax relating to the Commercialisation Business attributable to the period before the Completion Time;
N.the Inventory; and
O.the benefit of (including any obligation on a counterparty to make a payment under) the Commercialisation Business Contracts, the Shared Commercialisation Business Contracts, the Transferring Tenders and any Non-Transferring Tenders, to the extent that such benefit accrues or falls due to be performed, or arises in respect of the period or should have been performed, before the Completion Time.
Notwithstanding any other provision of this Agreement, each member of the Aspen Group shall retain its respective rights, title and interest in and to, and no member of the Purchaser’s Group shall obtain any rights, title, interest, liabilities or obligations in or to, the Excluded Assets pursuant to this Agreement.
2.4For clarity, Clause 2.1 is an assignment of such of the Transferring IPR with effect from Completion; the assignment of any Transferring IPR which is registered or which is the subject of an application for registration shall be perfected by the execution of the Transferring IPR Assignments.
2.5Part 1 of the Law of Property (Miscellaneous Provisions) Act 1994 shall not apply for the purposes of Clause 2.
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3.Conditions Precedent; Termination
Anti-trust and Foreign Investment
3.1Completion is conditional upon the Competition Conditions and the Foreign Investment Conditions.
3.2The Purchaser shall use all reasonable efforts to procure satisfaction of the Competition Conditions and Foreign Investment Conditions promptly after Effective Date and in any event on or before the Long Stop Date. Such reasonable efforts shall include the Purchaser taking, as promptly as practicable, all steps necessary, proper or advisable to obtain the consents, approvals or actions required in order to satisfy the Competition Conditions and Foreign Investment Conditions including (to the extent such filings have not been made prior to the Effective Date) using all reasonable efforts to make any appropriate filing or filings (with the co-operation of the Seller) in all jurisdictions which are the subject of a Competition Condition or Foreign Investment Condition as soon as reasonably practicable after the Effective Date. In addition, the Purchaser shall:
A.notify the Seller (or advisers nominated by the Seller), and provide copies to the Seller (or to advisers nominated by the Seller), of any material communications (whether written or oral) from any Governmental Authority in relation to obtaining any such consent, approval or action;
B.provide the Seller (or advisers nominated by the Seller) with draft copies of all submissions and material communications intended to be sent to Governmental Authorities at such time as will allow the Seller a reasonable opportunity to provide comments on such submissions and communications before they are submitted or sent, take into account any reasonable comments received from the Seller, and provide the Seller (or such nominated advisers) with copies of all such submissions and communications in the form submitted or sent, provided that submissions and material communications provided to the Seller may exclude Confidential Information which is confidential to the Purchaser’s Group (in the event that the Purchaser excludes such Confidential Information from a submission or material communication pursuant to this Clause 3.2(B) it shall at the same time provide to advisers nominated by the Seller a version of the submission or material communication which includes the Confidential Information on the basis that the advisers shall not transmit the Confidential Information to the Seller or any member of the Aspen Group);

C.give the Seller (or advisers nominated by the Seller) reasonable notice of, and the opportunity to participate in, all meetings and telephone calls with any such Governmental Authority; and

D.notify the Seller (or advisers nominated by the Seller) promptly on becoming aware that any of the consents or approvals specified in the Competition Conditions or Foreign Investment Conditions have been obtained.
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3.3The Purchaser shall be responsible for all filing fees to be paid to any Governmental Authority in relation to obtaining any consents or approvals required to satisfy each of the Competition Conditions.
3.4The Seller, using its reasonable endeavours, as required under Applicable Law, shall (and shall procure that each member of the Aspen Group shall) (i) co-operate with and provide all reasonable, proper or advisable assistance to the Purchaser to enable it to obtain any consents, approvals or actions required to satisfy the Competition Conditions and Foreign Investment Conditions, including making any filing required to be made by the Seller to an Foreign Investment Authority, provided that where reasonably possible and/or as may be required under Applicable Law, any such filing, submission and material communication from the Seller to any Foreign Investment Authority is approved by the Purchaser prior to submission, and (ii) in accordance with Applicable Law, promptly provide the Purchaser with any document or information in its control or possession that is reasonably required to obtain any clearances that are needed to satisfy the Competition Conditions and Foreign Investment Conditions, provided that documents and information provided to the Purchaser must exclude information which is confidential to the Aspen Group (in the event that the Seller excludes such Confidential Information from a submission or material communication pursuant to this Clause 3.4 it shall at the same time provide to advisers nominated by the Purchaser a version of the submission or material communication which includes the Confidential Information on the basis that the advisers shall not transmit the Confidential Information to the Purchaser).

3.5Neither Party shall be obligated to enter into or effect any undertakings, commitments, divestments, conditions, obligations, measures, undertakings and/or modifications, consents decrees, settlements or analogous procedures to enable approval of the Proposed Transaction by any Competition Authority or Foreign Investment Authority.

Aspen’s Funders’ Consent
3.6Completion is conditional upon the fulfilment of the condition set out in Part C of Schedule 2.
3.7The Seller shall use all reasonable endeavours to fulfil or procure the fulfilment of the condition set out in Part C of Schedule 2 as soon as possible and in any event on or before the Long Stop Date.
3.8The Purchaser shall, or shall procure that, the other members of the Purchaser’s Group shall, provide the Seller with such information and assistance as may reasonably be requested by the Seller for the purposes of obtaining the funders’ consent.
3.9The Seller shall comply with the provisions of Clause 31 in fulfilling the condition set out in Part C of Schedule 2.
3.10The condition set out in Part C of Schedule 2 may not be waived.
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3.11The Seller undertakes to keep the Purchaser informed as to the progress towards the satisfaction of the condition set out in Part C of Schedule 2.
3.12The Seller shall bear the costs and expenses incurred in connection with the actions undertaken in order to satisfy the condition set out in Part C of Schedule 2, including any out-of-pocket expenses of the Purchaser.
3.13Other Conditions Precedent
3.14This Agreement:
Ais conditional upon the conditions set out in Part D of Schedule 2;
Bin Germany (including for the avoidance of doubt the agreement to transfer the employment of the Employees to be Transferred by Law in Germany), is also conditional upon the condition set out in Part D of Schedule 2, to the extent not satisfied or waived by the Parties prior to the Effective Date; and
3.15The condition set out in Part D Schedule 2 may be waived, in whole or in part, only with the consent of the Seller and the Purchaser.
Inform and Consult Obligations
3.16The Parties shall use all their reasonable endeavours to fulfil or procure the fulfilment of the condition set out in Part D of Schedule 2 as soon as possible and in any event on or before the Long Stop Date and in particular, shall comply with their respective obligations set out in Schedule 2.
3.17The Seller, the Purchaser and each of their respective Affiliates shall bear their own costs and expenses incurred in connection with actions undertaken in order to comply with their obligations set out in Clause 3.16.
Third Party Consents
3.18The Purchaser’s obligations with respect to Completion are conditional upon the fulfillment of the condition set out in Part E of Schedule 2.
Representations and Warranties
3.19The Purchaser’s obligations with respect to Completion are subject to the Seller Warranties being true and correct in all material respects as if made at and as of the Completion Date other than the Seller Warranties that speak as of a specific date or time (which shall be true and correct as of such date or time).
3.20The Seller’s obligations with respect to Completion is subject to the Purchaser Warranties being true and correct in all material respects as if made at and as of the Completion Date
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other than the Purchaser Warranties that speak as of a specific date or time (which shall be true and correct as of such date or time).
Performance of Obligations
3.21The Purchaser’s obligations with respect to Completion are subject to the Seller having performed or complied in all material respects with all of the Seller’s covenants and agreements under this Agreement to be performed or complied prior to Completion.
3.22The Seller’s obligations with respect to Completion are subject to the Purchaser having performed or complied in all material respects with all of the Purchaser’s covenants and agreements under this Agreement to be performed or complied prior to Completion.

No Material Adverse Effect
3.23Completion is conditional upon, between the Effective Date and the Completion Date, there shall not have occurred, and be continuing, any Material Adverse Effect.
General; Termination
3.24This Agreement, subject to Clause 39, may be terminated at any time prior to the Completion Date as set forth below and be of no further effect, and the Parties shall be released and discharged from their respective obligations under this Agreement, provided that such termination of this Agreement shall be without prejudice to the rights and liabilities of the Parties in respect of any breach of this Agreement occurring before the termination:
3.25By either Party, if any of the other Party’s conditions set out in this Clause 3 or in Schedule 2, (i) becomes incapable of being satisfied, through no act or omission of the relevant Party, and where permitted not waived or (ii) is not satisfied, or where permitted waived, on or before 5.00 p.m. on the Long Stop Date;

3.26By both Parties by mutual agreement; or

3.27By either Party, if a Governmental Authority has enacted, promulgated, issued, entered or enforced (i) any Applicable Law prohibiting the transactions contemplated hereby or making them illegal, or (ii) any injunction, judgment, order or ruling or taking any other action, in each case, permanently enjoining, restraining or prohibiting the transactions contemplated hereby, which becomes final and non-appealable; provided that a Party may not terminate this Agreement pursuant to this sub-clause (C) if the basis for such termination results from a material breach by such Party of any of its agreements or covenants contained in this Agreement.
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4.Pre-Completion undertakings
4.1From the Effective Date until the Completion Date, the Purchaser shall not, pursuant to this Agreement, be entitled to:
A.receive detailed commercially sensitive information about the Aspen Group and its activities and included in the Data Room, or pursuant to a clean team arrangement or other appropriate mechanism to preserve confidentiality;
B.provide instructions to any member of the Aspen Group on how to carry out its ordinary course of business, or in respect of any act that would not have a negative impact on the value of the Purchaser’s investment in the Commercialisation Business; or

C.exercise decisive influence over any member of the Aspen Group or otherwise obtain rights not necessary to preserve the value of the Commercialisation Business.

4.2Subject to Clause 4.3, between the Effective Date and Completion, the Seller using commercially reasonable efforts shall, or shall cause the applicable member of the Aspen Group to:
A.maintain, prosecute, enforce, protect and retain any and all Transferring IPR and ensure that all filings, payments, and notifications required to be made in respect of the same are made in accordance with past practice;
B.progress, in accordance with past practice during the Relevant Period, any enforcement activities, applications, submissions, filings or other correspondence initiated by such member of the Aspen Group prior to the Effective Date in respect of the Commercialisation Business;

C.pay all of its liabilities and Taxes relating to the Commercialised Business Assets when due, subject to good faith disputes over such liabilities or Taxes;

D.use commercially reasonable efforts to (preserve good relationships with its employees, licensors, licensees, suppliers, customers, contractors and other persons with which the Seller has business relations with respect to the Commercialised Business Assets. For the avoidance of doubt, the foregoing shall not apply in relation to (i) any employee redundancy and/or restructuring process, and (ii) activities related to the Aspen Retained De-Commercialised Products;

E.promptly notify the Purchaser of any event or occurrence that would cause any covenant or agreement to fail to be performed in all material respects, any Seller Warranty to fail to be true and correct in all material respects at Closing, or which results in any Encumbrance on any of the Commercialised Business Assets,
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F.maintain in force (or procure that there is maintained in force) each Warranted Product Registration then held by the Seller or the Aspen Group; the Seller shall not voluntarily amend, cancel or surrender any Warranted Product Registration then held by the Seller or the Aspen Group unless required to do so under Applicable Laws, or by any Governmental Authority.
unless (in any case) requested in writing by the Purchaser or required by any applicable Governmental Authority.
4.3Subject to Clause 4.3, between the Effective Date and Completion, the Seller shall not, and shall cause the applicable member of the Aspen Group not to:
A.sell, license, lease, encumber, pledge or transfer, or agree to sell, license, lease, encumber, pledge or transfer, any of the Commercialised Business Assets or enter into any Contract, in writing or otherwise, to take such action;
B.cancel any material debts or waive any material claims or rights relating to the Commercialised Business Assets or enter into any Contract, in writing or otherwise, to take such action;

C.incur, assume or guarantee any indebtedness for borrowed money relating to the Commercialised Business Assets, other than trade debt incurred in the ordinary course of business or enter into any Contract, in writing or otherwise, to take such action;

D.commence, settle or agree to settle any Proceeding that would affect in any adverse manner the Commercialised Business Assets or enter into any Contract, in writing or otherwise, to take such action;

E.change any pricing terms in effect as of the date hereof, or provide discounts or other incentives for the Products, in each case, other than changes in the ordinary course of business consistent with past practice or enter into any Contract, in writing or otherwise, to take such action;

F.enter into any contracts relating to the Commercialised Business Assets, other than standard purchase orders made in the ordinary course of business and consistent with past practice and agreements concluded pursuant to this Agreement;

G.amend, modify, prematurely terminate, or breach, or waive any material rights or remedies under, any Commercialisation Business Contract, the Relevant Part of any Shared Commercialisation Business Contract, Transferring Tender or Non-
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Transferring Tender, other than as required to effect separation to give effect to this Agreement or enter into any Contract, in writing or otherwise, to take such action; and

H.take any action or fail to take any action that would cause a Material Adverse Effect.

4.4Clauses 4.2 and 4.3 shall not operate so as to restrict or prevent:
A.any matter reasonably undertaken in response to events beyond the control of any member of the Aspen Group with the intention of minimising any adverse effect of such events where it is not reasonably practicable in the circumstances for the Seller to have obtained the consent of the Purchaser before such matter is undertaken provided that the Seller shall inform the Purchaser in writing of the relevant matter and circumstances as soon as reasonably practicable after becoming aware of the same;
B.an increase in the quantity of Products or products under the Brand Names distributed to or held in any Country or Countries where in the reasonable opinion of the Seller such increase is necessary or desirable in connection with (i) the renewal of a Product Registration in that Country and/or (ii) any change or anticipated change in Applicable Laws, provided that the Seller shall, to the extent reasonably practicable and permitted by Applicable Laws, inform the Purchaser in writing and consult with the Purchaser in good faith prior to effecting any such increase that is material;

C.fluctuations in the quantity of Products or products under the Brand Names distributed to or held in any Country or Countries where in the reasonable opinion of the Aspen Group, such fluctuations are necessary or desirable in order to minimise the effects of parallel imports upon sales of Products or products under the Brand Names;

D.the completion or performance of any obligations undertaken pursuant to any contract or arrangement entered into and disclosed to the Purchaser prior to the Effective Date, to the extent that such completion or performance is due prior to Completion;

E.any matter contemplated by any Ancillary Transaction Agreements, including for the avoidance of doubt Planned Transfers, and consequential stock builds and//or in-market sales, necessary to ensure regulatory compliance and continuity of supply, or any action taken by any member of the Aspen Group pursuant to this Agreement, any Ancillary Transaction Agreement or the Transition Plan;

F.any action or omission which any member of the Aspen Group is required to take or omit to take by any Applicable Laws, or a Tax Authority or Governmental Authority,
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provided that the Seller shall inform the Purchaser in writing of the action or omission as soon as reasonably practicable after becoming aware of the same;

G.any disposal of Initial Stock, obsolete assets or redundant assets, or any payment of cash, in each case in the ordinary course of trading provided that the Seller shall, insofar as it is reasonably practicable to do so, inform the Purchaser in writing and consult with the Purchaser in good faith prior to effecting any such disposal of Initial Stock, obsolete assets or redundant assets;

H.any matter or action undertaken in response to (i) any notice, request, order, demand or correspondence received from any Governmental Authority in connection with any Product, or (ii) incidents concerning Products, in any such case in accordance with the policies and procedures of the Aspen Group from time to time in force, which matter or action may include, without limitation to the generality of the foregoing, instigating recalls of Products or issuing safety notifications in respect of relevant Products, provided that the Seller shall, insofar as it is reasonably practicable to do so, inform the Purchaser in writing and consult with the Purchaser in good faith prior to effecting any such matter or action which is material in accordance with the SDEAs executed pursuant to the Supply Agreement;

I.any repackaging of any Product provided that such repackaging is in compliance with Applicable Laws; or

J.any employee redundancies and/or restructuring processes or activities relating to the Aspen Retained De-Commercialised Products.

4.5Without derogating from the other provisions of this Clause 4 but subject to the provisions of Clause 33 and Applicable Laws, between the Effective Date and the Completion Date, the Seller shall, and the Seller shall procure that the Seller’s Affiliates shall, provide access to, and share with, the Purchaser and the member of the Purchaser’s Group, information in accordance with, and on the terms and conditions of Schedule 22. Each Party shall, and shall procure that each member of its Group shall, and their respective employees and contractors shall, comply with the principles set out in Schedule 22 of this Agreement in relation to any Personal information supplied by the other Party or its Group under or in connection with this Agreement, or any other Ancillary Transaction Agreements.
5.Consideration
5.1The aggregate consideration for the sale of the Commercialisation Business Assets shall be:
A.the payment by the Purchaser of the Commercialisation Business Consideration; and
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B.the assumption by the Purchaser of the Assumed Liabilities.

5.2The Commercialisation Business Consideration shall be payable in accordance with Clause 9, and may only be adjusted as is expressly provided for in this Agreement.

5.3The Commercialisation Business Consideration payable for the Commercialisation Business Assets shall be apportioned as set out in Schedule 6, and such apportionments shall be adopted by the Parties and the respective Groups for the purposes of all or any Tax arising out of or in connection with this Agreement.

5.4For the avoidance of doubt, it is understood and agreed by the Parties that any valuation of assets and liabilities used in order to determine the Commercialisation Business Consideration payable for the Commercialisation Business Assets pursuant to Clause 5.3 is not intended to be, and shall not be interpreted as, any Assurance by any Party as to the value of the assets and liabilities being transferred.

5.5If any payment under this Agreement is late, interest shall accrue on the past due amount at the Agreed Rate.

6.Orgaran New Business Opportunities
The provisions of Schedule 7 shall apply to the Orgaran New Business Opportunities.
7.Guarantees
The Purchaser, for itself and its successors and assigns, covenants that, at any time and from time to time on or after Completion, it will execute and deliver, or procure the execution and delivery of, all such instruments of assumption and acknowledgements or take such other action as the Seller may reasonably request in order to effect the release and discharge in full of any Assurance given by any member of the Aspen Group to any Person in respect of any Assumed Liability, and the Purchaser’s assumption of, and the substitution of an appropriate member of the Purchaser’s Group as the primary obligor in respect of, each such Assurance shall be, in each case, on a non-recourse basis to the Aspen Group. Pending such release and discharge, the Seller shall keep such Assurances in place, and the Purchaser hereby agrees with the Seller (on behalf of itself and each member of the Aspen Group) that it will assume and pay and discharge when due, and hereby indemnifies the Seller and each member of the Aspen Group from any and all actions, claims, demands, proceedings, judgments, liabilities, loss, damages, payments, costs and expenses arising out of or relating to the holding and maintenance of, all such Assurances. For the avoidance of doubt, the provisions of this Clause 7 shall not apply to Assurances in respect of any Excluded Liability.
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8.Tax and VAT
8.1The Parties will be liable for their own Tax in relation to this Agreement and will treat the transactions, for Tax purposes, in accordance with the terms of this Agreement.
8.2The Parties agree that their respective group tax functions will fully cooperate with each other in relation to any reasonable request for information required for the purpose of preparing and filing any Tax Return or any audit, investigation, dispute or appeal of raised by any Tax Authority but only to the extent that:
A.it is legally permissible to provide the requested information; and
B.the disclosure would not breach any duty of confidentiality or waive privilege.
Each Party shall bear its own costs in meeting its obligations under this Clause 8.2.
8.3The Purchaser will be liable for all Transfer Taxes arising from this Agreement.
8.4The Seller and the Purchaser shall and shall procure that the respective members of their Group shall cooperate with each other to take such steps as are lawful and reasonable to optimise the Tax treatment of, and Tax consequences arising from this Agreement.
8.5Any amounts payable by either Party under this Agreement (“Payments”) shall be paid free and clear of all deductions, withholdings, set-offs or counterclaims whatsoever save only as may be required by law.

8.6To the extent that any withholding tax is payable in terms of this Agreement, the withholding tax will be deducted from the amount that is due to the recipient thereof and the Party responsible for withholding shall pay the withholding tax to the Tax Authority within the required timeframe. The Person withholding the tax will provide the other Party with proof of payment of that withholding tax within a reasonable period of time. If the withholding tax rate can be legally reduced in terms of an international double taxation agreement, the Parties agree to co-operate with one another to secure the reduced withholding tax rate. Notwithstanding the foregoing, in the event a Party assigns its rights and obligations under this Agreement or otherwise makes payment from a jurisdiction other than the jurisdiction in which such Party has organised (each an “Assignment”), and immediately after such Assignment the amount of Tax required to be withheld on any payment pursuant to this Agreement is greater than the amount of such Tax that would have been required to have been withheld absent such Assignment, then such increased withholding Tax shall be borne by the Party making such Assignment.

8.7The Parties agree that, based on Applicable Laws as of the Effective Date, no VAT is chargeable on any amount payable hereunder. To the extent that one Party makes a taxable supply of goods or services to another Party under this Agreement for VAT purposes and is
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liable to account for such VAT to the appropriate Tax Authority, the consideration shall be exclusive of VAT and the Party receiving the supply shall pay the VAT to the Party making the supply in addition to the consideration and simultaneously the Party making the supply shall provide the Party receiving the supply with a valid VAT invoice that meets the requirements laid down by the Tax Authority in the country giving rise to the VAT liability. For the avoidance of doubt, even where no VAT is chargeable by the seller or supplier of the goods or services, invoices shall always be issued by such Party to the recipient of the goods or services.
8.8Where any payment is made under this Agreement pursuant to an indemnity, compensation or reimbursement provision (including for breach of any of the Warranties) and that sum is subject to a charge to Taxation (other than income tax, corporation tax or capital gains tax) in the hands of the recipient, the sum payable shall be increased to such sum as will ensure that after payment of such Taxation the recipient shall be left with a sum equal to the sum that it would have received in the absence of such a charge to Taxation, and after giving credit for any Tax relief available to the recipient (or any Affiliate of or Person with an interest in such recipient) in respect of the matter giving rise to the payment, provided that if a Party to this Agreement shall have assigned or novated or declared a trust in respect of the benefit in whole or in part of this Agreement or shall have changed its tax residence or the permanent establishment to which the rights under this Agreement are allocated then the liability of the other Party under this clause shall be limited to that (if any) which it would have been had no such assignment, novation, declaration of trust or change taken place.
8.9Where any sum constituting an indemnity, compensation or reimbursement to any Party to this Agreement (“Party A”) is paid to a Person other than Party A but is treated as taxable in the hands of Party A, the payer shall, as soon as reasonably practicable, pay Party A for all Taxation (other than income tax, corporation tax or capital gains tax) suffered by it in respect of the payment (after giving credit for any Tax relief available to Party A in respect of the matter giving rise to the payment), provided that if either Party to this Agreement shall have assigned or novated or declared a trust in respect of the benefit in whole or in part of this Agreement or shall have changed its tax residence or the permanent establishment to which the rights under this Agreement are allocated then the liability of the other Party under this clause shall be limited to that (if any) which it would have been had no such assignment, novation, declaration of trust or change taken place.
8.10If a Party (or any of its Affiliates) receives and uses a credit for, or receives a refund of, any Tax by reason of any deduction or withholding or gross-up on account of tax made pursuant to any indemnity, compensation or reimbursement that is made, that Party shall reimburse to the other Party such amount as will leave it (and its Affiliates) (after such reimbursement) in the same position it would have been if that other Party had not been required to make payment under Clauses 8.8 and 8.9. Each Party shall use (or procure the relevant Affiliate
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uses) all reasonable endeavours to obtain and utilise any available credit or obtain any refund.
9.Completion
9.1Completion shall take place on:
A.the date which is the last Business Day of the month in which the conditions shall have been satisfied or waived in accordance with this Agreement, unless the date on which the conditions are so satisfied or waived occurs less than five (5) Business Days before the last Business Day of the calendar month then current, in which case Completion shall be effected on the date which is the last Business Day of the next following calendar month; or
B.such other date as may be agreed in writing between the Purchaser and the Seller,
C.(the “Completion Date”).

9.2Completion of the sale and purchase of the Commercialisation Business Assets shall take place at 9.00 a.m. on the Completion Date at the offices of the Seller’s Solicitors.
9.3At Completion, the Seller and the Purchaser shall do, or procure the carrying out of, those things respectively listed in respect of them in (and for the purposes of this Clause 9.3, the Commercialisation Business Assets referred to in Clause 13, and the Commercialisation Business Contracts, the Shared Commercialisation Business Contracts and Transferring Tenders shall be deemed to have been delivered to and acquired by the Purchaser (on behalf of the relevant Designated Purchaser) for the purposes of determining whether the Seller has complied with its obligations pursuant to Schedule 3.
9.4The Commercialisation Business Consideration shall be payable by or on behalf of the Purchaser (on behalf of itself and the Designated Purchasers) in immediately available funds in Euros as follows:
A.a first instalment of two hundred and sixty-three million, one hundred and fifty-eight thousand Euros (EUR 263,158,000) on Completion in accordance with Paragraph 1.2(B) of Schedule 3; and
B.a second instalment of three hundred and seventy-eight million, seven hundred and twenty-seven thousand Euros (EUR 378,727,000) by no later than 25 June 2021, to the Seller’s Bank Account by CHAPS transfer for same day value.
9.5For the avoidance of doubt, the Commercialisation Business Consideration does not include the purchase price for Initial Stock. The Initial Stock will be sold and transferred, and separately paid for, in accordance with Schedule 24.
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9.6Receipt of funds in accordance with Clause 9.4 and Paragraph 1.2(B) of Schedule 3 shall constitute a good discharge of the Purchaser in respect of the payment of the Commercialisation Business Consideration due at Completion but not, for the avoidance of doubt, in respect of the Purchaser’s other obligations under this Clause 9.
10.Action after Completion
10.1The Seller shall, at any time and from time to time after Completion, upon the request of the Purchaser and at the expense of the Seller, do, execute, acknowledge and deliver, or cause to be done, executed, acknowledged and delivered, all such further deeds, assignments, transfers and conveyances as may reasonably be required for the better assigning, transferring, granting, conveying and confirming to the Purchaser, or the Designated Purchaser, as applicable or their respective successors and assigns, or for aiding and assisting in collecting and reducing to possession, any or all of the Commercialised Business Assets. The Seller hereby constitutes and appoints, effective as of Completion for the Commercialised Business Assets and with effect from the date of the relevant Third Party consent in respect of any Commercialised Business Assets subject to such a consent, the Purchaser, its successors and assigns as the true and lawful attorney of the Seller, at the expense and risk of the Purchaser, with full power of substitution in the name of the Purchaser or in the name of the Seller but for the benefit of the Purchaser to institute and prosecute all proceedings which the Purchaser may in its discretion deem proper in order to enforce any right, title or interest in, to or under the Commercialised Business Assets as the case maybe and to defend or compromise any and all actions, suits or proceedings in respect of any of the Assigned Assets and/or Licensed Assets, as applicable. The Purchaser shall be entitled to retain for its own account any amounts collected pursuant to the foregoing powers, including any amounts payable as interest in respect thereof.
10.2The Seller shall procure that originals of all notices, correspondence, information, orders or enquiries relating solely to the Commercialisation Business and copies of the relevant parts of all notices, correspondence, information, orders or enquiries relating partly to the Commercialisation Business and partly to one or more of the remaining businesses or assets of the Aspen Group which are received by any member of the Aspen Group on or after Completion shall be passed as soon as practicable to the Purchaser.

10.3The Purchaser shall procure that originals of all notices, correspondence, information, orders or enquiries relating solely to one or more of the remaining businesses or assets of the Aspen Group and copies of the relevant parts of all notices, correspondence, information, orders or enquiries relating partly to the Commercialisation Business and partly to one or more of the remaining businesses or assets of the Aspen Group which are received by any member of the Purchaser’s Group on or after Completion shall be passed as soon as practicable to the relevant member of the Aspen Group.
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10.4The Seller shall conduct the Ongoing Clinical Trials in accordance with all Applicable Laws at no cost or expense to the Purchaser. The Seller shall promptly provide the Purchaser with the results of the Ongoing Clinical Trials, including the final report for such Ongoing Clinical Trials, and such results and reports shall be licensed to the Purchaser at no cost pursuant to the provisions of Schedule 12.

10.5Any Clinical Trials of any Product to be initiated or conducted after the Completion Date by or on behalf of either Party (or its Affiliates) in the Territory, shall be subject to the prior written consent of the other Party, such consent not to be unreasonably withheld, delayed or made conditional. The Party conducting the Clinical Trial shall conduct the Clinical Trial in accordance with all Applicable Laws, at no cost or expense to the other Party. To the extent that a Party undertakes Clinical Trials during the period of ten (10) years post the Completion Date, the Party undertaking such Clinical Trial shall promptly provide the other Party with the results of the Clinical Trial, including the final report for such Clinical Trial, and such results and reports shall be licensed to the other Party, at no cost pursuant to the provisions of Schedule 12.

10.6For each of the Pending Product Registrations, from Completion until the transfer of the applicable Pending Product Registration to Purchaser or one of its Affiliates, Seller shall, and shall cause each of the Designated Sellers, as applicable, to (i) use commercially reasonable efforts in accordance with the Seller’s usual regulatory submission processes to receive registration of the relevant Pending Product Registration to from the applicable Governmental Authorities; (ii) notify Purchaser of any notifications or communications from a Governmental Authority regarding such Pending Product Registration; (iii) permit Purchaser or Purchaser’s Affiliate, upon Purchaser’s or its Affiliate’s request, to comment on, review or otherwise participate in all communications with the applicable Governmental Authority with respect to such Pending Product Registration; (iv) upon final approval of such Pending Product Registration, or at Purchaser’s option, and to the extent permitted by Applicable Law, prior to such final approval, transmit to Purchaser or one of its Affiliates all documents set forth on Exhibit 3 to Schedule 23 that are necessary for Purchaser to transfer the Pending Product Registration to Purchaser; and (v) maintain the approved Pending Product Registration until it is transferred to the Purchaser or Purchaser’s affiliate. As soon as possible after the approval of the Pending Product Registration and in any event within six (6) months of the Seller providing Purchaser all of the documentation set forth on Exhibit 3 to Schedule 23 to Purchaser’s satisfaction, on a Pending Product Registration-by-Pending Product Registration basis, the Seller (or its Affiliates as applicable) and the Purchaser will do all things necessary to enable the Purchaser (unless local laws require otherwise), using commercially reasonable efforts, to submit to the relevant Governmental Authority(ies) all documents required, and do all other things reasonably required, to procure the transfer of each Pending Product Registration. Subject to Paragraph 1.5.1 of B, the Parties are responsible for their own costs
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and expenses incurred by them in complying with the foregoing obligations; provided, that Purchaser shall pay the reasonable and documented out-of-pocket costs of the Seller incurred after such six (6) month period following the provision of all of the documentation set forth on Exhibit 3 to Schedule 23 to Purchaser’s satisfaction with respect a Pending Product Registrations. Notwithstanding the foregoing terms of this Clause 10.6, to the extent that Purchaser does not submit one or more Pending Product Registrations as a result of a request by the applicable Governmental Authority, then the six (6) month period shall be reasonably extended to the extent necessary for Purchaser to comply with such Governmental Authority’s request.

11.Wrong Pockets
11.1All payments, rebates or other items from third parties which are received by the Seller or any other member of the Aspen Group on or after Completion and which relate to (i) the period after the Completion time; and (ii) the Commercialisation Business sold or any of the Commercialisation Business Assets transferred pursuant to this Agreement shall be promptly paid over (and in any event within twenty (20) Business Days of such receipt) to the Purchaser (or to such other member of the Purchaser’s Group as the Purchaser may nominate) and, pending such payment, shall be held in trust (or procured to be held in trust) by the Seller or the applicable member of the Aspen Group for the Purchaser (or such other member of the Purchaser’s Group as the Purchaser may nominate).
11.2All payments, rebates or other items from third parties which are received by the Purchaser or by any other member of the Purchaser’s Group on or after Completion and which relate to (i) one or more of the remaining businesses or assets of the Aspen Group or (ii) any assets or liabilities of the Aspen Group which did not form part of the Commercialisation Business Assets or the Assumed Liabilities transferred or assumed pursuant to this Agreement (including (i) notwithstanding the provisions of Clauses 17.1 and 17.2 any money, rebates or items received by any member of the Purchaser’s Group in respect of the Receivables; and (ii) any money, rebates or items received by any member of the Purchaser’s Group pursuant to a Commercialisation Business Contract or Shared Commercialisation Business Contract to the extent such money, rebates or items relate to the period prior to the Completion Time) shall be promptly paid over (and in any event within twenty (20) Business Days of such receipt) to the Seller (or to such other member of the Aspen Group as the Seller may nominate) and, pending such payment, shall be held in trust (or procured to be held in trust) by the Purchaser or the applicable member of the Purchaser’s Group for the Seller (or such other member of the Aspen Group as the Seller may nominate).

11.3If the legal title to or the beneficial interest in any asset or liability:

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A.which is not exclusively used in or exclusively relating to the Commercialisation Business; and
B.which is used in or relating to the Aspen Business and which is required in connection with or for use in such Aspen Business,

is transferred to or vested in the Purchaser or any member of the Purchaser’s Group with the Commercialisation Business Assets or Assumed Liabilities, the Purchaser or that member of the Purchaser’s Group (as the case may be) shall be deemed to hold the asset or liability (a “Required Asset or Liability”) on trust and as bailee for the Seller or any member of the Aspen Group (as the case may be) and the Purchaser or that member of the Purchaser’s Group shall, at the Seller’s request, as soon as practicable and on terms that no consideration is provided by any Person for such transfer:
C.execute all such deeds or documents as may be necessary for the purpose of transferring (free of any Encumbrance created on or after Completion) the relevant interest in such Required Asset or Liability to the Seller or as it may direct; and
D.do or procure to be done all such further reasonable acts or things and procure the execution of all such other documents as the Seller (for itself or any member of the Aspen Group) may reasonably request for the purpose of vesting the relevant interest in such Required Asset or Liability in the Seller or any member of the Aspen Group as the case may be.
11.4The Purchaser shall notify the Seller forthwith upon it coming to its attention that there are any Required Asset or Liability in its possession or control or that of any member of the Purchaser’s Group.
11.5If the legal title to or the beneficial interest in any asset or liability:
A.which is used exclusively in or relates exclusively to the Commercialisation Business; and
B.which is not an Excluded Asset or an Excluded Liability or used in or does not relate to the Aspen Business and which is not required in connection with or for use in such Aspen Business,
remains vested in the Seller or any member of the Aspen Group after Completion, the Seller or that member of the Aspen Group (as the case may be) shall be deemed to hold the asset or liability (a “Missing Asset or Liability”) on trust and as bailee for the Purchaser, and the Seller or that member of the Aspen Group (as the case may be) shall, at the Purchaser’s request, as soon as practicable and on terms that no consideration is provided by any Person for such transfer:
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C.execute all such deeds or documents as may be necessary for the purpose of transferring (free of any Encumbrance created after Completion the relevant interest in the Missing Asset or Liability to the Purchaser or as it may direct; and
D.do or procure to be done all such further reasonable acts or things and procure the execution of all such other documents as the Purchaser may reasonably request for the purpose of vesting the relevant interest in the Missing Asset or Liability in the Purchaser or as the Purchaser may direct.
11.6The Seller shall notify the Purchaser forthwith upon it coming to its attention that there is any Missing Asset or Liability in its possession or control or that of any member of the Aspen Group.
11.7Any asset transferred to the Seller or to any other member of the Aspen Group pursuant to this Clause 11 shall be transferred for nil consideration.

11.8Any asset transferred to the Purchaser or to any other member of the Purchaser’s Group pursuant to this Clause 11 shall be transferred for nil consideration.
12.Transfer of Initial Stock
The Parties shall comply with the provisions of Schedule 24 in relation to Initial Stock.
13.Transfer of the Commercialisation Business Contracts, the Shared Commercialisation Business Contracts and Transferring Tenders
Commercialisation Business Contracts and Shared Commercialisation Business Contracts.
13.1The transfer of the Commercialisation Business Contracts and the Shared Commercialisation Business Contracts shall take place pursuant to the terms of Schedule 23.
A.The Tenders
Notification of Transferring Tenders and Non-Transferring Tenders
13.2The Parties shall co-operate and use their respective reasonable efforts to update the Transferring Tenders and the Non-Transferring Tenders listed in Schedule 10 prior to Completion.
13.3Transferring Tenders
The transfer of the Transferring Tenders shall take place pursuant to the terms of Schedule 23.
Non-Transferring Tenders
13.4The provisions of Schedule 23 shall apply to the Non-Transferring Tenders.
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Aspen Retained De-Commercialised Products
13.5It is recorded that as at the Completion Date, the Seller has initiated the discontinuation of the Aspen Retained De-Commercialised Products. From and after the Completion Date, the Seller shall continue to fulfil the pre-existing supply and other obligations in respect of the Aspen Retained De-Commercialised Products, and accordingly, the Seller shall retain such rights as are necessary to enable the Seller to do so. From and after the Completion Date, for each of the Aspen Retained De-Commercialised Products set out in Part A of Schedule 9, the Purchaser shall (at the Seller’s cost and liability), perform the Seller’s Distribution obligations with respect to Seller’s existing customers, and other obligations (the “De-Commercialisation Activities”) as are necessary under Applicable Law in respect of such Aspen Retained De-Commercialised Product, as an agent for and on behalf of the Seller. Pursuant to the Supply Agreement, Seller shall supply Purchaser with sufficient Aspen Retained De-Commercialised Products for Purchaser to perform its obligations under this Clause 13.5. The Seller shall indemnify each member of the Purchaser Group against any and all Losses arising in respect of the period on and after the Completion Time, and relating to the De-Commercialisation Activities in respect of any Aspen Retained De-Commercialised Product on or after the Completion Time including, but not limited to, personal injury (including death) caused thereby, save in respect of any Losses arising as a result of the breach, gross negligence or wilful misconduct of a member of the Purchaser Group under this Clause 13.5 provided further that such indemnity shall only apply, with respect to any Aspen Retained De-Commercialised Product the product registration of which is transferred to Purchaser, to the De-Commercialisation Activities conducted on behalf of the Seller prior to the date of such transfer. For the avoidance of doubt, the Purchaser shall not conduct any activities, including promotion activities so as to create additional demand for the Aspen Retained De-Commercialised Products, prior to the Purchaser taking transfer of the product registrations in respect of such Aspen Retained De-Commercialised Products pursuant to Clause 13.5, save to the extent required in terms of Applicable Law.
13.6The Seller shall notify the Purchaser once the De-Commercialisation Activities in respect of each Aspen Retained De-Commercialised Product is completed (as agreed with any relevant Governmental Authority or Agency). Within ninety (90) days of such notice, the Purchaser shall respond to the Seller with its written election to receive the transfer of the relevant product registrations, failing which the Seller shall cancel the relevant product registrations. In the event the Purchaser elects to receive the transfer of any such product registrations, the Parties will cooperate to transfer such product registrations to the Purchaser, and such product registrations shall be provided to the Purchaser on an as-is, where-is basis.
Technical Transfer
13.7The provisions of the Supply Agreement shall apply to Technical Transfer.
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General
13.8Nothing in this Clause 13 shall oblige the Seller to procure the Contract Transfer or Separation of any Commercialisation Business Contract or Shared Commercialisation Business Contract (as applicable) if such Contract Transfer or Separation would constitute a breach of such Commercialisation Business Contract or Shared Commercialisation Business Contract (as the case may be).
13.9The Commercialisation Business is currently negotiating in the ordinary course for certain contracts with suppliers to be entered into or amended. Where the entry into or amendment of any such contracts is not permitted under Clause 4.2, the Seller and the Purchaser will discuss in good faith (subject to compliance with Applicable Laws) whether these contracts should be entered into in connection with the Commercialisation Business and, if entered into, whether they will be subject to a Contract Transfer or a Separation.

13.10The Purchaser hereby undertakes to indemnify each member of the Aspen Group against any and all actions, claims, demands, proceedings, judgments, liabilities, loss, damages, payments, costs and expenses arising from any act or omission of the relevant Designated Purchaser (or other relevant member of the Purchaser’s Group) to perform or comply with (a) any obligation of the relevant Commercialisation Business Contract Transferor (or other member of the Aspen Group) which arises in respect of the period at or after the Completion Time and falls to be performed or complied with on or after Completion and (b) the terms of any sub-licence granted to the relevant Designated Purchaser pursuant to Schedule 12, provided that no member of the Aspen Group shall have a claim for indemnification in respect of any costs, expenses and/or liabilities to the extent they arise as a result of a breach by the Seller or a Designated Seller of its obligations pursuant to this Agreement.

13.11With respect to those countries in the Territory where Applicable Law requires that the Parties’ respective Affiliates execute a local transfer agreement or other similar documentation to give effect to the transfer of the Commercialised Business Assets pursuant to this Agreement, the Parties shall use their commercially reasonable efforts to prepare such agreement or other documentation and shall deliver executed counterparts thereto at Completion.
14.Assumed and Excluded Liabilities
14.4Except as otherwise provided in this Agreement, the Purchaser (on behalf of the relevant Designated Purchasers) hereby undertakes to the Seller (for itself and as trustee for each other member of the Aspen Group) that with effect from Completion, the Purchaser will (or will procure that the relevant Designated Purchaser or another member of the Purchaser’s Group will):
A.duly and properly perform, assume and pay and discharge when due the Assumed Liabilities; and
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B.indemnify each member of the Aspen Group on demand against, any and all actions, claims, demands, proceedings, judgments, liabilities, loss, damages, payments, costs and expenses arising in connection with:
i.the Assumed Liabilities; and
ii.the carrying on of the Commercialisation Business which relate to or arise from the period on and after the Completion Time,
provided that no member of the Aspen Group shall have a claim in respect of any costs, expenses and/or liabilities to the extent that they arise as a result of a breach by the Seller or a Designated Seller of its obligations pursuant to this Agreement.
14.2Subject always to Clause 14.3, “Assumed Liabilities” means the following:
A.all obligations and liabilities of the Seller, the Contract Transferors and any other member of the Aspen Group under the Commercialisation Business Contracts, the Transferring Tenders, the Non-Transferring Tenders or the Relevant Part of the Shared Commercialisation Business Contracts, (as the case may be) to the extent that such obligations or liabilities are incurred or fall due to be performed, or arise in respect of the period, at or after (but, for the avoidance of doubt, not before) the Completion Time; and
B.all obligations and liabilities arising in connection with any coupons, rebates, overrider arrangements or chargebacks relating to any Product sold at or after the Completion Time;

C.all liabilities, obligations, loss, damages, commitments, payments, costs and expenses in respect of (i) any claim, action, demand, proceeding or investigation arising out of or relating to the Products (including, for the avoidance of doubt, the Commercialisation of the Products), or the sale, use or lease of any of the Commercialisation Business Assets, in each case to the extent that such claim, action, demand, proceeding or investigation (as applicable) relates to any action or omission occurring at or after (but for the avoidance of doubt not before) the Completion Time;

D.the Assumed Employee Liabilities; and

E.all other liabilities and obligations to the extent they are incurred or fall due to be performed, or arise in respect of the period, from and after the Completion Time in respect of the Commercialisation Business Assets or the sale, use or lease of any of the Commercialisation Business Assets, in each case to the extent that such liabilities
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and obligations (as applicable) relate to any action or omission occurring on or after the Completion Time,

but excluding the Excluded Liabilities.
14.3A claim for indemnification by the Seller against the Purchaser pursuant to Clause 14.1, shall not be limited by time, quantum, or otherwise.
14.4Notwithstanding Clauses 14.1 and 14.2, the Seller (on behalf of each member of the Aspen Group) hereby undertakes to the Purchaser (for itself and as trustee for each other member of the Purchaser’s Group) that with effect from Completion, the Seller will (or will procure that another member of the Aspen Group will):
A.duly and properly perform, assume and pay and discharge when due the Excluded Liabilities; and
B.indemnify each member of the Purchaser’s Group against, any and all actions, claims, demands, proceedings, judgments, liabilities, loss, damages, payments, costs and expenses arising in connection with:
i.the Excluded Liabilities; and
ii.the carrying on of the Commercialisation Business which relate to or arise from the period before the Completion Time,
provided that no member of the Purchaser’s Group shall have a claim in respect of any costs, expenses and/or liabilities to the extent that they arise as a result of a breach by the Purchaser or a Designated Purchaser of its obligations pursuant to this Agreement or any Ancillary Transaction Agreement.
14.5In this Agreement, “Excluded Liabilities” means the following:
A.any obligations and liabilities under the Commercialisation Business Contracts, the Shared Commercialisation Business Contracts, the Transferring Tenders and the Non-Transferring Tenders to the extent that such obligations or liabilities are incurred or fall due to be performed, or arise in respect of the period or should have been performed, before the Completion Time;
B.any act, neglect, default or omission in respect of any Commercialisation Business Contract or Shared Commercialisation Business Contract or Transferring Tender or Non-Transferring Tender committed by the Seller, any Contract Transferor or any other member of the Aspen Group occurring before the Completion Time;

C.all liabilities, obligations, loss, damages, commitments, payments, costs and expenses in respect of any claim, action, demand, proceeding or investigation arising out of or relating to the Commercialisation of the Products, or the sale, use or lease of
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any of the Commercialisation Business Assets, in each case to the extent that such claim, action, demand, proceeding or investigation (as applicable) relates to any action or omission occurring before the Completion Time including, for the avoidance of doubt, those matters set forth on Exhibit D to the Disclosure Letter;

D.any liability of any member of the Aspen Group and any liability to make an actual payment of Tax in relation to the Commercialisation Business in respect of any period before the Completion Time;

E.all obligations and liabilities arising in connection with any coupons, rebates, overrider arrangements or chargebacks relating to any Product sold before the Completion Time;

F.any liabilities or obligations in respect of the Excluded Assets listed in Clause 2.2;

G.the Excluded Employee Liabilities;

H.any liabilities arising in connection with the litigation or pending contentious matters to the extent such litigation or contentious matter relates to any action or omission occurring prior to the Completion Time; and

I.all other liabilities and obligations to the extent that they are incurred or arise in respect of the period before the Completion Time in respect of the Commercialisation Business or the Commercialisation Business Assets, or the sale, use or lease of any of the Commercialisation Business Assets, in each case to the extent that such liabilities and obligations relates to any action or omission occurring before the Completion Time.

14.6Notwithstanding any other provision of this Agreement, the Parties’ respective responsibilities for administering all Product returns, (and any related destruction costs), replacement Products and credit notes shall be governed by the provisions of Schedule 24.

14.7The Purchaser, for itself and its successors and assigns, covenants that, at any time and from time to time on or after Completion, it will execute and deliver, or procure the execution and delivery of, all such further instruments of assumption and acknowledgements or take such other action as the Seller may reasonably request in order to effect:
A.the release and discharge in full of the relevant member of the Aspen Group in respect of any Assumed Liability;
B.the assumption by a member of the Purchaser’s Group of the Assumed Liabilities; and
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C.the substitution of a member of the Purchaser’s Group as the primary obligor in respect of the Assumed Liabilities,
in each case on a non-recourse basis to the Aspen Group.
14.8Notwithstanding Clause 14.1, the assumption by the Purchaser of the Assumed Liabilities shall be without prejudice to any rights which the Purchaser may have against any member of the Aspen Group under this Agreement or under any Ancillary Transaction Agreements to which a member of the Aspen Group is a party.
15.First Right of Negotiation
15.1The Seller hereby grants to the Purchaser an option (“First Right Option”), the exercise of which by the Purchaser in accordance with this Clause 15.1 will require the Seller to enter into good faith negotiations with the Purchaser in respect of the possible purchase, acquisition and assumption of the Option Business on the terms of this Clause 15.1.
15.2Within 5 (five) days of the occurrence of an Option Trigger Event, the Seller will give written notice (“Option Trigger Event Notice”) to the Purchaser of the occurrence of the Option Trigger Event in question.

15.3The First Right Option may only be exercised by the Purchaser upon receipt of an Option Trigger Event Notice and furthermore by notice in writing (“Exercise Notice”) from the Purchaser to the Seller during the Exercise Period.

15.4The Seller shall only be obliged to issue an Option Trigger Event Notice, and the Purchaser shall only have the rights to exercise the First Right Option in the event that there is an Option Trigger Event.

15.5The First Right Option shall lapse and cease to be of any effect on the first to occur of (i) 4 (four) years from the Completion Date; and (ii) without prejudice to the Purchaser’s rights under this Clause 15.5, upon the Seller selling and assigning the Option Business to a Third Party without any breach of the provisions of this Clause 15, provided that if only part of the Option Business is so sold and assigned to a Third Party, the First Right Option shall survive in respect of the remainder of the Option Business.

15.6Once the Exercise Notice has been notified by the Purchaser to the Seller (the date on which notice is given or deemed to be given being the “First Right Option Exercise Date”), the Purchaser and the Seller shall undertake in good faith to negotiate, and attempt to finalize and execute, as soon as possible and in any event within the Negotiation Period, the sale and purchase and other agreements as are reasonably required in order for the sale, transfer and assignment of the Option Business which is the subject of the Exercise Notice. The Seller and the Purchaser undertake, in good faith, at all times to cooperate and consult with each other
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insofar as may be reasonably necessary in order to facilitate negotiations during the Negotiation Period.

15.7During the Negotiation Period, neither the Seller nor its Affiliates will take any action to solicit, initiate, seek, encourage or support any inquiry, proposal or offer from, furnish any information to, or participate in any negotiations with, or enter into an agreement with any Person (other than discussions with the Purchaser) regarding any acquisition, sale or similar transaction or series of transactions, regardless of form, with respect to the Option Business (or any part thereof) which is the subject of the Exercise Notice. During the Negotiation Period, the Seller will, subject to any confidentiality obligations and Applicable Law, promptly notify the Purchaser regarding any contact by any Third Party regarding any offer, proposal or inquiry regarding any transaction referred to in the preceding sentence, including in any such notice the identity of the person making, and the terms of, such proposal.

15.8In the absence of agreement between the Seller and the Purchaser at the end of the Negotiation Period, then the First Right Option shall, absent a breach by the Seller of its obligations in this Clause 15, automatically lapse and cease to be of any effect in relation to the Option Trigger Event which is the subject of the Exercise Notice and the Seller (and its Affiliates) shall have the right, without restriction or further obligation to the Purchaser to sell, transfer and assign to any Third Party of its choice, on such terms and conditions as it may in its sole discretion determine, the Option Business which is the subject of the Exercise Notice; provided that if the proposed transaction or agreement that gave rise to the Option Trigger Event is terminated, then the First Right Option shall remain in effect, subject to Clause 15.5.

16.Transfer of Product Registrations and related matters
16.1The transfer of the Product Registrations shall take place in accordance with the terms of Schedule 23.
16.2All regulatory costs, expenses and fees arising in respect of the products under the Brand Names in the Retained Territory (including any costs, expenses or fees required to amend any Product Registration in any Retained Territory as a result of the Proposed Transaction) shall be borne by the Seller or the Seller’s Affiliates.

16.3The dormant Product Registrations will be sold and transferred on an as-is, where-is basis without any representations or warranties of any nature.

16.4Except as set forth in Paragraph 7 of Schedule 4, the pending Product Registrations will be sold and transferred on an as-is, where-is basis without any representations or warranties of any nature including as to registrability.
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17.Receivables
17.1The Purchaser shall not acquire, or procure the acquisition of, the Receivables, and accordingly, the Seller or, as the case may be, the other relevant members of the Aspen Group (as applicable) shall remain entitled to the Receivables in accordance with the terms of this Clause 17.
17.2The Purchaser agrees that the Seller (or such other member(s) of the Aspen Group as the Seller may nominate) (each, a “Collecting Seller”) shall be responsible for the collection of any of the Receivables and that:
A.each Collecting Seller shall be entitled to take such steps as it may think fit to recover any Receivables;
B.the Purchaser shall not take, and shall procure that no other member of the Purchaser’s Group takes, any step to collect any of the Receivables (unless agreed in writing with the Seller or relevant Collecting Seller), and shall not do anything to hinder their collection by any Collecting Seller; and
C.if the Purchaser or any other member of the Purchaser’s Group receives any communication or payment in respect of any Receivable, the Purchaser shall give, or shall procure that there are given, written details of any such communication or payment to the Seller as soon as reasonably practicable following receipt thereof.
17.3In the event that, notwithstanding Clauses 17.1 and 17.2 above, on or after Completion the Purchaser or any other member of the Purchaser’s Group receives any moneys or other items in respect of the Receivables, the provisions of Clause 11.2 shall apply.
18.Insurance
18.1The Purchaser acknowledges and agrees that:
A.upon Completion, all insurance cover provided in relation to the Commercialisation Business pursuant to the Aspen Group Insurance Policies shall cease to cover the Commercialisation Business in respect of the period following Completion; and
B.responsibility for procuring any insurance in relation to the Commercialisation Business which it acquires is, in respect of the period following Completion, the Purchaser’s alone and is not the responsibility of any member of the Aspen Group.
19.Employees
Subject to Applicable Law, the provisions of Schedule 21 shall apply.
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20.Seller Warranties and Indemnification; Purchaser’s Remedies
20.1The Seller shall defend the Purchaser and its Affiliates at the Seller's cost and expense, and will indemnify and hold the Purchaser and its directors, officers, employees and agents harmless from and against any and all Losses suffered, incurred and/or paid in connection with or arising out of any claim relating to (A) any breach or inaccuracy of any of the Seller’s Warranties made in this Agreement or any Ancillary Transaction Agreement, (B) the breach of or failure to perform any covenant or obligation by the Seller or any other member of the Aspen Group contained in this Agreement or any Ancillary Transaction Agreement, (C) any fraud, gross negligence or willful misconduct by the Seller or its directors, officers, employees and agents in connection with this Agreement and (D) any Excluded Liability.
20.2Except as set forth in the Disclosure Letter, the Seller warrants to the Purchaser that each of the Seller Warranties is true, accurate and not misleading as at the Effective Date.

20.3If after the Effective Date the Seller has discovered matters, facts or circumstances which exist as at the Effective Date and it believes constitutes a breach of a Seller Warranty given as at the Effective Date, the Seller shall promptly disclose such matters, facts or circumstances to the Purchaser in order to in good faith, without fraud or wilful concealment, make the Seller Warranties pursuant to this Clause 20.1 to the Purchaser. Any matters so disclosed shall not serve to qualify the Seller Warranties given in this Agreement as at the Effective Date or as of the Completion Date and shall not prevent the Purchaser from bringing a claim for breach of a Seller Warranty in respect of such matters, facts or circumstances, subject to the limitations set out in this Agreement.

20.4The Seller warrants to the Purchaser that each of the Seller Warranties will be true, accurate and not misleading as at Completion.

20.5The liability of the Seller under clause 20.1 shall be limited as set out in Schedule 5.

20.6Nothing in Schedule 5 or in the Disclosure Letter shall qualify or limit the liability of the Seller in relation to:
A.the Seller Fundamental Warranties or the Excluded Liabilities; or
B.any claim for breach of a Seller Warranty attributable to fraud or wilful concealment on the part of any member of the Aspen Group or any agent or adviser of any member of the Aspen Group.
20.7Any payment made by the Seller in respect of any claim under the Seller Warranties shall be treated as a repayment of, and adjustment to, the Commercialisation Business Consideration.
20.8Notwithstanding that the Purchaser becomes aware at any time (whether it does so by reason of any disclosure made in the Disclosure Letter or otherwise) that there has been or will be
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any breach of the Seller Warranties or any other term of this Agreement or that there may be a claim under any Assurance given by the Seller or any Designated Seller under this Agreement, following Completion the Purchaser shall not be entitled to rescind or terminate this Agreement or treat it as rescinded or terminated but shall be entitled to claim damages or exercise any other right, power or remedy under this Agreement or as otherwise provided by law. The Purchaser waives all and any rights of rescission in respect of this Agreement it may have (howsoever arising or deemed to arise) other than any such rights in respect of fraud or wilful concealment.

20.9Each of the Seller Warranties shall be construed as a separate and independent warranty and, except where expressly provided to the contrary, shall not be limited or restricted, or widened or extended, by reference to or inference from the terms of any other Seller Warranty.

20.10The Purchaser acknowledges and agrees for itself (and on behalf of each member of its Group) that neither the Seller nor any member of the Aspen Group makes any warranty (or, for the avoidance of doubt, gives any representation) as to the accuracy of the forecasts, estimates, projections, statements of intent or statements of opinion provided to the Purchaser or any member of its Group (howsoever and whensoever provided), including in the Data Room, the Disclosure Letter, any document appended, attached or provided pursuant to this Agreement or any Ancillary Transaction Agreement or in any documents provided to the Purchaser or any member of its Group or its advisers in the course of the Purchaser’s due diligence exercise, and neither the Seller nor any member of the Aspen Group shall incur any liability for any loss incurred by the Purchaser or any member of the Purchaser’s Group with respect to such matters.
21.Purchaser Warranties and Indemnification; Seller’s Remedies
21.1The Purchaser shall defend the Seller and its Affiliates at the Purchaser’s cost and expense, and will indemnify and hold the Seller and its directors, officers, employees and agents harmless from and against any and all Losses suffered, incurred and/or paid in connection with or arising out of any claim relating to (A) any breach or inaccuracy of any of the Purchaser’s Warranties made in this Agreement or any Ancillary Transaction Agreement, (B) the breach of or failure to perform any covenant or obligation by the Purchaser or any other member of the Purchaser’s Group contained in this Agreement or any Ancillary Transaction Agreement, (C) any fraud, gross negligence or willful misconduct by the Purchaser or its directors, officers, employees and agents in connection with this Agreement and (D) any Assumed Liability.
21.2The Purchaser warrants to the Seller (for itself and on trust for each of the Designated Sellers) as at the Effective Date that:
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A.it has the requisite capacity, power and authority to enter into and perform this Agreement and any other documents which are to be entered into by it pursuant to this Agreement whether at the Effective Date or at Completion (the “Purchaser’s Ancillary Transaction Agreements”);
B.subject to the fulfilment of the condition set out in Part B of Schedule 2, this Agreement constitutes and the Purchaser’s Ancillary Transaction Agreements will, when executed by the Purchaser and/or any other member of the Purchaser’s Group, as the case may be, constitute valid and binding obligations of the Purchaser and/or such other member of the Purchaser’s Group, as the case may be, in accordance with the respective terms of each such document, except as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or by the principles governing the availability of equitable remedies;
C.the execution and delivery of this Agreement and the Purchaser’s Ancillary Transaction Agreements, and the performance by the Purchaser or any other member of the Purchaser’s Group of their respective obligations under this Agreement and the Purchaser’s Ancillary Transaction Agreements to which each is respectively a party will not:
i.result in a breach of any provision of the memorandum or articles of association or by-laws or equivalent constitutional documents of the Purchaser or the relevant member of the Purchaser’s Group;
ii.result in a breach of, or constitute a default (with or without notice or lapse of time, or both) under, any instrument to which the Purchaser and/or the relevant member of the Purchaser’s Group is a party or by which the Purchaser or the relevant member of the Purchaser’s Group is bound where such breach or default is material to their ability to perform their obligations under this Agreement or under any of the Purchaser’s Ancillary Transaction Agreements;
iii.result in a breach of any existing order, judgment or decree of any court or Governmental Authority by which the Purchaser or the relevant member of the Purchaser’s Group is bound where such breach is material to their ability to perform their obligations under this Agreement or under any of the Purchaser’s Ancillary Transaction Agreements; or
iv.save as contemplated by this Agreement, require any consent, waiver, authorization, notice or approval of any Governmental Authority or any other Person;
D.each Designated Purchaser is, and will at and immediately after Completion be, a member of the Purchaser’s Group;
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E.it acknowledges that the Seller’s corporate policy requires that the Purchaser’s business must be conducted within the letter and the spirit of Applicable Law, including the Anti- Corruption Laws, and consistent with good business ethics. By signing this Agreement, the Purchaser agrees to conduct its activities under this Agreement in a manner that is consistent with good business ethics, all applicable Anti-Corruption Laws, and laws for the prevention of fraud, racketeering, and money laundering. Specifically, the Purchaser agrees that neither it nor its Affiliates or any directors, officers, or any other employees, or to the Purchaser’s knowledge, its agents, subcontractors or distributors acting on behalf of any of the above, will, directly or indirectly, make, offer, or authorize any payment or transfer of anything of value to any Governmental Authority or any Agency, instrumentality, or political subdivision thereof, or to any Government Official thereof, or to any customer or supplier, or to any employee thereof, for the purposes of: (i) influencing an act or decision of the recipient (including a decision not to act) in connection with the business operated by such party; (ii) inducing the recipient to use his or her influence to affect any act or decision in connection with the business conducted by such party; or (iii) inducing the recipient to violate his or her duty of loyalty to his or her organization, or as a reward for having done so, in each case in a manner that is in violation of Applicable Law; and

F.that all Persons acting on its behalf will comply with all Applicable Laws in connection with all work on behalf of the Purchaser, including but not limited to, the Anti-Corruption Laws or other Applicable Laws, prevailing in the country(ies) in which each of the Seller and the Purchaser have their principal places of business, perform work on behalf of the other Party, and in the Territory.
21.3The Purchaser warrants to the Seller at the Effective Date that at Completion the Purchaser will have sufficient cash resources available to it (on an unconditional basis) to satisfy its obligations under this Agreement and the Purchaser’s Ancillary Documents (including its obligation to pay the Commercialisation Business Consideration).
21.4Each of the Purchaser Warranties shall be construed as a separate and independent warranty and, except where expressly provided to the contrary, shall not be limited or restricted, or widened or extended, by reference to or inference from the terms of any other Purchaser Warranty.
22.Commercialisation Business Records and Historical Employee Information
22.1The Seller shall deliver to the Purchaser, or procure the delivery to the Purchaser of, all the Commercialisation Business Records on Completion or as soon as reasonably practicable thereafter, but excluding (for the avoidance of doubt) the Excluded Commercialisation Business Records.
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22.2The Purchaser acknowledges that the Seller and the relevant members of the Aspen Group may wish to retain copies of and/or inspect and/or copy the Commercialisation Business Records delivered to the Purchaser under this Agreement for the purpose of dealing with any report, return, statement, audit, filing or other requirement under any Applicable Laws, its Tax affairs or any Third Party Claim or as otherwise reasonably necessary in respect of the Aspen Business and, accordingly, the Purchaser shall, upon being given reasonable notice by the Seller (such notice to include, in the case of a request to inspect and/or to copy any accounting or Tax records, an explanation of the reasons for the making of the request) and subject to the Seller and/or the relevant members of the Aspen Group (as applicable) giving such undertaking(s) as to confidentiality as the Purchaser may reasonably require, make such Commercialisation Business Records available (or procure that the same are made available) to the Seller, the relevant members of the Aspen Group (other than operational employees) and/or their respective representatives and professional advisers for inspection (during Working Hours at the place where such Commercialisation Business Records are to be inspected) and copying (at the Seller’s expense) in each case for and only to the extent necessary for such purpose and for a period of seven (7) years from Completion.
22.3In respect of any Excluded Commercialisation Business Records, the Seller shall, upon being given reasonable notice by the Purchaser make available (or procure that there is made available) to the Purchaser and/or its representatives and professional advisers for inspection (during Working Hours at the place where the relevant part of such Excluded Commercialisation Business Records is to be inspected) and copying (at the Purchaser’s expense) that part of such Excluded Commercialisation Business Records relating to the Commercialisation Business to the extent reasonably necessary to enable the Purchaser (or any other member of the Purchaser’s Group) to carry on the Commercialisation Business.
22.4Should the Seller (in the case of a request to access Commercialisation Business Records consisting of accounting or Tax records) or the Purchaser (in the case of a request to access Excluded Commercialisation Business Records consisting of accounting or Tax records) reasonably consider that its use of any such information would adversely affect the Tax affairs of the other Party in a material way, it shall give notice to the other Party of that view.
22.5The Seller shall, upon being given reasonable notice by the Purchaser and for a period of three (3) years from Completion, provide (or procure that there is provided) to the Purchaser such Historical Employee Information as it reasonably requires in order to carry on the Commercialisation Business provided that the Seller shall not be obliged to provide (or to procure that there is provided) any such Historical Employee Information to the extent that (i) such Historical Employee Information contains legally privileged information which is confidential to any member of the Aspen Group; or (ii) the provision of such Historical Employee Information would unreasonably disrupt the Aspen Business; or (iii) the Aspen Group reasonably believes that the provision of such Historical Employee Information would
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constitute or may lead to a breach of Applicable Laws. Any such Historical Employee Information provided that constitutes Personal Information shall, for the avoidance of doubt, shall be held by the Purchaser strictly in accordance with Clause 4.5 and Schedule 22.
23.Intellectual Property
The provisions of Schedule 12 shall apply to the transfer and licensing of Intellectual Property.
24.Seller’s undertakings
24.1The Seller undertakes to the Purchaser and any other member of the Purchaser’s Group (with the intention of assuring to the Purchaser the full benefit and value of the goodwill and connections of the Commercialisation Business and as a constituent part of the agreement for the sale of the Commercialisation Business) that, except with the consent in writing of the Purchaser:
A.for the period of three (3) after the Effective Date or such shorter period as may be the maximum permitted under Applicable Laws, it shall not, and shall procure that each member of the Aspen Group shall not (for as long as the relevant entity remains a member of the Aspen Group), in the Territory, either on its own account or carry on or be engaged, concerned or interested, directly or indirectly, whether as a voting shareholder, director, partner, agent or otherwise, in any business that directly or indirectly Commercialises any Competing Product. Neither this Clause 24.1(A) nor any other term of this Agreement shall restrict or limit the Seller or any other member of the Aspen Group rights to (i) Manufacture products that have the same or substantially the same indications and/or formulations to the Products anywhere in the world (including the Territory) for Commercialisation by third parties anywhere in the world (including the Territory); (ii) Manufacture products which contain the same API or have the same or substantially the same indications and/or formulations to the Products anywhere in the world (including the Territory) for Commercialisation by the Seller or any member of the Aspen Group in the Retained Territory; or (iii) Commercialise the Products in the Retained Territory;
B.for the period of three (3) years after Completion or such shorter period as may be the maximum permitted under Applicable Laws, it shall not, and shall procure that each member of the Aspen Group shall not (for as long as the relevant entity remains a member of the Aspen Group), either on its own account or in conjunction with or on behalf of any other Person, canvass, solicit or approach or cause to be canvassed, solicited or approached any Person who shall at any time within the year preceding Completion have been a client or customer, prospective client or customer, representative or agent of the Seller in relation to the Commercialisation Business or in the habit of dealing with the Seller in relation to the Commercialisation Business for the purpose of offering to that Person the Products; and
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C.for the period of twelve (12) months after Completion or such shorter period as may be the maximum permitted under Applicable Laws, it shall not, and shall procure that each member of the Aspen Group shall not (for as long as the relevant entity remains a member of the Aspen Group), either, on its own account or in conjunction with or on behalf of any other Person, solicit or entice away or attempt to solicit or entice away from the Purchaser, offer employment to or employ, or offer to conclude any contract of services with, any Transaction Affected Employee employed in a managerial, supervisory, technical or sales capacity at Completion (whether or not such Person would commit a breach of contract by reason of leaving such employment), save where such solicitation or enticement is as a result of an advertisement or advertisements not specifically targeted at such Transaction Affected Employee or as a result of an unsolicited approach to the Seller or any other member of the Aspen Group from any such Transaction Affected Employee,
each of (A), (B) and (C) being a “Restricted Act”.

24.2The undertakings given in Clause 24.1 shall not be breached by any act or omission to the extent that the relevant member of the Aspen Group is exercising its rights or carrying out its obligations pursuant to any Ancillary Transaction Agreements.
24.3The undertakings given in Clause 24.1 shall not be breached:
A.where any member of the Aspen Group acquires (whether directly or indirectly) shares carrying a voting interest of not more than ten percent (10%) in a company which undertakes a Restricted Act;
B.by the Aspen Group’s undertaking of a Restricted Act following the acquisition of any business (whether by acquisition of shares, the whole or any part of the undertaking or assets of any Third Party or by other means) which involves the undertaking of a Restricted Act provided that the gross annual revenues of the business acquired which would constitute a Restricted Act do not represent greater than ten percent (10%) of the value of the relevant business acquired at the time of its being acquired;

C.in the case of any merger, joint venture or partnership arrangement between any member of the Aspen Group and any Third Party where the resulting entity (the “JV Entity”) undertakes a Restricted Act, provided that the relevant member of the Aspen Group does not:
i.directly or indirectly, or in conjunction with or on behalf of another Person, control the Commercialisation constituting the Restricted Act; or
ii.hold an interest (whether direct or indirect and whether by way of holding of shares, voting rights or otherwise) of more than ten percent (10%) in such JV Entity in circumstances where the
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Commercialisation constituting the Restricted Act contributes more than ten percent (10%) of the gross annual revenues of such JV Entity; or
D.where any Third Party acquires Control (as defined in the City Code on Takeovers and Mergers) of the Seller, by virtue of that Third Party’s then-existing activities, provided that the undertaking set out in Clause 24.1 above shall continue to apply (following the acquisition of such Control) to the Seller and those Affiliates and Associated Undertakings of the Seller which are members of the Aspen Group as at the Effective Date.
24.4Each undertaking contained in this Clause 24 shall be construed as a separate undertaking, and if one or more of the undertakings is held by a court of competent jurisdiction to be against the public interest or unlawful or in any way an unreasonable restraint of trade, the remaining undertakings shall continue to bind the Seller.
24.5The Seller agrees and undertakes on behalf of itself and each other member of the Aspen Group that (in the absence of fraud or wilful concealment) it has no rights against and shall not make any claim against any employee, director, agent, officer or adviser of any member of the Purchaser’s Group on whom it may have relied before agreeing to any term of or entering into this Agreement, or any other agreement or document entered into pursuant hereto.
25.Reserved
26.Purchaser’s undertakings
26.1The Purchaser agrees and undertakes on behalf of itself and each other member of the Purchaser’s Group that (in the absence of fraud or wilful concealment) it has no rights against and shall not make any claim against any employee, director, agent, officer or adviser of any member of the Aspen Group on whom it may have relied before agreeing to any term of or entering into this Agreement, or any other agreement or document entered into pursuant hereto (including, without prejudice to the generality of the foregoing, any such Persons as are named in Clause 1.2(L)).
26.2Save as otherwise expressly permitted in this Agreement, the Purchaser undertakes on behalf of itself and each member of the Purchaser’s Group that, subject to Clause 35.2, each member of the Purchaser’s Group will treat as strictly confidential and not disclose to any Person (other than any employee, director, officer or adviser of the Purchaser, other members of the Purchaser’s Group or any employee, director, officer or adviser of any member of the Purchaser’s Group, in any such case on a confidential basis) any Aspen Group Confidential Information. The Purchaser acknowledges that any future use of Aspen Group Confidential Information is at the risk of the Purchaser and other members of the Purchaser’s Group and is without representation, warranty or liability on the part of any member of the Aspen Group.
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26.3The Purchaser undertakes to the Seller that it shall not, and shall procure that each member of the Purchaser’s Group shall not (for as long as the relevant entity remains a member of the Purchaser’s Group), prior to and for a period of twelve (12) months from the Completion Date, solicit or entice away from the employment of any member of the Aspen Group any Relevant Aspen Group Employee without the prior written consent of the Seller, other than:
A.any Relevant Aspen Group Employee whose employment with the relevant member of the Aspen Group has then ceased or who has given or received notice terminating such employment; or
B.where such solicitation or enticement is as a result of an advertisement or advertisements not specifically targeted at such Relevant Aspen Group Employee or as a result of an unsolicited approach to the Purchaser or any other member of the Purchaser’s Group from any such Relevant Aspen Group Employee.
26.4Without prejudice to any other obligation of the Purchaser or an Affiliate of the Purchaser under any Ancillary Transaction Agreement, the Purchaser undertakes to the Seller that, to the extent required to comply with its obligations pursuant to this Agreement and/or to ensure the timely transfer of the Commercialisation Business from the Aspen Group to the Purchaser’s Group, by no later than the date that is twelve (12) months following the Completion Date, it shall establish (or procure the establishment of) a local presence (whether in the form of an Affiliate of the Purchaser or a Third Party distributor) in each Country in which any Product is Commercialised as at the Effective Date.
26.5The Purchaser shall procure that, for a period of eighteen (18) months after the Completion Date:
A.the Commercialisation Business shall prepare, where reasonably requested to do so by the Seller and subject to reimbursement by the Seller of all reasonable expenses of the Commercialisation Business incurred in connection with the preparation of the same, financial data in relation to all periods beginning prior to Completion and ending prior to, on or after Completion required for financial accounts, management accounts or statutory accounts of the Seller or any other member of the Aspen Group and any data to the extent reasonably required for compliance by the Seller or any other member of the Aspen Group with any reporting requirements of any stock exchange or securities or other regulatory authority or under any Applicable Laws which shall each be delivered to the Seller as soon as reasonably practicable following the relevant request; and    
B.the Seller, any other member of the Aspen Group, and its accountants and agents shall, as soon as reasonably practicable (and in any event within five
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(5) Business Days of request for the same), be given reasonable access during Working Hours at the relevant location to any employees, officers, advisers or premises of the Commercialisation Business and any of its books and records which may reasonably be required by the Seller or any other member of the Aspen Group in connection with any report, return, statement, audit, filing or other requirement under any Applicable Laws or otherwise required in respect of the Aspen Business.
26.6Without prejudice to any of the Seller’s remaining rights under Applicable Law, the Purchaser shall not, and shall procure that no member of the Purchaser’s Group shall, actively sell or export any Product or any product under a Brand Name in or to the Retained Territory for a period of ten (10) years from the date of Completion or such shorter period as may be the maximum permitted under Applicable Laws, whichever is earlier in time, nor will it knowingly assist a Third Party to do any of these things.
26.7The Purchaser undertakes to the Seller that, with effect from the Completion Date (or earlier where the Purchaser is the holder of the Product Registration, as agreed pursuant to B but without limitation in time thereafter, the Purchaser shall, or shall procure that the relevant member(s) of the Purchaser’s Group shall, provide the Seller or another member(s) of the Aspen Group full access to the then Product Registrations of the Products in order to enable the Seller or another member(s) of the Aspen Group to register in its name a duplicate Product Registration in any Country (and to amend that Product Registration) in order to enable the Seller or another member(s) of the Aspen Group to obtain any certificate of pharmaceutical product for the purposes of facilitating the Aspen Group or any agent designated by it procuring the registration of Product Registrations (and amending those Product Registrations) anywhere in the Retained Territory and/or to Manufacture the Products worldwide for their (i) Commercialisation (by the Seller or a member of the Aspen Group or any agent designated by it) in the Retained Territory; or (ii) Commercialisation (by the Purchaser or a member of the Purchaser Group or any agent designated by it) in the Territory. At least once every three (3) years (or more regularly as is required under Applicable Law) the Seller, another member of the Aspen Group or any agent designated by it shall have the right to sell one pack of each SKU of each product which is the subject of a duplicate Product Registration to the Purchaser, a member of the Purchaser Group or any agent designated by it for consideration of €1 per pack so as to enable the Seller or another member of the Aspen Group or any agent designated by it to retain the duplicate Product Registration in accordance with Applicable Laws.
26.8The Purchaser undertakes to the Seller, on its behalf, and on behalf of each other member of the Purchaser Group, neither it nor any other member of the Purchaser Group shall at any time after the Effective Date (i) use any Intellectual Property that constitutes Excluded IPR, save only to the extent to which the Purchaser requires such access in order to maintain the Product Registrations in the Territory; and (ii) use any of the Transferred IPR, Transferred
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Know-How, Licensed IPR, Licensed Know-How and Third Party IPR to Commercialise any pharmaceutical product outside the Territory, provided, however, the foregoing does not prohibit the Purchaser from undertaking Clinical Trials or Manufacturing the Products for the Territory outside of the Territory.
27.No set-off
Except as expressly provided under this Agreement, any payment to be made by any Party under this Agreement shall be made in full without any set off, restriction, condition or deduction for or on account of any counterclaim.
28.Effect of Completion
Save as otherwise provided herein, any provision of this Agreement or of any other document referred to herein which is capable of being performed after but which has not been performed at or before Completion and all Warranties and other Assurances contained in, or entered into pursuant to, this Agreement shall (subject to Schedule 5) remain in full force and effect notwithstanding Completion.
29.Capacity of Seller and Purchaser
29.1The undertakings, warranties and indemnities given by the Purchaser to, and agreements made by the Purchaser with, the Seller, on behalf of itself or a Designated Seller, in this Agreement are given and made to and with the Seller on behalf of itself and as trustee for the relevant Designated Seller and each other member of the Aspen Group. For the avoidance of doubt, any warranty in Schedule 4 made in respect of a Designated Seller is made by the Seller on behalf of such Designated Seller.
29.2The undertakings, warranties and indemnities given by the Seller, on behalf of itself or a Designated Seller, to, and agreements made by the Seller, on behalf of itself or a Designated Seller, with, the Purchaser in this Agreement are given and made to and with the Purchaser for itself and as trustee for the relevant Designated Purchaser and each other member of the Purchaser’s Group.

29.3Accordingly, in accordance with the provisions of this Agreement (and notwithstanding the provisions of Clause 42 or any other local transfer document):

A.the Seller, on behalf of itself and each applicable Designated Seller, will in respect of such undertakings, warranties, indemnities and agreements made by the Purchaser be entitled to claim, at its own choice, against either the Purchaser or a Designated Purchaser (as applicable) for losses or liabilities suffered by it or a relevant Designated Seller or other member of the Aspen Group; and
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B.the Purchaser will in respect of such undertakings, warranties, indemnities and agreements made by the Seller, on behalf of itself or a Designated Seller, be entitled to claim, at its own choice, against either the Seller or Designated Seller (as applicable) for losses or liabilities suffered by it or a relevant Designated Purchaser or other member of the Purchaser’s Group.
30.Indemnification and conduct of claims
30.1Indemnification obligations: Subject to the procedures set forth in Clause 30.4,
30.2The Seller shall indemnify the Purchaser, each member of the Purchaser Group and their respective officers, directors, and employees (each, a “Purchaser Indemnitee”) from and against any and all Losses incurred by a Purchaser Indemnitee as a result of: (i) the Excluded Liabilities, (ii) any breach or inaccuracy of the Seller Warranties, (iii) any Third Party Claim resulting from a breach of this Agreement by the Seller or any other member of the Aspen Group, including any failure to perform any covenant or obligation by the Seller contained in this Agreement, or (iv) the De-Commercialisation Activities in respect of the Aspen Retained De-Commercialised Product, including, but not limited to, personal injury (including death) caused; and
30.3The Purchaser shall indemnify the Seller, each member of the Aspen Group and their respective officers, directors, and employees (each, a “Seller Indemnitee”) from and against any and all Losses incurred by a Seller Indemnitee as a result of: (i) the Assumed Liabilities, (ii) any breach of the Purchaser Warranties, (iii) any Third Party Claim resulting from a breach of this Agreement by the Purchaser or any other member of the Purchaser Group, including any failure to perform any covenant or obligation by the Purchaser contained in this Agreement, or (iv) any Third Party Claim resulting from Purchaser’s use of any of the Aspen Marks or Licensed Rights pursuant to Schedule 12;

provided that in the event of a conflict between the indemnification obligations of the Parties under this Agreement and the indemnification obligations of the Parties under the Supply Agreement, the indemnification obligations under the Supply Agreement shall govern with respect to Products Commercialised by or on behalf of the Purchaser after the Completion.
30.4If any assessment, action, claim, demand, proceeding or investigation is filed, brought, alleged or instituted by a Third Party (a “Third Party Claim”) against any member of the Aspen Group or, as the case may be, any member of the Purchaser Group, (the “Relevant Indemnified Party”) in respect of which an indemnity is to be sought from the Purchaser or, as the case may be, the Seller (the “Relevant Indemnifying Party”) pursuant to this Agreement, the Purchaser or, as the case may be, the Seller shall procure that the Relevant Indemnified Party shall:
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A.as soon as practicable notify the Relevant Indemnifying Party thereof by written notice as soon as it appears to the Relevant Indemnifying Party that any Third Party Claim received by or coming to the notice of the Relevant Indemnified Party may result in a claim for indemnification;
B.subject to the Relevant Indemnifying Party indemnifying the Relevant Indemnified Party against any liability, cost, damage or expense which may be incurred thereby, take such action and give such information and access to personnel, premises, chattels, documents and records to the Relevant Indemnifying Party and their professional advisers as the Relevant Indemnifying Party may reasonably request in order to investigate such Third Party Claim, and the Relevant Indemnifying Party shall be entitled to require any relevant company (being a member of the Purchaser Group (where the Relevant Indemnified Party is a member of the Purchaser Group) or a member of the Aspen Group (where the Relevant Indemnified Party is a member of the Aspen Group)) to take such action and give such reasonable information and assistance in order to avoid, dispute, resist, mitigate, settle, compromise, defend or appeal any claim in respect thereof or adjudication with respect thereto;

C.allow the Relevant Indemnifying Party (subject to Clause 30.5 and Clause 30.6) to take the sole control the defence or settlement of such actions, claims, proceedings, investigations and/or negotiations as the Relevant Indemnifying Party may reasonably deem appropriate in connection with any such assessment, claim or investigation in the name of the Relevant Indemnified Party or any such relevant company referred to above, and in that connection the Relevant Indemnified Party shall give or cause to be given to the Relevant Indemnifying Party all such assistance as it may reasonably require in avoiding, disputing, resisting, settling, compromising, defending or appealing any such claim, proceeding or investigation and shall instruct such legal or other professional advisers as the Relevant Indemnifying Party may nominate to act on behalf of the Relevant Indemnified Party or any relevant company, as appropriate, but to act in accordance with the Relevant Indemnifying Party’s instructions, all at the Relevant Indemnifying Party’s cost and expense;

D.be entitled to participate in the defence of any Third Party Claim and to employ separate counsel to represent it at its own expense PROVIDED THAT the Relevant Indemnifying Party shall control the defence of the Third Party Claim;

E.make no admission of liability, agreement, settlement or compromise with any Third Party in relation to any such claim, investigation or adjudication without the prior written consent of the Relevant Indemnifying Party (such consent not to be unreasonably withheld or delayed); and

F.take reasonable action to mitigate any Loss suffered by it in respect of which a claim could be made for indemnification.
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30.5The Relevant Indemnifying Party shall be entitled at any stage and in its absolute discretion to settle any such Third Party Claim after giving reasonable advance written notice to the Relevant Indemnified Party and provided that the Relevant Indemnified Party is discharged in full of its liabilities under such Third Party Claim.
30.6Notwithstanding the provisions of Clauses 30.4 and 30.5, the Relevant Indemnifying Party shall not be entitled to assume the defence of any Third Party Claim (and shall be liable for the reasonable costs and expenses (including legal expenses) incurred by the Relevant Indemnified Party in defending such Third Party Claim) if the Third Party Claim seeks any relief other than damages (including any orders, injunctions or other equitable relief) against the Relevant Indemnified Party which the Relevant Indemnified Party reasonably determines cannot be separated from any related claim for damages. If such claim for other relief can be separated from the claim for damages, the Relevant Indemnifying Party shall be entitled to assume the defence of the claim for damages.

30.7If any amount payable by any Party under this Agreement is required by law to be paid subject to any deduction or withholding on account of Tax, the Party which is obliged to make the payment (the “Paying Party”) shall:
A.make the deduction or withholding in accordance with Applicable Law;
B.make its payments, after the withholding or deduction on the increased amount is taken into account, to the Party to which the payment is to be made (the “Receiving Party”); and

C.deliver to the Receiving Party evidence reasonably satisfactory to the Receiving Party that the deduction or withholding has been made and (as applicable) any appropriate payment has been made to the relevant Tax Authority.

30.8Each Party shall provide to the other Party any tax forms that may be reasonably necessary in order for such other Party not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty.
31.Notices
Any notice, request, consent or communication (collectively, a “Notice”) under this Agreement shall be effective if it is in writing and (a) personally delivered or (b) sent by an internationally recognised overnight delivery service, with delivery confirmed; addressed as set forth in this Clause 31 or to such other address as shall be furnished by either Party hereto to the other Party hereto. A Notice shall be deemed to have been given as of (i) the date when personally delivered, or (ii) two (2) Business Days after being delivered to said overnight delivery service properly addressed. All Notices shall specifically state: (a) the provision (or provisions) of this
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Agreement with respect to which such Notice is given, and (b) the relevant time period, if any, in which the Party receiving the Notice must respond.
In the case of the Seller: With a required copy to:
Aspen Global Incorporated
GBS Plaza
Cnr La Salette and Royal Roads Grand Bay
Mauritius

Attn:    Mr Samer Kassem, Chief Executive Officer
Email: skassem@aspengl.com
Aspen Pharmacare Holdings Limited
Aspen Place, 9 Rydall Vale Park, Douglas Saunders Drive, La Lucia Ridge, Durban, Kwa-Zulu Natal, Republic of South Africa
Attn: Mr Gus Attridge, Deputy Group Chief Executive Officer
Email: gattridge@aspenpharma.com
In the case of any Designated Seller: With a required copy to:
Aspen Global Incorporated
GBS Plaza
Cnr La Salette and Royal Roads Grand Bay
Mauritius
Attn:    Mr Samer Kassem, Chief Executive Officer
Email: skassem@aspengl.com

Aspen Pharmacare Holdings Limited
Aspen Place, 9 Rydall Vale Park, Douglas Saunders Drive, La Lucia Ridge, Durban, Kwa-Zulu Natal, Republic of South Africa
Attn: Mr Gus Attridge, Deputy Group Chief Executive Officer
Email: gattridge@aspenpharma.com
In the case of the Purchaser:
Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13, Ireland
Attn: Managing Director
With a required copy to:
 Mylan Inc.
1000 Mylan Boulevard
Canonsburg, PA 15317 U.S.A.
Attn: Global General Counsel

It is understood and agreed that this Clause 31 is not intended to govern the ordinary course business communications necessary between the Parties in performing their duties, in due course, under the terms of this Agreement.
32.Public Announcements
Each Party agrees not to issue any press releases, reports, or other statements in connection with this Agreement intended for use in the public or private media or otherwise disclose the terms of this Agreement to any Third Party without the prior written consent of the other Party hereto, which consent shall not be unreasonably withheld, except to such Party’s attorneys, advisers and others on a need to know basis in each case consistent with customary practice
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under circumstances that protect the confidentiality thereof; provided that the Purchaser may inform its customers, suppliers and business contacts that the Seller supplies Products to the Purchaser in the ordinary course of business without the Seller’s consent. Notwithstanding the foregoing, each Party may make announcements concerning the subject matter of this Agreement if required by Applicable Law or any securities exchange or Governmental Authority or any tax authority to which any Party is subject or submits, in which case the Party making such announcement shall provide the other Party with a copy of such announcement at least five (5) Business Days prior to issuance, to the extent practicable under the circumstances, and shall only disclose information required by Applicable Law or such exchange or authority.
33.Confidentiality
33.1This Agreement, and in particular this Clause 33 and Clauses 32, 34 and 38 shall supersede that certain confidentiality agreement between the Parties or their Affiliates dated April 16, 2020 (the “Prior CDA”) with respect to this Agreement and the subject matter hereof, and all Confidential Information disclosed pursuant to the Prior CDA shall be deemed to have been disclosed hereunder.
33.2The receiving Party shall protect all Confidential Information of the disclosing Party against unauthorised use and disclosure to third parties with the same degree of care as the receiving Party uses for its own similar information, but in no event less than a reasonable degree of care. The receiving Party shall be permitted to use the Confidential Information of the disclosing Party solely as reasonably necessary to exercise its rights and fulfil its obligations under this Agreement (including any surviving rights), including (a) in prosecuting or defending litigation, complying with Applicable Law, or (c) otherwise submitting information to tax or other Governmental Authorities. The receiving Party shall not disclose the Confidential Information of the disclosing Party to any Third Party other than to its Affiliates, and its and their respective directors, officers, employees, subcontractors, sublicensees, consultants, and attorneys, accountants, banks and investors (collectively, “Authorised Representatives”) who have a need to know such information for purposes related to this Agreement and who are made aware of the confidentiality obligations set forth in this Agreement or are bound by obligations of confidentiality at least as protective of such Confidential Information as those set forth in this Agreement. The receiving Party shall be responsible for any disclosures made by its Authorised Representatives in violation of this Agreement. Notwithstanding anything in this Clause 33 or Clause 34 to the contrary, at and after Completion, with respect to any Confidential Information solely contained in the Commercialised Business Assets, the Purchaser or the Designated Purchaser, as applicable, shall be deemed to be the disclosing Party and the Seller or Designated Seller, as applicable, shall be deemed to be the receiving Party.
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34.Authorised Disclosure
34.1The restrictions related to use and disclosure under Clause 34 shall not apply to any information to the extent the receiving Party can demonstrate by competent evidence that such information: (i) is (at the time of disclosure by the disclosing Party) or becomes (after the time of such disclosure by the disclosing Party) known to the public or part of the public domain through no breach of this Agreement by the receiving Party, or any the recipient to whom the receiving Party disclosed such information, of its confidentiality obligations to the receiving Party; (ii) was known to, or was otherwise in the possession of, the receiving Party prior to the time of disclosure by the disclosing Party; (iii) is disclosed to the receiving Party on a non-confidential basis by a Third Party who is not, to the actual knowledge of the receiving Party, prohibited from disclosing it without breaching any confidentiality obligation to the disclosing Party; or (iv) is independently developed by or on behalf of the receiving Party or any of its Affiliates, as evidenced by its written records, without use of or access to the Confidential Information.
34.2The restrictions set forth in this Agreement shall not apply to the extent that the receiving Party is required to disclose any Confidential Information under law or by an order of a Governmental Authority; provided that the receiving Party: (i) provides the disclosing Party with prompt written notice of such disclosure requirement if legally permitted, (ii) affords the Disclosing Party an opportunity, and cooperates with the disclosing Party’s efforts, to oppose or limit, or secure confidential treatment for such required disclosure (at the disclosing Party’s expense), and (iii) if the disclosing Party is unsuccessful in its efforts pursuant to subsection (ii), discloses only that portion of the Confidential Information that the receiving Party is legally required to disclose as advised by the receiving Party’s legal counsel.
35.Costs and expenses
35.1Notwithstanding Clause 35.2, all Transfer Taxes and all notarial fees payable or assessed in connection with, or directly or indirectly as a result of, this Agreement or any document referred to in it, or the sale or purchase of the Commercialisation Business Assets under this Agreement shall be paid by the Purchaser, and the Purchaser shall, on demand, pay to the Seller and each Designated Seller and each relevant member of the Aspen Group an amount equal to any such Transfer Taxes and fees for which the Seller or that Designated Seller or relevant member of the Aspen Group (as the case may be) is liable to account to any Tax Authority in connection with, or as a result of, this Agreement or the sale or purchase of the Commercialisation Business Assets under this Agreement or any document referred to in it.
35.2Except as otherwise stated in this Agreement (including in Clause 8 in relation to VAT and Clause 35.1 in relation to Transfer Taxes), each Party shall pay its own costs and expenses in relation to the negotiations leading up to the sale of the Commercialisation Business Assets
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and to the preparation, execution and carrying into effect of this Agreement and all other documents entered into pursuant to, or in connection with, it.
36.Counterparts
This Agreement may be executed in counterparts, each of which shall be deemed an original, but which together shall constitute one and the same document. This Agreement and any amendments hereto, to the extent signed and delivered by means of electronic reproduction (e.g., portable document format (.pdf)), shall be treated in all manner and respects as an original and shall be considered to have the same binding legal effects as if it were the original signed version thereof delivered in Person. At the request of a Party, the other Party shall re-execute original forms thereof and deliver them to the Party who made the said request.
37.Severability
Should one or more of the provisions of this Agreement, in any jurisdiction, become invalid, void, prohibited or unenforceable for any reason as a matter of law, then such provision, as to such jurisdiction, shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement, or affecting the validity or enforceability of such provision on any other jurisdiction. The Parties agree to negotiate in good faith a valid and enforceable provision therefor which, as nearly as possible, achieves the desired economic effect and mutual understanding of the Parties under this Agreement.
38.Injunctive Relief
Each Party agrees that breaches of this Agreement may cause irreparable harm to the other Party and shall entitle such other Party, in addition to any other remedies available to it (subject to the terms of this Agreement), to the right to seek injunctive relief enjoining such action
39.Survival
Expiration or termination of this Agreement shall not affect any accrued rights or liabilities of either Party. The provisions of Clauses 35 (Costs and expenses), 36 (Counterparts), 37 (Severability), 40 (Independent Contractors), 41 (Assignment), 42 (Entire Agreement; Amendments), 43 (No Third Party Beneficiaries) 44 (Remedies), 45 (Waiver), 46 (Headings), 47 (Interpretation), 48 (Construction), 49 (Governing Law), 50 (Dispute Resolution), 51 (Jurisdiction), 52 (Further Acts) and 53 (Agent for Service), shall survive expiration or termination of this Agreement.
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40.Independent Contractors
The Parties agree that the relationship between the Seller and the Purchaser established by this Agreement is that of independent contractors. Furthermore, the Parties agree that this Agreement does not, is not intended to, and shall not be construed to, establish a partnership or joint venture, and nor shall this Agreement create or establish an employment, agency or any other relationship. Except as may be specifically provided herein, neither Party shall have any right, power or authority, nor shall they represent themselves as having any authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other Party, or otherwise act as an agent for the other Party for any purpose. All Persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.
41.Assignment
This Agreement shall inure to the benefit of and be binding upon the Parties hereto and their respective permitted successors and assigns. Nothing contained herein shall give to any other Person any benefit or any legal or equitable right, remedy or claim. Neither Party shall at any time, without obtaining the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, assign or transfer this Agreement in whole or in part or subcontract its obligations hereunder to any Person, except that either Party shall be permitted, without the consent of the other Party, to assign this Agreement in whole or in part to any of its Affiliates or to any Third Party that acquires all or substantially all of the assets or business of such Party to which this Agreement relates by sale, transfer, merger, reorganization, operation of law or otherwise; provided that the assignee agrees in writing to be bound to the terms and conditions of this Agreement; provided further that such exception shall not apply (and the consent of the other Party shall be required to assign this Agreement to any Affiliate) in the event this Agreement would constitute all or substantially all of the assets of the assignee Affiliate.
42.Entire Agreement; Amendments.
This Agreement (including, for clarity, its Schedules), the Supply Agreement and any documents or agreements entered into pursuant thereto, constitute and contain the entire understanding and agreement of the Parties respecting the subject matter hereof and cancel and supersede any and all prior and contemporaneous negotiations, correspondence, understandings and agreements between the Parties, whether oral or written, regarding such subject matter. Notwithstanding the foregoing, except as expressly set forth in this Agreement, to the extent the terms and conditions of the body of this Agreement conflict with the terms and conditions of any Schedule hereto, the terms and conditions of the body of this Agreement shall govern. Each of the Parties acknowledges that in deciding to enter into this
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Agreement and to consummate the transactions contemplated hereby, neither Party has relied upon any statements or representations, written or oral, other than those explicitly set forth herein. No terms or provisions of this Agreement will be varied or modified by any prior or subsequent statement, conduct or act of either of the Parties, except that the Parties may amend this Agreement by written instruments specifically referring to and executed in the same manner as this Agreement.
43.No Third Party Beneficiaries
Except for the rights to indemnification provided for under Clause 31 above, all rights, benefits and remedies under this Agreement are solely intended for the benefit of the Seller and the Purchaser. Except for such rights to indemnification expressly provided pursuant to Clause 31, no Third Party shall have any rights whatsoever to (a) enforce any obligation contained in this Agreement; (b) seek a benefit or remedy for any breach of this Agreement; or take any other action relating to this Agreement under any legal theory, including actions in contract, tort (including negligence, gross negligence and strict liability), or as a defence, setoff or counterclaim to any action or claim brought or made by the Parties.
44.Remedies
Unless otherwise expressly provided, all remedies hereunder are cumulative, and in addition to any other remedies provided for by law and may, to the extent permitted by law, be exercised concurrently or separately, and the exercise of one remedy shall not be deemed to be an exclusive election of such remedy or to preclude the exercise of any other remedy.
45.Waiver
A waiver by any Party of any of the terms and conditions of this Agreement in any instance will not be deemed or construed to be a waiver of such term or condition for the future, or of any subsequent breach hereof. All rights, remedies, undertakings, obligations and agreements contained in this Agreement will be cumulative, and none of them will be in limitation of any other remedy, right, undertaking, obligation or agreement of either Party.
46.Headings
The Clause and Paragraph headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.
47.Interpretation
References in this Agreement to any gender include reference to all genders, and references to the singular included references to the plural and vice versa. The words “include”, “includes” and “including” when used in this Agreement shall be deemed to be followed by the
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phrase “without limitation”. Unless the context otherwise requires, references in this Agreement to Clauses, Paragraphs and Schedules shall be deemed references to Clauses and Paragraphs of, and Schedules to, this Agreement. Unless the context otherwise requires, the words “hereof”, “hereby” and “herein” and words of similar meaning when used in this Agreement refer to this Agreement in its entirety and not to any particular Clause, Paragraph or provision of this Agreement. All references to contracts, agreements, leases or other arrangements shall refer to oral as well as written matters. Provisions that require that a Party or the Parties “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing. The word “notice” shall require notice in writing (whether or not specifically stated) and shall include notices, consents, and approvals contemplated under the Agreement. References to any specific law, or article, section or other division thereof, shall be deemed to include then-current amendments thereto or any replacement thereof.
48.Construction
The Parties expressly agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting Party shall not be applied in the construction or interpretation of this Agreement. Each Party agrees that it has read and had the opportunity to review this Agreement with its legal counsel.
49.Governing Law
This Agreement and all rights and obligations of the Parties arising out of or relating to this Agreement shall be governed by, construed and enforced in accordance with the laws of England and Wales without giving effect to conflicts of laws principles. The Parties hereby expressly agree that the U.N. Convention on Contracts for the International Sale of Goods shall not apply. The Parties hereby irrevocably waive, and agree to cause their respective Affiliates to waive, the right to trial by jury in any action directly or indirectly arising out of, under or in connection with this Agreement or any transactions contemplated hereby.
50.Dispute Resolution
Except as otherwise provided herein, any dispute, controversy or claim arising under, out of or in connection with this Agreement, including any subsequent amendments, or the validity, termination, enforceability, construction, interpretation, performance or breach hereof, any request for specific performance, or claim based on contract, tort, or statute (and including the applicability of Clauses 49 and 51 or this Clause 50 to any such dispute, controversy or claim) (each a “Dispute”) shall be first submitted to an executive officer of each of the Parties having authority to resolve such Dispute for attempted resolution by good faith negotiations within thirty (30) Business Days. In such event, each Party shall cause its designated executive officer to meet and be available to attempt to resolve such an issue. If the Parties should
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resolve such Dispute, a memorandum setting forth their agreement will be prepared and signed by both Parties if requested by either Party. The Parties shall cooperate in an effort to limit the issues for consideration in such manner as narrowly as reasonably practicable in order to resolve the Dispute. A Party participating in such a meeting is a pre-requisite before such Party may institute any action under Clause 51; provided that the other Party has participated in such meeting. In addition, each Party agrees that it shall not institute formal proceedings for the resolution of any Dispute, unless it remains unresolved for a period of thirty (30) Business Days from such referral; provided, however, that either Party may institute formal proceedings at any time in order to avoid the expiration of any applicable limitations period, to preserve a superior position with respect to other creditors, or to seek equitable relief.
51.Jurisdiction
The Parties agree that any Dispute that is not resolved pursuant to Clause 50 shall be subject to the exclusive jurisdiction of the High Court of England located in London and each Party hereby submits to such jurisdiction.
52.Further Acts
Each Party shall do, execute and perform and shall procure to be done and performed all such further acts, deeds, documents and things as the other Parties may reasonably require from time to time to give full effect to the terms of this Agreement.
53.Agent for service
53.1The Purchaser irrevocably appoints Mylan Holdings Ltd. (for the attention of Jose Cotarelo) at Trident Place, Building 4, Mosquito Way, Hatfield Hertfordshire AL10 9UL, England, to be its agent for the receipt of Service Documents. It agrees that any Service Document may be effectively served on it in connection with Proceedings in England and Wales by service on its agent effected in any manner permitted by the Civil Procedure Rules.
53.2The Seller irrevocably appoints Gordon Dadds Process Agent Limited, (Attention: Alon Domb / Melanie Kincaid), Aldgate Tower 2 Leman Street, London, El8QN, to be its agent for the receipt of Service Documents. It agrees that any Service Document may be effectively served on it in connection with Proceedings in England and Wales by service on its agent effected in any manner permitted by the Civil Procedure Rules.
53.3If either the Seller or the Purchaser’s agent at any time ceases for any reason to act as such, the Seller or the Purchaser (as applicable) shall promptly appoint a replacement agent having an address for service in England or Wales and shall notify the other Party of the name and address of the replacement agent. Failing such appointment and notification, the other Party shall be entitled by notice to the Seller or the Purchaser (as is applicable) to appoint a
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replacement agent to act on behalf of the Seller or the Purchaser (as is applicable). The provisions of this Clause 53 applying to service on an agent, apply equally to service on a replacement agent.
53.4A copy of any Service Document served on an agent of the Seller or the Purchaser pursuant to the provisions of this Clause 53, shall be sent by post to the Seller or the Purchaser (as is applicable) pursuant to Clause 31. Failure or delay in so doing shall not prejudice the effectiveness of service of the Service Document.
IN WITNESS of which the Parties have entered into this Agreement on the day and year first before written.

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Signed by: /s/ Peter McCormick
For and on behalf of
Mylan Ireland Limited

Authorized Signatory





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Signed by: Samar Kassem /s/ Samar Kassem
For and on behalf of
ASPEN GLOBAL LIMITED

Authorized Signatory


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Schedule 2
Conditions
Part A
A.Competition Conditions
1.The EU
(a)the European Commission having adopted and formally notified the Distributor of (or having been deemed to have adopted) all decisions and approvals necessary pursuant to the EU Merger Regulation to allow completion of the Proposed Transaction;
(b)and if the Proposed Transaction has been referred back (or deemed to have been referred back) in part to the Competition Authority of any Country under Article 4(4) or Article 9 of the EU Merger Regulation, the European Commission having adopted the decision or decisions referred to in either Paragraphs (i) or (ii) above in respect of any and all parts of the Proposed Transaction not so referred to a Competition Authority of any Country; and
(c)to the extent that the European Commission refers (or is deemed to have referred) the Proposed Transaction in whole or in part to any such Competition Authority under Article 4(4) or Article 9 of the EU Merger Regulation:
(i)all consents and approvals of any such Competition Authority related to the part of the Proposed Transaction so referred and which are required to be obtained before the Proposed Transaction may be completed having been obtained; and
(ii)all applicable waiting periods in connection with any such filings, submissions or notification having expired or been terminated.
2.Serbia
In so far as required by Applicable Laws, the relevant Governmental Authority in Serbia having cleared or being deemed to have cleared the Proposed Transaction under applicable anti-trust or merger control rules on or before the Long Stop Date.
Part B
    



B.Foreign Investment Conditions
Insofar as required by Applicable Laws, the relevant Foreign Investment Authority in Germany, Italy and Spain having cleared, being deemed to have cleared or not having assumed jurisdiction under the Applicable Laws over the Proposed Transaction.
Part C
C.Aspen’s Funders’ Consent
Evidence reasonably satisfactory to the Purchaser that the lenders under the Facilities Agreement have consented to the disposal of the Commercialisation Business Assets on the terms of this Agreement and the release of all guarantees or Encumbrances over the Commercialisation Business Assets granted under or pursuant to the Facilities Agreement.
Part D
D.Inform and Consult Obligations
In so far as required by (i) Applicable Employment Laws, the completion of information and/or consultation obligations, if any, in the Purchaser’s and Seller’s Affiliates or (ii) the co-determination procedure with the German works council of the relevant Affiliate of the Seller and, if applicable, with the German works council of the relevant Affiliate of the Purchaser regarding the implementation plan (Interessenausgleich) in relation to the transactions contemplated by this Agreement.
Part E
E.Third Party Consents
Seller shall have obtained written consent from Glaxo Group Limited (“Glaxo”) in a form satisfactory to Purchaser (acting reasonably) for Seller to sub-license to Purchaser hereunder the Syringes IP rights (as referenced in Schedule 13) licensed by Glaxo to Seller pursuant to the Amended and Restated Master Asset Purchase Agreement (the “Glaxo Agreement”) in relation to the Manufacturing Business (as defined in the Glaxo Agreement) at the Site (as defined in the Glaxo Agreement) by and between Glaxo and Seller (or Seller’s Affiliate), dated 30 September 2013, as amended and restated on 20 December 2013, as further amended by the Side Letter to the Amended and Restated Master Asset Purchase Agreement in relation to the Manufacturing Business (as defined in the Glaxo Agreement) at the Site (as defined in the Glaxo Agreement), dated 14 December 2015.




Schedule 3
Completion arrangements
1.General
1.2Matters to be dealt with by the Seller
At Completion, the Seller shall:
Transfer of Commercialisation Business Assets capable of delivery
(A)subject to the provisions of this Agreement, procure that each relevant member of the Aspen Group with legal and beneficial title to any Commercialisation Business Asset delivers to the Purchaser (or the relevant Designated Purchaser) all the Commercialisation Business Assets to which such member of the Aspen Group has legal and beneficial title and which are capable of transfer by delivery (other than any Commercialisation Business Records, which shall be delivered to the Purchaser in accordance with Clause 22) with the intent that legal and beneficial title to these Commercialisation Business Assets shall pass at the Completion Time;
Other matters
(B)deliver to the Purchaser:
i.a copy of the minutes of a duly held meeting of the directors of the Seller (or a duly constituted committee thereof) authorising the execution by the Seller of this Agreement and those Seller’s Ancillary Transaction Agreements to be entered into at Completion and, in the case where such execution is authorised by a committee of the board of directors of the Seller, a copy of the minutes of a duly held meeting of the directors constituting such committee or the relevant extract thereof;
ii.an original counterpart of each of:

(a)the Transferring IPR Assignments;
(b)the Transferring Domain Name Assignments;

(c)the Supply Agreement;

(d)the Distribution and Supply Agreement;

(e)the Initial PO Units Side Letter; and




(f)in each case duly executed on behalf of the Seller and/or the relevant member(s) of the Aspen Group.
1.2Matters to be dealt with by the Purchaser
At Completion, the Purchaser shall:
A.deliver to the Seller:
i.a copy of the minutes of a duly held meeting of the directors of the Purchaser (or a duly constituted committee thereof) authorising the execution by the Purchaser of this Agreement and those of the Purchaser’s Ancillary Transaction Agreements to be entered into at Completion to which each of them respectively is a party and, in the case where such execution is authorised by a committee of the board of directors of the Purchaser, a copy of the minutes of a duly held meeting of the directors constituting such committee or the relevant extract thereof;
ii.an original receipt from the Purchaser acknowledging delivery of all documents required to be delivered by the Seller pursuant to this Schedule; and

iii.an original counterpart of each of:
a.the Transferring IPR Assignments;
b.the Transferring Domain Name Assignments;
c.the Supply Agreement;
d.the Distribution and Supply Agreement;
e.the Initial PO Units Side Letter; and
f.in each case duly executed on behalf of the Purchaser and/or the relevant member(s) of the Purchaser’s Group;
g.if available, the Seller, on behalf of itself and the Designated Sellers, shall provide their Irish tax reference number as required under Regulation 4(3) of the Stamp Duty (e-stamping of Instruments and self-assessment) Regulations 2012 (S.I. No. 234 of 2012).
B.pay, or procure the payment of, the first instalment of the Commercialisation Business Consideration set out in Clause 9.4(A), to the Seller’s Bank Account by CHAPS transfer for same day value.




Schedule 4
Seller Warranties
1.Capacity of the Seller and the Designated Sellers
1.1The Seller and each of the Designated Sellers is duly incorporated, validly existing and in good standing under the laws of its jurisdiction of incorporation.
1.2The Seller and each of the Designated Sellers has the requisite capacity, power and authority, corporate or otherwise, to conduct its business as now being conducted, to own, lease and operate its business as now being conducted, has obtained all necessary corporate consents, approvals and authorisations required in connection with the execution, delivery and performance of this Agreement and has all requisite power and authority, corporate or otherwise, to execute, deliver, perform and enter into this Agreement and any other documents which are to be entered by the Seller or the relevant Designated Seller pursuant to this Agreement, whether at the Effective Date or at Completion (the “Seller’s Ancillary Transaction Agreements”).
1.3This Agreement and the Seller’s Ancillary Transaction Agreements will, when executed, constitute legal, valid and binding obligations on the Seller and the relevant Designated Seller(s) in accordance with their respective terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or by the principles governing the availability of equitable remedies.
1.4Except for the consents and approvals set out in Schedule 2 (Conditions), the Seller and each Designated Seller has lawfully obtained all consents, authorisations, registrations, authorisations or permits required to empower it to enter into and perform its obligations under this Agreement and each of the Seller’s Ancillary Transaction Agreements to which it is party.
1.5Neither the Seller nor any Designated Seller is in insolvency, bankruptcy, administration, liquidation or receivership (and no order or resolution therefor has been presented, and no notice of appointment of any liquidator, receiver, administrative receiver or administrator has been received by the Seller or any Designated Seller), and, so far as the Seller is aware, there are no valid grounds or circumstances on the basis of which any such procedure may be requested. Neither the Seller nor any Designated Seller has stopped payment or suspended the payment of its debts generally, or is deemed unable to pay its debts as they fall due.
1.6The execution and delivery of this Agreement and the Ancillary Transaction Agreements by the Seller and each of the Designated Sellers and the performance by the Seller and each of the Designated Sellers of their respective obligations under them will not:



A.result in a breach of any provision of the memorandum or articles of association or by-laws or equivalent constitutional document of the Seller, the relevant Designated Seller or the relevant member of the Aspen Group (as applicable);
B.result in a breach of or constitute a default (with or without notice or lapse of time, or both) under or give rise to any payment obligations or right of termination, cancellation, modification or acceleration of any obligation or loss of any benefit under any instrument to which the Seller, the relevant Designated Seller or the relevant member of the Aspen Group (as applicable) is a party or by which it or its assets and properties may be bound or affected, save as may be set forth in the Disclosure Letter;

C.except for the consents and approvals set out in Schedule 2 (Conditions) (i) require any consent, waiver, authorization, registration, notice or approval of any Governmental Authority or any other Person, (ii) result in a breach of any provision of any law, rule, regulations, order, writ, judgment, injunctions, decree, determination or award of any court, Governmental Authority or regulatory body to which the Seller, the relevant Designated Seller or the relevant member of the Aspen Group (as applicable) is party or by which the Seller or the relevant Designated Seller (as applicable) is bound, or (iii) violate any provision of Applicable Law presently in effect;
2.Ownership and sufficiency of assets
2.1Each of the Commercialisation Business Assets (other than any Initial Stock acquired in the ordinary course of business on terms that the property does not pass until payment is made) is owned (including with respect to all right, title and interest) both legally and beneficially by the Seller or a Designated Seller or another member of the Aspen Group and each of those assets capable of possession is, save where in the possession of third parties in the ordinary course of business, in the possession of the Seller or a Designated Seller or another member of the Aspen Group.
2.2Save for Permitted Encumbrances, no Encumbrance or equity on, over or affecting the whole or any part of the Commercialisation Business Assets is outstanding and, save in relation to Permitted Encumbrances, there is no agreement or commitment entered into by any member of the Aspen Group to give or create any Encumbrance, and no claim has been made against any member of the Aspen Group by any Person to be entitled to any Encumbrance. Further, upon the consummation of the transactions contemplated hereby, the Purchaser will acquire good and valid title, and own all right, title and interest, in and to the Commercialisation Business Assets free and clear of all Encumbrances, other than Permitted Encumbrances. None of the Permitted Encumbrances could reasonably be expected to materially impair the continued use and operation of the Commercialisation Business Assets.



2.3The Commercialisation Business Assets (including for the avoidance of doubt, the Initial Stock to be transferred pursuant to 0), together with such other licenses, sub-licenses, facilities and services which are to be provided to the Purchaser’s Group pursuant to this Agreement and any Ancillary Transaction Agreement, comprise all of the rights, properties, assets and facilities necessary, sufficient or desirable to carry on the Promotion and Distribution activities and/or sales or offers for sale of Products and any related actions (but for the avoidance of doubt, not the Manufacturing) in the Territory associated with the Commercialisation Business in substantially the same manner as they have been during the Relevant Period.
2.4No Third Party or Affiliate of the Seller or any Designated Seller owns, beneficially or of record, any Commercialisation Business Asset or any rights or licenses from or through Seller or any Designated Seller to Commercialise the Products in or for the Territory. No amounts or other consideration are due to a Third Party or Affiliate of the Seller or any Designated Seller with respect to the Commercialisation Business Assets and no amounts, or other consideration will become due to a Third Party or Affiliate of the Seller or any Designated Seller as a result of the transactions contemplated by this Agreement or the Ancillary Transaction Agreements.
3.Products
3.1The list of SKUs of the Products set out in Schedule 8 (Products) is complete and accurate in all material respects, and, so far as the Seller is aware, there will be no change in such list of SKUs in the period prior to Completion Date.
3.2The Seller represents and warrants that, other than for the Aspen Retained De-Commercialised Products, the Aspen Group has no plans to discontinue any Product, and so far as the Seller is aware, there is no current or foreseeable discontinuation or disruption in the supply of the Product (or any component or API thereof), including without limitation as to the result of the current regulatory enforcement activity or due to notification by, or failure to come to terms with Third Party suppliers with regard to the supply of the Product (or any component or API thereof).
4.Contracts and commitments
4.1All Material Contracts have been concluded on arm’s length terms other than any Material Contract that will expire, has been fully performed, or has been terminated in accordance with its terms in each case prior to or at the Completion Time. All Material Contracts are valid, binding and in full force and effect.
4.2The Seller has listed in the Disclosure Letter and made available to the Purchaser complete and accurate copies of all Material Contracts, including all amendments, supplements, modifications and waivers thereof.



4.3No member of the Aspen Group is in, has received notice that it is in, breach of any Material Contract and, so far as the Seller is aware, no other party to any Material Contract is in material breach of any such Material Contract. No member of the Aspen Group has received any notice of the intention of any party to terminate any Material Contracts.
4.4Other than as set forth in the Disclosure Letter, there are no upfront, milestone, royalty, profit-share, capital commitments or other costs payable by the Seller or another member of the Aspen Group under any Material Contract.
5.Consents and licences
5.1All licences, consents, permissions, permits, waivers, exceptions and approvals (each a “License”) required for carrying on the Commercialisation Business have been obtained lawfully and the Seller, the Designated Sellers, the Aspen Group and their respective Affiliates possess, and have at all times possessed, such Licenses. Each License is validly and presently in effect (and the continuing validity and effectiveness of such will not be affected by the consummation of the transactions contemplated hereby), and Seller or the relevant Designated Seller, as applicable, is not in default (with or without notice or lapse of time, or both) under any such License.
5.2No Third Party consents are required to assign or transfer the Commercialisation Business Assets, or grant any licensed or sub-licenses (as are applicable) in respect of the Licensed IPR, to the Purchaser or the other members of the Purchaser Group in accordance with this Agreement or the Ancillary Transaction Documents.

5.3All Product Registrations pertaining to the Commercialisation Business Assets are in full force and effect, and no written or other notice has been received by the Seller, a Designated Seller or any member of the Aspen Group and no fact or circumstance exists which indicates that any Product Registration is likely to be revoked or which may confer a right of revocation.

6.Intellectual Property
6.1Correct details of all Transferring IPR which is registered or for which an application is pending as at the Effective Date are set out in Schedule 14 (Transferring Marks), Schedule 15 (Domain Names), Schedule 16 (Brand Names) and Schedule 17 (Transferring Patents and Registered Designs). So far as the Seller is aware, Schedule 14 (Transferring Marks), Schedule 15 (Domain Names), Schedule 16 (Brand Names) and Schedule 17 (Transferring Patents and Registered Designs) set forth all Transferring IPR that have been registered, filed, certified or otherwise perfected or recorded with or by any Governmental Authority or public registry or depository service. Each item of Registered IPR that is owned by the Seller, and, to the knowledge of the Seller, that is licensed by the Seller, is valid, subsisting and enforceable, and all necessary registration, maintenance and renewal fees in connection with



such Registered IPR have been paid, and all necessary documents and certificates in connection with such Registered IPR have been filed with the relevant Governmental Authorities for the purposes of perfecting, prosecuting and maintaining such Registered IPR. There are no acts or omissions of the Seller that would (A) constitute inequitable conduct, fraud or misrepresentation with respect to any Transferring IPR, Transferring Know-How, Licensed IPR, and Licensed Know-How, or (B) render any Transferring IPR, Transferring Know-How, Licensed IPR, and Licensed Know-How invalid or unenforceable in whole or in part.
6.2The Aspen House Marks, the Transferring IPR, the Transferring Know-How, the Licensed IPR, the Licensed Know-How, and Third Party IPR constitute the entire registered, and unregistered Intellectual Property used or necessary to Commercialise the Products in, or Manufacture the Products for, the Territory by the Purchaser in the same way those Products were Commercialised in, or Manufactured for, the Territory in the Relevant Period.

6.3The Seller exclusively owns and possesses all right, title and interest in, or has a license with the rights to sublicense or other equivalent right to use, all of the Transferring IPR, Transferring Know-How, Licensed IPR, and Licensed Know-How (including the right to seek past and future damages with respect thereto) and Third Party IPR, in each case free and clear of all Encumbrances, save in respect of Third Party IPR which is subject to the Encumbrances as recorded in Schedule 13. The Seller has the unrestricted right to assign, transfer or grant to the Purchaser all rights in the Transferring IPR, Transferring Know-How, Licensed IPR, and Licensed Know-How that are being assigned, transferred or granted to the Purchaser under this Agreement, in each case (subject to Schedule 13 in respect of Third Party IPR), free of any rights or claims of any Person and without payment of any royalties, license fees or other amounts to any Person. As of the Completion Date, the Purchaser will be permitted to assign, license or otherwise transfer all Transferring IPR, Transferring Know-How, Licensed IPR, Licensed Know-How and subject to Schedule 13, the Third Party IPR without restriction and without payment of any additional amounts or consideration to any Person. The Seller has not transferred ownership of, or granted any license of or right to use (including any covenant not to sue), or authorized the retention of any rights to use or joint ownership of, any Transferring IPR, Transferring Know-How, Licensed IPR, or Licensed Know-How to any Person in a manner inconsistent with the rights being assigned, transferred or granted to the Purchaser under this Agreement.

6.4So far as the Seller is aware, the Commercialisation Business does not infringe or misappropriate any Intellectual Property (including pending applications and registrations therefor if such applications or registrations were to issue or become registered) of any Person, violate any right of any Person (including any right to privacy or publicity) or constitute unfair competition or trade practices under the Applicable Law of any jurisdiction, and the Seller has not received notice from any Person claiming that such conduct infringes, violates



or misappropriates any Intellectual Property of any Person or constitutes unfair competition or trade practices under the Applicable Law of any jurisdiction (nor does the Seller have knowledge of any basis therefor).

6.5The Seller has no knowledge of any activities by Persons in the Territory that the Seller reasonably believes constitute an infringement, violation or misappropriation of any Transferring IPR, Transferring Know-How, Licensed IPR, or Licensed Know-How (including pending applications and registrations therefor as if such applications or registrations were to issue or become registered). The Seller has not brought a claim against any Third Party alleging any such infringement, violation or misappropriation and no such claim is otherwise pending.

6.6The Seller has not entered into any contract with any Third Party expressly agreeing to indemnify any Person against any charge of infringement as a result of the manufacture, use, sale, importation or other exploitation of the Products.

7.Product Registrations
7.1Each of the Warranted Product Registrations was lawfully obtained, and in respect of Product Registrations that are held by the relevant Product Registration Holder as at Completion, are validly held by the relevant Product Registration Holder and are in full force and effect.
7.2As at Completion with respect to Warranted Product Registrations, or on the date of transfer to Purchaser or one of its Affiliates with respect to Pending Product Registrations if different from Completion, all amounts due to any Governmental Authority in respect of the registration and/or maintenance of the Product Registrations have been paid and discharged in full in accordance with Applicable Law.

7.3The Warranted Product Registrations constitute all the material Product Registrations granted to any member of the Aspen Group which as at the Effective Date are used for the Commercialisation of the Products in the Territory.

7.4No member of the Aspen Group has during the Relevant Period received any notification or notice of any hearing, investigation or audit by any Competent Authority to vary, suspend, revoke, withdraw, cancel or otherwise declare any Warranted Product Registration to be invalid, nor are any such proceedings or actions ongoing.

7.5All applications for renewal of a Warranted Product Registration have been duly and timely filed.

7.6So far as the Seller is aware, the dossiers of each Warranted Product Registration and each Pending Product Registration have been compiled in all material respects in accordance with



Applicable Law, generally accepted pharmaceutical principles and the then current state of science and technology and, to the Seller’s knowledge, no part of such dossiers infringes the rights of any Third Party.

7.7So far as the Seller is aware, all Products that are, or have during the Relevant Period been, sold, placed on the market or otherwise Commercialised in the Territory by or on behalf of the Seller or the Aspen Group, were or are (as applicable) the subject of a valid regulatory licence held by a member of the Aspen Group in the Country of sale, and were sold, placed on the market or otherwise Commercialised in such Country in compliance with the applicable Product Registration and all Applicable Laws.

7.8So far as the Seller is aware, the Warranted Product Registrations and Pending Product Registrations do not infringe the rights of any Third Party.

8.Litigation
8.1There is no pending or currently outstanding litigation or arbitration, administrative or criminal proceedings or Third Party Claim, and no such litigation or arbitration, administrative or criminal proceedings or Third Party Claim is threatened, or during the 24 (twenty four) month period prior to the Completion Date, been threatened, including claims for product liability, in each case which relates to the Commercialisation Business Assets or the Products in the Territory.
8.2Neither the Seller, any Designated Seller, nor any member of the Aspen Group has been served with any formal written notice of any litigation or arbitration, administrative or criminal proceedings or Third Party Claim in the 24 (twenty four) month period prior to the Completion Date indicating that any litigation or arbitration, administrative or criminal proceedings or Third Party Claims will be commenced in relation to the Commercialisation Business Assets and there are no circumstances that the Seller, relevant Designated Seller or member of the Aspen Group expects to give rise to such litigation or arbitration, administrative or criminal proceedings or Third Party Claims.

8.3Neither the Seller, any Designated Seller, nor any other member of the Aspen Group has during the 24 (twenty four) month period prior to the Completion Date brought any claim or proceeding against any Third Party with respect to the Commercialisation Business Assets or the Products in the Territory or is otherwise party to any such claim or proceeding.

9.Compliance with Laws; Regulatory Matters
9.1The Seller and all members of the Aspen Group have, during the Relevant Period, conducted the Commercialisation Business in all material respects in accordance with their respective



constitutional documents and in compliance with all Applicable Laws and regulations in any relevant jurisdiction.

9.2None of the Seller, the Designated Sellers nor their Affiliates nor any Third Party acting on their behalf is currently conducting, or has any obligation to conduct, any pre-clinical or clinical trials, or other studies, related to the Products in the Territory other than the Ongoing Clinical Trials.

9.3All preclinical and clinical trials of the Products that are being or have been conducted by or on behalf of the Seller that have been submitted to any Governmental Authority in the Territory in connection with any Product Registrations are being or have been conducted in compliance in all material respects with all Applicable Laws, including good clinical practices and good laboratory practices, as applicable.

9.4During the Relevant Period, the Commercialisation of the Products in the Territory by, or on behalf of, the Seller, the Designated Sellers and their Affiliates, has been conducted in compliance with all Applicable Laws, and none of the marketing and promotional materials used by, or on behalf of, the Seller, the Designated Sellers and their Affiliates, including the labels and labelling and advertising, for the Products in the Territory, is or has been false or misleading. During the Relevant Period, all required notices, petitions and reports to Governmental Authorities in connection with such marketing and promotional activities for the Products in the Territory have been timely submitted.

9.5So far as the Seller is aware, during the Relevant Period, the Commercialisation of the Products in the Territory by any licensee or distributor, has been conducted in compliance with all Applicable Laws, and none of the marketing and promotional materials used by any licensee or distributor, including the labels and labelling and advertising, for the Products in the Territory, is or has been false or misleading. So far as the Seller is aware during the Relevant Period, all required notices, petitions and reports to Governmental Authorities in connection with any licensee or distributor marketing and promotional activities for the Products in the Territory have been timely submitted.

9.6The manufacture of the Products by, or on behalf of, the Seller, the Designated Sellers and their Affiliates has at all times been conducted in compliance with Applicable Laws. The processes used to produce the Products are adequate to ensure that the Products meet the specifications established therefor. Neither the Seller, the Designated Sellers nor any of their Affiliates has received any notification, written or oral, that remains unresolved from any Governmental Authority that (i) it has performed the Commercialisation Business in any way which does not in any respect comply with all Applicable Laws, regulations or standards or



which in any respect is defective or dangerous; or (ii) so far as the Seller is aware, is reasonably likely to result in an adverse finding with respect to any of the Products.

9.7Neither the Seller, the Designated Sellers nor any of their Affiliates (including their respective current and former officers, (during their employment with the Seller or Designated Seller), employees, and agents) has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in exclusion under Applicable Laws or been debarred by any Governmental Authority or Applicable Laws.

9.8During the Relevant Period (i) there have been no audits, inspections, examinations or investigations of the Seller or any Designated Seller by a Governmental Authority involving any of the Products, other than routine periodic inspections by a Governmental Authority that did not result in any adverse findings with respect to any Product; (ii) neither the Seller nor any Designated Seller has received any “notice of observation,” “notice of adverse finding,” “warning letters,” or “untitled letters,” or other similar Governmental Authority or Agency notice of inspectional observations or deficiencies or other written correspondence from any Governmental Authority or Agency concerning the Product or the facilities in which the Product is manufactured; and (iii) there has not been a recall or market withdrawal or replacement of any Product by, or on behalf of, the Seller, any Designated Seller or any of their Affiliates, whether voluntary or involuntary. Neither the Seller, any Designated Seller nor any of their Affiliates is aware of any facts which are reasonably likely to cause (1) the recall, market withdrawal or replacement of any Product sold by, or on behalf of, the Seller, any Designated Seller or any of their Affiliates, or by any licensee or distributor; (2) a change in the marketing classification or a material change in any approval, labelling, or manufacturing of any Product sold by, or on behalf of, the Seller, any Designated Seller or any of their Affiliates, or by any licensee or distributor; or (3) a termination or suspension of the marketing, or seizure, of any Product sold by, or on behalf of, the Seller, any Designated Seller or any of their Affiliates, or by any licensee or distributor; (4) a violation of any Applicable Laws or regulations in any relevant jurisdiction; or (5) a materially adverse impact on the Commercialisation Business Assets or the Products.

9.9The Seller, the Designated Sellers and their Affiliates are, and at all times have been, in compliance with all adverse event reporting requirements applicable to the Products. There have been no material adverse events reported during the Relevant Period.

9.10Neither the Seller, the Designated Seller nor any of their Affiliates has made any false statements on, or omissions from, the applications, reports, regulatory filings and other submissions or communications (written or oral) to any Governmental Authority or Agency with respect to the Products or their manufacture or any other records, reports and documentation prepared or maintained to comply with the requirements of all Warranted Product Registrations and Applicable Laws. Neither the Seller, the Designated Sellers nor any



of their Affiliates are the subject of any pending or threatened investigation by any Governmental Authority with respect to the Products or the Warranted Product Registrations. So far as the Seller is aware, no Governmental Authority is considering such act.

9.11The Seller, and each of the Designated Sellers, has fully complied with all applicable export control, economic sanctions laws and anti-boycott regulations of the United States of America and other governments, including the U.S. Export Administration Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control (Title 31 of the U.S. Code of Federal Regulations Part 500 et seq.).

9.12No Product has been directly or indirectly shipped by the Seller or any Designated Seller to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries.

9.13None of the Seller, nor any Designated Seller, is included on any of the restricted party lists maintained by the U.S. Government, including the Specially Designated Nationals List administered by the U.S. Treasury Department’s Office of Foreign Assets Control; the Denied Persons List, Unverified List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred Parties maintained by the U.S. State Department’s Directorate of Defense Trade Controls.

10.Insurance
All material insurance policies relating to the Commercialisation Business are in full force and effect, and no notice of cancellation, termination or default has been received with respect to any such insurance policy. All premiums due and payable on such policies covering the period from the Effective Date up to Completion have been paid in full or accrued.
11.Taxation
11.2Other than for Taxes arising from the transactions contemplated herein, or Taxes that become due in the ordinary course, there are no Taxes currently due and owing with respect to, or liens for Taxes (other than Permitted Encumbrances) on, any of the Commercialisation Business Assets. The Seller, and each Designated Seller, has filed all tax returns and made timely payment of all Taxes owed with respect to the Commercialisation Business Assets.
11.2The Seller is not involved in any dispute with any Tax Authority concerning any matter likely to affect the conduct of the Commercialisation Business after Completion or any of the Commercialisation Business Assets and, so far as the Seller is aware, no such dispute is likely.



12.Employment
12.1All contracts of service or for services with any of the Transaction Affected Employees are terminable by the relevant member of the Aspen Group without compensation (other than for unfair dismissal or a statutory redundancy payment).
12.2Each member of the Aspen Group has discharged its obligations in full in relation to salary, wages, fees, commission, bonuses, overtime pay, holiday pay, sick pay and all other benefits and emoluments relating to the Transaction Affected Employees in respect of all prior periods. Completion will not give rise to the payment of any remuneration, payment or benefit or any enhancement or acceleration thereof to any Transaction Affected Employees whether in accordance with the standard terms and conditions of employment of such Transaction Affected Employees or otherwise.

12.3There are no formal offers or obligations to increase the salaries of the Transaction Affected Employees, or vary the terms and conditions of employment of any Transaction Affected Employees, except for increases resulting from applicable bargaining agreements provided in the Data Room (save as required by Applicable Laws).

12.4So far as the Seller is aware, no member of the Aspen Group is engaged or involved in any material enquiry, investigation, dispute, claim or legal proceedings (whether arising under contract, common law, statute or in equity) with any of the Transaction Affected Employees or any other Person currently or previously employed by or engaged in the Commercialisation Business or their dependants and, so far as the Seller is aware, there is no event which could reasonably be expected to give rise to such enquiry, investigation, dispute, claim or proceedings.

12.5So far as the Seller is aware, the members of the Aspen Group have, during the Relevant Period, complied in all material respects with all Applicable Laws, collective agreements and contractual obligations owed to, or in respect of, the Transaction Affected Employees.

13.Suppliers
From January 1, 2020, through the Effective Date, no supplier has notified the Seller, any Designated Seller or any of their Affiliates that it will stop, or decrease the rate of, supplying products or services to the Seller, the applicable Designated Seller or their Affiliates with respect to the Product, which stop or decrease would be reasonably likely, individually or in the aggregate, to be material to the Commercialisation Business Assets. Each supplier of the Seller, any Designated Seller or any of their Affiliates is, and has been since January 1, 2020, in compliance in all material respects with all Applicable Laws relating to such supplier’s relationship with the Seller, the applicable Designated Seller or their Affiliates in connection



with the Product, and there are no regulatory actions threatened in writing against such supplier, except to the extent not material, individually or in the aggregate, to the Products.
14.Financial Information.
14.1The aggregate Net Sales information for the Products and net sales for the Aspen Retained De-Commercialised Products for the twelve (12) month period commencing 1 July 2017 and terminating 30 June 2018, as is annexed hereto as Exhibit 1, reflects actual bona fide transactions, is unaudited and was compiled in accordance with the Seller’s usual and customary accounting practices.
14.2The aggregate Net Sales information for the Products and net sales for the Aspen Retained De-Commercialised Products for the twelve (12) month period commencing 1 July 2018 and terminating 30 June 2019, as is annexed hereto as Exhibit 2 reflects actual bona fide transactions, is unaudited and was compiled in accordance with the Seller’s usual and customary accounting practices.

15.Anti-corruption
The Seller acknowledges that the Purchaser’s corporate policy requires that the Purchaser’s business must be conducted within the letter and the spirit of Applicable Law, including the United Kingdom Bribery Act 2010, the United States Foreign Corrupt Practices Act and any and all other Applicable Laws prohibiting corruption or bribery including the Applicable Laws in the Territory (“collectively, the Anti-Corruption Laws”), and consistent with good business ethics. By signing this Agreement, the Seller agrees to conduct its activities under this Agreement in a manner that is consistent with good business ethics, all applicable Anti-Corruption Laws, and laws for the prevention of fraud, racketeering, and money laundering. Specifically, the Seller warrants that neither it nor its Affiliates or any directors, officers, or any other employees, or, to the Seller’s Knowledge, its agents, subcontractors or distributors acting on behalf of any of the above, will, directly or indirectly, make, offer, or authorize any payment or transfer of anything of value to any Governmental Authority or any Agency, instrumentality, or political subdivision thereof, or to any Government Official thereof, or to any customer or supplier, or to any employee thereof, for the purposes of: (i) influencing an act or decision of the recipient (including a decision not to act) in connection with the business operated by such party; (ii) inducing the recipient to use his or her influence to affect any act or decision in connection with the business conducted by such party; or (iii) inducing the recipient to violate his or her duty of loyalty to his or her organization, or as a reward for having done so, in each case in a manner that is in violation of Applicable Law. For the purposes of this Agreement: “Government Official” means (a) any official or employee of any Governmental Authority, or any department, Agency, or instrumentality thereof (including without limitation commercial entities owned or controlled, directly or indirectly, by a



Governmental Authority), (b) any political party or official thereof, or any candidate for political office, in the United States of America or other country, or (c) any official or employee of any public international organization.
16.Broker’s and Finder’s Fees
There are no claims for brokerage commissions or finder’s fees or similar compensation in connection with the transactions contemplated by this Agreement or the Ancillary Transaction Agreements based on any arrangement made by or on behalf of the Seller, any Designated Seller or any of their Affiliates.
16.Accuracy of Information
None of the representations, warranties or statements of the Seller, any Designated Seller or any of their Affiliates contained in this Agreement or the Ancillary Transaction Agreements, contains any untrue statement of a material fact or omits to state any material fact necessary in order to make any of such representations, warranties or statements in light of the circumstances under which they were made, not misleading. Neither the Seller, and Designated Seller nor any of their Affiliates has knowledge of any fact that may have a material adverse effect on the Commercialisation Business Assets or the transactions contemplated hereby that has not been set forth in this Agreement or Ancillary Transaction Agreements.




Schedule 5
Limitations on Liability
1.Seller’s Limitations on Liability
1.1Limitations on quantum and general
Neither the Purchaser nor any other member of the Purchaser Group shall be entitled in any event to damages or other payment in respect of any claim or claims under any of the Seller Warranties in respect of any individual claim (or series of related claims with respect to related facts or circumstances) unless and until the aggregate amount of all claims made under or in respect of the Seller Warranties, exceeds eight million, seven hundred and seventy two thousand Euros (EUR 8,772,000) but, once the aggregate amount of all such claims has exceeded such sum, the Seller shall be liable for the full amount of all such claims and not merely in respect of the excess over such sum.
For the purposes of establishing whether any claim falls to be notified under paragraph 2 below, all amounts available for set-off or otherwise liable to be deducted from the amount of such claim by virtue of the operation of the subsequent paragraphs of this Schedule shall first be taken into account in order to determine whether the amount of the claim exceeds the threshold in this paragraph 1.1.
1.2The total aggregate liability of the Seller and all members of the Aspen Group under or in respect of any claim or claims under any of the Seller Warranties shall not, in any event, exceed an amount equal to:
A.for all claims made in respect of or under the Seller Warranties (other than the Seller Fundamental Warranties and the Seller Tier 2 Fundamental Warranties), the Transaction Liability Cap;
B.for all claims made in respect of or under the Seller Tier 2 Fundamental Warranties, fifty percent (50%) of the Commercialisation Business Consideration; and

C.subject to paragraphs 1.2(A) and (B), for all claims made in respect of or under the Seller Fundamental Warranties, one hundred percent (100%) of the Commercialisation Business Consideration.
1.3Neither the Purchaser nor any other member of the Purchaser Group shall be entitled to claim under this Agreement for any indirect or consequential loss (including loss of profit) or punitive damages, save that nothing in this paragraph 1.3 shall exclude or limit the Seller’s liability in respect of,



A.a Third Party claim which is the subject of an indemnification obligation under Clause 30, but solely insofar as it relates to the amounts claimed by that Third Party;
B.any Excluded Liabilities; or

C.a breach by the Seller of Clauses 24.1 or 34.
1.4The Seller shall only be liable in respect of any claim under or in respect of this Agreement if and to the extent that such claim is admitted by the Seller, agreed to by the Parties in writing pursuant to a settlement agreement or otherwise, or proven by a final non-appealable judgment (or judgment for which the right of appeal has lapsed) in a court of competent jurisdiction.
1.5Each provision of this Schedule shall be read and construed without prejudice to each of the other provisions of this Schedule.
2.Time Limits for bringing claims
No claim shall be brought against the Seller in respect of any of the Seller Warranties unless the Purchaser shall have given to the Seller written notice of such claim specifying (in reasonable detail) the matter which gives rise to the claim, the nature of the claim and the amount claimed in respect thereof (detailing the Purchaser’s good faith calculation of the loss thereby alleged to have been suffered, or anticipated to be suffered, by it or the relevant member of the Purchaser Group):
A.subject to sub-paragraphs 2(B) and 2(C), on or before the date falling twenty-four (24) months after the Completion Date; or
B.in respect of any claim under paragraph 8.1 of Schedule 4, on or before the date falling thirty-six (36) months after the Completion Date; or

C.in respect of any claim under the Seller Tax Warranties, the earlier of three (3) months after the expiry of the period specified by statute during which an assessment of that liability to Tax may be issued by the relevant Tax Authority and the seventh anniversary of the Completion Date;

PROVIDED THAT the liability of the Seller in respect of any claim referred to in paragraph (A) above shall absolutely determine (if such claim has not been previously satisfied, settled or withdrawn) if legal proceedings in respect of such claim shall not have been commenced within twelve (12) months of the service of such notice, and for this purpose, proceedings shall not be deemed to have been commenced unless they shall have been properly issued and validly served upon the Seller except:



D.in the case of a claim based upon a liability which is contingent or otherwise not capable of being quantified, in which case the twelve (12) month period shall commence on the date that the contingent liability becomes an actual liability or the liability is capable of being quantified; or
E.in the case of a claim where a member of the Purchaser Group has a made corresponding claim against an insurer or has a corresponding entitlement to recovery from some other person in which case the twelve (12) month period shall commence on the date that the corresponding claim or entitlement is finally settled or finally determined.
3.Conduct of litigation
3.1Upon the Purchaser or any other member of the Purchaser Group becoming aware of any claim, action or demand against it or any other matter likely to give rise to any claim in respect of any of the Seller Warranties (other than the Seller Tax Warranties), the Purchaser shall:
A.as soon as practicable notify the Seller thereof in writing in accordance with paragraph 2;
B.subject to the Seller’s agreement to indemnify the Purchaser or the relevant member of the Purchaser Group in a form reasonably satisfactory to the Purchaser against any liability, cost, damage or expense which may be properly incurred thereby (but without thereby implying any admission of liability on the part of the Seller), take such action and give such information and access to personnel, premises, chattels, documents and records (which the Purchaser shall procure are preserved) to the Seller and its professional advisers as the Seller may reasonably request for purposes of defending or settling such claim, in each case at Seller’s expense;

C.at the request of the Seller, allow the Seller to take the sole conduct of such claims, actions and/or demands (as applicable) as the Seller may deem appropriate in connection with any such claim, action or demand in the name of the Purchaser or any relevant member of the Purchaser Group and in that connection the Purchaser shall, at Seller’s expense, give or cause to be given (and shall procure that the relevant member of the Purchaser Group shall give or cause to be given) to the Seller all such assistance as it may reasonably require in avoiding, disputing, resisting, settling, compromising, defending or appealing any such claim, action or demand provided that neither the Purchaser nor the relevant member of the Purchaser Group shall be required to commence any legal proceedings where either:

i.the Purchaser or the relevant member of the Purchaser Group has validly assigned all of its rights in relation to the relevant claim, action or demand (as applicable) to the Seller in a manner which entitles the Seller to the same



benefits in respect of such rights as the Purchaser or the relevant member of the Purchaser Group had; or
ii.where sub-paragraph 3.1(C)(i) does not apply or where the Seller otherwise requests in writing, the Seller has not notified the relevant party against whom such proceedings are brought that such proceedings are being brought at the instruction of the Seller;
C.make no admission of liability, agreement, settlement or compromise with any person in relation to any such claim, action or demand without the prior written consent of the Seller; and
D.take, or procure that there is taken, all reasonable action to mitigate any loss suffered by it or by any member of the Purchaser Group in respect of which a claim could be made under the Seller Warranties.
3.2The Seller shall be entitled at any stage and at its sole discretion to settle any such claim, action or demand; provided that any such settlement is solely for monetary damages with respect to which Seller indemnifies Purchaser and includes a full release of any claims against Purchaser or the Purchaser Group.
3.3In the event of a conflict between this Paragraph 3 and Clause 30 of the Agreement, Clause 30 shall govern.

4.No liability if loss is otherwise compensated for
4.1No liability shall attach to the Seller or to any member of the Aspen Group by reason of any breach of any of the Seller Warranties (other than the Seller Tax Warranties) to the extent that the same loss has been recovered by the Purchaser or any other member of the Purchaser Group under any other Warranty or terms of this Agreement or any other document entered into pursuant hereto, and accordingly, the Purchaser and each other member of the Purchaser Group may only recover once in respect of the same loss.
4.2The Seller shall not be liable for breach of any of the Seller Warranties (other than the Seller Tax Warranties) to the extent that the subject of the claim has been or is made good or is otherwise compensated for without cost to the Purchaser or any other member of the Purchaser Group.

4.3In calculating the liability of the Seller for any breach of the Seller Warranties, (other than the Seller Tax Warranties), there shall be taken into account the amount by which any Taxation for which the Purchaser or any other member of the Purchaser Group is now or in the future accountable or liable to be assessed is reduced or extinguished as a result of the matter giving rise to such liability, with the intention that the outcome for the Purchaser and any other member of the Purchaser Group is economically neutral.



5.Recovery from third parties
5.1Where the Purchaser or any member of the Purchaser Group is at any time entitled to recover from some other person other than under its policy or policies of insurance any sum in respect of any matter giving rise to a claim under the Seller Warranties (other than the Seller Tax Warranties) the Purchaser shall, and shall procure that the member of the Purchaser Group concerned shall, take reasonable steps to enforce such recovery prior to taking action against the Seller (other than to notify the Seller of such claim) and, in the event that the Purchaser of any member of the Purchaser Group shall recover any amount from such other person, the amount of the claim against the Seller shall be reduced by the amount so recovered. For the avoidance of doubt, the provisions of this paragraph 5.1 shall have no application to the Purchaser or any member of the Purchaser Group’s recourse against its insurers under its/their policy or policies of insurance.
5.2If the Seller or any other member of the Aspen Group pays at any time to the Purchaser or any member of the Purchaser Group an amount pursuant to a claim in respect of the Seller Warranties or under any provision of this Agreement and the Purchaser or member of the Purchaser Group subsequently recovers from some other person, including its insurers under any policy or policy of insurance, any sum in respect of any matter giving rise to such claim, the Purchaser shall, and shall procure that the relevant member of the Purchaser Group shall, repay to the Seller the lesser of (i) the amount paid by the Seller (or other member of the Aspen Group) to the Purchaser or relevant member of the Purchaser Group and (ii) the sum (including interest (if any)) recovered from such other person including its insurers under any policy or policy of insurance, less any Tax thereon.

6.Acts of Purchaser
6.1No claim shall lie against the Seller under or in relation to the Seller Warranties to the extent that such claim is attributable to any admission of liability made in breach of the provisions of this Schedule after the date hereof by the Purchaser or on its behalf or by a member of the Purchaser Group on or after Completion.
6.2The Seller shall not be liable for any breach of any Warranty which would not have arisen but for any re-organisation (including a cessation of the whole or part of any trade) or change in ownership of any member of the Purchaser Group or of any assets of any such member after Completion or change in any accounting basis on which any member of the Purchaser Group values its assets or any accounting basis, method, policy or practice of any member of the Purchaser Group.



7.Retrospective legislation
No liability shall arise in respect of any breach of any of the Seller Warranties to the extent that liability for such breach or such claim occurs or is increased directly or indirectly as a result of:
A.any legislation not in force on or prior to the Effective Date; or
B.the withdrawal, after the Completion Date, of any extra-statutory concession or other agreement or arrangement currently granted by or made with any Governmental Authority (whether or not having the force of law); or

C.any change after the Effective Date of any generally accepted interpretation or application of any legislation or in the enforcement policy or practice of the relevant authorities.

8.Disclosure
Neither the Purchaser nor any member of the Purchaser Group shall be entitled to claim that any fact, matter or circumstance causes any of the Seller Warranties to be breached if fairly disclosed in the Disclosure Letter. For clarity, the foregoing shall not limit Seller’s liability with respect to the Excluded Liabilities, including any liabilities arising in connection with the litigation or pending litigation referred to in the Disclosure Letter.
9.Claim to be reduction of the Commercialisation Business Consideration
Any payment made by the Seller or any other person in respect of any claim under the Seller Warranties shall be deemed to be a reduction of the Commercialisation Business Consideration.
10.Exceptions to Limitations
Nothing in this Agreement shall operate to limit the liability of the Seller or any member of the Aspen Group to the extent that such exclusion or limitation of liability is prohibited by Applicable Law and regulation.
11.Purchaser’s Limitations on Liability
11.1The provisions of this Schedule 5 shall apply mutatis mutandis to limit the liability of the Purchaser and the members of the Purchaser Group under this Agreement and the Transaction Documents on the basis that all references to –
A.the “Purchaser” shall be deemed to be amended to read the “Seller”;
B.the “Purchaser Group” shall be deemed to be amended to read the “Aspen Group”;



C.the “Seller” shall be deemed to be amended to read the “Purchaser”;

D.the “Aspen Group” shall be deemed to be amended to read the “Purchaser Group”;

E.the “Seller Warranties” shall be deemed to be amended to read the “Purchaser Warranties”; and

F.Excluded Liabilities shall be deemed to be amended to read “Assumed Liabilities”.

11.2Each Purchaser Warranty shall be a “Purchaser Fundamental Warranty” with the effect that the Purchaser’s liability for breach of any Purchaser Warranty shall be capped at one hundred per cent (100%) of the Commercialisation Business Consideration.




Schedule 12
Intellectual Property Regime
1.Intellectual Property
1.1Save as expressly set out in this Schedule 12, the Purchaser acknowledges and agrees on behalf of itself and each member of the Purchaser’s Group that nothing in this Agreement shall operate as an agreement to transfer (nor shall transfer) any right, title or interest in or to, nor constitute any licence of, any Excluded IPR.
1.2For the avoidance of doubt, all the rights, title and interest transferred or granted to the Purchaser under this Schedule 12 are subject to Clause 26.8.
Licence of Aspen House Marks
1.3The Seller shall, with effect from Completion, procure the grant, and does hereby grant, to the Purchaser and each member of its Group of a non-exclusive, royalty-free, non-assignable licence (subject to Paragraph 1.17, with the right to sub-license through multiple tiers) to use the Aspen House Marks on:
A.any Initial Stock, solely to the extent required to Commercialise such Initial Stock pursuant to Schedule 24 and any Initial PO Units, solely to the extent required to Commercialise such Initial PO Units pursuant to the Initial PO Units Side Letter, and as permitted under Applicable Laws;
B.subject to the terms of the Supply Agreement, any Product supplied by the Seller or its Affiliate pursuant to the Supply Agreement that bears any Aspen House Marks; and

C.any sales literature used in the Commercialisation Business that has been approved by the Aspen Group for so long as the relevant member of the Aspen Group is Product Registration Holder in respect of the Products referred to in such sales literature, whereafter such sales literature shall not use any Aspen House Marks;

1.4For clarity, the Purchaser and each member of its Group shall have no right pursuant to this Agreement to use any of the Aspen House Marks as part of a corporate or trading name and undertakes not to hold itself out or otherwise represent itself to be a member of, or to be associated or connected with any member or business venture of the Aspen Group.
1.5The Purchaser and each member of its Group shall notify the Seller in writing of all complaints made to the Purchaser by any consumer association or pressure group and all other material complaints made by its customers or potential customers (including complaints referred to any court, tribunal, ombudsman or regulatory body (including any relevant Governmental



Authority)) in relation to the goods provided by, or on behalf of, it under any of the Aspen House Marks.
1.6The Purchaser acknowledges that all goodwill associated with the use of the Aspen House Marks by the Purchaser and each member of its Group vests and shall vest in the Seller and that the Purchaser and each member of its Group has no, and shall not by virtue of this Agreement obtain any, rights in any of the Aspen House Marks other than those expressly set out in this Schedule 12. The Purchaser undertakes that it shall not and shall ensure that each member of its Group does not make any claim to such goodwill or, save as set out in this Agreement, to any rights in the Aspen House Marks.
1.7Without prejudice to Paragraph 1.6, if any goodwill or proprietary right in relation to the Aspen House Marks vest in the Purchaser or a member of its Group, the Purchaser shall, immediately upon becoming aware of such vesting of such goodwill or right, assign or procure the assignment of, such goodwill or right to the Seller.

1.8The Purchaser shall, and shall ensure that each member of its Group, in its use of the Aspen House Marks, adhere to a level of quality standards and specifications for the goods on which the Aspen House Marks are applied and the protection of goodwill associated therewith that is consistent with that used by the Aspen Group for the Commercialisation of the Products prior to the Effective Date of the Distribution Agreement, as such quality standards and specifications may be reasonably amended by the Aspen Group from time to time upon at least thirty (30) days prior written notice to the Purchaser. The Purchaser and each member of its Group shall not make any changes to the labelling of the Initial Stock without the prior written consent of the Seller.
Licence of Licensed IPR and Licensed Know-How to the Purchaser
1.9At Completion, the Seller shall grant (or procure the grant), and hereby grants, to the Purchaser an exclusive, perpetual, irrevocable, royalty-free, fully paid-up licence (subject to Paragraph 1.16, with the right to sub-license through multiple tiers) (subject to Paragraph 1.17, with the rights to assign and to transfer) under the Licensed IPR and Licensed Know-How (i) to use, Commercialise, Manufacture, and otherwise exploit the Products, and (ii) to use and Manufacture the API in connection with the use, Commercialisation, Manufacture, and other exploitation of the Products, in each case in and for the Territory. For clarity, the foregoing licence includes the right to Manufacture the Products and/or the APIs on a non-exclusive basis in the Retained Territory for Commercialisation or other exploitation on an exclusive basis in the Territory.
1.10At Completion, the Seller shall grant (or procure the grant), and hereby grants to the Purchaser a non-exclusive, perpetual, revocable, royalty-free, fully paid-up license (subject to Paragraph 1.16, with the right to sub-license through multiple tiers) (subject to Paragraph 1.17, with the rights to assign and to transfer) under the Licensed IPR and Licensed Know-



How to use, Commercialise and otherwise exploit the Aspen Retained De-Commercialised Products in and for the Territory for the purpose of the Purchaser or its Affiliates performing its or their obligations under the Agreement and Ancillary Transaction Agreements.
License to Ongoing Clinical Trials
1.11At Completion, the Seller shall grant (or procure the grant), and hereby grants, to the Purchaser a non-exclusive, perpetual, irrevocable, royalty-free, fully paid-up license (subject to Paragraph 1.16, with the right to sub-license through multiple tiers) (subject to Paragraph 1.17, with the rights to assign and to transfer) to all information, data, results and reports of the Ongoing Clinical Trials to use, Commercialise, Manufacture, and otherwise exploit the Products in and for the Territory.
License to Clinical Trials
1.12At Completion, each Party shall grant (or procure the grant), and hereby grants, to the other Party, a non-exclusive, perpetual, irrevocable, royalty-free and fully paid-up license (subject to Paragraph 1.16, with the right to sub-license through multiple tiers) (subject to Paragraph 1.17, with the rights to assign and to transfer) to all information, data, results and reports of any clinical trials conducted on or relevant to the Products during the ten (10) year period following the Completion Date.
Licence to the Seller
1.13The Purchaser shall, with effect from Completion, grant to the Seller a non-exclusive, irrevocable, royalty-free licence or sub-licence (as applicable) (in each case, with the right to sub-license through multiple tiers) of the Transferring IPR and the Transferring Know-How to (i) Manufacture or procure the Manufacture of the Products anywhere in the world (including in the Territory) for the purpose of the Seller or its Affiliates performing its or their obligations under the Ancillary Transaction Agreements; and (ii) subject to Clause 10.5, undertake Clinical Trials relating to the Products in the Territory, solely for purposes of Commercialising the Products outside of the Territory or Manufacturing the Products in the Territory for Commercialisation of the Products outside the Territory; (iii) fulfil its supply and other obligations in respect of the Aspen Retained De-Commercialised Products pursuant to Clause 14.5 and/or (iv) exercising its rights pursuant to Clause 27.7. The provisions of the Distribution and Supply Agreement shall also apply to this Schedule 12.
Assignment of Transferring Know-How and Transferring IPR to the Purchaser
1.14At Completion, the Seller shall assign (and procure the assignment), and does hereby assign, to the Purchaser the Transferring Know-How and Transferring IPR. For clarity, this Paragraph 1.14 is an assignment of the Transferring Know-How and Transferring IPR with effect from Completion; the assignment of any Transferring Know-How or Transferring IPR which is



registered or which is the subject of an application for registration shall be perfected by the execution of an assignment agreement (on terms consistent with the terms of the Transferring IPR Assignments).
Sub-licence of Third Party IPR to the Purchaser
1.15At Completion, the Seller shall sub-license, and hereby grants, to the Purchaser a non-exclusive, royalty-free, fully paid-up, sub-licence (with the right to sub-license through multiple tiers) under the Third Party IPR to use, Commercialise, Manufacture, and otherwise exploit the Products in and for the Territory. For clarity, the foregoing licence includes the right to Manufacture the Products in the Retained Territory for Commercialisation or other exploitation in the Territory. The sub-license granted to the Purchaser pursuant to this Paragraph 1.15 shall be on the same terms and conditions existing between the Seller, or the relevant member of the Aspen Group, and the Third Party licensor at the Completion Date, including as to the duration of such sub-licence rights, and the Purchaser shall abide by, and shall procure that its Affiliates and its sub-licencees abide by, the restricted terms and covenants as set forth in Schedule 13 to the Agreement.
Sub-licencing by the Purchaser
1.16Any sub-license granted by the Purchaser to its Affiliates and/or Third Parties in respect of licensed rights granted by a member of the Aspen Group, to the Purchaser, pursuant to this Schedule 12 shall be on the same terms and conditions existing between the Seller, or the relevant member of the Aspen Group, and the Purchaser at the Completion Date, including as to the duration of such licence rights, and the Purchaser shall abide by, and shall procure that its Affiliates and its sub-licencees abide by, the restricted terms and covenants contained herein.
Assignment and Transfer of Licensed Rights
1.17Any assignment or transfer by the Purchaser to its Affiliates and/or Third Parties of any licensed rights granted by a member of the Aspen Group, to the Purchaser, pursuant to this Schedule 12, shall only be permitted upon (i) prior written notice by the Purchaser to the Seller and (ii) to a Purchaser Affiliate or Third Party which acquires the whole or substantially the whole of the business to which the licensed rights relate. In addition, the licensed rights so assigned or transferred are on the same terms and conditions existing between the Seller or the relevant member of the Aspen Group, and the Purchaser at the Completion Date, including as to the duration of such licensed rights.
Conflicts
1.18In the event that the Transferring IPR or Transferring Know-How is subject to any infringement, challenge to validity or other defensive or enforcement proceedings, and unless



otherwise agreed between the Parties (including in any Ancillary Transaction Agreement), the Purchaser shall assume responsibility for control of such proceedings with effect from Completion.
1.19In the event that the Excluded IPR or Third Party IPR is subject to any infringement, challenge to validity or other defensive or enforcement proceedings and unless otherwise agreed between the Parties (including in any Ancillary Transaction Agreement), the Seller shall continue to assume responsibility for control of any defensive or enforcement proceedings prior to and after Completion. If Seller decides not to exercise its right under this Paragraph 1.19, within thirty (30) days of the Purchaser’s written request, to enforce or defend any Excluded IPR for which it is proprietor, then Purchaser shall have the right to proceed with such an enforcement action at its own expense, and at Purchaser’s request and expense, Seller shall join any such enforcement action controlled by the Purchaser. Seller shall, upon Purchaser’s request, execute all documents and perform all actions necessary to allow Purchaser to bring an enforcement action hereunder.
1.20In the event that the Licensed IPR or Licensed Know-How is subject to any infringement, challenge to validity or other defensive or enforcement proceedings and unless otherwise agreed between the Parties (including in any Ancillary Transaction Agreement), the Parties shall jointly assume responsibility for control of any such defensive or enforcement proceedings after Completion, both Parties shall join any such proceeding (if permitted), and the Parties shall share all costs associated with litigating such proceedings.
Prosecution and Maintenance
1.21Seller shall have the right and obligation to prosecute and maintain protection with respect to the Licensed IPR (other than the Licensed IPR relating to the Aspen Retained De-Commercialised Products) in the Territory. If Seller decides to abandon, or otherwise fails to prosecute or maintain, any Licensed IPR (other than the Licensed IPR relating to the Aspen Retained De-Commercialised Products) in the Territory, Seller shall provide Purchaser with written notice of such decision at least thirty (30) days prior to any applicable filing deadline, and of any such failure promptly after it occurs, but in all cases, as long as reasonably possible prior to abandonment or the occurrence of other loss of rights. In such case, Purchaser shall have the right, but not the obligation, to prosecute and maintain protection with respect to such Licensed IPR (other than the Licensed IPR relating to the Aspen Retained De-Commercialised Products), as applicable, in such jurisdiction, and at its own expense.




Schedule 21
Employees
THE PROVISIONS OF THIS SCHEDULE 21 SHALL APPLY SUBJECT TO APPLICABLE EMPLOYMENT LAWS.
1.Part 1 – Employees to be Transferred by Law
1.1Subject to Clause 1.3, the Purchaser and the Seller agree that the Proposed Transaction shall constitute a transfer of an undertaking in the jurisdictions listed in the first column of the table in Exhibit 1 to this Schedule, as such term or similar term is used in Applicable Employment Laws.
1.2The Purchaser and the Seller agree that, as a result of this Agreement, the employment relationships between the relevant Affiliates of the Seller and affected employees involved in the Commercialisation Business (collectively, the “Employees to be Transferred by Law”) shall transfer under Applicable Employment Laws from the relevant Affiliate of the Seller to the Affiliate of the Purchaser, subject to Clause 1.3, specified in the second column of the table in Exhibit 1, or another Affiliate of the Purchaser unless such Employee to be Transferred by Law objects to that transfer or resigns from his employment under Applicable Employment Laws. The date of transfer shall be the Completion Date (the “Employee Transfer Date”).

1.3The Seller shall provide a list in the form of Exhibit 1 of the Employees to be Transferred by Law as soon as practicable after determining such list, and shall thereafter inform the Purchaser of any revisions that are proposed to such list of the Employees to be Transferred by Law as soon as practicable after becoming aware of the need to revise the list, along with a full explanation as to the reason for the revision. The Seller shall provide the Purchaser with a final list of Employees to be Transferred by Law for each jurisdiction thirty (30) Business Days before the Employee Transfer Date.

1.4 Immediately after the signature of this Agreement, the Purchaser shall provide the Seller with a list of information (the “Information Request”) that it requires in order to determine its plans for the Commercialisation Business. Within one (1) week of receiving the Information Request the Seller shall provide the Purchaser with all relevant information, including employee Personal Data pursuant to Schedule 22 regarding the Transaction Affected Employees to enable the Purchaser to determine its plans for the Commercialisation Business. Within two (2) weeks of receiving the information requested in the Information Request, the Purchaser shall inform the Seller of its plans for the Commercialisation Business and thereafter Seller undertakes to take such actions as may be necessary to facilitate the transition of the Commercialisation Business in accordance with such plans.




1.5The Seller undertakes to pay to the Purchaser all costs incurred in connection with the Employees to be Transferred by Law to the Purchaser to the extent that such employees exceed a total of seventy-four (74) sales and marketing employees such employees being identified in the final list of Employees to be Transferred by Law for each jurisdiction according to paragraph 1.3 (“Incremental Employees”) as follows:

A.For each Incremental Employee, the Seller shall pay to the Purchaser for twenty-four (24) months after the Employee Transfer Date, or longer if required by Applicable Employment Laws, the gross salary (including all benefits, costs and pension contributions etc.) of the Incremental Employees plus the relevant employer’s social security contributions, plus any severance payment which will be calculated in accordance with a formula reasonably determined by the Purchaser and in accordance with Applicable Employment Laws. For the avoidance of doubt, the Seller’s obligation to pay any severance payment with respect to each Incremental Employee shall fall away on the later of (i) twenty four (24) months after the Employee Transfer Date and (ii) such longer period as required by Applicable Employment Laws if Purchaser (x) has not delivered a notice of termination to such Incremental Employee by the later of such dates, or (y) if such notice is not permitted by Applicable Employee Laws to be made on or prior to the later of such dates, has not made a decision to terminate such Incremental Employee by the later of such dates.
B.The reimbursement by the Seller to Purchaser of the Incremental Employee salary payments and the severance payments and any other associated payments shall be made within thirty (30) days of the payment dates made by the Purchaser to the relevant employees.

1.6The Purchaser and the Seller shall, and shall procure that their relevant Affiliates shall, comply with their respective obligations under the Applicable Employment Laws that arise in connection with this Agreement, in particular as regards the information obligations towards the Employees to be Transferred by Law and towards Employee representatives and trade unions. The Purchaser and the Seller shall, and shall procure that their relevant Affiliates shall, provide such assistance as is reasonably required in order for all obligations under Applicable Laws to be complied with. Specifically in Germany, by means of a joint letter to be agreed upon between the Parties, the Parties will one month before the German Employee Transfer Date completely and comprehensively notify the German Employees to be Transferred by Law of the transfer of business pursuant to Section 613a para. 5 BGB and will inform them that they can object to the transfer of their employment relationship within a period of one month after receipt of such a letter. The Parties will mutually provide each other with all information required for a notification pursuant to Section 613a para. 5 BGB.
1.7The Purchaser shall, and shall procure that its Affiliates specified in the second column of the table in Exhibit 1 shall, provide for each Employee to be Transferred by Law to become a member of pension and/or employee incentivisation schemes with effect from the Employee



Transfer Date, that are substantially comparable in the aggregate to each Employee to be Transferred by Law to the Pension Schemes and/or employee incentivisation schemes that are provided to each Employee to be Transferred by Law, by the relevant Affiliate of the Seller immediately before the Employee Transfer Date.

1.8Refusal of Employee to be Transferred by Law in Germany. In Germany, if an Employee to be Transferred by Law passing to the Purchaser pursuant to Applicable Employment Laws should refuse to be transferred, such employee (and all contractual arrangements of any type whatsoever existing between the Seller and such Employee to be Transferred by Law) shall remain with the Seller, and his continued employment and termination shall be the Seller’s responsibility at the Seller’s discretion.

1.9Consultation with works council in Germany. In Germany, the Seller shall inform and consult with the German works council of the relevant Affiliate of the Seller regarding the implementation plan (Interessenausgleich) in relation to the transactions contemplated by this Agreement as soon as this Agreement has been signed and announced.

1.10If the employment relationship of any Employee to be Transferred by Law does not transfer under Applicable Employment Laws on the Employee Transfer Date from the relevant Affiliate of the Seller to any Affiliate of the Purchaser as envisaged by the table in Exhibit 1 (other than by reason of the objection of the Employee to be Transferred by Law), the Purchaser shall, or the relevant Affiliate of the Purchaser shall notify the Seller or relevant Affiliate of the Seller (the “Notification”) as soon as is reasonably practicable after the Employee Transfer Date and shall be entitled to offer to each such Employee to be Transferred by Law to enter into an agreement that is compliant with Applicable Laws under which each such Employee to be Transferred by Law’s employment relationship shall transfer with immediate effect from the relevant Affiliate of the Seller to the relevant Affiliate of the Purchaser specified in the second column of the table in Exhibit 1, on terms substantially comparable in the aggregate to each such Employee to be Transferred by Law than those on which each such Employee to be Transferred by Law is employed by the relevant Affiliate of the Seller. If admissible under Applicable Employment Laws the Parties agree that in this case, a tripartite transfer agreement having been coordinated between the Parties is submitted to the Employee to be Transferred by Law. If the Purchaser or relevant Affiliate of the Purchaser does not make an offer, or if the offer is made and rejected, the Seller or relevant Affiliate of the Seller may terminate the relevant employment relationship in accordance with Applicable Employment Laws.

2.Part 2 – Subsequent Transferring Employees
2.1As a result of the Purchaser taking over the responsibility for the activities and/or services carried out by the Seller in terms of B, the Parties will engage in good faith discussions to



determine which of the Seller employees carrying out those activities and/or services are required to transfer under Applicable Employment Laws from the relevant Affiliate of the Seller to the Affiliate of the Purchaser (collectively, the “Subsequent Transferring Employees”). In this respect, the Seller shall ensure that the Subsequent Transferring Employees are assigned to the business unit to be transferred to the Purchaser.
2.2The Purchaser and the Seller agree that the transfer of the Subsequent Transferring Employees and the consultations relating thereto will be carried out in accordance with Applicable Employment Laws.

3.Part 3 – Miscellaneous
3.1If the employment relationship of any employee of any Affiliate of the Seller (other than an Employee to be Transferred by Law or a Subsequent Transferring Employee) transfers under Applicable Employment Law from any Affiliate of the Seller to any Affiliate of the Purchaser, the Seller shall, or shall procure that the affected Affiliate of the Seller shall, within thirty (30) days of the Seller becoming or being made aware of the transfer, offer to re-employ or re-engage by the Seller or one of its Affiliates, such Person on the terms and conditions which they enjoyed before the relevant Employee Transfer Date. If an offer is not made within thirty (30) days of the Seller becoming or being made aware of the transfer, or if the offer is not accepted, then the Purchaser or relevant Affiliate of the Purchaser shall be obliged to take transfer of the employment relationship of any such Person (“Additional Employee(s)”). In this event, paragraph 1.6 shall apply.
3.2Subject to paragraph 3.4 below, the Purchaser shall procure that: (i) all obligations and liabilities in respect of each Transaction Affected Employee, to the extent that they are incurred, fall due, or arise in respect of the period, after the relevant Employee Transfer Date; and (ii) to the extent that they are increased by the actions of the Purchaser or an Affiliate of the Purchaser after the relevant Employee Transfer Date, all obligations and liabilities in respect of each Transaction Affected Employee, to the extent that they are incurred, fall due, or arise in respect of the period, before the relevant Employee Transfer Date, shall be borne by the Purchaser’s Affiliates specified in the second column of the table in Exhibit 1, and the Purchaser’s Affiliates to which a Subsequent Transferring Employee is transferred pursuant to paragraph 2.1 (the “Assumed Employee Liabilities”). For the avoidance of doubt, the Assumed Employee Liabilities include all obligations and liabilities that are incurred, fall due, or arise in respect of the period, after the relevant Employee Transfer Date in relation to the Pension Schemes or the Retirement Indemnities. Further, and for the avoidance of doubt, Assumed Employee Liabilities does not include any obligations or liabilities in relation to Employees to be Transferred by Law, or Subsequent Transferring Employees who object to their transfer, and therefore remain employed by the Seller.



3.3Subject to paragraph 3.4 below, the Seller shall procure that all obligations and liabilities in respect of the Employees to be Transferred by Law, the Subsequent Transferring Employees and the Additional Employees, to the extent that they are incurred, fall due, or arise in respect of any period ending, on or before the relevant Employee Transfer Date, except to the extent that they are increased by the actions of the Purchaser or an Affiliate of the Purchaser after the relevant Employee Transfer Date, shall be borne by the relevant Affiliates of the Seller (the “Excluded Employee Liabilities”). For the avoidance of doubt, the Excluded Employee Liabilities include all obligations and liabilities that are incurred, fall due, or arise in respect of any period ending, on or before the Completion Date in relation to the Pension Schemes or the Retirement Indemnities.

3.4Paragraphs 3.2 and 3.3 above do not apply in respect of any liabilities or obligations referred to in paragraph 4.1 below.

3.5The Seller shall pay to the Purchaser, in respect of any annual bonus awarded to any Transaction Affected Employee pursuant to an Annual Bonus Scheme, an amount equal to the Seller’s pro-rata share of any bonus awarded by the Purchaser or one of its Affiliates to any Transaction Affected Employee under that Annual Bonus Scheme (calculated on an allocation of time basis having regard to the number of months for which the relevant Transaction Affected Employee worked for the Seller and the Purchaser, respectively), but only if the award of the bonus in question would have met the rules of the Annual Bonus Scheme for making that award when it was administered by the Seller, within ten (10) Business Days after the Purchaser notifies the Seller in writing of any such award to a Transaction Affected Employee in respect of the Financial Year of the Purchaser or the relevant Purchaser’s Affiliate ending after the Completion Date.

3.6The Seller shall pay to the Purchaser the Employee Benefit Accruals corresponding to all amounts due to the Transaction Affected Employees in relation to the time period through and including the Completion Date, other than the items related to Pensions and mentioned in Part 4 and the annual bonus referred in paragraph 3.5, that have not yet been paid as at the Completion Date, including accrued paid holidays, thirteenth month salary, compensatory days off for the reduction of working time (RTT) and related Taxes.

3.7To the extent any Employee to be Transferred by Law, Subsequent Transferring Employee or Additional Employee is a participant in the Company Plan (“Eligible Employee”), such Eligible Employee shall be deemed to have been dismissed for operational reasons in applying the rules governing the Company Plan. The amount due to such Eligible Employee pursuant to the Company Plan shall be paid by the Seller directly to the Eligible Employee within sixty (60) days of the Completion Date. On and with effect from the Completion Date, the Purchaser shall establish and put in place a new plan that provides the Eligible Employees with benefits, entitlements and rights that are substantially similar in the aggregate



to the Eligible Employees than those of the Company Plan. For the avoidance of any doubt, the Company Plan will not be transferred to the Purchaser and, accordingly, with effect from the Completion Date, the Eligible Employees will have no further benefits, entitlements or rights under the Company Plan.

3.8The Purchaser agrees that it, or the relevant Affiliate of the Purchaser, shall, for a period of twelve (12) months from the relevant Employee Transfer Date, provide each Employee to be Transferred by Law, each Subsequent Transferring Employee and each Additional Employee with terms and conditions of employment that are, in the aggregate, substantially comparable to the terms and conditions of employment of those employees immediately prior to the relevant Employee Transfer Date. For the avoidance of doubt, this obligation will not apply in respect of Employees to be Transferred by Law or Subsequent Transferring Employee who object to their transfer, nor to who do not accept an offer of employment with an Affiliate of the Purchaser. For the avoidance of doubt, this obligation will not apply in respect of Employees to be Transferred by Law or Subsequent Transferring Employee who remain employees of the Seller.

3.9The Purchaser shall, or shall procure that the Affiliates of the Purchaser specified in the second column of the table in Exhibit 1, and the Affiliates of the Purchaser to which a Subsequent Transferring Employee is transferred pursuant to paragraph 2.1 shall, comply with any legal obligation to establish, maintain, continue or otherwise provide for the existence of a works council or other similar representative body with effect from the relevant Employee Transfer Date.

4.Part 4 - Pensions
4.1Under Applicable Employment Laws and with effect as of the relevant Employee Transfer Date, the Purchaser shall, or shall procure that the relevant Affiliates of the Purchaser, assume, with full discharge of the Seller and the relevant Affiliates of the Seller, certain liabilities and obligations arising out of or in connection with the Pension Schemes in respect of service prior to the relevant Employee Transfer Date by the Transaction Affected Employees whether on a collective or individual basis, including, without limitation, in relation to the Transaction Affected Employees in Germany and Poland.
4.2In respect of the liabilities and obligations relating to the Pension Schemes assumed by the Purchaser or the relevant Affiliates of the Purchaser in accordance with paragraph 4.1 above, i) the Seller covenants with the Purchaser to pay to the Purchaser an amount in cash equal to any Pension Shortfall within ten (10) Business Days of any Pension Shortfall having been determined in accordance with paragraph 4.3 below and/or ii) the Purchaser covenants with the Seller to pay to the Seller an amount in cash equal to any Pension Surplus within ten (10)



Business Days of any Pension Surplus having been determined in accordance with paragraph 4.3 below.

4.3For the purposes of paragraph 4.2 above, (i) “Pension Shortfall” means, in relation to the liabilities and obligations in relation to the Pension Schemes assumed by the Purchaser or the relevant Affiliates of the Purchaser referred to in 4.1 above, an amount equal to the amount (if any) by which the value of the relevant Pension Schemes’ assets (if any) or any assets transferred in respect of those Pension Schemes to a trust established or nominated by the Purchaser (or to the Purchaser) is exceeded by the value of the liabilities and obligations payable under those Pension Schemes in respect of the Transaction Affected Employees as at the relevant Employee Transfer Date and (ii) “Pension Surplus” means, in relation to the liabilities and obligations in relation to the Pension Schemes assumed by the Purchaser or the relevant Affiliates of the Purchaser referred to in 4.1 above, an amount equal to the amount (if any) by which the value of the relevant Pension Schemes’ assets (if any) or any assets transferred in respect of those Pension Schemes to a trust established or nominated by the Purchaser (or to the Purchaser) exceeds the value of the liabilities and obligations payable under those Pension Schemes in respect of the Transaction Affected Employees as at the relevant Employee Transfer Date. The Pension Shortfall and Pension Surplus will be calculated on a Pension Scheme by Pension Scheme basis.

4.4In relation to the Transaction Affected Employees, in Germany and Poland, the Pension Shortfall or Pension Surplus is to be calculated in respect of each Pension Scheme as at the close of business on the relevant Employee Transfer Date and shall be calculated on an IAS 19 basis based on the actuarial assumptions used by the Seller and/or its Affiliates to value the relevant pension liabilities as at 30 June 2020 for the purposes of its 2020 Annual Report and Accounts but updated as at the relevant Employee Transfer Date to reflect any changes to economic conditions agreed by the Seller and by the Purchaser (or, in default of agreement and pursuant to 4.6 below, determined by an Independent Actuary) and/or changes in the requirements of Applicable Law for such valuations. In relation to the Subsequent Transferring Employees and Additional Employees, the Pension Shortfall or Pension Surplus is to be calculated in respect of each Pension Scheme as at the close of business on the relevant Employee Transfer Date and shall be calculated on an IAS 19 basis based on the actuarial assumptions used by the Seller and/or its Affiliates to value the relevant pension liabilities as at the end of the Seller’s immediately preceding Financial Year (ending 30 June) for the purposes of its Annual Report and Accounts for that Financial Year but updated as at the relevant Employee Transfer Date to reflect any changes to economic conditions agreed by the Seller and by the Purchaser (or, in default of agreement and pursuant to 4.6 below, determined by an Independent Actuary) and/or changes in the requirements of Applicable Law for such valuations. The Seller shall, within sixty (60) days of the relevant Employee Transfer Date, provide to the Purchaser details of the actuarial assumptions for each Pension



Scheme which it proposes to use for the purposes of calculating the Pension Shortfall or Pension Surplus. The Purchaser shall have thirty (30) days from the date that it receives the assumptions to determine whether it agrees or disputes such assumptions. In the event that the actuarial assumptions for any Pension Scheme are agreed, then they shall be used for that Pension Scheme, but if they are not agreed, then the actuary appointed by the Seller and the actuary appointed by the Purchaser shall have until the date thirty (30) days from the date on which the Purchaser receives the assumptions (or such later date as the Seller and the Purchaser may agree) to agree on the relevant assumptions. If the assumptions are not agreed within this period, then either the Seller or the Purchaser may refer the matter to the Independent Actuary (pursuant to (4.6) below) who shall be asked to make his determination as soon as is reasonably practicable and at the latest within thirty (30) days of the reference of the matter to him.

4.5The Pension Shortfall to be calculated in respect of each Pension Scheme as at the close of business on the relevant Employee Transfer Date shall be determined as soon as is reasonably possible following the relevant Employee Transfer Date by an actuary appointed by the Seller and agreed by an actuary appointed by the Purchaser or, in default of agreement, as soon as is reasonably practicable and at the latest within thirty (30) days of the reference of the matter to the Independent Actuary.

4.6Any dispute between the actuary appointed by the Seller and the actuary appointed by the Purchaser concerning the agreement of the assumptions to be used to calculate the Pension Shortfall or Pension Surplus and/or the amount of the Pension Shortfall or Pension Surplus shall, in the absence of agreement between them, be referred to an independent actuary to be nominated jointly by the Seller and the Purchaser or, failing such nomination, to be nominated by the President for the time being of The Institute of Actuaries at the instance of the Party first applying to him (the “Independent Actuary”). The Independent Actuary shall act as an expert and not as an arbitrator; the Independent Actuary’s decision shall be final and binding, and the Independent Actuary’s costs shall be borne equally by the Seller and the Purchaser. The Seller and the Purchaser shall procure that the Independent Actuary shall, without charge, receive such reasonable access to all information, books and records as the Independent Actuary may request in connection with the determination of the Pension Shortfall or Pension Surplus.


Exhibit 31.1
Certification of Principal Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
I, Heather Bresch, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Mylan N.V.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
/s/ HEATHER BRESCH
Heather Bresch
Chief Executive Officer
(Principal Executive Officer)
Date: November 6, 2020


Exhibit 31.2
Certification of Principal Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
I, Paul B. Campbell, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Mylan N.V.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
/s/ PAUL B. CAMPBELL
Paul B. Campbell
Chief Accounting Officer and Corporate Controller
(Principal Accounting Officer)*
Date: November 6, 2020
*Note: Kenneth S. Parks departed as Chief Financial Officer and principal financial officer of Mylan N.V. effective as of September 1, 2020. Paul B. Campbell is the person for purposes of this certification performing a similar function to that of the principal financial officer as of the date of this Form 10-Q.


Exhibit 32
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report on Form 10-Q of Mylan N.V. (the “Company”) for the period ended September 30, 2020 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned, in the capacities and on the date indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
/s/ HEATHER BRESCH
Heather Bresch
Chief Executive Officer
(Principal Executive Officer)
/s/ PAUL B. CAMPBELL
Paul B. Campbell
Chief Accounting Officer and Corporate Controller
(Principal Accounting Officer)*
Date: November 6, 2020
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
The foregoing certification is being furnished in accordance with Securities and Exchange Commission Release No. 34-47551 and shall not be considered filed as part of the Form 10-Q.
*Note: Kenneth S. Parks departed as Chief Financial Officer and principal financial officer of Mylan N.V. effective as of September 1, 2020. Paul B. Campbell is the person for purposes of this certification performing a similar function to that of the principal financial officer as of the date of this Form 10-Q.